1. The Current Legal Framework for Food Innovation in the EU: An Overview of EU Novel Food and GMO Legislation
Francesco Planchenstainer, JD PhD
Sr. Regulatory & Food Law Expert
Global Regulatory & Nutrition Science

2. Agenda Introduction to the EU legal framework for innovation 1
The Novel Food Regulation
The biotechnology regulatory framework
Future developments 2 3 4
MJN Confidential and Proprietary Information

3. Food innovation and regulations
Currently covered
Regulation (EC) no 2015/2283
Novel Food Regulation (EU) 2015/2283
Food Improvement Agents
Regulation (EC) no 1331/2008
Food Additives
Regulation (EC) no 1333/2008
Enzyme
Regulation
Regulation (EC) no 1332/2008
Cloning
(???)
Food Innovation
GMOs
Regulation (EC) no 1829/2003 and 1830/2003
Flavoring Substances
Regulation (EC) no 1334/2008

4. EU legal framework for food innovation
2018
Regulation (EC) no 258/1997
Regulation (EC) no 1329/2003 and 1330/2003
Regulation (EU) 2015/2283
Novel Foods
GMOs
Nanomaterials
MJN Confidential and Proprietary Information

5. Agenda Introduction to the EU legal framework for innovation 1
The Novel Food Regulation
The biotechnology regulatory framework
Future developments 2 3 4
MJN Confidential and Proprietary Information

6. The old Regulation (EC) no 258/1997
Rationale for a change
Regulation (EC) no 258/1997 in force for almost 20 years
Lack of clarity about ‘history of use’
Barriers for Novel Foods from third countries
Long approval time
Most applications took almost 2 years to be approved
Botanicals and plant variety with long history of safe use outside the EU had to undergo a long authorization process
Duplication of assessments
MS safety review + EFSA evaluation and European Commission decision
Authorization addressed to applicants only
If other applicants wanted to use the same ingredient, they had to file a ‘substantial equivalence petition’

7. Regulation (EU) 2283/2015 background
How we got where we are today
Long legislative process started in 2008
Deadlock between the European Parliament and the European Council on cloning
Strong request for nano-materials regulation
Wide stakeholders’ participation
Industry and consumer’s organizations consulted by the European Commission
Goals of Regulation (EU) 2283/2015 include:
Reducing authorization time
Fostering innovation
Reducing barriers to Novel Foods which are traditional foods in non-EU countries

8. Overview of Regulation (EU) 2283/2015
Definition of Novel Food
‘Novel Food’ is:
‘a food that was not used for human consumption to a significant degree within the EU before 15 May 1997; and
Falling into one of the following categories
food with a new or intentionally modified molecular structure,
food consisting of, isolated from or produced from microorganisms, fungi or algae;
food consisting of, isolated from or produced from material of mineral origin;
food consisting of, isolated from or produced from plants or their parts;
food consisting of, isolated from or produced from new animals or their parts;
food consisting of, isolated from or produced from new cell culture or tissue culture derived from animals, plants, micro organisms, fungi or algae
food from a novel production process
food consisting of engineered nanomaterials
vitamins, minerals and other substances when produced with novel production process
food used exclusively in food supplements before 15 May 1997
MJN Confidential and Proprietary Information

9. Overview of Regulation (EU) 2283/2015
Definition of Novel Food
The following compounds aren’t in the scope of the regulation:
GMOs;
food enzymes;
food additives
food flavorings
extraction solvents used or intended to be used in the production of foodstuffs or food ingredients
But they may be considered as Novel Foods:
if employed for a different intended use or
E.g., Lycopene: used for technical purposes = additive / used as a nutrient = Novel Food
E.g., Stevia leaves = Novel Food / Steviol glycosides = additive
manufactured in a different way
E.g., vitamins produced with annotative manufacturing processes
MJN Confidential and Proprietary Information

10. Overview of Regulation (EU) 2283/2015
Safety of Novel Foods
A Novel Food must not:
pose a safety risk to human health
be misleading for consumer
be nutritionally disadvantageous for the consumer when it replaces another food
Precautionary Principles (Article 7 of Regulation (EC) no 178/2002)
EU must ensure the ‘high level of health protection’
Scientific uncertainty warrants risk management measures
Onus of demonstrating safety of the innovation on the applicant
MJN Confidential and Proprietary Information

11. Overview of Regulation (EU) 2283/2015
Union List of Novel Foods
The Union List is constantly updated by the Commission
Name of the manufacturer and address (if data protection granted)
The Union List may be updated:
The European Commission may update the Union List at any time
On Member States request
On applicant’s request
Adding a new Novel Food
On third Country request
Erasing a Novel Food
By the European Commission independently
Adopting post-marketing measures
The Union List contains:
Authorized Novel Foods under old regulation  as general Novel Foods in the Union List
Name of the food
Composition
Condition of use (e.g., intended population, labeling, etc….)
MJN Confidential and Proprietary Information

