Sittings · Document

Draft report (COM(2023)0411 – C9-0238/2023 – 2023/0226(COD)) 2023-11-19

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

Committee on the Environment, Public Health and Food Safety

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AM_Com_LegReport

Amendment 234

Pietro Fiocchi

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 traceability 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. Category 1 NGT plants shall be subject to the traceability system laid out in Regulation (EC) 1830/2003. Traceability measures are needed throughout the whole supply chain to enable food processors and operators to avoid the accidental or unavoidable adventitious presence of NGTs in their production process. These traceability requirements should facilitate both the withdrawal of products where unforeseen adverse effects on human health, animal health or the environment, including ecosystems, are established, and the targeting of monitoring to examine potential effects, particularly on the environment. Traceability should also facilitate the implementation of risk management measures in accordance with the precautionary principle.

Or. en

Amendment 235

Martin Häusling

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

Or. en

Amendment 236

Christophe Clergeau

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Provision should be made to ensure traceability 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. In order to ensure traceability, transparency and choice of operators at all stages between production and consumption of the final products, including processing, category 1 NGT plants and products must be labelled and traced. Traceability measures should make it easier to both withdraw products in the event of unforeseen effects on human health, animal health or the environment, and monitor the environmental effects. Traceability must also facilitate the implementation of crisis management measures in line with the precautionary principle.

Or. fr

Amendment 237

Günther Sidl

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 all in EU approved NGT plant varieties, to ensure that production chains that wish to remain free from NGTs can do so and thereby safeguard consumer trust. All in the EU approved NGT plants should be listed in a publicly available database. To ensure traceability, transparency and choice for operators, during research and plant breeding, when selling seed to farmers or making plant reproductive material available to consumers and third parties in any other way, plant reproductive material of NGT plants should be labelled as GMO according to existing EU law, Directive 2001/18 and Regulation (EC) No 1830/2003. consumers and farmers NGT plants and products should be labelled according to existing EU law, Directive 2001/18 and Regulation (EC) No 1830/2003.

Or. en

Justification

According to the ruling of the European Court of Justice (ECJ) of July 25, 2018, organisms obtained by mutagenesis are in principle to be classified as genetically modified organisms (GMOs) and are therefore subject to the regulations of the Genetic Engineering Act (Directive 2001/18/EC). The reason given for this is that mutagenesis processes lead to a change in the genetic material of an organism that is not possible in a natural way. A distinction between category 1 and category 2 NGT plants is therefore not expedient.

Amendment 238

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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 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 should be listed in a publicly available database. To ensure traceability, transparency and choice for consumers, food producers, farmers and other operators, plant reproductive material, plants, food and feed and products of NGT plants should be labelled as GMO and NGT.

Or. en

Amendment 239

Stanislav Polčák

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

Or. cs

Amendment 240

Erik Poulsen, Asger Christensen, Jan Huitema, Emma Wiesner

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 including information on the technique(s) used to obtain the trait(s). 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.

Or. en

Justification

It is important that farmers are provided with the knowledge to make an informed choice. Many organic farmers may want to use seeds which have been obtained with targeted mutagenesis but not with cisgenesis, it shall therefore be clear within the database which technique has been used.

Amendment 241

Lydie Massard

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 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 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 NGT plants should be labelled as NGT.

Or. en

Amendment 242

Martin Häusling

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Provision shall be made to ensure transparency as regards the use of category 1 and category 2 NGT plant varieties, to ensure that production chains that wish to remain free from NGTs can do so and thereby safeguard consumer trust. All NGT plant varieties approved in the EU shall be listed in a publicly available database. To ensure traceability, transparency and choice for operators, consumers and farmers all NGT verified and authorised in the EU shall be labelled according to existing EU law including Directive 2001/18 and Regulation (EC) No 1830/2003.

Or. en

Amendment 243

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

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. NGT plants, reproductive material, progeny and products derived from it shall be equally labelled to ensure traceability, transparency and freedom of choice for producers, operators and consumers throughout the whole food chain.

Or. en

Amendment 244

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

Or. en

Amendment 245

João Pimenta Lopes

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 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 an 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 NGT plants should be labelled as NGT.

Or. pt

Amendment 246

María Soraya Rodríguez Ramos, Michal Wiezik

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, as well as to facilitate the potential implementation of risk management measures, category 1 NGT plants and products shall be subject to traceability and labelling requirements throughout the whole supply chain.

Or. en

Amendment 247

Martin Häusling

Proposal for a regulation

Recital 24 b (new)

Text proposed by the Commission

Amendment

(24b) Organic and conventional operators should have the right and freedom not to use NGTs in their production process and throughout their supply chain. This Regulation shall lay out adequate provisions to ensure the freedom of choice for operators not to use NGT plants and seeds, both category 1 and 2, in their production processes. Any additional financial and legal burden to ensure the GMO and NGT-free status of production should not fall on farmers and operators who do not wish to use NGTs. Economic losses incurred due to the adventitious presence of GMOs shall not fall on NGT-free conventional and organic operators. In most cases of adventitious presence, it is impossible to establish the causes, faults, and therefore responsibilities. Thus, this Regulation shall establish coexistence measures, laying the basis for national liability provisions and compensation funds.

