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Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (Text with EEA relevance)
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1.Authorisations under this Regulation shall be renewable for 10-year periods, on application to the [F1appropriate authority] by the authorisation-holder at the latest one year before the expiry date of the authorisation.
2.The application shall be accompanied by the following:
(a)a copy of the authorisation for placing the food on the market;
(b)a report on the results of the monitoring, if so specified in the authorisation;
(c)any other new information which has become available with regard to the evaluation of the safety in use of the food and the risks of the food to the consumer or the environment;
(d)where appropriate, a proposal for amending or complementing the conditions of the original authorisation, inter alia the conditions concerning future monitoring.
3.Articles 5(2), 6 and 7 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 before its expiry date, the period of authorisation of the product shall automatically be extended until a decision is taken.
[F25.The appropriate authority, having first consulted the Food Safety Authority, may make provision for the application of this Article, by prescribing provisions concerning the preparation and the presentation of the application.]
6.The [F3Food Safety Authority] shall publish detailed guidance to assist the applicant in the preparation and the presentation of its application.
Textual Amendments
F1Words in Art. 11(1) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 15(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Art. 11(5) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 15(b); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Art. 11(6) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 15(c); 2020 c. 1, Sch. 5 para. 1(1)
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