1.After an authorisation has been issued in accordance with this Regulation, the authorisation-holder and parties concerned shall comply with any conditions or restrictions which have been imposed in the authorisation and shall in particular make sure that products not covered by the authorisation are not placed on the market as food or feed. Where post-market monitoring as referred to in Article 5(3)(k) and/or monitoring as referred to in Article 5(5)(b) has been imposed on the authorisation-holder, the authorisation-holder shall ensure that it is carried out and shall submit reports to the [F1Food Safety Authority] in accordance with the terms of the authorisation. The monitoring reports referred to shall be made accessible to the public after deletion of any information identified as confidential in accordance with Article 30.
2.If the authorisation-holder proposes to modify the terms of the authorisation, the authorisation-holder shall submit an application in accordance with Article 5(2). Articles 5, 6 and 7 shall apply mutatis mutandis.
3.The authorisation-holder shall forthwith inform the [F2Food Safety Authority] of any new scientific or technical information which might influence the evaluation of the safety in use of the food. In particular, the authorisation-holder shall forthwith inform the [F2Food Safety Authority] of any prohibition or restriction imposed by the competent authority of any third country in which the food is placed on the market.
[F34.The Food Safety Authority must make the information supplied by the applicant available to the appropriate authority without delay.]
Textual Amendments
F1Words in Art. 9(1) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 13(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 9(3) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 13(b); 2020 c. 1, Sch. 5 para. 1(1)
F3Art. 9(4) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 13(c); 2020 c. 1, Sch. 5 para. 1(1)