About authorisation
There are two types of authorisations:
- Authorisations issued to a holder of authorisation. Those authorisations are granted for additives belonging to the categories "Zootechnical additives" and "Coccidiostats and histomonostats" as well as additives consisting of, containing or produced from genetically modified organisms (GMOs)
- Authorisations not issued to a holder of authorisation for substances belonging to the categories of additives "technological additives", "sensory additives" and "nutritional additives".
Both types of authorisations are valid for 10 years throughout the EU and the European Economic Area (EEA). Those authorisations shall be renewable for 10-year period. An application for renewal shall be sent to the Commission at least 1 year before the expiry date of the authorisation. The procedure for renewal is described in Article 14 of Regulation (EC) No 1831/2003.
The Regulation also lays down a procedure for modification, suspension and revocation of the authorisation.
Authorisation procedure
- Applications for authorisation are submitted to the European Commission through the E-Submission Food Chain Platform. The Commission then ensures that MS are informed and forwards the applications to the European Food Safety Authority (EFSA).
- The applicant must upload on the Platform a copy of the application, the complete dossier (applicant’s name and address, a description of the method of production, manufacturing and intended uses of the additive, proposed conditions for placing the additive on the market, the safety and efficacy studies, etc.) and the summaries of the dossier in accordance with Article 7(3)(h) of Regulation (EC) No 1831/2003 and Annex II of Regulation (EC) No 429/2008.
- EFSA is responsible for conducting the risk assessment based on the dossier submitted by the applicant.
- The applicant must also send samples of the additive to the European Union Reference Laboratory for analysis.
- EFSA may, if necessary, ask through the Platform for further information and data to the applicant during the assessment procedure.
- Additives intended for use in animal nutrition must receive a favourable opinion before being granted authorisation for their use and placing on the market. Within 6 months of receipt of an application, which may be extended where supplementary information is requested to the applicant, EFSA gives an opinion based on the information provided by the applicant. The evaluation report prepared by the EU Reference Laboratory on the method of analysis of the additive is included in the opinion. If the opinion is favourable, it must include i.a. information on the specific conditions or restrictions relating to handling, monitoring requirements following placing on the market and use of the additive, including the animal species and categories of animals for which the additive is to be used, information on specific additional requirements for labelling of the additive, and, where appropriate, a proposal for the establishment of maximum residue limits in the relevant foodstuffs of animal origin.
- Based on the EFSA opinion, the Commission decides whether to grant or to deny the authorisation of the additive through an Implementing Regulation. In doing so, the Commission is assisted by the Member States within the Standing Committee on Plants, Animals, Food and Feed – section Animal Nutrition.
Feed Business Operators (FBO) are responsible for placing on the market and use of feed additives and for ensuring compliance with any conditions or restrictions imposed by the legislation.
Guidelines
Introduction
In accordance with Article 7, paragraph 4, of Regulation (EC) No 1831/2003, the Commission, having first consulted the European Food Safety Authority (EFSA), has established rules (Commission Regulation (EC) No 429/2008, containing the so-called "guidelines") 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 rules and procedures specified in Regulation (EC) No 1831/2003 and Regulation (EC) No 429/2008.
In accordance with Article2, paragraph 1, of Regulation (EC) 429/2008, applicants for the authorisation of a feed additive have to submit their application using the following application form.
Read the FAQs carefully before downloading or using this application form - FAQs.
Please ensure you save the latest version of the form on your computer before opening it in Acrobat! The electronic version 0.56 (updated 17 January 2022). of the application form (Annex I of Regulation 429/2008) can be downloaded by right-clicking here (use the "save file as" option).
VERY IMPORTANT: To use this form, make sure you have version 8.1.2 or higher of Acrobat. If you try to open the form with an older version of Acrobat, an error will occur.
Once the application is electronically submitted, please save the PDF document and upload it on the E-Submission Food Chain Platform, with the information indicated below.
Download the latest version of Adobe Acrobat free of charge.
The "guidelines" describe the rules and 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 in particular data on the identity, characterisation, conditions of use, analytical methods, efficacy and safety of the product.
Annex II of Regulation (EC) No 429/2008 provides for general requirements to be satisfied by the dossier, including a description of the requested studies, and Annex III of that Regulation is specifically 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, modification and renewal of authorisations.
Information to be submitted to the Commission on the E-Submission Food Chain Platform:
- Application form in accordance with Annex I of Regulation (EC) No 429/2008
- Summary of the dossier in accordance with Article 7(3)(h) of Regulation (EC) No 1831/2003;
- Scientific summary of the dossier in accordance with Annex II of Regulation (EC) No 429/2008;
- Complete technical dossier;
- All information concerning the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002;
- Confidentiality request in accordance with Article 18 of Regulation (EC) No 1831/2003;
- Copy of the administrative data of the applicant(s);
- Confirmation that the fee to the EU Reference Laboratory (EURL) has been paid.
These particulars and documents to be submitted to the Commission are in addition to the information to be submitted to the EURL.
EFSA has published additional detailed guidance for applicants on its website.
Analytical methods:
The analytical methods to determine the presence of an additive in feed and its possible residues in foods are evaluated by the EURL for feed additives authorisation.
In accordance with Commission Regulation (EC) No 378/2005, as last modified, the EURL has prepared practical guidance for applicants regarding the part of the application concerning the analytical methods.
Fees
The applicant for authorisation has to pay a fee to the EURL. The EURL shall use this fee towards supporting the costs of the duties and the tasks of the EURL and the consortium of national reference laboratories.
The amount of the fee is established in relation to the complexity of the application with a maximum of EUR 6 000 for application by Commission Regulation (EC) No 378/2005 as amended.
The amount of this fee may be adapted once a year.
See also the European Union Reference Laboratory website for detailed procedure.
Operators
Until the entry into force of Regulation (EC) No 183/2005 on feed hygiene on 1st of January 2006, the establishments and the intermediaries producing or putting into circulation certain categories of additives must be registered or approved following Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector
See related pages Animal nutrition - Approval and Registration of Establishments and Animal nutrition - Feed Hygiene.