Residue limits of veterinary medicinal products in foodstuffs of animal origin
The Council approved the following Conclusions related to a Commission proposal amending Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin:
"1. The Council asks the Commission to submit to it a proposal aimed at incorporating into Community legislation a mechanism for temporary exclusive rights of use for pharmaceutical companies by giving an economic incentive to encourage the compilation of data to establish maximum residue limits (MRLs).
2. The Council asks the Commission to set out in Annex V to Regulation (EEC) No 2377/90 the specific conditions in which specific MRLs can be laid down during a limited period for the list of substances proposed by the European Agency for the Evaluation of Medicinal Products.
3. The Council invites the Commission, in accordance with the procedure laid down in Article 10 of Regulation (EEC) No 2377/90 and after consultation of the CVMP and the Standing Veterinary Committee, to establish by 1 January 2000 specific MRLs for certain substances which are essential for therapeutic purposes and which will no longer be authorised after that date.
4. The Council invites the Commission to draw up as soon as possible a proposal aimed at establishing a Community procedure for identifying veterinary medicinal products urgently required for the treatment of rare species or diseases by using as a model - with the necessary adjustments - the proposal for a Regulation (EC) of the European Parliament and of the Council on orphan medicinal products of 4 September 1998.
5. The Council asks the Commission to submit as soon as possible a proposal for amendment of Directive 81/851/EEC to change the spillover rules in Article 4(4) of that Directive, in particular to allow, in a therapeutic emergency, medicinal products containing substances listed in Annexes I to III to Regulation (EEC) No 2377/90 to be administered to animals other than those stated in the authorisation; this proposal must take account of consumer protection concerns.
6. The Council urges the European Agency for the Evaluation of Medicinal Products to make use of the possibility of reducing fees as provided for in Article 9 of Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on the fees payable to the EMEA and of adjusting the guidelines for minor species as regards the possibility of extrapolating data compiled on major species to minor species and to make these possibilities known to the pharmaceutical companies in an appropriate fashion.
7. The Council asks the Commission to consider whether, in consultation with the CVMP, it might be possible for the EMEA to carry out studies on the substances determined in accordance with Article 6 of Regulation (EEC) No 2377/90 with a view to fixing an MRL to be used by pharmaceutical companies on payment of a fee to cover costs."
It is recalled that under the present rules maximum residue limits (MRLs) in foodstuff of animal origin must be established for every veterinary medicinal product on the market by 1.1.2000. As a consequence, it is possible that after this date a number of veterinary medicinal products for which MRLs have not yet been fixed will have to be withdrawn from the market.
To facilitate the process of fixing MRLs, the Commission proposal aims at conferring to the Agency for the Evaluation of Medicinal Products the competence for dealing with applications for their establishment, amendment and extension.
The Council gave its endorsement to a draft Resolution entitled "a strategy against the microbial threat", intended for adoption by the "Health" Council.
The Agriculture Council shared the concerns expressed in the draft Resolution as to the danger of antibiotic resistance arising from over-consumption of antibiotics and supported the overall approach to the extent that it is not possible to ascribe excessive use of antibiotics to one sector rather than another. It also expressed the wish that the problem of the use of banned antibiotics in animal production sytems outside the EU be addressed, as third countries allowing their use could continue exporting to the EU meat containing residues of such antibiotics.