Chapter III, Section 2, Article 14 · Regulation (EU) 2026/1388

Contents

Article 14Notification referred to in Article 13 of Directive 2001/18/EC#

1.As regards the placing on the market of category 2 NGT products for uses other than food or feed, the notification referred to in Article 13(1) of Directive 2001/18/EC shall contain, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002:

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

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

(c)scope of the notification:

(i)cultivation; or

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

(d)a copy of the studies, including relevant DNA sequence information, and any other available material to demonstrate that the plant concerned is an NGT plant, including information on the techniques used to obtain it as well as information that it does not contain any genetic material originating from outside the gene pool for conventional breeding purposes where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements laid down in the delegated act adopted in accordance with Article 25, point (a);

(e)the environmental risk assessment carried out in accordance with the principles and information set out in Parts 1 and 2 of Annex III and with the implementing act adopted in accordance with Article 27, first paragraph, point (a);

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

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

(h)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, which may be different from the proposed period for the consent; however, a monitoring plan shall not be required where the notifier duly justifies that it is not needed on the basis of the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the category 2 NGT plant concerned, 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, first paragraph, point (b), of this Regulation and the guidance referred to in Article 29(1) of this Regulation;

(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 24 of this Regulation;

(j)proposed commercial names of the products and names of the 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^note; after the consent, any new commercial names shall be provided to the competent authority;

(k)a description of how the product is intended to be used; differences in use or management of that product compared to similar products not containing or consisting of genetically modified organisms shall be highlighted;

(l)methods for sampling – including references to existing official or standardised sampling methods –, detection, identification and quantification of the category 2 NGT plant concerned; where the notifier duly justifies that it is not feasible to provide an analytical method for identification and quantification, the arrangements for complying with analytical method performance requirements shall be adapted as set out in the implementing act adopted in accordance with Article 27, first paragraph, point (c), and the guidance referred to in Article 29(2);

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

(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^note;

(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, in accordance with Article 25 of Directive 2001/18/EC;

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

2.The notifier shall include in the notification information on data or results from deliberate releases of the same category 2 NGT plant or the same combination of category 2 NGT plants previously or currently notified or carried out by the notifier, whether within or outside the Union.

3.The competent authority of the Member State 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 of this Article.