Food from Cloned Animals

The EU Member States have taken the position that cloned animals and their offspring should be included in the scope of a Regulation on Novel Foods until separate legislation specifically on cloned animals can be proposed and adopted. This point is contained in the Council’s “Common Position” (the formal position of the Member States at this stage of the legislative process) on this proposal, which will now go back to the Parliament for a “second reading”.
 
Novel foods are foods produced with new technologies or new breeding techniques, such as cloning. The category also includes traditional foods from third countries not previously introduced on the EU’s internal market, such as baobab dried fruit pulp or Allanblackia seed oil.

The Council’s Common Position

The Council’s Common Position on the Novel Foods proposal was adopted during a meeting of Environment Ministers earlier in March 2010. The European Parliament requested a delay in Council’s adoption of this Common Position, because it felt unready to deal with the proposal. Parliament has only a maximum of four months to adopt its second reading position once it receives the Council Common Position.
 
According to the Council's position, the new regulation would explicitly apply to food produced from animals obtained by a cloning technique. The scope of the Regulation would therefore be extended to food from the offspring of cloned animals. The Council also 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 this Regulation, and to submit, if appropriate, a proposal for a specific legislation on this topic.
 
The Council's view is that clones and their offspring should be included in the Novel Foods proposal until such legislation is in place in order to avoid creating a legal vacuum. The Council has also accepted Parliament's position in adding animal welfare to the list of the proposed Regulation's objectives.  Greece however abstained from the vote because it is totally opposed to including any mention of cloned animals in the Common Position. The UK also abstained, because it views the Council definition of offspring from cloned animals to be imprecise, and would prefer "clones and their decendents".

The Novel Foods Proposal

Novel Foods are currently regulated under Regulation 258/97. A stakeholder consultation carried out in 2002, however, found this Regulation was in need of revision; stakeholders found it cumbersome, inefficient and time-consuming. Questions were also raised over how new novel food technologies should be defined.
 
In 2008 the European Commission proposed a Regulation to amend an existing Regulation (Regulation (EC) No 258/97) on ‘novel foods’ (foods obtained with relatively recent technologies such as genetic modification, cloning, etc.).  The main goal of the Commission’s amending proposal was to streamline the authorisation procedure for such foods by clarifying the definition and categories of novel foods and introducing a centralised application procedure for novel foods, similar to that proposed for food additives, enzymes and flavourings.

Authorization Procedure

Currently, Member States carry out individual assessments and send them to their peers for comments. Under the new proposal, the Commission would receive an application and send it to the European Food Safety Authority (EFSA) for a scientific assessment. If EFSA’s opinion favourably reviews the safety of the novel product, the Commission would then present the proposal to the Standing Committee on the Food Chain and Animal Health, which would then adopt the application through the "comitology" procedure. The proposed Regulation would also establish three different authorisation procedures: a normal procedure concerning general authorisations; a procedure concerning specific applicants who benefit from intellectual property rights; and a facilitated notification procedure for foods from third countries. The last procedure would require proof of extensive and long-term use of the product in the third country.

Cloned Animals

Products from cloned animals intended for human consumption are not allowed in the EU. In February 2007, the Commission asked EFSA to issue a scientific opinion on the implications of cloning on food safety, animal welfare and the environment. EFSA argued that food from cloned animals was unlikely to be different from that of conventionally-bred animals. Cloning is one of the most controversial issues concerning this proposal, and there is disagreement within the institutions. While the European Parliament wants to remove cloning from the proposal altogether and introduce a total ban on cloning, the Council prefers to leave the door open on the question of Regulating cloning animals for food.

Ethical and Environmental Aspects

 Parliament wishes to bring safety and health more in the spotlight. As a result, it has called for the “precautionary principle” to be fully enforced when placing new products on the market. Furthermore, MEPs have also made it clear that they want environmental and ethical aspects be further taken into consideration. They claim that Member States should be able to refuse a product on their market on ethical grounds, and want to see the European Environment Agency be part of the assessment procedure.
 
The overall aim of the proposal for Regulation on Novel Foods is to facilitate the access of new and innovative foods on the internal market, while ensuring a high level of food safety and consumer protection. There are concerns however that a simplified process could in essence be too simple, and that controversial products could start appearing on consumer tables without proper and thorough assessment. The proposed centralised authorisation system is currently being applied to GMOs, but the procedure has proved to be anything but fast-track. This is because several Member States remain reluctant to go along with EFSA’s favourable opinions on GMOs, and Council routinely votes against lifting Member State bans, contrary to EFSA’s recommendations. Following the adoption of the Council’s Common Position, the European Parliament will now undergo a second reading on the proposal, most likely during the second quarter of 2010.