REPORT on the proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending[...]

Text proposed by the Commission

Amendment

(1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the Council (32), on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted, significant progress in biotechnology has led to the development of new genomic techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precise locations.

(1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the Council (32), on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted, significant progress in biotechnology has led to the development of new genomic techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precise locations.Major advances in genetic engineering have already contributed to the widespread use of marker-assisted selection, which makes it possible to identify and mobilise interesting genes that are present in biodiversity.

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32Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

32Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

Text proposed by the Commission

Amendment

(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 preciselocations 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.

(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 targetedlocations 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.

Text proposed by the Commission

Amendment

(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).

(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 tolerance to herbicides, 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).

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33Insights 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.

33Insights 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.

34Communication 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.

34Communication 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.

35Communication 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.

35Communication 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.

36Communication 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.

36Communication 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.

37Communication 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

37Communication 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

38Communication 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.

38Communication 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.

39European 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.

39European 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.

40Communication 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.

40Communication 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.

Text proposed by the Commission

Amendment

(8) It is therefore necessary to adopt a specific legal framework for GMOsobtained by targeted mutagenesis and cisgenesis and related products when deliberately released into the environment or placed on the market.

(8) Category 1 NGT plants and productsobtained by targeted mutagenesis and cisgenesis and related 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. Targeted mutagenesis Category 1 NGT plants and products should be exempted from Annex 1 B to Directive 2001/18/EC as other mutagenesis methods have been.

Text proposed by the Commission

Amendment

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae, excludingmicroorganisms, fungi and animals for which the available knowledge is more limited. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter 'NGT plants'), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non-crossable species (transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae. Available knowledge on other organisms, such asmicroorganisms, fungi and animals, should be reviewed with a view to future legislative initiatives on them. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter 'NGT plants'), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non-crossable species (transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene.

Text proposed by the Commission

Amendment

(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 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.

(10) With full regard to the precautionary principle,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 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.

Text proposed by the Commission

Amendment

(11) This Regulation constitutes lex specialis with regard to the Union GMO legislation. It introduces specific provisions for NGT plants and NGT products. However, where there are no specific rules in this Regulation, NGT plants and products (including food and feed)obtained from them should remain subject to the requirements of the Union GMO legislation and the rules on GMOs in sectoral legislation, such as Regulation (EU) 2017/625 on official controls or the legislation on certain products like plant and forest reproductive material.

(11) This Regulation constitutes lex specialis with regard to the Union GMO legislation. It introduces specific provisions for NGT plants and NGT products. However, where there are no specific rules in this Regulation, NGT plants and products obtained from them should remain subject to the requirements of the Union GMO legislation and the rules on GMOs in sectoral legislation, such as Regulation (EU) 2017/625 on official controls or the legislation on certain products like plant and forest reproductive material.

Text proposed by the Commission

Amendment

(13a) NGT plants with the potential to persist, reproduce or spread in the environment, within or beyond fields, should be evaluated with the highest level of scrutiny in respect of such plants' impact on nature and the environment.

Text proposed by the Commission

Amendment

(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.

(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny ('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 fulfilment 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.

Text proposed by the Commission

Amendment

(14a) Taking into account the high complexity of plant genomes, the criteria for considering that a NGT plant is equivalent to a naturally occurring or conventionally bred plant should reflect the diversity of plants genomic size and their characteristics. Polyploid plants contain more than two homologous chromosomes. Within that category of polyploid plants, tetraploid, hexaploid, and octoploid have 4, 6 and 8 sets of chromosomes respectively. Polyploid plants tend to exhibit greater numbers of genetic modifications compared to monoploid plants. For those reasons, any limit to the total number of individual modifications per plant should reflect the number of chromosomes set in a plant ("ploidy").

Text proposed by the Commission

Amendment

(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 levelin order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

(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 verification request is submitted prior to the placing on the market of NGT products, and if there are reasoned objections by other Member States,the procedure should be conducted in consultation with the Commission and the European Food Safety Authority ('the Authority') in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

Text proposed by the Commission

Amendment

(18a) In order to effectively select new varieties that help the agricultural sector increase food security, as well as sustainability, adaptation and resilience in relation to the consequences of climate change, it is necessary to consider the specificity of polyploid plants, which are plants that contain more than two genomes. For such plants, the maximum number of genetic modifications allowed for inclusion in category 1 NGT should be proportionate to the number of genomes they contain.

Text proposed by the Commission

Amendment

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

(19) The competent authorities of the Member States, the Commission and the Authorityshould be subject to appropriatedeadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.

Text proposed by the Commission

Amendment

(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.

(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. The information listed should include information on the techniqueor techniques used to obtain the trait or traits.

Text proposed by the Commission

Amendment

(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, 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 incompatiblewith the conceptof 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 alsoprohibited in organic production.

(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, it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. Currently, the compatibility ofthe use of new genomic techniques with the principlesof organic production requires further consideration. The use of category 1 NGT plants should therefore be prohibited in organic production, until such further consideration takes place.

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47Regulation (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).

47Regulation (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).

Text proposed by the Commission

Amendment

(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.

(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 including information on the techniqueor techniques used to obtain the trait or traits. 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.

Text proposed by the Commission

Amendment

(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 ifthe category 2 NGT plant is unlikely topose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment.

(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. In view of the precautionary principle, a monitoring plan for environmental effects should always be required when consent is first given. It should only be possible to waive the requirement for monitoring upon the renewal of consent, provided that it has been demonstrated that the category 2 NGT plant does not pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment.

Text proposed by the Commission

Amendment

(36) Herbicide tolerant plants are bred to be intentionally tolerant to herbicides, in order to be cultivated in combination with the use of those herbicides. If such cultivation is not done under appropriate conditions, it may lead to development of weeds resistant to those herbicides or to the need to increase of quantities of herbicides applied, regardless of the breeding technique. For this reason, NGT plants featuring herbicide-tolerant traits should not be eligible for incentives under this framework. However, this Regulation should not take other specific measures on herbicide tolerant NGT plants, because such measures are taken horizontally in [the Commission's Proposal for a Regulationof the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union].

(36) Herbicide tolerant plants are bred to be intentionally tolerant to herbicides, in order to be cultivated in combination with the use of those herbicides. If such cultivation is not done under appropriate conditions, it may lead to development of weeds resistant to those herbicides or to the need to increase of quantities of herbicides applied, regardless of the breeding technique. For this reason, NGT plants featuring herbicide-tolerant traits should not fall within the scopeof the category 1 NGT plants.

