2. 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
• Reporting current food law developments at blog FoodHealthLegal
3. Agenda
• Rationale for this seminar
• Legal framework alternative protein products
• Examples
• Implications of Novel Foods legislation
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4. Rationale for this seminar (1)
Reason # 1 to eat less meat: Health
• Scientific report WHO (26 October 2015)
Consumption of processed meat increases colon cancer risk.
• Dutch Health Council, Guidelines Healthy Food
(4 November 2015):
Promotes a diet containing more plant based than
animal based proteins.
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5. Rationale for this seminar (2)
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Reason # 2: to eat less meat: Sustainability
• Current food production methods require too much natural resources to
be sustainable in 2050 (expectation: 9 billion people to feed).
• In-balance in consumption: > 1 billion people overweight, 800 million
people undernourished.
• Increased prosperity increased meat consumption, e.g. in China
(1,3 billion inhabitants vs. 500 million inhabitants in Europe)
6. Rationale for this seminar (3)
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Reason # 3: to eat less meat: Animal welfare
• Although breeding of animals is regulated and well-being of animals is
controlled, bottom line: less animal consumption is less animals killed.
• Outbreak of infectious diseases resulted into massive slaughter of
animals, e.g. swine fever and mad-cow disease.
• Today, many meat alternatives.
7. Legal framework alternative
protein products (1)
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• Novel Foods legislation is applicable framework for many protein rich
products.
• What are Novel Foods? Food products that have not been used for
human consumption to a significant degree within the EU prior to 1997.
• Cut-off date refers to current Novel Foods Regulation in need of
reform for several reasons:
(1) streamlining authorisation procedure;
(2) keeping up with technological & scientific developments;
(3) facilitating introduction of traditional foods from third
countries into EU.
8. Legal framework alternative
protein products (2)
8
Revision NF-Regulation in a nutshell
• December 2013: Commission proposal
• 16 November 2015: EP proposal accepted by Council
• Entry into force: publication in OJ + 20 days (early 2016)
• Date of application: 2 years after entry into force (transition regime)
9. Legal framework alternative
protein products (3)
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Major changes of new NF-Regulation comprise:
(1) one centralized procedure for NF assessment and authorisation;
(2) simplified procedure for marketing traditional foods from third countries;
(3) Definition of “Novel Food” considerably broadened: 4 10 categories
10. Legal framework alternative
protein products (4)
10
Centralised procedure for NF assessment & authorisation
• Pre-market authorisation requested directly from the
Commission instead of from the MS authorities.
• If Commission requests safety opinion EFSA shall
render such opinion within 9 months from request.
• Publication of draft authorisation decision within 7 months of EFSA
opinion.
• System of individual authorization replaced by system of generic
authorizations
• Simplified procedure based on substantial equivalence will cease to
exist.
11. Legal framework alternative
protein products (5)
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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 months after notification to Commission, no
reasonable safety objections are received Union list.
• Any safety objections? EFSA opinion requested within 6 months of
valid application.
• Commission shall publish draft authorisation
within 3 months after publication of safety opinion.
12. Legal framework alternative
protein products (6)
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Broadened product definition of Novel Food, including
• food consisting of or isolated / produced from:
13. Examples: algae (1)
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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 (sorokiniana)
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
14. Examples: algae (2)
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• EU Novel Foods Catalogue
http://ec.europa.eu/food/food/biotechnology/novelfood/nfnetweb/mod_sear
ch/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 application:
NF authorization required
Further information required
15. Examples: algae (3)
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The Dutch Weed Burger also contains 2 types of algae:
• burger Royal Kombu (Laminaria saccharina)
• bun Chlorella sorokiniana (+ soy snips)
Both types of algae have a history of safe use in Europe predating 1997
outside the scope of the Novel Foods legislation.
16. Examples: cultured meat burger
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“Mark Post” burger is a typical Novel Food.
• Maastricht Prof. produces meat from cow cells outside the cow.
