Activites

• 2003/10/18 Final act published in Official Journal
  • Regulation 2003/1831
  • OJ L 268 18.10.2003, p. 0029-0043
• 2003/09/22 Final act signed
• 2003/09/22 End of procedure in Parliament
• #2524
• 2003/07/22 Council Meeting
• 2003/06/19 Debate in Parliament
  • Debate in Parliament
  • T5-0286/2003 summary

    The European Parliament adopted the report drafted by Hedwig KEPPELHOFF-WIECHERT (EPP-ED, Germany) and made some amendments to the common position. (Please see the document dated 20/05/03.) The amendments are as follows: - a new recital recalls the principle of Community food law enshrined in Regulation 178/2002/EC, whereby food and feed imported for placing on the market must comply with Community legislation. It is therefore necessary to subject imports of third countries of additives for use in animal nutrition to requirements equivalent to those which apply to additives produced in the EC; - for additives authorised without a time limit, a list of additives which require re-evaluation and their priority order for re-evaluation should be drawn up, after the European Food Safety Authority has been consulted. An application for authorisation shall be submitted no later than 7 years after the adoption of that list; - with a view to a decision on the phasing out of the use of coccidiostats and histomonostats as feed additives by 31/12/12, the Commission must submit a report on the use of these substances as feed additives and available alternatives by 01/01/08. This should be accompanied, where appropriate by legislative proposals; - to protect corporate know-how, mixtures and premixtures containing flavourings and appetite stimulants should be exempt from the labelling requirement for each additive. This should not apply, however, to flavourings and appetite stimulants subject to a quantitative limitation when used in feed and drinking water; - in specific cases where urgent authorisation is needed to ensure the protection of animal welfare, the Commission may, provisionally authorise the use of an additive for a maximum period of 5 years.�

• 2003/05/20 Vote in committee, 2nd reading
  • A5-0176/2003
• 2003/03/27 Committee referral announced in Parliament, 2nd reading
• #2494
• 2003/03/17 Council Meeting
  • 15776/2/2002 summary

    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.�

• #2486
• 2003/02/20 Council Meeting
• 2002/12/18 Modified legislative proposal published
  • COM(2002)0771 summary

    The Commission can accept 24 amendments out of 57 adopted by the European Parliament at first reading. These amendments improve or bring more clarification to the Commission's initial proposal. They refer in particular to: - the clarification of the status of coccidiostats - (inclusion of histomonostats and presentation of a report on the use of and coccidiostats and histomonostats before 1 January 2008); - the flexibility of the authorisation procedure, in particular concerning the extension to minor species and the extension to further categories of animals; - the clarification of the authorisation procedure, in particular concerning the steps and delays to be followed by the applicant, the Commission and the EFSA; - the improvement of transparency and traceability of additives and facilitates communication during the authorisation procedure; - indication of specific provisions for additives in pet food; - mixtures of feedingstuffs to be sold directly to the final user. Concerning the amendments accepted in principle, in part and/or subject to re-wording, these concern: - the extension to other substances : this amendment foresees in its first part, an extension for silage agents. This extension can be accepted because the scope of Directive 70/524/EEC is vague and therefore there is no uniform application in the MS concerning silage agents; - phasing out of antibiotics used as growth promoters : this amendment indicates that the antibiotics used as growth promoters still authorised on the date of entry into force of the Regulation shall be deleted from the Register from that date; - improvement of transparency : improves the transparency of the procedure. It is important that the applicant is involved in all decisions concerning his application and particularly concerning the time frame of the risk assessment and the provision of new information. On the other hand, the amendments not accepted by the Commission are considered to undermine the aim to sustain the overall Community legislation as more transparent, less complex and efficient. Lastly, certain technical changes have been made to the text to ensure its conformity with the Interinstitutional Agreement of 22 December 1998 on common guidelines for the quality of drafting of Community legislation.�

  • DG [{'url': 'http://ec.europa.eu/dgs/health_consumer/index_en.htm', 'title': 'Health and Consumers'}],
• #2476
• 2002/12/16 Council Meeting
• 2002/11/21 Decision by Parliament, 1st reading/single reading
  • T5-0560/2002 summary