Text proposed by the Commission

Amendment

(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. This requires predictability for breeders and farmers as regards the possibility to cultivate such plants in the Union. Therefore, the possibilityfor 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 would undermine those goals.

(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. This requires predictability for breeders and farmers as regards the possibility to cultivate such plants in the Union. Therefore, it should not be possiblefor 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, as thiswould undermine those goals.

Text proposed by the Commission

Amendment

(39) To achieve the goal of ensuring the effective functioning of the internal market, NGT plants and related products should benefit fromthe free movement of goods, provided they comply with therequirements of otherUnion law.

(39) To achieve the goal of ensuring the effective functioning of the internal market andthe free movement of NGT plant and NGT products across the Union, the deliberate release of NGT plants and placing on the market of NGT products should be based on the harmonisedrequirements and procedures laid down in this Regulation, leading to the adoption of a decision uniformly applicable to all Member States. Member States should not unilaterally derogate from the provisions set out in this Regulation in a way that would restrict, prohibit or hinder the free movement, placing on the market and deliberate release of NGT plants or NGT products within the territory of theUnion.

Text proposed by the Commission

Amendment

(40) Given the novelty of the NGTs, it will be important to monitor closely thedevelopment 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. Informationshould be collected regularly andwithin 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 anevaluation of this Regulation tomeasure the progress made towards the availability of NGT plants containing such characteristics or properties on the EU market.

(40) Given the ongoingdevelopment of new genomic techniques, the Commissionshould carry out an evaluationwithin 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. Thatevaluation shouldmeasure the progress made towards the availability of NGT plants or NGT productscontaining such characteristics or properties on the EU market, with the aim of further improving this Regulation.

Text proposed by the Commission

Amendment

(43) The types of NGT plants developed and the impact of certain traits on environmental, social and economic sustainability are continuously evolving. Therefore, based on the available evidence of such developments and impacts, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to adapt the list of traits that should be incentivized or discouraged to achieve the goals of the Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies.'

(43) The types of NGT plants developed and the impact of certain traits on environmental, social and economic sustainability are continuously evolving. Therefore, based on the available evidence of such developments and impacts,fully taking into account the precautionary principle,the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to adapt the list of traits that should be incentivized or discouraged to achieve the goals of the Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies.'

Text proposed by the Commission

Amendment

(45a) The European Parliament has called for the Union and its Member States not to grant patents on biological material and to safeguard the freedom to operate and the breeders' exemption for varieties. It should be ensured that breeders have full access to the genetic material of NGT plants, which by definition are not transgenic plants. Access to genetic materials can best be secured when the right of patent holders is exhausted in the hand of the breeder (breeder's exemption). As current provisions in patent law do not provide for a full breeder's exemption, it should be ensured that patents should not restrict the use of NGT plants by breeders and farmers. Hence, NGT plants should not be subject to patent legislation, but should for the protection of intellectual property solely be subject to the Community Plant Variety Rights (CPVR) system, as laid down in Council Regulation (EC) No 2100/94, which allows the use of the breeder's exemption. NGT plants, their derived seeds, their plant material, associated genetic material such as genes and gene sequences, and plant traits should therefore be excluded from patentability. The exclusion from patentability should be applied in a consistent manner across legislation. Furthermore, in order to avoid patents being granted or patent applications being submitted between the date of the entry into force of this Regulation and the application of its provisions, it should be ensured that plant material is excluded from patentability from the day of entry into force of this Regulation. For patents already granted or pending patent applications covering plant material, the effects of patents should be further limited. In addition, the Commission should assess and address, in the forthcoming study, how the broader problem of patents being granted, directly or indirectly, on plant material despite previous efforts to close loopholes, should be further addressed. The assessment should address in particular the role and impact of patents on breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, as well as on innovation and in particular on opportunities for SMEs. The report of the Commission should be accompanied by the appropriate legislative proposals in order to ensure further necessary adjustments are made to the intellectual property rights framework.

Text proposed by the Commission

Amendment

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.

This Regulation, in accordance with the precautionary principlelays 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, ensuring a high level of protection of human and animal health and the environment.

Text proposed by the Commission

Amendment

(2) 'NGT plant' means a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the condition that 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;

(2) 'NGT plant' means a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the condition that it does not contain any genetic material originating from outside the gene pool for conventional breeding purposesthat temporarily may have been inserted during the development of the NGT plant;

Text proposed by the Commission

Amendment

(4) 'targeted mutagenesis' means mutagenesis techniques resulting in modification(s) of the DNA sequence at preciselocations in the genome of an organism;

(4) 'targeted mutagenesis' means mutagenesis techniques resulting in modification(s) of the DNA sequence at targetedlocations in the genome of an organism;

Text proposed by the Commission

Amendment

(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 byusing advanced techniques such as embryo rescue, induced polyploidy and bridge crosses;

(6) 'gene pool for conventional breeding purposes'means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses;

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

(15b) "Chimeric protein" means proteins created through the joining of two or more genes or parts of genes that originally coded for separate proteins.

Text proposed by the Commission

Amendment

(b) is progeny of plant(s) referred to in point (a); or

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

Text proposed by the Commission

Amendment

(2) the plant is a category 2 NGT plant andhas been authorised in accordance with Chapter III.

(2) the plant is a category 2 NGT plant, and has been granted consent orhas been authorised in accordance with Chapter III.

Text proposed by the Commission

Amendment

1a. The implementation, enforcement and application of this Regulation shall not have the object or effect of preventing or impeding imports from third countries of NGT plants and products that meet the same standards as those laid down in this Regulation.

Text proposed by the Commission

Amendment

Article 4a

Exclusion from patentability

NGT plants, plant material, parts thereof, genetic information and the process features they contain shall not be patentable.

Text proposed by the Commission

Amendment

2. For the purposes of Regulation (EU) 2018/848, the rules set out in its Articles 5 (f) (iii) and11 shall apply to category 1 NGT plants and to products produced from or by such plants.

2. For the purposes of Regulation (EU) 2018/848, the rules set out in its Article 5 (f), (iii), and Article11 shall apply to category 1 NGT plants and to products produced from or by such plants. [7 years after the entry into force of this Regulation], the Commission shall present a report on the evolution of the consumers' and producers' perception, accompanied, where appropriate, by a legislative proposal.

Text proposed by the Commission

Amendment

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 progressas regards the types and extent of modifications which can occur naturally or through conventional breeding.

3. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the criteria of equivalence of NGT plants to conventional plants laid down in Annex I, taking into account potential associated risks and functional consequences in the verification procedurein order to adapt those criteria to the latestscientific and technological developmentsas regards the types and extent of modifications which can occur naturally or through conventional breeding.

