[ParlTrack]

Benoît BITEAU, Sarah WIENER, Claude GRUFFAT, Francisco GUERREIRO, Pär HOLMGREN, Thomas WAITZ, Rosa D'AMATO

Proposal for a regulation
–

The Committee on Agriculture and Rural Development calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to propose rejection of Commission proposal.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 2

(2) NGTs constitute a diverse group of genomic techniques, and each of them can be used in various ways to achieve different results and products. They can result in organisms with modifications equivalent to what can be obtained by conventional breeding methods or in organisms with more complex modifications. Among NGTs, targeted mutagenesis and cisgenesis (including intragenesis) introduce genetic modifications without inserting genetic material from non-crossable species (transgenesis). They rely only on the breeders’ gene pool, i.e. the total genetic information that is available for conventional breeding including from distantly related plant species that can be crossed by advanced breeding techniques. Targeted mutagenesis techniques result in modification(s) of the DNA sequence at precise locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool.deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 4

(4) The deliberate release into the environment of organisms obtained by NGTs, including products containing or consisting of such organisms, as well as the placing on the market of food and feed produced from these organisms, are subject to Directive 2001/18/EC and, Regulation (EC) No 1830/2003 (41 ) of the European Parliament and of the Council and, in the case of food and feed, also to Regulation (EC) No 1829/2003 (42 ), while the contained use of plant cells is subject to Directive 2009/1/EC, and transboundary movements of NGT plants to third countries are regulated by Regulation (EC) No 1946/2003 (‘the Union GMO legislation’), in line with the Cartagena Protocol on Biosafety. _________________ 41 Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, p. 24). 42 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 7

(7) The Commission’s study on new genomic techniques (45 ) concluded that the Union GMO legislation is not fit for the purpose of regulating the deliberate release of plants obtained by certain NGTs and the placing on the market of related products including food and feed. In particular, the study concluded that the authorisation procedure and risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs, namely targeted mutagenesis and cisgenesis (including intragenesis), and these requirements can be disproportionate or inadequate. The study showed that this is particularly the case for plants obtained by these techniques, given the amount of scientific evidence that is already available, in particular on their safety. Furthermore, the Union GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products. In certain cases, genetic modifications introduced by these techniques are indistinguishable with analytical methods from natural mutations or from genetic modifications introduced by conventional breeding techniques, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. The Union GMO legislation is also not conducive to developing innovative and beneficial products that could contribute to sustainability, food security and resilience of the agri-food chain. _________________ 45 Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C- 528/16, SWD(2021) 92 final.deleted

2023/11/14
Committee: AGRI

Marie TOUSSAINT, Tilly METZ, Lydie MASSARD, Manuela RIPA, Thomas WAITZ, Benoît BITEAU, Pär HOLMGREN, Rosa D'AMATO

Proposal for a regulation
–

The European Parliament rejects the Commission proposal.

2023/11/19
Committee: ENVI

Benoît BITEAU

Proposal for a regulation
Recital 10

(10) The legal framework for NGT plants should share the objectives of the Union GMO legislation to ensure a high level of protection of human and animal health and of the environment and the good functioning of the internal market for the concerned plants and products, while addressing the specificity of NGT plants, and while fully respecting the precautionary principle. This legal framework should enable the development and placing on the market of plants, food and feed containing, consisting of or produced from NGT plants and other products containing or consisting of NGT plants (‘NGT products’) so as to contribute to the innovation and sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and to enhance the competitiveness of the Union agri-food sector at Union and world level.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 12

(12) The potential risks of NGT plants vary, ranging from risk profiles similar to conventionally-bred plants to various types and degrees of hazards and risks that might be similar to those of plants obtained by transgenesis. This Regulation should therefore lay down special rules to adjust the risk assessment and risk management requirements according to the potential risks or lack thereof posed by NGT plants and NGT products.deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 13

~~(13) This Regulation should distinguish between two categories of NGT plants.~~deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 14

(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘category 1 NGT plants’) should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent and that their risks are comparable, thereby derogating in full from the Union GMO legislation and GMO related requirements in sectoral legislation. In order to ensure legal certainty, this Regulation should set out the criteria to ascertain if a NGT plant is equivalent to naturally occurring or conventionally bred plants and lay down a procedure for competent authorities to verify and take a decision on the fulfillment of those criteria, prior to the release or placing on the market of NGT plants or NGT products. Those criteria should be objective and based on science. They should cover the type and extent of genetic modifications that can be observed in nature or in organisms obtained with conventional breeding techniques and should include thresholds for both size and number of genetic modifications to the genome of NGT plants. Since scientific and technical knowledge evolves rapidly in this area, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to update these criteria in light of scientific and technical progress as regards the type and extent of genetic modifications that can occur in nature or through conventional breeding.deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 15