• He takes a few cells from a cow that divide by themselves, provides
anchor points that will grow into muscle.
• Such high tech product will need to obtain NF clearance. And the
Professor knows about it.
18. Examples: MushroomMeat
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MushroomMeat
• Combination of mushroom mycelium (roots & stems) + substrate
(growth medium).
• Mycelium is more concentrated than mushroom fruit body and can be
quickly cultivated (2 > 5 weeks).
• Various sorts of substrate are possible to vary in taste, such as grains,
carrots, pumpkin, shrimps shells or oat.
• Sterile production process is based on solid state fermentation.
• However this production process is new safety must be confirmed on
the basis of a NF-authorisation.
19. Examples: 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
21. Examples: insects
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EFSA scientific opinion 8 October 2015:
a. production method
b. the substrate used
c. stage of harvest
d. insect species and
e. method of further processing
Relevant for risk evaluation currently only limited data available
further research recommended.
• No immediate safety concerns. Shouldn’t insects be considered ‘safe’
under food law?
• ‘Safe’ in food law means: food is safe until unsafely has been found.
22. Implications of NF-legislation (1)
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Implications depend on type of product
• Cultured meat burger and MushroomMeat will defenitely be subject to
NF-authorization procedure.
• Algae products may not need authorisation at all, depending on type.
• For insect products, a distinction should be made for products marketed
now and in future.
23. Implications of NF-legislation (2)
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Insect based products and transition regime
• Products currently marketed do not need to be removed from market.
• However, for continued marketing an authorization should be requested
before 2 years after the date of application of the new NF-Regulation.
• Also, future insect based products will – according to the new Regulation
also need to request a market authorization.
• In this in line with created expectations at national levels?
.
24. Implications of NF-legislation (3)
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Requirements authorization procedure
In future, authorizations will be generic check Union List.
No third party authorizations? individual application for authorization
need to be filed substantiating the following.
• specification of the Novel Food
• effects of the applied production process
• background info on source of Novel Food
• expected uptake / frequency of use
• nutritional value
• microbiological information
• toxicological information
25. Conclusions
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1. Begin with the end in mind: before manufacturing and marketing an
alternative protein product, know its regulatory status.
2. If the product/ingredient of your choice falls within the NF-legislation,
pick the one for which a history of safe use exists (e.g. algae).
3. If no history of safe use exists, check the future Union List for third
party authorizations.
4. Only when no third party authorizations have been published, you
should file an application for NF-authorisation.
Editor's Notes
Rapport IARC – international Agency for Research on Cancer (WHO’s cancer agency)
Opgesteld door 22 wetenschappers uit 10 landen op basis van 800 epidemiologische studies (ter voorkoming van ontstaan en verspreiding van ziekten)
Resultaat: consumptie van 50 gram bewerkt vlees/dag vergroot risico op darmkanker met 18 %.
Gezondheidsraad is onafhankelijk wetenschappelijk adviesorgaan van Regering en Parlement.
Richtlijnen Gezonde Voeding zijn weergave van actuele stand van wetenschap over relatie tussen voeding en chronische ziekten.
Kern aanbevelingen voor gezond voedingspatroon: eten volgens meer plantaardig en minder dierlijk voedingspatroon.
Ziet verband tussen consumptie van rood en bewerkt vlees en hoger risico op bepaalde ziekten: beroerte, diabetes, darm- en longkanker.
Prof. Reijnders hoogleraar milieukunde UvA (tot 2011): duurzaam = in evenwicht met natuurlijke hulpbronnen.
Thans uitputting van natuurlijke fosfaatbronnen, zoet water en fossiele energie.
Klassieke varkenspest (swine fever) in NL: 1997/1998. In 13 maanden > 12 miljoen varkens vernietigd. Oorzaak: voeren van varkens met onverhitte restproducten uit keukens.
Van de 12 mio 700.000 geinfecteerde dieren; overige preventief geruimd. Bron vlees.nl.
