COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a proposal for a Regulation of the European Parliament and of the Council on additives for use in animal nutrition

2002/0073 (COD)

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a proposal for a Regulation of the European Parliament and of the Council on additives for use in animal nutrition

1- BACKGROUND

Date of transmission of the proposal to the EP and the Council (document COM (2002)153 final - 2002/0073 (COD)): // 22 March 2002

Date of the opinion of the European Economic and Social Committee: // 18 September 2002

Date of the opinion of the European Parliament, first reading: // 21 November 2002

Date of transmission of the amended proposal: // 18 December 2002

Date of adoption of the common position: // 17 March 2003

2- OBJECTIVE OF THE COMMISSION PROPOSAL

The proposal is intended to:

* Simplify the existing rules regarding the authorisation procedure of additives in feedingstuffs,

* Distinguish clearly between risk assessment (European Food Safety Authority (EFSA)) and risk management (Commission and Member States),

* Lay down provisions for the phasing out of antibiotics used as growth promoters,

* Maintain the use of coccidiostats as feed additives and to consolidate EU provisions on additives for use in animal nutrition.

3- COMMENTS ON THE COMMON POSITION

A. General Remark

The Council's common position broadly accords with the positions taken by the Commission and the Parliament, in as much as it:

- confirms the objectives and most of the arrangements proposed by the Commission and supported by the European Parliament;

- includes a large number of the amendments passed at first reading by the European Parliament.

In particular, the Council has retained the legal form of a Regulation with a view to consolidating existing provisions on the regulation of additives for use in animal nutrition which stem from a variety of Directives. The basic legislation (Directive 70/524/EEC) which it is intended to replace has undergone five major amendments and numerous modifications of the annexes, making its application increasingly difficult for operators and authorities.

B. Specific Comments

The Council felt appropriate to introduce a number of amendments, many of them at the suggestion of the Parliament.

(a) Status of coccidiostats - Inclusion of histomonostats - Report of use of coccidiostats and histomonostats

The Council included histomonostats in the same category of feed additives as coccidiostats, as listed in Article 6(1), thus maintaining these two groups within the framework of the feed additives legislation. While not prejudging the future use of these substances at the present time, the Council also followed Parliament in asking the Commission to present a report on the use of coccidiostats and histomonostats as feed additives before 1 January 2008, where appropriate together with a legislative proposal concerning further use.

The Commission's amended proposal took into account the acceptance of amendments 17 and 31 of the Parliament concerning the inclusion of histomonostats and the presentation of the report on the use of coccidiostats and histomonostats. Therefore it is in line with the Common Position on these matters.

(b) Scope of the Regulation and authorisation procedure

The Council decided to adapt several provisions regarding the scope of the Regulation and the authorisation procedure, in particular concerning the steps and time limits to be followed by the applicant, the Commission and the EFSA (Articles 1, 2, 3, 5, 7, 10 and 14 ). Part of these modifications correspond to Parliament amendments that were accepted by the Commission and included in the amended proposal (Amendments 12, 16, 19, 21, 25, 32, 37 and 38).

Further, a new paragraph in Article 20 specifies that applicants for authorisation of additives shall contribute to support the implied cost of the tasks carried out by the Community reference laboratory and the consortium of national reference laboratories. In spite of not being subject to any amendment of the Parliament and not being included in the Commission's amended proposal the Commission supports this element of the Common position.

(c) Improvement of transparency and traceability - Administrative review

The Council decided to introduce amendments to certain provisions in order to improve the traceability of additives and facilitate communication during the authorisation procedure and the availability of information to the public, in particular through modification of Article 13 on transparency and on Article 15 on labelling and packaging. Parliament amendments 36 and 43 on these matters were accepted by the Commission and included in the Commission's amended proposal that is in line with the Common Position.

New Articles 17 (on confidentiality), 18 (on the administrative review of decisions or failures to act by the EFSA) were included in the Common position.

In the interest of animal welfare, a new paragraph was included in Article 19 on data protection, providing rules for the sharing of information in order to avoid repeating toxicological tests on vertebrates.

In spite of not being included in the Commission's amended proposal these elements of the Common position can be accepted by the Commission.

(d) Minor species - Animal categories

The Council decided to introduce more flexibility in the authorisation procedure for minor species and the extension to further categories of animals (Article 7 (5) and Recitals 14, 15, and 17). Specific conditions were added to Article 19 regarding data protection when applying for authorisations for minor species.

These changes are in line with Parliament's amendments 27 and 44, which were accepted by the Commission and included in the Commission's amended proposal.

(e) Specific requirements for pets

The Council decided to modify Article 7 (5) and corresponding Recital 4 in order to provide that specific provisions for additives in pet food are appropriate.

The Commission's amended proposal has already taken into account the amendment 26 from the Parliament on this matter.

(f) Definitions and general conditions

The Council considered it appropriate in the interest of legal clarity to include several additional definitions in Article 2, in particular one of "feed additives". Various clarifications proposed by Parliament regarding mixtures of additives (Amendment 12) have been included in Articles 1 and 3 as well as in Recital 8. Likewise, the additive groups in Annex I have been completed. A new Annex IV gives room for establishing conditions of use applicable to all feed additives.

The Commission accepts this approach.

(g) Silage agents

The Council in Article 10 (7) added an extension for silage agents. This extension, accompanied by a transitional arrangement for silage agents which are currently marketed and used in the Community without an authorisation pursuant to Directive 70/524/EEC, was considered necessary because there is no uniform application in the Member States concerning silage agents.

This point of the Common position is in line with the Commission's amended proposal that accepted Amendment 33 on this matter.

(h) Phasing out of antibiotics used as growth promoters

On the Common Position, Article 11 clarifies that all antibiotics, other than coccidiostats and histomonostats, shall be deleted from the Register as from the phase-out date specified in that Article. In setting this date as 1 January 2006, the Council followed the Commission proposal and rejected the amendments of the Parliament for another date for the phasing out of antibiotic growth promoters (Amendment 35).

4- CONCLUSION

The Commission considers that the amendments introduced by the Council constitute an improvement to the original Commission proposal and, therefore, supports the common position adopted by the Council.