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

1. To obtain the declaration of category 1 NGT plant status referred to in Article 4(1), point (a), before undertaking a deliberate release of a NGT plant for any other purpose than placing on the market, the person intending to undertake the deliberate release shall submit a request to verify whether the criteria set out in Annex I are met ('verification request') to the competent authority designated in accordance with Article 4(4) of Directive 2001/18/EC of the Member State within whose territory the release is to take place in accordance with paragraphs 2 and 3 and the implementingact adopted in accordance with Article 27, point (b).

1. To obtain the declaration of category 1 NGT plant status referred to in Article 4(1), point (a), before undertaking a deliberate release of a NGT plant for any other purpose than placing on the market, the person intending to undertake the deliberate release shall submit a request to verify whether the criteria set out in Annex I at least one of the traits referred to in Annex III, Part 1, and the exclusion criteria in Annex III, Part 2,are met ('verification request'). That verification request shall be submittedto the competent authority designated in accordance with Article 4(4) of Directive 2001/18/EC of the Member State within whose territory the release is to take place in accordance with paragraphs 2 and 3 and the delegatedact adopted in accordance with Article 6(11a), point (b).

Text proposed by the Commission

Amendment

(c) a description of the trait(s) and characteristics which have been introduced or modified;

(c) a description of the trait or traits and characteristics which have been introduced or modified, including information on the technique or techniques used to obtain the trait or the traits and including disclosure of the sequence of genetic modification;

Text proposed by the Commission

Amendment

(i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders'gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementingact adopted in accordance with Article 27, point (a);

(i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the gene pool for conventional breeding purposeswhere such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the delegatedact adopted in accordance with Article 6(11a), point (a);

Text proposed by the Commission

Amendment

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

(ii) the NGT plant meets the criteria set out in Annex I, at least one of the traits in Annex III, Part 1, and the exclusion criteria of Annex III, Part 2;

Text proposed by the Commission

Amendment

(da) the denomination of the variety

Text proposed by the Commission

Amendment

6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working days from the date of receipt of a verification request. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

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

Text proposed by the Commission

Amendment

7. The other Member States and the Commission may make commentsto the verification report within 20 days from the date of receipt of that report.

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

Text proposed by the Commission

Amendment

8. In the absence of any commentsfrom a Member State or the Commission, within 10 working days from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.

8. In the absence of any reasoned objectionsfrom a Member State or the Commission, within 10 working days from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.

Text proposed by the Commission

Amendment

9. In cases where a commentis made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the comment(s) to the Commissionwithout undue delay.

9. In cases where a reasoned objectionis made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall make the reasoned objections publicly availablewithout undue delay.

Text proposed by the Commission

Amendment

10. The Commission, after having consulted the European Food SafetyAuthority ('the Authority'), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

10. The Commission, after having consulted the Authority, shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the reasoned objections, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

Text proposed by the Commission

Amendment

11a. The Commission is empowered to adopt delegated acts in accordance with Article 26 supplementing this Regulation concerning:

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

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

Text proposed by the Commission

Amendment

(ba) the denomination of the variety;

Text proposed by the Commission

Amendment

(c) a description of the trait(s) and characteristics which have been introduced or modified;

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

Text proposed by the Commission

Amendment

7. The Commission shall publish a summary ofthe decision in the Official Journal of the European Union.

7. The Commission shall publish the finaldecision in the Official Journal of the European Union and shall publish, in a dedicated and publicly available webpage, its draft decision and the reasoned objections referred to in Article 6.

Text proposed by the Commission

Amendment

(b) the designation of the category 1 NGT plant;

(b) the designation and specificationof the category 1 NGT plant;

Text proposed by the Commission

Amendment

(ba) the denomination of the variety;

Text proposed by the Commission

Amendment

(ea) if provided, the opinion or statement of EFSA, as referred to in Article 6 (10) and Article 7(5); and

Text proposed by the Commission

Amendment

2. The database shall be publicly available.

2. The database shall be publicly available, and in an online format.

Text proposed by the Commission

Amendment

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.

Plant reproductive material, including for breeding and scientific purposes that contains or consists of category 1 NGT plant or plants and is made available to third parties, whether in return for payment or free of charge, shall bear a label and a reference to a variety register automatically transmitted to the EU common registerindicating the words 'cat 1 NGT', followed by the identification number of the NGT plant or plants it has been derived from.

Text proposed by the Commission

Amendment

Article 16

deleted

Labelling in accordance with Article 23

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.

Text proposed by the Commission

Amendment

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 IIIand it does not have any traits referred to in Part 2 of that Annex.

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 traits of the NGT plant conveyed by the genetic modification is contained in Article 51(1) of Regulation (EU/…)* and it does not have any traits referred to in Part 2 of that Annex.

__________________

* Commission proposal for a Regulation on plant reproductive material (COM/2023/414), (2023/0227(COD)).

Text proposed by the Commission

Amendment

Member States shalltake appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

Member States maytake appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003, only in the event that the category 2 NGT plants are able to be detected, identified and quantified by analytical methods. These provisions shall not apply to category 1 NGT plants and category 1 NGT products.

Text proposed by the Commission

Amendment

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.

2. The power to adopt the delegated acts referred to in Article 5(3), Article 6(11a)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.

Text proposed by the Commission

Amendment

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.

3. The delegations of power referred to in Article 5(3), Article 6(11a)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.

Text proposed by the Commission

Amendment

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.

6. A delegated act adopted pursuant to Articles Article 5(3), Article 6(11a)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.

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

2. The report shall also address any ethical issues that have arisen with the application of this Regulation.

2. The report shall also identify andaddress any issues regarding biodiversity and environmental, human and animal health, changes to agronomic practices as well as socio-economic andethical issues that mayhave arisen with the application of this Regulation.

Text proposed by the Commission

Amendment

3. For the purpose of the reporting referred to in paragraph 1, the Commission, by [24 months after the date of entry into force of this Regulation] at the latest, shall establish, after consulting the competent authorities of the Member States in accordance with Directive 2001/18/EC and Regulation (EC) No 1829/2003, a detailed programme for monitoring, based on indicators, the impact of this Regulation. It shall specify the action to be taken by the Commission and by the Member States in collecting and analysing the data and other evidence.

