It

an may
d/
or be
pu su
bli bje
sh ct
ing to
an righ
d
an ts s
y c uch
om a
m s in
er te
cia lle
l e ctu
xp al
loi pr
ta op
tio e
n rty
an a
d nd
us c
e op Th
of y i
th rig s do
is ht c
do s o um
cu f t en
m he t i
en o s
t o wn the
r i er p
ts r
co and ope
nt th rty
en ird o
ts f
wi par (a)
th tie cu
ou s. rr
t t Fu en
he rt t/f
pe her orm
rm m er
iss ore m
ion , th em
of is d ber
th oc (s)
e
ow um of t
ne ent he
r o m co
f t ay ns
his fa or
do ll u tium
cu nd
m er see
en a
t m reg king
ay ula the
th tor G
er y ly
ef da ph
or
e ta p osa
be ro te
pr tec EU
oh tio re
ibi n
te reg new
d
an ime al.
d
vio . Co
lat ns
e eq
th ue
e
rig ntly
ht , a
so n
f it y p
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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dis
n,
OWNERSHIP STATEMENT

er tio
wn lica
.
s o ub
f it y p
This document, the data contained in it and copyright therein are owned by one or more of the member

so n
companies of the European Glyphosate Renewal Group (GRG) with the members Bayer Agriculture BV,

ht , a
rig ntly
Barclay Chemicals Manufacturing Ltd., CIECH Sarzyna S.A., Albaugh Europe SARL, Nufarm GmbH &

th ue
Co KG, SINON Corporation, Industrias Afrasa S.A., Syngenta Crop Protection AG and/or affiliated

e eq
e
entities.

lat ns
vio . Co
an ime al.
te reg new
The summaries and evaluations contained in this document are based on unpublished proprietary data

oh tio re

d
submitted for the purpose of the assessment undertaken by the regulatory authority. Other registration

pr tec EU
ibi n
authorities should not grant, amend, or renew a registration on the basis of the summaries and evaluation

d
be ro te
e ta p osa
of unpublished proprietary data contained in this document unless they have received the data on which the

ef da ph
summaries and evaluation are based, either:

er y ly
th tor G
ay ula the
• From Bayer Agriculture BV or respective affiliate; or

or
t m reg king
• From Barclay Chemicals Manufacturing Ltd. or respective affiliate; or

m er see
• From CIECH Sarzyna S.A. or respective affiliate; or

do ll u tium
en a
• From Albaugh Europe SARL or respective affiliate; or

cu nd
his fa or
• From Nufarm GmbH & Co KG or respective affiliate; or
f t ay ns
• From SINON Corporation or respective affiliate; or
r o m co
ne ent he

• From Industrias Afrasa S.A. or respective affiliate; or

ow um of t

• From Syngenta Crop Protection AG or respective affiliate; or

th oc (s)

• From other applicants once the period of data protection has expired.
of is d ber
ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
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cti
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Version history1

dis
n,
er tio
Date Data points containing amendments or additions Document identifier and

wn lica
and brief description version number

.
s o ub
22nd July 2020 Citrus added to Use 4a, 4b and 4c – typo correction Doc ID: 110054-

f it y p
so n
Update version number of cited documents MCP10_GRG_Rev

ht , a
rig ntly
1_Jul_2020

th ue
Replaces the Doc ID

e eq
110054-

e
lat ns
vio . Co
an ime al.
MCP10_GRG_Jun_2020 –

te reg new
Changes are given in yellow

oh tio re

d
pr tec EU
ibi n
d
be ro te
e ta p osa
1
It is suggested that applicants adopt a similar approach to showing revisions and version history as outlined in

ef da ph
SANCO/10180/2013, Chapter 4 “How to revise an Assessment Report”

er y ly
th tor G
ay ula the

or
t m reg king
m er see
do ll u tium
en a
cu nd
his fa or
f t ay ns
r o m co
ne ent he
ow um of t
th oc (s)
of is d ber
ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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Table of Contents

dis
n,
er tio
wn lica
CP 10 ECOTOXICOLOGICAL STUDIES ON PLANT

.
s o ub
PROTECTION PRODUCTS .......................................................... 5

f it y p
so n
ht , a
CP 10.1 Effects on Birds and Other Terrestrial Vertebrates ....................................................28

rig ntly
th ue
CP 10.1.1 Effects on birds ................................................................................................................28

e eq
e
lat ns
CP 10.1.1.1 Acute oral toxicity ...........................................................................................................74

vio . Co
an ime al.
te reg new
CP 10.1.1.2 Higher tier data on birds ................................................................................................75

oh tio re

d
CP 10.1.2 Effects on terrestrial vertebrates other than birds .......................................................75

pr tec EU
ibi n
d
be ro te
CP 10.1.2.1 Higher tier data on mammals.......................................................................................150

e ta p osa
ef da ph
CP 10.1.3 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)...............151

er y ly
th tor G
ay ula the
CP 10.2 Effects on Aquatic Organisms ......................................................................................156

or
t m reg king
CP 10.2.1 Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and

m er see
macrophytes ...................................................................................................................192

do ll u tium
en a
CP 10.2.2 Additional long-term and chronic toxicity studies on fish, aquatic

cu nd
his fa or
f t ay ns
invertebrates and sediment dwelling organisms .........................................................224
r o m co
ne ent he

CP 10.2.3 Further testing on aquatic organisms ..........................................................................224

ow um of t
th oc (s)

CP 10.3 Effects on Arthropods ...................................................................................................225

of is d ber

CP 10.3.1 Effects on bees................................................................................................................225

ion , th em
iss ore m

CP 10.3.1.1 Acute toxicity to bees .....................................................................................................263

rm m er
pe her orm

CP 10.3.1.1.1 Acute oral toxicity to bees .............................................................................................263

he rt t/f
t t Fu en
ou s. rr

CP 10.3.1.1.2 Acute contact toxicity to bees .......................................................................................267

th tie cu
wi par (a)

CP 10.3.1.2 Chronic toxicity to bees .................................................................................................270

f
en ird o
nt th rty

CP 10.3.1.3 Effects on honey bee development and other honey bee life stages ..........................270
co and ope
r

CP 10.3.1.4 Sub-lethal effects............................................................................................................270

ts
r i er p
t o wn the

CP 10.3.1.5 Cage and tunnel tests ....................................................................................................270

en o s
m he t i
cu f t en

ts

CP 10.3.1.6 Field tests with honeybees .............................................................................................283

do s o um
is ht c
th rig s do

CP 10.5 Effects on Soil Nitrogen Transformation ....................................................................358

i
e op Th

CP 10.6.3 Extended laboratory studies on non-target plants .....................................................408

of y

CP 10.6.4 Semi-field and field tests on non-target plants............................................................408

us c
d nd
an a

CP 10.7 Effects on Other Terrestrial s (Flora and Fauna) ......................................................408

n rty
tio e

CP 10.8 Monitoring Data ............................................................................................................409

ta op
loi pr
xp al

Annex M-CP 10-01: Avian risk assessment...........................................................................................410

l e ctu
cia lle

Annex M-CP 10-02: Calculations of the 21day time-weighted-average (twa) for glyphosate in
er te
m s in

grass foliage used in the avian and mammalian risk assessment ..............................436
om a
y c uch

Annex M-CP 10-03: Mammalian risk assessment ................................................................................441

an ts s

Annex M-CP 10-04: Aquatic risk assessment .......................................................................................485

an righ
d
ing to

Annex M-CP 10-05: Non-target terrestrial plant risk assessment ......................................................551

sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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dis
CP 10 ECOTOXICOLOGICAL STUDIES ON PLANT PROTECTION

n,
er tio
wn lica
PRODUCTS

.
s o ub
f it y p
Introduction

so n
ht , a
rig ntly
Commission Directive 2001/99/EC included glyphosate as an active substance in Annex I to Council

th ue
Directive 91/414/EEC. Following a peer review organised by the European Commission, glyphosate was

e eq
e
included in Annex I of Council Directive 91/414/EEC with Commission Directive 2001/99/EC, entering

lat ns
vio . Co
an ime al.
into force on 01st July 2002. According to Regulation (EU) No 540/2011, glyphosate was deemed for

te reg new
approval under Regulation (EC) No 1107/2009 as well.

oh tio re

d
pr tec EU
ibi n
In agreement with Article 4 of Regulation (EC) No 1141/2010 Monsanto Europe S.A./N.V. (now Bayer

d
be ro te
e ta p osa
Agriculture BV) on behalf of the then European Glyphosate Task Force submitted an application to

ef da ph
Germany as RMS and Slovakia as Co-RMS notifying the intention to renew the existing approval of

er y ly
th tor G
glyphosate on 24th March 2011 during the AIR 2 process. A collective supplementary dossier from the

ay ula the
Glyphosate Task Force comprising 24 applicants was submitted on 25th May 2012.

or
t m reg king
m er see
On 12th November 2015, the European Food Safety Authority (EFSA) published its conclusions on the peer

do ll u tium
en a
review of the pesticide risk assessment of the active substance glyphosate in the framework of the renewal

cu nd
of the approval under Commission Regulation (EU) No 1141/2010 (EFSA Journal 2015;13(11):4302)1.
his fa or
f t ay ns
r o m co
ne ent he

EFSA was requested by the European Commission (EC) to consider available information on the potential
ow um of t

endocrine activity of the pesticide active substance glyphosate in accordance with Article 31 of Regulation
th oc (s)

(EC) No 178/2002. The assessment concluded that the weight of evidence indicates glyphosate does not
of is d ber

possess endocrine disrupting properties via oestrogen, androgen, thyroid or steroidogenesis modes of action
ion , th em
iss ore m

based on a comprehensive database available in the toxicology area.

e
rm m er
pe her orm

On 17th March 2016, the rapporteur Member State, Germany, submitted a dossier to the European Chemical
he rt t/f
t t Fu en

Agency for harmonised classification and labelling of the substance glyphosate. The proposal document
ou s. rr
th tie cu

was prepared in accordance with Article 37 of Regulation (EC) No 1272/2008 of the European Parliament
wi par (a)

and of the Council.

f
en ird o
nt th rty
co and ope

The Committee for Risk Assessment (RAC) assessed the hazards presented by glyphosate against the
r

criteria in the Classification, Labelling and Packaging Regulation2. The RAC concluded that the available
ts
r i er p
t o wn the

scientific evidence did not meet the criteria in the CLP Regulation and that glyphosate would not be
en o s
m he t i

classified as possessing STOT (specific target organ toxicity), carcinogenicity, mutagenicity or

cu f t en

ts

reproductive toxicity.
do s o um
is ht c
th rig s do

The AIR 2 process at EU level, concluded that it has been established with respect to one or more
i
e op Th

representative uses of at least one plant protection product containing the active substance glyphosate that
of y

the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Thus, the
us c

approval criteria of demonstrating a safe use were deemed to be satisfied. It was therefore appropriate to
d nd
an a

renew the active substance glyphosate3. Glyphosate was renewed (date of approval) on 16th December 2017
n rty

with the expiration of approval set up for 15th December 2022.

tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a

1
Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate in the framework of the renewal
y c uch

of the approval under Commission Regulation (EU) No 1141/2010; EFSA Journal 2015;13(11):4302, 107 pp;
an ts s

doi:10.2903/j.efsa.2015.4302.
an righ

2 RAC Opinion proposing harmonised classification and labelling at EU level of glyphosate (ISO); N (phosphono-methyl)glycine.

CLH-O-0000001412-86-149/F. Adopted 15 Mar 2017.

d
ing to

3 COMMISSION IMPLEMENTING REGULATION (EU) 2017/2324.

sh ct
bli bje
pu su
or be

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Bayer Agriculture BV4 submits the dossier on behalf of the Glyphosate Renewal Group (GRG) for the

ut
rib
AIR 5 process.

t
dis
n,
er tio
In the frame of the pre-submission meeting held between the GRG and the Assessment Group on

wn lica
.
Glyphosate (AGG) on 27th September 2019, the AGG provided a reference document to GRG on the

s o ub
f it y p
process to be considered when summarizing studies from past submissions in the June 2020 renewal

so n
dossier5.

ht , a
rig ntly
th ue
In 1995, glyphosate active substance dossiers were submitted by both task force and individual companies

e eq
e
lat ns
comprising a total of 19 applicants. The majority of applicants of the 1995 submissions did not join the

vio . Co
an ime al.
2012 Glyphosate Task Force (GTF) nor the GRG submitting the AIR 5 dossier in 2020. The GRG was not

te reg new
able to get access to a total of 46 study reports from three companies that were part of the submissions in

oh tio re

d
1995 (for details please refer to the Document B, Doc ID: 110054-B-GRG_Rev 1_Jul_2020), because some

pr tec EU
ibi n
of the companies involved in the submissions in 1995 have subsequently been acquired by/merged with

d
be ro te
e ta p osa
other companies or have since exited the market. Therefore, the GRG contacted Germany as the former

ef da ph
RMS for glyphosate to discuss options available in order for AGG to get access to all said 46 study reports.

er y ly
th tor G
A list of all these studies was sent to BVL (letter from 03rd March 2020). BVL replied to this request on

ay ula the
24th March 2020, advising the AGG to send a “request for administrative assistance (Art. 39 of Regulation

or
t m reg king
(EC) No. 1107/2009)” to the BVL. Then, BVL will forward the respective studies directly to the AGG. In

m er see
the present AIR 5 Dossier, information on those inaccessible studies has been summarised based on the

do ll u tium
en a
2000 monograph documents6 and are identified (as Category 4a and 4b) in the present AIR 5 dossier7. In

cu nd
his fa or
these cases, GRG was unable to provide updated Appendix E summaries due to lack of access to these
f t ay ns
studies.
r o m co
ne ent he
ow um of t

A number of new regulatory studies, generated after the previous EU renewal process and/or not previously
th oc (s)

submitted at EU level, are presented as part of the data package of this AIR 5 dossier. To date, those new
of is d ber

studies have not been peer-reviewed at EU level (please refer to the Application document Rev 3 Dated
ion , th em
iss ore m

July 2020 – Document F, Doc ID: 110054-F-GRG_Rev 1_Jul_2020).

e
rm m er
pe her orm

A literature search for the active substance glyphosate and metabolites was performed in accordance with
he rt t/f
t t Fu en

the provisions of the EFSA Guidance “Submission of scientific peer-reviewed open literature for the
ou s. rr
th tie cu

approval of pesticide active substances under Regulation (EC) 1107/2009” and according to the updated
wi par (a)

Appendix to this Guidance document8. The scientific literature review was performed for the period of
f
en ird o

01st January 2010 until 31st December 2019, please refer to M-CA Section Ecotoxicology (Doc ID: 110054-
nt th rty
co and ope

MCA8_GRG_Rev 1_Jul_2020). The identified relevant and reliable articles are presented as appendix E
r

summaries in the M-CA Section Ecotoxicology. For further detailed information on the Literature Review
ts
r i er p
t o wn the

Report (LRR) and the corresponding evaluation, please refer to M-CA Section 9 “Literature”. In the frame
en o s
m he t i

of the pre-submission meeting held on 27th September 2019, the AGG provided a reference document to
cu f t en

ts

GRG on the process to be considered when presenting literature in the June 2020 submission dossier9.
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr

4
Due to the Bayer-Monsanto acquisition in 2018, the legal entity name Monsanto Europe S.A. / N.V. has been changed to Bayer
xp al

Agriculture BV.
l e ctu

5
AGG_Advice to GTF2_Literature search_Final Oct 2019 “HOW TO SUMMARISE STUDIES IN DOSSIERS FROM 1998
cia lle

AND 2012 IN THE DOSSIER TO BE SUBMITTED JUNE 2020”

er te
m s in

6
Monograph and Addendum to the monograph EU 2001: Glyphosate monograph
om a

7
In the AIR 5 dossier, in each M document, a category has been assigned to each regulatory study included in the AIR 5 dossier
y c uch

(for details please refer to the Doc ID: 110054-B-GRG_Jun_2020).

an ts s

8
Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances
an righ

approved 27 March 2019 (doi: 10.2903/sp.efsa.2019.EN-1612)

9 AGG_Advice to GTF2_Literature search_Final Oct 2019 “ADVICE TO GTF2: HOW TO PRESENT THE LITERATURE
d
ing to

SEARCH IN THE DOSSIER TO BE SUBMITTED JUNE 2020”

sh ct
bli bje
pu su
or be

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ut
During the former EU processes, public literature data was evaluated, listed and reported by the RMS. An

rib
appendix, containing information about all previously submitted and/or included public literature articles

t
dis
from the former EU process is presented, for sake of completeness, as Annex to the M-CA Section 8 at the

n,
er tio
end of this document.

wn lica
.
s o ub
f it y p
The representative formulation MON 52276, is a soluble concentrate (SL) herbicide containing 360 g/L

so n
glyphosate as isopropylamine salt. The content of glyphosate in the GAP (Table 10-1) is expressed as

ht , a
rig ntly
glyphosate acid, which corresponds to MON 52276 at 360 g/L.

th ue
e eq
e
lat ns
Ecotoxicological studies have been conducted with the active substance glyphosate, glyphosate acid,

vio . Co
an ime al.
glyphosate salts and its metabolites and are detailed in the document M-CA Section 8. Where applicable,

te reg new
ecotoxicological studies have been conducted with the representative formulation MON 52276 to compare

oh tio re

d
the toxicity of the active substance with that of MON 52276.

pr tec EU
ibi n
d
be ro te
e ta p osa
Studies with the active substance that are relevant to the risk assessment are presented in tabular form at

ef da ph
the beginning of each section, alongside the studies conducted with MON 52276. Full summaries for

er y ly
th tor G
MON 52276 studies are provided for each organism groups. Irrespective of the test item, all presented

ay ula the
endpoints for MON 52276 and glyphosate are given in glyphosate acid equivalents (i.e. recalculated to acid

or
t m reg king
equivalents).

m er see
do ll u tium
en a
Risk assessments according to current and relevant guidance documents have been conducted for each

cu nd
his fa or
organism group according to the proposed uses of MON 52276 to control broadleaf weeds in field crops,
f t ay ns
orchards, vineyards, railroad tracks and for the control of invasive species in agricultural and
r o m co
ne ent he

non-agricultural areas. A risk assessment strategy is presented at the beginning of each section to
ow um of t

demonstrate how the proposed uses of MON 52276 are addressed for each organism group.
th oc (s)
of is d ber

Full details of the proposed uses are provided in the table below.
ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 8 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
PRE-SOWING, PRE-PLANTING
wi par (a)

1a EU Root & tuber F Emerged annual Tractor Pre-sowing, a) 1 a) 4 L/ha a) 1.44 kg as/ha 100 – N/A Also applicable to renovation /
f
en ird o

vegetables, weeds, emerged mounted Pre-planting, b) 1 b) 4 L/ha b) 1.44 kg as/ha 400 change of land use applications.
nt th rty

Bulb vegetables, perennial and broadcast Pre-emergence

co and ope

Fruiting biennial weeds spray of the crop Application to 100 % of the

r

ts
r i er p

vegetables, BBCH > 13 field.

t o wn the

Brassica, Use 75 % drift reducing

en o s

Leafy vegetables, nozzles.

m he t i
cu f t en

Stem vegetables,
ts
do s o um

Sugar beet Maximum application rate of

1.44 kg as/ha glyphosate in any
is ht c
th rig s do

12 months period.
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 9 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
1b EU Root & tuber F Emerged annual Tractor Pre-sowing, a) 1 a) 3 L/ha a) 1.08 kg as/ha 100 – N/A Also applicable to renovation /
wi par (a)

vegetables, weeds, emerged mounted Pre-planting, b) 1 b) 3 L/ha b) 1.08 kg as/ha 400 change of land use applications.
f

Bulb vegetables, perennial and broadcast Pre-emergence

en ird o
nt th rty

Fruiting biennial weeds spray of the crop Application to 100 % of the

co and ope

vegetables, (BBCH 13 – 21) field.

Brassica, Use 75 % drift reducing
r

ts
r i er p

Leafy vegetables, nozzles.

t o wn the

Stem vegetables,
en o s
m he t i

Sugar beet Maximum application rate of

cu f t en

ts

1.08 kg as/ha glyphosate in any

do s o um

12 months period.
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 10 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
1c EU Root & tuber F Emerged annual Tractor Pre-sowing, a) 1 a) 2 L/ha a) 0.72 kg as/ha 100 – N/A Also applicable to renovation /
wi par (a)

vegetables, weeds mounted Pre-planting, b) 1 b) 2 L/ha b) 0.72 kg as/ha 400 change of land use applications.
f

Bulb vegetables, broadcast Pre-emergence

en ird o
nt th rty

Fruiting spray of the crop Application to 100 % of the

co and ope

vegetables, field.
Brassica, Use 75 % drift reducing
r

ts
r i er p

Leafy vegetables, nozzles.

t o wn the

Stem vegetables,
en o s
m he t i

Sugar beet Maximum application rate of

cu f t en

ts

0.72 kg as/ha glyphosate in any

do s o um

12 months period.
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 11 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
POST-HARVEST, PRE-SOWING, PRE-PLANTING
wi par (a)

2a EU Root & tuber F Emerged annual, Tractor Post-harvest, a) 1 – 2 a) 3 – 4 a) 1.08 – 1.44 kg 100 – N/A Application to existing row
f
en ird o

vegetables, perennial and mounted pre-sowing, (28 days) L/ha as/ha 400 cropland after harvest for
nt th rty

Bulb vegetables, biennial weeds broadcast pre-planting b) 1 – 2 b) 6 L/ha b) 2.16 kg as/ha removal of remaining crop /
co and ope

Fruiting spray (28 days) stubble and for control of

r

ts
r i er p

vegetables, actively growing weeds and

t o wn the

Brassica, mature annual weeds with

en o s

Leafy vegetables, hardened-off surface

m he t i
cu f t en

Stem vegetables,
ts
do s o um

Sugar beet Application to 100 % of the

field.
is ht c
th rig s do

Use 75 % drift reducing

i

nozzles.
e op Th
of y

Maximum application rate of

2.16 kg as/ha glyphosate in any
us c
d nd

12 months period.
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 12 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
2b EU Root & tuber F Emerged annual, Tractor Post-harvest, a) 1 – 3 a) 2 – 3 a) 0.72 – 1.08 kg 100 – N/A Application to existing row
wi par (a)

vegetables, perennial and mounted pre-sowing, (28 days) L/ha as/ha 400 cropland after harvest for
f

Bulb vegetables, biennial weeds broadcast pre-planting b) 1 – 3 b) 6 L/ha b) 2.16 kg as/ha removal of remaining crop /
en ird o
nt th rty

Fruiting spray (28 days) stubble and for control of

co and ope

vegetables, actively growing weeds.

Brassica,
r

ts
r i er p

Leafy vegetables, Application to 100 % of the

t o wn the

Stem vegetables, field.

en o s
m he t i

Sugar beet Use 75 % drift reducing

cu f t en

ts

nozzles.
do s o um
is ht c

Maximum application rate of

th rig s do

2.16 kg as/ha glyphosate in any

i
e op Th

12 months period.
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 13 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
2c EU Root & tuber F Emerged annual Tractor Post-harvest, a) 1 – 3 a) 2 L/ha a) 0.72 kg as/ha 100 – N/A Application to existing row
wi par (a)

vegetables, weeds mounted pre-sowing, (28 days) b) 6 L/ha b) 2.16 kg as/ha 400 cropland after harvest for
f

Bulb vegetables, broadcast pre-planting b) 1 – 3 removal of remaining crop /

en ird o
nt th rty

Fruiting spray (28 days) stubble and for control of

co and ope

vegetables, actively growing annual weeds

Brassica,
r

ts
r i er p

Leafy vegetables, Application to 100 % of the

t o wn the

Stem vegetables, field.

en o s
m he t i

Sugar beet Use 75 % drift reducing

cu f t en

ts

nozzles.
do s o um
is ht c

Maximum application rate of

th rig s do

2.16 kg as/ha glyphosate in any

i
e op Th

12 months period.
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 14 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
3a EU Root & tuber F Cereal volunteers Tractor Post-harvest, a) 1 a) 1.5 L/ha a) 0.54 kg as/ha 100 – N/A Application to existing row
wi par (a)

vegetables, mounted pre-sowing, b) 1 b) 1.5 L/ha b) 0.54 kg as/ha 400 cropland after harvest for
f

Bulb vegetables, broadcast pre-planting removal of cereal volunteers.

en ird o
nt th rty

Fruiting spray
co and ope

vegetables, Maximum application rate of

Brassica, 0.54 kg as/ha glyphosate in any
r

ts
r i er p

Leafy vegetables, 12 months period.

t o wn the

Stem vegetables,
en o s
m he t i

Sugar beet
cu f t en

ts
do s o um

3b EU Root & tuber F Cereal volunteers Tractor Post-harvest, a) 1 a) 1.5 L/ha a) 0.54 kg as/ha 100 – N/A Application to existing row
vegetables, mounted pre-sowing, b) 1 b) 1.5 L/ha b) 0.54 kg as/ha 400 cropland after harvest for
is ht c
th rig s do

Bulb vegetables, broadcast pre-planting removal of cereal volunteers

i

Fruiting spray once every three years.

e op Th

vegetables,
of y

Brassica, Maximum application rate of

Leafy vegetables, 0.54 kg as/ha glyphosate in any
us c
d nd

Stem vegetables, 36 months period.

an a

Sugar beet
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 15 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
POST-EMERGENCE OF WEEDS
wi par (a)

4a EU Orchard crops F Emerged annual, Ground Post-emergence a) 1 – 2 a) 3 – 4 a) 1.08 – 1.44 kg 100 – 7 Avoid crop contamination
f
en ird o

(citrus, stone and biennial and directed, of weeds (28 days) L/ha as/ha 400 during treatment.
nt th rty

pome fruits, kiwi, perennial weeds shielded b) 1 – 2 b) 8 L/ha b) 2.88 kg as/ha

co and ope

tree nuts, banana, spray, (28 days) Maximum application rate of

r

ts
r i er p

and table olives) band 2.88 kg as/ha treated area

t o wn the

application glyphosate in any 12 months

en o s

period.
m he t i
cu f t en

ts
do s o um

Band application in the rows

below the trees or as spot
is ht c
th rig s do

treatments. The treated area

i

represents not more than 50 %

e op Th

of the total orchard area. The

of y

application rate with reference

to the total orchard surface area
us c
d nd

is not more than 50 % of the

an a

stated dose rate.

n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 16 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
4b EU Orchard crops F Emerged annual, Ground Post-emergence a) 1 – 3 a) 2 – 3 a) 0.72 – 1.08 kg 100 – 7 Avoid crop contamination
wi par (a)

(citrus, stone and biennial and directed, of weeds (28 days) L/ha as/ha 400 during treatment.
f

pome fruits, kiwi, perennial weeds shielded b) 1 – 3 b) 8 L/ha b) 2.88 kg as/ha

en ird o
nt th rty

tree nuts, banana, spray, (28 days) Maximum application rate of

co and ope

and table olives) band 2.88 kg as/ha treated area

application glyphosate in any 12 months
r

ts
r i er p

period.
t o wn the
en o s
m he t i
cu f t en

ts

Band application in the rows

do s o um

below the trees or as spot

is ht c

treatments. The treated area

th rig s do

represents not more than 50 %

i
e op Th

of the total orchard area. The

application rate with reference
of y

to the total orchard surface area

us c

is not more than 50 % of the

d nd

stated dose rate.

an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 17 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
4c EU Orchard crops F Emerged annual Ground Post-emergence a) 1 – 3 a) 2 L/ha a) 0.72 kg as/ha 100 – 7 Avoid crop contamination
wi par (a)

(citrus, stone and weeds directed, of weeds (28 days) b) 6 L/ha b) 2.16 kg as/ha 400 during treatment.
f

pome fruits, kiwi, shielded b) 1 – 3

en ird o
nt th rty

tree nuts, banana, spray, (28 days) Maximum application rate of

co and ope

and table olives) band 2.16 kg as/ha treated area

application glyphosate in any 12 months
r

ts
r i er p

period.
t o wn the
en o s
m he t i

Band application in the rows

cu f t en

ts

below the trees or as spot

do s o um

treatments. The treated area

is ht c

represents not more than 50 %

th rig s do

of the total orchard area. The

i
e op Th

application rate with reference

to the total orchard surface area
of y

is not more than 50 % of the

us c

stated dose rate.

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 18 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
5a EU Vines F Emerged annual, Ground Post-emergence a) 1 – 2 a) 3 – 4 a) 1.08 – 1.44 kg 100 – 7 Avoid crop contamination
wi par (a)

(table and wine biennial and directed, of weeds (28 days) L/ha as/ha 400 during treatment.
f

grape, leaves not perennial weeds shielded b) 1 – 2 b) 8 L/ha b) 2.88 kg as/ha

en ird o
nt th rty

intended for human spray, band (28 days) Maximum application rate of
co and ope

consumption) application 2.88 kg as/ha treated area

glyphosate in any 12 months
r

ts
r i er p

period.
t o wn the
en o s
m he t i

Band application in the rows

cu f t en

ts

below the vine stock or as spot

do s o um

treatments. The treated area

is ht c

represents not more than 50 %

th rig s do

of the total vineyard area. The

i
e op Th

application rate with reference

to the total vineyard surface
of y

area is not more than 50 % of

us c

the stated dose rate.

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 19 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
5b EU Vines F Emerged annual, Ground Post-emergence a) 1 – 3 a) 2 – 3 a) 0.72 – 1.08 kg 100 – 7 Avoid crop contamination
wi par (a)

(table and wine biennial and directed, of weeds (28 days) L/ha as/ha 400 during treatment.
f

grape, leaves not perennial weeds shielded b) 1 – 3 b) 8 L/ha b) 2.88 kg as/ha

en ird o
nt th rty

intended for human spray, band (28 days) Maximum application rate of
co and ope

consumption) application 2.88 kg as/ha treated area

glyphosate in any 12 months
r

ts
r i er p

period.
t o wn the
en o s
m he t i

Band application in the rows

cu f t en

ts

below the vine stock or as spot

do s o um

treatments. The treated area

is ht c

represents not more than 50 %

th rig s do

of the total vineyard area. The

i
e op Th

application rate with reference

to the total vineyard surface
of y

area is not more than 50 % of

us c

the stated dose rate.

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 20 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
5c EU Vines F Emerged annual Ground Post-emergence a) 1 – 3 a) 2 L/ha a) 0.72 kg as/ha 100 – 7 Avoid crop contamination
wi par (a)

(table and wine weeds directed, of weeds (28 days) b) 6 L/ha b) 2.16 kg as/ha 400 during treatment.
f

grape, leaves not shielded b) 1 – 3

en ird o
nt th rty

intended for human spray, band (28 days) Maximum application rate of
co and ope

consumption) application 2.16 kg as/ha treated area

glyphosate in any 12 months
r

ts
r i er p

period.
t o wn the
en o s
m he t i

Band application in the rows

cu f t en

ts

below the vine stock or as spot

do s o um

treatments. The treated area

is ht c

represents not more than 50%

th rig s do

of the total vineyard area. The

i
e op Th

application rate with reference

to the total vineyard surface
of y

area is not more than 50 % of

us c

the stated dose rate.

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 21 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
6a EU Vegetables (Root F Emerged annual, Inter-row Crop BBCH < a) 1 a) 3 L/ha a) 1.08 kg as/ha 100 – 60 Avoid crop contamination
wi par (a)

and tuber biennial and application: 20 b) 1 b) 3 L/ha b) 1.08 kg as/ha 400 during treatment.
f

vegetables perennial weeds ground

en ird o
nt th rty

Bulb vegetables, directed, Maximum application rate of

co and ope

Fruiting vegetables shielded 1.08 kg as/ha glyphosate in any

Legume vegetables spray 12 months period.
r

ts
r i er p

Leafy vegetables)
t o wn the

Applications are performed

en o s
m he t i

between the crop rows. The rate

cu f t en

ts

refers to the treated area only,

do s o um

which represents not more than

is ht c

50 % of the total area. The

th rig s do

application rate with reference

i
e op Th

to the total surface area is not

more than 50 % of the stated
of y

dose rate
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 22 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
6b EU Vegetables (Root F Emerged annual Inter-row Crop BBCH < a) 1 a) 2 L/ha a) 0.72 kg as/ha 100 – 60 Avoid crop contamination
wi par (a)

and tuber weeds application: 20 b) 1 b) 2 L/ha b) 0.72 kg as/ha 400 during treatment.
f

vegetables ground
en ird o
nt th rty

Bulb vegetables, directed, Maximum application rate 0.72

co and ope

Fruiting vegetables shielded kg as/ha glyphosate in any 12

Legume vegetables spray months period.
r

ts
r i er p

Leafy vegetables)
t o wn the

Applications are performed

en o s
m he t i

between the crop rows. The rate

cu f t en

ts

refers to the treated area only,

do s o um

which represents not more than

is ht c

50 % of the total area. The

th rig s do

application rate with reference

i
e op Th

to the total surface area is not

more than 50 % of the stated
of y

dose rate
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 23 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
7a EU Railroad tracks F Emerged annual, Ground Post-emergence a) 2 (90 days) a) 5 L/ha a) 1.8 kg as/ha 100 – N/A Application by spray train
wi par (a)

biennial and directed, of weeds b) 2 (90 days) b) 10 L/ha b) 3.6 kg as/ha 400
f

perennial weeds spray Maximum application rate 3.6

en ird o
nt th rty

kg as/ha glyphosate in any 12

co and ope

months period.
r

ts
r i er p

7b EU Railroad tracks F Emerged annual, Ground Post-emergence a) 1 a) 5 L/ha a) 1.8 kg as/ha 100 – N/A Application by spray train
t o wn the

biennial and directed, of weeds b) 1 b) 5 L/ha b) 1.8 kg as/ha 400

en o s

perennial weeds spray Maximum application rate 1.8

m he t i
cu f t en

kg as/ha glyphosate in any 12

ts
do s o um

months period.
is ht c
th rig s do

8 EU Invasive species in F Giant hogweed Spot Post-emergence a) 1 a) 5 L/ha a) 1.8 kg as/ha 5 – 400 N/A Maximum application rate 1.8
i
e op Th

agricultural and (Heracleum treatment of invasive b) 1 b) 5 L/ha b) 1.8 kg as/ha kg as/ha glyphosate in any 12
non-agricultural mantegazzianum) (shielded) species months period.
of y

areas
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 24 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
9 EU Invasive species in F Japanese Spot Late summer, a) 1 a) 5 L/ha a) 1.8 kg as/ha 5 – 400 N/A Maximum application rate 1.8
wi par (a)

agricultural and knotweed treatment early fall b) 1 b) 5 L/ha b) 1.8 kg as/ha kg as/ha glyphosate in any 12
f

non-agricultural (Reynoutria (shielded), months period.

en ird o
nt th rty

areas japonica) cut stem:

co and ope

spray
application
r

ts
r i er p
t o wn the

10a EU Root & tuber F Couch grass Spot Post-harvest, a) 1 a) 3 L/ha a) 1.08 kg as/ha 100 – N/A Application to existing row
en o s

vegetables, (Elymus repens) treatment pre-sowing, b) 1 b) 3 L/ha b) 1.08 kg as/ha 400 cropland after harvest for
m he t i
cu f t en

Bulb vegetables, (shielded) pre-planting removal of couch grass.

ts
do s o um

Fruiting
vegetables, Maximum application rate of
is ht c
th rig s do

Brassica, 1.08 kg as/ha glyphosate in any

i

Leafy vegetables, 12 months period.

e op Th

Stem vegetables,
of y

Sugar beet The treated area represents not

more than 20 % of the cropland.
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 25 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
10b EU Root & tuber F Couch grass Spot Post-harvest, a) 1 a) 2 L/ha a) 0.72 kg as/ha 100 – N/A Application to existing row
wi par (a)

vegetables, (Elymus repens) treatment pre-sowing, b) 1 b) 2 L/ha b) 0.72 kg as/ha 400 cropland after harvest for
f

Bulb vegetables, (shielded) pre-planting removal of couch grass.

en ird o
nt th rty

Fruiting
co and ope

vegetables, Maximum application rate of

Brassica, 0.72 kg as/ha glyphosate in any
r

ts
r i er p

Leafy vegetables, 12 months period.

t o wn the

Stem vegetables,
en o s
m he t i

Sugar beet The treated area represents not

cu f t en

ts

more than 20 % of the cropland.

do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 26 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10-1 : MON 52276 (360 g/L glyphosate)

te reg new
oh tio re

d
pr tec EU
ibi n
PPP (product name/code) MON 52276 Formulation type: SL

d
be ro te
active substance 1 glyphosate as isopropylammonium salt Conc. of as 1: 360 g/L (486 g/L isopropylammonium salt)

e ta p osa
ef da ph
er y ly
safener - Conc. of safener: -

th tor G
synergist - Conc. of synergist: -

ay ula the

or
t m reg king
Applicant: GRG professional use

m er see
Zone(s): central, southern and northern non-professional use

do ll u tium
en a
Verified by MS: y/n

cu nd
his fa or
f t ay ns
1 2 3 4 5 6 7 8 10 11 12 13 14

r o m co
Use- Member Crop and/ F Pests or Group Application Application rate PHI Remarks:

ne ent he
No. state(s) or situation G of pests (days)

ow um of t
or controlled Method / Timing / Max. kg, L g, kg as/ha Water e.g. safener/synergist per ha

th oc (s)
(crop destination / I Kind Growth stage number product/ha L/ha

of is d ber
purpose of crop) (additionally: of crop & (min. a) max. a) max. rate per e.g. recommended or

ion , th em
developmental season interval rate per appl. min / mandatory tank mixtures

iss ore m
stages of the between appl. b) max. total rate max

e
rm m er
pest or pest applications) b) max. per crop/season

pe her orm
group) a) per use total rate
b) per crop/ per

he rt t/f
t t Fu en
ou s. rr
th tie cu season crop/season
10c EU Root & tuber F Couch grass Spot Post-harvest, a) 1 a) 2 L/ha a) 0.72 kg as/ha 100 – N/A Application to existing row
wi par (a)

vegetables, (Elymus repens) treatment pre-sowing, b) 1 b) 2 L/ha b) 0.72 kg as/ha 400 cropland after harvest for
f

Bulb vegetables, (shielded) pre-planting removal of couch grass once

en ird o
nt th rty

Fruiting every three years.

co and ope

vegetables,
Brassica, Maximum application rate of
r

ts
r i er p

Leafy vegetables, 0.72 kg as/ha glyphosate in any

t o wn the

Stem vegetables, 36 months period.

en o s
m he t i

Sugar beet
cu f t en

ts

The treated area represents not

do s o um

more than 20 % of the cropland.

is ht c
th rig s do

Remarks (a) e g wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (d) Select relevant
i
e op Th

table (b) Catalogue of pesticide formulation types and international coding system CropLife (e) Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in
heading: International Technical Monograph n°2, 6th Edition Revised May 2008 column 1
of y

(c) g/kg or g/l (f) No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the
us c

notifier no longer supports this use

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 27 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Remarks 1 Numeration necessary to allow references 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997,

te reg new
columns: 2 Use official codes/nomenclatures of EU Member States Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of application
3 For crops, the EU and Codex classifications (both) should be used; when relevant, the 8 The maximum number of application possible under practical conditions of use must be provided

oh tio re

d
use situation should be described (e g fumigation of a structure) 9 Minimum interval (in days) between applications of the same product

pr tec EU
4 F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field 10 For specific uses other specifications might be possible, e g : g/m³ in case of fumigation of empty rooms

ibi n
d
use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non- See also EPPO-Guideline PP 1/239 Dose expression for plant protection products

be ro te
e ta p osa
professional greenhouse use, I: indoor application 11 The dimension (g, kg) must be clearly specified (Maximum) dose of a s per treatment (usually g, kg or L
5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when relevant, the common product / ha)

ef da ph
names of the pest groups (e g biting and sucking insects, soil born insects, foliar fungi, weeds) and the 12 If water volume range depends on application equipments (e g ULVA or LVA) it should be mentioned

er y ly
developmental stages of the pests and pest groups at the moment of application must be named under “application: method/kind”

th tor G
6 Method, e g high volume spraying, low volume spraying, spreading, dusting, drench 13 PHI - minimum pre-harvest interval

ay ula the
Kind, e g overall, broadcast, aerial spraying, row, individual plant, between the plants - type of 14 Remarks may include: Extent of use/economic importance/restrictions

or
t m reg king
equipment used must be indicated

m er see
do ll u tium
en a
cu nd
his fa or
f t ay ns
r o m co
ne ent he
ow um of t
th oc (s)
of is d ber
ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 28 of 553

ep
,r
ion
ut
t rib
CP 10.1 Effects on Birds and Other Terrestrial Vertebrates

dis
n,
er tio
CP 10.1.1 Effects on birds

wn lica
.
s o ub
Studies considering the toxicity of glyphosate and relevant metabolites to birds were assessed for their

f it y p
validity to current and relevant guidelines. The results of these studies demonstrate that glyphosate and

so n
ht , a
AMPA are of low acute and chronic toxicity to avian species.

rig ntly
th ue
e eq
Relevant and reliable studies for the risk assessment for birds of glyphosate and relevant metabolites are

e
lat ns
vio . Co
an ime al.
summarised in the tables below. Details of the acute studies are summarised in the Document M-CA,

te reg new
Section 8, point 8.1.1.1.

oh tio re

d
pr tec EU
ibi n
Table 10.1.1-1: Relevant endpoints for risk assessment: Acute oral toxicity of glyphosate and

d
be ro te
e ta p osa
AMPA to birds

ef da ph
er y ly
th tor G
Reference Substance Species Test design LD50

ay ula the
(mg a.e./kg bw)

or
t m reg king
CA 8.1.1.1 Glyphosate Bird1 Acute oral Extrapolated

m er see
LD50 = 4334 mg/kg

do ll u tium
en a
bw/day2

cu nd
his fa or
AMPA Colinus virginianus Acute oralf t ay ns LD50 ˃ 2250 mg/kg bw/day
r o m co
1991
ne ent he

CA 8.1.1.1/009
ow um of t
th oc (s)

1
Tested species: Bobwhite quail (Colinus virginianus), Japanese quail (Coturnix coturnix japonica), Mallard duck (Anas
of is d ber

platyrhynchos)
ion , th em

2 All acute oral bird studies resulted in endpoints > 2000 mg/kg bw (see Section CA 8.1.1.1). Therefore an extrapolations factor
iss ore m

of 2.167 as recommended in the Guidance Document on Risk Assessment for Birds and Mammals on request from EFSA (EFSA
rm m er

Journal 2009; 7(12): 1438) was applied.

pe her orm

Endpoints in bold are used for risk assessment

he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)

Details of this reproduction study is summarised in the Document M-CA, Section 8, point 8.1.1.3.
f
en ird o
nt th rty
co and ope

Table 10.1.1-2: Relevant endpoints for risk assessment: Reproductive toxicity of glyphosate to
r

birds
ts
r i er p
t o wn the
en o s
m he t i

Reference Substance Species Test design NOAEL NOAEL

cu f t en

ts
do s o um

(mg a.e./kg feed) (mg a.e./kg

is ht c

bw/d)
th rig s do

1978 Glyphosate 17 weeks 1000 96.3

i

Colinus
e op Th

CA 8.1.1.3/003 technical virginianus reproduction

of y

a.e.: acid equivalents

us c
d nd
an a
n rty
tio e
ta op

Risk assessment for metabolites

loi pr

The primary metabolite of glyphosate is aminomethylphosphonic acid (AMPA). Most of the parent
xp al
l e ctu

glyphosate is eliminated unchanged and only a small amount (less than 1 % of the applied dose) is
cia lle

transformed to aminomethylphosphonic acid (AMPA). The metabolite AMPA has been tested in several
er te
m s in

mammal toxicity studies which demonstrated that it is of lower toxicity than glyphosate acid (see
om a

Section CA 5.8). Avian toxicity tests with metabolites of glyphosate showed equally low acute toxicity as
y c uch

glyphosate.
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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ep
,r
ion
ut
Following application to plant tissues, unchanged glyphosate was the only significant residue. In presence

rib
of soil as a substrate the active substance is quickly degraded, leaving AMPA at rates comparable or even

t
dis
higher than parent glyphosate. However, the uptake via the roots and the translocation in the plants was

n,
er tio
very low, not resulting in significant residue levels as confirmed by plant metabolism and confined

wn lica
.
rotational crop studies. A major part of the glyphosate was degraded into CO2. Therefore, it can be

s o ub
f it y p
concluded that the risk to birds will be acceptably low and no further quantitative risk assessment is

so n
conducted.

ht , a
rig ntly
th ue
Risk assessment for the representative formulation

e eq
e
lat ns
An acute oral mammalian study is available with the formulation which is presented in the toxicological

vio . Co
an ime al.
section under Section CP 7.1.1/01. This study shows, that the acute toxicity of the formulation

te reg new
(>5000 mg/kg bw) is not more elevated than the toxicity of the active substance alone (>2000 mg/kg bw).

oh tio re

d
Therefore the avian risk assessment for the representative formulation is considered to be covered by the

pr tec EU
ibi n
avian risk assessment presented for the active substance glyphosate.

d
be ro te
e ta p osa
ef da ph
There are no literature articles and peer-reviewed published data considered to be relevant and reliable or

er y ly
th tor G
reliable with restrictions with regards to the impact of glyphosate or its relevant metabolites on avian

ay ula the
species. Full literature evaluation is provided in document M-CA Section 9. A summary of previously

or
t m reg king
evaluated peer reviewed literature from the RAR 2015 is also available in Annex M-CA 8-01 of the

m er see
M-CA Section 8. For discussions of literature regarding toxicity to birds, please refer to document M-CP

do ll u tium
en a
Section 10.2.

cu nd
his fa or
f t ay ns
r o m co
Risk assessment for birds
ne ent he

The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment for
ow um of t

Birds and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438); hereafter referred to as
th oc (s)
of is d ber

EFSA/2009/1438.
ion , th em
iss ore m

The table below summarises how the risk assessment for birds considers all the proposed uses and the
rm m er
pe her orm

application rates presented in the GAP.

he rt t/f
t t Fu en
ou s. rr

Table 10.1.1-3: Risk assessment strategy for birds

th tie cu
wi par (a)
f

GAP number and summary of use Application rate considered (28 day interval unless otherwise stated)
en ird o
nt th rty

1× 1× 1× 2× 1× 3× 1× 2× 2× 2 × 1800
co and ope

540 720 1080 720 1440 720 1800 1080 1440 g/ha (90
r

ts
r i er p

g/ha1 g/ha days apart)

t o wn the

g/ha g/ha g/ha g/ha g/ha g/ha g/ha

Uses 1a-c: Applied to weeds; pre- X X X
en o s
m he t i
cu f t en

sowing, pre-planting, pre emergence

ts
do s o um

of field crops.
is ht c
th rig s do

Uses 2 a-c: Applied to weeds; post- X X X X X X

harvest, pre-sowing, pre-planting of
i
e op Th

field crops.
of y

Use 3 a-b: Applied to cereal X

us c

volunteers; post-harvest, pre-sowing,

d nd
an a

pre-planting of field crops.

n rty

Use 4 a-c: Applied to weeds (post X X X X X X X

tio e
ta op

emergence) below trees in orchards.

loi pr
xp al

Use 5 a-c: Applied to weeds (post X X X X X X X

l e ctu

emergence) below vines in vineyards

cia lle

Use 6 a-b: Applied to weeds (post X X

er te
m s in

emergence) in field crops BBCH

om a

<20
y c uch

Use 7 a-b: Applied to weeds (post X X

an ts s

emergence) around railroad tracks

an righ

Use 8 and 9: Applied to invasive X

d
ing to

species (post emergence) in

sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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ep
,r
ion
ut
Table 10.1.1-3: Risk assessment strategy for birds

t rib
dis
GAP number and summary of use Application rate considered (28 day interval unless otherwise stated)

n,
er tio
1× 1× 1× 2× 1× 3× 1× 2× 2× 2 × 1800

wn lica
.
540 720 1080 720 1440 720 1800 1080 1440 g/ha (90

s o ub
f it y p
g/ha g/ha g/ha g/ha g/ha g/ha g/ha g/ha1 g/ha days apart)

so n
ht , a
agricultural and non-agricultural

rig ntly
areas

th ue
Uses 10 a-c: Applied to couch grass; X X

e eq
post-harvest, pre-sowing, pre-planting

e
lat ns
vio . Co
of field crops

an ime al.
te reg new
X = this use is covered by the application rate indicated.
1 Due to the long spray interval of 28 days this use covers also the following possible application pattern: 2 × 1080 g a.e./ha plus

oh tio re

d
1 × 720 g a.e./ha (28 day interval between each application)

pr tec EU
ibi n
d
be ro te
e ta p osa
ef da ph
For the screening assessment; crops that maybe present at time of application to target weeds and the

er y ly
th tor G
relevant application rates shown in the table above are considered. The acute and long-term screening

ay ula the
assessment results are presented below according to the following main uses:

or
t m reg king
m er see
 in field crops (covering GAP uses 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c); pre-sowing, pre-planting pre-

do ll u tium
en a
emergence, post-harvest. Exposure to birds via grassland, bare soil and field crops is considered

cu nd
his fa or
and is covered by the general screening scenarios grassland, bare soil and bulb and onion like crops
f t ay ns
r o m co
(etc.).
ne ent he

 in orchards (covering GAP uses 4 a-c) applied to weeds post emergence exposure below trees;
ow um of t

exposure to small insectivorous birds in orchards is considered and is covered by the general
th oc (s)

screening scenario orchards (etc.)

of is d ber
ion , th em

 in vineyards (covering GAP uses 5 a-c) applied to weeds post emergence exposure below vines;
iss ore m

exposure to small omnivorous birds in vineyards is considered and is covered by the general
rm m er
pe her orm

screening scenario vineyard.

he rt t/f

 in railroad tracks (covering GAP uses 7 a-b) and in the control of invasive species (covering
t t Fu en

GAP uses 8 and 9) applied to weeds post emergence; exposure to birds via grassland, bare soil and
ou s. rr
th tie cu

field crops is considered and is covered by the general screening scenarios grassland, bare soil and
wi par (a)

bulb and onion like crops (etc.).

f
en ird o
nt th rty
co and ope
r

ts
r i er p

Screening assessment
t o wn the
en o s

Field crops
m he t i
cu f t en

ts
do s o um

Table 10.1.1-4: Screening assessment of the acute risk for birds due to the use of glyphosate in field
is ht c
th rig s do

crops: Uses 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c

i
e op Th

Active substance Glyphosate

of y

Acute toxicity (mg/kg bw) 4334

us c
d nd

TER criterion 10
an a
n rty

GAP crop Application Crop Indicator SV90 MAF90 DDD90 TERa

tio e
ta op

rate scenario species (mg/kg bw/d)

loi pr
xp al

(g a.e./ha)
l e ctu

Pre-sow, pre-planting, 1 × 1440 Grassland Large 30.5 1 43.9 98.7

cia lle

pre-emergence & post-

er te

herbivorous
m s in

harvest of; birds

om a

Root and Stem veg,

y c uch

Bare soil Small 24.7 1 35.6 122

Potato
an ts s

granivorous
Bulb and onion like
an righ

birds
crops,
Bulb and Small 158.8 1 229 19.0
d
ing to

fruiting veg,
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
,r
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ut
Table 10.1.1-4: Screening assessment of the acute risk for birds due to the use of glyphosate in field

t rib
crops: Uses 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c

dis
n,
er tio
Active substance Glyphosate

wn lica
.
4334

s o ub
Acute toxicity (mg/kg bw)

f it y p
TER criterion 10

so n
ht , a
GAP crop Application Crop Indicator SV90 MAF90 DDD90 TERa

rig ntly
rate scenario species (mg/kg bw/d)

th ue
e eq
(g a.e./ha)

e
lat ns
leafy veg, onion like omnivorous

vio . Co
an ime al.
Sugar beet. crops birds

te reg new
Pre-sow, pre-planting, 2 × 1080 Grassland Large 30.5 1.1 36.2 120

oh tio re

d
pre-emergence & post- (28 d) herbivorous

pr tec EU
ibi n
harvest of;

d
birds

be ro te
e ta p osa
Root and Stem veg, Bare soil Small 24.7 1.1 29.3 148

ef da ph
Potato granivorous

er y ly
Bulb and onion like

th tor G
birds

ay ula the
crops,
Bulb and Small 158.8 1.1 189 23.0

or
t m reg king
fruiting veg,
onion like omnivorous
leafy veg,

m er see
crops birds
Sugar beet.

do ll u tium
en a
Pre-sow, pre-planting, 1 × 540 Grassland Large 30.5 1 16.5 263

cu nd
his fa or
pre-emergence & post- herbivorous f t ay ns
r o m co
harvest of; birds
ne ent he

Root and Stem veg, Bare soil Small 24.7 1 13.3 325
ow um of t

Potato granivorous
th oc (s)

Bulb and onion like birds

of is d ber

crops,
ion , th em

Bulb and Small 158.8 1 85.8 50.5

fruiting veg,
iss ore m

onion like omnivorous

leafy veg,
rm m er

crops birds
pe her orm

Sugar beet.
he rt t/f

Pre-sow, pre-planting, 1 × 720 Grassland Large 30.5 1 22.0 197

t t Fu en

pre-emergence & post-

ou s. rr

herbivorous
th tie cu

harvest of; birds

wi par (a)

Root and Stem veg, Bare soil Small 24.7 1 17.8 244
f
en ird o

Potato
nt th rty

granivorous
co and ope

Bulb and onion like birds

r

crops,
ts
r i er p

Bulb and Small 158.8 1 114 37.9

t o wn the

fruiting veg,
onion like omnivorous
en o s

leafy veg,
m he t i

crops birds
cu f t en

ts

Sugar beet.
do s o um

Pre-sow, pre-planting, 2 × 720 Grassland Large 30.5 1.1 24.2 179

is ht c
th rig s do

pre-emergence & post- (28 d) herbivorous

i

harvest of;
e op Th

birds
Root and Stem veg,
of y

Bare soil Small 24.7 1.1 19.6 222

Potato granivorous
us c
d nd

Bulb and onion like birds

an a

crops,
n rty

Bulb and Small 158.8 1.1 126 34.5

tio e

fruiting veg,
ta op

onion like omnivorous

leafy veg,
loi pr

crops birds
xp al

Sugar beet.
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 32 of 553

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Table 10.1.1-4: Screening assessment of the acute risk for birds due to the use of glyphosate in field

t rib
crops: Uses 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c

dis
n,
er tio
Active substance Glyphosate

wn lica
.
4334

s o ub
Acute toxicity (mg/kg bw)

f it y p
TER criterion 10

so n
ht , a
GAP crop Application Crop Indicator SV90 MAF90 DDD90 TERa

rig ntly
rate scenario species (mg/kg bw/d)

th ue
e eq
(g a.e./ha)

e
lat ns
Pre-sow, pre-planting, 1 × 1080 Grassland Large 30.5 1 32.9 132

vio . Co
an ime al.
pre-emergence & post- herbivorous

te reg new
harvest of; birds

oh tio re

d
Root and Stem veg, Bare soil Small 24.7 1 26.7 163

pr tec EU
ibi n
Potato

d
granivorous

be ro te
e ta p osa
Bulb and onion like birds
crops,

ef da ph
Bulb and Small 158.8 1 172 25.3

er y ly
fruiting veg,

th tor G
onion like omnivorous

ay ula the
leafy veg, crops birds

or
Sugar beet.

t m reg king
Pre-sow, pre-planting, 3 × 720 Grassland Large 30.5 1.1 24.2 179

m er see
pre-emergence & post- (28 d) herbivorous

do ll u tium
en a
harvest of; birds

cu nd
his fa or
Root and Stem veg, Bare soil Small 24.7 1.1 19.6 222
f t ay ns
Potato
r o m co
granivorous
ne ent he

Bulb and onion like birds

ow um of t

crops, Bulb and Small 158.8 1.1 126 34.5

th oc (s)

fruiting veg, onion like omnivorous

of is d ber

leafy veg, crops birds

ion , th em

Sugar beet.
iss ore m

SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio.
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr

Table 10.1.1-5: Screening assessment of the long-term/reproductive risk for birds due to the use of
th tie cu

glyphosate in field crops: Uses 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c

wi par (a)
f
en ird o
nt th rty

Reprod. Toxicity (mg/kg bw/d) 96.3

co and ope

TER criterion 5
r

ts
r i er p
t o wn the

GAP crop Application Crop scenario Indicator SVm MAFm DDDm TERlt
rate species × (mg/kg bw/d)
en o s
m he t i
cu f t en

(g a.e./ha) TWA
ts
do s o um

Pre-sow, pre-planting, 1 × 1440 Grassland Large 16.2 1.0 × 12.4 7.80

is ht c
th rig s do

pre-emergence & post- herbivorous 0.53

harvest of; birds
i
e op Th

Root and Stem veg,

of y

Potato Bare soil Small 11.4 1.0 × 8.70 11.1

us c

Bulb and onion like granivorous 0.53

d nd
an a

crops, birds
n rty

fruiting veg,
tio e
ta op

leafy veg, Bulb and onion Small 64.8 1.0 × 49.5 1.95
loi pr

Sugar beet. like crops omnivorous 0.53

xp al
l e ctu

Post-emergence of weeds birds

cia lle
er te
m s in

Pre-sow, pre-planting, 2 × 1080 Grassland Large 16.2 1.1 × 10.2 9.44

om a

pre-emergence & post- (28 d) herbivorous 0.53

y c uch

harvest of; birds

an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 33 of 553

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Table 10.1.1-5: Screening assessment of the long-term/reproductive risk for birds due to the use of

t rib
glyphosate in field crops: Uses 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c

dis
n,
er tio
Reprod. Toxicity (mg/kg bw/d) 96.3

wn lica
.
5

s o ub
TER criterion

f it y p
GAP crop Application Crop scenario Indicator SVm MAFm DDDm TERlt

so n
ht , a
rate species × (mg/kg bw/d)

rig ntly
(g a.e./ha) TWA

th ue
Root and Stem veg, Bare soil Small 11.4 1.1 × 7.18 13.4

e eq
Potato granivorous 0.53

e
lat ns
vio . Co
Bulb and onion like

an ime al.
birds

te reg new
crops,
fruiting veg,

oh tio re
Bulb and onion Small 64.8 1.1 × 40.8 2.36

d
pr tec EU
leafy veg, like crops omnivorous 0.53

ibi n
d
be ro te
Sugar beet. birds

e ta p osa
Post-emergence of weeds

ef da ph
Pre-sow, pre-planting, 1 × 540 Grassland Large 16.2 1.0 × 4.64 20.8

er y ly
th tor G
pre-emergence & post- herbivorous 0.53

ay ula the
harvest of; birds

or
t m reg king
Root and Stem veg,

m er see
Potato Bare soil Small 11.4 1.0 × 3.26 29.5

do ll u tium
en a
Bulb and onion like granivorous 0.53
crops, birds

cu nd
his fa or
fruiting veg, f t ay ns
r o m co
leafy veg, Bulb and onion Small 64.8 1.0 × 18.6 5.19
ne ent he

Sugar beet. like crops omnivorous 0.53

ow um of t

Post-emergence of weeds birds

th oc (s)
of is d ber
ion , th em

Pre-sow, pre-planting, 1 × 720 Grassland Large 16.2 1.0 × 6.18 15.6

iss ore m

pre-emergence & post- herbivorous 0.53

e
rm m er

harvest of; birds

pe her orm

Root and Stem veg,

he rt t/f
t t Fu en

Potato Bare soil Small 11.4 1.0 × 4.35 22.1

ou s. rr

Bulb and onion like granivorous 0.53

th tie cu
wi par (a)

crops, birds
f

fruiting veg,
en ird o
nt th rty

leafy veg, Bulb and onion Small 64.8 1.0 × 24.7 3.89
co and ope

Sugar beet. like crops omnivorous 0.53

r

ts
r i er p

Post-emergence of weeds birds

t o wn the
en o s
m he t i

Pre-sow, pre-planting, 2 × 720 Grassland Large 16.2 1.1 × 6.80 14.2

cu f t en

ts
do s o um

pre-emergence & post- (28 d) herbivorous 0.53

is ht c

harvest of; birds

th rig s do

Root and Stem veg,

i
e op Th

Potato Bare soil Small 11.4 1.1 × 4.79 20.1

of y

Bulb and onion like granivorous 0.53

us c

crops, birds
d nd

fruiting veg,
an a
n rty

leafy veg, Bulb and onion Small 64.8 1.1 × 27.2 3.54
tio e
ta op

Sugar beet. like crops omnivorous 0.53

loi pr

Post-emergence of weeds birds

xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
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cti
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 34 of 553

ep
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ut
Table 10.1.1-5: Screening assessment of the long-term/reproductive risk for birds due to the use of

t rib
glyphosate in field crops: Uses 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c

dis
n,
er tio
Reprod. Toxicity (mg/kg bw/d) 96.3

wn lica
.
5

s o ub
TER criterion

f it y p
GAP crop Application Crop scenario Indicator SVm MAFm DDDm TERlt

so n
ht , a
rate species × (mg/kg bw/d)

rig ntly
(g a.e./ha) TWA

th ue
Pre-sow, pre-planting, 1 × 1080 Grassland Large 16.2 1.0 × 9.27 10.4

e eq
pre-emergence & post- herbivorous 0.53

e
lat ns
vio . Co
harvest of; birds

an ime al.
te reg new
Root and Stem veg,
Potato

oh tio re
Bare soil Small 11.4 1.0 × 6.53 14.8

d
pr tec EU
Bulb and onion like granivorous 0.53

ibi n
d
be ro te
crops, birds

e ta p osa
fruiting veg,

ef da ph
leafy veg, Bulb and onion Small 64.8 1.0 × 37.1 2.60

er y ly
th tor G
Sugar beet. like crops omnivorous 0.53

ay ula the
Post-emergence of weeds birds

or
t m reg king
m er see
Pre-sow, pre-planting, 3 × 720 Grassland Large 16.2 1.2 × 7.42 13.0

do ll u tium
en a
pre-emergence & post- (28 d) herbivorous 0.53
harvest of; birds

cu nd
his fa or
Root and Stem veg, f t ay ns
r o m co
Potato Bare soil Small 11.4 1.2 × 5.22 18.5
ne ent he

Bulb and onion like granivorous 0.53

ow um of t

crops, birds
th oc (s)
of is d ber

fruiting veg,
ion , th em

leafy veg, Bulb and onion Small 64.8 1.2 × 29.7 3.25
iss ore m

Sugar beet. omnivorous 0.53

e

like crops
rm m er

Post-emergence of weeds birds

pe her orm
he rt t/f
t t Fu en

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
ou s. rr

toxicity to exposure ratio.

th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
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Orchards

t rib
dis
Table 10.1.1-6: Screening assessment of the acute and long-term/reproductive risk for birds due to

n,
er tio
the use of glyphosate in orchards: Uses 4 a-c

wn lica
.
s o ub
f it y p
Active substance Glyphosate

so n
ht , a
Acute toxicity (mg/kg bw) 4334

rig ntly
TER criterion 10

th ue
e eq
GAP crop Application Crop Indicator SV90 MAF90 DDD90 TERa

e
lat ns
rate scenario species (mg/kg bw/d)

vio . Co
an ime al.
(g a.e./ha)

te reg new
Orchards 2 × 1440 Orchards Small 46.8 1.1 74.1 58.5

oh tio re

d
post-emergence of (28 d) insectivorous

pr tec EU
ibi n
weeds birds

d
be ro te
e ta p osa
1 × 720

ef da ph
Orchards Orchards Small 46.8 1.0 33.7 129

er y ly
post-emergence of insectivorous

th tor G
ay ula the
weeds birds

or
t m reg king
Orchards 1 × 1080 Orchards Small 46.8 1.0 50.5 85.7

m er see
post-emergence of insectivorous

do ll u tium
en a
weeds birds

cu nd
his fa or
Orchards 2 × 720 Orchards Small 46.8 1.1
f t ay ns
r o m co 37.1 117
post-emergence of (28 d) insectivorous
ne ent he

weeds birds
ow um of t
th oc (s)

Orchards 1 × 1440 Orchards Small 46.8 1.0 67.4 64.3

of is d ber

post-emergence of insectivorous
ion , th em

weeds birds
iss ore m

e
rm m er

Orchards 3 × 720 Orchards Small 46.8 1.1 37.1 117

pe her orm

post-emergence of (28 d) insectivorous

he rt t/f
t t Fu en

weeds birds
ou s. rr
th tie cu

Orchards 2 × 1080 Orchards Small 46.8 1.1 55.6 78.0

wi par (a)

post-emergence of (28 d) insectivorous

f
en ird o

weeds birds
nt th rty
co and ope

Reprod. Toxicity (mg/kg bw/d) 96.3

r

ts
r i er p
t o wn the

TER criterion 5
en o s
m he t i
cu f t en

ts

GAP crop Application Crop Indicator SVm MAFm DDDm TERlt

do s o um

rate scenario species × TWA (mg/kg bw/d)

is ht c
th rig s do

Orchards 2 × 1440 Orchards Small 18.2 1.1 × 15.3 6.30

i

post-emergence of (28 d) insectivorous 0.53

e op Th

weeds birds
of y
us c

Orchards 1 × 720 Orchards Small 18.2 1.0 × 6.95 13.9

d nd

post-emergence of insectivorous 0.53

an a
n rty

weeds birds
tio e
ta op

Orchards 1 × 1080 Orchards Small 18.2 1.0 × 10.4 9.24

loi pr

insectivorous 0.53
xp al

post-emergence of
l e ctu

weeds birds
cia lle
er te

Orchards 2 × 720 Orchards Small 18.2 1.1 × 7.64 12.6

m s in

post-emergence of (28 d) insectivorous 0.53

om a
y c uch

weeds birds
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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 on
cti
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 36 of 553

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Table 10.1.1-6: Screening assessment of the acute and long-term/reproductive risk for birds due to

t rib
dis
the use of glyphosate in orchards: Uses 4 a-c

n,
er tio
wn lica
Active substance Glyphosate

.
s o ub
Acute toxicity (mg/kg bw) 4334

f it y p
so n
TER criterion 10

ht , a
rig ntly
GAP crop Application Crop Indicator SV90 MAF90 DDD90 TERa

th ue
rate scenario species (mg/kg bw/d)

e eq
(g a.e./ha)

e
lat ns
1 × 1440 Orchards Small 18.2 1.0 × 13.9 6.93

vio . Co
Orchards

an ime al.
te reg new
post-emergence of insectivorous 0.53
weeds birds

oh tio re

d
pr tec EU
Orchards 3 × 720 Orchards Small 18.2 1.2 × 8.33 11.6

ibi n
d
be ro te
post-emergence of (28 d) insectivorous 0.53

e ta p osa
weeds birds

ef da ph
er y ly
Orchards 2 × 1080 Orchards Small 18.2 1.1 × 11.5 8.40

th tor G
ay ula the
post-emergence of (28 d) insectivorous 0.53

or
t m reg king
weeds birds

m er see
SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:

do ll u tium
en a
toxicity to exposure ratio.

cu nd
his fa or
f t ay ns
r o m co

Vineyards
ne ent he
ow um of t

Table 10.1.1-7: Screening assessment of the acute and long-term/reproductive risk for birds due to
th oc (s)
of is d ber

the use of glyphosate in vineyards: Uses 5 a-c

ion , th em
iss ore m

Active substance Glyphosate

rm m er
pe her orm

Acute toxicity (mg/kg bw) 4334

he rt t/f

10
t t Fu en

TER criterion
ou s. rr
th tie cu

GAP crop Application Crop Indicator SV90 MAF90 DDD90 TERa

wi par (a)

rate scenario species (mg/kg bw/d)

f
en ird o

(g a.e./ha)
nt th rty

Vineyard 2 × 1440 Vineyard Small 95.3 1.1 151 28.7

co and ope

post-emergence of (28 d) omnivorous birds

r

ts
r i er p

weeds
t o wn the
en o s

Vineyard 1 × 720 Vineyard Small 95.3 1.0 68.6 63.2

m he t i
cu f t en

ts

post-emergence of omnivorous birds

do s o um

weeds
is ht c
th rig s do

Vineyard 1 × 1080 Vineyard Small 95.3 1.0 103 42.1

i
e op Th

post-emergence of omnivorous birds

weeds
of y
us c

Vineyard 2 × 720 Vineyard Small 95.3 1.1 75.5 57.4

d nd

post-emergence of (28 d) omnivorous birds

an a
n rty

weeds
tio e
ta op
loi pr

Vineyard 3 × 720 Vineyard Small 95.3 1.1 75.5 57.4

xp al

post-emergence of (28 d) omnivorous birds

l e ctu

weeds
cia lle
er te
m s in

Vineyard 1 × 1440 Vineyard Small 95.3 1.0 137 31.6

om a

post-emergence of omnivorous birds

y c uch

weeds
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 37 of 553

ep
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ion
ut
Table 10.1.1-7: Screening assessment of the acute and long-term/reproductive risk for birds due to

t rib
the use of glyphosate in vineyards: Uses 5 a-c

dis
n,
er tio
Active substance Glyphosate

wn lica
.
4334

s o ub
Acute toxicity (mg/kg bw)

f it y p
TER criterion 10

so n
ht , a
GAP crop Application Crop Indicator SV90 MAF90 DDD90 TERa

rig ntly
rate scenario species (mg/kg bw/d)

th ue
e eq
(g a.e./ha)

e
lat ns
Vineyard 2 × 1080 Vineyard Small 95.3 1.1 113 38.3

vio . Co
an ime al.
post-emergence of (28 d) omnivorous birds

te reg new
weeds

oh tio re

d
pr tec EU
ibi n
Reprod. Toxicity (mg/kg bw/d) 96.3

d
be ro te
e ta p osa
TER criterion 5

ef da ph
GAP crop Application Crop Indicator species SVm MAFm DDDm TERlt

er y ly
th tor G
rate scenario × TWA (mg/kg bw/d)

ay ula the
(g a.e./ha)

or
t m reg king
Vineyard 2 × 1440 (28 Vineyard Small 38.9 1.1 × 32.7 2.95
d) omnivorous birds 0.53

m er see
post-emergence of
weeds

do ll u tium
en a
cu nd
his fa or
Vineyard 1 × 720 Vineyard Small 38.9 1.0 × 14.8 6.49
omnivorous birds f t ay ns 0.53
post-emergence of
r o m co
ne ent he

weeds
ow um of t

Vineyard 1 × 1080 Vineyard Small 38.9 1.0 × 22.3 4.32

th oc (s)
of is d ber

post-emergence of omnivorous birds 0.53

ion , th em

weeds
iss ore m

e
rm m er

Vineyard 2 × 720 Vineyard Small 38.9 1.1 × 16.3 5.90

pe her orm

post-emergence of (28 d) omnivorous birds 0.53

he rt t/f

weeds
t t Fu en
ou s. rr
th tie cu

Vineyard 3 × 720 Vineyard Small 38.9 1.2 × 17.8 5.41

wi par (a)

post-emergence of (28 d) omnivorous birds 0.53

f
en ird o

weeds
nt th rty
co and ope

Vineyard 1 × 1440 Vineyard Small 38.9 1.0 × 29.7 3.24

r

ts
r i er p

post-emergence of omnivorous birds 0.53

t o wn the

weeds
en o s
m he t i
cu f t en

ts

Vineyard 2 × 1080 Vineyard Small 38.9 1.1 × 24.5 3.93

do s o um

post-emergence of (28 d) omnivorous birds 0.53

is ht c
th rig s do

weeds
i
e op Th

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER: toxicity to exposure
ratio. TER values shown in bold fall below the relevant trigger
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 38 of 553

ep
,r
ion
ut
Railroad tracks and control of invasive species

t rib
dis
Table 10.1.1-8: Screening assessment of the acute and long-term/reproductive risk for birds due to

n,
the use of glyphosate on railroad tracks and to control invasive species: Uses 7a-b, 8, 9

er tio
wn lica
.
s o ub
Active substance Glyphosate

f it y p
4334

so n
Acute toxicity (mg/kg bw)

ht , a
rig ntly
TER criterion 10

th ue
GAP crop Application Crop Indicator species SV90 MAF90 DDD90 TERa

e eq
rate scenario (mg/kg bw/d)

e
lat ns
vio . Co
(g a.e./ha)

an ime al.
te reg new
Railroad tracks – application 2 × 1800 Grassland Large herbivorous 30.5 1.0 54.9 78.9

oh tio re
by spray train. Post (90 d) birds

d
pr tec EU
emergence of weeds (90d Bare soil Small granivorous 24.7 1.0 44.5 97.5

ibi n
d
be ro te
apart). birds

e ta p osa
1 × 1800 Grassland Large herbivorous 30.5 1.0 54.9 78.9

ef da ph
er y ly
birds

th tor G
ay ula the
Bare soil Small granivorous 24.7 1.0 44.5 97.5

or
t m reg king
birds

m er see
Invasive species in 1 × 1800 Grassland Large herbivorous 30.5 1.0 54.9 78.9
agricultural and non- birds

do ll u tium
en a
agricultural areas. Post Bare soil Small granivorous 24.7 1.0 44.5 97.5

cu nd
his fa or
emergence of invasive birds f t ay ns
r o m co
species. Bulb and Small omnivorous 158.8 1.0 286 15.2
ne ent he
ow um of t

onion like birds

th oc (s)

crops
of is d ber

Reprod. Toxicity 96.3

ion , th em

(mg/kg bw/d)
iss ore m

TER criterion 5
rm m er
pe her orm

GAP crop Application Crop Indicator species SVm MAFm DDDm TERlt
he rt t/f

rate scenario × (mg/kg bw/d)

t t Fu en
ou s. rr

(g a.e./ha) TWA
th tie cu

Railroad tracks – application 2 × 1800 Grassland Large herbivorous 16.2 1.0 × 15.5 6.23
wi par (a)

by spray train. Post (90 d) birds 0.53

f
en ird o

Small granivorous 11.4 1.0 × 10.9 8.85

nt th rty

emergence of weeds (90d Bare soil

co and ope

apart). birds 0.53

r

ts

Large herbivorous 16.2 1.0 × 15.5 6.23

r i er p

1 × 1800 Grassland
t o wn the

birds 0.53
en o s
m he t i

Bare soil Small granivorous 11.4 1.0 × 10.9 8.85

cu f t en

ts

birds 0.53
do s o um

Invasive species in 1 × 1800 Grassland Large herbivorous 16.2 1.0 × 15.5 6.23
is ht c
th rig s do

agricultural and non- birds 0.53

i
e op Th

agricultural areas. Post Bare soil Small granivorous 11.4 1.0 × 10.9 8.85
emergence of invasive birds 0.53
of y

species. Bulb and Small omnivorous 64.8 1.0 × 61.8 1.56

us c
d nd

onion like birds 0.53

an a
n rty

crops
tio e
ta op

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
loi pr

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger
xp al
l e ctu
cia lle
er te
m s in

The screening TERa values for all proposed uses of MON 52276 in field crops, orchards, vineyards, railroad
om a

tracks and control of invasive species are greater than the Commission Regulation (EU) No. 546/2011
y c uch

trigger of 10, indicating that acute risk to birds is acceptable following the proposed use patterns for these
an ts s

crops.
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 39 of 553

ep
,r
ion
ut
Field crops (Uses: 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c)

t rib
dis
The screening TERlt values for use of MON 52276 in field crops for the scenarios “bare soil” and

n,
“grassland” are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5. For the use rate

er tio
wn lica
of 1 × 540 g a.e./ha (Uses 3 a-b) acceptable long-term risk for the “bulbs and onion like crops” scenario is

.
s o ub
concluded in the screening assessment. However, regarding the scenario “bulbs and onion like crops” a

f it y p
Tier 1 risk assessment is necessary for the application rates 1 × 1440 g a.e./ha, 2 × 1080 g a.e./ha, 1 × 720

so n
ht , a
g a.e./ha, 1 × 1080 g a.e./ha and 3 × 720 g a.e./ha.

rig ntly
th ue
e eq
Orchards (Uses: 4 a-c)

e
lat ns
vio . Co
an ime al.
The screening TERlt values for use of MON 52276 are greater than the Commission Regulation (EU)

te reg new
No. 546/2011 trigger of 5, indicating that the long-term risk to birds is acceptable following the proposed

oh tio re

d
use patterns in orchards.

pr tec EU
ibi n
d
be ro te
e ta p osa
Vineyards (Uses: 5a-c)

ef da ph
er y ly
The screening TERlt values for use of MON 52276 are greater than the Commission Regulation (EU)

th tor G
No. 546/2011 trigger of 5 for the application rates; 2 × 720 g a.e./ha, 3 × 720 g a.e./ha, 1 × 1440 g a.e./ha

ay ula the

or
and 2 × 1080 g a.e./ha, indicating that the long-term risk to birds is acceptable following the proposed use

t m reg king
patterns in vineyards. For the application rates of 2 × 1440 g a.e./ha and 1 × 1080 g a.e./ha a Tier 1 risk

m er see
assessment is necessary.

do ll u tium
en a
cu nd
his fa or
Railroad tracks – application by spray train (Uses: 7a-c) f t ay ns
r o m co
ne ent he

The screening TERlt values for use of MON 52276 on railroad tracks are greater than the Commission
ow um of t

Regulation (EU) No. 546/2011 trigger of 5, indicating that the long-term risk to birds is acceptable
th oc (s)

following the proposed use patterns around railroad tracks.

of is d ber
ion , th em

Invasive species in agricultural and non-agricultural areas (Uses: 8 and 9)

iss ore m

e
rm m er
pe her orm

The screening TERlt values for use of MON 52276 on invasive species in agricultural and non-agricultural
he rt t/f

areas for the scenarios “bare soil” and “grassland” are greater than the Commission Regulation (EU) No.
t t Fu en
ou s. rr

546/2011 trigger of 5, indicating that the long-term risk to birds is acceptable following the proposed use
th tie cu

pattern. Regarding the scenario “bulbs and onion like crops” a Tier 1 risk assessment is necessary for the
wi par (a)

intended application rate of 1 × 1800 g a.e./ha.

f
en ird o
nt th rty
co and ope

Tier 1 assessment
r

ts
r i er p
t o wn the

The Tier 1 risk assessment is conducted for those proposed uses, for which the calculated TERlt values are
en o s

below the trigger of 5 in the screening assessment e.g. uses in field crops (except use 3 a-b), uses in
m he t i
cu f t en

ts

vineyards and uses to control invasive species. The Tier 1 assessment initially requires identification of the
do s o um
is ht c

appropriate crop groupings and generic focal bird species from Appendix A of EFSA/2009/1438.
th rig s do
i
e op Th

Due to the proposed uses of the product MON 52276 in agricultural and non-agricultural areas,
of y

justifications are provided below considering which scenarios are relevant for the risk assessment. For those
us c

proposed uses where a large number of scenarios is relevant (Field crops: Use 2 a-c, 6 a-b, 10 a-c, Control
d nd
an a

of invasive species: Use 8 - 9) an approach has been taken to present only the worst-case risk assessment
n rty

in this section. Therefore the worst-case scenarios have been selected based on the relevant generic focal
tio e
ta op

species with the highest short-cut values as these are considered protective of the other scenarios with lower
loi pr
xp al

short-cut values. For completeness, a full and complete avian Tier I risk assessment that considers all other
l e ctu

scenarios and focal species is presented in Annex M-CP 10-01 of this document.
cia lle
er te
m s in

A summary of all relevant scenarios and focal species (includes those presented in this section and in Annex
om a
y c uch

M-CP 10-01 of this document) is provided in the table below. Please note that numbers in brackets refer to
an ts s

the bird scenarios stated in the Appendix A of EFSA/2009/1438.

an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
,r
ion
ut
Field crops (Use 1 a-c, 2 a-c, 6 a-b, 10 a-c)

rib
For the Tier 1 assessment of the crop group “field crops”, the intended use of MON 52276 includes several

t
dis
general uses on field crops as described further below. The applications are intended to be made by tractor

n,
er tio
mounted sprayers (Uses 1 a-c, 2 a-c, 6 a-b) or by hand-held equipment (Uses 10 a-c).

wn lica
.
s o ub
f it y p
Use 1 a-c is, the “pre-sowing, pre-planting, pre-emergence” use, where the intention of this use is to prepare

so n
a non-agricultural area for agriculture use, meaning that the product is applied when no agricultural crop is

ht , a
rig ntly
present. Therefore the “bare soil”, the “grassland” and the “leafy vegetable” scenarios are considered

th ue
relevant. As an acceptable risk for the “bare soil” and “grassland” scenarios was concluded at the screening

e eq
e
lat ns
assessment, a Tier 1 risk assessment will be presented only for “leafy vegetables”. The “leafy vegetables”

vio . Co
an ime al.
scenario was considered relevant to cover species that feed on broad-leaved weeds; the small granivorous

te reg new
bird “finch” (71, 72), the small omnivorous bird “lark” (79, 81), the medium herbivorous/granivorous bird

oh tio re

d
“pigeon” (82) and the small insectivorous bird “wagtail” (83, 84) are taken into account.

pr tec EU
ibi n
d
be ro te
e ta p osa
Uses 2 a-c and 10 a-c are the “post-harvest, pre-sowing, pre-planting” use where the product can be applied

ef da ph
to existing cropland after harvest for removal of remaining crops. Thus, for this use almost all field crops

er y ly
th tor G
need to be considered. Only for those crops where safe risk could be concluded in the screening assessment,

ay ula the
i.e. “bare soil” and “grassland” and for crops which are generally not considered relevant (“cotton”) or for

or
t m reg king
spatial cultures like “bush & cane fruit”, “hops”, “orchards”, “ornamentals/nursery” and “vineyards” a risk

m er see
assessment is not considered necessary. As the product is applied after post-harvest, late crop stages will

do ll u tium
en a
be taken into account for risk assessment. Frugivorous bird scenarios were not taken into account, as the

cu nd
his fa or
product is intended to be applied after harvest and will not be applied at typical crop stages when fruits are
f t ay ns
ripe. For the same reason also the two cereals scenario (late post emergence (May-June), BBCH 71 – 89
r o m co
ne ent he

(19); late season, seed heads (35)) and the sunflower scenario (Late (Flowering, seed ripening) BBCH 61
ow um of t

– 92 (216) are not considered relevant.

th oc (s)
of is d ber

Thus, for the Tier 1 risk assessment for the uses 2 a-c and 10 a-c, the relevant generic focal species with the
ion , th em
iss ore m

highest short-cut values at late crop stages across all relevant crop scenarios were taken into account; the
e
rm m er

medium granivorous bird “gamebird” in maize (101), the medium herbivorous / granivorous bird “pigeon”
pe her orm

in maize (117), the small insectivorous bird “dunnock” (120), the small granivorous bird “finch” in oilseed
he rt t/f
t t Fu en

rape (122), the small insectivorous bird “wagtail” in bulbs & onion like crops (18) and the small omnivorous
ou s. rr
th tie cu

bird “lark” in bulbs & onion like crops (16). These selected scenarios cover the risk for all relevant
wi par (a)

scenarios. For completeness, a risk assessment for all other relevant scenarios and species is presented in
f
en ird o

Annex M-CP 10-01 of this document.

nt th rty
co and ope
r

Uses 6 a-b are the “shielded ground directed inter-row application” uses at crop stages <BBCH 20 and all
ts
r i er p
t o wn the

crops scenarios at early growth stages are taken into account, which are presented in the GAP, i.e.
en o s
m he t i

vegetables (root and tuber vegetables, bulb vegetables, fruiting vegetables, legume vegetables and leafy
cu f t en

ts
do s o um

vegetables). To avoid exposure of crops, a shielded sprayer is used to ensure that the product is only applied
is ht c

to grasses and weeds in the inter-row. Therefore, only those vegetables crop scenarios are considered
th rig s do

relevant where the generic focal species does not directly feed on the crop. In addition, the “bare soil” and
i
e op Th

the “grassland” scenario are considered relevant. However, as an acceptable risk was concluded for these
of y

scenarios already at the screening assessment the Tier 1 risk assessment is not required.
us c
d nd
an a

Thus, for the tier 1 risk assessment for the uses 6a-b, the relevant generic focal species with the highest
n rty
tio e

short-cut values at early crop stages (<BBCH 20) across all relevant crops scenarios were taken into
ta op
loi pr

account, i.e. the medium herbivorous/granivorous bird “pigeon” in leafy vegetables (82), the small
xp al

insectivorous bird “wagtail” in bulbs & onion like crops (17), the small omnivorous bird “lark” in bulbs &
l e ctu
cia lle

onion like crops (14) and the small granivorous bird “finch” in leafy vegetables (71). These selected
er te
m s in

scenarios cover the risk for all relevant scenarios. For completeness, a risk assessment for all other relevant
om a

scenarios and species is presented in Annex M-CP 10-01 of this document.

y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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d/
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
,r
ion
ut
Vineyards (Use 5 a-c)

rib
For the crop grouping “vines“ all non-frugivorous bird scenarios were taken into account, i.e. the small

t
dis
insectivorous bird “redstart” (217, 218), the small granivorous bird “finch” (219, 220, 221) and the small

n,
er tio
omnivorous bird “lark” (231, 232, 233) are taken into account.

wn lica
.
s o ub
f it y p
Invasive species in agricultural and non-agricultural areas (Use 8-9)

so n
For the use on invasive species in agricultural and non-agricultural areas, almost all crops need to be

ht , a
rig ntly
considered. Only for those crops where safe risk could be proven in the screening assessment, i.e. “bare

th ue
soil” and “grassland” or which are not considered relevant (“cotton”) do not need to be assessed in the Tier

e eq
e
lat ns
1 risk assessment. In general, those scenarios need to be taken into account, where a downward application

vio . Co
an ime al.
of the product is relevant. Frugivorous bird scenarios were not taken into account, as the product is intended

te reg new
to be applied only on the invasive species Giant hogweed (Heracleum mantegazzianum) and Japanese

oh tio re

d
knotweed (Reynoutria japonica) and due to the specific application method (handheld, spraying shield)

pr tec EU
ibi n
fruits will not be exposed to the product. For the same reason also the cereal scenario (late season, seed

d
be ro te
e ta p osa
heads; 35) and the sunflower scenario (Late (Flowering, seed ripening) BBCH 61 – 92 (216) are not

ef da ph
considered relevant.

er y ly
th tor G
ay ula the
Thus, for the Tier 1 risk assessment for uses 8 and 9, the relevant generic focal species with the highest

or
t m reg king
short-cut values across all relevant crop scenarios were taken into account, i.e. the large herbivorous bird

m er see
“goose” in cereals (22), the medium granivorous bird “gamebird” in maize (99), the medium herbivorous

do ll u tium
en a
granivorous bird “pigeon” in leafy vegetables (82), the small granivorous bird “finch” in leafy vegetables

cu nd
his fa or
(71), the small insectivorous bird “dunnock” in oilseed rape (120), the small insectivorous bird “finch” in
f t ay ns
hop (66), the small insectivorous bird “passerine” in cereals (21), the small insectivorous bird “tit” in
r o m co
ne ent he

orchards (141), the small insectivorous bird “wagtail” in bulbs and onion like crops (17), the small
ow um of t

insectivorous bird “warbler” in bush and cane fruit (20), the small insectivorous bird “redstart” in vineyards
th oc (s)

(217), the small insectivorous / worm feeding species “thrush” in maize (102), and the small omnivorous
of is d ber

bird “lark” (14). These selected scenarios cover the risk for all relevant scenarios. For completeness, a risk
ion , th em
iss ore m

assessment for all other relevant scenarios and species is presented in

e
rm m er

Annex M-CP 10-01 of this document.

pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 42 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
Field crops (Pre-sowing, pre-planting, pre-emergence): Use 1 a-c

er y ly
th tor G
ay ula the
No. 71 Leafy vegetables Small granivorous bird “finch” 12.6 MCP 10.1.1

or
t m reg king
BBCH 10 – 49 Serin (Serinus serinus)

m er see
No. 72 Leafy vegetables Small granivorous bird “finch” 3.8 MCP 10.1.1

do ll u tium
en a
BBCH ≥ 50 Serin (Serinus serinus)

cu nd
his fa or
f t ay ns
No. 79 Leafy vegetables Small omnivorous bird “lark” 10.9 MCP 10.1.1

r o m co
BBCH 10 – 49 Woodlark (Lullula arborea)

ne ent he
ow um of t
No. 81 Leafy vegetables Small omnivorous bird “lark” 3.3 MCP 10.1.1

th oc (s)
BBCH ≥ 50 Woodlark (Lullula arborea)

of is d ber
No. 82 Leafy vegetables Medium herbivorous/granivorous bird 22.7 MCP 10.1.1

ion , th em
iss ore m
Leaf development BBCH 10 – 19 “pigeon”

e
rm m er
pe her orm
No. 83 Leafy vegetables Small insectivorous bird “wagtail” 11.3 MCP 10.1.1

he rt t/f
BBCH 10 – 19 Yellow wagtail (Motacilla flava)
t t Fu en
ou s. rr
No. 84 Leafy vegetables Small insectivorous bird “wagtail” 9.7 MCP 10.1.1
th tie cu

BBCH ≥ 20 Yellow wagtail (Motacilla flava)

wi par (a)
f
en ird o

Field crops (Post-harvest, pre-sowing, pre-planting): Use 2 a-c, 10 a-c

nt th rty
co and ope
r

No. 7 Bulb and onion like crops Small granivorous bird “finch” 6.9 Annex M-CP 10-01
ts
r i er p
t o wn the

BBCH ≥ 40 Linnet (Carduelis cannabina) (Covered by scenario no. 122)

en o s
m he t i

No. 16 Bulb and onion like crops Small omnivorous bird “lark” 6.5 MCP 10.1.1
cu f t en

ts
do s o um

BBCH ≥ 40 Woodlark (Lullula arborea) (Worst case scenario)

is ht c
th rig s do

No. 18 Bulb and onion like crops Small insectivorous bird “wagtail” 9.7 MCP 10.1.1
i
e op Th

BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Worst case scenario)

of y

No. 34 Cereals Small omnivorous bird “lark” 3.3 Annex M-CP 10-01
us c

BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no. 16)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 43 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
No. 49 Fruiting vegetables Small granivorous bird “finch” 3.4 Annex M-CP 10-01

er y ly
BBCH ≥ 50 Linnet (Carduelis cannabina) (Covered by scenario no. 7)

th tor G
ay ula the
No. 58 Fruiting vegetables Small omnivorous bird “lark” 3.3 Annex M-CP 10-01

or
t m reg king
BBCH ≥ 50 Woodlark (Lullula arborea) (Covered by scenario no 16)

m er see
No. 61 Fruiting vegetables Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01

do ll u tium
en a
BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 18)

cu nd
his fa or
f t ay ns
No. 72 Leafy vegetables Small granivorous bird “finch” 3.8 Annex M-CP 10-01

r o m co
BBCH ≥ 50 Serin (Serinus serinus) (Covered by scenario no. 7)

ne ent he
ow um of t
No. 81 Leafy vegetables Small omnivorous bird “lark” 3.3 Annex M-CP 10-01

th oc (s)
BBCH ≥ 50 Woodlark (Lullula arborea) (Covered by scenario no 16)

of is d ber
No. 84 Leafy vegetables Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01

ion , th em
BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 18)

iss ore m

e
rm m er
pe her orm
No. 86 Legume forage Small granivorous bird “finch” 3.4 Annex M-CP 10-01
BBCH ≥ 50 Linnet (Carduelis cannabina) (Covered by scenario no. 7)

he rt t/f
t t Fu en
ou s. rr
No. 95 Legume forage Small omnivorous bird “lark” 3.3 Annex M-CP 10-01
th tie cu

BBCH ≥ 50 Woodlark (Lullula arborea) (Covered by scenario no 16)

wi par (a)
f
en ird o

No. 98 Legume forage Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01
nt th rty

BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 18)

co and ope
r

ts
r i er p

No. 101 Maize Medium granivorous bird “gamebird” 0.8 MCP 10.1.1
t o wn the

BBCH ≥ 40 Partridge (Perdix perdix) (Worst case scenario)

en o s
m he t i

No. 114 Maize Small omnivorous bird “lark” 2.7 Annex M-CP 10-01
cu f t en

ts
do s o um

BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no 16)

is ht c
th rig s do

No. 117 Maize Medium herbivorous/granivorous bird 5.7 MCP 10.1.1

i
e op Th

BBCH ≥ 40 “pigeon” (Worst case scenario)

of y

No. 119 Maize Small insectivorous bird “wagtail” 4.8 Annex M-CP 10-01
us c

BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 18)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
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ht
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 44 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
No. 120 Oilseed rape Small insectivorous bird “dunnock” 2.7 MCP 10.1.1

er y ly
Late (with seeds) BBCH 30 – 99 Dunnock (Prunella modularis) (Worst case scenario)

th tor G
ay ula the
No. 122 Oilseed rape Small granivorous bird “finch” 11.4 MCP 10.1.1

or
t m reg king
Late (with seeds) BBCH 80 – 99 Linnet (Carduelis cannabina) (Worst case scenario)

m er see
No. 134 Oilseed rape Small omnivorous bird “lark” 2.7 Annex M-CP 10-01

do ll u tium
en a
BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no 16)

cu nd
his fa or
f t ay ns
No. 138 Oilseed rape Medium herbivorous/granivorous bird “pigeon” 0.9 Annex M-CP 10-01

r o m co
BBCH ≥ 40 Wood pigeon (Columba palumbus) (Covered by scenario no 117)

ne ent he
ow um of t
No. 160 Potatoes Small omnivorous bird “lark” 3.3 Annex M-CP 10-01

th oc (s)
BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no 16)

of is d ber
No. 162 Potatoes Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01

ion , th em
BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 18)

iss ore m

e
rm m er
pe her orm
No. 164 Pulses Small granivorous bird “finch” 3.4 Annex M-CP 10-01
BBCH ≥ 50 Linnet (Carduelis cannabina) (Covered by scenario no. 7)

he rt t/f
t t Fu en
ou s. rr
No. 173 Pulses Small omnivorous bird “lark” 3.3 Annex M-CP 10-01
th tie cu

BBCH ≥ 50 Woodlark (Lullula arborea) (Covered by scenario no 16)

wi par (a)
f
en ird o

No. 176 Pulses Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01
nt th rty

BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 18)

co and ope
r

No. 178 Root & stem vegetables Small granivorous bird “finch” 3.4 Annex M-CP 10-01
ts
r i er p
t o wn the

BBCH ≥ 40 Linnet (Carduelis cannabina) (Covered by scenario no. 7)

en o s
m he t i

No. 187 Root & stem vegetables Small omnivorous bird “lark” 3.3 Annex M-CP 10-01
cu f t en

ts
do s o um

BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no 16)

is ht c
th rig s do

No. 189 Root & stem vegetables Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01
i

BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 18)

e op Th
of y

No. 198 Strawberries Small omnivorous bird “lark” 4.4 Annex M-CP 10-01
us c

BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no 16)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
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s
ht
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 45 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
No. 201 Strawberries Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01

er y ly
BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 18)

th tor G
ay ula the
Field crops (Shielded ground directed inter-row application): Use 6a, b

or
t m reg king
m er see
No. 6 Bulbs and onion like crops Small granivorous bird “finch” 11.4 Annex M-CP 10-01

do ll u tium
en a
BBCH 10 – 39 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

cu nd
his fa or
f t ay ns
No. 14 Bulbs and onion like crops Small omnivorous bird “lark” 10.9 MCP 10.1.1

r o m co
BBCH 10 – 39 Woodlark (Lullula arborea) (Worst case scenario)

ne ent he
ow um of t
No. 17 Bulbs and onion like crops Small insectivorous bird “wagtail” 11.3 MCP 10.1.1

th oc (s)
BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Worst case scenario)

of is d ber
No. 48 Fruiting vegetables Small granivorous bird “finch” 11.4 Annex M-CP 10-01

ion , th em
BBCH 10 – 49 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

iss ore m

e
rm m er
pe her orm
No. 56 Fruiting vegetables Small omnivorous bird “lark” 10.9 Annex M-CP 10-01
BBCH 10 – 49 Woodlark (Lullula arborea) (Covered by scenario no. 14)

he rt t/f
t t Fu en
ou s. rr
No. 60 Fruiting vegetables Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01
th tie cu

BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

wi par (a)
f
en ird o

No. 71 Leafy vegetables Small granivorous bird “finch” 12.6 MCP 10.1.1
nt th rty

BBCH 10 – 49 Serin (Serinus serinus) (Worst case scenario)

co and ope
r

No. 79 Leafy vegetables Small omnivorous bird “lark” 10.9 Annex M-CP 10-01
ts
r i er p
t o wn the

BBCH 10 – 49 Woodlark (Lullula arborea) (Covered by scenario no. 14)

en o s
m he t i

No. 82 Leafy vegetables Medium herbivorous/granivorous bird 22.71 MCP 10.1.1

cu f t en

ts
do s o um

Leaf development BBCH 10 – 19 “pigeon” (Worst case scenario)

is ht c
th rig s do

No. 83 Leafy vegetables Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01
i

BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

e op Th
of y

No. 85 Legume forage Small granivorous bird “finch” 11.4 Annex M-CP 10-01
us c

BBCH 10 – 49 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
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s
ht
 di
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.
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 46 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
No. 93 Legume forage Small omnivorous bird “lark” 10.9 Annex M-CP 10-01

er y ly
BBCH 10 – 49 Woodlark (Lullula arborea) (Covered by scenario no. 14)

th tor G
ay ula the
No. 97 Legume forage Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01

or
t m reg king
BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

m er see
No. 158 Potatoes Small omnivorous bird “lark” 10.9 Annex M-CP 10-01

do ll u tium
en a
BBCH 10 – 39 Woodlark (Lullula arborea) (Covered by scenario no. 14)

cu nd
his fa or
f t ay ns
No. 161 Potatoes Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01

r o m co
BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

ne ent he
ow um of t
No. 163 Pulses Small granivorous bird “finch” 11.4 Annex M-CP 10-01

th oc (s)
BBCH 10 – 49 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

of is d ber
No. 171 Pulses Small omnivorous bird “lark” 10.9 Annex M-CP 10-01

ion , th em
BBCH 10 – 49 Woodlark (Lullula arborea) (Covered by scenario no. 14)

iss ore m

e
rm m er
pe her orm
No. 174 Pulses Medium herbivorous/granivorous bird “pigeon” 22.7 Annex M-CP 10-01
Leaf development BBCH 10 – 19 Wood pigeon (Columba palumbus) (Covered by scenario no. 82)

he rt t/f
t t Fu en
ou s. rr
No. 175 Pulses Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01
th tie cu

BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

wi par (a)
f
en ird o

No. 177 Root & stem vegetables Small granivorous bird “finch” 11.4 Annex M-CP 10-01
nt th rty

BBCH 10 – 39 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

co and ope
r

No. 185 Root & stem vegetables Small omnivorous bird “lark” 10.9 Annex M-CP 10-01
ts
r i er p
t o wn the

BBCH 10 – 39 Woodlark (Lullula arborea) (Covered by scenario no. 14)

en o s
m he t i

No. 188 Root & stem vegetables Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01
cu f t en

ts
do s o um

BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

is ht c
th rig s do

No. 206 Sugar beet Small omnivorous bird “lark” 10.9 Annex M-CP 10-01
i

Early (spring) (BBCH 10 – 19) Woodlark (Lullula arborea) (Covered by scenario no. 14)
e op Th
of y

No. 207 Sugar beet Small insectivorous bird “wagtail” 5.9 Annex M-CP 10-01
us c

BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
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ht
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ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 47 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
Vineyard: Use 5 a-c

er y ly
th tor G
ay ula the
No. 217 Vineyard Small insectivorous bird “redstart” 11.5 MCP 10.1.1

or
t m reg king
BBCH 10 – 19 Black redstart (Phoenicurus ochruros)

m er see
No. 218 Vineyard Small insectivorous bird “redstart” 9.9 MCP 10.1.1

do ll u tium
en a
BBCH 20 – 39 Black redstart (Phoenicurus ochruros)

cu nd
his fa or
f t ay ns
No. 219 Vineyard Small granivorous bird “finch” 6.9 MCP 10.1.1

r o m co
BBCH 10 – 19 Linnet (Carduelis cannabina)

ne ent he
ow um of t
No. 220 Vineyard Small granivorous bird “finch” 5.7 MCP 10.1.1

th oc (s)
BBCH 20 – 39 Linnet (Carduelis cannabina)

of is d ber
No. 221 Vineyard Small granivorous bird “finch” 3.4 MCP 10.1.1

ion , th em
iss ore m
BBCH ≥ 40 Linnet (Carduelis cannabina)

e
rm m er
pe her orm
No. 231 Vineyard Small omnivorous bird “lark” 6.5 MCP 10.1.1

he rt t/f
BBCH 10 – 19 Woodlark (Lullula arborea)
t t Fu en
ou s. rr
No. 232 Vineyard Small omnivorous bird “lark” 5.4 MCP 10.1.1
th tie cu

BBCH 20 – 39 Woodlark (Lullula arborea)

wi par (a)
f
en ird o

No. 233 Vineyard Small omnivorous bird “lark” 3.3 MCP 10.1.1
nt th rty

BBCH ≥ 40 Woodlark (Lullula arborea)

co and ope
r

Control of invasive species in agricultural and non-agricultural areas: Use 8 - 9

ts
r i er p
t o wn the
en o s
m he t i

No. 6 Bulbs and onion like crops Small granivorous bird “finch” 11.4 Annex M-CP 10-01
cu f t en

ts
do s o um

BBCH 10 – 39 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

is ht c
th rig s do

No. 7 Bulb and onion like crops Small granivorous bird “finch” 6.9 Annex M-CP 10-01
i

BBCH ≥ 40 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

e op Th
of y

No. 14 Bulbs and onion like crops Small omnivorous bird “lark” 10.9 MCP 10.1.1
us c

BBCH 10 – 39 Woodlark (Lullula arborea) (Worst case scenario)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 48 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
No. 16 Bulb and onion like crops Small omnivorous bird “lark” 6.5 Annex M-CP 10-01

er y ly
BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no. 14)

th tor G
ay ula the
No. 17 Bulbs and onion like crops Small insectivorous bird “wagtail” 11.3 MCP 10.1.1

or
t m reg king
BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Worst case scenario)

m er see
No. 18 Bulb and onion like crops Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01

do ll u tium
en a
BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

cu nd
his fa or
f t ay ns
No. 20 Bush & cane fruit Small insectivorous bird “warbler” 20.3 MCP 10.1.1

r o m co
Whole season BBCH 00 – 79 Currants Willow warbler (Phylloscopus trochilus) (Worst case scenario)

ne ent he
ow um of t
No. 21 Cereals Small insectivorous bird “passerine” 22.4 MCP 10.1.1

th oc (s)
Late post-emergence (May-June) Fan tailed warbler (Worst case scenario)

of is d ber
BBCH 71 – 89

ion , th em
iss ore m
No. 22 Cereals Large herbivorous bird “goose” 16.2 MCP 10.1.1

e
rm m er
Early (shoots) autumn-winter BBCH 10 – 29 Pink-foot goose (Anser brachyrhynchus) (Worst case scenario)

pe her orm
No. 31 Cereals Small omnivorous bird “lark” 10.9 Annex M-CP 10-01

he rt t/f
t t Fu en
BBCH 10 – 29 ou s. rr Woodlark (Lullula arborea) (Covered by scenario no. 14)
th tie cu

No. 33 Cereals Small omnivorous bird “lark” 5.4 Annex M-CP 10-01
wi par (a)

BBCH 30 – 39 Woodlark (Lullula arborea) (Covered by scenario no. 14)

f
en ird o
nt th rty

No. 34 Cereals Small omnivorous bird “lark” 3.3 Annex M-CP 10-01
co and ope

BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no. 14)

r

ts
r i er p
t o wn the

No. 48 Fruiting vegetables Small granivorous bird “finch” 11.4 Annex M-CP 10-01
en o s

BBCH 10 – 49 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

m he t i
cu f t en

ts
do s o um

No. 49 Fruiting vegetables Small granivorous bird “finch” 3.4 Annex M-CP 10-01
is ht c

BBCH ≥ 50 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

th rig s do
i

No. 56 Fruiting vegetables Small omnivorous bird “lark” 10.9 Annex M-CP 10-01
e op Th

BBCH 10 – 49 Woodlark (Lullula arborea) (Covered by scenario no. 14)

of y
us c

No. 58 Fruiting vegetables Small omnivorous bird “lark” 3.3 Annex M-CP 10-01
d nd

BBCH ≥ 50 Woodlark (Lullula arborea) (Covered by scenario no. 14)

an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
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er tio
wn lica
.
s o ub
f it y p
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ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 49 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
No. 60 Fruiting vegetables Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01

er y ly
BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

th tor G
ay ula the
No. 61 Fruiting vegetables Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01

or
t m reg king
BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

m er see
No. 66 Hops Small insectivorous bird “finch” 9.1 MCP 10.1.1

do ll u tium
en a
BBCH 10 – 19 Chaffinch (Fringilla colebs) (Worst case scenario)

cu nd
his fa or
f t ay ns
No. 67 Hops Small insectivorous bird “finch” 10.6 Annex M-CP 10-01

r o m co
BBCH ≥ 20 Chaffinch (Fringilla colebs) (Covered by scenario no. 66)

ne ent he
ow um of t
No. 68 Hops Small granivorous bird “finch” 11.4 Annex M-CP 10-01

th oc (s)
BBCH 10 – 19 Goldfinch (Carduelis carduelis) (Covered by scenario no. 71)

of is d ber
No. 69 Hops Small granivorous bird “finch” 5.7 Annex M-CP 10-01

ion , th em
BBCH 20 – 39 Goldfinch (Carduelis carduelis) (Covered by scenario no. 71)

iss ore m

e
rm m er
pe her orm
No. 70 Hops Small granivorous bird “finch” 3.4 Annex M-CP 10-01
BBCH ≥ 40 Goldfinch (Carduelis carduelis) (Covered by scenario no. 71)

he rt t/f
t t Fu en
ou s. rr
No. 71 Leafy vegetables Small granivorous bird “finch” 12.6 MCP 10.1.1
th tie cu

BBCH 10 – 49 Serin (Serinus serinus) (Worst case scenario)

wi par (a)
f
en ird o

No. 72 Leafy vegetables Small granivorous bird “finch” 3.8 Annex M-CP 10-01
nt th rty

BBCH ≥ 50 Serin (Serinus serinus) (Covered by scenario no. 71)

co and ope
r

No. 79 Leafy vegetables Small omnivorous bird “lark” 10.9 Annex M-CP 10-01
ts
r i er p
t o wn the

BBCH 10 – 49 Woodlark (Lullula arborea) (Covered by scenario no. 14)

en o s
m he t i

No. 81 Leafy vegetables Small omnivorous bird “lark” 3.3 Annex M-CP 10-01
cu f t en

ts
do s o um

BBCH ≥ 50 Woodlark (Lullula arborea) (Covered by scenario no. 14)

is ht c
th rig s do

No. 82 Leafy vegetables Medium herbivorous/granivorous bird 22.71 MCP 10.1.1

i
e op Th

Leaf development BBCH 10 – 19 “pigeon” (Worst case scenario)

of y

No. 83 Leafy vegetables Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01
us c

BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
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er tio
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.
s o ub
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ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 50 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
No. 84 Leafy vegetables Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01

er y ly
BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

th tor G
ay ula the
No. 85 Legume forage Small granivorous bird “finch” 11.4 Annex M-CP 10-01

or
t m reg king
BBCH 10 – 49 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

m er see
No. 86 Legume forage Small granivorous bird “finch” 3.4 Annex M-CP 10-01

do ll u tium
en a
BBCH ≥ 50 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

cu nd
his fa or
f t ay ns
No. 93 Legume forage Small omnivorous bird “lark” 10.9 Annex M-CP 10-01

r o m co
BBCH 10 – 49 Woodlark (Lullula arborea) (Covered by scenario no. 14)

ne ent he
ow um of t
No. 94 Legume forage Small omnivorous bird “lark” 3.3 Annex M-CP 10-01

th oc (s)
BBCH ≥ 50 Woodlark (Lullula arborea) (Covered by scenario no. 14)

of is d ber
No. 96 Legume forage Medium herbivorous/granivorous bird “pigeon” 22.7 Annex M-CP 10-01

ion , th em
Leaf development BBCH 21 – 49 Wood pigeon (Columba palumbus) (Covered by scenario no. 14)

iss ore m

e
rm m er
pe her orm
No. 97 Legume forage Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01
BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

he rt t/f
t t Fu en
ou s. rr
No. 98 Legume forage Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01
th tie cu

BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

wi par (a)
f
en ird o

No. 99 Maize Medium granivorous bird 3.0 MCP 10.1.1

nt th rty

BBCH 10 – 29 “gamebird” Partridge (Perdix perdix) (Worst case scenario)

co and ope
r

No. 100 Maize Medium granivorous bird 1.5 Annex M-CP 10-01
ts
r i er p
t o wn the

BBCH 30 – 39 “gamebird” Partridge (Perdix perdix) (Covered by scenario no. 99)

en o s
m he t i

No. 101 Maize Medium granivorous bird “gamebird” 0.8 Annex M-CP 10-01
cu f t en

ts
do s o um

BBCH ≥ 40 Partridge (Perdix perdix) (Covered by scenario no 99)

is ht c
th rig s do

No. 102 Maize Small insectivorous / worm feeding species 5.7 MCP 10.1.1
i
e op Th

Leaf development BBCH 10 – 19 “thrush” (Worst case scenario)

of y

No. 111 Maize Small omnivorous bird “lark” 10.9 Annex M-CP 10-01
us c

BBCH 10 – 29 Woodlark (Lullula arborea) (Covered by scenario no. 14)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
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.
s o ub
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ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 51 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
No. 113 Maize Small omnivorous bird “lark” 5.4 Annex M-CP 10-01

er y ly
BBCH 30 – 39 Woodlark (Lullula arborea) (Covered by scenario no. 14)

th tor G
ay ula the
No. 114 Maize Small omnivorous bird “lark” 2.7 Annex M-CP 10-01

or
t m reg king
BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no. 14)

m er see
No. 115 Maize Medium herbivorous/granivorous bird “pigeon” 22.7 Annex M-CP 10-01

do ll u tium
en a
BBCH 10 – 29 Wood pigeon (Columba palumbus) (Covered by scenario no. 14)

cu nd
his fa or
f t ay ns
No. 116 Maize Medium herbivorous/granivorous bird “pigeon” 11.4 Annex M-CP 10-01

r o m co
BBCH 30 – 39 Wood pigeon (Columba palumbus) (Covered by scenario no. 14)

ne ent he
ow um of t
No. 117 Maize Medium herbivorous/granivorous bird “pigeon” 5.7 Annex M-CP 10-01

th oc (s)
BBCH ≥ 40 Wood pigeon (Columba palumbus) (Covered by scenario no. 14)

of is d ber
No. 118 Maize Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01

ion , th em
BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

iss ore m

e
rm m er
pe her orm
No. 119 Maize Small insectivorous bird “wagtail” 4.8 Annex M-CP 10-01
BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

he rt t/f
t t Fu en
ou s. rr
No. 120 Oilseed rape Small insectivorous bird “dunnock” 2.7 MCP 10.1.1
th tie cu

Late (with seeds) BBCH 30 – 99 Dunnock (Prunella modularis) (Worst case scenario)
wi par (a)
f
en ird o

No. 121 Oilseed rape Large herbivorous bird “goose” 15.9 Annex M-CP 10-01
nt th rty

Early (shoots) BBCH 10 – 19 Greylag goose (Anser anser) (Covered by scenario no. 22)
co and ope
r

No. 122 Oilseed rape Small granivorous bird “finch” 11.4 Annex M-CP 10-01
ts
r i er p
t o wn the

Late (with seeds) BBCH 80 – 99 Linnet (Carduelis cannabina) (Covered by scenario no. 71)
en o s
m he t i

No. 131 Oilseed rape Small omnivorous bird “lark” 10.9 Annex M-CP 10-01
cu f t en

ts
do s o um

BBCH 10 – 29 Woodlark (Lullula arborea) (Covered by scenario no. 14)

is ht c
th rig s do

No. 133 Oilseed rape Small omnivorous bird “lark” 3.3 Annex M-CP 10-01
i

BBCH 30 – 39 Woodlark (Lullula arborea) (Covered by scenario no. 14)

e op Th
of y

No. 134 Oilseed rape Small omnivorous bird “lark” 2.7 Annex M-CP 10-01
us c

BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no. 14)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
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er tio
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.
s o ub
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ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 52 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
No. 135 Oilseed rape Medium herbivorous/granivorous bird “pigeon” 22.7 Annex M-CP 10-01

er y ly
BBCH 10 – 19 Wood pigeon (Columba palumbus) (Covered by scenario no. 14)

th tor G
ay ula the
No. 136 Oilseed rape Medium herbivorous/granivorous bird “pigeon” 3.5 Annex M-CP 10-01

or
t m reg king
BBCH 20 – 29 Wood pigeon (Columba palumbus) (Covered by scenario no. 14)

m er see
No. 137 Oilseed rape Medium herbivorous/granivorous bird “pigeon” 1.1 Annex M-CP 10-01

do ll u tium
en a
BBCH 30 – 39 Wood pigeon (Columba palumbus) (Covered by scenario no. 14)

cu nd
his fa or
f t ay ns
No. 138 Oilseed rape Medium herbivorous/granivorous bird “pigeon” 0.9 Annex M-CP 10-01

r o m co
BBCH ≥ 40 Wood pigeon (Columba palumbus) (Covered by scenario no. 14)

ne ent he
ow um of t
No. 139 Oilseed rape Small insectivorous bird “wagtail” 5.9 Annex M-CP 10-01

th oc (s)
BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

of is d ber
No. 140 Oilseed rape Small insectivorous bird “wagtail” 2.8 Annex M-CP 10-01

ion , th em
BBCH 20 – 29 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

iss ore m

e
rm m er
pe her orm
No. 141 Orchard Small insectivorous bird “tit” 18.2 MCP 10.1.1

he rt t/f
Spring Summer Bluetit (Parus caeruleus) (Worst case scenario)
t t Fu en
ou s. rr
No. 142 Orchard Small insectivorous/worm feeding species “thrush” 2.7 Annex M-CP 10-01
th tie cu

Not crop directed application all season Robin (Erithacus rubecula) (Covered by scenario no. 14)
wi par (a)
f
en ird o

No. 146 Orchard Small granivorous bird “finch” 12.6 Annex M-CP 10-01
nt th rty

Not crop directed application all season Serin (Serinus serinus) (Covered by scenario no. 71)
co and ope
r

No. 158 Potatoes Small omnivorous bird “lark” 10.9 Annex M-CP 10-01
ts
r i er p
t o wn the

BBCH 10 – 39 Woodlark (Lullula arborea) (Covered by scenario no. 14)

en o s
m he t i

No. 160 Potatoes Small omnivorous bird “lark” 3.3 Annex M-CP 10-01
cu f t en

ts
do s o um

BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no. 14)

is ht c
th rig s do

No. 161 Potatoes Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01
i

BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

e op Th
of y

No. 162 Potatoes Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01
us c

BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 53 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
No. 163 Pulses Small granivorous bird “finch” 11.4 Annex M-CP 10-01

er y ly
BBCH 10 – 49 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

th tor G
ay ula the
No. 164 Pulses Small granivorous bird “finch” 3.4 Annex M-CP 10-01

or
t m reg king
BBCH ≥ 50 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

m er see
No. 171 Pulses Small omnivorous bird “lark” 10.9 Annex M-CP 10-01

do ll u tium
en a
BBCH 10 – 49 Woodlark (Lullula arborea) (Covered by scenario no. 14)

cu nd
his fa or
f t ay ns
No. 173 Pulses Small omnivorous bird “lark” 3.3 Annex M-CP 10-01

r o m co
BBCH ≥ 50 Woodlark (Lullula arborea) (Covered by scenario no. 14)

ne ent he
ow um of t
No. 174 Pulses Medium herbivorous/granivorous bird “pigeon” 22.7 Annex M-CP 10-01

th oc (s)
Leaf development BBCH 10 – 19 Wood pigeon (Columba palumbus) (Covered by scenario no. 14)

of is d ber
No. 175 Pulses Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01

ion , th em
BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

iss ore m

e
rm m er
pe her orm
No. 176 Pulses Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01
BBCH ≥ 20 Yellow wagtail (Motcailla flava) (Covered by scenario no. 17)

he rt t/f
t t Fu en
ou s. rr
No. 177 Root & stem vegetables Small granivorous bird “finch” 11.4 Annex M-CP 10-01
th tie cu

BBCH 10 – 39 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

wi par (a)
f
en ird o

No. 178 Root & stem vegetables Small granivorous bird “finch” 3.4 Annex M-CP 10-01
nt th rty

BBCH ≥ 40 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

co and ope
r

No. 185 Root & stem vegetables Small omnivorous bird “lark” 10.9 Annex M-CP 10-01
ts
r i er p
t o wn the

BBCH 10 – 39 Woodlark (Lullula arborea) (Covered by scenario no. 14)

en o s
m he t i

No. 187 Root & stem vegetables Small omnivorous bird “lark” 3.3 Annex M-CP 10-01
cu f t en

ts
do s o um

BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no. 14)

is ht c
th rig s do

No. 188 Root & stem vegetables Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01
i

BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

e op Th
of y

No. 189 Root & stem vegetables Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01
us c

BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 54 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
No. 196 Strawberries Small omnivorous bird “lark” 10.9 Annex M-CP 10-01

er y ly
BBCH 10 – 39 Woodlark (Lullula arborea) (Covered by scenario no. 14)

th tor G
ay ula the
No. 198 Strawberries Small omnivorous bird “lark” 4.4 Annex M-CP 10-01

or
t m reg king
BBCH ≥ 40 Woodlark (Lullula arborea) (Covered by scenario no. 14)

m er see
No. 200 Strawberries Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01

do ll u tium
en a
BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

cu nd
his fa or
f t ay ns
No. 201 Strawberries Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01

r o m co
BBCH ≥ 20 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

ne ent he
ow um of t
No. 202 Sugar beet Small granivorous bird “finch” 11.4 Annex M-CP 10-01

th oc (s)
Late (summer / autumn) Linnet (Carduelis cannabina) (Covered by scenario no. 71)

of is d ber
No. 206 Sugar beet Small omnivorous bird “lark” 10.9 Annex M-CP 10-01

ion , th em
Early (spring) (BBCH 10 – 19) Woodlark (Lullula arborea) (Covered by scenario no. 14)

iss ore m

e
rm m er
pe her orm
No. 207 Sugar beet Small insectivorous bird “wagtail” 5.9 Annex M-CP 10-01
BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

he rt t/f
t t Fu en
ou s. rr
No. 209 Sugar beet Small insectivorous bird “wagtail” 5.9 Annex M-CP 10-012
th tie cu

BBCH 10 – 19 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

wi par (a)
f
en ird o

No. 210 Sugar beet Small insectivorous bird “wagtail” 9.7 Annex M-CP 10-01
nt th rty

BBCH 20 – 49 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)

co and ope
r

No. 214 Sunflower Small omnivorous bird “lark” 10.9 Annex M-CP 10-01
ts
r i er p
t o wn the

Early germination / Leaf development (BBCH 00 Woodlark (Lullula arborea) (Covered by scenario no. 14)
en o s
m he t i

No. 215 Sunflower Small insectivorous bird “wagtail” 11.3 Annex M-CP 10-01
cu f t en

ts
do s o um

Early germination / Leaf development (BBCH 00 Yellow wagtail (Motacilla flava) (Covered by scenario no. 17)
is ht c
th rig s do

No. 217 Vineyard Small insectivorous species “redstart” 11.5 MCP 10.1.1
i
e op Th

BBCH 10 – 19 Black redstart “Phoenicurus ochruros” (Worst case scenario)

of y

No. 218 Vineyard Small insectivorous species “redstart” 9.9 Annex M-CP 10-01
us c

BBCH ≥ 20 Black redstart “Phoenicurus ochruros” (Covered by scenario no. 217)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 55 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.1-9: Summary of avian scenarios presented for Tier 1

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SVm Risk assessment

ibi n
d
be ro te
Scenario Number presented

e ta p osa
ef da ph
No. 219 Vineyard Small granivorous bird “finch” 6.9 Annex M-CP 10-01

er y ly
BBCH 10 – 19 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

th tor G
ay ula the
No. 220 Vineyard Small granivorous bird “finch” 5.7 Annex M-CP 10-01

or
t m reg king
BBCH 20 – 39 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

m er see
No. 221 Vineyard Small granivorous bird “finch” 3.4 Annex M-CP 10-01

do ll u tium
en a
BBCH ≥ 40 Linnet (Carduelis cannabina) (Covered by scenario no. 71)

cu nd
his fa or
f t ay ns
No. 231 Vineyard Small omnivorous bird “lark” 6.5 Annex M-CP 10-01

r o m co
BBCH 10 – 19 Wood lark (Lullula arborea) (Covered by scenario no. 14)

ne ent he
ow um of t
No. 232 Vineyard Small omnivorous bird “lark” 5.4 Annex M-CP 10-01

th oc (s)
BBCH 20 – 39 Wood lark (Lullula arborea) (Covered by scenario no. 14)

of is d ber
No. 233 Vineyard Small omnivorous bird “lark” 3.3 Annex M-CP 10-01

ion , th em
BBCH ≥ 40 Wood lark (Lullula arborea) (Covered by scenario no. 14)

iss ore m

e
rm m er
Worst case scenarios are indicated in bold.

pe her orm
1
The given short-cut value is corrected and deviates from the short-cut value presented in the Appendix A of the EFSA/2009/1438. In the Appendix A for the wood pigeon (Columba palumbus) a

he rt t/f
short-cut value of 37.0 is stated. This value was calculated by multiplication of the FIR/BW (1.29) with the mean RUD value (28.7). As the correct FIR/BW for the wood pigeon is 0.79, as stated
t t Fu en
ou s. rr
for all other crop scenarios in the Appendix A the risk assessment was done with the corrected short-cut value of 22.7 (28.7 × 0.79).
th tie cu
2
Same scenario like scenario 207. Only presented once in the Annex M-CP 10-01.
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
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ht
 on
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du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 56 of 553

ep
,r
ion
ut
The Tier 1 risk assessment is presented in the following tables for the relevant uses in field crops (except

rib
use 3 a-b), uses in vineyards and uses to control invasive species, taking into account those generic focal

t
dis
species scenarios which were indicated in bold in the table above.

n,
er tio
wn lica
Field crops

.
s o ub
f it y p
so n
ht , a
rig ntly
Table 10.1.1-10: Tier 1 assessment of the long-term/reproductive risk for birds due the use of

th ue
glyphosate in field crops (Pre-sowing, pre-planting, pre-emergence): Use 1 a-c

e eq
e
lat ns
vio . Co
an ime al.
Active substance Glyphosate

te reg new
Reprod. toxicity (mg/kg bw/d) 96.3

oh tio re

d
TER criterion 5

pr tec EU
ibi n
d
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

be ro te
e ta p osa
rate Growth stage × (mg/kg bw/d)

ef da ph
(g a.e./ha) TWA

er y ly
th tor G
Field crops (Pre- 1 × 1440 Leafy Small granivorous bird 12.6 1.0 × 9.62 10.0

ay ula the
sowing, pre-planting, vegetables “finch” Serin (Serinus 0.53

or
t m reg king
pre-emergence) BBCH 10 – 49 serinus)

m er see
Leafy Small granivorous bird 3.8 1.0 × 2.90 33.2
vegetables

do ll u tium
en a
“finch” Serin (Serinus 0.53
BBCH ≥50 serinus)

cu nd
his fa or
Leafy f t ay ns
Small omnivorous bird 10.9 1.0 × 8.32 11.6
r o m co

vegetables “lark” Woodlark (Lullula 0.53

ne ent he
ow um of t

BBCH 10 – 49 arborea)
th oc (s)

Leafy Small omnivorous bird 3.3 1.0 × 2.52 38.2

of is d ber

vegetables “lark” Woodlark (Lullula 0.53

ion , th em

BBCH ≥ 50 arborea)
iss ore m

Leafy
rm m er

Medium 22.7 1.0 × 17.3 5.60

pe her orm

vegetables herbivorous/granivorous 0.53

he rt t/f

Leaf bird “pigeon” Wood

t t Fu en

development
ou s. rr

pigeon (Columba
th tie cu

BBCH 10 – 19 palumbus)
wi par (a)

Leafy Small insectivorous bird 11.3 1.0 × 8.62 11.2

f
en ird o
nt th rty

vegetables “wagtail” Yellow wagtail 0.53

co and ope

BBCH 10 – 19 (Motacilla flava)

r

ts
r i er p

Leafy Small insectivorous bird 9.7 1.0 × 7.40 13.0

t o wn the

vegetables “wagtail” Yellow wagtail 0.53

en o s
m he t i

BBCH ≥ 20 (Motacilla flava)

cu f t en

ts
do s o um

1 × 1080 Leafy Small granivorous bird 12.6 1.0 × 7.21 13.4

is ht c

vegetables
th rig s do

“finch” Serin (Serinus 0.53

BBCH 10 – 49 serinus)
i
e op Th

Leafy Small granivorous bird 3.8 1.0 × 2.18 44.3

of y

vegetables “finch” Serin (Serinus 0.53

us c

BBCH ≥ 50
d nd

serinus)
an a

Leafy Small omnivorous bird 10.9 1.0 × 6.24 15.4

n rty
tio e

vegetables “lark” Woodlark (Lullula 0.53

ta op

BBCH 10 – 49
loi pr

arborea)
xp al

Leafy Small omnivorous bird 3.3 1.0 × 1.89 51.0

l e ctu
cia lle

vegetables “lark” Woodlark (Lullula 0.53

er te

BBCH ≥ 50 arborea)
m s in

Leafy
om a

Medium 22.7 1.0 × 13.0 7.40

y c uch

vegetables herbivorous/granivorous 0.53

an ts s

Leaf bird “pigeon” Wood

an righ

development pigeon (Columba

d
ing to

BBCH 10 – 19 palumbus)
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 57 of 553

ep
,r
ion
ut
Table 10.1.1-10: Tier 1 assessment of the long-term/reproductive risk for birds due the use of

t rib
glyphosate in field crops (Pre-sowing, pre-planting, pre-emergence): Use 1 a-c

dis
n,
er tio
wn lica
Active substance Glyphosate

.
s o ub
Reprod. toxicity (mg/kg bw/d) 96.3

f it y p
TER criterion 5

so n
ht , a
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

rig ntly
rate Growth stage × (mg/kg bw/d)

th ue
e eq
(g a.e./ha) TWA

e
lat ns
Leafy Small insectivorous bird 11.3 1.0 × 6.47 14.9

vio . Co
an ime al.
vegetables “wagtail” Yellow wagtail 0.53

te reg new
BBCH 10 – 19 (Motacilla flava)

oh tio re

d
pr tec EU
Leafy Small insectivorous bird 9.7 1.0 × 5.55 17.3

ibi n
d
vegetables “wagtail” Yellow wagtail 0.53

be ro te
e ta p osa
BBCH ≥ 20 (Motacilla flava)

ef da ph
1 × 720 Leafy 12.6 1.0 × 4.81 20.0

er y ly
th tor G
vegetables Small granivorous bird 0.53

ay ula the
BBCH 10 – 49 “finch” Serin (Serinus

or
t m reg king
serinus)

m er see
Leafy Small granivorous bird 3.8 1.0 × 1.45 66.4

do ll u tium
en a
vegetables “finch” Serin (Serinus 0.53

cu nd
his fa or
BBCH ≥ 50 serinus)
f t ay ns
Leafy
r o m co
Small omnivorous bird 10.9 1.0 × 4.16 23.2
ne ent he

vegetables “lark” Woodlark (Lullula 0.53

ow um of t

BBCH 10 – 49 arborea)
th oc (s)

Leafy Small omnivorous bird 3.3 1.0 × 1.26 76.5

of is d ber

vegetables “lark” Woodlark (Lullula 0.53

ion , th em

BBCH ≥ 50 arborea)
iss ore m

e
rm m er

Leafy Medium 22.7 1.0 × 8.66 11.1

pe her orm

vegetables herbivorous/granivorous 0.53

he rt t/f
t t Fu en

Leaf bird “pigeon” Wood

ou s. rr

development pigeon (Columba

th tie cu

BBCH 10 – 19
wi par (a)

palumbus)
f

Leafy
en ird o

Small insectivorous bird 11.3 1.0 × 4.31 22.3

nt th rty

vegetables “wagtail” Yellow wagtail 0.53

co and ope

BBCH 10 – 19 (Motacilla flava)

r

ts
r i er p
t o wn the

Leafy Small insectivorous bird 9.7 1.0 × 3.70 26.0

vegetables “wagtail” Yellow wagtail
en o s

0.53
m he t i
cu f t en

BBCH ≥ 20 (Motacilla flava)

ts
do s o um

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
is ht c
th rig s do

toxicity to exposure ratio

i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 58 of 553

ep
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ion
ut
Table 10.1.1-11: Tier 1 assessment of the long-term/reproductive risk for birds due the use of

t rib
glyphosate in field crops (Post-harvest, pre-sowing, pre-planting): Use 2 a-c, 10 a-c

dis
n,
er tio
Active substance Glyphosate

wn lica
.
96.3

s o ub
Reprod. toxicity (mg/kg

f it y p
bw/d)

so n
ht , a
TER criterion 5

rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm × DDDm TERlt

th ue
rate Growth stage TWA (mg/kg bw/d)

e eq
e
lat ns
(g a.e./ha)

vio . Co
an ime al.
Field crops 1 × 1440 Maize Medium granivorous bird 0.8 1.0 × 0.612 158

te reg new
(Post-harvest, BBCH ≥ 40 “gamebird” Partridge 0.53

oh tio re
pre-sowing, (Perdix perdix)

d
pr tec EU
ibi n
pre-planting)

d
be ro te
Maize

e ta p osa
Medium 5.7 1.0 × 4.35 22.1
BBCH ≥ 40

ef da ph
herbivorous/granivorous 0.53

er y ly
bird “pigeon” Wood pigeon

th tor G
ay ula the
(Columba palumbus)

or
t m reg king
Oilseed rape Small insectivorous bird 2.7 1.0 × 2.06 46.7
Late (with “dunnock” 0.53

m er see
seeds) BBCH Dunnock (Prunella

do ll u tium
en a
30 – 99 modularis)

cu nd
his fa or
Oilseed rape Small granivorous bird f t ay ns 11.4 1.0 × 8.70 11.1
r o m co
Late (with “finch” 0.53
ne ent he

seeds) BBCH Linnet (Carduelis

ow um of t

80 – 99 cannabina)
th oc (s)
of is d ber

Bulbs and Small insectivorous bird 9.7 1.0 × 7.40 13.0

ion , th em

onion like “wagtail” Yellow wagtail 0.53

iss ore m

crops
e

(Motacilla flava)
rm m er

BBCH ≥ 20
pe her orm

Bulbs & onion Small omnivorous bird 6.5 1.0 × 4.96 19.4
he rt t/f
t t Fu en

like crops “lark” Woodlark (Lullula 0.53

ou s. rr

BBCH ≥ 40
th tie cu

arborea)
wi par (a)

2 × 1080 Maize Medium granivorous bird 0.8 1.1 × 0.504 191

f
en ird o

(28 d) BBCH ≥ 40 “gamebird” Partridge 0.53

nt th rty

(Perdix perdix)
co and ope

Maize
r

Medium 5.7 1.1 × 3.59 26.8

ts
r i er p
t o wn the

BBCH ≥ 40 herbivorous/granivorous 0.53

en o s

bird “pigeon” Wood pigeon

m he t i
cu f t en

ts

(Columba palumbus)
do s o um

Oilseed rape Small insectivorous bird 2.7 1.1 × 1.70 56.6

is ht c
th rig s do

Late (with “dunnock” 0.53

i
e op Th

seeds) BBCH Dunnock (Prunella

30 – 99 modularis)
of y

Oilseed rape Small granivorous bird 11.4 1.1 × 7.18 13.4

us c
d nd

Late (with “finch” 0.53

an a
n rty

seeds) BBCH Linnet (Carduelis

tio e

80 – 99
ta op

cannabina)
loi pr

Bulbs and Small insectivorous bird 9.7 1.1 × 6.11 15.8

xp al
l e ctu

onion like “wagtail” Yellow wagtail 0.53

cia lle

crops (Motacilla flava)

er te
m s in

BBCH ≥ 20
om a

Bulbs & onion Small omnivorous bird 6.5 1.1 × 4.09 23.5
y c uch

like crops “lark” Woodlark (Lullula 0.53

an ts s

BBCH ≥ 40 arborea)
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 59 of 553

ep
,r
ion
ut
Table 10.1.1-11: Tier 1 assessment of the long-term/reproductive risk for birds due the use of

t rib
glyphosate in field crops (Post-harvest, pre-sowing, pre-planting): Use 2 a-c, 10 a-c

dis
n,
er tio
Active substance Glyphosate

wn lica
.
96.3

s o ub
Reprod. toxicity (mg/kg

f it y p
bw/d)

so n
ht , a
TER criterion 5

rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm × DDDm TERlt

th ue
rate Growth stage TWA (mg/kg bw/d)

e eq
e
lat ns
(g a.e./ha)

vio . Co
an ime al.
1 × 720 Maize Medium granivorous bird 0.8 1.0 × 0.305 315

te reg new
BBCH ≥ 40 “gamebird” Partridge 0.53

oh tio re
(Perdix perdix)

d
pr tec EU
ibi n
Maize Medium 5.7 1.0 × 2.18 44.3.

d
be ro te
BBCH ≥ 40

e ta p osa
herbivorous/granivorous 0.53

ef da ph
bird “pigeon” Wood pigeon

er y ly
(Columba palumbus)

th tor G
ay ula the
Oilseed rape Small insectivorous bird 2.7 1.0 × 1.13 85.0

or
t m reg king
Late (with “dunnock” 0.53
seeds) BBCH Dunnock (Prunella

m er see
30 – 99 modularis)

do ll u tium
en a
Oilseed rape Small granivorous bird 11.4 1.0 × 4.79 20.1

cu nd
his fa or
Late (with “finch” f t ay ns 0.53
r o m co
seeds) BBCH Linnet (Carduelis
ne ent he

80 – 99 cannabina)
ow um of t

Bulbs and Small insectivorous bird 9.7 1.0 × 3.70 26.0

th oc (s)
of is d ber

onion like “wagtail” Yellow wagtail 0.53

ion , th em

crops (Motacilla flava)

iss ore m

BBCH ≥ 20
e
rm m er

Bulbs & onion Small omnivorous bird 6.5 1.0 × 2.48 38.8
pe her orm

like crops “lark” Woodlark (Lullula 0.53

he rt t/f
t t Fu en

BBCH ≥ 40 arborea)
ou s. rr
th tie cu

2 × 720 Maize Medium granivorous bird 0.8 1.1 × 0.336 287

wi par (a)

(28 d) BBCH ≥ 40 “gamebird” Partridge 0.53

f
en ird o

(Perdix perdix)
nt th rty
co and ope

Maize Medium 5.7 1.1 × 2.39 40.2

BBCH ≥ 40
r

herbivorous/granivorous 0.53
ts
r i er p
t o wn the

bird “pigeon” Wood pigeon

en o s

(Columba palumbus)
m he t i
cu f t en

ts

Oilseed rape Small insectivorous bird 2.7 1.1 × 1.13 85.0

do s o um

Late (with “dunnock” 0.53

is ht c
th rig s do

seeds) BBCH Dunnock (Prunella

i
e op Th

30 – 99 modularis)
Oilseed rape Small granivorous bird
of y

11.4 1.1 × 4.79 20.1

Late (with “finch” 0.53
us c
d nd

seeds) BBCH Linnet (Carduelis

an a
n rty

80 – 99 cannabina)
tio e
ta op

Bulbs and Small insectivorous bird 9.7 1.1 × 4.07 23.7

loi pr

onion like “wagtail” Yellow wagtail 0.53

xp al
l e ctu

crops (Motacilla flava)

cia lle

BBCH ≥ 20
er te
m s in

Bulbs & onion Small omnivorous bird 6.5 1.1 × 2.73 35.3
om a

like crops “lark” Woodlark (Lullula 0.53

y c uch

BBCH ≥ 40 arborea)
an ts s

1 × 1080 Maize Medium granivorous bird 0.8 1.0 × 0.458 210

an righ

BBCH ≥ 40 “gamebird” Partridge 0.53

d
ing to

(Perdix perdix)
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 60 of 553

ep
,r
ion
ut
Table 10.1.1-11: Tier 1 assessment of the long-term/reproductive risk for birds due the use of

t rib
glyphosate in field crops (Post-harvest, pre-sowing, pre-planting): Use 2 a-c, 10 a-c

dis
n,
er tio
Active substance Glyphosate

wn lica
.
96.3

s o ub
Reprod. toxicity (mg/kg

f it y p
bw/d)

so n
ht , a
TER criterion 5

rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm × DDDm TERlt

th ue
rate Growth stage TWA (mg/kg bw/d)

e eq
e
lat ns
(g a.e./ha)

vio . Co
an ime al.
Maize Medium 5.7 1.0 × 3.26 29.5

te reg new
BBCH ≥ 40 herbivorous/granivorous 0.53

oh tio re
bird “pigeon” Wood pigeon

d
pr tec EU
ibi n
(Columba palumbus)

d
be ro te
Oilseed rape Small insectivorous bird

e ta p osa
2.7 1.0 × 1.55 62.3
Late (with “dunnock”

ef da ph
0.53

er y ly
seeds) BBCH Dunnock (Prunella

th tor G
ay ula the
30 – 99 modularis)

or
t m reg king
Oilseed rape Small granivorous bird 11.4 1.0 × 6.52 14.8
Late (with “finch” 0.53

m er see
seeds) BBCH Linnet (Carduelis

do ll u tium
en a
80 – 99 cannabina)

cu nd
his fa or
Bulbs and Small insectivorous bird f t ay ns 9.7 1.0 × 5.55 17.3
r o m co
onion like “wagtail” Yellow wagtail 0.53
ne ent he

crops (Motacilla flava)

ow um of t

BBCH ≥ 20
th oc (s)

Bulbs & onion Small omnivorous bird 6.5 1.0 × 3.72 25.9
of is d ber

like crops “lark” Woodlark (Lullula 0.53

ion , th em

BBCH ≥ 40
iss ore m

arborea)
e
rm m er

3 × 720 Maize Medium granivorous bird 0.8 1.2 × 0.366 263

pe her orm

(28 d) BBCH ≥ 40 “gamebird” Partridge 0.53

he rt t/f
t t Fu en

(Perdix perdix)
ou s. rr
th tie cu

Maize Medium 5.7 1.2 × 2.61 36.9

wi par (a)

BBCH ≥ 40 herbivorous/granivorous 0.53

f
en ird o

bird “pigeon” Wood pigeon

nt th rty

(Columba palumbus)
co and ope

Oilseed rape Small insectivorous bird

r

2.7 1.2 × 1.24 77.9

ts
r i er p
t o wn the

Late (with “dunnock” 0.53

en o s

seeds) BBCH Dunnock (Prunella

m he t i
cu f t en

ts

30 – 99 modularis)
do s o um

Oilseed rape Small granivorous bird 11.4 1.2 × 5.22 18.4

is ht c
th rig s do

Late (with “finch” 0.53

i
e op Th

seeds) BBCH Linnet (Carduelis

80 – 99 cannabina)
of y

Bulbs and Small insectivorous bird 9.7 1.2 × 4.44 21.7

us c
d nd

onion like “wagtail” Yellow wagtail 0.53

an a
n rty

crops (Motacilla flava)

tio e

BBCH ≥ 20
ta op
loi pr

Bulbs & onion Small omnivorous bird 6.5 1.2 × 2.98 32.4
xp al

like crops
l e ctu

“lark” Woodlark (Lullula 0.53

cia lle

BBCH ≥ 40 arborea)
er te
m s in

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
om a

toxicity to exposure ratio.

y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 61 of 553

ep
,r
ion
ut
Table 10.1.1-12: Tier 1 assessment of the long-term/reproductive risk for birds due the use of

t rib
dis
glyphosate in field crops (Shielded ground directed inter-row application): Use 6 a-b

n,
er tio
wn lica
Active substance Glyphosate

.
s o ub
Reprod. toxicity (mg/kg 96.3

f it y p
bw/d)

so n
ht , a
5

rig ntly
TER criterion

th ue
GAP crop Application Crop Generic focal species SVm MAFm DDDm TERlt

e eq
rate scenario × TWA (mg/kg bw/d)

e
lat ns
vio . Co
(g a.e./ha) Growth stage

an ime al.
te reg new
Field crops 1 × 1080 Bulbs and Small insectivorous bird 11.3 1.0 × 6.47 14.9
(Shielded onion like “wagtail” Yellow wagtail 0.53

oh tio re

d
pr tec EU
ground directed crops (Motacilla flava)

ibi n
d
BBCH 10 –

be ro te
inter-row

e ta p osa
application) 19

ef da ph
Bulbs & Small omnivorous bird 10.9 1.0 × 6.24 15.4

er y ly
th tor G
onion like “lark” Woodlark (Lullula 0.53

ay ula the
crops arborea)

or
t m reg king
BBCH 10 –

m er see
39
Leafy Small granivorous bird 12.6 1.0 × 7.21 13.4

do ll u tium
en a
vegetables “finch” Serin (Serinus 0.53

cu nd
his fa or
BBCH 10 – serinus) f t ay ns
r o m co
49
ne ent he

Leafy Medium 22.7 1.0 × 13.0 7.40

ow um of t

vegetables herbivorous/granivorous 0.53

th oc (s)

Leaf bird “pigeon” Wood pigeon

of is d ber

development
ion , th em

(Columba palumbus)
iss ore m

BBCH 10 –
e
rm m er

19
pe her orm

1 × 720 Bulbs and Small insectivorous bird 11.3 1.0 × 4.31 22.3
he rt t/f
t t Fu en

onion like “wagtail” Yellow wagtail 0.53

ou s. rr

crops (Motacilla flava)

th tie cu

BBCH 10 –
wi par (a)

19
f
en ird o
nt th rty

Bulbs & Small omnivorous bird 10.9 1.0 × 4.16 23.2

co and ope

onion like “lark” Woodlark (Lullula 0.53

r

ts
r i er p

crops arborea)
t o wn the

BBCH 10 –
en o s
m he t i

39
cu f t en

ts
do s o um

Leafy Small granivorous bird 12.6 1.0 × 4.81 20.0

is ht c

vegetables “finch” Serin (Serinus 0.53

th rig s do

BBCH 10 – serinus)
i
e op Th

49
of y

Leafy Medium 22.7 1.0 × 8.66 11.1

us c

vegetables herbivorous/granivorous 0.53

d nd

Leaf bird “pigeon” Wood pigeon

an a
n rty

development (Columba palumbus)

tio e
ta op

BBCH 10 –
loi pr

19
xp al
l e ctu

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
cia lle

toxicity to exposure ratio.

er te
m s in
om a
y c uch

The Tier 1 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
an ts s

indicating that long-term risk to birds is acceptable following the proposed use patterns in field crops (Uses
an righ

1 a-c, 2 a-c, 10 a-c and 6 a-b).

d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
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cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 62 of 553

ep
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ion
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rib
Vineyard

t
dis
n,
er tio
Table 10.1.1-13: Tier 1 assessment of the long-term/reproductive risk for birds due the use of

wn lica
glyphosate in vineyards: Use 5 a-c

.
s o ub
f it y p
so n
ht , a
Active substance Glyphosate

rig ntly
Reprod. toxicity (mg/kg 96.3

th ue
bw/d)

e eq
e
lat ns
TER criterion 5

vio . Co
an ime al.
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

te reg new
rate Growth stage × TWA (mg/kg bw/d)

oh tio re

d
(g a.e./ha)

pr tec EU
ibi n
Vineyard 2 × 1440 Vineyard Small insectivorous bird 11.5 1.1 × 9.65

d
9.97

be ro te
e ta p osa
post- (28 d) BBCH 10 – 19 “redstart” 0.53

ef da ph
emergence of Black Redstart

er y ly
weeds (Phoenicurus ochrurus)

th tor G
ay ula the
Vineyard Small insectivorous bird 9.9 1.1 × 8.31 11.6

or
t m reg king
BBCH 20 – 39 “redstart” 0.53

m er see
Black Redstart
(Phoenicurus ochrurus)

do ll u tium
en a
Vineyard Small granivorous bird 6.9 1.1 × 5.79 16.6

cu nd
his fa or
BBCH 10 – 19 “finch” Linnet (Carduelisf t ay ns 0.53
r o m co
cannabina)
ne ent he
ow um of t

Vineyard Small granivorous bird 5.7 1.1 × 4.79 20.1

BBCH 20 – 39
th oc (s)

“finch” Linnet (Carduelis 0.53

of is d ber

cannabina)
ion , th em

Vineyard Small granivorous bird 3.4 1.1 × 2.85 33.7

iss ore m

BBCH ≥ 40 “finch” Linnet (Carduelis 0.53

rm m er
pe her orm

cannabina)
he rt t/f

Vineyard Small omnivorous bird 6.5 1.1 × 5.46 17.6

t t Fu en

BBCH 10 – 19
ou s. rr

“lark” 0.53
th tie cu

Woodlark (Lullula
wi par (a)

arborea)
f
en ird o
nt th rty

Vineyard Small omnivorous bird 5.4 1.1 × 4.53 21.2

co and ope

BBCH 20 – 39 “lark” 0.53

r

ts
r i er p

Woodlark (Lullula
t o wn the

arborea)
en o s
m he t i

Vineyard Small omnivorous bird 3.3 1.1 × 2.77 34.8

cu f t en

ts

BBCH ≥ 40
do s o um

“lark” 0.53
is ht c

Woodlark (Lullula
th rig s do

arborea)
i
e op Th

1 × 1080 Vineyard Small insectivorous bird 11.5 1.0 × 6.58 14.6

of y

BBCH 10 – 19 “redstart” 0.53

us c

Black Redstart
d nd
an a

(Phoenicurus ochrurus)
n rty

Vineyard Small insectivorous bird 9.9 1.0 × 5.67 17.0

tio e
ta op

BBCH 20 – 39 “redstart” 0.53

loi pr
xp al

Black Redstart
l e ctu

(Phoenicurus ochrurus)
cia lle
er te

Vineyard Small granivorous bird 6.9 1.0 × 3.95 24.4

m s in

BBCH 10 – 19 “finch” Linnet (Carduelis 0.53

om a
y c uch

cannabina)
an ts s

Vineyard Small granivorous bird 5.7 1.0 × 3.26 29.5

an righ

BBCH 20 – 39 “finch” Linnet (Carduelis 0.53

d

cannabina)
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 63 of 553

ep
,r
ion
ut
Table 10.1.1-13: Tier 1 assessment of the long-term/reproductive risk for birds due the use of

t rib
dis
glyphosate in vineyards: Use 5 a-c

n,
er tio
wn lica
Active substance Glyphosate

.
s o ub
Reprod. toxicity (mg/kg 96.3

f it y p
bw/d)

so n
ht , a
5

rig ntly
TER criterion

th ue
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

e eq
rate Growth stage × TWA (mg/kg bw/d)

e
lat ns
vio . Co
(g a.e./ha)

an ime al.
te reg new
Vineyard Small granivorous bird 3.4 1.0 × 1.95 49.5
BBCH ≥ 40 “finch” Linnet (Carduelis 0.53

oh tio re

d
pr tec EU
cannabina)

ibi n
d
be ro te
Vineyard Small omnivorous bird 6.5 1.0 × 3.72 25.9

e ta p osa
BBCH 10 – 19 “lark” 0.53

ef da ph
Woodlark (Lullula

er y ly
th tor G
arborea)

ay ula the

or
Vineyard Small omnivorous bird 5.4 1.0 × 3.09 31.2

t m reg king
BBCH 20 – 39 “lark” 0.53

m er see
Woodlark (Lullula

do ll u tium
en a
arborea)

cu nd
his fa or
Vineyard Small omnivorous bird 3.3 1.0 × 1.89 51.0
f t ay ns
BBCH ≥ 40
r o m co
“lark” 0.53
ne ent he

Woodlark (Lullula
ow um of t

arborea)
th oc (s)

1 × 1440 Vineyard Small insectivorous bird 11.5 1.0 × 8.78 11.0

of is d ber

BBCH 10 – 19 “redstart” 0.53

ion , th em

Black Redstart
iss ore m

e
rm m er

(Phoenicurus ochrurus)
pe her orm

Vineyard Small insectivorous bird 9.9 1.0 × 7.56 12.7

he rt t/f

BBCH 20 – 39
t t Fu en

“redstart” 0.53
ou s. rr

Black Redstart
th tie cu

(Phoenicurus ochrurus)
wi par (a)
f

Vineyard
en ird o

Small granivorous bird 6.9 1.0 × 5.27 18.3

nt th rty

BBCH 10 – 19 “finch” Linnet (Carduelis 0.53

co and ope

cannabina)
r

ts
r i er p

Vineyard
t o wn the

Small granivorous bird 5.7 1.0 × 4.35 22.1

BBCH 20 – 39 “finch” Linnet (Carduelis 0.53
en o s
m he t i
cu f t en

ts

cannabina)
do s o um

Vineyard Small granivorous bird 3.4 1.0 × 2.59 37.1

is ht c
th rig s do

BBCH ≥ 40 “finch” Linnet (Carduelis 0.53

i
e op Th

cannabina)
Vineyard Small omnivorous bird 6.5 1.0 × 4.96 19.4
of y

BBCH 10 – 19 “lark” 0.53

us c
d nd

Woodlark (Lullula
an a
n rty

arborea)
tio e

Vineyard
ta op

Small omnivorous bird 5.4 1.0 × 4.12 23.4

loi pr

BBCH 20 – 39 “lark” 0.53

xp al
l e ctu

Woodlark (Lullula
cia lle

arborea)
er te
m s in

Vineyard Small omnivorous bird 3.3 1.0 × 2.52 38.2

om a

BBCH ≥ 40 “lark” 0.53

y c uch

Woodlark (Lullula
an ts s

arborea)
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.1.1-13: Tier 1 assessment of the long-term/reproductive risk for birds due the use of

t rib
dis
glyphosate in vineyards: Use 5 a-c

n,
er tio
wn lica
Active substance Glyphosate

.
s o ub
Reprod. toxicity (mg/kg 96.3

f it y p
bw/d)

so n
ht , a
5

rig ntly
TER criterion

th ue
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

e eq
rate Growth stage × TWA (mg/kg bw/d)

e
lat ns
vio . Co
(g a.e./ha)

an ime al.
te reg new
2 × 1080 Vineyard Small insectivorous bird 11.5 1.1 × 7.24 13.3
BBCH 10 – 19 “redstart” 0.53

oh tio re

d
pr tec EU
Black Redstart

ibi n
d
be ro te
(Phoenicurus ochrurus)

e ta p osa
Vineyard Small insectivorous bird 9.9 1.1 × 6.23 15.4

ef da ph
BBCH 20 – 39 “redstart” 0.53

er y ly
th tor G
Black Redstart

ay ula the
(Phoenicurus ochrurus)

or
t m reg king
Vineyard Small granivorous bird 6.9 1.1 × 4.34 22.2

m er see
BBCH 10 – 19 “finch” Linnet (Carduelis 0.53

do ll u tium
en a
cannabina)

cu nd
his fa or
Vineyard Small granivorous bird 5.7 1.1 × 3.59 26.8
f t ay ns
BBCH 20 – 39
r o m co
“finch” Linnet (Carduelis 0.53
ne ent he

cannabina)
ow um of t

Vineyard Small granivorous bird 3.4 1.1 × 2.14 45.0

th oc (s)

BBCH ≥ 40 “finch” Linnet (Carduelis 0.53

of is d ber

cannabina)
ion , th em

Vineyard
iss ore m

Small omnivorous bird 6.5 1.1 × 4.09 23.5

e
rm m er

BBCH 10 – 19 “lark” 0.53

pe her orm

Woodlark (Lullula
he rt t/f
t t Fu en

arborea)
ou s. rr

Vineyard
th tie cu

Small omnivorous bird 5.4 1.1 × 3.40 28.3

wi par (a)

BBCH 20 – 39 “lark” 0.53

f
en ird o

Woodlark (Lullula
nt th rty

arborea)
co and ope

Vineyard Small omnivorous bird 3.3 1.1 × 2.08 46.3

r

ts
r i er p

BBCH ≥ 40
t o wn the

“lark” 0.53
Woodlark (Lullula
en o s
m he t i
cu f t en

ts

arborea)
do s o um

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
is ht c
th rig s do

toxicity to exposure ratio.

i
e op Th
of y

The Tier 1 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
us c
d nd

indicating that long-term risk to birds is acceptable following the proposed use patterns in vineyards (Uses
an a
n rty

5 a-c).
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Control of invasive species

t rib
dis
Table 10.1.1-14: Tier 1 assessment of the long-term/reproductive risk for birds due the use of

n,
glyphosate on invasive species in agricultural and non-agricultural areas: Use 8, 9

er tio
wn lica
.
s o ub
Glyphosate

f it y p
Active substance

so n
Reprod. toxicity (mg/kg 96.3

ht , a
rig ntly
bw/d)

th ue
TER criterion 5

e eq
e
lat ns
GAP crop Application Crop Generic focal species SVm MAFm DDDm TERlt

vio . Co
an ime al.
rate scenario × (mg/kg bw/d)

te reg new
(g a.e./ha) Growth TWA

oh tio re
stage

d
pr tec EU
Invasive 1 × 1800 Cereals Large herbivorous bird 16.2 1.0 × 15.5 6.20

ibi n
d
be ro te
species in Early “goose” Pink-foot goose 0.53

e ta p osa
agricultural (shoots) (Anser brachyrhynchus)

ef da ph
er y ly
and non- autumn-

th tor G
agricultural winter BBCH

ay ula the

or
areas. Post 10 – 29

t m reg king
emergence

m er see
of invasive

do ll u tium
en a
species.

cu nd
his fa or
Maize Medium granivorous bird 3.0 1.0 × 2.86 33.6
f t ay ns
BBCH 10 – “gamebird” Partridge 0.53
r o m co
ne ent he

29 (Perdix perdix)
ow um of t

Leafy Medium 22.7 1.0 × 21.7 4.40

th oc (s)

vegetables herbivorous/granivorous 0.53

of is d ber

BBCH 10 – bird “pigeon” Wood

ion , th em

19 pigeon (Columba
iss ore m

e
rm m er

palumbus)
pe her orm

Leafy Small granivorous bird 12.6 1.0 × 12.0 8.00

he rt t/f
t t Fu en

vegetables “finch” Serin (Serinus 0.53

ou s. rr

BBCH 10 – serinus)
th tie cu
wi par (a)

49
f
en ird o

Oilseed rape Small insectivorous bird 2.7 1.0 × 2.58 37.4

nt th rty

Late (with “dunnock” Dunnock 0.53

co and ope

seeds) BBCH (Prunella modularis)

r

ts
r i er p
t o wn the

30 – 99
en o s

Hops Small insectivorous bird 9.1 1.0 × 8.68 11.1

m he t i
cu f t en

ts

BBCH 10 – “finch” Chaffinch 0.53

do s o um

19 (Fringilla coelebs)
is ht c
th rig s do

Cereals Small insectivorous bird 22.4 1.0 × 21.4 4.50

i
e op Th

Late post – “passerine” Fan tailed 0.53

emergence warbler
of y

(May – June)
us c
d nd

BBCH 71 –
an a
n rty

89
tio e
ta op

Orchards Small insectivorous bird 18.2 1.0 × 17.4 5.50

loi pr

Spring “tit” Bluetit (Parus 0.53

xp al
l e ctu

Summer caeruleus)
cia lle

Bulbs and Small insectivorous bird 11.3 1.0 × 10.8 8.90

er te
m s in

onion like “wagtail” Yellow wagtail 0.53

om a

crops (Motacilla flava)

y c uch

BBCH 10 –
an ts s

19
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.1.1-14: Tier 1 assessment of the long-term/reproductive risk for birds due the use of

t rib
dis
glyphosate on invasive species in agricultural and non-agricultural areas: Use 8, 9

n,
er tio
wn lica
Active substance Glyphosate

.
s o ub
Reprod. toxicity (mg/kg 96.3

f it y p
bw/d)

so n
ht , a
5

rig ntly
TER criterion

th ue
GAP crop Application Crop Generic focal species SVm MAFm DDDm TERlt

e eq
rate scenario × (mg/kg bw/d)

e
lat ns
vio . Co
(g a.e./ha) Growth TWA

an ime al.
te reg new
stage
Bush and Small insectivorous bird 20.3 1.0 × 19.4

oh tio re
4.97

d
pr tec EU
cane fruit “warbler” Willow warbler 0.53

ibi n
d
be ro te
Whole (Phylloscopus trochilus)

e ta p osa
season

ef da ph
BBCH 00 –

er y ly
th tor G
79 Currants

ay ula the
Vineyard Small insectivorous bird 11.5 1.0 ×

or
11.0 8.78

t m reg king
BBCH 10 – “redstart” Black redstart 0.53

m er see
19 (Phoenicurus ochruros)

do ll u tium
en a
Maize Small insectivorous / 5.7 1.0 × 5.44 17.7

cu nd
his fa or
Leaf worm feeding species 0.53
f t ay ns
“thrush” Robin (Erithacus
r o m co
development
ne ent he

BBCH 10 – rubecula)
ow um of t

19
th oc (s)

Bulbs and Small omnivorous bird 10.9 1.0 10.4 9.30

of is d ber

onion like “lark” Woodlark (Lullula

ion , th em

crops arborea)
iss ore m

e
rm m er

BBCH 10 –
pe her orm

39
he rt t/f
t t Fu en

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER: toxicity to exposure
ou s. rr

ratio. TER values shown in bold fall below the relevant trigger
th tie cu
wi par (a)
f
en ird o
nt th rty

The Tier 1 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
co and ope

indicating that long-term risk to birds is acceptable following the proposed use patterns for all the crops in
r

ts
r i er p

the use to control invasive species considered except in the following two scenarios where a refined risk
t o wn the

assessment is required:
en o s
m he t i
cu f t en

ts
do s o um

 cereals; the small insectivorous bird “passerine” Fan tailed warbler

is ht c
th rig s do

 bulb and onion like vegetables; the small insectivorous bird “warbler” Willow warbler
i
e op Th

 leafy vegetables; the medium herbivorous/granivorous bird “pigeon” Wood pigeon

of y
us c

Higher tier assessment

d nd
an a
n rty

Long-term Tier 2 exposure was calculated for those intended uses, for which the Tier 1 risk assessment
tio e
ta op

indicates need for a refined long-term risk assessment.

loi pr
xp al
l e ctu

Refinement of TWA and MAF based on glyphosate residue decline on grass

cia lle
er te
m s in

In Tier 2, TWA and MAF values for glyphosate can be refined based on measured residues on grass foliage.
om a
y c uch
an ts s

The methodology used to calculate the TWA for glyphosate on grass foliage for the long-term risk
an righ

assessment follows the procedure described in the Guidance Document on Terrestrial Ecotoxicology
d
ing to
sh ct
bli bje
pu su
or be

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(2002). According to the approach outlined in the Guidance Document on Terrestrial Ecotoxicology, the

rib
dissipation of glyphosate in grass was estimated using the standard first-order dissipation model:

t
dis
n,
er tio
Ct =Ci × e –kt

wn lica
.
k = first order rate constant

s o ub
Ci = initial residue concentration

f it y p
Ct = residue concentration at time t

so n
ht , a
rig ntly
The decline of glyphosate residue on grass was characterised using data from 22 residue trials each of which

th ue
e eq
had a day 0 value. Based on this data, the k value for grass foliage was calculated to be 0.2476 days-1

e
lat ns
(Renewal Assessment Report for glyphosate, 29 January 2015, Volume 3, Annex B.9, B.9.13). For

vio . Co
an ime al.
convenience these calculations are reproduced without change, in Annex M-CP 10-02 to this document.

te reg new
oh tio re

d
pr tec EU
Residue half-life times (DT50) in days were calculated with following equation:

ibi n
d
be ro te
e ta p osa
 ln 0.5

ef da ph
DT50 

er y ly
k

th tor G
ay ula the

or
The average DT50 for grass foliage was 2.8 days.

t m reg king
m er see
The 21-day time weighted average (TWA) for glyphosate on grass foliage has been calculated according

do ll u tium
en a
to the following formula:

cu nd
his fa or
f t ay ns
r o m co

 1 - e -kt 
ne ent he

TWA 
ow um of t

kt
th oc (s)
of is d ber

The 21-day TWA is calculated to be 0.19 for the active substance glyphosate acid and grass. For the refined
ion , th em

risk assessment this value is applied for the medium herbivorous/granivorous bird “pigeon” Wood pigeon
iss ore m

(Columba palumbus). Although the calculated 21-day TWA of 0.19 is based on residue decline on “grass”
rm m er
pe her orm

it is considered to be valid for “non-grass herbs” as well. This assumption can be supported by Ebeling &
he rt t/f

Wang (2018)10, who evaluated the residue dissipation of 30 active substances (including glyphosate) on
t t Fu en
ou s. rr

grasses / cereals (177 trials) and non-grass herbs (101 trials). No significant difference between residue
th tie cu
wi par (a)

dissipation on grasses / cereals and non-grass herbs was found. In addition also in the EFSA Conclusion
f

for glyphosate (2015)11 (EFSA Journal 2015;13(11):4302) the 21-day TWA of 0.19 was applied to refine
en ird o
nt th rty

the risk to the medium herbivorous/granivorous bird “pigeon” Wood pigeon (Columba palumbus).
co and ope
r

ts
r i er p
t o wn the

Use specific considerations

en o s
m he t i

Control of invasive species

cu f t en

ts
do s o um

For the use on invasive species on agricultural and non-agricultural areas (Use 8-9) the product MON 52276
is ht c
th rig s do

is intended to be applied on the two invasive species; Giant hogweed (Heracleum montegazzianum) and
i
e op Th

Japanese knotweed (Reynoutrica japonica). Both species are easy recognisable, are usually well known by
operators and can reach impressive sizes (more than 2 m height).
of y
us c
d nd

Control of invasive plant species that pose a risk to man and society, may be achieved by direct targeted
an a
n rty

overspray of the plant or by first cutting back the plants and applying directly to fresh regrowth. In both
tio e
ta op

cases, the aim is to achieve exposure of the plant systemically, targeting all growing areas of the plant. The
loi pr

type of plant to be controlled and the density of plants in the target area, will dictate the management
xp al
l e ctu

approach that is ultimately used. In all cases, the spray applications made, will be directed and targeted to
cia lle
er te

a specific plant or stand of plants. This approach contrasts with a boom spray application where the entire
m s in
om a
y c uch

10
Ebeling, M., Wang, M. Dissipation of Plant Protection Products from Foliage. Environmental Toxicology and
an ts s

Chemistry (2018). Wiley Online Library.

an righ

11
Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate (2015).
d
ing to

European Food Safte Authority (EFSA), Parma, Italy.

sh ct
bli bje
pu su
or be

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area under the boom is exposed, whether there is a target plant present or not. It is therefore appropriate

rib
when considering applications made to control invasive plant species, that the total applied area considered

t
dis
in the risk calculation, is reduced compared to a boom spray application, given the very directed and

n,
er tio
targeted application method used, which includes use of shielded sprayers that further reduces the risk to

wn lica
.
non-target plants.

s o ub
f it y p
so n
When spraying invasive plant species, different plant density scenarios are applicable. A small reduction in

ht , a
rig ntly
the application rate (10-30 % reduction) would reflect a scenario where a high density of invasive species

th ue
can be expected. Such a scenario is considered relevant in non-agricultural fields where higher densities of

e eq
e
lat ns
the invasive plant species Giant hogweed or Japanese knotweed may occur. The only scenario which is

vio . Co
an ime al.
considered relevant in non-agricultural fields and did not pass the Tier 1 risk assessment is the leafy

te reg new
vegetables scenario with the medium herbivorous/granivorous bird “pigeon” Wood pigeon (82). Therefore,

oh tio re

d
as a conservative worst case approach, a reduction of the application rate to 90 % applied is taken into

pr tec EU
ibi n
account for the chronic risk assessment in non-agricultural areas.

d
be ro te
e ta p osa
ef da ph
In agricultural areas farmers won’t tolerate higher amounts of invasive plant species in their fields. Thus

er y ly
th tor G
the density in comparison to non-agricultural fields is much lower and plants are more dispersed as they

ay ula the
are not allowed to spread over several years. The product is applied by hand-held equipment to invasive

or
t m reg king
plant species at BBCH stages when the intended crop is present, it can be expected that only few invasive

m er see
plant species are present and that the operator avoids exposure of the intended crops. In conclusion to

do ll u tium
en a
address the lower plant density of invasive species in agricultural fields, a 40% reduction in the application

cu nd
his fa or
rate based on the reduced total area is applied and considered appropriate to cover the chronic risk to birds.
f t ay ns
r o m co
ne ent he

Control of invasive species (Non-agricultural areas): Use 8-9

ow um of t
th oc (s)

Table 10.1.1-15: Tier 2 assessment of the long-term/reproductive risk for birds due the use of
of is d ber

glyphosate on invasive species in non-agricultural areas: Use 8-9

ion , th em
iss ore m

e
rm m er

Active substance Glyphosate

pe her orm

Reprod. toxicity (mg/kg 96.3

he rt t/f
t t Fu en

bw/d)
ou s. rr

5
th tie cu

TER criterion
wi par (a)

GAP crop Application Crop scenario Generic Focal species SVm MAFm × DDDm TERlt
f
en ird o

rate Growth stage TWA (mg/kg bw/d)

nt th rty

(g a.e./ha)
co and ope

Invasive 1 × 16201 Leafy Medium 22.7 1.0 × 6.99 13.8

r

ts
r i er p

species in non- vegetables herbivorous/granivorous 0.19

t o wn the

agricultural BBCH 10 – 19 bird “pigeon” Wood

en o s
m he t i

areas. Post pigeon (Columba

cu f t en

ts
do s o um

emergence of palumbus)
is ht c

invasive
th rig s do

species.
i
e op Th
of y
us c

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
d nd
an a

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger
n rty

1 Equivalent to 90 % of 1 × 1800 g a.e./ha

tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Control of invasive species (Agricultural areas): Use 8-9

t rib
dis
Table 10.1.1-16: Tier 2 assessment of the long-term/reproductive risk for birds due the use of

n,
er tio
glyphosate on invasive species in agricultural areas: Use 8-9

wn lica
.
s o ub
f it y p
Active substance Glyphosate

so n
Reprod. toxicity (mg/kg 96.3

ht , a
rig ntly
bw/d)

th ue
TER criterion 5

e eq
GAP crop Application Crop scenario Generic Focal species SVm MAFm × DDDm TERlt

e
lat ns
vio . Co
rate Growth stage TWA (mg/kg bw/d)

an ime al.
te reg new
(g a.e./ha)
Invasive 1 × 10801 Leafy Medium 22.7 1.0 × 4.66 20.7

oh tio re

d
pr tec EU
species in vegetables herbivorous/granivorous 0.19

ibi n
d
be ro te
agricultural BBCH 10 – 19 bird “pigeon” Wood

e ta p osa
areas. Post pigeon (Columba

ef da ph
emergence of palumbus)

er y ly
th tor G
invasive Cereals Small insectivorous bird 20.3 1.0 × 11.6 8.29

ay ula the
species. Late post- “passerine” 0.53

or
t m reg king
emergence Fan tailed warbler

m er see
(May-June) (Cisticola juncidis)

do ll u tium
en a
BBCH 71 – 89

cu nd
Bush and cane Small insectivorous bird 22.4 1.0 ×
his fa or
12.8 7.51
fruit Whole “warbler” Willow warbler 0.53 f t ay ns
r o m co

season BBCH (Phylloscopus trochilus)

ne ent he
ow um of t

00 – 79
th oc (s)

Currants
of is d ber

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
ion , th em

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger
iss ore m

1
Equivalent to 60% of 1 × 1800 g a.e./ha
rm m er
pe her orm
he rt t/f
t t Fu en

The refined TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
ou s. rr
th tie cu

indicating that long-term risk to birds is acceptable following the proposed use patterns for the use on
wi par (a)

invasive species in agricultural and non-agricultural areas (Uses 8, 9).

f
en ird o
nt th rty
co and ope

Drinking water exposure

r

ts
r i er p
t o wn the

There are two scenarios provided in the EFSA Guidance Document for assessing the risk from drinking
en o s
m he t i

water.
cu f t en

ts
do s o um
is ht c
th rig s do

Leaf scenario
i
e op Th

The ‘Leaf scenario’ is relevant for birds taking water that is collected in leaf whorls after application and
of y

applies to leafy vegetables forming heads or with a morphology that facilitates collection of rain / irrigation
us c
d nd

water sufficiently to attract birds, i.e. for the before named crops at BBCH ≥ 41.
an a
n rty
tio e
ta op

Since none of the proposed uses falls into these categories, the leaf scenario does not apply to the use of
loi pr

MON 52276.
xp al
l e ctu
cia lle

Puddle scenario
er te
m s in
om a

The ‘Puddle scenario’ is relevant for birds taking water from puddles formed on the soil surface of a field
y c uch

when a (heavy) rainfall event follows the application of a pesticide to a crop or bare soil. This is therefore
an ts s

relevant for all uses of MON 52276 and should therefore be assessed.
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Due to the characteristics of the exposure scenario in connection with the standard assumptions for water

rib
uptake by animals, no specific calculations of exposure and TER are necessary since the ratio of effective

t
dis
application rate (in g/ha) to acute and long-term endpoint (in mg/kg bw/d) does not exceed 50 (KOC <

n,
er tio
500 L/kg) or 3000 (KOC ≥ 500 L/kg), as specified in EFSA/2009/1438.

wn lica
.
s o ub
f it y p
As pointed out in EFSA/2009/1438, specific calculations of exposure and TER values are only necessary

so n
when the ratio of effective application rate (in g a.e./ha) to relevant endpoint (in mg a.e./kg bw/d) exceeds

ht , a
rig ntly
50 in the case of less sorptive (KOC < 500 L/kg) or 3000 in the case of more sorptive (KOC ≥ 500 L/kg)

th ue
substances.

e eq
e
lat ns
vio . Co
an ime al.
For glyphosate, the ratio of highest application rate (1800 g a.e./ha) to lowest relevant endpoint (NOAEL

te reg new
= 96.3 mg a.e./kg bw/d) is 19. As the Kf,OC for glyphosate is 4245 mL/g (See MCA section 7) the risk can

oh tio re

d
be considered acceptable without the need for further calculations.

pr tec EU
ibi n
d
be ro te
e ta p osa
Effects of secondary poisoning

ef da ph
er y ly
th tor G
According to the EFSA/2009/1438, substances with a log POW ≥ 3 have potential for bioaccumulation and

ay ula the
should be assessed for the risk of biomagnification in aquatic and terrestrial food chains.

or
t m reg king
m er see
Since the log POW values of glyphosate is log POW < -3.2 (pH 2 – 5, 20 °C), the active substance is deemed

do ll u tium
en a
to have a negligible potential to bioaccumulate in animal tissues. No formal risk assessment from secondary

cu nd
his fa or
poisoning is therefore required.
f t ay ns
r o m co
ne ent he

The primary metabolite of glyphosate is aminomethylphosphonic acid (AMPA). Most of the parent
ow um of t

glyphosate is eliminated unchanged and only a small amount (less than 1 % of the applied dose) is
th oc (s)

transformed to aminomethylphosphonic acid (AMPA). The metabolite AMPA has been tested in several
of is d ber

mammal toxicity studies which demonstrated that it is of lower toxicity than glyphosate acid (see Section
ion , th em
iss ore m

CA 5.8). Furthermore, the log POW for AMPA – estimated via EpiSuite Program and SMILES code
e
rm m er

(C(N)P(=O)(O)O) – is -2.47 and does not indicate a potential for bioaccumulation (EFSA Journal
pe her orm

2015;13(11): 4302).
he rt t/f
t t Fu en
ou s. rr
th tie cu

Indirect effects via trophic interactions

wi par (a)

A large regulatory data package exists with acute and long-term studies to inform the avian risk assessments
f
en ird o

(MCA section 8.1.1). The results of the avian risk assessment (Section 10.1.1) demonstrate that under the
nt th rty
co and ope

intended uses of glyphosate there is negligible risk from direct effects.

r

ts
r i er p
t o wn the

An assessment of indirect effects is in part covered by the current EFSA Birds and Mammals assessment
en o s
m he t i

guidance through an evaluation of the potential for secondary poisoning (e.g., consumption of earthworms,
cu f t en

ts
do s o um

fish, drinking water) as discussed above.

is ht c
th rig s do

However, methodology for assessing indirect effects through trophic interaction resulting from in-crop
i
e op Th

weed control is not addressed. Throughout the development of the EFSA (2009) bird and mammal guidance
of y

document, it was raised that indirect effects through trophic interactions should be eventually be addressed,
us c

and it was decided when the guidance on how this could be achieved was finalized, that this topic would
d nd
an a

need to be addressed by revised guidance. However, many experts in the Member States who reviewed the
n rty
tio e

guidance document commented that this is area that requires further research and that it may be preferable
ta op
loi pr

to manage indirect effects to birds through mechanisms other than that pesticide approvals (e.g., farmland
xp al

management and/or conservation policies).

l e ctu
cia lle
er te
m s in

Furthermore, concerning specifically potential impacts on biodiversity, there currently is no EU wide

om a

guidance on how this should be assessed at the taxa group level within the context of a single active
y c uch

substance renewal risk assessment.

an ts s
an righ
d
ing to
sh ct
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or be

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ep
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Further information on the biodiversity assessment for glyphosate may be found in the [doc number]

rib
accompanying this dossier submission.

t
dis
n,
er tio
wn lica
.
Scientific literature that informs the avian and mammal indirect effects assessment

s o ub
f it y p
Farmland is the most important habitat for bird conservation in Europe, harbouring more than 50% of bird

so n
species in the European Union (EU) and 55 % of European bird species listed in the IUCN Red List

ht , a
rig ntly
(Burfield, 2005; Donald et al., 2006).

th ue
e eq
e
lat ns
In Europe, trend data are available from the Pan-European Common Bird Monitoring Scheme, which is

vio . Co
an ime al.
currently implemented in 18 countries (Gregory et al. 2003; Traba and Morales, 2019). The data show

te reg new
trends in farmland and woodland birds since 1980. On average, populations of woodland birds in Europe

oh tio re

d
have remained stable. In contrast, populations of farmland birds in Europe declined particularly in the 1980s

pr tec EU
ibi n
and the downward trend over the next two decades continued, but at a slower rate (trend 1980–2002, 29

d
be ro te
e ta p osa
%). This rapid decrease in farmland birds is believed to reflect deterioration in the quality of farmland

ef da ph
habitats in Europe (Traba and Morales, 2019).

er y ly
th tor G
ay ula the
Several reviews and studies on indirect effects through trophic interactions to populations of farmland bird

or
t m reg king
species are available. These studies and reviews mainly focus on arable landscapes in the UK (Campbell et

m er see
al. 1997; Marshall et al., 2001; Boatman et al. 2004; DEFRA 2005; Bright et al. 2008; Jahn et al. 2013;

do ll u tium
en a
Traba and Morales, 2019).

cu nd
his fa or
f t ay ns
After forestry applications, changes in bird community composition, and reductions in abundance, densities
r o m co
ne ent he

and species richness of bird populations often occurred in the first few years after glyphosate application
ow um of t

(Guiseppe et al. 1986, Easton and Martin, 1998, Santillo et al. 1989b), and in Santillo et al. (1989b) the
th oc (s)

decline in bird densities was correlated with the decline in habitat complexity. These changes were assessed
of is d ber

against untreated control sites to differentiate the effects of glyphosate from other background
ion , th em
iss ore m

environmental factors such as the recovery trajectory following tree harvest and showed similar declines in
e
rm m er

bird densities where habitats removed following the use of other herbicides commonly used in managed
pe her orm

forests (Guvnn et al., 2004).

he rt t/f
t t Fu en
ou s. rr
th tie cu

Sullivan and Sullivan (2003) published a comprehensive glyphosate assessment addressing vegetation
wi par (a)

management and ecosystem disturbance focusing on plant and animal biodiversity that considered both
f
en ird o

direct effects at the individual level, but also indirect effects on habitats / refuges and resource. Their
nt th rty
co and ope

analysis was based on 60 published studies of terrestrial plants and animals in temperate forests and
r

agroecosystems. Species richness of plants was either unaffected or increased in the case of herbaceous
ts
r i er p
t o wn the

species in those receiving glyphosate treatments. Species richness and diversity of songbirds, in open
en o s
m he t i

habitats representative of agricultural lands, did not appear to be negatively impacted in glyphosate use
cu f t en

ts
do s o um

areas. In fact, conservation tillage, which is enabled by glyphosate, promoted greater abundance of
is ht c

songbirds and other fowl compared with ploughed fields (McLaughlin and Mineau, 1995; Cunningham et
th rig s do

al., 2005).
i
e op Th
of y

Overall, the magnitude of changes in species richness and diversity of plants, birds, and small mammals in
us c

the studies reviewed by Sullivan and Sullivan (2003) were within the mean range of natural fluctuations
d nd
an a

and considered direct and indirect effects.

n rty
tio e
ta op
loi pr

The following approach has been taken to assess potential indirect effects via trophic interactions, considers
xp al

the proposed Specific Protection Goals drawn from the existing EU guidance and working documents, and
l e ctu
cia lle

the 2016 EFSA Guidance on developing protection goals for ecological risk assessments (ERA) for
er te
m s in

pesticides. The SPGs based on direct effects assessment considering representative sensitive populations
om a

across the tested trophic levels. The biodiversity assessment, aimed to develop a flexible framework that
y c uch

informs the development of risk mitigation options to achieve the specific protection goals, that includes
an ts s

considering indirect effects via trophic interaction. For example, reduced application rates relative to
an righ

previous Annex I renewals, a reduced overall application volume of product on the land, and inclusion of
d
ing to
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bli bje
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or be

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no-spray buffer zones - a standard mitigation measure to protect non-target terrestrial plant communities in

rib
off-target areas, which indirectly supports bird biodiversity by maintaining habitat and refuges for birds to

t
dis
nest and feed. Therefore, where an acceptable direct effects risk assessment is concluded upon after

n,
er tio
incorporation of standard mitigation measures to reduce off-target movement via drift to off-target areas,

wn lica
.
coupled with the standard mitigation measures, is considered protective of indirect effects occurring outside

s o ub
f it y p
of the target area. When defining SPGs for birds that reflects both direct and indirect effects, it is the

so n
responsibility of the risk assessors in the Member States to acknowledge existing protection goals and

ht , a
rig ntly
regulatory data requirements, to propose possible SPG options, and describe the possible environmental

th ue
consequences of each option. The risk assessors within the Member States will need to propose realistic

e eq
e
lat ns
SPGs and exposure assessment goals and the interrelationships between them in a clear and transparent

vio . Co
an ime al.
manner.

te reg new
oh tio re

d
In the following table, the specific protection goals relevant to birds are presented with the relationship

pr tec EU
ibi n
between the SPGs, the direct effects study types, assessment and measurement endpoints. The assessment

d
be ro te
e ta p osa
endpoint is an explicit expression of an environmental entity and the specific property of that entity to be

ef da ph
protected. Measurement endpoints relates directly to the effects study endpoints.

er y ly
th tor G
ay ula the
A conclusion that a given data requirement has been satisfied, requires that an acceptable level of risk has

or
t m reg king
been achieved (i.e. there is a protective margin of exposure or through a weight of evidence).

m er see
do ll u tium
en a
Based on the measurement endpoints from the study types, and the direct effects assessment presented

cu nd
his fa or
above in this section, it is anticipated that for the proposed uses on the GAP table, that there will be no
f t ay ns
reduction in bird survival, growth, development and reproduction of avian populations and this in turn
r o m co
ne ent he

meets the specific protection goal for birds.

ow um of t
th oc (s)
of is d ber

Table 10.1.1-17: Protection goals and associated assessment and measurement endpoints for birds.
ion , th em
iss ore m

e
rm m er

Specific Protection Goals1

pe her orm

Assessment Endpoints Measurement Endpoints Glyphosate Study Types

he rt t/f

No visible mortality and No reduction in survival, Survival, growth, Acute oral avian and rat
t t Fu en
ou s. rr

long-term impacts on growth, development, development and Avian reproduction

th tie cu

abundance and diversity reproduction of avian reproduction

wi par (a)

populations.
f
en ird o
nt th rty
co and ope

Avian Biodiversity Assessment

r

Based on the current direct effects risk assessment for glyphosate, there is acceptable acute and long-term risk
ts
r i er p
t o wn the

assessments based on current guidance and the intended use patterns for glyphosate.
en o s
m he t i
cu f t en

ts

However, if additional risk mitigation measures are determined to be required, to mitigate indirect effects resulting
do s o um

from in-crop weed control on avian populations, options to be considered by risk assessors and risk managers
is ht c
th rig s do

within Member States are presented in Table 10.1.1-18.

i
e op Th

1 When protection goals are defined more precisely by risk managers or legislators to address indirect effect, then the protection

goals and assessment procedures should be revised.

of y
us c
d nd
an a
n rty

Conclusion on Indirect effects to birds via trophic interactions

tio e

Based on the current direct effects risk assessment for glyphosate, there is acceptable acute and long-term
ta op
loi pr

risk assessments based on current guidance and the intended use patterns for glyphosate. Currently, the
xp al
l e ctu

EFSA (2009) guidance for birds and mammals does not include assessment methodology for indirect effects
cia lle

through trophic interactions. Addressing potential indirect effects to birds by limiting in-crop weed control
er te
m s in

may be better handled though policies and programs outside the PPP framework. However, if additional
om a

risk mitigation measures are determined to be required, to mitigate indirect effects resulting from in-crop
y c uch

weed control on avian populations, options to be considered by risk assessors and risk managers within
an ts s

Member States are presented in the following tables.

an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.1.1-18: Examples of standard mitigation measures as described in MAgPIE (2017) across

t rib
the various Member States to mitigate effects of glyphosate on biodiversity.

dis
n,
er tio
Type of Mitigation Risk Mitigation Benefits Glyphosate renewal dossier (2020)

wn lica
.
Measure Measure

s o ub
Restrictions or Application rate, Lower transfers to

f it y p
Significant reductions (50 % in volume)

so n
modifications of Application frequency, groundwater and surface in newly proposed application rates

ht , a
products’ conditions application timing, water; Reduces exposure compared with the representative use

rig ntly
of application and interval between of organisms in-crop and presented in the 2012 renewal dossier.

th ue
e eq
applications off-crop. See 12Appendix 2 of the biodiversity

e
lat ns
document accompanying this

vio . Co
an ime al.
submission.

te reg new
oh tio re

d
Treated area restriction

pr tec EU
ibi n
1. for the representative use GAPs:

d
be ro te
e ta p osa
applying to only 50 % of the total area in

ef da ph
orchard/vineyard area.

er y ly
2. maximum of 50 % of the total area for

th tor G
ay ula the
broad acre vegetable inter-row

or
t m reg king
3. Invasive species control e.g., couch grass
– maximum of 20 % of the cropland +

m er see
extended application intervals.

do ll u tium
en a
cu nd
his fa or
Limited frequency and timing of
f t ay ns
r o m co
application: 28-day interval between
ne ent he

applications and no pre-harvest

ow um of t

applications
th oc (s)
of is d ber

Application Spray drift reduction Reduces exposure of Reduction of spray drift to the off-field:
ion , th em

equipment nozzles (SDRN), organisms in-crop 1. Use 75 % drift reducing nozzles for pre-
iss ore m

with Spray Drift shields, (precision treatment) and sowing/pre-planting in arable crops.
rm m er
pe her orm

Reduction Precision treatment, off-crop 2. Use of ground directed, shielded spray

he rt t/f

Technology (SDRT) etc. for band application in orchards /

t t Fu en

vineyards and broad-acre vegetable inter-

ou s. rr
th tie cu

row application.
wi par (a)

Buffer zones Non-sprayed zone at Reduces exposure of Establishment of buffer zones:

f
en ird o

the edge of a crop organisms and off-crop Buffer zones of varying size (depending on
nt th rty
co and ope

the type of SDRT) are required as

r

protection for off-crop NTTP communities

ts
r i er p
t o wn the

from spray drift.

en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do

References relied upon in Indirect effects via trophic interaction for Birds discussion
i
e op Th
of y

Boatman N, Brickle N, Hart J, Milsom T, Morris A, Murray A, Murray K, Robertson P. 2004. Evidence
us c

for the indirect effects of pesticides on farmland birds. Ibis 146 Supplement 2, 131-143.
d nd
an a
n rty

Bright, J. A., Morris, A. J. & Winspear, R. (2008): A review of Indirect Effects of Pesticides on Birds and
tio e
ta op

mitigating land-management practices. The Royal Society for the Protection of Birds, 1-66.
loi pr
xp al
l e ctu

Burfeld, I. J. 2005. The conservation status of steppic birds in Europe” In Ecology and Conservation of
cia lle
er te

Steppe-land Birds, Bota, G., Morales, M. B., Mañosa, S. & Camprodon, J. Eds, pp 119–140 (Lynx Edicions,
m s in

2005).
om a
y c uch
an ts s

12
an righ

(2020) Glyphosate: Indirect effects via trophic interaction - A Practical Approach to

Biodiversity Assessment (TRR0000305).
d
ing to
sh ct
bli bje
pu su
or be

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ep
,r
ion
ut
rib
Campbell LH, Cooke AS. 1997. The indirect effects of pesticides on birds. Joint Nature Conservation

t
dis
Committee 18pp. Peterborough.

n,
er tio
wn lica
.
Cunningham HM, Bradbury RB, Chaney K, Wilcox, A 2005 The effect of non-inversion tillage on field

s o ub
f it y p
usage by UK farmland birds in winter. Bird Study, 52:173-179.

so n
DEFRA. 2005. Assessing the indirect effects of pesticides on birds. Central Science Laboratory, Game

ht , a
rig ntly
Conservancy Trust, Royal Society for the Protection of Birds and Department of Zoology, University of

th ue
Oxford; DEFRA Research Project PN0925. Final report. http://randd.defra.gov.uk

e eq
e
lat ns
vio . Co
an ime al.
Donald, P. F., Sanderson, F. J., Burfeld, I. J. & van Bommel, F. P. J. 2006. Further evidence of continent-

te reg new
wide impacts of agricultural intensification on European farmland birds, 1990–2000. Agric. Ecosyst.

oh tio re

d
Environ 116, 189–196.

pr tec EU
ibi n
d
be ro te
e ta p osa
Easton WE, Martin K. 1998. The effect of vegetation management on breeding bird communities in British

ef da ph
Columbia. Ecol. Appl. 8:1092–1103.

er y ly
th tor G
ay ula the
Guiseppe KFL, Drummond FA, Stubbs C, Woods S. 2006. The Use of Glyphosate Herbicides in Managed

or
t m reg king
Forest Ecosystems and their Effects on Non-Target Organisms with Particular Reference to Ants as

m er see
Bioindicators; Maine Agricultural and Forest Experiment Station Technical Bulletin 192; Maine

do ll u tium
en a
Agricultural and Forest Experiment Station, University of Maine: Orono, ME, USA, p. 51.

cu nd
his fa or
f t ay ns
Guynn DC, Guynn ST, Wigley TB, DA Miller 2004. Herbicides and forest biodiversity-what do we know
r o m co
ne ent he

and where do we go from here? Wildl. Soc. Bull. 32:1085–1092.

ow um of t
th oc (s)

Jahn T, Hötker H, Oppermann R, Bleil R, Vele L. 2013. Protection of biodiversity of free living birds and
of is d ber

mammals in respect of the effects of pesticides, Main Report. Umweltbundesamt Development & Research
ion , th em
iss ore m

Project FKZ 371063411. Available at www.umweltbundesamt.de

e
rm m er
pe her orm

Marshall J, Brown V, Boatman N, Lutman P, Squire G. 2001. The impact of herbicides on weed abundance
he rt t/f
t t Fu en

and biodiversity In: A report for the UK Pesticides Safety Directorate - PN0940: 147. British Health and
ou s. rr
th tie cu

Safety Executive, Chemicals Regulation Directorate Pesticides

wi par (a)
f
en ird o

McLaughlin A, Mineau P. 1995. The impact of agricultural practices on biodiversity. Agriculture,

nt th rty
co and ope

Ecosystems and Environment 55:201-212.

r

ts
r i er p
t o wn the

Santillo DJ, Brown PW, Leslie DM. 1989b. Response of songbirds to glyphosate-induced habitat changes
en o s
m he t i

on clearcuts. J. Wildl. Manag. 53:64–71.

cu f t en

ts
do s o um
is ht c

Sullivan TP, Sullivan DS. 2003. Vegetation management and ecosystem disturbance: impact of glyphosate
th rig s do

herbicides on plant and animal diversity in terrestrial systems. Env Rev 11:37-59.
i
e op Th
of y

Traba J, Morales MB. 2019. The decline of farmland birds in Spain is strongly associated to the loss of
us c

fallowland. Sci Rep. 1:9473.

d nd
an a
n rty
tio e
ta op
loi pr

CP 10.1.1.1 Acute oral toxicity

xp al
l e ctu

An avian acute oral toxicity study with the formulation MON 52276 is not considered required for the
cia lle

following reasons:
er te
m s in
om a
y c uch

A comparison between the acute oral toxicity of glyphosate acid technical and MON 52276 to mammals
an ts s

indicates that no increased risk needs to be expected from the product over that posed from the technical
an righ

grade. Furthermore, all available toxicity data for birds demonstrate that glyphosate acid is of relatively low
d
ing to
sh ct
bli bje
pu su
or be

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ep
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toxicity to birds. Thus, it was concluded that toxicity can be reasonably predicted based on the data for the

rib
active substances.

t
dis
n,
er tio
In addition, a risk assessment for birds was performed in accordance with the recommendations of the

wn lica
.
EFSA/2009/1438 and showed acceptable risk for all intended uses of the representative formulation

s o ub
f it y p
MON 52276.

so n
ht , a
rig ntly
In conclusion, for reasons listed above and for reasons of animal welfare (in order to avoid unnecessary

th ue
testing on terrestrial vertebrates in particular with regard to the European legislation on animal welfare,

e eq
e
lat ns
(e.g. Articles 61 and 62 of the Regulation (EC) No 1107/2009), it is not considered necessary to conduct

vio . Co
an ime al.
an avian acute oral toxicity study with the product MON 52276 in addition to the data available for the

te reg new
active substance.

oh tio re

d
pr tec EU
ibi n
d
CP 10.1.1.2 Higher tier data on birds

be ro te
e ta p osa
ef da ph
Additional studies are not considered required, since an acceptable risk for birds in consideration of each

er y ly
th tor G
potential route of exposure was concluded (see data point CP 10.1.1).

ay ula the

or
t m reg king
m er see
CP 10.1.2 Effects on terrestrial vertebrates other than birds

do ll u tium
en a
Studies considering the toxicity of glyphosate and relevant metabolites to mammals were assessed for their

cu nd
his fa or
f t ay ns
validity to current and relevant guidelines. The results of these studies demonstrate that glyphosate and
r o m co
AMPA are of low acute and chronic toxicity to mammals and are summarised in the tables below.
ne ent he
ow um of t
th oc (s)

A detailed evaluation is provided in Annex M-CA 8-02 of the document M-CA Section 8 which outlines
of is d ber

the selection of endpoints and the discussion surrounding those used in the risk assessment.
ion , th em
iss ore m

e
rm m er

Details of the acute studies are summarised in the document M-CA, Section 5.
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu

Table 10.1.2-1: Relevant endpoints for risk assessment: Acute oral toxicity of glyphosate and
wi par (a)

AMPA to mammals
f
en ird o
nt th rty
co and ope

Reference Substance Species Test design LD50

r

ts
r i er p
t o wn the

KCA 5.2.1/001 Glyphosate acid Rat/Mice Acute toxicity Screening Step / Tier 1:
to KCA 5.2.1/039
en o s

> 2000 mg a.e./kg bw

m he t i
cu f t en

ts
do s o um

KCA 5.2.1/001 Glyphosate acid Rat/Mice Acute toxicity Tier 2:

is ht c
th rig s do

to KCA 5.2.1/039 3694.1 mg a.e./kg bw

i
e op Th

M-CA Section 5 AMPA Mouse Acute toxicity > 5000 mg/kg bw

of y
us c
d nd
an a

a.e.: acid equivalents

n rty

Endpoints in bold are used for risk assessment

tio e
ta op
loi pr
xp al
l e ctu

Details of the reproduction studies are summarised in the document M-CA, Section 5.
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.1.2-2: Relevant endpoints for risk assessment: Reproductive toxicity of glyphosate and

t rib
AMPA to mammals

dis
n,
er tio
wn lica
Reference Substance Species Test design NOAEL

.
s o ub
M-CA Section 5 Glyphosate acid Rabbit Developmental Screening Step / Tier 1:

f it y p
toxicity 50 mg a.e./kg bw/d

so n
ht , a
(long-term)

rig ntly
M-CA Section 5 Glyphosate acid Rabbit Developmental Tier 2:

th ue
toxicity

e eq
100 mg a.e./kg bw/d

e
lat ns
(long-term)

vio . Co
an ime al.
M-CA Section 5 Glyphosate acid Rat Developmental Tier 3:

te reg new
toxicity (long-term) 300 mg a.e./kg bw/d

oh tio re

d
M-CA Section 5 AMPA Rat 13 week oral > 1000 mg/kg bw/d

pr tec EU
ibi n
a.e.: acid equivalents

d
be ro te
Endpoints in bold are used for risk assessment

e ta p osa
ef da ph
er y ly
th tor G
ay ula the
Risk assessment for metabolites

or
t m reg king
The primary metabolite of glyphosate is aminomethylphosphonic acid (AMPA). Most of the parent
glyphosate is eliminated unchanged and only a small amount (less than 1 % of the applied dose) is

m er see
transformed to aminomethylphosphonic acid (AMPA). The metabolite AMPA has been tested in several

do ll u tium
en a
mammal toxicity studies which demonstrated that it is of lower toxicity than glyphosate acid (see

cu nd
his fa or
Section CA 5.8). f t ay ns
r o m co
ne ent he
ow um of t

Following application to plant tissues, unchanged glyphosate was the only significant residue. In presence
th oc (s)

of soil as a substrate the active substance is quickly degraded, leaving AMPA at rates comparable or even
of is d ber

higher than parent glyphosate. However, the uptake via the roots and the translocation in the plants was
ion , th em

very low, not resulting in significant residue levels as confirmed by plant metabolism and confined
iss ore m

rotational crop studies. A major part of the glyphosate was degraded into CO2. Therefore, it can be
rm m er
pe her orm

concluded that the risk to mammals will be acceptably low and no further quantitative risk assessment on
he rt t/f

the main metabolite is conducted.

t t Fu en
ou s. rr
th tie cu
wi par (a)

Risk assessment for the representative formulation

f

An acute oral mammalian study is available with the formulation which is presented in the toxicological
en ird o
nt th rty

section under document M-CP Section 7.1.1/01. This study shows, that the acute toxicity of the formulation
co and ope

(>5000 mg/kg bw) is not more elevated than the toxicity of the active substance alone (>2000 mg/kg bw).
r

ts
r i er p
t o wn the

Therefore the mammalian risk assessment for the representative formulation is considered to be covered by
en o s

the mammalian risk assessment presented for the active substance glyphosate.
m he t i
cu f t en

ts
do s o um
is ht c

Table 10.1.2-3: Relevant endpoints for risk assessment: Acute oral toxicity of MON 52276 to
th rig s do

mammals
i
e op Th

Reference Substance Species Test design LD50

of y

, 1991 MON 52276 Rat Acute toxicity

us c

> 5000 mg
d nd

CP 7.1.1/001 a.e./kg bw
an a
n rty
tio e
ta op
loi pr

There are no literature articles and peer-reviewed published data considered to be relevant and reliable or
xp al
l e ctu

reliable with restrictions with regards to the impact of glyphosate or its relevant metabolites on mammals.
cia lle

Full literature evaluation is provided in document M-CA Section 9. A summary of previously evaluated
er te
m s in

peer reviewed literature from the RAR 2015 is also available in Annex M-CA 8-01 of the document
om a

M-CA Section 8. In common with the previous literature review, there were no endpoints considered
y c uch
an ts s

relevant for use in the mammalian risk assessment. In the previous literature review, reference is made to
an righ

the literature on amphibians - which is discussed within this dossier.

d
ing to
sh ct
bli bje
pu su
or be

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Effects on vertebrates by the action of surface-active substances in glyphosate based formulations was also

rib
discussed in the previous literature review, with two papers relating to mammals, Santilio et al., (1989) and

t
dis
Sullivan et al., (2003) which were both considered in the previous RMS concluding weight of evidence.

n,
er tio
The conclusion by the RMS to the first paper on the ‘Response of small mammals and habitat to glyphosate

wn lica
.
application on clearcuts’ was to emphasise that herbicides cause indirect effects and highlighted the need

s o ub
f it y p
for risk mitigation measures by the Member States, proposing compensation measures as a suitable tool.

so n
The second paper on ‘Ecosystem disturbance: Impact of glyphosate herbicide on plant and animal diversity

ht , a
rig ntly
in terrestrial systems’ was considered supporting information. This paper considered the impact of Anglo-

th ue
Saxon practice of managing the vegetation for purposes of enhancing forest and other crop yields. This

e eq
e
lat ns
paper considered roadside vegetation management and its role in the maintenance of ecological processes

vio . Co
an ime al.
in terrestrial ecosystems. There were four other papers considered in the weight of evidence for vertebrates

te reg new
– specifically birds.

oh tio re

d
pr tec EU
ibi n
Concerning effects at the ecosystem level – specifically indirect effects on mammals via trophic

d
be ro te
e ta p osa
interactions, and considering impacts on biodiversity at a wider landscape level, a biodiversity assessment

ef da ph
is presented at the end of this section.

er y ly
th tor G
ay ula the
For the mammalian risk assessment, supporting information are presented on endpoint selection and on the

or
t m reg king
population dynamics of small herbivorous mammals that is considered relevant to the risk assessment.

m er see
These data are presented in Annex M-CA 8-02 of the document M-CA Section 8.

do ll u tium
en a
cu nd
his fa or
Risk assessment for other terrestrial vertebrates f t ay ns
r o m co
ne ent he

The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment for
ow um of t

Mammals and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438; hereafter referred to as
th oc (s)

EFSA/2009/1438).
of is d ber
ion , th em

The table below summarises how the risk assessment for mammals considers all the proposed uses and the
iss ore m

e
rm m er

application rates presented in the GAP.

pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.1.2- 4: Risk assessment strategy for mammals

t rib
dis
Application rate considered (28 day interval unless otherwise stated)

n,
er tio
wn lica
1× 1× 1× 2× 1× 3× 1× 2× 2× 2×

.
GAP number and summary of 540

s o ub
720 1080 720 1440 720 1800 1080 1440 1800

f it y p
use g/ha g/ha g/ha g/ha g/ha g/ha g/ha g/ha1 g/ha g/ha (90

so n
ht , a
days

rig ntly
apart)

th ue
Uses 1a-c: Applied to weeds;

e eq
pre-sowing, pre-planting, pre X X X

e
lat ns
vio . Co
emergence of field crops.

an ime al.
te reg new
Uses 2 a-c: Applied to weeds;
post-harvest, pre-sowing, pre- X X X X X X

oh tio re

d
pr tec EU
planting of field crops.

ibi n
d
be ro te
Use 3 a-b: Applied to cereal

e ta p osa
volunteers; post-harvest, pre-

ef da ph
X
sowing, pre-planting of field

er y ly
th tor G
crops.

ay ula the
Use 4 a-c: Applied to weeds

or
t m reg king
(post emergence) below trees in X X X X X X X

m er see
orchards.

do ll u tium
en a
Use 5 a-c: Applied to weeds
(post emergence) below vines in X X X X X X X

cu nd
his fa or
vineyards f t ay ns
r o m co

Use 6 a-b: Applied to weeds

ne ent he

(post emergence) in field crops X X

ow um of t

BBCH < 20
th oc (s)
of is d ber

Use 7 a-b: Applied to weeds

ion , th em

(post emergence) around X X

iss ore m

railroad tracks
rm m er

Use 8 and 9: Applied to

pe her orm

invasive species (post

he rt t/f

X
t t Fu en

emergence) in agricultural and

ou s. rr
th tie cu

non-agricultural areas
wi par (a)

Uses 10 a-c: Applied to couch

f
en ird o

grass; post-harvest, pre-sowing, X X

nt th rty

pre-planting of field crops

co and ope

X = this use is covered by the application rate indicated.

r

ts
r i er p

1
Due to the long spray interval of 28 days this use covers also the following possible application pattern: 2 × 1080 g a.s./ha plus
t o wn the

1 × 720 g a.s./ha (28 day interval between each application)

en o s
m he t i
cu f t en

ts
do s o um
is ht c

For the screening assessment; crops that maybe present at time of application to target weeds and the
th rig s do

relevant application rates shown in the table above are considered. The acute and long-term screening
i
e op Th

assessment results are presented below according to the following main uses:
of y
us c
d nd

 in field crops (covering GAP uses 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c); pre-sowing, pre-planting pre
an a

emergence, post-harvest. Exposure to mammals via grassland, bare soil and field crops is
n rty
tio e

considered and is covered by the general screening scenarios bare soil, bulb and onion like crops
ta op
loi pr

(etc.) and fruiting vegetables (etc.).

xp al
l e ctu
cia lle

 in orchards and vineyards (covering GAP uses 4 a-c, 5a-c) applied to weeds post emergence
er te
m s in

exposure below trees; exposure to small herbivorous mammals in orchards and vineyards is
om a

considered and is covered by the general screening scenario fruiting vegetables (etc.).
y c uch
an ts s

in railroad tracks (covering GAP uses 7 a-b) applied to weeds pots emergence; exposure to
an righ


mammals via grassland, bare soil and field crops (leafy vegetables) is considered and is covered by
d
ing to
sh ct
bli bje
pu su
or be

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the general screening scenarios bare soil and fruiting vegetables (etc.).

t rib
dis
 In control of invasive species (covering GAP uses 8 and 9) applied; exposure to mammals via

n,
er tio
grassland, bare soil and field crops is considered and is covered by the general screening scenarios

wn lica
.
bare soil bush and cane fruit, bulb and onion like crops (etc.) and fruiting vegetables (etc.).

s o ub
f it y p
so n
ht , a
Screening assessment

rig ntly
th ue
e eq
Field crops

e
lat ns
vio . Co
an ime al.
Table 10.1.2- 5: Screening assessment of the acute risk for mammals due to the use of glyphosate in

te reg new
field crops: Uses 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c.

oh tio re

d
pr tec EU
ibi n
Glyphosate

d
Active substance

be ro te
e ta p osa
Acute toxicity (mg/kg bw) > 2000

ef da ph
TER criterion 10

er y ly
th tor G
GAP crop Application Crop scenario Indicator species SV90 MAF90 DDD90 TERa

ay ula the

or
rate (mg/kg bw/d)

t m reg king
(g a.s./ha)

m er see
Pre-sow, pre-planting, 1 × 1440 Bare soil Small 14.4 1.0 20.7 96.6

do ll u tium
en a
post-harvest of; granivorous

cu nd
Root and Stem veg,
his fa or
mammal
Potato f t ay ns
Bulb and onion Small 118.4 1.0 170 11.7
r o m co

Bulb and onion like

ne ent he

like crops herbivorous

ow um of t

crops, mammal
fruiting veg,
th oc (s)

Fruiting Small 136.4 1.0 196 10.2

of is d ber

leafy veg,
vegetables herbivorous
ion , th em

Sugar beet.
mammal
iss ore m

Post-emergence of weeds
rm m er
pe her orm

Pre-sow, pre-planting, 2 × 1080 Bare soil Small 14.4 1.1 17.1 117
pre-emergence & post- (28 d) granivorous
he rt t/f
t t Fu en

harvest of; mammal

ou s. rr
th tie cu

Root and Stem veg, Bulb and onion Small 118.4 1.1 141 14.2
wi par (a)

Potato like crops herbivorous

f
en ird o

Bulb and onion like mammal

nt th rty

crops,
co and ope

Fruiting Small 136.4 1.1 162 12.3

fruiting veg,
r

vegetables herbivorous
ts
r i er p

leafy veg,
t o wn the

mammal
Sugar beet.
en o s
m he t i

Post-emergence of weeds
cu f t en

ts
do s o um

Pre-sow, pre-planting, 1 × 540 Bare soil Small 14.4 1.0 7.78 257
is ht c

post-harvest of;
th rig s do

granivorous
Root and Stem veg, mammal
i
e op Th

Potato Bulb and onion Small 118.4 1.0 63.9 31.3

of y

Bulb and onion like like crops herbivorous

us c

crops,
d nd

mammal
fruiting veg,
an a

Fruiting Small 136.4 1.0 73.7 27.1

n rty

leafy veg,
tio e

vegetables herbivorous
ta op

Sugar beet.
loi pr

mammal
Post-emergence of weeds
xp al
l e ctu

Pre-sow, pre-planting, 1 × 720 Bare soil Small 14.4 1.0 10.4 192
cia lle

pre-emergence & post- granivorous

er te
m s in

harvest of; mammal

om a

Root and Stem veg, Bulb and onion Small 118.4 1.0 85.2 23.5
y c uch

Potato like crops herbivorous

an ts s

Bulb and onion like mammal

an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.1.2- 5: Screening assessment of the acute risk for mammals due to the use of glyphosate in

t rib
field crops: Uses 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c.

dis
n,
er tio
Active substance Glyphosate

wn lica
.
> 2000

s o ub
Acute toxicity (mg/kg bw)

f it y p
TER criterion 10

so n
ht , a
GAP crop Application Crop scenario Indicator species SV90 MAF90 DDD90 TERa

rig ntly
rate (mg/kg bw/d)

th ue
(g a.s./ha)

e eq
e
lat ns
crops, Fruiting Small 136.4 1.0 98.2 20.4

vio . Co
an ime al.
fruiting veg, vegetables herbivorous

te reg new
leafy veg, mammal

oh tio re
Sugar beet.

d
pr tec EU
Post-emergence of weeds

ibi n
d
be ro te
Sugar beet.

e ta p osa
Post-emergence of weeds

ef da ph
er y ly
Pre-sow, pre-planting, 2 × 720 Bare soil Small 14.4 1.1 11.4 175

th tor G
pre-emergence & post- (28 d) granivorous

ay ula the

or
harvest of; mammal

t m reg king
Root and Stem veg, Bulb and onion Small 118.4 1.1 93.8 21.3

m er see
Potato like crops herbivorous

do ll u tium
en a
Bulb and onion like mammal

cu nd
crops,
his fa or
Fruiting Small f t ay ns 136.4 1.1 108 18.5
fruiting veg,
r o m co
vegetables herbivorous
leafy veg,
ne ent he

mammal
ow um of t

Sugar beet.
Post-emergence of weeds
th oc (s)
of is d ber

Sugar beet.
ion , th em

Post-emergence of weeds
iss ore m

Pre-sow, pre-planting, 1 × 1080 Bare soil Small 14.4 1.0 15.6 128
rm m er
pe her orm

pre-emergence & post- granivorous

harvest of; mammal
he rt t/f
t t Fu en

Root and Stem veg,

ou s. rr

Bulb and onion Small 118.4 1.0 128 15.6

th tie cu

Potato
like crops herbivorous
wi par (a)

Bulb and onion like

mammal
f
en ird o

crops,
nt th rty

fruiting veg, Fruiting Small 136.4 1.0 147 13.6

co and ope

leafy veg, vegetables herbivorous

r

ts
r i er p

Sugar beet. mammal

t o wn the

Post-emergence of weeds
en o s
m he t i

Pre-sow, pre-planting, 3 × 720

cu f t en

Bare soil Small 14.4 1.1 11.4 175

ts
do s o um

post-harvest of; (28 d) granivorous

is ht c
th rig s do

Root and Stem veg, mammal

Potato Bulb and onion Small 118.4 1.1 93.8 21.3
i
e op Th

Bulb and onion like like crops herbivorous

of y

crops, mammal
us c

fruiting veg, Fruiting Small 136.4 1.1 108 18.5

d nd

leafy veg,
an a

vegetables herbivorous
n rty

Sugar beet. mammal

tio e
ta op

Post-emergence of weeds
loi pr
xp al

SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio.
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.1.2- 6: Screening assessment of the long-term/reproductive risk for mammals due to the

t rib
use of glyphosate in field crops: Use 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c.

dis
n,
er tio
Active substance Glyphosate

wn lica
.
50

s o ub
Reprod. toxicity (mg/kg bw/d)

f it y p
TER criterion 5

so n
ht , a
GAP crop Application Crop scenario Indicator species SVm MAFm DDD90 TERlt

rig ntly
rate × (mg/kg bw/d)

th ue
TWA

e eq
(g a.s./ha)

e
lat ns
Pre-sow, pre-planting, 1 × 1440 Bare soil Small 6.6 1.0 × 5.04 9.92

vio . Co
an ime al.
pre-emergence & post- granivorous 0.53

te reg new
harvest of; mammal

oh tio re

d
Root and Stem veg,

pr tec EU
Bulb and onion Small 48.3 1.0 × 36.9 1.36

ibi n
Potato

d
like crops herbivorous 0.53

be ro te
e ta p osa
Bulb and onion like crops, mammal

ef da ph
fruiting veg,
Fruiting Small 72.3 1.0 × 55.2 0.91

er y ly
leafy veg,

th tor G
vegetables herbivorous 0.53

ay ula the
Sugar beet.
mammal

or
Post-emergence of weeds

t m reg king
Pre-sow, pre-planting, 2 × 1080 Bare soil Small 6.6 1.1 × 4.16 12.0

m er see
pre-emergence & post- (28 d) granivorous 0.53

do ll u tium
en a
harvest of; mammal

cu nd
his fa or
Root and Stem veg, Bulb and onion Small f t ay ns 48.3 1.1 × 30.4 1.64
r o m co
Potato like crops herbivorous 0.53
ne ent he

Bulb and onion like crops, mammal

ow um of t

fruiting veg,
Fruiting Small 72.3 1.1 × 45.5 1.10
th oc (s)

leafy veg,
of is d ber

vegetables herbivorous 0.53

Sugar beet.
ion , th em

mammal
Post-emergence of weeds
iss ore m

Pre-sow, pre-planting,
rm m er

1 × 540 Bare soil Small 6.6 1.0 × 1.89 26.5

pe her orm

pre-emergence & post- granivorous 0.53

he rt t/f

harvest of; mammal

t t Fu en

Root and Stem veg,

ou s. rr

Bulb and onion Small 48.3 1.0 × 13.8 3.62

th tie cu

Potato like crops herbivorous 0.53

wi par (a)

Bulb and onion like crops, mammal

f
en ird o

fruiting veg,
nt th rty

Fruiting Small 72.3 1.0 × 20.7 2.42

co and ope

leafy veg,
vegetables herbivorous 0.53
r

Sugar beet.
ts
r i er p

mammal
t o wn the

Post-emergence of weeds
en o s

Pre-sow, pre-planting, 1 × 720 Bare soil Small 6.6 1.0 × 2.52 19.9
m he t i
cu f t en

ts

pre-emergence & post- granivorous 0.53

do s o um

harvest of; mammal

is ht c
th rig s do

Root and Stem veg, Bulb and onion Small 48.3 1.0 × 18.4 2.71
i

Potato
e op Th

like crops herbivorous 0.53

Bulb and onion like crops, mammal
of y

fruiting veg,
us c

Fruiting Small 72.3 1.0 × 27.6 1.81

d nd

leafy veg,
vegetables herbivorous 0.53
an a

Sugar beet.
n rty

mammal
tio e

Post-emergence of weeds
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Table 10.1.2- 6: Screening assessment of the long-term/reproductive risk for mammals due to the

t rib
use of glyphosate in field crops: Use 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c.

dis
n,
er tio
Active substance Glyphosate

wn lica
.
50

s o ub
Reprod. toxicity (mg/kg bw/d)

f it y p
TER criterion 5

so n
ht , a
GAP crop Application Crop scenario Indicator species SVm MAFm DDD90 TERlt

rig ntly
rate × (mg/kg bw/d)

th ue
TWA

e eq
(g a.s./ha)

e
lat ns
Pre-sow, pre-planting, 2 × 720 Bare soil Small 6.6 1.1 × 2.77 18.0

vio . Co
an ime al.
pre-emergence & post- (28 d) granivorous 0.53

te reg new
harvest of; mammal

oh tio re

d
Root and Stem veg,

pr tec EU
Bulb and onion Small 48.3 1.1 × 20.3 2.47

ibi n
Potato

d
like crops herbivorous 0.53

be ro te
e ta p osa
Bulb and onion like crops, mammal

ef da ph
fruiting veg,
Fruiting Small 72.3 1.1 × 30.3 1.65

er y ly
leafy veg,

th tor G
vegetables herbivorous 0.53

ay ula the
Sugar beet.
mammal

or
Post-emergence of weeds

t m reg king
Pre-sow, pre-planting, 1 × 1080 Bare soil Small 6.6 1.0 × 3.78 13.2

m er see
pre-emergence & post- granivorous 0.53

do ll u tium
en a
harvest of; mammal

cu nd
his fa or
Root and Stem veg, Small 48.3 1.0 × 27.7
Bulb and onion f t ay ns 1.81
r o m co
Potato like crops herbivorous 0.53
ne ent he

Bulb and onion like crops, mammal

ow um of t

fruiting veg, Fruiting Small 72.3 1.0 × 41.38 1.21

th oc (s)

leafy veg, vegetables herbivorous 0.53

of is d ber

Sugar beet. mammal

ion , th em

Post-emergence of weeds
iss ore m

Pre-sow, pre-planting, 3 × 720 Small 6.6 1.2 × 3.02 16.5

rm m er

Bare soil
pe her orm

pre-emergence & post- (28 d) granivorous 0.53

he rt t/f

harvest of; mammal

t t Fu en

Root and Stem veg, Small 48.3 1.2 × 22.1

ou s. rr

Bulb and onion 2.26

th tie cu

Potato like crops herbivorous 0.53

wi par (a)

Bulb and onion like crops, mammal

f
en ird o

fruiting veg, Small 72.3 1.2 × 33.1

nt th rty

Fruiting 1.51
co and ope

leafy veg, vegetables herbivorous 0.53

r

Sugar beet. mammal

ts
r i er p
t o wn the

Post-emergence of weeds
en o s
m he t i

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
cu f t en

ts

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Orchards and vineyards

t rib
dis
Table 10.1.2- 7: Screening assessment of the acute risk for mammals due to the use of glyphosate in

n,
orchards and vineyards: Uses 4 a-c, 5 a-c.

