Changes from adopted text to adopted text

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

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

AddedAs 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:

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

Added(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);

Added(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:

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

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

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

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

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

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

Added(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;

Added(viii) a summary of the dossier;

Added(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).

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

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

Added1. 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:

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

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

Added(c) scope of the notification:

Added(i) cultivation;

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

Added(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);

Added(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);

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

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

Added(h) where appropriate, a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the 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, point (d), the notifier considers that the NGT plant does not need a monitoring plan, the notifier may propose not to submit a monitoring plan;

Added(i) a proposal for labelling which shall comply with the requirements laid down in point A.8. of Annex IV to Directive 2001/18/EC, Article 4(6) of Regulation (EC) No 1830/2003 and Article 23 of this Regulation;

Added(j) proposed commercial names of the products and names of category 2 NGT plants contained therein, and a proposal for a unique identifier for the category 2 NGT plant, developed in accordance with Commission Regulation (EC) No 65/2004 (). After the consent any new commercial names should be provided to the competent authority;

Added(k) description of how the product is intended to be used. Differences in use or management of that product compared to similar non-genetically modified products shall be highlighted;

Added(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier, the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);

Added(m) samples of the category 2 NGT plant and their control samples, and information as to the place where the reference material can be accessed;

Added(n) where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity;

Added(o) 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/EC and Articles 39 to 39e of Regulation (EC) No 178/2002;

Added(p) a summary of the dossier in a standardised form.

Added2. The notifier shall include in this notification information on data or results from releases of the same category 2 NGT plant or the same combination of category 2 NGT plants previously or currently notified and/or carried out by the notifier either inside or outside the Union.

Added3. The competent authority that prepares the assessment report referred to in Article 14 of Directive 2001/18/EC shall examine the notification for compliance with paragraphs 1 and 2.

AddedArticle 15 Specific provisions on monitoring

AddedThe written consent referred to in Article 19 of Directive 2001/18/EC shall either specify monitoring requirements, as described in Article 19(3) point (f) or state that monitoring is not required. Article 17(2), point (b), of Directive 2001/18/EC shall not apply if monitoring is not required by the consent.

AddedArticle 16 Labelling in accordance with Article 23

AddedIn addition to Article 19(3) of Directive 2001/18/EC, the written consent shall specify the labelling in accordance with Article 23 of this Regulation. [Am. 56]

AddedArticle 17 Duration of the validity of the consent after renewal

Added1. The consent granted under Part C of Directive 2001/18/EC shall, after the first renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for an unlimited period, unless the decision referred to in Article 17(6) or (8) provides that the renewal is for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the consent.

Added2. The last sentence in Article 17(6) and (8) of Directive 2001/18/EC shall not apply.

Added2a. If 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. 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. 268]

AddedSECTION 3 Placing on the market of category 2 NGT plants for food or feed use and of category 2 NGT food and feed

AddedArticle 18 Scope

AddedThis Section shall apply to:

Added(a) category 2 NGT plants for food use or for feed use;

Added(b) food containing, consisting or produced from category 2 NGT plants or containing ingredients produced from category 2 NGT plants (‘category 2 NGT food’);

Added(c) feed containing, consisting or produced from category 2 NGT plants (‘category 2 NGT feed’).

AddedArticle 19 Specific provisions on the application for authorisation referred to in Articles 5 and 17 of Regulation (EC) No 1829/2003

Added1. By way of derogation from Articles 5(3), point (e), and 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, including, where available, independent, peer-reviewed studies, which have been carried out and any other available material to demonstrate that:

Added(a) 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(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 criteria laid down in Parts 1 and 3 of Annex II to this Regulation and with the implementing act adopted in accordance with Article 27, point (c).

Added2. By way of derogation from Articles 5(3), point (i), and 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 NGT plant and, where applicable, for the detection and identification of the NGT plant in the NGT food or feed.

AddedIn cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant or concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);

Added3. By way of derogation from Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, in the case of category 2 NGT plants or food or feed containing or consisting of category 2 NGT plants, the application shall also be accompanied by:

Added(a) 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);