Opinion of the Economic and Social Committee on the "Proposal for a Council Regulation (EC) 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"

(1999/C 169/11)

On 1 April 1999 the Council decided to consult the Economic and Social Committee, under Articles 43 and 198 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Economic and Social Committee decided to appoint Mr Braghin to act as rapporteur-general for this work.

At its 363rd plenary session of 28 and 29 April 1999 (meeting of 28 April) the Economic and Social Committee adopted the following opinion with 57 votes in favour and four abstentions.

1. Introduction

1.1. The proposed Council Regulation (EC) is intended to adjust the procedures laid down in 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. It aims to make them consistent with the new set of rules resulting from the entry into force of Council Regulation (EEC) No. 2309/93 of 22 July 1993, which established a European Agency for the Evaluation of Medicinal Products and gave it the task of handling matters concerning the determination of the maximum residue limits acceptable.

1.2. This adjustment, somewhat late in the day, concerns a situation which has already been in existence for four years. The proposal does not relate to changes in the technical/scientific aspects and criteria on which the maximum residue limits of veterinary medicinal products considered acceptable in foodstuffs of animal origin are based; it solely concerns procedural changes to preserve the Regulation's legal consistency while at the same time facilitating compliance with the commitments made in connection with the Uruguay Round multilateral negotiations (transparency of health measures via the introduction of reasonable periods of assigning areas of competence).

1.3. The Economic and Social Committee welcomes this move to achieve clearer and consistent rules, a matter of particular importance for both human and animal health.

2. Specific comments

2.1. The ESC observes that Article 1 duly sets out the roles of the European Agency for the Evaluation of Medicinal Products, the applicant and the Commission; in particular, the ESC endorses the proposed fixed period (120 days) for the completion of the procedure for establishing the maximum acceptable residue limits.

2.2. The ESC would stress the importance of respecting the timelimits set in the revised Article 7 of Regulation (EEC) 2377/90 to ensure transparency and legal certainty in a sector which has vital health implications and hopes that all bodies involved make it a priority in their work to meet the specified deadlines.

2.3. The ESC feels that set deadlines will enhance the system's credibility and provide the applicant with greater safeguards, bearing in mind the more onerous responsibilities that the EAEMP will be required to shoulder in examining applications for determining, amending or extending maximum residue limits.

2.4. The new version of the first sentence of Article 9(2) could be improved if the vague phrase "shall as soon as possible examine..." were replaced by specific, binding deadlines, possibly spelling out the technical/scientific details in the sections concerning assessment of the justification of such grounds and consultation of the Committee for Veterinary Medicinal Products. The ESC suggests that the procedure should not exceed a set length of 120 days in all, as is provided for in the Agency's opinion.

2.5. The ESC particularly welcomes the proposed publication of a summary of the assessment of the safety of thesubstances concerned, while respecting the confidential nature of any proprietary data, and suggests that such summaries should be included in the annual report of the European Agency for the Evaluation of Medicinal Products.

Brussels, 28 April 1999.

The President

of the Economic and Social Committee

Beatrice RANGONI MACHIAVELLI