WRITTEN QUESTION E-2629/00

by Raffaele Costa (PPE-DE) to the Commission

(1 August 2000)

Subject: Assessment of the efficacy of additives used in animal feedingstuffs

Registration of all enzymes and micro-organism based products used in animal feedingstuffs has been made compulsory under the ministerial decree of 28 November 1994 and Directives 94/40/EC(1) and 93/113/EC(2). This legislation stipulates that products may not be manufactured or marketed in Italy or other countries unless they have been authorised by the Community.

Although they may have complied with the numerous obligations imposed by the protracted formalities, small specialised manufacturers of additives produced from starter cultures for use in animal feedingstuffs encounter discrimination when the scientific and technical requirements to be met by those additives are assessed by SCAN (the Scientific Committee on Animal Nutrition) and the EMO Expert Group, a body under the responsibility of DG XXIV.

In the crucial final stages of the assessment (which covers products of different companies), doubts have arisen as to whether individual applications for authorisation are treated fairly.

Can the Commission answer the following questions:

1. What procedures, criteria, and objective parameters are used when individual products are assessed by the above-mentioned committees and groups of experts?

2. What happens when an assessment procedure, criterion, or objective parameter is introduced for the first time or altered? Are products which have already been assessed immediately reassessed in accordance with the new procedure, or is their reassessment postponed indefinitely (resulting in disparities of appreciation from one product to the next)?

3. What are the powers, responsibilities, and roles of the individual members of SCAN on the one hand and the EMO Expert Group on the other?

4. Are minutes taken at the meetings of the committees, groups, and subgroups of experts in order to record the opinions of individual members on particular products? Who has the task of drafting, signing, and looking after the minutes? How are the opinions recorded brought to the notice of product sponsors and how far they are to be considered confidential, given that they do not relate to products associated with a single holder of rights?

(1) OJ L 208, 11.8.1994, p. 15.

(2) OJ L 334, 31.12.1993, p. 17.

Answer given by Mr Byrne on behalf of the Commission

(3 November 2000)

1. The Community procedure for authorising additives in animal feedingstuffs, including enzymes and micro-organisms, was laid down by Council Directive 70/524/EEC of 23 November 1970(1). The applicant for authorisation selects a Member State to act as rapporteur, and submits to it a dossier for the additive for which authorisation is sought which complies with Directive 87/153/EEC(2). The Member State selected has then to verify that it does indeed comply with Directive 87/153/EEC, and also to check on the basis of the dossier that the substance appears to satisfy the requirements for authorisation. Then the Member State submits it to the Commission. At the Commission's request, the Scientific Committee on Animal Nutrition (SCAN) conducts a scientific assessment of the risks on the basis of the information in the dossier in compliance with Directive 70/524/EEC.

2. The authorisation procedure was amended by Council Directive 96/51/EC of 23 July 1996(3). This applies to new products subject to authorisation and provides for a review of existing authorisations for additives, depending on when they were first authorised.

In its Communication of 30 April 1997(4), the Commission undertook to apply the principles of excellence, independence and transparency in delivering scientific opinions. The assessment made by SCAN is underpinned by the competence and expertise of the members of the Committee and the ad hoc working parties which examine the dossiers. The scientific committees are fully aware of the need to ensure that the opinions they deliver are consistent. For this reason, the SCAN working parties on Enzymes and Micro-organisms are responsible for all assessments of dossiers on enzyme and micro-organism-based additives respectively.

3. SCAN is responsible for delivering independent scientific opinions in response to questions from the Commission. The group of Member State experts is a legislative working party set up by the Standing Group on Feedingstuffs which considers all the aspects of a dossier, including those which SCAN is not asked to examine (such as the effectiveness of a product for which an application for provisional Community authorisation has to be made).

4. The minutes of the plenary meetings of the scientific committees are adopted at their plenary meetings and are published on the Internet at http://europa.eu.int/comm/food/fs/sc/index_en.html.

They do not include individual comments made by the committee members. However, minority opinions are mentioned when the opinions are published.

The minutes of meetings and the notes of the working parties are not published because they constitute preparatory deliberations which are part of the committees' internal processes. The Commission acts as a secretariat for the committees.

Finally, in the case of enzymes and micro-organisms, communications between the Commission and the applicant for an authorisation are conducted via the Member State selected by the applicant to act as a rapporteur in compliance with the procedure under Directive 70/524/EEC.

(1) OJ L 270, 14.12.1970.

(2) Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutrition (OJ L 64, 7.3.1987).

(3) OJ L 235, 17.9.1996.

(4) COM(97) 183 final.