Opinion of the Economic and Social Committee on the 'Proposal for a Council Regulation (EC) 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` (97/C 133/10)

On 19 December 1996 the Council decided to consult the Economic and Social Committee, under Article 43 of the Treaty establishing the European Union, on the above-mentioned proposal.

The Section for Protection of the Environment, Public Health and Consumer Affairs, which was responsible for preparing the Committee's work on the subject, set up a study group and appointed Mr Colombo rapporteur.

At its 343rd plenary session (meeting of 26 February 1997) the Economic and Social Committee appointed Mr Colombo as rapporteur-general and adopted the following opinion by 77 votes to two, with two abstentions.

The Committee notes that the amendments in question concern various procedural aspects and deadlines. Each will be considered in detail. Given the urgency as a result of the legal void which has been created, the Committee has adopted an opinion on the procedural aspects and deadlines contained in the proposal, and will return to the substantial issues raised subsequently as soon as the Commission formulates new proposals.

1. Introduction

1.1. The aim of Council Regulation 2377/90 () is to:

- prevent maximum residue limits from hindering the free movements of veterinary medicinal products and foodstuffs within the European Union;

- protect public health.

1.2. Since 1 January 1992 it has not been possible to authorize the placing of a veterinary medicinal product on the market unless a maximum residue limit has been established beforehand.

1.3. Maximum residue limits were to have been established by 1 January 1997 for substances whose use was authorized earlier than 1992.

1.4. Pursuant to the regulation, the Commission firstly took note of the scientific opinion of the Committee for Veterinary Medicinal Products (CVMP), and, in accordance with the procedure of the Regulatory Committee, adopted a legally binding decision classifying 282 substances into the four annexes to the regulation, namely:

- Annex I, substances for which a maximum residue level may be fixed;

- Annex II, substances not subject to maximum residue levels;

- Annex III, substances for which a provisional limit is set in the absence of the scientific data needed;

- Annex IV, substances of which any quantity poses a health risk to the consumer.

2. The need to update the procedure

2.1. The primary motivation behind the proposed amendment is to bring the procedure for determining maximum residue levels into line with the radical changes to Community procedures introduced under Regulation 2309/93 () and Council Directives 93/40/CEE () and 93/41/CEE ().

2.2. These measures laid down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and established the European Agency for the Evaluation of Medicinal Products.

2.3. The CVMP is thus now answerable to the Agency, whose responsibilities include that of issuing an opinion on the maximum residue limits of veterinary medicinal products which are acceptable in foodstuffs of animal origin.

2.4. The decision-making process thus needs to be brought into line with the so-called centralized procedure established under Regulation 2309/93.

2.5. The procedure further needs to be adapted to enable the Community to meet its obligations under the Agreements on the application of sanitary and phytosanitary measures which emerged from the multilateral negotiations of the Uruguay Round, approved by the European Court by Council Decision 94/800/EEC () of 22 December 1994. To meet the obligation for transparency, it is necessary to introduce reasonable periods for consulting members of the World Trade Organization.

2.6. The Committee considers that the proposed amendments to Articles 7, 8 10 and 12 are appropriate to the new legal framework for medicinal products and the Community's international obligations.

3. The need to extend the deadline for the review of substances already in use

3.1. While continuing as planned for new substances, the Commission is requesting that the deadline for the evaluation of substances already in use on and submitted to EMEA by 1 January 1996 should be extended to 1 January 1999.

3.2. The reasons behind this request are:

a) The delayed start to the Agency's work at its London base, which started operations only on 1 January 1995.

b) The difficulties encountered by the industry in collecting the data necessary to establish dossiers and by the national authority in evaluating them.

c) The large number of products to be submitted for evaluation by the Agency and the time this is likely to take, as detailed in the table on page 6 of the proposal.

d) The lengthening of the time required for administration as a result of consultation requirements arising from international agreements.

e) The impossibility of speeding up the process without compromising the transparency required for trade in medicinal products. Correct and scientifically rigorous procedures must be followed; this is an absolute requirement for consumer safety.

3.3. Given the rate at which substances already in use are being examined, and the fact that over 200 remain to be dealt with, the Committee is obliged to approve the extension laid down in the first and second paragraphs of Article 14.

3.4. The Committee does not however consider two years to be sufficient, given the time required for in-depth examination, which is essential to consumer and animal health protection and if the practice of repeated extensions is not to continue. This is partly on the basis of the data gathered by the European Agency for the Evaluation of Medicinal Products. The Committee proposes that the deadline be set definitively for 1 January 2000, with no possibility of extension.

3.5. Under no circumstances should this lengthening of the extension be taken as a pretext for slowing down work. In this regard, the Committee is concerned to note that the Member States have not so far been in a position to provide adequate funding and staff for the revision work, and that this is one of the causes of the delays which have occurred. It therefore feels that if the new deadlines are to be met in the interest of consumer protection and the availability and movement of veterinary medicines, the question of optimizing national and European-level financial and human resources must be considered as a matter of urgency.

3.6. While noting that new dossiers for substances already in use cannot be lodged, the Committee recommends adopting a procedure allowing the Agency to examine those substances already submitted during the course of 1996 and which are of particular therapeutic importance.

4. Establishment of maximum residue limits for substances undergoing clinical trials

4.1. A further aspect of the proposed amendments is the matter of animals used in clinical trials of medicinal products.

4.2. Article 4(2) of Directive 81/851/EEC () lays down that foodstuffs for human consumption may not be taken from test animals unless maximum residue limits have been established and an appropriate withdrawal period allowed. Thus, as from 1 January 1997, unless a maximum residue limit is established before the clinical trial is carried out, foodstuffs from the animals used, and possibly the animals themselves, would have to be destroyed.

4.3. The Commission proposes the addition of a new Article 4(a) to the existing regulation allowing a provisional maximum limit to be set, along with a suitable waiting period, not to exceed two years.

4.4. The regulation would also be supplemented by an ad hoc Annex III(a), which would include all the substances undergoing clinical trials together with their provisional maximum residue levels and appropriate time periods, in order to ensure the protection of the consumer.

4.5. Since the Committee considers that consumer protection is already provided at national level by the rules under Directive 93/40/EEC and by the good clinical practices laid down in Directive 92/18/EEC, it does not believe that establishing a provisional MRL will enhance consumer safety, on account of the lack of available data in the first phase of clinical trials. This view is strengthened by the reservations expressed in this regard by the CVMP which is shortly to adopt a document containing alternative proposals for submission to the Commission.

4.6. Consequently, the Committee does not accept the addition of a new Article 4(a) or of the third paragraph of Article 14, and calls upon the Commission to draft a new proposal reflecting the CVMP guidelines so as to reconcile consumer safety with the need to avoid the destruction of animals used for trials wherever possible.

Brussels, 26 February 1997.

The President of the Economic and Social Committee

Tom JENKINS

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