(15) All NGT plants ~~that are not category 1 (‘category 2 NGT plants’)~~ should remain subject to the requirements of the Union GMO legislation because they feature ~~more~~ complex sets of modifications to the genome.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 16

(16) Category 1 NGT plants and products should not be subject to the rules and requirements of the Union GMO legislation and to provisions in other Union legislation that apply to GMOs. For legal certainty for operators and transparency, a declaration of the category 1 NGT plant status should be obtained prior to deliberate release, including the placing on the market.deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 17

(17) This declaration should be obtained prior to any deliberate release of any category 1 NGT plants for any other purpose than placing on the market, such as for field trials that are to take place in the territory of the Union, since the criteria are based on data that is available before the field trials and does not depend on these field trials. When no field trials are to take place in the territory of the Union, operators should obtain that declaration before placing the category 1 NGT product on the market.deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 18

(18) Since the criteria for considering that a NGT plant is equivalent to naturally occurring or conventionally bred plants are unrelated to the type of activity that requires the deliberate release of the NGT plant, a declaration of the category 1 NGT plant status made prior to its deliberate release for any other purpose than placing on the market in the territory of the Union should also be valid for the placing on the market of related NGT products. In view of the high uncertainty existing at the field trial stage about the product reaching the market and the likely involvement of smaller operators in such releases, the verification procedure of category 1 NGT plant status prior to field trials should be conducted by national competent authorities as this would be less administratively burdensome for operators, and a decision should be taken at Union level only in case there are comments to the verification report by other national competent authorities. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 19

(19) The competent authorities of the Member States, the Commission and the European Food Safety Authority (‘the Authority’) should be subject to strict deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 20

(20) The verification of category 1 NGT plant status is of technical nature and does not involve any risk assessment or risk management considerations and the decision on the status is only declaratory. Therefore, when the procedure is conducted at Union level, such implementing decisions should be adopted by the advisory procedure, supported by scientific and technical assistance by the Authority.deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 21

(21) Decisions declaring the category 1 NGT plant status should assign an identification number to the NGT plant concerned in order to ensure transparency and traceability of such plants when they are listed in the database and for the purpose of labelling of plant reproductive material derived from them.deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 22

(22) ~~Category 1~~ NGT plants should remain subject to any regulatory framework that applies to conventionally bred plants. As is the case for conventional plants and products, those NGT plants and their products will be subject to the applicable sectoral legislation on seed and other plant reproductive material, food, feed and other products, and horizontal frameworks, such as the nature conservation legislation and environmental liability. In this regard, ~~category 1~~ NGT food featuring a significantly changed composition or structure that affects the nutritional value, metabolism or level of undesirable substances of the food will be considered as novel food and thus fall into the scope of Regulation (EU) 2015/2283 of the European Parliament and of the Council (46 ) and will be risk assessed in that context. _________________ 46 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 23

(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(47 ) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. ~~As a result, category 2 NGT plants will be banned in organic production. However, i~~It is necessary to clarify the status of ~~category 1~~ NGT plants for the purposes of organic production. The use of new genomic techniques is currently incompatible with the concept of organic production in the Regulation (EC) 2018/848 and with consumers’ perception of organic products. The use of ~~category 1~~ NGT plants should therefore be also prohibited in organic production. _________________ 47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 24

(24) Provision should be made to ensure transparency as regards the use of ~~category 1~~ NGT plant varieties, to ensure that production chains that wish to remain free from NGTs can do so and thereby safeguard consumer trust. NGT plants ~~that have obtained a category 1 NGT plant status declaration~~ should be listed in a publicly available database. To ensure traceability, transparency and choice for operators, during research and plant breeding, when selling seed to farmers or making plant reproductive material available to third parties in any other way, plant reproductive material of ~~category 1~~ NGT plants should be labelled as ~~category 1 NGT~~GMO.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 25

(25) ~~Category 2~~ NGT plants should remain subject to the requirements of the Union GMO legislation given that on the basis of current scientific and technical knowledge, their risks need to be assessed. Special rules should be provided in order to adapt the procedures and certain other rules laid down in Directive 2001/18/EC and Regulation (EC) No 1829/2003 to the specific nature of ~~category 2~~ NGT plants and the differing levels of risk that they may pose.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 26

