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 Regulation (EU) 2017/625

29.1.2024 - (COM(2023)0411 – C9‑0238/2023 – 2023/0226(COD)) - ***I

Committee on the Environment, Public Health and Food Safety
Rapporteur: Jessica Polfjärd


Procedure : 2023/0226(COD)
Document stages in plenary
Document selected :  
A9-0014/2024

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

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 Regulation (EU) 2017/625

(COM(2023)0411 – C9‑0238/2023 – 2023/0226(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

 having regard to the Commission proposal to Parliament and the Council (COM(2023)0411),

 having regard to Article 294(2), Article 43(2), Article 114 and Article 168(4)(b)of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9‑0238/2023),

 having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

 having regard to the reasoned opinions submitted, within the framework of Protocol No 2 on the application of the principles of subsidiarity and proportionality, by the Cypriot Parliament and the Hungarian Parliament, asserting that the draft legislative act does not comply with the principle of subsidiarity,

 having regard to the opinion of the European Economic and Social Committee of 26 April 2023[1],

 after consulting the Committee of the Regions,

 having regard to Rules 59 of its Rules of Procedure,

 having regard to the opinion of the Committee on Agriculture and Rural Development,

 having regard to the report of the Committee on the Environment, Public Health and Food Safety (A9-0014/2024),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

 


Amendment  1

Proposal for a regulation

Recital 1

 

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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32 Directive 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).

32 Directive 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).

Amendment  2

Proposal for a regulation

Recital 2

 

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 precise locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool.

(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 targeted locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool.

Amendment  3

Proposal for a regulation

Recital 3

 

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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33 Insights and solutions stemming from EU-funded research and innovation projects on plant breeding strategies may contribute to address detection challenges, ensure traceability and authenticity, and promote innovation in the area of new genomic techniques. More than 1,000 projects were funded under the Seventh Framework Programme and successor Horizon 2020 programme with an investment of over 3 billion Euros. Horizon Europe support to new collaborative research projects on plant breeding strategies is also ongoing, SWD(2021) 92.

33 Insights and solutions stemming from EU-funded research and innovation projects on plant breeding strategies may contribute to address detection challenges, ensure traceability and authenticity, and promote innovation in the area of new genomic techniques. More than 1,000 projects were funded under the Seventh Framework Programme and successor Horizon 2020 programme with an investment of over 3 billion Euros. Horizon Europe support to new collaborative research projects on plant breeding strategies is also ongoing, SWD(2021) 92.

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final.

35 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, healthy and environmentally friendly food system, COM/2020/381 final.

35 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, healthy and environmentally friendly food system, COM/2020/381 final.

36 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030: Bringing nature back into our lives, COM/2020/380 final.

36 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030: Bringing nature back into our lives, COM/2020/380 final.

37 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions forging a Climate-Resilient Europe - The New EU Strategy on Adaptation to Climate Change, COM(2021) 82 final

37 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions forging a Climate-Resilient Europe - The New EU Strategy on Adaptation to Climate Change, COM(2021) 82 final

38 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, Safeguarding food security and reinforcing the resilience of food systems, COM (2022) 133 final; Food and Agriculture Organisation of the United Nations (FAO), 2022, Gene editing and agrifood systems, Rome, ISBN 978-92-5-137417-7.

38 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, Safeguarding food security and reinforcing the resilience of food systems, COM (2022) 133 final; Food and Agriculture Organisation of the United Nations (FAO), 2022, Gene editing and agrifood systems, Rome, ISBN 978-92-5-137417-7.

39 European Commission, Directorate-General for Research and Innovation, A sustainable bioeconomy for Europe – Strengthening the connection between economy, society and the environment: updated bioeconomy strategy, Publications Office, 2018, https://data.europa.eu/doi/10.2777/792130.

39 European Commission, Directorate-General for Research and Innovation, A sustainable bioeconomy for Europe – Strengthening the connection between economy, society and the environment: updated bioeconomy strategy, Publications Office, 2018, https://data.europa.eu/doi/10.2777/792130.

40 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Trade Policy Review - An Open, Sustainable and Assertive Trade Policy, COM(2021)66 final.

40 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Trade Policy Review - An Open, Sustainable and Assertive Trade Policy, COM(2021)66 final.

Amendment  4

Proposal for a regulation

Recital 8

 

Text proposed by the Commission

Amendment

(8) It is therefore necessary to adopt a specific legal framework for GMOs obtained 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 products obtained 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.

