PURPOSE: to suspend the use of the technique and the marketing of animal clones for farming purposes ensures that all Union farmers and breeders are subject to the same conditions while adequately protecting animal welfare.
PROPOSED ACT: Directive of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: Directive 98/58/EC on the protection of animals kept for farming purposes sets very general minimum animal welfare standards for animals used in agriculture. It does not refer explicitly to cloning, but calls on Member States to avoid unnecessary pain, suffering or injury in farm animals. If cloning causes unnecessary pain, suffering or injury Member States have to act at national level to avoid it.
In 2008, the Commission presented a proposal to streamline the approval process in Regulation (EC) N° 258/97 on novel foods. In the legislative procedure, lawmakers aimed to amend the proposal to introduce specific rules on cloning. Yet no agreement was reached on the scope and features of these insertions so that the proposal was abandoned after a failed Conciliation in March 2011.
As a result, the Commission was asked to prepare a legislative proposal on cloning in food production based on an impact assessment outside the Novel Food Regulation.
The European Parliament resolution of 6 July 2011 on the Commission Work Programme 2012 requested a legislative proposal to prohibit food from clones, offspring and descendants.
The European Food Safety Authority (EFSA) views cloning primarily as an animal welfare hazard related to the low efficiency of the technique. It up-dated its opinion on cloning of animals in 2012 concluding that scientific knowledge available on cloning has increased but that nevertheless its efficiency remains low compared to other reproduction techniques.
Union citizens, on the other hand, held a broadly negative perception of the use of the cloning technique for the production of animals for farming purposes.
IMPACT ASSESSMENT: the option calling for a temporary suspension of the technique and of imports of live clones was retained as the basis of the present proposal.
CONTENT: the proposal envisages a suspension on Union territory of:
- the use of the technique for food production purposes;
- the marketing of live clones (animal clones).
These provisional prohibitions will confine a production technique causing distress to animals to areas where it appears to have particular benefit.
The provisional prohibitions are kept under review given the development of knowledge on the technique and progress in the application of the technique in areas outside farming.
This proposal excludes cloning carried out in research, for the preservation of rare breeds or endangered species and for the production of medicinal products and medical devices.