Changes from adopted text to adopted text

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

RemovedThe 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.

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

Removed1. 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).

RemovedThe database shall contain the following information:

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

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

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

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

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

Removed(e) an identification number, and

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

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

Removed2. The database shall be publicly available, and in an online format. [Am. 54]

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

RemovedCategory 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]

RemovedAppropriate 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]

RemovedArticle 11 Confidentiality

Removed1. 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.

Removed2. The competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1.

Removed3. 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:

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

Removed(b) DNA sequence information; and

Removed(c) breeding patterns and strategies.

Removed4. 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.

Removed5. 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.

Removed6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis.

Removed7. 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.

RemovedArticle 11a Withdrawal of the decision

RemovedIf 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]

RemovedCHAPTER III Category 2 NGT plants and category 2 NGT products

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

RemovedThe 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.

RemovedSECTION 1 Deliberate release of category 2 NGT plants for any other purpose than for placing on the market

RemovedArticle 13 Content of the notification referred in Article 6 of Directive 2001/18/EC

RemovedAs regards the deliberate release of a category 2 NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:

Removed(a) the name and the address of the notifier;

Removed(b) a copy of the studies, which have been carried out and any other available material to demonstrate that 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);

Removed(c) a technical dossier supplying the information specified in Annex II necessary to carry out the environmental risk assessment of the deliberate release of a NGT plant or combination of NGT plants:

Removed(i) general information including information on personnel and training;

Removed(ii) information relating to the category 2 NGT plant(s);

Removed(iii) information relating to the conditions of release and the potential receiving environment;

Removed(iv) information on the interactions between the category 2 NGT plant(s) and the environment;

Removed(v) a plan for monitoring in order to identify effects of the category 2 NGT plant(s) on human health or the environment;

Removed(vi) where relevant, information on control, remediation methods, waste treatment and emergency response plans;

Removed(vii) an identification of the parts of the notification and any other supplementary information that the notifier requests to be treated as confidential, accompanied by verifiable justification, pursuant to Article 25 of Directive 2001/18;

Removed(viii) a summary of the dossier;

Removed(d) the environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c).

RemovedSECTION 2 Placing on the market of category 2 NGT products other than food or feed

RemovedArticle 14 Content of the notification referred to in Article 13 of Directive 2001/18/EC

Removed1. As regards the placing on the market of category 2 NGT products other than food and feed, the notification referred to in Article 13(2) of Directive 2001/18/EC, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, shall contain:

Removed(a) name and address of the notifier and of its representative established in the Union (if the notifier is not established in the Union);

Removed(b) designation and specification of the category 2 NGT plant;

Removed(c) scope of the notification:

Removed(i) cultivation;

Removed(ii) other uses (to be specified in the notification);

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

Removed(e) the environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);

Removed(f) the conditions for the placing on the market of the product, including specific conditions of use and handling;

Removed(g) with reference to Article 15(4) of Directive 2001/18/EC, a proposed period for the consent, which should not exceed 10 years;