BETA

150 Amendments of Günther SIDL related to 2023/0226(COD)

Proposal for a regulation
–

The European Parliament rejects the Commission proposal.

2023/11/19
Committee: ENVI

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.

2023/11/19
Committee: ENVI

Proposal for a regulation
Recital 3

(3) There is ongoing public and private research using NGTs on a wider variety of crops and traits compared to those obtained through transgenic techniques authorised in the Union or globally(33 ). This includes plants with improved tolerance or resistance to plant diseases and pests, plants with improved tolerance or resistance to climate change effects and environmental stresses, improved nutrient and water-use efficiency, plants with higher yields and resilience and improved quality characteristics. These types of new plants, coupled with the fairly easy and speedy applicability of those new techniques, could deliver benefits to farmers, consumers and to the environment. Thus, NGTs have the potential to contribute to the innovation and sustainability goals of the European Green Deal (34 ) and of the ‘Farm to Fork’ (35 ), Biodiversity (36 ) and Adaptation to Climate Change(37 ) Strategies, to global food security (38 ), the Bioeconomy Strategy (39 ) and to the Union’s strategic autonomy (40 ). _________________ 33 Insights and solutions stemming from EU-funded research and innovation projects on plant breeding strategies may contribute to address detection challenges, ensure traceability and authenticity, and promote innovation in the area of new genomic techniques. More than 1,000 projects were funded under the Seventh Framework Programme and successor Horizon 2020 programme with an investment of over 3 billion Euros. Horizon Europe support to new collaborative research projects on plant breeding strategies is also ongoing, SWD(2021) 92. 34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final. 35 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, healthy and environmentally friendly food system, COM/2020/381 final. 36 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030: Bringing nature back into our lives, COM/2020/380 final. 37 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions forging a Climate-Resilient Europe - The New EU Strategy on Adaptation to Climate Change, COM(2021) 82 final 38 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, Safeguarding food security and reinforcing the resilience of food systems, COM (2022) 133 final; Food and Agriculture Organisation of the United Nations (FAO), 2022, Gene editing and agrifood systems, Rome, ISBN 978-92-5- 137417-7. 39 European Commission, Directorate- General for Research and Innovation, A sustainable bioeconomy for Europe – Strengthening the connection between economy, society and the environment: updated bioeconomy strategy, Publications Office, 2018, https://data.europa.eu/doi/10.2777/792130 . 40 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Trade Policy Review - An Open, Sustainable and Assertive Trade Policy, COM(2021)66 final.

2023/11/19
Committee: ENVI

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).

2023/11/19
Committee: ENVI

Proposal for a regulation
Recital 5

(5) In its judgment in case C-528/16 Confédération paysanne and Others43 the Court of Justice of the European Union held that GMOs obtained by means of new techniques/methods of mutagenesis that had appeared or had been mostly developed since Directive 2001/18/EC was adopted could not be considered excluded from the scope of that Directive, as the new mutagenesis techniques/methods have a comparable risk potential to the production of transgenic plants, in which foreign genetic material is introduced into the genome of organisms. In accordance with the precautionary principle, the regulations of the Genetic Engineering Law would therefore have to be applied (Art.2 No.2 of Directive 2001/18; fourth, eighth and 25th recitals). These organisms and all products derived from them must therefore be subjected to a comprehensive safety assessment for humans, animals and the environment before being placed on the market. Likewise, they must be traceable and labelled. _________________ 43 Judgement of the Court of Justice of 25 July 2018, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, C-528/16, ECLI:EU:C:2018:583.

2023/11/19
Committee: ENVI

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.

2023/11/19
Committee: ENVI

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~~. 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 o~~, while fully respecting ther 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 levelecautionary principle.

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Recital 13

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

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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.deleted

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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).deleted

2023/11/19
Committee: ENVI

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~~NGT should be banned in organic production. ~~However, 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).

2023/11/19
Committee: ENVI

Proposal for a regulation
Recital 24

(24) Provision should be made to ensure transparency as regards the use of ~~category 1~~all in EU approved 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~~All in the EU approved NGT plants 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 consumers and third parties in any other way, plant reproductive material of ~~category 1 NGT plants should be labelled as category 1 NGT~~NGT plants should be labelled as GMO according to existing EU law, Directive 2001/18 and Regulation (EC) No 1830/2003. consumers and farmers NGT plants and products should be labelled according to existing EU law, Directive 2001/18 and Regulation (EC) No 1830/2003.

