Brussels, 15/03/2010 (Agence Europe) - On Monday 15 March, the EU Council of Ministers adopted, without debate, its first-reading position on a draft regulation on novel foods, translating into law the political agreement approved on 22 June 2009 (see EUROPE 9929 for the detail). Greece and the United Kingdom abstained. The Commission did not accept the introduction of the definition of offspring of cloned animals and the inclusion of the said offspring within the scope of the draft regulation. In a statement, Greece said that food produced from animals that are the result of reproduction by cloning and the offspring of these animals must not be included within the scope of the draft regulation at issue here. It said that to protect human health, animal health and welfare and the environment, such foods should not be allowed to be marketed. Most member states take the view that there should be separate, specific legislation for food produced from cloned animals or their offspring. In the meantime, in order to avoid any gaps in the legislation, most delegations agree that such foods should come within the scope of the regulation on novel foods.
The main objective of the draft regulation is to stimulate the development and placing on the EU market of safe innovative foods and to ensure a high level of food safety and of human health protection. The Council did not put in place a legal framework for foodstuffs produced from cloned animals. Such a framework already exists. However, the agreement on this text makes it clear that these products are indeed covered by the regulation on novel foods. What is new is the extension of the scope of the regulation to products from first generation offspring of cloned animals. The new regulation, then, strengthens barriers to the marketing of foodstuffs produced from cloned animals since current legislation allows such products to be marketed without prior specific authorisation.
The draft regulation includes the following provisions:
1) The authorisation procedure will be streamlined by switching to a centralised EU level procedure. According to the Council's political agreement, all applications for the approval of novel food must be submitted to the Commission and then transmitted to the European Food Safety Authority (EFSA) for a risk assessment. The final decision to include a novel food in the EU list of authorised novel foods is then made by the Commission via the committee procedure. Currently, an application must be made to a single member state which submits it to its competent national food assessment body for initial safety assessment. This is then sent to the other member states and the Commission for comments. If neither the Commission nor the member states raise any objection, the applicant may place the product on the market; otherwise an authorisation decision by the committee procedure is required. As is the case under the existing legislation, the Council wants novel foods to be authorised only if they do not present a danger for consumers, do not mislead them and are not nutritionally disadvantageous for them.
2) An accelerated authorisation procedure is to be introduced for traditional food from non-EU countries (i.e. food derived from primary production which has been part of the customary diet for at least 25 years in a large part of the population of a non-EU country). EFSA must give its opinion within six months (rather than nine months under the normal procedure), and the Commission is to submit any proposals for an update of the list of traditional foods within three months (rather than nine months under the normal procedure).
3) The definition of novel food and the scope of the regulation have been clarified. According to the Council's position, the new regulation will explicitly apply to food produced from animals obtained by a cloning technique, and the scope of the regulation will be extended to food from the offspring of cloned animals. The Council invites the Commission to report on all aspects of food from cloned animals and their offspring within one year after the entry into force of the regulation and to submit, if appropriate, a proposal for a specific legislation on this topic. Furthermore, food containing or consisting of engineered nanomaterials is explicitly included in the scope of the regulation. The general definition of novel food remains unchanged, i.e. food not used for human consumption to a significant degree within the Community before 15 May 1997 (when the current Regulation 258/97 entered into force).
4) The new regulation allows applicants to request the protection of scientific data on newly developed innovative foods for a period of five years, with the aim of stimulating innovations in the food sector.
Hitherto, more than 30 novel foods have been authorised for use in the EU, such as “rapeseed oil high in unsaponifiable matter”, “rye bread with added phytosterols/phytostanols”, “milk type products and yoghurt type products with added phytosterol esters”, “coagulated potato proteins and hydrolysates thereof” and “phospholipids from egg yolk”. The Council's position will now be sent to the European Parliament for a second reading. (L.C./transl.rt)