Or. en

Amendment 248

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

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

(25) NGT plants should remain subject to the requirements of the Union GMO legislation given that on the basis of current scientific and technical knowledge, their risks need to be assessed.

Or. en

Amendment 249

Günther Sidl

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25) NGT plants should remain subject to the requirements of the Union GMO legislation given that on the basis of current scientific and technical knowledge, their risks need to be assessed. Special rules should be provided in order to adapt the procedures and certain other rules laid down in Directive 2001/18/EC and Regulation (EC) No 1829/2003 to the specific nature of NGT plants and the differing levels of risk that they may pose. The precautionary principle may not be harmed, if differing risk levels will be chosen.

Or. en

Amendment 250

Christophe Clergeau

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

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

Or. fr

Amendment 251

João Pimenta Lopes

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

Or. pt

Amendment 252

Lydie Massard

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

Or. en

Amendment 253

Lydie Massard

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26) Category 2 NGT plants and products, in order to be released into the environment or placed on the market, should remain subject to a consent or authorisation in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. However, given the wide variety of those NGT plants, the amount of information necessary for the risk assessment will vary on a case-by-case basis. The Authority, in its scientific opinions on plants developed through cisgenesis and intragenesis48 and on plants developed through targeted mutagenesis49 recommended flexibility in data requirements for the risk assessment of these plants. Based on the Authority’s ‘Criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis’ (50 ), considerations on the history of safe use, familiarity for the environment and the function and structure of the modified/inserted sequence(s) should assist in determining the type and amount of data required to perform the risk assessment of those NGT plants. It is therefore necessary to establish general principles and criteria for the risk assessment of these plants, while providing for flexibility and possibility to adapt risk assessment methodologies to scientific and technical progress.

_________________

48 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta, J, Fernandez Dumont A, Gennaro A, Lenzi, P, Lewandowska A, Munoz Guajardo IP, Papadopoulou N and Rostoks N, 2022. Updated scientific opinion on plants developed through cisgenesis and intragenesis. EFSA Journal 2022;20(10):7621, 33 pp. https://doi.org/10.2903/j.efsa.2022.7621.

49 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Naegeli H, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Mullins E, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Gennaro A, Paraskevopoulos K, Raffaello T and Rostoks N, 2020. Applicability of the EFSA Opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis. EFSA Journal 2020;18(11):6299, 14 pp. https://doi. org/10.2903/j.efsa.2020.6299.

50 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Fernandez A, Gennaro A, Papadopoulou N, Raffaello T and Schoonjans R, 2022. Statement on criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis. EFSA Journal 2022;20(10):7618, 12 pp. https://doi.org/10.2903/j.efsa.2022.7618.

Or. en

Amendment 254

João Pimenta Lopes

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26) Category 2 NGT plants and products, in order to be released into the environment or placed on the market, should remain subject to a consent or authorisation in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. However, given the wide variety of those NGT plants, the amount of information necessary for the risk assessment will vary on a case-by-case basis. The Authority, in its scientific opinions on plants developed through cisgenesis and intragenesis48 and on plants developed through targeted mutagenesis49 recommended flexibility in data requirements for the risk assessment of these plants. Based on the Authority’s ‘Criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis’ (50), considerations on the history of safe use, familiarity for the environment and the function and structure of the modified/inserted sequence(s) should assist in determining the type and amount of data required to perform the risk assessment of those NGT plants. It is therefore necessary to establish general principles and criteria for the risk assessment of these plants, while providing for flexibility and possibility to adapt risk assessment methodologies to scientific and technical progress.

(26) NGT plants and products, in order to be released into the environment or placed on the market, should remain subject to a consent or authorisation in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. It is therefore necessary to establish general principles and criteria for the risk assessment of these plants, while providing for flexibility and possibility to adapt risk assessment methodologies to scientific and technical progress.

_________________

Or. pt

Amendment 255

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 256

Günther Sidl

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26) NGT plants and products, in order to be released into the environment or placed on the market, should remain subject to a consent or authorisation in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. However, given the wide variety of those NGT plants, the amount of information necessary for the risk assessment will vary on a case-by-case basis. The Authority, in its scientific opinions on plants developed through cisgenesis and intragenesis48 and on plants developed through targeted mutagenesis49 recommended flexibility in data requirements for the risk assessment of these plants. Based on the Authority’s ‘Criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis’ (50 ), considerations on the history of safe use, familiarity for the environment and the function and structure of the modified/inserted sequence(s) should assist in determining the type and amount of data required to perform the risk assessment of those NGT plants. It is therefore necessary to establish general principles and criteria for the risk assessment of these plants, while providing for flexibility and possibility to adapt risk assessment methodologies to scientific and technical progress.