2023/11/19
Committee: ENVI

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. The precautionary principle may not be harmed, if differing risk levels will be chosen.

2023/11/19
Committee: ENVI

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.

2023/11/19
Committee: ENVI

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.

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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.deleted

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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 decisionlabel all NGT products which comply with the requirements laid down existing EU law, Directive 2001/18 and Regulation (EC) No 1830/2003.

2023/11/19
Committee: ENVI

Proposal for a regulation
Recital 33

(33) Regulatory incentives should be offered to potential notifiers or applicants for ~~category 2~~ NGT plants and products containing traits with the potential to contribute to a sustainable agri-food system, in order to steer the development of ~~category 2~~ NGT plants towards such traits. The criteria to trigger these incentives should focus on broad trait categories with the potential to contribute to sustainability (such as those linked to tolerance or resistance to biotic and abiotic stresses, improved nutritional characteristics or increased yield) and should be based on the contribution to the value for sustainable cultivation and use as defined in [Article 52(1) of 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 Union52 ]. The applicability of the criteria across the EU does not allow a narrower definition of traits to focus on specific issues or address local and regional specificities. _________________ 52 COM(2023) 414 final

2023/11/19
Committee: ENVI

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 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.

2023/11/19
Committee: ENVI

Proposal for a regulation
Recital 38

(38) The special rules laid down in this Regulation concerning the authorisation procedure for category 2 NGT plants are expected to result in more cultivation in the Union of category 2 NGT plants compared to the situation so far under the current Union GMO legislation. That renders necessary for Member States’ public authorities to define coexistence measures to balance the interests of producers of conventional, organic and GM plants and thereby allow producers a choice between different types of production, in line with the Farm to Fork Strategy’s target of 25 % of agricultural land under organic farming by 2030.deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Recital 39

(39) To achieve the goal of ensuring the effective functioning of the internal market, NGT plants and related products should benefit from the free movement of goods, provided they comply with the requirements of other Union law.deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Recital 40

(40) In its judgment of 25 July 2018, in case C-528/1610 the Court of Justice of the European Union held that organisms obtained by means of techniques/methods of mutagenesis which have not conventionally been used in a number of applications and do not have a long safety record come within the scope of Directive 2001/18 and are, therefore, subject to the obligations arising from that directive. Given the novelty of the NGTs, it will be important to monitor closely the development and presence on the market of NGT plants and products and evaluate any accompanying impact on human and animal health, the environment and environmental, economic and social sustainability. Information should be collected regularly and within five years after the adoption of the first decision allowing the deliberate release or the marketing of NGT plants or NGT products in the Union, the Commission should carry out an evaluation of this Regulation to measure the progress made towards the availability of NGT plants containing such characteristics or properties on the EU market.

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Recital 46

(46) The Commission should regularly collect information in order to assess the performance of the legislation in achieving the development and availability of NGT plants and NGT products in the market that can contribute to the objectives of the Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and in order to inform an evaluation of the legislation. A broad set of indicators have been identified56 and should be periodically reviewed by the Commission. The indicators should support monitoring of potential risks to health or the environment of ~~category 2~~ NGT plants and related NGT products, impact of NGT plants on environmental, economic and social sustainability as well as impact on organic agriculture and on consumers acceptance of NGT products. A first monitoring report should be presented three years after the first products have been notified/authorised, to ensure that enough data is available after full implementation of the new legislation, and at regular intervals thereafter. The Commission should carry out an evaluation of this Regulation two years after the first monitoring report has been published, in order to allow for the impact of the first products going through the verification or authorisation to fully materialise. _________________ 56 SWD(2023) 412

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1

This Regulation corresponds to the provisions of Directive 2001/18 and extends these provisions to the deliberate release of plants obtained by certain new genomic techniques (hereinafter "NGT plants"). In accordance with the precautionary principle, and with the primary objective of ensuring a high level of protection of human and animal health and the environment, this Regulation lays down specific rules for the deliberate release into the environment for any other purpose than placing on the market of plants obtained by certain new genomic techniques (‘NGT plants’) and for the placing on the market of food and feed containing, consisting of or produced from such plants, and of products, other than food or feed, containing or consisting of such plants.

