Changes from adopted text to adopted text

RemovedAnnex I – point 3: deleted / (deleted) / (deleted)

Added(2) food containing, consisting of or produced from NGT plants, or containing ingredients produced from NGT plants;

RemovedAnnex I – point 4: deleted

Added(3) feed containing, consisting or produced from NGT plants;

RemovedAnnex I – point 5: deleted

Added(4) products, other than food and feed, containing or consisting of NGT plants.

RemovedAnnex II – Part 1 – paragraph 2 – point a a (new): (aa) the characteristics of the recipient plant like allergenicity, potential for gene flow, weed potential, ecological function;

AddedArticle 3 Definitions

RemovedAnnex II – Part 2 – point 6 a (new): (6a) Impacts on organic cultivation

AddedFor the purposes of this Regulation, the following definitions shall apply:

RemovedAnnex II – Part 2 – point 8 a (new): (8a) Effects on protecting and conserving biodiversity

Added(1) the definitions of ‘organism’, ‘deliberate release’ and ‘placing on the market’ set out in Directive 2001/18/EC, those of ‘food’ and ‘feed’ set out in Regulation (EC) No 178/2002, that of ‘traceability’ set out in Regulation (EC) No 1830/2003, that of ‘plant’ set out in Regulation (EU) 2016/2031 of the European Parliament and of the Council() and that of ‘plant reproductive material’ set out in [the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union];

RemovedAnnex III – title 1: Traits referred to in Article 6 and Article 22

Added(2) ‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis orcisgenesis, or a combination thereof, on the condition that it does not contain any genetic material originating from outside the breeders’ gene pool for conventional breeding purposes that temporarily may have been inserted during the development of the NGT plant; [Am. 25]

RemovedAnnex III – Part 1 – paragraph 1 – point 1: (1) yield, including yield stability and yield under low-input conditions, provided that those traits also contribute to either point (2), (3) or (4) of this Annex;

Added(3) ‘genetically modified organism’ or ‘GMO’ means a genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex I B to Directive 2001/18/EC;

RemovedAnnex III – Part 1 – paragraph 1 – point 7: (7) reduced need for external inputs, such as fertilisers, if it does not contradict with Annex III, part 2.

Added(4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at precisetargeted locations in the genome of an organism; [Am. 26]

Added(5) ‘cisgenesis’ means techniques of genetic modification resulting in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool;

Added(6) ‘breeders’ gene pool for conventional breeding purposes’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses; [Am. 27]

Added(7) ‘category 1 NGT plant’ means a NGT plant that:

Added(a) fulfils the criteria of equivalence to conventional plants, set out in Annex I, or

Added(b) is progeny of the NGT plant(s) referred to in point (a), including progeny derived by crossing of such plants, on the condition that there are no further modifications that would make it subject to Directive 2001/18/EC or Regulation 1829/2003;

Added(8) ‘category 2 NGT plant’ means a NGT plant other than a category 1 NGT plant;

Added(9) ‘NGT plant for food use’ means a NGT plant that may be used as food or as a source material for the production of food;

Added(10) ‘NGT plant for feed use’ means a NGT plant that may be used as feed or as a source material for the production of feed;

Added(11) ‘produced from a NGT plant’ means derived, in whole or in part, from a NGT plant, but not containing or consisting of a NGT plant;

Added(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;

Added(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;

Added(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;

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

Added(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]

Added(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]

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

AddedWithout 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:

Added(1) the plant is a category 1 NGT plant and

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

Added(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]

Added(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]

AddedThe 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]

AddedArticle 4a Exclusion from patentability

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

AddedCHAPTER II Category 1 NGT plants and category 1 NGT products

AddedArticle 5 Status of category 1 NGT plants

Added1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plants.

Added2. 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]

Added3. 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]

Added3a. 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]

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

Added1. 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]

Added2. 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.

Added3. 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:

Added(a) the name and the address of the requester;

Added(b) the designation and specification of the NGT plant;

Added(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]

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

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

Added(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]

Added(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]

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