Background info on Novel Foods and discussion of Commission proposal for new Novel Foods Regulation (Dec. 2013), including EP Report (Oct. 2014)

1. NOVEL FOODS
SEXY OR BURDENSOME
FOOD PRODUCTS?
Food Valley Expo
23 October 2014 Karin Verzijden en
www.axonadvocaten.nl

2. Agenda
• Legal framework Novel Foods
• Changes Ahead
• Practical Examples
Salvia Hispanica
2

3. Legal framework Novel Foods (1)
3
3 questions on Novel Foods
(1) What are Novel Foods?
(2) Why are they currently subject of debate?
(3) What are the most eminent concerns for consumers and industry?
The answers provided by MP’s from Brussels
http://europarltv.europa.eu/en/player.aspx?pid=20247771-2a5b-4577-95f3-
a3bd00ef67ed

4. Legal framework Novel Foods (2)
4
What are Novel Foods?
• Food and food ingredients that have not been used for human
consumption to a significant degree within the EU prior to 1997.
• Current Regulation 258/97 defines 4 categories: food / food ingredients
(1) with a new or intentionally modified primary molecular structure;
(2) consisting of or isolated from micro-organisms, fungi or algae;
(3) consisting of or isolated from plants / animals;
(4) to which a new production process has been applied, creating
significant changes in the composition / structure of the food
è affecting nutritional value / metabolism / undesirable substances

5. Legal framework Novel Foods (3)
5
Basic requirements Novel Foods should not
• present a danger for the consumer
• mislead the consumer
• differ from food / food ingredients that they intend to replace è normal
consumption should not be disadantageous for the consumer
Two types of authorisation procedures
• Full blown authorisation procedure based on scientific evidence
demonstrating that above criteria are met
• Simplified procedure based on “substantial equivalence”

6. Legal framework Novel Foods (4)
6
Granted authorisations
• Yellow fat spreads with added phytosterol-esters (Unilever, UK, 1998)
• Fruit preparations pasteurized using a high presssure treatment
(Danone, France, 1998)
• Coagulated potato protein and hydrolysates
thereof (Avebe, NL, 2001)

7. Legal framework Novel Foods (5)
7
Some more granted authorisations
• Whole Chia (Salvia hispanica L.) and Ground whole Chia
(R Craig and Sons, UK, 2003)
• Baobab (Adansonia digitata) dried fruit pulp
(Phyto Trade Africa, UK, 2006)
• Fermented black bean extract (Cantox Health Sciences
Int, UK, 2008)

8. Legal framework Novel Foods (6)
8
Guidance on Novel Food status
• EU Novel Foods Catalogue: non- exhaustive
list of food / food ingredients
èserves as an orientation if NF authorisation is required;
èhowever specific national legislation may apply
http://ec.europa.eu/food/food/biotechnology/novelfood/nfnetweb/
mod_search/index.cfm

9. Legal framework Novel Foods (7)
9
Further guidance to confirm Novel Food Status
• Information and Guidance document on “Human
consumption to a Significant Degree”
http://ec.europa.eu/food/food/biotechnology/novelfood/documents/
substantial_equivalence_en.pdf
è Established history of food use in > 1 MS è no NF authorization
è 15 May 1997 cut-off date applicable in all MS, independent from
accession date
è Products used for medicinal effects / food supplements are not food
(Regulation 258/97)

10. Changes Ahead (1)
10
• On 18 December 2013, Commission published a proposal for a new
Novel Foods Regulation.
• Major changes comprise:
(1) Food from cloned animals no longer covered;
(2) Change of definition of “Novel Food”;
(3) One centralized procedure for NF assessment and authorisation;
(4) Simplified procedure for marketing traditional foods from third countries;
(5) Introduction of data protection regime.
http://foodhealthlegal.com/?p=371

11. Changes Ahead (2)
11
Change # 1: Food from cloned animals no longer covered
• One of the NF categories under Regulation 258/97 is food / food
ingredients isolated from animals è heavily debated subject
• Debate was resolved by separating of food from cloned animals from
Novel Food framework. Instead:
(1) Directive on cloning of animals kept and reproduced for farming
purposes
(2) Directive on the placing on the market of food from animal clones
• Two Directives only allows cloning for:
(a) research and conservation of rare breads and endangered species
(b) production of pharmaceuticals and medical devices, where the use of
this technique can be justified.

12. Changes Ahead (3)
12
Change # 2: new definition of “Novel Food”
• No longer exhaustive enumeration of NF categories.
• Instead: 4 non-limitative categories consisting of:
(1) food to which a new production process is applied;
(2) food containing or consisting of engineered nanomaterials;
(3) vitamins and minerals to which a new production process has been
applied or containing or consisting of engineered nanomaterials;
(4) food exclusively used in food supplements in the EU prior to 1997,
where it is intended to be used in any other food.
Explanatory Memorandum, p. 7 è “It may be determined with the
examination procedure if a food falls within the scope of the Regulation”

13. Changes ahead (4)
13
Change # 3: centralized procedure for NF assessment & authorisation
• NF will continue to require pre-market authorisation è
requested directly from the Commission instead of from
the MS authorities.
• If Commission requests safety opinion è EFSA shall
render such opinion within 9 months from request.
• Publication of draft authorisation decision within 9 months of EFSA
opinion.
• System of individual authorization replaced by system of generic
authorizations
• Simplified procedure based on substantial equivalence will cease to
exist.

