Article 12U.K.Renewal of authorisations
1.Without prejudice to Article 11, authorisations under this Regulation shall be renewable for 10-year periods on application to the [F1Authority] by the authorisation holder, at the latest 18 months before the expiry date of the authorisation.
2.The application shall be accompanied by the following particulars and documents:
(a)a reference to the original authorisation;
(b)any available information concerning the points listed in Annex II which supplements the information already provided to the Authority [F2, or provided to the European Food Safety Authority, if provided before IP completion day] in the course of the previous evaluation(s) and updates this in the light of the most recent scientific and technical developments;
(c)a reasoned statement affirming that the product complies with Article 4(1), first indent.
3.Articles 7 to 9 shall apply mutatis mutandis.
4.Where, for reasons beyond the control of the authorisation holder, no decision is taken on the renewal of an authorisation until one month before its expiry date, the period of authorisation of the product shall automatically be extended by six months. The [F3Authority] shall inform the authorisation holder F4... about the delay.
Textual Amendments
F1Word in Art. 12(1) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 22(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 12(2)(b) inserted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 22(b) (as amended by S.I. 2020/1504, regs. 1(2), 18(5)); 2020 c. 1, Sch. 5 para. 1(1)
F3Word in Art. 12(4) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 22(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Art. 12(4) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 22(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)