12. Provision fostering innovation
Confidentiality
Data protection
Applicant may request that certain information is kept confidential
Certain information cannot be kept confidential
Composition of Novel Food
Condition of use
Summary of safety data
Restriction by third countries
Applicant may withdraw the submission in case of disagreement
European Commission may adopt an implementing act regulating this topic
European Commission may grant a 5 years exclusive use of the innovation
Nor applicable to traditional foods from third countries
Requirements:
Submission is based on proprietary data
Applicant enjoys exclusive use of the data
EFSA deems that the Novel Food could not have been approved without proprietary data
Competitor may obtain authorization based on new or different data

13. Engineered Nano-materials
Ad hoc rules
Current situation:
Regulation of nano-materials by Regulation (EU) 2011/1169 on food information to consumers (FIC)
Definition and labelling requirement until January 1, 2018
Future:
Definition will be deleted from FIC Regulation
FIC regulation will incorporate per reference the new definition in Novel Food Regulation
Commission empowered to update the definition in light of the scientific and technical progress with delegated acts

14. Authorization procedure
Risk Management
New Novel Foods
Combined Health Claimed petition
Draft Decision submitted to the PAFF Committee for endorsement (qualified majority)
7 mo
The European Commission adopts an Implementing Decision adding the Novel Food to the Union List
Aye
1/2 mo (est)
The European Commission verifies the validity of the dossier
EFSA is tasked to deliver an opinion, which is circulated to the MSs
1 mo
Applicants submits a dossier to the European Commission
The European Commission drafts a Decision based on EFSA assessment
9 mo
Risk Assessment
Nay
Novel Food not authorized / Cannot be placed on the market

15. Authorization procedure
Traditional foods from third countries
Application resumes following authorization procedure
Applicant requested to submit additional information
Reasoned
Objections
Commission informs the applicant about the objections
EFSA and MSs review the notification
1 mo
Applicant submits a notification concerning a traditional food
The European Commission verifies the validity of the notification
4 mo
No objection
Commission includes the food in the Union List
1 mo

16. Novel Foods Dossier Outline
Draft EFSA Guidance
Introduction
Description of the Novel Food
Production Process
Compositional Data
Specifications
History of use of the Novel Food and of its source
Proposed uses and use levels and anticipated intake
Absorption, distribution, metabolism, and excretion (ADME)
Nutritional information
Toxicological information
Allergenicity
Concluding remarks

17. Regulatory issues waiting for a solution
Problems that the European Commission is expected to address
Proprietary data
European Commission → ‘Published data cannot be claimed as proprietary’ (2009)
European Commission currently revising its position
Risk: increased unpublished safety data
Confidentiality
The Regulation introduces increased transparency and much information will be publicly available (analytical methods)
The Regulation requires European Commission and EFSA to ensure confidentiality but no operational rules are provided yet
MJN Confidential and Proprietary Information

18. Regulatory issues waiting for a solution
Problems that the European Commission is expected to address
Extracts
In the past, European Commission held the view that some extracts were not novel (e.g., aqueous extractions), meanwhile others weren’t (e.g., extraction with hexane)
Reduction of animal studies
Regulations recommend keeping animal studies at the bear minimum
But authorities across the world request for different animal data (e.g. FDA)
Compliance with authorize Novel Foods left to the manufacturer
Do small variations in composition trigger the need for a new submission?
MJN Confidential and Proprietary Information

19. Regulation (EU) 2283/2015 milestones
Upcoming deadlines
EFSA expected to adopt the final Guidance for submission and final guidance on Novel Foods from third countries
Submissions must follow old rules
Sep 2016
By 2017
Until
2018
Jan
2018
European Commission expected to adopt the implementing rules on administrative requirements for dossier submission and consultation with Member States
New rules enter in force
MJN Confidential and Proprietary Information

20. EU vs. the Rest of the World
No Codex Standard exists for new food applications (with exception of GMOs)
All countries have in place rules to review the use of new ingredients in food
Rules may be based on a self-assessment by the supplier (e.g., USA) or formal approval process with a safety review by authorities (e.g., EU)
Novel Food
(Health Canada)
Novel Food
(EFSA/EC)
GRAS
(FDA)
Nutrition fortifier (CFDA)
New Raw Material (NHFPC)
Novel Food
(ANVISA)
Non-traditional food
Novel Food
(FSANZ)
MJN Confidential and Proprietary Information

