1.On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether an authorisation still meets the conditions set out by this Regulation. It shall forthwith transmit this opinion to the Commission, to the Member States and, where applicable, to the holder of the authorisation. The opinion shall be made public.
2.The Commission shall examine the opinion of the Authority without delay. Any appropriate measures shall be taken in accordance with Articles 53 and 54 of Regulation (EC) No 178/2002. A decision on the modification, suspension or revocation of an authorisation shall be taken in accordance with the procedure referred to in Article 22(2) of this Regulation.
3.If the holder of the authorisation proposes changing the terms of the authorisation by submitting an application to the Commission, accompanied by the relevant data supporting the request for the change, the Authority shall transmit its opinion on the proposal to the Commission and the Member States. The Commission shall examine the opinion of the Authority without delay and decide in accordance with the procedure referred to in Article 22(2).
4.The Commission shall without delay inform the applicant of the decision taken. The Register shall be amended where appropriate.
5.Articles 7(1) and (2), 8 and 9 shall apply accordingly.