What changed between the adopted text of 24 Apr 2024 and the adopted text of 17 Jun 2026

Removed:(12) ‘NGT product’ means a product, other than food and feed, containing or consisting of a NGT plant and food and feed containing, consisting of or produced from such a plant;

Removed:(13) ‘category 1 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 1 NGT plant;

Removed:(14) ‘category 2 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 2 NGT plant;

Removed:(15) ‘small or medium sized enterprise (SME)’ means a SME within the meaning of Commission Recommendation 2003/361/EC2.

Removed:(15a) ‘One Health Approach’ means an integrated, unifying approach that aims to sustainably balance and optimise the health of people, animals, plants and ecosystems and recognises that the health of humans, domestic and wild animals, plants, and the wider environment including ecosystems are closely interlinked and inter-dependent; [Am. 28]

Removed:(15b) “Chimeric protein” means proteins created through the joining of two or more genes or parts of genes that originally coded for separate proteins. [Am. 29]

Removed:Article 4 Deliberate release of NGT plants for any other purpose than placing on the market and placing on the market of NGT products

Removed:Without prejudice to other requirements of Union law, a NGT plant may only be deliberately released into the environment for any other purpose than placing on the market, and a NGT product may only be placed on the market, if:

Removed:(1) the plant is a category 1 NGT plant and

Removed:(a) has obtained a decision declaring that status in accordance with Article 6 or 7; or

Removed:(b) is progeny of plant(s) referred to in point (a) on condition that the criteria of equivalence set out in Annex I are still satisfied ; or [Am. 30]

Removed:(2) the plant is a category 2 NGT plant, and has been granted consent or and has been authorised in accordance with Chapter III. [Am. 31]

Removed:The implementation, enforcement and application of this Regulation shall not have the object or effect of preventing or impeding imports from third countries of NGT plants and products that meet the same standards as those laid down in this Regulation. [Am. 32]

Removed:Article 4a Exclusion from patentability

Removed:NGT plants, plant material, parts thereof, genetic information and the process features they contain shall not be patentable. [Am. 33]

Removed:CHAPTER II Category 1 NGT plants and category 1 NGT products

Removed:Article 5 Status of category 1 NGT plants

Removed:1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plants.

Removed:2. For the purposes of Regulation (EU) 2018/848, the rules set out in its Articles 5 (f) (iii) andArticle 5 (f), (iii), and Article 11 shall apply to category 1 NGT plants and to products produced from or by such plants. [7 years after the entry into force of this Regulation], the Commission shall present a report on the evolution of the consumers' and producers' perception, accompanied, where appropriate, by a legislative proposal. [Am. 34]

Removed:3. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the criteria of equivalence of NGT plants to conventional plants laid down in Annex I, taking into account potential associated risks and functional consequences in the verification procedure in order to adapt them tothose criteria to the latest scientific and technological progressdevelopments as regards the types and extent of modifications which can occur naturally or through conventional breeding. [Am. 35]

Removed:3a. The adventitious or technically unavoidable presence of category 1 NGT plants, reproductive material or parts thereof in organic production, or in non-organic products authorised in organic production in accordance with Articles 24 and 25 of Regulation (EU) 2018/848, shall not constitute non-compliance with that Regulation. [Am. 36]

Removed:Article 6 Verification procedure of category 1 NGT plant status prior to the deliberate release for any other purpose than placing on the market

Removed:1. To obtain the declaration of category 1 NGT plant status referred to in Article 4(1), point (a), before undertaking a deliberate release of a NGT plant for any other purpose than placing on the market, the person intending to undertake the deliberate release shall submit a request to verify whether the criteria set out in Annex I at least one of the traits referred to in Annex III, Part 1, and the exclusion criteria in Annex III, Part 2, are met (‘verification request’). That verification request shall be submitted to the competent authority designated in accordance with Article 4(4) of Directive 2001/18/EC of the Member State within whose territory the release is to take place in accordance with paragraphs 2 and 3 and the implementingdelegated act adopted in accordance with Article 276(11a), point (b). [Am. 37]

Removed:2. Where a person intends to undertake such a deliberate release simultaneously in more than one Member State, that person shall submit the verification request to the competent authority of one of those Member States.

