Changes from adopted text to adopted text

Added(b) where appropriate, 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. This duration may be different from the duration of the authorisation. 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 applicant considers that the NGT plant does need a monitoring plan, the applicant may propose not to submit a monitoring plan.

Added4. The application shall also contain a proposal for labelling in accordance with Article 23.

AddedArticle 20 Specific provisions on the opinion of the Authority

Added1. By way of derogation from Article 6(1) and (2) and Article 18(1) and (2) of Regulation (EC) No 1829/2003, the Authority shall deliver an opinion on the application for authorisation referred to in Article 19 of this Regulation within six months as from the receipt of a valid application.

AddedWhere the Authority or the competent authority of the Member State carrying out the environmental risk assessment or the safety assessment of the food or feed pursuant to Article 6(3), points (b) and (c) and Article 18(3), points (b) and (c) of Regulation (EC) No 1829/2003 considers that additional information is necessary, the Authority, or the national competent authority through the Authority, shall ask the applicant to submit that information within a specified time limit. In that case, the six months period shall be extended by that additional period. The extension shall not exceed six months unless it is justified by the nature of the data requested or by exceptional circumstances.

Added2. In addition to the tasks referred to in Article 6(3) and Article 18(3) of Regulation (EC) No 1829/2003, the Authority shall verify whether all the particulars and documents submitted by the applicant are in conformity with Article 19 of this Regulation.

Added3. By way of derogation from Article 6(3), point (d), and Article 18(3), point (d), of Regulation (EC) No 1829/2003, the Authority shall forward to the Union reference laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 the particulars referred to in Article 19(2) of this Regulation and in Article 5(3), point (j), and Article 17(3), point (j), of Regulation (EC) No 1829/2003.

Added4. The Union reference laboratory shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 19(2) or assess whether the information provided by. If the applicant justifies the application of adapted modalities to comply with detection method requirements, the Union reference laboratory shall carry out its own research and analyses to confirm the claimed unfeasibility. referred to In that paragraphcase, the decision of the Union reference laboratory shall be motivated and be made public. [Am. 228]

Added5. By way of derogation from Article 6(5), point (f), and Article 18(5), point (f), of Regulation (EC) No 1829/2003, in the event of an opinion in favour of authorising the food or the feed, the opinion shall also include:

Added(a) the method, validated by the Union reference laboratory, for detection, including sampling, and, where applicable, identification and quantification of the NGT plant and detection and identification of the NGT plant in the NGT food or feed, and a justification of any adaptation of the method in the cases referred to in Article 19(2), subparagraph 2;

Added(b) an indication of where appropriate reference material can be accessed.

Added6. In addition to the particulars mentioned in Article 6(5), point (d) and Article 18(5), point (d) of Regulation (EC) No 1829/2003, the opinion shall also include a proposal for labelling in accordance with Article 23 of this Regulation.

AddedArticle 21 Duration of the validity of the authorisation after renewal

AddedBy way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) No 1829/2003, after the first renewal, the authorisation shall be valid for an unlimited period, unless the Commission decides to renew the authorisation 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 authorisation.

AddedIf the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis or if 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. 270]

AddedSECTION 4 Common provisions for category 2 NGT plants and category 2 NGT products

AddedArticle 22 Incentives for category 2 NGT plants and category 2 NGT products containing traits relevant for sustainability

Added1. The incentives in this Article shall apply to category 2 NGT plants and category 2 NGT products, where at least one of the intended trait(s)traits of the NGT plant conveyed by the genetic modification is contained in Part 1 of Annex IIIArticle 51(1) of Regulation (EU/…)* and it does not have any traits referred to in Part 2 of that Annex. [Am. 57]

Added2. The following incentives shall apply to applications for authorisation submitted in accordance with Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19:

Added(a) by way of derogation from Article 20(1), subsection (1) of this Regulation, the Authority shall deliver its opinion on the application within 4 months from the receipt of a valid application, unless the complexity of the product requires application of the time limit referred to in Article 20(1). The time limit shall be extendable under the conditions set out in Article 20(1), subsection (2);

Added(b) where the applicant is a SME, it shall be exempted from the payment of the financial contributions to the Union Reference Laboratory and to the European Network of GMO Laboratories referred to in Article 32 of Regulation (EC) No 1829/2003.

Added3. The following pre-submission advice for the purposes of the risk assessment conducted in accordance with Annex II shall, in addition to Article 32a of Regulation (EC) No 178/2002, apply prior to notifications submitted in accordance with Article 13 of Directive 2001/18/EC in conjunction with Article 14 and to applications for authorisation submitted in accordance with Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19:

Added(a) the staff of the Authority shall, at the request of a potential applicant or notifier, provide advice on plausible risk hypotheses that the potential applicant or notifier has identified based on the properties of a plant, product or hypothetical plant or product, that need to be addressed by providing the information under Parts 2 and 3 of Annex II. The advice shall not, however, cover the design of studies to address the risk hypotheses;

Added(b) where the potential applicant or notifier is a SME, it may notify the Authority of how it intends to address the plausible risk hypotheses referred to in point (a) that it has identified based on the properties of a plant, product or hypothetical plant or product, including the design of the studies it intends to perform in accordance with the requirements laid down Parts 2 and 3 of Annex II. The Authority shall provide advice on the notified information, including on the design of the studies.

