WRITTEN QUESTION P-0526/00

by Gary Titley (PSE) to the Commission

(21 February 2000)

Subject: Harmonisation of veterinary medicines and pesticide product licensing

What progress has been made in harmonising veterinary and pesticide product licensing arrangements?

What are the main obstacles to progress?

Answer given by Mr Byrne on behalf of the Commission

(30 March 2000)

Council Directive 81/851/EEC on the approximation of laws of the Member States relating to veterinary medicinal products(1), stipulates that a veterinary medicinal product can only be placed on the market if the documentation shows that the requirements on safety, quality and efficiency have

been fulfilled. These requirements are laid down in Council Directive 81/852/EEC on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products(2). Furthermore, this Directive requires that medicines for animals intended for food consumption contain only pharmacologically active substances that have positively been evaluated. For these substances, residues have to be evaluated according to Council Regulation (EEC) no 2377/90(3) and a withdrawal time has to be established, which determines when after the treatment food products may be taken from the treated animals.

In the context of a general evaluation of the veterinary medicines approval system, the Commission has recently started the process of evaluating the entire system of authorisation and supervision of medicinal products in the Community. Based on this evaluation, a proposal for modifications to the existing system will be made to the Council and Parliament in 2001.

Council Directive 91/414/EEC(4) on the placing of plant protection products on the market stipulates that the authorisation of pesticides products is the responsibility of the Member States and that such authorisations may only be made for those products containing pesticides active substances in Annex I to the Directive. Detailed uniform principles for the authorisation of plant protection products are laid out in Annex VI to the Directive and Member States are obliged to respect these principles when granting such authorisations.

For those substances for which a Commission decision has been taken not to include them in Annex I to the Directive, no authorisations may be made and existing authorisations must be rescinded. For those active substances that were already on the market on 1 June 1993 and where a decision has not yet been taken to include in or to exclude from Annex I, Member States may continue to grant authorisations up until 1st July 2003 in accordance with the basic provisions of Article 4 (concerning safety requirements) of the Directive.

The Commission will report to the Council and the Parliament in July 2001 on the operation of the Directive and based on the conclusions of that report, may propose amendments to existing legislation and procedures.

The Commission is aware of differences in a small number of cases between the residue evaluations performed in products containing the same substance but used for different purposes. These products that may have a dual use, such as pesticides and veterinary medicines, have different legal classifications. These divergences are currently under discussion at both European level and on a wider international basis, under the Codex alimentarius framework.

(1) (OJ L 317, 6.11.1981), as amended by Council Directive 90/676/EEC (OJ L 373, 31.12.1990) and Council Directive 93/40/EEC (OJ L 214, 24.8.1993).

(2) OJ L 317, 6.11.1981.

(3) Council 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 (OJ L 224, 18.8.1990) Amended by Council Regulation (EC) no 434/97 of 3 March 1997 amending Council 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 (OJ L 67, 7.3.1997).

(4) OJ L 230, 10.8.1991.