er tio
wn lica
.
s o ub
Active substance Glyphosate

f it y p
Acute toxicity (mg/kg bw) > 2000

so n
ht , a
TER criterion 10

rig ntly
th ue
GAP crop Application Crop Indicator species SV90 MAF90 DDD90 TERa

e eq
rate scenario (mg/kg bw/d)

e
lat ns
(g a.s./ha)

vio . Co
an ime al.
Orchards / 2 × 1440 Fruiting Small herbivorous 136.4 1.1 216

te reg new
9.3
vineyards (28 d) vegetables mammal

oh tio re

d
post-emegence of

pr tec EU
ibi n
d
weeds

be ro te
e ta p osa
Orchards / 1 × 720 Fruiting Small herbivorous 136.4 1.0 98.2 20.4

ef da ph
vineyards vegetables mammal

er y ly
th tor G
post-emegence of

ay ula the
weeds

or
t m reg king
Orchards / 1 × 1080 Fruiting Small herbivorous 136.4 1.0 147 13.6

m er see
vineyards vegetables mammal

do ll u tium
en a
post-emegence of

cu nd
weeds
his fa or
Orchards / 2 × 720 Fruiting f t ay ns
Small herbivorous 136.4 1.1 108 18.5
r o m co

vineyards (28 d) vegetables mammal

ne ent he
ow um of t

post-emegence of
th oc (s)

weeds
of is d ber
ion , th em

Orchards / 3 × 720 Fruiting Small herbivorous 136.4 1.1 108 18.5

iss ore m

vineyards (28 d) vegetables mammal

e
rm m er

post-emegence of
pe her orm

weeds
he rt t/f
t t Fu en

Orchards / 1 × 1440 Fruiting Small herbivorous 136.4 1.0 196 10.2

ou s. rr
th tie cu

vineyards vegetables mammal

wi par (a)

post-emegence of
f
en ird o

weeds
nt th rty

2 × 1080
co and ope

Orchards / Fruiting Small herbivorous 136.4 1.1 162 12.3

vineyards (28 d) vegetables mammal
r

ts
r i er p
t o wn the

post-emegence of
en o s

weeds
m he t i
cu f t en

ts

SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values
do s o um

shown in bold fall below the relevant trigger

is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.1.2- 8: Screening assessment of the long-term/reductive risk for mammals due to the use

t rib
of glyphosate in orchards and vineyards: Uses 4 a-c, 5 a-c.

dis
n,
er tio
Active substance Glyphosate

wn lica
.
50

s o ub
Reprod. toxicity (mg/kg bw/d)

f it y p
TER criterion 5

so n
ht , a
GAP crop Application Crop Indicator species SVm MAFm DDD90 TERlt

rig ntly
rate scenario × TWA (mg/kg bw/d)

th ue
e eq
(g a.s./ha)

e
lat ns
Orchards / 2 × 1440 Fruiting Small herbivorous 72.3 1.1 × 60.7 0.82

vio . Co
an ime al.
vineyards (28 d) vegetables mammal 0.53

te reg new
post-emegence of

oh tio re

d
weeds

pr tec EU
ibi n
d
Orchards / 1 × 720 Fruiting Small herbivorous 72.3 1 × 0.53 27.6

be ro te
1.81

e ta p osa
vineyards vegetables mammal

ef da ph
post-emegence of

er y ly
th tor G
weeds

ay ula the
Orchards / 1 × 1080 Fruiting Small herbivorous 72.3 1 × 0.53 41.4 1.21

or
t m reg king
vineyards vegetables mammal

m er see
post-emegence of

do ll u tium
en a
weeds

cu nd
2 × 720
his fa or
Orchards / Fruiting Small herbivorous 72.3 1.1 × 30.3 1.65
vineyards (28 d) vegetables mammal f t ay ns 0.53
r o m co

post-emegence of
ne ent he
ow um of t

weeds
th oc (s)

Orchards / 3 × 720 Fruiting Small herbivorous 72.3 1.2 × 33.1 1.51

of is d ber

vineyards (28 d) vegetables mammal 0.53

ion , th em

post-emegence of
iss ore m

weeds
rm m er
pe her orm

Orchards / 1 × 1440 Fruiting Small herbivorous 72.3 1 × 0.53 55.2 0.91

he rt t/f

vineyards vegetables mammal

t t Fu en
ou s. rr

post-emegence of
th tie cu

weeds
wi par (a)

Orchards / 2 × 1080 Fruiting Small herbivorous 72.3 1.1 × 45.5

f

1.10
en ird o
nt th rty

vineyards (28 d) vegetables mammal 0.53

co and ope

post-emegence of
r

ts
r i er p

weeds
t o wn the

SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values
en o s
m he t i

shown in bold fall below the relevant trigger

cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.1.2- 9: Screening assessment of the acute risk for mammals due to the use of glyphosate

t rib
on railroad tracks and to control invasive species: Uses 7a-b, 8 and 9.

dis
n,
er tio
Active substance Glyphosate

wn lica
.
> 2000

s o ub
Acute toxicity (mg/kg bw)

f it y p
TER criterion 10

so n
ht , a
GAP crop Application Crop scenario Indicator species SV90 MAF90 DDD90 TERa

rig ntly
rate (mg/kg bw/d)

th ue
(g a.s./ha)

e eq
e
lat ns
Railroad tracks – 2 × 1800 Bare soil Small granivorous 14.4 1.1 28.5 70.1

vio . Co
an ime al.
application by (90 d) mammal

te reg new
spray train. Post Fruiting Small herbivorous 136.4 1.1 270 7.41

oh tio re

d
emergence of vegetables mammal

pr tec EU
ibi n
weeds (90d apart).

d
be ro te
e ta p osa
1 × 1800 Bare soil Small granivorous 14.4 1.0 25.9 77.2

ef da ph
mammal

er y ly
th tor G
Fruiting Small herbivorous 136.4 1.0 246 8.13

ay ula the
vegetables mammal

or
t m reg king
Invasive species in 1 × 1800 Bare soil Small granivorous 14.4 1 25.9 77.2

m er see
agricultural and mammal

do ll u tium
en a
non-agricultural Bush and cane Small herbivorous 81.9 1 147 13.6

cu nd
his fa or
areas. Post fruit mammal f t ay ns
r o m co
emergence of Bulbs and onion Small herbivorous 118.4 1 213 9.38
ne ent he

invasive species. like crops mammal

ow um of t
th oc (s)

Fruiting Small herbivorous 136.4 1 246 8.13

of is d ber

vegetables mammal
ion , th em

SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values
iss ore m

shown in bold fall below the relevant trigger

rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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cti
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
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ion
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Table 10.1.2- 10: Screening assessment of the long-term/reductive risk for mammals due to the use

t rib
of glyphosate on railroad tracks and to control invasive species: Uses 7a-b, 8 and 9.

dis
n,
er tio
Active substance Glyphosate

wn lica
.
50

s o ub
Reprod. toxicity (mg/kg bw/d)

f it y p
TER criterion 5

so n
ht , a
GAP crop Application Crop scenario Indicator species SVm MAFm DDD90 TERa

rig ntly
rate × TWA (mg/kg bw/d)

th ue
e eq
(g a.s./ha)

e
lat ns
Railroad tracks – 2 × 1800 Bare soil Small granivorous 6.6 1.0 × 6.30 7.94

vio . Co
an ime al.
application by spray (90 d) mammal 0.53

te reg new
train. Post Fruiting Small herbivorous 72.3 1.0 × 69.0 0.72

oh tio re

d
emergence of

pr tec EU
vegetables mammal 0.53

ibi n
d
weeds (90d apart). 1 × 1800

be ro te
Bare soil Small granivorous 6.6 1.0 × 6.30 7.94

e ta p osa
mammal 0.53

ef da ph
er y ly
Fruiting Small herbivorous 72.3 1.0 × 69.0 0.72

th tor G
vegetables mammal 0.53

ay ula the

or
Invasive species in 1 × 1800 Bare soil Small granivorous 6.6 1.0 × 6.30 7.94

t m reg king
agricultural and mammal 0.53

m er see
non-agricultural Bush and cane Small herbivorous 43.4 1.0 × 41.4 1.21

do ll u tium
en a
areas. Post fruit mammal 0.53

cu nd
his fa or
emergence of Bulbs and onion f t ay ns
Small herbivorous 48.3 1.0 × 46.1 1.09
invasive species.
r o m co
like crops mammal 0.53
ne ent he
ow um of t

Fruiting Small herbivorous 72.3 1.0 × 69.0 0.72

vegetables mammal 0.53
th oc (s)
of is d ber

SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values
ion , th em

shown in bold fall below the relevant trigger

iss ore m

e
rm m er
pe her orm
he rt t/f

Field crops (Uses: 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c)

t t Fu en
ou s. rr
th tie cu

The screening TERa values for use of MON 52276 in field crops for all scenarios are greater than the
wi par (a)

Commission Regulation (EU) No. 546/2011 trigger of 10, indicating that acute risk to mammals is
f
en ird o

acceptable following use the proposed use patterns for these crops.
nt th rty
co and ope

The screening TERlt values for use of MON 52276 in field crops for the scenario “bare soil” are greater
r

ts
r i er p
t o wn the

than the Commission Regulation (EU) No. 546/2011 trigger of 5. Regarding the scenarios “bulbs and onion
en o s

like crops” and “fruiting vegetables” a long-term Tier 1 risk assessment is necessary for all intended
m he t i
cu f t en

ts

application rates.
do s o um
is ht c
th rig s do

Orchards and vineyards (Uses: 4 a-c and 5 a-c)

i
e op Th

The screening TERa values for use of MON 52276 in orchards and vineyards for the scenario “fruiting
of y

vegetables” are greater than the Commission Regulation (EU) No. 546/2011 trigger of 10 for the application
us c
d nd

rates 1 × 720 g a.s./ha, 1 × 1080 g a.s./ha, 2 × 720 g a.s./ha, 3 × 720 g a.s./ha, 1 × 1440 g a.s./ha and 2 ×
an a

1080 g a.s./ha. For the application rate of 2 × 1440 the TERa value is slightly below the trigger of 10.
n rty
tio e

Therefore, an acute Tier 1 risk assessment is necessary for this rate.

ta op
loi pr
xp al
l e ctu

The screening TERlt values for use of MON 52276 in orchards and vineyards for the scenario “fruiting
cia lle

vegetables” are below the Commission Regulation (EU) No. 546/2011 trigger of 5. Therefore, a long-term
er te
m s in

Tier 1 risk assessment is necessary for all intended application rates.

om a
y c uch

Railroad tracks – application by spray train (Uses: 7 a-b)

an ts s
an righ

The screening TERa and TERlt values for use of MON 52276 on railroad tracks for the scenario “bare soil”
d
ing to

are greater than the Commission Regulation (EU) No. 546/2011 trigger of 10 and 5 respectively. The
sh ct
bli bje
pu su
or be

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screening TERa and TERlt values for the “fruiting vegetables” scenario are below the Commission

rib
Regulation (EU) No. 546/2011 trigger of 10 and 5, respectively. Therefore, an acute and long-term Tier 1

t
dis
risk assessment is necessary for all intended application rates.

n,
er tio
wn lica
.
Invasive species in agricultural and non-agricultural areas (Uses: 8 and 9)

s o ub
f it y p
The screening TERa values for use of MON 52276 on invasive species in agricultural and non-agricultural

so n
ht , a
areas for the scenarios “bare soil” and “bush and cane fruit” are greater than the Commission Regulation

rig ntly
(EU) No. 546/2011 trigger of 10. The screening TERa values for the “bulbs and onion like crops” and

th ue
e eq
“fruiting vegetables” scenarios are below the Commission Regulation (EU) No. 546/2011 trigger of 10.

e
lat ns
Therefore an acute Tier 1 risk assessment is necessary for the intended application rate of 1 × 1800 g a.s./ha.

vio . Co
an ime al.
te reg new
The screening TERlt values for use of MON 52276 on invasive species in agricultural and non-agricultural

oh tio re

d
pr tec EU
area for the scenario “bare soil” are greater than the Commission Regulation (EU) No. 546/2011 trigger of

ibi n
d
be ro te
5. The screening TERlt values for the “bush and cane fruit”, “bulbs and onion like crops” and “fruiting

e ta p osa
vegetables” scenarios are below the trigger of 5. Therefore a long-term Tier 1 risk assessment is necessary

ef da ph
er y ly
for the intended application rate of 1 × 1800 g a.s./ha.

th tor G
ay ula the

or
t m reg king
Tier 1 assessment

m er see
do ll u tium
en a
Tier 1 risk assessment is conducted for those intended uses, for which the calculated TERa or TERlt values

cu nd
his fa or
were below the trigger of 10 or 5, respectively, e.g. for uses in field crops, uses in orchards and vineyards,
f t ay ns
uses on railroad tracks and uses to control invasive species in agricultural and non-agricultural areas. The
r o m co
ne ent he

Tier 1 assessment initially requires identification of the appropriate crop groupings and generic focal
ow um of t

mammalian species from Appendix A of EFSA/2009/1438.

th oc (s)
of is d ber

Due to the proposed uses of the product MON 52276 in agricultural and non-agricultural areas,
ion , th em

justifications are provided below considering which scenarios are relevant for the risk assessment. For those
iss ore m

e
rm m er

proposed uses where a large number of scenarios is relevant (Field crops: Use 2 a-c, 6 a, b, 10 a-c, Control
pe her orm

of invasive species: Use 8 - 9) an approach has been taken to present only the worst-case risk assessment
he rt t/f
t t Fu en

in this section. Therefore the worst-case scenarios have been selected based on the relevant generic focal
ou s. rr
th tie cu

species with the highest short-cut values as these are considered protective of the other scenarios with lower
wi par (a)

short-cut values. For completeness, a full and complete mammalian Tier I risk assessment that considers
f
en ird o

all other scenarios and focal species is presented in Annex M-CP 10-03 to this document.
nt th rty
co and ope
r

A summary of all relevant scenarios and focal species (includes those presented in this section and in Annex
ts
r i er p
t o wn the

M-CP 10-03) is provided in the Table below. Please note that numbers in brackets refer to the mammals’
en o s
m he t i

scenarios stated in the Appendix A of EFSA/2009/1438.

cu f t en

ts
do s o um
is ht c

Field crops (Uses: 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c)

th rig s do
i
e op Th

For the Tier 1 assessment of the crop group “field crops”, the intended use of MON 52276 includes several
general uses on field crops as described further below. The applications are intended to be made by tractor
of y

mounted sprayers (Uses 1 a-c, 2 a-c, 3 a-b, 6 a-b) or by hand-held equipment (Uses 10 a-c).
us c
d nd
an a
n rty

Use 1 a-c is, the “pre-sowing, pre-planting, pre-emergence” use, where the intention of this use is to prepare
tio e
ta op

a non-agricultural area for agriculture use, meaning that the product is applied when no agricultural crop is
loi pr

present. Therefore the “bare soil”, the “grassland” and the “leafy vegetable” scenarios are considered
xp al
l e ctu

relevant. As an acceptable risk for the “bare soil” scenario was concluded at the screening assessment, a
cia lle

Tier 1 risk assessment will be presented only for “grassland” and “leafy vegetables”. The “grassland”
er te
m s in

scenario was considered relevant to cover species that feed on grass; the large herbivorous mammal
om a
y c uch

“lagomorph” (72), the small insectivorous mammal “shrew” (73), the small herbivorous mammal “vole”
an ts s

(74) and the small omnivorous mammal “mouse” (75) are taken into account. The “leafy vegetables”
an righ

scenario was considered relevant to cover species that feed on broad-leaved weeds; the small insectivorous
mammal “shrew” (91, 92), the small herbivorous mammal “vole” (93, 94), the large herbivorous mammal
d
ing to
sh ct
bli bje
pu su
or be

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“lagomorph” (95) and the small omnivorous mammal “mouse” (102, 103) are taken into account.

t rib
dis
Uses 2 a-c, 3 a-b and 10 a-c are the “post-harvest, pre-sowing, pre-planting” use where the product can be

n,
er tio
applied to existing cropland after harvest for removal of remaining crops. Thus, for this use almost all field

wn lica
.
crops need to be considered. Only for the crop where safe risk could be concluded in the screening

s o ub
f it y p
assessment, i.e. “bare soil” and for crops which are generally not considered relevant (“cotton”) or for

so n
spatial cultures like “bush & cane fruit”, “hops”, “orchards”, “ornamentals/nursery” and “vineyards” a risk

ht , a
rig ntly
assessment is not considered necessary. As the product is applied after post-harvest, late crop stages will

th ue
be taken into account for risk assessment. Frugivorous mammal scenarios were not taken into account, as

e eq
e
lat ns
the product is intended to be applied after harvest and will not be applied at typical crop stages when fruits

vio . Co
an ime al.
are ripe. For the same reason also the pulses scenario (pre harvest seed, BBCH 81-99) is not considered

te reg new
relevant.

oh tio re

d
pr tec EU
ibi n
Thus, for the Tier 1 risk assessment for the uses 2 a-c, 3 a-b and 10 a-c, the relevant generic focal species

d
be ro te
e ta p osa
with the highest short-cut values at late crop stages across all relevant crop scenarios were taken into

ef da ph
account; the small insectivorous mammal “shrew” in bulb and onion like crops (5), the large herbivorous

er y ly
th tor G
mammal “lagomorph” in grassland (72), the small herbivorous mammal “vole” in grassland (74) and the

ay ula the
small omnivorous mammal “mouse” in grassland (75). These selected scenarios cover the risk for all

or
t m reg king
relevant scenarios. For completeness, a risk assessment for all other relevant scenarios and species is

m er see
presented in Annex M-CP 10-03.

do ll u tium
en a
cu nd
his fa or
Uses 6 a-b are the “shielded ground directed inter-row application” uses at crop stages < BBCH 20 and all
f t ay ns
crops scenarios at early growth stages are taken into account, which are presented in the GAP, i.e.
r o m co
ne ent he

vegetables (root and tuber vegetables, bulb vegetables, fruiting vegetables, legume vegetables and leafy
ow um of t

vegetables). To avoid exposure of crops, a shielded sprayer is used to ensure that the product is only applied
th oc (s)

to grasses and weeds in the inter-row. Therefore, only those vegetables crop scenarios are considered
of is d ber

relevant where the generic focal species does not directly feed on the crop. In addition, the “bare soil” and
ion , th em
iss ore m

the “grassland” scenario are considered relevant. However, as an acceptable risk was concluded for the
e
rm m er

“bare soil” scenario already at the screening assessment the Tier 1 risk assessment is not required for this
pe her orm

scenario.
he rt t/f
t t Fu en
ou s. rr
th tie cu

Thus, for the Tier 1 risk assessment for the uses 6 a-b, the relevant generic focal species with the highest
wi par (a)

short-cut values at early crop stages (< BBCH 20) across all relevant crops scenarios were taken into
f
en ird o

account, i.e. the small insectivorous mammal “shrew” in bulb and onion like crops (4), the small
nt th rty
co and ope

omnivorous mammal “mouse” (13) in bulbs and onion like crops, the small herbivorous mammal “vole” in
r

fruiting vegetables (62) and the large herbivorous mammal “lagomorph” (95) in leafy vegetables.
ts
r i er p
t o wn the
en o s
m he t i

Orchards (Uses: 4 a-c)

cu f t en

ts
do s o um

For the crop grouping “orchards“ due to the downward application of the product all generic focal species
is ht c
th rig s do

for not “crop directed” applications were taken into account, i.e. the small insectivorous mammal “shrew”
i
e op Th

(148), the small herbivorous mammal “vole” (149), the large herbivorous mammal “lagomorph” (154) and
the small omnivorous mammal “mouse” (170).
of y
us c
d nd

Vineyards (Uses: 5 a-c)

an a
n rty
tio e

For the crop grouping “vineyards” due to the downward application of the product all generic focal species,
ta op
loi pr

for not “crop directed” applications were taken into account, i.e. the large herbivorous mammal
xp al

“lagomorph” (267, 268, 269, 270), the small insectivorous mammal “shrew” (271, 272), the small
l e ctu
cia lle

herbivorous mammal “vole” (273) and the small omnivorous mammal “mouse” (287).
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 89 of 553

ep
,r
ion
ut
Railroad tracks – application by spray train (Uses: 7 a-b)

t rib
dis
For the use on railroad tracks the same scenarios were selected like for use 1 a-c, i.e. the “bare soil”, the

n,
“grassland” and the “leafy vegetable” were considered relevant. As an acceptable risk for the “bare soil”

er tio
wn lica
scenario was concluded at the screening assessment a Tier 1 risk assessment will be presented only for

.
s o ub
“grassland” and “leafy vegetables”. The “grassland” scenario was considered relevant to cover species that

f it y p
feed on grass; the large herbivorous mammal “lagomorph” (72), the small insectivorous mammal “shrew”

so n
ht , a
(73), the small herbivorous mammal “vole” (74) and the small omnivorous mammal “mouse” (75) are taken

rig ntly
into account. The “leafy vegetables” scenario was considered relevant to cover species that feed on broad-

th ue
e eq
leaved weeds; the small insectivorous mammal “shrew” (91, 92), the small herbivorous mammal “vole”

e
lat ns
(93, 94), the large herbivorous mammal “lagomorph” (95) and the small omnivorous mammal “mouse”

vio . Co
an ime al.
te reg new
(102, 103) are taken into account.

oh tio re

d
pr tec EU
Invasive species in agricultural and non-agricultural areas (Uses: 8 - 9)

ibi n
d
be ro te
e ta p osa
For the use on invasive species in agricultural and non-agricultural areas, almost all crops need to be

ef da ph
considered. Only for the crop where safe risk could be concluded in the screening assessment, i.e. “bare

er y ly
th tor G
soil” and for crops which are generally not considered relevant (“cotton”) do not need to be assessed in the

ay ula the
Tier 1 risk assessment. In general, those scenarios need to be taken into account, where a downward

or
t m reg king
application of the product is relevant. Frugivorous mammal scenarios were not taken into account, as the

m er see
product is intended to be applied only on the invasive species Giant hogweed (Heracleum mantegazzianum)

do ll u tium
en a
and Japanese knotweed (Reynoutria japonica) and due to the specific application method (handheld,

cu nd
his fa or
spraying shield) fruits will not be exposed to the product. For the same reason also the pulses scenario (pre
f t ay ns
harvest seed, BBCH 81-99) is not considered relevant.
r o m co
ne ent he
ow um of t

Thus, for the Tier 1 risk assessment for uses 8 and 9, the relevant generic focal species with the highest
th oc (s)

short-cut values across all relevant crop scenarios were taken into account, i.e. the small insectivorous
of is d ber

mammal “shrew” in bulb and onion like crops (4), the small omnivorous mammal “mouse” in bulb and
ion , th em

onion like crops (13), the large herbivorous mammal “lagomorph” in cereals (35) and the small herbivorous
iss ore m

e
rm m er

mammal “vole” in fruiting vegetables (62). These chosen scenarios cover the risk for all relevant scenarios.
pe her orm

For completeness, a risk assessment for all other relevant scenarios and species is presented in Annex M-
he rt t/f
t t Fu en

CP 10-03 of this document.

ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 90 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
Field crops (Pre-sowing, pre-planting, pre-emergence): Use 1 a-c

er y ly
th tor G
ay ula the

or
No. 72 Grassland Large herbivorous mammal “lagomorph” - 17.3 MCP 10.1.2

t m reg king
All season Brown hare (Lepus europaeus)

m er see
No. 73 Grassland Small insectivorous mammal “shrew” - 1.9 MCP 10.1.2

do ll u tium
en a
Late Common shrew (Sorex araneus)

cu nd
his fa or
f t ay ns
No. 74 Grassland Small herbivorous mammal “vole” - 72.3 MCP 10.1.2

r o m co
All season Common vole (Microtulus arvalis)

ne ent he
ow um of t
No. 75 Grassland Small omnivorous mammal “mouse” - 6.6 MCP 10.1.2

th oc (s)
Late season (seed heads) Wood mouse (Apodemus sylvaticus)

of is d ber
ion , th em
No. 91 Leafy vegetables Small insectivorous mammal “shrew” - 4.2 MCP 10.1.2

iss ore m
BBCH 10 - 19 Commnon shrew (Sorex araneus)

e
rm m er
pe her orm
No. 92 Leafy vegetables Small insectivorous mammal “shrew” - 1.9 MCP 10.1.2

he rt t/f
BBCH ≥ 20 Commnon shrew (Sorex araneus)
t t Fu en
ou s. rr
No. 93 Leafy vegetables Small herbivorous mammal “vole” - 72.3 MCP 10.1.2
th tie cu

BBCH 40 - 49 Common vole (Microtulus arvalis)

wi par (a)
f
en ird o

No. 94 Leafy vegetables Small herbivorous mammal “vole” - 21.7 MCP 10.1.2
nt th rty

BBCH ≥ 50 Common vole (Microtulus arvalis)

co and ope
r

ts
r i er p

No. 95 Leafy vegetables Large herbivorous mammal “lagomorph” - 14.3 MCP 10.1.2
t o wn the

All season Rabbit (Oryctolagus cuniculus)

en o s
m he t i
cu f t en

No. 102 Leafy vegetables Small omnivorous mammal “mouse” - 7.8 MCP 10.1.2
ts
do s o um

BBCH 10 – 49 Wood mouse (Apodemus sylvaticus)

is ht c
th rig s do

No. 103 Leafy vegetables Small omnivorous mammal “mouse” - 2.3 MCP 10.1.1
i
e op Th

BBCH ≥ 50 Wood mouse (Apodemus sylvaticus)

of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 91 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
Field crops (Post-harvest, pre-sowing, pre-planting): Use 2 a-c, 3 a-b, 10 a-c

er y ly
th tor G
No. 5 Bulbs and onion like crops Small insectivorous mammal “shrew” - 1.9 MCP 10.1.2

ay ula the

or
BBCH ≥ 20 Common shrew (Sorex araneus) (Worst case scenario)

t m reg king
No. 6 Bulbs and onion like crops Small herbivorous mammal “vole” - 43.4 Annex M-CP 10-03

m er see
BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 74)

do ll u tium
en a
cu nd
No. 14 Bulbs and onion like crops Small omnivorous mammal “mouse”

his fa or
- 4.7 Annex M-CP 10-03

f t ay ns
BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

r o m co
ne ent he
No. 33 Cereals Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03

ow um of t
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 5)

th oc (s)
of is d ber
No. 34 Cereals Small herbivorous mammal “vole” - 21.7 Annex M-CP 10-03

ion , th em
BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 74)

iss ore m

e
rm m er
No. 46 Cereals Small omnivorous mammal “mouse” - 2.3 Annex M-CP 10-03

pe her orm
BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

he rt t/f
t t Fu en
No. 61 Fruiting vegetables ou s. rr Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03
th tie cu
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 5)
wi par (a)

No. 63 Fruiting vegetables Small herbivorous mammal “vole” - 21.7 Annex M-CP 10-03
f
en ird o
nt th rty

BBCH ≥ 50 Common vole (Microtus arvalis) (Covered by scenario no. 74)

co and ope

No. 71 Fruiting vegetables Small omnivorous mammal “mouse” - 2.3 Annex M-CP 10-03
r

ts
r i er p
t o wn the

BBCH ≥ 50 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

en o s
m he t i

No. 72 Grassland Large herbivorous mammal “lagomorph” - 17.3 MCP 10.1.2

cu f t en

ts
do s o um

All season Brown hare (Lepus europaeus) (Worst case scenario)

is ht c
th rig s do

No. 73 Grassland Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03
Late
i

Common shrew (Sorex araneus) (Covered by scenario no. 5)

e op Th
of y

No. 74 Grassland Small herbivorous mammal “vole” - 72.3 MCP 10.1.2

us c

All season Common vole (Microtus arvalis) (Worst case scenario)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 92 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 75 Grassland Small omnivorous mammal “mouse” - 6.6 MCP 10.1.2

er y ly
th tor G
Late season (seed heads) Wood mouse (Apodemus sylvaticus) (Worst case scenario)

ay ula the
No. 92 Leafy vegetables Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03

or
t m reg king
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 5)

m er see
No. 94 Leafy vegetables Small herbivorous mammal “vole” - 21.7 Annex M-CP 10-03

do ll u tium
en a
BBCH ≥ 50 Common vole (Microtus arvalis) (Covered by scenario no. 74)

cu nd
his fa or
f t ay ns
No. 95 Leafy vegetables Large herbivorous mammal “lagomorph” - 14.3 Annex M-CP 10-03

r o m co
All season Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 72)

ne ent he
ow um of t
No. 103 Leafy vegetables Small omnivorous mammal “mouse” - 2.3 Annex M-CP 10-03

th oc (s)
BBCH ≥ 50 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

of is d ber
ion , th em
No. 105 Legume forage Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03

iss ore m

e
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 5)

rm m er
pe her orm
No. 107 Legume forage Small herbivorous mammal “vole” - 21.7 Annex M-CP 10-03

he rt t/f
BBCH ≥ 50 Common vole (Microtus arvalis) (Covered by scenario no. 74)
t t Fu en
ou s. rr
th tie cu
No. 116 Legume forage Small omnivorous mammal “mouse” - 2.3 Annex M-CP 10-03
wi par (a)

BBCH ≥ 50 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

f
en ird o
nt th rty

No. 118 Maize Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03
co and ope

BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 5)

r

ts
r i er p
t o wn the

No. 121 Maize Small herbivorous mammal “vole” - 18.1 Annex M-CP 10-03
en o s

BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 74)

m he t i
cu f t en

ts

No. 132 Maize Small omnivorous mammal “mouse” - 1.9 Annex M-CP 10-03
do s o um
is ht c

BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

th rig s do

No. 134 Oilseed rape

i

Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03

e op Th

BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 5)

of y
us c

No. 135 Oilseed rape Small herbivorous mammal “vole” - 18.1 Annex M-CP 10-03
d nd

BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 74)

an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 93 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 136 Oilseed rape Large herbivorous mammal “lagomorph” - 14.3 Annex M-CP 10-03

er y ly
All season Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 72)

th tor G
ay ula the
No. 147 Oilseed rape Small omnivorous mammal “mouse” - 1.9 Annex M-CP 10-03

or
t m reg king
BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

m er see
No. 186 Potatoes Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03

do ll u tium
en a
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 5)

cu nd
his fa or
f t ay ns
No. 187 Potatoes Small herbivorous mammal “vole” - 21.7 Annex M-CP 10-03

r o m co
BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 74)

ne ent he
ow um of t
No. 189 Potatoes Large herbivorous mammal “lagomorph” - 4.3 Annex M-CP 10-03

th oc (s)
BBCH ≥ 40 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 72)

of is d ber
ion , th em
No. 197 Potatoes Small omnivorous mammal “mouse” - 2.3 Annex M-CP 10-03

iss ore m

e
BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

rm m er
pe her orm
No. 199 Pulses Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03

he rt t/f
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 5)
t t Fu en
ou s. rr
th tie cu
No. 201 Pulses Small herbivorous mammal “vole” - 21.7 Annex M-CP 10-03
wi par (a)

BBCH ≥ 50 Common vole (Microtus arvalis) (Covered by scenario no. 74)

f
en ird o
nt th rty

No. 203 Pulses Large herbivorous mammal “lagomorph” - 4.3 Annex M-CP 10-03
co and ope

BBCH ≥ 50 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 72)

r

ts
r i er p
t o wn the

No. 212 Pulses Small omnivorous mammal “mouse” - 2.3 Annex M-CP 10-03
en o s

BBCH ≥ 50 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

m he t i
cu f t en

ts

No. 214 Root and stem vegetables Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03
do s o um
is ht c

BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 5)

th rig s do

No. 215 Root and stem vegetables

i

Small herbivorous mammal “vole” - 21.7 Annex M-CP 10-03

e op Th

BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 74)

of y
us c

No. 223 Root and stem vegetables Small omnivorous mammal “mouse” - 2.3 Annex M-CP 10-03
d nd

BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 94 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 225 Strawberries Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03

er y ly
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 5)

th tor G
ay ula the
No. 226 Strawberries Small herbivorous mammal “vole - 28.9 Annex M-CP 10-03

or
t m reg king
BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 74)

m er see
No. 228 Strawberries Large herbivorous mammal “lagomorph” - 5.7 Annex M-CP 10-03

do ll u tium
en a
BBCH ≥ 40 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 72)

cu nd
his fa or
f t ay ns
No. 236 Strawberries Small omnivorous mammal “mouse” - 3.1 Annex M-CP 10-03

r o m co
BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

ne ent he
ow um of t
No. 238 Sugar beet Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03

th oc (s)
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 5)

of is d ber
ion , th em
No. 239 Sugar beet Small herbivorous mammal “vole - 18.1 Annex M-CP 10-03

iss ore m

e
BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 74)

rm m er
pe her orm
No. 241 Sugar beet Large herbivorous mammal “lagomorph” - 3.6 Annex M-CP 10-03

he rt t/f
BBCH ≥ 40 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 72)
t t Fu en
ou s. rr
th tie cu
No. 249 Sugar beet Small omnivorous mammal “mouse” - 1.9 Annex M-CP 10-03
wi par (a)

BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

f
en ird o
nt th rty

No. 251 Sunflower Small insectivorous mammal “shrew” - 1.9 Annex M-CP 10-03
co and ope

BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 5)

r

ts
r i er p
t o wn the

No. 252 Sunflower Small herbivorous mammal “vole” - 18.1 Annex M-CP 10-03
en o s

BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 74)

m he t i
cu f t en

ts

No. 255 Sunflower Large herbivorous mammal “lagomorph” - 3.6 Annex M-CP 10-03
do s o um
is ht c

BBCH ≥ 40 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 72)

th rig s do

No. 266 Sunflower

i

Small omnivorous mammal “mouse” - 1.9 Annex M-CP 10-03

e op Th

BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 75)

of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 95 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
Field crops (Shielded ground directed inter-row application): Use 6 a, b

er y ly
th tor G
No. 4 Bulbs & onion like crops Small insectivorous mammal “shrew” - 4.2 MCP 10.1.2

ay ula the

or
BBCH 10 – 19 Common shrew (Sorex araneus) (Worst case scenario)

t m reg king
m er see
No. 13 Bulbs & onion like crops Small omnivorous mammal “mouse” - 7.8 MCP 10.1.2
BBCH 10 – 39 Wood mouse (Apodemus sylvaticus) (Worst case scenario)

do ll u tium
en a
cu nd
No. 60 Fruiting vegetables Small insectivorous mammal “shrew”

his fa or
- 4.2 Annex M-CP 10-03

f t ay ns
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

r o m co
ne ent he
No. 62 Fruiting vegetables Small herbivorous mammal “vole” - 72.3 MCP 10.1.2

ow um of t
BBCH 10 – 49 Common vole (Microtus arvalis) (Worst case scenario)

th oc (s)
of is d ber
No. 70 Fruiting vegetables Small omnivorous mammal “mouse” - 7.8 Annex M-CP 10-03

ion , th em
BBCH 10 – 49 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 4)

iss ore m

e
rm m er
No. 91 Leafy vegetables Small insectivorous mammal “shrew” - 4.2 Annex M-CP 10-03

pe her orm
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

he rt t/f
No. 95 Leafy vegetables t t Fu en
Large herbivorous mammal “lagomorph” - 14.3 MCP 10.1.2
ou s. rr
th tie cu
All season Rabbit (Oryctolagus cuniculus) (Worst case scenario)
wi par (a)

No. 102 Leafy vegetables Small omnivorous mammal “mouse” - 7.8 Annex M-CP 10-03
f
en ird o
nt th rty

BBCH 10 – 49 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 4)

co and ope

No. 104 Legume forage Small insectivorous mammal “shrew” - 4.2 Annex M-CP 10-03
r

ts
r i er p
t o wn the

BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

en o s
m he t i

No. 115 Legume forage Small omnivorous mammal “mouse” - 7.8 Annex M-CP 10-03
cu f t en

ts

BBCH 10 – 49 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 4)

do s o um
is ht c
th rig s do

No. 185 Potatoes Small insectivorous mammal “shrew” - 4.2 Annex M-CP 10-03
BBCH 10 – 19
i

Common shrew (Sorex araneus) (Covered by scenario no. 4)

e op Th
of y

No. 188 Potatoes Large herbivorous mammal “lagomorph” - 14.3 Annex M-CP 10-03
us c

BBCH 10 – 40 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 95)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 96 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 196 Potatoes Small omnivorous mammal “mouse” - 7.8 Annex M-CP 10-03

er y ly
BBCH 10 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 4)

th tor G
ay ula the
No. 198 Pulses Small insectivorous mammal “shrew” - 4.2 Annex M-CP 10-03

or
t m reg king
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

m er see
No. 202 Pulses Large herbivorous mammal “lagomorph” - 14.3 Annex M-CP 10-03

do ll u tium
en a
BBCH 10 – 49 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 95)

cu nd
his fa or
f t ay ns
No. 211 Pulses Small omnivorous mammal “mouse” - 7.8 Annex M-CP 10-03

r o m co
BBCH 10 – 49 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 4)

ne ent he
ow um of t
No. 213 Root & stem vegetables Small insectivorous mammal “shrew” - 4.2 Annex M-CP 10-03

th oc (s)
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

of is d ber
ion , th em
No. 222 Root & stem vegetables Small omnivorous mammal “mouse” - 7.8 Annex M-CP 10-03

iss ore m

e
BBCH 10 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 4)

rm m er
pe her orm
No. 237 Sugar beet Small insectivorous mammal “shrew” - 4.2 Annex M-CP 10-03

he rt t/f
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)
t t Fu en
ou s. rr
th tie cu
No. 240 Sugar beet Large herbivorous mammal “lagomorph” - 14.3 Annex M-CP 10-03
wi par (a)

BBCH 10 – 39 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 95)

f
en ird o
nt th rty

No. 248 Sugar beet Small omnivorous mammal “mouse” - 7.8 Annex M-CP 10-03
co and ope

BBCH 10 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 4)

r

ts
r i er p
t o wn the

Orchards: Use 4 a-c

en o s
m he t i

No. 148 Orchards Small insectivorous mammal “shrew” 5.4 1.9 MCP 10.1.2
cu f t en

ts
do s o um

Application crop directed BBCH < 10 or not Common shrew (Sorex araneus)
is ht c

crop directed
th rig s do
i

No. 149 Orchards Small herbivorous mammal “vole” 136.4 72.3 MCP 10.1.2
e op Th

Application crop directed BBCH < 10 or not Common vole (Microtus arvalis)
of y

crop directed
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
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s
ht
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 97 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 154 Orchards Large herbivorous mammal “lagomorph” 35.1 14.3 MCP 10.1.2

er y ly
th tor G
Application crop directed BBCH < 10 or not Rabbit (Oryctolagus cuniculus)

ay ula the
crop directed

or
t m reg king
No. 170 Orchards Small omnivorous mammal “mouse” 17.2 7.8 MCP 10.1.2

m er see
Application crop directed BBCH < 10 or not Wood mouse (Apodemus sylvaticus)

do ll u tium
en a
crop directed

cu nd
his fa or
Vineyards: Use 5 a-c

f t ay ns
r o m co
No. 267 Vineyard Large herbivorous mammal “lagomorph” 27.2 11.1 MCP 10.1.2

ne ent he
ow um of t
Application ground directed Brown hare (Lepus europaeus)

th oc (s)
No. 268 Vineyard Large herbivorous mammal “lagomorph” 16.3 6.7 MCP 10.1.2

of is d ber
BBCH 10 – 19 Brown hare (Lepus europaeus)

ion , th em
iss ore m

e
No. 269 Vineyard Large herbivorous mammal “lagomorph” 13.6 5.5 MCP 10.1.2

rm m er
pe her orm
BBCH 20 – 39 Brown hare (Lepus europaeus)

he rt t/f
t t Fu en
No. 270 Vineyard ou s. rr Large herbivorous mammal “lagomorph” 8.1 3.3 MCP 10.1.2
BBCH ≥ 40 Brown hare (Lepus europaeus)
th tie cu
wi par (a)

No. 271 Vineyard Small insectivorous mammal “shrew” 7.6 4.2 MCP 10.1.2
f
en ird o

BBCH 10 – 19 Common shrew (Sorex araneus)

nt th rty
co and ope

No. 272 Vineyard Small insectivorous mammal “shrew” 5.4 1.9 MCP 10.1.2
r

ts
r i er p

BBCH ≥ 20 Common shrew (Sorex araneus)

t o wn the
en o s

No. 273 Vineyard Small herbivorous mammal “vole” 136.4 72.3 MCP 10.1.2
m he t i
cu f t en

ts

Application ground directed Common vole (Microtus arvalis)

do s o um
is ht c

No. 287 Vineyard Small omnivorous mammal “mouse” 17.2 7.8 MCP 10.1.2
th rig s do

Application ground directed Wood mouse (Apodemus sylvaticus)

i
e op Th

Railroad tracks – application by spray train: Use 7a-b

of y
us c

No. 72 Grassland Large herbivorous mammal “lagomorph” 32.6 17.3 MCP 10.1.2
d nd

All season Brown hare (Lepus europaeus)

an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
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.
s o ub
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ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 98 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 73 Grassland Small insectivorous mammal “shrew” 5.4 1.9 MCP 10.1.2

er y ly
th tor G
Late Common shrew (Sorex araneus)

ay ula the

or
No. 74 Grassland Small herbivorous mammal “vole” 136.4 72.3 MCP 10.1.2

t m reg king
All season Common vole (Microtulus arvalis)

m er see
No. 75 Grassland Small omnivorous mammal “mouse” 14.4 6.6 MCP 10.1.2

do ll u tium
en a
Late season (seed heads) Wood mouse (Apodemus sylvaticus)

cu nd
his fa or
f t ay ns
No. 91 Leafy vegetables Small insectivorous mammal “shrew” 7.6 4.2 MCP 10.1.2

r o m co
BBCH 10 - 19 Commnon shrew (Sorex araneus)

ne ent he
ow um of t
No. 92 Leafy vegetables Small insectivorous mammal “shrew” 5.4 1.9 MCP 10.1.2

th oc (s)
BBCH ≥ 20 Commnon shrew (Sorex araneus)

of is d ber
ion , th em
No. 93 Leafy vegetables Small herbivorous mammal “vole” 136.4 72.3 MCP 10.1.2

iss ore m

e
BBCH 40 - 49 Common vole (Microtulus arvalis)

rm m er
pe her orm
No. 94 Leafy vegetables Small herbivorous mammal “vole” 40.9 21.7 MCP 10.1.2

he rt t/f
t t Fu en
BBCH ≥ 50 ou s. rr
th tie cu Common vole (Microtulus arvalis)
No. 95 Leafy vegetables Large herbivorous mammal “lagomorph” 35.1 14.3 MCP 10.1.2
wi par (a)

All season Rabbit (Oryctolagus cuniculus)

f
en ird o
nt th rty

No. 102 Leafy vegetables Small omnivorous mammal “mouse” 17.2 7.8 MCP 10.1.2
co and ope

BBCH 10 – 49 Wood mouse (Apodemus sylvaticus)

r

ts
r i er p
t o wn the

No. 103 Leafy vegetables Small omnivorous mammal “mouse” 5.2 2.3 MCP 10.1.1
en o s

BBCH ≥ 50 Wood mouse (Apodemus sylvaticus)

m he t i
cu f t en

ts

Control of invasive species in agricultural and non-agricultural areas: Use 8-9

do s o um
is ht c
th rig s do

No. 4 Bulbs & onion like crops Small insectivorous mammal “shrew” 7.6 4.2 MCP 10.1.2
i

BBCH 10 – 19 Common shrew (Sorex araneus) (Worst case scenario)

e op Th
of y

No. 5 Bulbs & onion like crops Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03
us c

BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 99 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 6 Bulbs & onion like crops Small herbivorous mammal “vole” 81.9 43.4 Annex M-CP 10-03

er y ly
BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 62)

th tor G
ay ula the

or
No. 13 Bulbs & onion like crops Small omnivorous mammal “mouse” 17.2 7.8 MCP 10.1.2

t m reg king
BBCH 10 – 39 Wood mouse (Apodemus sylvaticus) (Worst case scenario)

m er see
No. 14 Bulbs & onion like crops Small omnivorous mammal “mouse” 10.3 4.7 Annex M-CP 10-03

do ll u tium
en a
BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

cu nd
his fa or
f t ay ns
No. 15 Bush & cane fruit Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03

r o m co
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

ne ent he
ow um of t
No. 16 Bush & cane fruit Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03

th oc (s)
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

of is d ber
ion , th em
No. 17 Bush & cane fruit Small herbivorous mammal “vole” 81.9 43.4 Annex M-CP 10-03

iss ore m

e
BBCH 10 – 19 Common vole (Microtus arvalis) (Covered by scenario no. 62)

rm m er
pe her orm
No. 18 Bush & cane fruit Small herbivorous mammal “vole” 68.2 36.1 Annex M-CP 10-03

he rt t/f
BBCH 20 – 39 Common vole (Microtus arvalis) (Covered by scenario no. 62)
t t Fu en
ou s. rr
th tie cu
No. 19 Bush & cane fruit Small herbivorous mammal “vole” 40.9 21.7 Annex M-CP 10-03
wi par (a)

BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 62)

f
en ird o
nt th rty

No. 29 Bush & cane fruit Small omnivorous mammal “mouse” 10.3 4.7 Annex M-CP 10-03
co and ope

BBCH 10 – 19 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

r

ts
r i er p
t o wn the

No. 30 Bush & cane fruit Small omnivorous mammal “mouse” 8.6 3.9 Annex M-CP 10-03
en o s

BBCH 20 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

m he t i
cu f t en

ts

No. 31 Bush & cane fruit Small omnivorous mammal “mouse” 5.2 2.3 Annex M-CP 10-03
do s o um
is ht c

BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

th rig s do

No. 32 Cereals
i

Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03

e op Th

BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

of y
us c

No. 33 Cereals Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03
d nd

BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 100 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 34 Cereals Small herbivorous mammal “vole” 40.9 21.7 Annex M-CP 10-03

er y ly
BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 62)

th tor G
ay ula the

or
No. 35 Cereals Large herbivorous mammal “lagomorph” 42.1 22.3 MCP 10.1.2

t m reg king
Early (shoots) Rabbit (Oryctolagus cuniculus) (Worst case scenario)

m er see
No. 44 Cereals Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03

do ll u tium
en a
BBCH 10 – 29 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

cu nd
his fa or
f t ay ns
No. 45 Cereals Small omnivorous mammal “mouse” 8.6 3.9 Annex M-CP 10-03

r o m co
BBCH 30 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

ne ent he
ow um of t
No. 46 Cereals Small omnivorous mammal “mouse” 5.2 2.3 Annex M-CP 10-03

th oc (s)
BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

of is d ber
ion , th em
No. 60 Fruiting vegetables Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03

iss ore m

e
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

rm m er
pe her orm
No. 61 Fruiting vegetables Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03

he rt t/f
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)
t t Fu en
ou s. rr
th tie cu
No. 62 Fruiting vegetables Small herbivorous mammal “vole” 136.4 72.3 MCP 10.1.2
wi par (a)

BBCH 10 – 49 Common vole (Microtus arvalis) (Worst case scenario)

f
en ird o
nt th rty

No. 63 Fruiting vegetables Small herbivorous mammal “vole” 40.9 21.7 Annex M-CP 10-03
co and ope

BBCH ≥ 50 Common vole (Microtus arvalis) (Covered by scenario no. 62)

r

ts
r i er p
t o wn the

No. 70 Fruiting vegetables Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03
en o s

BBCH 10 – 49 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

m he t i
cu f t en

ts

No.71 Fruiting vegetables Small omnivorous mammal “mouse” 5.2 2.3 Annex M-CP 10-03
do s o um
is ht c

BBCH ≥ 50 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

th rig s do

No. 72 Grassland
i

Large herbivorous mammal “lagomorph” 32.6 17.3 Annex M-CP 10-03

e op Th

All season Brown hare (Lepus europaeus) (Covered by scenario no. 35)
of y
us c

No. 73 Grassland Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03
d nd

Late Common shrew (Sorex araneus) (Covered by scenario no. 4)

an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 101 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 74 Grassland Small herbivorous mammal “vole” 136.4 72.3 Annex M-CP 10-03

er y ly
All season Common vole (Microtus arvalis) (Covered by scenario no. 62)

th tor G
ay ula the
No. 75 Grassland Small omnivorous mammal “mouse” 14.4 6.6 Annex M-CP 10-03

or
t m reg king
Late season (seed heads) Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

m er see
No. 77 Hop Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03

do ll u tium
en a
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

cu nd
his fa or
f t ay ns
No. 78 Hop Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03

r o m co
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

ne ent he
ow um of t
No. 79 Hop Small herbivorous mammal “vole” 40.9 21.7 Annex M-CP 10-03

th oc (s)
BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 62)

of is d ber
ion , th em
No. 88 Hop Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03

iss ore m

e
BBCH 10 – 19 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

rm m er
pe her orm
No. 89 Hop Small omnivorous mammal “mouse” 8.6 3.9 Annex M-CP 10-03

he rt t/f
BBCH 20 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)
t t Fu en
ou s. rr
th tie cu
No. 90 Hop Small omnivorous mammal “mouse” 5.2 2.3 Annex M-CP 10-03
wi par (a)

BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

f
en ird o
nt th rty

No. 91 Leafy vegetables Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03
co and ope

BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

r

ts
r i er p
t o wn the

No. 92 Leafy vegetables Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03
en o s

BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

m he t i
cu f t en

ts

No. 93 Leafy vegetables Small herbivorous mammal “vole” 136.4 72.3 Annex M-CP 10-03
do s o um
is ht c

BBCH 40 – 49 Common vole (Microtus arvalis) (Covered by scenario no. 62)

th rig s do

No. 94 Leafy vegetables

i

Small herbivorous mammal “vole” 40.9 21.7 Annex M-CP 10-03

e op Th

BBCH ≥ 50 Common vole (Microtus arvalis) (Covered by scenario no. 62)

of y
us c

No. 95 Leafy vegetables Large herbivorous mammal “lagomorph” 35.1 14.3 Annex M-CP 10-03
d nd

All season Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 102 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 102 Leafy vegetables Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03

er y ly
BBCH 10 – 49 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

th tor G
ay ula the
No. 103 Leafy vegetables Small omnivorous mammal “mouse” 5.2 2.3 Annex M-CP 10-03

or
t m reg king
BBCH ≥ 50 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

m er see
No. 104 Legume forage Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03

do ll u tium
en a
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

cu nd
his fa or
f t ay ns
No. 105 Legume forage Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03

r o m co
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

ne ent he
ow um of t
No. 106 Legume forage Small herbivorous mammal “vole” 136.4 72.3 Annex M-CP 10-03

th oc (s)
BBCH 40 – 49 Common vole (Microtus arvalis) (Covered by scenario no. 62)

of is d ber
ion , th em
No. 107 Legume forage Small herbivorous mammal “vole” 40.9 21.7 Annex M-CP 10-03

iss ore m

e
BBCH ≥ 50 Common vole (Microtus arvalis) (Covered by scenario no. 62)

rm m er
pe her orm
No. 108 Legume forage Large herbivorous mammal “lagomorph” 35.1 14.3 Annex M-CP 10-03

he rt t/f
Leaf development BBCH 21 – 49 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)
t t Fu en
ou s. rr
th tie cu
No. 115 Legume forage Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03
wi par (a)

BBCH 10 – 49 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

f
en ird o
nt th rty

No. 116 Legume forage Small omnivorous mammal “mouse” 5.2 2.3 Annex M-CP 10-03
co and ope

BBCH ≥ 50 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

r

ts
r i er p
t o wn the

No. 117 Maize Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03
en o s

BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 13)

m he t i
cu f t en

ts

No. 118 Maize Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03
do s o um
is ht c

BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

th rig s do

No. 119 Maize

i

Small herbivorous mammal “vole” 136.4 72.3 Annex M-CP 10-03

e op Th

BBCH 10 -29 Common vole (Microtus arvalis) (Covered by scenario no. 62)
of y
us c

No. 120 Maize Small herbivorous mammal “vole” 68.2 36.1 Annex M-CP 10-03
d nd

BBCH 30 – 39 Common vole (Microtus arvalis) (Covered by scenario no. 62)

an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
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s
ht
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 103 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 121 Maize Small herbivorous mammal “vole” 34.1 18.1 Annex M-CP 10-03

er y ly
BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 62)

th tor G
ay ula the
No. 130 Maize Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03

or
t m reg king
BBCH 10 – 29 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

m er see
No. 131 Maize Small omnivorous mammal “mouse” 8.6 3.9 Annex M-CP 10-03

do ll u tium
en a
BBCH 30 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

cu nd
his fa or
f t ay ns
No. 132 Maize Small omnivorous mammal “mouse” 4.3 1.9 Annex M-CP 10-03

r o m co
BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

ne ent he
ow um of t
No. 133 Oilseed rape Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03

th oc (s)
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

of is d ber
ion , th em
No. 134 Oilseed rape Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03

iss ore m

e
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

rm m er
pe her orm
No. 135 Oilseed rape Small herbivorous mammal “vole” 34.1 18.1 Annex M-CP 10-03

he rt t/f
BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 62)
t t Fu en
ou s. rr
th tie cu
No. 136 Oilseed rape Large herbivorous mammal “lagomorph” 35.1 14.3 Annex M-CP 10-03
wi par (a)

All season Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

f
en ird o
nt th rty

No. 145 Oilseed rape Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03
co and ope

BBCH 10 – 29 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

r

ts
r i er p
t o wn the

No. 146 Oilseed rape Small omnivorous mammal “mouse” 5.2 2.3 Annex M-CP 10-03
en o s

BBCH 30 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

m he t i
cu f t en

ts

No. 147 Oilseed rape Small omnivorous mammal “mouse” 4.3 1.9 Annex M-CP 10-03
do s o um
is ht c

BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

th rig s do

No. 148 Orchards

i

Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03

e op Th

Application crop directed BBCH < 10 or not Common shrew (Sorex araneus) (Covered by scenario no. 4)
of y

crop directed
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
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ht
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 104 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 149 Orchards Small herbivorous mammal “vole” 136.4 72.3 Annex M-CP 10-03

er y ly
Application crop directed BBCH < 10 or not Common vole (Microtus arvalis) (Covered by scenario no. 62)

th tor G
ay ula the
crop directed

or
t m reg king
No. 154 Orchards Large herbivorous mammal “lagomorph” 35.1 14.3 Annex M-CP 10-03

m er see
Application crop directed BBCH < 10 or not Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

do ll u tium
en a
crop directed

cu nd
his fa or
No. 170 Orchards Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03

f t ay ns
r o m co
Application crop directed BBCH < 10 or not Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

ne ent he
crop directed

ow um of t
No. 175 Ornamentals/nursery Small herbivorous mammal “vole” 136.4 72.3 Annex M-CP 10-03

th oc (s)
of is d ber
BBCH 40 – 49 Common vole (Microtus arvalis) (Covered by scenario no. 62)

ion , th em
No. 176 Ornamentals/nursery Small herbivorous mammal “vole” 68.2 36.1 Annex M-CP 10-03

iss ore m

e
rm m er
BBCH ≥ 50 Common vole (Microtus arvalis) (Covered by scenario no. 62)

pe her orm
No. 185 Potatoes Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03

he rt t/f
t t Fu en
BBCH 10 – 19 ou s. rr Common shrew (Sorex araneus) (Covered by scenario no. 4)
th tie cu

No. 186 Potatoes Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03
wi par (a)

BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

f
en ird o
nt th rty

No. 187 Potatoes Small herbivorous mammal “vole” 40.9 21.7 Annex M-CP 10-03
co and ope

BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 62)

r

ts
r i er p
t o wn the

No. 188 Potatoes Large herbivorous mammal “lagomorph” 35.1 14.3 Annex M-CP 10-03
en o s
m he t i

BBCH 10 – 40 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

cu f t en

ts
do s o um

No. 189 Potatoes Large herbivorous mammal “lagomorph” 10.5 4.3 Annex M-CP 10-03
is ht c
th rig s do

BBCH ≥ 40 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

i
e op Th

No. 196 Potatoes Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03
of y

BBCH 10 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

us c

No. 197 Potatoes Small omnivorous mammal “mouse” 5.2 2.3 Annex M-CP 10-03
d nd
an a

BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
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s
ht
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s o ub
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 105 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 198 Pulses Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03

er y ly
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

th tor G
ay ula the
No. 199 Pulses Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03

or
t m reg king
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

m er see
No. 200 Pulses Small herbivorous mammal “vole” 136.4 72.3 Annex M-CP 10-03

do ll u tium
en a
BBCH 40 – 49 Common vole (Microtus arvalis) (Covered by scenario no. 62)

cu nd
his fa or
f t ay ns
No. 201 Pulses Small herbivorous mammal “vole” 40.9 21.7 Annex M-CP 10-03

r o m co
BBCH ≥ 50 Common vole (Microtus arvalis) (Covered by scenario no. 62)

ne ent he
ow um of t
No. 202 Pulses Large herbivorous mammal “lagomorph” 35.1 14.3 Annex M-CP 10-03

th oc (s)
BBCH 10 – 49 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

of is d ber
ion , th em
No. 203 Pulses Large herbivorous mammal “lagomorph” 10.5 4.3 Annex M-CP 10-03

iss ore m

e
BBCH ≥ 50 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

rm m er
pe her orm
No. 211 Pulses Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03

he rt t/f
BBCH 10 – 49 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)
t t Fu en
ou s. rr
th tie cu
No. 212 Pulses Small omnivorous mammal “mouse” 5.2 2.3 Annex M-CP 10-03
wi par (a)

BBCH ≥ 50 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

f
en ird o
nt th rty

No. 213 Root & stem vegetables Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03
co and ope

BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

r

ts
r i er p
t o wn the

No. 214 Root & stem vegetables Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03
en o s

BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

m he t i
cu f t en

ts

No. 215 Root & stem vegetables Small herbivorous mammal “vole” 40.9 21.7 Annex M-CP 10-03
do s o um
is ht c

BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 62)

th rig s do

No. 222 Root & stem vegetables

i

Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03

e op Th

BBCH 10 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

of y
us c

No. 223 Root & stem vegetables Small omnivorous mammal “mouse” 5.2 2.3 Annex M-CP 10-03
d nd

BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 106 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 224 Strawberries Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03

er y ly
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

th tor G
ay ula the
No. 225 Strawberries Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03

or
t m reg king
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

m er see
No. 226 Strawberries Small herbivorous mammal “vole 54.6 28.9 Annex M-CP 10-03

do ll u tium
en a
BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 62)

cu nd
his fa or
f t ay ns
No. 227 Strawberries Large herbivorous mammal “lagomorph” 35.1 14.3 Annex M-CP 10-03

r o m co
BBCH 10 – 39 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

ne ent he
ow um of t
No. 228 Strawberries Large herbivorous mammal “lagomorph” 14.0 5.7 Annex M-CP 10-03

th oc (s)
BBCH ≥ 40 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

of is d ber
ion , th em
No. 235 Strawberries Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03

iss ore m

e
BBCH 10 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

rm m er
pe her orm
No. 236 Strawberries Small omnivorous mammal “mouse” 6.9 3.1 Annex M-CP 10-03

he rt t/f
BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)
t t Fu en
ou s. rr
th tie cu
No. 237 Sugar beet Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03
wi par (a)

BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

f
en ird o
nt th rty

No. 238 Sugar beet Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03
co and ope

BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

r

ts
r i er p
t o wn the

No. 239 Sugar beet Small herbivorous mammal “vole 34.1 18.1 Annex M-CP 10-03
en o s

BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 62)

m he t i
cu f t en

ts

No. 240 Sugar beet Large herbivorous mammal “lagomorph” 35.1 14.3 Annex M-CP 10-03
do s o um
is ht c

BBCH 10 – 39 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

th rig s do

No. 241 Sugar beet

i

Large herbivorous mammal “lagomorph” 8.8 3.6 Annex M-CP 10-03

e op Th

BBCH ≥ 40 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

of y
us c

No. 248 Sugar beet Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03
d nd

BBCH 10 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
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.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 107 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 249 Sugar beet Small omnivorous mammal “mouse” 4.3 1.9 Annex M-CP 10-03

er y ly
BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

th tor G
ay ula the
No. 250 Sunflower Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03

or
t m reg king
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

m er see
No. 251 Sunflower Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03

do ll u tium
en a
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

cu nd
his fa or
f t ay ns
No. 252 Sunflower Small herbivorous mammal “vole” 34.1 18.1 Annex M-CP 10-03

r o m co
BBCH ≥ 40 Common vole (Microtus arvalis) (Covered by scenario no. 62)

ne ent he
ow um of t
No. 253 Sunflower Large herbivorous mammal “lagomorph” 35.1 14.3 Annex M-CP 10-03

th oc (s)
BBCH 10 – 19 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

of is d ber
ion , th em
No. 254 Sunflower Large herbivorous mammal “lagomorph” 17.6 7.2 Annex M-CP 10-03

iss ore m

e
BBCH 20 – 39 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)

rm m er
pe her orm
No. 255 Sunflower Large herbivorous mammal “lagomorph” 8.8 3.6 Annex M-CP 10-03

he rt t/f
BBCH ≥ 40 Rabbit (Oryctolagus cuniculus) (Covered by scenario no. 35)
t t Fu en
ou s. rr
th tie cu
No. 264 Sunflower Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03
wi par (a)

BBCH 10 – 19 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

f
en ird o
nt th rty

No.265 Sunflower Small omnivorous mammal “mouse” 8.6 3.9 Annex M-CP 10-03
co and ope

BBCH 20 – 39 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

r

ts
r i er p
t o wn the

No.266 Sunflower Small omnivorous mammal “mouse” 4.3 1.9 Annex M-CP 10-03
en o s

BBCH ≥ 40 Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

m he t i
cu f t en

ts

No. 267 Vineyard Large herbivorous mammal “lagomorph” 27.2 11.1 Annex M-CP 10-03
do s o um
is ht c

Application ground directed Brown hare (Lepus europaeus) (Covered by scenario no. 35)
th rig s do

No. 268 Vineyard

i

Large herbivorous mammal “lagomorph” 16.3 6.7 Annex M-CP 10-03

e op Th

BBCH 10 – 19 Brown hare (Lepus europaeus) (Covered by scenario no. 35)

of y
us c

No. 269 Vineyard Large herbivorous mammal “lagomorph” 13.6 5.5 Annex M-CP 10-03
d nd

BBCH 20 – 39 Brown hare (Lepus europaeus) (Covered by scenario no. 35)

an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 108 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
Table 10.1.2- 11: Tier 1 mammalian scenarios

te reg new
oh tio re

d
pr tec EU
EFSA Appendix A Tier 1 scenario Generic focal species SV90 SVm Risk assessment

ibi n
d
be ro te
Scenario given by glyphosate RAR presented under

e ta p osa
ef da ph
No. 270 Vineyard Large herbivorous mammal “lagomorph” 8.1 3.3 Annex M-CP 10-03

er y ly
BBCH ≥ 40 Brown hare (Lepus europaeus) (Covered by scenario no. 35)

th tor G
ay ula the
No. 271 Vineyard Small insectivorous mammal “shrew” 7.6 4.2 Annex M-CP 10-03

or
t m reg king
BBCH 10 – 19 Common shrew (Sorex araneus) (Covered by scenario no. 4)

m er see
No. 272 Vineyard Small insectivorous mammal “shrew” 5.4 1.9 Annex M-CP 10-03

do ll u tium
en a
BBCH ≥ 20 Common shrew (Sorex araneus) (Covered by scenario no. 4)

cu nd
his fa or
f t ay ns
No. 273 Vineyard Small herbivorous mammal “vole” 136.4 72.3 Annex M-CP 10-03

r o m co
Application ground directed Common vole (Microtus arvalis) (Covered by scenario no. 62)

ne ent he
ow um of t
No. 287 Vineyard Small omnivorous mammal “mouse” 17.2 7.8 Annex M-CP 10-03

th oc (s)
Application ground directed Wood mouse (Apodemus sylvaticus) (Covered by scenario no. 13)

of is d ber
ion , th em
Worse case scenarios are indicated in bold.

iss ore m

e
rm m er
The Tier 1 risk assessment is presented in the following tables for the relevant uses in field crops, orchards, vineyards, for the uses on railroad tracks and for the

pe her orm
uses to control invasive species in agricultural and non-agricultural areas, taking into account those generic focal species scenarios which were indicated in bold

he rt t/f
t t Fu en
in the table above. ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
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ht
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 109 of 553

ep
,r
ion
ut
Field crops

t rib
dis
Table 10.1.2- 12: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

n,
er tio
of glyphosate in field crops (Pre-sowing, pre-planting, pre-emergence); Uses 1 a-

wn lica
.
c

s o ub
f it y p
so n
Glyphosate

ht , a
Active substance

rig ntly
Reprod. toxicity 50

th ue
(mg/kg bw/d)

e eq
TER criterion 5

e
lat ns
vio . Co
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TER

an ime al.
te reg new
rate × TWA (mg/kg b t

oh tio re
(g a.s./ha) w/d)

d
pr tec EU
Field crops 1 × 1440 Grassland Large herbivorous mammal 17.3 1.0 × 13.2 3.79

ibi n
d
be ro te
(Pre-sowing, All season “lagomorph” 0.53

e ta p osa
pre-planting, Brown hare (Lepus europaeus)

ef da ph
pre-

er y ly
Grassland Small insectivorous mammal 1.9 1.0 × 1.45 34.5

th tor G
emergence)

ay ula the
Late “shrew” 0.53

or
t m reg king
Common shrew (Sorex araneus)

m er see
Grassland Small herbivorous mammal “vole” 72.3 1.0 × 55.2 0.91

do ll u tium
en a
All season Common vole (Microtus arvalis) 0.53

cu nd
his fa or
f t ay ns
r o m co
Grassland Small omnivorous mammal “mouse” 6.6 1.0 × 5.04 9.93
ne ent he

Late season Wood mouse (Apodemus sylvaticus) 0.53

ow um of t

(seed heads)
th oc (s)
of is d ber

Leafy Small insectivorous mammal 4.2 1.0 × 3.21 15.6

ion , th em

vegetables “shrew” 0.53

iss ore m

e
rm m er

BBCH 10 – 19 Common shrew (Sorex araneus)

pe her orm
he rt t/f

Leafy Small insectivorous mammal 1.9 1.0 × 1.45 34.5

t t Fu en

vegetables “shrew” 0.53

ou s. rr
th tie cu

BBCH ≥ 20 Common shrew (Sorex araneus)

wi par (a)
f

Leafy Small herbivorous mammal “vole” 72.3 1.0 × 55.2

en ird o

0.91
nt th rty

vegetables Common vole (Microtus arvalis) 0.53

co and ope

BBCH 40 – 49
r

ts
r i er p
t o wn the

Leafy Small herbivorous mammal “vole” 21.7 1.0 × 16.6 3.02

en o s
m he t i

vegetables Common vole (Microtus arvalis) 0.53

cu f t en

ts

BBCH ≥ 50
do s o um
is ht c
th rig s do

Leafy Large herbivorous mammal 14.3 1.0 × 10.9 4.58

i

vegetables “lagomorph” 0.53

e op Th

All season Rabbit (Oryctolagus cuniculus)

of y
us c

Leafy Small omnivorous mammal “mouse” 7.8 1.0 × 5.95 8.40

d nd

vegetables Wood mouse (Apodemus sylvaticus) 0.53

an a
n rty

BBCH 10 – 49
tio e
ta op
loi pr

Leafy Small omnivorous mammal “mouse” 2.3 1.0 × 1.76 28.5

xp al

vegetables Wood mouse (Apodemus sylvaticus) 0.53

l e ctu
cia lle

BBCH ≥ 50
er te
m s in

1 × 1080 Grassland Large herbivorous mammal 17.3 1.0 × 9.90 5.05

om a

All season “lagomorph” 0.53

y c uch

Brown hare (Lepus europaeus)

an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Table 10.1.2- 12: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate in field crops (Pre-sowing, pre-planting, pre-emergence); Uses 1 a-

dis
c

n,
er tio
wn lica
.
Active substance Glyphosate

s o ub
50

f it y p
Reprod. toxicity

so n
(mg/kg bw/d)

ht , a
rig ntly
TER criterion 5

th ue
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TER

e eq
rate × TWA (mg/kg b t

e
lat ns
(g a.s./ha) w/d)

vio . Co
an ime al.
te reg new
Grassland Small insectivorous mammal 1.9 1.0 × 1.09 46.0
Late “shrew” 0.53

oh tio re

d
pr tec EU
Common shrew (Sorex araneus)

ibi n
d
be ro te
e ta p osa
Grassland Small herbivorous mammal “vole” 72.3 1.0 × 41.4 1.21
All season Common vole (Microtus arvalis) 0.53

ef da ph
er y ly
th tor G
ay ula the
Grassland Small omnivorous mammal “mouse” 6.6 1.0 × 3.78 13.2

or
t m reg king
Late season Wood mouse (Apodemus sylvaticus) 0.53

m er see
(seed heads)

do ll u tium
en a
Leafy Small insectivorous mammal 4.2 1.0 × 2.40 20.8

cu nd
his fa or
vegetables “shrew” f t ay ns 0.53
r o m co
BBCH 10 – 19 Common shrew (Sorex araneus)
ne ent he
ow um of t

Leafy Small insectivorous mammal 1.9 1.0 × 1.09 46.0

th oc (s)

vegetables “shrew” 0.53

of is d ber

BBCH ≥ 20 Common shrew (Sorex araneus)

ion , th em
iss ore m

Leafy Small herbivorous mammal “vole” 72.3 1.0 × 41.4 1.21

rm m er
pe her orm

vegetables Common vole (Microtus arvalis) 0.53

BBCH 40 – 49
he rt t/f
t t Fu en
ou s. rr

Leafy Small herbivorous mammal “vole” 21.7 1.0 × 12.4 4.03

th tie cu

vegetables Common vole (Microtus arvalis) 0.53

wi par (a)

BBCH ≥ 50
f
en ird o
nt th rty
co and ope

Leafy Large herbivorous mammal 14.3 1.0 × 8.19 6.11

r

vegetables “lagomorph” 0.53

ts
r i er p
t o wn the

All season Rabbit (Oryctolagus cuniculus)

en o s
m he t i
cu f t en

Leafy Small omnivorous mammal “mouse” 7.8 1.0 × 4.47 11.2

ts
do s o um

vegetables Wood mouse (Apodemus sylvaticus) 0.53

is ht c
th rig s do

BBCH 10 – 49
i
e op Th

Leafy Small omnivorous mammal “mouse” 2.3 1.0 × 1.32 38.0

of y

vegetables Wood mouse (Apodemus sylvaticus) 0.53

BBCH ≥ 50
us c
d nd
an a

1 × 720 Grassland Large herbivorous mammal 17.3 1.0 × 6.60 7.57

n rty
tio e

All season “lagomorph” 0.53

ta op
loi pr

Brown hare (Lepus europaeus)

xp al
l e ctu

Grassland Small insectivorous mammal 1.9 1.0 × 0.73 69.0

cia lle

Late “shrew” 0.53

er te
m s in

Common shrew (Sorex araneus)

om a
y c uch

Grassland Small herbivorous mammal “vole” 72.3 1.0 × 27.6 1.81

an ts s

All season Common vole (Microtus arvalis) 0.53

an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Table 10.1.2- 12: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate in field crops (Pre-sowing, pre-planting, pre-emergence); Uses 1 a-

dis
c

n,
er tio
wn lica
.
Active substance Glyphosate

s o ub
50

f it y p
Reprod. toxicity

so n
(mg/kg bw/d)

ht , a
rig ntly
TER criterion 5

th ue
GAP crop Application Crop scenario Generic focal speciesSVm MAFm DDDm TER

e eq
rate × TWA (mg/kg b t

e
lat ns
(g a.s./ha) w/d)

vio . Co
an ime al.
te reg new
Grassland Small omnivorous mammal “mouse” 6.6 1.0 × 2.52 19.9
Late season Wood mouse (Apodemus sylvaticus) 0.53

oh tio re

d
pr tec EU
(seed heads)

ibi n
d
be ro te
e ta p osa
Leafy Small insectivorous mammal 4.2 1.0 × 1.60 31.2
vegetables “shrew” 0.53

ef da ph
er y ly
BBCH 10 – 19 Common shrew (Sorex araneus)

th tor G
ay ula the
Leafy Small insectivorous mammal 1.9 1.0 × 0.73 69.0

or
t m reg king
vegetables “shrew” 0.53

m er see
BBCH ≥ 20 Common shrew (Sorex araneus)

do ll u tium
en a
Leafy Small herbivorous mammal “vole” 72.3 1.0 × 27.6 1.81

cu nd
his fa or
vegetables Common vole (Microtus arvalis) f t ay ns 0.53
r o m co
BBCH 40 – 49
ne ent he
ow um of t

Leafy Small herbivorous mammal “vole” 21.7 1.0 × 8.28 6.04

th oc (s)

vegetables Common vole (Microtus arvalis) 0.53

of is d ber

BBCH ≥ 50
ion , th em
iss ore m

Leafy Large herbivorous mammal 14.3 1.0 × 5.46 9.16

rm m er
pe her orm

vegetables “lagomorph” 0.53

All season Rabbit (Oryctolagus cuniculus)
he rt t/f
t t Fu en
ou s. rr

Leafy Small omnivorous mammal “mouse” 7.8 1.0 × 2.98 16.8

th tie cu

vegetables Wood mouse (Apodemus sylvaticus) 0.53

wi par (a)

BBCH 10 – 49
f
en ird o
nt th rty
co and ope

Leafy Small omnivorous mammal “mouse” 2.3 1.0 × 0.88 57.0

r

vegetables Wood mouse (Apodemus sylvaticus) 0.53

ts
r i er p
t o wn the

BBCH ≥ 50
en o s
m he t i
cu f t en

ts

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
do s o um

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.
is ht c
th rig s do
i
e op Th

The Tier 1 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
of y

indicating that long-term risk to mammals is acceptable following the proposed use patterns in field crops
us c
d nd

(Pre-sowing, pre-planting, pre-emergence, Uses 1 a-c) except for the following scenarios where a refined
an a
n rty

risk assessment is required for some or all intended application rates:

tio e
ta op
loi pr

 Grassland; the large herbivorous mammal “lagomorph” brown hare (1 × 1440 g a.s./ha).
xp al
l e ctu
cia lle

 Grassland; the small herbivorous mammal “vole” common vole (1 × 1440 g a.s./ha, 1 × 1080 g a.s./ha,
er te
m s in

1 × 720 g a.s./ha).
om a
y c uch
an ts s

 Leafy vegetables; the small herbivorous mammal “vole” common vole (1 × 1440 g a.s./ha, 1 × 1080 g
an righ

a.s./ha, 1 × 720 g a.s./ha).

d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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 Leafy vegetables; the large herbivorous mammal “lagomorph” rabbit (1 × 1440 g a.s./ha).

t rib
dis
Table 10.1.2- 13: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

n,
er tio
of glyphosate in field crops (Post-harvest, pre-sowing, pre-planting): Use 2 a-c,

wn lica
.
3 a-b, 10 a-c

s o ub
f it y p
so n
Glyphosate

ht , a
Active substance

rig ntly
Reprod. toxicity 50

th ue
(mg/kg bw/d)

e eq
TER criterion 5

e
lat ns
vio . Co
an ime al.
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

te reg new
rate × TWA (mg/kg

oh tio re
(g a.s./ha) bw/d)

d
pr tec EU
Field crops 1 × 1440 Bulbs and onion Small insectivorous mammal “shrew” 1.9 1.0 × 1.45 34.5

ibi n
d
be ro te
(Post- like crops Common shrew (Sorex araneus) 0.53

e ta p osa
harvest, pre- BBCH ≥ 20

ef da ph
sowing, pre-

er y ly
th tor G
planting) Grassland Large herbivorous mammal 17.3 1.0 × 13.2 3.8

ay ula the
All season “lagomorph” 0.53

or
t m reg king
Brown hare (Lepus europaeus)

m er see
Grassland Small herbivorous mammal “vole” 72.3 1.0 × 55.2 0.90

do ll u tium
en a
All season Common vole (Microtus arvalis) 0.53

cu nd
his fa or
f t ay ns
r o m co

Grassland Small omnivorous mammal “mouse” 6.6 1.0 × 5.04 9.90

ne ent he

Late season Wood mouse (Apodemus sylvaticus) 0.53

ow um of t

(seed heads)
th oc (s)
of is d ber

2 × 1080 Bulbs and onion Small insectivorous mammal “shrew” 1.9 1.1 × 1.20 41.8
ion , th em

(28 d) like crops Common shrew (Sorex araneus) 0.53

iss ore m

e
rm m er

BBCH ≥ 20
pe her orm
he rt t/f

Grassland Large herbivorous mammal 17.3 1.1 × 10.9 4.60

t t Fu en

All season “lagomorph” 0.53

ou s. rr
th tie cu

Brown hare (Lepus europaeus)

wi par (a)
f
en ird o

Grassland Small herbivorous mammal “vole” 72.3 1.1 × 45.5 1.10

nt th rty

All season Common vole (Microtus arvalis) 0.53

co and ope
r

ts
r i er p
t o wn the

Grassland Small omnivorous mammal “mouse” 6.6 1.1 × 4.16 12.0

en o s
m he t i

Late season Wood mouse (Apodemus sylvaticus) 0.53

cu f t en

ts

(seed heads)
do s o um
is ht c
th rig s do

1 × 540 Bulbs and onion Small insectivorous mammal “shrew” 1.9 1.0 × 0.544 91.9
i

like crops Common shrew (Sorex araneus) 0.53

e op Th

BBCH ≥ 20
of y
us c

Grassland Large herbivorous mammal 17.3 1.0 × 4.95 10.1

d nd
an a

All season “lagomorph” 0.53

n rty

Brown hare (Lepus europaeus)

tio e
ta op
loi pr

Grassland Small herbivorous mammal “vole” 72.3 1.0 × 20.7 2.40

xp al
l e ctu

All season Common vole (Microtus arvalis) 0.53

cia lle
er te
m s in

Grassland Small omnivorous mammal “mouse” 6.6 1.0 × 1.89 26.5

om a
y c uch

Late season Wood mouse (Apodemus sylvaticus) 0.53

(seed heads)
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Table 10.1.2- 13: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate in field crops (Post-harvest, pre-sowing, pre-planting): Use 2 a-c,

dis
3 a-b, 10 a-c

n,
er tio
wn lica
.
Active substance Glyphosate

s o ub
50

f it y p
Reprod. toxicity

so n
(mg/kg bw/d)

ht , a
rig ntly
TER criterion 5

th ue
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

e eq
rate × TWA (mg/kg

e
lat ns
(g a.s./ha) bw/d)

vio . Co
an ime al.
te reg new
1 × 720 Bulbs and onion Small insectivorous mammal “shrew” 1.9 1.0 × 0.725 69.0
like crops Common shrew (Sorex araneus) 0.53

oh tio re

d
pr tec EU
BBCH ≥ 20

ibi n
d
be ro te
e ta p osa
Grassland Large herbivorous mammal 17.3 1.0 × 6.60 7.60
All season “lagomorph” 0.53

ef da ph
er y ly
Brown hare (Lepus europaeus)

th tor G
ay ula the
Grassland Small herbivorous mammal “vole” 72.3 1.0 × 27.6

or
1.80

t m reg king
All season Common vole (Microtus arvalis) 0.53

m er see
do ll u tium
en a
Grassland Small omnivorous mammal “mouse” 6.6 1.0 × 2.52 19.9

cu nd
his fa or
Late season f t ay ns
Wood mouse (Apodemus sylvaticus) 0.53
r o m co
(seed heads)
ne ent he
ow um of t

2 × 720 Bulbs and onion Small insectivorous mammal “shrew” 1.9 1.1 × 0.798 62.7
th oc (s)

(28 d) like crops Common shrew (Sorex araneus) 0.53

of is d ber

BBCH ≥ 20
ion , th em
iss ore m

Grassland Large herbivorous mammal 17.3 1.1 × 7.26 6.90

rm m er
pe her orm

All season “lagomorph” 0.53

Brown hare (Lepus europaeus)
he rt t/f
t t Fu en
ou s. rr

Grassland Small herbivorous mammal “vole” 72.3 1.1 × 30.4 1.60

th tie cu

All season Common vole (Microtus arvalis) 0.53

wi par (a)
f
en ird o
nt th rty
co and ope

Grassland Small omnivorous mammal “mouse” 6.6 1.1 × 2.77 18.0

r

Late season Wood mouse (Apodemus sylvaticus) 0.53

ts
r i er p
t o wn the

(seed heads)
en o s
m he t i
cu f t en

1 × 1080 Bulbs and onion Small insectivorous mammal “shrew” 1.9 1.0 × 1.09 46.0
ts
do s o um

like crops Common shrew (Sorex araneus) 0.53

is ht c
th rig s do

BBCH ≥ 20
i
e op Th

Grassland Large herbivorous mammal 17.3 1.0 × 9.90 5.00

of y

All season “lagomorph” 0.53

Brown hare (Lepus europaeus)
us c
d nd
an a

Grassland Small herbivorous mammal “vole” 72.3 1.0 × 41.4

n rty

1.20
tio e

All season Common vole (Microtus arvalis) 0.53

ta op
loi pr
xp al
l e ctu

Grassland Small omnivorous mammal “mouse” 6.6 1.0 × 3.78 13.2

cia lle

Late season Wood mouse (Apodemus sylvaticus) 0.53

er te
m s in

(seed heads)
om a
y c uch

3 × 720 Bulbs and onion Small insectivorous mammal “shrew” 1.9 1.2 × 0.870 57.5
an ts s

(28 d) like crops Common shrew (Sorex araneus) 0.53

an righ

BBCH ≥ 20
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Page 114 of 553

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Table 10.1.2- 13: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate in field crops (Post-harvest, pre-sowing, pre-planting): Use 2 a-c,

dis
3 a-b, 10 a-c

n,
er tio
wn lica
.
Active substance Glyphosate

s o ub
50

f it y p
Reprod. toxicity

so n
(mg/kg bw/d)

ht , a
rig ntly
TER criterion 5

th ue
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

e eq
rate × TWA (mg/kg

e
lat ns
(g a.s./ha) bw/d)

vio . Co
an ime al.
te reg new
Grassland Large herbivorous mammal 17.3 1.2 × 7.92 6.30
All season “lagomorph” 0.53

oh tio re

d
pr tec EU
Brown hare (Lepus europaeus)

ibi n
d
be ro te
e ta p osa
Grassland Small herbivorous mammal “vole” 72.3 1.2 × 33.1 1.50
All season Common vole (Microtus arvalis) 0.53

ef da ph
er y ly
th tor G
ay ula the
Grassland Small omnivorous mammal “mouse” 6.6 1.2 × 3.02 16.5

or
t m reg king
Late season Wood mouse (Apodemus sylvaticus) 0.53

m er see
(seed heads)

do ll u tium
en a
SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:

cu nd
his fa or
toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger. f t ay ns
r o m co
ne ent he
ow um of t

The Tier 1 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
th oc (s)
of is d ber

indicating that long-term risk to mammals is acceptable following the proposed use patterns in field crops
ion , th em

(Post-harvest, pre-sowing, pre-planting, Use 2 a-c, 3 a-b, 10 a-c) except for the following scenarios where
iss ore m

a refined risk assessment is required for some or all intended application rates:
rm m er
pe her orm
he rt t/f

 Grassland; the large herbivorous mammal “lagomorph” brown hare (1 × 1440 g a.s./ha,
t t Fu en
ou s. rr

2 × 1080 g a.s./ha).
th tie cu
wi par (a)
f

 Grassland; the small herbivorous mammal “vole” common vole (1 × 1440 g a.s./ha, 2 × 1080 g
en ird o
nt th rty

a.s./ha, 1 × 540 g a.s./ha, 1 × 720 g a.s./ha, 2 × 720 g a.s./ha, 1 × 1080 g a.s./ha, 3 × 720 g a.s./ha).
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 115 of 553

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Table 10.1.2- 14: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate in field crops (Shielded ground directed inter-row application): Use 6 a-b

dis
n,
er tio
Active substance Glyphosate

wn lica
50

.
Reprod. toxicity

s o ub
f it y p
(mg/kg bw/d)

so n
TER criterion 5

ht , a
rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

th ue
rate × TWA (mg/kg

e eq
(g a.s./ha) bw/d)

e
lat ns
Field crops 1 × 1080 Bulbs & onion Small insectivorous mammal “shrew” 4.2 1.0 × 2.40 20.8

vio . Co
an ime al.
(Shielded like crops Common shrew (Sorex araneus) 0.53

te reg new
ground inter- BBCH 10 – 19

oh tio re

d
row

pr tec EU
ibi n
Bulbs & onion Small omnivorous mammal “mouse” 7.8 1.0 × 4.46 11.2

d
application)

be ro te
like crops Wood mouse (Apodemus sylvaticus) 0.53

e ta p osa
BBCH 10 – 39

ef da ph
er y ly
th tor G
Fruiting Small herbivorous mammal “vole” 72.3 1.0 × 41.4 1.21

ay ula the
vegetables Common vole (Microtus arvalis) 0.53

or
t m reg king
BBCH 10 – 49

m er see
Leafy vegetables Large herbivorous mammal 14.3 1.0 × 8.19 6.11

do ll u tium
en a
All season “lagomorph” 0.53

cu nd
his fa or
Rabbit (Oryctolagus cuniculus) f t ay ns
r o m co
ne ent he

1 × 720 Bulbs & onion Small insectivorous mammal “shrew” 4.2 1.0 × 1.60 31.2
ow um of t

like crops Common shrew (Sorex araneus) 0.53

th oc (s)

BBCH 10 – 19
of is d ber
ion , th em

Bulbs & onion Small omnivorous mammal “mouse” 7.8 1.0 × 2.98 16.8
iss ore m

like crops Wood mouse (Apodemus sylvaticus) 0.53

rm m er

BBCH 10 – 39
pe her orm
he rt t/f

Fruiting Small herbivorous mammal “vole” 72.3 1.0 × 27.6

t t Fu en

1.81
ou s. rr

vegetables Common vole (Microtus arvalis) 0.53

th tie cu

BBCH 10 – 49
wi par (a)
f
en ird o

Leafy vegetables Large herbivorous mammal 14.3 1.0 × 5.46 9.16

nt th rty
co and ope

All season “lagomorph” 0.53

Rabbit (Oryctolagus cuniculus)
r

ts
r i er p
t o wn the
en o s

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
m he t i
cu f t en

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.
ts
do s o um
is ht c
th rig s do

The Tier 1 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
indicating that long-term risk to mammals is acceptable following the proposed use patterns in field crops
i
e op Th

(Shielded ground directed inter-row application, uses 6 a-b) except for the following scenario where a
of y

refined risk assessment is required for all intended application rates:

us c
d nd
an a
n rty

 Fruiting vegetables; the small herbivorous mammal “vole” common vole (1 × 1080 g a.s./ha,
tio e
ta op

1 × 720 g a.s./ha).
loi pr
xp al
l e ctu
cia lle

Orchards
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Page 116 of 553

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Table 10.1.2- 15: Tier 1 assessment of the acute risk for mammals due to the use of glyphosate in

t rib
orchards: Uses 4 a-c

dis
n,
er tio
Active substance Glyphosate

wn lica
.
Acute toxicity > 2000

s o ub
f it y p
(mg/kg bw)

so n
TER criterion 10

ht , a
rig ntly
GAP crop Application Crop scenario Generic focal species SV90 MAF90 DDD90 TERa

th ue
rate (mg/kg

e eq
(g a.s./ha) bw/d)

e
lat ns
Orchard 2 × 1440 Orchards Small insectivorous mammal 5.4 1.1 8.55 234

vio . Co
an ime al.
te reg new
Post- (28 d) Application crop “shrew”
emergence directed BBCH Common shrew (Sorex araneus)

oh tio re

d
pr tec EU
of weeds < 10 or not crop

ibi n
d
directed

be ro te
e ta p osa
Orchards Small herbivorous mammal 136.4 1.1 216 9.26

ef da ph
Application crop “vole”

er y ly
th tor G
directed BBCH Common vole (Microtus arvalis)

ay ula the

or
< 10 or not crop

t m reg king
directed

m er see
Orchards Large herbivorous mammal 35.1 1.1 55.6 36.0

do ll u tium
en a
Application crop “lagomorph”

cu nd
his fa or
directed BBCH Rabbit (Oryctolagus cuniculus)
f t ay ns
r o m co
< 10 or not crop
ne ent he

directed
ow um of t
th oc (s)

Orchards Small omnivorous mammal 17.2 1.1 27.2 73.4

of is d ber

Application crop “mouse”

ion , th em

directed BBCH Wood mouse (Apodemus

iss ore m

< 10 or not crop sylvaticus)

rm m er
pe her orm

directed
he rt t/f
t t Fu en

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
ou s. rr

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.
th tie cu
wi par (a)
f

The Tier 1 TERa values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 10,
en ird o
nt th rty

indicating that acute risk to mammals is acceptable following the proposed use patterns in orchards (Uses
co and ope

4 a –c) except for the following scenario where a refined risk assessment is required for one intended
r

ts
r i er p

application rate:
t o wn the
en o s
m he t i
cu f t en

ts

 Orchards; the small herbivorous mammal “vole” common vole (2 × 1440 g a.s./ha).
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 117 of 553

ep
,r
ion
ut
Table 10.1.2- 16: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate in orchards: Use 4 a-c

dis
n,
er tio
Active substance Glyphosate

wn lica
50

.
Reprod. toxicity

s o ub
f it y p
(mg/kg bw/d)

so n
TER criterion 5

ht , a
rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

th ue
rate × (mg/kg bw/d)

e eq
(g a.s./ha) TWA

e
lat ns
Vineyard 2 × 1440 Orchards Small insectivorous mammal 1.9 1.1 × 1.60 31.3

vio . Co
an ime al.
Post- (28 d) Application crop “shrew” 0.53

te reg new
emergence directed BBCH Common shrew (Sorex araneus)

oh tio re

d
of weeds < 10 or not crop

pr tec EU
ibi n
d
directed

be ro te
e ta p osa
Orchards Small herbivorous mammal 72.3 1.1 × 60.7 0.82

ef da ph
Application crop “vole” 0.53

er y ly
th tor G
directed BBCH Common vole (Microtus arvalis)

ay ula the
< 10 or not crop

or
t m reg king
directed

m er see
Orchards Large herbivorous mammal 14.3 1.1 × 12.0 4.16
Application crop “lagomorph” 0.53

do ll u tium
en a
directed BBCH Rabbit (Oryctolagus cuniculus)

cu nd
his fa or
< 10 or not crop f t ay ns
r o m co
directed
ne ent he

Orchards Small omnivorous mammal 7.8 1.1 × 6.55 7.64

ow um of t

Application crop “mouse” 0.53

th oc (s)

directed BBCH Wood mouse (Apodemus

of is d ber

< 10 or not crop sylvaticus)

ion , th em

directed
iss ore m

e
rm m er

1 × 720 Orchards Small insectivorous mammal 1.9 1.0 × 0.725 69.0

pe her orm

Application crop “shrew” 0.53

he rt t/f

directed BBCH Common shrew (Sorex araneus)

t t Fu en
ou s. rr

< 10 or not crop

th tie cu

directed
wi par (a)

Orchards Small herbivorous mammal 72.3 1.0 × 27.6

f

1.81
en ird o
nt th rty

Application crop “vole” 0.53

co and ope

directed BBCH Common vole (Microtus arvalis)

r

ts
r i er p

< 10 or not crop

t o wn the

directed
en o s
m he t i

Orchards Large herbivorous mammal 14.3 1.0 × 5.46 9.16

cu f t en

ts

Application crop “lagomorph” 0.53

do s o um

directed BBCH Rabbit (Oryctolagus cuniculus)

is ht c
th rig s do

< 10 or not crop

i
e op Th

directed
Orchards Small omnivorous mammal 7.8 1.0 × 2.98 16.8
of y

Application crop “mouse” 0.53

us c
d nd

directed BBCH Wood mouse (Apodemus

an a
n rty

< 10 or not crop sylvaticus)

tio e

directed
ta op
loi pr

1 × 1080 Orchards Small insectivorous mammal 1.9 1.0 × 1.09 46.0

xp al

Application crop “shrew” 0.53

l e ctu
cia lle

directed BBCH Common shrew (Sorex araneus)

er te

< 10 or not crop

m s in

directed
om a
y c uch

Orchards Small herbivorous mammal 72.3 1.0 × 41.4 1.21

an ts s

Application crop “vole” 0.53

an righ

directed BBCH Common vole (Microtus arvalis)

< 10 or not crop
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 118 of 553

ep
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Table 10.1.2- 16: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate in orchards: Use 4 a-c

dis
n,
er tio
Active substance Glyphosate

wn lica
50

.
Reprod. toxicity

s o ub
f it y p
(mg/kg bw/d)

so n
TER criterion 5

ht , a
rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

th ue
rate × (mg/kg bw/d)

e eq
(g a.s./ha) TWA

e
lat ns
directed

vio . Co
an ime al.
Orchards Large herbivorous mammal 14.3 1.0 × 8.19 6.11

te reg new
Application crop “lagomorph” 0.53

oh tio re

d
directed BBCH Rabbit (Oryctolagus cuniculus)

pr tec EU
ibi n
d
< 10 or not crop

be ro te
e ta p osa
directed

ef da ph
Orchards Small omnivorous mammal 7.8 1.0 × 4.47 11.2

er y ly
th tor G
Application crop “mouse” 0.53

ay ula the
directed BBCH Wood mouse (Apodemus

or
t m reg king
< 10 or not crop sylvaticus)

m er see
directed
2 × 720 Orchards Small insectivorous mammal 1.9 1.1 × 1.90 62.7

do ll u tium
en a
(28 d) Application crop “shrew” 0.53

cu nd
his fa or
directed BBCH Common shrew (Sorex araneus)
f t ay ns
r o m co
< 10 or not crop
ne ent he

directed
ow um of t

Orchards Small herbivorous mammal 72.3 1.1 × 72.3 1.65

th oc (s)

Application crop “vole” 0.53

of is d ber

directed BBCH Common vole (Microtus arvalis)

ion , th em

< 10 or not crop

iss ore m

e
rm m er

directed
pe her orm

Orchards Large herbivorous mammal 14.3 1.1 × 14.3 8.33

he rt t/f

Application crop “lagomorph” 0.53

t t Fu en
ou s. rr

directed BBCH Rabbit (Oryctolagus cuniculus)

th tie cu

< 10 or not crop

wi par (a)

directed
f
en ird o
nt th rty

Orchards Small omnivorous mammal 7.8 1.1 × 7.80 15.3

co and ope

Application crop “mouse” 0.53

r

ts
r i er p

directed BBCH Wood mouse (Apodemus

t o wn the

< 10 or not crop sylvaticus)

en o s
m he t i

directed
cu f t en

ts

3 × 720 Orchards Small insectivorous mammal 1.9 1.2 × 0.87 57.5

do s o um
is ht c

(28 d) Application crop “shrew” 0.53

th rig s do

directed BBCH Common shrew (Sorex araneus)

i
e op Th

< 10 or not crop

directed
of y

Orchards Small herbivorous mammal 72.3 1.2 × 33.1

us c

1.51
d nd

Application crop “vole” 0.53

an a
n rty

directed BBCH Common vole (Microtus arvalis)

tio e
ta op

< 10 or not crop

loi pr

directed
xp al
l e ctu

Orchards Large herbivorous mammal 14.3 1.2 × 6.55 7.64

cia lle

Application crop “lagomorph” 0.53

er te

directed BBCH Rabbit (Oryctolagus cuniculus)

m s in

< 10 or not crop

om a
y c uch

directed
an ts s

Orchards Small omnivorous mammal 7.8 1.2 × 3.57 14.0

an righ

Application crop “mouse” 0.53

d

directed BBCH Wood mouse (Apodemus

ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
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cti
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 119 of 553

ep
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ion
ut
Table 10.1.2- 16: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate in orchards: Use 4 a-c

dis
n,
er tio
Active substance Glyphosate

wn lica
50

.
Reprod. toxicity

s o ub
f it y p
(mg/kg bw/d)

so n
TER criterion 5

ht , a
rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

th ue
rate × (mg/kg bw/d)

e eq
(g a.s./ha) TWA

e
lat ns
< 10 or not crop sylvaticus)

vio . Co
an ime al.
directed

te reg new
1 × 1440 Orchards Small insectivorous mammal 1.9 1.0 × 1.45 34.5

oh tio re

d
Application crop “shrew” 0.53

pr tec EU
ibi n
d
directed BBCH Common shrew (Sorex araneus)

be ro te
e ta p osa
< 10 or not crop

ef da ph
directed

er y ly
th tor G
Orchards Small herbivorous mammal 72.3 1.0 × 55.2 0.91

ay ula the
Application crop “vole” 0.53

or
t m reg king
directed BBCH Common vole (Microtus arvalis)

m er see
< 10 or not crop
directed

do ll u tium
en a
Orchards Large herbivorous mammal 14.3 1.0 × 10.9 4.58

cu nd
his fa or
Application crop “lagomorph” f t ay ns
r o m co 0.53
directed BBCH Rabbit (Oryctolagus cuniculus)
ne ent he

< 10 or not crop

ow um of t

directed
th oc (s)

Orchards Small omnivorous mammal 7.8 1.0 × 5.95 8.40

of is d ber

Application crop “mouse” 0.53

ion , th em

directed BBCH Wood mouse (Apodemus

iss ore m

e
rm m er

< 10 or not crop sylvaticus)

pe her orm

directed
he rt t/f

2 × 1080 Orchards Small insectivorous mammal 1.9 1.1 × 1.20 41.8

t t Fu en
ou s. rr

(28 d) Application crop “shrew” 0.53

th tie cu

directed BBCH Common shrew (Sorex araneus)

wi par (a)

< 10 or not crop

f
en ird o
nt th rty

directed
co and ope

Orchards Small herbivorous mammal 72.3 1.1 × 45.5 1.10

r

ts
r i er p

Application crop “vole” 0.53

t o wn the

directed BBCH Common vole (Microtus arvalis)

en o s
m he t i

< 10 or not crop

cu f t en

ts

directed
do s o um
is ht c

Orchards Large herbivorous mammal 14.3 1.1 × 9.00 5.55

th rig s do

Application crop “lagomorph” 0.53

i
e op Th

directed BBCH Rabbit (Oryctolagus cuniculus)

< 10 or not crop
of y

directed
us c
d nd

Orchards Small omnivorous mammal 7.8 1.1 × 4.91 10.2

an a
n rty

Application crop “mouse” 0.53

tio e
ta op

directed BBCH Wood mouse (Apodemus

loi pr

< 10 or not crop sylvaticus)

xp al

directed
l e ctu
cia lle

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
er te
m s in

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 120 of 553

ep
,r
ion
ut
The Tier 1 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,

rib
indicating that long-term risk to mammals is acceptable following the proposed use patterns in orchards

t
dis
(Uses 4 a-c) except for the following scenario where a refined risk assessment is required for some or all

n,
er tio
intended application rates:

wn lica
.
s o ub
f it y p
 Orchards; the small herbivorous mammal “vole” common vole (2 × 1440 g a.s./ha, 1 × 720 g a.s./ha,

so n
ht , a
1 × 1080 g a.s./ha, 2 × 720 g a.s./ha, 3 × 720 g a.s./ha, 1 × 1440 g a.s./ha, 2 × 1080 g a.s./ha).

rig ntly
 Orchards: the large herbivorous mammal “lagomorph” rabbit (2 × 1440 g a.s./ha, 1 × 1440 g a.s./ha).

th ue
e eq
e
lat ns
Vineyards

vio . Co
an ime al.
te reg new
Table 10.1.2- 17: Tier 1 assessment of the acute risk for mammals due to the use of glyphosate in

oh tio re

d
vineyards: Use 5 a-c

pr tec EU
ibi n
d
be ro te
e ta p osa
Active substance Glyphosate

ef da ph
Acute toxicity > 2000

er y ly
th tor G
(mg/kg bw)

ay ula the
TER criterion 10

or
t m reg king
GAP crop Application Crop scenario Generic focal species SV90 MAF90 DDD90 TERa

m er see
rate (mg/kg

do ll u tium
en a
(g a.s./ha) bw/d)
Vineyard 2 × 1440 Vineyard Large herbivorous mammal 27.2 1.1 43.1 46.4

cu nd
his fa or
Post- (28 d) Application “lagomorph” f t ay ns
r o m co
emergence ground directed Brown hare (Lepus europaeus)
ne ent he

of weeds
ow um of t

Vineyard Large herbivorous mammal 16.3 1.1 25.8 77.5

th oc (s)

BBCH 10 – 19 “lagomorph”
of is d ber

Brown hare (Lepus europaeus)

ion , th em
iss ore m

Vineyard Large herbivorous mammal 13.6 1.1 21.5 92.8

rm m er
pe her orm

BBCH 20 – 39 “lagomorph”
he rt t/f

Brown hare (Lepus europaeus)

t t Fu en
ou s. rr

Vineyard Large herbivorous mammal 8.1 1.1 12.8 156

th tie cu
wi par (a)

BBCH ≥ 40 “lagomorph”
f

Brown hare (Lepus europaeus)

en ird o
nt th rty
co and ope

Vineyard Small insectivorous mammal “shrew” 7.6 1.1 12.0 166

r

ts
r i er p

BBCH 10 – 19 Common shrew (Sorex araneus)

t o wn the
en o s
m he t i
cu f t en

ts

Vineyard Small insectivorous mammal “shrew” 5.4 1.1 8.55 234

do s o um

BBCH ≥ 20 Common shrew (Sorex araneus)

is ht c
th rig s do
i
e op Th

Vineyard Small herbivorous mammal “vole” 136. 1.1 216 9.26

of y

Application Common vole (Microtus arvalis) 4

us c

ground directed
d nd
an a
n rty

Vineyard Small omnivorous mammal “mouse” 17.2 1.1 27.2 73.4

tio e

Application Wood mouse (Apodemus sylvaticus)

ta op
loi pr

ground directed
xp al
l e ctu

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
cia lle
er te

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 121 of 553

ep
,r
ion
ut
The Tier 1 TERa values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 10,

rib
indicating that acute risk to mammals is acceptable following the proposed use patterns in vineyards (Uses

t
dis
5 a-c) except for the following scenario where a refined risk assessment is required for one application rate:

n,
er tio
wn lica
.
 Vineyards; the small herbivorous mammal “vole” common vole (2 × 1440 g a.s./ha).

s o ub
f it y p
so n
ht , a
Table 10.1.2- 18: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

rig ntly
of glyphosate in vineyards: Use 5 a-c

th ue
e eq
e
lat ns
Active substance Glyphosate

vio . Co
an ime al.
50

te reg new
Reprod. toxicity
(mg/kg bw/d)

oh tio re

d
pr tec EU
TER criterion 5

ibi n
d
be ro te
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

e ta p osa
rate × TWA (mg/kg

ef da ph
(g a.s./ha) bw/d)

er y ly
th tor G
Vineyard 2 × 1440 Vineyard Large herbivorous mammal 11.1 1.1 × 9.32 5.37

ay ula the
Post- (28 d) Application “lagomorph” 0.53

or
t m reg king
emergence ground directed Brown hare (Lepus europaeus)

m er see
of weeds
Vineyard Large herbivorous mammal 6.7 1.1 × 5.62 8.89

do ll u tium
en a
BBCH 10 – 19 “lagomorph” 0.53

cu nd
his fa or
Brown hare (Lepus europaeus)
f t ay ns
r o m co

Vineyard Large herbivorous mammal 5.5 1.1 × 4.62 10.8

ne ent he
ow um of t

BBCH 20 – 39 “lagomorph” 0.53

th oc (s)

Brown hare (Lepus europaeus)

of is d ber

Vineyard Large herbivorous mammal 3.3 1.1 × 2.77 18.0

ion , th em
iss ore m

BBCH ≥ 40 “lagomorph” 0.53

e
rm m er

Brown hare (Lepus europaeus)

pe her orm
he rt t/f

Vineyard Small insectivorous mammal “shrew” 4.2 1.1 × 3.53 14.2

t t Fu en

BBCH 10 – 19 Common shrew (Sorex araneus) 0.53

ou s. rr
th tie cu
wi par (a)
f
en ird o

Vineyard Small insectivorous mammal “shrew” 1.9 1.1 × 1.60 31.3

nt th rty

BBCH ≥ 20 Common shrew (Sorex araneus) 0.53

co and ope
r

ts
r i er p
t o wn the

Vineyard Small herbivorous mammal “vole” 72.3 1.1 × 60.7 0.82

en o s

Application Common vole (Microtus arvalis) 0.53

m he t i
cu f t en

ts

ground directed
do s o um
is ht c
th rig s do

Vineyard Small omnivorous mammal “mouse” 7.8 1.1 × 6.55 7.64

Application Wood mouse (Apodemus sylvaticus) 0.53
i
e op Th

ground directed
of y

1 × 720 Vineyard Large herbivorous mammal 11.1 1.0 × 4.24 11.8

us c
d nd

Application “lagomorph” 0.53

an a
n rty

ground directed Brown hare (Lepus europaeus)

tio e
ta op
loi pr

Vineyard Large herbivorous mammal 6.7 1.0 × 2.56 19.6

xp al

BBCH 10 – 19 “lagomorph” 0.53

l e ctu

Brown hare (Lepus europaeus)

cia lle
er te
m s in

Vineyard Large herbivorous mammal 5.5 1.0 × 2.10 23.8

om a

BBCH 20 – 39 “lagomorph” 0.53

y c uch

Brown hare (Lepus europaeus)

an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 122 of 553

ep
,r
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ut
Table 10.1.2- 18: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
dis
of glyphosate in vineyards: Use 5 a-c

n,
er tio
wn lica
Active substance Glyphosate

.
s o ub
Reprod. toxicity 50

f it y p
(mg/kg bw/d)

so n
ht , a
TER criterion 5

rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

th ue
rate × TWA (mg/kg

e eq
e
lat ns
(g a.s./ha) bw/d)

vio . Co
an ime al.
Vineyard Large herbivorous mammal 3.3 1.0 × 1.26 39.7

te reg new
BBCH ≥ 40 “lagomorph” 0.53

oh tio re
Brown hare (Lepus europaeus)

d
pr tec EU
ibi n
d
be ro te
Vineyard Small insectivorous mammal “shrew” 4.2 1.0 × 1.60 31.2

e ta p osa
BBCH 10 – 19 Common shrew (Sorex araneus) 0.53

ef da ph
er y ly
th tor G
ay ula the
Vineyard Small insectivorous mammal “shrew” 1.9 1.0 × 0.725 69.0

or
t m reg king
BBCH ≥ 20 Common shrew (Sorex araneus) 0.53

m er see
do ll u tium
en a
Vineyard Small herbivorous mammal “vole” 72.3 1.0 × 27.6 1.81

cu nd
his fa or
Application Common vole (Microtus arvalis) 0.53
ground directed f t ay ns
r o m co
ne ent he

Vineyard Small omnivorous mammal “mouse” 7.8 1.0 × 2.98 16.8

ow um of t

Application Wood mouse (Apodemus sylvaticus) 0.53

th oc (s)

ground directed
of is d ber
ion , th em

1 × 1080 Vineyard Large herbivorous mammal 11.1 1.0 × 6.35 7.90

iss ore m

e
rm m er

Application “lagomorph” 0.53

pe her orm

ground directed Brown hare (Lepus europaeus)

he rt t/f
t t Fu en

Vineyard Large herbivorous mammal 6.7 1.0 × 3.84 13.0

ou s. rr
th tie cu

BBCH 10 – 19 “lagomorph” 0.53

wi par (a)

