Changes from adopted text to adopted text

Removed(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;

Removed(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.

Removed5. 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:

Removed(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;

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

Removed(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.

Removed6. 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.

Removed7. The Authority shall lay down the practical arrangements to implement paragraphs (3) to (6).

Removed8. 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:

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

Removed(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;

Removed(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.

RemovedArticle 23 Labelling of authorised category 2 NGT products

RemovedIn 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.

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

RemovedMember 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.

RemovedArticle 25 Cultivation

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

RemovedCHAPTER IV FINAL PROVISIONS

RemovedArticle 26 Exercise of the delegation

Removed1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

Removed2. 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]

Removed3. 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]

Removed4. 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().

Removed5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

Removed6. 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]

RemovedArticle 27 Implementing acts

RemovedThe Commission shall adopt implementing acts concerning:

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

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

Removed(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;

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

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

RemovedBefore adopting the implementing acts referred to in points (a) to (d), the Commission shall consult the Authority. The implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).

RemovedArticle 28 Committee procedure

Removed1. The Commission shall be assisted by the committee set up by Article 58 of Regulation (EC) No 178/2002.

Removed2. Where reference is made to this paragraph, Article 4 of Regulation (EC) No 182/2011 shall apply.

Removed3. Where reference is made to this paragraph, Article 5 of Regulation (EC) No 182/2011 shall apply.

RemovedArticle 29 Guidance

Removed1. Before the date of application of this Regulation, the Authority shall publish detailed guidance to assist the notifier or the applicant in the preparation and the presentation of the notifications and the application referred to in Chapters II and III and for the implementation of Annex II.

Removed2. Before the date of application of this Regulation, the European Union Reference Laboratory for Genetically Modified Food and Feed established pursuant to Article 32 of Regulation (EC) No 1829/2003, assisted by the European Network of GMO Laboratories, shall publish detailed guidance to assist the notifier or the applicant for the application of Article 14(1), point (l), and Article 19(2).

RemovedArticle 30 Monitoring, reporting and evaluation

Removed1. No sooner than three years after the first decision is adopted in accordance with Article 6(8) or (10) or Article 7(6) or in accordance with Sections 2 or 3 of Chapter III, whichever is the earliest, and thereafter every five years, the Commission shall forward to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Regulation.

Removed2. The report shall also identify and address any issues regarding biodiversity and environmental, human and animal health, changes to agronomic practices as well as socio-economic and ethical issues that may have arisen with the application of this Regulation. [Am. 64]

Removed3. For the purpose of the reporting referred to in paragraph 1, the Commission, by [24 months after the date of entry into force of this Regulation] at the latest, shall establish, after consulting the competent authorities of the Member States in accordance with Directive 2001/18/EC and Regulation (EC) No 1829/2003, a detailed programme for monitoring, based on indicators, the impact of this Regulation, including the intended and unintended effects and systematic effects on the environment, biodiversity and ecosystems. It shall specify the action to be taken by the Commission and by the Member States in collecting and analysing the data and other evidence. [Am. 65]

Removed4. No sooner than two years after the publication of the first report referred to in paragraph 1 the Commission shall carry out an evaluation of the implementation of this Regulation and its impact on human and animal health, the environment, consumer information, the functioning of the internal market, and economic, environmental and social sustainability.

Removed5. The Commission shall present a report on the main findings of the evaluation referred to in paragraph 4 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

Removed5a. By June 2025 the Commission shall submit a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the role and impact of patents on breeders' and farmers' access to varied plant reproductive material, as well as on innovation and, in particular, on opportunities for SMEs. The report shall assess whether further legal provisions are necessary in addition to those provided for in Article 4a and Article 33a of this Regulation. Where appropriate to ensure breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, the report shall be accompanied by a legislative proposal to address further necessary adjustments in the intellectual property rights framework. [Am. 66]

Removed5b. By 2024, the Commission shall submit a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions evaluating the specificities of and needs for other sectors not covered in this legislation, such as microorganisms, including a proposal for further policy actions. [Am. 67]

Removed5c. Every four years, the Commission shall assess the criteria of equivalence established in Annex I and, if necessary, update them through a delegated act as referred to in Article 5(3). [Am. 68]

RemovedArticle 31 References in other Union legislation

RemovedWith regard to category 2 NGT plants, references in other Union legislation to Annex II or Annex III to Directive 2001/18/EC shall be construed as references to Parts 1 and 2 of Annex II to this Regulation.

RemovedArticle 32 Administrative review

RemovedAny decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.

RemovedTo this effect a request shall be submitted to the Commission within two months from the day on which the party concerned became aware of the act or omission in question.

RemovedThe Commission shall prepare a draft decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.

RemovedArticle 33 Amendments to Regulation (EU) 2017/625

RemovedArticle 23 of Regulation (EU) 2017/625 is amended as follows:

Removed(1) in paragraph 2, point (a)(ii) is replaced by the following:

Removed‘(ii) the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];;’