2023/11/19
Committee: ENVI

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

(1) NGT plants in their use as agricultural crops;

2023/11/19
Committee: ENVI

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

This regulation does not apply to: (1) patented material or material for which a patent application is being processed; (2) Wild plants and trees.

2023/11/19
Committee: ENVI

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

(1) the definitions of ‘organism’~~, ‘deliberate release’~~ set out in Directive 2001/18/EC (1a), ‘deliberate release’ set out in Directive 2001/18/EC (1b) and ‘placing on the market’ set out in Directive 2001/18/EC, (1e) those of ‘food’ and ‘feed’ set out in Regulation (EC) No 178/2002, (1f) that of ‘traceability’ set out in Regulation (EC) No 1830/2003, (1e) that of ‘plant’ set out in Regulation (EU) 2016/2031 of the European Parliament and of the Council(58 ) ~~and that of~~(1f) ‘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 Union59 ]; _________________ 58 Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p. 4). 59 COM(2023) 414 final

2023/11/19
Committee: ENVI

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: (a) 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, (b) it is not patented and no patent application is being processed regarding that plant;

2023/11/19
Committee: ENVI

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

(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;

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 3 – paragraph 1 – point 6

(6) ‘breeders’ gene pool’ 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;deleted

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 3 – paragraph 1 – point 9

(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 in line with the One Health approach;

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 3 – paragraph 1 – point 10

(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 in line with the One Health approach;

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 3 – paragraph 1 – point 15 a (new)

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 3 – paragraph 1 – point 15 b (new)

(15b) 'polluter pays principle’ means a principle according to which polluters should bear the costs of their pollution or environmental damage, including the cost of measures taken to prevent, control and remedy pollution, as well as the costs the polluters impose on society.

2023/11/19
Committee: ENVI

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, an NGT plant may only be deliberately released into the environment for any other purpose other than placing on the market, and an NGT product may only be placed on the market, if: the plant has been authorised in accordance with Chapter III.

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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

(2) the plant is a ~~category 2~~n NGT plant and has been authorised in accordance with Chapter III and is front-labelled as “NGT food” or “NGT feed”.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 1 – point 2 a (new)

(2a) an extended producer responsibility (EPR) scheme has been established by an implementing act to ensure the financement of risks and possible future damages of human health, animal health or the environment or cross-contamination of organic food are financed in line with the polluter pays principle.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 1 – point 2 b (new)

(2b) a social impact assessment has been made by the Commission to ensure the affordability of food for consumers, taking into account the short-, mid- and long-term effects of patent and monopols on the price for end consumers and the freedom of choice to consume or not consume NGT products and price difference between non-NGT products and organic food in respect of affordability and social implications.

2023/11/19
Committee: ENVI

Proposal for a regulation
Chapter II – title

II ~~Category 1 NGT plants and category 1 NGT products~~The European Parliament deletes this chapter

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 5

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 6

~~[...]~~deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 7

~~[...]~~deleted

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 9

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 Database of decisions declaring the category 1 NGT plant status

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 10

Labelling of category 1 NGT plant 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 material

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Chapter III – title

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 12 – title

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

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

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

As regards the deliberate release of a ~~category 2~~n 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:

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 1 – point c – point ii

(ii) information relating to the ~~category 2~~ NGT plant(s);

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 1 – point c – point iv

(iv) information on the interactions between the ~~category 2~~ NGT plant(s) and the environment;

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 1 – point c – point v

(v) a plan for monitoring in order to identify effects of the ~~category 2~~ NGT plant(s) on human health or the environment;

2023/11/19
Committee: ENVI

Proposal for a regulation
Chapter III – Section 2 – title

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 14 – paragraph 1 – introductory part

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

2023/11/19
Committee: ENVI

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

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

2023/11/19
Committee: ENVI

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

(h) ~~where appropriate,~~ a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, 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, point (d), the notifier considers that the NGT plant does not need a monitoring plan, the notifier may propose not to submit a monitoring plan;

2023/11/19
Committee: ENVI

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

(j) proposed commercial names of the products and names of ~~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 (60 ). After the consent any new commercial names should be provided to the competent authority; _________________ 60 Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004, p. 5).