Brown hare (Lepus europaeus)

f
en ird o
nt th rty

Vineyard Large herbivorous mammal 5.5 1.0 × 3.15 15.9

co and ope

BBCH 20 – 39 “lagomorph” 0.53

r

ts
r i er p

Brown hare (Lepus europaeus)

t o wn the
en o s

Vineyard Large herbivorous mammal 3.3 1.0 × 1.89 26.5

m he t i
cu f t en

ts

BBCH ≥ 40 “lagomorph” 0.53

do s o um

Brown hare (Lepus europaeus)

is ht c
th rig s do

Vineyard Small insectivorous mammal “shrew” 4.2 1.0 × 2.40 20.8

i
e op Th

BBCH 10 – 19 Common shrew (Sorex araneus) 0.53

of y
us c
d nd

Vineyard Small insectivorous mammal “shrew” 1.9 1.0 × 1.09 46.0

an a
n rty

BBCH ≥ 20 Common shrew (Sorex araneus) 0.53

tio e
ta op
loi pr
xp al

Vineyard Small herbivorous mammal “vole” 72.3 1.0 × 41.4 1.21

l e ctu

Application Common vole (Microtus arvalis) 0.53

cia lle
er te

ground directed
m s in
om a

Vineyard Small omnivorous mammal “mouse” 7.8 1.0 × 4.47 11.2

y c uch

Application Wood mouse (Apodemus sylvaticus) 0.53

an ts s

ground directed
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
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Table 10.1.2- 18: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
dis
of glyphosate in vineyards: Use 5 a-c

n,
er tio
wn lica
Active substance Glyphosate

.
s o ub
Reprod. toxicity 50

f it y p
(mg/kg bw/d)

so n
ht , a
TER criterion 5

rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

th ue
rate × TWA (mg/kg

e eq
e
lat ns
(g a.s./ha) bw/d)

vio . Co
an ime al.
2 × 720 Vineyard Large herbivorous mammal 11.1 1.1 × 4.66 10.7

te reg new
(28 d) Application “lagomorph” 0.53

oh tio re
ground directed Brown hare (Lepus europaeus)

d
pr tec EU
ibi n
d
be ro te
Vineyard Large herbivorous mammal 6.7 1.1 × 2.81 17.8

e ta p osa
BBCH 10 – 19 “lagomorph” 0.53

ef da ph
Brown hare (Lepus europaeus)

er y ly
th tor G
ay ula the
Vineyard Large herbivorous mammal 5.5 1.1 × 2.31 21.7

or
t m reg king
BBCH 20 – 39 “lagomorph” 0.53
Brown hare (Lepus europaeus)

m er see
do ll u tium
en a
Vineyard Large herbivorous mammal 3.3 1.1 × 1.39 36.1

cu nd
his fa or
BBCH ≥ 40 “lagomorph” 0.53
f t ay ns
Brown hare (Lepus europaeus)
r o m co
ne ent he

Vineyard Small insectivorous mammal “shrew” 4.2 1.1 × 1.76 28.4

ow um of t

BBCH 10 – 19 Common shrew (Sorex araneus) 0.53

th oc (s)
of is d ber
ion , th em

Vineyard Small insectivorous mammal “shrew” 1.9 1.1 × 0.798 62.7

iss ore m

e
rm m er

BBCH ≥ 20 Common shrew (Sorex araneus) 0.53

pe her orm
he rt t/f
t t Fu en

Vineyard Small herbivorous mammal “vole” 72.3 1.1 × 30.4 1.65

ou s. rr
th tie cu

Application Common vole (Microtus arvalis) 0.53

wi par (a)

ground directed
f
en ird o
nt th rty

Vineyard Small omnivorous mammal “mouse” 7.8 1.1 × 3.27 15.3

co and ope

Application Wood mouse (Apodemus sylvaticus) 0.53

r

ts
r i er p

ground directed
t o wn the
en o s

3 × 720 Vineyard Large herbivorous mammal 11.1 1.2 × 5.08 9.84

m he t i
cu f t en

ts

(28 d) Application “lagomorph” 0.53

do s o um

ground directed Brown hare (Lepus europaeus)

is ht c
th rig s do

Vineyard Large herbivorous mammal 6.7 1.2 × 3.07 16.3

i
e op Th

BBCH 10 – 19 “lagomorph” 0.53

of y

Brown hare (Lepus europaeus)

us c
d nd

Vineyard Large herbivorous mammal 5.5 1.2 × 2.52 19.9

an a
n rty

BBCH 20 – 39 “lagomorph” 0.53

tio e
ta op

Brown hare (Lepus europaeus)

loi pr
xp al

Vineyard Large herbivorous mammal 3.3 1.2 × 1.51 33.1

l e ctu

BBCH ≥ 40 “lagomorph” 0.53

cia lle
er te

Brown hare (Lepus europaeus)

m s in
om a

Vineyard Small insectivorous mammal “shrew” 4.2 1.2 × 1.92 26.0

y c uch

BBCH 10 – 19 Common shrew (Sorex araneus) 0.53

an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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It
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cti
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 124 of 553

ep
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ut
Table 10.1.2- 18: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
dis
of glyphosate in vineyards: Use 5 a-c

n,
er tio
wn lica
Active substance Glyphosate

.
s o ub
Reprod. toxicity 50

f it y p
(mg/kg bw/d)

so n
ht , a
TER criterion 5

rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

th ue
rate × TWA (mg/kg

e eq
e
lat ns
(g a.s./ha) bw/d)

vio . Co
an ime al.
Vineyard Small insectivorous mammal “shrew” 1.9 1.2 × 0.87 57.5

te reg new
BBCH ≥ 20 Common shrew (Sorex araneus) 0.53

oh tio re

d
pr tec EU
ibi n
d
be ro te
Vineyard Small herbivorous mammal “vole” 72.3 1.2 × 33.1 1.51

e ta p osa
Application Common vole (Microtus arvalis) 0.53

ef da ph
ground directed

er y ly
th tor G
ay ula the
Vineyard Small omnivorous mammal “mouse” 7.8 1.2 × 3.57 14.0

or
t m reg king
Application Wood mouse (Apodemus sylvaticus) 0.53
ground directed

m er see
do ll u tium
en a
1 × 1440 Vineyard Large herbivorous mammal 11.1 1.0 × 8.47 5.90

cu nd
his fa or
Application “lagomorph” 0.53
ground directed Brown hare (Lepus europaeus) f t ay ns
r o m co
ne ent he

Vineyard Large herbivorous mammal 6.7 1.0 × 5.11 9.78

ow um of t

BBCH 10 – 19 “lagomorph” 0.53

th oc (s)

Brown hare (Lepus europaeus)

of is d ber
ion , th em

Vineyard Large herbivorous mammal 5.5 1.0 × 4.20 11.9

iss ore m

e
rm m er

BBCH 20 – 39 “lagomorph” 0.53

pe her orm

Brown hare (Lepus europaeus)

he rt t/f
t t Fu en

Vineyard Large herbivorous mammal 3.3 1.0 × 2.52 19.9

ou s. rr
th tie cu

BBCH ≥ 40 “lagomorph” 0.53

wi par (a)

Brown hare (Lepus europaeus)

f
en ird o
nt th rty

Vineyard Small insectivorous mammal “shrew” 4.2 1.0 × 3.21 15.6

co and ope

BBCH 10 – 19 Common shrew (Sorex araneus) 0.53

r

ts
r i er p
t o wn the
en o s

Vineyard Small insectivorous mammal “shrew” 1.9 1.0 × 1.45 34.5

m he t i
cu f t en

ts

BBCH ≥ 20 Common shrew (Sorex araneus) 0.53

do s o um
is ht c
th rig s do

Vineyard Small herbivorous mammal “vole” 72.3 1.0 × 55.2

i

0.91
e op Th

Application Common vole (Microtus arvalis) 0.53

of y

ground directed
us c
d nd

Vineyard Small omnivorous mammal “mouse” 7.8 1.0 × 5.95 8.40

an a
n rty

Application Wood mouse (Apodemus sylvaticus) 0.53

tio e
ta op

ground directed
loi pr
xp al

2 × 1080 Vineyard Large herbivorous mammal 11.1 1.1 × 6.99 7.15

l e ctu

(28 d) Application “lagomorph” 0.53

cia lle
er te

ground directed Brown hare (Lepus europaeus)

m s in
om a

Vineyard Large herbivorous mammal 6.7 1.1 × 4.22 11.9

y c uch

BBCH 10 – 19 “lagomorph” 0.53

an ts s

Brown hare (Lepus europaeus)

an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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It
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cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 125 of 553

ep
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ut
Table 10.1.2- 18: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
dis
of glyphosate in vineyards: Use 5 a-c

n,
er tio
wn lica
Active substance Glyphosate

.
s o ub
Reprod. toxicity 50

f it y p
(mg/kg bw/d)

so n
ht , a
TER criterion 5

rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

th ue
rate × TWA (mg/kg

e eq
e
lat ns
(g a.s./ha) bw/d)

vio . Co
an ime al.
Vineyard Large herbivorous mammal 5.5 1.1 × 3.46 14.4

te reg new
BBCH 20 – 39 “lagomorph” 0.53

oh tio re
Brown hare (Lepus europaeus)

d
pr tec EU
ibi n
d
be ro te
Vineyard Large herbivorous mammal 3.3 1.1 × 2.08 24.1

e ta p osa
BBCH ≥ 40 “lagomorph” 0.53

ef da ph
Brown hare (Lepus europaeus)

er y ly
th tor G
ay ula the
Vineyard Small insectivorous mammal “shrew” 4.2 1.1 × 2.64 18.9

or
t m reg king
BBCH 10 – 19 Common shrew (Sorex araneus) 0.53

m er see
do ll u tium
en a
Vineyard Small insectivorous mammal “shrew” 1.9 1.1 × 1.20 41.8

cu nd
his fa or
BBCH ≥ 20 Common shrew (Sorex araneus) 0.53
f t ay ns
r o m co
ne ent he

Vineyard Small herbivorous mammal “vole” 72.3 1.1 × 45.5 1.10

ow um of t

Application Common vole (Microtus arvalis) 0.53

th oc (s)

ground directed
of is d ber
ion , th em

Vineyard Small omnivorous mammal “mouse” 7.8 1.1 × 4.91 10.2

iss ore m

e
rm m er

Application Wood mouse (Apodemus sylvaticus) 0.53

pe her orm

ground directed
he rt t/f
t t Fu en

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
ou s. rr
th tie cu

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.
wi par (a)
f
en ird o

The Tier 1 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
nt th rty
co and ope

indicating that long-term risk to mammals is acceptable following the proposed use patterns in vineyards
r

(Uses 5 a-c) except for the following scenario where a refined risk assessment is required for all intended
ts
r i er p
t o wn the

application rates:
en o s
m he t i
cu f t en

ts
do s o um

 Vineyards; the small herbivorous mammal “vole” common vole (2 × 1440 g a.s./ha, 1 × 720 g a.s./ha,
is ht c

1 × 1080 g a.s./ha, 2 × 720 g a.s./ha, 3 × 720 g a.s./ha, 1 × 1440 g a.s./ha, 2 × 1080 g a.s./ha).
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 It
an may
d/
or be
pu su
bli bje
sh ct
ing to
an righ
d
an ts s
y c uch
om a
m s in
er te
cia lle
l e ctu
xp al
loi pr
ta op
tio e
n rty
an a
d nd
us c
e op Th
Annex to Regulation 284/2013

of y i
th rig s do
is ht c
do s o um
cu f t en
m he t i
en o s
t o wn the
r i er p

Glyphosate Renewal Group AIR 5 – July 2020

ts r
co and ope
nt th rty
en ird o
ts f
wi par (a)
th tie cu
Railroad tracks – application by spray train

ou s. rr
t t Fu en
he rt t/f
pe her orm
rm m er
iss ore m
ion , th em
of is d ber
MON 52276

th oc (s)
e
ow um of t
ne ent he
r o m co
f t ay ns
his fa or
do ll u tium
cu nd
m er see
en a
t m reg king
ay ula the
th tor G
er y ly
ef da ph
or
e ta p osa
be ro te
pr tec EU
oh tio re
ibi n
te reg new
d
an ime al.
d
vio . Co
lat ns
e eq
th ue
e
rig ntly
ht , a
so n
f it y p
s o ub
wn lica

Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020

Page 126 of 553
M-CP, Section 10

er tio
. n,
dis
trib
ut
ion
,r
ep
ro
du
cti
on
 on
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du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 127 of 553

ep
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Table 10.1.2- 19: Tier 1 assessment of the acute risk for mammals due to the use of glyphosate on

t rib
railroad tracks: Use 7 a-b

dis
n,
er tio
Active substance Glyphosate

wn lica
.
Acute toxicity > 2000

s o ub
f it y p
(mg/kg bw)

so n
TER criterion 10

ht , a
rig ntly
GAP crop Application Crop scenario Generic focal species SV90 MAF9 DDD90 TERa

th ue
rate 0 (mg/kg

e eq
(g a.s./ha) bw/d)

e
lat ns
Railroad 2 × 1800 Grassland Large herbivorous mammal 32.6 1.0 58.7 34.1

vio . Co
an ime al.
te reg new
tracks – (90 d) All season “lagomorph”
application Brown hare (Lepus europaeus)

oh tio re

d
pr tec EU
by spray

ibi n
Grassland Small insectivorous mammal “shrew” 5.4 1.0 9.72 206

d
train. Post

be ro te
e ta p osa
emergence Late Common shrew (Sorex araneus)

ef da ph
of weeds

er y ly
th tor G
(90d apart). Grassland Small herbivorous mammal “vole” 136.4 1.0 246 8.15

ay ula the
All season Common vole (Microtulus arvalis)

or
t m reg king
m er see
Grassland Small omnivorous mammal “mouse” 14.4 1.0 25.9 77.2

do ll u tium
en a
Late season Wood mouse (Apodemus sylvaticus)

cu nd
his fa or
(seed heads) f t ay ns
r o m co
ne ent he

Leafy vegetables Small insectivorous mammal “shrew” 7.6 1.0 13.7 146
ow um of t

BBCH 10 – 19 Commnon shrew (Sorex araneus)

th oc (s)
of is d ber
ion , th em

Leafy vegetables Small insectivorous mammal “shrew” 5.4 1.0 9.72 206
iss ore m

BBCH ≥ 20 Commnon shrew (Sorex araneus)

rm m er
pe her orm
he rt t/f
t t Fu en

Leafy vegetables Small herbivorous mammal “vole” 136.4 1.0 246 8.15
ou s. rr

BBCH 40 – 49 Common vole (Microtulus arvalis)

th tie cu
wi par (a)
f
en ird o

Leafy vegetables Small herbivorous mammal “vole” 40.9 1.0 73.6 27.2
nt th rty
co and ope

BBCH ≥ 50 Common vole (Microtulus arvalis)

r

ts
r i er p
t o wn the

Leafy vegetables Large herbivorous mammal 35.1 1.0 63.2 31.7

en o s
m he t i
cu f t en

All season “lagomorph”

ts
do s o um

Rabbit (Oryctolagus cuniculus)

is ht c
th rig s do

Leafy vegetables Small omnivorous mammal “mouse” 17.2 1.0 31.0 64.6
i
e op Th

BBCH 10 – 49 Wood mouse (Apodemus sylvaticus)

of y
us c
d nd

Leafy vegetables Small omnivorous mammal “mouse” 5.2 1.0 9.36 214
an a

BBCH ≥ 50 Wood mouse (Apodemus sylvaticus)

n rty
tio e
ta op
loi pr

1 × 1800 Grassland Large herbivorous mammal 32.6 1.0 58.7 34.1

xp al
l e ctu

All season “lagomorph”

cia lle

Brown hare (Lepus europaeus)

er te
m s in
om a

Grassland Small insectivorous mammal “shrew” 5.4 1.0 9.72 206

y c uch

Late Common shrew (Sorex araneus)

an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
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ion
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Grassland Small herbivorous mammal “vole” 136.4 1.0 246 8.15

rib
All season Common vole (Microtulus arvalis)

t
dis
n,
er tio
wn lica
Grassland Small omnivorous mammal “mouse” 14.4 1.0 25.9 77.2

.
s o ub
Late season Wood mouse (Apodemus sylvaticus)

f it y p
(seed heads)

so n
ht , a
rig ntly
Leafy vegetables Small insectivorous mammal “shrew” 7.6 1.0 13.7 146

th ue
BBCH 10 – 19 Commnon shrew (Sorex araneus)

e eq
e
lat ns
vio . Co
an ime al.
Leafy vegetables Small insectivorous mammal “shrew” 5.4 1.0 9.72 206

te reg new
BBCH ≥ 20 Commnon shrew (Sorex araneus)

oh tio re

d
pr tec EU
ibi n
d
be ro te
Leafy vegetables Small herbivorous mammal “vole” 136.4 1.0 246 8.15

e ta p osa
BBCH 40 – 49 Common vole (Microtulus arvalis)

ef da ph
er y ly
th tor G
ay ula the
Leafy vegetables Small herbivorous mammal “vole” 40.9 1.0 73.6 27.2

or
t m reg king
BBCH ≥ 50 Common vole (Microtulus arvalis)

m er see
do ll u tium
en a
Leafy vegetables Large herbivorous mammal 35.1 1.0 63.2 31.7

cu nd
his fa or
All season “lagomorph”
f t ay ns
Rabbit (Oryctolagus cuniculus)
r o m co
ne ent he
ow um of t

Leafy vegetables Small omnivorous mammal “mouse” 17.2 1.0 31.0 64.6
BBCH 10 – 49 Wood mouse (Apodemus sylvaticus)
th oc (s)
of is d ber
ion , th em

Leafy vegetables Small omnivorous mammal “mouse” 5.2 1.0 9.36 214
iss ore m

e
rm m er

BBCH ≥ 50 Wood mouse (Apodemus sylvaticus)

pe her orm
he rt t/f
t t Fu en
ou s. rr

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
th tie cu

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.
wi par (a)
f
en ird o
nt th rty

The Tier 1 TERa values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 10,
co and ope

indicating that acute risk to mammals is acceptable following the proposed use patterns on railroad tracks
r

ts
r i er p

(Uses 7a-b) except for the following scenarios where a refined risk assessment is required for all intended
t o wn the

application rates:
en o s
m he t i
cu f t en

ts
do s o um

 Grassland; the small herbivorous mammal “vole” common vole (2 × 1800 g a.s./ha, 1 × 1800 g
is ht c
th rig s do

a.s./ha).
i

 Leafy vegetables; the small herbivorous mammal “vole” common vole (2 × 1800 g a.s./ha, 1 × 1800
e op Th

g a.s./ha).
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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ep
,r
ion
ut
Table 10.1.2- 20: Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate on railroad tracks: Use 7 a-b

dis
n,
er tio
Active substance Glyphosate

wn lica
.
Reprod. toxicity 50

s o ub
f it y p
(mg/kg bw/d)

so n
TER criterion 5

ht , a
rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

th ue
rate × TWA (mg/kg

e eq
(g a.s./ha) bw/d)

e
lat ns
Railroad 2 × 1800 Grassland Large herbivorous mammal 17.3 1.0 × 16.5

vio . Co
3.03

an ime al.
te reg new
tracks – (90 d) All season “lagomorph” 0.53
application Brown hare (Lepus europaeus)

oh tio re

d
pr tec EU
by spray

ibi n
Grassland Small insectivorous mammal “shrew” 1.9 1.0 × 1.81 27.6

d
train. Post

be ro te
e ta p osa
emergence Late Common shrew (Sorex araneus) 0.53

ef da ph
of weeds

er y ly
th tor G
(90d apart). Grassland Small herbivorous mammal “vole” 72.3 1.0 × 69.0 0.720

ay ula the
All season Common vole (Microtulus arvalis) 0.53

or
t m reg king
m er see
Grassland Small omnivorous mammal “mouse” 6.6 1.0 × 6.30 7.94

do ll u tium
en a
Late season Wood mouse (Apodemus sylvaticus) 0.53

cu nd
his fa or
(seed heads) f t ay ns
r o m co
ne ent he

Leafy vegetables Small insectivorous mammal “shrew” 4.2 1.0 × 4.01 12.5
ow um of t

BBCH 10 – 19 Commnon shrew (Sorex araneus) 0.53

th oc (s)
of is d ber
ion , th em

Leafy vegetables Small insectivorous mammal “shrew” 1.9 1.0 × 1.81 27.6
iss ore m

BBCH ≥ 20 Commnon shrew (Sorex araneus) 0.53

rm m er
pe her orm
he rt t/f
t t Fu en

Leafy vegetables Small herbivorous mammal “vole” 72.3 1.0 × 69.0 0.720
ou s. rr

BBCH 40 – 49 Common vole (Microtulus arvalis) 0.53

th tie cu
wi par (a)
f
en ird o

Leafy vegetables Small herbivorous mammal “vole” 21.7 1.0 × 20.7

nt th rty

2.42
co and ope

BBCH ≥ 50 Common vole (Microtulus arvalis) 0.53

r

ts
r i er p
t o wn the

Leafy vegetables Large herbivorous mammal 14.3 1.0 × 13.6

en o s

3.67
m he t i
cu f t en

All season “lagomorph” 0.53

ts
do s o um

Rabbit (Oryctolagus cuniculus)

is ht c
th rig s do

Leafy vegetables Small omnivorous mammal “mouse” 7.8 1.0 × 7.44 6.72
i
e op Th

BBCH 10 – 49 Wood mouse (Apodemus sylvaticus) 0.53

of y
us c
d nd

Leafy vegetables Small omnivorous mammal “mouse” 2.3 1.0 × 2.19 22.8
an a

BBCH ≥ 50 Wood mouse (Apodemus sylvaticus) 0.53

n rty
tio e
ta op
loi pr

1 × 1800 Grassland Large herbivorous mammal 17.3 1.0 × 16.5

xp al

3.03
l e ctu

All season “lagomorph” 0.53

cia lle

Brown hare (Lepus europaeus)

er te
m s in
om a

Grassland Small insectivorous mammal “shrew” 1.9 1.0 × 1.81 27.6

y c uch

Late Common shrew (Sorex araneus) 0.53

an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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ep
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ut
Grassland Small herbivorous mammal “vole” 72.3 1.0 × 69.0 0.720

rib
All season Common vole (Microtulus arvalis) 0.53

t
dis
n,
er tio
wn lica
Grassland Small omnivorous mammal “mouse” 6.6 1.0 × 6.30 7.94

.
s o ub
Late season Wood mouse (Apodemus sylvaticus) 0.53

f it y p
(seed heads)

so n
ht , a
rig ntly
Leafy vegetables Small insectivorous mammal “shrew” 4.2 1.0 × 4.01 12.5

th ue
BBCH 10 – 19 Commnon shrew (Sorex araneus) 0.53

e eq
e
lat ns
vio . Co
an ime al.
Leafy vegetables Small insectivorous mammal “shrew” 1.9 1.0 × 1.81 27.6

te reg new
BBCH ≥ 20 Commnon shrew (Sorex araneus) 0.53

oh tio re

d
pr tec EU
ibi n
d
be ro te
Leafy vegetables Small herbivorous mammal “vole” 72.3 1.0 × 69.0 0.720

e ta p osa
BBCH 40 – 49 Common vole (Microtulus arvalis) 0.53

ef da ph
er y ly
th tor G
ay ula the
Leafy vegetables Small herbivorous mammal “vole” 21.7 1.0 × 20.7 2.42

or
t m reg king
BBCH ≥ 50 Common vole (Microtulus arvalis) 0.53

m er see
do ll u tium
en a
Leafy vegetables Large herbivorous mammal 14.3 1.0 × 13.6 3.67

cu nd
his fa or
All season “lagomorph” 0.53
f t ay ns
Rabbit (Oryctolagus cuniculus)
r o m co
ne ent he
ow um of t

Leafy vegetables Small omnivorous mammal “mouse” 7.8 1.0 × 7.44 6.72
BBCH 10 – 49 Wood mouse (Apodemus sylvaticus) 0.53
th oc (s)
of is d ber
ion , th em

Leafy vegetables Small omnivorous mammal “mouse” 2.3 1.0 × 2.19 22.8
iss ore m

e
rm m er

BBCH ≥ 50 Wood mouse (Apodemus sylvaticus) 0.53

pe her orm
he rt t/f
t t Fu en
ou s. rr

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
th tie cu

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.
wi par (a)
f
en ird o
nt th rty

The Tier 1 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
co and ope

indicating that long-term risk to mammals is acceptable following the proposed use patterns on railroad
r

ts
r i er p

tracks (Uses 7 a-b) except for the following scenarios where a refined risk assessment is required for all
t o wn the

intended application rates:

en o s
m he t i
cu f t en

ts
do s o um

 Grassland; the large herbivorous mammal “lagomorph” brown hare (2 × 1800 g a.s./ha,
is ht c
th rig s do

1 × 1800 g a.s./ha).
i

 Grassland; the small herbivorous mammal “vole” common vole (2 × 1800 g a.s./ha, 1 × 1800 g
e op Th

a.s./ha).
of y

 Leafy vegetables; the small herbivorous mammal “vole” common vole (2 × 1800 g a.s./ha,
us c
d nd

1 × 1800 g a.s./ha).
an a
n rty

 Leafy vegetables: the large herbivorous mammal “lagomorph” rabbit (2 × 1800 g a.s./ha,
tio e
ta op

1 × 1800 g a.s./ha).
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
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Page 131 of 553

ep
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ion
ut
Control of invasive species

t rib
dis
Table 10.1.2- 21: Tier 1 assessment of the acute risk for mammals due to the use of glyphosate on

n,
invasive species in agricultural and non-agricultural areas: Uses 8, 9

er tio
wn lica
.
s o ub
Active substance Glyphosate

f it y p
Acute toxicity > 2000

so n
ht , a
(mg/kg bw)

rig ntly
TER criterion 10

th ue
e eq
GAP crop Application Crop scenario Generic focal species SV90 MAF9 DDD90 TERa

e
lat ns
rate 0 (mg/kg

vio . Co
an ime al.
(g a.s./ha) bw/d)

te reg new
Invasive 1 × 1800 Bulbs & onion Small insectivorous mammal “shrew” 7.6 1.0 13.7 146

oh tio re

d
species in like crops Common shrew (Sorex araneus)

pr tec EU
ibi n
agricultural BBCH 10 – 19

d
be ro te
e ta p osa
and non-
agricultural Bulbs & onion Small omnivorous mammal “mouse” 17.2 1.0 31.0 64.6

ef da ph
like crops Wood mouse (Apodemus sylvaticus)

er y ly
areas. Post

th tor G
BBCH 10 – 39

ay ula the
emergence

or
of invasive

t m reg king
Cereals Large herbivorous mammal 42.1 1.0 75.8 26.4
species.

m er see
Early (shoots) “lagomorph”
Rabbit (Oryctolagus cuniculus)

do ll u tium
en a
cu nd
his fa or
Fruiting Small herbivorous mammal “vole” 136.4 1.0 246 8.15
f t ay ns
r o m co
vegetables Common vole (Microtus arvalis)
ne ent he

BBCH 10 – 49
ow um of t
th oc (s)

SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values
of is d ber

shown in bold fall below the relevant trigger.

ion , th em
iss ore m

The Tier 1 TERa values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 10,
rm m er
pe her orm

indicating that acute risk to mammals is acceptable following the proposed use patterns on invasive species
he rt t/f

(Uses 8 and 9) except for the following scenario where a refined risk assessment is required for the intended
t t Fu en
ou s. rr

application rates:
th tie cu
wi par (a)

 Fruiting vegetables; the small herbivorous mammal “vole” common vole (1 × 1800 g a.s./ha).
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
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du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 132 of 553

ep
,r
ion
ut
t rib
dis
Table 10.1.2- 22:Tier 1 assessment of the long-term/reproductive risk for mammals due to the use

n,
of glyphosate on invasive species in agricultural and non-agricultural areas: Uses 8, 9

er tio
wn lica
.
s o ub
Active substance Glyphosate

f it y p
Reprod. toxicity 50

so n
ht , a
(mg/kg bw/d)

rig ntly
TER criterion 5

th ue
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

e eq
e
lat ns
rate × TWA (mg/kg

vio . Co
an ime al.
(g a.s./ha) bw/d)

te reg new
Invasive 1 × 1800 Bulbs & onion Small insectivorous mammal “shrew” 4.2 1.0 × 4.01 12.5

oh tio re
species in like crops Common shrew (Sorex araneus) 0.53

d
pr tec EU
agricultural BBCH 10 – 19

ibi n
d
be ro te
and non-

e ta p osa
agricultural Bulbs & onion Small omnivorous mammal “mouse” 7.8 1.0 × 7.44 6.70

ef da ph
areas. Post like crops Wood mouse (Apodemus sylvaticus) 0.53

er y ly
th tor G
emergence BBCH 10 – 39

ay ula the
of invasive

or
t m reg king
Cereals Large herbivorous mammal 22.3 1.0 × 21.3 2.40
species. Early (shoots) “lagomorph” 0.53

m er see
Rabbit (Oryctolagus cuniculus)

do ll u tium
en a
cu nd
Fruiting Small herbivorous mammal “vole”
his fa or
72.3 1.0 × 69.0 0.725
vegetables f t ay ns
Common vole (Microtus arvalis) 0.53
r o m co

BBCH 10 – 49
ne ent he
ow um of t

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
th oc (s)
of is d ber

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.
ion , th em
iss ore m

The Tier 1 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
rm m er
pe her orm

indicating that long-term risk to mammals is acceptable following the proposed use patterns on invasive
he rt t/f

species (Uses 8 and 9) except for the following scenarios where a refined risk assessment is required for
t t Fu en

the intended application rate:

ou s. rr
th tie cu
wi par (a)

 Cereals; the large herbivorous mammal “lagomorph” rabbit (1 × 1800 g a.s./ha).

f
en ird o
nt th rty

 Fruiting vegetables; the small herbivorous mammal “vole” common vole (1 × 1800 g a.s./ha).
co and ope
r

ts
r i er p
t o wn the

Higher tier assessment (Tier 2)

en o s
m he t i
cu f t en

ts

Acute and long-term Tier 2 exposure was calculated for those intended uses, for which the Tier 1 risk
do s o um

assessment indicates the need for a refined acute or long-term risk assessment. As indicated in the
is ht c
th rig s do

tables above further refinements are needed for herbivorous mammals, i.e. the small herbivorous
i
e op Th

mammal “vole” and the large herbivorous mammal “lagomorph” (hare, rabbit).
of y
us c

Refinement of TWA and MAF based on glyphosate residue decline on grass

d nd
an a
n rty

In Tier 2, TWA and MAF values for glyphosate can be refined based on measured residues on grass foliage.
tio e
ta op
loi pr

The methodology used to calculate the TWA for glyphosate on grass foliage for the long-term risk
xp al
l e ctu

assessment follows the procedure described in the Guidance Document on Terrestrial Ecotoxicology
cia lle
er te

(2002). According to the approach outlined in the Guidance Document on Terrestrial Ecotoxicology, the
m s in

dissipation of glyphosate in grass was estimated using the standard first-order dissipation model:
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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ep
,r
ion
Ct =Ci × e –kt

ut
t rib
dis
k = first order rate constant

n,
er tio
Ci = initial residue concentration

wn lica
Ct = residue concentration at time t

.
s o ub
f it y p
The decline of glyphosate residue on grass was characterized using data from 22 residue trials each of which

so n
ht , a
had a day 0 value. Based on this data, the k value for grass foliage was calculated to be 0.2476 days-1

rig ntly
(Renewal Assessment Report for glyphosate, 29 January 2015, Volume 3, Annex B.9, B.9.13). For

th ue
e eq
convenience these calculations are reproduced without change, in Annex M-CP 10-02 to this document.

e
lat ns
vio . Co
an ime al.
Residue half-life times (DT50) in days were calculated with following equation:

te reg new
oh tio re

d
pr tec EU
 ln 0.5

ibi n
d
DT50 

be ro te
e ta p osa
k

ef da ph
er y ly
The average DT50 for grass foliage was 2.8 days.

th tor G
ay ula the

or
t m reg king
The 21-day time weighted average (TWA) for glyphosate on grass foliage has been calculated according

m er see
to the following formula:

do ll u tium
en a
cu nd
-kt

his fa or
 1- e 
TWA  f t ay ns
r o m co
kt
ne ent he
ow um of t

The 21-day TWA is calculated to be 0.19 for the active substance glyphosate acid and grass. For the refined
th oc (s)

risk assessment this value is applied for the small herbivorous mammal “vole” Common vole (Microtus
of is d ber

arvalis), the large herbivorous mammal “lagomorph” Brown hare (Lepus europaeus) and the large
ion , th em
iss ore m

herbivorous mammal “lagomorph” Rabbit (Oryctolagus cuniculus). Although the calculated 21-day TWA
e
rm m er

of 0.19 is based on residue decline on “grass” it is considered to be valid for “non-grass herbs” as well. This
pe her orm

assumption can be supported by Ebeling & Wang (2018)13, who evaluated the residue dissipation of 30
he rt t/f
t t Fu en

active substances (including glyphosate) on grasses / cereals (177 trials) and non-grass herbs (101 trials).
ou s. rr
th tie cu

No significant difference between residue dissipation on grasses / cereals and non-grass herbs was found.
wi par (a)

In addition also in the EFSA Conclusion for glyphosate (2015)14 (EFSA Journal 2015;13(11):4302) the 21-
f
en ird o

day TWA of 0.19 was applied to refine the risk for the large herbivorous mammal “lagomorph” Rabbit
nt th rty
co and ope

(Oryctolagus cuniculus) feeding on “Non-grass herbs” (Diet according to Appendix A of

r

EFSA/2009/1438).
ts
r i er p
t o wn the
en o s
m he t i

In addition, MAF90 and MAFm values for the application intervals of 28 and 90 days and based on the
cu f t en

ts

measured foliar half-life were calculated using the formula in Appendix H of EFSA/2009/1438. Resulting
do s o um
is ht c

MAF values for two and three applications are presented in the following table.
th rig s do
i
e op Th

Table 10.1.2- 23: MAF90, MAFm and MAFm × TWA values based on a measured foliar DT50 of 2.8
of y

days
us c
d nd

Number of Application Measured foliar MAF90 MAFm MAFm × TWA

an a
n rty

applications interval (d) DT50 (d)

tio e
ta op

2 28 2.8 1.00 1.00 0.19

loi pr

3 28 2.8 1.00 1.00 0.19

xp al
l e ctu

2 90 2.8 1.00 1.00 0.19

cia lle
er te
m s in
om a
y c uch

13
Ebeling, M., Wang, M. Dissipation of Plant Protection Products from Foliage. Environmental Toxicology and
an ts s

Chemistry (2018). Wiley Online Library.

an righ

14
Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate (2015).
d
ing to

European Food Safety Authority (EFSA), Parma, Italy.

sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Page 134 of 553

ep
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ut
t rib
Refined endpoints

dis
At Tier 2, a refined endpoint of 3694.1 mg/kg bw is used for the acute risk assessment and a refined

n,
er tio
endpoint of 100 mg/kg bw/d for the chronic risk assessment. Detailed justifications for the acute and

wn lica
.
chronic Tier 2 endpoints are presented in Annex M-CA 8.02 of the document M-CA Section 8.

s o ub
f it y p
so n
Field crops

ht , a
rig ntly
Table 10.1.2- 24: Tier 2 assessment of the long-term/reproductive risk for mammals due to the use

th ue
e eq
of glyphosate in field crops (Pre-sowing, pre-planting, pre-emergence): Use 1 a-c

e
lat ns
vio . Co
an ime al.
te reg new
Active substance Glyphosate
Reprod. toxicity 100

oh tio re

d
pr tec EU
(mg/kg bw/d)

ibi n
d
be ro te
TER criterion 5

e ta p osa
GAP crop Application Crop Generic focal species SVm MAFm DDDm TERlt

ef da ph
rate scenario × (mg/kg bw/d)

er y ly
th tor G
(g a.s./ha) TWA

ay ula the
Field crops 1 × 1440 Grassland Large herbivorous mammal 17.3 1.0 × 4.73 21.1

or
t m reg king
(Pre-sowing, All season “lagomorph” 0.19

m er see
pre-planting, Brown hare (Lepus europaeus)

do ll u tium
pre-

en a
emergence) Grassland Small herbivorous mammal “vole” 72.3 1.0 × 19.8 5.06

cu nd
his fa or
All season Common vole (Microtus arvalis) 0.19
f t ay ns
r o m co

Leafy Small herbivorous mammal “vole” 72.3 1.0 × 19.8 5.06

ne ent he
ow um of t

vegetables Common vole (Microtus arvalis) 0.19

th oc (s)

BBCH 40 –
of is d ber

49
ion , th em

Leafy Small herbivorous mammal “vole” 21.7 1.0 × 5.94 16.8

iss ore m

vegetables Common vole (Microtus arvalis) 0.19

e
rm m er

BBCH ≥ 50
pe her orm
he rt t/f

Leafy Large herbivorous mammal 14.3 1.0 × 3.91 25.6

t t Fu en
ou s. rr

vegetables “lagomorph” 0.19

th tie cu

All season Rabbit (Oryctolagus cuniculus)

wi par (a)
f
en ird o

1 × 1080 Grassland Small herbivorous mammal “vole” 72.3 1.0 × 14.8 6.74
nt th rty
co and ope

All season Common vole (Microtus arvalis) 0.19

r

ts
r i er p

Leafy Small herbivorous mammal “vole” 72.3 1.0 × 14.8 6.74

t o wn the

vegetables Common vole (Microtus arvalis) 0.19

en o s
m he t i

BBCH 40 –
cu f t en

ts
do s o um

49
Leafy Small herbivorous mammal “vole” 21.7 1.0 × 4.45 22.5
is ht c
th rig s do

vegetables Common vole (Microtus arvalis) 0.19

i
e op Th

BBCH ≥ 50
of y

1 × 720 Grassland Small herbivorous mammal “vole” 72.3 1.0 × 9.89 10.1
us c

All season Common vole (Microtus arvalis) 0.19

d nd
an a
n rty
tio e
ta op

Leafy Small herbivorous mammal “vole” 72.3 1.0 × 9.89 10.1

loi pr

vegetables Common vole (Microtus arvalis) 0.19

xp al
l e ctu

BBCH 40 –
cia lle

49
er te
m s in

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.
om a
y c uch
an ts s

The Tier 2 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
an righ

indicating that long-term risk to mammals is acceptable following the proposed use patterns in field crops
d
ing to

(Pre-sowing, pre-planting, pre-emergence, Uses 1 a-c).

sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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t rib
Table 10.1.2- 25: Tier 2 assessment of the long-term/reproductive risk for mammals due to the use

dis
of glyphosate in field crops (Post-harvest, pre-sowing, pre-planting): Use 2 a-c, 3 a-b, 10 a-c

n,
er tio
wn lica
.
Active substance Glyphosate

s o ub
f it y p
Reprod. toxicity 100

so n
(mg/kg bw/d)

ht , a
rig ntly
TER criterion 5

th ue
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

e eq
rate × (mg/kg bw/d)

e
lat ns
vio . Co
(g a.s./ha) TWA

an ime al.
te reg new
Field crops 1 × 1440 Grassland Large herbivorous mammal 17.3 1.0 × 4.73 21.1
(Post- All season “lagomorph” 0.19

oh tio re

d
pr tec EU
harvest, Brown hare (Lepus europaeus)

ibi n
d
be ro te
pre-sowing,

e ta p osa
pre- Grassland Small herbivorous mammal “vole” 72.3 1.0 × 19.8 5.06

ef da ph
planting) All season Common vole (Microtus arvalis) 0.19

er y ly
th tor G
ay ula the

or
2 × 1080 Grassland Large herbivorous mammal 17.3 1.0 × 3.55 28.2

t m reg king
(28 d) All season “lagomorph” 0.19

m er see
Brown hare (Lepus europaeus)

do ll u tium
en a
Grassland Small herbivorous mammal “vole” 72.3 1.0 × 14.8 6.74

cu nd
his fa or
All season Common vole (Microtus arvalis) f t ay ns 0.19
r o m co
ne ent he
ow um of t

1 × 540 Grassland Small herbivorous mammal “vole” 72.3 1.0 × 7.42 13.5
th oc (s)

All season Common vole (Microtus arvalis) 0.19

of is d ber
ion , th em
iss ore m

1 × 720 Grassland Small herbivorous mammal “vole” 72.3 1.0 × 9.89 10.1
rm m er
pe her orm

All season Common vole (Microtus arvalis) 0.19

he rt t/f
t t Fu en
ou s. rr

2 × 720 Grassland Small herbivorous mammal “vole” 72.3 1.0 × 9.89 10.1
th tie cu
wi par (a)

(28 d) All season Common vole (Microtus arvalis) 0.19

f
en ird o
nt th rty
co and ope

1 × 1080 Grassland Small herbivorous mammal “vole” 72.3 1.0 × 14.8 6.74
r

All season Common vole (Microtus arvalis) 0.19

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts

3 × 720 Grassland Small herbivorous mammal “vole” 72.3 1.0 × 9.89 10.1
do s o um

(28 d) All season Common vole (Microtus arvalis) 0.19

is ht c
th rig s do
i
e op Th

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
of y

toxicity to exposure ratio.

us c
d nd
an a

The Tier 2 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
n rty

indicating that long-term risk to mammals is acceptable following the proposed use patterns in field crops
tio e
ta op

(Post-harvest, pre-sowing, pre-planting, Uses 2 a-c, 3 a-b and 10 a-c).

loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Table 10.1.2- 26: Tier 2 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate in field crops (Shielded ground directed inter-row application): Use 6 a-b

dis
n,
er tio
Active substance Glyphosate

wn lica
.
Reprod. toxicity 100

s o ub
f it y p
(mg/kg bw/d)

so n
TER criterion 5

ht , a
rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

th ue
rate × (mg/kg bw/d)

e eq
(g a.s./ha) TWA

e
lat ns
Field crops 1 × 1080 Fruiting Small herbivorous mammal “vole” 72.3 1.0 × 14.8 6.74

vio . Co
an ime al.
te reg new
(Shielded vegetables Common vole (Microtus arvalis) 0.19
ground BBCH 10 – 49

oh tio re

d
pr tec EU
inter-row

ibi n
application) 1 × 720 Fruiting Small herbivorous mammal “vole” 72.3 1.0 × 9.89 10.1

d
be ro te
e ta p osa
vegetables Common vole (Microtus arvalis) 0.19
BBCH 10 – 49

ef da ph
er y ly
th tor G
ay ula the
SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:

or
toxicity to exposure ratio.

t m reg king
m er see
The Tier 2 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,

do ll u tium
en a
indicating that long-term risk to mammals is acceptable following the proposed use patterns in field crops

cu nd
his fa or
(Uses 6 a-b); shielded ground directed inter-row application. f t ay ns
r o m co
ne ent he
ow um of t

Orchards
th oc (s)
of is d ber
ion , th em

Table 10.1.2- 27: Tier 2 assessment of the acute risk for mammals due to the use of glyphosate in
iss ore m

orchards: Uses: 4 a-c

rm m er
pe her orm
he rt t/f

Active substance Glyphosate

t t Fu en

3694.1
ou s. rr

Acute toxicity
th tie cu

(mg/kg bw)
wi par (a)

TER criterion 10
f
en ird o
nt th rty

GAP crop Application Crop scenario Generic focal species SV90 MAF90 DDD90 TERa
co and ope

rate (mg/kg bw/d)

r

ts
r i er p

(g a.s./ha)
t o wn the

Orchard 2 × 1440 Orchards Small herbivorous mammal 136.4 1.0 196 18.8
en o s
m he t i

Post- (28 d) Application “vole”

cu f t en

ts

emergence crop directed Common vole (Microtus arvalis)

do s o um

of weeds BBCH < 10 or

is ht c
th rig s do

not crop
i
e op Th

SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio.
of y
us c

The Tier 2 TERa value is greater than the Commission Regulation (EU) No. 546/2011 trigger of 10,
d nd
an a

indicating that acute risk to mammals is acceptable following the proposed use patterns in orchards.
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Table 10.1.2- 28: Tier 2 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate in orchards: Uses: 4 a-c

dis
Active substance Glyphosate

n,
er tio
Reprod. toxicity 100

wn lica
.
(mg/kg bw/d)

s o ub
5

f it y p
TER criterion

so n
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

ht , a
rig ntly
rate × (mg/kg

th ue
(g a.s./ha) TWA bw/d)

e eq
Orchard 2 × 1440 Orchards Small herbivorous mammal 72.3 1.0 × 19.8 5.06

e
lat ns
Post-emergence (28 d) Application crop “vole” 0.19

vio . Co
an ime al.
of weeds directed BBCH Common vole (Microtus arvalis)

te reg new
< 10 or not crop

oh tio re

d
directed

pr tec EU
ibi n
d
Orchards Large herbivorous mammal 14.3 1.0 × 3.91 25.6

be ro te
e ta p osa
Application crop “lagomorph” 0.19

ef da ph
directed BBCH Rabbit (Oryctolagus cuniculus)

er y ly
th tor G
< 10 or not crop

ay ula the
directed

or
t m reg king
1 × 720 Orchards Small herbivorous mammal 72.3 1.0 × 9.89 10.1

m er see
Application crop “vole” 0.19
directed BBCH Common vole (Microtus arvalis)

do ll u tium
en a
< 10 or not crop

cu nd
his fa or
directed f t ay ns
r o m co
1 × 1080 Orchards Small herbivorous mammal 72.3 1.0 × 14.8 6.74
ne ent he

Application crop “vole” 0.19

ow um of t

directed BBCH Common vole (Microtus arvalis)

th oc (s)

< 10 or not crop

of is d ber

directed
ion , th em

2 × 720 Orchards Small herbivorous mammal 72.3 1.0 × 9.89 10.1

iss ore m

e
rm m er

(28 d) Application crop “vole” 0.19

pe her orm

directed BBCH Common vole (Microtus arvalis)

he rt t/f

< 10 or not crop

t t Fu en
ou s. rr

directed
th tie cu

3 × 720 Orchards Small herbivorous mammal 72.3 1.0 × 9.89 10.1

wi par (a)

(28 d) Application crop “vole” 0.19

f
en ird o
nt th rty

directed BBCH Common vole (Microtus arvalis)

co and ope

< 10 or not crop

r

ts
r i er p

directed
t o wn the

1 × 1440 Orchards Small herbivorous mammal 72.3 1.0 × 19.8 5.06

en o s
m he t i

Application crop “vole” 0.19

cu f t en

ts

directed BBCH Common vole (Microtus arvalis)

do s o um

< 10 or not crop

is ht c
th rig s do

directed
i
e op Th

Orchards Large herbivorous mammal 14.3 1.0 × 3.91 25.6

Application crop “lagomorph” 0.19
of y

directed BBCH Rabbit (Oryctolagus cuniculus)

us c
d nd

< 10 or not crop

an a
n rty

directed
tio e
ta op

2 × 1080 Orchards Small herbivorous mammal 72.3 1.0 × 14.8 6.74

loi pr

(28 d) Application crop “vole” 0.19

xp al

directed BBCH Common vole (Microtus arvalis)

l e ctu
cia lle

< 10 or not crop

er te

directed
m s in
om a

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
y c uch

toxicity to exposure ratio.

an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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The Tier 2 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,

rib
indicating that long-term risk to mammals is acceptable following the proposed use patterns in orchards

t
dis
(Uses 4 a-c).

n,
er tio
wn lica
.
Vineyards

s o ub
f it y p
so n
ht , a
Table 10.1.2- 29: Tier 2 assessment of the acute risk for mammals due to the use of glyphosate in

rig ntly
vineyards: Uses 5 a-c

th ue
e eq
e
lat ns
Active substance Glyphosate

vio . Co
an ime al.
Acute toxicity 3694.1

te reg new
(mg/kg bw)

oh tio re
TER criterion 10

d
pr tec EU
ibi n
GAP crop Application Crop scenario Generic focal species SV90 MAF90 DDD90 TERa

d
be ro te
e ta p osa
rate (mg/kg
(g a.s./ha) bw/d)

ef da ph
er y ly
Vineyard 2 × 1440 Vineyard Small herbivorous mammal “vole” 136.4 1.0 196 18.8

th tor G
Post- (28 d) Application Common vole (Microtus arvalis)

ay ula the

or
emergence ground directed

t m reg king
of weeds

m er see
SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio.

do ll u tium
en a
cu nd
his fa or
The Tier 2 TERa value is greater than the Commission Regulation (EU) No. 546/2011 trigger of 10, f t ay ns
r o m co

indicating that acute risk to mammals is acceptable following the proposed use patterns in vineyards.
ne ent he
ow um of t
th oc (s)
of is d ber
ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
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Table 10.1.2- 30: Tier 2 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate in vineyards: Use 5 a-c

dis
n,
er tio
Active substance Glyphosate

wn lica
.
Reprod. toxicity 100

s o ub
f it y p
(mg/kg bw/d)

so n
TER criterion 5

ht , a
rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

th ue
rate × (mg/kg

e eq
(g a.s./ha) TWA bw/d)

e
lat ns
Vineyard 2 × 1440 Vineyard Small herbivorous mammal “vole” 72.3 1.0 × 19.8 5.06

vio . Co
an ime al.
te reg new
Post- (28 d) Application Common vole (Microtus arvalis) 0.19
emergence ground directed

oh tio re

d
pr tec EU
of weeds

ibi n
d
be ro te
1 × 720 Vineyard Small herbivorous mammal “vole” 72.3 1.0 × 9.89 10.1

e ta p osa
Application Common vole (Microtus arvalis) 0.19

ef da ph
ground directed

er y ly
th tor G
ay ula the

or
1 × 1080 Vineyard Small herbivorous mammal “vole” 72.3 1.0 × 14.8 6.74

t m reg king
Application Common vole (Microtus arvalis) 0.19

m er see
ground directed

do ll u tium
en a
cu nd
his fa or
2 × 720 Vineyard Small herbivorous mammal “vole” f t ay ns
r o m co 72.3 1.0 × 9.89 10.1
(28 d) Application Common vole (Microtus arvalis) 0.19
ne ent he

ground directed
ow um of t
th oc (s)

3 × 720 Vineyard Small herbivorous mammal “vole” 72.3 1.0 × 9.89 5.06
of is d ber
ion , th em

(28 d) Application Common vole (Microtus arvalis) 0.19

iss ore m

ground directed
e
rm m er
pe her orm

1 × 1440 Vineyard Small herbivorous mammal “vole” 72.3 1.0 × 19.8 5.06
he rt t/f
t t Fu en

Application Common vole (Microtus arvalis) 0.19

ou s. rr
th tie cu

ground directed
wi par (a)
f
en ird o

2 × 1080 Vineyard Small herbivorous mammal “vole” 72.3 1.0 × 14.8 6.74
nt th rty
co and ope

(28 d) Application Common vole (Microtus arvalis) 0.19

r

ground directed
ts
r i er p
t o wn the
en o s
m he t i

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
cu f t en

ts
do s o um

toxicity to exposure ratio.

is ht c
th rig s do
i

The Tier 2 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
e op Th

indicating that long-term risk to mammals is acceptable following the proposed use patterns in vineyards
of y

(Uses 5 a-c).
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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ep
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Railroad tracks – application by spray train

t rib
dis
Table 10.1.2- 31: Tier 2 assessment of the acute risk for mammals due to the use of glyphosate on

n,
railroad tracks: Use 7 a-b

er tio
wn lica
.
s o ub
Active substance Glyphosate

f it y p
Acute toxicity 3694.1

so n
ht , a
(mg/kg bw)

rig ntly
TER criterion 10

th ue
e eq
GAP crop Application Crop scenario Generic focal species SV90 MAF90 DDD90 TERa

e
lat ns
rate (mg/kg

vio . Co
an ime al.
(g a.s./ha) bw/d)

te reg new
Railroad 2 × 1800 Grassland Small herbivorous mammal “vole” 136.4 1.0 246 15.0

oh tio re

d
tracks – (90 d) All season Common vole (Microtulus arvalis)

pr tec EU
ibi n
application

d
be ro te
by spray

e ta p osa
train. Post

ef da ph
Leafy vegetables Small herbivorous mammal “vole” 136.4 1.0 246 15.0

er y ly
emergence BBCH 40 – 49 Common vole (Microtulus arvalis)

th tor G
of weeds

ay ula the

or
(90d apart).

t m reg king
m er see
1 × 1800 Grassland Small herbivorous mammal “vole” 136.4 1.0 246 15.0

do ll u tium
en a
All season Common vole (Microtulus arvalis)

cu nd
his fa or
f t ay ns
r o m co

Leafy vegetables Small herbivorous mammal “vole” 136.4 1.0 246 15.0
ne ent he
ow um of t

BBCH 40 – 49 Common vole (Microtulus arvalis)

th oc (s)
of is d ber
ion , th em

SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio.
iss ore m

e
rm m er
pe her orm

The Tier 2 TERa values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 10,
he rt t/f
t t Fu en

indicating that acute risk to mammals is acceptable following the proposed use patterns on railroad tracks.
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 141 of 553

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Table 10.1.2- 32: Tier 2 assessment of the long-term/reproductive risk for mammals due to the use

t rib
of glyphosate on railroad tracks: Use 7 a-b

dis
n,
er tio
Active substance Glyphosate

wn lica
.
Reprod. toxicity 100

s o ub
f it y p
(mg/kg bw/d)

so n
TER criterion 5

ht , a
rig ntly
GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt

th ue
rate × TWA (mg/kg

e eq
(g a.s./ha) bw/d)

e
lat ns
Railroad 2 × 1800 Grassland Large herbivorous mammal 17.3 1.0 × 5.92 16.9

vio . Co
an ime al.
te reg new
tracks – (90 d) All season “lagomorph” 0.19
application Brown hare (Lepus europaeus)

oh tio re

d
pr tec EU
by spray

ibi n
Grassland Small herbivorous mammal “vole” 72.3 1.0 × 24.7 4.04

d
train. Post

be ro te
e ta p osa
emergence All season Common vole (Microtulus arvalis) 0.19

ef da ph
of weeds

er y ly
th tor G
(90d apart). Leafy vegetables Small herbivorous mammal “vole” 72.3 1.0 × 24.7 4.04

ay ula the
BBCH 40 – 49 Common vole (Microtulus arvalis) 0.19

or
t m reg king
m er see
Leafy vegetables Small herbivorous mammal “vole” 21.7 1.0 × 7.42 13.5

do ll u tium
en a
BBCH ≥ 50 Common vole (Microtulus arvalis) 0.19

cu nd
his fa or
f t ay ns
r o m co
ne ent he

Leafy vegetables Large herbivorous mammal 14.3 1.0 × 4.89 20.5

ow um of t

All season “lagomorph” 0.19

th oc (s)

Rabbit (Oryctolagus cuniculus)

of is d ber
ion , th em

1 × 1800 Grassland Large herbivorous mammal 17.3 1.0 × 5.92 16.9

iss ore m

All season “lagomorph” 0.19

rm m er
pe her orm

Brown hare (Lepus europaeus)

he rt t/f
t t Fu en

Grassland Small herbivorous mammal “vole” 72.3 1.0 × 24.7 4.04

ou s. rr

All season Common vole (Microtulus arvalis) 0.19

th tie cu
wi par (a)
f
en ird o

Leafy vegetables Small herbivorous mammal “vole” 72.3 1.0 × 24.7

nt th rty

4.04
co and ope

BBCH 40 – 49 Common vole (Microtulus arvalis) 0.19

r

ts
r i er p
t o wn the

Leafy vegetables Small herbivorous mammal “vole” 21.7 1.0 × 7.42 13.5
en o s
m he t i
cu f t en

BBCH ≥ 50 Common vole (Microtulus arvalis) 0.19

ts
do s o um
is ht c
th rig s do

Leafy vegetables Large herbivorous mammal 14.3 1.0 × 4.89 20.5

i
e op Th

All season “lagomorph” 0.19

of y

Rabbit (Oryctolagus cuniculus)

us c
d nd

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
an a
n rty

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.
tio e
ta op
loi pr
xp al
l e ctu

The Tier 2 TERlt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
cia lle

indicating that long-term risk to mammals is acceptable following the proposed use patterns on railroad
er te
m s in

tracks (uses 7a-b) except for the following scenarios where a refined risk assessment is required for all
om a

intended application rates:

y c uch
an ts s

 Grassland; the small herbivorous mammal “vole” common vole (2 × 1800 g a.s./ha, 1 × 1800 g
an righ

a.s./ha).
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
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 Leafy vegetables; the small herbivorous mammal “vole” common vole (2 × 1800 g a.s./ha, 1 × 1800

rib
g a.s./ha).

t
dis
n,
er tio
wn lica
.
Control of invasive species

s o ub
f it y p
Table 10.1.2- 33:Tier 2 assessment of the acute risk for mammals due to the use of glyphosate on

so n
ht , a
invasive species in agricultural and non-agricultural areas: Uses 8 and 9

rig ntly
th ue
e eq
Active substance Glyphosate

e
lat ns
Acute toxicity 3694.1

vio . Co
an ime al.
te reg new
(mg/kg bw)
TER criterion 10

oh tio re

d
pr tec EU
GAP crop Application Crop scenario Generic focal species SV90 MAF90 DDD90 TERa

ibi n
d
be ro te
rate (mg/kg

e ta p osa
(g a.s./ha) bw/d)

ef da ph
Invasive 1 × 1800 Fruiting Small herbivorous mammal “vole” 136.4 1.0 246 15.0

er y ly
th tor G
species in vegetables Common vole (Microtus arvalis)

ay ula the
agricultural BBCH 10 – 49

or
t m reg king
and non-

m er see
agricultural
areas. Post

do ll u tium
en a
emergence

cu nd
his fa or
of invasive f t ay ns
r o m co
species.
ne ent he
ow um of t

SV: shortcut value; MAF: multiple application factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values
th oc (s)

shown in bold fall below the relevant trigger.

of is d ber
ion , th em
iss ore m

The Tier 2 TERa value is greater than the Commission Regulation (EU) No. 546/2011 trigger of 10,
rm m er
pe her orm

indicating that acute risk to mammals is acceptable following the proposed use patterns on invasive species.
he rt t/f
t t Fu en

Table 10.1.2-34: Tier 2 assessment of the long-term/reproductive risk for mammals due to the use
ou s. rr
th tie cu

of glyphosate on invasive species in agricultural and non-agricultural areas: Uses 8 and 9

wi par (a)
f
en ird o
nt th rty

Active substance Glyphosate

co and ope

Reprod. toxicity 100

r

ts
r i er p

(mg/kg bw/d)
t o wn the

TER criterion 5
en o s
m he t i

GAP crop Application Crop scenario Generic focal species SVm MAFm DDDm TERlt
cu f t en

ts
do s o um

rate × TWA (mg/kg

is ht c

(g a.s./ha) bw/d)
th rig s do

Invasive 1 × 1800 Cereals Large herbivorous mammal 22.3 1.0 × 7.63 13.1
i
e op Th

species in Early (shoots) “lagomorph” 0.19

of y

agricultural Rabbit (Oryctolagus cuniculus)

and non-
us c
d nd

agricultural Fruiting Small herbivorous mammal “vole” 72.3 1.0 × 24.7 4.04
an a

vegetables Common vole (Microtus arvalis) 0.19

n rty

areas. Post
tio e

BBCH 10 – 49
ta op

emergence
loi pr

of invasive
xp al
l e ctu

species.
cia lle
er te

SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER:
m s in

toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.
om a
y c uch
an ts s
an righ

The Tier 2 TERLt values are greater than the Commission Regulation (EU) No. 546/2011 trigger of 5,
indicating that long-term risk to mammals is acceptable following the proposed use patterns on invasive
d
ing to
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species (Uses 8 and 9) except for the following scenarios where a refined risk assessment is required for

rib
the intended application rate:

t
dis
n,
er tio
 Fruiting vegetables; the small herbivorous mammal “vole” common vole (1 × 1800 g a.s./ha).

wn lica
.
s o ub
f it y p
Higher tier – Long-term mammalian refined (Tier 3) assessment

so n
ht , a
rig ntly
As indicated in the tables above, further refinements of the long-term mammal risk assessment are

th ue
e eq
required for the small herbivorous mammal “vole” considering two exposure scenarios, namely the

e
lat ns
‘Grassland – all season’ scenario and the leafy vegetable (BBCH 40 – 49) scenario for applications to

vio . Co
an ime al.
te reg new
control invasive and noxious weeds and for application to railroad tracks at 1800 g/ha.
In addition to the refined TWA and MAF values applied for the Tier 2 assessment, use specific

oh tio re

d
pr tec EU
considerations and a further refined chronic mammalian endpoint is considered for risk assessment.

ibi n
d
be ro te
Annex M-CA 8.02 of the document M-CA Section 8, presents further information to support a further

e ta p osa
refinement of the chronic mammalian endpoint. In the toxicology section of the dossier submission

ef da ph
er y ly
(M-CA Section 5), a weight of evidence position is presented concerning the relevance of the rabbit

th tor G
ay ula the
developmental toxicology study for use in risk assessment. The toxicology section presents a weight

or
t m reg king
of evidence to support the conclusion that the observed maternal effects in this study type are not due
to systemic exposure to glyphosate, but are due to GI-tract irritation resulting from the dosing route.

m er see
An additional endpoint is presented in Annex M-CA 8-02 of the document M-CA Section 8, based on

do ll u tium
en a
the results of seven rat developmental toxicity studies, where an endpoint of 300 mg/kg bw/day is

cu nd
his fa or
concluded. f t ay ns
r o m co
ne ent he
ow um of t

Applying this endpoint to the chronic mammal risk assessment considering single and multiple
th oc (s)

applications at 1800 g/ha to control invasive species or for application on railroad tracks with a daily
of is d ber

dietary dose value of 24.7 mg/kg diet (

ion , th em

and Table 10.1.2-34) for the two exposure scenarios as described above, results in TER values of 12.1
iss ore m

for both scenarios, which exceeds the trigger value of 5. Thus, indicating that an acceptable exposure
rm m er
pe her orm

risk to small herbivorous mammals can be achieved for application of MON 52276 to control invasive
he rt t/f

and noxious weeds and for application on railroad tracks.

t t Fu en
ou s. rr
th tie cu

The results of multi-generational studies in rats are also discussed in Annex M-CA 8-02 of the document
wi par (a)
f

M-CA Section 8. The 700 mg/kg bw/day NOAEL achieved for this study type demonstrate the expected
en ird o
nt th rty

reduction in the risk, where animals are exposed via the diet, which would be the route of exposure in the
co and ope

field.
r

ts
r i er p
t o wn the
en o s

Further considerations are presented in the following to support an acceptable chronic exposure risk
m he t i
cu f t en

ts

to mammals for all proposed GAP table uses of MON 52276.

do s o um
is ht c

Railroad tracks
th rig s do
i
e op Th

The application of the product on railroad tracks is done by spray trains. These trains are equipped with
high resolution cameras and are able to identify weeds on the tracks. The product is applied very targeted
of y

to the weeds and only on those sections were weeds are present. Thus this application method is not
us c
d nd

comparable to a standard broadcast application where application takes place on the whole area. In general
an a
n rty

railroad tracks are placed on aggregate, i.e. small rocks, providing an environment for plants which are
tio e
ta op

adapted to dryer conditions. Due to management and rather dry and hostile conditions that a railroad track
loi pr

provides, it is not expected that dense and long grass vegetation would be present, thus creating an
xp al
l e ctu

uninviting habitat for small mammals to exist, feed and burrow.

cia lle
er te
m s in

According to Le Louarn & Quere (2003)15 the common vole is a grassland species and inhabit meadows,
om a
y c uch

set-aside land, flower strips as primary habitats. It lives in shallow burrows rarely more than about 30 cm
an ts s
an righ

15
Le Louarn, H., Quéré, J. P. Les Rongeurs de France. Faunistique et biologie. INRA Editions, Paris, France, pp. 1-
d
ing to

256 (2003)
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deep (Stein, 1958)16. These primary habitats provide food and shelter from predators so that monthly

rib
survival of voles in primary habitats like set-aside grasslands is about 0.5 – 0.6, while being close to zero

t
dis
in arable fields (Jacob & Halle 2001)17. According to Stein (1958)4 secondary habitats for voles are cropped

n,
er tio
areas such as grain cereals, oilseed rape, peas, beans, carrots and occasionally sugar beet and potato fields.

wn lica
.
Jacob et al. (2014)18 conclude that those secondary habitats may be invaded by voles when the carrying

s o ub
f it y p
capacity (critical population density) of primary habitats is exceeded. According to Frank (1957)19 and

so n
Briner et al (2005)20 common voles of both sexes tend to be highly territorial, when population densities

ht , a
rig ntly
are low.

th ue
Railroad tracks might be occasionally visited by voles when population densities are high in 9primary

e eq
e
lat ns
habitats but it can be assumed that they don’t spend much time in such hostile environments. Due to

vio . Co
an ime al.
disturbance, rather dry conditions and the risk from predators, typical primary or secondary habitats provide

te reg new
better environmental conditions for voles than railroad tracks. Therefore the small herbivorous mammal

oh tio re

d
“vole” should not be regarded as a relevant focal species on railroad tracks. Therefore, to provide a

pr tec EU
ibi n
conservative approach for the application on railroad tracks 50 % of the application rate could be taken into

d
be ro te
e ta p osa
account for an alternative refined chronic risk assessment.

ef da ph
er y ly
th tor G
By virtue of the very high residues per unit dose (RUD) value for common voles feeding on 100 % grasses

ay ula the
as stated in the EFSA /2009/1438 guidance document, the vole is considered the worst-case exposure model

or
t m reg king
/ focal species. An acceptable risk assessment for the common vole is considered protective of all focal

m er see
mammal species in the EFSA guidance. It is highly probable that other mammal species may frequent the

do ll u tium
en a
habitats associated with railroad tracks. However, the Tier I level of the risk assessment – for both the small

cu nd
his fa or
omnivorous (e.g., woodmouse) and large herbivorous mammals (e.g. rabbits and hares) was considered
f t ay ns
acceptable across all proposed GAP table uses.
r o m co
ne ent he
ow um of t

An additional point is that across the EU, different vole species exist and for some EU member states,
th oc (s)

different small mammal species are considered more relevant to the risk assessment, based on the local
of is d ber

situation or due to the level of protection for this particular being considered differently in different member
ion , th em

states. (21Jacobs et al., 2014).

iss ore m

e
rm m er
pe her orm

A full risk assessment covering all focal mammal species is presented in the Annex M-CP 10-03 to this
he rt t/f
t t Fu en

dossier section that covers all mammal focal species feeding guilds. Worst case representative focal species
ou s. rr
th tie cu

from each of the feeding guilds across all mammal species in the EFSA guidance are considered in the
wi par (a)

presented assessment above.

f
en ird o
nt th rty
co and ope

Control of invasive species

r

ts
r i er p

For the use on invasive species on agricultural and non-agricultural areas (Uses 8-9) the product
t o wn the

MON 52276 is intended to be applied on the two invasive species; Giant hogweed (Heracleum
en o s
m he t i
cu f t en

ts

montegazzianum) and Japanese knotweed (Reynoutrica japonica). Both species are easily recognisable, are
do s o um

usually well known by operators and can reach impressive sizes (more than 2 m height).
is ht c
th rig s do
i
e op Th
of y
us c
d nd

16
Stein, G.H.W. Die Feldmaus. Franckh’sche Verlagshandlung, Stuttgart, Germany (1958).
an a

17
Jacob, J., Halle, S. The importance of land management for population parameters and spatial behaviour in
n rty
tio e

common voles (Microtus arvalis). Advances in Vertebrate Pest Management II. Filander Verlag, Fürth, Germany,
ta op

pp. 319-330 (2001)

loi pr
xp al

18
Jacob, J., Manson, P., Barfknecht, R., Fredricks, T. Common vole (Microtus arvalis) ecology and management:
l e ctu

implications for risk assessment of plant protection products. Published online in Wiley Online Library (15th
cia lle
er te

January 2014).
m s in

19
Frank, F. The causality of microtine cycles in Germany. The Journal of Wildlife Management 21(2): 113-121
om a
y c uch

(1957)
20
Briner, T., Nentwig, W, Airolid, J.P. Habitat quality of wildflower strips for common voles (Microtus arvalis) and
an ts s

its relevance for agriculture. Agriculture, Ecosystems & Environment 105:173-179 (2005)
an righ

21
Jacob, J., Manson, P., Barfknecht, R., Fredricks, T. (2014) Common vole (Microtus arvalis) ecology and
d
ing to

management: implications for risk assessment of plant protection products. Pest Management Science 70:869-878
sh ct
bli bje
pu su
or be

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Control of invasive plant species that pose a risk to man and society, may be achieved by direct targeted

rib
overspray of the plant or by first cutting back the plants and applying directly to fresh regrowth. In both

t
dis
cases, the aim is to achieve exposure of the plant systemically, targeting all growing areas of the plant. The

n,
er tio
type of plant to be controlled and the density of plants in the target area, will dictate the management

wn lica
.
approach that is ultimately used. In all cases, the spray applications made, will be directed and targeted to

s o ub
f it y p
a specific plant or stand of plants. This approach contrasts with a boom spray application where the entire

so n
area under the boom is exposed, whether there is a target plant present or not. It is therefore appropriate

ht , a
rig ntly
when considering applications made to control invasive species, that the total applied area considered in

th ue
the risk calculation, is reduced compared to a boom spray application, given the very directed and targeted

e eq
e
lat ns
application method used, which includes use of shielded sprayers that further reduces the risk to non-target

vio . Co
an ime al.
plants.

te reg new
oh tio re

d
When spraying invasive species, different plant density scenarios are applicable. A small reduction in the

pr tec EU
ibi n
application rate (10 – 30 % reduction) would reflect a scenario where a high density of invasive species can

d
be ro te
e ta p osa
be expected. Such a scenario is considered relevant in non-agricultural fields where higher densities of the

ef da ph
invasive species Giant hogweed or Japanese knotweed may occur. Therefore, as a conservative worst case

er y ly
th tor G
approach a reduction of the application rate to 90 % can be taken into account for an alternative chronic

ay ula the
risk assessment in non-agricultural areas.

or
t m reg king
m er see
In agricultural areas farmers won’t tolerate higher amounts of invasive species in their fields. Thus, the

do ll u tium
en a
density in comparison to non-agricultural fields is much lower and plants are more dispersed as they are

cu nd
his fa or
not allowed to spread over several years. In case the product is applied by hand-held equipment to invasive
f t ay ns
species at BBCH stages when the intended crop is present it can be expected that only few invasive species
r o m co
ne ent he

are present and that the operator avoids exposure of cultured crops. In conclusion, to address the lower plant
ow um of t

density of invasive species in agricultural fields, a 40 % reduction in the application rate based on the
th oc (s)

reduced total area can be applied in an alternative risk assessment. This is also considered appropriate to
of is d ber

cover the chronic risk to mammals.

ion , th em
iss ore m

e
rm m er

Drinking water exposure

pe her orm
he rt t/f
t t Fu en

Only the puddle scenario is relevant for risk assessment for mammals through drinking water.
ou s. rr
th tie cu
wi par (a)

Puddle scenario
f
en ird o
nt th rty
co and ope

The ‘Puddle scenario’ is relevant for mammals taking water from puddles formed on the soil surface of a
r

field when a (heavy) rainfall event follows the application of a pesticide to a crop or bare soil. This is
ts
r i er p
t o wn the

therefore relevant for all uses of MON 52276 and should therefore be assessed.
en o s
m he t i
cu f t en

ts
do s o um

Due to the characteristics of the exposure scenario in connection with the standard assumptions for water
is ht c

uptake by animals, no specific calculations of exposure and TER are necessary since the ratio of effective
th rig s do

application rate (in g/ha) to acute and long-term endpoint (in mg/kg bw/d) does not exceed 50 (KOC <
i
e op Th

500 L/kg) or 3000 (KOC ≥ 500 L/kg), as specified in EFSA/2009/1438.

of y
us c

As pointed out in EFSA/2009/1438, specific calculations of exposure and TER values are only necessary
d nd
an a

when the ratio of effective application rate (in g a.s./ha) to relevant endpoint (in mg a.s./kg bw/d) exceeds
n rty
tio e

50 in the case of less sorptive (KOC < 500 L/kg) or 3000 in the case of more sorptive (KOC ≥ 500 L/kg)
ta op
loi pr

substances.
xp al
l e ctu
cia lle

For glyphosate, the ratio of highest application rate (1800 g a.s./ha) to lowest relevant endpoint (NOAEL =
er te
m s in

100 mg a.s./kg bw/d) is 18. As the Kf,OC for glyphosate is 4245 mL/g (See M-CA Section 7) the risk can be
om a

considered acceptable without the need for further calculations.

y c uch
an ts s

Effects of secondary poisoning

an righ
d
ing to
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or be

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According to the EFSA/2009/1438, substances with a log POW ≥ 3 have potential for bioaccumulation and

rib
should be assessed for the risk of biomagnification in aquatic and terrestrial food chains.

t
dis
n,
er tio
Since the log Pow values of glyphosate is log POW < –3.2 (pH 2 – 5, 20 °C), the active substance is deemed

wn lica
.
to have a negligible potential to bioaccumulate in animal tissues. No formal risk assessment from secondary

s o ub
f it y p
poisoning is therefore required.

so n
ht , a
rig ntly
The primary metabolite of glyphosate is aminomethylphosphonic acid (AMPA). Most of the parent

th ue
glyphosate is eliminated unchanged and only a small amount (less than 1 % of the applied dose) is

e eq
e
lat ns
transformed to aminomethylphosphonic acid (AMPA). The metabolite AMPA has been tested in several

vio . Co
an ime al.
mammal toxicity studies which demonstrated that it is of lower toxicity than glyphosate acid (see Section

te reg new
CA 5.8). Furthermore, the log POW for AMPA – estimated via EpiSuite Program and SMILES code

oh tio re

d
(C(N)P(=O)(O)O) – is -2.47 and does not indicate a potential for bioaccumulation (EFSA Journal

pr tec EU
ibi n
2015;13(11): 4302).

d
be ro te
e ta p osa
ef da ph
Indirect Effects Via Trophic Interaction

er y ly
th tor G
A large regulatory dataset exists with acute and long-term studies to inform the wild mammal risk

ay ula the
assessments, with the results of the wild mammal risk assessments (MCP 10.1.2) that demonstrate that

or
t m reg king
under the intended uses of glyphosate there is negligible risk of direct effects.

m er see
do ll u tium
en a
An assessment of indirect effects is in part covered by the current EFSA Birds and Mammals assessment

cu nd
his fa or
guidance through an evaluation of the potential for secondary poisoning (e.g., consumption of earthworms,
f t ay ns
fish, drinking water). However, methodology for assessing indirect effects through trophic interaction
r o m co
ne ent he

resulting from in-crop weed control was not addressed. Throughout the development of the EFSA (2009)
ow um of t

guidance document, it was raised that indirect effects through trophic interactions should be eventually be
th oc (s)

addressed, and it was decided when the guidance was finalized that this topic would need to be addressed
of is d ber

in revised guidance. However, many experts in the Member States who reviewed the birds and mammals
ion , th em
iss ore m

guidance document commented that this is an area that requires further research and that it may be
e
rm m er

preferable to manage indirect effects to birds and mammals through mechanisms other than pesticide
pe her orm

approvals (e.g., farmland management and/or conservation policies).

he rt t/f
t t Fu en
ou s. rr
th tie cu

The following assessment approach considers both direct effects and the potential for indirect effects via
wi par (a)

trophic interactions, based on the proposed Specific Protection Goals drawn from the existing EU guidance
f
en ird o

and working documents, and the 2016 EFSA Guidance on developing protection goals for ecological risk
nt th rty
co and ope

assessments (ERA) for pesticides. The SPGs based on direct effects assessment considering representative
r

sensitive populations across the tested trophic levels. The biodiversity assessment, aimed to develop a
ts
r i er p
t o wn the

flexible framework that informs the development of risk mitigation options to achieve the specific
en o s
m he t i

protection goals, that includes considering indirect effects via trophic interaction. For example, reduced
cu f t en

ts
do s o um

application rates relative to previous Annex I renewals, a reduced overall application volume of product on
is ht c

the land, and inclusion of no-spray buffer zones as a standard mitigation measure to protect edge of field
th rig s do

surface waters. When defining SPGs for mammals, it is the responsibility of the risk assessors in the
i
e op Th

Member States to acknowledge existing protection goals and regulatory data requirements, to propose
of y

possible SPG options, and describe the possible environmental consequences of each option. The risk
us c

assessors within the Member States will need to propose realistic SPGs and exposure assessment goals and
d nd
an a

the interrelationships between them in a clear and transparent manner.

n rty
tio e
ta op
loi pr
xp al
l e ctu

Biodiversity Assessment.
cia lle

The assessment approach – as previously defined aims to assess the potential indirect effects via trophic
er te
m s in

interactions and the impact on biodiversity, by developing a flexible framework that informs the
om a

development of risk mitigation options to achieve the specific protection goals. In the following table, the
y c uch

specific protection goals relevant to mammals are presented with the relationship between the SPGs, the
an ts s

direct effects study types, assessment and measurement endpoints. The assessment endpoint is an explicit
an righ
d
ing to
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expression of an environmental entity and the specific property of that entity to be protected. Measurement

rib
endpoints relates directly to the effects study endpoints.

t
dis
n,
er tio
A conclusion that a given data requirement has been satisfied, requires that an acceptable level of risk has

wn lica
.
been achieved (i.e. there is a protective margin of exposure or through a weight of evidence).

s o ub
f it y p
so n
Based on the measurement endpoints from the study types, and the direct effects assessment presented

ht , a
rig ntly
above in this section, direct effects from glyphosate on aquatic organisms are not anticipated.

th ue
e eq
e
lat ns
The impact on mammalian species will be additionally supported by the required in-field no spray buffer

vio . Co
an ime al.
area for the NTTPs, which will protect mammals occurring in field margins.

te reg new
oh tio re

d
The following table assessment illustrates that ecological function of wild mammals in off-target areas/

pr tec EU
ibi n
edge of field, will be sufficiently maintained to achieve the SPG for wild mammals according to the

d
be ro te
e ta p osa
protection goals as defined in the EFSA guidance that sustains habitat and food resources for other

ef da ph
organisms.

er y ly
th tor G
ay ula the
Table 10.1.2-35: Protection Goals and Associated Assessment and Measurement Endpoints for

or
t m reg king
Wild Mammals.

m er see
Specific Protection Assessment Endpoints Measurement Endpoints Glyphosate Study Types

do ll u tium
en a
Goals1

cu nd
his fa or
No visible mortality and No reduction in survival, Survival, growth, Acute oral avian and rat
f t ay ns
r o m co
long-term impacts on growth, development, development and Avian reproduction
ne ent he

abundance and diversity reproduction of avian reproduction Rabbit teratology

ow um of t

populations. Rat 2-generation

th oc (s)
of is d ber

Wild Mammal Biodiversity Assessment

ion , th em

Based on the current direct effects risk assessment for glyphosate, there is acceptable acute and long-term risk
iss ore m

assessments based on current guidance and the intended use patterns for glyphosate. However, if additional risk
rm m er
pe her orm

mitigation measures are determined to be required based on local conditions, to mitigate indirect effects
he rt t/f

resulting from in-crop weed control on mammalian populations, options to be considered by risk assessors and
t t Fu en

risk managers within Member States are presented in Table 10.1.2- 36.
ou s. rr
th tie cu

1
When protection goals are defined more precisely by risk managers or legislators to address indirect effect, then the protection
wi par (a)

goals and assessment procedures should be revised.

f
en ird o
nt th rty
co and ope

Scientific literature that informs the wild mammal indirect effects assessment
r

ts
r i er p

The residue left over on the soil surface from practicing conservation tillage increases cover and benefits
t o wn the

to wildlife. The general rule is that the greater the amount of crop residue a tillage practice leaves on the
en o s
m he t i

surface, particularly standing residue, the better the practice is for small mammals, acting as a refuge from
cu f t en

ts
do s o um

predation but also providing a habitat in which food items will occur. The studies on the benefits of
is ht c

conservation tillage have shown that fields using conservation tillage, where there may be an increase in
th rig s do

crop residue, tend to increase the diversity of small mammals in crop fields. In addition, crop residues also
i
e op Th

harbor insects and other arthropods that are an important food source for wild mammals.
of y
us c
d nd

For mammals, studies on indirect effects through trophic interactions at the population level are generally
an a

lacking. However, a number of studies have investigated the potential for indirect effects of on birds and
n rty
tio e

mammals in managed forest systems. Studies on small mammals (i.e., rodents, shrews, voles, chipmunks)
ta op
loi pr

have shown that some short-term changes after forestry applications of glyphosate were observed at the
xp al
l e ctu

species (Anthony and Morrison, 2985; D’Anieri et al. 1987; Gagné et al. 1999) and functional feeding
cia lle

group levels (Santillo et al., 1989a), which the authors attributed to the reduction in invertebrates, plant
er te
m s in

cover, and food. At the population level, glyphosate did not appear to have significant or long-lasting effects
om a

in the first few years after application (D’Anieri et al. 1987; Santillo et al., 1989a; Sullivan et al. 1987).
y c uch

Similar to small mammals, changes in bird community composition, and reductions in abundance, densities
an ts s

and species richness of bird populations often occurred in the first few years after glyphosate application
an righ

(Guiseppe et al. 1986, Easton and Martin, 1998, Santillo et al. 1989b), and in Santillo et al. (1989b) the
d
ing to
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decline in bird densities was correlated with the decline in habitat complexity. These changes were assessed

rib
against untreated control sites to differentiate the effects of glyphosate from other background

t
dis
environmental factors such as the recovery trajectory following tree harvest and showed similar responses

n,
er tio
to other herbicides commonly used in managed forests (Guvnn et al., 2004).

wn lica
.
s o ub
f it y p
Sullivan and Sullivan (2003) published a comprehensive glyphosate assessment addressing vegetation

so n
management and ecosystem disturbance focusing on plant and animal biodiversity that consider direct and

ht , a
rig ntly
indirect effects. Their analysis was based on 60 published studies of terrestrial plants and animals in

th ue
temperate forests and agroecosystems. Species richness of plants was either unaffected or increased in the

e eq
e
lat ns
case of herbaceous species in those receiving glyphosate treatments. Species richness and diversity of

vio . Co
an ime al.
songbirds, in open habitats representative of agricultural lands, did not appear to be negatively impacted in

te reg new
glyphosate use areas. In fact, conservation tillage, which is enabled by glyphosate, promoted greater

oh tio re

d
abundance of songbirds and other fowl compared with ploughed fields (McLaughlin and Mineau, 1995;

pr tec EU
ibi n
Cunningham et al., 2005). Similarly, in studies on small mammal communities, there was no long-term

d
be ro te
e ta p osa
negative impact on species richness and diversity. When there were declines in some species of small

ef da ph
mammals, they were transient and other species of small mammals in those systems increased likely

er y ly
th tor G
because they were better generalists in these systems. Larger mammalian herbivores (e.g., rabbit, deer)

ay ula the
were not negatively affected by glyphosate treatments. However, assessment of a wide range of terrestrial

or
t m reg king
invertebrate taxa showed variable responses in abundance and their diversity is largely a function of the

m er see
degree of vegetation control. Overall, the magnitude of changes in species richness and diversity of plants,

do ll u tium
en a
birds, small mammals in the studies reviewed by Sullivan and Sullivan were within the mean range of

cu nd
his fa or
natural fluctuations and considered direct and indirect effects.
f t ay ns
r o m co
ne ent he

Conclusion:
ow um of t

Based on the current direct effects risk assessment for glyphosate, there is acceptable acute and long-term
th oc (s)

risk based on current guidance and the intended use patterns for glyphosate. Currently, the EFSA birds and
of is d ber

mammals guidance does not include assessment methodology for indirect effects through trophic
ion , th em

interactions. Addressing potential indirect effects to birds and mammals by limiting in-crop weed control
iss ore m

e
rm m er

or compensating for its effects may be better handled though policies and programs outside the PPP
pe her orm

framework. However, if additional risk mitigation measures are concluded to be required, to mitigate
he rt t/f
t t Fu en

indirect effects resulting from in-crop weed control on avian populations, options to be considered by risk
ou s. rr
th tie cu

assessors and risk managers within Member States are presented in Table 10.1.2-36. These mitigation
wi par (a)

options will bring the greatest ecological benefit when implemented in simplified landscapes or in
f
en ird o

intensified production areas, where the refuge areas for insects, birds and mammals are limited. It is
nt th rty
co and ope

anticipated that this measure will not bring a high ecological benefit in complex landscapes where enough
r

refuges are available off-field.

ts
r i er p
t o wn the
en o s
m he t i

Risk mitigation options to address direct and indirect effects to ecological species
cu f t en

ts

Environmental risk mitigation measures are a key component in defining the conditions of use of pesticides
do s o um
is ht c

in crop protection in Europe ((EC) No 1107/2009) and (EU) No 547/2011). These risk mitigation measures
th rig s do

are derived directly from the evaluation of pesticide products and the risk assessment conducted for each
i
e op Th

use and are specific of the type of risk they are intended to mitigate. They therefore range from the
of y

adjustment of the conditions of use, to minimizing transfers to surface and groundwater, to the setting of
us c

buffer zones at the edge of the crop, and to requiring compensatory measures (e.g., field margins).
d nd
an a
n rty
tio e

Risk mitigation measures can be divided into “standard” mitigation measures where an impact can be
ta op
loi pr

calculated in the frame of environmental risk assessment and “non-standard” mitigation measures where
xp al

the impact on biodiversity cannot be directly expressed in numerical values. It needs to be noted that
l e ctu
cia lle

biodiversity related mitigation measures need to be adapted to the local Member State level, to the local
er te

environmental circumstances (e.g. landscape), to the local biodiversity conservation status and to the
m s in
om a

desired protection and conservation goals.

y c uch
an ts s

It is therefore appropriate to consider the available mitigation tools available across the EU that could be
an righ

applied by risk managers. Currently, the most up-to-date compilation of plant protection mitigation tools
d
ing to

available across Europe was compiled during a series of workshops in 2013 under the auspices of the
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Society of Environmental Toxicology and Chemistry (SETAC) and the European Commission. The goal

rib
of the MAgPIE workshops was to develop a toolbox of mitigation measures from across the EU. The

t
dis
outcome of these workshops was a proceedings published in 2017 “Mitigating the Risks of Plant Protection

n,
er tio
Products in the Environment MAgPIE.

wn lica
.
s o ub
f it y p
The MAgPIE workshop proceedings and associated publications were inventories of the available risk

so n
mitigation options across the various Member States in the EU and included a toolbox of recommendations

ht , a
rig ntly
in view of future implementation.

th ue
e eq
e
lat ns
Examples of the standard mitigation measures considered applicable at the EU level (MAgPIE, 2017) are

vio . Co
an ime al.
presented in the following table. Many of these have been considered in the current dossier submission.

te reg new
oh tio re

d
Table 10.1.2- 36: Types of standard risk mitigation measures described in MAgPIE across the

pr tec EU
ibi n
d
various Member States to mitigate effects on biodiversity and how they could be applied to

be ro te
e ta p osa
glyphosate products.

ef da ph
Type of Mitigation Risk Mitigation Benefits Glyphosate renewal dossier (2020)

er y ly
th tor G
Measure Measure

ay ula the
Restrictions or Application rate, Lower transfers to Significant reductions (50 % in volume)

or
t m reg king
modifications of Application frequency, groundwater and surface in newly proposed application rates

m er see
products’ conditions application timing, water; Reduces exposure compared with the representative use

do ll u tium
en a
of application and interval between of organisms in-crop and presented in the 2012 renewal dossier.
applications off-crop. See 22Appendix 2 of the biodiversity

cu nd
his fa or
f t ay ns report that accompanies this submission.
r o m co
ne ent he
ow um of t

Treated area restriction

4. for the representative use GAPs:
th oc (s)
of is d ber

applying to only 50 % of the total area in

ion , th em

orchard/vineyard area.
iss ore m

5. maximum of 50 % of the total area for

e
rm m er

broad acre vegetable inter-row

pe her orm

6. Invasive species control e.g., couch grass

he rt t/f
t t Fu en

– maximum of 20 % of the cropland +

ou s. rr
th tie cu

extended application intervals.

wi par (a)
f
en ird o

Limited frequency and timing of

nt th rty

application: 28-day interval between

co and ope

applications and no pre-harvest

r

ts
r i er p

applications
t o wn the
en o s
m he t i

Application Spray drift reduction Reduces exposure of Reduction of spray drift to the off-field:
cu f t en

ts
do s o um

equipment nozzles (SDRN), organisms in-crop 3. Use 75 % drift reducing nozzles for pre-
is ht c

with Spray Drift shields, (precision treatment) and sowing/pre-planting in arable crops.
th rig s do

Reduction Precision treatment, off-crop 4. Use of ground directed, shielded spray

i
e op Th

Technology (SDRT) etc. for band application in orchards /

of y

vineyards and broad-acre vegetable inter-

us c

row application.
d nd
an a
n rty

Buffer zones Non-sprayed zone at Reduces exposure of Establishment of buffer zones:

tio e
ta op

the edge of a crop organisms and off-crop Buffer zones of varying size (depending on
loi pr

the type of SDRT) are required as

xp al
l e ctu

protection for off-crop NTTP communities

cia lle

from spray drift.

er te
m s in
om a
y c uch

For example in the current dossier;

an ts s
an righ

22 (2020) Glyphosate: Indirect effects via trophic interaction - A Practical Approach to

d
ing to

Biodiversity Assessment (TRR0000305).

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- Reductions in maximum annual application rates of up to 50 % are considered in this dossier

rib
compared to the maximum rates applied for in the 2012 Annex I renewal dossier.

t
dis
o In 2012, the maximum annual application rate was 4.32 kg/ha.

n,
er tio
o In the current dossier submission, the maximum annual application rate is 2.16 kg/ha

wn lica
.
s o ub
f it y p
- Reducing the total area being applied on a per hectare basis for certain uses, will reduce the total

so n
volume of product being applied to the landscape.

ht , a
rig ntly
o For example, controlling actively growing weeds in vineyards, orchards where a reduced

th ue
area, up to a maximum of 50 % of the total application area is proposed e.g. using strip or

e eq
e
lat ns
band applications. Applications target weeds around the base of trees within tree rows,

vio . Co
an ime al.
leaving the area between tree rows unsprayed, which is typically managed using

te reg new
mechanical methods.

oh tio re

d
pr tec EU
ibi n
- The use of shielded or hooded sprayers, hand-held sprayers and drift reducing technologies, e.g.

d
be ro te
e ta p osa
75% drift reducing nozzles are recommended for all applications made for the control of actively

ef da ph
growing weeds when applied to control invasive species. These measures will further reduce the

er y ly
th tor G
off-target exposure risk.

ay ula the

or
t m reg king
- For weed control on railroad tracks, recommendations are made in the GAP table to use precision

m er see
application equipment on spray trains, that detects and targets spray directly onto unwanted plants,

do ll u tium
en a
thereby reducing the amount of product being applied, whilst maintaining an acceptable level of

cu nd
his fa or
safety on the railroad tracks.
f t ay ns
r o m co
ne ent he

- No spray buffer areas in-field, are necessary to meet the specific protection goals for avoiding direct
ow um of t

effects on non-target plants in off-target areas. This measure will in turn support non-target
th oc (s)

arthropod communities in off-field areas and reduces further, the potential for indirect effects on
of is d ber

bees through trophic interaction.

ion , th em
iss ore m

e
rm m er

In addition to the standard mitigation measures, ‘non-standard mitigation measures’ could also be
pe her orm

considered where a local and specific mitigation need is identified. For example, in simplified landscapes
he rt t/f
t t Fu en

or landscapes that are intensively managed, where typically there are limited refuge areas for insects, birds
ou s. rr
th tie cu

and mammals. Non-standard mitigation measures options could include for example, creation of off-target
wi par (a)

habitats, utilizing edge of field habitats and semi-field habitats that assist biodiversity by improving wildlife
f
en ird o

connectivity. However, these measures will bring the greatest ecological benefit when implemented in
nt th rty
co and ope

simplified landscapes or in intensified production areas, where the refuge areas for insects, birds and
r

mammals are limited. It is anticipated that this measure will not bring a high ecological benefit in complex
ts
r i er p
t o wn the

landscapes where enough refuges are available off-field.

en o s
m he t i
cu f t en

ts

For further information on mitigation measures pleased refer to the supplementary information document23
do s o um
is ht c

titled ‘Glyphosate: Indirect Effects via Trophic Interaction – A Practical Approach to Biodiversity
th rig s do

Assessment.’ that accompanies this dossier submission.

i
e op Th
of y
us c
d nd

CP 10.1.2.1 Higher tier data on mammals

an a
n rty

Additional studies are not considered to be required, since sufficient information is available from studies
tio e
ta op

performed with the active substance and the representative product. Furthermore, the risk assessment for
loi pr

mammals indicates an acceptable ecotoxicological risk for mammals in consideration of each potential
xp al
l e ctu

route of exposure from the proposed uses in the GAP; in field crops, orchards, vineyards, railroad tracks
cia lle

and non-agricultural areas.

er te
m s in
om a
y c uch

See MCA Section 5 for detailed summary of the acute study conducted with MON 52276.
an ts s
an righ

23
(2020) Glyphosate: Indirect effects via trophic interaction - A Practical Approach to
d
ing to

Biodiversity Assessment (TRR0000305).

sh ct
bli bje
pu su
or be

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dis
CP 10.1.3 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)

n,
er tio
wn lica
A consideration of the potential effects of glyphosate and glyphosate products on amphibians was part of

.
s o ub
the previous Annex I renewal of glyphosate in the EU (Glyphosate RAR 11 Vol. 3 CA-CP_B9, 2015).

f it y p
so n
ht , a
The RAR (2015) produced by the UBA for the last Annex I submission for the renewal glyphosate in the

rig ntly
EU contained an extensive review of the available public domain literature on amphibians and the potential

th ue
e eq
for effects on amphibians. Since the last Annex I renewal guidance on how to conduct environmental risk

e
lat ns
assessment on amphibians – specifically terrestrial phase amphibians has not been forthcoming. The

vio . Co
an ime al.
te reg new
assessment for both, the aquatic and terrestrial life phases, is still considered to be covered by the risk
assessments on aquatic organisms (covering the aquatic life phases) and the terrestrial vertebrates covering

oh tio re

d
pr tec EU
the terrestrial life phases.

ibi n
d
be ro te
e ta p osa
In the previous Annex I renewal RAR (2015), a review was presented that considered acute and chronic

ef da ph
er y ly
amphibian toxicity studies in the public domain literature, conducted with glyphosate and / or commercial

th tor G
ay ula the
glyphosate-based formulations. The RMS (UBA) considered acute effects based on studies with 96 hours

or
t m reg king
or less duration. Chronic studies were evaluated that focused mostly on lethality effects, with some studies
considering effects of glyphosate formulations on body weights and/or performance at metamorphosis.

m er see
There were very few studies considering effects on terrestrial stages of amphibians.

do ll u tium
en a
cu nd
his fa or
f t ay ns
In the current literature review to support the 2020 submission for Annex I renewal in the EU, the available
r o m co
24
guidance have been used to distinguish which public domain literature are relevant and reliable for
ne ent he

inclusion into the ecotoxicological risk assessment.

ow um of t
th oc (s)
of is d ber

There were a number of acute toxicity endpoints presented in the RAR (2015) for amphibians exposed to
ion , th em

glyphosate and its salts range from >17.9 to >466 mg a.s./L (see table below), which were summarised in
iss ore m

the following way:

rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ

24 EFSA (European Food Safety Authority), 2011. Submission of scientific peer-reviewed open literature for the approval of

pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011;9(2):2092. 49 pp.
d
ing to

doi:10.2903/j.efsa.2011.2092
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Table 10.1.3-1: Effect values reported in peer reviewed literature for amphibians of glyphosate

t rib
acid and salts of glyphosate

dis
n,
er tio
Species Substance Study duration LC50 Reference

wn lica
.
(mg a.s./L)

s o ub
f it y p
Crinia insignifera Glyphosate acid 96 h 103.2 Bidwell & Gorrie 1995

so n
ht , a
tadpoles glyphnosubm_023

rig ntly
Crinia insignifera Glyphosate acid 96 h 75.0 Bidwell & Gorrie 1995

th ue
e eq
adult glyphnosubm_023

e
lat ns
vio . Co
Glyphosate acid 48 h 81.2 Mann & Bidwell 1999

an ime al.
Litoria moorei

te reg new
tadpoles glyphnosubm_024

oh tio re

d
Litoria moorei Glyphosate acid 48 h 121.0 Mann & Bidwell 1999

pr tec EU
ibi n
glyphnosubm_024

d
tadpoles

be ro te
e ta p osa
Crinia insignifera Glyphosate acid 48 h 83.6 Mann & Bidwell 1999

ef da ph
glyphnosubm_024

er y ly
adult

th tor G
ay ula the
Rana clamitans Glyphosate IPA 96 h > 17.91 Howe et al., 2004

or
t m reg king
glyphecotox_025

m er see
Lymnodynastes dorsalis Glyphosate IPA 48 h > 400.0 Mann & Bidwell 1999

do ll u tium
en a
tadpoles glyphnosubm_024

cu nd
his fa or
Litoria moorei Glyphosate IPA 48 h > 343.0
f t ay ns
r o m co Mann & Bidwell 1999
tadpoles glyphnosubm_024
ne ent he
ow um of t

Crinia insignifera Glyphosate IPA 48 h > 466.0 Mann & Bidwell 1999
glyphnosubm_024
th oc (s)

tadpoles
of is d ber

Heleioporus eyrei Glyphosate IPA 48 h > 373.0 Mann & Bidwell 1999
ion , th em

glyphnosubm_024
iss ore m

tadpoles
e
rm m er
pe her orm
he rt t/f
t t Fu en

Of note in the previous Annex I evaluation was the influence of surfactants on the toxicity of glyphosate-
ou s. rr
th tie cu

based herbicides containing specific surfactant classes, to amphibians, being far lower than for glyphosate
wi par (a)

acid or its salts. The surfactants displaying a high toxicity in glyphosate-based formulations belonged
f
en ird o

typically to the classes of poly-oxyethoxylated alkylamines (POEA; e.g. ethoxylated tallow- and
nt th rty
co and ope

cocoamines) - or are e.g. fatty nitrogen derivate etheramines. The representative formulation (MON 52276)
r

ts
r i er p

does not contain surfactants belonging to these classes of compounds. Across 26 different studies that were
t o wn the

considered in the RAR (2015), considering glyphosate-based products that contained POEA based
en o s
m he t i

surfactants or surfactants considered to be very similar, the acute LC50 values ranged between 1.1 and 17.9
cu f t en

ts
do s o um

mg a.e./L. The products considered were IPA salt-based formulations containing a similar loading of
is ht c

glyphosate compared to the representative formulation.

th rig s do
i
e op Th

Based on the aquatic toxicity profile of MON 52276, it is evident that the formulated product is less
of y

sensitive to a range of aquatic organisms compared to the technical material.

us c
d nd
an a

Further information on the effects of surfactants such as POEA and the implications of exposure to these
n rty
tio e

types of surfactants by amphibians are described in detail in the previous literature review presented in the
ta op
loi pr

RAR (2015), Section B9.11.

xp al
l e ctu
cia lle

Concerning terrestrial phase amphibians, the risk assessment for birds and mammals is considered
er te
m s in

protective of terrestrial phase amphibians in terrestrial environments.

om a
y c uch

In the conclusions drawn by the RMS (UBA), it is indicated that the findings from the reviewed public
an ts s

literature data on amphibians pointed towards toxicity of surfactants in the glyphosate-based formulations.
an righ

In some cases, the experimental difficulties or set-ups were considered contributing factors, but overall the
d
ing to
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results indicate effects of ethoxylated surfactants on amphibians and that there were implications for

rib
registering glyphosate-based products containing these types of surface-active chemicals. The

t
dis
representative formulation does not contain POEA or ethoxylated surfactants known to be of toxic concern

n,
er tio
to amphibians. In fact, the aquatic toxicity profile of MON 52276 is substantially protected by the

wn lica
.
ecotoxicological profile of the active substance.

s o ub
f it y p
so n
ht , a
rig ntly
Risk assessment / Weight of evidence

th ue
Of the current literature reviewed for the Annex I renewal, the following paper was considered to have been

e eq
e
lat ns
conducted according to an appropriate test guideline and is reviewed below.

vio . Co
an ime al.
te reg new
Table 10.1.3-2: Literature on toxicity of representative formulation to Amphibians

oh tio re

d
pr tec EU
ibi n
Study Study type Substance(s) Status Remark

d
be ro te
e ta p osa
Daam et al., 2019 Lethal toxicity of the Glyphosate Relevant and The 96 h LC50 for

ef da ph
herbicides acetochlor, technical reliable glyphosate technical

er y ly
ametryn, glyphosate (99.2 % exposure to two

th tor G
ay ula the
and metribuzin to purity) tropical frog species;

or
tropical frog larvae.

t m reg king
Physalaemus cuvieri
and Hypsiboas

m er see
pardalis were

do ll u tium
en a
determined to be 115

cu nd
his fa or
and 106 mg
f t ay ns
a.s./L,respectively.
r o m co
ne ent he
ow um of t

The author concluded

th oc (s)

that these data were

of is d ber

protective of tropical
ion , th em

amphibians.
iss ore m

e
rm m er
pe her orm

In Daam et al., (2019) despite some uncertainty over the analytical integrity of the studies i.e., analytical
he rt t/f
t t Fu en

exposure could not be confirmed from the paper, effects of a glyphosate-based herbicide on tadpoles of the
ou s. rr

tropical amphibian species using a recognised experimental approach, with tadpoles exposed for 96 hours
th tie cu
wi par (a)

after dispersion of the test substance into water. Data previously evaluated by the RMS (UBA) from the
f
en ird o

paper by Bidwell (1999) was also considered, where it was concluded that glyphosate based herbicides
nt th rty

were much less toxic than technical glyphosate. The achieved endpoints in Daam, are not considered in the
co and ope

risk assessment as the assessment for fish is considered protective.

r

ts
r i er p
t o wn the
en o s

From the reviewed papers that were part of the literature review, but that were not considered relevant to
m he t i
cu f t en

ts

the assessment as they were not conducted on a formulation related to the representative formulation,
do s o um

terrestrial phase and aquatic phase amphibians were assessed. The findings from these studies are
is ht c
th rig s do

considered briefly in the following paragraphs to address the possible impacts of glyphosate-based
i
e op Th

herbicides on terrestrial phase amphibians.

of y
us c

In the relevant but supplemental studies by Edge et al., 2012, 2013 and 2014, larval and juvenile amphibians
d nd
an a

were exposed to glyphosate-based herbicides in extended field experiments. In Edge, (2012) a replicated
n rty

field experiment in a wetland habitat, demonstrated that exposing amphibian larvae to a glyphosate-based
tio e
ta op

herbicide under field conditions (Roundup Vision) at applications rates up to 2.88 kg a.e./ha had negligible
loi pr
xp al

impact on survival or growth of green frogs (Lithobates clamitans). In Edge, (2013) both laboratory and
l e ctu

field experiments were conducted with exposure of two frog species to a glyphosate-based herbicide to
cia lle
er te

assess the effects on survival, liver somatic index, body condition and the incidence of disease caused by
m s in

Batachochyrtrium dendrotalis. The results concluded that glyphosate-based herbicide (Roundup

om a
y c uch

WeatherMax) was unlikely to cause significant deleterious effects on juvenile amphibians at rates applied
an ts s

in silviculture up to 8.64 kg a.e./ha. A similar conclusion was drawn in Edge (2014) where amphibians
an righ

growth and survival of wood frogs was also monitored following wetland exposure, with no toxicity
d
ing to

observed in exposed individuals up to a maximum rate of 2.88 kg a.e./ha. Whilst these studies were not
sh ct
bli bje
pu su
or be

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conducted with the representative formulation, they demonstrates that under field conditions, those

rib
endpoints achieved under laboratory conditions are ameliorated when exposure occurs in the field.

t
dis
n,
er tio
Considering the direct effects risk assessment, there is an amphibian toxicity test that is submitted as part

wn lica
.
of the submission. The study by (2012) was a Glyphosate: Amphibian Metamorphosis assay for

s o ub
f it y p
the detection of thyroid active substances. The study was conducted at water concentrations up to 90 mg

so n
a.e./L, and despite a slight increase in the wet weight of Xenopus laevis tadpoles at 90 mg a.e./L, there were

ht , a
rig ntly
no other effects observed in the study with no effects on growth and development, no mortality and no

th ue
effects on the thyroid, following a 21 day exposure period.

e eq
e
lat ns
vio . Co
an ime al.
Based on the available evidence from the current literature and the information presented in the previous

te reg new
RAR (2015), the risk to amphibians from exposure to the representative formulation, is considered to be

oh tio re

d
within the toxicity profile of the active substance and as such, the risk assessments presented for aquatic

pr tec EU
ibi n
organisms, specifically fish and also those for terrestrial vertebrates are considered to be protective.

d
be ro te
e ta p osa
ef da ph
For mammals, studies on indirect effects through trophic interactions at the population level are generally

er y ly
th tor G
lacking. However, a number of studies have investigated the potential for indirect effects on birds and

ay ula the
mammals in managed forest systems.

or
t m reg king
m er see
From a diversity and abundance perspective, studies on small mammals (i.e., rodents, shrews, voles,

do ll u tium
en a
chipmunks) have shown that some short-term changes after forestry applications of glyphosate were

cu nd
his fa or
observed at the species (Anthony and Morrison, 2985; D’Anieri et al. 1987; Gagné et al. 1999) and
f t ay ns
functional feeding group levels (Santillo et al., 1989a), which the authors attributed to the reduction in
r o m co
ne ent he

invertebrates, plant cover, and food. At the population level, glyphosate did not appear to have significant
ow um of t

or long-lasting effects in the first few years after application (D’Anieri et al. 1987; Santillo et al., 1989a;
th oc (s)

Sullivan et al. 1987). Similar to small mammals, changes in bird community composition, and reductions
of is d ber

in abundance, densities and species richness of bird populations often occurred in the first few years after
ion , th em
iss ore m

glyphosate application (Guiseppe et al. 1986, Easton and Martin, 1998, Santillo et al. 1989b), and in
e
rm m er

Santillo et al. (1989b) the decline in bird densities was correlated with the decline in habitat complexity.
pe her orm

These changes were assessed against untreated control sites to differentiate the effects of glyphosate from
he rt t/f
t t Fu en

other background environmental factors such as the recovery trajectory following tree harvest and showed
ou s. rr
th tie cu

similar responses to other herbicides commonly used in managed forests (Guvnn et al., 2004).
wi par (a)
f
en ird o

Sullivan and Sullivan (2003) published a comprehensive glyphosate assessment addressing vegetation
nt th rty
co and ope

management and ecosystem disturbance focusing on plant and animal biodiversity that consider direct and
r

indirect effects. Their analysis was based on 60 published studies of terrestrial plants and animals in
ts
r i er p
t o wn the

temperate forests and agroecosystems. Species richness of plants was either unaffected or increased in the
en o s
m he t i

case of herbaceous species in those receiving glyphosate treatments. Species richness and diversity of
cu f t en

ts
do s o um

songbirds, in open habitats representative of agricultural lands, did not appear to be negatively impacted in
is ht c

glyphosate use areas. Similarly, in studies on small mammal communities, there was no long-term negative
th rig s do

impact on species richness and diversity. When there were declines in some species of small mammals,
i
e op Th

they were transient and other species of small mammals in those systems increased likely because they
of y

were better generalists in these systems. Larger mammalian herbivores (e.g., rabbit, deer) were not
us c

negatively affected by glyphosate treatments. However, assessment of a wide range of terrestrial

d nd
an a

invertebrate taxa showed variable responses in abundance and their diversity is largely a function of the
n rty
tio e

degree of vegetation control. Overall, the magnitude of changes in species richness and diversity of plants,
ta op
loi pr

birds, small mammals in the studies reviewed by Sullivan and Sullivan were within the mean range of
xp al

natural fluctuations and considered direct and indirect effects.

l e ctu
cia lle
er te
m s in

Indirect effects via Trophic Interactions

om a

Amphibians have both aquatic and terrestrial habitats. The biodiversity assessments presented for the
y c uch

aquatic organisms and for terrestrial invertebrates are considered protective of effects on amphibians
an ts s

occurring in both aquatic and terrestrial habitats. The no spray buffer area required to support the direct
an righ

effects risk assessment for non-target terrestrial plants in off-target areas, is considered to also be protective
d
ing to
sh ct
bli bje
pu su
or be