Added4. The pre-submission advice referred to in paragraph 3 shall comply with the following requirements:

Added(a) it shall be without prejudice and non-committal as to any subsequent assessment of applications or notifications by the Panel on Genetically Modified Organisms of the Authority. The staff of the Authority providing the advice shall not be involved in any preparatory scientific or technical work that is directly or indirectly relevant to the application or notification that is the subject of the advice;

Added(b) for potential notifications in accordance with Article 13 of Directive 2001/18/EC in conjunction with Article 14 and for potential applications under Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19 concerning a category 2 NGT plant to be used as seeds or other plant reproductive material, the pre-submission advice shall be provided by the Authority together, or in close collaboration with the competent authority of the Member State to which the notification or application is going to be submitted;

Added(c) the Authority shall make public without delay a summary of the pre-submission advice once an application or notification has been considered valid. Articles 38(1a) shall apply mutatis mutandis;

Added(d) potential applicants or notifiers demonstrating that they are a SME can request the pre-submission advice referred to in paragraph 3, point (a), at different points in time.

Added5. Any request for the incentives shall be submitted to the Authority at the time of request of advice referred to in paragraph 3 or the application referred to in Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19, and accompanied by the following information:

Added(a) the information necessary to establish that the intended trait(s) conveyed by the genetic modification of the category 2 NGT plant meet the conditions referred to in paragraph 1;

Added(b) where applicable, the information necessary to demonstrate the (potential) applicant or notifier is a SME;

Added(c) for the purpose of paragraph 3, information on the aspects listed in Part 1 of Annex II as far as it can already be provided and any other relevant information.

Added6. Article 26 of Directive 2001/18/EC and Article 30 of Regulation (EC) No 1829/2003 shall apply to information submitted under this article to the Authority, as appropriate.

Added7. The Authority shall lay down the practical arrangements to implement paragraphs (3) to (6).

Added8. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the lists of traits of NGT plants laid down in Annex III in order to adapt them to scientific and technological progress and to new evidence relating to the impact on sustainability of those traits, subject to the following conditions:

Added(a) the Commission shall take into account the monitoring of the impacts of this Regulation in accordance with Article 30(3);

Added(b) the Commission shall conduct an up-to-date scientific literature review of the impact on environmental, social and economic sustainability of the trait(s) it intends to add to or delete from the list in Annex III;

Added(c) where applicable, the Commission shall take into account the results of monitoring which was carried out in accordance with Article 14, point (h), or Article 19(3), of NGT plants harbouring the trait(s) conveyed by their genetic modification.

AddedArticle 23 Labelling of authorised category 2 NGT products

AddedIn addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003, and without prejudice to the requirements under other Union legislation, the labelling of authorised category 2 NGT products may also mention the trait(s) conveyed by the genetic modification, as specified in the consent or the authorisation pursuant to Sections 2 or 3 of Chapter III of this Regulation.

AddedArticle 24 Measures to avoid the unintended presence of category 2 NGT plants

AddedMember States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

AddedArticle 25 Cultivation

AddedArticle 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.

AddedCHAPTER IV FINAL PROVISIONS

AddedArticle 26 Exercise of the delegation

Added1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

Added2. The power to adopt the delegated acts referred to in Article 5(3), Article 6(11a) and Article 22(8) shall be conferred on the Commission for a period of 5 years from [date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. [Am. 59]

Added3. The delegations of power referred to in Article 5(3), Article 6(11a) and Article 22(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. [Am. 60]

Added4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making().

Added5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

Added6. A delegated act adopted pursuant to Articles Article 5(3), Article 6(11a) and Article 22(8) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council. [Am. 61]

AddedArticle 27 Implementing acts

AddedThe Commission shall adopt implementing acts concerning:

Added(a) the information required to demonstrate that a plant is a NGT plant; [Am. 62]

Added(b) the preparation and the presentation of the verification requests referred to in Articles 6 and 7; [Am. 63]

Added(c) the methodology and information requirements for the environmental risk assessment of category 2 NGT plants and the safety assessments of category 2 NGT food and feed, in accordance with the principles and criteria laid down in Annex II;

Added(d) the application of Articles 14 and 19, including rules concerning the preparation and the presentation of the notification or application;

Added(e) adapted modalities to comply with analytical method requirements referred to in Article 14(1), point (l), and Article 19(2).