(26) ~~Category 2~~ NGT plants and products, in order to be released into the environment or placed on the market, should remain subject to a consent or authorisation in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. However, given the wide variety of those NGT plants, the amount of information necessary for the risk assessment will vary on a case-by-case basis. The Authority, in its scientific opinions on plants developed through cisgenesis and intragenesis48 and on plants developed through targeted mutagenesis49 recommended flexibility in data requirements for the risk assessment of these plants. Based on the Authority’s ‘Criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis’ (50 ), considerations on the history of safe use, familiarity for the environment and the function and structure of the modified/inserted sequence(s) should assist in determining the type and amount of data required to perform the risk assessment of those NGT plants. It is therefore necessary to establish general principles and criteria for the risk assessment of these plants, while providing for flexibility and possibility to adapt risk assessment methodologies to scientific and technical progress. _________________ 48 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta, J, Fernandez Dumont A, Gennaro A, Lenzi, P, Lewandowska A, Munoz Guajardo IP, Papadopoulou N and Rostoks N, 2022. Updated scientific opinion on plants developed through cisgenesis and intragenesis. EFSA Journal 2022;20(10):7621, 33 pp. https://doi.org/10.2903/j.efsa.2022.7621. 49 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Naegeli H, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Mullins E, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Gennaro A, Paraskevopoulos K, Raffaello T and Rostoks N, 2020. Applicability of the EFSA Opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis. EFSA Journal 2020;18(11):6299, 14 pp. https://doi. org/10.2903/j.efsa.2020.6299. 50 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Fernandez A, Gennaro A, Papadopoulou N, Raffaello T and Schoonjans R, 2022. Statement on criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis. EFSA Journal 2022;20(10):7618, 12 pp. https://doi.org/10.2903/j.efsa.2022.7618.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 27

(27) Requirements on the content of notifications for consent for the placing on the market of products containing or consisting of GMOs other than food or feed and on the content of applications for authorisation for the placing on the market of genetically modified food and feed are laid down in different pieces of legislation. To ensure consistency between the notifications for consent and applications for authorisation for ~~category 2~~ NGT products, the content of such notifications and applications should be the same, except those concerning the assessment of food and feed safety assessment as these are only relevant to ~~category 2~~ NGT food and feed.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 28

(28) The European Union Reference Laboratory for GM Food and Feed (EURL), in collaboration with the European Network of GM Laboratories (ENGL), concluded that analytical testing is not considered feasible for all products obtained by targeted mutagenesis and cisgenesis (51 ). When the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not allow the differentiation of the NGT plant from conventional plants. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier or the applicant, the modalities to comply with analytical method requirements should be adapted. This should be done in the implementing acts adopted pursuant to this Regulation. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants on the minimum performance requirements for analytical methods. Modalities for performing method validation may also be adapted. _________________ 51 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 29

(29) Directive 2001/18/EC requires a monitoring plan for environmental effects of GMOs after their deliberate release or placing on the market but provides for flexibility as to the design of the plan taking into account the environmental risk assessment, the characteristics of the GMO, of its expected use and of the receiving environment. Genetic modifications in category 2 NGT plants may range from changes only needing a limited risk assessment to complex alterations requiring a more thorough analysis of potential risks. Therefore, post-market monitoring requirements for environmental effects of category 2 NGT plants should be adapted in the light of the environmental risk assessment and the experience in field trials, the characteristics of the NGT plant concerned, the characteristics and scale of its expected use, in particular any history of safe use of the plant and the characteristics of the receiving environment. Therefore, a monitoring plan for environmental effects should not be required if the category 2 NGT plant is unlikely to pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 30

(30) For reasons of proportionality, after a first renewal of the authorisation, the authorisation should be valid for an unlimited period, unless decided differently at the time of that renewal based on the risk assessment and the available information on the NGT plant concerned, subject to reassessment when new information has become available.deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 32

(32) To increase transparency and consumers’ information, operators should be allowed to complement the labelling of category 2 NGT products as GMO with information on the trait conferred by the genetic modification. In order to avoid misleading or confusing indications, a proposal for such a labelling should be provided in the notification for consent or in the application for authorisation and should be specified in the consent or in the authorisation decision.deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 37