3. For the purpose of the reporting referred to in paragraph 1, the Commission, by [24 months after the date of entry into force of this Regulation] at the latest, shall establish, after consulting the competent authorities of the Member States in accordance with Directive 2001/18/EC and Regulation (EC) No 1829/2003, a detailed programme for monitoring, based on indicators, the impact of this Regulation, including the intended and unintended effects and systematic effects on the environment, biodiversity and ecosystems. It shall specify the action to be taken by the Commission and by the Member States in collecting and analysing the data and other evidence.

Text proposed by the Commission

Amendment

5a. By June 2025 the Commission shall submit a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the role and impact of patents on breeders' and farmers' access to varied plant reproductive material, as well as on innovation and, in particular, on opportunities for SMEs. The report shall assess whether further legal provisions are necessary in addition to those provided for in Article 4a and Article 33a of this Regulation. Where appropriate to ensure breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, the report shall be accompanied by a legislative proposal to address further necessary adjustments in the intellectual property rights framework.

Text proposed by the Commission

Amendment

5b. By 2024, the Commission shall submit a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions evaluating the specificities of and needs for other sectors not covered in this legislation, such as microorganisms, including a proposal for further policy actions.

Text proposed by the Commission

Amendment

5c. Every four years, the Commission shall assess the criteria of equivalence established in Annex I and, if necessary, update them through a delegated act as referred to in Article 5, (3).

Text proposed by the Commission

Amendment

Article 33a

Amendments to Directive 98/44/EC1a

1. Article 4 of Directive 98/44/EC on the legal protection of biotechnological inventions is amended as follows:

(a) In paragraph 1, the following points are added:

'(c) NGT plants, plant material, parts thereof, genetic information and process features they contain, as defined in Regulation (EU) .../... [O.J. please insert the number of this Regulation];

(d) plants, plant material, parts thereof, genetic information and process features they contain that can be yielded by techniques excluded from the scope of Directive 2001/18/EC as listed in Annex I B to that directive.'

(b) the following paragraph 4 is added:

'4. Paragraph 2 and 3 shall be without prejudice to the exclusions from patentability covered in paragraph 1.'

_______________________________

1aDirective 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, p. 13).

Text proposed by the Commission

Amendment

It shall apply from [24 months from the date of entry into force of this Regulation].

It shall apply from [24 months from the date of entry into force of this Regulation]. Article 4a and Article 33a shall apply from the date of entry into force.

Text proposed by the Commission

Amendment

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 typesreferred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.

A NGT plant is considered equivalent to conventional plants if the following conditionsreferred to in points 1 and 1a are met:

Text proposed by the Commission

Amendment

(1) substitution or insertion of no more than 20 nucleotides;

(1) The number of the following genetic modifications, which can be combined with each other, does not exceed 3 per any protein-coding sequence taking into account that mutations in introns and regulatory sequences are excluded from this limit:

(a) substitution or insertion of no more than 20 nucleotides;

(b) deletion of any number of nucleotides;

Text proposed by the Commission

Amendment

(1a) The following genetic modifications, which can be combined with each other, do not create a chimeric protein that is not present in species from the gene pool for breeding purposes or does not interrupt an endogenous gene;

(a) insertion of continuous DNA sequences existing in the gene pool for breeding purposes;

(b) substitution of endogenous DNA sequences with continuous DNA sequences existing in the gene pool for breeding purposes;

(c) inversion or translocation of continuous endogenous DNA sequences existing in the gene pool for breeding purposes.

Text proposed by the Commission

Amendment

(2) deletion of any number of nucleotides;

deleted

Text proposed by the Commission

Amendment

(3) on the condition that the genetic modification does not interrupt an endogenous gene:

deleted

(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;

Text proposed by the Commission

Amendment

(4) targeted inversion of a sequence of any number of nucleotides;

deleted

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

(aa) the characteristics of the recipient plant like allergenicity, potential for gene flow, weed potential, ecological function;

Text proposed by the Commission

Amendment

(6a) Impacts on organic cultivation

Text proposed by the Commission

Amendment

(8a) Effects on protecting and conserving biodiversity

Text proposed by the Commission

Amendment

Traits referred to in Article 22

Traits referred to in Article 6 and Article22

Text proposed by the Commission

Amendment

(1) yield, including yield stability and yield under low-input conditions;

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

Text proposed by the Commission

Amendment

(7) reduced need for external inputs, such as plant protection products andfertilisers.

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

Text proposed by the Commission

Amendment

ANNEX IIIa

In-door safety assessment

A Cat.1 NGT plant is considered safe if, when compared to the non modified parent of the same species, through confined experiments evidence is provided that:

(1) the whole genome sequencing and profiling shows that the intended and unintended genetic modifications have not adversely modified the function of one or more genes; and

(2) the whole transcriptome sequencing carried out on the relevant part of the plant shows that the intended and unintended genetic modifications have not adversely modified biochemical pathways, leading in particular to adverse compositional consequences, verified for instancethrough gene ontology analysis; and

(3) biochemical metabolite (metabolomics) and protein (proteomics) profiling realised on the relevant part of the plant shows that the intended and unintended genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of toxic or allergenic novel biochemicals or proteins other than those sought after and tested .

Entity and/or person

Euroseeds

KRAV Ekonomisk Förening

KWS SAAT SE & Co. KGaA

European Commission: DG Sante

Text proposed by the Commission

Amendment

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625

(Text with EEA relevance)

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain precision breedingtechniques and their food and feed, and amending Regulation (EU) 2017/625 and Directive 98/44/EC(Text with EEA relevance)

Text proposed by the Commission

Amendment

(1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the Council (32), on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted, significant progress in biotechnology has led to the development of new genomic techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at preciselocations.

(1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the Council (32), on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted, significant progress in biotechnology has led to the development of new genomic techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at targetedlocations.

_________________

_________________

32Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

32Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

Text proposed by the Commission

Amendment

(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 preciselocations 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.

(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 targetedlocations 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.

Text proposed by the Commission

Amendment

(8) It istherefore necessary to adopt a specific legal framework for GMOsobtained by targeted mutagenesis and cisgenesis and related products when deliberately released into the environment or placed on the market.

(8) Therefore, category 1 NGT plants and productsobtained by targeted mutagenesis and cisgenesis and related 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. Targeted mutagenesis and cisgenesis to obtain Category 1 NGT plants and products should be exempted in Directive 2001/18/EC Annex 1 B like mutagenesis and cell fusion. A periodic review of the approach to establishing equivalence to conventional breeding methods is required in order to reflect scientific and technological progress.