Amendment  5

Proposal for a regulation

Recital 9

 

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, excluding microorganisms, 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 as microorganisms, 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. 

Amendment  6

Proposal for a regulation

Recital 10

 

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.

Amendment  7

Proposal for a regulation

Recital 11

 

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.

Amendment  8

Proposal for a regulation

Recital 13 a (new)

 

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.

Amendment  9

Proposal for a regulation

Recital 14

 

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.

Amendment  10

Proposal for a regulation

Recital 14 a (new)

 

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”).

Amendment  11

Proposal for a regulation

Recital 18

 

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 level 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 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.

Amendment  12

Proposal for a regulation

Recital 18 a (new)

 

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.

Amendment  13

Proposal for a regulation

Recital 19

 

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 strict deadlines 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 appropriate deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.

Amendment  14

Proposal for a regulation

Recital 21

 

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.

Amendment  15

Proposal for a regulation

Recital 23

 

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. However, it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. Currently, the compatibility of the use of new genomic techniques with the principles of 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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47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

Amendment  16

Proposal for a regulation

Recital 24

 

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.

Amendment  17

Proposal for a regulation

Recital 29

 

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

(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.

Amendment  18

Proposal for a regulation

Recital 36

 

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].

(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 scope of the category 1 NGT plants.

Amendment  19

Proposal for a regulation

Recital 37

 

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 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 possible for Member States to adopt measures restricting or prohibiting the cultivation of category 2 NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC, as this would undermine those goals.

Amendment  20

Proposal for a regulation

Recital 39

 

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 from the free movement of goods, provided they comply with the requirements of other Union law.

(39) To achieve the goal of ensuring the effective functioning of the internal market and the 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 harmonised requirements 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 the Union.

Amendment  21

Proposal for a regulation

Recital 40

 

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 ongoing development of new genomic techniques, the Commission should carry out an evaluation 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. That evaluation should measure the progress made towards the availability of NGT plants or NGT products containing such characteristics or properties on the EU market, with the aim of further improving this Regulation.

Amendment  22

Proposal for a regulation

Recital 43

 

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.’

Amendment  23

Proposal for a regulation

Recital 45 a (new)

 

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.

Amendment  24

Proposal for a regulation

Article 1 – paragraph 1

 

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 principle 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, ensuring a high level of protection of human and animal health and the environment.

Amendment  25

Proposal for a regulation

Article 3 – paragraph 1 – point 2

 

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 purposes that temporarily may have been inserted during the development of the NGT plant;

Amendment  26

Proposal for a regulation

Article 3 – paragraph 1 – point 4

 

Text proposed by the Commission

Amendment

(4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at precise locations in the genome of an organism;

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

Amendment  27

Proposal for a regulation

Article 3 – paragraph 1 – point 6

 

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 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;

Amendment  28

Proposal for a regulation

Article 3 – paragraph 1 – point 15 a (new)

 

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;

Amendment  29

Proposal for a regulation

Article 3 – paragraph 1 – point 15 b (new)

 

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.

Amendment  30

Proposal for a regulation

Article 4 – paragraph 1 – point 1 – point b

 

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

Amendment  31

Proposal for a regulation

Article 4 – paragraph 1 – point 2

 

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 or has been authorised in accordance with Chapter III.

Amendment  32

Proposal for a regulation

Article 4 – paragraph 1 a (new)

 

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.

Amendment  33

Proposal for a regulation

Article 4 a (new)

 

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.

Amendment  34

Proposal for a regulation

Article 5 – paragraph 2

 

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 Article 5 (f), (iii), and Article 11 shall apply to category 1 NGT plants and to products produced from or by such plants. [7 years after the entry into force of this Regulation], the Commission shall present a report on the evolution of the consumers' and producers' perception, accompanied, where appropriate, by a legislative proposal.

Amendment  35

Proposal for a regulation

Article 5 – paragraph 3

 

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 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 procedure in order to adapt those criteria to the latest scientific and technological developments as regards the types and extent of modifications which can occur naturally or through conventional breeding.

Amendment  36

Proposal for a regulation

Article 5 – paragraph 3 a (new)

 

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.

Amendment  37

Proposal for a regulation

Article 6 – paragraph 1

 

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 implementing act 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 submitted to the competent authority designated in accordance with Article 4(4) of Directive 2001/18/EC of the Member State within whose territory the release is to take place in accordance with paragraphs 2 and 3 and the delegated act adopted in accordance with Article 6(11a), point (b).