(37) In order to enable NGT plants to contribute to the sustainability objectives of the Green Deal and the Farm to Fork and Biodiversity Strategies, cultivation of NGT plants in the Union should be ~~facilitated~~regulated under existing EU law, in particular Directive 2001/18 and Regulation (EC) No 1830/2003. This requires predictability for breeders and farmers as regards the possibility to cultivate such plants in the Union. Therefore, the possibility for Member States to adopt measures restricting or prohibiting the cultivation of ~~category 2~~ NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC wshould ~~undermine those goals~~remain.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Recital 45

(45) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the information required to demonstrate that a NGT plant is a category 1 NGT plant, as regards the preparation and the presentation of the notification for that determination, and as regards the methodology and information requirements for the environmental risk assessments of category 2 NGT plants and of NGT food and NGT feed, in accordance with the principles and criteria laid down in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(55 ). _________________ 55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 2 – paragraph 1 a (new)

This regulation shall not apply to: (1) patented material or material for which a patent application is being processed; (2) herbicide-tolerant plants; (3) wild plants, trees and algae.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 3 – paragraph 1 – point 2

(2) ‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the conditions that: (i) it does not contain any genetic material originating from outside the breeders’ gene pool that temporarily may have been inserted during the development of the NGT plant; and; (ii) there are no patents or exclusive rights covering the process used to develop the plant, and there are no patents or exclusive rights covering the plant or parts thereof, and no application has been tabled for such patents or exclusive rights to be granted;

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 3 – paragraph 1 – point 7

(7) ‘category 1 NGT plant’ means a NGT plant that: (a) fulfils the criteria of equivalence to conventional plants, set out in Annex I, or (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;deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b a (new)

(b a) is not covered by patents or exclusive rights and for which no application has been tabled for such patents or exclusive rights to be granted;

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 3 – paragraph 1 – point 8

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

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 3 – paragraph 1 – point 13

~~(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;~~deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 3 – paragraph 1 – point 14

~~(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;~~deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 4 – paragraph 1 – introductory part

Without prejudice to other requirements of Union law, and with strict regard to the precautionary principle, 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: the plant is a NGT plant and has been authorised in accordance with Chapter III.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 4 – paragraph 1 – point 1

~~(1) the plant is a category 1 NGT plant and (a) has obtained a decision declaring that status in accordance with Article 6 or 7; or (b) is progeny of plant(s) referred to in point (a); or~~deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 4 – paragraph 1 – point 2

~~(2) the plant is a category 2 NGT plant and has been authorised in accordance with Chapter III.~~deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 5 – paragraph 1

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

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 5 – paragraph 2

2. For the purposes of Regulation (EU) 2018/848, the rules set out in its Articles 5 (f) (iii) and 11 shall apply to ~~category 1~~ NGT plants and to products produced from or by such plants.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 5 – paragraph 3

~~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 in order to adapt them to scientific and technological progress as regards the types and extent of modifications which can occur naturally or through conventional breeding.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 6

~~[...]~~deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 7

~~[...]~~deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 7 – paragraph 2 – point d a (new)

(d a) the proof that: (i) there are no patents or exclusive rights covering the process used to develop the plant; (ii) there are no patents or exclusive rights covering the plant or parts thereof; (iii) no application has been tabled for such patents or exclusive rights to be granted;

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 8

System of exchange of information between Member States, the Commission The Commission shall set up and maintain an electronic system for the submission of verification requests in accordance with Articles 6 and 7 and the exchange of the information under this Title.Article 8 deleted and the Authority

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 9

Database of decisions declaring the 1. The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6). The database shall contain the following information: (a) name and the address of the requester; (b) the designation of the category 1 NGT plant; (c) a summarised description of the technique(s) used to obtain the genetic modification; (d) a description of the trait(s) and characteristics which have been introduced or modified; (e) an identification number, and (f) the decision referred to in Article 6(8) or (10), and Article 7(6), as appropriate. 2. The database shall be publicly available.Article 9 deleted category 1 NGT plant status

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 10

reproductive material, including breeding Plant reproductive material, including for breeding and scientific purposes, that contains or consists of category 1 NGT plant(s) and is made available to third parties, whether in return for payment or free of charge, shall bear a label indicating the words ‘cat 1 NGT’, followed by the identification number of the NGT plant(s) it has been derived from.Article 10 deleted Labelling of category 1 NGT plant material

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 10 a (new)

Article 10a Cultivation During the authorisation procedure of a given category 1 NGT or during the renewal of consent/authorisation, a Member State may demand that the geographical scope of the written consent or authorisation be adjusted to the effect that all or part of the territory of that Member State is to be excluded from cultivation, according to article 26b of Directive 2001/18/EC.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 11

