EFSA provides scientific advice on the safety and/or efficacy of additives and products or substances used in animal feed.
Frequently Asked Questions
1. I have submitted a feed additive application for scientific evaluation by EFSA. How can I check the status of my application?
All applications received by EFSA are given an application number. EFSA then assigns an EFSA Question number (e.g. EFSA-Q-2011-12345) to the application in the Register of Questions (ROQ) once the corresponding mandate is received from the European Commission. In the ROQ, applicants are able to monitor the status and progress of EFSA’s scientific work related to their applications. To find an application in the ROQ, click on the ‘Question’ option in the top menu, then in the ‘Question type’ field select ‘Application’ and select the relevant ‘Food sector area’. You can then search using key words or a Question number if you know it. After locating your application, the ‘Status’ column indicates the present stage of the evaluation. When a question is ‘Finished’, an opinion has been adopted by EFSA’s Panel on Additives and Products or Substance used in Animal Feed (FEEDAP) and is scheduled for publication within a few days. When the opinion is published, it is available via the ‘View’ link. Further information: ROQ User Guide.
While EFSA is undertaking its evaluation, you can further monitor the progress of an application in the agendas and minutes of the specific Working Groups of the FEEDAP Panel and of the plenary meetings of the Panel.
2. I am not sure if my product is a feed additive requiring authorisation? Who should I contact ?
If the definition of ‘feed additive’ laid down in Article 2(2) of Regulation EC 1831/2003 does not allow you to determine whether or not your product is a feed additive that requires authorisation, please contact: Unit E5 - Animal nutrition, veterinary medicines, Directorate-General for Health and Food Safety (DG SANTE).
3. Is there an official list of all authorised feed additives?
The European Commission published the European Union Register of feed additives in compliance with Article 17 of Regulation EC 1831/2003 on additives for use in animal nutrition. The Register is a list of all authorised feed additives and existing products that can be placed on the market in the European Union.
4. I am a new applicant. How do I prepare an application?
The application procedure for authorisations is described in Regulation EC 1831/2003. Applicants must send: (1) an application to the European Commission, (2) a technical dossier directly to EFSA, (3) three reference samples of the feed additive to the European Union Reference Laboratory. The European Commission website provides an overview of the authorisation process for feed additives. EFSA carries out the risk assessment whilst the European Commission decides whether or not to authorise the feed additive.
For any type of feed additive application, applicants should refer to Regulation EC 429/2008 on detailed rules for the implementation of Regulation EC 1831/2003 on additives for use in animal nutrition, as well as to the related administrative guidance and technical guidance documents developed by EFSA’s Panel on Additives and Products or Substance used in Animal Feed to provide assistance to applicants in the preparation and presentation of dossiers. EFSA’s administrative and technical guidance documents for feed additive applications are regularly updated and therefore applicants are reminded to ensure that they use the latest version of these documents. Detailed information about guidance documents for feed additive applications.
5. Are the requirements the same for all feed additive applications?
No, the requirements vary according to the different categories of feed additives and types of authorisations. Details are included in Annexes II and III of Regulation EC 429/2008, which provides the list and the characteristics of studies and information on feed additives to be submitted:
New feed additives or a new uses of a feed additive – for applications requesting authorisation for a new feed additive or a new use of a feed additive, Article 4(1) of Regulation EC 1831/2003) applies. For the preparation of the application and the technical dossier, see Question 4, above.
Authorisation holder wishing to change the terms of their authorisation – for applications requesting change(s) in the terms of authorisation, Article 13(3) of Regulation EC 1831/2003 applies. For the preparation of the application and the technical dossier, see Question 4, above.
Renewal of the authorisation period for feed additives – under Article 14(1) of Regulation EC 1831/2003, authorisations under this Regulation are renewable for 10-year periods. An application for renewal should be sent to the European Commission at the latest one year before the expiry date of the authorisation. The particulars and documents to be sent to EFSA are indicated in Article 14(2) of Regulation EC 1831/2003 and in point 10 of Annex III of Regulation EC 429/2008.
Re-evaluation of a feed additive –The submission of applications for the re-evaluation of feed additives under Article 10(2) of Regulation EC 1831/2003 ended on 7 November 2010 (additives authorised without a time limit or authorised by Directive 82/471/EEC). Applications for the re-evaluation of products (linked to a holder of an authorisation or with a limited authorisation period) have to be submitted one year before the expiry of the authorisation granted under Directive 70/524/EEC.
6. What happens to my application when EFSA has received it?
Completeness check – Following receipt of a technical dossier by the applicant, an acknowledgement of receipt is sent to the applicant. In parallel, the European Commission sends a request to EFSA to carry out the risk assessment. EFSA then carries out a completeness check to verify that the details submitted by the applicant comply with Regulation EC 1831/2003 and Regulation EC 429/2008. During this completeness check, the status of an application in Register of Questions (ROQ) is described as ‘Registration not yet completed’ or ‘Under Consideration’.
Incomplete dossiers – Applicants should make every effort to include all information, data and full study reports as requested in the respective guidance documents, when they first submit their application. If some information is missing or incomplete, the applicant is asked to provide the missing data and the status bar in the ROQ reads ‘Waiting for full dossier’.
Valid applications – Once the dossier is complete, the application is declared valid and EFSA can start its scientific assessment, which is done by its Panel on Additives and Products or Substances used in Animal Feed. The status in the ROQ then changes to ‘In progress’.
7. How long does EFSA’s evaluation take?
According to Regulation EC 1831/2003, EFSA’s Panel on Additives and Products or Substances used in Animal Feed must endeavour to give an opinion within six months of receipt of a valid application. This time limit may be extended during the evaluation process if EFSA needs to request additional information from the applicant. EFSA’s work ends with the publication of a scientific opinion and the status of the application in EFSA’s Register of Questions is described as ‘Finished’. The European Commission prepares a draft Regulation to grant authorisation within three months of receipt of EFSA’s opinion.
8. Do I need to pay?
The only payment directly associated with the submission of an application for authorisation of a feed additive is the contribution requested by the European Union Reference Laboratory according to Article 21 of Regulation EC 1831/2003. Currently, EFSA does not charge a fee for its scientific evaluations. However, this practice is under review by the EU decision-makers.
9. Does EFSA authorise feed additives?
No. The authorisation of these substances is not within EFSA’s remit. In the European food safety system, scientific risk assessment (the responsibility of EFSA) is done independently from risk management, which includes authorisation of substances, products, claims, processes or organisms for their placing on the European Union market or use in the European Union. EFSA’s scientific advice is available in the adopted scientific opinions of the Panel on Additives and Products or Substance used in Animal Feed.. Under Article 9 of Regulation EC 1831/2003, it is the European Commission that decides whether or not to authorise a feed additive. If you require further information on the authorisation of feed additives, as well as other administrative or authorisation-related issues, such as import requirements, information on specific brands or products on the market, please contact the European Commission (see Question 2, above) or your national competent authority
The EU Register published by the European Commission lists all authorised feed additives in the European Union.
10. Short cuts for applicants
- Application procedure for FEED: Regulation EC 1831/2003 and Regulation EC 429/2008
- Requirements for technical dossiers: administrative guidance and Contact regarding authorisation: Unit E5 - Animal nutrition, veterinary medicines - DG SANTE
- Contact regarding feed additive samples and analytical methods: European Union Reference Laboratory