Amendment  38

Proposal for a regulation

Article 6 – paragraph 3 – point c

 

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;

Amendment  39

Proposal for a regulation

Article 6 – paragraph 3 – point d – point i

 

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 implementing act 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 purposes where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the delegated act adopted in accordance with Article 6(11a), point (a);

Amendment  40

Proposal for a regulation

Article 6 – paragraph 3 – point d – point ii

 

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;

Amendment  41

Proposal for a regulation

Article 6 – paragraph 3 – point d a (new)

 

Text proposed by the Commission

Amendment

 

(da) the denomination of the variety

Amendment  42

Proposal for a regulation

Article 6 – paragraph 6

 

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 authority shall make available the verification report to the other Member States and to the Commission without undue delay.

Amendment  43

Proposal for a regulation

Article 6 – paragraph 7

 

Text proposed by the Commission

Amendment

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

Amendment  44

Proposal for a regulation

Article 6 – paragraph 8

 

Text proposed by the Commission

Amendment

8. In the absence of any comments from 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 objections from 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.

Amendment  45

Proposal for a regulation

Article 6 – paragraph 9

 

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 comment(s) to the Commission without undue delay.

9. In cases where a reasoned objection is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall make the reasoned objections publicly available without undue delay.

Amendment  46

Proposal for a regulation

Article 6 – paragraph 10

 

Text proposed by the Commission

Amendment

10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the comment(s), 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).

Amendment  47

Proposal for a regulation

Article 6 – paragraph 11 a (new)

 

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.

Amendment  48

Proposal for a regulation

Article 7 – paragraph 2 – point b a (new)

 

Text proposed by the Commission

Amendment

 

(ba) the denomination of the variety;

Amendment  49

Proposal for a regulation

Article 7 – paragraph 2 – point c

 

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;

Amendment  50

Proposal for a regulation

Article 7 – paragraph 7

 

Text proposed by the Commission

Amendment

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

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

Amendment  51

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point b

 

Text proposed by the Commission

Amendment

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

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

Amendment  52

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point b a (new)

 

Text proposed by the Commission

Amendment

 

(ba) the denomination of the variety;

Amendment  53

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2 – point e a (new)

 

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

Amendment  54

Proposal for a regulation

Article 9 – paragraph 2

 

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.

Amendment  55

Proposal for a regulation

Article 10 – paragraph 1

 

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 register indicating the words ‘cat 1 NGT’, followed by the identification number of the NGT plant or plants it has been derived from.

Amendment  56

Proposal for a regulation

Article 16

 

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.

 

Amendment  57

Proposal for a regulation

Article 22 – paragraph 1

 

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 III and 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)).

Amendment  58

 

Proposal for a regulation

Article 24

 

Text proposed by the Commission

Amendment

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

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

Amendment  59

Proposal for a regulation

Article 26 – paragraph 2

 

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.

Amendment  60

Proposal for a regulation

Article 26 – paragraph 3

 

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.

Amendment  61

Proposal for a regulation

Article 26 – paragraph 6

 

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.

Amendment  62

Proposal for a regulation

Article 27 – paragraph 1 – point a

 

Text proposed by the Commission

Amendment

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

deleted

Amendment  63

Proposal for a regulation

Article 27 – paragraph 1 – point b

 

Text proposed by the Commission

Amendment

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

deleted

Amendment  64

Proposal for a regulation

Article 30 – paragraph 2

 

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 and address any issues regarding biodiversity and environmental, human and animal health, changes to agronomic practices as well as socio-economic and ethical issues that may have arisen with the application of this Regulation.

Amendment  65

Proposal for a regulation

Article 30 – paragraph 3

 

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.

Amendment  66

Proposal for a regulation

Article 30 – paragraph 5 a (new)

 

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.

Amendment  67

Proposal for a regulation

Article 30 – paragraph 5 b (new)

 

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.

Amendment  68

Proposal for a regulation

Article 30 – paragraph 5 c (new)

 

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).

Amendment  69

Proposal for a regulation

Article 33 a (new)

Directive 98/44/EC

Article 4

 

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.’

 

 _______________________________

 

1a Directive 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).

Amendment  70

Proposal for a regulation

Article 34 – paragraph 2 – subparagraph 1

 

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.

Amendment  71

Proposal for a regulation

Annex I – paragraph 1

 

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

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

Amendment  72

Proposal for a regulation

Annex I – point 1

 

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;

Amendment  73

Proposal for a regulation

Annex I – point 1 a (new)

 

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.

