Regulatory requirements

The legislative framework for the authorisation of feed additives is set in

• The Feed Additives Regulation (EC) No 1831/2003, which is the core EU law establishing the procedure for authorisation
• Implementing Regulation (EC) No 429/2008, containing detailed procedural rules and data requirements

The main institutions involved in the authorisation procedure of feed additives are

• The European Commission, which is responsible for the regulatory procedure for the entire authorisation process, starting with the receipt of the application form from the applicant, the notification of the new application to the Member States, the forwarding of the dossier and studies submitted by the applicant via the E-Submission Food Chain platform (ESFC) and finally granting of the authorisation for a (new) feed additive.
• The European Food Safety Authority (EFSA), which is responsible for carrying out the risk assessment of the feed additive based on the dossier submitted via the ESFC platform. EFSA also provides advice prior to the submission of the dossier, gives guidance on all relevant data points for dossier preparation, provides the risk assessment tools and is in close contact with the applicant throughout the authorisation process. At the end of the risk assessment phase and the evaluation, EFSA publishes the scientific opinion on the feed additive, which forms the basis for the European Commission’s decision.
• The European Union Reference Laboratory (EURL), which analyses the samples of the feed additive submitted by the applicant in parallel to the risk assessment by EFSA. The EURL evaluates the analytical methods for detection and quantification proposed and described in the submitted dossier.