21. Agenda Introduction to the EU legal framework for innovation 1
The Novel Food Regulation
The biotechnology regulatory framework
Future developments 2 3 4
MJN Confidential and Proprietary Information

22. Main Regulatory References on GMOs
Codex, WHO/FAO
Safety assessment and approval procedures
Codex, Cartagena Convention
Labeling
Codex, Cartagena Convention
Post-market surveillance
Codex, OECD
Detection Methods
Cartagena Convention
Traceability
MJN Confidential and Proprietary Information

23. Global Regulatory References on GMOs
At an international level
Standards by Codex Alimentarius Commission
Principles for the Risk Analysis of Foods Derived From Modern Biotechnology (CAC/Gl )
Guideline for the Conduct of Food Safety Assessment of Foods Derived From Recombinant-DNA Plants (CAC/Gl )
Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Micro-Organisms (CAC/Gl )
Guideline for the Conduct of Food Safety Assessment of Foods Derived From Recombinant-DNA Animals (CAC/Gl )
Guidelines on Performance Criteria and Validation of Methods for Detection, Identification and Quantification of Specific DNA Sequences and Specific Proteins in Food (CAC/GL )
Compilation of Codex Texts Relevant to Labelling of Foods Derived from Modern Biotechnology (CAC/GL )
MJN Confidential and Proprietary Information

24. Regulatory Environment on GMOs
Codex Alimentarius
SAFETY ASSESSMENT
Substantial equivalence test
Human health
Environmental impact
Socio-economical/ethical aspects
Broader Safety assessment (i.e. animal welfare, religious values)
GM PLANTS
NON-PLANT GMOs
GM animals &
GM Microorganisms (GMMs)
POST MARKET
MEASURES
Detection methods
Labeling
Now national labeling regulations are allowed
MJN Confidential and Proprietary Information

25. Regulatory Environment on GMOs
At an international level
WTO → Regulates international trade
GM food is as safe as traditional food (no phitosanitary measure may be adopted under SPS);
Biotech dispute settled in 2003 (USA, Canada, Argentina v. EU);
No more barrier to GMOs trade.
Cartagena Protocol → Regulates biosafety of LMOs
Rules movement across countries of Living Modified Organisms (LMOs);
Traceability, record keeping, labeling.
Food operator is liable in case of an unauthorized release of a LMO
OECD → Fosters cooperation among developed countries
Detection methods based on Polymerase Chain Reaction (PCR) and Enzyme-Linked Immunosorbent Assay (ELISA)
Database of GMO events
MJN Confidential and Proprietary Information

26. Regulatory Environment on GMOs
3 models for countries
EU: process-based approach
Premarket approval
Traceability
Labeling
USA: substantial equivalence
Substantial equivalence
Voluntary consultation with FDA
Labeling only for allergens
Non-GMO labeling possible (voluntary)
Australia-New Zealand: product-based approach
Labeling (only if DNA/ protein present in final product)
MJN Confidential and Proprietary Information

27. Substantial equivalence Process-based approach
3 model countries
Substantial equivalence
Final products although derived from GMOs are substantial equivalent to their traditional counterpart (no matter how is produced). No specific labeling is required.
Process-based approach
Foodstuffs processed from biotechnology are Novel Foods: they must be approved and labeled as GMO (even if the new DNA trait is absent in final product)
Product based approach
Foodstuffs derived from authorized GMOs with no new DNA in final product are considered substantial equivalent to the counterpart. Mandatory labeling when DNA and or novel protein is present in final product
MJN Confidential and Proprietary Information

28. The EU biotech regulatory framework
Regulation (EC) no 178/2002
General Food Law (GFL)
Directive 2001/18/EC
Release of GMOs into the environment
Regulation (EC) no 1829/2003
GMO approval
Regulation (EC) no 1830/2003
GMO labeling
Regulation (EC) no 1946/2003
GMO transboundary movement
Directive 2009/41/EC
Contained use of GMMs
Directive (EU) 2015/412
Restrictions to GMO cultivation
MJN Confidential and Proprietary Information

29. MJN Confidential and Proprietary Information
What is a GMO?
Definitions
Article 3(1) of Regulation 1830/2003 incorporates per reference the definition of GMO found in Directive 2001/18/EC on deliberate release of GMOs in the environment;
Article 2(2) of Directive 2001/18/EC defines a GMO as:
an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination;
Techniques include:
recombinant nucleic acid techniques involving the formation of new combinations of genetic material
techniques involving the direct introduction into an organism of heritable material prepared outside the organism
cell fusion (including protoplast fusion) or hybridization techniques
Excluded:
in vitro fertilization
natural processes such as conjugation, transduction, transformation etc…
polyploidy induction
MJN Confidential and Proprietary Information