Amendment  74

Proposal for a regulation

Annex I – point 2

 

Text proposed by the Commission

Amendment

(2) deletion of any number of nucleotides;

deleted

Amendment  75

Proposal for a regulation

Annex I – point 3

 

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;

 

Amendment  76

Proposal for a regulation

Annex I – point 4

 

Text proposed by the Commission

Amendment

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

deleted

Amendment  77

Proposal for a regulation

Annex I – point 5

 

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

Amendment  78

Proposal for a regulation

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

 

Text proposed by the Commission

Amendment

 

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

Amendment  79

Proposal for a regulation

Annex II – Part 2 – point 6 a (new)

 

Text proposed by the Commission

Amendment

 

(6a) Impacts on organic cultivation

Amendment  80

Proposal for a regulation

Annex II – Part 2 – point 8 a (new)

 

Text proposed by the Commission

Amendment

 

(8a) Effects on protecting and conserving biodiversity

Amendment  81

Proposal for a regulation

Annex III – title 1

 

Text proposed by the Commission

Amendment

Traits referred to in Article 22

Traits referred to in Article 6 and Article 22

Amendment  82

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – point 1

 

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;

Amendment  83

Proposal for a regulation

Annex III – Part 1 – paragraph 1 – point 7

 

Text proposed by the Commission

Amendment

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

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

Amendment  84

Proposal for a regulation

Annex III a (new)

 

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 .

 

 


EXPLANATORY STATEMENT

New genomic techniques (NGTs) provide unprecedented opportunities for European agriculture and food production. These techniques enable us to alter the genetic materials of a certain organism providing swift development of different plant varieties with certain characteristics. NGTs are not limited to one specific technique but rather represent a diverse group of techniques that can contribute to a more tailored modification of the genome in comparison to conventional plant breeding. The achieved modification of the genome could or could not be produced in nature or obtained by conventional breeding techniques.

Innovative technologies such as CRISPR/Cas9, which was awarded the Nobel Prize in Chemistry in 2020, have the ability to improve plant breeding by strengthening various crops through more targeted changes and without the need to add anything new in the genetic composition of a crop.

NGTs therefore have the ability to enhance agriculture by making crops and harvests more resilient and sustainable. Given their low operating and entry costs, these techniques could also contribute to improving the Union´s trade policy and competitiveness.

Unfortunately, the European Union currently cannot utilize this potential.

In its judgment of 25 July 2018, the Court of Justice of the European Union held that Directive 2001/18 cannot be interpreted as excluding from its scope genetically modified organisms (GMOs) obtained by certain new techniques.

The practical implication of this has been significant, as NGTs have still not been introduced within the Union.

As the European Commission concluded in a 30 April 2021 study delivered at the request of the Council on 8 November 2019, EU legislation should be adapted in line with scientific and technical progress in this area.

A new, adapted, legislation is essential to enable the use of these new techniques. It is essential to have adequate risk assessment requirements and authorisation procedures to ensure that a variety of potential plant products can be introduced within the EU. The current requirements and processes for genetically modified crops are not enabling the new techniques or a variety of plant products.

Without an enabling framework in line with the scientific and technical progress, these problems continue to affect operators affected by the current regulations across the agri-food system. Consumers, farmers and the innovative sector cannot currently benefit from NGTs. 

In the absence of a modern regulatory framework in the EU, other countries in the world have already undertaken measures to enable the usage of NGTs. The EU therefore risks falling behind in both competitiveness and scientific and technological research. This would negatively impact European food safety as well as resilience in European food production.

 

Objectives and ambitions of the draft proposal

The rapporteur supports the overall approach of the European Commission and welcomes its proposal to introduce a new regulation on plants obtained by certain new genomic techniques and their food and feed. Taking into account that the current regulatory framework is not in line with the latest scientific and technological development, the rapporteur welcomes this proposal with its objectives set out in the food safety-strategy Farm to fork. The proposal goes in line with the Farm to fork-strategy and its aim to transform European agriculture and food production towards sustainability and strengthen European competitiveness. 

The COVID-19 pandemic and Russia´s war of aggression against Ukraine have both aggravated the situation for European agriculture and food production by showing the Union´s external dependencies on critical inputs for agriculture.

While the rapporteur believes that the Commission proposal is a solid starting point, she believes that some further improvements and additions are required to ensure the best possible usage of the techniques. 

