Food Law
& pre-market prior authorisation and approval schemes
Dr Hanna Schebesta
all kinds
of laws
... For which areas does the
EU have authorization
procedures?
other stuff
Novel Food
GMO
Additives,
enzymes,
flavourings,
extraction
solvents
Aims of the session
▪ Participants have an insight in market authorisation schemes
▪ Participants can recognise situations in which market-authorisation
schemes apply
▪ Participants can identify the steps to be taken in the different
authorisation procedures
Readings
▪ Regulation 2015/2283 ‘Novel Foods Regulation’
▪ Directive 2001/18/EC ‘GMO Directive’
▪ Regulation 1829/2003 ‘GMO Regulation’
▪ Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility
for Member States to restrict or prohibit the cultivation of genetically modified
organisms (GMOs) in their territory
▪ Case C-528/16, GMO interpretation [25 July 2018] ECLI:EU:C:2018:20
Aims of this week and agenda
1. General Food Law – the EU food market
2. General introduction and the ‘philosophy’ behind having
authorizations
3. GMO
4. Novel Food applications
5. Food Improvement Agents Package
1 General introduction – EU Food Market
... From the point of view of
the General Food Law, what
is the basic principle of
placing food on the market?
Structure GFL - Businesses
Article 17 (1) – obligation to
comply with Food Law
Article 14 – unsafe
food may not be
placed on the market
Article 19 -
responsibilities
General principle for placing food on the market
▪ Food shall not be placed on the market if it is
unsafe
Article 14(1) General Food Law
Food is unsafe if it ....
▪ True/False - has an unusual strong odour
▪ True/False – there is a fingernail in it
▪ True/False – if it has mold on it
Food is unsafe if it is .... (Article 14(2) GFL)
▪ (a) injurious to health
▪ (b) unfit for human consumption
Food is unsafe if it is .... (Article 14(2) GFL)
▪ (a) injurious to health
▪ (b) unfit for human consumption
To determine safety, we look at.... ?
Food is unsafe if it is .... (Article 14(2) GFL)
▪ (a) injurious to health
▪ (b) unfit for human consumption
To determine safety, we look at.... ?
Article 14(3) → normal conditions of the food; information provided
Food is unsafe if it is .... (Article 14(2) GFL)
▪ (a) injurious to health
Food is unsafe if it is .... (Article 14(2) GFL)
▪ (a) injurious to health (Article 14(4))
Food is unsafe if it is .... (Article 14(2) GFL)
▪ (a) injurious to health (Article 14(4))
“Food could be injurious to health without exceeding a particular legal limit. For example, this could apply
when glass, which is not a specifically banned substance, is found to be present in food, or if, for example,
a hazardous chemical not specifically identified by legislation on contaminants in food is found to be
present. “
“An example might be botulinum toxin in a manufactured food. Food could be injurious even if the harm
was cumulative or only became apparent over a long period of time, such as contamination with dioxins,
methyl mercury, or genotoxic carcinogens that could affect subsequent generations.”
https://ec.europa.eu/food/sites/food/files/safety/docs/gfl_req_implem
entation-guidance_en.pdf
Food is unsafe if it is .... (Article 14(2) GFL)
▪ (b) unfit for human consumption
Food is unsafe if it is .... (Article 14(2) GFL)
▪ (b) unfit for human consumption (Article 14(5) GFL)
Food is unsafe if it is .... (Article 14(2) GFL)
▪ (b) unfit for human consumption
“The central concept of unfitness is unacceptability. Food can be rendered unfit by
reason of contamination, such as that caused by a high level of non-pathogenic
microbiological contamination (see Article 14(3) and (5) of the Regulation), by the
presence of foreign objects, by unacceptable taste or odour as well as by more
obvious detrimental deterioration such as putrefaction or decomposition.”
Decomposing fish with a strong smell; or a fingernail in a sausage roll.
https://ec.europa.eu/food/sites/food/files/safety/docs/gfl_req_implem
entation-guidance_en.pdf
2 Authorisation rationale
... For placing a product on
the market, what does that
mean?
▪ Generally, food can
be placed on the
market...
▪ ... unless it is unsafe
= ‘free’ market
... Who, therefore, in first
instance is responsible for
deciding whether a food is
placed on the market?
▪ ex-ante self-assessment
by food business
operators
▪ ex-post official controls
and alerts
... Not unrestricted
Specific authorisation/approval schemes
▪ Genetically modified organisms
▪ Novel Foods
▪ Food Improvement Agent Package (Additives, enzymes, flavourings,
extraction solvents)
[product requirements]
...But also:
▪ Nutrition and Health claims [information requirements]
Relationship to the precautionary principle
....“prior approval (marketing authorisation) requirements on products
that they deem dangerous a priori reverse the burden of proving
injury, by treating them as dangerous unless and until
businesses do the scientific work necessary to demonstrate
that they are safe.” [COM Communication on Precautionary Principle]
Relationship to the precautionary principle
“the principle of prior approval (positive list) before the placing on the market of
certain products, such as drugs, pesticides or food additives. This is one way of
applying the precautionary principle, by shifting responsibility for producing
scientific evidence. This applies in particular to substances deemed "a priori"
hazardous or which are potentially hazardous at a certain level of absorption. In this
case the legislator, by way of precaution, has clearly reversed the burden of proof by
requiring that the substances be deemed hazardous until proven otherwise. Hence it
is up to the business community to carry out the scientific work needed to evaluate
the risk.” [COM Communication on Precautionary Principle]
Authorisation requirements
▪ 1962 onwards: colours, sweeteners & other additives ‘synthetic
foods’
▪ 1997: novel foods
▪ 2002: food supplements
▪ 2002 (GFL): general ban on unsafe food
▪ 2004: GMOs
▪ 2005: novel packaging
▪ 2008: enzymes, flavourings
▪ 2015: novel foods
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... Authorisation procedures
– general questions:
Across the different procedures, different
mechanisms
▪ Positive list, negative list, or individual products?