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of indirect effects on amphibians through loss of habitat and prey items in area surrounding the application

rib
areas.

t
dis
n,
er tio
Refer to the CP 10.1,1 10.1.2 and 10.2 for further information on the indirect effects assessment. In addition,

wn lica
.
please refer to t. V (2020), Glyphosate: Indirect effects via trophic

s o ub
f it y p
interaction - A Practical Approach to Biodiversity Assessment, submitted with this dossier submission.

so n
ht , a
rig ntly
th ue
Additional References relied upon in the Indirect Effects via Trophic Interactions Discussions

e eq
e
lat ns
vio . Co
an ime al.
Anthony RG, Morrison ML, Influence of glyphosate herbicide on small-mammal populations in western

te reg new
Oregon. Northwest Sci. 1985, 59, 159–168.

oh tio re

d
pr tec EU
ibi n
D’Anieri P, Leslie D Jr, McCormack M. 1987. Small mammals in glyphosate-treated clearcuts in northern

d
be ro te
e ta p osa
Maine. Can. Field-Nat. Ottawa ON, 101:547–550.

ef da ph
er y ly
th tor G
Edge CB, Gahl MK, Pauli BD, Thompson DG, Houlahan JE. 2011. Exposure of juvenile green frogs

ay ula the
(Lithobates clamitans) in littoral enclosures to a glyphosate-based herbicide.Ecotoxicol Environ Saf.

or
t m reg king
74:1363-9.

m er see
do ll u tium
en a
Edge CB, Thompson DG, Hao C, Houlahan JE. 2012 A silviculture application of the glyphosate-based

cu nd
his fa or
herbicide VisionMAX to wetlands has limited direct effects on amphibian larvae. Environ Toxicol Chem.
f t ay ns
31:2375-83. doi: 10.1002/etc.1956. Epub 2012 Aug 16.
r o m co
ne ent he
ow um of t

Edge CB, Gahl MK, Thompson DG, Houlahan JE. 2013. Laboratory and field exposure of two species of
th oc (s)

juvenile amphibians to a glyphosate-based herbicide and Batrachochytrium dendrobatidis. Sci Total

of is d ber

Environ. 444:145-52.
ion , th em
iss ore m

e
rm m er

Edge C, Thompson D, Hao C, Houlahan J. 2014. The response of amphibian larvae to exposure to a
pe her orm

glyphosate-based herbicide (Roundup WeatherMax) and nutrient enrichment in an ecosystem experiment.

he rt t/f
t t Fu en

Ecotoxicol Environ Saf. 109:124-32.

ou s. rr
th tie cu
wi par (a)

Edge CB, Baker LF, Lanctôt CM, Melvin SD, Gahl MK, Kurban M, Navarro-Martín L, Kidd KA, Trudeau
f
en ird o

VL, Thompson DG, Mudge JF, Houlahan JE. 2020. Compensatory indirect effects of an herbicide on
nt th rty
co and ope

wetland communities. Sci Total Environ. 718:137254.

r

ts
r i er p
t o wn the

Gagné N, Bélanger L, J Huot. 1999. Comparative responses of small mammals, vegetation, and food
en o s
m he t i

sources to natural regeneration and conifer release treatments in boreal balsam fir stands of Quebec. Can.
cu f t en

ts
do s o um

J. For. Res. 29:1128–1140.

is ht c
th rig s do

Guynn DC, Guynn ST, Wigley TB, DA Miller 2004. Herbicides and forest biodiversity-what do we know
i
e op Th

and where do we go from here? Wildl. Soc. Bull. 32:1085–1092.

of y
us c

Guiseppe KFL, Drummond FA, Stubbs C, Woods S. 2006. The Use of Glyphosate Herbicides in Managed
d nd
an a

Forest Ecosystems and their Effects on Non-Target Organisms with Particular Reference to Ants as
n rty
tio e

Bioindicators; Maine Agricultural and Forest Experiment Station Technical Bulletin 192; Maine
ta op
loi pr

Agricultural and Forest Experiment Station, University of Maine: Orono, ME, USA, p. 51.
xp al
l e ctu
cia lle

Santillo DJ, Leslie DM, Brown PW. 1989a. Responses of small mammals and habitat to glyphosate
er te
m s in

application on clearcuts. J. Wildl. Manag. 53:164–172.

om a
y c uch

Santillo DJ, Brown PW, Leslie DM. 1989b. Response of songbirds to glyphosate-induced habitat changes
an ts s

on clearcuts. J. Wildl. Manag. 53:64–71.

an righ
d
ing to
sh ct
bli bje
pu su
or be

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ep
,r
ion
ut
Sullivan DS, TP Sullivan. 2000. Non-target impacts of the herbicide glyphosate: A compendium of

rib
references and abstracts. 5th Edition. Applied Mammal Research Institute, Summerland, British Columbia,

t
dis
Canada.

n,
er tio
wn lica
.
Sullivan TP, Sullivan DS. 2003. Vegetation management and ecosystem disturbance: impact of glyphosate

s o ub
f it y p
herbicides on plant and animal diversity in terrestrial systems. Env Rev 11:37-59.

so n
ht , a
rig ntly
McLaughlin A, Mineau P. 1995. The impact of agricultural practices on biodiversity. Agriculture,

th ue
Ecosystems and Environment 55:201-212.

e eq
e
lat ns
vio . Co
an ime al.
te reg new
CP 10.2 Effects on Aquatic Organisms

oh tio re

d
pr tec EU
ibi n
d
be ro te
Relevant and reliable studies for the risk assessment of aquatic organisms from the active substance

e ta p osa
glyphosate and the relevant metabolites (AMPA and HMPA) are summarised in the tables below,

ef da ph
er y ly
presenting the most sensitive endpoints for each organism group. Details of these studies are summarised

th tor G
ay ula the
in the document M-CA, Section 8, point 8.2 and relevant endpoints for the risk assessment are provided in

or
t m reg king
the tables below.

m er see
Table 10.2-1: Endpoints and effect values of glyphosate relevant for the risk assessment for

do ll u tium
en a
aquatic organisms

cu nd
his fa or
f t ay ns
r o m co
ne ent he

Reference Test item Species Test design Endpoint LC/EC50 NOEC

ow um of t

based on (mg a.e./L) (mg a.e./L)

th oc (s)

Fish
of is d ber
ion , th em

Glyphosate Lepomis Acute, 96 h, nom 47 32

iss ore m

acid static
rm m er

1995 macrochirus
pe her orm

CA 8.2.1/009
he rt t/f
t t Fu en

2010 Glyphosate Oncorhynchus Chronic, 85 d gm -

ou s. rr

≥ 9.63
th tie cu

CA 8.2.2.1/001 acid mykiss (60 days post-

wi par (a)

hatch) ELS,
f
en ird o

flow-through
nt th rty
co and ope

Aquatic invertebrate
r

ts
r i er p
t o wn the

Glyphosate Crassostrea 48h static nom 40 32

en o s
m he t i

1996 acid gigas

cu f t en

ts

CA
do s o um
is ht c

8.2.4.2/003
th rig s do

Glyphosate Daphnia 21 d nom - 12.5

i
e op Th

acid magna Reproduction

of y

1999 semi-static
us c

CA
d nd
an a

8.2.5.1/001
n rty
tio e

Algae
ta op
loi pr
xp al

Glyphosate Skeletonema 72h static nom ErC50 = 13.5 -

l e ctu

1996 acid costatum

cia lle

EyC50 = 9.0
er te

CA
m s in

8.2.6.2/006
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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,r
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Table 10.2-1: Endpoints and effect values of glyphosate relevant for the risk assessment for

t rib
aquatic organisms

dis
n,
er tio
Reference Test item Species Test design Endpoint LC/EC50 NOEC

wn lica
.
based on (mg a.e./L) (mg a.e./L)

s o ub
f it y p
Aquatic macrophytes

so n
ht , a
Relative Relative

rig ntly
2012 Glyphosate Myriophyllum 14 d static nom
increase: increase:

th ue
CA 8.2.7/010 acid aquaticum

e eq
TSL: 78.7 TSL: 5.0

e
lat ns
FW: 12.3 FW: < 5.0

vio . Co
an ime al.
DW: 25.2 DW: 50.0

te reg new
RL: 18.0 RL: < 5.0

oh tio re

d
Growth rate: Growth rate:

pr tec EU
ibi n
TSL: 276 TSL: 5.0

d
be ro te
e ta p osa
FW: 23.4 FW: < 5.0

ef da ph
DW: 30.2 DW: 50.0

er y ly
RL: < 5.0

th tor G
RL: > 500

ay ula the
a.e.: acid equivalents; nom: nominal; gm: geometric mean measured, GR: growth rate; Y: yield; TSL: total shoot length; FW:

or
t m reg king
fresh weight; DW: dry weight; RL: root length.

m er see
Endpoints in bold are used for risk assessment

do ll u tium
en a
cu nd
his fa or
f t ay ns
r o m co
ne ent he
ow um of t

Table 10.2-2: Endpoints and effect values of AMPA and HMPA relevant for the risk assessment
th oc (s)

for aquatic organisms.

of is d ber
ion , th em
iss ore m

Test item Species Test design Endpoint LC/EC50 NOEC

rm m er

Reference
pe her orm

based on (mg/L) (mg/L)

he rt t/f
t t Fu en

Fish
ou s. rr
th tie cu

AMPA Acute, 96 h, nom -

wi par (a)

1991 Oncorhynchus 520

static
f

mykiss
en ird o

CA 8.2.1/019
nt th rty
co and ope

AMPA Pimephales Chronic, 33 d nom - ≥ 12

r

ts
r i er p

2011 promelas (7 days post-

t o wn the

CA 8.2.2.1/003 hatch) ELS,

en o s
m he t i

flow-through
cu f t en

ts
do s o um
is ht c

Aquatic invertebrates
th rig s do

AMPA Daphnia magna 48h static nom 690 -

i
e op Th

1991
of y

CA 8.2.4.1/014
us c
d nd
an a

2011 HMPA Daphnia magna 48h static nom > 100 -

n rty

CA 8.2.4.1/015
tio e
ta op
loi pr

AMPA Daphnia magna 21 d nom - 15

xp al

2011 Reproduction
l e ctu

semi-static
cia lle

CA 8.2.5.1/007
er te
m s in

Algae
om a
y c uch

1998 AMPA Pseudokirchneriella 72 h static nom ErC50 = 191 -

an ts s

CA 8.2.6.1/016 subcapitata EyC50 = 110

an righ

(Raphidocelis
d
ing to

subcapitata)
sh ct
bli bje
pu su
or be

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Table 10.2-2: Endpoints and effect values of AMPA and HMPA relevant for the risk assessment

t rib
dis
for aquatic organisms.

n,
er tio
wn lica
Test item Species Test design Endpoint LC/EC50 NOEC

.
Reference

s o ub
based on (mg/L) (mg/L)

f it y p
so n
2011

ht , a
HMPA Pseudokirchneriella 72h static nom ErC50 > 120 -

rig ntly
CA 8.2.6.1/019 subcapitata EyC50 > 120

th ue
(Raphidocelis

e eq
e
lat ns
subcapitata)

vio . Co
an ime al.
te reg new
Aquatic macrophytes

oh tio re
2012 AMPA 14 d static gm Relative Relative

d
Myriophyllum

pr tec EU
increase: increase:

ibi n
CA 8.2.7/011 aquaticum

d
be ro te
TSL: 103.3 TSL: 14.3

e ta p osa
FW: 70.8 FW: 14.3

ef da ph
DW: 63.2 DW: 37.1

er y ly
th tor G
RL: 31.1 RL: 5.4

ay ula the
Growth rate: Growth

or
t m reg king
TSL: > 94.6 rate:

m er see
FW: 97.3 TSL: 14.3

do ll u tium
en a
DW: 72.0 FW: 14.3
DW: 37.1

cu nd
RL: 150.1
his fa or
f t ay ns RL: 5.4
r o m co

2011 HMPA 7d am Fronds: ≥ 123

ne ent he

Lemna gibba
ow um of t

CA 8.2.7/012 GR:> 123

Y:> 123
th oc (s)
of is d ber

Biomass:
ion , th em

GR: > 123

iss ore m

Y: > 123
rm m er
pe her orm

a.e.: acid equivalents; nom: nominal; gm: geometric mean measured; am: arithmetic mean measured; GR: growth rate; Y: yield;
TSL: total shoot length; FW: fresh weight; DW: dry weight; RL: root length.
he rt t/f
t t Fu en

Endpoints in bold are used for risk assessment

ou s. rr
th tie cu
wi par (a)

Studies on effects of the representative formulation MON 52276 on aquatic organisms to fulfil the data
f
en ird o
nt th rty

requirements according to EU Regulation No 284/2013 are presented in the following. Studies previously
co and ope

evaluated in either the monograph 2001 or the RAR 2015 were also included in this assessment. Studies
r

ts
r i er p

considering the effects of MON 52276 on aquatic organisms were assessed for their validity to current and
t o wn the

relevant guidelines and are presented in the following tables.

en o s
m he t i
cu f t en

ts
do s o um

Table 10.2-3:Studies on the toxicity of MON 52276 to aquatic organisms

is ht c
th rig s do
i
e op Th

Annex point Study Study type Test species Substance(s) Status Remark
CP 10.2.1/001 1992 Acute, Oncorhynchus MON 52276 Valid
of y

static mykiss
us c
d nd

CP 10.2.1/002 1992 Acute, Cyprinus carpio MON 52276 Valid

an a
n rty

static
tio e
ta op

CP 10.2.1/003 1992 Acute, Daphnia magna MON 52276 Valid

loi pr

flow-
xp al
l e ctu

through
cia lle

CP 10.2.1/004 1992 Acute, Selenastrum MON 52276 Supportive1 No analytical

er te
m s in

static capricornutum verification of

om a

(Raphidocelis test
y c uch

subcapitata) concentrations
an ts s

CP 10.2.1/005 , 2002 Acute, Lemna gibba MON 52276 Supportive2 Bacterial

an righ

semi-static contamination
d
ing to
sh ct
bli bje
pu su
or be

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,r
ion
ut
Table 10.2-3:Studies on the toxicity of MON 52276 to aquatic organisms

t rib
dis
n,
Annex point Study Study type Test species Substance(s) Status Remark

er tio
CP 10.2.1/006 , 2012 Acute, Myriophyllum MON 52276 Valid

wn lica
.
static aquaticum

s o ub
f it y p
1 The product study on algae ( 1992) was performed according to the valid test guideline at the time of conduct. In the

so n
ht , a
last Annex I renewal, this study was evaluated and considered acceptable for use in risk assessment. See study summary for

rig ntly
more details (CP 10.2.1/004).

th ue
2
Concerning the product study performed on Lemna gibba ( 2002), the study was conducted according to the draft

e eq
OECD 221 test guideline from October 2000. The currently adopted test guideline is largely unchanged from the draft guideline.

e
lat ns
vio . Co
In the last Annex I renewal, this study was evaluated and considered acceptable for use in risk assessment. See study summary

an ime al.
te reg new
for more details (CP 10.2.1/005).

oh tio re

d
pr tec EU
ibi n
d
be ro te
Literature articles and peer-reviewed published data considered to be relevant and reliable or reliable with

e ta p osa
restrictions with regards to the impact of glyphosate on aquatic organisms are summarised in the table

ef da ph
er y ly
below. Full literature evaluation is provided in document M-CA Section 9. A summary of previously

th tor G
ay ula the
evaluated peer reviewed literature from the RAR 2015 is also available in Annex M-CA 8-01 of the

or
t m reg king
document M-CA Section 8. Each literature article summary is presented below according to the respective
annex point. For discussions of literature regarding toxicity to aquatic organisms, please see below.

m er see
do ll u tium
en a
cu nd
his fa or
Table 10.2-4: Literature on toxicity of glyphosate, metabolites and MON 52276 to aquatic
organisms f t ay ns
r o m co
ne ent he
ow um of t

Annex point Study Study type Substance(s) Status Remark

th oc (s)

CP 10.2.1/007 Gabriel, 2010. Acute study Roundup Relevant and The effects of
of is d ber

Toxicity of roundup (a on African containing reliable with Roundup were tested

ion , th em

glyphosate product) to catfish 360 g/l restrictions in an acute test with C.

iss ore m

e
rm m er

fingerlings of Clarias glyphosate gariepinus fingerlings.

pe her orm

gariepinus. The 96 hour-LC90 was

he rt t/f

determined to be 19.91
t t Fu en
ou s. rr

mg prod./L.
th tie cu
wi par (a)
f
en ird o
nt th rty

In the last Annex I submission (RAR, 2015), 30 peer reviewed papers were submitted for the algal group,
co and ope

approximately 42 papers submitted on aquatic invertebrates and 60 papers submitted on aquatic vertebrates,
r

ts
r i er p
t o wn the

with the majority of papers cited being conducted on formulated products and not with the active substance.
en o s

The formulated product was not the representative formulation and therefore could not be directly related
m he t i
cu f t en

ts

to the risk assessment to EU renewal. The conclusion by the RMS (UBA) was that there were no critical
do s o um

data that could directly be included in the environmental risk assessment for the active substance. The
is ht c
th rig s do

literature review from the previous Annex I renewal is included in Annex

i
e op Th

M-CA 8-01 of the document M-CA Section 8.

of y
us c

Concerning the recent literature review for the 2020 submission:

d nd
an a
n rty

The document M-CA Sections 8.2.1 to 8.2.7 and Table 10.2-4 above, present relevant and reliable articles
tio e
ta op

in the area of aquatic ecotoxicology, considered relevant to include in this section. The papers are
loi pr

considered relevant and reliable according to the EFSA guidance on submitting peer-reviewed open (EFSA
xp al
l e ctu

(2011) literature review guidance.

cia lle
er te
m s in

In Antunes A. M. et al. (2017), KCA 8.2.1/021: Gender-specific histopathological responses in guppies

om a
y c uch

Poecilia reticulata exposed to glyphosate or its metabolite aminomethylphosphonic acid, were assessed.
an ts s

This study was considered relevant and reliable with restrictions, due mainly to the lack of analytical dose
an righ

verification. The study determined the acute exposure effects of glyphosate and AMPA to guppies after a
d
ing to

96 h exposure period. The test was conducted according to USEPA acute toxicity testing methods, and 96 h
sh ct
bli bje
pu su
or be

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ep
,r
ion
ut
acute LC50 values for male and female guppies of 68.78 and 70.87 mg/L, and for AMPA of 80 and

rib
164.32 mg/L, respectively were determined. Histopathological examination of tissues was also performed

t
dis
in the study, but it is not possible to relate the histopathological information presented in the paper, to a risk

n,
er tio
assessment for Annex I renewal from an ecotox perspective. The achieved endpoints do not affect the acute

wn lica
.
fish endpoints selected for the risk assessment and the outcome is unchanged.

s o ub
f it y p
so n
ht , a
Gholami et al., (2013) KCA 8.2.1/022; Toxicity of roundup (a glyphosate product) to fingerlings of

rig ntly
Cyprinus carpio. The acute toxicity of glyphosate was tested in an acute fish toxicity test with C. carpio

th ue
fingerlings, where a 96 h-LC50 of 6.753 mg/L was achieved. The study is not however considered relevant

e eq
e
lat ns
to the EU Annex I renewal risk assessment, as the identity of the test substance cannot be confirmed and

vio . Co
an ime al.
the fact there was no study validity criteria presented and test item exposure was not confirmed. Based on

te reg new
the available regulatory study toxicity data for glyphosate acid (96 hr LC50 > 100 mg a.e./L) and the

oh tio re

d
representative formulation – MON 52276 (96 hr LC50 > 277 mg a.e./L), that are considered relevant and

pr tec EU
ibi n
d
reliable, the achieved endpoint in this study should be treated with a high degree of caution. It is not

be ro te
e ta p osa
therefore considered reliable for use in risk assessment.

ef da ph
er y ly
th tor G
In Daam M.A et al.,(2019), KCA 8.2.8/001: Lethal toxicity of the herbicides acetochlor, ametryn,

ay ula the
glyphosate and metribuzin to tropical frog larvae, the acute exposure of glyphosate to Phsalaemus cuvieri

or
t m reg king
and Hypsiboas paradalis amphibians, in 96 h acute toxicity tests according to ASTM and OECD methods

m er see
were determined. For glyphosate the 96 hr LC50 values for P. cuvieri and H. paradalis were 115 and 106

do ll u tium
en a
mg/L, respectively. This study was conducted according to elements of OECD 241. However, validity

cu nd
his fa or
criteria were not reported and it is unknown if the larvae were exposed to any other chemicals as no analysis
f t ay ns
r o m co
of watershed water was provided. The source of the animals is also not reported. With no analytical
ne ent he

verification of test concentrations reported in the article, exposure is difficult to confirm. Based on these
ow um of t

uncertainties, this study is considered not to provide additional information to inform on the endpoint list
th oc (s)

and the risk assessment.

of is d ber
ion , th em
iss ore m

For Levine et al., (2015) KCA 8.2.5.1/008; the data presented in the paper are relevant for use in risk
e
rm m er

assessment and the daphnia chronic and fish early life stage test endpoints are presented in the following
pe her orm

risk assessment.
he rt t/f
t t Fu en
ou s. rr
th tie cu

Gabriel U. U., 2010. CP 10.2.1/007; Toxicity of roundup (a glyphosate product) to fingerlings of Clarias
wi par (a)

gariepinus. The effects of Roundup were tested in an acute fish toxicity test with C. gariepinus fingerlings.
f
en ird o
nt th rty

The 96 h-LC50 was determined to be 15.88 mg prod./L. There is however insufficient information presented
co and ope

in the article to confirm the identity of the test substance used, therefore these data should be considered
r

ts
r i er p

relevant but with restrictions over the uncertainty over the identity of the formulated product used. Based
t o wn the

on the year the study was conducted and considering the Roundup products registered in the country at that
en o s
m he t i
cu f t en

time the study was conducted, it is highly probable that the formulation used contained a surfactant that is
ts
do s o um

not used in the EU and is not relevant to the EU representative formulation. In the previous Annex I RAR
is ht c
th rig s do

(2015), the RMS (UBA) presented an extensive overview of acute fish toxicity endpoints achieved in
i

studies performed with formulations containing POEA or related surfactants. The achieved endpoint in this
e op Th

study is within the range of endpoints achieved for POEA containing formulations. The results of the study
of y

would not affect the outcome of the presented fish acute risk assessment, with the PEC/RAC value still
us c
d nd

being < 1.0 based on the current PECsw values at FOCUS Step 1. However, given the uncertainty associated
an a
n rty

with the study and the test item identity, this endpoint should be considered with a degree of caution.
tio e
ta op
loi pr

Rodrigues L. B. et al., (2019) KCA 8.2.2.1/005; assessed the impact of the glyphosate-based commercial
xp al
l e ctu

herbicide, its components and its metabolite AMPA on non-target aquatic organisms. The formulation
cia lle
er te

tested contained POEA, which is not relevant to the EU renewal of glyphosate as the representative
m s in

formulation does not contain POEA. Only technical data are considered in the following. An acute LC50 >
om a
y c uch

100 mg/L was determined. The FET data indicated some genotoxic damage from glyphosate at exposure
an ts s

concentrations beyond 10 mg/L. No other effects relevant to glyphosate were discussed. In this study, the
an righ

acute toxicity of technical glyphosate, its metabolite aminomethylphosphonic acid (AMPA) and of a
d

glyphosate based formulation (Antor 48) to zebrafish embryos was investigated. Glyphosate and AMPA
ing to
sh ct
bli bje
pu su
or be

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ep
,r
ion
ut
caused no acute toxic effect (LC50-96 h > 100 mg/L), while Antor 48 induced significant lethal effect in

rib
zebrafish embryo (LC50 96 h = 76.50 mg/L). The study was stated to have been conducted according to

t
dis
OECD guideline 236, but there is no information on hatching rates in the treatment and control groups, so

n,
er tio
exposure of the embryo without a potential barrier function of the chorion cannot be confirmed. Concerning

wn lica
.
the validity of the study, four of the six validity criteria from the test guideline are mentioned in the paper

s o ub
f it y p
(fertilization rate of embryo batches used was > 90 %, survival in the negative control group was > 90 %,

so n
temperature was maintained at 26 ±1 ºC and dissolved oxygen was at an acceptable level 8ppm). There is

ht , a
rig ntly
no information presented on the performance of the positive control group (3, 4-dichloroaniline) and no

th ue
information provided on the hatching rates in the negative control group at 96 hours, which for the control

e eq
e
lat ns
group should exceed 80 %. As this information is not presented and the fact that there was no analytical

vio . Co
an ime al.
verification of test concentrations reported, the reliability of the test and the achieved endpoints is

te reg new
considered questionable. Therefore, this study should be supportive information only.

oh tio re

d
pr tec EU
ibi n
The paper by Schweizer M. et al., (2019) KCA 8.2.2.1/006; deals with how glyphosate and its associated

d
be ro te
e ta p osa
acidity affect early development in zebrafish (Danio rerio). For Zebrafish (Danio rerio) embryos acutely

ef da ph
exposed to glyphosate at concentrations between 1.69 and 1690.7 mg glyphosate/L (10 µM to 10 mM) for

er y ly
th tor G
96 h post fertilization (hpf) the LC10 and LC50 values (96 hpf) were calculated to be 65.1 mg a.s./L (385

ay ula the
µM) and 98.4 mg a.s./L (582 µM), respectively (in unbuffered glyphosate medium). Regarding heart rates

or
t m reg king
the EC10 was 7.27 mg a.s./L (43 µM). Concerning hatching rate, 96 hpf -EC10 and EC50 values were 26.2

m er see
mg a.s./L (155 µM) and 37.9 (224 µM), respectively. For developmental delays at 24 hpf the EC10 was 21.3

do ll u tium
en a
mg a.s./L (126 µM). The test was conducted according to OECD 236 test guideline. Concerning the validity

cu nd
his fa or
criteria in the OECD 236, despite the stated > 80% mortality in the positive control (>30% required) there
f t ay ns
are no details presented to confirm the level of mortality. The fertilisation rate of the batch of eggs used
r o m co
ne ent he

was not reported. Finally, acute endpoints based on developmental delay and heart rate are not relevant to
ow um of t

an EU level risk assessment for Annex I renewal purposes. The test design is adequately described,
th oc (s)

however, there was no analytical verification of test concentrations reported in the study, thus the endpoints
of is d ber

should be considered with some caution. Therefore, the study should be considered reliable with
ion , th em
iss ore m

restrictions.
e
rm m er

Then, of those papers considered relevant and reliable, Tian et al ., (2015) KCA 8.2.7/013, concerned the
pe her orm

aquatic macrophyte ‘Growth inhibition of two herbicides on Spirodela polyrrhiza, The effects of glyphosate
he rt t/f
t t Fu en

to the aquatic macrophyte Spirodela polyrhiza was tested in a semi-static exposure of 7 days at
ou s. rr
th tie cu

concentrations between 8.4 and 20.902 mg/L. The 7 day-EC50 value was determined to be 12.817 mg/L.
wi par (a)

This species is closely related to Lemna sp. but does not present information that could influence the
f
en ird o

endpoint list used for the Annex 1 renewal. This study was conducted to guideline but not to GLP. The test
nt th rty
co and ope

concentrations were not analytically verified and thus the exact exposure concentrations of the aquatic
r

macrophyte are unknown. Therefore, the derived endpoint is questionable and the study should be
ts
r i er p
t o wn the

considered acceptable as supportive information only.

en o s
m he t i
cu f t en

ts
do s o um

Endpoints of studies considered valid with the representative product MON 52276 are shown in the table
is ht c
th rig s do

below. In order to make a direct comparison of toxicity between studies conducted with MON 52276 and
those conducted with IPA salt, glyphosate technical and glyphosate acid, the endpoints from all these
i
e op Th

studies have been converted to acid equivalents (a.e.). This conversion has been made by the acid equivalent
of y

purity of the test item stated in the reports.

us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
,r
ion
ut
Table 10.2-5: Endpoints and effect values of MON 52276 relevant for the risk assessment for

t rib
dis
aquatic organisms

n,
er tio
wn lica
Reference Test item Species Test design Endpoint LC/EC50

.
s o ub
based on (mg a.e./L)

f it y p
so n
1992 MON 52276 Oncorhynchus Acute, am > 306

ht , a
CP 10.2.1/001 96 h, static

rig ntly
mykiss

th ue
, 1992 MON 52276 Cyprinus carpio Acute, am > 277

e eq
CP 10.2.1/002 96 h, static

e
lat ns
vio . Co
an ime al.
1992 MON 52276 Daphnia magna Acute, am 209

te reg new
CP 10.2.1/003 48 h flow-

oh tio re

d
through

pr tec EU
ibi n
d
2012 MON 52276 Myriophyllum 14 d static gm relative increase:

be ro te
e ta p osa
CP 10.2.1/006 aquaticum SL = 13.44

ef da ph
FW = 4.44 L

er y ly
th tor G
DW = not determined

ay ula the
RL = 5.84

or
t m reg king
growth rate:

m er see
SL = 42.79

do ll u tium
en a
FW= 10.33

cu nd
his fa or
DW = 143.34
a.e.: acid equivalents; nom: nominal; gm: geometric mean measured; am: arithmetic mean measured. f t ay ns
r o m co

GR: growth rate; Y: yield; TSL: total shoot length; FW: fresh weight; DW: dry weight; RL: root length.
ne ent he
ow um of t

Endpoints in bold are used for risk assessment

th oc (s)
of is d ber

The toxicity to aquatic plants from MON 52276 (ErC50 = 10.33 mg a.e./L, fresh weight) is slightly higher
ion , th em

compared to the toxicity shown by the active substance (ErC50 = 23.4 mg a.e./L, fresh weight) but this is
iss ore m

within a factor of 2.5 allowing for biological variability within the test systems and due to the impact of the
rm m er
pe her orm

additional components in the composition of the product that enhance the uptake of the active substance to
he rt t/f

the plant. Nevertheless the lower endpoint from the study with MON 52276 is used in the risk assessment
t t Fu en
ou s. rr

as a worst case.
th tie cu
wi par (a)
f

Risk assessment for aquatic organisms

en ird o
nt th rty
co and ope

The evaluation of the risk for aquatic organisms was performed in accordance with the recommendations
r

ts
r i er p

of the Guidance document on tiered risk assessment for plant protection products for aquatic organisms in
t o wn the

edge-of-field surface waters in the context of Regulation (EC) No 1107/2009 (EF-SA Journal 2013;
en o s
m he t i
cu f t en

ts

11(7):3290); hereafter referred to as EFSA/2013/3290.

do s o um
is ht c
th rig s do

The table below summarises how the risk assessment for aquatic organisms considers all the proposed uses
i
e op Th

and the application rates presented in the GAP. The grey shaded cells indicate that a worst-case risk
assessment for aquatic organisms for the proposed uses is provided below. The ‘X” in the table indicates
of y

where PECsw values have been calculated and the risk assessment has been conducted. For completeness,
us c
d nd

all risk assessment is shown in Annex M-CP 10-04 to this document. PECsw values have been generated
an a
n rty

for glyphosate and the relevant metabolites; AMPA and HMPA. Where appropriate applications in spring
tio e
ta op

and autumn have been considered and the maximum PECsw values from either application timing for each
loi pr

scenario has been used in risk assessment. Full details are provided in the environmental fate document
xp al
l e ctu

M-CA Section 7.
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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 It
an may
d/
or be
pu su
bli bje
sh ct
ing to
an righ
d
an ts s
y c uch
om a
m s in
er te
cia lle
l e ctu
xp al
loi pr
ta op
tio e
n rty
an a
d nd
us c
e op Th
of y i
th rig s do
is ht c
do s o um
cu f t en
m he t i
en o s
t o wn the
r i er p
ts r
co and ope
nt th rty
en ird o
ts f
wi par (a)
th tie cu
ou s. rr
t t Fu en
he rt t/f
pe her orm
rm m er
iss ore m
ion , th em
of is d ber
th oc (s)
e
ow um of t
ne ent he
r o m co
f t ay ns
his fa or
do ll u tium
cu nd
m er see
en a
t m reg king
ay ula the
th tor G
er y ly
ef da ph
or
e ta p osa
be ro te
pr tec EU
oh tio re
ibi n
te reg new
d
an ime al.
d
vio . Co
lat ns
e eq
th ue
e
rig ntly
ht , a
so n
f it y p
s o ub
wn lica
er tio
. n,
dis
trib
ut
ion
,r
ep
ro
du
cti
on
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 164 of 553

ep
,r
ion
ut
rib
The derivation of RAC values for the risk assessment is presented in the following tables. The most

t
dis
sensitive endpoint between the active substance (glyphosate, glyphosate acid or glyphosate salt) and the

n,
er tio
representative formulation MON 52276 is used to provide the representative RAC for each organism group

wn lica
.
and exposure (acute and chronic).

s o ub
f it y p
so n
ht , a
Table 10.2-7: Derivation of RAC values used in the risk assessment – glyphosate and relevant

rig ntly
metabolites

th ue
e eq
e
lat ns
Species Substance Exposure Results Assessment RAC

vio . Co
an ime al.
(µg/L) Safety factor (µg/L)

te reg new
oh tio re
Glyphosate

d
pr tec EU
ibi n
Lepomis macrochirus Glyphosate 96 h LC50 = 47000 100 470

d
be ro te
acid

e ta p osa
ef da ph
Oncorhynchus mykiss Glyphosate 85 d NOEC ≥ 9630 10 963

er y ly
th tor G
acid

ay ula the
Crassostrea gigas Glyphosate 48h static EC50 = 40000 100 400

or
t m reg king
acid

m er see
Daphnia magna Glyphosate 168 h NOEC = 12500 10 1250

do ll u tium
en a
acid

cu nd
his fa or
Skeletonema costatum Glyphosate 72h static f t ay ns
ErC50 = 13500 10 1350
r o m co
acid
ne ent he
ow um of t

Myriophyllum aquaticum MON 52276 14 d static ErC50 = 10330 10 1033

th oc (s)

AMPA
of is d ber
ion , th em

Oncorhynchus mykiss AMPA 96 h static EC50 = 520000 100 5200

iss ore m

Pimephales promelas AMPA 33 d flow through NOEC = 12000 10 1200

rm m er
pe her orm

Daphnia magna AMPA 48 h static EC50 = 690000 100 6900

he rt t/f
t t Fu en

Daphnia magna AMPA 21 d semi static EC50 = 15000 10 1500

ou s. rr
th tie cu

Pseudokirchneriella AMPA 72 h NOEC = 191000 10 19100

wi par (a)

subcapitata
f
en ird o
nt th rty

Myriophyllum aquaticum AMPA 14 d ErC50 = 72000 10 7200

co and ope

HMPA
r

ts
r i er p
t o wn the

Daphnia magna HMPA 48 h EC50 > 100000 100 1000

en o s
m he t i

Pseudokirchneriella HMPA 72 h ErC50 > 120000 10 12000

cu f t en

ts
do s o um

subcapitata
is ht c
th rig s do

Lemna gibba HMPA 14 d EC50 > 123000 10 12300

i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 165 of 553

th ue
e eq
e
lat ns
vio . Co
In the following tables, the ratios between predicted environmental concentrations of glyphosate in surface water (PECSW) and regulatory acceptable concentrations

an ime al.
te reg new
(RAC) for aquatic organisms are given per intended use (as described in Table 10.2-6) for each FOCUS scenario and for each organism group.

oh tio re

d
pr tec EU
Please note that the PEC/RAC ratios in the following tables are rounded to 3 decimal places. For endpoints and the corresponding RAC value which are presented

ibi n
d
be ro te
as “>” or “≥” the PEC/RAC ratios are presented without the symbol of ‘<’. This does not have any impact on the outcome of the risk assessment presented below.

e ta p osa
ef da ph
er y ly
Table 10.2-8: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for glyphosate for each organism group based on FOCUS Steps 1, 2 and 3

th tor G
ay ula the
calculations for the use of MON 52276 in root vegetables (2 × 1080 g a.s./ha, with application interval of 28 days). Uses 2 a-c.

or
t m reg king
m er see
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

do ll u tium
en a
Test species Lepomis Oncorhynchus mykiss Crassostrea gigas Daphnia magna Skeletonema costatum Myriophyllum aquaticum

cu nd
macrochirus

his fa or
f t ay ns
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

r o m co
(µg/L) 47000 ≥ 9630 40000 12500 13500 10330

ne ent he
ow um of t
AF 100 10 100 10 10 10

th oc (s)
RAC (µg/L) 470 ≥ 963 400 1250 1350 1033

of is d ber
FOCUS PECsw,max

ion , th em
Scenario (µg/L)

iss ore m

e
Step 1

rm m er
pe her orm
128.016 0.272 0.133 0.320 0.102 0.095 0.124

he rt t/f
Step 2
N-Europe 39.622 0.084 0.041 t t Fu en
0.099 0.032 0.029 0.038
ou s. rr
th tie cu

S-Europe 32.382 0.069 0.034 0.081 0.026 0.024 0.031

wi par (a)

Step 3
f
en ird o

D3/ditch 6.756 0.014 0.007 0.017 0.005 0.005 0.007

nt th rty
co and ope

D6/ditch 6.774 0.014 0.007 0.017 0.005 0.005 0.007

r

ts

R1/pond 0.542 0.001 < 0.001 0.001 < 0.001 < 0.001 < 0.001
r i er p
t o wn the

R1/stream 4.453 0.009 0.005 0.011 0.004 0.003 0.004

en o s
m he t i

R2/stream 5.977 0.013 0.006 0.015 0.005 0.004 0.006

cu f t en

ts

R2/stream 2nd 5.977 0.013 0.006 0.015 0.005 0.004 0.006

do s o um
is ht c

R3/stream 6.287 0.013 0.007 0.016 0.005 0.005 0.006

th rig s do

R4/stream 4.396 0.009 0.005 0.011 0.004 0.003 0.004

i
e op Th

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 166 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-9: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for glyphosate for each organism group based on FOCUS Steps 1, 2 and 3

oh tio re
calculations for the use of MON 52276 in potatoes (2 × 1080 g a.s./ha, with application interval of 28 days). Uses 2 a-c.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

ef da ph
Test species Lepomis Oncorhynchus Crassostrea gigas Daphnia magna Skeletonema costatum Myriophyllum aquaticum

er y ly
macrochirus mykiss

th tor G
ay ula the
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

or
t m reg king
(µg/L) 47000 ≥ 9630 40000 12500 13500 10330

m er see
AF 100 10 100 10 10 10

do ll u tium
en a
RAC (µg/L) 470 ≥ 963 400 1250 1350 1033

cu nd
his fa or
f t ay ns
FOCUS PECsw,m

r o m co
Scenario ax

ne ent he
(µg/L)

ow um of t
Step 1

th oc (s)
128.016 0.272 0.133 0.320 0.102 0.095 0.124

of is d ber
ion , th em
Step 2

iss ore m
N-Europe 39.622 0.084 0.041 0.099 0.032 0.029 0.038

e
rm m er
S-Europe 32.382 0.069 0.034 0.081 0.026 0.024 0.031

pe her orm
Step 3

he rt t/f
t t Fu en
D3/ditch 5.567 0.012 0.006 0.014 ou s. rr
th tie cu 0.004 0.004 0.005
D4/pond 0.252 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001
wi par (a)

D4/stream 4.736 0.010 0.005 0.012 0.004 0.004 0.005

f
en ird o

D6/ditch 5.605 0.012 0.006 0.014 0.004 0.004 0.005

nt th rty

D6/ditch 2nd 5.622 0.012 0.006 0.014 0.004 0.004 0.005

co and ope

R1/pond 0.902 0.002 < 0.001 0.002 < 0.001 < 0.001 < 0.001
r

ts
r i er p

R1/stream 3.861 0.008 0.004 0.010 0.003 0.003 0.004

t o wn the

R2/stream 5.183 0.011 0.005 0.013 0.004 0.004 0.005

en o s
m he t i
cu f t en

R3/stream 5.451 0.012 0.006 0.014 0.004 0.004 0.005

ts
do s o um

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 167 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-10: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for glyphosate for each organism group based on FOCUS Steps 1, 2 and 3

oh tio re
calculations for the use of MON 52276 in bulb vegetables (2 × 1080 g a.s./ha, with application interval of 28 days). Uses 2 a-c.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

ef da ph
Test species Lepomis macrochirus Oncorhynchus mykiss Crassostrea gigas Daphnia magna Skeletonema Myriophyllum aquaticum

er y ly
costatum

th tor G
ay ula the
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

or
t m reg king
(µg/L) 47000 ≥ 9630 40000 12500 13500 10330
AF 100 10 100 10 10 10

m er see
RAC (µg/L) 470 ≥ 963 400 1250 1350 1033

do ll u tium
en a
FOCUS PECsw,max

cu nd
his fa or
f t ay ns
Scenario (µg/L)

r o m co
Step 1

ne ent he
128.016 0.272 0.133 0.320 0.102 0.095 0.124

ow um of t
Step 2

th oc (s)
N-Europe 39.622 0.084 0.041 0.099 0.032 0.029 0.038

of is d ber
ion , th em
S-Europe 32.382 0.069 0.034 0.081 0.026 0.024 0.031

iss ore m

e
Step 3

rm m er
D3/ditch 6.732 0.014 0.007 0.017 0.005 0.005 0.007

pe her orm
D4/pond 0.260 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001

he rt t/f
t t Fu en
D4/stream 5.323 0.011 0.006 0.013
ou s. rr
th tie cu 0.004 0.004 0.005
D6/ditch 6.803 0.014 0.007 0.017 0.005 0.005 0.007
wi par (a)

D6/ditch 2nd 6.803 0.014 0.007 0.017 0.005 0.005 0.007

f
en ird o

R1/pond 0.888 0.002 < 0.001 0.002 < 0.001 < 0.001 < 0.001
nt th rty

R1/stream 4.453 0.009 0.005 0.011 0.004 0.003 0.004

co and ope

R2/stream 5.977 0.013 0.006 0.015 0.005 0.004 0.006

r

ts
r i er p
t o wn the

R3/stream 6.286 0.013 0.007 0.016 0.005 0.005 0.006

en o s

R4/stream 4.452 0.009 0.005 0.011 0.004 0.003 0.004

m he t i
cu f t en

ts

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 168 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-11: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for glyphosate for each organism group based on FOCUS Steps 1, 2 and 3

oh tio re
calculations for the use of MON 52276 in fruiting vegetables (2 × 1080 g a.s./ha, with application interval of 28 days). Uses 2 a-c.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

ef da ph
Test species Lepomis Oncorhynchus Crassostrea gigas Daphnia magna Skeletonema Myriophyllum

er y ly
macrochirus mykiss costatum aquaticum

th tor G
ay ula the
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

or
t m reg king
(µg/L) 47000 ≥ 9630 40000 12500 13500 10330
AF 100 10 100 10 10 10

m er see
RAC (µg/L) 470 ≥ 963 400 1250 1350 1033

do ll u tium
en a
FOCUS PECsw,max

cu nd
his fa or
f t ay ns
Scenario (µg/L)

r o m co
Step 1

ne ent he
128.016 0.272 0.133 0.320 0.102 0.095 0.124

ow um of t
Step 2

th oc (s)
N-Europe 39.622 0.084 0.041 0.099 0.032 0.029 0.038

of is d ber
ion , th em
S-Europe 32.382 0.069 0.034 0.081 0.026 0.024 0.031

iss ore m

e
Step 3

rm m er
D6/ditch 6.789 0.014 0.007 0.017 0.005 0.005 0.007

pe her orm
R2/stream 5.977 0.013 0.006 0.015 0.005 0.004 0.006

he rt t/f
t t Fu en
R3/stream 6.287 0.013 0.007 ou s. rr
th tie cu 0.016 0.005 0.005 0.006
R4/stream 4.452 0.009 0.005 0.011 0.004 0.003 0.004
wi par (a)

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 169 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-12: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for glyphosate for each organism group based on FOCUS Steps 1, 2 and 3

oh tio re
calculations for the use of MON 52276 in leafy vegetables (2 × 1080 g a.s./ha, with application interval of 28 days). Uses 2 a-c.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

ef da ph
Test species Lepomis Oncorhynchus Crassostrea gigas Daphnia magna Skeletonema costatum Myriophyllum aquaticum

er y ly
macrochirus mykiss

th tor G
ay ula the
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

or
t m reg king
(µg/L) 47000 ≥ 9630 40000 12500 13500 10330
AF 100 10 100 10 10 10

m er see
RAC (µg/L) 470 ≥ 963 400 1250 1350 1033

do ll u tium
en a
FOCUS PECsw,max

cu nd
his fa or
f t ay ns
Scenario (µg/L)

r o m co
Step 1

ne ent he
128.016 0.272 0.133 0.320 0.102 0.095 0.124

ow um of t
Step 2

th oc (s)
N-Europe 39.622 0.084 0.041 0.099 0.032 0.029 0.038

of is d ber
ion , th em
S-Europe 32.382 0.069 0.034 0.081 0.026 0.024 0.031

iss ore m

e
Step 3

rm m er
D3/ditch 6.755 0.014 0.007 0.017 0.005 0.005 0.007

pe her orm
D3/ditch 2nd 6.750 0.014 0.007 0.017 0.005 0.005 0.007

he rt t/f
t t Fu en
D4/pond 0.260 < 0.001 < 0.001 < 0.001
ou s. rr
th tie cu < 0.001 < 0.001 < 0.001
D4/stream 5.430 0.012 0.006 0.014 0.004 0.004 0.005
wi par (a)

D6/ditch 6.803 0.014 0.007 0.017 0.005 0.005 0.007

f
en ird o

R1/pond 0.451 < 0.001 < 0.001 0.001 < 0.001 < 0.001 < 0.001
nt th rty

R1/pond 2nd 1.201 0.003 0.001 0.003 < 0.001 < 0.001 0.001
co and ope

R1/stream 4.451 0.009 0.005 0.011 0.004 0.003 0.004

r

ts
r i er p
t o wn the

R1/stream 2nd 4.448 0.009 0.005 0.011 0.004 0.003 0.004

en o s

R2/stream 5.977 0.013 0.006 0.015 0.005 0.004 0.006

m he t i
cu f t en

R2/stream 2nd
ts

5.977 0.013 0.006 0.015 0.005 0.004 0.006

do s o um

R3/stream 6.287 0.013 0.007 0.016 0.005 0.005 0.006

is ht c
th rig s do

R3/stream 2nd 6.287 0.013 0.007 0.016 0.005 0.005 0.006

i

R4/stream 4.452 0.009 0.005 0.011 0.004 0.003 0.004

e op Th

R4/stream 2nd 4.452 0.009 0.005 0.011 0.004 0.003 0.004

of y

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 170 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-13: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for glyphosate for each organism group based on FOCUS Steps 1, 2 and 3

oh tio re
calculations for the use of MON 52276 in sugar beets (2 × 1080 g a.s./ha, with application interval of 28 days). Uses 2 a-c.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

ef da ph
Test species Lepomis macrochirus Oncorhynchus Crassostrea gigas Daphnia magna Skeletonema costatum Myriophyllum aquaticum

er y ly
mykiss

th tor G
ay ula the
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

or
t m reg king
(µg/L) 47000 ≥ 9630 40000 12500 13500 10330
AF 100 10 100 10 10 10

m er see
RAC (µg/L) 470 ≥ 963 400 1250 1350 1033

do ll u tium
en a
FOCUS PECsw,max

cu nd
his fa or
f t ay ns
Scenario (µg/L)

r o m co
Step 1

ne ent he
128.016 0.272 0.133 0.320 0.102 0.095 0.124

ow um of t
Step 2

th oc (s)
N-Europe 39.622 0.084 0.041 0.099 0.032 0.029 0.038

of is d ber
ion , th em
S-Europe 32.382 0.069 0.034 0.081 0.026 0.024 0.031

iss ore m

e
Step 3

rm m er
D3/ditch 5.567 0.012 0.006 0.014 0.004 0.004 0.005

pe her orm
D4/pond 0.256 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001

he rt t/f
t t Fu en
D4/stream 4.880 0.010 0.005 0.012
ou s. rr
th tie cu 0.004 0.004 0.005
R1/pond 1.165 0.002 0.001 0.003 < 0.001 < 0.001 0.001
wi par (a)

R1/stream 3.861 0.008 0.004 0.010 0.003 0.003 0.004

f
en ird o

R3/stream 5.451 0.012 0.006 0.014 0.004 0.004 0.005

nt th rty

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 171 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-14: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for glyphosate for each organism group based on FOCUS Steps 1, 2 and 3

oh tio re
calculations for the use of MON 52276 in pome/stone fruit (2 × 1440 g a.s./ha, with application interval of 28 days). Uses 4 a-c.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. Algae Aquatic macrophytes

ef da ph
prolonged

er y ly
Test species Lepomis Oncorhynchus Crassostrea gigas Daphnia magna Skeletonema costatum Myriophyllum aquaticum

th tor G
ay ula the
macrochirus mykiss

or
t m reg king
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50
(µg/L) 47000 ≥ 9630 40000 12500 13500 10330

m er see
AF 100 10 100 10 10 10

do ll u tium
en a
RAC (µg/L) 470 ≥ 963 400 1250 1350 1033

cu nd
his fa or
f t ay ns
FOCUS PECsw,max

r o m co
Scenario (µg/L)

ne ent he
Step 1

ow um of t
170.688 0.363 0.177 0.427 0.137 0.126 0.165

th oc (s)
Step 2

of is d ber
N-Europe 52.829 0.112 0.055 0.132 0.042 0.039 0.051

ion , th em
iss ore m
S-Europe 43.176 0.092 0.045 0.108 0.035 0.032 0.042

e
rm m er
Step 3

pe her orm
D3/ditch 3.814 0.008 0.004 0.010 0.003 0.003 0.004

he rt t/f
t t Fu en
D4/pond 0.278 < 0.001 < 0.001 < 0.001
ou s. rr
th tie cu < 0.001 < 0.001 < 0.001
D4/stream 3.372 0.007 0.004 0.008 0.003 0.002 0.003
wi par (a)

D5/pond 0.283 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001
f
en ird o

D5/stream 3.724 0.008 0.004 0.009 0.003 0.003 0.004

nt th rty

R1/pond 0.267 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001
co and ope

R1/stream 2.635 0.006 0.003 0.007 0.002 0.002 0.003

r

ts
r i er p
t o wn the

R2/stream 3.538 0.008 0.004 0.009 0.003 0.003 0.003

R3/stream 3.721 0.008 0.004 0.009 0.003 0.003 0.004
en o s
m he t i
cu f t en

ts

R4/stream 3.225 0.007 0.003 0.008 0.003 0.002 0.003

do s o um

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 172 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-15: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for glyphosate for each organism group based on FOCUS Steps 1, 2 and 3

oh tio re
calculations for the use of MON 52276 in olives (2 × 1440 g a.s./ha, with application interval of 28 days). Uses 4 a-c.

d
pr tec EU
ibi n
d
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

be ro te
e ta p osa
Test species Lepomis macrochirus Oncorhynchus mykiss Crassostrea gigas Daphnia magna Skeletonema costatum Myriophyllum aquaticum

ef da ph
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

er y ly
th tor G
(µg/L) 47000 ≥ 9630 40000 12500 13500 10330

ay ula the
AF 100 10 100 10 10 10

or
t m reg king
RAC (µg/L) 470 ≥ 963 400 1250 1350 1033

m er see
FOCUS PECsw,max

do ll u tium
en a
Scenario (µg/L)

cu nd
Step 1

his fa or
f t ay ns
170.688 0.363 0.177 0.427 0.137 0.126 0.165

r o m co
Step 2

ne ent he
ow um of t
N-Europe 52.829 0.112 0.055 0.132 0.042 0.039 0.051
S-Europe 43.176 0.092 0.045 0.108 0.035 0.032 0.042

th oc (s)
of is d ber
Step 3

ion , th em
D6/ditch 3.830 0.008 0.004 0.010 0.003 0.003 0.004

iss ore m

e
R4/stream 4.511 0.010 0.005 0.011 0.004 0.003 0.004

rm m er
pe her orm
AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 173 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-16: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for glyphosate for each organism group based on FOCUS Steps 1, 2 and 3

oh tio re
calculations for the use of MON 52276 in vines (2 × 1440 g a.s./ha, with application interval of 28 days). Uses 5 a-c.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. Algae Aquatic macrophytes

ef da ph
prolonged

er y ly
Test species Lepomis Oncorhynchus Crassostrea gigas Daphnia magna Skeletonema Myriophyllum aquaticum

th tor G
ay ula the
macrochirus mykiss costatum

or
t m reg king
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50
(µg/L) 47000 ≥ 9630 40000 12500 13500 10330

m er see
AF 100 10 100 10 10 10

do ll u tium
en a
RAC (µg/L) 470 ≥ 963 400 1250 1350 1033

cu nd
his fa or
f t ay ns
FOCUS PECsw,max

r o m co
Scenario (µg/L)

ne ent he
Step 1

ow um of t
170.688 0.363 0.177 0.427 0.137 0.126 0.165

th oc (s)
Step 2

of is d ber
N-Europe 52.829 0.112 0.055 0.132 0.042 0.039 0.051

ion , th em
iss ore m
S-Europe 43.176 0.092 0.045 0.108 0.035 0.032 0.042

e
rm m er
Step 3

pe her orm
D6/ditch 3.830 0.008 0.004 0.010 0.003 0.003 0.004

he rt t/f
t t Fu en
R1/pond 0.267 < 0.001 < 0.001 < 0.001
ou s. rr
th tie cu < 0.001 < 0.001 < 0.001
R1/stream 2.635 0.006 0.003 0.007 0.002 0.002 0.003
wi par (a)

R2/stream 3.538 0.008 0.004 0.009 0.003 0.003 0.003

f
en ird o

R3/stream 3.721 0.008 0.004 0.009 0.003 0.003 0.004

nt th rty

R4/stream 4.363 0.009 0.005 0.011 0.003 0.003 0.004

co and ope

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 174 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-17: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for glyphosate for each organism group based on HardSPEC calculations

oh tio re
for the use of MON 52276 to railroad tracks, 1 x 3600 g a.s./ha. Uses 7 a-b.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

ef da ph
Test species Lepomis Oncorhynchus Crassostrea gigas Daphnia magna Skeletonema costatum Myriophyllum aquaticum

er y ly
macrochirus mykiss

th tor G
ay ula the
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

or
t m reg king
(µg/L) 47000 ≥ 9630 40000 12500 13500 10330
AF 100 10 100 10 10 10

m er see
RAC (µg/L) 470 ≥ 963 400 1250 1350 1033

do ll u tium
en a
HardSPEC PECsw,max

cu nd
his fa or
f t ay ns
Scenario (µg/L)

r o m co
Railroad track 9.458 0.020 0.010 0.024 0.008 0.007 0.009

ne ent he
ditch leaching

ow um of t
Railroad track 9.458 0.020 0.010 0.024 0.008 0.007 0.009

th oc (s)
ditch runoff

of is d ber
AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 175 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-18: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for glyphosate for each organism group based on FOCUS Steps 1, 2 and 3

oh tio re
calculations for the use of MON 52276 in grass/alfalfa, (1 × 1800 g a.s./ha). Uses 8 and 9.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

ef da ph
Test species Lepomis Oncorhynchus mykiss Crassostrea gigas Daphnia magna Skeletonema Myriophyllum aquaticum

er y ly
macrochirus costatum

th tor G
ay ula the
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

or
t m reg king
(µg/L) 47000 ≥ 9630 40000 12500 13500 10330
AF 100 10 100 10 10 10

m er see
RAC (µg/L) 470 ≥ 963 400 1250 1350 1033

do ll u tium
en a
FOCUS PECsw,max

cu nd
his fa or
f t ay ns
Scenario (µg/L)

r o m co
Step 1

ne ent he
106.680 0.227 0.111 0.267 0.085 0.079 0.103

ow um of t
Step 2

th oc (s)
N-Europe 44.120 0.094 0.046 0.110 0.035 0.033 0.043

of is d ber
ion , th em
S-Europe 35.993 0.077 0.037 0.090 0.029 0.027 0.035

iss ore m

e
Step 3

rm m er
D1/ditch 11.400 0.024 0.012 0.029 0.009 0.008 0.011

pe her orm
D1/stream 9.964 0.021 0.010 0.025 0.008 0.007 0.010

he rt t/f
t t Fu en
D2/ditch 11.410 0.024 0.012 0.029
ou s. rr
th tie cu 0.009 0.008 0.011
D2/stream 10.150 0.022 0.011 0.025 0.008 0.008 0.010
wi par (a)

D3/ditch 11.300 0.024 0.012 0.028 0.009 0.008 0.011

f
en ird o

D4/pond 0.380 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001
nt th rty

D4/stream 9.736 0.021 0.010 0.024 0.008 0.007 0.009

co and ope

D5/pond 0.380 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 < 0.001
r

ts
r i er p
t o wn the

D5/stream 10.510 0.022 0.011 0.026 0.008 0.008 0.010

en o s

R2/stream 9.938 0.021 0.010 0.025 0.008 0.007 0.010

m he t i
cu f t en

ts

R3/stream 10.480 0.022 0.011 0.026 0.008 0.008 0.010

do s o um

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold
is ht c
th rig s do
i
e op Th

Calculated PEC/RAC ratios for glyphosate based on maximum PECSW values are below 1 indicating an acceptable risk following use of MON 52276 according to
of y

the proposed use patterns in field crops, orchards, vineyards, railroad tracks and to control invasive species in agricultural and non-agricultural areas.
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 176 of 553

th ue
e eq
e
lat ns
vio . Co
In the following tables, the ratios between predicted environmental concentrations of AMPA in surface water (PECSW) and regulatory acceptable concentrations

an ime al.
te reg new
(RAC) for aquatic organisms are given per intended use (as described in Table 10.2-6) for each FOCUS scenario and for each organism group.

oh tio re

d
pr tec EU
Please note that the PEC/RAC ratios in the following tables are rounded to 3 decimal places. For endpoints and the corresponding RAC value which are presented

ibi n
d
be ro te
as “>” or “≥” the PEC/RAC ratios are presented without the symbol of ‘<’. This does not have any impact on the outcome of the risk assessment presented below.

e ta p osa
ef da ph
er y ly
Table 10.2-19: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for AMPA for each organism group based on FOCUS Steps 1 and 2

th tor G
ay ula the
calculations for the use of MON 52276 in field crops1 (2 × 1080 g a.s./ha, with application interval of 28 days). Uses 2 a-c.

or
t m reg king
m er see
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

do ll u tium
en a
Test species Oncorhynchus mykiss Pimephales promelas Daphnia magna Daphnia magna Pseudokirchneriella Myriophyllum

cu nd
subcapitata aquaticum

his fa or
f t ay ns
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

r o m co
(µg/L) 520000 ≥ 12000 690000 15000 191000 72000

ne ent he
100 10 100 10 10 10

ow um of t
AF
5200 ≥ 1200 6900 1500 19100 7200

th oc (s)
RAC (µg/L)

of is d ber
FOCUS PECsw,max

ion , th em
Scenario (µg/L)

iss ore m

e
Step 1

rm m er
pe her orm
103.639 0.020 0.086 0.015 0.069 0.005 0.014

he rt t/f
Step 2
N-Europe 40.490 0.008 0.034 t t Fu en 0.006 0.027 0.002 0.006
ou s. rr
th tie cu
S-Europe 32.636 0.006 0.027 0.005 0.022 0.002 0.005
wi par (a)

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold
f
en ird o

1
covering all corresponding uses in root vegetables, potatoes, bulb vegetables, fruiting vegetables, leafy vegetables and sugar beets
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 177 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-20: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for AMPA for each organism group based on FOCUS Steps 1 and 2

oh tio re
calculations for the use of MON 52276 in orchards1 (2 × 1440 g a.s./ha, with application interval of 28 days). Uses 4 a-c.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

ef da ph
Test species Oncorhynchus mykiss Pimephales promelas Daphnia magna Daphnia magna Pseudokirchneriella Myriophyllum

er y ly
subcapitata aquaticum

th tor G
ay ula the
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

or
t m reg king
(µg/L) 520000 ≥ 12000 690000 15000 191000 72000
AF 100 10 100 10 10 10

m er see
RAC (µg/L) 5200 ≥ 1200 6900 1500 19100 7200

do ll u tium
en a
FOCUS PECsw,max

cu nd
his fa or
f t ay ns
Scenario (µg/L)

r o m co
Step 1

ne ent he
138.185 0.027 0.115 0.020 0.092 0.007 0.019

ow um of t
Step 2

th oc (s)
of is d ber
N-Europe 53.986 0.010 0.045 0.008 0.036 0.003 0.007

ion , th em
S-Europe 43.514 0.008 0.036 0.006 0.029 0.002 0.006

iss ore m

e
AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

rm m er
1
covering all corresponding uses in pome/stone fruit and olives

pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 178 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-21: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for AMPA for each organism group based on FOCUS Steps 1 and 2

oh tio re
calculations for the use of MON 52276 in vines (2 × 1440 g a.s./ha, with application interval of 28 days). Uses 5 a–c.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

ef da ph
Test species Oncorhynchus mykiss Pimephales promelas Daphnia magna Daphnia magna Pseudokirchneriella Myriophyllum

er y ly
subcapitata aquaticum

th tor G
ay ula the
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

or
t m reg king
(µg/L) 520000 ≥ 12000 690000 15000 191000 72000
AF 100 10 100 10 10 10

m er see
RAC (µg/L) 5200 ≥ 1200 6900 1500 19100 7200

do ll u tium
en a
FOCUS PECsw,max

cu nd
his fa or
f t ay ns
Scenario (µg/L)

r o m co
Step 1

ne ent he
138.185 0.027 0.115 0.020 0.092 0.007 0.019

ow um of t
Step 2

th oc (s)
N-Europe 53.986 0.010 0.045 0.008 0.036 0.003 0.007

of is d ber
ion , th em
S-Europe 43.514 0.008 0.036 0.006 0.029 0.002 0.006

iss ore m
AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 179 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-22: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for AMPA for each organism group based on HardSPEC calculations for

oh tio re
the use of MON 52276 to railroad tracks, 1 x 3600 g a.s./ha. Uses 7 a-b.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

ef da ph
Test species Oncorhynchus mykiss Pimephales promelas Daphnia magna Daphnia magna Pseudokirchneriella Myriophyllum

er y ly
subcapitata aquaticum

th tor G
ay ula the
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

or
t m reg king
(µg/L) 520000 ≥ 12000 690000 15000 191000 72000
AF 100 10 100 10 10 10

m er see
RAC (µg/L) 5200 ≥ 1200 6900 1500 19100 7200

do ll u tium
en a
HardSPEC PECsw,max

cu nd
his fa or
f t ay ns
Scenario (µg/L)

r o m co
Railroad track ditch 3.913 0.001 0.003 0.001 0.003 < 0.001 0.001

ne ent he
leaching

ow um of t
Railroad track ditch 3.913 0.001 0.003 0.001 0.003 < 0.001 0.001

th oc (s)
runoff

of is d ber
AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 180 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-23: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for AMPA for each organism group based on FOCUS Steps 1 and 2

oh tio re
calculations for the use of MON 52276 in grass/alfalfa, (1 × 1800 g a.s./ha). Uses 8 and 9.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Fish acute Fish prolonged Inverteb. acute Inverteb. prolonged Algae Aquatic macrophytes

ef da ph
Test species Oncorhynchus mykiss Pimephales promelas Daphnia magna Daphnia magna Pseudokirchneriella Myriophyllum

er y ly
subcapitata aquaticum

th tor G
ay ula the
Endpoint LC50 NOEC EC50 NOEC ErC50 ErC50

or
t m reg king
(µg/L) 520000 ≥ 12000 690000 15000 191000 72000
AF 100 10 100 10 10 10

m er see
RAC (µg/L) 5200 ≥ 1200 6900 1500 19100 7200

do ll u tium
en a
FOCUS Scenario PECsw,max

cu nd
his fa or
f t ay ns
(µg/L)

r o m co
Step 1

ne ent he
86.366 0.017 0.072 0.013 0.058 0.005 0.012

ow um of t
Step 2

th oc (s)
N-Europe 39.761 0.008 0.033 0.006 0.027 0.002 0.006

of is d ber
ion , th em
S-Europe 32.062 0.006 0.027 0.005 0.021 0.002 0.004

iss ore m
AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

e
rm m er
pe her orm
he rt t/f
t t Fu en
Calculated PEC/RAC ratios for the metabolite AMPA based on maximum PECSW values are below 1 indicating an acceptable risk following use of MON 52276
ou s. rr
th tie cu

according to the proposed use patterns in field crops, orchards, vineyards, railroad tracks and to control invasive species in agricultural and non-agricultural areas.
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 181 of 553

th ue
e eq
e
lat ns
vio . Co
In the following tables, the ratios between predicted environmental concentrations of HMPA in surface water (PECSW) and regulatory acceptable concentrations

an ime al.
te reg new
(RAC) for aquatic organisms are given per intended use (as described in Table 10.2-6) for each FOCUS scenario and for each organism group.

oh tio re

d
pr tec EU
Please note that the PEC/RAC ratios in the following tables were rounded to 3 decimal places. For endpoints and the corresponding RAC value which are presented

ibi n
d
be ro te
as “>” or “≥” the PEC/RAC ratios are presented without the symbol of ‘<’. This does not have any impact on the outcome of the risk assessment presented below.

e ta p osa
ef da ph
er y ly
Table 10.2-24: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for HMPA for each organism group based on FOCUS Steps 1 and 2

th tor G
ay ula the
calculations for the use of MON 52276 in field crops1 (2 × 1080 g a.s./ha, with application interval of 28 days). Uses 2 a - c.

or
t m reg king
m er see
Group Inverteb. acute Algae Aquatic macrophytes

do ll u tium
en a
Test species Daphnia magna Pseudokirchneriella subcapitata Lemna gibba
EC50 ErC50 ErC50

cu nd
Endpoint

his fa or
f t ay ns
(µg/L) > 100000 > 120000 > 123000

r o m co
AF 100 10 10

ne ent he
> 1000

ow um of t
RAC (µg/L) ≥ 12000 > 12300

th oc (s)
FOCUS PECsw,max

of is d ber
Scenario (µg/L)

ion , th em
Step 1

iss ore m

e
48.385 0.048 0.004 0.004

rm m er
pe her orm
Step 2

he rt t/f
N-Europe 16.892 0.017 0.001 0.001
S-Europe 13.741 0.014 t t Fu en 0.001 0.001
ou s. rr
th tie cu
AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold
wi par (a)

1 covering all corresponding uses in root vegetables, potatoes, bulb vegetables, fruiting vegetables, leafy vegetables and sugar beets
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 182 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-25: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for HMPA for each organism group based on FOCUS Steps 1 and 2

oh tio re
calculations for the use of MON 52276 in orchards1 (2 × 1440 g a.s./ha, with application interval of 28 days). Uses 4 a-c.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Inverteb. acute Algae Aquatic macrophytes

ef da ph
Test species Daphnia magna Pseudokirchneriella subcapitata Lemna gibba

er y ly
Endpoint EC50 ErC50 ErC50

th tor G
ay ula the
(µg/L) > 100000 > 120000 > 123000

or
t m reg king
AF 100 10 10
> 1000 ≥ 12000 > 12300

m er see
RAC (µg/L)
FOCUS PECsw,max

do ll u tium
en a
Scenario (µg/L)

cu nd
his fa or
f t ay ns
Step 1

r o m co
64.513 0.065 0.005 0.005

ne ent he
Step 2

ow um of t
N-Europe 22.523 0.023 0.002 0.002

th oc (s)
S-Europe 18.322 0.018 0.002 0.001

of is d ber
ion , th em
AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold
1 covering all corresponding uses in pome/stone fruit and olives

iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 183 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-26: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for HMPA for each organism group based on FOCUS Steps 1 and 2

oh tio re
calculations for the use of MON 52276 in vines (2 × 1440 g a.s./ha, with application interval of 28 days). Use 5 a-c.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Inverteb. acute Algae Aquatic macrophytes

ef da ph
Test species Daphnia magna Pseudokirchneriella subcapitata Lemna gibba

er y ly
Endpoint EC50 ErC50 ErC50

th tor G
ay ula the
(µg/L) > 100000 > 120000 > 123000

or
t m reg king
AF 100 10 10
> 1000 ≥ 12000 > 12300

m er see
RAC (µg/L)

do ll u tium
en a
FOCUS PECsw,max

cu nd
his fa or
Scenario (µg/L)

f t ay ns
Step 1

r o m co
64.513 0.065 0.005 0.005

ne ent he
ow um of t
Step 2

th oc (s)
N-Europe 22.523 0.023 0.002 0.002

of is d ber
S-Europe 18.322 0.018 0.002 0.001

ion , th em
AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 184 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-27: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for HMPA for each organism group based on HardSPEC calculations for

oh tio re
the use of MON 52276 to railroad tracks, 1 x 3600 g a.s./ha. Uses 7 a-b.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Inverteb. acute Algae Aquatic macrophytes

ef da ph
Test species Daphnia magna Pseudokirchneriella subcapitata Lemna gibba

er y ly
Endpoint EC50 ErC50 ErC50

th tor G
ay ula the
(µg/L) > 100000 > 120000 > 123000

or
t m reg king
AF 100 10 10
> 1000 ≥ 12000 > 12300

m er see
RAC
(µg/L)

do ll u tium
en a
HardSPEC Scenario PECsw,max

cu nd
his fa or
f t ay ns
(µg/L)

r o m co
Railroad track 0.627 0.001 < 0.001 < 0.001

ne ent he
ditch leaching

ow um of t
Railroad track 0.627 0.001 < 0.001 < 0.001

th oc (s)
ditch runoff

of is d ber
AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 di
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

rig ntly
Page 185 of 553

th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
Table 10.2-28: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for HMPA for each organism group based on FOCUS Steps 1 and 2

oh tio re
calculations for the use of MON 52276 in grass/alfalfa, (1 × 1800 g a.s./ha). Uses 8 and 9.

d
pr tec EU
ibi n
d
be ro te
e ta p osa
Group Inverteb. acute Algae Aquatic macrophytes

ef da ph
Test species Daphnia magna Pseudokirchneriella subcapitata Lemna gibba

er y ly
Endpoint EC50 ErC50 ErC50

th tor G
ay ula the
(µg/L) > 100000 > 120000 > 123000

or
t m reg king
AF 100 10 10
> 1000 ≥ 12000 > 12300

m er see
RAC (µg/L)
FOCUS PECsw,max

do ll u tium
en a
Scenario (µg/L)

cu nd
his fa or
f t ay ns
Step 1

r o m co
40.321 0.040 0.003 0.003

ne ent he
Step 2

ow um of t
N-Europe 18.768 0.019 0.002 0.002

th oc (s)
S-Europe 15.232 0.015 0.001 0.001

of is d ber
ion , th em
AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

iss ore m

e
rm m er
pe her orm
Calculated PEC/RAC ratios for the metabolite HMPA based on maximum PECSW values are below 1 indicating an acceptable risk following use of MON 52276

he rt t/f
according to the proposed use patterns in field crops, orchards, vineyards, railroad tracks and to control invasive species in agricultural and non-agricultural areas.
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
cia lle
er te
m s in
om a
y c such
s
ht
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 186 of 553

ep
,r
ion
ut
Indirect Effects via Trophic Interactions

t rib
dis
The available regulatory ecotoxicology data for glyphosate and its main metabolite AMPA includes a

n,
er tio
battery of acute and chronic aquatic guideline studies, across multiple trophic levels, that have been

wn lica
.
designed to assess the potential for direct and indirect effects through trophic interactions. Consideration of

s o ub
f it y p
indirect effects through trophic interactions has been used to derive a SPG that is consistent with the current

so n
EFSA aquatic guidance (2013) and the Regulation ((EC) No 1107/2009). The SPG used for the biodiversity

ht , a
rig ntly
assessment states: “Negligible acute and long-term effects to aquatic plant and animal populations from

th ue
direct and indirect effects through trophic interactions” (

e eq
e
lat ns
vio . Co
an ime al.
Table 10.2-29). Negligible in the context of this assessment, and the EFSA aquatic guidance, means that

te reg new
there is a sufficient margin of safety to conclude there will be no unacceptable effects to aquatic ecosystems

oh tio re

d
for the intended uses.

pr tec EU
ibi n
d
be ro te
e ta p osa
As previously discussed, glyphosate is an important tool to realize the benefits that conservation tillage has

ef da ph
on biodiversity in agroecosystems. Low soil disturbance leaves the surface with adequate crop residue and

er y ly
th tor G
organic matter that resists soil aggregate breakdown and soil crusting that contribute to runoff and erosion

ay ula the
and consequently soil / particulate matter reaching aquatic systems resulting in sedimentation. The primary

or
t m reg king
nutrient forms carried in runoff are ammonium, nitrate, and phosphate that contribute to degradation and

m er see
eutrophication of aquatic ecosystems. Therefore, using glyphosate within conservation agriculture schemes

do ll u tium
en a
can minimize impact to aquatic biodiversity.

cu nd
his fa or
f t ay ns
The groups of aquatic organisms that were tested are well suited for direct and indirect effects assessment
r o m co
ne ent he

through trophic interactions because it contains the key components of the aquatic food chain as well as
ow um of t

macrophytes that are an important structural component of aquatic waterbodies. Indeed, the test battery
th oc (s)

includes numerous representative species of primary producers (i.e., chronic studies with algae, diatoms,
of is d ber

aquatic macrophytes), representative primary consumers (i.e., acute and chronic studies with pelagic
ion , th em
iss ore m

invertebrates and sediment dwelling invertebrates) and acute and chronic studies with secondary consumers
e
rm m er

(i.e., fish development and reproduction and larval amphibian development) (Table 1, see document MCP
pe her orm

Section 10.1 for details on the tested species).

he rt t/f
t t Fu en
ou s. rr
th tie cu

The following assessment approach considers both direct effects and the potential for indirect effects via
wi par (a)

trophic interactions, based on the proposed Specific Protection Goals drawn from the existing EU guidance
f
en ird o

and working documents, and the 2016 EFSA Guidance on developing protection goals for ecological risk
nt th rty
co and ope

assessments (ERA) for pesticides. The SPGs based on direct effects assessment considering representative
r

sensitive populations across the tested trophic levels. The biodiversity assessment, aimed to develop a
ts
r i er p
t o wn the

flexible framework that informs the development of risk mitigation options to achieve the specific
en o s
m he t i

protection goals, that includes considering indirect effects via trophic interaction. For example, reduced
cu f t en

ts
do s o um

application rates relative to previous Annex I renewals, a reduced overall application volume of product on
is ht c

the land, and inclusion of no-spray buffer zones as a standard mitigation measure to protect edge of field
th rig s do

surface waters. When defining SPGs for aquatic plants and animals, it is the responsibility of the risk
i
e op Th

assessors in the Member States to acknowledge existing protection goals and regulatory data requirements,
of y

to propose possible SPG options, and describe the possible environmental consequences of each option.
us c

The risk assessors within the Member States will need to propose realistic SPGs and exposure assessment
d nd
an a

goals and the interrelationships between them in a clear and transparent manner
n rty
tio e
ta op
loi pr

The direct effects assessment covering a broad range of aquatic taxa groups, informs on the biodiversity
xp al

assessment by highlighting an acceptable risk across multiple trophic layers of the aquatic food chain.
l e ctu
cia lle

Therefore, where an acceptable direct effects risk assessment is concluded upon after incorporation of
er te
m s in

standard mitigation measures to reduce off-target movement to surface waters (anyway required to support
om a

the NTTP assessment) coupled with the other standard mitigation measures that are applied, they are
y c uch

considered protective of indirect effects occurring outside of the target area.

an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
,r
ion
ut
However, for the purpose of this biodiversity assessment, the SPGs developed for aquatic systems is

rib
considered consistent with current EFSA guidance and what will likely be adopted in future EFSA

t
dis
guidance. The SPG is aimed at achieving negligible acute and long term direct and indirect effects on

n,
er tio
aquatic plant and animal populations.

wn lica
.
s o ub
f it y p
Available study results and the risk assessment for direct effects presented in M-CP 10 show negligible risk

so n
from direct effects on the representative species for the various trophic levels. Moreover, glyphosate and

ht , a
rig ntly
its main metabolite AMPA, do not bioaccumulate (Log Pow less than 3 and a BCF = 1.1). Additionally,

th ue
the basic principles that underlie an aquatic mixture assessment for glyphosate have been provided in

e eq
25

e
lat ns
Appendix 1 of the biodiversity assessment document. In addition, based on predicted environmental

vio . Co
an ime al.
concentrations, either from FOCUS surface water modelling or from surface water monitoring studies, the

te reg new
risk of additive effects of glyphosate in the presence of other plant protection products in surface waters is

oh tio re

d
low to negligible.

pr tec EU
ibi n
d
be ro te
e ta p osa
Biodiversity Assessment

ef da ph
er y ly
th tor G
The assessment approach – as previously defined aims to assess the potential indirect effects via trophic

ay ula the
interactions and the impact on biodiversity, by developing a flexible framework that informs the

or
t m reg king
development of risk mitigation options to achieve the specific protection goals. In the following table, the

m er see
specific protection goals relevant to aquatic organisms are presented with the relationship between the

do ll u tium
en a
SPGs, the direct effects study types, assessment and measurement endpoints. The assessment endpoint is

cu nd
his fa or
an explicit expression of an environmental entity and the specific property of that entity to be protected.
f t ay ns
Measurement endpoints relates directly to the effects study endpoints.
r o m co
ne ent he
ow um of t

A conclusion that a given data requirement has been satisfied, requires that an acceptable level of risk has
th oc (s)

been achieved (i.e. there is a protective margin of exposure or through a weight of evidence).
of is d ber
ion , th em
iss ore m

Based on the measurement endpoints from the study types, and the direct effects assessment presented
e
rm m er

above in this section, indirect effects from glyphosate on aquatic organisms are not anticipated.
pe her orm
he rt t/f
t t Fu en

The following table assessment illustrates that ecological function of aquatic organisms in off-field / off-
ou s. rr
th tie cu

target areas / edge of field surface water, will be sufficiently maintained to achieve the SPG for the aquatic
wi par (a)

organisms according to the protection goals as defined in the EFSA guidance (2016), that sustains habitat
f
en ird o

and food resources for other organisms whilst achieving negligible acute and chronic effects on aquatic
nt th rty
co and ope

plants and animals.

r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ

25
(2020) Glyphosate: Indirect effects via trophic interaction - A Practical Approach to
Biodiversity Assessment (TRR0000305).
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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ep
,r
ion
ut
Table 10.2-29: The relationship between the Specific Protection Goal, assessment endpoints and

t rib
measurement endpoints for aquatic systems (wetlands, rivers and lakes) exposed by runoff and/or

dis
spray drift.

n,
er tio
Specific Protection Goal1 Assessment Endpoints Measurement Endpoints Glyphosate Study Types2

wn lica
.
s o ub
Negligible acute and Survival, growth and Acute and chronic toxicity Algal

f it y p
long-term effects to reproduction of aquatic to aquatic plants and Vascular plants

so n
ht , a
aquatic plant and animal populations animals and Acute Daphnia

rig ntly
populations from direct bioaccumulation Daphnia life-cycle3

th ue
and indirect effects Chironomid emergence3

e eq
e
lat ns
through trophic Acute fish

vio . Co
an ime al.
interactions. Fish ELS*

te reg new
Fish repro screening 3

oh tio re
Fish Full Life-cycle3

d
pr tec EU
Amphibian metamorphosis 3

ibi n
d
be ro te
Fish bioconcentration

e ta p osa
ef da ph
Biodiversity Assessment for Aquatic Ecosystems

er y ly
th tor G
Based on the specific protection goal, inclusion of a 1 m buffer between the application area and the adjacent

ay ula the
surface water body, for applications of MON 52276 made according to the proposed GAP, is considered

or
t m reg king
protective of both direct and indirect effects on biodiversity in aquatic ecosystems through trophic interactions.

m er see
1
By accepting no population-level effects on representative sensitive populations in edge-of-field surface waters, these populations

do ll u tium
en a
will be protected and propagation of effects to the community-, ecosystem- and landscape-level will not occur (Option 1: EFSA

cu nd
aquatic guidance, 2013).
his fa or
f t ay ns
2 Acute and chronic aquatic studies for aquatic plants and animals are presented in the ecotoxicology section. Endpoints for AMPA
r o m co
are similar to endpoints for the same studies with glyphosate.
ne ent he

3 Note these studies were performed to assess the potential for impacts to the endocrine pathways. No effects to the four endocrine
ow um of t

pathways can be concluded based on the results of these studies and a weight of evidence evaluation (USEPA, 2015, EFSA, 2017,
th oc (s)

KCA 5.8.3/010, 2020)

of is d ber
ion , th em

As a conservative approach for finalizing the aquatic biodiversity assessment, the lower tier assessment
iss ore m

e
rm m er

option known as the Ecological Threshold Option (ETO) from the EFSA’s tiered guidance for aquatic risk
pe her orm

assessments (EFSA (2013). This option aims at ensuring that negligible effects only, may occur in aquatic
he rt t/f
t t Fu en

populations (transient effects followed by recovery are not accepted with this option). Both direct and
ou s. rr

indirect effects on the food chain are covered within this option. When applied to the representative
th tie cu
wi par (a)

sensitive populations in edge-of-field surface water, this option allows to conclude that aquatic populations
f
en ird o

will be protected, and that propagation of effects to the community-, ecosystem-, and landscape level will
nt th rty

not occur.
co and ope
r

ts
r i er p
t o wn the

The current direct effects aquatic risk assessment in MCP10 shows that inclusion of a one-meter buffer
en o s

between the applied area and the edge-of-field surface water for glyphosate applications is considered
m he t i
cu f t en

ts

protective of both direct effects and indirect effects through trophic interactions on aquatic biodiversity for
do s o um

the intended uses.

is ht c
th rig s do
i
e op Th

Ecotoxicological relevance of the glyphosate surface water monitoring data

of y
us c

In addition to the predicted environmental concentrations from FOCUS modeling used for the standard
d nd
an a

aquatic assessment, there is an extensive amount of surface water monitoring data that can be used to further
n rty

evaluate potential effects of glyphosate on biodiversity in aquatic ecosystems.

tio e
ta op
loi pr
xp al

Horth (2012) provided a review that covers glyphosate and AMPA monitoring results for surface waters
l e ctu

from all 27 Member States. The maximum concentrations of glyphosate found in surface water ranged from
cia lle
er te

1.3 to 370 µg acid equivalents (a.e.)/L and the maximum concentrations of AMPA ranged from 0.22 to >
m s in

200 µg/L. Glyphosate and AMPA concentrations in the monitoring data exceeded the predicted
om a
y c uch

environmental concentration (PECsw), using the FOCUS (2000) surface water model for glyphosate and
an ts s

AMPA at an exceedingly small frequency. When calculating TER values with the concentrations monitored
an righ

in the study by Horth, the outcome of the assessment demonstrates that the risk for direct and indirect effects
d
ing to

to aquatic organisms from the intended uses of glyphosate is acceptable.

sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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d/
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ep
,r
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rib
Based on a more recent analysis of the European Environment Agency water monitoring ( , 2020)

t
dis
database, it can be concluded that 99.99 % of the measured glyphosate surface water concentrations are

n,
er tio
below a regulatory acceptable concentration (RAC). For surface water, there were > 250,000 analyses and

wn lica
.
exceedance rates of the RAC were 0.01 % for glyphosate and 0.001 % for AMPA ( , 2020). The

s o ub
f it y p
original RAC value (100 µg/L) concluded in the report is considered highly conservative, as the

so n
underlying fish toxicity study on which the RAC had been based ( , 2000; MCA 8.2.2.1/002) is not

ht , a
rig ntly
acceptable for use in risk assessment (KCA 8.2.2.1/002 and KCA 8.2.2.1/003). Based on the now proposed

th ue
lowest RAC value (400 µg/L) from the available reliable ecotoxicology aquatic endpoints, evaluated against

e eq
e
lat ns
current validity criteria for the study types, a further 4-fold margin of safety may be applied to the evaluation

vio . Co
an ime al.
of the surface water detects in the monitoring report.

te reg new
oh tio re

d
Glyphosate aquatic risk assessment under the PPP regulation in the context of the Water

pr tec EU
ibi n
d
Framework Directive (WFD)

be ro te
e ta p osa
The protection goal underlying the WFD refers to human and ecosystem health. Within the context of

ef da ph
ecosystem health and setting Environmental Quality Standards (EQS) it is assumed that (1) ecosystem

er y ly
th tor G
sensitivity depends on the most sensitive species population, and (2) protecting ecosystem structure protects

ay ula the
community functioning. Aquatic risk assessments for the WFD focus on larger water bodies (e.g., river

or
t m reg king
basins) and EQSs should be linked to an annual average concentration or the maximum of the measured

m er see
concentrations (MAC-EQS). In contrast, the aquatic risk assessment for PPP Regulation focuses on

do ll u tium
en a
concentrations that can be achieved in edge-of-field surface waters in agricultural landscapes and the

cu nd
his fa or
exposure assessment uses harmonized exposure scenarios (FOCUS surface water scenarios). These
f t ay ns
scenarios, in combination with models that estimate the emissions and the fate and behavior of PPPs in
r o m co
ne ent he

surface waters, predict realistic worst-case exposure concentrations in edge-of-field surface waters.
ow um of t

In terms of effects endpoints, EQSs are derived on the basis of predicted no effect concentrations (PNECs)
th oc (s)

for all relevant populations of water organisms and is generally comparable to the ETO approach used for
of is d ber

a PPP aquatic assessment. Overall, the general protection goal of the WFD and PPP Regulation do not
ion , th em
iss ore m

differ substantially. EQS setting within the context of the WFD in principle is based on the Ecological
e
rm m er

Threshold Option approach (ETO, EFSA, aquatic guidance 2013), and glyphosate satisfies the ETO option
pe her orm

as discussed above. Glyphosate was identified as “low risk” to the water compartment in the 2011
he rt t/f
t t Fu en

evaluation of candidate EU priority substances using a PNEC in water of 24 µg a.e./L. To put this value
ou s. rr
th tie cu

into perspective with the new surface water monitoring data, and including values identified as outliers,
wi par (a)

less than 0.042 % of samples exceed 24 µg a.e./L ( , 2020). Moreover, considering the large margin
f
en ird o

of safety (>350-fold) between the endpoint driving the standard aquatic risk assessment, and measured
nt th rty
co and ope

levels of glyphosate from monitoring studies, risk of direct effects and indirect effects through trophic
r

interactions on aquatic communities is negligible.

ts
r i er p
t o wn the
en o s
m he t i

Relevance of the Drinking Water Threshold to Biodiversity Assessment

cu f t en

ts
do s o um

The Drinking Water Directive (DWD) sets the compliance limits at the tap of the consumer as 0.1 µg/L for
is ht c

individual pesticides and 0.5 µg/L for total pesticides. Only those pesticides which are likely to be present
th rig s do

in a given supply need be monitored. From the environmental monitoring report ( 2020), the
i
e op Th

analysis of the dataset available for drinking water for glyphosate and AMPA indicates that compliance is
of y

to these requirements very high. Indeed, detections above 0.1 µg/L are very rare. When they do sporadically
us c

occur, they occur at low concentrations that are well below human health thresholds. The measured
d nd
an a

environmental concentrations available show that neither glyphosate nor AMPA pose a risk to human health
n rty
tio e

via drinking water where the point of compliance is at the tap of the consumer. The drinking water threshold
ta op
loi pr

is not therefore considered relevant to the ecotoxicological risk assessment.

xp al
l e ctu
cia lle

Scientific Literature that informs the aquatic biodiversity assessment

er te
m s in

Baker et al. (2016) investigated the potential for indirect effects on natural communities of phytoplankton
om a

and zooplankton with a glyphosate-based formulation at concentrations up to 2.88 mg a.e./L, which

y c uch

represents a concentration resulting from an overspray application to a shallow waterbody (approximately

an ts s

4.3 kg a.e./ha over-sprayed in to 15 cm water). Their co-application of herbicide and nutrients resulted in a
an righ
d
ing to
sh ct
bli bje
pu su
or be

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ep
,r
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ut
transient decline in dietary quality of phytoplankton and zooplankton community similarity. However,

rib
direct and indirect effects were not evident in wetlands treated only with the formulation.

t
dis
n,
er tio
Rolando et al. (2017) conducted an extensive review of the available scientific literature for glyphosate-

wn lica
.
based herbicides used in forest management, at applications up to a rate of 4 kg a.e./ha and concluded that

s o ub
f it y p
glyphosate use does not pose a significant long-term risk of direct and indirect effects in aquatic

so n
environments. Indirect effects of glyphosate to aquatic fauna were observed when high concentrations of

ht , a
rig ntly
the product were applied as overspray to the waterbodies. Effects on the aquatic fauna were associated with

th ue
changes in aquatic plant community composition and habitat structure, cover, and food sources as a

e eq
e
lat ns
consequence of glyphosate’s phytotoxic effects, rather than resulting from the toxicity of glyphosate on the

vio . Co
an ime al.
aquatic fauna. To help put this observation of indirect effects into perspective, Edge et al. (2020)

te reg new
investigated the potential for indirect effects on aquatic animals from using a glyphosate-based formulation

oh tio re

d
to control emergent aquatic vegetation. Results showed that control of the aquatic vegetation indirectly

pr tec EU
ibi n
increased the abundance of benthic invertebrates and wood frog larvae. This study shows how glyphosate

d
be ro te
e ta p osa
can be safely used to control aquatic vegetation and has benefits to aquatic biodiversity.

ef da ph
er y ly
th tor G
Edge et al. (2011, 212, 2013, 2014) conducted field studies to assess effects of a glyphosate-based

ay ula the
formulation, commonly used in Canadian forestry, on larval tadpoles at concentrations representative of a

or
t m reg king
direct overspray into shallow water (2.88 mg a.e./L). The results from these studies showed no impact on

m er see
growth, development and survival and it was concluded that there was no unacceptable risk to larval

do ll u tium
en a
amphibians. The absence of chronic effects was concluded to result from rapid dissipation of glyphosate

cu nd
his fa or
and its adjuvant in the water column and showed the importance of testing under environmentally realistic
f t ay ns
conditions.
r o m co
ne ent he
ow um of t

Conclusion
th oc (s)
of is d ber

The current aquatic risk assessment for glyphosate, its environmental metabolites, and the representative
ion , th em
iss ore m

formulation demonstrate that a 1 m no-spray buffer zone from edge-of-field is protective of aquatic
e
rm m er

biodiversity from direct effects and indirect effects through trophic interactions. By demonstrating
pe her orm

negligible risk of population-level effects on representative sensitive populations in edge-of-field surface

he rt t/f
t t Fu en

waters, aquatic populations will be protected and propagation of indirect effects to the community,
ou s. rr
th tie cu

ecosystem, and landscape levels will not occur. When performing our assessment using the measured levels
wi par (a)

of glyphosate and AMPA from aquatic monitoring programs, we come to the same conclusion that no direct
f
en ird o

or indirect effects to aquatic biodiversity are likely to occur.

nt th rty
co and ope
r

Environmental risk mitigation measures are a key component in defining the conditions of use of pesticides
ts
r i er p
t o wn the

in crop protection in Europe ((EC) No 1107/2009) and (EU) No 547/2011). These risk mitigation measures
en o s
m he t i

are derived directly from the evaluation of pesticide products and the risk assessment conducted for each
cu f t en

ts
do s o um

use and are specific of the type of risk they are intended to mitigate. They therefore range from the
is ht c

adjustment of the conditions of use, to minimizing transfers to surface and groundwater, to the setting of
th rig s do

buffer zones at the edge of the crop, and to requiring compensatory measures (e.g., field margins).
i
e op Th
of y

Examples of the standard mitigation measures considered applicable at the EU level (MAgPIE, 2017) are
us c

presented in the following table. Many of these have been considered in the current dossier submission.
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Table 10.2-30: Types of standard risk mitigation measures described in MAgPIE across the

t rib
various Member States to mitigate effects on biodiversity and how they could

dis
be applied to glyphosate products.

n,
er tio
wn lica
Type of Mitigation Risk Mitigation Benefits Glyphosate renewal dossier (2020)

.
s o ub
Measure Measure

f it y p
Restrictions or Application rate, Lower transfers to Significant reductions (50 % in volume)

so n
ht , a
modifications of Application frequency, groundwater and surface in newly proposed application rates

rig ntly
products’ conditions application timing, water; Reduces exposure compared with the representative use

th ue
of application and interval between of organisms in-crop and presented in the 2012 renewal dossier.

e eq
See 26Appendix 2 of the biodiversity

e
lat ns
applications off-crop.

vio . Co
an ime al.
report that accompanies this submission.

te reg new
oh tio re

d
Treated area restriction

pr tec EU
7. for the representative use GAPs:

ibi n
d
be ro te
applying to only 50 % of the total area in

e ta p osa
orchard/vineyard area.

ef da ph
er y ly
8. maximum of 50 % of the total area for

th tor G
broad acre vegetable inter-row

ay ula the

or
9. Invasive species control e.g., couch grass

t m reg king
– maximum of 20 % of the cropland +

m er see
extended application intervals.

do ll u tium
en a
cu nd
his fa or
Limited frequency and timing of
f t ay ns application: 28-day interval between
r o m co

applications and no pre-harvest

ne ent he
ow um of t

applications
th oc (s)
of is d ber

Application Spray drift reduction Reduces exposure of Reduction of spray drift to the off-field:
ion , th em

equipment nozzles (SDRN), organisms in-crop 5. Use 75 % drift reducing nozzles for pre-
iss ore m

with Spray Drift shields, (precision treatment) and sowing/pre-planting in arable crops.
rm m er
pe her orm

Reduction Precision treatment, off-crop 6. Use of ground directed, shielded spray

Technology (SDRT) etc. for band application in orchards /
he rt t/f
t t Fu en

vineyards and broad-acre vegetable inter-

ou s. rr
th tie cu

row application.
wi par (a)
f
en ird o

Buffer zones Non-sprayed zone at Reduces exposure of Establishment of buffer zones:

nt th rty

the edge of a crop organisms and off-crop Buffer zones of varying size (depending on
co and ope

the type of SDRT) are required as

r

ts
r i er p

protection for off-crop NTTP communities

t o wn the

from spray drift.

en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do

For example in the current dossier;

i
e op Th

- Reductions in maximum annual application rates of up to 50 % are considered in this dossier and
of y

are compared to the maximum rates applied for in the 2012 Annex I renewal dossier.
us c
d nd

o In 2012, the maximum annual application rate was 4.32 kg/ha.

an a
n rty

o In the current dossier submission, the maximum annual application rate is 2.16 kg/ha
tio e
ta op
loi pr

- Reducing the total area being applied on a per hectare basis for certain uses, will reduce the total
xp al
l e ctu

volume of product being applied to the landscape.

cia lle

o For example, controlling actively growing weeds in vineyards, orchards where a reduced
er te
m s in

area, up to a maximum of 50 % of the total application area is proposed e.g. using strip or
om a

band applications. Applications on target weeds around the base of trees within tree rows,
y c uch
an ts s
an righ

26
(2020) Glyphosate: Indirect effects via trophic interaction - A Practical Approach to
Biodiversity Assessment (TRR0000305).
d
ing to
sh ct
bli bje
pu su
or be

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leaving the area between tree rows unsprayed, which is typically managed using

rib
mechanical methods.

t
dis
n,
er tio
- The use of shielded or hooded sprayers, hand-held sprayers and drift reducing technologies, e.g.

wn lica
.
75 % drift reducing nozzles are recommended for all applications made for the control of actively

s o ub
f it y p
growing weeds when applied to control invasive species. These measures will further reduce the

so n
off-target exposure risk.

ht , a
rig ntly
- For weed control on railroad tracks, recommendations are made in the GAP table to use precision

th ue
application equipment on spray trains, that detects and targets spray directly onto unwanted plants,

e eq
e
lat ns
thereby reducing the amount of product being applied, whilst maintaining an acceptable level of

vio . Co
an ime al.
safety on the railroad tracks.

te reg new
oh tio re

d
- No spray buffer areas in-field (such as compensation areas), are necessary to meet the specific

pr tec EU
ibi n
protection goals for avoiding direct effects on non-target plants in off-target areas. This measure

d
be ro te
e ta p osa
will in turn support non-target arthropod communities in off-field areas and reduces further, the

ef da ph
potential for indirect effects on bees through trophic interaction.

er y ly
th tor G
ay ula the
In addition to the standard mitigation measures, ‘non-standard mitigation measures’ could also be

or
t m reg king
considered where a local and specific mitigation need is identified. For example, in simplified landscapes

m er see
or landscapes that are intensively managed, where typically there are limited refuge areas for insects, birds

do ll u tium
en a
and mammals. Non-standard mitigation measures options could include for example, creation of off-target

cu nd
his fa or
habitats, utilizing edge of field habitats and semi-field habitats that assist biodiversity by improving wildlife
f t ay ns
connectivity.
r o m co
ne ent he
ow um of t

For further information on mitigation measures pleased refer to the supplementary information document27
th oc (s)

titled ‘Glyphosate: Indirect Effects via Trophic Interaction – A Practical Approach to Biodiversity
of is d ber

Assessment.’ that accompanies this dossier submission.

ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f

CP 10.2.1 Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and
t t Fu en
ou s. rr

macrophytes
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ

27
(2020) Glyphosate: Indirect effects via trophic interaction - A Practical Approach to
d
ing to

Biodiversity Assessment (TRR0000305).

sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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ro
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ep
,r
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1. Information on the study

t rib
dis
Data point CP 10.2.1/001

n,
er tio
Report author

wn lica
.
s o ub
Report year 1992

f it y p
so n
Report title MON 52276: Acute Toxicity To Rainbow Trout, Oncorhynchus

ht , a
rig ntly
mykiss, Under Flow-Through Test Conditions

th ue
J9108002b

e eq
Report No

e
lat ns
-91-296

vio . Co
Document No

an ime al.
te reg new
Guidelines followed in study US EPA FIFRA 72-1 (1982), OECD 203, and EEC Method C.1.

oh tio re

d
pr tec EU
Deviations from current test Deviations from the current OECD 203 guideline (2019):

ibi n
d
be ro te
guideline Major:

e ta p osa
- Fish were acclimatised 48 hours prior to the test (7 days are required)

ef da ph
er y ly
Minor:

th tor G
ay ula the
- Observations occurred after 24h, 48h and 96h instead of twice/day

or
t m reg king
- pH of the highest concentration (5.9) was slightly below the specified

m er see
range of 6.0 – 8.5.

do ll u tium
en a
Previous evaluation Yes, accepted in RAR (2015)

cu nd
his fa or
GLP/Officially recognised Yes f t ay ns
r o m co
testing facilities
ne ent he
ow um of t

Acceptability/Reliability Valid
th oc (s)

Category study in AIR 5 Category 2a

of is d ber
ion , th em

dossier (L docs)
iss ore m

e
rm m er
pe her orm
he rt t/f

2. Full summary
t t Fu en
ou s. rr
th tie cu

Executive Summary
wi par (a)

The effects of MON 52276 (30.95 % glyphosate acid) on rainbow trout (Oncorhynchus mykiss) were
f
en ird o

evaluated in a 96-hour flow-through toxicity test. Two groups of ten fish each were exposed for 96 hours
nt th rty

to nominal concentrations of MON 52276 at 0 (control), 130, 216, 360, 600 and 1000 mg/L. The test water
co and ope

was a blend of treated municipal water and treated well water. At 0, 48 and 96 hours, samples of test medium
r

ts
r i er p
t o wn the

were taken for the analysis of glyphosate content.

en o s
m he t i
cu f t en

ts

Mortality and signs of toxicity were recorded at 24, 48, 72 and 96 hours after test initiation.
do s o um
is ht c
th rig s do

Mortality to one fish was observed at the lowest test concentration (119 mg/L), but it was judged to be not
i
e op Th

treatment-related. No mortality was observed at the higher test concentrations. No sublethal effects were
of y

observed at any test concentration. The present study is considered valid according to OECD guideline 203.
us c
d nd

Based on mean measured concentrations, the 96-hour LC50 for rainbow trout (Oncorhynchus mykiss)
an a
n rty

exposed to MON 52276 in a flow-through test system was > 989 mg/L (> 306 mg glyphosate/L, arithmetic
tio e
ta op

mean measured). The corresponding no observed effect concentration (NOEC) was ≥ 989 mg/L
loi pr
xp al

(≥ 306 mg glyphosate/L, arithmetic mean measured), based on the absence of mortality and abnormal
l e ctu

sublethal effects at this concentration.

cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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an may
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ep
,r
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I. MATERIALS AND METHODS

t rib
dis
n,
er tio
A. MATERIALS

wn lica
.
1. Test material:

s o ub
f it y p
Test item: MON 52276

so n
ht , a
Active substance: Glyphosate

rig ntly
th ue
Description: Amber liquid

e eq
e
lat ns
Lot/Batch #: LLN-9105-3135F

vio . Co
an ime al.
te reg new
Purity: 30.95 %

oh tio re
none

d
2. Vehicle and/or positive control:

pr tec EU
ibi n
d
be ro te
3. Test organism:

e ta p osa
Species: Rainbow trout (Oncorhynchus mykiss)

ef da ph
er y ly
th tor G
Age: Juveniles

ay ula the

or
Size: Length: 3.1 – 4.1 cm

t m reg king
m er see
Loading: 10 test individual for 15 L test solution

do ll u tium
en a
Source:

cu nd
his fa or
Acclimation period: 48 hours prior to the test initiation f t ay ns
r o m co
Body weight of the animals: 0.35 – 0.95 g (mean = 0.60 ± 0.16 g)
ne ent he
ow um of t

Food live brine shrimp, nauplii and flake until 48h prior to test
th oc (s)

initiation
of is d ber
ion , th em

4. Environmental conditions:
iss ore m

e
rm m er

Temperature: 11.5 – 13.8 °C

pe her orm

Photoperiod: 16 hours, 392 – 500 lux

he rt t/f
t t Fu en
ou s. rr

pH: 8.1 (control);

th tie cu
wi par (a)

5.9 – 7.4 (test item concentrations)

f
en ird o

Dissolved oxygen: ≥ 7.1 mg/L (≥ 67 % of saturation)

nt th rty
co and ope

Conductivity: 382 – 705 µmhos/cm

r

ts
r i er p
t o wn the

Hardness: 38 – 116 mg CaCO3/L

en o s
m he t i

Alkalinity: 57 – 77 mg CaCO3/L
cu f t en

ts
do s o um

Dissolved oxygen saturation 10.8 mg/L at 12 °C

is ht c
th rig s do

5. Dates of experimental work: October 7th to October 11th 1991

i
e op Th
of y

B. STUDY DESIGN
us c
d nd

Experimental treatments: Two groups of ten fish each were exposed under flow-through conditions in a
an a
n rty

proportional diluter system 4.8 cycles/h (approx. 5.4 volume addition every 24h) for 96 hours to nominal
tio e
ta op

concentrations of MON 52276 at 0 (controls), 130, 216, 360, 600 and 1000 mg/L. For flow-through system,
loi pr

the recommended maximum loading is 0.5 g wet weight fish/L per 24 hours. Taking into account a 15 L
xp al
l e ctu

tank with a flow rate of 5.4 tank volumes per 24 hours, a total of 81 L passed through the tank in 24 hours.
cia lle

With 0.6 g fish and ten fish per tank (= 6 g), this was corresponding to 6 g in 81 L in 24 hours equivalent
er te
m s in

to 0.07 g/L in 24 hours.

om a
y c uch

The test water was a blend of treated municipal water and treated well water. During the 14-day holding
an ts s

period prior to test initiation, fish were fed daily and were in good health. There were two vessels per
an righ

treatment, each containing ten fish (appr.24 L glass vessels containing 15 L test medium).
d
ing to
sh ct
bli bje
pu su
or be

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Observations: Mortality and signs of toxicity were recorded at 24, 48, 72 and 96 hours after test initiation.

rib
Water temperature in a control vessel was measured hourly throughout the test, and water pH and dissolved

t
dis
oxygen were measured daily in all test vessels. Hardness, total alkalinity and specific conductivity were

n,
er tio
measured at test initiation and test termination. At 0, 48 and 96 hours, samples of test medium were taken

wn lica
.
for quantification of glyphosate by HPLC.

s o ub
f it y p
so n
Statistical calculations: LC50 values were calculated along with the 95 % confidence limits using non-

ht , a
rig ntly
linear interpolation.

th ue
e eq
e
lat ns
II. RESULTS AND DISCUSSION

vio . Co
an ime al.
te reg new
oh tio re
A. FINDINGS

d
pr tec EU
Analytical data: The arithmetic mean measured concentrations during the 96-hour exposure ranged from

ibi n
d
be ro te
119 to 989 mg MON 52276/L and from 92 to 100 % of nominal. The results are provided based on mean

e ta p osa
measured concentrations.

ef da ph
er y ly
th tor G
ay ula the
Table 10.2.1-1: Analytical results

or
t m reg king
m er see
Nominal Measured concentration [mg MON52276/L] Mean (±SD) % of

do ll u tium
en a
concentration [mg MON 52276/L] nominal

cu nd
0hr 48hr 96hr
his fa or
[mg MON 52276/L]
f t ay ns
r o m co
Control ND ND ND - -
ne ent he

130 124 114 123 119 (5.1) 92

ow um of t

119 112 123

th oc (s)
of is d ber

216 202 190 195 208 (30.2) 96

ion , th em

244 172 246

iss ore m

e
rm m er

360 368 339 373 362 (16.9) 100

pe her orm

357 348 385

he rt t/f
t t Fu en

600 584 520 598 581 (42.4) 97

ou s. rr
th tie cu

599 545 639

wi par (a)

1000 1030 921 1010 989 (49.1) 99

f
en ird o
nt th rty

994 937 1040

co and ope

ND = not detection, limit of detection 2.6 mg/L.

r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

The LC50 and NOEC values are given below based on mean measured concentrations.
ts
do s o um
is ht c
th rig s do

Table 10.2.1-2: Endpoints

i
e op Th

Endpoints (96 h) MON 52276 [mg/L] Glyphosate [mg/L]1

of y
us c

LC50 (95% C.I.) > 989 > 306.1

d nd
an a

NOEC 989 306.1

n rty

1
MON 52276 is 30.95% glyphosate as active ingredient.
tio e
ta op
loi pr
xp al
l e ctu

B. OBSERVATIONS
cia lle
er te
m s in

Mortality and signs of toxicity in control and treated groups are reported in the table below. Mortality to
om a
y c uch

one fish was observed at the lowest test concentration (119 mg/L), but it was judged to be not treatment-
an ts s

related. No mortality was observed at the higher test concentrations. No sublethal effects were observed at
an righ

any test concentration.

d
ing to
sh ct
bli bje
pu su
or be

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Table 10.2.1-3: Acute toxicity of MON 52276 to rainbow trout (Oncorhynchus mykiss) under

t rib
flow-through conditions

dis
n,
er tio
MON 52276 Time point Abnormalities/ Mortality2 Cumulative

wn lica
.
[mg /L] 1 [h] Sublethal Effects % mortality

s o ub
f it y p
0 24 None 0 0

so n
ht , a
48 observed

rig ntly
72

th ue
96

e eq
e
lat ns
119 24 None 1 5

vio . Co
an ime al.
48 observed

te reg new
72

oh tio re

d
96

pr tec EU
ibi n
d
be ro te
208 24 None 0 0

e ta p osa
48 observed

ef da ph
72

er y ly
th tor G
96

ay ula the

or
362 24 None 0 0

t m reg king
48 observed

m er see
72

do ll u tium
en a
96

cu nd
his fa or
581 24 None f t ay ns 0 0
r o m co
48 observed
ne ent he

72
ow um of t

96
th oc (s)
of is d ber

989 24 None 0 0
ion , th em

48 observed
iss ore m

72
rm m er
pe her orm

96
he rt t/f

1 Mean measured values.

t t Fu en

2 Number of dead fish of 20 total.

ou s. rr
th tie cu
wi par (a)
f
en ird o

All validity criteria according to OECD 203 were fulfilled, as no mortality was observed in control group,
nt th rty
co and ope

dissolved oxygen concentration was ≥ 60 % of air saturation and constant exposure conditions have been
r

ts
r i er p

maintained.
t o wn the
en o s
m he t i

The following points deviated from current guideline too:

cu f t en

ts
do s o um

 Fish were acclimatised 48 hours prior to the test instead of the 7 required
is ht c
th rig s do

 Observations occurred after 24h, 48h, 72h and 96h. The requirements are the following a minimum
of 2 observations within the first 24 hours of the study and on days 2 – 4 of the test, all vessels with
i
e op Th

living fish inspected twice per day (preferably early morning and late afternoon to best cover the
of y

24-hour periods).
us c
d nd

 The pH in the highest concentration outside of accepted range of 6.0 – 8.5 so the stock solution
an a
n rty

should have been adjusted to lie within this specified range.

tio e
ta op
loi pr

These deviations are not considered to have a negative impact on the study.
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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,r
ion
ut
III. CONCLUSIONS

t rib
dis
n,
er tio
Assessment and conclusion by applicant:

wn lica
Based on mean measured concentrations, the 96-hour LC50 for rainbow trout (Oncorhynchus mykiss)

.
s o ub
f it y p
exposed to MON 52276 in a flow-through test system was > 989 mg/L (> 306 mg glyphosate/L,

so n
arithmetic mean measured). The corresponding no observed effect concentration (NOEC) was

ht , a
rig ntly
≥ 989 mg/L (≥ 306 mg glyphosate/L, arithmetic mean measured), based on the absence of mortality and

th ue
abnormal sublethal effects at this concentration.

e eq
e
lat ns
vio . Co
an ime al.
The study is considered to be valid and suitable for use in the risk assessment.

te reg new
oh tio re

d
pr tec EU
ibi n
d
be ro te
Assessment and conclusion by RMS:

e ta p osa
ef da ph
er y ly
th tor G
ay ula the

or
t m reg king
m er see
1. Information on the study

do ll u tium
en a
Data point: CP 10.2.1/002

cu nd
his fa or
Report author f t ay ns
r o m co

1992
ne ent he

Report year
ow um of t

Report title MON 52276: Acute Toxicity To The Common Carp, Cyprinus carpio,
th oc (s)

Under Flow-Through Test Conditions

of is d ber
ion , th em

Report No J9108002c
iss ore m

e
rm m er

Document No -91-298
pe her orm

Guidelines followed in study OECD guideline 203

he rt t/f
t t Fu en

Deviations from current test Deviations from the current OECD 203 guideline (2019):
ou s. rr
th tie cu

guideline Major:
wi par (a)

- Dissolved oxygen concentration dropped under 60% of

f
en ird o
nt th rty

saturation (from 8.7 mg/L to 2.5 mg/L = 28.7 %)

co and ope

Minor:
r

ts
r i er p

- Temperature range should not vary more than ±1°C and should
t o wn the

be within the range 20 – 24 °C (current values: 21.7 – 23.8 °C).

en o s
m he t i

- Observations occurred after 24h, 48h and 96h instead of

cu f t en

ts
do s o um

twice/day
is ht c
th rig s do

- Fish length ranged from 2.7 – 5 cm, outside the recommended

length of 2.0 – 4.0 cm.
i
e op Th

- pH of the highest concentration (5.7) was not in the specified

of y

range of 6.0 – 8.5.

us c
d nd

- The test concentrations were not maintained within 80 % of

an a

nominal concentrations at 96 h (current values from 52 to

n rty
tio e

84 %).
ta op
loi pr

Previous evaluation Yes, accepted in RAR (2015)

xp al
l e ctu

Yes
cia lle

GLP/Officially recognised
er te

testing facilities
m s in
om a

Acceptability/Reliability Valid
y c uch

Category 2a
an ts s

Category study in AIR 5

an righ

dossier (L docs)
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 198 of 553

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2. Full summary

t rib
dis
Executive Summary

n,
The effects of MON 52276 (30.95 % glyphosate acid) on common carp (Cyprinus carpio) were evaluated

er tio
wn lica
in a 96-hour flow-through toxicity test. Two groups of ten fish each were exposed for 96 hours to nominal

.
s o ub
concentrations of MON 52276 at 0 (controls), 130, 216, 360, 600 and 1000 mg/L. The test water was a

f it y p
blend of treated municipal water and treated well water. At 0, 48 and 96 hours, samples of test medium

so n
ht , a
were taken for the analysis of glyphosate content.

rig ntly
Mortality and signs of toxicity were recorded at 24, 48, 72 and 96 hours after test initiation.

th ue
e eq
No treatment related mortality or sublethal effects were observed in common carp at any test concentration.

e
lat ns
The present study is considered valid according to OECD guideline 203 (even if the dissolved oxygen

vio . Co
an ime al.
te reg new
criterion is not met).
Based on arithmetic mean measured concentrations, the 96-hour LC50 for common carp (Cyprinus carpio)

oh tio re

d
pr tec EU
exposed to MON 52276 in a flow-through test system was > 895 mg/L (> 277 mg glyphosate/L). The

ibi n
d
be ro te
corresponding no observed effect concentration (NOEC) was ≥ 895 mg/L (≥ 277 mg glyphosate/L,

e ta p osa
arithmetic mean measured).

ef da ph
er y ly
th tor G
ay ula the
I. MATERIALS AND METHODS

or
t m reg king
A. MATERIALS

m er see
1. Test material:

do ll u tium
en a
cu nd
his fa or
Test item: MON 52276
f t ay ns
r o m co
Active substance Glyphosate
ne ent he
ow um of t

Description: Amber liquid

th oc (s)

Lot/Batch #: LLN-9105-3135F
of is d ber
ion , th em

Purity: 30.95 %
iss ore m

e
rm m er

2. Vehicle and/or positive control: None

pe her orm
he rt t/f

3. Test organism:
t t Fu en
ou s. rr

Species: Common carp (Cyprinus carpio)

th tie cu
wi par (a)

Age: Juveniles
f
en ird o
nt th rty

Size: 2.7 – 5.0 cm

co and ope

Loading: 10 test individuals for 15 L test solution (0.93 g fish/L)

r

ts
r i er p
t o wn the

Source:
en o s
m he t i

Acclimation period: 14 days prior to the test initiation

cu f t en

ts
do s o um

Body weight of the animals: 0.57 – 2.97 g (mean of 1.39 g)

is ht c
th rig s do

Food brine shrimp, nauplii and flake until 48h prior test initiation
i
e op Th

4. Environmental conditions:
of y
us c

Temperature: 21.7 – 23.8 °C

d nd
an a

Photoperiod: 16 hours light, 350 - 425 lux

n rty
tio e
ta op

pH: 8.1 (control); 7.1 to 5.7 (test item concentrations)

loi pr
xp al

Dissolved oxygen: 6.7 – 8.7 mg/L (8.7 mg/L is 100 % saturation)

l e ctu
cia lle

Conductivity: 1614 – 1688 µmhos/cm

er te
m s in

Hardness: 184 – 192 mg CaCO3/L

om a
y c uch

Alkalinity: 34 – 45 mg CaCO3/L
an ts s

5. Dates of experimental work: November 19th to November 23rd 1991

an righ
d
ing to
sh ct
bli bje
pu su
or be

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t rib
B. STUDY DESIGN

dis
n,
Experimental treatments: Two groups of ten fish each were exposed under flow-through conditions using

er tio
wn lica
a proportional diluter system (3.8 daily volume turnover) for 96 hours to nominal concentrations of MON

.
s o ub
52276 at 0 (controls), 130, 216, 360, 600 and 1000 mg/L. The test water was a blend of treated municipal

f it y p
water and treated well water. During the 14-day holding period prior to test initiation, fish were fed daily

so n
ht , a
and were in good health. There were two vessels per treatment, each containing ten fish (appr. 24 L glass

rig ntly
vessels containing 15 L test medium).

th ue
e eq
e
lat ns
Observations: Mortality and signs of toxicity were recorded at 24, 48, 72 and 96 hours after test initiation.

vio . Co
an ime al.
te reg new
Water temperature in a control chamber was measured hourly throughout the test, and water pH and
dissolved oxygen were measured daily in all test chambers. Hardness, total alkalinity and specific

oh tio re

d
pr tec EU
conductivity were measured at test initiation and test termination. At 0, 48 and 96 hours, samples of test

ibi n
d
be ro te
medium were taken for quantification of glyphosate by HPLC.

e ta p osa
ef da ph
er y ly
Statistical calculations: LC50 values were calculated along with the 95 % confidence limits using non-

th tor G
ay ula the
linear interpolation.

or
t m reg king
m er see
II. RESULTS AND DISCUSSION

do ll u tium
en a
cu nd
his fa or
A. FINDINGS
f t ay ns
r o m co
For an estimated period of 4 – 6 hours, beginning at 8 hours prior to test termination, only dilution water
ne ent he

was delivered to test chambers due to a malfunction in the diluter system. Since there were no indications
ow um of t

of stress or any other effects, it is unlikely that the reduction in exposure concentration for this short period
th oc (s)
of is d ber

had any effect on the outcome of the test.

ion , th em
iss ore m

Analytical data: The arithmetic mean measured concentrations during the 96 hour exposure ranged from
rm m er
pe her orm

98 to 895 mg test item/L and from 75 to 90 % of nominal on the overall period. The results were determined
he rt t/f

based on mean measured concentrations.

t t Fu en
ou s. rr
th tie cu
wi par (a)
f

Table 10.2.1-4: Analytical results

en ird o
nt th rty
co and ope

Nominal Measured concentration [mg MON52276/L] Mean (±SD) % of

r

ts
r i er p
t o wn the

concentration [mg MON 52276/L] nominal

en o s

[mg MON 52276/L] 0hr 48hr 96hr

m he t i
cu f t en

ts

Control ND ND ND - -
do s o um
is ht c

130 111 117 74 98 (21.7) 75

th rig s do

112 107 67
i
e op Th

216 171 188 125 176 (48.4) 81

of y

235 219 116

us c
d nd

360 395 366 215 340 (69.6) 94

an a
n rty

371 390 302

tio e
ta op

600 570 592 481 552 (92.8) 92

loi pr
xp al

619 649 403

l e ctu
cia lle

1000 1020 1002 677 895 (94.6) 90

er te
m s in

1047 1010 615

om a

ND = not detection, limit of detection 1.9 mg/L.

y c uch
an ts s
an righ

The LC50 and NOEC values are given below based on mean measured concentrations.
d
ing to
sh ct
bli bje
pu su
or be

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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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t rib
Table 10.2.1-5: Endpoints

dis
n,
er tio
Endpoints (96 h) MON 52276 [mg/L] Glyphosate [mg/L]1

wn lica
.
s o ub
LC50 (95 % C.I.) > 895 > 277

f it y p
NOEC ≥ 895 ≥ 277

so n
ht , a
1 MON 52276 is 30.95 % glyphosate as active ingredient.

rig ntly
th ue
e eq
e
lat ns
B. OBSERVATIONS

vio . Co
an ime al.
te reg new
oh tio re
Mortality and signs of toxicity in control and treated groups are reported below. No mortality and no

d
pr tec EU
ibi n
sublethal effects were observed at any test concentrations.

d
be ro te
e ta p osa
ef da ph
Table 10.2.1-6: Acute toxicity of MON 52276 to Common carp (Cyprinus carpio) under

er y ly
th tor G
flow-through conditions

ay ula the

or
t m reg king
MON 52276 Time point Abnormalities/ Mortality2 Cumulative

m er see
(mg/L)1 (h) Sublethal Effects % mortality

do ll u tium
en a
0 24 None 0 0

cu nd
his fa or
48 observed
72 f t ay ns
r o m co
ne ent he

96
ow um of t

98 24 None 0 0
th oc (s)

48 observed
of is d ber

72
ion , th em

96
iss ore m

e
rm m er

176 24 None 0 0
pe her orm

48 observed
he rt t/f
t t Fu en

72
ou s. rr
th tie cu

96
wi par (a)

340 24 None 0 0
f
en ird o
nt th rty

48 observed
co and ope

72
r

ts
r i er p

96
t o wn the

552 24 None 0 0
en o s
m he t i

48 observed
cu f t en

ts
do s o um

72
is ht c
th rig s do

96
i

895 24 None 0 0
e op Th

48 observed
of y

72
us c
d nd

96
an a

1
n rty

Mean measured values.

tio e

2 Number of dead fish of 20 total.

ta op
loi pr
xp al
l e ctu
cia lle

All validity criteria according to OECD 203 were fulfilled, as no mortality was observed in control group,
er te

dissolved oxygen concentration was ≥ 60 % of air saturation and constant exposure conditions have been
m s in

maintained.
om a
y c uch

During the test period, the dissolved oxygen during the test fell below 60 % of the air saturation value in
an ts s

at least one replicate at every dose level and in both replicates at the two highest dose levels; the fish did
an righ

not appear stressed as a result.

d
ing to
sh ct
bli bje
pu su
or be

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The following validity criteria according to the OECD 203 (2019) were fulfilled:

t rib
 The control mortality was lower than 10 % at the end of the study.

dis
 Analytical measurement of the test concentrations was reported.

n,
er tio
wn lica
.
The following validity criterion according to the OECD 203 (2019) was not fulfilled:

s o ub
f it y p
 The dissolved oxygen concentration was below the trigger value of ≥ 60 % of the air saturation

so n
ht , a
value (ranging from 8.7 mg/L to 2.5 mg/L = 28.7 % through the study).

rig ntly
th ue
The following points deviated from current guideline too:

e eq
e
lat ns
 Observations occurred after 24 h, 48 h, 72 h and 96 h. The requirements are the following a

vio . Co
an ime al.
minimum of 2 observations within the first 24 hours of the study and on days 2 – 4 of the test, all

te reg new
vessels with living fish inspected twice per day (preferably early morning and late afternoon to best

oh tio re

d
cover the 24-hour periods).

pr tec EU
ibi n
d
be ro te
 The pH in the highest concentration outside of accepted range of 6.0 – 8.5 so the stock solution

e ta p osa
should have been adjusted to lie within this specified range.

ef da ph
 Dissolved oxygen concentration dropped under 60 % of saturation (from 8.7 mg/L to 2.5 mg/L =

er y ly
th tor G
28.7 %)

ay ula the

or
 Temperature range should not vary more than ±1 °C and should be within the range 20 – 24 °C

t m reg king
(current values: 21.7 – 23.8 °C).

m er see
 Fish length ranged from 2.7 – 5 cm, outside the recommended length of 2.0 – 4.0 cm.

do ll u tium
en a
 The test concentrations were not maintained within 80 % of nominal concentrations at 96 h

cu nd
his fa or
f t ay ns
(current values from 52 to 84 %). The endpoints have been based on the overall mean measured
r o m co

concentrations.
ne ent he
ow um of t
th oc (s)

These deviations are not considered to have a negative impact on the study.
of is d ber
ion , th em

III. CONCLUSIONS
iss ore m

e
rm m er
pe her orm

Assessment and conclusion by applicant:

he rt t/f
t t Fu en

Based on arithmetic mean measured concentrations, the 96-hour LC50 for common carp (Cyprinus
ou s. rr
th tie cu

carpio) exposed to MON 52276 in a flow-through test system was > 895 mg/L (> 277 mg glyphosate/L).
wi par (a)

The corresponding no observed effect concentration (NOEC) was ≥ 895 mg/L (≥ 277 mg glyphosate/L,
f
en ird o
nt th rty

arithmetic mean measured).

co and ope
r

ts
r i er p

The study is considered to be valid and suitable for use in the risk assessment.
t o wn the
en o s
m he t i
cu f t en

ts
do s o um

Assessment and conclusion by RMS:

is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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cti
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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1. Information on the study

t rib
dis
Data point: CP 10.2.1/003

n,
er tio
Report author

wn lica
.
1992

s o ub
Report year

f it y p
Report title MON 52276: Acute toxicity to the water flea, Daphnia magna, under

so n
ht , a
flow-through test conditions

rig ntly
th ue
Report No J9108002a

e eq
e
lat ns
Document No TO-91-296

vio . Co
an ime al.
Guidelines followed in study US EPA FIFRA 72-2 (1982), OECD 202 (1984), and EEC Method

te reg new
C.2 (1992).

oh tio re

d
pr tec EU
Deviations from current test Deviations from current OECD 202 guideline (2004):

ibi n
d
be ro te
guideline Major:

e ta p osa
- none

ef da ph
er y ly
Minor:

th tor G
ay ula the
- The pH of the test system was correlated with MON 52276

or
t m reg king
concentration and varied by more than 1 unit across the 5 dose levels.
- The temperature was slightly higher and ranged from 20.0 – 23.8 °C

m er see
instead of 18.0 – 22.0 °C. This did not have a negative effect on the

do ll u tium
en a
study and validity criteria are met.

cu nd
his fa or
Previous evaluation Yes, accepted in RAR (2015) f t ay ns
r o m co
ne ent he

GLP/Officially recognised Yes

ow um of t

testing facilities
th oc (s)
of is d ber

Acceptability/Reliability Valid
ion , th em

Category study in AIR 5 Category 2a

iss ore m

e
rm m er

dossier (L docs)
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu

2. Full summary
wi par (a)

Executive Summary
f
en ird o
nt th rty

The effects of MON 52276 (30.95 % w/w glyphosate acid) on Daphnia magna were evaluated in a 48-hour
co and ope

flow-through toxicity test. Neonates of Daphnia magna were exposed to nominal concentrations of MON
r

ts
r i er p

52276 at 130, 216, 360, 600, and 1000 mg/L and a negative control consisting of dilution water. The test
t o wn the

consisted of two replicates per treatment group and control. 10 Daphnids were exposed per replicate and
en o s
m he t i

were not fed during the test. Total number of Daphnia magna exhibiting immobility and other clinical signs
cu f t en

ts
do s o um

of toxicity was recorded at 24 and 48 hours after test initiation.

is ht c
th rig s do
i

Temperature, pH-values and dissolved oxygen concentrations were measured at the beginning, at
e op Th

approximately 24 hours during the test and at the end of the test. At 0 and 48 hours, samples of test medium
of y

were taken for quantification of glyphosate by HPLC. The analysed test concentrations ranged between 95
us c
d nd

and 105 % of the nominal values.

an a
n rty
tio e
ta op

No mortality to Daphnia magna from exposure to MON 52276 was observed at test concentrations
loi pr

< 356 mg/L. At 580 mg/L, 20 % mortality was observed at 48 hours, with 100 % mortality observed at
xp al
l e ctu

948 mg/L. Sublethal effects were observed only at the 580 mg/L concentration.
cia lle
er te
m s in

Based on mean measured concentrations, the 48-hour EC50 for Daphnia magna exposed to MON 52276 in
om a

a flow-through test system was 676 mg/L (95 % confidence limits of 580 and 948 mg/L), (equivalent to
y c uch

209 mg glyphosateL). The corresponding no observed effect concentration (NOEC) was 356 mg/L
an ts s

(107 mg glyphosate/L), based on the lack of mortality and sublethal effects at this concentration.
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 203 of 553

ep
,r
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I. MATERIALS AND METHODS

t rib
dis
A. MATERIALS

n,
er tio
wn lica
.
s o ub
1. Test material:

f it y p
Test item:: MON 52276

so n
ht , a
rig ntly
Active substance: Glyphosate

th ue
Purity: 30.95 %

e eq
e
lat ns
Lot/Batch #: LLN-9105-3135F

vio . Co
an ime al.
te reg new
Appearance: Amber liquid

oh tio re

d
None

pr tec EU
2. Vehicle and/or positive control:

ibi n
d
be ro te
3. Test organism:

e ta p osa
ef da ph
Species: Daphnia magna Straus

er y ly
th tor G
Age: Neonates (< 24 h old)

ay ula the

or
t m reg king
Loading: 1 daphnid per 30 mL test medium

m er see
Source: In-house culture (originally from: U.S. Environmental

do ll u tium
en a
Protection Agency, Duluth, Minnesota)

cu nd
his fa or
Diet/Food: none f t ay ns
r o m co

Acclimation period: Not stated

ne ent he
ow um of t

4. Environmental conditions:
th oc (s)
of is d ber

Temperature: 20.0 – 23.8 °C

ion , th em

Photoperiod: 16 hours light, 384 – 517 lux

iss ore m

e
rm m er

pH: 5.9 – 8.3

pe her orm
he rt t/f

Dissolved oxygen: 7.4 – 8.7 mg O2/L

t t Fu en
ou s. rr

Conductivity: 436 – 644 µS/cm

th tie cu
wi par (a)

Hardness: 60 – 96 mg CaCO3/L
f
en ird o
nt th rty

5.Dates of experimental work: Oct 16th to Oct 18th 1991

co and ope
r

ts
r i er p
t o wn the

B. STUDY DESIGN AND METHODS

en o s
m he t i
cu f t en

1. Experimental treatments: The effects of MON 52276 (30.95 % w/w glyphosate acid) on neonates of
ts
do s o um

Daphnia magna were evaluated in a 48-hour flow-through toxicity test using a proportional diluter system
is ht c
th rig s do

(1.6 cycles/h). Twenty Daphnids (2 replicates of 10 animals per test beaker) were exposed to nominal
i
e op Th

concentrations of MON 52276 at 130, 216, 360, 600, and 1000 mg/L dissolved in a blend of treated
municipal water and treated well water (corresponding to 133, 227, 356, 580 and 948 mg/L of the measured
of y

concentrations). In addition, a control group was exposed to test water without test substance (blank
us c
d nd

control).
an a
n rty
tio e
ta op

2. Observations: Total number of immobile Daphnia magna was recorded 24 h and 48 h after test
loi pr

initiation. In addition, specimens were observed for clinical signs of toxicity.

xp al
l e ctu

Water temperature was measured at 0 and 48 hours in each test chamber, as well as hourly in one negative
cia lle

control replicate. Water pH and dissolved oxygen were recorded at test start then every 24 hours. Hardness,
er te
m s in

alkalinity and specific conductance were measured once in the dilution water at test initiation.
om a
y c uch
an ts s

At 0 and 48 hours, samples of test medium were taken for quantification of glyphosate by HPLC.
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 204 of 553

ep
,r
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The validity criteria according to the current OECD 202 guideline are the following:

t rib
 In the control, not more than 10 percent of the daphnids should have been immobilised or show

dis
other signs of disease or stress.

n,
er tio
 The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test

wn lica
.
vessels.

s o ub
f it y p
so n
ht , a
3. Statistical calculations: EC50 values including 95 % confidence limit were determined by non-linear

rig ntly
interpolation.

th ue
e eq
e
lat ns
II. RESULTS AND DISCUSSION

vio . Co
an ime al.
te reg new
A. FINDINGS

oh tio re

d
pr tec EU
ibi n
The analysed test concentrations ranged between 95 and 105 % of the nominal values. The results were

d
be ro te
e ta p osa
determined based on mean measured concentrations.

ef da ph
er y ly
th tor G
Table 10.2.1-7: Analytical results

ay ula the

or
t m reg king
Nominal Measured concentration [mg MON 52276/L] Mean (±SD) % of

m er see
concentration [mg MON 52276/L] nominal

do ll u tium
en a
[mg MON 52276/L] 0hr 24hr 48hr

cu nd
his fa or
Control ND ND ND
f t ay ns
r o m co - -
130 122 125 123 133 (12.1) 102
ne ent he
ow um of t

139 136 153

th oc (s)

216 217 221 236 227 (9.9) 105

of is d ber

228 217 240

ion , th em
iss ore m

360 373 346 362 356 (16.8) 99

e
rm m er
pe her orm

370 328 359

he rt t/f

600 593 512 593 580 (41.4) 97

t t Fu en
ou s. rr

612 550 621

th tie cu
wi par (a)

1000 969 911 985 948 (48.1) 95

f
en ird o

961 870 994

nt th rty
co and ope

ND = not detected, limit of detection 1.9 mg/L.

r

ts
r i er p
t o wn the
en o s

The LC50 and NOEC values are given below based on mean measured concentrations.
m he t i
cu f t en

ts
do s o um

Table 10.2.1-8: Endpoints

is ht c
th rig s do
i
e op Th

Endpoints MON 52276 [mg/L] Glyphosate [mg/L]1

of y

EC50 (48 h) 676 mg/L (580 – 948 mg/L) 209 mg/L

us c
d nd

NOEC (48 h) 356 mg/L 107 mg/L

an a

1
MON 52276 is 30.95 % glyphosate as active ingredient.
n rty
tio e
ta op
loi pr
xp al
l e ctu

B. OBSERVATIONS
cia lle
er te

No mortality to Daphnia magna from exposure to MON 52276 was observed at test concentrations
m s in
om a

< 356 mg/L. At 580 mg/L, 20 % mortality was observed at 48 hours, with 100 % mortality observed at
y c uch

948 mg/L. Sublethal effects were observed only at the 580 mg/L concentration.
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.2.1-9: Acute toxicity of MON 52276 to Daphnia magna under flow-through conditions

t rib
dis
n,
Measured concentration Time point Abnormalities/ No. of Daphnia Cumulative

er tio
MON 52276 (h) Sublethal Effects immobilised or % mortality

wn lica
.
(mg/L) 1 dead2

s o ub
f it y p
0 24 None 0 0

so n
ht , a
48 observed 0 0

rig ntly
133 24 None 0 0

th ue
e eq
48 observed 0 0

e
lat ns
227 24 None 0 0

vio . Co
an ime al.
te reg new
48 observed 0 0

oh tio re
356 24 None 0 0

d
pr tec EU
48 observed 0 0

ibi n
d
be ro te
e ta p osa
580 24 None observed 0 0
48 3 lethargic 4 20

ef da ph
er y ly
th tor G
948 24 None observed 11 55

ay ula the
48 -- 20 100

or
t m reg king
1 Mean measured values.

m er see
2 Of 20 total Daphnia in group.

do ll u tium
en a
cu nd
his fa or
f t ay ns
All validity criteria according to the OECD 202 were fulfilled, as no immobility of Daphnids was observed
r o m co

in control groups and dissolved oxygen concentration was ≥ 3 mg/L in all test vessels.
ne ent he
ow um of t

The following points deviated from current guideline:

th oc (s)

- the pH of the test system was correlated with MON 52276 concentration and varied by more than 1 unit
of is d ber

across the 5 dose levels. Within each test concentration, the pH variation was less than one unit.
ion , th em

- The temperature range during the test was 3.8 ºC, rather than the maximum range of 2 ºC specified in the
iss ore m

guideline.
rm m er
pe her orm
he rt t/f

These deviations are not considered to have a negative impact on the study.
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o

III. CONCLUSIONS
nt th rty
co and ope

Assessment and conclusion by applicant:

r

ts
r i er p

Based on mean measured concentrations, the 48-hour EC50 for Daphnia magna exposed to MON 52276
t o wn the

in a flow-through test system was 676 mg/L (95% confidence limits of 580 and 948 mg/L), (equivalent
en o s
m he t i
cu f t en

ts

to 209 mg glyphosate/L). The corresponding no observed effect concentration (NOEC) was 356 mg/L
do s o um

(107 mg glyphosate/L), based on the lack of mortality and sublethal effects at this concentration.
is ht c
th rig s do
i
e op Th

The study is considered to be valid and suitable for use in the risk assessment.
of y
us c
d nd
an a

Assessment and conclusion by RMS:

n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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an may
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1. Information on the study

t rib
dis
Data point CP 10.2.1/004

n,
Report author

er tio
wn lica
Report year 1992

.
s o ub
Report title Alga, growth inhibition test. Effect of MON 52276 on the

f it y p
growth of Selenastrum capricornutum

so n
ht , a
WE-06-057

rig ntly
Report No

th ue
Document No TO-91-298

e eq
Guidelines followed in study OECD Guideline 201 (1981)

e
lat ns
vio . Co
EU Directive 87/302/EEC, Part C (1987)

an ime al.
te reg new
NEN 6506, Delft (1984)

oh tio re
Deviation from current OECD 201 guideline (2011):

d
Deviations from current test

pr tec EU
ibi n
guideline Major:

d
be ro te
e ta p osa
- The test concentrations were not verified.

ef da ph
Minor:

er y ly
- none

th tor G
ay ula the
Previous evaluation Yes, accepted in RAR (2015)

or
t m reg king
GLP/Officially recognised testing Yes

m er see
facilities

do ll u tium
en a
Acceptability/Reliability Supportive

cu nd
his fa or
Category study in AIR 5 dossier Category 2b
f t ay ns
(L docs)
r o m co
ne ent he
ow um of t
th oc (s)

2. Full summary
of is d ber
ion , th em

Executive Summary
iss ore m

The effects of MON 52276 on Selenastrum capricornutum (currently known as Raphidocelis subcapitata)
rm m er
pe her orm

were evaluated in a 72-hour static toxicity test. Algal cells were exposed to five nominal MON 52276
he rt t/f

concentrations of 50, 90, 160, 290 and 500 mg test item/L. In addition, a control group was prepared with
t t Fu en
ou s. rr

algae added to test medium without test substance.

th tie cu

Six replicate vessels were prepared for the control and three replicates for each test concentration. Each
wi par (a)

vessel was inoculated with an initial algal cell density 1 x 104 cells/mL.
f
en ird o
nt th rty

After 24, 48, and 72 hours, mean cell densities for each test concentration and control were determined
co and ope

based on spectrophotometrical measurements and cell counting. The concentration resulting in 50 %

r

ts
r i er p

inhibition of cell growth (biomass) and reduction of cell growth rate (EbC50 & ErC50 values respectively)
t o wn the

were then calculated. as well as the associated NOEC values.

en o s
m he t i
cu f t en

ts

The 72 hour EbC50 for MON 52276 was calculated to be 150 mg/L and the 72 hour ErC50 was calculated to
do s o um

be 393 mg/L, with a corresponding NOEC determined to be 90 mg/L.

is ht c
th rig s do
i
e op Th

I. MATERIALS AND METHODS

of y
us c
d nd

A. MATERIALS
an a
n rty
tio e

Test Material:
ta op
loi pr

Identification: MON 52276

xp al
l e ctu

Lot No.: LLN 260491 B

cia lle
er te
m s in

Chemical purity: 31 % glyphosate acid equivalent, as 41 % isopropylamine salt of

om a

glyphosate
y c uch
an ts s

Physical state: Light amber-brown liquid

an righ

Density: 1.16 mg/cm3

d
ing to
sh ct
bli bje
pu su
or be

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rib
Vehicle and/or positive control:

t
dis
Vehicle: None

n,
er tio
wn lica
Positive control: None

.
s o ub
f it y p
Test organism:

so n
ht , a
Species: Selenastrum capricornutum (currently known as Raphidocelis

rig ntly
subcapitata)

th ue
e eq
Initial cell concentration: 1 x 104 cells/mL

e
lat ns
vio . Co
an ime al.
Source: Inoculum obtained from a 4 day incubated laboratory pre-culture, prepared

te reg new
at the performing laboratory (Original parent culture source is the Culture

oh tio re

d
pr tec EU
Centre for Amoeba and Protozoa in the UK. Strain No. CCAP 278/4)

ibi n
d
be ro te
e ta p osa
Environmental conditions:

ef da ph
Temperature: 20.9 – 23.1 °C (Required: 21 to 25 ºC ± 2 ºC)

er y ly
th tor G
ay ula the
Photoperiod: 24 h light

or
t m reg king
Light intensity: 8875 ± 125 lux

m er see
pH: 8.31 – 8.97 (control),

do ll u tium
en a
6.38 – 8.89 at 50, 160 and 290 mg/L

cu nd
his fa or
f t ay ns
7.32 – 8.99 at 90 mg/L- deviated by more than 1 pH unit (1984 guideline
r o m co

requirement, but within 1.5 pH units (current OECD 201 guideline

ne ent he
ow um of t

requirement).
th oc (s)

5.88 – 5.98 at 500 mg/L

of is d ber
ion , th em

Conductivity: Not stated

iss ore m

e
rm m er

Hardness: Not stated

pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu

B. STUDY DESIGN
wi par (a)

Experimental dates: 15 October – 18 October 1991

f
en ird o
nt th rty
co and ope

Experimental treatments
Based on a range finding test, the definitive algal growth inhibition test was performed with five
r

ts
r i er p
t o wn the

concentrations (50, 90, 160, 290 and 500 mg test item/L) prepared by appropriate dilution of a 10 g/L stock
en o s

solution. In addition, a control was also prepared where algae were exposed to algal medium only without
m he t i
cu f t en

ts

test substance (blank control). OECD 201 recommended algal medium was used as the diluent. For each
do s o um
is ht c

MON 52276 concentration, three replicate vessels were prepared, and six replicate vessels were prepared
th rig s do

for the control group. (150 mL Erlenmeyer glass flasks with cotton wool bungs.) To each test or control
i
e op Th

vessel, 100 mL of the test medium was added, and all replicates vessels were then inoculated with algal
of y

cells, at an initial algal cell density of 1 × 104 cells/mL.

us c
d nd
an a

Observations
n rty

After 24, 48, and 72 hours, mean cell densities for each test concentration and control were determined
tio e
ta op

based on spectrophotometrical measurements (absorbance measurement). In addition, the algal cell

loi pr
xp al

concentrations were also determined by microscopic counting at 48 hours and 72 hours. Inhibition of cell
l e ctu

growth and reduction of cell growth rate were derived graphically, by plotting the average algal cell
cia lle
er te

concentrations for each test concentration against time. Concentrations resulting in 50 % reduction of
m s in

growth rate (ErC50) and 50 % inhibition of cell growth (EbC50) were determined, as well as the associated
om a
y c uch

NOEC values. The endpoints were calculated for the absorbance and cell counting method. Temperature
an ts s

and the light intensity were recorded daily during the test, while the pH was measured in one replicate of
an righ

each test concentration at the start and end of the test.

d
ing to
sh ct
bli bje
pu su
or be

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t rib
Statistical calculations

dis
The median effect concentration is determined using the logit model of Chou and Chou (1985).

n,
er tio
wn lica
.
II. RESULTS AND DISCUSSION

s o ub
f it y p
so n
ht , a
A. FINDINGS

rig ntly
th ue
The ErC50, EbC50 and NOEC values are given below based on nominal concentrations.

e eq
e
lat ns
vio . Co
an ime al.
Table 10.2.1-10: Toxicity of MON 52276 to Selenastrum capricornutum

te reg new
oh tio re

d
pr tec EU
Endpoint MON 52276 [mg test item/L]

ibi n
d
be ro te
absorbance cell counting

e ta p osa
0 - 72 h ErC50 393 284

ef da ph
0 - 72 h EbC50 150 178

er y ly
th tor G
NOEC 90

ay ula the

or
t m reg king
m er see
B. OBSERVATIONS

do ll u tium
en a
Based on cell counting, reduction of algal growth rate increased with increasing concentration of

cu nd
his fa or
MON 52276 from a nominal concentration of 160 mg test item/L upwards. For the two lowest test f t ay ns
r o m co
concentrations of 50 mg test item/L and 90 mg test item/L, increases of algal growth rate of 13.6 % and
ne ent he

8.4 %, respectively, were observed, with nearly 100 % inhibition in cell growth at the highest nominal
ow um of t

concentration, compared to the control. Reduction of growth rate and cell growth results are below.
th oc (s)
of is d ber
ion , th em

Table 10.2.1-11: Percentage reduction of growth rate and inhibition of cell growth of Selenastrum
iss ore m

capricornutum exposed for 72 hours to MON 52276

rm m er
pe her orm
he rt t/f

Control MON 52276 [mg test item/L]

t t Fu en
ou s. rr
th tie cu

Test parameters - 50 90 160 290 500

wi par (a)

Mean absorbance (0-72 h) 0.260 0.419 0.391 0.128 0.027 0.015

f
en ird o
nt th rty

Cell growth rate reduction (0-72 h) [%] based

co and ope

- -13.6 -8.4 10.9 42.8 58.2

on absorbance
r

ts
r i er p
t o wn the

Cell growth inhibition (0-72 h) [%] based on - -36.9 -27.7 50.3 81.5 89.6
absorbance
en o s
m he t i
cu f t en

Mean cell densities (0-72 h) (× 1000 cells/mL) 644 741 663 315 45 33
ts
do s o um
is ht c

Cell growth rate reduction (0-72 h) [%] based - -3.4 -0.7 17.5 64.8 72.5
th rig s do

on cell counting
i
e op Th

Cell growth inhibition (0-72 h) [%] - -1.7 8.3 54.1 84.7 93.2
of y

based on cell counting

us c
d nd
an a
n rty

III. CONCLUSIONS
tio e
ta op
loi pr
xp al

Based on absorbance, the 72 h ErC50 and the 72 h EbC50 for Selenastrum capricornutum exposed to
l e ctu

MON 52276 were calculated to be 393 mg test item/L and 150 mg test item/L. The NOEC was determined
cia lle
er te

to be 90 mg test item/L. For cell counting method, 72 h ErC50 and 72 h EbC50 for Selenastrum capricornutum
m s in

exposed to MON 52276 were calculated to be 284 mg test item/L and 178 mg test item/L, respectively. The
om a
y c uch

NOEC was determined to be 90 mg test item/L.

an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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3. Assessment and conclusion

t rib
dis
Assessment and conclusion by applicant:

n,
Validity of the study was re-evaluated according to the current test guideline OECD 201 (2011) and

er tio
wn lica
EC10, EC20, and EC50, NOEC and LOEC values were calculated to fulfil the data requirements according

.
s o ub
to regulation EU 283/2013.

f it y p
so n
ht , a
Validity criteria

rig ntly
th ue
Required Obtained
Validity criteria acc. to OECD 201 (2011)

e eq
(0 - 72 h) (0 - 72 h)

e
lat ns
The biomass in the control cultures should have increased

vio . Co
an ime al.
te reg new
exponentially by a factor of at least 16 within the 72-hour test ≥ 16 59
period.

oh tio re

d
pr tec EU
The mean coefficient of variation for section-by-section

ibi n
d
specific growth rates in the control cultures must not exceed ≤ 35 % 20.4 %

be ro te
e ta p osa
35 %.

ef da ph
The coefficient of variation of average specific growth rates

er y ly
th tor G
during the whole test period in replicate solvent control ≤7% 4.1 %

ay ula the
cultures must not exceed 7 %.

or
t m reg king
m er see
The biomass in the control cultures increased by a factor of ≥ 16 (actual: 59), the coefficient of variance

do ll u tium
en a
for section specific growth rates was ≤ 35 % (actual: 20.4 %) and the coefficient of variance for the

cu nd
whole test period it was ≤ 7 % (actual: 4.1 %).
his fa or
f t ay ns
r o m co
ne ent he

This study was performed according to the valid test guideline at the time of conduct. In the last Annex
ow um of t

I renewal, this study was evaluated and considered acceptable for use in risk assessment. In the current
th oc (s)

submission dossier, a re-evaluation of the study against the current test guideline validity criteria was
of is d ber

conducted (at least a 16 fold increase in biomass, a mean coefficient of variation for section-by-section
ion , th em

growth rates in the control being < 35 % and a coefficient of variation of the average specific growth
iss ore m

e
rm m er

rate over the test period in the controls being < 7 %) and against these criteria, the study was considered
pe her orm

valid. Chemical analysis was not conducted during the study. However, glyphosate is very water soluble
he rt t/f
t t Fu en

(> 10 g/L) and stable under conditions of exposure in laboratory algal studies is supported by more recent
ou s. rr
th tie cu

studies performed with alga. The principal route of degradation of glyphosate is via microbial action.
wi par (a)

Degradation of glyphosate over a short exposure period is not expected. Glyphosate is stable under
f
en ird o

conditions of continuous illumination (see results of the photolysis studies presented in the
nt th rty
co and ope

Environmental Fate section (see M-CA Section 7). Therefore, the losses of glyphosate from the test
r

system following 72 or 96 hr exposure would not be expected. The study should therefore be considered
ts
r i er p
t o wn the

strongly supportive of the risk assessment. The endpoints achieved in the MON 52276 algal study were
en o s
m he t i

72 hr ErC50 = 284 mg test item/L; 72 hr EbC50 = 178 mg test item/L and NOEC = 90 mg test item/L.
cu f t en

ts
do s o um
is ht c
th rig s do
i

Assessment and conclusion by RMS:

e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
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,r
ion
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1. Information on the study

t rib
dis
Data point: CP 10.2.1/005

n,
er tio
Report author

wn lica
.
2002

s o ub
Report year

f it y p
Report title Assessment of toxic effects of MON 52276 on aquatic plants using the

so n
ht , a
duckweed Lemna gibba.

rig ntly
th ue
Report No GA-2002-051

e eq
e
lat ns
Document No 20021186/01-AALg

vio . Co
an ime al.
Guidelines followed in study OECD 221 (draft of October 2000)

te reg new
oh tio re
Deviations from current test Deviation from current OECD 221 guideline (2006):

d
pr tec EU
guideline Major:

ibi n
d
be ro te
- Bacterial contamination occurred in test concentrations 2.4 and 6.8

e ta p osa
mg/L.

ef da ph
er y ly
Minor:

th tor G
ay ula the
- none

or
t m reg king
Previous evaluation Yes, accepted in RAR (2015)

m er see
GLP/Officially recognised Yes

do ll u tium
en a
testing facilities

cu nd
his fa or
Acceptability/Reliability Supportive f t ay ns
r o m co

Category study in AIR 5 Category 2b

ne ent he
ow um of t

dossier (L docs)
th oc (s)
of is d ber
ion , th em

2. Full summary
iss ore m

e
rm m er
pe her orm

Executive Summary
he rt t/f

The effects on the growth of the aquatic plant Lemna gibba G3 exposed to MON 52276 (30.9 % w/w
t t Fu en

glyphosate acid) were determined in a seven-day semi-static study. For the main test, three replicates of 12
ou s. rr
th tie cu

fronds in AAP Medium for Lemna gibba were exposed in glass beakers under continuous illumination to
wi par (a)

nominal MON 52276 concentrations of 0 (control), 0.9, 2.4, 6.8, 19.1, 53.6 and 150 mg/L, equivalent to
f
en ird o
nt th rty

0.278; 0.742; 2.10; 5.90; 16.6; 46.4 mg glyphosate acid/L. Renewal of the test media was performed on day
co and ope

3 and 5 after test initiation. Direct counts of number of fronds were conducted on day 3, 5 and 7.
r

ts
r i er p

Observations of changes in plant development, frond size, appearance, necrosis or other abnormalities were
t o wn the

also performed at those times. The effect on biomass production was evaluated by determining the final
en o s
m he t i

dry weights of the plants. The growth rate inhibition was determined by counting the number of fronds
cu f t en

ts
do s o um

produced for each test concentration and control group. The effect on biomass production was evaluated
is ht c
th rig s do

by determining the final dry weights of the plants. Samples from all the test concentrations were collected
i

for analysis of glyphosate by HPLC on Days 0, 3, 5 and 7.

e op Th
of y

Significant inhibitory effects of MON 52276 were observed at 53.6 and 150 mg/L (43 %) for frond
us c
d nd

numbers, growth rate and biomass increase. These were equivalent to 16.6 and 46.4 mg glyphosate acid/L
an a
n rty

respectively.
tio e
ta op
loi pr

The EC50 for frond number, biomass and growth rates based on frond number and biomass for MON 52276
xp al
l e ctu

were determined to be 66.58, 118.16 and > 150 mg MON 52276/L, respectively. The overall NOEC was
cia lle

determined to be 19.1 mg MON 52276/L. Hence, The EC50 for frond number, biomass and growth rates
er te
m s in

based on frond number and biomass were determined to be 20.57, 36.51 and > 46.35 mg glyphosate acid/L,
om a

respectively. The overall NOEC was determined to be 5.9 mg glyphosate acid/L. The validity criteria
y c uch

according to guideline OECD 221 are fulfilled.

an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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an may
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,r
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I. MATERIALS AND METHODS

t rib
dis
A. MATERIALS

n,
er tio
wn lica
.
1. Test material:

s o ub
f it y p
Test item:: MON 52276

so n
ht , a
rig ntly
Description: Light amber-brown liquid formulation

th ue
Lot/Batch #: A1C1204104

e eq
e
lat ns
Purity: 30.9 % glyphosate acid equivalent, as 41.5 %

vio . Co
an ime al.
isopropylamine salt of glyphosate

te reg new
None

oh tio re
2. Vehicle and/or positive control:

d
pr tec EU
ibi n
3. Test organism:

d
be ro te
e ta p osa
Species: Young Lemna gibba G3, 2 – 5 fronds

ef da ph
er y ly
Source: Institut für Pflanzenökologie und Ökotoxikologie,

th tor G
University of Hohenheim, Stuttgart, Germany

ay ula the

or
t m reg king
4. Environmental conditions:

m er see
Temperature: 22 – 25 °C

do ll u tium
en a
Light intensity: Continuous illumination, 7000 lux

cu nd
his fa or
pH: 7.49 – 9.42 (adjusted to 7.5) f t ay ns
r o m co
ne ent he

Conductivity: not stated

ow um of t

Hardness: Not stated

th oc (s)
of is d ber

5. Dates of experimental work: May 24th to June 15th 2002

ion , th em
iss ore m

e
rm m er
pe her orm

B. STUDY DESIGN AND METHODS

he rt t/f
t t Fu en
ou s. rr
th tie cu

1. Experimental treatments: On the basis of the results of a range finding test, the definitive test was
wi par (a)

performed with six concentration levels, 0.9, 2.4, 6.8, 19.1, 53.6 and 150 mg MON 52276/L, equivalent to
f
en ird o

0.278; 0.742; 2.10; 5.90; 16.6; 46.4 mg glyphosate acid/L, with 3 replicates per test concentration. Three
nt th rty
co and ope

control replicates (without test substance) were tested under the same conditions. Colonies consisting of 2
r

– 5 fronds totalling 12 fronds per replicate were added to each replicate test chamber. The plants were
ts
r i er p
t o wn the

placed in 100 mL test vessels containing 50 mL 20X-AAP test media. The pH of the test medium was
en o s

adjusted at each test media renewal to 7.5, to avoid extreme pH values. The test was conducted under a 7-
m he t i
cu f t en

ts

day static-renewal test conditions. The renewal of the test media was performed on day 3 and 5 after test
do s o um
is ht c

initiation.
th rig s do
i
e op Th

2. Observations:
of y
us c

Biological data: Observations were made on the number and the condition of the fronds on Days 3, 5 and
d nd
an a

7. The growth rate inhibition was determined by counting the number of fronds produced for each test
n rty

concentration and control group. The effect on biomass production was evaluated by determining the final
tio e
ta op

dry weights of the plants.

loi pr
xp al
l e ctu

Physical data: pH and temperature of the test vessels were measured on days 0, 3, 5 and 7. Samples from
cia lle
er te

all the test concentrations were collected for analysis of glyphosate by HPLC on Days 0, 3, 5 and 7.
m s in
om a
y c uch

3. Statistical calculations: The 7-day EC50 value for frond counts and growth rates based on frond counts
an ts s

and biomass were determined by probit analysis and the calculation of statistical significance was
an righ

determined by using one-way analysis of variance (ANOVA) and Dunnett’s test ( = 0.05).
d
ing to
sh ct
bli bje
pu su
or be

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II. RESULTS AND DISCUSSION

t rib
dis
A. FINDINGS

n,
er tio
wn lica
.
Analytical data: The mean measured glyphosate concentrations were 82.9 % to 112 % of nominal over the

s o ub
test period. The test substance remained stable, therefore the results are based on the nominal

f it y p
so n
concentrations.

ht , a
rig ntly
th ue
Table 10.2.1-12: Analytical results

e eq
e
lat ns
vio . Co
an ime al.
Nominal concentration Nominal concentration Mean measured % of nominal

te reg new
[mg MON 52276/L] [mg glyphosate acid/L] [mg glyphosate acid/L]

oh tio re

d
pr tec EU
ibi n
Control - -

d
be ro te
e ta p osa
0.9 0.278 0.231 82.9

ef da ph
2.4 0.742 0.701 94.5

er y ly
th tor G
6.8 2.10 2.11 101

ay ula the

or
t m reg king
19.1 5.90 6.62 112

m er see
53.6 16.6 17.4 105

do ll u tium
en a
150 46.4 48.5 104

cu nd
his fa or
f t ay ns
r o m co
ne ent he

Results were based on nominal MON 52276 concentrations.

ow um of t
th oc (s)

Table 10.2.1-13: Endpoints

of is d ber
ion , th em
iss ore m

Endpoint Frond number Growth rate based on frond Biomass

e
rm m er

[mg/L] number [mg/L]

pe her orm

[mg/L]
he rt t/f
t t Fu en

Nominal concentration of MON 52276 [mg/L]

ou s. rr
th tie cu

EC50 ( 7 days) 66.58 (56.30 – 79.66) > 150 118.16 (91.37 – 171.37)
wi par (a)

NOEC ( 7 days) 19.1 19.1 19.1

f
en ird o

Nominal concentration of glyphosate a.e. [mg/L]

nt th rty
co and ope

EC50 ( 7 days) 20.57 (17.39 – 24.61) > 46.35 36.51 (28.23 – 52.95)
r

NOEC ( 7 days) 5.9 5.9 5.9

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um

B. OBSERVATIONS
is ht c
th rig s do

Observations: Significant inhibitory effects were observed at 2.4 and 6.8 mg/L for frond numbers and
i
e op Th

growth rates, and at 6.8 mg/L for biomass. However, these effects were not dose-related and were
of y

considered to be due to a reduced uptake of nutrients following a root decay caused by a bacterial infection.
us c

Additional dose-related significant inhibitory effects were observed at 53.6 and 150.0 mg/L for frond
d nd
an a

numbers, growth rates and biomass increase.

n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Table 10.2.1-14: Toxicity of MON 52276 to Lemna gibba under semi-static conditions

t rib
dis
MON 52276 Mean frond number 2 Mean dry weight Average specific Mean biomass

n,
er tio
concentration (mg) 3 growth rate () increase

wn lica
.
(mg/L) 1 (based on dry

s o ub
f it y p
weight)

so n
Day 3 Day 5 Day 7 Day 7 0 – 7 days 0 – 7 days

ht , a
rig ntly
0 (control) 44 120 270 32.4 0.444 31.0

th ue
0.9 45 116 234 28.5 0.4233 27.2

e eq
2.4 43 100 204 27.8 0.4010 26.5

e
lat ns
vio . Co
an ime al.
6.8 40 98 193 26.3 0.3961 25.0

te reg new
19.1 49 119 242 28.3 0.4284 27.0

oh tio re

d
53.6 39 84 157 24.6 0.3668 23.3

pr tec EU
ibi n
150.0 27 48 71 14.1 0.2533 12.8

d
be ro te
e ta p osa
1
Nominal values.
2

ef da ph
Initial mean frond number: 12

er y ly
3 Initial mean dry weight: 1.3 mg

th tor G
ay ula the

or
t m reg king
Based on nominal concentrations, the EC50 for frond count of Lemna gibba exposed to MON 52276 under

m er see
semi-static test conditions for 7 days was 66.58 mg MON 52276/L (95 % confidence limits of 56.30 and

do ll u tium
en a
79.66 mg MON 52276/L), equivalent to 20.57 mg a.e./L. Since the percentage inhibition compared to

cu nd
his fa or
f t ay ns
control was only 43 % at the highest MON 52276 concentrations tested, the ErC50 was estimated to be
r o m co
 150 mg MON 52276/L, equivalent to 46.35 mg a.e./L. Based on nominal concentrations, the EbC50 was
ne ent he

118.16 mg MON 52276/L (95 % confidence limits of 91.37 and 171.37mg MON 52276/L), equivalent to
ow um of t

36.51 mg a.e./L. The no-observed-effect-concentration (NOEC) was 19.1 mg MON 52276/L, equivalent to
th oc (s)
of is d ber

5.90 mg a.e./L.
ion , th em
iss ore m

The doubling time of frond numbers in the control was less than 2.5 days (37.4 hours). The validity criteria
rm m er
pe her orm

according to the current guideline OECD 221 are therefore fulfilled.

he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)

III. CONCLUSION
f
en ird o
nt th rty

Assessment and conclusion by applicant:

co and ope
r

ts
r i er p
t o wn the

Based on nominal concentrations, the EC50 for frond count of Lemna gibba exposed to MON 52276
en o s

under semi-static test conditions for 7 days was calculated to be 66.58 mg/L (95 % confidence limits of
m he t i
cu f t en

ts

56.30 and 79.66 mg MON 52276/L), equivalent to 20.57 mg a.e./L. Since the percentage inhibition
do s o um

compared to control was only 43 % at the highest MON 52276 concentrations tested, the ErC50 was
is ht c
th rig s do

estimated to be 150 mg MON 52276/L, equivalent to 46.35 mg a.e./L. Based on nominal

i
e op Th

concentrations, the EbC50 was 118.16 mg MON 52276/L (95 % confidence limits of 91.37 and 171.37mg
of y

MON 52276/L), equivalent to 36.51 mg a.e./L. The no-observed-effect-concentration (NOEC) was

us c

19.1 mg MON 52276/L, equivalent to 5.90 mg a.e./L.

d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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This study was conducted according to the draft OECD 221 test guideline from October 2000. The

t rib
currently adopted test guideline is largely unchanged from the draft guideline. In the last Annex I

dis
renewal, this study was evaluated and considered acceptable for use in risk assessment. For this

n,
er tio
submission, the study has been re-evaluated. The study was conducted at nominal rates of 0.9, 2.4, 6.8,

wn lica
.
19.1, 53.6 and 150 mg MON 52276/L. Chemical analysis was conducted during the study with mean

s o ub
f it y p
measured concentrations of product between 82.9 and 104 % of nominal achieved. The study was

so n
ht , a
considered valid with a doubling time of < 48 hours compared to the required < 2.5 days in the test

rig ntly
guideline. The report identifies bacterial infection in some test cultures, most notably in the two lowest

th ue
exposure concentrations. Relative to the control group, there was no significant difference in the frond

e eq
e
lat ns
number inhibition (%) at the end of the study across the four lowest exposure concentrations. However,

vio . Co
an ime al.
there was a significant inhibition in frond number at the highest exposure concentration (150 mg MON

te reg new
52276/L), where there was 43 % inhibition. Despite the apparent bacterial infection which was not

oh tio re

d
confirmed in the study report – only based on observation, the study should be considered supportive for

pr tec EU
ibi n
d
use in risk assessment.

be ro te
e ta p osa
ef da ph
er y ly
Assessment and conclusion by RMS:

th tor G
ay ula the

or
t m reg king
m er see
do ll u tium
en a
cu nd
his fa or
1. Information on the study f t ay ns
r o m co
ne ent he

Data point: CP 10.2.1/006

ow um of t
th oc (s)

Report author
of is d ber

Report year 2012

ion , th em
iss ore m

Report title Effect of MON 52276 (Glyphosate formulation) on the Growth of

e
rm m er

Myriophyllum aquaticum in the Presence of Sediment, with a

pe her orm

subsequent Recovery Period.

he rt t/f
t t Fu en

CHE-016/4-80/A
ou s. rr

Report No
th tie cu
wi par (a)

Document No -
f
en ird o

Guidelines followed in study Maltby, L., et al. (2008): Aquatic Macrophyte Risk Assessment for
nt th rty
co and ope

Pesticides, SETAC AMRAP

r

ts
r i er p

Deviations from current test

t o wn the

None according to Maltby et al. (2008)

guideline
en o s
m he t i
cu f t en

Yes, accepted in RAR (2015)

ts

Previous evaluation
do s o um

GLP/Officially recognised Yes

is ht c
th rig s do

testing facilities
i
e op Th

Acceptability/Reliability Valid
of y

Category study in AIR 5 Category 2a

us c
d nd

dossier (L docs)
an a
n rty
tio e
ta op
loi pr

2. Full summary
xp al
l e ctu
cia lle

Executive Summary
er te

The toxicity of MON 52276 on growth of Myriophyllum aquaticum was evaluated in a 14 day static toxicity
m s in

test, with subsequent 7 day recovery test, performed at concentrations of 0.78, 3.91, 19.6, 97.8, 489 and
om a
y c uch

2445 mg MON52276/L, equivalent to 0.24, 1.2, 6.0, 30, 150 and 750 mg glyphosate acid equivalent/L. A
an ts s

negative control (Smart & Bako medium) was prepared in parallel.

an righ
d
ing to
sh ct
bli bje
pu su
or be

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Two sets of vessels (exposure and recovery set) were prepared, with each set comprising three replicates

rib
for each test concentration and six replicates for the controls. Test vessels were 2 L beakers, each containing

t
dis
five individual plants potted in individual pots containing artificial sediment. Shoot length, fresh weight,

n,
er tio
dry weight and root length were determined in all vessels. Plant length was recorded at test start and after

wn lica
.
3, 7, 10 and 14 days and after 21 days (recovery vessels). At test start and test end, fresh weight of each

s o ub
f it y p
plant was determined. Dry weight was determined at test initiation using 25 additional plants and at test

so n
end on the tested plants. At the end of the test all plants were harvested and the root length was assessed

ht , a
rig ntly
semi-quantitatively in terms of length of the main root.

th ue
e eq
e
lat ns
Test media were analysed for Glyphosate content at test start and end of exposure and recovery periods.

vio . Co
an ime al.
The measured concentrations ranged from 83.9-145 % of nominal. Glyphosate was not detected in the

te reg new
control group.

oh tio re

d
pr tec EU
ibi n
Result showed a significant inhibition of fresh weight of 20.7 % at the lowest test concentration of 0.3 mg

d
be ro te
e ta p osa
glyphosate acid equivalent/L. Shoot length increase and growth rate were unaffected at this concentration.

ef da ph
Relative to the control group, at the highest treatment rate (723 mg test item/L) there was 93.8 % growth

er y ly
th tor G
inhibition based on fresh weights, shoot length increase was inhibited by 94.1 growth rate by 90.2 %. The

ay ula the
recovery period demonstrated that Myriophyllum aquaticum pre-exposed to up to 26.80 mg MON52276/L

or
t m reg king
were able to recover to control levels of growth, in untreated culture medium within 7 days of transfer.

m er see
The study fulfilled the validity criteria of achieving at least 50 % increase in control plant growth in terms

do ll u tium
en a
of length within 7 days of test initiation. The test was therefore considered to be valid.

cu nd
his fa or
MON 52276 significantly inhibited the fresh weight of Myriophyllum aquaticum after 14 days at a mean
f t ay ns
measured concentration of < 0.3 mg glyphosate acid equivalent/L. Shoot length was inhibited at or above
r o m co
ne ent he

mean measured concentrations of 5.16 mg glyphosate acid equivalent/L. The 14-d EC50 value for fresh
ow um of t

weight inhibition was 4.4 mg glyphosate acid equivalent/L and for shoot length it was 13.44 mg glyphosate
th oc (s)

acid equivalent/L. Myriophyllum aquaticum pre-exposed for 14 days to up to 26.80 mg glyphosate acid
of is d ber

equivalent/L were able to recover in untreated culture medium after a 7 day recovery period.
ion , th em
iss ore m

e
rm m er

I. MATERIALS AND METHODS

pe her orm
he rt t/f
t t Fu en

A. MATERIALS
ou s. rr
th tie cu
wi par (a)

1. Test material:
f
en ird o
nt th rty

Test item: Glyphosate SL formulation (MON 52276)

co and ope
r

Description: Clear, yellow, viscous liquid

ts
r i er p
t o wn the

Lot/Batch #: A9K0106104
en o s
m he t i
cu f t en

ts

Purity: 358.8 ± 4.0 g glyphosate acid equivalent/L (30.68 % w/w)

do s o um
is ht c

2. Vehicle and/or positive control: None

th rig s do
i

3. Test organism:
e op Th

Species: Myriophyllum aquaticum

of y
us c

Source: Institut für Gewässerschutz, MESOCOSM GmbH, Neu-

d nd
an a

Ulrichstein 5, D-35315 Homberg (Ohm), Germany

n rty
tio e
ta op

4. Environmental conditions:
loi pr
xp al

Growth medium: Smart & Bako medium

l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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d/
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Artificial sediment: 4 – 5 % peat

t rib
dis
20% kaolin clay

n,
er tio
75 – 76% quartz sand

wn lica
.
CaCO3 (if needed to adjust pH to 7.0 ± 0.5)

s o ub
f it y p
Based on artificial soil used in OECD guideline 219

so n
ht , a
rig ntly
Moistening of sediment up to 30 % with deionised water or

th ue
nutrient medium (ammonium chloride and sodium

e eq
phosphate)

e
lat ns
vio . Co
an ime al.
Temperature: 20.0 °C

te reg new
Photoperiod: 16 h light

oh tio re

d
pr tec EU
ibi n
Light intensity 7295 – 7518 lux

d
be ro te
e ta p osa
pH: Values recorded at test start and end (in brackets) of 14 day

ef da ph
exposure period:

er y ly
th tor G
ay ula the
Controls = 7.97 (8.78 – 8.82)

or
t m reg king
0.3 mg/= 8.25 (8.82)

m er see
1.1 mg/L = 8.01 (8.82)

do ll u tium
en a
5.16 mg/L = 8.15 (8.82)

cu nd
his fa or
26.8 mg/L = 7.79 (8.81 – 8.82) f t ay ns
r o m co
ne ent he

145 mg/L = 7.26 (6.11 – 8.82)

ow um of t

723 mg/L = 5.86 (6.09 – 6.82)

th oc (s)
of is d ber

Values at start and end of 7 day recovery period:

ion , th em

Recovery period start = 6.0 – 9.2

iss ore m

e
rm m er
pe her orm

Recovery period end = 8.3 – 9.8

he rt t/f

Oxygen saturation Values recorded at test start and end (in brackets) of 14 day
t t Fu en
ou s. rr

exposure period:
th tie cu
wi par (a)

Controls = 96 % (102 – 108 %)

f
en ird o

0.3 mg/L = 90 % (107 – 108 %)

nt th rty
co and ope

1.1 mg/L = 96 % (107 – 111 %)

r

ts
r i er p
t o wn the

5.16 mg/L = 91 % (114 – 132 %)

en o s
m he t i

26.8 mg/L = 95 % (100 – 104 %)

cu f t en

ts
do s o um

145 mg/L = 90 % (116 – 122 %)

is ht c
th rig s do

723 mg/L = 96 % (4 – 9 %)
i
e op Th

Values at start and end of 7 day recovery period:

of y

Controls = 103 – 110 % (99 – 109 %)

us c
d nd

0.3 mg/L not included in the recovery period

an a
n rty

1.1 mg/L = 108 – 114 % (103 – 110 %)

tio e
ta op
loi pr

5.16 mg/L = 111 – 113 % (115 – 121 %)

xp al
l e ctu

26.8 mg/L = 123 – 130 % (123 – 126 %)

cia lle
er te

145 mg/L = 127 – 137 % (104 – 143 %)

m s in
om a

723 mg/L = 6 – 33 % (107 – 111 %)

y c uch

5. Dates of experimental work: Oct 28th to Nov 18th 2010

an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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B. STUDY DESIGN AND METHODS

t rib
dis
1. Experimental treatments: The toxicity test on Myriophyllum aquaticum was performed with six

n,
er tio
concentration levels of 0.24, 1.2, 6.0, 30, 150 and 750 mg glyphosate acid equivalent/L, equivalent to 0.78,

wn lica
.
3.91, 19.6, 97.8, 489 and 2445 mg MON 52276/L, with 3 replicates per test concentration. Six control

s o ub
f it y p
replicates (without test substance) were tested under the same conditions as the test groups. Two sets of

so n
vessels (exposure and recovery) were prepared at the start of the test.

ht , a
rig ntly
th ue
The plants were planted in small plastic plant pots into sediment and placed in glass beakers (test vessels),

e eq
containing 2 L Smart & Bako medium. The test was conducted under static conditions. Five plants were

e
lat ns
vio . Co
an ime al.
added to each test and control replicate.

te reg new
oh tio re

d
After 14 days exposure another set of Myriophyllum aquaticum replicates, exposed to the same

pr tec EU
ibi n
concentration levels, were transferred into freshly prepared test medium without test item to determine the

d
be ro te
e ta p osa
potential recovery after an exposure event.

ef da ph
er y ly
th tor G
2. Observations: Plant length, fresh weight, dry weight and root length were determined in all vessels.

ay ula the
Plant length was recorded at test start and after 5, 8, 11 and 14 days. At test start and test end, fresh weight

or
t m reg king
of each plant was determined. Dry weight was determined at test initiation using 25 additional plants and

m er see
at test end on the tested plants (dried at 105 °C for 24 h). At the end of the test all plants were harvested

do ll u tium
en a
and the root length was assessed semi-quantitatively in terms of length of the main root. Temperature in

cu nd
his fa or
the test chamber was recorded continuously. Oxygen content, pH and light intensity was recorded at test
f t ay ns
start and after 14 days.
r o m co
ne ent he

Analytical control measurements of the actual concentration of the glyphosate were performed by means
ow um of t

of LC/MS-MS analysis at test start, after 14 (after exposure phase) and 21 days (after recovery phase).
th oc (s)
of is d ber

3. Statistical calculations: The EC10, EC20 and EC50 and its 95 % confidence interval were calculated by
ion , th em

probit analysis modified for continuous data. The NOEC values were determined by calculation of
iss ore m

e
rm m er

statistical significance using one-way analysis of variance (ANOVA), followed by Williams’ t-test,
pe her orm

Dunnett’s t-test or Welch’s t-test (p = 0.05).

he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)

II. RESULTS AND DISCUSSION

f
en ird o
nt th rty
co and ope

A. FINDINGS
r

ts
r i er p
t o wn the
en o s

Analytical data: Analytical control measurements of the actual concentration of the glyphosate were
m he t i
cu f t en

ts

performed at test start, after 14 and 21 days (after recovery phase). The measured concentrations ranged
do s o um
is ht c

from 83.9 – 145 % of nominal at test start and 88.1 to 110 % of nominal at test end. Except for the lowest
th rig s do

treatment level the test item was stable during the test period. The results were evaluated using the
i
e op Th

geometric mean measured concentrations.

of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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,r
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Table 10.2.1-15: Analytical results

t rib
dis
n,
Nominal concentration Test start Test end Geometric mean

er tio
[mg glyphosate a.e./L] [mg glyphosate/L] [mg glyphosate/L] [mg glyphosate/L]

wn lica
.
Measured % of nominal Measured % of nominal

s o ub
Measured % of nominal

f it y p
[mg/L] [mg/L] [mg/L]

so n
ht , a
Control <LOQ - <LOQ - - -

rig ntly
0.24 0.35 145.0 0.26 110.0 0.30 125.0

th ue
e eq
1.2 1.15 95.6 1.05 87.8 1.10 91.7

e
lat ns
vio . Co
an ime al.
6.0 5.03 83.9 5.29 88.1 5.16 86.0

te reg new
30 26.3 87.5 27.4 91.5 26.8 89.3

oh tio re

d
150 145.0 96.5 145.0 96.4 145.0 96.7

pr tec EU
ibi n
d
be ro te
750 722.0 96.3 723.0 96.4 723.0 100.4

e ta p osa
LOQ = 0.25 mg/L.

ef da ph
er y ly
th tor G
ay ula the

or
The EC50 and NOEC values after 14 day growth inhibition test are given below based on geometric mean

t m reg king
measured concentrations.

m er see
do ll u tium
en a
Table 10.2.1-16: 14-day endpoints

cu nd
his fa or
f t ay ns
r o m co
Endpoint Concentration in glyphosate a.e. [mg/L]
ne ent he
ow um of t

1
14 Day EC10 14 Day EC20 1 14 Day EC50 1 14 Day
th oc (s)

NOEC
of is d ber

Shoot length/relative increase 0.43 (0.1 – 1.06) 1.41 (0.48 – 2.8) 13.44 (7.72 – 23.74) 5.16
ion , th em
iss ore m

Shoot length/growth rate 1.07 (0.23 – 2.67) 3.81 (1.29 – 7.61) 42.79 (24.74 – 76.48) 5.16
rm m er
pe her orm

Fresh weight/relative increase 0.11 (0.01 – 0.33) 0.39 (0.09 – 0.9) 4.44 (2.28 – 8.51) < 0.30
he rt t/f
t t Fu en

Fresh weight/ growth rate 0.16 (0.03 – 0.46) 0.66 (0.19 – 1.48) 10.33 (5.59 – 19.21) < 0.30
ou s. rr
th tie cu

Dry weight/relative increase n.d. n.d. n.d. 145

wi par (a)

Dry weight/ growth rate 0.44 (n.d. – 7.50) 3.23 (n.d. – 30.52) 143.3 (10.06 – n.d.) 145
f
en ird o
nt th rty

Root length/relative increase 1.05 (0.59 – 1.53) 1.89 (1.24 – 2.53) 5.84 (4.65 – 7.37) 1.10
co and ope
r

ts
r i er p

Root length/growth rate 2.23 (1.10 – 3.75) 6.33 (3.77 – 9.39) 46.50 (34.75 – 62.52) 1.10
t o wn the
en o s

Equivalence in concentration in MON52276 [mg/L]

m he t i
cu f t en

ts

14 Day EC10 1 14 Day EC20 1 14 Day EC50 1 14 Day

do s o um

NOEC
is ht c
th rig s do

Shoot length/relative increase 1.39 (0.32 – 3.43) 4.60 (1.56 – 9.13) 43.81 (25.2 – 77.4) 16.82
i
e op Th

Shoot length/growth rate 3.46 (0.74 – 8.64) 12.42 (4.20 – 139.5 (80.6 – 249.3) 16.82
of y

24.8)
us c
d nd

Fresh weight/relative increase 0.36 (0.03 – 1.07) 1.27 (0.29 – 2.93) 14.47 (7.43 – 27.7) < 0.98
an a
n rty
tio e

Fresh weight/ growth rate 0.518 (0.10 – 1.49) 2.15 (0.62 – 4.82) 33.67 (18.2 – 62.6) < 0.98
ta op
loi pr

Dry weight/relative increase n.d. n.d. n.d. 473

xp al
l e ctu

Dry weight/ growth rate 1.42 (n.d. – 24.27) 10.52 (n.d. – 99.5) 467.1 (32.8 – n.d.) 473
cia lle
er te

Root length/relative increase 3.40 (1.91 – 4.95) 6.16 (4.04 – 8.25) 19.04 (15.2 – 24.0) 3.59
m s in
om a

Root length/growth rate 7.22 (3.56 – 12.14) 20.63 (12.3 – 151.6 (123.0 – 203.8) 3.59
y c uch

30.6)
an ts s

1
an righ

(CI) = 95% confidence interval

n.d.: not determined due to mathematical reasons or inappropriate data; highlighted value indicates most sensitive measured parameter
d
ing to
sh ct
bli bje
pu su
or be

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rib
The EC50 and NOEC values after 7 day recovery period are given below based on geometric mean measured

t
dis
concentrations.

n,
er tio
wn lica
.
Table 10.2.1-17: 7-day recovery endpoints

s o ub
f it y p
so n
ht , a
Endpoint Concentrations in glyphosate a.e. [mg/L]

rig ntly
7 Day Recovery EC50 7 Day Recovery NOEC

th ue
e eq
Shoot length/relative increase n.d. 26.80

e
lat ns
vio . Co
an ime al.
Shoot length/growth rate n.d. 26.80

te reg new
Fresh weight/relative increase n.d. ≥ 723

oh tio re

d
pr tec EU
Fresh weight/ growth rate n.d. ≥ 723

ibi n
d
be ro te
e ta p osa
Dry weight/relative increase n.d. ≥ 723

ef da ph
Dry weight/ growth rate n.d. ≥ 723

er y ly
th tor G
ay ula the
Root length/relative increase n.d. ≥ 723

or
t m reg king
Root length/growth rate n.d. ≥ 723

m er see
Equivalence in concentration in MON52276 [mg/L]

do ll u tium
en a
Shoot length/relative increase n.d. 87.35

cu nd
his fa or
Shoot length/growth rate f t ay ns n.d. 87.35
r o m co
ne ent he

Fresh weight/relative increase n.d. ≥ 2357

ow um of t
th oc (s)

Fresh weight/ growth rate n.d. ≥ 2357

of is d ber

Dry weight/relative increase n.d. ≥ 2357

ion , th em
iss ore m

Dry weight/ growth rate n.d. ≥ 2357

rm m er
pe her orm

Root length/relative increase n.d. ≥ 2357

he rt t/f
t t Fu en

Root length/growth rate n.d. ≥ 2357

ou s. rr
th tie cu

n.d.: not determined due to mathematical reasons or inappropriate data

wi par (a)
f
en ird o
nt th rty
co and ope

B. OBSERVATIONS
r

ts
r i er p
t o wn the

There was a concentration dependent effect on growth, root length, fresh and dry weight of Myriophyllum
en o s
m he t i

aquaticum. Growth was significantly reduced at 5.16 mg glyphosate acid equivalent /L, fresh weight at
cu f t en

ts
do s o um

< 0.3 mg glyphosate acid equivalent/L, dry weight at 145 mg glyphosate acid equivalent/L and root length
is ht c
th rig s do

at 1.10 mg glyphosate acid equivalent L during the 14 day exposure test. In the subsequent recovery test it
was shown that Myriophyllum aquaticum, pre-exposed to up to 26.80 mg glyphosate acid equivalent/L were
i
e op Th

able to recover to control levels of growth in untreated culture medium within 7 days of the exposure period.
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.2.1-18: Percentage of inhibition of Myriophyllum aquaticum exposed for 14 days to

t rib
MON 52276

dis
n,
er tio
Test parameters Glyphosate a.e.[mg/L]

wn lica
.
(mean measured)

s o ub
f it y p
0.3 1.1 5.12 26.8 145 723

so n
Inhibition of shoot length increase (%)

ht , a
-3.5 5.1 30.5 74.1 70.3 94.1

rig ntly
Inhibition of shoot length growth rate (%) -2.6 2.0 17.5 58.1 53.6 88.3

th ue
e eq
Inhibition of fresh weight increase (%) 20.7 19.2 61.2 80.1 77.6 93.8

e
lat ns
vio . Co
Inhibition of fresh weight growth rate (%) 14.6 13.3 49.4 70.9 67.8 90.2

an ime al.
te reg new
Inhibition of dry weight increase (%) 14.7 18.2 34.3 15.8 -6.9 106.6

oh tio re

d
pr tec EU
Inhibition of dry weight growth rate (%) 11.1 14.4 29.6 19.6 -4.7 112.3

ibi n
d
be ro te
Inhibition of root length increase (%) -6.8 -3.9 52.0 82.9 94.5 98.3

e ta p osa
ef da ph
Inhibition of root length growth rate (%) -1.7 -0.9 18.3 43.9 66.7 86.8

er y ly
th tor G
ay ula the

or
t m reg king
For Myriophyllum aquaticum, plant fresh weight measurements are relevant for risk assessment as lower

m er see
variability is associated with individual plant measurement compared to procedure used for dry weights

do ll u tium
en a
which attracts a greater variability - with all plants pooled according to treatment and then compared to dry

cu nd
his fa or
weights established at test start using a separate set of plants. Furthermore, root length measurements are
f t ay ns
r o m co
considered semi-quantitatively, as only the length of the longest roots have been measured. The number of
ne ent he

side roots and total number have not been determined given the practical constraints associated with the
ow um of t

sediment Myriophyllum test design. Effects on roots are considered to be reflected in fresh weight
th oc (s)

measurements.
of is d ber
ion , th em

The study fulfils the validity criteria as stated in the study plan which follows the criteria established by the
iss ore m

AMRAP working group; with an increase of biomass (shoot length) in controls was > 50 %, indicating that
rm m er
pe her orm

continuous growth was supported throughout the test duration. Furthermore, constant maintenance of
he rt t/f

temperature (20 ± 2 °C) was also achieved.

t t Fu en
ou s. rr
th tie cu

III. CONCLUSIONS
wi par (a)
f
en ird o
nt th rty
co and ope

Assessment and conclusion by applicant:

r

ts

MON 52276 significantly inhibited the fresh weight of Myriophyllum aquaticum after 14 days. Based
r i er p
t o wn the

on geometric mean measured concentrations, the 14-d ErC50 value for fresh weight inhibition was 10.33
en o s
m he t i

mg glyphosate acid equivalent/L and for shoot length it was 42.79 mg glyphosate acid equivalent/L.
cu f t en

ts
do s o um

Myriophyllum aquaticum pre-exposed for 14 days to up to 26.80 mg glyphosate acid equivalent/L were
is ht c

able to recover in untreated culture medium after a 7 day recovery period.

th rig s do
i
e op Th

The study is considered to be valid and suitable for risk assessment purposes.
of y
us c
d nd
an a
n rty

Assessment and conclusion by RMS:

tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in

1. Information on the study

om a
y c uch

Data point: CP 10.2.1

an ts s

Report author Gabriel, U.U. et al.

an righ

Report year 2010

d
ing to
sh ct
bli bje
pu su
or be

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Report title Toxicity of roundup (a glyphosate product) to fingerlings of

t rib
Clarias gariepinus

dis
ISSN: 159 – 3115

n,
Document No

er tio
Guidelines followed in study None

wn lica
.
s o ub
f it y p
so n
Deviations from current test Not applicable

ht , a
rig ntly
guideline

th ue
GLP/Officially recognised testing No, not conducted under GLP/Officially recognised testing

e eq
facilities (literature publication)

e
facilities

lat ns
vio . Co
an ime al.
Acceptability/Reliability: Yes/Reliable with restrictions

te reg new
oh tio re

d
2. Full summary

pr tec EU
ibi n
d
be ro te
Acute static renewal bioassays were conducted on fingerling and adult of Clarias gariepinus (mean weight,

e ta p osa
1.22 ± 0.6 g; mean total length, 5.25 ± 1.25 cm) using the herbicide, Roundup (glyphosate). In the acute

ef da ph
er y ly
study, fingerlings were exposed in triplicate to 0.0, 14.0, 16.0, 18.0, 20.0 22.0, and 24.0 mg/L of the

th tor G
herbicide for 96 hours to determine general behavioural responses.

ay ula the

or
The 96 hour LC50 of Roundup on the fish was 19.58 mg/L.

t m reg king
m er see
Materials and methods

do ll u tium
en a
The fingerlings of C. gariepinus (mean weight 1.22 ± 0.6 g; mean total length 5.25 ± 1.25 cm) were obtained

cu nd
his fa or
f t ay ns
from a private farm, Comsystem, Kpite, Rivers State and transported in 25 litre jerry can to the Wet
r o m co
Laboratory, Department of Fisheries and Aquatic Environment, Rivers State University of Science and
ne ent he

Technology, where they were distributed 60 fish per aquarium in four rectangular aquaria filled with 20
ow um of t

litre borehole water (dissolved oxygen, 0.01 ± 0.05 mg/L, pH- 7.5 ± 1.3; conductivity, 410 ± 20.4 μS/cm;
th oc (s)
of is d ber

total dissolved solid 400 ± 10.25 ppm). They were fed at one percent biomass, half at 0900 and 1600 hours
ion , th em

for a week. Cleaning of the tanks and water exchange were done daily. Mortality during acclimation period
iss ore m

was less than one percent. Mucus accumulation on the skin as well as gills and skin pigmentation were
rm m er
pe her orm

recorded.
he rt t/f

Range finding test and trial runs were done. Twenty litres of each of the following concentrations: 14, 16,
t t Fu en
ou s. rr

18, 20, 22 and 24 ppm of Roundup containing 360 g/l glyphosate (in the form of 480g/l isopropylamine
th tie cu

salt) and a control were prepared in triplicate in glass aquaria. Ten fish was randomly distributed into each
wi par (a)

of the tanks. The general behaviours, opercular beat frequency, OBF, tail beat frequency, TBF and mortality
f
en ird o
nt th rty

(%) were recorded at 12, 24, 48, 72 and 96th hour, respectively. The exposure lasted for 96 hours. Data
co and ope

obtained from the experiments were subjected to ANOVA using Statistical Package for the Social Sciences,
r

ts
r i er p

SPSS version 15 and differences among means were separated by Duncan Multiple Range test at 0.05%.
t o wn the

The dependent variables in the trials (OBF, TBF and cumulative mortality) were regressed on concentration
en o s
m he t i
cu f t en

of the toxicant to obtain the regression lines of best fit for predicting the values of the dependent variables
ts
do s o um

with changes in that of the independent with Microsoft Excel®. Correlation analysis was used to determine
is ht c
th rig s do

the degree of association among the dependent and independent variables. Lethal concentrations (LC50)
i
e op Th

values for the 24, 48, 72 and 96 hour and the median lethal times (MLT50) for the various concentrations
of herbicide were done with Probit Analysis. Safe concentration of the herbicide at the various time intervals
of y

were obtained by multiplying the lethal concentration by a factor, 0.1. The interaction effects of the
us c
d nd

behavioural responses (TBF and OBF) with exposure duration and concentrations of the herbicides were
an a
n rty

presented graphically.
tio e
ta op
loi pr

Results
xp al
l e ctu

On introduction into the toxicant the fish showed initial hyper-excitability, stress responses such as
cia lle

increased opercular ventilatory rate, dash and erratic swimming and gasping for air within the first two
er te
m s in

hours. As exposure time increased before death occurred they “hung” on the surface of the solution gulping
om a
y c uch

air, fell steadily to the aquaria bottom. This was usually followed by dash swimming. This sequence was
an ts s

repeated several times before the fish lost balance, lay flat on the bottom (exertion), tail beat stopped,
an righ

followed by cessation of opercular movement and then death (non-response to tactile stimuli).
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.2.1-19: Tail and opercular beat frequency (TBF and OBF) and cumulative mortality of

t rib
fingerlings of C. gariepinus exposed to various concentrations of Roundup for

dis
96 hours

n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
rig ntly
th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
oh tio re

d
pr tec EU
ibi n
d
be ro te
e ta p osa
ef da ph
er y ly
th tor G
ay ula the

or
t m reg king
Means with the same superscript in the row are not significantly different (p > 0.05)

m er see
do ll u tium
en a
cu nd
his fa or
f t ay ns
Table 10.2.1-20: Regression lines of best fit for the prediction of the values of OBF/min., TBF/min.
r o m co

and cumulative mortality of C. gariepinus exposed to acute levels Roundup for

ne ent he
ow um of t

96 hours
th oc (s)
of is d ber
ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i

Where x = independent variable, y= dependent variable

cu f t en

ts
do s o um
is ht c

Cumulative mortality of exposed fish was very variable relative to the concentration of the herbicide (Figure
th rig s do

1).
i
e op Th
of y

The cumulative mortality differed with the time of exposure (p < 0.01), concentration of toxicant
us c
d nd

(p < 0.001) and interactions between exposure duration and herbicide concentration (p < 0.01, Figure 1).
an a

Exposed fish produced copious amount of mucus on the gill and skin which appeared to be concentration-
n rty
tio e

dependent in exposed fish with minimal amount on the control group. Pigmentation of the skin of the fish
ta op
loi pr

was not noticed in any of the exposure concentrations.

xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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,r
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ut
t rib
dis
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
rig ntly
th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
oh tio re

d
pr tec EU
ibi n
d
be ro te
e ta p osa
ef da ph
Figure 1: Percentage cumulative mortality of fingerlings of C. gariepinus exposed to various

er y ly
th tor G
concentrations of Roundup for 96 hours

ay ula the

or
t m reg king
m er see
The 24, 48, 72 and 96 hour LC50 and associated 95 % confidence limits of the herbicide concentrations

do ll u tium
en a
shown below indicated that the range of the values between the 24 hour and 96 hour LC50 (4.93 mg/L) as

cu nd
his fa or
very narrow. Safe concentrations of Roundup to fingerlings of C. gariepinus were very low (2.08 mg/L for
f t ay ns
24 hour and 1.59 mg/L for 96 hour). The time it took for half of the exposed fish to die at the various
r o m co
ne ent he

exposure concentrations decreased with time with the highest concentration (24 mg/L) killing half of the
ow um of t

exposed fish at about one sixth the time it took for 14 mg/L of the herbicide.
th oc (s)
of is d ber
ion , th em

Table 10.2.1-21: Lethal concentrations and associated 95 % confidence limits of Roundup to C.

iss ore m

e
rm m er

gariepinus fingerling exposure to Roundup for 96 hours

pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a

Where y=dependent variable, x= independable variable

n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Discussion

t rib
dis
The threshold concentration causing 100 % mortality in this study was 22 mg/L which is lower than that

n,
er tio
reported for other toxicants tested on any of the clariid species 7 suggesting that it may be more toxic than

wn lica
.
other tested toxicants. Half of the exposed fish (50 %) were killed by 15.88 mg/L of herbicide in

s o ub
f it y p
19.69 hours, hence the herbicide can be classified as being slightly toxic. Besides, in the wild where the

so n
agro-chemical is indiscriminately used the impact of the exposure stress caused by the herbicide, may be

ht , a
rig ntly
protracted, following the survivors throughout life and may affect various aspects of their lives.

th ue
e eq
e
lat ns
Conclusion

vio . Co
an ime al.
te reg new
The 24, 48, 72 and 96 hour LC50 and associated 95 % confidence limits indicated that the range of the

oh tio re

d
values between the 24 hour and 96 hour LC50 (4.93 mg/L) as very narrow. Safe concentrations of Roundup

pr tec EU
ibi n
to fingerlings of C. gariepinus were very low (2.08 mg/L for 24 hour and 1.59 mg/L for 96 hour). The 96

d
be ro te
e ta p osa
hour LC50 of Roundup on the fish was 19.58 mg/L.

ef da ph
er y ly
th tor G
ay ula the
3. Assessment and conclusion

or
t m reg king
m er see
Assessment and conclusion by applicant:

do ll u tium
en a
cu nd
his fa or
f t ay ns
The effects of Roundup containing 360 g/l glyphosate (equivalent to 480 g/L isopropylamine salt) were
r o m co

tested in an acute test with C. gariepinus fingerlings. The 96 hour-LC90 was determined to be 19.91 mg
ne ent he
ow um of t

product/L.
th oc (s)
of is d ber

There is no analytical verification of test concentrations reported and thus the reliability of the endpoint
ion , th em

is questionable. The appearance of mucus accumulation on the skin and gills and skin pigmentation
iss ore m

recorded in fish in the holding / stock vessels is a clear indicator of stress. Therefore, the condition of
rm m er
pe her orm

the fish used in the test is questionable. The study was not conducted in accordance with a recognised
he rt t/f

test guideline and was not performed under conditions of GLP. Furthermore, the purity of the
t t Fu en
ou s. rr

formulation roundup is not clearly given as the specification in the full text contains some typing errors.
th tie cu
wi par (a)

The study is considered reliable with restrictions.

f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s

CP 10.2.2 Additional long-term and chronic toxicity studies on fish, aquatic

m he t i
cu f t en

ts

invertebrates and sediment dwelling organisms

do s o um
is ht c
th rig s do

Available acute toxicity data on glyphosate acid and the representative product MON 52276 to fish, aquatic
i

invertebrates, algae and aquatic macrophytes indicate no significantly enhanced toxicity of the formulated
e op Th

product MON 52276 in comparison to the active substance glyphosate. Therefore, based on the results of
of y

these studies the performance of any further study is not deemed necessary.
us c
d nd
an a
n rty
tio e
ta op

CP 10.2.3 Further testing on aquatic organisms

loi pr
xp al

Further testing is not considered to be required, since the comparison of the RAC values for fish, aquatic
l e ctu

invertebrates, algae, aquatic plants and aquatic macrophytes with the maximum PECsw values for
cia lle
er te

glyphosate and the metabolites AMPA and HMPA, indicate an overall acceptable risk for aquatic
m s in

organisms.
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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CP 10.3 Effects on Arthropods

t rib
dis
n,
CP 10.3.1 Effects on bees

er tio
wn lica
Relevant and reliable studies for the risk assessment of honey bees, bumble bees and solitary bees, covering

.
s o ub
exposure to the different life stages of these Apis and non-Apis bee species from the active substance

f it y p
glyphosate are summarised in the tables below, presenting the most sensitive endpoints.

so n
ht , a
rig ntly
th ue
Details of these studies with the active substance are summarised in the Document M-CA, Section 8, point

e eq
8.3.1 and relevant endpoints for the risk assessment for honey bees are provided in the table below (Table

e
lat ns
vio . Co
10.3.1-1) and for bumble bees and solitary bees in Table 10.3.1-29 and Table 10.3.1-39, respectively.

an ime al.
te reg new
oh tio re
Table 10.3.1-1: Endpoints and effect values of glyphosate relevant for the risk assessment for honey

d
pr tec EU
ibi n
bees

d
be ro te
e ta p osa
ef da ph
Acute toxicity

er y ly
th tor G
Reference Test item Species Test design/ LD50 NOED

ay ula the
GLP (μg a.e./bee) (μg a.e./bee)

or
t m reg king
2003 Glyphosate acid Apis Acute oral, > 104 -

m er see
CA 8.3.1.1.1/001 mellifera 48 h

do ll u tium
en a
, 2003 Glyphosate Apis Acute contact, > 100 -

cu nd
his fa or
CA 8.3.1.1.2/001 IPA salt mellifera 48 h
Chronic toxicity f t ay ns
r o m co

Reference Test item Test design/ Species LDD50 NOEDD

ne ent he
ow um of t

GLP (μg a.e./bee/d) (μg a.e./bee/d)

th oc (s)

Glyphosate IPA- Apis Chronic, > 179.9 179.9

of is d ber

2017 salt mellifera Adult

ion , th em

CA 8.3.1.2/001
iss ore m

10 days
e
rm m er
pe her orm

Honey bee development and other honey bee life stages toxicity
he rt t/f

Reference Test item Species Test design/ LD50 NOED

t t Fu en

(μg a.e./larva) (μg a.e./larva)

ou s. rr

GLP
th tie cu

Glyphosate IPA- Apis -

wi par (a)

2020 Chronic larvae, 80

salt
f

mellifera
en ird o

CA 8.3.1.3/001 22-day
nt th rty
co and ope

Sub-lethal toxicity
r

Test item Species LD50 NOAEL

ts
r i er p

Reference Test
t o wn the

design/GLP (μg a.e./L) (μg a.e./L)

en o s
m he t i

2012 Glyphosate IPA- Apis Bee brood - ≥ 301000

cu f t en

ts

salt
do s o um

CA 8.3.1.4/001 mellifera feeding test. (301 mg a.e./L)

is ht c

Field study
th rig s do

a.e.: glyphosate acid equivalents

i
e op Th

Endpoints in bold are used for risk assessment

of y
us c
d nd
an a

Studies on effects of the representative formulation MON 52276 on pollinators to fulfil the data
n rty

requirements according to EU Regulation No 284/2013 are presented in the following. Studies considering
tio e
ta op

the effects of MON 52276 on honey bees were assessed for their validity to current and relevant guidelines
loi pr
xp al

and are presented in the following table.

l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.3.1-2: Studies on the toxicity of MON 52276 to honey bees

t rib
dis
n,
Annex point Study Study type Test species Substance(s) Status Remark

er tio
CP 10.3.1.1.1/001 2001 Acute oral and Apis mellifera MON 52276 Valid

wn lica
.
contact

s o ub
f it y p
CP 10.3.1.5/001 Residues Apis mellifera MON 52276 Valid

so n
ht , a
2011 Semi-field

rig ntly
th ue
e eq
e
lat ns
Literature articles and peer-reviewed published data considered to be relevant and reliable or reliable with

vio . Co
an ime al.
restrictions with regards to the impact on pollinators are summarised in the table below. Full literature

te reg new
evaluation is provided in document M-CA Section 9. A summary of previously evaluated peer reviewed

oh tio re

d
literature from the RAR 2015 is also available in Annex M-CA 8-01 of the M-CA Section 8. Each literature

pr tec EU
ibi n
article summary is presented below according to the respective annex point.

d
be ro te
e ta p osa
ef da ph
Table 10.3.1-3: Literature on toxicity of MON 52276 to pollinators

er y ly
th tor G
ay ula the

or
Annex point Study Study type Substance(s) Status Remark

t m reg king
CP 10.3.1.5/002 Thompson et al. Colony MON 52276 Relevant NOEC for effects at

m er see
(2014) feeding study applied on colony level was

do ll u tium
en a
Evaluating Exposure phacelia for 301 mg a.e./L

cu nd
his fa or
and Potential Effects residues in bee
f t ay ns
matrices.
r o m co
on Honeybee Brood
ne ent he

(Apis mellifera) Oomen study

ow um of t

Development Using conducted with

th oc (s)

Glyphosate as an IPA salt.

of is d ber

Example.
ion , th em
iss ore m

e
rm m er
pe her orm

Endpoints of studies considered valid with the representative product MON 52276 are shown in the table
he rt t/f
t t Fu en

below. In order to make a direct comparison of toxicity between studies conducted with MON 52276 and
ou s. rr
th tie cu

those conducted with IPA salt, glyphosate technical and glyphosate acid, the endpoints from all these
wi par (a)

studies have been converted to acid equivalents (a.e.). This conversion has been made by the acid equivalent
f
en ird o

purity of the test item stated in the reports.

nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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t rib
dis
Table 10.3.1-4: Endpoints and effect values of MON 52276 relevant for the risk assessment for

n,
honey bees

er tio
wn lica
.
s o ub
Acute toxicity

f it y p
Reference Test item Species Test design/GLP LD50 NOED

so n
ht , a
(μg a.e./bee) (μg a.e./bee)

rig ntly
th ue
2001 MON 52276 Apis mellifera Acute oral, > 77 -

e eq
CP 10.3.1.1.1/001 48 h

e
lat ns
vio . Co
an ime al.
, 2001 MON 52276 Apis mellifera Acute contact, > 100 -

te reg new
CP 10.3.1.1.1/001 48 h

oh tio re

d
pr tec EU
Cage and tunnel toxicity tests

ibi n
d
be ro te
Reference Test item Species Test design/GLP Magnitude of residues

e ta p osa
in mg a.e./kg

ef da ph
er y ly
Residues in honeybee

th tor G
2011 MON 52276 Apis mellifera nectar: 2.78 – 31.3

ay ula the
CP 10.3.1.5/001 colony - pollen: 87.2 – 629

or
t m reg king
Phacelia semi-field total daily intake based on

m er see
application at 8 L mean residues over 1-3 d: 22
product/ha (2.88 g

do ll u tium
en a
a.e./ha) during

cu nd
his fa or
f t ay ns
flowering and in the
r o m co
presence of foraging
ne ent he

bees
ow um of t

a.e.: glyphosate acid equivalents

th oc (s)
of is d ber

Endpoints in bold are used for risk assessment

ion , th em
iss ore m

e
rm m er
pe her orm

Consideration of metabolites
The primary metabolite of glyphosate is aminomethylphosphonic acid (AMPA). Most of the parent
he rt t/f
t t Fu en

glyphosate is remained unchanged and only a small amount (less than 1 % of the applied dose) is
ou s. rr
th tie cu

transformed to aminomethylphosphonic acid (AMPA).

wi par (a)
f
en ird o
nt th rty

Following application to plant tissues, unchanged glyphosate was the only residue detected in significant
co and ope

amounts. In presence of soil as a substrate and rotational crops glyphosate degrades quickly and AMPA
r

ts
r i er p

was found at rates comparable or even higher than the parent glyphosate. However, the uptake via roots
t o wn the

and translocation in the plants was very low, resulting in not significant residue levels as confirmed by
en o s
m he t i

several plant metabolism and confined rotational crop studies (e.g. lettuce, cabbage, peas, barley, wheat,
cu f t en

ts
do s o um

carrot, beets and radishes) involving application rates to bare soil equivalent to 3.87 – 6.5 kg ae/ha
is ht c
th rig s do

(exceeding the application rates according to the recent GAP). Neither glyphosate nor AMPA show a
potential uptake into crops, as a major part of the glyphosate is degraded into CO2. See M-CA Section 6,
i
e op Th

for details.
of y
us c
d nd

Therefore, studies with the metabolites are not considered necessary since the exposure to bees is covered
an a

by the assessment conducted with the parent glyphosate.

n rty
tio e
ta op
loi pr

Risk assessment for bees

xp al
l e ctu

The table below indicates that the risk assessment for pollinators covers all the proposed uses presented in
cia lle
er te

the GAP. There are some uses in the GAP that consider multiple applications, with a 28 day or 90 day
m s in

interval, however the risk assessment presented here represents the maximum single application rates for
om a
y c uch

relevant crop types for the proposed uses of MON 52276 according to available guidelines.
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.3.1-5: Risk assessment strategy for Pollinators

t rib
dis
GAP number and summary of use Maximum single application rate (g a.e./ha)

n,
er tio
wn lica
1 x 540 1 x 720 1 x 1080 1 x 1440 1 x 1800

.
s o ub
Uses 1 a-c: Applied to weeds; pre-sowing, pre- X X X

f it y p
planting, pre emergence of field crops

so n
ht , a
Uses 2 a-c: Applied to weeds; post-harvest, pre- X X X

rig ntly
sowing, pre-planting of field crops

th ue
e eq
Use 3 a-b: Applied to cereal volunteers; post- X

e
lat ns
harvest, pre-sowing, pre-planting of field crops

vio . Co
an ime al.
Uses 4 a-c, 5a-c: Applied to weeds (post X X X

te reg new
emergence) below trees in orchards and

oh tio re

d
vineyards

pr tec EU
ibi n
d
Use 6 a-b: Applied to weeds (post emergence) X X

be ro te
e ta p osa
in field crops BBCH < 20

ef da ph
Use 7 a-b: Applied to weeds (post emergence) X

er y ly
th tor G
around rail tracks

ay ula the
Use 8 and 9: Applied to invasive species (post X

or
t m reg king
emergence) in agricultural and non-

m er see
agricultural areas
Uses 10 a-c: Applied to couch grass; post- X X X

do ll u tium
en a
harvest, pre-sowing, pre-planting of field crops

cu nd
his fa or
X = this use is covered by the application rate indicated and a risk assessment in provided. f t ay ns
r o m co
ne ent he
ow um of t

The evaluation of the risk for bees was performed in accordance with the recommendations of the
th oc (s)
of is d ber

“Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services

ion , th em

(SANCO/10329/2002 rev.2 (final), October 17, 2002). In addition, a risk assessment according to the
iss ore m

“EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera,
rm m er
pe her orm

Bombus spp. and solitary bee)” (2013) is presented to address the data requirements of the Regulation (EU)
he rt t/f

No. 284/2013, chronic risk to adult honey bees and honey bee brood. In consideration of the
t t Fu en

recommendations of the “Technical report on the outcome of the pesticides peer review meeting on general
ou s. rr
th tie cu

recurring issues in ecotoxicology”28 currently no risk assessment for bumble bees and solitary bees is
wi par (a)

required, given that the EFSA Bee Guidance has not yet been noted. Furthermore, EFSA stated that it is
f
en ird o
nt th rty

not recommended to routinely perform a risk assessment for bumble bees and solitary bees. Nevertheless,
co and ope

acute studies for bumble bees and solitary bees are available and the results are presented.
r

ts
r i er p
t o wn the

Although acute contact and oral data with MON 52276 are available, the endpoints are greater than values,
en o s
m he t i

indicating no enhanced toxicity of the formulated product in comparison to the active substance. Thus the
cu f t en

ts
do s o um

LD50 values from the active substance acute studies have been used in the acute risk assessment. This
is ht c
th rig s do

assessment adequately represents also the risk from MON 52276.

i
e op Th

Risk assessment according to SANCO/10329/2002 rev 2 final

of y
us c

The hazard quotients for oral and contact exposure of honey bees are based on the recommended field use
d nd
an a

rates and are presented in the table below.

n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ

28
Technical report on the outcome of the pesticides peer review meeting on general recurring issues in
d
ing to

ecotoxicology, provided by EFSA, published December 22, 2015

sh ct
bli bje
pu su
or be

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dis
Table 10.3.1-6: Assessment of the risk of glyphosate for honey bees due to the use of MON 52276

n,
er tio
All uses (Uses: 1a-10c)

wn lica
Intended use

.
glyphosate

s o ub
Active substance

f it y p
Use pattern 1-2 x 1800 g a.e./ha,

so n
ht , a
1-2 x 1440 g a.e./ha,

rig ntly
1-3 x 1080 g a.e./ha,

th ue
1-3 x 720 g a.e./ha,

e eq
1 x 540 g a.e./ha

e
lat ns
vio . Co
an ime al.
Test design LD50 (lab.) Single max. application QHO, QHC

te reg new
(µg a.e./bee) rate criterion: QH ≤ 50

oh tio re
(g a.e./ha)

d
pr tec EU
Oral toxicity 104 1800 17.3

ibi n
d
be ro te
1440 14.0

e ta p osa
1080 10.4

ef da ph
720 6.9

er y ly
th tor G
540 5.2

ay ula the

or
Contact toxicity > 100 1800 < 18.0

t m reg king
1440 < 14.4

m er see
1080 < 11.0

do ll u tium
en a
720 < 7.2

cu nd
his fa or
540 < 5.4
QHO, QHC: Hazard quotients for oral and contact exposure. f t ay ns
r o m co
ne ent he
ow um of t
th oc (s)

The oral and contact hazard quotients (QHO, QHC) are below the Regulation (EC) 549/2011 trigger value of
of is d ber

50. Low risk to honey bees is concluded for all intended use patterns and no further testing is required.
ion , th em
iss ore m

e
rm m er

Further considerations regarding the risk to bees

pe her orm

A low acute contact and oral risk has been demonstrated in the risk assessment above for all uses. Studies
he rt t/f
t t Fu en

to evaluate the chronic toxicity to adult honey bees and larval honey bee development are also provided
ou s. rr
th tie cu

along with additional information on the acute toxicity to non-Apis bees (see section on Bumble bees and
wi par (a)

Solitary bees below). Acute toxicity testing indicated that bumble bees (Bombus terrestris) and solitary
f
en ird o

bees (Osmia bicornis) are not more sensitive compared to the honey bee and hence the risk assessment for
nt th rty

honey bees is considered to cover other types of bee.

co and ope
r

ts
r i er p
t o wn the

Chronic toxicity
en o s

A 10-day chronic feeding study on adult honey bees has been conducted ( , 2017,
m he t i
cu f t en

ts

KCA 8.3.1.2/001). The findings of this study indicated that there were no delayed or cumulative toxicity
do s o um
is ht c

effects when exposure to honey bees takes place chronically. Compared with acute testing, i.e. daily dosing
th rig s do

with 179.9 μg a.e./bee over 10 days (total dose = 1799 μg a.e./bee) led to negligible mortality (3.3 %) and
i
e op Th

did not exhibit a higher mortality than after single acute oral exposure at 104 µg a.e./bee.
of y
us c

Larval toxicity/effects on brood

d nd
an a

A 22-day repeated dose laboratory test has been conducted ( , 2020, KCA 8.3.1.3/001). A NOED
n rty

for honey bee larvae of 80 μg a.e./larva was recorded indicating similar sensitivity as adult honey bees.
tio e
ta op
loi pr
xp al

There is currently no agreed chronic or larval risk assessment. However, as both endpoints are presented in
l e ctu

terms of concentration in diet in addition to dose per honey bee and larva, respectively, it is possible to
cia lle
er te

extrapolate the exposure to honey bees under natural conditions. (2011, CP 10.3.1.5/001)
m s in

provides measurements of the levels of exposure in nectar and honey following an application at
om a
y c uch

2.88 kg a.e./ha, which exceeds the maximum single application rate of the proposed uses in the GAP.
an ts s

Residues in nectar samples taken from forager bees at various time points after application ranged from
an righ

2.78 to 31.3 mg a.e./kg. Residues in pollen samples taken from the pollen trap (higher than from pollen
d
ing to

taken from foragers) at various times after application ranged from 87.2 to 629 mg a.e./kg. Using this
sh ct
bli bje
pu su
or be

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information, a risk assessment may be conducted in line with the recommendations of Reg (EU) No

rib
283/2013 section 8(10) which states:

t
dis
n,
er tio
“Pending the validation and adoption of new studies and of a new risk assessment scheme, existing

wn lica
.
protocols shall be used to address the acute and chronic risk to bees, including those on colony survival

s o ub
f it y p
and development, and the identification and measurement of relevant sub-lethal effects in the risk

so n
ht , a
assessment”.

rig ntly
th ue
Furthermore, under section 8.3.1. Effects on bees of the same Regulation it states that:

e eq
e
lat ns
vio . Co
an ime al.
“[…] risk assessment shall be based on a comparison of the relevant endpoint with those residue

te reg new
concentrations. If this comparison indicates that an exposure to toxic levels cannot be excluded, effects

oh tio re

d
shall be investigated with higher tier tests.”

pr tec EU
ibi n
d
be ro te
e ta p osa
A comparison can be made between the chronic and larval endpoint based on concentration in test diets

ef da ph
and the maximum concentrations of glyphosate measured in nectar and pollen. In the chronic adult study

er y ly
th tor G
the NOEC and NOEDD values (10 days) were 10000 mg a.e./kg feeding solution and 179.9 µg a.e./bee/day,

ay ula the
respectively. As forager bees consume a diet which is virtually 100 % nectar this endpoint can be compared

or
t m reg king
to the maximum measured residues in nectar of 31.3 mg a.e./kg demonstrating a margin of safety of 31.9.

m er see
do ll u tium
en a
In the larval toxicity study the NOEC and NOED values (over the larval development period) were 505 mg

cu nd
his fa or
a.e./kg diet and 80 µg a.e./larva. Because larvae consume a mix of nectar and pollen it is necessary to
f t ay ns
consider the proportion of nectar and pollen in the diet and the contribution towards the exposure
r o m co
ne ent he

concentration. According to Rortais et al. (2015)29 a single larva consumes 59.4 mg sugar and 2 mg pollen
ow um of t

over 5 days. Assuming the nectar is foraged from treated weeds with a sugar content of 30 % (w/w) this
th oc (s)

means that the larval diet consists of 396 mg nectar and 2 mg of pollen, i.e. a ratio of 0.995:0.05
of is d ber

(nectar:pollen). As the maximum concentration in nectar was 31.3 mg a.e./kg and in pollen 629 mg a.e./kg
ion , th em
iss ore m

the diet would have a concentration of:

e
rm m er
pe her orm

Nectar: 0.995 x 31.3 mg a.e./kg = 31.1 mg a.e./kg + Pollen: 0.05 x 629 mg a.e./kg = 31.45 mg a.e./kg diet
he rt t/f
t t Fu en
ou s. rr
th tie cu

Concentration of glyphosate in the larval diet = 62.6 mg a.e./kg (based on nectar and pollen)
wi par (a)
f
en ird o

Comparing the larval endpoint to the maximum measured residues in the larval diet of 62.6 mg a.e./kg a
nt th rty
co and ope

margin of safety of 8.1 is calculated. Note: This is considered a worst-case estimate of exposure as honey
r

bee larvae are fed with royal jelly for the first two days of their development period.
ts
r i er p
t o wn the
en o s
m he t i

Overall, a margin of safety between 31.9 and 8.1 is demonstrated for chronic exposure to adult honey bees
cu f t en

ts
do s o um

and honey bee larvae. This approach indicates that the risk to honey bees is acceptable.
is ht c
th rig s do

In addition, a honey bee brood feeding test ( 2012, KCA 8.3.1.4/001) was conducted to evaluate
i
e op Th

the potential risk to honey bee brood when they are directly exposed to glyphosate (tested as IPA salt). This
of y

study provides further information regarding the chronic risk to honey bees and honey bee brood. The dose
us c

levels of the test item were based on the residues characterised in the glasshouse study ( 2011,
d nd
an a

