Official Journal EN

of the European Union L series

2024/261 18.1.2024

COMMISSION IMPLEMENTING REGULATION (EU) 2024/261

of 17 January 2024
concerning the authorisation of black pepper essential oil and black pepper oleoresin from Piper
nigrum L. as feed additives for all animal species and black pepper supercritical extract from Piper
nigrum L. as a feed additive for cats and dogs

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on
additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the
grounds and procedures for granting such authorisation. Article 10(2) of that Regulation provides for the
re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2) The substances black pepper essential oil and black pepper oleoresin from Piper nigrum L. and black pepper
supercritical extract from Piper nigrum L. were authorised without a time limit in accordance with
Directive 70/524/EEC as feed additives for all animal species. These substances were subsequently entered in the
Register of Feed Additives as existing products belonging to the category ‘sensory additives’ and to the functional
group ‘flavouring compounds’, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.

(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an
application was submitted for the authorisation of black pepper essential oil, black pepper oleoresin and black
pepper supercritical extract from Piper nigrum L. as feed additives for all animal species, requesting the additives to
be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That
application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC)
No 1831/2003. The applicant subsequently withdrew the application for authorisation of black pepper
supercritical extract from Piper nigrum L. as regards the use for all animal species except cats and dogs.

(4) The applicant requested the additives to be authorised for use also in water for drinking. However, Regulation (EC)
No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore,
the use of those additives in water for drinking should not be allowed.

(5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 September 2022 (3) that, under
the proposed conditions of use, black pepper essential oil, black pepper supercritical extract and black pepper
oleoresin from Piper nigrum L. are safe for the target species, consumers and the environment. It also concluded that
black pepper essential oil, black pepper supercritical extract and black pepper oleoresin should be considered as
irritant to skin and eyes, and as dermal and respiratory sensitisers. The Authority further concluded that since the
substances are recognised to flavour food and since their function in feed would be essentially the same as that in
food, no further demonstration of efficacy is considered necessary. It also verified the report on the method of
analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC)
No 1831/2003.

(1) OJ L 268, 18.10.2003, p. 29.

(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3) EFSA Journal 2022;20(11):7599

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(6) In view of the above, the Commission considers that black pepper essential oil, black pepper oleoresin and black
pepper supercritical extract from Piper nigrum L. satisfy the conditions provided for in Article 5 of Regulation (EC)
No 1831/2003. Accordingly, the use of these substances should be authorised. The Commission considers that
safety reasons do not require the setting of maximum levels for the substances concerned. The large margin of
exposure and the lack of substances of concern permit to establish maximum recommended contents. In order to
allow better control, the recommended maximum content should be indicated on the label of the feed additives.
Where such contents are exceeded, certain information should be indicated on the label of the premixtures
concerned. In addition, the Commission considers that appropriate protective measures should be taken to prevent
adverse effects on the health of the users of the additives.

(7) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation
of the substances concerned, it is appropriate to provide for a transitional period for interested parties to prepare
themselves to meet the new requirements resulting from the authorisation.

(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group
‘flavouring compounds’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Transitional measures

1. The substances specified in the Annex and premixtures containing those substances, which are produced and labelled
before 7 August 2024 in accordance with the rules applicable before 7 February 2024 may continue to be placed on the
market and used until the existing stocks are exhausted.

2. Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled
before 7 February 2025 in accordance with the rules applicable before 7 February 2024 may continue to be placed on the
market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3. Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled
before 7 February 2026 in accordance with the rules applicable before 7 February 2024 may continue to be placed on the
market and used until the existing stocks are exhausted if they are intended for non-food producing animals.

Article 3

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.

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OJ L, 18.1.2024 EN

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 January 2024.

For the Commission

The President
Ursula VON DER LEYEN

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 ANNEX
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EN
Minimum Maximum
content content
Identification Species or
Composition, chemical formula, Maximum mg active substance/kg End of period of
number of the Additive category of Other provisions
description, analytical method age of complete feed with a authorisation
additive animal
moisture content of
12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b347-eo Black pepper Additive composition All animal — — — 1. The additive shall be incorporated into the feed in 7 February 2034
essential oil species the form of a premixture.
Black pepper essential oil obtained 2. In the directions for use of the additive and pre­
from fruits of Piper nigrum L. mixtures, the storage conditions and stability to
heat treatment shall be indicated.
Liquid form 3. On the label of the additive, the following shall be
indicated:
Characterisation of the active substance ‘Recommended maximum content of the active
substance per kg of complete feedingstuff with a
Black pepper essential oil obtained by moisture content of 12 %:
steam distillation of dried and — 5 mg for chickens for fattening and minor
crushed unripe fruits from Piper poultry for fattening
nigrum L. as defined by the Council — 7 mg for turkeys for fattening
of Europe (1). — 8 mg for poultry for laying and breeding pur­
poses,
Specifications: — 9,5 mg for piglets, piglets of minor Suidae and
— b-Caryophyllene: 12-40 % pigs for fattening of minor Suidae
— Limonene: 7-20 % — 11,5 mg for pigs for fattening
— Sabinene (4(10)-thujene): 4-17 % — 14 mg for sows
ELI: http://data.europa.eu/eli/reg_impl/2024/261/oj

— a-Pinene (pin-2(3)-ene): 2,5-16 % — 14 mg for dairy cows and minor dairy rumi­
— Safrole: ≤ 0,0003 % nants, except dairy sheep and goats
— 20 mg for ruminants for fattening, except
CAS number: 8006-82-4 sheep and goats
FEMA number: 2845 — 20 mg for sheep and goats
CoE number: 347 — 20 mg for horses
— 8,5 mg for rabbits
— 20 mg for fish