1. The requester referred to in Articles 6 and 7 may submit a request to the Member State competent authority or to the Authority, as appropriate, to treat certain parts of the information submitted under this Title as confidential, accompanied by verifiable justification, in accordance with paragraphs 3 and 6. 2. The competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1. 3. The competent authority or the Authority, as appropriate, may grant confidential treatment only with respect to the following items of information, upon verifiable justification, where the disclosure of such information is demonstrated by the requester to potentially harm its interests to a significant degree: (a) items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002; (b) DNA sequence information; and (c) breeding patterns and strategies. 4. The competent authority or the Authority, as appropriate, shall, after consultation with the requester, decide which information is to be treated as confidential and shall inform the requester of its decision. 5. Member States, the Commission and the Authority shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public. 6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis. 7. In the event of a withdrawal of the verification request by the requester, Member States, the Commission and the Authority shall respect the confidentiality as granted by the competent authority or the Authority in accordance with this Article. Where the withdrawal of the verification request takes place before the competent authority or the Authority has decided on the relevant confidentiality request, Member States, the Commission and the Authority shall not make public the information for which confidentiality has been requested.Article 11 deleted Confidentiality

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Chapter III – title

III ~~Category 2~~ NGT plants and ~~category 2~~ NGT products

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 12 – title

Status of ~~Category 2~~ NGT plants and ~~category 2~~ NGT products

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Chapter III – Section 1 – title

1 Deliberate release of ~~category 2~~ NGT plants for any other purpose than for placing on the market

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 13 – paragraph 1 – introductory part

As regards the deliberate release of a ~~category 2~~ NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 13 – paragraph 1 – point d a (new)

(d a) the proof that: (i) there are no patents or exclusive rights covering the process used to develop the plant; (ii) there are no patents or exclusive rights covering the plant or parts thereof; (iii) no application has been tabled for such patents or exclusive rights to be granted;

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Chapter III – Section 2 – title

2 Placing on the market of ~~category 2~~ NGT products other than food or feed

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 15

The written consent referred to in Article 19 of Directive 2001/18/EC shall either specify monitoring requirements, as described in Article 19(3) point (f) or state that monitoring is not required. Article 17(2), point (b), of Directive 2001/18/EC shall not apply if monitoring is not required by the consent.Article 15 deleted Specific provisions on monitoring

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 17

Duration of the validity of the consent 1. The consent granted under Part C of Directive 2001/18/EC shall, after the first renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for an unlimited period, unless the decision referred to in Article 17(6) or (8) provides that the renewal is for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the consent. 2. The last sentence in Article 17(6) and (8) of Directive 2001/18/EC shall not apply.Article 17 deleted after renewal

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2

In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant or concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 21

Duration of the validity of the authorisation after renewal By way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) No 1829/2003, after the first renewal, the authorisation shall be valid for an unlimited period, unless the Commission decides to renew the authorisation for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.Article 21 deleted

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 21 a (new)

Article21a Safeguard clause 1. Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a NGT as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory. The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public. The Member State shall immediately inform the Commission and the other Member States of actions taken under this Article and give reasons for its decision, supplying its review of the environmental risk assessment, indicating whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based. 2. Within 60 days of the date of receipt of the information trans mitted by the Member State, a decision shall be taken on the measure taken by that Member State in accordance with the regulatory procedure referred to in Article 30(2). For the purpose of calculating the 60-day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee or Committees which has or have been consulted shall not be taken into account. The period of time during which the Commission is awaiting the opinion of the Scientific Committee or Committees consulted shall not exceed 60 days. Likewise, the period of time the Council takes to act in accordance with the regulatory procedure referred to in Article 30(2) shall not be taken into account.

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Article 25

Article 2~~6b of Directive 2001/18/EC shall not apply to category 2 NGT plants.~~5 deleted Cultivation

2023/11/14
Committee: AGRI

Benoît BITEAU

Proposal for a regulation
Annex I

Criteria of equivalence of NGT plants to conventional plants A NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications of the types referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools. (1) substitution or insertion of no more than 20 nucleotides; (2) deletion of any number of nucleotides; (3) on the condition that the genetic modification does not interrupt an endogenous gene: (a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool; (b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool; (4) targeted inversion of a sequence of any number of nucleotides; (5) any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (possibly with modifications as accepted under points (1) and/or (2)) in a species from the breeders’ gene pool.deleted

2023/11/14
Committee: AGRI

Activities of Benoît BITEAU related to 2023/0226(COD)

Plenary speeches (2)

Shadow opinions (1)

Amendments (62)

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