Contents
Article 20Specific provisions on the application for authorisation referred to in Articles 5 and 17 of Regulation (EC) No 1829/2003#
1.By way of derogation from Article 5(3), point (e), and Article 17(3), point (e), of Regulation (EC) No 1829/2003, and without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, an application for authorisation of a category 2 NGT plant for food or feed use, or category 2 NGT food or feed shall be accompanied by a copy of the studies which have been carried out, including relevant DNA sequence information and, where available, independent, peer-reviewed studies, and any other available material to demonstrate that:
(a)the plant is an NGT plant, including information on the techniques used to obtain it as well as information that it does not contain any genetic material originating from outside the gene pool for conventional breeding purposes where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements laid down in the delegated act adopted in accordance with Article 25, point (a);
(b)the food or the feed complies with the criteria referred to in Article 4(1) or Article 16(1) of Regulation (EC) No 1829/2003, respectively, based on a safety assessment of the food or feed carried out in accordance with the principles and information laid down in Parts 1 and 3 of Annex III to this Regulation and with the implementing act adopted in accordance with Article 27, first paragraph, point (a), of this Regulation.
2.By way of derogation from Article 5(3), point (i), and Article 17(3), point (i), of Regulation (EC) No 1829/2003, an application for authorisation shall be accompanied by methods for sampling – including references to existing official or standardised sampling methods –, detection, identification and quantification of the category 2 NGT plant and, where applicable, for the detection, identification and quantification of the category 2 NGT plant in the NGT food or feed.Where the applicant duly justifies, or where the European Union Reference Laboratory (EURL) established by Article 32, first paragraph, of Regulation (EC) No 1829/2003 concludes during the procedure referred to in Article 21(4) of this Regulation, that it is not feasible to provide an analytical method for identification and quantification, the arrangements for complying with analytical method performance requirements shall be adapted as set out in the implementing act adopted in accordance with Article 27, first paragraph, point (c), of this Regulation and the guidance referred to in Article 29(2) of this Regulation.
3.By way of derogation from Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, in the case of category 2 NGT plants for food or feed use, or food or feed containing or consisting of category 2 NGT plants, the application for authorisation shall be accompanied by:
(a)an environmental risk assessment carried out in accordance with the principles and information set out in Parts 1 and 2 of Annex III to this Regulation and with the implementing act adopted in accordance with Article 27, first paragraph, point (a), of this Regulation;
(b)a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan, which may be different from the duration of the authorisation.
The monitoring plan referred to in the first subparagraph, point (b), of this paragraph shall not be required where the applicant duly justifies that it is not needed on the basis of the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the category 2 NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, first paragraph, point (b), of this Regulation and the guidance referred to in Article 29(1) of this Regulation.
4.The application for authorisation shall contain a proposal for labelling in accordance with Article 24.
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