Vb. NF: Food produced using new technologies and production processes and food traditionally eaten outside the EU.
Recentely approved NF: rapeseed protein and coriander seed oil.
1997 – 2014: around 170 applications, around 90 authorisations
Before entry into force: formal adoption by EP.
Met de klok mee:
microorganisms, fungi or algae;
cell or tissue culture derived from animals, plants, micro-organisms, fungi or algae;
plants or their parts, except when the food has a history of safe food use in the Union and one out of two alternative conditions are met;
animals or their parts, except where these animals were obtained from traditional breeding practises and the food from those animals has a history of safe food use;
FOR EACH TYPE OF PRODUCT CATEGORY, AN EXAMPLE WILL BE DISCUSSED HEREAFTER.
(1) Algae belongs to the Chlorophytae Family, grown in Japan, China and Taïwan since 1955. Composition is quite similar to the other macroalgae. It is a nutrient-dense unicellular fresh water green alga .
(2) Large kelp up to 2 m in length commonly found at low water during spring tides on rocky shores in the north west Atlantic from Greenland south to Cape Cod and in the north east Atlantic from northern Russia and Iceland south to France.
(3) Seaweed specie of 20 to 30 cm in length. Aquatic plant living on the rocks. Geographic distribution spreads on the coasts of the Manche, the Atlantic Ocean, Greenland and France.
NB Broodje bevat ook nog zilte sojasnippers van sojabonen afkomstig van gecontroleerde teelt uit Noord-Amerika.
MushroomMeat is vb. van een voedingsmiddel vervaardigd op basis van delen van planten. Tegeiljkertijd valt het in de categorie nieuw productieproces, waarvoor doorgaans ook NF-autorisatie is vereist.
Info Olga Patijn (stichting EcoConsult d.d. 19-11-15: productiewijze is niet geheel nieuw t.o.v. de productiewijze van tempe, maar de combinatie van een specifiek soort substraat (m.n. graan) + mycelium van Konings Oesterzwam (Oyster mushroom) weer wel. Uit onderzoek van WUR-studenten zou volgen dat op basis van de tempe-methode een notificatie zou volstaan – hun conclusie was namelijk dat mycelium = paddenstoel; stichting EcoConsult betwijfelt dat. Zelf weet ik nagenoeg zeker dat de notificatie op basis van van wezenlijke gelijkwaardigheid niet opgaat. Tempe (soja) is nu eenmaal heel ander uitgangspunt dan paddenstoelen en bij de fermentatie wordt ook een ander soort schimmel gebruikt.
NB Productie van MushroomMeat vindt plaats volgens geoctrooieerde methode beschreven in NL2011277
Insectenburger is bv. voorbeeld van product vervaardigd op basis van delen van dieren.
Het feit dat insecten nu ook gelden als Novel Foods veroorzaakte nogal wat ophef in de pers.
NB toevoegen: EFSA rapport!
EFSA was requested to assess the micro-biological, chemical and environmental risks posed by the use of insects in food relative to the risks posed by the use of other protein sources in food.
As to products providing alternative protein, such as insects, we understand that the safety aspects from rearing to consumption should be carefully assessed. However, we note that EFSA does not have any immediate safety concerns per se. Furthermore, it should be stressed that the notion of “safety” in EU food law has only been negatively defined. That is, food is safe as long as it is was not found unsafe. Therefore, we consider that alternative protein products that were marketed for a number of years without any problems reported should not be subject to further barriers.
Entry into force NF-legislation: publication in OJ + 20 days
Date of application: Entry into force + 2 years
Stel 1 januari 2016 > entry into force
Dan 1 january 2018 > date of application
Zie Commissie Aanbeveling 27 juli 2007 voor toelichting van bovenstaande categorieën.
Vergelijk ook artikel 9.1.a. nieuwe NF-Vo.
Vertel hoe (door welke studies) bepaalde data kunnen worden gegenereerd.