30. Main rules concerning the use of GMOs
Premarket approval and safety requirements
All GMOs must undergo a premarket approval before being placed on the market
Directive 2001/18/EC  approval of GMOs deliberate release into the environment
Regulation (EC) no 1829/2003  approval of GMOs for the intended use in food and feed
‘One door, one key’ principle  Single application possible both for cultivation and food use (when application falls under Regulation (EC) no 1829/2003
GMOs must not (Article 16 of Regulation (EC) no 1829/2003):
have adverse effects on human health, animal health or the environment;
mislead the consumer;
harm or mislead the consumer by impairing the distinctive features of the animal products;
differ from feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for animals or humans
GMOs likely to be used both in food and feed (e.g., corn) must be authorized accordingly
MJN Confidential and Proprietary Information

31. MJN Confidential and Proprietary Information
Traceability rules
Provisions in Regulation (EC) no 1830/2003
Traceability  basic requirement of General Food Law (Article 18)
The general objectives are to facilitate:
control and verification of labelling claims
Post-market surveillance of adverse effects on health and the environment
Rapid withdrawal of products in case unforeseen risks are established
Food business operators must provide to subsequent recipients information about:
each of the food ingredients which is produced from, contains or consist in GMOs;
GMO identifier needed if food contains or consist in GMOs
each of the feed materials or additives which is produced from GMOs;
the fact that the product is produced from GMOs (in case of list of ingredients is missing)
Food business operators must maintain records on subsequent recipient of GMO and GM foods (5 years retention)
MJN Confidential and Proprietary Information

32. MJN Confidential and Proprietary Information
Labeling rules
Provisions in Regulation (EC) no 1830/2003
All pre-packaged food products consisting of or containing GMO must indicate on the label
All products derived from GMOs must be labelled irrespective of the DNA/novel protein content in the final product
‘This product contains genetically modified organisms’ or
E.g. Ultra-refined soybean oil or corn syrup  GMO
‘This product contains genetically [(name of organism(s)]’
Products containing <0.9% approved GM material do not need to be labeled
provided that the presence of the material is adventitious or technically unavoidable
E.g. commingling on cargos carrying GMO and conventional commodities
MJN Confidential and Proprietary Information

33. Exception to the labeling rules
Biotech applications that don’t trigger labeling requirements
Exception
Rationale
Enzymes from genetically modified origin
In the scope of Regulation (EC) no /2004
Technological/ processing aids from genetically modified origin
Recital 16 of Regulation (EC) /2003
Foods produced by fermentation using GMMs (genetically modified micro-organisms) under contained conditions (cf. Directive 2009/41/EC) not present in the final product
Conclusions of the Standing Committee on the Food Chain and Animal Health, section on Genetically Modified Food and Feed and Environmental Risks of September 24, 2004
Animal products (e.g., milk) derived from animals fed with GMO feed or treated with GMO-derived drugs
Article 3.1 and Recital 16 of Regulation (EC) No 1829/2003

34. Documentation requirements
How to prove to authorities that a product is non-GMO
Non-GMO
A GMO variety exists
(e.g. soybeans)
A GMO variety doesn’t exist
(e.g. sunflower)
Supplier’s certification
Identify Preserved Certificate
No need for additional documentation
0.9% threshold may be present as a result of adventitious or unavoidable presence (accidental commingling)

35. Recent developments Still low acceptance for GMOs by EU consumers
The future of GMO cultivation
Still low acceptance for GMOs by EU consumers
Directive (EU) 2015/412 allows MS to restrict the cultivation of GMOs in their territories
During a GMO authorization a MS may ask to exclude part of or all its territory;
After authorization, MS may opt out measures restricting GM crops on environmental, economical, sociological grounds
MS cannot block the free movement of approved GMOs
Principle of Free Circulation of Goods
MJN Confidential and Proprietary Information

36. Agenda Introduction to the EU legal framework for innovation 1
The Novel Food Regulation
The biotechnology regulatory framework
Future developments 2 3 4
MJN Confidential and Proprietary Information

37. Future developments Increasing influence of the EU on non-EU countries
What to expect from the future
Increasing influence of the EU on non-EU countries
Many non-EU countries (e.g., China) follow the example provided by the EU
Cloning still waits to be regulated by the European Parliament and European Council
Stalemate likely to endure due to European Parliament fierce opposition
Increasing scholarship on nano-materials
Are nano-materials our next GMOs?
REFIT exercise
European Commission is evaluating the effectiveness of European regulations in protecting human health and fostering economic growth
TTIP may have an impact on regulation of innovation
Discrepancies between GRAS submission process and Novel Food authorization procedure
MJN Confidential and Proprietary Information

38. Thanks for your attention!
MJN Confidential and Proprietary Information