2023/11/19
Committee: ENVI

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

(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if ~~duly justified by the notifier~~concluded by the Union Reference Laboratory, 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);

2023/11/19
Committee: ENVI

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

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 14 – paragraph 2

2. The notifier shall include in this notification information on data or results from releases of the same ~~category 2~~ NGT plant or the same combination of ~~category 2~~ NGT plants previously or currently notified and/or carried out by the notifier either inside or outside the Union.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 15 – paragraph 1

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) o~~r 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~~f this regulation. Seeds and other reproductive material has to be subjected to monitoring. Exemption from monitoring may be granted, if duly justified, for the release of non-reproductive material.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 16 – paragraph 1

~~In addition to Article 19(3) of Directive 2001/18/EC, the written consent shall specify the labelling in accordance with Article 23 of this Regulation.~~deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 17 – paragraph 1

1. The consent granted under Part C of Directive 2001/18/EC shall, after ~~the first~~each 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 consent10 years.

2023/11/19
Committee: ENVI

Proposal for a regulation
Chapter III – Section 3 – title

3 Placing on the market of ~~category 2~~ NGT plants for food or feed use and of ~~category 2~~ NGT food and feed

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 18 – paragraph 1 – point a

(a) ~~category 2~~ NGT plants for food use or for feed use;

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 18 – paragraph 1 – point b

(b) food containing, consisting or produced from ~~category 2~~ NGT plants or containing ingredients produced from ~~category 2~~ NGT plants (‘~~category 2~~ NGT food’);

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 18 – paragraph 1 – point c

(c) feed containing, consisting or produced from ~~category 2~~ NGT plants (‘~~category 2~~ NGT feed’).

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 19 – paragraph 1 – introductory part

1. By way of derogation from Articles 5(3), point (e), and 17(3), point (e), of Regulation (EC) No 1829/2003, and without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, an application for authorisation of a ~~category 2~~ NGT plant for food or feed use, or ~~category 2~~ NGT food or feed shall be accompanied by a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out and any other available material to demonstrate that:

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 19 – paragraph 3 – introductory part

3. By way of derogation from Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, in the case of ~~category 2~~ NGT plants or food or feed containing or consisting of ~~category 2~~ NGT plants, the application shall also be accompanied by:

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 19 – paragraph 4

~~4. The application shall also contain a proposal for labelling in accordance with Article 23.~~deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 21 – paragraph 1

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 authorisationThe authorisation shall be valid for a period of 10 years.

2023/11/19
Committee: ENVI

Proposal for a regulation
Chapter III – Section 4 – title

4 Common provisions for ~~category 2~~ NGT plants and ~~category 2~~ NGT products

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 22 – title

Incentives for ~~category 2~~ NGT plants and ~~category 2~~ NGT products containing traits relevant for sustainability

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 22 – paragraph 1

1. The incentives in this Article shall apply to ~~category 2~~ NGT plants and ~~category 2~~ NGT products, where at least one of the intended trait(s) of the NGT plant conveyed by the genetic modification is contained in Part 1 of Annex III and it does not have any traits referred to in Part 2 of that Annex.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 22 – paragraph 4 – point b

(b) for potential notifications in accordance with Article 13 of Directive 2001/18/EC in conjunction with Article 14 and for potential applications under Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19 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;

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 22 – paragraph 4 – point c

(c) the Authority shall make public without delay a summary of the pre- submission advice once an application or notification has been considered valid. Articles 38(1a) (enter regulation) shall apply mutatis mutandis;

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 22 – paragraph 5 – point a

(a) the information necessary to establish that the intended trait(s) conveyed by the genetic modification of the ~~category 2~~ NGT plant meet the conditions referred to in paragraph 1;

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 22 – paragraph 8

~~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 III in order to adapt them to scientific and technological progress and 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 30(3); (b) the Commission shall conduct an up- to-date scientific literature review of the impact on environmental, social and economic sustainability of the trait(s) it intends to add to or delete from the list in Annex III; (c) where applicable, the Commission shall take into account the results of monitoring which was carried out in accordance with Article 14, point (h), or Article 19(3), of NGT plants harbouring the trait(s) conveyed by their genetic modification.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 23 – title

Labelling of authorised ~~category 2~~ NGT products

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 23 – paragraph 1

In addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003, and without prejudice to the requirements under other Union legislation, the labelling of authorised category 2 NGT products may also mention the trait(s) conveyed by the genetic modification, as specified in the consent or the authorisation pursuant to Sections 2 or 3 of Chapter III of this Regulation.deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 24 – title

Measures to avoid the unintended presence of ~~category 2~~ NGT plants

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 24 – paragraph 1

Member States shall take appropriate measures to avoid the unintended presence of ~~category 2~~ NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003. This includes an obligation of NGT growers to inform organic and certified non-gm growers with field plots in a distance were outcrossing is possible to those where NGT plants are grown, according to the details specified in implementing act XXX.

