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Topics: Novel Food
Organisations: Eurogroup for Animals

GMO Novel Food

6 rue des Patriotes – B - 1000 Brussels Tel : +32 (0)2 740 08 20 - Fax : +32 (0)2 740 08 29 Email : info@eurogroupforanimals.org

www.eurogroupforanimals.org

Placing on the market of Novel Foods

Background information

Novel foods are foods and food ingredients that have not been used for human consumption to a ignificant degree before 15 May 1997. Regulation EC 258/97 of 27 January 1997 of the European Parliament and the Council lays out detailed rules for the authorisation of novel foods and novel food ingredients. This is in particular to food produced using new techniques and technologies, such as nanomaterials.

In order to ensure the highest level of protection of human health, novel foods must undergo a safety assessment before being placed on the EU market. This safety assessment includes testing on animals. Only those products considered to be safe for human consumption are authorised for marketing.

Revision of Novel Food Regulation

A revision of the Novel Food Regulation was deemed necessary in order to reflect the fact that genetically modified (GM) food no longer falls under its scope, to create a more favourable legislative environment for innovation in the food industry, and to better facilitate both internal and external trade in foodstuffs.

On the 14 January 2008, the European Commission adopted a proposal to revise the Novel Foods Regulation however the EU institutions failed to reach agreement on the dossier, mostly due to the fact that cloning was to be included and the institutions had varying positions on cloning.

Recent developments

On the 18 December 2013 the Commission adopted their new proposal for a Regulation of the European Parliament and of the Council on Novel Foods (COM(2013) 894 final). It revises the existing Novel Food Regulation with a view to improving access of new and innovative food to the EU market, while still maintaining a high level of consumer protection.

Under the draft Regulation, novel food would be subject to a simpler, clearer and more efficient authorisation procedure fully centralised at EU level, which should enable safe and innovative food to be placed on the EU market faster without compromising a high level of public health. Novel food refers to all food which were not consumed in the EU to a significant degree before May 1997, i.e. before the current Regulation entered into force and in particular to food produced using new techniques and technologies, such as nanomaterials. Special provisions are also made for food which has not been marketed in the EU but which has a history of safe use in non-EU countries. This creates a more balanced system and a positive environment for trade. Protecting innovation is also a feature of the draft law. Under the new system, in case of innovation upported by new scientific developments, the food company which submitted the application, may be given the authorisation to market the food for 5 years before it can be produced and marketed by others.

Eurogroup Position

However, the Regulation does not go far enough to ensure animal welfare is properly considered. If tests are performed for the safety assessment of novel foods, they should comply with the relevant

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requirements for the protection of laboratory animals, set out in Directive 2010/63/EU on the protection of animals used for scientific purposes. In accordance with the provisions of this Directive, it is necessary to replace, reduce or refine experiments on vertebrate animals. The Novel Foods Regulation should ensure the use of alternative test methods wherever possible. To avoid duplicate animal testing, the sharing of animal test data must take place where possible.

Eurogroup calls for the resubmission of the following amendments which were supported during the Novel food Discussions in 2008:

Amendment

Proposal for a regulation – amending act

Recital 1

Text proposed by the Commission

Amendment

(1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes ignificantly to the health and well-being of citizens, as well as to their social and economic interests. Differences between national laws, regulations and administrative provisions concerning the afety assessment and authorisation of novel foods may hinder their free movement, thereby creating unfair competition conditions.

(1) In implementing Community policy and having regard to the Treaty establishing the European Community, a high level of protection of human health and consumer protection should be guaranteed and also a high level of animal welfare and environmental protection. At all times, moreover, the precautionary principle as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food afety

1,should

be applied.

_____________

1

OJ L 31, 1.2.2002, p. 1.

Amendment

Proposal for a regulation

−−−−

amending act

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2a) Article 13 of the Treaty on the Functioning of the European Union clarifies that the Union and the Member States shall pay full regard to the welfare requirements of animals when formulating and implementing policies,

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ince animals are sentient beings.

Amendment

Proposal for a regulation

− −− −

amending act

Recital 19 a (new)

Text proposed by the Commission

Amendment

(19a) In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation should be undertaken only as a last resort. This Regulation should ensure that testing on vertebrate animals is minimised and that double-testing is avoided, and should promote the use of non-animal test methods and intelligent testing strategies. Existing results from tests on vertebrate animals should be shared in the process of developing novel foods. Moreover, in accordance with Directive 2010/63/EU of 22 September 2010 on the protection of animals used for scientific purposes, tests on vertebrate animals must be replaced, restricted or refined. Implementation of this Regulation should, where possible, be based on the use of appropriate alternative testing methods. Not later than ...

*,

the Commission should review the

rules on the data protection of results from tests on vertebrate animals and, where necessary, change those rules.

* Seven years after the entry into force of this Regulation.

Amendment

Proposal for a regulation

−−−−

amending act

Recital 21 a (new)

Text proposed by the Commission

Amendment

(21a) Test methods currently available are not adequate for assessing the risks associated with nanomaterials. Nanopecific non-animal test methods should

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be developed as a matter of urgency.

Amendment

Proposal for a regulation – amending act

Article 1.1

Text proposed by the Commission

Amendment

1.This Regulation lays down harmonised rules for the placing of novel foods on the market in the Community with a view to ensuring a high level of human health

and

consumers’ protection, whilst ensuring the effective functioning of the internal market.

1.This Regulation lays down harmonised rules for the placing of novel foods on the market in the Community with a view to ensuring a high level

of protection

of

human life and health, animal health and welfare, the environment and the interests of consumers

whilst ensuring

transparency and the effective functioning of the internal market.

Amendment

Proposal for a regulation – amending act

Article 23 3 new

Text proposed by the Commission

Amendment

3. In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort. The use of non-animal tests and intelligent testing strategies shall be promoted.

Amendment

Proposal for a regulation – amending act

Article 24– paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. Data from research projects partly or completely paid by the EC and/or public institutions and risk studies or data related to risk studies, like feeding studies, hould be published together with the application and shall be freely available for use by other applicants.

Amendment

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Proposal for a regulation – amending act

Article 24 - paragraph 1 b (new)

Text proposed by the Commission

Amendment

1b. In order to avoid the repetition of tudies involving vertebrates, reference by a subsequent applicant to studies on vertebrates and other studies that may prevent animal testing shall be allowed. The owner of the data may claim adequate compensation for the use of the data.

Amendment

Proposal for a regulation – amending act

Article 25 b (new)

Text proposed by the Commission

Amendment

Article 25b

Inspection and control measures

In order to enforce compliance with this Regulation, official controls are to be carried out in accordance with Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules.

Document Info

  • Title: Microsoft Word - Eurogroup position on Novel Foods 2014
  • Language: en
  • Author: kreid
  • Created: March 18, 2014 2:20 PM
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