 

Clarification and improvement of the criteria for NGT 1-plants

The rapporteur is of the opinion that the provisions related to category 1 (NGT 1) should be further improved. She believes that the criteria in annex I that defines an NGT 1 plant should be further clarified and improved. The Commission proposes a threshold of 20 genetically modified changes that cannot be exceeded if a plant were to be defined as an NGT 1. 

Concerning the criteria set out in annex I to fall under NGT 1: the threshold of 20 genetically modified changes should be specified by ensuring that each change in a plant and/or a crop must be relative to the ploidity status in the crop. If, for example, a plant has a duplication of chromosomes and one modification de facto makes two changes, 10 modifications can already make up to 20 potential changes. This would risk going beyond its purpose. The particular change in a crop or a plant must be based on a single copy of a gene. 

 

Organic farming 

The rapporteur also believes that NGTs should be allowed and enabled in organic farming. The purpose of this draft report is to ensure that any operators without discrimination can use the techniques. Thus, the proposed ban by the Commission for the techniques to be used in organic farming is lifted to ensure a fair playing field without imposing the technique on any operator. 

The proposal should ensure that every operator could have access to these new technologies. The freedom of choice is essential for operators and the technique should remain available. 

 

Ensuring science-based verification processes 

The proposed regulation also introduces verification procedures for NGT 1 prior to the deliberate release of plants for this category. The rapporteur believes that is important to ensure full compliance with the regulation. However, she believes that the verification process should be for the competent authority in a Member State where the application is submitted and without additional Member States able to challenge a certain decision of approval without a reasoned objection. 

The verification process should be based on the scientifically approved criteria set out in the annex defining a category 1 plant and, where appropriate, in close consultation with the European Commission and the European Food Safety Authority.

 

Traceability and labelling 

As regards the traceability and labelling of NGT 1 plants, the rapporteur supports the proposal by the commission by making information about the use of NGTs publicly available in the proposed public database. This ensures transparency and consumer choice. However, the rapporteur does not support seed bag labelling for verified conventional-like NGT plants as that would be discriminatory. Conventional-like NGT plants should be treated conventionally; this extra requirement is creating unjustified distinctions and administrative burden

 

Patents and patentability 

The rapporteur also takes note of the concerns expressed with regard to the patent on NGTs by breeders and farmers. The rapporteur believes that this should be regulated in existing separate regulations where they are currently regulated to avoid having this proposal go beyond its scope. The rapporteur therefore supports the proposed approach by the commission to assess on a regular basis and submit a report on how to address this after the legislation has worked in practice in order to assess if a technique is subject to be patentable. 

The Committee on Agriculture and Rural Development (AGRI) also has shared competencies on some provisions pursuant to Rule 57 with the Committee on the Environment, Public Health and Food Safety (ENVI). The rapporteur is therefore committed to working constructively with the rapporteur from the AGRI committee to find a good and balanced proposal for these techniques. 

 


ANNEX: LIST OF ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that she has received input from the following entities or persons in the preparation of the report, until the adoption thereof in committee:

Entity and/or person

Euroseeds

KRAV Ekonomisk Förening

KWS SAAT SE & Co. KGaA

European Commission: DG Sante

 

The list above is drawn up under the exclusive responsibility of the rapporteur.


 

MINORITY POSITION

pursuant to Rule 55(4) of the Rules of Procedure

Christophe Clergeau, Martin Häusling and Anja Hazekamp

 

 

By exempting category 1 NGTs, which will be the vast majority of NGTs, from GMO risk assessment, monitoring, traceability and consumer labelling, the Commission fails to respect consumer rights as well as the precautionary principle, laid down in the TFEU. Furthermore, there is no scientific basis underlying the criteria in Annex I, which defines if a NGT fulfils the criteria of ‘equivalence’ to conventional plants. The criteria have no bearing on safety therefore there is no guarantee that GM plants meeting the criteria have a lower level of risk to human health and the environment. The Commission proposal ignores aspects linked to coexistence with organic and conventional production. Finally, the alleged benefits of NGTs do not justify excluding NGT products from existing GMO rules and will not contribute to the necessary just transition in agriculture.

 

Unfortunately, the compromise amendments presented by the rapporteur further exacerbate these issues. We would like to record our disapproval regarding the extremely tight timeline that was applied to this dossier, which made it impossible to adequately consider and discuss different scientific opinions, notably when it came to what could constitute proper criteria for NGT category 1.


