Foodstuffs of animal origin: procedures for the establishment of residue limits of pharmacologically active substances

The Council's common position confirms the objectives and most of the arrangements proposed by the Commission and includes, in part or in their entirety 34 amendments passed at first reading by the European Parliament.

The Council introduced the following amendments to the Commission proposal:

Improvement of the availability of veterinary medicinal products: at the suggestion of the Parliament, amendments were made to a few provisions in order to try to improve the availability of veterinary medicinal products for food producing animals, in particular with regard to minor species and minor uses. More specifically, the Council wanted to clarify the cases in which Member States and the Commission may ask an opinion on MRLs to the Agency. In addition, the Council judged preferable to add provisions on the modalities of financing of MRL evaluations for active substances included in biocidal products. Furthermore, the Council recalled the importance of ensuring a high degree of human health protection and made some changes to insist on this aspect.

Establishment/review and functioning of reference points for action: following a series of Parliament amendments, several provisions were adapted to clarify the Commission proposal regarding in particular the definition of reference points for action and conditions for their establishment and review. Further, the conditions for placing food of animal origin on the market were specified. Likewise the measures to be taken when a forbidden or non authorised substance is found were defined.

Report to European Parliament and the Council: the Council also followed Parliament in asking the Commission to present a report on the experience gained from the application of the regulation, not later than 5 years after its entry into force. In addition, the Council requested that the report considers in particular substances classified under the regulation and having a multiple use.

The Council, like the Commission, could not accept 5 amendments.

Contrary to the Parliament the Council deemed essential to maintain a double legal basis as the proposal is relevant to the functioning of the internal market for products of animal origin included in Annex I to the Treaty. Moreover, the Council could not accept the comitology procedure with scrutiny considering the fixing of MRLs for specific substances to be a purely implementing measure with no quasi-legislative character. Lastly, the Council could not accept the complete deletion of the free circulation clause.