14. Changes Ahead (5)
14
Change # 4: Simplified procedure for marketing traditional foods
• For traditional foods from third countries a history of safe use in a non-
EU country for at least 25 years should be demonstrated.
• Placing on the market of traditional food shall be authorized if within 4
month after notification made to Commission, no reasonable safety
objections are received è food shall be placed on Union list.
• In case safety objections are received EFSA è shall be requested an
opinion to be rendered within 6 months of a valid application.
• Commission shall publish draft authorisation within 3 months after
publication of safety opinion.

15. Changes Ahead (6)
15
Change # 5: Introduction of data protection regime
• As a measure to stimulate the EU food industry, a data protection
regime was introduced.
• Similar mechanism is contained in Health Claim Regulation 1924/2006
for data supporting new function claims under article 13.5.
• Data covered may not be used for subsequent application during 5
years from inclusion of Novel Food in Union list.
• NB This does not prevent other applicants to file applications based on
independently generated scientific data è may be identical / similar to
protected data.

16. Changes Ahead (7)
16
Evaluation of changes laid down in proposal for new NF Regulation
Entry into force: 2016 at the earliest
• March 2014: EP appointed James Nicholson
(1945, “euro realist”) as Rapporteur on NF review
• Role of Rapporteur is to consult with local producers, industry experts
and food business operators è draft EP legislative resolution
• 6 October 2014: draft resolution produced by Rapporteur, defining 3 key
area’s of concern:
(1) definition of Novel Foods;
(2) streamlining of authorization process;
(3) robust data protection provisions.

17. Changes Ahead (8)
17
Definition of Novel Foods
• Open definition created legal uncertainty and failed to clarify NF scope
• Re-introduction of existing NF categories in updated form
• Introduction of new NF category covering a new source of starting
material used for vitamins & minerals
and request for Commision to publish
Guidelines re. NF qualification
• Purpose: align NF Regulation to technological progress and new kinds
of foods entering EU marketplace.

18. Changes Ahead (9)
18
Streamlining authorization process
• Current authorization process expensive and lengthy: average of 3
years for successful NF application è impediment to innovation and
participation of SME’s.
Measures proposed include:
• clarification of conditions and timelines that apply when Commission
asks EFSA opinion;
• shortening the term for publication of a draft authorisation decision from
9 è 6 months;
NB! No fixed time frames for Member States to comment NF application.

19. Changes Ahead (10)
19
Robust data protection provisions
• Required to counterbalance system of generic authorizations
è applicant’s investment should receive adequate protection.
• Alignment with data protection granted under Health Claim Regulation
è 2 periods of data protection should run concurrently.
• Lowered threshold for requesting confidential treatment of certain info
submitted with NF application.
NB1 Confidentiality shall not apply to results of the studies carried out to
demonstrate the safety of the food.
NB2 Scope of data protection also includes scientific publications.
è Limited exclusivity

20. Practical Examples (1)
20
• http://www.thechiaco.com.au/ successfully applied for a NF authorisation
for Chia Seeds.
• Claimed to the highest combined plant source of omega-3, fibre and
protein, alongside a range of vitamins, minerals and antioxidants.
• Authorisation was granted in 2009 for use in bread products, with a
maximum of 5 % Chia (Salvia Hispanica) seeds.
• In 2013, The Chia Company applied for - and obtained - an extension of
the use of Chia Seeds.
QUESTION: What type of extension do you expect was obtained?

21. Practical Examples (2)
21
Extension of use for Chia Seeds obtained by The Chia Company on the
basis of Commission Implementing Decision of 22 January 2013

22. Practical Examples (3)
22
Example taken from real life (FD 11 October 2014)
QUESTION
If you would like to market a
burger based on duckweed,
how would you proceed?

23. Practical Examples (4)
23
Actions to be taken prior to marketing duckweed burger
(1) Check granted NF authorisationè substantially equivalent product?
(2) Establish if duckweed has been used for human consumption to a
significant degree in EU prior to 1997 è use EU decision tree
(3) NB if duckweed was subject to additional processing, altering its
composition è resultant product could qualify as NF
(4) Check Novel Foods catalogue
(5) If no clue at all è duckweed burger potentially is NF

24. Practical Examples (5)
24
How about algae and Novel Foods?
• Many algae have already been marketed prior to 1997.
• Check Novel Food Catalogue and you will find the following examples:
http://ec.europa.eu/food/food/biotechnology/novelfood/
novel_food_catalogue_en.htm
(1) Chlorella pyrenoidosa - not subject to NF legislation
(2) Laminaria digitata - idem
(3) Rhodymenia palmata - only used as Food Supplement
prior to 1997

25. Practical Examples (6)
25
Do you know about any products containing algae?
Laminaria saccharina
sweet seaweed
Apple-algae-elderberry juice
containing 4 % chlorella

26. Conclusions
26
www.axonlawyers.com
(1) Novel Foods offer interesting opportunities to develop sustainable and
high tech food products.
(2) Future legal framework with generic authorisations will make marketing
thereof more attractive
(3) Legal framework is under development – stay posted!