OPINION OF THE COMMITTEE ON AGRICULTURE AND RURAL DEVELOPMENT (13.12.2023)

for the Committee on the Environment, Public Health and Food Safety

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 Regulation (EU) 2017/625

(COM(2023)0411 – C9‑0238/2023 – 2023/0226(COD))

Rapporteur for opinion: Veronika Vrecionová

 

 

AMENDMENTs

The Committee on Agriculture and Rural Development calls on the Committee on Agriculture and Rural Development, as the committee responsible, to take the following into account:

Amendment  1

 

Proposal for a regulation

Title 1

 

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 breeding techniques and their food and feed, and amending Regulation (EU) 2017/625 and Directive 98/44/EC (Text with EEA relevance)

 

Amendment  2

Proposal for a regulation

Recital 1

 

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 targeted locations.

_________________

_________________

32 Directive 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).

32 Directive 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).

Amendment  3

Proposal for a regulation

Recital 2

 

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 precise locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool.

(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 targeted locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool.

Amendment  4

 

Proposal for a regulation

Recital 8

 

Text proposed by the Commission

Amendment

(8) It is therefore necessary to adopt a specific legal framework for GMOs obtained 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 products obtained 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.

Amendment  5

Proposal for a regulation

Recital 9

 

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, excluding microorganisms, 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. For other organisms, such as microorganisms, 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 wider GMO 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.

Justification

The Explanatory Memorandum notes that “The Union risks being excluded to a significant extent from the technological developments and economic, social and environmental benefits that these new technologies can potentially generate, if its GMO framework is not adapted to NGTs. In turn, this would lead to less strategic autonomy for the Union. Therefore, the Union’s regulatory framework should be adapted to make NGTs subject to the appropriate level of regulatory oversight.” It is therefore relevant to make similar legislation on microorganisms.

Amendment  6

 

Proposal for a regulation

Recital 14

 

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, extent, dimensions and number of genetic modifications that can occur in nature or through conventional breeding.

Amendment  7

 

Proposal for a regulation

Recital 16

 

Text proposed by the Commission

Amendment

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

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

Amendment  8

 

Proposal for a regulation

Recital 18

 

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 level 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 products should be conducted by national competent authorities as this would be less administratively burdensome for operators. The verification procedure of category 1 NGT plant status should be conducted at national level based on the scientific opinion of the European Food Safety Authority (‘the Authority’) only if there are reasoned scientific objections by other Member States in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

Amendment  9

 

Proposal for a regulation

Recital 21

 

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).

Amendment  10

Proposal for a regulation

Recital 23

 

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.

_________________

_________________

47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

Amendment  11

 

Proposal for a regulation

Recital 24

 

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

Amendment  12

Proposal for a regulation

Recital 29 a (new)

 

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.

Amendment  13

 

Proposal for a regulation

Recital 30

 

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 2 NGT plant concerned, subject to reassessment when new information has become available.

Amendment  14

Proposal for a regulation

Recital 32

 

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 GMO with information on the trait conferred by the genetic modification. In order to avoid misleading or confusing indications, a proposal for such a labelling should be provided in the notification for consent or in the application for authorisation and should be specified in the consent or in the authorisation decision.

(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.

Justification

NGTs should not be labelled as GMOs, but as NGTs.

Amendment  15

Proposal for a regulation

Recital 36

 

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].

deleted

Amendment  16

 

Proposal for a regulation

Recital 37

 

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 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, 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.

Amendment  17

Proposal for a regulation

Recital 38

 

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 plants 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.

Amendment  18

 

Proposal for a regulation

Recital 39

 

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 from the free movement of goods, provided they comply with the requirements of other Union law.

(39) To achieve the goal of ensuring the effective functioning of the internal market and the 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 harmonized requirements 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 the Union.

Amendment  19

Proposal for a regulation

Recital 40

 

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 2 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 category 2 NGT 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 2 NGT plants containing such characteristics or properties on the EU market with the aim of further improving the Regulation

Amendment  20

 

Proposal for a regulation

Recital 45 a (new)

 

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.

Amendment  21

Proposal for a regulation

Recital 46 a (new)

 

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.

 

Amendment  22

 

Proposal for a regulation

Article 3 – point 2

 

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 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 purposes that temporarily may have been inserted during the development of the NGT plant;

 

__________________

 

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

Amendment  23

 

Proposal for a regulation

Article 3– point 4

 

Text proposed by the Commission

Amendment

(4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at precise locations in the genome of an organism;

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

Amendment  24

 

Proposal for a regulation

Article 3– point 6

 

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;

Amendment  25

Proposal for a regulation

Article 3– point 6 a (new)

 

Text proposed by the Commission

Amendment

 

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

Amendment  26

Proposal for a regulation

Article 3– point 7 – point b

 

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 no further 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 undergone further modifications and fulfils the criteria of equivalence to conventional plants, set out in Annex I;

Justification

Breeders constantly improve on commercial varieties, in order to reach incremental productivity gains over time. This provision is not future-proof and would greatly limit the range of what could be achieved when combining complex traits, like drought tolerance with disease resistance.

