STATUS QUO OF NOVEL FOODS IN THE EU

UNDER THE NEW REGULATION

Vitafoods Europe, Geneva

5 May 2015 Karin Verzijden www.axonlawyers.com

Introduction Axon Lawyers

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•  Amsterdam based law firm with international focus

•  Fully dedicated to life sciences, familiar with food business

•  Assisting high tech companies bringing innovative food products to the market

•  International network through European Alliance of Life Sciences Law Firms

•  Reporting current food law developments at blog FoodHealthLegal

Agenda

•  Rationale Novel Foods Legislation for ingredient innovations

•  Legal framework Novel Foods

•  Changes Ahead

•  Novel Foods in practise: nano foods, algae, insects and duckweed

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Rationale NF legislation for ingredient innovations

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Begin with the end in mind •  Before manufacturing and marketing an algae / insects / duckweed /

nano based food product, a FBO should know the regulatory status thereof.

•  Ingredients that have been marketed as a source of food prior to 1997 è outside the scope of the NF Regulation.

•  Ingredients without history of safe use clearly fall within the scope of the NF legislation è subject to pre market authorization.

Legal framework Novel Foods (1)

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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

Legal framework Novel Foods (2)

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Basic requirements Novel Foods should: •  not present a danger for the consumer (science based evaluation) •  not mislead the consumer (intended use - presentation - labelling) •  have a positive relationship vis-à-vis foods / food ingredients that they

intend to replace (nutritional - health - environmental - social terms)

Labeling requirements •  Requirements for labelling of novel food and ingredients are additional

to the general EU requirements on food labelling (Regulation 1169/2011) •  Example: list of ingredients containing algal oil authorized as a Novel

Food should state: “oil from the micro-algae Schizochytrium sp.”

Legal framework Novel Foods (3)

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Two types of authorisation procedures (1) Full blown authorisation procedure based on scientific evidence demonstrating that applicable safety criteria are met

•  System of individual authorisations •  Applications should be made at national level •  National authorities forward application to Commission •  Commission distributes application to MS •  If MS raise any “reasoned objections” èEFSA opinion requested •  Average authorization term: 3 – 5 years (!)

(2) Simplified procedure based on “substantial equivalence” •  Notification to Commission based on report from national

competent authorities •  Average time span: up to 9 months

Legal framework Novel Foods (4)

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Granted authorisations •  Yellow fat spreads with added phytosterol-esters (Unilever, UK, 1998) NB BCL = blood cholesterol lowering

•  Fruit preparations pasteurized using a high pressure treatment (Danone, France, 1998)

•  Coagulated potato protein and hydrolysates thereof (Avebe, NL, 2001)

Legal framework Novel Foods (5)

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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)

Legal Framework Novel Foods (6)

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Guidance on Novel Food status

•  Commission Guidance “Human consumption to a Significant Degree” http://ec.europa.eu/food/food/biotechnology/novelfood/documents/substantial_equivalence_en.pdf •  EU Novel Foods Catalogue http://ec.europa.eu/food/food/biotechnology/novelfood/nfnetweb/mod_search/index.cfm

History of safe use; no NF authorization required

Only use as food supplement is known; NF authorization required

No history of safe use apparent from previous appliation: NF authorization required Further information required

Changes ahead (1)

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•  18 December 2013: Commission proposal for a new Novel Foods Regulation.

•  March 2014: EP nominated Rapporteur Nicholson •  6 October 2014: draft report Nicholson •  2 December 2014: ENVI Committee approved draft legislation •  Current status quo: EP amendments being discussed

Major changes comprise:

(1) one centralized procedure for NF assessment and authorisation; (2) simplified procedure for marketing traditional foods from third countries; (3) covers food from cloned animals; (4)  introduction of data protection regime; (5) moratorium on the use of nanomaterials in food; (6) change of definition of “Novel Food”.

http://foodhealthlegal.com/?p=371

Changes ahead (2)

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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.

Changes ahead (3)

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Simplified procedure for marketing traditional foods •  History of safe use in a non-EU country for > 25 years should be

demonstrated.

•  Authorization if within 4 month after notification to Commission, no reasonable safety objections are received è Union list.

•  Any safety objections? èEFSA opinion requested within 6 months of valid application.

•  Commission shall publish draft authorisation within 3 months after publication of safety opinion.

Novel foods in practise: nano foods

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•  Nano foods: food resulting from intentional changes in particle size, shape or structure or in the particle size distribution, through any technology that reduces them to nanoscale (100 nm or less).

•  New: Nano-foods are considered Novel Foods under new NF Regulation.

•  New: Introduction of 10 % nano-particles threshold for a food ingredient to qualify as nano instead of 50 %.

Novel foods in practise: algae

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•  Algae are explicitly mentioned as being Novel Foods •  2 granted authorisations for algae based products (algal oil)

•  Many algae already marketed in EU prior to 1997. Examples include: (1) Chlorella pyrenoidosa Not subject to Novel Food legislation

(2) Laminaria digitata Not subject to Novel Food legislation (3) Rhodymenia palmata Only used as a food supplement in the EU prior to 1997

Novel foods in practise: insects

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•  New: insects are considered Novel Food ingredients under new NF Regulation.

•  Contrary to practise in various Member States: Belgium and Holland

Novel foods in practise: duckweed

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•  Duckweed covered under the Novel Foods Regulation (current & new).

•  So far, no history of safe use of duckweed as a food ingredient in the EU prior to 1997.

•  Novel Food catalogue: lemna minor

•  Currently: Option to demonstrate substantial equivalence to existing food ingredients based on RuBisCO protein contained in duckweed and occurring in many green plants.

•  New: chance to obtain authorization via notification procedure as traditional foods from third countries.

Conclusions

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(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!