Text proposed by the Commission

Amendment

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae, excludingmicroorganisms, fungi and animals for whichthe available knowledge is more limited. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter 'NGT plants'), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non-crossable species (transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene. Moreover, there is no indication that current requirements in the UnionGMO legislation for GMOs obtained by transgenesis need adaptation at the present time.

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae. For other organisms, such asmicroorganisms, the available knowledge will be reviewed in view of a future proposal. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter 'NGT plants'), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non-crossable species (transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene. Moreover, the widerGMO legislation should be examined in view of the Commission conclusion that it is no longer fit for purpose to ensure that requirements are science-based and proportional to the risk.

Text proposed by the Commission

Amendment

(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 fulfillmentof 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 andextent of genetic modifications that can occur in nature or through conventional breeding.

(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny ('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 fulfilmentof 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,extent, dimensions and numberof genetic modifications that can occur in nature or through conventional breeding.

Text proposed by the Commission

Amendment

(16) Category 1 NGT plants and products shouldnot 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.

(16) Category 1 NGT plants and products mustnot 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. NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny ('category 1 NGT plants') should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques.

Text proposed by the Commission

Amendment

(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 tothe verification report by other national competent authorities. Where the verification request is submitted prior to the placing on the market of NGT products, theprocedure should be conducted at Unionlevel in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

(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 and prior to the placing on the market of NGT productsshould be conducted by national competent authorities as this would be less administratively burdensome for operators.The verification procedure of category 1 NGT plant statusshould be conducted at nationallevel based on the scientific opinion of the European Food Safety Authority ('the Authority') only if there are reasoned scientific objections by other Member Statesin order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

Text proposed by the Commission

Amendment

(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.

(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. The information listed shall include information on the technique(s) used to obtain the trait(s).

Text proposed by the Commission

Amendment

(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, 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.

(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. The use of category 1 NGT plants should be clarified in Regulation (EU) 2018/848.

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47Regulation (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).

47Regulation (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).

Text proposed by the Commission

Amendment

(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 andplant 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.

(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 indicated by a mention in the national catalogues and/or common catalogue of varieties of agriculturalplant species , including information on the technique(s) used to obtain the trait(s).

Text proposed by the Commission

Amendment

(29a) After the successful authorisation of a category 1 NGT plant based on scientific criteria, the authorisation should be valid for an unlimited period.

Text proposed by the Commission

Amendment

(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.

(30) For reasons of proportionality, after a first renewal of the authorisation of a category 2 NGT plant, 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 category 2NGT plant concerned, subject to reassessment when new information has become available.

Text proposed by the Commission

Amendment

(32) To increase transparency and consumers' information, operators should be allowed to complement the labelling of category 2 NGT products as GMOwith 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.

(32) To increase transparency and consumers' information, operators should be allowed to complement the labelling of category 2 NGT products with information on the trait conferred. 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.

Text proposed by the Commission

Amendment

(36) Herbicide tolerant plants are bred to be intentionally tolerant to herbicides, in order to be cultivated in combination with the use of those herbicides. If such cultivation is not done under appropriate conditions, it may lead to development of weeds resistant to those herbicides or to the need to increase of quantities of herbicides applied, regardless of the breeding technique. For this reason, NGT plants featuring herbicide-tolerant traits should not be eligible for incentives under this framework. However, this Regulation should not take other specific measures on herbicide tolerant NGT plants, because such measures are taken horizontally in [the Commission's Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union].

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Text proposed by the Commission

Amendment

(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. 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 2NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC would undermine those goals.

(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. 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 NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC would undermine those goals.

Text proposed by the Commission

Amendment

(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.

(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 for category 2NGT plantsto 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.

Text proposed by the Commission

Amendment

(39) To achieve the goal of ensuring the effective functioning of the internal market, NGT plants and related products should benefit fromthe free movement of goods, provided they comply with therequirements of otherUnion law.

(39) To achieve the goal of ensuring the effective functioning of the internal market andthe free movement of NGT plant products across the Union, the deliberate release of NGT plants and placing on the market of NGT products should be based on the harmonizedrequirements and procedures laid down in this Regulation, leading to the adoption of a decision uniformly applicable to all Member States. Member States should not unilaterally derogate from the provisions set out in this Regulation in a way that would restrict, prohibit or hinder the free movement, placing on the market and deliberate release of NGT plants or related products within the territory of theUnion.

Text proposed by the Commission

Amendment

(40) 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.

(40) Given the novelty of the NGTs, it will be important to monitor closely the development and presence on the market of category 2NGT 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 category 2NGT plants or category 2 NGT products in the Union, the Commission should carry out an evaluation of this Regulation to measure the progress made towards the availability of category 2NGT plants containing such characteristics or properties on the EU market with the aim of further improving the Regulation

Text proposed by the Commission

Amendment

(45 a) The European Parliament has called for the EU and its Member States not to grant patents on biological material and to safeguard the freedom to operate and the breeder's exemption for varieties. It should be ensured that breeders have full access to the genetic material of NGT plants, which by definition are not transgenic plants. Access to genetic materials can best be secured when the right of patent holders is exhausted in the hand of the breeder (breeder's exemption). As current provisions do not provide for a full breeder's exemption in patent law, it should be ensured that patents should not restrict the use of NGT plants by breeders and farmers. Hence, these plants should not be subject to patent legislation, but should for the protection of intellectual property solely be subject to the Community Plant Variety Rights (CPVR) system, as laid down in Council Regulation (EC) No 2100/94, which allows the use of the breeder's exemption. NGT plants, their derived seed, their plant material, associated genetic material such as genes and gene sequences, and plant traits should therefore be excluded from patentability. The exclusion from patentability should be applied in a consistent manner across legislation. Furthermore, in order to avoid that patents are being granted or patent applications can be submitted while further legal provisions on the issue would be postponed, it should be ensured that the plant material is excluded from patentability from the day of entry into force of this Regulation. In addition, the Commission in the announced forthcoming study should assess how the broader problem of patents being granted, directly or indirectly, on plant material despite previous efforts to close loopholes, should be further addressed. The assessment should address in particular the role and impact of patents on breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, as well as on innovation and particularly on the opportunities for SMEs. The Commission should present its report no later than 2026, accompanied by the appropriate legislative proposals in order to ensure further necessary changes to the framework for intellectual property rights.

Text proposed by the Commission

Amendment

(46 a) Member States should organise factual public information campaigns regarding the safety and the benefits of plants obtained through new genomic techniques, with a particular emphasis on category 1 NGT plants. Member States should aim to dispel myths and misconceptions about new genomic techniques as well as to counteract disinformation and misinformation on this subject via these public information campaigns or by other means. The Commission should provide assistance and guidelines to Member States in this respect, upon request.