Removed:3. The verification request referred to in paragraph 1 shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and shall include, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002:

Removed:(a) the name and the address of the requester;

Removed:(b) the designation and specification of the NGT plant;

Removed:(c) a description of the trait(s) or traits and characteristics which have been introduced or modified, including information on the technique or techniques used to obtain the trait or the traits and including disclosure of the sequence of genetic modification; [Am. 38]

Removed:(ca) any patent or pending application for a patent that covers the whole or part of Cat.1 NGT plant; [Am. 253]

Removed:(d) a copy of the studies, which have been carried out and any other available material to demonstrate that:

Removed:(i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ 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 specified in the implementingdelegated act adopted in accordance with Article 276(11a), point (a); [Am. 39]

Removed:(ii) the NGT plant meets the criteria set out in Annex I, at least one of the traits in Annex III, Part 1, and the exclusion criteria of Annex III, Part 2; [Am. 40]

Removed:(da) the denomination of the variety; [Am. 41]

Removed:(e) in the cases referred to in paragraph 2, an indication of the Member States in which the requester intends to undertake the deliberate release;

Removed:(f) an identification of the parts of the verification request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, pursuant to Article 11 of this Regulation and Article 39 of Regulation (EC) No 178/2002.

Removed:4. The competent authority shall acknowledge receipt of the verification request to the requester without undue delay, stating the date of receipt. It shall make available the request to the other Member States and to the Commission without undue delay.

Removed:5. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the competent authority within 30 working days within the date of receipt of a verification request. The competent authority shall inform the requester, the other Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

Removed:6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working days from the date of receipt of a verification request. The competent authority may, where appropriate, consult with the European Food Safety Authority ('EFSA') while preparing the verification report. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay. [Am. 42]

Removed:7. The other Member States and the Commission may make commentsreasoned objections to the verification report, as regards the fulfilment of the criteria set out in Annex I, within 20 days from the date of receipt of that report. Such reasoned objections shall solely refer to the criteria as set out in Annex I and Annex III and shall include a scientific justification. [Am. 43]

Removed:8. In the absence of any commentsreasoned scientific objections from a Member State or the Commission, within 10 working days from the expiry of the deadline referred to in paragraph 7, the national competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. ItThe national competent authority shall transmit the decision without undue delaywithin 10 working days to the requester, the other Member States and to the Commission. [Am. 311]

Removed:9. In cases where a commentreasoned objection is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the the comment(s) to the Commissionmake the reasoned objections publicly available without undue delay. [Am. 45]

Removed:10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the comment(s)reasoned objections, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2). [Am. 46]

Removed:11. The Commission shall publish a summary of the decisions referred to in paragraphs 8 and 10 in the Official Journal of the European Union.

Removed:Article 7 Verification procedure of category 1 NGT plant status prior to the placing on the market of NGT products

Removed:1. Where a declaration of category 1 NGT plant status referred to in Article 4(1), point (a), has not already been made in accordance with Article 6, to obtain such a declaration before placing on the market a NGT product, the person intending to place the product on the market shall submit a verification request to the Authority in accordance with paragraph 2 and the implementing act adopted in accordance with Article 27, point (b).

Removed:2. The verification request referred to in paragraph 1 shall be submitted to the Authority in accordance with standard data formats, where they exist, pursuant to Article 39f of Regulation (EC) No 178/2002, and shall include, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002:

Removed:(a) the name and the address of the requester;

Removed:(b) the designation and specification of the NGT plant;

Removed:(ba) the denomination of the variety; [Am. 48]

Removed:(c) a description of the trait(s) and characteristics which have been introduced or modified including information on the technique or techniques used to obtain the trait or the traits and on disclosure of the sequence of genetic modification; [Am. 49]

Removed:(d) a copy of the studies, which have been carried out and any other available material to demonstrate that:

Removed:(i) 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);

Removed:(ii) the NGT plant meets the criteria set out in Annex I;

Removed:(da) a monitoring plan for environmental effects; [Am. 260]

Removed:(e) an identification of the parts of the verification request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, pursuant to Article 11 of this Regulation and Article 39 of Regulation (EC) No 178/2002.

Removed:3. The Authority shall acknowledge receipt of the verification request to the requester without delay, stating the date of receipt. It shall make available the verification request to the Member States and to the Commission without undue delay and make public the verification request, relevant supporting information and any supplementary information supplied by the requester, in accordance with article 38(1) of Regulation (EC) No 178/2002, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.

Removed:4. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the Authority within 30 working days within the date of receipt of a verification request. The Authority shall inform the requester, the Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.

Removed:5. If the verification request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its statement on whether the NGT plant fulfils the criteria set out in Annex I within 30 working days from the date of receipt of a verification request. The Authority shall make available the statement to the Commission and the Member States. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.

Removed:6. The Commission shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 30 working days from the date of receipt of the statement of the Authority, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

Removed:7. The Commission shall publish a summary of the final decision in the Official Journal of the European Union and shall publish, in a dedicated and publicly available webpage, its draft decision and the reasoned objections referred to in Article 6. [Am. 50]