Food safety: additive in feedingstuffs and in drinking water for animal nutrition

The Council's common position broadly agrees with the positions taken by the Commission and the European 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. The Council felt appropriate to introduce a number of amendments, many of them at the suggestion of the Parliament. - 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, 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. - 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. Further, a new paragraph has been included that 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. - 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. New Articles on confidentiality and 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 on data protection, providing rules for the sharing of information in order to avoid repeating toxicological tests on vertebrates. - 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. Specific conditions were added regarding data protection when applying for authorisations for minor species. - Specific requirements for pets : the Council decided to modify the text in order to provide that specific provisions for additives in pet food are appropriate. - Definitions and general conditions : the Council considered itappropriate in the interest of legal clarity to include several additional definitions, in particular one of "feed additives". Various clarifications proposed by Parliament regarding mixtures of additives have been included. 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. - Silage agents : the Council 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. - Phasing out of antibiotics used as growth promoters : following the Parliament's suggestion, the common position clarifies that all antibiotics, other than coccidiostats and histomonostats, shall be deleted from the Register as from 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.