In accordance with Article 7 paragraph 4 of Council Regulation (EC) No 1831/2003, the Commission, having first consulted the European Food Safety Authority, has established rules (Commission Regulation (EC) No 429/2008) concerning the procedures to be followed for the preparation and the presentation of applications and technical dossiers for authorisation for placing a feed additive on the market.
Applications have to be submitted following the procedures specified in Regulation 1831/2003 and Regulation 429/2008.
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The guidelines describe the procedures to be followed for the preparation and the presentation of applications and technical dossiers for authorisation for placing a feed additive on the market. The technical dossiers contain data on the identity, characterisation, conditions of use, analytical methods, efficacy and safety of the product.
Regulation 429/2008 includes an application form (Annex I), a description of the studies requested to prepare a dossier (Annex II) and a specific part (Annex III). This specific part is dedicated to different additive categories and functional groups, feed additives already used in food, additives used only for "minor species", additives only used in pet food, modifications and re-evaluation of additives authorised under Directive 70/524/EEC (Art. 10(2) of Regulation (EC) No 1831/2003).
Information to be submitted to the Commission:
- Application form in accordance with Annex I of Regulation (EC) No 429/2008
- Public summary of the dossier;
- Detailed summary of the dossier;
- List of the parts of the dossier requested to be treated as confidential and a copy of the respective concerned parts of the dossier In accordance with Article 2 " ….The applicant shall send to the Commission a copy of the parts of the dossier requested to be treated as confidential and of the accompanying justification….".
These particulars and documents to be submitted to the Commission are in addition to the information to be submitted to EFSA and the European Union Reference Laboratory (EURL)
The European Food Safety Authority has published additional detailed guidance for applicants in its website.
The analytical methods to determine the presence of an additive in feed and its possible residues in foods are evaluated by the European Union Reference Laboratory for feed additives authorisation.
In accordance with Commission Regulation (EC) No 378/2005, as last modified by Commission Regulation (EC) No 850/2007, the EURL has prepared practical guidance for applicants regarding the part of the application concerning the analytical methods.
The applicant for authorisation has to pay a fee to the European Union Reference Laboratory (EURL). The EURL shall use this fee towards supporting the costs of supporting the duties and the tasks of the EURL and the consortium of national reference laboratories.
The amount of the fee is fixed at EUR 6 000 for each application by
Commission Regulation (EC) No 378/2005 as last amended by
Commission Regulation (EC) No 885/2009 of 25 September 2009 as last modified by
Commission Regulation (EC) No 850/2007.
The amount of this fee may be adapted once a year.
See also the European Union Reference Laboratory (EURL) website for detailed procedure.
Fees for additives still in evaluation under Council Directive 70/524/EEC
Member States acting as "rapporteur" between a company and the other Member States and the Commission shall charge fees to the companies for the examination of an application dossier. Council Decision 98/728/EC sets up a Community system of fees in the animal feed sector. Council Directive 98/92/EC provides measures concerning the fees in order to avoid distortion of competition.