CHAPTER II AUTHORISATION, USE, MONITORING AND TRANSITIONAL MEASURES APPLICABLE FOR FEED ADDITIVES

Article 14 Renewal of authorisations
1 Authorisations under this Regulation shall be renewable for 10-year periods. An application for renewal shall be sent to the Commission at the latest one year before the expiry date of the authorisation.
In the case of authorisations not issued to a specific holder, any person who first places the additive on the market or any other interested party may submit the application to the Commission and shall be considered as the applicant.
In the case of authorisations issued to a specific holder, the holder of the authorisation or his legal successor or successors may submit the application to the Commission and shall be deemed to be the applicant.
2 At the time of application, the applicant shall send the following particulars and documents directly to the Authority:
(a) a copy of the authorisation for placing the feed additive on the market;
(b) a report on the results of the post-market monitoring, if such monitoring requirements are included in the authorisation;
(c) any other new information which has become available with regard to the evaluation of the safety in use of the feed additive and the risks of the feed additive to animals, humans or the environment;
(d) where appropriate, a proposal for amending or supplementing the conditions of the original authorisation, inter alia, the conditions concerning future monitoring.
3 Articles 7(1), (2), (4) and (5), 8 and 9 shall apply accordingly.
4 Where, for reasons beyond the control of the applicant, no decision is taken on the renewal of an authorisation before its expiry date, the period of authorisation of the product shall automatically be extended until the Commission takes a decision. Information on this extension of the authorisation shall be made available to the public in the Register referred to in Article 17.