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 25 – paragraph 1

~~Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.~~deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 26 – paragraph 1

~~1. The power to adopt the~~ delegated ~~acts is conferred on the Commission subject to the conditions laid down in this Article.~~

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 26 – paragraph 2

~~2. The power to adopt the~~ delegated acts referred to in Article 5(3) and Article 22(8) shall be conferred on the Commission for a period of 5 years from [date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 26 – paragraph 3

3. The delegations of power referred to in Article 5(3) and Article 22(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 26 – paragraph 4

~~4. Before adopting a~~ delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(61 ). _________________ 61 OJ L 123, 12.5.2016, p. 1.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 26 – paragraph 5

~~5. As soon as it adopts a~~ delegated ~~act, the Commission shall notify it simultaneously to the European Parliament and to the Council.~~

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 26 – paragraph 6

~~6. A~~ delegated act adopted pursuant to Articles Article 5(3) and Article 22(8) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 27 – paragraph 1 – point a

~~(a) the information required to demonstrate that a plant is a NGT plant;~~deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 27 – paragraph 1 – point b

~~(b) the preparation and the presentation of the verification requests referred to in Articles 6 and 7;~~deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 27 – paragraph 1 – point c

(c) the methodology and information requirements for the environmental risk assessment of category 2 NGT plants and the safety assessments of category 2 NGT food and feed, in accordance with the principles and criteria laid down in Annex II;deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 27 – paragraph 1 – point e a (new)

(ea) the methodology and information requirements to demonstrate that a trait can be considered to be sustainable.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 27 – paragraph 1 – point e b (new)

(eb) the methodology and information on how to define the inclusion of genetic information in the breeders gene pool.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 27 – paragraph 1 – point e c (new)

(ec) Definitions of and methodology to define risk profiles necessary for Annex II.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 27 – paragraph 2

Before adopting the implementing acts referred to in points (a) to (d), the Commission shall consult the Authority. Before adopting the implementing act(s) referred to in point (e), the Commission shall consult the Joint Research Centre with the European Union Reference Laboratory for Genetically Modified Food and Feed. The implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 28 – paragraph 2

~~2. Where reference is made to this paragraph, Article 4 of Regulation (EC) No 182/2011 shall apply.~~deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 30 – paragraph 1

1. No sooner than three years after the first decision is adopted in accordance with ~~Article 6(8) or (10) or Article 7(6) or in accordance with~~ Sections 2 or 3 of Chapter III, whichever is the earliest, and thereafter every five years, the Commission shall forward to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Regulation.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 30 – paragraph 2

2. The report shall also address any ~~ethical~~social, ethical or economic issues that have arisen with the application of this Regulation.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 31 – paragraph 1

With regard to ~~category 2~~ NGT plants, references in other Union legislation to Annex II or Annex III to Directive 2001/18/EC shall be construed as references to Part~~s 1 and~~ 2 of Annex II to this Regulation.

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 32

Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned. To this effect a request shall be submitted to the Commission within two months from the day on which the party concerned became aware of the act or omission in question. The Commission shall prepare a draft decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.rticle 32 deleted Administrative review

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 33

EU 2017/625
Article 23

Amendments to Regulation (EU) Article 23 of Regulation (EU) 2017/625 is amended as follows: (1) in paragraph 2, point (a)(ii) is replaced by the following: ‘(ii) the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];; ‘(b) the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];.rticle 33 deleted 2017/625

2023/11/19
Committee: ENVI

Proposal for a regulation
Article 34 – paragraph 2 – subparagraph 1

It shall apply from [248 months from the date of entry into force of this Regulation].