Amendment  27

Proposal for a regulation

Article 3 – point 7 – point b a (new)

 

Text proposed by the Commission

Amendment

 

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

Justification

The proposal suggests that for certain Category 2 NGT plants no, or only an adapted, identification method can be developed. However, as they are regulated GMOs, these plants will not be fully identifiable or distinguishable from conventional plants, which makes it a specific challenge for imports where it is not possible to identify unauthorised NGTs with Category 2 changes. It is therefore discriminatory to require GM traceability and labelling of such products. Consequently, such Category 2 NGT plants should logically be treated as Category 1 NGT plants (conventional-like).

Amendment  28

 

Proposal for a regulation

Article 3 – point 12

 

Text proposed by the Commission

Amendment

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

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

Amendment  29

 

Proposal for a regulation

Article 4 – point 2

 

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 or has been authorised in accordance with Chapter III.

Amendment  30

Proposal for a regulation

Article 4 -  paragraph 1a (new)

 

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.

Amendment  31

 

Proposal for a regulation

Article 4 a (new)

 

Text proposed by the Commission

Amendment

 

Article 4a

 

Exclusion from patentability

 

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

Amendment  32

 

Proposal for a regulation

Article 5 – paragraph 1

 

Text proposed by the Commission

Amendment

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

Amendment  33

Proposal for a regulation

Article 5 – paragraph 1 a (new)

 

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.

Amendment  34

Proposal for a regulation

Article 5 – paragraph 2

 

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.

Amendment  35

Proposal for a regulation

Article 5 – paragraph 2 a (new)

 

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.

Justification

As no specific coexistence measures exist between conventional and organic production systems, and as Cat1 NGT plants are conventional-like, no coexistence measures are  needed.

Amendment  36

Proposal for a regulation

Article 5 – paragraph 3

 

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

Amendment  37

 

Proposal for a regulation

Article 6 – title

 

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.

Amendment  38

Proposal for a regulation

Article 6 – paragraph 3 – point c

 

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);

Justification

To align with previous amendments on information in the database - see recital 23.

Amendment  39

Proposal for a regulation

Article 6 – paragraph 4

 

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.

Justification

The timeline should be more predictable with firm number of days to make it easier for particularly SMEs to know the length of the process.

Amendment  40

Proposal for a regulation

Article 6 – paragraph 5

 

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 delay of 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 days of the inadmissibility of the verification request and shall provide the reasons of its decision.

Amendment  41

 

Proposal for a regulation

Article 6 – paragraph 6

 

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 national 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 national competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

Amendment  42

 

Proposal for a regulation

Article 6 – paragraph 7

 

Text proposed by the Commission

Amendment

7. The other Member States and the Commission may make comments to 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 objections to 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.

Amendment  43

 

Proposal for a regulation

Article 6 – paragraph 8

 

Text proposed by the Commission

Amendment

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

Amendment  44

 

Proposal for a regulation

Article 6 – paragraph 9

 

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.

deleted

Amendment  45

 

Proposal for a regulation

Article 6 – paragraph 10

 

Text proposed by the Commission

Amendment

10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the comment(s), 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 ask the European Food Safety Authority (‘the Authority’) for a scientific opinion on the verification report. The Authority shall issue its scientific opinion on the verification report within 30 days from the date of receipt of that report. The competent authority shall adopt a decision based on the Authority’s scientific opinion within 20 working days from the date of receipt of that opinion. The competent authority shall transmit the decision without undue delay to the requester, the other Member States and the Commission.

Amendment  46

 

Proposal for a regulation

Article 7

 

Text proposed by the Commission

Amendment

[...]

deleted

Amendment  47

 

Proposal for a regulation

Article 7 a (new)

 

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.

Amendment  48

Proposal for a regulation

Article 7 b (new)

 

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.

Justification

It is very useful to clarify the category 1 NGT status of plants that are the result of a conventional cross between two verified category 1 NGT plants.

Amendment  49

Proposal for a regulation

Article 10

 

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.

