Procedure for the verification of category 1 NGT plant status for requests submitted prior to the placing on the market of NGT products
Article 7
1. Where a declaration of category 1 NGT plant status referred to in Article 4, point (a)(i), has not already been made in accordance with Article 6, to obtain such a declaration before placing on the market an NGT product, the person intending to place the product on the market shall submit a verification request to the Authority in accordance with paragraphs 2 and 3 of this Article and the delegated act adopted in accordance with Article 25, point (b). 2. The verification request shall be submitted in accordance with standard data formats, where they exist, in accordance with Article 39f of Regulation (EC) No 178/2002, and shall include, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002: (a) the name and the address of the requester; (b) the designation and specification of the NGT plant; (c) a description of the traits and characteristics which have been introduced or modified; (d) a copy of the studies, including relevant DNA sequence information, and any other available material to demonstrate that: (i) 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); (ii) the NGT plant meets the criteria set out in Annex I; (e) an identification of the parts of the verification request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, in accordance with Article 11 of this Regulation and Article 39 of Regulation (EC) No 178/2002. 3. The verification request shall also include a declaration that none of the traits intended to be conveyed by the genetic modifications is listed in Annex II. The declaration shall be accompanied by scientific evidence, available at the time of submission of the request, substantiating the relation between the introduced genetic modifications and the traits intended to be conveyed by those genetic modifications. 4. Together with the verification request, the requester shall submit information, to the best of its knowledge, on patents or published patent applications including one or more claims on the biological material of the NGT plant, or declare the absence of such patents or published patent applications. 5. Together with the verification request and the patent information referred to in paragraph 4, the requester may submit a written declaration of the holder of a patent identified under paragraph 4 confirming the patent holder’s willingness to license the protected subject matter under fair and reasonable conditions in all Member States where the patent holder is entitled to grant such a licence. If the requester is the patent holder, it shall submit a written declaration clarifying whether: (a) it is willing to license the protected subject matter under fair and reasonable conditions in all Member States where it is entitled to grant such a licence; and (b) it is, or intends to become, a member of relevant and appropriate licensing platforms. 6. The patent information referred to in paragraph 4 and the licence declarations referred to in paragraph 5 shall not be subject to verification and shall have only declaratory value. 7. The Authority shall acknowledge receipt of the verification request, the patent information referred to in paragraph 4 of this Article and, where applicable, the licence declarations referred to in paragraph 5 of this Article to the requester without undue delay, stating the date of receipt, and shall make them available to the Commission and to the Member States without undue delay. It shall make public the verification request, relevant supporting information and any supplementary information supplied by the requester, in accordance with Article 38(1) of Regulation (EC) No 178/2002, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation. 8. If the verification request does not contain all the necessary information or if the patent information referred to in paragraph 4 or, where the requester is the holder of a patent identified under paragraph 4, the licence declaration referred to in paragraph 5 is missing, the Authority shall declare the verification request inadmissible within 30 working days of the date of its receipt. The Authority shall inform the requester, the Commission and the Member States without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision. 9. If the verification request is not declared inadmissible in accordance with paragraph 8 of this Article, the Authority shall deliver a statement on whether the NGT plant fulfils the conditions set out in Article 3, point (13)(a), within 30 working days of the date of receipt of that verification request. It shall make the statement available to the Commission and to the Member States. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation. 10. The Commission shall prepare an implementing decision declaring whether the NGT plant is a category 1 NGT plant within 30 working days of the date of receipt of the statement of the Authority, taking the latter into account. That implementing decision shall be adopted in accordance with the procedure referred to in Article 28(2). The Commission shall publish a summary of that decision in the Official Journal of the European Union .