CP 10.3.1.5/001). The lowest test dose (75 mg glyphosate a.e./L) was based on the mean measured pollen
n rty
tio e

and nectar concentration over the first 3 days following spray application, the mid-dose (150 mg a.e./L)
ta op
loi pr

was based on the highest residue concentration determined (in pollen and nectar following spray
xp al

application) and the highest dose (301 mg a.e./L) was twice as high as the highest detected residue
l e ctu
cia lle

concentration. Mortality of adult honey bees as well as honey bee brood was assessed over a period of 7
er te
m s in

days. Overall, no treatment related effects were observed. The NOAEL for adult mortality and brood
om a

development was the highest dose tested; 301 mg a.e./L.

y c uch
an ts s
an righ

29
Rortais et al. (2015) Modes of honeybees exposure to systemic insecticides: estimated amounts of contaminated
d
ing to

pollen and nectar consumed by different categories of bees. Apidologie 36 (2005) 71–83
sh ct
bli bje
pu su
or be

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Consequently, the presented risk assessment for honey bees according to SANCO10329/2002 and taking

rib
into account the provisions in Reg (EU) No 283/2013 demonstrate a low risk to honey bees for glyphosate

t
dis
and for all uses of MON 52276.

n,
er tio
wn lica
.
s o ub
f it y p
Risk assessment according to the EFSA GD on the Risk Assessment on Bees (2013)

so n
ht , a
In addition, the risk assessment for honey bees is performed in accordance with the recommendations of

rig ntly
the “Guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and

th ue
e eq
solitary bees)”, as provided by the European Food Safety Authority (EFSA Journal 2013;11(7):3295 doi:

e
lat ns
10.2903/j.efsa.2013.3295, July 04, 2014). All calculations are based on the EFSA Screening Step and 1st

vio . Co
an ime al.
te reg new
Tier calculator (BeeTool v3).

oh tio re

d
pr tec EU
The risk assessment presented here considers also the consumption of contaminated water (guttation water,

ibi n
d
be ro te
surface water and puddles).

e ta p osa
ef da ph
er y ly
The screening step was conducted considering all recommended application rates according to the proposed

th tor G
use pattern (downwards spray).

ay ula the

or
t m reg king
Table 10.3.1-7: Screening assessment of the risk of glyphosate for honey bees due to the use of

m er see
MON 52276

do ll u tium
en a
cu nd
his fa or
Intended use All uses (Uses: 1a-10c) f t ay ns
r o m co
Application method downward spraying
ne ent he
ow um of t

Active substance Glyphosate

th oc (s)

Use pattern 1-2 x 1800 g a.e./ha,

of is d ber

1-2 x 1440 g a.e./ha,

ion , th em

1-3 x 1080 g a.e./ha,

iss ore m

1-3 x 720 g a.e./ha,

rm m er
pe her orm

1 x 540 g a.e./ha
he rt t/f

Type design LD50 (g a.e./bee) Max. single application rate HQcontact Trigger
t t Fu en

(g a.e./ha) criterion
ou s. rr
th tie cu

1800 < 18.0 42

wi par (a)
f
en ird o

Adult acute contact > 100 1440 < 14.4

nt th rty

toxicity
co and ope

1080 < 10.8

r

ts
r i er p

720 < 7.2

t o wn the

540 < 5.4

en o s
m he t i
cu f t en

ts

Type design Endpoint Max. single Ef × SV ETR Trigger

do s o um

application rate
is ht c
th rig s do

(kg a.e./ha)
i
e op Th

Adult acute oral LD50 = 104 µg a.e./bee 1.80 7.6 0.13 ≤ 0.2
toxicity
of y

1.44 0.11
us c

1.08 0.08
d nd
an a

0.72 0.05
n rty
tio e
ta op

0.54 0.04
loi pr

1.80 7.6 ≤ 0.03

xp al

< 0.076
l e ctu

Adult chronic oral LDD50 > 179.9 µg a.e./bee/day 1.44

cia lle

< 0.06
er te

toxicity
m s in

1.08 < 0.04

om a

0.72 < 0.0304

y c uch
an ts s

0.54 < 0.023

an righ

Larval toxicity NOED = 80 μg a.e./larva 1.80 4.4 0.10 ≤ 0.2

d
ing to
sh ct
bli bje
pu su
or be

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Table 10.3.1-7: Screening assessment of the risk of glyphosate for honey bees due to the use of

t rib
MON 52276

dis
n,
er tio
1.44 0.08

wn lica
.
s o ub
1.08 0.06

f it y p
0.72 0.04

so n
ht , a
rig ntly
0.54 0.03

th ue
Ef: exposure factor; SV: shortcut value; HQcontact: Hazard quotient for contact exposure; ETR: Exposure toxicity ratio; ETR

e eq
values shown in bold breach the relevant trigger.

e
lat ns
vio . Co
an ime al.
te reg new
oh tio re
The exposure toxicity ratio (ETR) for adult chronic toxicity is above the respective trigger value for

d
pr tec EU
application rates of 720 g a.e./ha, 1080 g a.e./ha, 1440 g a.e./ha and 1800 g a.e./ha. Therefore, a Tier 1 risk

ibi n
d
be ro te
assessment is required for these use patterns. No risk is indicated at the screening step for the use rate of

e ta p osa
540 g a.e./ha.

ef da ph
er y ly
th tor G
ay ula the
For the Tier 1 risk assessment calculations considering application of MON 52276 in crops planted in wide

or
t m reg king
rows (i.e. orchards and vines) the “under crop application” scenario is used. The crop itself will not be over-

m er see
sprayed as the application is done only to the area under the crop. Thus, no treated crop scenario is included
in the following (Table 10.3.1-8 to Table 10.3.1-10). Only weeds, field margin, adjacent crop and next

do ll u tium
en a
crop scenarios are considered.

cu nd
his fa or
f t ay ns
r o m co

Table 10.3.1-8: First-tier assessment (oral exposure) of the risk for honey bees due to the use of
ne ent he
ow um of t

MON 52276 in orchard crops and vines at 1440 g a.e./ha

th oc (s)
of is d ber

Intended use Orchard crops, vines (Uses: 4a, 5a)

ion , th em

Application method downward spraying

iss ore m

Crop Category under crop application1

rm m er
pe her orm

Active substance glyphosate

he rt t/f

Use pattern 1-2 x 1440 g a.e./ha2

t t Fu en
ou s. rr

Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

th tie cu

Adult LDD50 > 179.9 Weeds weed < 10 1 0.27 < 0.01 0.03
wi par (a)

chronic oral µg a.e./bee/day weed ≥ 10 1 2.9 < 0.02

f
en ird o

toxicity
nt th rty

field margin weed < 10 0.0092 2.9 < 0.01

co and ope

weed ≥ 10 0.0092 2.9 < 0.01

r

ts
r i er p

adjacent crop weed < 10 0.0033 5.8 < 0.01

t o wn the

weed ≥ 10 0.0033 5.8 < 0.01

en o s
m he t i

next crop weed < 10 1 0.54 < 0.01

cu f t en

ts

weed ≥ 10 1 0.54 < 0.01

do s o um
is ht c

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
th rig s do

1 Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
i
e op Th

Screening Step and 1st Tier Calculator

2
Max. single application rate of 1440 g a.e./ha considered for risk calculation
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Table 10.3.1-9: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

t rib
MON 52276 in orchard crops and vines at 1080 g a.e./ha

dis
n,
er tio
Intended use Orchard crops, vines (Uses: 4a, 4b, 5a, 5b)

wn lica
.
Application method downward spraying

s o ub
under crop application1

f it y p
Crop category

so n
Active substance glyphosate

ht , a
1-3 x 1080 g a.e./ha2

rig ntly
Use pattern

th ue
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e eq
Adult LDD50 > 179.9 Weeds weed < 10 1 0.27 < 0.001 0.03

e
lat ns
vio . Co
chronic oral µg a.e./bee/day weed ≥ 10 1 2.9 < 0.013

an ime al.
te reg new
toxicity field margin weed < 10 0.0092 2.9 < 0.001

oh tio re
weed ≥ 10 0.0092 2.9 < 0.001

d
pr tec EU
adjacent crop weed < 10 0.0033 5.8 < 0.001

ibi n
d
be ro te
weed ≥ 10 0.0033 5.8 < 0.001

e ta p osa
next crop weed < 10 1 0.54 < 0.002

ef da ph
weed ≥ 10 1 0.54 < 0.002

er y ly
th tor G
Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.

ay ula the
1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

or
t m reg king
Screening Step and 1st Tier Calculator

m er see
2
Max. single application rate of 1080 g a.e./ha considered for risk calculation

do ll u tium
en a
cu nd
his fa or
f t ay ns
Table 10.3.1-10: First-tier assessment (oral exposure) of the risk for honey bees due to the use of
r o m co

MON 52276 in orchard crops and vines at 720 g a.e./ha

ne ent he
ow um of t
th oc (s)

Intended use Orchard crops, vines (Uses: 4b, 4c, 5b, 5c)
of is d ber

Application method downward spraying

ion , th em

Crop Category under crop application1

iss ore m

glyphosate
rm m er

Active substance
pe her orm

Use pattern 1-3 x 720 g a.e./ha2

he rt t/f

Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

t t Fu en
ou s. rr

Adult LDD50 > 179.9 Weeds weed < 10 1 0.27 < 0.001 0.03
th tie cu

chronic oral µg a.e./bee/day weed ≥ 10 1 2.9 < 0.008

wi par (a)

toxicity field margin weed < 10 0.0092 2.9 < 0.001

f
en ird o
nt th rty

weed ≥ 10 0.0092 2.9 < 0.001

co and ope

adjacent crop weed < 10 0.0033 5.8 < 0.001

r

ts
r i er p

weed ≥ 10 0.0033 5.8 < 0.001

t o wn the

next crop weed < 10 1 0.54 < 0.002

en o s
m he t i

weed ≥ 10 1 0.54 < 0.002

cu f t en

ts
do s o um

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
is ht c
th rig s do

Screening Step and 1st Tier Calculator

i

2
e op Th

Max. single application rate of 720 g a.e./ha considered for risk calculation
of y
us c
d nd

All exposure toxicity ratios (ETRs) for adult chronic toxicity are below the respective trigger value,
an a
n rty

indicating acceptable risk to honey bees following application of MON 52276 in orchard crops and vines
tio e
ta op

according to the proposed use pattern.

loi pr
xp al
l e ctu

The recommended use pattern for MON 52276 includes also application on railroad tracks. Application is
cia lle

done by spray trains (spraying tanks, pumps and nozzles are mounted on special trains). Spray trains have
er te
m s in

an automatic plant detection system (infrared sensors and video cameras) to detect weeds using image
om a

processing. The automation system allows the nozzles to be opened or closed. So, MON 52276 is only
y c uch

sprayed on sections of the track that have weeds. The maximum application rate in any 12 months period
an ts s

is 3600 g a.e./ha (2 x 1800 g a.e./ha with a 90-day interval). Thus, the growth stage of weeds should not
an righ

exceed BBCH 00 – 19. However, bees may possibly be exposed to MON 52276 by direct spraying while
d
ing to
sh ct
bli bje
pu su
or be

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bees are foraging on flowers and weeds by oral uptake of contaminated pollen and nectar. As no definite

rib
crop scenario for railroad tracks is provided by EFSA, the under-crop application scenario was considered

t
dis
to address uses on railroad tracks.

n,
er tio
wn lica
.
Table 10.3.1-11: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

s o ub
f it y p
MON 52276 – railroad tracks at 1800 g a.e./ha

so n
ht , a
rig ntly
Intended use Railroad tracks (Uses: 7a, 7b)

th ue
Application method downward spraying

e eq
under crop application1

e
lat ns
Crop Category

vio . Co
an ime al.
Active substance glyphosate

te reg new
Use pattern 1-2 x 1800 g a.e./ha2

oh tio re

d
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

pr tec EU
Adult LDD50 > 179.9 Weeds weed < 10 1 0.27 < 0.002 0.03

ibi n
d
be ro te
chronic oral µg a.e./bee/day weed ≥ 10 1 2.9 < 0.021

e ta p osa
toxicity field margin weed < 10 0.0092 2.9 < 0.001

ef da ph
er y ly
weed ≥ 10 0.0092 2.9 < 0.001

th tor G
ay ula the
adjacent crop weed < 10 0.0033 5.8 < 0.001

or
weed ≥ 10 0.0033 5.8 < 0.001

t m reg king
next crop weed < 10 1 0.54 < 0.004

m er see
weed ≥ 10 1 0.54 < 0.004

do ll u tium
en a
Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.

cu nd
his fa or
1 As no definite scenario for railroad tracks is provided by the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
f t ay ns
Screening Step and 1st Tier Calculator, the under crop application scenario was considered to address uses on railroad tracks
r o m co
2 Max. single application rate of 1800 g a.e./ha considered for risk calculation
ne ent he
ow um of t
th oc (s)
of is d ber

All exposure toxicity ratios (ETRs) for adult chronic toxicity are below the respective trigger value,
ion , th em

indicating acceptable risk to honey bees following application of MON 52276 on railroad tracks according
iss ore m

to GAP.
rm m er
pe her orm
he rt t/f

Besides uses in agricultural areas and railroad tracks a proposed use of MON 52276 is also to control
t t Fu en
ou s. rr

invasive weeds. It is important to control noxious, invasive weeds to help protect our diverse native plants,
th tie cu
wi par (a)

natural resources, and agriculture, as well as ensuring the safety of humans in the environment (e.g., Giant
f

Hogweed). Although some noxious weeds may serve as forage for bees and other pollinators, e.g. invasive
en ird o
nt th rty

knotweed species are considered valuable to many beekeepers since they bloom later in the season than
co and ope

many other plants. However, the detrimental impacts of these invasive plants significantly outweigh their
r

ts
r i er p
t o wn the

value as a pollen and nectar source.

en o s
m he t i
cu f t en

ts

MON 52276 is applied by spot application with a maximum single application rate of 1800 g a.s/ha in a 12
do s o um

month period. Nevertheless, bees can be exposed while they are foraging by direct overspray or dried
is ht c
th rig s do

residues on plants and by oral uptake of contaminated pollen and nectar. Thus, an appropriate assessment
i
e op Th

is presented here to address risk from the use of MON 52276 on invasive weeds in agricultural and non-
of y

agricultural areas.
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.3.1-12: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

t rib
MON 52276 – invasive plant species in agricultural and non-agricultural areas at 1800 g a.e./ha

dis
n,
er tio
Intended use invasive plant species in agricultural and non-agricultural areas (Uses: 8, 9)

wn lica
.
Application method downward spraying

s o ub
under crop application1

f it y p
Crop Category

so n
Active substance glyphosate

ht , a
rig ntly
Use pattern 1 x 1800 g a.e./ha

th ue
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e eq
Adult LDD50 > 179.9 Weeds weed < 10 1 0.27 < 0.002 0.03

e
lat ns
vio . Co
chronic oral µg a.e./bee/day weed > 10 1 2.9 < 0.021

an ime al.
te reg new
toxicity field margin weed < 10 0.0092 2.9 < 0.001

oh tio re
weed > 10 0.0092 2.9 < 0.001

d
pr tec EU
adjacent crop weed < 10 0.0033 5.8 < 0.001

ibi n
d
be ro te
weed > 10 0.0033 5.8 < 0.001

e ta p osa
next crop weed < 10 1 0.54 < 0.004

ef da ph
weed > 10 1 0.54 < 0.004

er y ly
th tor G
Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.

ay ula the
1
As no definite scenario for invasive weeds is provided by the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

or
t m reg king
Screening Step and 1st Tier Calculator, under crop application: giant hogweed (Heracleum spp.) and Japanese knotweed

m er see
(Reynoutria japonica)

do ll u tium
en a
cu nd
his fa or
f t ay ns
All exposure toxicity ratios (ETRs) for adult chronic toxicity are below the respective trigger value,
r o m co

indicating acceptable risk to honey bees following application of MON 52276 on invasive species in
ne ent he
ow um of t

agricultural and non-agricultural areas according to GAP.

th oc (s)
of is d ber

For the Tier 1 risk assessment calculations considering the pre-sowing, pre-planting and post-harvest uses
ion , th em

the “bare soil application” scenario is selected.

iss ore m

e
rm m er
pe her orm

Table 10.3.1-13: First-tier assessment (oral exposure) of the risk for honey bees due to the use of
he rt t/f

MON 52276 – pre-sowing, pre-planting and post-harvest uses at 1440 g a.e./ha

t t Fu en
ou s. rr
th tie cu
wi par (a)

Intended use Root & tuber vegetables, Bulb vegetables, Fruiting vegetables, Brassica,
f

Leafy vegetables, Stem vegetables, Sugar beet (Uses: 1a, 2a)

en ird o
nt th rty

Application method downward spraying

co and ope

Crop category bare soil application – crop attractive for pollen and nectar1
r

ts
r i er p

Active substance glyphosate

t o wn the

Use pattern 1-2 x 1440 g a.e./ha2

en o s
m he t i
cu f t en

Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

ts
do s o um

Adult LDD50 > 179.9 treated crop < 10 1 0.54 < 0.003 0.03
is ht c
th rig s do

chronic oral µg a.e./bee/day Weeds < 10 1 0.27 < 0.002

toxicity field margin < 10 0.0092 2.9 < 0.001
i
e op Th

adjacent crop < 10 0.0033 5.8 < 0.001

of y

next crop < 10 1 0.54 < 0.003

us c

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
d nd
an a

1 Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
n rty

Screening Step and 1st Tier Calculator

tio e
ta op

2
Max. single application rate of 1440 g a.e./ha considered for risk calculation
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Table 10.3.1-14: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

t rib
MON 52276 - pre-sowing, pre-planting and post-harvest uses at 1080 g a.e./ha

dis
n,
er tio
Intended use Root & tuber vegetables, Bulb vegetables, Fruiting vegetables, Brassica,

wn lica
.
Leafy vegetables, Stem vegetables, Sugar beet, Legume vegetables

s o ub
f it y p
(Uses: 1b, 2a, 2b, 2c, 6a, 10a)

so n
Application method downward spraying

ht , a
bare soil application – crop attractive for pollen and nectar1

rig ntly
Crop category

th ue
Active substance Glyphosate

e eq
Use pattern 1-3 x 1080 g a.e./ha2

e
lat ns
vio . Co
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

an ime al.
te reg new
Adult LDD50 > 179.9 treated crop < 10 1 0.54 < 0.002 0.03
chronic oral µg a.e./bee/day Weeds < 10 1 0.27 < 0.001

oh tio re

d
pr tec EU
toxicity field margin < 10 0.0092 2.9 < 0.001

ibi n
d
be ro te
adjacent crop < 10 0.0033 5.8 < 0.001

e ta p osa
next crop < 10 1 0.54 < 0.002

ef da ph
Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.

er y ly
th tor G
1 Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

ay ula the
Screening Step and 1st Tier Calculator

or
t m reg king
2 Max. single application rate of 1080 g a.e./ha considered for risk calculation

m er see
do ll u tium
en a
Table 10.3.1-15: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

cu nd
his fa or
MON 52276 - pre-sowing, pre-planting and post-harvest uses at 720 g a.e./ha f t ay ns
r o m co
ne ent he
ow um of t

Intended use Root & tuber vegetables, Bulb vegetables, Fruiting vegetables, Brassica,
th oc (s)

Leafy vegetables, Stem vegetables, Sugar beet, Legume vegetables

of is d ber

(Uses: 1c, 2b, 6b, 10b, 10c)

ion , th em

Application method downward spraying

iss ore m

Crop category bare soil application – crop attractive for pollen and nectar1
rm m er
pe her orm

Active substance glyphosate

1-3 x 720 g a.e./ha2
he rt t/f

Use pattern
t t Fu en

Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

ou s. rr
th tie cu

Adult LDD50 > 179.9 treated crop < 10 1 0.54 < 0.002 0.03
wi par (a)

chronic oral µg a.e./bee/day Weeds < 10 1 0.27 < 0.001

f
en ird o

toxicity field margin < 10 0.0092 2.9 < 0.001

nt th rty
co and ope

adjacent crop < 10 0.0033 5.8 < 0.001

r

next crop < 10 1 0.54 < 0.002

ts
r i er p
t o wn the

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
en o s

1
Crop category in the first tier oral assessment according to the EFSA GD on the Risk Assessment on Bees (2013)
m he t i
cu f t en

2
ts

Max. single application rate of 720 g a.e./ha considered for risk calculation
do s o um
is ht c
th rig s do
i

All exposure toxicity ratios (ETRs) for adult chronic toxicity are below the respective trigger value,
e op Th

indicating acceptable risk to honey bees following application of MON 52276 pre-sowing, pre-planting and
of y

post-harvest.
us c
d nd
an a
n rty

For the Tier 1 risk assessment calculations, considering ground directed inter-row applications in vegetables
tio e
ta op

the following crop categories are selected:

loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Crop according to GAP Crop Category1

t rib
dis
Root vegetables Root vegetables

n,
er tio
Tuber vegetables Potatoes

wn lica
.
Bulb vegetables Bulb vegetables

s o ub
f it y p
Fruiting vegetables Fruiting vegetables 1, fruiting vegetables 2

so n
ht , a
Brassica Leafy vegetables

rig ntly
th ue
Leafy vegetables Leafy vegetables, lettuce

e eq
e
lat ns
Stem vegetables Leafy vegetables

vio . Co
an ime al.
te reg new
Sugar beet Sugar beet

oh tio re
Legume vegetables Pulses

d
pr tec EU
ibi n
1 Cropcategory chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

d
be ro te
Screening Step and 1st Tier Calculator

e ta p osa
ef da ph
er y ly
th tor G
ay ula the
Table 10.3.1-16: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

or
t m reg king
MON 52276 – fruiting, leafy and tuber vegetables at 1440 g a.s./ha

m er see
Intended use Fruiting vegetables, Leafy vegetables, Tuber vegetables (Uses: 1a, 2a)

do ll u tium
en a
Application method downward spraying

cu nd
his fa or
Crop category fruiting vegetables 2, lettuce and potatoes1 f t ay ns
r o m co
Active substance glyphosate
ne ent he

Use pattern 1-2 x 1440 g a.e./ha2

ow um of t

Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

th oc (s)

< 10 1 0.012 < 0.001

of is d ber

treated crop
ion , th em

≥ 70 1 0 < 0.001
iss ore m

< 10 1 2.9 < 0.017

e

Weeds
rm m er

≥ 70 0.3 2.9 < 0.005

pe her orm

Adult
LDD50 > 179.9 < 10 0.0092 2.9 < 0.001
he rt t/f

chronic oral field margin 0.03

t t Fu en

µg a.e./bee/day ≥ 70 0.0092 2.9 < 0.001

toxicity
ou s. rr
th tie cu

< 10 0.0033 5.8 < 0.001

adjacent crop
wi par (a)

≥ 70 0.0033 5.8 < 0.001

f
en ird o

< 10 1 0.54 < 0.003

nt th rty

next crop
≥ 70 1 0.54 < 0.003
co and ope

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
r

ts
r i er p

1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
t o wn the

Screening Step and 1st Tier Calculator, e.g. fruiting vegetables 2 = tomatoes, eggplants
en o s
m he t i

2
Max. single application rate of 1440 g a.e./ha considered for risk calculation
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 238 of 553

ep
,r
ion
ut
Table 10.3.1-17: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

t rib
MON 52276 - fruiting, leafy and tuber vegetables at 1080 g a.e./ha

dis
n,
er tio
Intended use Fruiting vegetables, Leafy vegetables, Tuber vegetables (Uses: 1b, 2a, 2b, 2c, 6a,

wn lica
.
10a)

s o ub
f it y p
Application method downward spraying

so n
Crop category fruiting vegetables 2, lettuce and potatoes1

ht , a
rig ntly
Active substance glyphosate
1-3 x 1080 g a.e./ha2

th ue
Use pattern

e eq
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e
lat ns
vio . Co
Adult LDD50 > 179.9 treated crop < 10 1 0.012 < 0.001 0.03

an ime al.
te reg new
chronic oral µg a.e./bee/day 10 – 393 1 0.92 < 0.004
toxicity 10 – 49 1 0.92 < 0.004

oh tio re

d
pr tec EU
≥ 70 1 0 < 0.001

ibi n
d
be ro te
Weeds < 10 1 2.9 < 0.013

e ta p osa
10 – 393 1 2.9 < 0.013

ef da ph
10 – 493 1 2.9 < 0.013

er y ly
th tor G
≥ 70 0.3 2.9 < 0.004

ay ula the

or
field margin < 10 0.0092 2.9 < 0.001

t m reg king
10 – 393 0.0092 2.9 < 0.001

m er see
10 – 49 0.0092 2.9 < 0.001

do ll u tium
en a
≥ 70 0.0092 2.9 < 0.001

cu nd
his fa or
adjacent crop < 10 0.0033 5.8 < 0.001
10 – 393 0.0033 5.8 f t ay ns
< 0.001
r o m co
ne ent he

10 – 49 0.0033 5.8 < 0.001

ow um of t

≥ 70 0.0033 5.8 < 0.001

th oc (s)

next crop < 10 1 0.54 < 0.002

of is d ber

10 – 393 1 0.54 < 0.002

ion , th em

10 – 49 1 0.54 < 0.002

iss ore m

e
rm m er

≥ 70 1 0.54 < 0.002

pe her orm

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
he rt t/f

1 Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
t t Fu en

Screening Step and 1st Tier Calculator, e.g. fruiting vegetables 2 = tomatoes, eggplants
ou s. rr
th tie cu

2 Max. single application rate of 1080 g a.e./ha considered for risk calculation
wi par (a)

3 BBCH stage 10-39 relevant for the crop category potatoes

f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 239 of 553

ep
,r
ion
ut
Table 10.3.1-18: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

t rib
MON 52276 – fruiting, leafy and tuber vegetables at 720 g a.e./ha

dis
n,
er tio
Intended use Fruiting vegetables, Leafy vegetables, Tuber vegetables (Uses: 1c, 2b, 6b, 10b, 10c)

wn lica
.
Application method downward spraying

s o ub
fruiting vegetables 2, lettuce and potatoes1

f it y p
Crop category

so n
Active substance glyphosate

ht , a
1-3 x 720 g a.e./ha2

rig ntly
Use pattern

th ue
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e eq
Adult LDD50 > 179.9 treated crop < 10 1 0.012 < 0.001 0.03

e
lat ns
10 – 393

vio . Co
chronic oral µg a.e./bee/day 1 0.92 < 0.003

an ime al.
te reg new
toxicity 10 – 49 1 0.92 < 0.003

oh tio re
≥ 70 1 0 < 0.001

d
pr tec EU
Weeds < 10 1 2.9 < 0.008

ibi n
d
be ro te
10 – 393 1 2.9 < 0.008

e ta p osa
10 – 49 1 2.9 < 0.008

ef da ph
≥ 70 0.3 2.9 < 0.003

er y ly
th tor G
field margin < 10 0.0092 2.9 < 0.001

ay ula the

or
10 – 39 0.0092 2.9 < 0.001

t m reg king
10 – 49 0.0092 2.9 < 0.001

m er see
≥ 70 0.0092 2.9 < 0.001

do ll u tium
en a
adjacent crop < 10 0.0033 5.8 < 0.001

cu nd
his fa or
10 – 393 0.0033 5.8 < 0.001
f t ay ns
10 – 49 0.0033 5.8 < 0.001
r o m co
ne ent he

≥ 70 0.0033 5.8 < 0.001

ow um of t

next crop < 10 1 0.54 < 0.002

th oc (s)

10 – 393 1 0.54 < 0.002

of is d ber

10 – 49 1 0.54 < 0.002

ion , th em

≥ 70 1 0.54 < 0.002

iss ore m

e
rm m er

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
pe her orm

1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
he rt t/f

Screening Step and 1st Tier Calculator, e.g. fruiting vegetables 2 = tomatoes, eggplants
t t Fu en

2
Max. single application rate of 720 g a.e./ha considered for risk calculation
ou s. rr
th tie cu

3
BBCH stage 10 – 39 relevant for the crop category potatoes
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 240 of 553

ep
,r
ion
ut
Table 10.3.1-19: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

t rib
MON 52276 – Brassica, leafy, stem, root, fruiting vegetables at 1440 g a.e./ha

dis
n,
er tio
Intended use Root vegetables, Fruiting vegetables, Brassica,

wn lica
.
Leafy vegetables, Stem vegetables (Uses: 1a, 2a)

s o ub
downward spraying

f it y p
Application method
leafy vegetables, root vegetables and fruiting vegetables 11

so n
Crop category

ht , a
glyphosate

rig ntly
Active substance
1-2 x 1440 g a.e./ha2

th ue
Use pattern

e eq
Test design Endpoint Scenario BBCH Ef SV ETR Trigger

e
lat ns
(lab.)

vio . Co
an ime al.
Adult LDD50 > 179.9 treated crop < 10 1 0.54 < 0.003 0.03

te reg new
chronic oral µg a.e./bee/day ≥ 70 1 0 < 0.001

oh tio re

d
toxicity

pr tec EU
Weeds < 10 1 2.9 < 0.017

ibi n
d
be ro te
≥ 70 0.3 2.9 < 0.005

e ta p osa
field margin < 10 0.0092 2.9 < 0.001

ef da ph
≥ 70 0.0092 2.9 < 0.001

er y ly
th tor G
adjacent crop < 10 0.0033 5.8 < 0.001

ay ula the
≥ 70 0.0033 5.8 < 0.001

or
t m reg king
next crop < 10 1 0.54 < 0.003

m er see
≥ 70 1 0.54 < 0.003

do ll u tium
en a
Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

cu nd
his fa or
f t ay ns
Screening Step and 1st Tier Calculator, e.g. leafy vegetables: artichokes, asparagus, cabbages and other brassicas, cauliflowers and
r o m co
broccoli, chicory roots, spinach; root vegetables: anise, badian, fennel, corian, carrots, turnips for fodder, viper´s grass; fruiting
ne ent he

vegetables 1: chillies, peppers, cucumbers, gherkins, pumpkins, squash, gourds, melon, watermelons
ow um of t

2
Max. single application rate of 1440 g a.e./ha considered for risk calculation
th oc (s)
of is d ber
ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 241 of 553

ep
,r
ion
ut
Table 10.3.1-20: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

t rib
MON 52276 - Brassica, leafy, stem, root, fruiting and legume vegetables at 1080 g a.e./ha

dis
n,
er tio
Intended use Root vegetables, Fruiting vegetables, Brassica,

wn lica
.
Leafy vegetables, Stem vegetables, Legume vegetables (Use 1b, 2a, 2b, 2c, 6a, 10a)

s o ub
downward spraying

f it y p
Application method
leafy vegetables, root vegetables, fruiting vegetables 1 and pulses1

so n
Crop category

ht , a
glyphosate

rig ntly
Active substance
1-3 x 1080 g a.e./ha2

th ue
Use pattern

e eq
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e
lat ns
Adult LDD50 > 179.9 treated crop < 10 1 0.54 < 0.002 0.03

vio . Co
an ime al.
chronic oral µg a.e./bee/day 10 – 393

te reg new
1 5.8 < 0.025
toxicity 10 – 49 1 5.8 < 0.025

oh tio re

d
pr tec EU
≥ 70 1 0 < 0.001

ibi n
d
be ro te
Weeds < 10 1 2.9 < 0.013

e ta p osa
10 – 393 1 2.9 < 0.013

ef da ph
10 – 49 1 2.9 < 0.013

er y ly
th tor G
≥ 70 0.3 2.9 < 0.004

ay ula the
field margin < 10 0.0092 2.9 < 0.001

or
t m reg king
10 – 393 0.0092 2.9 < 0.001

m er see
10 – 49 0.0092 2.9 < 0.001

do ll u tium
en a
≥ 70 0.0092 2.9 < 0.001

cu nd
his fa or
adjacent crop < 10 0.0033 5.8 < 0.001
10 – 393 0.0033 5.8 f t ay ns
< 0.001
r o m co

10 – 49 0.0033 5.8 < 0.001

ne ent he
ow um of t

≥ 70 0.0033 5.8 < 0.001

th oc (s)

next crop < 10 1 0.54 < 0.002

of is d ber

10 – 393 1 0.54 < 0.002

ion , th em

10 – 49 1 0.54 < 0.002

iss ore m

≥ 70 1 0.54 < 0.002

rm m er
pe her orm

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
he rt t/f

1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
t t Fu en

Screening Step and 1st Tier Calculator, e.g. leafy vegetables: artichokes, asparagus, cabbages and other brassicas, cauliflowers and
ou s. rr
th tie cu

broccoli, chicory roots, spinach; root vegetables: anise, badian, fennel, corian, carrots, turnips for fodder, viper´s grass; fruiting
wi par (a)

vegetables 1: chillies, peppers, cucumbers, gherkins, pumpkins, squash, gourds, melon, watermelons; pulses: beans, broad beans,
f

horse beans, buckwheat, chick peas, cow peas, leguminous for silage, leguminous vegetables, lentis, lupins, peas, soybeans,
en ird o
nt th rty

vetches
co and ope

2
Max. single application rate of 1080 g a.e./ha considered for risk calculation
r

3
ts
r i er p

BBCH stage 10-39 relevant for the crop category root vegetables
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 242 of 553

ep
,r
ion
ut
Table 10.3.1-21: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

t rib
MON 52276 - Brassica, leafy, stem, root, fruiting and legume vegetables at 720 g a.e./ha

dis
n,
er tio
Intended use Root vegetables, Fruiting vegetables, Brassica,

wn lica
.
Leafy vegetables, Stem vegetables, Legume vegetables (Uses: 1c, 2b, 6b, 10b, 10c)

s o ub
downward spraying

f it y p
Application method
leafy vegetables, root vegetables, fruiting vegetables 1 and pulses1

so n
Crop category

ht , a
glyphosate

rig ntly
Active substance
1-3 x 720 g a.e./ha2

th ue
Use pattern

e eq
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e
lat ns
Adult LDD50 > 179.9 treated crop < 10 1 0.54 < 0.002 0.03

vio . Co
an ime al.
chronic oral µg a.e./bee/day 10 – 393

te reg new
1 5.8 < 0.017
toxicity 10 – 49 1 5.8 < 0.017

oh tio re

d
pr tec EU
≥ 70 1 0 < 0.001

ibi n
d
be ro te
Weeds < 10 1 2.9 < 0.008

e ta p osa
10 – 393 1 2.9 < 0.008

ef da ph
10 – 49 1 2.9 < 0.008

er y ly
th tor G
≥ 70 0.3 2.9 < 0.003

ay ula the
field margin < 10 0.0092 2.9 < 0.001

or
t m reg king
10 – 393 0.0092 2.9 < 0.001

m er see
10 – 49 0.0092 2.9 < 0.001

do ll u tium
en a
≥ 70 0.0092 2.9 < 0.001

cu nd
his fa or
adjacent crop < 10 0.0033 5.8 < 0.001
10 – 393 0.0033 5.8 f t ay ns
< 0.001
r o m co

10 – 49 0.0033 5.8 < 0.001

ne ent he
ow um of t

≥ 70 0.0033 5.8 < 0.001

th oc (s)

next crop < 10 1 0.54 < 0.002

of is d ber

10 – 393 1 0.54 < 0.002

ion , th em

10 – 49 1 0.54 < 0.002

iss ore m

≥ 70 1 0.54 < 0.002

rm m er
pe her orm

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
he rt t/f

1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
t t Fu en

Screening Step and 1st Tier Calculator, e.g. leafy vegetables: artichokes, asparagus, cabbages and other brassicas, cauliflowers and
ou s. rr
th tie cu

broccoli, chicory roots, spinach; root vegetables: anise, badian, fennel, corian, carrots, turnips for fodder, viper´s grass; fruiting
wi par (a)

vegetables 1: chillies, peppers, cucumbers, gherkins, pumpkins, squash, gourds, melon, watermelons, leguminous for silage,
f

leguminous vegetables, lentis, lupins, peas, soybeans, vetches

en ird o
nt th rty

2
Max. single application rate of 720 g a.e./ha considered for risk calculation
co and ope

3
BBCH stage 10 – 39 relevant for the crop category root vegetables
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 243 of 553

ep
,r
ion
ut
Table 10.3.1-22: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

t rib
MON 52276 - bulb vegetables at 1440 g a.e./ha

dis
n,
er tio
Intended use Bulb vegetables (Uses: 1a, 2a)

wn lica
.
Application method downward spraying

s o ub
bulb vegetables1

f it y p
Crop category

so n
Active substance glyphosate

ht , a
1-2 x 1440 g a.e./ha2

rig ntly
Use pattern

th ue
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e eq
Adult LDD50 > 179.9 treated crop < 10 1 0.54 < 0.003 0.03

e
lat ns
vio . Co
chronic oral µg a.e./bee/day ≥ 70 1 0 < 0.001

an ime al.
te reg new
toxicity weeds < 10 1 2.9 < 0.017

oh tio re
≥ 70 0.6 2.9 < 0.010

d
pr tec EU
field margin < 10 0.0092 2.9 < 0.001

ibi n
d
be ro te
≥ 70 0.0092 2.9 < 0.001

e ta p osa
adjacent crop < 10 0.0033 5.8 < 0.001

ef da ph
≥ 70 0.0033 5.8 < 0.001

er y ly
th tor G
next crop < 10 1 0.54 < 0.003

ay ula the

or
≥ 70 1 0.54 < 0.003

t m reg king
Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.

m er see
1 Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

do ll u tium
en a
Screening Step and 1st Tier Calculator, e.g. bulb vegetables: garlic, leeks and other alliaceous vegetables, onions
2 Max. single application rate of 1440 g a.e./ha considered for risk calculation

cu nd
his fa or
f t ay ns
r o m co
ne ent he
ow um of t

Table 10.3.1-23: First-tier assessment (oral exposure) of the risk for honey bees due to the use of
th oc (s)

MON 52276 - bulb vegetables at 1080 g a.e./ha

of is d ber
ion , th em

Intended use Bulb vegetables (Uses: 1b, 2a, 2b, 2c, 6a, 10a)
iss ore m

Application method downward spraying (bulb vegetables1)

rm m er
pe her orm

Crop category bulb vegetables1

he rt t/f

Active substance glyphosate

t t Fu en

Use pattern 1-3 x 1080 g a.e./ha2

ou s. rr
th tie cu

Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

wi par (a)

Adult LDD50 > 179.9 treated crop <10 1 0.54 <0.002 0.03
f
en ird o

chronic oral µg a.e./bee/day 10-39 1 5.8 <0.025

nt th rty
co and ope

toxicity ≥70 1 0 <0.001

r

ts
r i er p

weeds <10 1 2.9 <0.013

t o wn the

10-39 1 2.9 <0.013

en o s
m he t i

≥70 0.6 2.9 <0.008

cu f t en

ts

field margin <10 0.0092 2.9 <0.001

do s o um
is ht c

10-39 0.0092 2.9 <0.001

th rig s do

≥70 0.0092 2.9 <0.001

i
e op Th

adjacent crop <10 0.0033 5.8 <0.001

of y

10-39 0.0033 5.8 <0.001

us c

≥70 0.0033 5.8 <0.001

d nd

next crop <10 1 0.54 <0.002

an a
n rty

10-39 1 0.54 <0.002

tio e
ta op

≥70 1 0.54 <0.002

loi pr

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
xp al
l e ctu

1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
cia lle

Screening Step and 1st Tier Calculator, e.g. bulb vegetables: garlic, leeks and other alliaceous vegetables, onions
er te

2
Max. single application rate of 1080 g a.e./ha considered for risk calculation
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 244 of 553

ep
,r
ion
ut
Table 10.3.1-24: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

t rib
MON 52276- bulb vegetables at 720 g a.e./ha

dis
n,
er tio
Intended use Bulb vegetables (Uses: 1c, 2b, 6b, 10b, 10c)

wn lica
.
Application method downward spraying

s o ub
bulb vegetables1

f it y p
Crop category

so n
Active substance glyphosate

ht , a
1-3 x 720 g a.e./ha2

rig ntly
Use pattern

th ue
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e eq
Adult LDD50 > 179.9 treated crop < 10 1 0.54 < 0.002 0.03

e
lat ns
vio . Co
chronic oral µg a.e./bee/day 10 – 39 1 5.8 < 0.017

an ime al.
te reg new
toxicity ≥ 70 1 0 < 0.001

oh tio re
weeds < 10 1 2.9 < 0.008

d
pr tec EU
10 – 39 1 2.9 < 0.008

ibi n
d
be ro te
≥ 70 0.6 2.9 < 0.005

e ta p osa
field margin < 10 0.0092 2.9 < 0.001

ef da ph
10 – 39 0.0092 2.9 < 0.001

er y ly
th tor G
≥ 70 0.0092 2.9 < 0.001

ay ula the

or
adjacent crop < 10 0.0033 5.8 < 0.001

t m reg king
10 – 39 0.0033 5.8 < 0.001

m er see
≥ 70 0.0033 5.8 < 0.001

do ll u tium
en a
next crop < 10 1 0.54 < 0.002

cu nd
his fa or
10 – 39 1 0.54 < 0.002
f t ay ns
≥ 70 1 0.54 < 0.002
r o m co
ne ent he

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
ow um of t

1 Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

Screening Step and 1st Tier Calculator, e.g. bulb vegetables: garlic, leeks and other alliaceous vegetables, onions
th oc (s)
of is d ber

2 Max. single application rate of 720 g a.e./ha considered for risk calculation
ion , th em
iss ore m

e
rm m er
pe her orm

Table 10.3.1-25: First-tier assessment (oral exposure) of the risk for honey bees due to the use of
he rt t/f

MON 52276 - sugar beet at 1440 g a.e./ha

t t Fu en
ou s. rr
th tie cu

Intended use Sugar beet (Uses: 1a, 2a)

wi par (a)

Application method downward spraying

f
en ird o

sugar beet1
nt th rty

Crop category
co and ope

Active substance glyphosate

r

1-2 x 1440 g a.e./ha2

ts
r i er p

Use pattern
t o wn the

Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

en o s
m he t i

Adult LDD50 > 179.9 treated crop < 10 1 0.54 < 0.003 0.03
cu f t en

ts

chronic oral µg a.e./bee/day ≥ 70 1 0 < 0.001

do s o um

toxicity
is ht c

weeds < 10 1 2.9 < 0.017

th rig s do

≥ 70 0.25 2.9 < 0.004

i
e op Th

field margin < 10 0.0092 2.9 < 0.001

of y

≥ 70 0.0092 2.9 < 0.001

us c

adjacent crop < 10 0.0033 5.8 < 0.001

d nd

≥ 70 0.0033 5.8 < 0.001

an a
n rty

next crop < 10 1 0.54 < 0.003

tio e
ta op

≥ 70 1 0.54 < 0.003

loi pr

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
xp al
l e ctu

1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
cia lle

Screening Step and 1st Tier Calculator

er te

2
Max. single application rate of 1440 g a.e./ha considered for risk calculation
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.3.1-26: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

t rib
MON 52276 - sugar beet at 1080 g a.e./ha

dis
n,
er tio
Intended use Sugar beet (Uses: 1b, 2a, 2b, 2c, 6a, 10a)

wn lica
.
Application method downward spraying

s o ub
sugar beet1

f it y p
Crop category

so n
Active substance glyphosate

ht , a
1-3 x 1080 g a.e./ha2

rig ntly
Use pattern

th ue
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e eq
Adult LDD50 > 179.9 treated crop < 10 1 0.54 < 0.002 0.03

e
lat ns
vio . Co
chronic oral µg a.e./bee/day ≥ 70 1 0 < 0.001

an ime al.
te reg new
toxicity 10 – 39 1 5.8 < 0.025

oh tio re
weeds < 10 1 2.9 < 0.013

d
pr tec EU
≥ 70 0.25 2.9 < 0.003

ibi n
d
be ro te
10 – 39 1 2.9 < 0.013

e ta p osa
field margin < 10 0.0092 2.9 < 0.001

ef da ph
≥ 70 0.0092 2.9 < 0.001

er y ly
th tor G
10 – 39 0.0092 2.9 < 0.001

ay ula the

or
adjacent crop < 10 0.0033 5.8 < 0.001

t m reg king
≥ 70 0.0033 5.8 < 0.001

m er see
10 – 39 0.0033 5.8 < 0.001

do ll u tium
en a
next crop < 10 1 0.54 < 0.002

cu nd
his fa or
≥ 70 1 0.54 < 0.002
f t ay ns
10 – 39 1 0.54 < 0.002
r o m co
ne ent he

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
ow um of t

1 Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

Screening Step and 1st Tier Calculator

th oc (s)
of is d ber

2 Max. single application rate of 1080 g a.e./ha considered for risk calculation
ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.3.1-27: First-tier assessment (oral exposure) of the risk for honey bees due to the use of

t rib
MON 52276 - sugar beet at 720 g a.e./ha

dis
n,
er tio
Intended use Sugar beet (Use 1c, 2b, 6b, 10b, 10c)

wn lica
.
Application method downward spraying

s o ub
sugar beet1

f it y p
Crop category

so n
Active substance glyphosate

ht , a
rig ntly
Use pattern 1-3 x 720 g a.e./ha

th ue
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e eq
Adult LDD50 > 179.9 treated crop < 10 1 0.54 < 0.002 0.03

e
lat ns
vio . Co
chronic oral µg a.e./bee/day ≥ 70 1 0 < 0.001

an ime al.
te reg new
toxicity 10 – 39 1 5.8 < 0.017

oh tio re
weeds < 10 1 2.9 < 0.008

d
pr tec EU
≥ 70 0.25 2.9 < 0.002

ibi n
d
be ro te
10 – 39 1 2.9 < 0.008

e ta p osa
field margin < 10 0.0092 2.9 < 0.001

ef da ph
≥ 70 0.0092 2.9 < 0.001

er y ly
th tor G
10 – 39 0.0092 2.9 < 0.001

ay ula the

or
adjacent crop < 10 0.0033 5.8 < 0.001

t m reg king
≥ 70 0.0033 5.8 < 0.001

m er see
10 – 39 0.0033 5.8 < 0.001

do ll u tium
en a
next crop < 10 1 0.54 < 0.002

cu nd
his fa or
≥ 70 1 0.54 < 0.002
f t ay ns
10 – 39 1 0.54 < 0.002
r o m co
ne ent he

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
ow um of t

1 Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

Screening Step and 1st Tier Calculator

th oc (s)
of is d ber

2 Max. single application rate of 720 g a.e./ha considered for risk calculation
ion , th em
iss ore m

e
rm m er
pe her orm

All exposure toxicity ratios (ETRs) for adult chronic toxicity are below the respective trigger value,
he rt t/f

indicating acceptable risk to honey bees following application of MON 52276 in vegetables.
t t Fu en
ou s. rr
th tie cu

Overall, a low risk to honey bees has been demonstrated in the risk assessment above for all uses according
wi par (a)

to proposed GAP.
f
en ird o
nt th rty
co and ope

Assessment of risk according to EFSA GD on bees (2013) from exposure to contaminated water
r

ts
r i er p
t o wn the

An assessment of the risk to bees from contaminated water is provided in the table below. The risk
en o s

assessment for contaminated water focuses on honey bees only based on the very high level of water fluxes
m he t i
cu f t en

ts

in honey bee colonies. This should be also sufficiently protective for bumble bees and solitary bees.
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Table 10.3.1-28: Assessment of the risk for bees due to the use of MON 52276 considering exposure

t rib
to contaminated water

dis
n,
er tio
Intended use All uses (Uses: 1a-10c)

wn lica
.
Application method downward spraying

s o ub
f it y p
Active substance glyphosate

so n
Use pattern 1 x 1800 g a.e./ha

ht , a
rig ntly
2 x 1440 g a.e./ha

th ue
Water solubility 12000 mg/L

e eq
PECsw1 0.01141 µg a.e./L (Step 3, grass/alfalfa, D2 ditch, early/late application)

e
lat ns
PECpuddle2 0.032340 µg a.e./L (Step 3, pome/stone fruit, R4, early application)

vio . Co
an ime al.
te reg new
Surface water1

oh tio re
Test design Endpoint (lab.) water consumption (l) ETR1 Trigger

d
pr tec EU
Acute 104 g a.e./bee 11.4 < 0.01 0.2

ibi n
d
be ro te
Chronic > 179.9 g a.e./bee/day 11.4 < 0.001 0.03

e ta p osa
Larvae 80 g a.e./larva 111 < 0.01 0.2

ef da ph
er y ly
Puddle water1,2

th tor G
ay ula the
Test design Endpoint (lab.) water consumption (l) ETR2 Trigger

or
t m reg king
Acute 104 g a.e./bee 11.4 < 0.01 0.2
Chronic 11.4 < 0.001 0.03

m er see
> 179.9 g a.e./bee/day
Larvae 80 g a.e./larva 111 < 0.01 0.2

do ll u tium
en a
Guttation water

cu nd
his fa or
Test design Endpoint (lab.) f t ay ns
water consumption (l) ETR Trigger
r o m co
Acute 104 g a.e./bee 11.4 1.32 0.2
ne ent he

Chronic
ow um of t

> 179.9 g a.e./bee/day 11.4 0.411 0.03

th oc (s)

Larvae 80 g a.e./larva 111 11.99 0.2

of is d ber

ETR: exposure toxicity ratio.

ion , th em

Values shown in bold breach the relevant trigger.

iss ore m

1 Highest application rate of 1800 g a.e./ha considered for risk calculation, calculation based on FOCUS (2001) (for details refer
e
rm m er

to MCP Section 9)
pe her orm

2
Application rate of 2 x 1440 g a.e./ha considered for risk calculation, PECpuddle was calculated using a PRZM model (for details
he rt t/f

see MCP Section 9), which is independent from the PECsw

t t Fu en
ou s. rr
th tie cu
wi par (a)

The calculated exposure toxicity ratios (ETRs) are below the relevant trigger values for surface and puddle
f
en ird o
nt th rty

water indicating no risk from exposure via contaminated water to honey bees. However, the calculated
co and ope

ETRs are above the trigger for guttation water. In EFSA (2013) the assumptions for the guttation risk
r

ts
r i er p

assessment are for the crop to be the source of guttation and that this covers the risk to other sources of
t o wn the

guttation fluid. The crop is a uniform stand of plants of a single species and at similar growth stages at any
en o s
m he t i
cu f t en

ts

given time. In contrast MON 52276 applications are made to a potentially diverse assemblage of weeds to
do s o um

be controlled. Consequently, the conditions of EFSA 2013 regarding guttation do not relate to the use of
is ht c
th rig s do

the product. Therefore, several species of weed at different growth stages may be present and will not
i
e op Th

necessarily all be producing guttation fluid. Furthermore, it was observed in Thompson (2011 CP
10.3.1.5/001) that the treated plants start to wilt soon after treatment and honey bee foraging was greatly
of y

reduced after 4 – 5 days. Root pressure and cell turgor are required for a plant to produce guttation fluid
us c
d nd

and wilted plants will rapidly stop producing guttation fluid. The reduced bee activity will also limit
an a
n rty

exposure.
tio e
ta op
loi pr

The assumption that guttation fluid will contain the active substance at its limit of solubility is a huge over
xp al
l e ctu

estimate of exposure for substances of higher water solubility such as glyphosate. There are technical
cia lle
er te

considerations regarding this point to consider in relation to the risk assessment. Assuming a guttation
m s in

droplet contains glyphosate at the limit of water solubility, ca. 12000 mg/L, and the daily water intake of
om a
y c uch

11.4 l/bee/day (EFSA bee GD 2013) this is equivalent to a forager daily intake of 136.8 µg a.e./bee. In the
an ts s

10-day chronic study honey bees were observed to consume 179.9 µg a.e./bee/day without any observed
an righ

mortality or other adverse effects. Given that the chronic risk assessment requires a trigger equivalent to
d
ing to

approximately 34x the endpoint this would mean in order to pass the risk assessment the endpoint would
sh ct
bli bje
pu su
or be

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need to be > 4651.2 µg a.e./bee/day which is almost 5 % of the average body weight of a honey bee of

rib
100 mg. This level of consumption would not be achievable in a standard laboratory test with ad libitum

t
dis
feeding and is not likely to occur under field conditions. Currently it is not possible to gavage honey bees

n,
er tio
to achieve higher doses. Even so the 10-day chronic endpoint, which is a NOEDD, is higher than the worst-

wn lica
.
case unrealistic daily dose via guttation fluid which gives a good indication that there is an acceptable risk.

s o ub
f it y p
so n
For larvae the exposure to water is considered a moot point. For the first 3 days they are fed exclusively on

ht , a
rig ntly
worker jelly which is a secretion from the glands of nurse bees. After that on days 4 and 5 they are still fed

th ue
with jelly but also receive some pollen and nectar from hive stores. Larval water needs are met from the

e eq
e
lat ns
liquid food they receive but some dilution of stored honey may occur and fed to the larvae on days 4 and 5

vio . Co
an ime al.
of their development if these coincide with periods of cool wet weather and the colony needs to use some

te reg new
of the stored honey. Overall of the 111 µl water required by larval bees (EFSA bee GD 2013) only a minor

oh tio re

d
proportion would come from extraneously collected water and of that only a fraction would be derived from

pr tec EU
ibi n
guttation fluid. The real-life exposure of larvae to guttation water is probably negligible and the level of

d
be ro te
e ta p osa
exposure to a low toxicity substances such as glyphosate arising from this is unlikely to pose a risk to honey

ef da ph
bee brood.

er y ly
th tor G
ay ula the
The water exposure route and in particular via consumption of guttation fluid, is not considered as a major

or
t m reg king
exposure route compared to nectar and pollen. The presented higher-tier assessment for honey bees based

m er see
on the worst-case exposure via nectar and pollen should be sufficiently protective for the risk from exposure

do ll u tium
en a
via contaminated water.

cu nd
his fa or
f t ay ns
Additionally, it has to be considered that the bee guidance assumes that the whole water consumption is
r o m co
ne ent he

based on guttation, surface or puddle water. However, honey bees also use different sources and is most
ow um of t

likely a mixture of available water resources.

th oc (s)
of is d ber
ion , th em
iss ore m

Higher-tier assessment for exposure via contaminated water

e
rm m er
pe her orm

A glasshouse study was conducted to determine worst-case field exposure of bees to glyphosate by
he rt t/f

quantifying residues in relevant bee matrices; pollen and nectar ( 2011, CP 10.3.1.5/001).
t t Fu en
ou s. rr

Additionally, residues in honey bee larvae were measured. In total two large glasshouses with Phacelia
th tie cu

tanacetifolia were set up, each glasshouse contained two honey bee colonies. Glasshouses were unheated
wi par (a)

and well ventilated but insect-proof during the exposure phase, each glasshouse comprised an area of
f
en ird o
nt th rty

180 m2. MON 52276 was applied once during full flowering at a rate of 2880 g a.e./ha.
co and ope
r

ts
r i er p

Samples of pollen were collected from pollen traps. For nectar samples forager bees were collected and
t o wn the

their stomachs were prepared. Pollen and nectar samples were collected on days -1 (control), 1, 2, 3, 4 and
en o s
m he t i
cu f t en

ts

7. Additionally, nectar samples were taken directly from the colonies on day 7. Also honey bee larvae were
do s o um

collected from the combs on days 4 and 7 in each hive.

is ht c
th rig s do
i
e op Th

Residue analysis indicated no residues in pollen and nectar before application of MON 52276 (samples on
day -1, served as control, < 0.3 mg a.e./kg).
of y

Residues in nectar samples from forager honey bees ranged from 2.78 to 31.3 mg a.e./kg. Residues in nectar
us c
d nd

samples from the colonies 7 days after application ranged from < LOQ (1.0 mg a.e./kg) to 1.30 mg a.e./kg.
an a
n rty
tio e
ta op

Residues in pollen samples taken from the pollen traps ranged from 87.2 mg a.e./kg to 629 mg a.e./kg.
loi pr

Residues in larvae samples at day 4 and day 7 ranged from 1.23 mg a.e./kg to 19.50 mg a.e./kg.
xp al
l e ctu

During the study also the foraging activity as well as the crop status was recorded. Thus, combined with
cia lle
er te

the residue data the approximate daily exposure of a honey bee colony to glyphosate residues was
m s in

calculated.
om a
y c uch
an ts s

Results indicated a daily intake of glyphosate residues of 44.0 mg per colony (40.6 mg via nectar and 3.4 mg
an righ

via pollen) considering the max. mean residues at day 1 at 22.0 mg per colony (20.1 mg via nectar and 1.9
d

mg via pollen) considering the mean residues over days 1-3.

ing to
sh ct
bli bje
pu su
or be

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rib
Subsequently, a honey bee brood feeding test (according to Oomen et al. (1992)) was conducted to evaluate

t
dis
the potential risk to honey bee brood when they are directly exposed to glyphosate (tested as IPA salt)

n,
er tio
(Study No. V7H1001). The dose levels of the test item were based on the residues characterised in the

wn lica
.
glasshouse study (Study No. V7H1002, see below). The lowest dose (75 mg glyphosate a.e./L) was based

s o ub
f it y p
on the mean pollen and nectar residue concentrations over the first 3 days following spray application, the

so n
mid-dose (150 mg a.e./L) was based on the highest residue concentration determined in pollen and nectar

ht , a
rig ntly
following spray application and the highest dose (301 mg a.e./L) was twice as high as the highest detected

th ue
residue concentration.

e eq
e
lat ns
vio . Co
an ime al.
Mortality of adult honey bees as well as honey bee brood was assessed over a period of 7 days. Overall,

te reg new
no treatment related effects were observed.

oh tio re

d
Considering the outcome of the Tier I calculation for contaminated water. The detected potential risk from

pr tec EU
ibi n
contaminated water (guttation water) is sufficiently covered by the presented higher tier risk assessment

d
be ro te
e ta p osa
considering exposure of honey bee via pollen and nectar. The NOAEL (301 mg a.e./L) is based on the

ef da ph
measured residues after an application of 2880 g a.e./ha. The highest maximum single application rate

er y ly
th tor G
according to proposed GAP is 1800 g a.e./ha on grasses and 1440 g a.e/ha on field crops, thus, there is no

ay ula the
uncertainty left that the risk from contaminated water can be considered as negligible.

or
t m reg king
m er see
Bumble bees

do ll u tium
en a
In consideration of the recommendations of the “Technical report on the outcome of the pesticides peer

cu nd
his fa or
review meeting on general recurring issues in ecotoxicology”30 currently no risk assessment for bumble
f t ay ns
r o m co
bees is required, given that the EFSA Guidance Document on the risk assessment of plant protection
ne ent he

products on bees has not yet been noted. Furthermore, EFSA stated that it cannot be recommended to
ow um of t

routinely perform a risk assessment for bumble bees. Nevertheless, acute studies for bumble bees are
th oc (s)
of is d ber

available and a corresponding risk assessment is presented.

ion , th em

Details of the acute studies with Bombus terrestris and glyphosate are summarised in the Document
iss ore m

e
rm m er

M-CA, Section 8, point 8.3.1 and relevant endpoints for the risk assessment are provided in the table below.
pe her orm
he rt t/f
t t Fu en
ou s. rr

Table 10.3.1-29: Endpoints and effect values of glyphosate relevant for the risk assessment for bees
th tie cu
wi par (a)

Reference Test item Species Test design/ LD50 NOED

f
en ird o

GLP (μg a.e./bee) (μg a.e./bee)

nt th rty
co and ope

2017a Glyphosate Bombus Acute oral, > 412 ≥ 412

r

ts
r i er p

CA 8.3.1.1.1/007 K-salt terrestris 48 h

t o wn the

2017a Glyphosate Acute contact, ≥ 461

en o s

Bombus > 461

m he t i
cu f t en

48 h
ts

CA 8.3.1.1.2/008 IPA-salt terrestris

do s o um
is ht c
th rig s do

Further testing with the representative product MON 52276 and the toxicity to Bombus terrestris was not
i
e op Th

considered necessary and the risk assessment will be conducted on the active substance data.
of y
us c
d nd

Risk assessment for bumble bees

an a
n rty
tio e

The risk assessment for the proposed uses of MON 52276 and the effects on bumble bees is provided below.
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ

30
Technical report on the outcome of the pesticides peer review meeting on general recurring issues in
d
ing to

ecotoxicology, provided by EFSA, published December 22, 2015

sh ct
bli bje
pu su
or be

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Table 10.3.1-30: Screening assessment of the risk of glyphosate for bumble bees due to the use of

t rib
MON 52276

dis
n,
er tio
Intended use All uses (Uses: 1a to 10c)

wn lica
.
Application method downward spraying

s o ub
f it y p
Active substance glyphosate

so n
ht , a
Use pattern 1-2 x 1800 g a.e./ha,

rig ntly
1-2 x 1440 g a.e./ha,

th ue
1-3 x 1080 g a.e./ha,

e eq
1-3 x 720 g a.e./ha,

e
lat ns
vio . Co
1 x 540 g a.e./ha

an ime al.
te reg new
Type design LD50 (g a.e./bee) Max. single application rate HQcontact Trigger

oh tio re
(g a.e./ha) criterion

d
pr tec EU
ibi n
d
1800 < 3.9 7

be ro te
e ta p osa
Acute contact > 461 1440 < 3.1

ef da ph
toxicity

er y ly
1080 < 2.3

th tor G
ay ula the
720 < 1.6

or
t m reg king
540 < 1.2

m er see
Type design LD50 (g a.e./bee) Max. single Ef × SV ETR Trigger

do ll u tium
en a
application rate

cu nd
his fa or
(kg a.e./ha)
Acute oral toxicity > 412 1.80 f t ay ns 11.2 0.036
r o m co
< 0.05
ne ent he

1.44 < 0.04

ow um of t

1.08 < 0.03

th oc (s)
of is d ber

0.72 < 0.02

ion , th em

0.54 < 0.01

iss ore m

e
rm m er

Ef: exposure factor; SV: shortcut value; HQcontact: Hazard quotient for contact exposure; ETR: Exposure toxicity ratio; ETR
pe her orm

values shown in bold breach the relevant trigger.

he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)

The exposure toxicity ratio (ETR) for acute oral toxicity is above the respective trigger value for the
f
en ird o

application rates of 1440 g a.e./ha and 1800 g a.e./ha. Therefore, Tier 1 risk assessment is required for these
nt th rty

use patterns. No risk is indicated at the screening step for the use rate of 540 g a.e./ha, 720 g a.e./ha and
co and ope

1080 g a.e./ha.
r

ts
r i er p
t o wn the
en o s

For the Tier 1 risk assessment calculations considering application of MON 52276 in crops planted in wide
m he t i
cu f t en

ts

rows (i.e. orchards and vines) the “under crop application” scenario is used. The crop itself will not be over-
do s o um

sprayed as the application is done only to the area under the crop. Thus, no treated crop scenario is included
is ht c
th rig s do

in the following assessment. Only weeds, field margin, adjacent crop and next crop scenarios are
i
e op Th

considered.
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
,r
ion
ut
Table 10.3.1-31: First-tier assessment (oral exposure) of the risk for bumble bees due to the use of

t rib
MON 52276 in orchard crops and vines at 1440 g a.e./ha

dis
n,
er tio
Intended use Orchard crops, vines (Uses: 4a, 5a)

wn lica
.
Application method downward spraying

s o ub
under crop application1

f it y p
Crop Category

so n
Active substance glyphosate

ht , a
1-2 x 1440 g a.e./ha2

rig ntly
Use pattern

th ue
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e eq
Acute oral LD50 > 412 µg weeds weed < 10 1 0.46 < 0.01 0.036

e
lat ns
vio . Co
toxicity a.e./bee weed ≥ 10 1 6.5 < 0.023

an ime al.
te reg new
field margin weed < 10 0.0092 6.5 < 0.01

oh tio re
weed ≥ 10 0.0092 6.5 < 0.01

d
pr tec EU
adjacent crop weed < 10 0.0033 11.2 < 0.01

ibi n
d
be ro te
weed ≥ 10 0.0033 11.2 < 0.01

e ta p osa
next crop weed < 10 1 0.9 < 0.01

ef da ph
weed ≥ 10 1 0.9 < 0.01

er y ly
th tor G
Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.

ay ula the
1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

or
t m reg king
Screening Step and 1st Tier Calculator

m er see
2
Max. single application rate of 1440 g a.e./ha considered for risk calculation

do ll u tium
en a
All exposure toxicity ratios (ETRs) for acute oral toxicity are below the respective trigger value, indicating

cu nd
his fa or
f t ay ns
acceptable risk to bumble bees following application of MON 52276 in orchard crops and vines according
r o m co

to the proposed use pattern.

ne ent he
ow um of t
th oc (s)
of is d ber

The recommended use pattern for MON 52276 includes also application on railroad tracks. Application is
ion , th em

done by spray trains (spraying tanks, pumps and nozzles are mounted on special trains). Spray trains have
iss ore m

an automatic plant detection system (infrared sensors and video cameras) to detect weeds using image
rm m er
pe her orm

processing. The automation system allows the nozzles to be opened or closed. So, MON 52276 is only
he rt t/f

sprayed on sections of the track that have weeds. The maximum application rate in any 12 months period
t t Fu en
ou s. rr

is 3600 g a.e./ha (2 × 1800 g a.e./ha with a 90-day interval). Thus, the growth stage of weeds should not
th tie cu
wi par (a)

exceed BBCH 00-19. However, bees may possibly be exposed to MON 52276 by direct spraying while
f

bees are foraging on flowers and weeds by oral uptake of contaminated pollen and nectar. As no definite
en ird o
nt th rty

crop scenario for railroad tracks is provided by EFSA, the under crop application scenario was considered
co and ope

to address uses on railroad tracks as well.

r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
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cti
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 252 of 553

ep
,r
ion
ut
Table 10.3.1-32: First-tier assessment (oral exposure) of the risk for bumble bees due to the use of

t rib
MON 52276 – railroad tracks at 1800 g a.e./ha

dis
n,
er tio
Intended use Railroad tracks (Uses: 7a, 7b)

wn lica
.
Application method downward spraying

s o ub
under crop application1

f it y p
Crop Category

so n
Active substance glyphosate

ht , a
1-2 x 1800 g a.e./ha2

rig ntly
Use pattern

th ue
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e eq
Acute oral LD50 > 412 µg weeds weed < 10 1 0.46 < 0.002 0.036

e
lat ns
vio . Co
toxicity a.e./bee weed ≥ 10 1 6.5 < 0.028

an ime al.
te reg new
field margin weed < 10 0.0092 6.5 < 0.001

oh tio re
weed ≥ 10 0.0092 6.5 < 0.001

d
pr tec EU
adjacent crop weed < 10 0.0033 11.2 < 0.001

ibi n
d
be ro te
weed ≥ 10 0.0033 11.2 < 0.001

e ta p osa
next crop weed < 10 1 0.9 < 0.004

ef da ph
weed ≥ 10 1 0.9 < 0.004

er y ly
th tor G
Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.

ay ula the
1
As no definite scenario for railroad tracks is provided by the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

or
t m reg king
Screening Step and 1st Tier Calculator, the under crop application was considered to address uses on railroad tracks

m er see
2
Max. single application rate of 1800 g a.e./ha considered for risk calculation

do ll u tium
en a
cu nd
his fa or
f t ay ns
All exposure toxicity ratios (ETRs) for acute oral toxicity are below the respective trigger value, indicating
r o m co

acceptable risk to bumble bees following application of MON 52276 on railroad tracks.
ne ent he
ow um of t
th oc (s)

Besides uses in agricultural areas and railroad tracks MON 52276 is also used to control invasive weeds. It
of is d ber

is important to control noxious, invasive weeds to help protect our diverse native plants, natural resources,
ion , th em

and agriculture. Although some noxious weeds may serve as forage for bees and other pollinators, e.g.
iss ore m

e
rm m er

invasive knotweed species are considered valuable to many beekeepers since they bloom later in the season
pe her orm

than many other plants. However, the detrimental impacts of these invasive plants significantly outweigh
he rt t/f

their value as a pollen and nectar source.

t t Fu en
ou s. rr
th tie cu
wi par (a)

MON 52276 is applied by spot application with a maximum single application rate of 1800 g a.s/ha in a 12
f

month period. Nevertheless, bees can be exposed while they are foraging by direct overspray or dried
en ird o
nt th rty

residues on plants and by oral uptake of contaminated pollen and nectar. Thus, an appropriate risk
co and ope

assessment is presented in the following to address risk from the use of MON 52276 on invasive weeds.
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
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cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
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ep
,r
ion
ut
Table 10.3.1-33: First-tier assessment (oral exposure) of the risk for bumble bees due to the use of

t rib
MON 52276 – invasive plant species in agricultural and non-agricultural areas at 1800 g a.e./ha

dis
n,
er tio
Intended use invasive plant species in agricultural and non-agricultural areas (Uses: 8, 9)

wn lica
.
Application method downward spraying

s o ub
under crop application 1

f it y p
Crop Category

so n
Active substance glyphosate

ht , a
1 x 1800 g a.e./ha2

rig ntly
Use pattern

th ue
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e eq
Acute oral LD50 > 412 µg weeds weed < 10 1 0.46 < 0.002 0.036

e
lat ns
vio . Co
toxicity a.e./bee weed > 10 1 6.5 < 0.028

an ime al.
te reg new
field margin weed < 10 0.0092 6.5 < 0.001

oh tio re
weed > 10 0.0092 6.5 < 0.001

d
pr tec EU
adjacent crop weed < 10 0.0033 11.2 < 0.001

ibi n
d
be ro te
weed > 10 0.0033 11.2 < 0.001

e ta p osa
next crop weed < 10 1 0.9 < 0.004

ef da ph
weed > 10 1 0.9 < 0.004

er y ly
th tor G
Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.

ay ula the
1
As no definite scenario for invasive weeds is provided by the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

or
t m reg king
Screening Step and 1st Tier Calculator, under crop application: giant hogweed (Heracleum spp.), Japanese knotweed (Reynoutria

m er see
japonica)
2
Max. single application rate of 1800 g a.e./ha considered for risk calculation

do ll u tium
en a
cu nd
his fa or
f t ay ns
r o m co
All exposure toxicity ratios (ETRs) for adult chronic toxicity are below the respective trigger value,
ne ent he

indicating acceptable risk to honey bees following application of MON 52276 on invasive species in
ow um of t

agricultural and non-agricultural areas according to proposed GAP.

th oc (s)
of is d ber
ion , th em

For the Tier 1 risk assessment calculations considering the pre-sowing, pre-planting and post-harvest uses
iss ore m

the “bare soil application” scenario is selected.

rm m er
pe her orm
he rt t/f

Table 10.3.1-34: First-tier assessment (oral exposure) of the risk for bumble bees due to the use of
t t Fu en
ou s. rr

MON 52276 –pre-sowing, pre-planting and post-harvest uses at 1440 g a.e./ha

th tie cu
wi par (a)
f

Intended use Root & tuber vegetables, Bulb vegetables, Fruiting vegetables, Brassica,
en ird o
nt th rty

Leafy vegetables, Stem vegetables, Sugar beet (Uses: 1a, 2a)

co and ope

Application method downward spraying

r

ts
r i er p

Crop category bare soil application – crop attractive for pollen and nectar1
t o wn the

Active substance glyphosate

en o s
m he t i

Use pattern 1-2 x 1440 g a.e./ha2

cu f t en

ts
do s o um

Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

is ht c

Acute oral LD50 > 412 µg treated crop < 10 1 0.9 < 0.004 0.036
th rig s do

toxicity a.e./bee weeds < 10 1 0.46 < 0.002

i
e op Th

field margin < 10 0.0092 6.5 < 0.001

of y

adjacent crop < 10 0.0033 11.2 < 0.001

us c

next crop < 10 1 0.9 < 0.004

d nd
an a

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
n rty

1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
tio e
ta op

Screening Step and 1st Tier Calculator

loi pr

2
Max. single application rate of 1440 g a.e./ha considered for risk calculation
xp al
l e ctu
cia lle
er te
m s in

All exposure toxicity ratios (ETRs) for acute oral toxicity are below the respective trigger value, indicating
om a

acceptable risk to bumble bees following application of MON 52276 pre-sowing, pre-planting and post-
y c uch

harvest.
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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ro
Page 254 of 553

ep
,r
ion
ut
For the Tier 1 risk assessment calculations considering ground directed inter-row applications at a rate of

rib
1440 g a.e./ha in vegetables the following crop categories are selected:

t
dis
n,
er tio
Crop according to GAP Crop Category1

wn lica
.
s o ub
Root vegetables Root vegetables

f it y p
so n
Tuber vegetables Potatoes

ht , a
rig ntly
Bulb vegetables Bulb vegetables

th ue
e eq
Fruiting vegetables Fruiting vegetables 1, fruiting vegetables 2

e
lat ns
vio . Co
Brassica Leafy vegetables

an ime al.
te reg new
Leafy vegetables Leafy vegetables, lettuce

oh tio re

d
Stem vegetables Leafy vegetables

pr tec EU
ibi n
d
be ro te
Sugar beet Sugar beet

e ta p osa
1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

ef da ph
Screening Step and 1st Tier Calculator

er y ly
th tor G
ay ula the

or
Table 10.3.1-35: First-tier assessment (oral exposure) of the risk for bumble bees due to the use of

t m reg king
MON 52276 – fruiting, leafy and tuber vegetables at 1440 g a.e./ha

m er see
do ll u tium
en a
Intended use Fruiting vegetables, Leafy vegetables, Tuber vegetables (Uses: 1a, 2a)

cu nd
his fa or
Application method downward spraying f t ay ns
r o m co
Crop category fruiting vegetables 2, lettuce and potatoes1
ne ent he

Active substance glyphosate

ow um of t

Use pattern 1-2 x 1440 g a.e./ha2

th oc (s)

Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

of is d ber

Acute oral LD50 > 412 µg treated crop < 10 1 0.03 < 0.001 0.036
ion , th em

toxicity a.e./bee ≥ 70 1 0 < 0.001

iss ore m

e
rm m er

weeds < 10 1 6.5 < 0.023

pe her orm

≥ 70 0.3 6.5 < 0.007

he rt t/f
t t Fu en

field margin < 10 0.0092 6.5 < 0.001

ou s. rr

≥ 70 0.0092 6.5 < 0.001

th tie cu
wi par (a)

adjacent crop < 10 0.0033 11.2 < 0.001

f

≥ 70 0.0033 11.2 < 0.001

en ird o
nt th rty

next crop < 10 1 0.9 < 0.004

co and ope

≥ 70 1 0.9 < 0.004

r

ts
r i er p

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
t o wn the

1 Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
en o s
m he t i

Screening Step and 1st Tier Calculator, e.g. fruiting vegetables 2 = tomatoes, eggplants
cu f t en

ts

2 Max. single application rate of 1440 g a.e./ha considered for risk calculation
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 255 of 553

ep
,r
ion
ut
Table 10.3.1-36: First-tier assessment (oral exposure) of the risk for bumble bees due to the use of

t rib
MON 52276 – Brassica, leafy, stem, root, fruiting vegetables at 1440 g a.e./ha

dis
n,
er tio
Intended use Root vegetables, Fruiting vegetables, Brassica,

wn lica
.
Leafy vegetables, Stem vegetables (Uses: 1a, 2a)

s o ub
downward spraying

f it y p
Application method
leafy vegetables, root vegetables and fruiting vegetables 11

so n
Crop category

ht , a
glyphosate

rig ntly
Active substance
1-2 x 1440 g a.e./ha2

th ue
Use pattern

e eq
Test design Endpoint Scenario BBCH Ef SV ETR Trigger

e
lat ns
(lab.)

vio . Co
an ime al.
Acute oral LD50 > 412 µg treated crop < 10 1 0.9 < 0.004 0.036

te reg new
toxicity a.e./bee ≥ 70 1 0 < 0.001

oh tio re

d
pr tec EU
weeds < 10 1 6.5 < 0.023

ibi n
d
be ro te
≥ 70 0.3 6.5 < 0.007

e ta p osa
field margin < 10 0.0092 6.5 < 0.001

ef da ph
≥ 70 0.0092 6.5 < 0.001

er y ly
th tor G
adjacent crop < 10 0.0033 11.2 < 0.001

ay ula the
≥ 70 0.0033 11.2 < 0.001

or
t m reg king
next crop < 10 1 0.9 < 0.004

m er see
≥ 70 1 0.9 < 0.004

do ll u tium
en a
Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
1
Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

cu nd
his fa or
f t ay ns
Screening Step and 1st Tier Calculator, e.g. leafy vegetables: artichokes, asparagus, cabbages and other brassicas, cauliflowers and
r o m co
broccoli, chicory roots, spinach; root vegetables: anise, badian, fennel, corian, carrots, turnips for fodder, viper´s grass; fruiting
ne ent he

vegetables 1: chillies, peppers, cucumbers, gherkins, pumpkins, squash, gourds, melon, watermelons
ow um of t

2
Max. single application rate of 1440 g a.e./ha considered for risk calculation
th oc (s)
of is d ber
ion , th em
iss ore m

Table 10.3.1-37: First-tier assessment (oral exposure) of the risk for bumble bees due to the use of
e
rm m er

MON 52276 - bulb vegetables at 1440 g a.e./ha

pe her orm
he rt t/f
t t Fu en

Intended use Bulb vegetables (Uses: 1a, 2a)

ou s. rr
th tie cu

Application method downward spraying

wi par (a)

Crop category bulb vegetables1

f
en ird o

Active substance glyphosate

nt th rty

Use pattern 1-2 x 1440 g a.e./ha2

co and ope

Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

r

ts
r i er p
t o wn the

Acute oral LD50 > 412 µg treated crop < 10 1 0.9 < 0.004 0.036
toxicity a.e./bee ≥ 70 1 0 < 0.001
en o s
m he t i
cu f t en

ts

weeds < 10 1 6.5 < 0.023

do s o um

≥ 70 0.6 6.5 < 0.014

is ht c
th rig s do

field margin < 10 0.0092 6.5 < 0.001

i

≥ 70 0.0092 6.5 < 0.001

e op Th

adjacent crop < 10 0.0033 11.2 < 0.001

of y

≥ 70 0.0033 11.2 < 0.001

us c
d nd

next crop < 10 1 0.9 < 0.004

an a

≥ 70 1 0.9 < 0.004

n rty
tio e

Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.
ta op

1 Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA
loi pr
xp al

Screening Step and 1st Tier Calculator, e.g. bulb vegetables: garlic, leeks and other alliaceous vegetables, onions
l e ctu

2 Max. single application rate of 1440 g a.e./ha considered for risk calculation
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 256 of 553

ep
,r
ion
ut
Table 10.3.1-38: First-tier assessment (oral exposure) of the risk for bumble bees due to the use of

t rib
MON 52276 - sugar beet at 1440 g a.e./ha

dis
n,
er tio
Intended use Sugar beet (Uses: 1a, 2a)

wn lica
.
Application method downward spraying

s o ub
sugar beet1

f it y p
Crop category

so n
Active substance glyphosate

ht , a
1-2 x 1440 g a.e./ha2

rig ntly
Use pattern

th ue
Test design Endpoint (lab.) Scenario BBCH Ef SV ETR Trigger

e eq
Acute oral LD50 > 412 µg treated crop < 10 1 0.9 < 0.004 0.036

e
lat ns
vio . Co
toxicity a.e./bee ≥ 70 1 0 < 0.001

an ime al.
te reg new
weeds < 10 1 6.5 < 0.023

oh tio re
≥ 70 0.25 6.5 < 0.006

d
pr tec EU
field margin < 10 0.0092 6.5 < 0.001

ibi n
d
be ro te
≥ 70 0.0092 6.5 < 0.001

e ta p osa
adjacent crop < 10 0.0033 11.2 < 0.001

ef da ph
≥ 70 0.0033 11.2 < 0.001

er y ly
th tor G
next crop < 10 1 0.9 < 0.004

ay ula the

or
≥ 70 1 0.9 < 0.004

t m reg king
Ef: exposure factor; SV: shortcut value; ETR: exposure toxicity ratio.

m er see
1 Crop category chosen according to the recommendations of the EFSA GD on the Risk Assessment on Bees (2013) and the EFSA

do ll u tium
en a
Screening Step and 1st Tier Calculator
2 Max. single application rate of 1440 g a.e./ha considered for risk calculation

cu nd
his fa or
f t ay ns
r o m co
ne ent he

All exposure toxicity ratios (ETRs) for acute oral toxicity are below the respective trigger value, indicating
ow um of t

acceptable risk to bumble bees following application of MON 52276 in vegetables.

th oc (s)
of is d ber
ion , th em

Solitary bees
iss ore m

e
rm m er

In consideration of the recommendations of the “Technical report on the outcome of the pesticides peer
pe her orm

review meeting on general recurring issues in ecotoxicology”31 currently no risk assessment for solitary
he rt t/f
t t Fu en

bees is required, given that the EFSA Guidance Document on the risk assessment of plant protection
ou s. rr
th tie cu

products on bees has not yet been noted. Furthermore, EFSA stated that it cannot be recommended to
wi par (a)

routinely perform a risk assessment for solitary bees. Nevertheless, an acute contact study for solitary bees
f
en ird o

is available and a corresponding risk assessment is presented.

nt th rty
co and ope
r

Details of the studies with Osmia bicornis and glyphosate are summarised in the Document M-CA, Section
ts
r i er p
t o wn the

8, point 8.3.1 and relevant endpoints for the risk assessment are provided in the table below.
en o s
m he t i
cu f t en

ts
do s o um

Table 10.3.1-39: Endpoints and effect values of glyphosate relevant for the risk assessment for
is ht c

bees
th rig s do
i
e op Th

Acute toxicity
of y
us c
d nd

Reference Test item Species Test design/ LD50 NOED

an a
n rty

GLP (μg a.e./bee) (μg a.e./bee)

tio e
ta op

, 2017b Glyphosate Acute contact, ≥ 461

loi pr

Osmia > 461

xp al

bicornis 48 h
l e ctu

CA 8.3.1.1.2/009 K-salt
cia lle
er te
m s in
om a
y c uch
an ts s
an righ

31
Technical report on the outcome of the pesticides peer review meeting on general recurring issues in
d
ing to

ecotoxicology, provided by EFSA, published December 22, 2015

sh ct
bli bje
pu su
or be

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Further testing with the representative product MON 52276 and the toxicity to Osmia bicornis was not

rib
considered necessary and the risk assessment will be conducted on the active substance data.

t
dis
n,
er tio
Risk assessment for solitary bees

wn lica
.
s o ub
f it y p
The risk assessment for the proposed uses of MON 52276 and the effects on solitary bees is provided below.

so n
ht , a
rig ntly
Table 10.3.1-40: Screening assessment of the risk of glyphosate for solitary bees due to the use of

th ue
MON 52276

e eq
e
lat ns
vio . Co
an ime al.
Intended use All uses (Uses: 1a-10c)

te reg new
Application method downward spraying

oh tio re

d
Active substance glyphosate

pr tec EU
ibi n
d
Use pattern 1-2 x 1800 g a.e./ha,

be ro te
e ta p osa
1-2 x 1440 g a.e./ha,

ef da ph
1-3 x 1080 g a.e./ha,

er y ly
th tor G
1-3 x 720 g a.e./ha,

ay ula the
1 x 540 g a.e./ha

or
t m reg king
Type design LD50 (g a.e./bee) Max. single application rate HQcontact Trigger

m er see
(g a.e./ha) criterion

do ll u tium
en a
1800 < 3.9 8

cu nd
his fa or
Adult acute contact > 461 1440 f t ay ns
r o m co < 3.1
toxicity 1080 < 2.3
ne ent he
ow um of t

720 < 1.6

th oc (s)

540 < 1.2

of is d ber
ion , th em

HQcontact: Hazard quotient for contact exposure

iss ore m

e
rm m er
pe her orm

The hazard quotients (HQ) for acute contact toxicity are above the respective trigger value for the
he rt t/f
t t Fu en

application rates of 540 g a.e./ha, 720 g a.e./ha, 1080 g a.e./ha, 1440 g a.e./ha and 1800 g a.e./ha. Therefore,
ou s. rr
th tie cu

no Tier 1 risk assessment is required.

wi par (a)
f
en ird o

Currently no official OECD test guideline considering oral toxicity to solitary bees is available. Thus, no
nt th rty
co and ope

study was conducted. However, comparison of the available acute contact data indicated that solitary bees
r

ts
r i er p

did not show a higher sensitivity towards glyphosate. Therefore, the presented risk assessment considers
t o wn the

that oral exposure of honey bees and bumble bees should be protective for solitary bees.
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do

Indirect Effects on bees via Trophic Interactions

The ecotoxicology regulatory studies database for glyphosate includes a battery of acute and chronic
i
e op Th

guideline studies, designed to assess the potential for direct effects to bees, covering a range of life stages
of y

and different bee species.

us c
d nd
an a

The following approach has been taken to assess potential indirect effects via trophic interactions considers
n rty
tio e

the proposed Specific Protection Goals drawn from the existing EU guidance and working documents, and
ta op
loi pr

the 2016 EFSA Guidance on developing protection goals for ecological risk assessments (ERA) for
xp al

pesticides. The SPGs based on direct effects assessment considering representative sensitive populations
l e ctu
cia lle

across the tested trophic levels.

er te
m s in
om a

Currently, specific protection goals (SPGs) for bees have not been adopted. However, for the purpose of
y c uch

this biodiversity assessment, three SPGs have been developed (Table 10-41).
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Concerning specifically potential impacts on biodiversity, there currently is no EU wide guidance on how

rib
this should be assessed at the taxa group level within the context of a single active substance renewal risk

t
dis
assessment.

n,
er tio
wn lica
.
The first SPG is derived from the Plant Protection Product (PPP) regulations to achieve no significant effect

s o ub
f it y p
on honeybee colony survival and development. The second SPG is aimed at protection of pollination

so n
services and production of hive products. The third SPG is aimed at protecting bee biodiversity.

ht , a
rig ntly
th ue
The submitted risk assessment for direct effects considering the proposed GAP, is based on the existing

e eq
e
lat ns
EPPO and EFSA approaches (section 10.3.1). This has concluded low to negligible acute and chronic risk

vio . Co
an ime al.
to larval and adult bees from direct effects and no risk mitigation measures are considered necessary.

te reg new
oh tio re

d
Further information on the biodiversity assessment for glyphosate may be found in the [doc number]

pr tec EU
ibi n
accompanying this dossier submission.

d
be ro te
e ta p osa
ef da ph
Indirect effects assessment for Bees

er y ly
th tor G
Indirect effects to bees, resulting from reduction of off-crop pollen and nectar sources, may be mitigated

ay ula the
through required no-spray buffer zones implemented to protect non-target terrestrial plant (NTTP)

or
t m reg king
communities (Section 10.6).

m er see
do ll u tium
en a
Indirect effects to bees may potentially result from reducing pollen and nectar sources by control of in-crop

cu nd
his fa or
flowering weeds. However, a recent analysis of the likelihood of indirect effects by reduction of in-crop
f t ay ns
flowering weeds shows that indirect effects are unlikely to occur because of the relatively low amount of
r o m co
ne ent he

flowering weeds in-crop (Last et al., 2019). This data was derived from herbicide efficacy trial control data
ow um of t

from a range of arable crops (sunflower, maize, oilseed rape, cereals, sugar beet, potatoes, peas and beans)
th oc (s)

as well as some permanent crops (orchards, citrus and grapes) and from a large data set on the presence of
of is d ber

weed species within trial plots. Relevant information was extracted from the efficacy data with the intention
ion , th em
iss ore m

of demonstrating that, for some crops, the occurrence of attractive flowering weeds in treated fields is
e
rm m er

relatively rare and constitutes < 10 % of the area of use, thereby highlighting that the presence of bee weeds
pe her orm

in the treated field scenario, is not applicable for many commercially grown crops.
he rt t/f
t t Fu en
ou s. rr
th tie cu

Ecotoxicological relevance of monitoring data for glyphosate residues in honey and pollen
wi par (a)

The duration of exposure of honey bees to glyphosate in the environment will be transient and of limited
f
en ird o

duration. The reason for this is that only a small proportion of weeds in the field will be flowering at the
nt th rty
co and ope

time of application (Last et al., 2019) and flowering weeds that are sprayed – for example in crop inter-row
r

applications, in recently emerged crops, will rapidly wilt and their flowers will no longer be attractive to
ts
r i er p
t o wn the

bees (Thompson et al., 2014). In addition, levels of glyphosate in nectar and honey will rapidly decline
en o s
m he t i

with 50 % of initial levels after only 1 to 2 days (Thompson et al., 2014).

cu f t en

ts
do s o um
is ht c

Laberge et al., (1997) measured glyphosate levels in nectar and pollen in a field study conducted in an agro-
th rig s do

forestry environment. For this study, hives were placed within or at various distances from treated sites.
i
e op Th

Detectable residues of glyphosate were observed in approximately 50 % of the pollen samples and 3 of 9
of y

honey samples, with maximal residues of 8.2 mg a.e./kg in pollen sampled 3 days post-treatment from a
us c

hive situated directly within the treated area. Based on their risk assessment, Laberge et al., (1997)
d nd
an a

concluded that risks associated with glyphosate were negligible.

n rty
tio e
ta op
loi pr

Data, on the frequency of detection and the level of glyphosate in honey, are summarized within the EFSA
xp al

residue database. These data show a 10 % frequency of detection (42 out of 406 samples), with a maximum
l e ctu
cia lle

level detected of 0.61 ppm and an average of 0.09 ppm (minimum LOQ of 0.01 ppm and max LOQ of 0.14
er te
m s in

ppm).
om a
y c uch

Another representative honey residue study was conducted by the US FDA with an LC-MS/MS assay
an ts s

(Chamkasem and Vargo, 2017). Their validated assay had an LOQ = 16 µg/kg, and 9 of 16 samples bought
an righ

from a local market had glyphosate > LOQ. Of these, the median concentration of glyphosate was 0.026
d
ing to
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or be

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ppm with a range of 0.017 to 0.121 ppm. Low levels of glyphosate in honey were likely as the outcome of

rib
processing of the nectar by the bee’s, limited exposure to glyphosate in the environment, and/or dilution

t
dis
with untreated nectar in the hive.

n,
er tio
wn lica
.
Additional studies in the literature report similar residues in honey and have been summarized in Vicini et

s o ub
f it y p
al., (2020). The results of these monitoring studies demonstrate low environmental exposures to glyphosate

so n
and the conservative nature of the exposure values used for glyphosate exposure assessment for bees.

ht , a
rig ntly
th ue
e eq
e
lat ns
Scientific Literature that informs the bee assessment

vio . Co
an ime al.
The potential for adverse effects of glyphosate and Roundup to honey bees have been extensively tested in

te reg new
colony level feeding studies (Ferguson, 1987, 1988; Burgett and Fisher, 1990; Thompson et al, 2014). The

oh tio re

d
first colony feeding study was performed in Australia and found no significant effects to larval and adult

pr tec EU
ibi n
honey bees after six consecutive days of whole-hive exposure to 5 mg a.e./kg sucrose solution (Ferguson,

d
be ro te
e ta p osa
1987; Ferguson, 1988). Ferguson concluded from her study that glyphosate could be safely used around

ef da ph
honey bee hives. Further, Ferguson reported that levels for a range of pesticides rapidly decline in nectar

er y ly
th tor G
and pollen, with > 90 % dissipation in 3 to 4 days after spraying. Similar results, showing a rapid decline

ay ula the
of glyphosate residues in nectar and pollen, were also reported by Thompson et al. (2014). This rapid

or
t m reg king
decline of glyphosate residues in nectar and pollen greatly limits exposure of honey bee colonies to

m er see
glyphosate.

do ll u tium
en a
cu nd
his fa or
These original findings by Ferguson were supported by colony feeding trials conducted by two well-
f t ay ns
established apicultural experts, Burgett and Fisher, from Oregon State University (Burgett and Fisher,
r o m co
ne ent he

1990). In their first honey bee colony feeding study, colonies were fed Roundup in sucrose solution at a
ow um of t

concentration that was 100 to 1000 times above worst-case glyphosate exposure levels reported by
th oc (s)

Thompson et al. (2014). No significant effects were observed to honey bee adults or brood production after
of is d ber

42 days of observation, which is an indicator of no effects to egg production, egg laying and brood
ion , th em
iss ore m

maintenance. In their second whole-hive study, blooming bee-attractive vegetation adjacent to the hives
e
rm m er

were treated at 6.8 kg a.e./ha. As with the colony feeding study, there were no effects to adult honey bee or
pe her orm

brood production over the 42-day post-application period. These earlier findings are supported by a more
he rt t/f
t t Fu en

recently published colony feeding study followed international guidance for honey bee testing (OECD
ou s. rr
th tie cu

guidance document 75) and this study was found to be acceptable for risk assessment in the recent
wi par (a)

glyphosate Annex 1 renewal (Thompson et al, 2014). Thompson et al. demonstrated no effect to larval
f
en ird o

development, growth and survival and adult survival at glyphosate concentrations of 75, 150 and 300 mg
nt th rty
co and ope

a.e./L.
r

ts
r i er p
t o wn the

All of the other bee effect studies reviewed in the literature did not measure effects on survival, growth,
en o s
m he t i

development, or reproduction with the exception of one study that evaluated effects on survival after an
cu f t en

ts
do s o um

extreme challenge with the opportunistic pathogen Serratia marcescens (Motta et al. 2018). The relevance
is ht c

of the laboratory study conducted by Motta et al. is questionable because of the relatively high exposure
th rig s do

levels (10 mg a.e./L) and artificial nature of the study.

i
e op Th
of y

Assessment
us c

After a through literature review and considering all recent guidance, the approach taken, aimed to assess
d nd
an a

potential indirect effects via trophic interactions and the impact on biodiversity for bees including Apis and
n rty
tio e

non-Apis bee species, using a flexible framework that informs the development of risk mitigation options
ta op
loi pr

to achieve the specific protection goals.

xp al
l e ctu
cia lle

In the following table, the specific protection goals relevant to bees / pollinators are presented with the
er te
m s in

relationship between the SPGs, the direct effects study types, assessment and measurement endpoints. The
om a

assessment endpoint is an explicit expression of an environmental entity and the specific property of that
y c uch

entity to be protected. Measurement endpoints relates directly to the effects study endpoints. A conclusion
an ts s

that a given data requirement has been satisfied, requires that an acceptable level of risk has been achieved
an righ
d
ing to
sh ct
bli bje
pu su
or be

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(i.e. there is a protective margin of exposure or through a weight of evidence) and if necessary through the

rib
application of standard mitigation measures as recognised at the EU level.

t
dis
n,
er tio
Based on the measurement endpoints from the study types, and the direct effects assessment presented

wn lica
.
above in this section, it is anticipated that for the proposed uses on the GAP table, that there will be no

s o ub
f it y p
indirect effects on bee populations in terms of loss of foraging habitat that is not protected by the required

so n
in-field buffer distance required to support the non-target terrestrial plant – direct effects risk assessment,

ht , a
rig ntly
required to meet the specific protection goal for NTTPs which will also support bees, given the limited

th ue
relevance to bees of weed species found in-field.

e eq
e
lat ns
vio . Co
an ime al.
Table 10.3.1-41: The relationship between Specific Protection Goals, assessment and measurement

te reg new
endpoints for bees from contact and dietary exposure.

oh tio re

d
pr tec EU
ibi n
d
Specific Protection Assessment Endpoints Measurement Endpoints Study Types

be ro te
e ta p osa
Goals

ef da ph
No significant effect on Population size and stability Adult and larval survival Adult honeybee acute

er y ly
th tor G
honeybee colony of managed bees and larval emergence Adult Bumble bee acute

ay ula the
survival and Adult solitary bee acute

or
t m reg king
development. Adult honeybee chronic
Larval honeybee emergence

m er see
Pollination services and Population size and stability Adult and larval survival Honeybee semi-field brood

do ll u tium
en a
production of hive of native and commercially and larval emergence study

cu nd
his fa or
products managed bees and quantity
f t ay ns
and quality of honeybee
r o m co
ne ent he

hive products.
ow um of t

Bee Biodiversity Species richness and Adult and larval survival

th oc (s)
of is d ber

abundance and larval emergence

ion , th em
iss ore m

e
rm m er

Bee Biodiversity Assessment

pe her orm

The direct effects assessment demonstrates negligible acute and chronic risk to adult and larval bees and is
he rt t/f

protective of effects at the population level. Indirect effects to bee populations from in-crop weed control is
t t Fu en

unlikely because in-crop flowering weeds are not a significant resource for nectar and honey and the off-crop
ou s. rr
th tie cu

NTTP community will be protected by in-crop no spray zones. Taken together, impacts on bee biodiversity from
wi par (a)

the intended uses of glyphosate and following the required risk mitigation measures, impacts to bee biodiversity
f
en ird o

are unlikely.
nt th rty
co and ope
r

ts
r i er p
t o wn the

Conclusion
en o s
m he t i
cu f t en

ts

Glyphosate is a critical tool to enable conservation tillage systems, which can greatly improve water quality
do s o um
is ht c

in agroecosystems by reducing sediment and nutrient run-off. Negligible risk of direct effects to bee
th rig s do

biodiversity is supported by measures of glyphosate residues in honey from monitoring programs. Indirect
i
e op Th

effects from in-crop weed control is unlikely to impact bee populations because in-crop flowering weeds
of y

are not a significant resource for nectar, pollen and honey. In addition, the off-crop NTTP community will
us c

be protected by in-crop no-spray zones as a required mitigation. Taken together, impacts on bee biodiversity
d nd
an a

from the intended uses of glyphosate and following the required risk mitigation measures, impacts to bee
n rty
tio e

biodiversity are unlikely.

ta op
loi pr
xp al

Examples of the standard mitigation measures considered applicable at the EU level are presented in the
l e ctu
cia lle

following table. Many of these have been considered in the current dossier submission.
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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,r
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Table 10.3.1-42: Examples of standard mitigation measures as described in MAgPIE (2017) across

t rib
the various Member States to mitigate effects of glyphosate on biodiversity.

dis
n,
er tio
Type of Mitigation Risk Mitigation Benefits Glyphosate renewal dossier (2020)

wn lica
.
Measure Measure

s o ub
Restrictions or Application rate, Lower transfers to

f it y p
Significant reductions (50 % in volume)

so n
modifications of Application frequency, groundwater and surface in newly proposed application rates

ht , a
products’ conditions application timing, water; Reduces exposure compared with the representative use

rig ntly
of application and interval between of organisms in-crop and presented in the 2012 renewal dossier.

th ue
e eq
applications off-crop. See 32Appendix 2 of the biodiversity

e
lat ns
document accompanying this

vio . Co
an ime al.
submission.

te reg new
oh tio re

d
Treated area restriction

pr tec EU
ibi n
10. for the representative use GAPs:

d
be ro te
e ta p osa
applying to only 50 % of the total area in

ef da ph
orchard/vineyard area.

er y ly
11. maximum of 50 % of the total

th tor G
ay ula the
area for broad acre vegetable inter-row

or
t m reg king
12. Invasive species control e.g.,
couch grass – maximum of 20 % of the

m er see
cropland + extended application

do ll u tium
en a
intervals.

cu nd
his fa or
f t ay ns
r o m co
Limited frequency and timing of
ne ent he

application: 28-day interval between

ow um of t

applications and no pre-harvest

th oc (s)

applications
of is d ber
ion , th em

Application Spray drift reduction Reduces exposure of Reduction of spray drift to the off-field:
iss ore m

equipment nozzles (SDRN), organisms in-crop 7. Use 75 % drift reducing nozzles for pre-
rm m er
pe her orm

with Spray Drift shields, (precision treatment) and sowing/pre-planting in arable crops.
he rt t/f

Reduction Precision treatment, off-crop 8. Use of ground directed, shielded spray

t t Fu en

Technology (SDRT) etc. for band application in orchards /

ou s. rr
th tie cu

vineyards and broad-acre vegetable

wi par (a)

inter-row application.
f
en ird o

Buffer zones Non-sprayed zone at Reduces exposure of

nt th rty

Establishment of buffer zones:

co and ope

the edge of a crop organisms and off-crop Buffer zones of varying size (depending on
r

the type of SDRT) are required as

ts
r i er p
t o wn the

protection for off-crop NTTP communities

en o s

from spray drift.

m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th

For example;
- Reductions in maximum annual application rates of up to 50 % considered in this dossier are
of y

compared to the maximum rates applied for in the 2012 Annex I renewal dossier.
us c
d nd

o In 2012, the maximum annual application rate was 4.32 kg/ha.

an a
n rty

o In the current dossier submission, the maximum annual application rate is 2.16 kg/ha
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s

32
an righ

(2020) Glyphosate: Indirect effects via trophic interaction - A Practical Approach to

Biodiversity Assessment (TRR0000305).
d
ing to
sh ct
bli bje
pu su
or be

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,r
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- Reducing the total area being applied on a per hectare basis for certain uses, will reduce the total

rib
volume of product being applied to the landscape.

t
dis
o For example, controlling actively growing weeds in vineyards, orchards where a reduced

n,
er tio
area, up to a maximum of 50 % of the total application area is proposed e.g. using strip or

wn lica
.
band applications. Applications on target weeds around the base of trees within tree rows,

s o ub
f it y p
leaving the area between tree rows unsprayed, which is typically managed using

so n
mechanical methods.

ht , a
rig ntly
th ue
- The use of shielded or hooded sprayers, hand-held sprayers and drift reducing technologies, e.g.

e eq
e
lat ns
75 % drift reducing nozzles are recommended for all applications made for the control of actively

vio . Co
an ime al.
growing weeds when applied to control invasive species. These measures will further reduce the

te reg new
off-target exposure risk.

oh tio re

d
pr tec EU
ibi n
- For weed control on rail tracks, recommendations are made in the GAP table to use precision

d
be ro te
e ta p osa
application equipment on spray trains, that detect and targets spray directly onto unwanted plants,

ef da ph
thereby reducing the amount of product being applied, whilst maintaining an acceptable level of

er y ly
th tor G
safety on the railways.

ay ula the

or
t m reg king
- No spray-buffer areas in-field are considered necessary to meet the specific protection goals for

m er see
avoiding direct effects on non-target plants in off-target areas. This measure will in turn support

do ll u tium
en a
non-target arthropod communities, including beneficial insects such as the pollinators, in off-field

cu nd
his fa or
areas and reduces further, the potential for indirect effects on bees through trophic interaction.
f t ay ns
r o m co
ne ent he

In addition to the standard mitigation measures, ‘non-standard mitigation measures’ could also be
ow um of t

considered where a local and specific mitigation need is identified. For example, in simplified landscapes
th oc (s)

or landscapes that are intensively managed, where typically there are limited refuge areas for insects, birds
of is d ber

and mammals. Non-standard mitigation measures options could include for example, creation of off-target
ion , th em
iss ore m

habitats, utilizing edge of field habitats and semi-field habitats that assist biodiversity by improving wildlife
e
rm m er

connectivity.
pe her orm
he rt t/f
t t Fu en

For further information on mitigation measures pleased refer to the supplementary information document33
ou s. rr
th tie cu

titled ‘Glyphosate: Indirect Effects via Trophic Interaction – A Practical Approach to Biodiversity
wi par (a)

Assessment.’ (DOC No.) that accompanies this dossier submission.

f
en ird o
nt th rty
co and ope

References for the Indirect Effects via Trophic Interaction Section

r

ts
r i er p
t o wn the

Burgett M, Fisher G. 1990. A review of the Belizean honey bee industry: Final report prepared at the request
en o s
m he t i

of The Belize Honey Producers Federation. Department of Entomology, Oregon State University, Corvallis,
cu f t en

ts
do s o um

Oregon.
is ht c
th rig s do

Chamkasem N, JD Vargo. 2017. Development and independent laboratory validation of an analytical

i
e op Th

method for the direct determination of glyphosate, glufosinate, and aminomethylphosphonic acid in honey
of y

by liquid chromatography/tandem mass spectrometry. J Reg Sci 5:1-9.

us c
d nd
an a

Ferguson F. 1987. Interim report. Long term effects of systemic pesticides on honey bees. The Australian
n rty
tio e

Beekeeper (September issue). Pages: 49-53.

ta op
loi pr
xp al

Laberge L, Legris J, Couture G. 1997. Glyphosate residues in pollen and honey after applications in an
l e ctu
cia lle

agro-forest environment. Draft Report Ministere des Ressources naturelles du Quebec, Direction de
er te
m s in

lenvironement forestier Quebec.

om a
y c uch
an ts s
an righ

33
(2020) Glyphosate: Indirect effects via trophic interaction - A Practical Approach to
d
ing to

Biodiversity Assessment (TRR0000305).

sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
,r
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ut
Last G, Lewis G and G Pap. 2019. Regulatory report on the occurrence of flowering weeds in agricultural

rib
fields. Sponsored by the European Crop Protection Association. ERM report number (submitted upon

t
dis
request).

n,
er tio
wn lica
.
Motta Erick V S; Raymann Kasie; Moran Nancy A 2019 Glyphosate perturbs the gut microbiota of honey

s o ub
f it y p
bees. Proceedings of the National Academy of Sciences of the United States of America, (20181009) Vol.

so n
115, No. 41, pp. 10305-10310.

ht , a
rig ntly
th ue
Thompson HM, Levine SL, Doering J, Norman S, Manson P, Sutton P, G von Mérey. 2016. Evaluating

e eq
e
lat ns
exposure and potential effects on honeybee brood (Apis mellifera) development using glyphosate as an

vio . Co
an ime al.
example. Integr. Environ Assess Manag. 10(3):463-70.

te reg new
oh tio re

d
pr tec EU
ibi n
d
CP 10.3.1.1 Acute toxicity to bees

be ro te
e ta p osa
ef da ph
CP 10.3.1.1.1 Acute oral toxicity to bees

er y ly
th tor G
ay ula the

or
1. Information on the study

t m reg king
m er see
Data point: CP 10.3.1.1.1/001

do ll u tium
en a
Report author

cu nd
his fa or
Report year 2001 f t ay ns
r o m co

Report title Laboratory bioassays to determine acute oral and contact toxicity of
ne ent he
ow um of t

MON 52276 to the honeybee, Apis mellifera

th oc (s)

Report No MON-00-2 version 2

of is d ber
ion , th em

Document No -
iss ore m

EPPO Guideline on test methods for evaluating the side-effects of

rm m er

Guidelines followed in study

pe her orm

plant protection products on honeybees. No. 170 (1992).

he rt t/f
t t Fu en

Deviations from current test Deviations from the current guideline OECD 213 (1998):
ou s. rr
th tie cu

guideline Major:
wi par (a)

- none
f
en ird o

Minor:
nt th rty
co and ope

- 3 to 4 hours starvation instead of 1 to 2 hours recommended

r

- Humidity was slightly outside the expected range: 46 – 83%

ts
r i er p
t o wn the

instead of 50 – 70 %
en o s

- 4 hours assessment was not carried out

m he t i
cu f t en

ts

These deviations are not expected to have a negative impact on the

do s o um
is ht c

validity of the study which was valid at the time of conduct.

th rig s do

Previous evaluation Yes, accepted in RAR (2015)

i
e op Th

GLP/Officially recognised Yes

of y

testing facilities
us c
d nd

Valid
an a

Acceptability/Reliability
n rty
tio e

Category study in AIR 5 Category 2a

ta op
loi pr

dossier (L docs)
xp al
l e ctu
cia lle
er te
m s in

2. Full summary
om a
y c uch

Executive Summary
an ts s

The acute oral toxicity of the formulated product MON 52276 to worker bees (Apis mellifera L.) was
an righ

determined in a limit test at the nominal dose of 103 µg glyphosate isopropylamine/bee (a.s.), equivalent to
d
ing to

