Chapter III, Section 4, Article 23 · Regulation (EU) 2026/1388

Contents

Article 23Incentives for category 2 NGT plants and category 2 NGT products containing traits relevant for sustainability#

1.The incentives set out in this Article shall apply to category 2 NGT plants and category 2 NGT products where at least one of the traits of the category 2 NGT plant intended to be conveyed by the genetic modifications is contained in Part 1 of Annex IV and that plant does not have any of the traits referred to in Part 2 of that Annex.

2.The following incentives shall apply to applications for authorisation submitted in accordance with Article 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 20 of this Regulation:

(a)by way of derogation from Article 21(1), first subparagraph, of this Regulation, the Authority shall deliver its opinion on the application within four months of the date of receipt of a valid application, unless the complexity of the product requires application of the time limit referred to in Article 21(1) of this Regulation; both time limits may be extended under the conditions set out in Article 21(1), second subparagraph of this Regulation;

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

3.In addition to the pre-submission advice referred to in Article 32a of Regulation (EC) No 178/2002, pre-submission advice for the purposes of the risk assessment conducted in accordance with Annex III to this Regulation shall be provided in accordance with this paragraph prior to notifications submitted in accordance with Article 13 of Directive 2001/18/EC in conjunction with Article 14 of this Regulation and to applications submitted in accordance with Article 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 20 of this Regulation.The staff of the Authority shall, at the request of a potential applicant or potential notifier, provide advice on the risk hypotheses that the potential applicant or potential notifier has identified to be tested in the risk assessment by providing the information under Parts 2 and 3 of Annex III to this Regulation.That advice shall not cover the design of studies to address the risk hypotheses unless the advice concerns guidance documents developed by the Authority in which study design is addressed. However, where the potential applicant or potential notifier is an SME, it may notify the Authority of how it intends to address the risk hypotheses referred to in the second subparagraph that it has identified to be tested in the risk assessment, including the design of the studies it intends to perform in accordance with the requirements laid down in Parts 2 and 3 of Annex III. The Authority shall provide advice on the notified information, including on the design of the studies.

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

(a)it shall be without prejudice and non-committal as to any subsequent assessment of notifications or applications 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;

(b)for potential notifications and potential applications 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;

(c)the Authority shall make public without delay a summary of the pre-submission advice once an application or notification has been considered valid; Article 38(1a) of Regulation (EC) No 178/2002 shall apply mutatis mutandis;

(d)a potential notifier or potential applicants that is an SME can request the pre-submission advice at different points in time.

5.The Authority shall verify whether the conditions set out in paragraph 1 of this Article are met. Any request for incentives shall be submitted to the Authority at the time of request of advice referred to in paragraph 3 of this Article or the application referred to in Article 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 20 of this Regulation, and accompanied by the following information:

(a)the information necessary to establish that the category 2 NGT plant meets the conditions referred to in paragraph 1;

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

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

6.Article 25 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.

7.The Authority shall lay down the practical arrangements to implement paragraphs 3 to 6.

8.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 IV in order to adapt them to scientific and technological progress or to new evidence relating to the impact on sustainability of those traits, subject to the following conditions:

(a)the Commission shall take into account the monitoring of the impacts of this Regulation in accordance with Article 32(2);

(b)the Commission shall conduct and make public an up-to-date scientific literature review of the impact on environmental, social and economic sustainability of the traits it intends to add to or delete from the lists in Annex IV;

(c)where applicable, the Commission shall take into account the results of monitoring which was carried out in accordance with Article 14(1), point (h), or Article 20(3), point (b), in respect of category 2 NGT plants harbouring the traits conveyed by their genetic modifications.