PART 3Amendment of retained direct EU legislation

Amendment of Regulation 1831/2003

22.  For Article 14, substitute—

Renewal of authorisation

1.  Authorisations under this Regulation are renewable for 10 year periods. An application for renewal must be sent to the appropriate authority 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 appropriate authority and must be considered as the applicant. In the case of authorisations issued to a specific holder, the holder of the authorisation or the holder’s legal successor may submit the application to the appropriate authority and is deemed to be the applicant.

2.  At the time of application, the applicant must send the following particulars and documents directly to the Food Safety 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, including, among other things, the conditions concerning future monitoring.

3.  Articles 7(1), (2), (4) ,(5), (6) and (7), 8 and 9 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 is automatically extended until the appropriate authority makes a determination. Information on this extension of the authorisation must be made available to the public in the Register..