77 µg glyphosate acid equivalent/bee (a.e.) for oral exposure. Bees were also exposed to dimethoate at
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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concentrations from 0.075 to 0.3 µg dimethoate/bee (reference toxicant group) or to an aqueous sucrose

rib
solution (negative control). The test comprised 5 replicate groups of 10 bees for the test treatments and the

t
dis
control group. Further 3 replicate cages containing each 10 bees were prepared for the reference group. Bee

n,
er tio
condition was assessed after 1, 3, 24 and 48 hours.

wn lica
.
s o ub
After 48 hours, there were no sub-lethal effects observed. Mortality did not reach or exceed 50 %. The

f it y p
control and treatment group mortality were both 4 %. All validity criteria according to OECD guideline

so n
ht , a
213 were fulfilled. In the oral test, the 48 h LD50 for honey bees exposed to MON 52276 was

rig ntly
> 103 µg a.s./bee, equivalent to > 77 µg a.e./bee, the maximum amount consumed over a 5 h period.

th ue
e eq
e
lat ns
I. MATERIALS AND METHODS

vio . Co
an ime al.
te reg new
A. MATERIALS

oh tio re

d
Test material:

pr tec EU
ibi n
d
be ro te
Test item: MON 52276

e ta p osa
ef da ph
Formulation type Soluble concentrate (SL)

er y ly
th tor G
Description: Dark yellow-coloured fluid

ay ula the

or
Active substance glyphosate isopropylamine salt

t m reg king
m er see
Lot/Batch #: 100399

do ll u tium
en a
Purity: 41.5 % w/w glyphosate isopropylamine

cu nd
his fa or
f t ay ns
30.3 % w/w glyphosate acid equivalent (measured)
r o m co

Density: 1.168 g/cm3 (nominal)

ne ent he
ow um of t

Vehicle and/or positive control: BASF Dimethoate 40 (400 g dimethoate/L)

th oc (s)
of is d ber

Test organisms:
ion , th em

Species: Honey bee (Apis mellifera L.)

iss ore m

e
rm m er

Age: Adult worker bees

pe her orm
he rt t/f

Source: Roselea Apiaries, East Wellow, Hampshire, UK

t t Fu en
ou s. rr
th tie cu

Environmental conditions:
wi par (a)

Temperature: 24 – 26 °C
f
en ird o
nt th rty

Humidity: 46 – 83 %
co and ope
r

Photoperiod: 24 h dark
ts
r i er p
t o wn the

Experimental dates: Not stated in the report

en o s
m he t i
cu f t en

ts
do s o um

B. STUDY DESIGN
is ht c
th rig s do

Experimental treatments
i
e op Th

For the oral test, the test treatments and negative control group comprised five groups of 10 bees, maintained
of y

in stainless steel coated 2 – 2.5mm wire mesh cylinders measuring 140 mm deep × 40 mm in diameter,
us c

closed by polyurethane foam bungs at both ends. For the reference toxicant, 3 groups of 10 bees were held
d nd
an a

in mesh cages of the same design, for each of the treatment groups.
n rty
tio e

Worker honey bees were collected from a queen right hive on the morning of the tests. All bees were lightly
ta op
loi pr

anaesthetised using humidified carbon dioxide and added to cages in groups of ten and allowed to recover.
xp al

Honeybees for the oral test remained unfed during recovery.

l e ctu
cia lle

In the oral test, honeybees were exposed to MON 52276 dispersed in a 50 % sucrose solution delivered to
er te
m s in

the cages using a glass feeding tube inserted through one of the polyurethane bungs. A 200 µL volume of
om a

solution was provided and assumed that each bee would consume at least 20 µL of solution over a 5 h
y c uch

exposure period. After 5 h, the feeding tube was replaced with a tube containing 50 % sucrose solution
an ts s

only, which was replenished ab libitum for the 48 h duration of the test.
an righ

The reference item group was prepared in the same way as for the treatment groups. The reference item
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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group was evaluated in two stages, the highest application rate was tested alongside the treatment and

rib
control groups, with the lower two treatment rate evaluated five days later with an additional control group

t
dis
included for comparison.

n,
er tio
All cages were maintained in the dark in an incubator for the duration of the test.

wn lica
.
s o ub
Observations

f it y p
In the oral test, the feeding vials were weighed prior to treatment and again after 5 h to establish the actual

so n
ht , a
dose per bee consumed. An assessment of the condition of the bees was made 1, 3, 24 and 48 hours after

rig ntly
treatment. The bees were classified as being live, affected, moribund/dead.

th ue
e eq
e
lat ns
Validity criteria

vio . Co
an ime al.
For a test to be valid the following conditions apply:

te reg new
 The average mortality for the total number of controls must not exceed 10 % at the end of the test.

oh tio re

d
pr tec EU
 The LD50 of the toxic standard meets the specified range.

ibi n
d
be ro te
e ta p osa
ef da ph
Statistical calculations

er y ly
Descriptive statistics only based on empirical observation. As the tests were conducted as limit tests, and

th tor G
ay ula the
not dose response tests, statistical analysis was not required.

or
t m reg king
m er see
II. RESULTS AND DISCUSSION

do ll u tium
en a
A. FINDINGS

cu nd
his fa or
The oral LD50 and NOEL values for honeybees exposed to MON 52276 are given below based on nominalf t ay ns
r o m co

concentrations.
ne ent he
ow um of t
th oc (s)

Table 10.3.1.1.1-1: Toxicity of MON 52276 to honey bees (Apis mellifera L.) in an oral toxicity test
of is d ber
ion , th em
iss ore m

Endpoints (48 h) MON 52276 MON 52276

rm m er
pe her orm

glyphosate acid equivalent [µg a.e./bee] glyphosate isopropylamine [µg a.s./bee]

he rt t/f

LD50 oral > 77 > 103

t t Fu en
ou s. rr
th tie cu

NOEL oral > 77 > 103

wi par (a)
f
en ird o
nt th rty
co and ope

B. OBSERVATIONS
r

ts
r i er p
t o wn the

The mortality in control and in the treatment groups was 4 % in the 48-hour exposure. There were no
en o s

observations of treated bees being sick or behaving abnormally.

m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
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Table 10.3.1.1.1-2: Oral toxicity of MON 52276 to honey bees (Apis mellifera L.)

t rib
dis
n,
Exposure Mortality [%] Corrected mortality2

er tio
wn lica
Control MON 52276 [%]

.
s o ub
103 µg a.s./bee1

f it y p
so n
77 µg a.e/bee1

ht , a
rig ntly
1h 0 0 -

th ue
-

e eq
3h 0 0

e
lat ns
24 h 0 0 -

vio . Co
an ime al.
te reg new
48 h 4 4 0

oh tio re

d
1
Based on mean weight of test solution of 5 µg/µL consumed per cage of 10 bees, corrected for the density of the

pr tec EU
ibi n
d
50 % w/w sugar solution

be ro te
e ta p osa
2
Corrected mortality according to Abbott (1925)

ef da ph
a.e = glyphosate acid equivalent, a.s.= glyphosate isopropylamine

er y ly
th tor G
ay ula the

or
t m reg king
For the reference group (BASF Dimethoate 40), 100 % and 33 % mortality were observed in 0.3 and

m er see
0.15 µg dimethoate/bee concentrations after 24 hours exposure, respectively. The LD50-24h was in the

do ll u tium
en a
range 0.10 – 0.35 µg a.s./bee requested in the guideline and was in line with published values (Gough et

cu nd
his fa or
al., 1994), indicating that the test insects were suitably sensitive.
f t ay ns
r o m co
ne ent he

The mortality in the control treatments did not exceed 10 %.

ow um of t

All the validity criteria according to guideline OECD 213 were therefore fulfilled.
th oc (s)
of is d ber

The following points are deviated from the current guideline but are not expected to have any negative on
ion , th em
iss ore m

the study validity:

e
rm m er

- 3 to 4 hours starvation instead of 1 to 2 hours recommended.

pe her orm

- Humidity was slightly outside the expected range: 46 – 83 % instead of 50 –70 %.

he rt t/f
t t Fu en

- 1 and 3 hours assessments were carried out instead of the 4 hours requested.
ou s. rr
th tie cu
wi par (a)

III. CONCLUSION
f
en ird o
nt th rty
co and ope

Assessment and conclusion by applicant:

r

ts
r i er p

The LD50 (48 h) for honey bees exposed to MON 52276 was determined to be > 103 µg a.s./bee,
t o wn the

equivalent to > 77 µg a.e./bee for oral exposure.

en o s
m he t i
cu f t en

ts
do s o um

This study is considered valid and suitable for risk assessment purposes.
is ht c
th rig s do
i
e op Th

Assessment and conclusion by RMS:

of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
It
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cti
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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Page 267 of 553

ep
,r
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CP 10.3.1.1.2 Acute contact toxicity to bees

t rib
dis
n,
1. Information on the study

er tio
wn lica
.
Data point CP 10.3.1.1.2/001

s o ub
f it y p
Report author

so n
ht , a
Report year 2001

rig ntly
th ue
Report title Laboratory bioassays to determine acute oral and contact toxicity of

e eq
MON 52276 to the honeybee, Apis mellifera

e
lat ns
vio . Co
an ime al.
Report No MON-00-2 version 2

te reg new
Document No -

oh tio re

d
pr tec EU
EPPO Guideline on test methods for evaluating the side-effects of plant

ibi n
Guidelines followed in study

d
be ro te
protection products on honeybees. No. 170. (1992).

e ta p osa
ef da ph
Deviations from current test Deviations from the current guideline OECD 214 (1998):

er y ly
th tor G
guideline Major:

ay ula the
- none

or
t m reg king
Minor:

m er see
- Humidity was slightly outside the expected range: 46 – 83 %

do ll u tium
en a
instead of 50 – 70 %

cu nd
his fa or
- 4 hours assessment was not carried out
f t ay ns
These deviations are not expected to have a negative impact on the
r o m co
ne ent he

validity of the study which was valid at the time of conduct.

ow um of t

Previous evaluation Yes, accepted in RAR (2015)

th oc (s)
of is d ber

GLP/Officially recognised Yes

ion , th em

testing facilities
iss ore m

e
rm m er

Acceptability/Reliability Yes, Valid Study

pe her orm

Category study in AIR 5 Category 2a

he rt t/f
t t Fu en

dossier (L docs)
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty

2. Full summary
co and ope

Executive Summary
r

ts
r i er p
t o wn the

The acute contact toxicity of the formulated product MON 52276, to young adult worker bees (Apis
en o s

mellifera L.) was determined in a limit test at the equivalent of a single nominal dose of 134 µg glyphosate
m he t i
cu f t en

ts

isopropylamine salt/bee, equivalent to 100 µg glyphosate acid equivalent (a.e.)/bee. Bees were also exposed
do s o um

to dimethoate at concentrations of 0.075 and 0.3 µg dimethoate/bee (reference toxicant group) or to an

is ht c
th rig s do

aqueous sucrose solution (negative control). The test comprised 5 replicate groups of 10 bees for the test
i
e op Th

treatments and the control group. Further 3 replicate cages containing each 10 bees were prepared for the
of y

reference group. Bee condition was assessed after 1, 3, 24 and 48 hours.

us c

After 48 hours, there were no sub-lethal effects observed. Mortality did not reach or exceed 50 %. After
d nd

48 hours control and treatment group mortality were 2 % and 12 % respectively. All validity criteria
an a
n rty

according to OECD guideline 214 were fulfilled.

tio e
ta op

The 48 h LD50 for honeybees exposed to MON 52276 was > 134 µg a.s./bee, equivalent to
loi pr
xp al

> 100 µg a.e./bee for contact exposure.

l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 268 of 553

ep
,r
ion
ut
I. MATERIALS AND METHODS

t rib
dis
A. MATERIALS

n,
er tio
Test material:

wn lica
.
Test item: MON 52276

s o ub
f it y p
Formulation type Soluble concentrate (SL)

so n
ht , a
Description: Dark yellow-coloured fluid

rig ntly
th ue
Active substance glyphosate isopropylamine salt

e eq
e
lat ns
Lot/Batch #: 100399

vio . Co
an ime al.
te reg new
Purity: 41.5 % w/w glyphosate isopropylamine

oh tio re

d
30.3 % w/w glyphosate acid equivalent (measured)

pr tec EU
ibi n
d
Density: 1.168 g/cm3 (nominal)

be ro te
e ta p osa
Vehicle and/or positive control: BASF Dimethoate 40 (400 g dimethoate/L)

ef da ph
er y ly
th tor G
Test organisms:

ay ula the

or
Species: Honey bee (Apis mellifera L.)

t m reg king
Age: Young adult worker bees

m er see
do ll u tium
en a
Source: Roselea Apiaries, East Wellow, Hampshire, UK

cu nd
his fa or
Environmental conditions: f t ay ns
r o m co

Temperature: 24 – 26 °C
ne ent he
ow um of t

Humidity: 46 – 83 %
th oc (s)
of is d ber

Photoperiod: 24 h dark
ion , th em
iss ore m

e
rm m er

B. STUDY DESIGN
pe her orm
he rt t/f

Experimental dates: No dates reported

t t Fu en
ou s. rr
th tie cu
wi par (a)

Experimental treatments
f

For the contact tests, the test treatments and negative control group comprised five groups of 10 bees,
en ird o
nt th rty

maintained in stainless steel coated 2 – 2.5mm wire mesh cylinders measuring 140 mm deep × 40 mm in
co and ope

diameter, closed by polyurethane foam bungs at both ends. For the reference toxicant, 3 groups of 10 bees
r

ts
r i er p

were held in mesh cages of the same design, for each of the treatment groups.
t o wn the

Worker honey bees were collected from a queen right hive on the morning of the tests. All bees were lightly
en o s
m he t i
cu f t en

ts

anaesthetised using humidified carbon dioxide and added to cages in groups of ten and allowed to recover.
do s o um

Bees for the contact test were provided with sucrose solution during the recovery period.
is ht c
th rig s do

For the contact test, the bees were again lightly anaesthetised with humidified carbon dioxide and then in
i
e op Th

groups of 10 were turned onto their back using lightweight forceps, and a 1 µL volume of test solution
(MON 52276 dispersed in 0.01 % v/v Farmon blue – used to facilitate application to the hydrophobic hairs
of y

on the thorax) was applied to the ventral thorax using a micro-applicator and the bees were returned to the
us c
d nd

cages. The bees were fed 50 % sucrose solution ad libitum via a glass feeding tube inserted through one
an a
n rty

bung for the 48 h duration of the test

tio e
ta op

The reference item group was prepared in the same way as for the treatment groups. The reference item
loi pr

group was evaluated in two stages, the highest application rate was tested alongside the treatment and
xp al
l e ctu

control groups, with the lower treatment rate evaluated five days later with an additional control group
cia lle
er te

included for comparison.

m s in

All cages were maintained in the dark in an incubator for the duration of the test.
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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ep
,r
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Observations

rib
An assessment of the condition of the bees was made 1, 3, 24 and 48 hours after treatment. The bees were

t
dis
classified as being live, affected, moribund/dead.

n,
er tio
wn lica
.
Validity criteria

s o ub
f it y p
For a test to be valid the following conditions apply:

so n
ht , a
 The average mortality for the total number of controls must not exceed 10 % at the end of the test.

rig ntly
 The LD50 of the toxic standard meets the specified range.

th ue
e eq
e
lat ns
Statistical calculations

vio . Co
an ime al.
Descriptive statistics only based on empirical observation. As the tests were conducted as limit tests, and

te reg new
not dose response tests, statistical analysis was not required.

oh tio re

d
pr tec EU
ibi n
d
be ro te
e ta p osa
II. RESULTS AND DISCUSSION

ef da ph
A. FINDINGS

er y ly
th tor G
ay ula the
The contact LD50 and NOEL values for honeybees exposed to MON 52276 are given below based on

or
t m reg king
nominal concentrations.

m er see
Table 10.3.1.1.2-1: Endpoints

do ll u tium
en a
cu nd
his fa or
Endpoints (48 h) MON 52276 f t ay ns
MON 52276
r o m co
ne ent he

glyphosate acid equivalent [µg a.e./bee] glyphosate isopropylamine [µg a.s./bee]

ow um of t

LD50 contact > 100 > 134

th oc (s)
of is d ber

NOEL contact ≥ 100 ≥ 134

ion , th em
iss ore m

e
rm m er
pe her orm

B. OBSERVATIONS
he rt t/f
t t Fu en

After 48-hour exposure, the mortality was 2 % and 6 % in the control and treatment groups, respectively.
ou s. rr
th tie cu

The corrected mortality was 4 % after 48 hours of exposure. There were no observations of treated bees
wi par (a)

being sick or behaving abnormally.

f
en ird o
nt th rty
co and ope

Table 10.3.1.1.2-2: Contact toxicity of MON 52276 to honey bees (Apis mellifera L.)
r

ts
r i er p
t o wn the

Exposure Mortality [%] Corrected mortality1

en o s
m he t i

[%]
cu f t en

ts

Control MON 52276

do s o um

134 µg a.s/bee
is ht c
th rig s do

100 µg a.e/bee
i
e op Th

1h 0 0 -
of y

3h 0 0 -
us c

-
d nd

24 h 0 0
an a
n rty

48 h 2 6 0
tio e
ta op

1
Corrected mortality according to Abbott (1925)
loi pr

a.e = glyphosate acid equivalent, a.s.= glyphosate isopropylamine

xp al
l e ctu
cia lle
er te
m s in

For the reference group (BASF Dimethoate 40), 100 % and 22 % mortality were observed in 0.3 and
om a
y c uch

0.075 µg dimethoate/bee concentrations after 24 hours exposure, respectively. The LD50-24h was in the
an ts s

range 0.10 – 0.35 µg a.s./bee requested in the guideline and was in line with published values (Gough et
an righ

al., 1994), indicating that the test insects were suitably sensitive.
The mortality in the control treatments did not exceed 10 %. The validity criteria according to guideline
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 270 of 553

ep
,r
ion
ut
OECD 214 were therefore fulfilled.

t rib
dis
n,
er tio
III. CONCLUSION

wn lica
.
s o ub
f it y p
3. Assessment and conclusion

so n
ht , a
Assessment and conclusion by applicant:

rig ntly
The contact LD50 (48 h) for honey bees exposed to MON 52276 was determined to be > 134 µg a.s./bee,

th ue
e eq
equivalent to > 100 µg a.e./bee.

e
lat ns
vio . Co
an ime al.
te reg new
This study is considered valid and suitable for risk assessment purposes.

oh tio re

d
pr tec EU
ibi n
Assessment and conclusion by RMS:

d
be ro te
e ta p osa
ef da ph
er y ly
th tor G
ay ula the

or
t m reg king
CP 10.3.1.2 Chronic toxicity to bees

m er see
Further studies with honeybees are not considered required with representative product MON 52276

do ll u tium
en a
based on the low toxicity demonstrated by the risk assessments above.

cu nd
his fa or
f t ay ns
r o m co
ne ent he

CP 10.3.1.3 Effects on honey bee development and other honey bee life stages
ow um of t
th oc (s)

Further studies with honeybees are not considered required with representative product MON 52276
of is d ber

based on the low toxicity demonstrated by the risk assessments above.

ion , th em
iss ore m

e
rm m er
pe her orm

CP 10.3.1.4 Sub-lethal effects

he rt t/f
t t Fu en

Further studies with honeybees are not considered required with representative product MON 52276
ou s. rr
th tie cu

based on the low toxicity demonstrated by the risk assessments above.

wi par (a)
f
en ird o
nt th rty
co and ope

CP 10.3.1.5 Cage and tunnel tests

r

ts
r i er p
t o wn the

Further studies with honeybees are not considered required with representative product MON 52276
en o s

based on the low toxicity demonstrated by the risk assessments above.

m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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ep
,r
ion
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1. Information on the study

t rib
dis
Data point CP 10.3.1.5/001

n,
Report author

er tio
wn lica
Report year 2011

.
s o ub
Report title Glyphosate: Study to determine potential exposure of honeybee

f it y p
colonies to residues under semi-field conditions

so n
ht , a
V7YH1002

rig ntly
Report No

th ue
Document No -

e eq
Guidelines followed in study None; tailor made study

e
lat ns
vio . Co
an ime al.
Deviations from current test

te reg new
Not applicable field study
guideline

oh tio re

d
pr tec EU
Previous evaluation Yes, accepted in RAR (2015)

ibi n
d
be ro te
GLP/Officially recognised testing Yes

e ta p osa
facilities

ef da ph
Valid

er y ly
Acceptability/Reliability

th tor G
Category 2a

ay ula the
Category study in AIR 5 dossier

or
t m reg king
(L docs)

m er see
do ll u tium
en a
2. Full summary

cu nd
his fa or
f t ay ns
Executive Summary
r o m co
ne ent he

A semi-field study was undertaken to determine the potential exposure of honeybee colonies to glyphosate
ow um of t

by quantifying residues in relevant food matrices, i.e. pollen and nectar, when the formulation MON 52276
th oc (s)

was applied to flowering Phacelia grown in two large (180 m²) glasshouses. Following treatment of
of is d ber

nominal 8 L/ha, equivalent to 2.88 kg a.e./ha, two honeybee colonies per glasshouse were exposed.
ion , th em

Foraging activity in the crop and activity at each hive was assessed daily for 7 days. On days 0, 1, 2, 3, 4
iss ore m

e
rm m er

and 7, forager bees were taken to get hold of the nectar from the honey stomach of the bees after foraging
pe her orm

in the treated crop. On days -1, 1, 2, 3, 4 and 7, samples of pollen were collected from the pollen traps fitted
he rt t/f
t t Fu en

to each hive. Samples of nectar were also collected from the combs in each hive on day 7. Furthermore,
ou s. rr
th tie cu

samples of larvae were collected from the combs in each hive on days 4 and 7. Daily assessments were
wi par (a)

made of the percentage of plants with wilted leaves or flowers.

f
en ird o

Foraging assessment showed foraging activity on the crop from start of study throughout the exposure
nt th rty
co and ope

period in glasshouse 1 with a peak on day 4. The lowest foraging activity was observed on day 5 at 38 %
r

of the mean pre-spray activity. In glasshouse 2 the activity declined throughout the assessment period to
ts
r i er p
t o wn the

reach less than 10 % of mean spray activity on days 5 – 7. In line with the decreased foraging activity in
en o s
m he t i

glasshouse 2, the crop started to show significant effects of the treatment from day 4 onwards.
cu f t en

ts

Residues in nectar samples taken from forager bees at various time points after application ranged from
do s o um
is ht c

2.78 to 31.3 mg a.e./kg; residues in nectar samples taken from the colonies ranged from below LOQ
th rig s do

(1.0 mg a.e./kg) to 1.30 mg a.e./kg. Residues in pollen samples taken from the pollen trap at various time
i
e op Th

points after application ranged from 87.2 to 629 mg a.e./kg. Residues in larvae samples ranged from 1.23
of y

to 19.50 mg a.e./kg.
us c

The residue data can be used to assess the approximate exposure level of brood within colonies exposed
d nd
an a

under worst-case conditions.

n rty
tio e

The maximum pollen collected per colony was 2.9 g on day 0 and the traps are estimated to be about 50 %
ta op
loi pr

efficient so about 6 g of pollen per day was returned to the hive (the colony is using about 4.5 g of this
xp al

based on the Rortais et al. 2005).

l e ctu
cia lle

The nectar can be assessed using a mean of 18 foragers returning to the hive per 30 seconds and
er te

approximately 50 µL per load (max), which gives 18 trips/30 sec × 60 sec/min × 60 min/hour × 12 hours
m s in
om a

max foraging/day, equal to 25,920 trips/day × 0.050 mL, resulting in 1296 mL/day (of which the colony is
y c uch

using 135 g based on Rortais et al. 2005).

an ts s

As a worst-case example considering the colony size of the present study, a honey bee colony collects 6 g
an righ

pollen and 1296 mL nectar and of this the brood consumes 4.5 g pollen and 135 g nectar, which allows the
d
ing to

excess to be stored for later consumption. As simulated in this study, for honeybee colonies foraging on the
sh ct
bli bje
pu su
or be

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model crop Phacelia treated with 8 L MON 52276/ha, a total daily intake of glyphosate residues of 44.0 mg

rib
a.e. (based on day 1 maximum mean residues) and of 22 mg a.e. (based on mean residues over days 1-3)

t
dis
can be estimated.

n,
er tio
wn lica
.
I. MATERIALS AND METHODS

s o ub
f it y p
A. MATERIALS

so n
ht , a
Test material:

rig ntly
Test item: MON 52276 (Soluble concentrate)

th ue
e eq
Active substance: Glyphosate acid

e
lat ns
vio . Co
an ime al.
360 g glyphosate acid equivalents/L (nominal)

te reg new
Active substance content: 358.8 g glyphosate acid equivalents/L (according to the

oh tio re

d
pr tec EU
Certificate of Analysis)

ibi n
d
be ro te
Proposed use: Herbicide

e ta p osa
ef da ph
Description: Clear brown liquid

er y ly
th tor G
Lot/Batch #: A9K0106104

ay ula the

or
t m reg king
1.1693 g/mL at 20 °C (according to the Certificate of
Density:

m er see
Analysis)

do ll u tium
en a
Vehicle and/or positive control: None

cu nd
his fa or
Test organism: f t ay ns
r o m co

Species: Apis mellifera L.

ne ent he
ow um of t

4 honeybee colonies containing 4 – 6 frames of brood,

th oc (s)

containing 6000 – 12000 adult bees

of is d ber
ion , th em

Age: Not stated

iss ore m

e
rm m er

Source: UK national Bee Unit

pe her orm

Acclimatisation: 3 days
he rt t/f
t t Fu en
ou s. rr

Test system: Two 180 m² glasshouses at Stockbridge Technology

th tie cu

Centre, Selby, North Yorkshire, U.K.

wi par (a)
f
en ird o

Crop cultivated: Phacelia (sown directly into soil of the glasshouse, no

nt th rty
co and ope

pesticide use during cultivation)

r

ts
r i er p

Replication: 2 glasshouses, each containing 2 bee colonies

t o wn the
en o s

Environmental conditions:
m he t i
cu f t en

ts

Temperature: Glasshouse 1:
do s o um
is ht c

7.7 – 39.9 °C, temperatures of > 35 °C were recorded on

th rig s do

day 6 and 7 for 10 and 30 min.

i
e op Th

Glasshouse 2:
of y

8.3 – 47.4 °C, temperatures of > 35 °C were recorded on

us c
d nd

days -1, 1, 2, 4, 6 and 7 for up to 30 min until day 4, for

an a
n rty

1.5 h on day 4, 50 min on day 6 and 40 min on day 7.

tio e
ta op

High temperatures occurred primarily between 11:30 and

loi pr
xp al

14:00 and exhibited no obvious effects on crop or foraging

l e ctu

bees
cia lle
er te
m s in

Humidity: Glasshouse 1:
om a

19.5 to 93.4 %
y c uch
an ts s

Glasshouse 2:
an righ

13.9 to 100 %
d
ing to

Experimental dates: 12 May – 22 June 2011

sh ct
bli bje
pu su
or be

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t rib
dis
B. STUDY DESIGN

n,
er tio
wn lica
.
Experimental treatments

s o ub
Study site: The study was conducted in two 180 m² glasshouses situated at Stockbridge Technology Centre,

f it y p
so n
Cawood, Selby, North Yorkshire. The glasshouses were well ventilated (but equipped with insect proof) to

ht , a
rig ntly
be as representative as possible of the outdoor situation but without direct precipitation. Phacelia was

th ue
planted directly into the soil inside the glasshouse and no pesticides were applied during cultivation. The

e eq
timing of the start of test i.e. transfer of colonies into the glasshouse was determined by the flowering of

e
lat ns
vio . Co
an ime al.
the crops. Temperature and humidity in the glasshouses were recorded continuously.

te reg new
Experimental design: Four colonies of bees and brood comprising each of 4 to 6 frames of brood and

oh tio re

d
containing 6000 to 12000 adult bees were used. Hives were fitted with a pollen trap. Three days prior to

pr tec EU
ibi n
application two colonies each were located on opposite sides of each glasshouse and allowed to fly freely

d
be ro te
e ta p osa
within the glasshouse. Colonies A and B were placed in glasshouse 1, colonies C and D were placed in

ef da ph
glasshouse 2.

er y ly
th tor G
Test item application: The test item MON 52276 (nominal content: 360 g glyphosate acid equivalent/L)

ay ula the
was applied onto the crop grown in the glasshouse on day 0 during a period when bees were actively

or
t m reg king
foraging using a 3 nozzle lunch box sprayer unit with a hand-held boom fitted with Lurmark 03 F110

m er see
nozzles. The sprayer was pre-calibrated to deliver a known application rate of 400 L/ha. The colonies were

do ll u tium
en a
protected from direct overspray and spray drift during the application.

cu nd
his fa or
Observations f t ay ns
r o m co
ne ent he

Foraging assessments were performed each day during times peak foraging activity. The assessments were
ow um of t

performed by counting the number of bees foraging in a marked area (5 m by 1 m transects) during a 1
th oc (s)

minute period during peak activity. In addition, the number of bees returning to each hive and the number
of is d ber

carrying pollen loads were counted during a 30 second period.

ion , th em

Visual assessment of the crop was performed daily by determination of the proportion of plants with wilted
iss ore m

e
rm m er

flowers and wilted leaves.

pe her orm

The contents of the pollen traps were collected on days -1, 1, 2, 3, 4 and 7 after application. Samples of
he rt t/f
t t Fu en

forager bees were collected on days 0, 1, 2, 3, 4 and 7 after application. The nectar was collected from the
ou s. rr
th tie cu

bees honey stomachs. On days 4 and 7 samples of ten 4 – 5 day old larvae were taken from each colony,
wi par (a)

on day 7 an additional sample of nectar was collected from the combs of each colony.
f
en ird o
nt th rty
co and ope

Residues analysis
r

Analysis of glyphosate acid in samples was conducted following extraction with acetonitrile:water (1:4,
ts
r i er p
t o wn the

v/v), clean up by solid phase extraction on C18 and derivatisation as FMOC-glyphosate and a second clean
en o s
m he t i

up (solid phase extraction on Oasis HLB, methanolic elution) by HPLC-MS/MS. Limit of quantification
cu f t en

ts

(LoQ) and limit of detection (LoD) were 1.0 and 0.3 mg/kg, respectively.
do s o um
is ht c
th rig s do

Data analysis
i
e op Th

Considering residue levels determined in nectar and pollen after treatment of a model crop, possible
of y

exposure scenarios of honeybee brood are estimated based on information available from literature and the
us c

present study.
d nd
an a
n rty
tio e
ta op

II. RESULTS AND DISCUSSION

loi pr
xp al
l e ctu

A. FINDINGS
cia lle

Verification of test item application: The actual application rates were 8.19 L MON 52276/ha (2.94 kg
er te
m s in

a.e./ha) in glasshouse 1 and , 8.30 L MON 52276/ha (2.98 kg a.e./ha) in glasshouse 2. The application rate
om a

was 102 – 104 % of the nominal application rate of 8 L MON 52276/ha and 102 – 103 % of the nominal
y c uch

application rate of 2.88 kg a.e./ha.

an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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Residue analysis: Residues in nectar samples taken from forager bees at various time points after application

rib
ranged from 2.78 to 31.3 mg a.e./kg; residues in nectar samples taken from the colonies ranged from below

t
dis
LOQ (1.0 mg a.e./kg) to 1.30 mg a.e./kg. Residues in pollen samples taken from the pollen trap various

n,
er tio
times after application ranged from 87.2 to 629 mg a.e./kg. Residues in larvae samples ranged from 1.23 to

wn lica
.
19.50 mg a.e./kg.

s o ub
f it y p
so n
ht , a
Table 10.3.1.5-1: Summary of residue analysis of pollen, nectar and larvae samples

rig ntly
th ue
Days after treatment

e eq
e
lat ns
[mg glyphosate acid equivalent/kg]

vio . Co
an ime al.
Hive -1 1 2 3 4 7

te reg new
Nectar A+B n.d. 25.5 9.24 4.90

oh tio re

d
(honey (samples combined DAT 3, 4, 7)

pr tec EU
ibi n
d
stomachs) C+D n.d. 31.3 15.2 7.18 2.78

be ro te
e ta p osa
(samples combined DAT 3, 4)

ef da ph
Overall n.d. 28.4 12.2 6.0

er y ly
th tor G
mean

ay ula the
Nectar A - - - - - <LOQ

or
t m reg king
(hive) B - - - - - 1.30

m er see
C - - - - - 1.06

do ll u tium
en a
D - - - - - 1.00

cu nd
his fa or
Mean 0.99
f t ay ns
r o m co
Larvae A - - - - 8.32 2.54
ne ent he

(comb) B - - - - 16.70 10.6

ow um of t

C - - - - 19.50 6.72
th oc (s)

D - - - - 2.88 1.23
of is d ber
ion , th em

Mean 11.9 5.3

iss ore m

Pollen A n.d. 325 255 119 134 87.2

e
rm m er

(pollen B n.d. 405 213 (samples (samples (samples

pe her orm

trap) combined) combined) combined)

he rt t/f
t t Fu en

Mean A&B n.d. 365 234 119 134 87.2

ou s. rr
th tie cu

C n.d. 518 333 181 176 130

wi par (a)

D n.d. 629 477 147 180 (samples

f
en ird o

combined)
nt th rty
co and ope

Mean C&D n.d. 574 405 164 178 130

r

ts
r i er p

Overall n.d. 470 320 142 156 109

t o wn the

mean
en o s
m he t i

DAT day after treatment

cu f t en

ts

n.d. not detected

do s o um

< LOQ 0.6 mg/kg

is ht c
th rig s do

LOD 0.3 mg/kg

LOQ 1.0 mg/kg
i
e op Th
of y
us c
d nd

B. OBSERVATIONS
an a
n rty
tio e

Foraging activity: Foraging assessment showed foraging activity on the crop from start of study throughout
ta op
loi pr

the exposure period in glasshouse 1 with a peak on day 4. The lowest foraging activity was observed on
xp al

day 5 at 38 % of the mean pre-spray activity. In glasshouse 2 the activity declined throughout the assessment
l e ctu
cia lle

period to reach less than 10 % of mean spray activity on days 5 – 7. In line with the decreased foraging
er te
m s in

activity in glasshouse 2, the crop started to show significant effects of the treatment from day 4 onwards.
om a
y c uch

Data analysis: The residue data can be used to assess the approximate exposure level of brood within
an ts s

colonies exposed under worst-case conditions.

an righ
d
ing to
sh ct
bli bje
pu su
or be

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Table 10.3.1.5-2: Assessment of possible exposure of honey bee colonies to glyphosate residues

t rib
under two scenarios is depicted below.

dis
n,
er tio
Scenario Daily intake of Daily intake of Total daily intake of

wn lica
.
s o ub
glyphosate residues in glyphosate residues in glyphosate residues

f it y p
nectar pollen [mg a.e.]

so n
ht , a
(1296 g nectar/d) (6 g pollen/d)

rig ntly
[mg] [mg]

th ue
e eq
Day 1 maximum mean residues 40.6 3.4 44.0

e
lat ns
(31.3 µg a.e./g in nectar,

vio . Co
an ime al.
574 µg a.e./g in pollen,

te reg new
glasshouse 2)

oh tio re

d
pr tec EU
Mean residues over days 1-3 20.1 1.9 22.0

ibi n
d
be ro te
(15.5 µg a.e./g in nectar,

e ta p osa
310 µg a.e./g in pollen,

ef da ph
er y ly
both glasshouses)

th tor G
ay ula the

or
t m reg king
m er see
Two approaches can be made to assessing exposure - one based on generic published data on the
requirements for nectar and pollen by larvae (generic data) and the other based on the observations made

do ll u tium
en a
in this study (study data).

cu nd
his fa or
f t ay ns
r o m co

Generic data: The calculations are based on a daily brood requirement of 30 mg nectar (based on 40 %
ne ent he
ow um of t

sugar in nectar) and 1 mg pollen for worker brood (Rortais et al. 2005). Based on a brood frame being
th oc (s)

3600 cells and 25 % of the time is as unsealed brood (hatch day 3 to sealed day 8 with emergence day 21)
of is d ber

then five frames of brood (4 – 6 were used in this study) is 18,000 brood cells therefore for 4500 larvae
ion , th em

with a requirement of 135 g/day nectar and 4.5 g/day pollen for the colony.
iss ore m

e
rm m er
pe her orm

Study data: The second approach is to assess the amount of pollen and nectar returning to the hive over the
he rt t/f

time course of exposure using the data on the numbers of returning foragers in the study and the amounts
t t Fu en
ou s. rr

of pollen and nectar collected from bees by using the pollen trap and individual bee samples.
th tie cu
wi par (a)

The maximum pollen collected per colony was 2.9 g on day 1 and the traps are estimated to be about 50 %
f
en ird o

efficient so about 6 g of pollen per day was returned to the hive (the colony is using about 4.5 g of this
nt th rty

based on the Rortais et al. 2005).

co and ope
r

ts
r i er p
t o wn the

The nectar can be assessed using a mean of 18 foragers returning to the hive per 30 seconds and
en o s

approximately 50 µL per load (max), which gives 18 trips/30 sec × 60 sec/min × 60 min/hour × 12 hours
m he t i
cu f t en

ts

max foraging/day, equal to 25,920 trips/day × 0.050 mL, resulting in 1296 mL/day (of which the colony is
do s o um

using 135 g based on Rortais et al. 2005).

is ht c
th rig s do
i
e op Th

III. CONCLUSION
of y
us c
d nd

3. Assessment and conclusion

an a
n rty

Assessment and conclusion by applicant:

tio e
ta op
loi pr

As a worst case example considering the colony size of the present study, a honey bee colony collects
xp al
l e ctu

6 g pollen and 1296 mL nectar and of this the brood consumes 4.5 g pollen and 135 g nectar, which
cia lle

allows the excess to be stored for later consumption. As simulated in this study, for honeybee colonies
er te
m s in

foraging on the model crop Phacelia treated with 8 L MON 52276/ha, a total daily intake of glyphosate
om a

residues of 44.0 mg a.e. (based on day 1 maximum mean residues) and of 22 mg a.e. (based on mean
y c uch

residues over days 1 – 3) can be estimated.

an ts s
an righ

This study is considered valid and suitable for risk assessment purposes.
d
ing to
sh ct
bli bje
pu su
or be

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Assessment and conclusion by RMS:

t rib
dis
n,
er tio
wn lica
.
s o ub
1. Information on the study

f it y p
so n
Data point: CA 8.3.1.3 / CP 10.3.1.5/002

ht , a
rig ntly
Report author Thompson et al.

th ue
Report year 2014

e eq
Evaluating Exposure and Potential Effects on Honeybee Brood

e
Report title

lat ns
vio . Co
an ime al.
(Apis mellifera) Development Using Glyphosate as an Example

te reg new
Document No DOI: 10.1002/ieam.1529

oh tio re

d
E-ISSN: 1551-3793

pr tec EU
ibi n
Oomen et al. 1992

d
Guidelines followed in study

be ro te
e ta p osa
Deviations from current test Not applicable

ef da ph
guideline

er y ly
th tor G
GLP/Officially recognised testing No, not conducted under GLP/Officially recognised testing

ay ula the
facilities facilities (literature publication)

or
t m reg king
Acceptability/Reliability: Yes/Reliable

m er see
do ll u tium
en a
2. Full summary

cu nd
his fa or
Executive summary f t ay ns
r o m co
ne ent he

This study aimed to develop an approach to evaluate potential effects of plant protection products on
ow um of t

honeybee brood with colonies at realistic worst‐case exposure rates. The approach comprised 2 stages. In
th oc (s)

the first stage, honeybee colonies were exposed to a commercial formulation of glyphosate applied to
of is d ber

flowering Phacelia tanacetifolia with glyphosate residues quantified in relevant matrices (pollen and
ion , th em
iss ore m

nectar) collected by foraging bees on days 1, 2, 3, 4, and 7 post-application and glyphosate levels in larvae
e
rm m er

were measured on days 4 and 7. Glyphosate levels in pollen were approximately 10 times higher than in
pe her orm

nectar and glyphosate demonstrated rapid decline in both matrices. Residue data along with foraging rates
he rt t/f
t t Fu en

and food requirements of the colony were then used to set dose rates in the effects study. In the second
ou s. rr
th tie cu

stage, the toxicity of technical glyphosate to developing honeybee larvae and pupae, and residues in larvae,
wi par (a)

were then determined by feeding treated sucrose directly to honeybee colonies at dose rates that reflect
f
en ird o

worst‐case exposure scenarios. There were no significant effects from glyphosate observed in brood
nt th rty
co and ope

survival, development, and mean pupal weight. Additionally, there were no biologically significant levels
r

ts
r i er p

of adult mortality observed in any glyphosate treatment group. Significant effects were observed only in
t o wn the

the fenoxycarb toxic reference group and included increased brood mortality and a decline in the numbers
en o s
m he t i

of bees and brood. Mean glyphosate residues in larvae were comparable at 4 days after spray application in
cu f t en

ts
do s o um

the exposure study and also following dosing at a level calculated from the mean measured levels in pollen
is ht c

and nectar, showing the applicability and robustness of the approach for dose setting with honeybee brood
th rig s do

studies. This study has developed a versatile and predictive approach for use in higher tier honeybee toxicity
i
e op Th

studies. It can be used to realistically quantify exposure of colonies to pesticides to allow the appropriate
of y

dose rates to be determined, based on realistic worst‐case residues in pollen and nectar and estimated intake
us c
d nd

by the colony, as shown by the residue analysis. Previous studies have used the standard methodology
an a

developed primarily to identify pesticides with insect‐growth disrupting properties of pesticide

n rty
tio e

formulations, which are less reliant on identifying realistic exposure scenarios. However, this adaptation of
ta op
loi pr

the method can be used to determine dose–response effects of colony level exposure to pesticides with a
xp al

wide range of properties. This approach would limit the number of replicated tunnel or field‐scale studies
l e ctu
cia lle

that need to be undertaken to assess effects on honeybee brood and may be of particular benefit where
er te
m s in

residues in pollen and nectar are crop‐ and/or formulation‐specific, such as systemic seed treatments and
om a

granular applications.
y c uch
an ts s
an righ
d
ing to
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Materials and methods

t rib
dis
Technical grade glyphosate (62.27 % w/w glyphosate isopropylamine [IPA] salt corresponding to 46.14 %

n,
w/w glyphosate acid equivalent [a.e.]) and the soluble concentrate formulation of glyphosate (MON 52276)

er tio
wn lica
(30.68 % glyphosate a.e. as the IPA salt, batch no GLP-0810-19515-A), supplied by Monsanto (St. Louis,

.
s o ub
MO) were used in the study. All honeybee colonies were obtained from National Bee Unit, FERA, (York,

f it y p
UK) apiaries and were confirmed as having low incidence of adult bee diseases, viruses, and varroa with

so n
ht , a
no clinical signs of brood diseases.

rig ntly
th ue
e eq
Exposure assessment

e
lat ns
Two 180 m2 well‐ventilated but insect‐proof glasshouses were used for the study so as to be as

vio . Co
an ime al.
te reg new
representative as possible of the outdoor situation (e.g., polytunnel) but without direct rainfall. Phacelia
was planted directly into the soil in the glasshouses and no pesticides were used during its cultivation.

oh tio re

d
pr tec EU
Application was performed when Phacelia flowers were at 100 % of full bloom.

ibi n
d
be ro te
Three days before the application, 2 small honeybee colonies comprised of 4 to 6 frames of brood and 6000

e ta p osa
to 12 000 adult bees were located on opposite sides of each glasshouse and allowed to fly freely. At the

ef da ph
er y ly
time of installation, each colony was fitted with a pollen trap and provided with a limited amount of stores

th tor G
to ensure that feeding on the crop was encouraged. This was done by removing as many frames as possible

ay ula the

or
which contain only nectar or pollen, while ensuring survival and a maximum foraging activity. A supply of

t m reg king
clean water, with provision to prevent bees from drowning, i.e., a sponge, was provided and replenished as

m er see
required (it was removed during spray application).

do ll u tium
en a
To confirm that bees were foraging on the flowering Phacelia, foraging assessments were carried out each

cu nd
his fa or
f t ay ns
day during times when peak activity was expected. The assessments were performed by marking a 5 m × 1
r o m co
m wide transect within the crop and counting the number of bees foraging within the marked area during a
ne ent he

1 min period once each day during the peak activity period (between 10.00 – 15.00 h in this study, based
ow um of t

on previous experience). In addition, the number of bees returning to each hive and the number carrying
th oc (s)
of is d ber

pollen loads were counted during a 30 s period. These 2 counts provided information on the level of foraging
ion , th em

activity of each hive within each glasshouse. Daily assessments of the crop were undertaken by visual
iss ore m

assessment of the quality of the forage available, e.g., % plants with wilted flowers, wilted leaves.
rm m er
pe her orm

The glyphosate formulation was applied at a rate equivalent to 8 L/ha (2.88 kg a.e./ha) in 400 L water/ha
he rt t/f

achieving an application efficiency of between 102 % to 104 % of the target rate, in both glasshouses. The
t t Fu en
ou s. rr

application rate of 2.88 kg a.e./ha is the highest single application rate recommended for glyphosate,
th tie cu

whereas the typical single application rate is 2.16 kg a.e./ha. The final treatment solution was prepared by
wi par (a)

adding the required quantities of test item—measured by weight, to measured volumes of tap water and
f
en ird o
nt th rty

thoroughly mixing in the field immediately before use to give the final treatment solution. The application
co and ope

was made during a period when the bees were actively foraging, using a 3 nozzle lunch box sprayer unit
r

ts
r i er p

with a hand‐held boom fitted with Lurmark 03 F110 nozzles. Direct spray drift onto the colonies was
t o wn the

avoided by directing the spray away from the hives, and no direct overspray of the colonies occurred.
en o s
m he t i
cu f t en

ts

Pollen traps were activated 24 h before pollen collection, and the content of the pollen trap fitted to each
do s o um

hive was collected on days 1 (i.e., the day before application), 1, 2, 3, 4, and 7 after the application. The
is ht c
th rig s do

content of the traps was discarded on day 6 so as to only collect a sample from days 6 to 7. Each day and
i
e op Th

hive sample was kept separate unless they were too small for residue analysis, in which case samples from
of y

the same glasshouse were combined. All samples of pollen, nectar, and larvae were stored at 20 °C.
us c

On days 0 (before application), 1, 2, 3, 4, and 7 after the application samples of approximately 40 returning
d nd

forager bees were collected from each colony by blocking the entrance of the hives with a foam bung and
an a
n rty

collecting returning foraging bees directly into collection jars. The nectar was collected from the honey
tio e
ta op

stomachs of individual honeybees by removal of the stomach by dissection and placed in a preweighed
loi pr
xp al

tube. Samples were combined to produce samples large enough for residue analysis (minimum 200 mg).
l e ctu

On days 4 and 7 after the application, samples of 10 4 – 5 day old larvae were taken from each colony using
cia lle
er te

a forceps and stored at 20 °C. Each day and hive sample was kept separate. On day 7, an additional sample
m s in

of nectar was taken from the combs using a syringe in each colony and each hive sample was kept separate.
om a
y c uch

Residue analysis
an ts s

Residues of glyphosate were extracted from larvae, pollen, nectar, and sucrose solution samples with
an righ

acetonitrile/water (1:4, v/v). Recovery samples were fortified by spiking blank samples after weighing. For
d
ing to

larvae, pollen, and nectar, the whole sample was accurately weighed into a single‐use centrifugation tube.
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The sample was then homogenized, extracted with acetonitrile–water (1:4) with a high speed laboratory

rib
mixer, separated by centrifugation followed by solid-phase extraction of the supernate using a C18 column.

t
dis
All samples were then derivatized with fluorenylmethyl‐chloroformate (FMOC‐Cl). For derivatization,

n,
er tio
internal standard (1.0 µg/mL), borate buffer (0.2 mol/L sodium tetraborate decahydrate in water), and

wn lica
.
FMOC‐Cl (5 g/L in acetonitrile) were added to the diluted extract. The samples were closed, mixed, and

s o ub
f it y p
incubated at ambient temperature for at least 1 h. Finally, pH 3 water was added.

so n
A second cleanup was carried out by applying the derivatized product to an Oasis HLB SPE column

ht , a
rig ntly
(equilibrated with dichloromethane followed by methanol and pH 3 water) and then rinsed with

th ue
dichloromethane and the glyphosate‐FMOC was eluted with methanol. The eluate was evaporated to

e eq
e
lat ns
dryness using a vacuum rotary evaporator. The residue was reconstituted in 5 % acetonitrile solution and

vio . Co
an ime al.
transferred into a glass vial for high‐performance liquid chromatography (HPLC)‐tandem mass

te reg new
spectrometry (MS/MS) analysis.

oh tio re

d
The samples were analyzed using high‐pressure liquid chromatography (Shimadzu LC‐System) coupled

pr tec EU
ibi n
with a triple quadrupole mass spectrometry detector (Sciex API4000). A Phenomenex Synergi column

d
be ro te
e ta p osa
2.5 µm Max‐RP, 20 × 2.0 mm, 2.5 µm (No. 00M‐4372‐B0‐CE) + 4 mm guard column was used. The

ef da ph
column temperature was 40 °C and a 30 µL injection volume was used. The mobile phase comprised A:

er y ly
th tor G
water + 0.1 % acetic acid (80 %), B: methanol + 0.1 % acetic acid (15 %), and C: 100 mM ammonium

ay ula the
acetate solution in methanol (5 %) with a linear gradient over 5 min to comprise A: water + 0.1 % acetic

or
t m reg king
acid (0 %); B: methanol + 0.1 % acetic acid (95 %) and C: 100 mM ammonium acetate solution in methanol

m er see
(5 %). Glyphosate‐FMOC was quantified using the transition 390.0 to 149.8 with an internal standard

do ll u tium
en a
glyphosate 1,2‐13C2 15N‐FMOC transition 393.0 to 152.8.

cu nd
his fa or
At the start of the analytical sequence, the detector linearity was confirmed over the calibration range of
f t ay ns
interest by constructing a calibration function of peak area versus concentration within the range from
r o m co
ne ent he

2.0 ng/mL to 5000 ng/mL for larvae and nectar samples, 1.0 ng/mL to 3500 ng/mL for pollen samples, and
ow um of t

from 2.0 ng/mL to 4000 ng/mL for sucrose solution samples. Injections of sample extracts were interspersed
th oc (s)

with injections of quality control standards after 2 to 4 samples to verify the detector response.
of is d ber

The methods were validated before use and showed 92 % – 102 % recovery with relative standard deviation
ion , th em
iss ore m

(RSD) < 15 % with sucrose samples spiked at 1 and 400 mg a.e./kg, larval samples spiked at 1 and 200 mg
e
rm m er

a.e./kg, pollen samples spiked at 1, 500 and 700 mg a.e./kg and nectar samples spiked at 1 and 500 mg
pe her orm

a.e./kg. Calibrations were linear within the range. Unless otherwise specified the limit of detection (LOD)
he rt t/f
t t Fu en

was 0.3 mg a.e./kg, denoted as not detected (n.d.), and the limit of quantitation (LOQ) was 1.0 mg a.e./kg.
ou s. rr
th tie cu

Where data were used to generate mean values residues less than the LOQ were ascribed a value of 0.6 mg
wi par (a)

a.e./kg.
f
en ird o
nt th rty
co and ope

Effects assessment
r

Two approaches were made to assess exposure levels to be used in the effects study: one based on generic
ts
r i er p
t o wn the

published data on the requirements for nectar and pollen by larvae (generic data) and the other based on the
en o s
m he t i

observations made in the exposure study (study data).

cu f t en

ts
do s o um

Generic data. The calculations were based on a daily brood requirement of 30 mg nectar (based on 40 %
is ht c

sugar in nectar) and 1mg pollen per worker larva (Rortais et al. 2005). Based on a brood frame being
th rig s do

3600 cells (British Standard frame) and 5 frames of brood (4 – 6 were used in this study), there are
i
e op Th

18000 brood cells. The brood is unsealed for 25 % of the time (hatch day 3 to sealed day 8 with emergence
of y

day 21, empirically determined in this study) therefore 4500 larvae have a requirement for 135 g/d nectar
us c

and 4.5 g/d pollen.

d nd
an a
n rty
tio e

Study data
ta op
loi pr

The second approach was to assess the amount of pollen and nectar returning to the hive over the time
xp al

course of exposure using the data on the numbers of returning foragers in the study and the amounts of
l e ctu
cia lle

pollen and nectar collected from bees by using the pollen trap and individual bee samples.
er te
m s in

The maximum pollen collected per colony was 2.9 g on day 1 and the traps were estimated to be
om a

approximately 50 % efficient based on calculated pollen collection (Levin and Loper 1984; Delaplane et
y c uch

al. 2013). Thus 6 g of pollen per day was returned to the hive (the colony was using approximately 4.5 g of
an ts s

this based on the study by Rortais et al. [2005]).

an righ

The nectar collection was more difficult to directly assess but with a mean of 18 foragers returning to the
d
ing to
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hive per 30 s (observed in this study) and approximately 50 µL per load (max) this gives 18 trips/30 s × 60

rib
s/min × 60 min/h × 12 h max foraging/d = 25 920 trips/d × 0.050 mL = 1296 mL/day (of which the colony

t
dis
was using 135 g, based on Rortais et al. [2005]). Because the assessment is brood exposure, the conservative

n,
er tio
collection estimate is justified. Therefore, as a worst case example considering the colony size used in the

wn lica
.
exposure study, the colony collected 6 g pollen and 1296 mL (i.e., 518 g sugar, assuming 40 % sugar

s o ub
f it y p
content) nectar and of this the brood consumes 4.5 g pollen and 135 g nectar (Rortais et al. 2005) that

so n
allowed the excess to be stored for later consumption.

ht , a
rig ntly
Considering that bee colonies used in the brood study were up to 50 % bigger than those used in the residue

th ue
study, an additional calculation for the expected total daily intake of glyphosate residues was undertaken

e eq
e
lat ns
assuming that such colonies would collect 9 g pollen and 1944 mL nectar. Furthermore, the determined

vio . Co
an ime al.
residue content based on a worst‐case application rate of 2.88 kg a.e./ha for spot treatments in orchards and

te reg new
vines and was adjusted to reflect the more realistic maximum application rate of 2.16 kg a.e./ha for

oh tio re

d
preplanting, preemergence of crops, and preharvest applications.

pr tec EU
ibi n
The brood feeding study was undertaken using glyphosate as the technical grade IPA salt. Three dose levels

d
be ro te
e ta p osa
of the test item were used based on the residues identified in pollen and nectar in a glass house study

ef da ph
performed before the initiation of the bee brood study. The lowest dose was based on the mean residue

er y ly
th tor G
concentrations achieved over the first 3 days following the residue study spray application

ay ula the
(75 mg glyphosate a.e./L). The mid‐dose was based on the highest residue concentrations following the

or
t m reg king
spray application (150 mg glyphosate a.e./L) and the highest dose was equivalent to twice this latter rate

m er see
(301 mg glyphosate a.e./L). The test item was introduced into each hive in equivalent volumes of 50 %

do ll u tium
en a
sucrose (w/v) solution (1 L) for each treatment group. Hence, the range could also be expressed in terms of

cu nd
his fa or
concentration in the introduced dosing solution (mg glyphosate a.e./L and mg glyphosate a.e./kg). Control
f t ay ns
colonies were supplied with 50 % w/v sucrose solution in deionized water and the toxic reference,
r o m co
ne ent he

fenoxycarb, (750 mg a.s./L as the formulation Insegar WG 250 g a.s./kg, batch no SM01A406) reported to
ow um of t

have significant adverse effects on honeybee brood, was used to ensure that the study had the ability to
th oc (s)

detect effects of the test substance if they occurred (de Ruijter and van der Steen 1987).
of is d ber

Twenty standardized honeybee colonies each consisting of a single wooden Smith hive with British
ion , th em
iss ore m

Standard frames and a queen were used; each of the queens used in the study was of similar age and lineage.
e
rm m er

The colonies were divided into 5 groups of 4 colonies. Each colony had a dead bee trap fitted to the front
pe her orm

and the contents were counted daily during the brood assessment period (Imdorf et al. 1987). The colonies
he rt t/f
t t Fu en

contained a mean of 14 250 to 19 500 adult bees, 1.5 to 2.5 frames of brood, 1.0 to 1.9 frames of stores,
ou s. rr
th tie cu

and 0.2 to 0.7 frames of pollen. The test colonies were allowed to fly freely, there were no nearby flowering
wi par (a)

crops and few flowering weeds (clover). Colonies were assembled according to treatment and groups were
f
en ird o

placed at least 20 m apart from each other. Two colonies (one control colony and one of the highest exposure
nt th rty
co and ope

rate colonies) (301 mg glyphosate a.e./L) became queenless after dosing but were retained in the study as
r

the marked brood was viable and this was therefore not considered to have a significant impact on the study.
ts
r i er p
t o wn the

All colonies were generally assessed within 1 week before dosing and again within weeks 1, 2, and 3 after
en o s
m he t i

dosing (day 0). Each assessment was carried out on every frame within each colony, and included counts
cu f t en

ts
do s o um

of the number of combs of adults, brood (sealed and unsealed), and stores (nectar and pollen) as well as
is ht c

any behavioral or physical abnormalities.

th rig s do

The processes during the study followed the method for honeybee brood feeding test with insect growth
i
e op Th

regulating compounds (Oomen et al. 1992). Up to 24 h before dosing, 100 brood cells containing eggs,
of y

100 cells containing 1‐ to 2‐day‐old larvae and 100 cells containing 3‐ to 4‐day‐old larvae were selected in
us c

each colony and marked using the standard Oomen et al. (1992) acetate overlay sheet method.
d nd
an a

On day 0, one group was an untreated control, i.e., fed 1 L 50 % sucrose solution, 3 groups were treated
n rty
tio e

with glyphosate IPA salt (added to 1 L of 50 % sucrose to achieve doses of 301, 150 and 75 mg glyphosate
ta op
loi pr

a.e./L), and one group was treated with the toxic reference, fenoxycarb, dispersed in 1 L of 50 % w/v sucrose
xp al

(750 mg a.s./L). Doses were administered by removing frames of stores from the colonies and placing a 1
l e ctu
cia lle

L glass container containing the treated or control sucrose within the brood chamber. The container
er te
m s in

contained a cork float to allow access to the sucrose solution. Samples of each concentration of test item
om a

treated sucrose solution were retained for analysis by subsampling 5 mL from each of the prepared solutions
y c uch

and combining to a single sample (total 4 samples; control and 3 doses of glyphosate). The uptake of each
an ts s

sucrose solution was checked daily and the container removed when empty or after 5 days whichever was
an righ

later.
d
ing to
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pu su
or be

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On day 7, the marked brood cells (eggs, young, and old larvae) were assessed for mortality and appearance

rib
in each test colony. The final assessment for each larval was undertaken at day 13 for brood cells marked

t
dis
as containing old larvae, day 15 for cells containing young larvae, and day 16 for cells containing eggs. The

n,
er tio
cells were uncapped, the bee removed carefully with forceps, and the age of the bee assessed, weighed, and

wn lica
.
any deformities noted.

s o ub
f it y p
On days 4 and 7 (when the marked brood cells were assessed), samples of ten 4‐ to 5‐day‐old larvae were

so n
sampled from each treated colony (not from an area in which marked brood cells were located) for residue

ht , a
rig ntly
analysis. For the purpose of this study, mortality was defined as the total number of cells in any one group

th ue
at any one observation period that were empty (other than recently emerged), contained dead larvae or

e eq
e
lat ns
pupae or contained larvae or pupae that were considered unhealthy (sick) and unlikely to survive. Brood

vio . Co
an ime al.
mortality was statistically analyzed using a generalized linear model linked to a logit distribution for the

te reg new
brood mortality data and an analysis of variance for pupae weight data to determine the no observed effect

oh tio re

d
concentration (NOEC) (equivalent to the no observed adverse effect level [NOAEL]) statistically, using the

pr tec EU
ibi n
software Genstat v12 (VSN International). The study was considered valid if there were significant effects

d
be ro te
e ta p osa
of the toxic reference (> 40 % effects on all stages) during the detailed brood assessment when compared

ef da ph
to the control. The performance of the colonies in the control group were comparable with historical control

er y ly
th tor G
data for the testing facility (10 % – 30 % larval mortality overall), and demonstrate that the control colonies

ay ula the
had performed correctly.

or
t m reg king
m er see
Results

do ll u tium
en a
cu nd
his fa or
Exposure study
f t ay ns
Daily assessments were made of the percentage of the plants that had wilted leaves or flowers. The crop
r o m co
ne ent he

started to show significant effects of the treatment from day 4 onward in both glasshouses and this coincided
ow um of t

with the decreased foraging activity in glasshouse 2 although less pronounced effects on foraging were
th oc (s)

observed in glasshouse 1.
of is d ber

Foraging assessments showed foraging activity on the crop at the start of the study and this continued
ion , th em
iss ore m

throughout the exposure period in glasshouse 1 with a peak on day 4; lowest foraging activity was on day
e
rm m er

5 at 38 % of the mean prespray activity. In glasshouse 2, the foraging activity declined throughout the
pe her orm

assessment period and reached < 10 % of the mean prespray activity on days 5 to 7. The weights of pollen
he rt t/f
t t Fu en

collected from the traps fitted to each hive ranged from 0.37 to 1.8 g per colony per day.
ou s. rr
th tie cu

Samples of honeybee products (nectar and pollen) and larvae were analyzed for residues of glyphosate acid
wi par (a)

equivalents. Glyphosate residues in nectar samples taken from forager bees before the application were not
f
en ird o

detectable (< 0.3 mg a.e./kg). Residues in nectar samples taken at various time points after the application
nt th rty
co and ope

and originating from forager honeybees ranged from 2.78 to 31.3 mg a.e./kg and declined over time (Figure
r

1A). Residues in nectar samples taken from the colonies 7 days after the application ranged from below the
ts
r i er p
t o wn the

LOQ (1.0 mg a.e./kg) to 1.30 mg a.e./kg.

en o s
m he t i

Residues in pollen samples taken from the pollen trap before the application were not detectable (< 0.3 mg
cu f t en

ts
do s o um

a.e./kg). Residues in pollen samples taken at various time points after the application and originating from
is ht c

the trap ranged from 87.2 mg a.e./kg to 629 mg a.e./kg and declined over time (Figure 1B). Residues in
th rig s do

larvae samples at 2 time points (day 4 and day 7) after the application ranged from 1.23 mg a.e./kg to 19.50
i
e op Th

mg a.e./kg.
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

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t rib
dis
n,
er tio
wn lica
.
s o ub
f it y p
so n
ht , a
rig ntly
th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
oh tio re

d
pr tec EU
ibi n
d
be ro te
e ta p osa
ef da ph
Fig. 1. Decline of glyphosate residues (mg a.e./kg ± SE). (A) Nectar collected from foragers. The nectar

er y ly
th tor G
sample from days 3 and 4 were combined due to the small amount collected for analysis. (B)

ay ula the
Pollen collected in pollen traps in mg a.e./kg matrix.

or
t m reg king
m er see
Effects study

do ll u tium
en a
cu nd
his fa or
Consumption of treated sucrose. Analysis of the dosing solutions showed they were within 11 % of the
f t ay ns
nominal doses. The control colonies consumed between 0.63 and 1.0 L of untreated sucrose. In the
r o m co
ne ent he

glyphosate‐treated colonies, at least 3 of the 4 colonies in each group consumed the total volume of treated
ow um of t

sucrose fed to each of them. There was no statistically significant difference in sucrose consumption in
th oc (s)

comparison to control for the 301 mg a.e./L group (p = 0.438), 150 mg a.i./L group (p = 0.212), the 75 mg
of is d ber

a.i./L group (p = 0.054), which was slightly higher than the control, and the positive control fenoxycarb (p
ion , th em
iss ore m

= 0.151).
e
rm m er

In the 301 mg glyphosate a.e./L group, one colony consumed 0.39 L and the other 3 each consumed 1.0 L
pe her orm

resulting in mean exposure to 255 ± 26 mg glyphosate a.e. In the 150 mg glyphosate a.e./L group, one
he rt t/f
t t Fu en

colony consumed 0.67 L and the other 3 each consumed 1.0 L resulting in mean exposure to 130 ± 12 mg
ou s. rr
th tie cu

glyphosate a.e. In the 75 mg glyphosate a.e./L group one colony consumed 0.90 L and the other 3 each
wi par (a)

consumed 1.0 L resulting in mean exposure to 73 ± 2 mg glyphosate a.e. In the fenoxycarb treated colonies,
f
en ird o

consumption rates ranged from 0.45 to 0.88 L resulting in mean exposure to 510 ± 72 mg fenoxycarb.
nt th rty
co and ope

Exposure at the 150 mg a.i./L dose was significantly lower than at the 301 mg a.i./L dose (p = 0.049) and
r

ts
r i er p

exposure at the 75 mg a.i./L dose was significantly lower than at 150 mg a.i./L dose (p = 0.002).
t o wn the

Brood mortality. Figure 2 summarizes the survival of marked brood stages at day 7 after dosing and just
en o s
m he t i

before emergence. There were no significant treatment‐related effects except in the fenoxycarb toxic
cu f t en

ts
do s o um

reference treated colonies, in which overall survival of marked cells was 20 % for marked eggs (p < 0.001),
is ht c

0 % for marked young larvae (p < 0.001) and 12 % for marked old larvae (p < 0.001), meeting the
th rig s do

established validity criterion for the toxic reference (> 40 % effects at all stages). This can be compared
i
e op Th

with overall survival of 85 % for marked eggs, 96 % for marked young larvae, and 96 % for marked old
of y

larvae in controls and 82 % – 87 % for marked eggs (300 mg a.i./L: p = 0.435, 150 mg a.i./L: p = 0.310, 75
us c
d nd

mg a.i./L: p = 0.250), 87 % – 94 % for marked young larvae (300 mg a.i./L: p = 0.185, 150 mg a.i./L: p =
an a

0.060, 75 mg a.i./L: p = 0.254), and 94 % – 95 % for marked old larvae (300 mg a.i./L: p = 0.434, 150 mg
n rty
tio e

a.i./L: p = 0.202, 75 mg a.i./L: p = 0.291) in the glyphosate‐treated colonies. The control mortality is similar
ta op
loi pr

to historical levels in studies conducted at the Food and Environmental Research Agency (FERA) (10 % –
xp al

30 %). Deformities were observed in the fenoxycarb‐treated colonies where discolored heads, thorax, and
l e ctu
cia lle

abdomens were noted. No deformities were observed in of the control or any glyphosate‐treated colonies.
er te
m s in

Additionally, there were no significant effects on the mean weight of the exposed pupae (Table 1) compared
om a

to controls in the 300 mg a.i./L group (p = 0.424), the 150 mg a.i./L (p = 0.207), or the 75 mg a.i./L (p =
y c uch

0.292). The fenoxycarb‐treated colonies showed significant effects on weight of surviving pupae marked
an ts s

as old larvae (p = 0.003). The only dead pupae observed in any significant number were those in the
an righ

fenoxycarb treated group where a mean of up to 190 pupae/day was observed and a mean of 600 pupae
d
ing to
sh ct
bli bje
pu su
or be

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ep
,r
ion
ut
were recovered from the colonies over the 17‐day period after dosing compared with 2.0 pupae/d in the

rib
control and 1.3 to 1.8 pupae/d in the glyphosate‐treated colonies. The only adverse effects on colony

t
dis
development were observed in the fenoxycarb‐treated colonies where declines in the numbers of bees and

n,
er tio
brood were observed in the latter stages of the study compared to controls for the 300 mg a.i./L group (p =

wn lica
.
0.401), the 150 mg a.i./L group (p = 0.414), the 75 mg a.i./L group (p = 0.360), or the positive control

s o ub
f it y p
fenoxycarb (p = 0.070).

so n
ht , a
rig ntly
th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
oh tio re

d
pr tec EU
ibi n
d
be ro te
e ta p osa
ef da ph
er y ly
th tor G
ay ula the

or
t m reg king
m er see
do ll u tium
en a
cu nd
his fa or
f t ay ns
r o m co
ne ent he

Fig. 2. Survival (% ± SE) of Eggs (7 and 16 Days After Treatment, DAT), Young Larvae (7 and 15 DAT)
ow um of t

and Old Larvae (7 and 13 DAT) for treatment groups (mean consumption) Control (0 mg
th oc (s)
of is d ber

glyphosate a.e.), A (255 ± 46 mg glyphosate a.e.), B (138 ± 12 mg a.e.), C (73 ± 2 mg glyphosate

ion , th em

a.e.), and Fenoxycarb (510 ± 72 mg). Different letters above the bars indicate statistical difference
iss ore m

(p < 0.05) from the respective control. # no statistical analysis as no variance due to 100 %
rm m er
pe her orm

mortality.
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)

Table 10.3.1.5-3 Mean pupae weight with SE at final assessment including dead and sick in the
f
en ird o

fenoxycarb treatment
nt th rty
co and ope
r

Treatment Dose rate Mean dose Weight‐surviving Weight‐surviving Weight‐surviving

ts
r i er p
t o wn the

mg/L consumed pupae marked as pupae marked as pupae marked as

en o s

mg (SE) eggs (mg) young larvae (mg) old larvae (mg)

m he t i
cu f t en

ts
do s o um
is ht c
th rig s do

Control 0 0 127.5 ± 0.7 128.4 ± 0.6 128.9 ± 0.4

i
e op Th

Glyphosate 301 255 ± 46 135.7 ± 0.6 125.4 ± 0.6 125.6 ± 0.4

of y

Glyphosate 150 138 ± 12 126.7 ± 0.6 124.4 ± 0.8 122.6 ± 0.5

us c
d nd

Glyphosate 75 73 ± 2 124.7 ± 0.8 128.3 ± 1.0 121.2 ± 0.5

an a
n rty

115.4 ± 1.0a
tio e

Fenoxycarb 750 510 ± 72 125.9 ± 0.9 128.8 ± 1.3

ta op
loi pr

SE = standard error
xp al

a
Statistically different effect (p < 0.01)
l e ctu
cia lle
er te
m s in

Adult bee mortality. No biologically significant adult mortality was observed in any treatment group with
om a
y c uch

a mean total of 73 to 25 dead adult workers were recovered from dead bee traps over the entire 17‐day
an ts s

period after dosing.

an righ

Residue analysis. The residues in larvae sampled at 2 time points (day 4 and day 7) after dosing of the
d
ing to

colonies (Figure 3) ranged from below the LOQ (1.0 mg a.e./kg) to 82.1 mg a.e./kg (at the highest dose
sh ct
bli bje
pu su
or be

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rate) confirming that larvae were exposed to test item provided in the sucrose solution and consumed it.

rib
There was a linear relationship between dose level and glyphosate levels in larvae on days 4 and 7. Levels

t
dis
of day 7 were considerably lower than on day 4 and are likely the result of larval growth and glyphosate

n,
er tio
exposure ending after 5 days of exposure. Notably, these residue levels are comparable with values from

wn lica
.
the exposure study which ranged from 2.9 to 19.5 mg a.e./kg with a mean of 11.5 mg a.e./kg on day 4 to

s o ub
f it y p
1.2 to 10.6 mg a.e./kg with a mean of 5.3 mg a.e./kg on day 7 after the glyphosate application.

so n
ht , a
rig ntly
th ue
e eq
e
lat ns
vio . Co
an ime al.
te reg new
oh tio re

d
pr tec EU
ibi n
d
be ro te
e ta p osa
ef da ph
er y ly
th tor G
ay ula the

or
t m reg king
m er see
do ll u tium
en a
Fig. 3. Residues (mg a.e./kg ± SE) in larvae 4 and 7 days after treatment (DAT) for dose groups with dose

cu nd
his fa or
rate of 300, 150, 75, and 0 mg a.e./kg sucrose solution. f t ay ns
r o m co
ne ent he
ow um of t

Conclusion
th oc (s)

There were no significant effects from glyphosate observed in brood survival, development, and mean pupal
of is d ber

weight. Additionally, there were no biologically significant levels of adult mortality observed in any
ion , th em

glyphosate treatment group. Significant effects were observed only in the fenoxycarb toxic reference group
iss ore m

e
rm m er

and included increased brood mortality and a decline in the numbers of bees and brood. Mean glyphosate
pe her orm

residues in larvae were comparable at 4 days after spray application in the exposure study and also following
he rt t/f
t t Fu en

dosing at a level calculated from the mean measured levels in pollen and nectar, showing the applicability
ou s. rr

and robustness of the approach for dose setting with honeybee brood studies.
th tie cu
wi par (a)
f
en ird o

3. Assessment and conclusion

nt th rty
co and ope

Assessment and conclusion by applicant:

r

ts
r i er p
t o wn the

The Oomen et al. (1992) approach was used to quantify at residues in relevant matrices (pollen, nectar,
en o s
m he t i
cu f t en

and larvae) following application of glyphosate at 2.88 kg a.e./ha (400 L water/ha) to flowering Phacelia
ts
do s o um

tenacetifolia in large glasshouses. Then brood feeding tests following the Oomen approach, were
is ht c
th rig s do

conducted by feeding 1 L treated sucrose solution at 75 / 150 and 301 mg glyphosate a.e./L directly to
i

honeybee colonies.
e op Th
of y

The study is adequately described and all information to evaluate the study are available. At the time
us c
d nd

the study was conducted, there were no field level test guidelines adopted for use in the EU. The test did
an a
n rty

follow a recognised approach and is considered fit for purpose. The study is considered as reliable.
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te

CP 10.3.1.6 Field tests with honeybees

m s in
om a
y c uch

Further studies with honeybees are not considered required with representative product MON 52276
an ts s

based on the low toxicity demonstrated by the risk assessments above.

an righ
d
ing to
sh ct
bli bje
pu su
or be

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CP 10.3.2 Effects on non-target arthropods other than bees

t rib
dis
n,
Studies on effects of the representative formulation MON 52276 on non-target arthropods to fulfil the data

er tio
wn lica
requirements according to EU Regulation No 284/2013 are presented in the following.

.
s o ub
f it y p
Studies considering the toxicity of MON 52276 to non-target arthropods at Tier 1 and Tier 2 were assessed

so n
ht , a
for validity against current and relevant guidelines and are presented in the following table. Studies

rig ntly
previously evaluated in either the monograph 2001 or the RAR 2015 were also included in this assessment.

th ue
e eq
Study summaries for all studies are presented in this section below.

e
lat ns
vio . Co
an ime al.
te reg new
oh tio re

d
pr tec EU
ibi n
d
be ro te
e ta p osa
ef da ph
er y ly
th tor G
ay ula the

or
t m reg king
m er see
do ll u tium
en a
cu nd
his fa or
f t ay ns
r o m co
ne ent he
ow um of t
th oc (s)
of is d ber
ion , th em
iss ore m

e
rm m er
pe her orm
he rt t/f
t t Fu en
ou s. rr
th tie cu
wi par (a)
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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,r
ion
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Table 10.3.2-1: Studies on the toxicity of MON 52276 to non-target arthropods other than bees

t rib
dis
n,
Study
Annex point Study type Test species Substance Status Remark

er tio
reference

wn lica
.
s o ub
Tier 1 – laboratory studies

f it y p
Single rate tested

so n
ht , a
3.6 kg a.e/ha. 100 %

rig ntly
CP Aphidius MON mortality at 24 hrs,

th ue
Laboratory supportive
10.3.2.1/001 1995 rhopalosiphi 52276 therefore no

e eq
e
lat ns
reproduction endpoints

vio . Co
an ime al.
available.

te reg new
Single rate tested

oh tio re
3.6 kg a.e/ha. 100 %

d
CP MON

pr tec EU
Typhlodromus
Laboratory supportive mortality at day 4,

ibi n
d
10.3.2.1/002 1995 pyri 52276

be ro te
therefore no

e ta p osa
reproduction endpoints.

ef da ph
er y ly
CP MON

th tor G
Poecilus
Laboratory Valid

ay ula the
10.3.2.1/003 1995 cupreus 52276

or
t m reg king
CP MON

m er see
Laboratory Pardosa sp. Valid
10.3.2.1/004 1995 52276

do ll u tium
en a
cu nd
his fa or
Tier 2 – extended laboratory and aged residue
f t ay ns
r o m co
ne ent he

CP Extended Typhlodromus MON

Valid
ow um of t

10.3.2.2/001 2010 laboratory pyri 52276

th oc (s)
of is d ber

Several minor
ion , th em

deviations to relevant
iss ore m

CP Extended Typhlodromus MON guideline. A more

rm m er

supportive
pe her orm

10.3.2.2/002 1999 laboratory pyri 52276 recent study

( 2010)
he rt t/f
t t Fu en

is available.
ou s. rr
th tie cu

Several minor
wi par (a)

deviations to relevant
f
en ird o

CP Extended Typhlodromus MON guideline. A more

nt th rty

supportive
10.3.2.2/003 1998 laboratory pyri 52276 recent study
co and ope

( 2010)
r

ts
r i er p

is available.
t o wn the
en o s
m he t i

CP Extended Aphidius MON

cu f t en

Valid
ts

10.3.2.2/004 2010 laboratory rhopalosiphi 52276

do s o um
is ht c
th rig s do

CP Extended Aphidius MON

i

Valid
e op Th

10.3.2.2/005 1999 laboratory rhopalosiphi 52276

of y
us c

CP Extended Aleochara MON

d nd

Valid
an a

10.3.2.2/007 2010 laboratory bilineata 52276

n rty
tio e
ta op

Control eggs < 15.

loi pr

CP Extended Chrysoperla MON

supportive Mean No. eggs per
xp al

10.3.2.2/008 1999 laboratory carnea 52276

l e ctu

female/day was 7.9.

cia lle
er te
m s in
om a

Endpoints of studies considered valid with the representative product MON 52276 are shown in the table
y c uch
an ts s

below. In order to make a direct comparison of toxicity between studies conducted with MON 52276 and
an righ

those conducted with IPA salt, glyphosate technical and glyphosate acid, the endpoints from all these
studies have been converted to acid equivalents (a.e.). Although no NTA studies with the active substance
d
ing to
sh ct
bli bje
pu su
or be

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are available, the endpoints for MON 52276 have been converted to be consistent with the other organism

rib
groups. This conversion has been made by the acid equivalent purity of the test item stated in the reports.

t
dis
n,
er tio
Table 10.3.2-2: Endpoints: studies on toxicity of MON 52276 to non-target arthropods other than

wn lica
.
s o ub
bees

f it y p
so n
ht , a
rig ntly
Reference Test item Species Test design Mortality LR50 Effects on

th ue
reproduction

e eq
e
lat ns
Tier 1 – laboratory studies

vio . Co
an ime al.
, 1995 MON 52276 Poecilus cupreus Laboratory > 10 L/ha -

te reg new
CP 10.3.2.1/003 (3600 g a.e./ha)

oh tio re

d
pr tec EU
ibi n
d
1995 MON 52276 Pardosa sp. Laboratory > 10 L/ha -

be ro te
e ta p osa
CP 10.3.2.1/004 (3600 g a.e./ha)

ef da ph
er y ly
th tor G
Tier 2 – extended laboratory and aged residue

ay ula the

or
, 2010 MON 52276 Typhlodromus Extended > 16.0 L/ha ER50 ≥ 12 L/ha

t m reg king
CP 10.3.2.2/001 pyri laboratory (5760 g a.e./ha) (4320 g a.e./ha)

m er see
2D

do ll u tium
en a
NOER = 8 L/ha

cu nd
his fa or
f t ay ns
r o m co (2880 g a.e./ha)
2010 MON 52276 Aphidius Extended > 16.0 L/ha ER50 > 16 L/ha
ne ent he
ow um of t

CP 10.3.2.2/004 rhopalosiphi laboratory (5760 g a.e./ha) (5760 g a.e./ha)

th oc (s)

3D
of is d ber

NOER ≥ 16 L/ha
ion , th em

(5760 g a.e./ha)
iss ore m

e
rm m er

1999 MON 52276 Aphidius Extended > 12.0 L/ha ER50 > 12 L/ha
pe her orm

CP 10.3.2.2/005 rhopalosiphi laboratory (4320 g a.e./ha) (4320 g a.e./ha)

he rt t/f
t t Fu en

3D
ou s. rr
th tie cu

NOER ≥ 12 L/ha
wi par (a)

(4320 g a.e./ha)
f
en ird o
nt th rty

2010 MON 52276 Aleochara Extended > 12.0 L/ha ER50 > 12 L/ha
co and ope

CP 10.3.2.2/007 bilineata laboratory (4320 g a.e./ha) (4320 g a.e./ha)

r

ts
r i er p
t o wn the

NOER ≥ 12 L/ha
en o s
m he t i

(4320 g a.e./ha)
cu f t en

ts
do s o um

a.e. glyphosate acid equivalents

is ht c
th rig s do

Endpoints in bold are used for risk assessment

i
e op Th
of y

There are no literature articles and peer-reviewed published data considered to be relevant and reliable or
us c
d nd

reliable with restrictions with regards to the impact of glyphosate or its relevant metabolites on non-target
an a
n rty

arthropods. Full literature evaluation is provided in document M-CA Section 9. A summary of previously
tio e
ta op

evaluated peer reviewed literature from the RAR 2015 is also available in Annex M-CA 8-01 of the
loi pr

M-CA Section 8.
xp al
l e ctu
cia lle

Risk assessment for other non-target arthropods

er te
m s in

The table below summarises how the risk assessment for non-target arthropods considers all the proposed
om a

uses and the application rates presented in the GAP. The risk assessment presented here is shown by the
y c uch

grey shaded cells in the table, which represents the worst-case exposure to non-target arthropods and are
an ts s
an righ

selected based on the application rate, multiple application factor and the crop type for the proposed uses
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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 It
an may
d/
or be
pu su
bli bje
sh ct
ing to
an righ
d
an ts s
y c uch
om a
m s in
er te
cia lle
l e ctu
xp al
loi pr
ta op
tio e
n rty
an a
d nd
us c
e op Th
of y i
th rig s do
is ht c
do s o um
cu f t en
m he t i
en o s
t o wn the
r i er p
ts r
co and ope
nt th rty
en ird o
ts f
wi par (a)
th tie cu
ou s. rr
t t Fu en
he rt t/f
pe her orm
rm m er
iss ore m
ion , th em
of is d ber
th oc (s)
e
ow um of t
ne ent he
r o m co
f t ay ns
his fa or
do ll u tium
cu nd
m er see
en a
t m reg king
ay ula the
th tor G
er y ly
ef da ph
or
e ta p osa
be ro te
pr tec EU
oh tio re
ibi n
te reg new
d
an ime al.
d
vio . Co
lat ns
e eq
th ue
e
rig ntly
ht , a
so n
f it y p
s o ub
wn lica
er tio
. n,
dis
trib
ut
ion
,r
ep
ro
du
cti
on
 on
cti
du
Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

ro
Page 288 of 553

ep
,r
ion
ut
recommendations of the guidance document ESCORT 2 34.

t rib
dis
Where multiple applications per season are applicable, a multiple application factor is applied to the risk

n,
er tio
assessment, considering an application interval of 28 days. Therefore, the MAF is based on a DT50 of

wn lica
.
2.8 days for decline of residues on leaf surfaces in a grass residues study, which is considered to cover

s o ub
f it y p
decline on broadleaf plant foliage. This DT50 is supported by Ebeling & Wang (2018)35, who evaluated the

so n
residue dissipation of 30 active substances (including glyphosate) on grasses / cereals (177 trials) and non-

ht , a
rig ntly
grass herbs (101 trials). No significant difference between residue dissipation on grasses / cereals and non-

th ue
grass herbs was found. In addition, in the EFSA Conclusion for glyphosate (2015)36 (EFSA Journal

e eq
e
lat ns
2015;13(11):4302) the DT50 of 2.8 days was used to determine a calculated 21-day TWA of 0.19, that was

vio . Co
an ime al.
applied to refine the risk to the medium herbivorous/granivorous bird “pigeon” Wood pigeon (Columba

te reg new
palumbus).

oh tio re

d
pr tec EU
ibi n
The principal route of non-target terrestrial plant exposure is via spray drift away from the applied areas.

d
be ro te
e ta p osa
Currently, estimation of spray drift deposition is based on the values given by Rautmann (2001). These

ef da ph
values apply to 90th percentile conditions. According to ESCORT 2 and Rautmann (2001) the estimated

er y ly
th tor G
spray drift deposition for field crops (% of in-field target deposition) downwind of a sprayed (ground

ay ula the
directed application) to a bare soil surface (without interception by vegetation) representing a field crop

or
t m reg king
situation at distances of 1, 5 and 10 meters from the target area, are 2.77, 0.57 and 0.29 %.

m er see
do ll u tium
en a
Applications using high boom or blast sprayer applicators associated with for example, ‘over the top’

cu nd
his fa or
applications in perennial crops, are not a use on the proposed GAP table. The assessment does therefore
f t ay ns
only consider low boom – ground directed applications. The stated percentage drift values are for field crop
r o m co
ne ent he

drift values used for all crops according to recommendations of the Guidance Document on Terrestrial
ow um of t

Ecotoxicology (2002) and are based on Rautmann (2001).

th oc (s)
of is d ber

An assessment considering the Tier 2 extended laboratory studies for T. pyri and A. rhopalosiphi is provided
ion , th em
iss ore m

below. The extended laboratory studies provide more realistic test conditions to assess the toxicity of MON
e
rm m er

52276 on the indicator species using plant substrates in 2-dimentional (T.pyri) or 3-dimentional (A.
pe her orm

rhopalosiphi) study designs.

he rt t/f
t t Fu en
ou s. rr
th tie cu

The in-field risk assessment is presented below for the use of MON 52276 in field crops, orchards,
wi par (a)

vineyards, railroad tracks and agricultural/non-agricultural areas for the control of invasive species.
f
en ird o
nt th rty
co and ope
r

ts
r i er p
t o wn the
en o s
m he t i
cu f t en

ts
do s o um
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in

34
Candolfi MP, Barrett KL, Campbell PJ, Forster R, Grandy N, Huet MC, Lewis G, Oomen PA, Schmuck R and Vogt H (eds)
om a

(2001): Guidance document on regulatory testing and risk assessment procedures for plant protection products with non-target
y c uch

arthropods. From the ESCORT 2 workshop. SETAC, Pensacola, 46 p

an ts s

35
Ebeling, M., Wang, M. Dissipation of Plant Protection Products from Foliage. Environmental Toxicology and Chemistry
an righ

(2018). Wiley Online Library.

36 Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate (2015). European Food
d
ing to

Safety Authority (EFSA), Parma, Italy.

sh ct
bli bje
pu su
or be

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Table 10.3.2-4: In-field HQs for non-target arthropods (T. pyri and A. rhopalosiphi; Tier 2) exposed

t rib
to MON 52276 in field crops (Uses: 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c) – considering downward

dis
ground-directed spray

n,
er tio
wn lica
.
s o ub
Crop Application Test species ER50 MAF 1 PERin-field 2 PERin-field below

f it y p
scenario pattern [g a.e./ha] [g a.e./ha] rate with ≤ 50%

so n
ht , a
effect?

rig ntly
th ue
Field 1 × 540 g a.e./ha T. pyri > 4320 1 (foliar)/ 540 (foliar)/ yes (foliar)/

e eq
crops 1 (soil) 540 (soil) yes (soil)

e
lat ns
vio . Co
an ime al.
A. rhopalosiphi > 5760 yes (foliar)/

te reg new
yes (soil)

oh tio re
1 × 720 g a.e./ha > 4320 1 (foliar)/ 720 (foliar)/ yes (foliar)/

d
T. pyri

pr tec EU
ibi n
1 (soil) 720 (soil) yes (soil)

d
be ro te
e ta p osa
A. rhopalosiphi > 5760 yes (foliar)/

ef da ph
yes (soil)

er y ly
th tor G
3 × 720 g a.e./ha T. pyri > 4320 1 (foliar)/ 720 (foliar)/ yes (foliar)/

ay ula the
1 (soil) 720 (soil) yes (soil)

or
t m reg king
A. rhopalosiphi > 5760 yes (foliar)/

m er see
yes (soil)

do ll u tium
en a
2 × 1080 g a.e./ha T. pyri > 4320 1 (foliar)/ 1080 (foliar)/ yes (foliar)/

cu nd
1 (soil) 1080 (soil) yes (soil)
his fa or
A. rhopalosiphi > 5760 f t ay ns yes (foliar)/
r o m co

yes (soil)
ne ent he
ow um of t

a.e. glyphosate acid equivalents

th oc (s)

PER: Predicted environmental rate

of is d ber

1 MAF = 1.00 (considering at least a 28 day interval and a DT of 2.8 days)

50
ion , th em

2
PER (g a.e./ha) based on drift rate (%) at 1 m from the application area considering downward ground directed spray
iss ore m

e
rm m er
pe her orm
he rt t/f

Table 10.3.2-5: In-field HQs for non-target arthropods (T. pyri and A. rhopalosiphi; Tier 2) exposed
t t Fu en

to MON 52276 in Orchards (Uses: 4 a-c) – considering downward ground-directed spray

ou s. rr
th tie cu
wi par (a)
f
en ird o

PERin-field below
nt th rty

Crop Application ER50 PERin-field 2

Test species MAF 1 rate with ≤ 50%
co and ope

scenario pattern [g a.e./ha] [g a.e./ha]

effect?
r

ts
r i er p
t o wn the

yes (foliar)/
en o s

T. pyri > 4320

m he t i

1 × 720 g 1 (foliar)/ 360 (foliar)/ yes (soil)

cu f t en

ts
do s o um

a.e./ha 1 (soil) 360 (soil) yes (foliar)/

Stone and A. rhopalosiphi > 5760
is ht c

yes (soil)
th rig s do

pome fruit,
yes (foliar)/
i
e op Th

Fruit crops T. pyri > 4320

2 × 1440 g 1 (foliar)/ 1440 (foliar)/ yes (soil)
of y

a.e./ha 1 (soil) 1440 (soil) yes (foliar)/

us c

A. rhopalosiphi > 5760 yes (soil)

d nd
an a

a.e. glyphosate acid equivalents

n rty
tio e

PER: Predicted environmental rate

ta op

1 MAF = 1.00 (considering at least a 28 day interval and a DT of 2.8 days)

loi pr

50
2 PER (g a.e./ha) based on drift rate of 2.77 % at 1 m from the application area considering downward ground directed spray
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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t rib
dis
Table 10.3.2-6: In-field HQs for non-target arthropods (T. pyri and A. rhopalosiphi; Tier 2) exposed

n,
to MON 52276 in Vineyards (Uses: 5 a-c) – considering downward ground-directed spray

er tio
wn lica
.
s o ub
Crop Application Test species ER50 MAF 1 PERin-field 2 PERin-field below

f it y p
so n
scenario pattern [g a.e./ha] [g a.e./ha] rate with ≤ 50%

ht , a
effect?

rig ntly
th ue
Table and 1 × 1080 g a.e./ha T. pyri > 4320 1 (foliar)/ 540 (foliar)/ yes (foliar)/

e eq
yes (soil)

e
1 (soil) 540 (soil)

lat ns
wine

vio . Co
an ime al.
grapes A. rhopalosiphi > 5760 yes (foliar)/

te reg new
yes (soil)

oh tio re

d
2 × 1440 g a.e./ha T. pyri > 4320 1 (foliar)/ 1440 (foliar)/ yes (foliar)/

pr tec EU
ibi n
1 (soil) 1440 (soil) yes (soil)

d
be ro te
e ta p osa
A. rhopalosiphi > 5760 yes (foliar)/

ef da ph
yes (soil)

er y ly
th tor G
a.e. glyphosate acid equivalents

ay ula the
PER: Predicted environmental rate

or
t m reg king
1 MAF = 1.00 (considering at least a 28 day interval and a DT of 2.8 days)
50
2 PER (g a.e./ha) based on drift rate of 2.77 % at 1 m from the application area considering downward ground directed spray

m er see
do ll u tium
en a
cu nd
his fa or
f t ay ns
Table 10.3.2-7: In-field HQs for non-target arthropods (T. pyri and A. rhopalosiphi; Tier 2) exposed
r o m co
to MON 52276 in railroad tracks (Uses: 7 a-c) – considering downward ground-directed spray
ne ent he
ow um of t
th oc (s)

Crop Application Test species ER50 MAF 1 PERin-field 2 PERin-field below

of is d ber

scenario pattern [g a.e./ha] [g a.e./ha] rate with ≤ 50%

ion , th em

effect?
iss ore m

e
rm m er
pe her orm

Field crops 1 × 1800 g T. pyri > 4320 1 (foliar)/ 1800 (foliar)/ yes (foliar)/
a.e./ha 1 (soil) 1800 (soil) yes (soil)
he rt t/f

(Railroad
t t Fu en

tracks) A. rhopalosiphi > 5760 yes (foliar)/

ou s. rr
th tie cu

yes (soil)
wi par (a)

2 × 1800 g T. pyri > 4320 1 (foliar)/ 1800 (foliar)/ yes (foliar)/

f
en ird o

a.e./ha 1 (soil) 1800 (soil) yes (soil)

nt th rty
co and ope

A. rhopalosiphi > 5760 yes (foliar)/

r

ts
r i er p

yes (soil)
t o wn the

a.e. glyphosate acid equivalents

en o s
m he t i

PER: Predicted environmental rate

cu f t en

ts

1 MAF = 1.00 (considering at least a 28 day interval and a DT of 2.8 days)

do s o um

50
2 PER (g a.e./ha) based on drift rate of 2.77 % at 1 m from the application area considering downward ground directed spray
is ht c
th rig s do
i
e op Th
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
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Table 10.3.2-8: In-field HQs for non-target arthropods (T. pyri and A. rhopalosiphi; Tier 2) exposed

t rib
to MON 52276 for the control of invasive species (Uses: 8 and 9) – considering downward ground-

dis
n,
directed spray

er tio
wn lica
.
s o ub
Crop Application Test species ER50 MAF 1 PERin-field 2 PERin-field below

f it y p
scenario pattern [g a.e./ha] [g a.e./ha] rate with ≤ 50%

so n
ht , a
effect?

rig ntly
th ue
Field crops 1 × 1800 g T. pyri > 4320 1 (foliar)/ 1800(foliar)/ yes (foliar)/

e eq
a.e./ha 1 (soil) 1800 (soil) yes (soil)

e
lat ns
(Invasive

vio . Co
an ime al.
species A. rhopalosiphi > 5760 yes (foliar)/

te reg new
control) yes (soil)

oh tio re

d
a.e. glyphosate acid equivalents

pr tec EU
ibi n
PER: Predicted environmental rate

d
be ro te
1
MAF = 1.00 (considering at least a 28 day interval and a DT50 of 2.8 days)

e ta p osa
2
PER (g a.e./ha) based on drift rate of 2.77 % at 1 m from the application area considering downward ground directed spray

ef da ph
er y ly
th tor G
ay ula the

or
The off-field risk assessment is presented below for the use of MON 52276 in field crops, orchards,

t m reg king
vineyards, railroad tracks and agricultural/non-agricultural areas.

m er see
do ll u tium
en a
Table 10.3.2-9: Off-field HQs for non-target arthropods (T. pyri and A. rhopalosiphi; Tier 2)

cu nd
his fa or
exposed to MON 52276 in field crops (Uses: 1 a-c, 2 a-c, 3 a-b, 6 a-b, 10 a-c) – considering f t ay ns
r o m co
downward ground-directed spray
ne ent he
ow um of t
th oc (s)

Crop Application Test species ER50 MAF 1 vdf PERoff-field 2 CF corr. PERoff-
of is d ber

scenario pattern [g a.e./ha] (foliar) [g a.e./ha] below rate

field
ion , th em

with ≤ 50 %
iss ore m

effect?
rm m er
pe her orm

Field 1 × 540 g a.e./ha T. pyri > 4320 1 10 1.5 10 yes

he rt t/f
t t Fu en

crops
ou s. rr

A. rhopalosiphi > 5760 1 15 yes

th tie cu
wi par (a)

1 × 720 g a.e./ha T. pyri > 4320 1 10 1.99 yes

f
en ird o

A. rhopalosiphi > 5760 1 19.9 yes

nt th rty
co and ope

3 × 720 g a.e./ha T. pyri > 4320 1 10 1.99 yes

r

ts
r i er p

A. rhopalosiphi > 5760 1 19.9 yes

t o wn the
en o s

2 × 1080 g T. pyri > 4320 1 10 2.99 yes

m he t i
cu f t en

ts

a.e./ha > 5760 1 29.9 yes

do s o um

A. rhopalosiphi
is ht c

a.e. glyphosate acid equivalents

th rig s do

PER: Predicted environmental rate, vdf: vegetation distribution factor; CF: correction factor
i
e op Th

1
MAF = 1.00 (considering at least a 28 day interval and a DT50 of 2.8 days)
2
PER (g a.e./ha) based on drift rate of 2.77 % at 1 m from the application area considering downward ground directed spray
of y
us c
d nd
an a
n rty
tio e
ta op
loi pr
xp al
l e ctu
cia lle
er te
m s in
om a
y c uch
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
d/
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Annex to Regulation 284/2013 MON 52276 M-CP, Section 10

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ep
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ut
Table 10.3.2-10: Off-field HQs for non-target arthropods (T. pyri and A. rhopalosiphi; Tier 2)

t rib
dis
exposed to MON 52276 in orchards (Uses: 4 a-c) – considering downward ground-directed spray

n,
er tio
wn lica
Crop Application Test species ER50 MAF 1 vdf PERoff-field 2 CF corr. PERoff-

.
s o ub
scenario pattern [g a.e./ha] (foliar) [g a.e./ha] below rate
field

f it y p
with ≤ 50 %

so n
ht , a
effect?

rig ntly
th ue
Stone and 1 × 720 g T. pyri > 4320 1 10 1.99 10 yes

e eq
pome fruit, a.e./ha

e
> 5760 1 19.9

lat ns
A. rhopalosiphi yes
fruit crops

vio . Co
an ime al.
2 × 1440 g T. pyri > 4320 1 10 3.98 yes

te reg new
a.e./ha > 5760 1 39.8 yes

oh tio re
A. rhopalosiphi

d
pr tec EU
a.e. glyphosate acid equivalents

ibi n
d
be ro te
PER: Predicted environmental rate, vdf: vegetation distribution factor; CF: correction factor

e ta p osa
1
MAF = 1.00 (considering at least a 28 day interval and a DT50 of 2.8 days)

ef da ph
2
PER (g a.e./ha) based on drift rate of 2.77 % at 1 m from the application area considering downward ground directed spray

er y ly
th tor G
ay ula the

or
t m reg king
Table 10.3.2-11: Off-field HQs for non-target arthropods (T. pyri and A. rhopalosiphi; Tier 2)

m er see
exposed to MON 52276 in vineyards (Uses: 5 a-c) – considering downward ground-directed spray

do ll u tium
en a
cu nd
his fa or
Crop Application Test species ER50 MAF 1
f t ay ns
r o m co vdf PERoff-field 2 CF corr. PERoff-field
scenario pattern [g a.e./ha] (foliar) [g a.e./ha] below rate with
ne ent he

≤ 50 % effect?
ow um of t
th oc (s)

Table and 1 × 1080 g T. pyri > 4320 1 10 8.66 10 yes

of is d ber

wine grapes a.e./ha > 5760 1 86.6 yes

ion , th em

A. rhopalosiphi
iss ore m

2 × 1440 g T. pyri > 4320 1 10 3.98 yes

rm m er
pe her orm

a.e./ha A. rhopalosiphi > 5760 1 39.8 yes

he rt t/f

a.e. glyphosate acid equivalents

t t Fu en
ou s. rr

PER: Predicted environmental rate, vdf: vegetation distribution factor; CF: correction factor
th tie cu

1
MAF = 1.00 (considering at least a 28 day interval and a DT50 of 2.8 days)
wi par (a)

2
PER (g a.e./ha) based on drift rate of 2.77 % at 1 m from the application area considering downward ground directed spray
f
en ird o
nt th rty
co and ope
r

ts
r i er p

Table 10.3.2-12: Off-field HQs for non-target arthropods (T. pyri and A. rhopalosiphi; Tier 2)
t o wn the

exposed to MON 52276 in railroad tracks (Uses 7a-c) – considering downward ground-directed
en o s
m he t i

spray
cu f t en

ts
do s o um
is ht c
th rig s do

Crop Application Test species ER50 MAF 1 vdf PERoff-field 2 CF corr. PERoff-
i
e op Th

scenario pattern [g a.e./ha] (foliar) [g a.e./ha] below rate

field
with ≤ 50 %
of y

effect?
us c
d nd
an a

Field crops 1 × 1800 g T. pyri > 4320 1 10 4.99 10 yes

n rty

(Railroad a.e./ha
tio e

A. rhopalosiphi > 5760 1 49.9 yes

ta op

tracks)
loi pr

2 × 1800 g T. pyri > 4320 1 10 4.99 yes

xp al
l e ctu

a.e./ha A. rhopalosiphi > 5760 1 49.9 yes

cia lle
er te

a.e. glyphosate acid equivalents

m s in

PER: Predicted environmental rate, vdf: vegetation distribution factor; CF: correction factor
om a

1 MAF = 1.00 (considering at least a 28 day interval and a DT of 2.8 days)

y c uch

50
2 PER (g a.e./ha) based on drift rate of 2.77 % at 1 m from the application area considering downward ground directed spray
an ts s
an righ
d
ing to
sh ct
bli bje
pu su
or be

Glyphosate Renewal Group AIR 5 – July 2020 Doc ID: 110054-MCP10_GRG_Rev 1_Jul_2020
an may
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ep
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ut
t rib
dis
Table 10.3.2-13: Off-field HQs for non-target arthropods (T. pyri and A. rhopalosiphi; Tier 2)

n,
exposed to MON 52276 for the control of invasive species (Uses 8 and 9) ) – considering downward

er tio
wn lica
ground-directed spray

.
s o ub
f it y p
so n
Crop Application Test species ER50 MAF 1 vdf PERoff-field 2 CF corr. PERoff-field

ht , a
rig ntly
scenario pattern [g a.e./ha] (foliar) [g a.e./ha] below rate with

th ue
≤ 50 % effect?

e eq
e
lat ns
Field crops 1 × 1800 g T. pyri > 4320 1 10 4.99 10 yes

vio . Co
an ime al.
(Invasive a.e./ha

te reg new
species A. rhopalosiphi > 5760 1 49.9 yes

oh tio re

d
control)

pr tec EU
ibi n
a.e. glyphosate acid equivalents

d
be ro te
e ta p osa
PER: Predicted environmental rate, vdf: vegetation distribution factor; CF: correction factor
1 MAF = 1.00 (considering at least a 28 day interval and a DT of 2.8 days)

ef da ph
50

er y ly
2
PER (g a.e./ha) based on drift rate of 2.77 % at 1 m from the application area considering downward ground directed spray

th tor G
ay ula the

or
t m reg king
For Aphidius rhopalosiphi and Typhlodromus pyri, the trigger value of HQ ≤ 1 demonstrates that no

m er see
unacceptable effects are expected from the proposed uses of MON 52276 considering in-field or off-field

do ll u tium
en a
habitats of field crops, orchards, vineyards, railroad tracks and agricultural/non-agricultural areas for the

cu nd
his fa or
control of invasive species. No further testing is required. f t ay ns
r o m co
ne ent he

Indirect Effects via trophic Interactions

ow um of t

The ecotoxicology regulatory study database for the representative formulation (MON 52276) includes
th oc (s)
of is d ber

guideline studies and risk assessment methodology that was designed to assess potential direct and indirect
ion , th em

effects on beneficial insect communities (ESCORT 2, 2000). For the Tier 1 NTA assessment, studies were
iss ore m

conducted using ecologically important and highly sensitive indicator species of adverse effects (Table
rm m er
pe her orm

10.3.2-1). Then at Tier II (extended studies) additional levels of realism were introduced into the exposure
he rt t/f

scenario, by intrudcing exposure on leaf-based substrates. Specific protection goals (SPGs) for non-target
t t Fu en

arthropods (NTAs) were developed at the ESCORT 2 and 3, (2000 and 2010) workshops, with separate
ou s. rr
th tie cu

SPGs developed for athropods occurring in the crop / in-field and off the crop / off-field. SCORT 3 saw
wi par (a)

further distinction between in-field and off-field scenarios. It was considered practical by the experts during
f
en ird o
nt th rty

the ESCORT 3 workshop to make distinctions and recognize trade-offs between in-crop and off-crop and
co and ope

in-field and off-field area, given the differences in the socio-economic and ecological functions of these
r

ts
r i er p

two distinct areas. This is consistent with the recommendation of the EFSA problem formulation workshop
t o wn the

that was convened to prepare guidance that would inform the development of SPGs (EFSA, 2010).
en o s
m he t i
cu f t en

ts
do s o um

The first SPG from the ESCORT workshop addresses in-crop applications, where the goal is to maintain
is ht c
th rig s do

pest control (i.e., activity of parasitoids and predators) and to also provide a food source for wildlife -
i

minimizing indirect effects through trophic interactions. In turn the aim here is to enable an in-crop NTA
e op Th

community to recover (Table 10.3.2-44 to Table 10.3.2-88).

of y
us c
d nd

The in-crop measurement endpoint and risk assessment procedures developed to achieve this SPG, allow
an a
n rty

for a maximum of a 50 % direct effect on individuals in-crop from a Tier 1 - 2 assessment approach. At the
tio e
ta op

1st tier lethality effects are considered, whilst at the second tier, impacts on reproduction are considered.
loi pr

The rationale for 50 % effect threshold for direct effects, is based on the principle that this level of effect
xp al
l e ctu

would allow for in-field recovery via immigration of beneficial insects from the off-field areas to the in-
cia lle

field areas, or from in-field / off-crop areas, where for example, a no spray buffer in-field / off-crop buffer
er te
m s in

is included, thereby enhancing recovery.

om a
y c uch

The second SPG was derived to protect the off-crop NTA community, with the goal to maintain NTA
an ts s
an righ

biodiversity off-crop to facilitate in-field recovery of non-target arthropod species (Table 10.3.2-99 to Table
10.3.2-133).
d
ing to
sh ct
bli bje
pu su
or be

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Scientific Literature that informs the NTA assessment

dis
The scientific literature review conducted for the last Annex I renewal (submitted in 2012) that appears in

n,
er tio
the RAR (2015) contains an extensive review of ecotoxicological papers considered relevant but

wn lica
.
supplementary to the Annex I renewal.

s o ub
f it y p
so n
These papers presented information that could not be relatable to an EU level ecotoxicological risk

ht , a
rig ntly
assessment, but that were considered in the previous dossier, where they were also evaluated by the previous

th ue
RMS (UBA). A further evaluation of these reviewed literature has not been conducted. The previous

e eq
e
lat ns
literature review has been submitted as part of the Literature review requirements and is presented in Annex

vio . Co
an ime al.
M-CA 8-01 of the document M-CA Section 8.

te reg new
oh tio re

d
Literature review for non-target arthropods from the previous Annex I (2012) submission.

pr tec EU
ibi n
In the area of arthropods other than bees, a total of 31 peer reviewed papers were submitted, with no paper

d
be ro te
e ta p osa
considered relevant for use in risk assessment. The RMS (UBA) re-evaluated the submitted papers with 11

ef da ph
papers recognised as information having a low weight and a further 7 publications being considered as

er y ly
th tor G
supportive information.

ay ula the

or
t m reg king
In the evaluation of the literature from the previous Annex I submission, the RMS (UBA) indicated that

m er see
indirect effects on beneficial arthropod communities take place within treated areas and are principally

do ll u tium
en a
due to vegetation changes subsequent to herbicide application. These vegetation changes, mainly

cu nd
his fa or
decomposition / loss of plant cover, might result in a drastic reduction of the habitats of beneficial
f t ay ns
and other non-target arthropod communities and a loss of their refuges from predators. This would
r o m co
ne ent he

anyway be the case if a non-chemical means of weed control was applied.

ow um of t