Text proposed by the Commission

Amendment

(2) 'NGT plant' means a genetically modifiedplant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the condition that 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;

(2) 'NGT plant' means a plant as defined in Article 2 point (1) of Regulation (EU) 2016/2031 (1a)obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the condition that it does not contain any genetic material originating from outside the gene pool for breeding purposesthat temporarily may have been inserted during the development of the NGT plant;

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1a Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants

Text proposed by the Commission

Amendment

(4) 'targeted mutagenesis' means mutagenesis techniques resulting in modification(s) of the DNA sequence at preciselocations in the genome of an organism;

(4) 'targeted mutagenesis' means mutagenesis techniques resulting in modification(s) of the DNA sequence at targetedlocations in the genome of an organism;

Text proposed by the Commission

Amendment

(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;

(6) 'gene pool for breeding purposes' means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses;

Text proposed by the Commission

Amendment

(6a) 'Polyploidy' means the presence of more than two genomes in a single cell;

Text proposed by the Commission

Amendment

(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 nofurther modifications that would make it subject to Directive 2001/18/EC or Regulation 1829/2003;

(b) is progeny of the NGT plant(s) referred to in point (a), including progeny derived by crossing of such plants, or progeny that has undergonefurther modifications and fulfils the criteria of equivalence to conventional plants, set out in Annex I;

Text proposed by the Commission

Amendment

(b a) for which it is not feasible to provide an analytical method that detects, identifies and quantifies;

Text proposed by the Commission

Amendment

(12) 'NGT product' means a product, other than food and feed, containing or consisting of a NGT plant andfood and feed containing, consisting of or produced from such a plant;

(12) 'NGT product' means food and feed containing, consisting of or produced from NGT plants, and other products containing or consisting of such plants;

Text proposed by the Commission

Amendment

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

(2) the plant is a category 2 NGT plant and has been granted consent orhas been authorised in accordance with Chapter III.

Text proposed by the Commission

Amendment

(1 a) The implementation, enforcement and application of this Regulation shall not have the object or effect of preventing or impeding imports from third countries of NGT plants and products that meet the same standards as those laid down in this Regulation.

Text proposed by the Commission

Amendment

Article 4a

Exclusion from patentability

NGT plants, plant material and parts thereof shall not be patentable.

Text proposed by the Commission

Amendment

1. The rules which apply to GMOs in Union legislationshall notapply to category 1 NGT plants.

1. The rules which apply to organisms that result from the application of techniques of genetic modification listed in Annex I B to Directive 2001/18/ECshall alsoapply to category 1 NGT plants.

Text proposed by the Commission

Amendment

(1a) Category 1 NGT plants shall be subject to the same legal framework as conventionally bred plants, in particular with regard to plant breeders' rights and to self-propagation.

Text proposed by the Commission

Amendment

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.

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. Seven years after the entry into force of this Regulation, the Commission shall present a report on the evolution of the consumers' and producers' perception, accompanied, if appropriate, by a legislative proposal to lift the ban on the use of NGTs in organic production.

Text proposed by the Commission

Amendment

2 a. Category 1 NGT plants and products obtained from or by such plants shall not be subject to coexistence measures established under Article 24 of this Regulation or Regulation 1829/2003.

Text proposed by the Commission

Amendment

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 extentof modifications which can occur naturally or through conventional breeding.

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, extent, dimensions and numberof modifications which can occur naturally or through conventional breeding.

Text proposed by the Commission

Amendment

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

Verification procedure of category 1 NGT plant status.

Text proposed by the Commission

Amendment

(c) a description of the trait(s) and characteristics which have been introduced or modified;

(c) a description of the trait(s) and characteristics which have been introduced or modified including information on the technique(s) used to obtain the trait(s);

Text proposed by the Commission

Amendment

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

4. The competent authority shall acknowledge receipt of the verification request to the requester within 10 working days, stating the date of receipt. It shall make available the request to the other Member States and to the Commission within 10 working days.

Text proposed by the Commission

Amendment

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

5. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the competent authority within 30 working days within the date of receipt of a verification request. The competent authority shall inform the requester, the other Member States and the Commission within 10 working daysof the inadmissibility of the verification request and shall provide the reasons of its decision.

Text proposed by the Commission

Amendment

6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working days from the date of receipt of a verification request. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the nationalcompetent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working days from the date of receipt of a verification request. The nationalcompetent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

Text proposed by the Commission

Amendment

7. The other Member States and the Commission may make commentsto the verification report within 20 days from the date of receipt of that report.

7. The other Member States and the Commission may make reasoned scientific objectionsto the verification report within 20 days from the date of receipt of that report. Those reasoned scientific objections shall solely refer to the criteria set out in Annex I and shall include a scientific justification.

Text proposed by the Commission

Amendment

8. In the absence of any commentsfrom a Member State or the Commission, within 10 working days from the expiry ofthe deadline referred to in paragraph 7, the competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. Itshall transmit the decision without undue delayto the requester, the other Member States and tothe Commission.

8. In the absence of any reasoned scientific objectionsfrom a Member State or the Commission, within the deadline referred to in paragraph 7, the nationalcompetent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. The national competent authorityshall transmit the decision within 10 working daysto the requester, the other Member States and the Commission.

Text proposed by the Commission

Amendment

9. In cases where a comment is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the the comment(s) to the Commission without undue delay.

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Text proposed by the Commission

Amendment

10. The Commission, after having consultedthe European Food Safety Authority ('the Authority'),shall prepare a draftdecision declaring whether the NGT plant is a category 1 NGT plantwithin 45working days from the date of receipt of the comment(s), taking the latter into account.The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

10. Where reasoned scientific objections have been made, the national competent authority shall askthe European Food Safety Authority ('the Authority') for a scientific opinion on the verification report. The Authorityshall issue its scientific opinion on the verification report within 30 days from the date of receipt of that report. The competent authority shall adopt adecision based on the Authority's scientific opinionwithin 20working days from the date of receipt of that opinion. The competent authority shall transmitthe decision without undue delay to the requester, the other Member States and the Commission.

Text proposed by the Commission

Amendment

[...]

deleted

Text proposed by the Commission

Amendment

Article 7a

Free movement of category 1 NGT plants and category 1 NGT products

Member States shall not prohibit, restrict or impede the deliberate release or the placing on the EU single market of category 1 NGT plants and category 1 NGT products, which comply with the requirements of this Regulation.

