Changes from adopted text to adopted text

Added(e) in the cases referred to in paragraph 2, an indication of the Member States in which the requester intends to undertake the deliberate release;

Added(f) 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, pursuant to Article 11 of this Regulation and Article 39 of Regulation (EC) No 178/2002.

Added4. The competent authority shall acknowledge receipt of the verification request to the requester without undue delay, stating the date of receipt. It shall make available the request to the other Member States and to the Commission without undue delay.

Added5. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the competent authority within 30 working days within the date of receipt of a verification request. The competent authority shall inform the requester, the other Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

Added6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working days from the date of receipt of a verification request. The competent authority may, where appropriate, consult with the European Food Safety Authority ('EFSA') while preparing the verification report. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay. [Am. 42]

Added7. The other Member States and the Commission may make commentsreasoned objections to the verification report, as regards the fulfilment of the criteria set out in Annex I, within 20 days from the date of receipt of that report. Such reasoned objections shall solely refer to the criteria as set out in Annex I and Annex III and shall include a scientific justification. [Am. 43]

Added8. In the absence of any commentsreasoned scientific objections from a Member State or the Commission, within 10 working days from the expiry of the deadline referred to in paragraph 7, the national competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. ItThe national competent authority shall transmit the decision without undue delaywithin 10 working days to the requester, the other Member States and to the Commission. [Am. 311]

Added9. In cases where a commentreasoned objection is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the the comment(s) to the Commissionmake the reasoned objections publicly available without undue delay. [Am. 45]

Added10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the comment(s)reasoned objections, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2). [Am. 46]

Added11. The Commission shall publish a summary of the decisions referred to in paragraphs 8 and 10 in the Official Journal of the European Union.

AddedArticle 7 Verification procedure of category 1 NGT plant status prior to the placing on the market of NGT products

Added1. Where a declaration of category 1 NGT plant status referred to in Article 4(1), point (a), has not already been made in accordance with Article 6, to obtain such a declaration before placing on the market a NGT product, the person intending to place the product on the market shall submit a verification request to the Authority in accordance with paragraph 2 and the implementing act adopted in accordance with Article 27, point (b).

Added2. The verification request referred to in paragraph 1 shall be submitted to the Authority in accordance with standard data formats, where they exist, pursuant to 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:

Added(a) the name and the address of the requester;

Added(b) the designation and specification of the NGT plant;

Added(ba) the denomination of the variety; [Am. 48]

Added(c) a description of the trait(s) and characteristics which have been introduced or modified including information on the technique or techniques used to obtain the trait or the traits and on disclosure of the sequence of genetic modification; [Am. 49]

Added(d) a copy of the studies, which have been carried out and any other available material to demonstrate that:

Added(i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Added(ii) the NGT plant meets the criteria set out in Annex I;

Added(da) a monitoring plan for environmental effects; [Am. 260]

Added(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, pursuant to Article 11 of this Regulation and Article 39 of Regulation (EC) No 178/2002.

Added3. The Authority shall acknowledge receipt of the verification request to the requester without delay, stating the date of receipt. It shall make available the verification request to the Member States and to the Commission without undue delay and 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.

Added4. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the Authority within 30 working days within the date of receipt of a verification request. The Authority shall inform the requester, the Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

Added5. If the verification request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its statement on whether the NGT plant fulfils the criteria set out in Annex I within 30 working days from the date of receipt of a verification request. The Authority shall make available the statement to the Commission and 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.

Added6. The Commission shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 30 working days from the date of receipt of the statement of the Authority, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

Added7. The Commission shall publish a summary of the final decision in the Official Journal of the European Union and shall publish, in a dedicated and publicly available webpage, its draft decision and the reasoned objections referred to in Article 6. [Am. 50]

AddedArticle 8 System of exchange of information between Member States, the Commission and the Authority

AddedThe Commission shall set up and maintain an electronic system for the submission of verification requests in accordance with Articles 6 and 7 and the exchange of the information under this Title.

AddedArticle 9 Database of decisions declaring the category 1 NGT plant status

Added1. The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6).

AddedThe database shall contain the following information:

Added(a) name and the address of the requester;

Added(b) the designation and specification of the category 1 NGT plant; [Am. 51]

Added(ba) the denomination of the variety; [Am. 52]

Added(c) a summarised description of the technique(s) used to obtain the genetic modification;

Added(d) a description of the trait(s) and characteristics which have been introduced or modified;

Added(e) an identification number, and

Added(ea) if provided, the opinion or statement of EFSA, as referred to in Article 6 (10) and Article 7(5); and [Am. 53]

Added(f) the decision referred to in Article 6(8) or (10), and Article 7(6), as appropriate.

Added2. The database shall be publicly available, and in an online format. [Am. 54]

AddedArticle 10 Labelling of category 1 NGT plant reproductive material, including breeding material

AddedCategory 1 NGT plants, products containing or consisting of category 1 NGT plant(s) and plant reproductive material, including for breeding and scientific purposes, that contains or consists of category 1 NGT plant(s) and is made available to third parties, whether in return for payment or free of charge, shall bear a label indicating the words ‘cat 1 NGT’New Genomic Techniques’. In the case of plant reproductive material, it shall be followed by the identification number of the NGT plant(s) it has been derived from. [Am. 264]

AddedAppropriate document-based traceability for NGTs shall be provided by the transmission and holding of information that products contain or consist of NGT plants and product, and the unique codes for those NGTs, at each stage of their placing on the market. [Am. 265]

AddedArticle 11 Confidentiality

Added1. The requester referred to in Articles 6 and 7 may submit a request to the Member State competent authority or to the Authority, as appropriate, to treat certain parts of the information submitted under this Title as confidential, accompanied by verifiable justification, in accordance with paragraphs 3 and 6.

Added2. The competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1.

Added3. The competent authority or the Authority, as appropriate, may grant confidential treatment only with respect to the following items of information, upon verifiable justification, where the disclosure of such information is demonstrated by the requester to potentially harm its interests to a significant degree:

Added(a) items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002;

Added(b) DNA sequence information; and

Added(c) breeding patterns and strategies.

Added4. The competent authority or the Authority, as appropriate, shall, after consultation with the requester, decide which information is to be treated as confidential and shall inform the requester of its decision.

Added5. Member States, the Commission and the Authority shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public.

Added6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

Added7. In the event of a withdrawal of the verification request by the requester, Member States, the Commission and the Authority shall respect the confidentiality as granted by the competent authority or the Authority in accordance with this Article. Where the withdrawal of the verification request takes place before the competent authority or the Authority has decided on the relevant confidentiality request, Member States, the Commission and the Authority shall not make public the information for which confidentiality has been requested.

AddedArticle 11a Withdrawal of the decision

AddedIf the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis, the competent authority may withdraw its decision referred to in Article 6(8) or statement referred to in Article 7(5). The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who shall have 15 days in which to make observations. In that case, the marketing of the NGT plant or product shall be prohibited from the day following the date of receipt of the registered letter. [Am. 266]

AddedCHAPTER III Category 2 NGT plants and category 2 NGT products

AddedArticle 12 Status of Category 2 NGT plants and category 2 NGT products

AddedThe rules which apply to GMOs in Union legislation in so far as they are not derogated from by this Regulation, shall apply to category 2 NGT plants and category 2 NGT products.