2023/11/19
Committee: ENVI

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

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – subheading 1

Risk assessment of ~~category 2~~ NGT plants and ~~category 2~~ NGT food and feed

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – paragraph 1

Part 1 of this Annex describes the general principles to be followed to perform the environmental risk assessment of ~~category 2~~ NGT plants referred to in Article 13, points (c) and (d), Article 14(1), point (e), and Article 19(3), point (a), and the safety assessment of ~~category 2~~ NGT food and feed referred to in Article 19(1), point (b). Part 2 describes specific information for the environmental risk assessment of ~~category 2~~ NGT plants and Part 3 describes specific information for the safety assessment of ~~category 2~~ NGT food and feed.

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 1

The environmental risk assessment shall be carried out in accordance with the precautionary principle and the principles set out in Annex II to Directive 2001/18/EC.

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 2 – introductory part

The type and amount of information necessary for the environmental risk assessment of ~~category 2~~ NGT plants laid down in Annex III of Directive 2001/18/EC and for the food and feed safety assessment of ~~category 2~~ NGT food and feed shall be adapted to their risk profile. Factors to be considered include:

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 2 – point a a (new)

(aa) characteristics of the recipient plant (i.a. allergenicity; potential for gene flow; weed potential; ecological function);

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 2 – point a b (new)

(ab) long safety record of the recipient plant;

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 3 – introductory part

The environmental risk assessment of ~~category 2~~ NGT plants and the risk assessment of ~~category 2~~ NGT food and NGT feed shall consist of the following:

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point a

(a) problem formulation including hazard identification and hazard characterisation;

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point b

(b) exposure characterisation and assessment;

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point c a (new)

(ca) risk management strategies

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point c b (new)

(cb) overall evaluation

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point a – introductory part

(a) problem formulation, hazard identification and characterisation

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point a – point i a (new)

(ia) information relating to the genetic modification and their intended effects

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point a – point ii

(ii) molecular characterisation to check for intended and unintended effects. The information shall be provided by collating already available data from scientific literature or from other sources or generating scientific data where necessary by performing appropriate experimental and bioinformatic studies.

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point b – paragraph 1

Information shall be provided ~~on the likelihood of each identified potential adverse effect. This~~to cover all relevant exposure routes to humans, livestock, and the environment. Exposure shall be evaluated taking into consideration, ~~as relevant,~~ the characteristics of the receiving environment(s), the intended function, the dietary role, the expected level of use of the food and feed in the EU and the scope of the application for authorisation.

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point c – paragraph 1

The applicant shall base its risk characterisation of NGT plants and foods and feed on information from hazard identification, hazard characterisation and exposure assessment. The risk shall for each protection goal (including specific protection goals) be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk~~. Where relevant, the uncertainty for each identified risk shall be described~~ and the uncertainties associated with this estimate.

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 1 – paragraph 5

Any information on hazard identification and characterisation specified under Parts 2 and 3 shall only be required if the specific characteristics and the intended use of the category 2 NGT plant or category 2 NGT food or feed give rise to a plausible risk hypothesis that can be addressed utilising the specified information.deleted

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 2 – title

2 Specific information for the environmental risk assessment of ~~category 2~~ NGT plants concerning hazard identification and characterisation

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 2 – point 1

(1) Analysis of agronomic, phenotypic and compositional characteristics according to Annex II of Directive 2001/18/EC

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 2 – point 8

(8) Effects on human ~~and~~, animal health and the food and feed chain

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 3 – title

3 Specific information for the ~~environmental risk assessment of category 2 NGT plants~~safety assessment of NGT food and feed concerning hazard identification and characterisation

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 3 – point 1 a (new)

(1a) Analysis of potential for persistence and invasiveness resulting from transport, loss, and spillage

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex II – Part 3 – point 2

(2) Ecotoxicology and Toxicology

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex III – subheading 1

Traits referred to in Article 3 and 22

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 1

(1) yield, including yield stability and yield under low-input conditions can justify incentives when combined with another trait or other traits under (2)-(7);

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 7

(7) reduced need for external inputs, such as ~~plant protection products and fertilisers~~fertilisers, if it does not contradict with Annex III part 2.

2023/11/19
Committee: ENVI

Proposal for a regulation
Annex III – Part 2 – paragraph 1

Traits excluding the application of the incentives referred to in Article 22: tolerance to herbicides, plants producing insecticides, pesticides.

2023/11/19
Committee: ENVI