Text proposed by the Commission

Amendment

Article 7b

Plants resulting from a conventional cross between two category 1 NGT plants

A plant that is the result of a conventional cross between two verified category 1 NGT plants and in which the introduced modifications are maintained is not considered a new NGT plant and automatically maintains category 1 NGT status.

Text proposed by the Commission

Amendment

Article 10

deleted

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.

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.

Text proposed by the Commission

Amendment

It shall be prohibited to label consumer products as containing NGT products or having been developed using NGT. It shall furthermore be prohibited to use 'negative labelling' by labelling products as not containing or not having been developed using NGT.

Text proposed by the Commission

Amendment

(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, 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);

(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, the NGT plant shall fall under category 1 in accordance with Article 3(7)(ba).

Text proposed by the Commission

Amendment

Article 16

deleted

Labelling in accordance with Article 23

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.

Text proposed by the Commission

Amendment

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 IIIand it does not have any traits referred to in Part 2 of thatAnnex.

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 Article 52(1) of Regulation (EU) …/… (on Plant Reproductive Material)and it does not have any traits referred to in Part 2 of Annex III to this Regulation.

Text proposed by the Commission

Amendment

Article 23

deleted

Labelling of authorised category 2 NGT products

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.

Text proposed by the Commission

Amendment

Member States shalltake appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

Member States maytake appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003, only in the event that the category 2 NGT plants are able to be detected, identified and quantified by analytical method. These provisions shall not apply to category 1 NGT plants and category 1 NGT products.

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

5 a. No later than 2026, the Commission shall present a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the role and impact of patents on breeders' and farmers' access to varied plant reproductive material, as well as on innovation and particularly on the opportunities for SMEs. The report shall assess whether further legal provisions are necessary in addition to those provided for in Article 4a and Article 33a of this Regulation. Where appropriate to ensure breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, as well as the ongoing promotion of innovation, particularly with a view to opportunities for SMEs, the report shall be accompanied by a roadmap to address further necessary adjustments in the intellectual property framework.

Text proposed by the Commission

Amendment

Article 33a

Amendments to Directive 98/44/EC

Article 4 of Directive 98/44/EC on the legal protection of biotechnological inventions is amended as follows:

In paragraph 1, points (c) and (d) are added:

'(c) NGT plants, plant material and parts thereof, as defined in Regulation (EU) .../... [insert reference to this Regulation];

(d) plants, plant material and parts thereof that can be yielded by techniques excluded from the scope of Directive 2001/18/EC as listed in Annex I B to that directive.'

Text proposed by the Commission

Amendment

It shall apply from [24 months from the date of entry into force of this Regulation].

It shall apply from [24 months from the date of entry into force of this Regulation]. However, Article 4a and Article 33a shall apply from the date of entry into force.

Text proposed by the Commission

Amendment

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 typesreferred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.

A NGT plant is considered equivalent to conventional plants if the following conditionsreferred to in points 1 and 1a are met:

Text proposed by the Commission

Amendment

(1) substitution or insertion of no more than 20 nucleotides;

(1) The number of the following mutation events, which can be combined with each other, does not exceed 3 per any protein-coding sequence (mutations in introns and regulatory sequences are excluded from this limit):

(a)substitution or insertion of no more than 20 nucleotides;

(b) deletion of any number of nucleotides;

Text proposed by the Commission

Amendment

(1 a) The following genetic modifications, which can be combined with each other, do not create a chimeric protein that is not present in species from the gene pool for breeding purposes:

(a) targeted insertion of continuous DNA sequences existing in the gene pool for breeding purposes;

(b) targeted substitution of endogenous DNA sequences with continuous DNA sequences existing in the gene pool for breeding purposes;

(c) inversion or translocation of continuous endogenous DNA sequences existing in the gene pool for breeding purposes.

Text proposed by the Commission

Amendment

(2) deletion of any number of nucleotides;

deleted

Text proposed by the Commission

Amendment

(3) on the condition that the genetic modification does not interrupt an endogenous gene:

deleted

(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;

Text proposed by the Commission

Amendment

(4) targeted inversion of a sequence of any number of nucleotides;

deleted

Text proposed by the Commission

Amendment

(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

Text proposed by the Commission

Amendment

Traits justifying the incentives referred to in Article 22:

Traits justifying the incentives referred to in Article 22 are listed in Article 52(1) of Regulation (EU) .../... ( on Plant Reproductive Material).

Text proposed by the Commission

Amendment

(1) yield, including yield stability and yield under low-input conditions;

deleted

Text proposed by the Commission

Amendment

(2) tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses and other pests;

deleted

Text proposed by the Commission

Amendment

(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change;

deleted

Text proposed by the Commission

Amendment

(4) more efficient use of resources, such as water and nutrients;

deleted

Text proposed by the Commission

Amendment

(5) characteristics that enhance the sustainability of storage, processing and distribution;

deleted

Text proposed by the Commission

Amendment

(6) improved quality or nutritional characteristics;

deleted

Text proposed by the Commission

Amendment

(7) reduced need for external inputs, such as plant protection products and fertilisers.

deleted

Text proposed by the Commission

Amendment

2 Traits excluding the application of the incentives referred to in Article 22: tolerance to herbicides.

deleted

Title

Plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625

References

COM(2023)0411 - C9-0238/2023 - 2023/0226(COD)

Committee responsible

Date announced in plenary

ENVI

19.10.2023

Opinion by

Date announced in plenary

AGRI

19.10.2023

Associated committees - date announced in plenary

19.10.2023

Rapporteur for the opinion

Date appointed

Veronika Vrecionová

28.8.2023

Discussed in committee

26.10.2023

Date adopted

11.12.2023

Result of final vote

+:

-:

0:

34

11

1

Members present for the final vote

Mazaly Aguilar, Clara Aguilera, Daniel Buda, Isabel Carvalhais, Asger Christensen, Dacian Cioloş, Ivan David, Paolo De Castro, Jérémy Decerle, Salvatore De Meo, Herbert Dorfmann, José Manuel Fernandes, Paola Ghidoni, Martin Häusling, Martin Hlaváček, Krzysztof Jurgiel, Jarosław Kalinowski, Elsi Katainen, Camilla Laureti, Norbert Lins, Elena Lizzi, Colm Markey, Marlene Mortler, Ulrike Müller, Maria Noichl, Juozas Olekas, Eugenia Rodríguez Palop, Daniela Rondinelli, Katarína Roth Neveďalová, Bert-Jan Ruissen, Anne Sander, Veronika Vrecionová, Sarah Wiener, Juan Ignacio Zoido Álvarez

