THE COMMISSION’S

PROPOSALS ON ANIMAL CLONING AND NOVEL

FOODERA Annual Conference on European Food Law 2014, 5 and 6 May, Trier, Germany

OVERVIEW

• Current Novel Foods Regulation 258/97• New proposal Regulation on Novel Foods COM(2013) 894• New proposals on Animal Cloning COM(2013) 892 &

COM(2013) 893

NOVEL FOOD?

• Newly developed innovative foods

• Exotic foods (noni-juice)

• Food to which a new production technique has been applied (high pressure fruit juice)

NOVEL FOOD?

Regulation 258/97 concerning novel foods andnovel food ingredients.

Novel foods are not:

• Medicinal products (Directive 2001/83, Regulation 726/2004)

• GM Food (Regulation 1829/2003)

• Food additives, food enzymes or food flavourings (so-called “food improvement agents”. (Regulation 1331-4/2008)

• Food supplements (Directive 2002/46)

• Vitamins, minerals etc. regulated under Regulation 1925/2006)

NOVEL FOODS REGULATIONNovel foods: food products (including ingredients) that have not been used to a significant degree for human consumption within the EU prior to the entry into force of the Novel Foods Regulation on 15 May 1997.

Four categories of food and food ingredients:1. 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 and food ingredients isolated from animals;

4. to which a new production process has been applied, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.

NOVEL FOODS REGULATION

Novel foods should in the first place be safe. Novel foods must not:

• Present a danger for the consumer• Mislead the consumer (proper labelling!)• Be nutritiously disadvantageous for the consumer (in comparison

to food they intend to replace).

Two types of authorisation procedures:

1. Full blown procedure based on new scientific evidence demonstrating that above criteria are met (1-6 years, average 3,5 years)

2. Simplified procedure for products that are substantially equivalent to existing foods (a few months)

• 7 – 10 applications per year

NOVEL FOODS REGULATIONFull blown authorisation procedure

Start: company applies to a EU country authority for authorisation, presenting the scientific information and safety assessment report (and send a copy of the application to the Commission). Initial safety assessment Member State.

Commission: The Commission circulates initial national assessments to all Member States. It allows the marketing of the product if the Member States do not raise any reasoned safety objections.(In the majority of the 68 NF authorisations granted between 2000 and 2013, such objections were raised).

EFSA: In case of raised objections: obtaining EFSA safety assessment (opinion). The current regulation does not set a time frame and quite often, the 60 days term for the Member State to provide their opinion is not enforced. Authorisation procedures can last up to 6 years!

REGULATION ON NOVEL FOODS18 December 2013: proposal for a new regulation on novel foods (COM(2013) 894 final)

Highlights:

• Food from cloned animals no longer covered.

• 3 new categories of novel foods.

• One centralized procedure for assessment and authorisation, aimed at the reduction of the authorization procedure from 3 years in average to 18 months.

• Special procedure for placing on the market of traditional foods from third countries.

• Introduction of a data protection regime covering newly developed scientific evidence and proprietary data during a maximum period of 5 years.

REGULATION ON NOVEL FOODSCategories of novel foods:

One ‘old’ category remained:• food to which a new production process is applied.

3 new categories are introduced, being:(i) food containing of or consisting of engineered nano materials;

(ii) vitamins and minerals to which a new production process has been applied or consisting of or containing engineered nano materials; and

(iii) food used exclusively in food supplements prior to 1997, where it is intended to be used in foods other than food supplements.

REGULATION ON NOVEL FOODS

Central authorisation procedure:

• Application for an authorisation should be directly made to the Commission.

• If Commission requests a safety opinion, EFSA shall adopt such opinion within 9 months (Article 10(1) proposal).

• The Commission shall publish a draft authorisation decision within 9 months from the date of publication of the EFSA opinion.

• The system of individual authorisations will be replaced by a system of generic authorisations.

• Authorised novel foods will be included in a Union list.

REGULATION ON NOVEL FOODS

Special authorisation of traditional foods

• Placing on the market of traditional foods from third countries, provided that a history of safe use can be demonstrated (Article 14).

• Substantiated with compositional data and experience of continued use for at least 25 years in the customary diet of a large part of the population of a third country.

• Foods have to be derived from primary production.

The current “simplified procedure” based on substantial equivalence will cease to exist!

REGULATION ON NOVEL FOODS

Special authorisation of traditional foods

• Applicant has to notify the Commission prior to placing on the market. No safety objections within 4 months? The product can be marketed in the EU.

• Objections? New application taking into account said objections, which the Commission forwards to EFSA.

• EFSA: within 6 months from the date of application, EFSA adopts a safety opinion.

• The Commission shall publish a draft authorisation decision within 3 months from the date of publication of the EFSA opinion.

REGULATION ON NOVEL FOODSData protectionOn request of the applicant, data protection is available for newly developed scientific evidence or scientific data supporting the application.

Data covered may not be used for the benefit of a subsequent application during 5 years, to be calculated from the inclusion of the novel food in the Union list.

Three conditions need to be fulfilled:

1. the developed scientific evidence/data was designated as proprietary by the prior applicant at the time the first application was made;

2. the prior applicant had exclusive right of reference to the proprietary scientific evidence / data at the time the first application was made; and

3. the novel food could not have been authorised without the submission of the proprietary scientific evidence / data by the prior applicant.

