Authorisation Types and Withdrawal

Authorisation Types and Withdrawal

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. The Commission then ensures that MS are informed and forwards the applications to the European Food Safety Authority (EFSA).
  • The applicant must send to EFSA a copy of the application and 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.).
  • 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 for further information 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, the EFSA gives an opinion based on the information provided by the applicant. The evaluation report prepared by the Community Reference Laboratory on the method of analysis of the additive is included in the opinion. The opinion is favourable, it must include 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 authorise or deny the authorisation of the additive. The Commission prepares a draft implementing Regulation to grant or deny the authorisation. The Commission is assisted in the procedure 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

Operators

Withdrawal of Authorisations