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OJ L, 18.1.2024
Analytical method (2) — 20 mg for dogs and cats
— 5 mg for ornamental birds
For the determination of the — 5 mg for other animal species and categories.’
phytochemical marker 4. The functional group, the identification number,
β-caryophyllene: gas the name and the added amount of the active
chromatography coupled with flame substance shall be indicated on the label of the
ionisation detection (GC-FID)) based premixture where the use level on the label of
on ISO 3061. the premixture would result in exceeding the con­
tent referred to in point 3.
5. For users of the additive and premixtures, feed
business operators shall establish operational
procedures and organisational measures to ad­
dress the potential risks resulting from their use.
Where those risks cannot be eliminated by such
procedures and measures, the additive and pre­
mixtures shall be used with personal breathing,
eye and skin protective equipment.
(1) Natural sources of flavourings – Report No 2 (2007).
(2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

EN
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EN
Minimum Maximum
content content
Identification Species or mg of the active
Composition, chemical formula, Maxi-mum End of period of
number of the Additive category of substance/kg of Other provisions
description, analytical method age authorisation
additive animal complete feed with a
moisture content of
12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b347-ex Black pepper Additive composition Cats and — — — 1. The additive shall be incorporated into the feed in 7 February 2034
supercritical dogs the form of a premixture.
extract Black pepper supercritical extract 2. In the directions for use of the additive and pre­
obtained from fruits of Piper nigrum L. mixtures, the storage conditions and stability to
heat treatment shall be indicated.
Liquid form 3. On the label of the additive the following shall be
indicated:
Characterisation of the active substance ‘Recommended maximum content of the active
substance per kg of complete feedingstuff with a
Black pepper supercritical extract moisture content of 12 %: 1,5 mg for cats and
obtained by CO2 supercritical dogs.’
extraction from the dried and 4. The functional group, the identification number,
crushed unripe fruits of Piper nigrum the name and the added amount of the active
L. (with no additional solvent substance shall be indicated on the label of the
addition) as defined by the Council premixture where the use level on the label of
of Europe (1). the premixture would result in exceeding the con­
tent referred to in point 3.
Specifications: 5. For users of the additive and premixtures, feed
— β-Caryophyllene: 8-30 % business operators shall establish operational
— Limonene: 10-18 % procedures and organisational measures to ad­
ELI: http://data.europa.eu/eli/reg_impl/2024/261/oj

— Sabinene (4(10)-thujene): 5-17 % dress the potential risks resulting from their use.
— α-Pinene (pin-2(3)-ene):7-18 % Where those risks cannot be eliminated by such
— Safrole: ≤ 0,0003 % procedures and measures, the additive and pre­
mixtures shall be used with personal breathing,
CoE number: 347 eye and skin protective equipment.

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OJ L, 18.1.2024
Analytical method (2)

For the determination of the

phytochemical marker
β-caryophyllene: gas
chromatography coupled with flame
ionisation detection (GC-FID) based
on ISO 3061.
(1) Natural sources of flavourings – Report No 2 (2007).
(2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

EN
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EN
Minimum Maximum
content content
Identification Species or mg of the active
Composition, chemical formula, Maxi-mum End of period of
number of the Additive category of substance/kg of Other provisions
description, analytical method age authorisation
additive animal complete feed with a
moisture content of
12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b347-or Black pepper Additive composition All animal — — — 1. The additive shall be incorporated into the feed in 7 February 2034
oleoresin species the form of a premixture.
Preparation of black pepper oleoresin 2. In the directions for use of the additive and pre­
obtained from fruits of Piper nigrum L. mixtures, the storage conditions and stability to
Liquid form heat treatment shall be indicated.
3. On the label of the additive the following shall be
Characterisation of the active substance indicated:
‘Recommended maximum content of the active
Black pepper oleoresin produced by substance per kg of complete feedingstuff with a
organic solvent extraction of the moisture content of 12 %:
dried unripe fruits of Piper nigrum L. — 1 mg for chickens for fattening and minor
as defined by the Council of poultry species for fattening,
Europe (1). — 1,3 mg for turkeys for fattening
— 1,4 mg for poultry for laying and breeding
Specifications: purposes
— Piperine: 20-50 % — 1,7 mg for piglets, piglets of minor Suidae and
— Safrole: ≤ 0,0003 % pigs for fattening of minor Suidae
— 2 mg for pigs for fattening.
CAS number: 84929–41-9 — 2,5 mg for sows
FEMA number: 2846 — 2,4 mg for dairy cows and minor dairy rumi­
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CoE number: 347 nants, except dairy sheep and goats

— 12,5 mg for calves for fattening
Analytical method (2) — 11,5 for ruminants for fattening except sheep
and goats
For the determination of the — 11,5 mg for sheep and goats
phytochemical marker piperine: — 11,5 mg for horses
high performance liquid — 1,5 mg for rabbits
chromatography coupled to
photometric detection (HPLC-UV)
based on ISO 11027.

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OJ L, 18.1.2024
— 13,5 mg for salmonids and minor fin fish
— 51,5 mg for ornamental fish
— 14 mg for dogs
— 3,8 mg for cats
— 1 mg for ornamental birds
— 1 mg for other animal species or categories.’
4. The functional group, the identification number,
the name and the added amount of the active
substance shall be indicated on the label of the
premixture where the use level on the label of
the premixture would result in exceeding the con­
tent referred to in point 3.
5. For users of the additive and premixtures, feed
business operators shall establish operational
procedures and organisational measures to ad­
dress the potential risks resulting from their use.
Where those risks cannot be eliminated by such
procedures and measures, the additive and pre­
mixtures shall be used with personal breathing,
eye and skin protective equipment.
(1) Natural sources of flavourings – Report No 2 (2007).
(2) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

EN
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