Not applicable to applications concerning the placing on the market of traditional food originating from third countries!

REGULATION ON NOVEL FOODS

Transitional measures, post-market requirements and timelines

Novel foods authorised prior to the entry into force of the new Regulation, will be included in the Union list.

A food that was legally placed on the market prior to the application of the new Regulation may be further marketed under the condition that the food undergoes authorisation under the new Regulation.

If the food is authorized and included in the Union list, the Commission may introduce post-market requirements to monitor the use, to ensure that the food is within safe limits as established by EFSA.

Entry into force: 2016 at the earliest.

REGULATION ON NOVEL FOODSEvaluation

• Definition of a novel food clarified?

• Authorisation delays could still easily increase. For instance, if EFSA requests additional information from the applicant, the authorisation will not make it within 18 months.

• Authorisation of traditional foods from third countries will minimally take 13 months if an EFSA opinion is requested -> simplified?

• Proposal does not contain a fixed term for reasoned objections by Member States.

• Already authorized novel foods will have to undergo the authorization procedure again under the new Regulation. -> legal uncertainty?

FOOD FROM CLONED ANIMALS

EU citizens’ perspective on animal cloning in EU…

FOOD FROM CLONED ANIMALSCloning: a relatively new reproduction technique used to duplicate rare, valuable or high performing animals without modifying their genes. Why? To create elite livestock for milk and meat.

FOOD FROM CLONED ANIMALS

• Presently regulated under Novel Food Regulation 258/97 and subject to pre-market approval based on a safety risk assessment.

• 14 January 2008: Commission presents proposal (COM(2007)872 final) to streamline the approval process in the Novel Food Regulation. Lawmakers aimed to amend the proposal to introduce specific rules on cloning. No agreement was reached. Proposal was not adopted.

• Commission was asked to prepare a proposal outside the Novel Food Regulation.

• EFSA statements of 2010 and 2012 http://www.efsa.europa.eu/en/efsajournal/pub/2794.htm

FOOD FROM CLONED ANIMALSIn its opinions EFSA concluded that:

• There is no indication of any difference for food safety for meat and milk of clones and their progeny compared with those of conventionally bred animals.

However, cloning of farm animals for food production is under discussion for the following three reasons:

1. Concerns regarding animal health and welfare regarding clones and the surrogate mothers. Low efficiency of technique (high mortality rate);

2. Negative perception of EU citizens of cloning;

3. Request from the co-legislator to address the issue.

FOOD FROM CLONED ANIMALS

January 2008: EGE Opinion

The European Group on Ethics in Science and New Technologies (EGE) provided an opinion on ethical aspects of animal cloning for food.

The EGE concludes that:

“considering the current level of suffering and health problems of surrogate dams and animal clones, the EGE has doubts as to whether cloning animals for food supply is ethically justified. Whether this applies also to offspring is open to further scientific research. At present, the EGE does not see convincing arguments to justify the production of food from clones and their offspring.”

FOOD FROM CLONED ANIMALSDecember 2013: Commissions’ Impact assessment with four policy options.

1. No policy change;2. Pre-market approval of food from clones, offspring and

descendants;3. Labelling of food from clones, offspring and descendants;4. Suspension of the cloning techniques and of imports of live

clones, of food from clones and of reproductive material of clones.

Option 4 is basis for present proposals. Why?

• Animals are presently not cloned for farming purposes and food production.

• The farming, breeding and food industry have no interest to produce animals for farm purposes or food through cloning.

• EU citizens have a broad negative perception of cloning.

FOOD FROM CLONED ANIMALS

FOOD FROM CLONED ANIMALS

• Proposed Regulation on Novel Foods (COM(2013) 894 final) excludes authorizations on foods originating from cloned animals (Article 1(2)(c)).

• Proposed Directive on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept andreproduced for farming purposes (COM(2013) 892 final).

• Proposed Directive on the placing on the market of food from animal clones (COM(2013) 893 final).

FOOD FROM CLONED ANIMALS

The proposals related to animal cloning result in:

• A temporary ban on the imports of animal clones and a prohibition to place food from animal clones on the market;

• A temporary ban on the use of cloning technique in the EU for farm animals;

Cloning will be allowed:

• For purposes of research or conservation of rare breeds and endangered species;

• For the production of pharmaceuticals and medical devices.

LINKS

EC novel foods: http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm

EC guidance document on ‘Human consumption to a significant degree’: http://ec.europa.eu/food/food/biotechnology/novelfood/documents/substantial_equivalenc_en.pdf

EFSA on cloning: http://www.efsa.europa.eu/en/topics/topic/cloning.htm

THANK YOU FOR YOUR ATTENTION

Sofie van der MeulenAxon AdvocatenPiet Heinkade 1831019 HC Amsterdam

+31 88 650 6500+31 6 53 44 05 67sofie.vandermeulen@axonlawyers.com

www.foodhealthlegal.com @FoodHealthLegal

www.axonlawyers.com

LEGAL STUFF

The information in this presentation is provided for information purposes only.

The information is not exhaustive. While every endeavor is made to ensure that the information is correct at the time of publication, the legal position may change as a result of matters including new legislative developments, new case law, local implementation variations or other developments.

The information does not take into account the specifics of any person's position and may be wholly inappropriate for your particular circumstances.

The information is not intended to be legal advice, cannot be relied on as legal advice and should not be a substitute for legal advice.