    The European Parliament adopted a resolution drafted by Hedwig KEPPELHOFF - WIECHERT (EPP-ED, Germany) on additives in animal nutrition. (Please refer to the document dated 5/11/02.) Parliament also added the following amendments: -unless otherwise specified, the mixing of additives to be sold directly to the end user will be allowed, subject to compliance with the conditions for use laid down in the authorisation for each single additive. The mixing of additives does not, therefore, require specific authorisation other than the requirements laid down in Directive 95/69/EC. -if no decision is taken on the renewal of an authorisation before its expiry date, the period of authorisation is automatically extended until the Commission takes a decision. -mixtures and premixtures containing flavourings and appetite stimulants will be exempt from the labelling requirement for each additive. This does not apply to flavouring and appetite stimulants subject to a quantitative limitation when used in feed and water. -the ten-year data protection period will be extended by one year for each new species of additives for which use extension authorisation is granted. In specific cases where urgent authorisation is needed to ensure the protection of animal welfare, the commission may, by special derogation, provisionally authorise use for a maximum of five years, with the possibility of extension subject to a satisfactory outcome of the post-market monitoring programme.�

• 2002/11/20 Debate in Parliament
  • Debate in Parliament
• 2002/11/05 Vote in committee, 1st reading/single reading
  • A5-0373/2002
• #2422
• 2002/04/22 Council Meeting
  • 2422
• 2002/04/08 Committee referral announced in Parliament, 1st reading/single reading
• 2002/03/22 Legislative proposal published
  • COM(2002)0153 summary

    PURPOSE: To consolidate EU provisions on additives for use in animal nutrition. CONTENT: Existing provisions on the regulation of additives for use in animal nutrition stem from a variety of (frequently outdated) Directives. So far, the basic legislation (Directive 70/524/EEC) has undergone five major amendments and numerous modifications of the annexes (over 100). The Directive has never been consolidated and provisions for authorisation contain many faults. Recognised problems include, no clear separation for risk evaluation or risk management, too much dependence on Member States who tend not be impartial and time-consuming, intransparent procedures. In light of these short comings the general objective of this proposed Regulation is to re-haul the entire regulatory process taking into account new products, feeding techniques and the short-coming of existing legislation. The Regulation will incorporate additives in feeding-stuffs and drinking water as well as the use of additives in silage. Only those additives which do not present a risk to human health, animal health or the environment may be included. Importantly, responsibility for authorisation will rest in the hands of the European Food Safety Authority (EFSA). The advantages are that the EFSA will provide a single framework for dossier evaluation for all feed additives, will bring clarity through guidelines which will be updated and adopted to various types of additives, efficiency through a single evaluation and transparency through the adoption of an assessment report and public consultation. Specifically, the Regulation contains the following elements: - In terms of scope the Regulation seeks to define "feed additives" Processing aids and veterinary medicines will not be covered by the Regulation. Only additives covered by an authorisation under the terms of the Regulation will be allowed to be put on the market, used or processed. Further, the borderline between veterinary medicinal products and feed additives is clarified. Thus, antibiotics are not authorised as feed additives. The use of coccidiostats as feed additives will be given limited authority depending on strict Maximum Residue Limits (MRLs). - The list of authorised additives will be divided into a restricted number of categories including technological additives; sensory additives; nutritional additives; zootechnical additives; coccidiostats. Additionally, a number of antibiotic feed additives will be withdrawn including avoparcin, tylosin phosphate, spiramycin, virginiamycin and bacitracin zinc. The Scientific Steering Committee recommends that the use of anti-microbials as growth promoting agents should be phased out as soon as possible and ultimately abolished. - In terms of registration, a positive list is maintained whereby only the additives listed in a register are allowed to be placed on the market, used or processed. Strict guidelines on the authorisation procedure are outlined. - On labelling rules the following will be required: the labelling of all additives; the name of the additive, the name and address of the person responsible for placing the product on the market, the net weight of the active component, directions for use and safety recommendations. The labelling will also indicate whether the additive is intended to be incorporated in feeding-stuffs or in drinking water. Lastly, the Commission will be responsible for implementation in accordance with Council Decision 1999/468/EC.�

  • DG [{'url': 'http://ec.europa.eu/dgs/health_consumer/index_en.htm', 'title': 'Health and Consumers'}],

Documents

• Legislative proposal published: COM(2002)0153
• Debate in Council: 2422
• Committee report tabled for plenary, 1st reading/single reading: A5-0373/2002
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 1st reading/single reading: T5-0560/2002
• Modified legislative proposal published: COM(2002)0771
• Council position published: 15776/2/2002
• Committee recommendation tabled for plenary, 2nd reading: A5-0176/2003
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 2nd reading: T5-0286/2003
• : Regulation 2003/1831
• : OJ L 268 18.10.2003, p. 0029-0043

History

(these mark the time of scraping, not the official date of the change)