▪ Who can apply?
▪ Where to apply?
▪ Who has to provide scientific evidence for safety?
▪ Who assesses the safety (risk assessment)?
▪ Who takes the final decision (risk management)?
▪ How long is the authorisation valid?
Authorisation procedures
▪ General: ‘positive list’, made by legislator; companies can apply for
inclusion in the list; will be generally valid for everybody
▪ Individual: individual companies apply with specific products, their
application will be examined, and they are responsible
3 Genetically Modified Food
GMO EU legal framework
▪ Directive 2001/18/EC ‘GMO framework’ deliberate release into the
environment of genetically modified organisms
▪ Regulation 1829/2003 ‘GMO Regulation’ on genetically modified food
and feed
▪ Directive (EU) 2015/412 amending Directive 2001/18/EC as regards
the possibility for Member States to restrict or prohibit the
cultivation of genetically modified organisms (GMOs) in their
territory
▪ Case C-528/16, GMO interpretation [25 July 2018]
ECLI:EU:C:2018:20
Pre-market approval
▪ ‘One-door-one-key’
● EU-wide authorisation
● Environment & food safety risk assessment
● Cultivation and/or food & feed use in one go
GMO Authorisations
▪ Authorisations are valid throughout the EU and may be for:
● Cultivation
and/or
● Marketing of food and feed and derived products
Positive list
▪ http://ec.europa.eu/food/dyna/gm_register/index_en.cfm
... Break...
Case C-528/16
... What was Case C-528/16
about???
GMO EU legal framework
▪ Case C-528/16, GMO interpretation [25 July 2018]
ECLI:EU:C:2018:20
▪ Main question is: What can be considered a GMO under the EU
legislative framework for GMOs?
Examples of mutagenesis: CRISPR/Cas systems
GMO definition – Art. 2.2 Directive
4 Novel Food Authorisations
Knowledge about Novel Food Authorisations
▪ Take 3 minutes to browse the Regulation (for next sessions, I am
going to assume that you have done that!)
▪ Run through the list of ‘characteristics of authorisation procedures’
and find the answers for the novel food authorisation procedures
▪ Follow a ‘Food Business Operator’ journey that wants to market a
new product
Practice case
... Sorghum syrup is produced of
the sorghum plant; no products
containing this syrup are on the EU
market yet – therefore
FoodCompany is very excited to be
the first to bring this to the EU.
Material scope: Novel foods
▪ Not consumed in EU before 1997
● Modified molecular structure
● Micro organisms, fungi, algae
● Mineral origin
● Plants, Animals
● Cell culture
● Nanotechnology
● New production process
▪ Example: Becel pro-activ
Definition
▪ any food not used for human consumption to a significant degree
within the Union before 15 May 1997, irrespective of the dates of
accession of Member States to the Union, and that
falls under at least one of the following categories
Food Business Duty?
Union list
▪ Inclusion by European Commission
▪ Criteria
● The food does not, on the basis of the scientific evidence
available, pose a safety risk to human health
● Does not mislead consumer
● Not nutritionally disadvantageous
▪ Application by business (or initiative EC)
▪ Safety assessment by EFSA
Objectives of the new Novel Food Regulation
▪ Ensure food safety
▪ Functioning of the internal market
▪ Support innovation
▪ Streamline procedure
● Clarify definition
● No substantial changes …
● Simplified procedure for traditional foods from 3rd countries
(a.k.a. exotic foods)
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Novelty under new Regulation: Data protection
▪ Authorisation exclusive for 5 ● Not applicable to exotic
years, if based on foods
● Recently developed ▪ Request confidentiality
scientific evidence or ● Verifiable reasons
data
● 6 weeks to withdraw
● Proprietary application
● Exclusive right of use
● Necessary for
authorisation
Proprietary?
▪ Rationale: investment
▪ Interpretation EC. (at
claims): secret
▪ Problem:
● Against rationale
● Unscientific
Examples
▪ Three novel foods specifically targeted for use in special purpose
foods will be added to the Union list of authorized novel foods
following the Commission Regulations of 30 October 2018.
● Cranberry extract powder
● Shrimp peptide concentrate
● Bovine milk basic whey protein isolate shall be allowed in
infant and follow-on formulae, total diet replacement foods for
weight control, foods for special medical purposes as well as
food supplements.
Cranberry extract powder
▪ ... will be permitted for use in food supplements intended for adults.
The approval was obtained with protection of proprietary data
providing an exclusive authorization for the applicant Ocean Spray
Cranberries Inc. until November 2023. Other applicants may obtain
concurrent approval on the basis of legally obtained information
supporting safety substantiation.
▪ “... Is based on proprietary scientific evidence and scientific data
protected in accordance with Article 26 of Regulation (EU)
2015/2283”
Refined shrimp peptide concentrate
▪ Likewise, refined shrimp peptide concentrate whey protein isolate
are authorized for use with proprietary data protection to the benefit
of the applicants. The authorization of refined shrimp peptide
concentrate relates to food supplements only.
Bovine milk basic whey protein isolate
▪ Bovine milk basic whey protein isolate shall be allowed in infant and
follow-on formulae, total diet replacement foods for weight control,
foods for special medical purposes as well as food supplements.
Some housekeeping
- Database assignment, please
attach it to the Legal Brief 1
file you submit
- Tutorials: logistics will be
explained by announcement
today – strict observance of
hygiene rules expected at all
times!
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