 

Amendment  50

Proposal for a regulation

Article 10 – paragraph 1 a (new)

 

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.

Justification

It is important to ensure that there will not be any labelling on consumer products - also ‘negative labelling’ as described. Such labelling is discriminatory and misleading towards consumers as the knowledge of plant breeding techniques is not widespread and is traditionally never labelled.

Amendment  51

Proposal for a regulation

Article 14 – paragraph 1 – point l

 

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).

Justification

NGT plants for which no unique identification method can be developed, should be regulated as Category 1 NGT plants, as they will be indistinguishable from conventionally-bred plants. Any other outcome will result in enforcement issues and create challenges for imports.

Amendment  52

Proposal for a regulation

Article 16

 

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.

 

Amendment  53

 

Proposal for a regulation

Article 22 – paragraph 1

 

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 III and 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 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.

Amendment  54

Proposal for a regulation

Article 23

 

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.

 

Amendment  55

 

Proposal for a regulation

Article 24

 

Text proposed by the Commission

Amendment

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

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

Amendment  56

Proposal for a regulation

Article 25

 

Text proposed by the Commission

Amendment

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

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

Justification

Since Category 1 NGT plants are equivalent to conventional ones, no opt-out from cultivation of these products should be needed.

Amendment  57

 

Proposal for a regulation

Article 30 – paragraph 5 a (new)

 

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.

Amendment  58

 

Proposal for a regulation

Article 33 a (new)

 

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.'

Justification

Technical alignment in relation to the exclusion of the plant material from patentability.

Amendment  59

 

Proposal for a regulation

Article 34 – paragraph 2

 

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.

Amendment  60

 

Proposal for a regulation

Annex I – paragraph 1

 

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

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

Amendment  61

 

Proposal for a regulation

Annex I – point 1

 

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;

Amendment  62

 

Proposal for a regulation

Annex I – point 1 a (new)

 

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.

Amendment  63

 

Proposal for a regulation

Annex I – point 2

 

Text proposed by the Commission

Amendment

(2) deletion of any number of nucleotides;

deleted

Amendment  64

 

Proposal for a regulation

Annex I – point 3

 

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;

 

 

 

Amendment  65

 

Proposal for a regulation

Annex I – point 4

 

Text proposed by the Commission

Amendment

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

deleted

Amendment  66

 

Proposal for a regulation

Annex I – point 5

 

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

Amendment  67

Proposal for a regulation

Annex III – Part 1 – introductory part

 

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).

Justification

The sustainability assessment should be in line with Regulation on Plant Reproductive Material, which establishes the sustainability requirements for all types of Plant Reproductive Material. The following points (1 to 7 ) are deleted.

Amendment  68

Proposal for a regulation

Annex III – Part 1– point 1

 

Text proposed by the Commission

Amendment

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

deleted

Amendment  69

Proposal for a regulation

Annex III – Part 1– point 2

 

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

Amendment  70

Proposal for a regulation

Annex III – Part 1 – point 3

 

Text proposed by the Commission

Amendment

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

deleted

Amendment  71

Proposal for a regulation

Annex III – Part 1– point 4

 

Text proposed by the Commission

Amendment

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

deleted

Amendment  72

Proposal for a regulation

Annex III – Part 1– point 5

 

Text proposed by the Commission

Amendment

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

deleted

Amendment  73

Proposal for a regulation

Annex III – Part 1– point 6

 

Text proposed by the Commission

Amendment

(6) improved quality or nutritional characteristics;

deleted

Amendment  74

Proposal for a regulation

Annex III – Part 1– point 7

 

Text proposed by the Commission

Amendment

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

deleted

Amendment  75

Proposal for a regulation

Annex III – Part 2

 

Text proposed by the Commission

Amendment

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

deleted

Justification

Annex III, Part 2 excludes NGT plants featuring herbicide-tolerant traits from the regulatory incentives. Such an exclusion is further not consistent with recital 36 which clarifies that the proposed Regulation is not intended to take specific measures on herbicide tolerant NGT plants.


ANNEX: ENTITIES OR PERSONS
FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

The rapporteur declares under her exclusive responsibility that she did not receive input from any entity or person to be mentioned in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.

 


PROCEDURE – COMMITTEE ASKED FOR OPINION

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

 


 

FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION

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

 

Key to symbols:

+ : in favour

- : against

0 : abstention


PROCEDURE – COMMITTEE RESPONSIBLE

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

 


 

FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE

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

 

Key to symbols:

+ : in favour

- : against

0 : abstention

 

 

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