Substitutes present for the final vote

Anna Deparnay-Grunenberg, Dino Giarrusso, Charles Goerens, Claude Gruffat, Anja Hazekamp, Peter Jahr, Cristina Maestre Martín De Almagro, Sandra Pereira, Michaela Šojdrová, Tom Vandenkendelaere, Thomas Waitz

Substitutes under Rule 209(7) present for the final vote

Mercedes Bresso

34

+

ECR

Mazaly Aguilar, Bert-Jan Ruissen, Veronika Vrecionová

ID

Ivan David, Paola Ghidoni, Elena Lizzi

NI

Dino Giarrusso

PPE

Daniel Buda, Salvatore De Meo, Herbert Dorfmann, José Manuel Fernandes, Peter Jahr, Jarosław Kalinowski, Norbert Lins, Colm Markey, Marlene Mortler, Anne Sander, Michaela Šojdrová, Tom Vandenkendelaere, Juan Ignacio Zoido Álvarez

Renew

Asger Christensen, Dacian Cioloş, Jérémy Decerle, Charles Goerens, Martin Hlaváček, Elsi Katainen, Ulrike Müller

S&D

Clara Aguilera, Mercedes Bresso, Paolo De Castro, Camilla Laureti, Cristina Maestre Martín De Almagro, Juozas Olekas, Daniela Rondinelli

11

-

ECR

Krzysztof Jurgiel

NI

Katarína Roth Neveďalová

S&D

Maria Noichl

The Left

Anja Hazekamp, Sandra Pereira, Eugenia Rodríguez Palop

Verts/ALE

Anna Deparnay-Grunenberg, Claude Gruffat, Martin Häusling, Thomas Waitz, Sarah Wiener

1

0

S&D

Isabel Carvalhais

Title

Plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625

References

COM(2023)0411 - C9-0238/2023 - 2023/0226(COD)

Date submitted to Parliament

6.7.2023

Committee responsible

Date announced in plenary

ENVI

19.10.2023

Committees asked for opinions

Date announced in plenary

AGRI

19.10.2023

Associated committees

Date announced in plenary

AGRI

19.10.2023

Rapporteurs

Date appointed

Jessica Polfjärd

28.8.2023

Discussed in committee

7.11.2023

Date adopted

24.1.2024

Result of final vote

+:

-:

0:

47

31

4

Members present for the final vote

Catherine Amalric, Maria Arena, Hildegard Bentele, Sergio Berlato, Michael Bloss, Delara Burkhardt, Pascal Canfin, Sara Cerdas, Mohammed Chahim, Nathalie Colin-Oesterlé, Maria Angela Danzì, Esther de Lange, Christian Doleschal, Bas Eickhout, Pietro Fiocchi, Heléne Fritzon, Malte Gallée, Gianna Gancia, Catherine Griset, Teuvo Hakkarainen, Anja Hazekamp, Martin Hojsík, Jan Huitema, Karin Karlsbro, Petros Kokkalis, Peter Liese, Javi López, César Luena, Marian-Jean Marinescu, Lydie Massard, Liudas Mažylis, Marina Mesure, Silvia Modig, Dolors Montserrat, Alessandra Moretti, Ville Niinistö, Nikos Papandreou, Francesca Peppucci, Stanislav Polčák, Jessica Polfjärd, Erik Poulsen, Nicola Procaccini, Frédérique Ries, María Soraya Rodríguez Ramos, Maria Veronica Rossi, Silvia Sardone, Günther Sidl, Maria Spyraki, Nils Torvalds, Edina Tóth, Achille Variati, Petar Vitanov, Alexandr Vondra, Mick Wallace, Pernille Weiss, Emma Wiesner, Michal Wiezik, Tiemo Wölken

Substitutes present for the final vote

Asger Christensen, Christophe Clergeau, Margarita de la Pisa Carrión, Martin Häusling, Ska Keller, Danilo Oscar Lancini, Sara Matthieu, Marlene Mortler, Manuela Ripa, Nicolae Ştefănuță, Idoia Villanueva Ruiz

Substitutes under Rule 209(7) present for the final vote

Mazaly Aguilar, Katarina Barley, Franc Bogovič, Daniel Buda, Ana Collado Jiménez, Paola Ghidoni, Peter Jahr, Thierry Mariani, Nora Mebarek, Sara Skyttedal, Michaela Šojdrová, Veronika Vrecionová, Stefania Zambelli

Date tabled

29.1.2024

47

+

ECR

Mazaly Aguilar, Sergio Berlato, Pietro Fiocchi, Teuvo Hakkarainen, Margarita de la Pisa Carrión, Nicola Procaccini, Alexandr Vondra, Veronika Vrecionová

ID

Gianna Gancia, Paola Ghidoni, Danilo Oscar Lancini, Maria Veronica Rossi, Silvia Sardone

PPE

Hildegard Bentele, Franc Bogovič, Daniel Buda, Nathalie Colin-Oesterlé, Ana Collado Jiménez, Christian Doleschal, Peter Jahr, Esther de Lange, Peter Liese, Marian-Jean Marinescu, Liudas Mažylis, Dolors Montserrat, Marlene Mortler, Francesca Peppucci, Stanislav Polčák, Jessica Polfjärd, Sara Skyttedal, Michaela Šojdrová, Maria Spyraki, Pernille Weiss, Stefania Zambelli

Renew

Catherine Amalric, Pascal Canfin, Asger Christensen, Jan Huitema, Karin Karlsbro, Erik Poulsen, Frédérique

Ries, Nils Torvalds, Emma Wiesner

S&D

Heléne Fritzon, Javi López, César Luena, Achille Variati

31

-

NI

Maria Angela Danzì, Edina Tóth

Renew

Martin Hojsík, Michal Wiezik

S&D

Maria Arena, Katarina Barley, Delara Burkhardt, Sara Cerdas, Mohammed Chahim, Christophe Clergeau, Nora Mebarek, Nikos Papandreou, Günther Sidl, Petar Vitanov, Tiemo Wölken

The Left

Anja Hazekamp, Petros Kokkalis, Marina Mesure, Silvia Modig, Idoia Villanueva Ruiz, Mick Wallace

Verts/ALE

Michael Bloss, Bas Eickhout, Malte Gallée, Martin Häusling, Ska Keller, Lydie Massard, Sara Matthieu, Ville Niinistö, Manuela Ripa, Nicolae Ştefănuță

4

0

ID

Catherine Griset, Thierry Mariani

Renew

María Soraya Rodríguez Ramos

S&D

Alessandra Moretti