_________________

Or. en

Amendment 257

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26) NGT plants and products, in order to be released into the environment or placed on the market, should remain subject to a consent or authorisation in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. However, given the wide variety of NGT plants, the amount of information necessary for the risk assessment will vary on a case-by-case basis. The Authority, in its scientific opinions on plants developed through cisgenesis and intragenesis48 and on plants developed through targeted mutagenesis49 recommended flexibility in data requirements for the risk assessment of these plants. Based on the Authority’s ‘Criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis’ (50 ), considerations on the history of safe use, familiarity for the environment and the function and structure of the modified/inserted sequence(s) should assist in determining the type and amount of data required to perform the risk assessment of those NGT plants. It is therefore necessary to establish general principles and criteria for the risk assessment of these plants, while providing for flexibility and possibility to adapt risk assessment methodologies to scientific and technical progress.

_________________

Or. en

Amendment 258

Christophe Clergeau

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

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

Or. fr

Amendment 259

João Pimenta Lopes

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(27) Requirements on the content of notifications for consent for the placing on the market of products containing or consisting of GMOs other than food or feed and on the content of applications for authorisation for the placing on the market of genetically modified food and feed are laid down in different pieces of legislation. To ensure consistency between the notifications for consent and applications for authorisation for NGT products, the content of such notifications and applications should be the same

Or. pt

Amendment 260

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(27) Requirements on the content of notifications for consent for the placing on the market of products containing or consisting of GMOs other than food or feed and on the content of applications for authorisation for the placing on the market of genetically modified food and feed are laid down in different pieces of legislation. To ensure consistency between the notifications for consent and applications for authorisation for NGT products, the content of such notifications and applications should be the same.

Or. en

Amendment 261

Lydie Massard

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

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

Or. en

Amendment 262

Günther Sidl

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

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

Or. en

Justification

Amendment 263

Günther Sidl

Proposal for a regulation

Recital 28

Text proposed by the Commission

Amendment

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

deleted

_________________

51 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)

Or. en

Amendment 264

Sirpa Pietikäinen

Proposal for a regulation

Recital 28

Text proposed by the Commission

Amendment

(28) Research and scientific knowledge related to the development of analytical detection methods, which allow the differentiation of NGT plant from conventional plants are still under development. The European Union Reference Laboratory for GM Food and Feed (EURL), in collaboration with the European Network of GM Laboratories (ENGL), concluded that analytical testing is not considered feasible for all products obtained by targeted mutagenesis and cisgenesis (51 ). When the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not allow the differentiation of the NGT plant from conventional plants. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier or the applicant, the modalities to comply with analytical method requirements should be adapted. This should be done in the implementing acts adopted pursuant to this Regulation. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants on the minimum performance requirements for analytical methods. Modalities for performing method validation may also be adapted. It should be noted that the availability of detection methods is not a pre-requisite for the establishment of a traceability system.

_________________

51 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)

Or. en

Amendment 265

Martin Häusling

Proposal for a regulation

Recital 28

Text proposed by the Commission

Amendment

(28) Research and scientific knowledge related to the development of analytical detection methods, which allow the differentiation of NGT plant from conventional plants are still under development. The European Union Reference Laboratory for GM Food and Feed (EURL), in collaboration with the European Network of GM Laboratories (ENGL), concluded that analytical testing is not considered feasible for all products obtained by targeted mutagenesis and cisgenesis (51 ). When the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not yet allow the differentiation of the NGT plant from conventional plants. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies the modalities to comply with analytical method requirements should be adapted. This should be done in the implementing acts adopted pursuant to this Regulation. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants on the minimum performance requirements for analytical methods. Modalities for performing method validation may also be adapted. It should be noted that the availability of detection methods is not a pre-requisite for the establishment of a traceability system.

_________________

51 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)

Or. en

Amendment 266

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 28

Text proposed by the Commission

Amendment

(28) The European Union Reference Laboratory for GM Food and Feed (EURL), in collaboration with the European Network of GM Laboratories (ENGL), concluded that analytical testing is not yet considered feasible for all products obtained by targeted mutagenesis and cisgenesis (51 ). When the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not allow the differentiation of the NGT plant from conventional plants. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, the notifier or the applicant should be required to ensure one, and provide the exact information needed for the laboratories to differentiate the specific NGT. Furthermore, the Commission and Member States should develop better analytical testing methods. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants on the minimum performance requirements for analytical methods. Modalities for performing method validation may also be adapted.

_________________

51 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)

Or. en

Amendment 267

Christophe Clergeau

Proposal for a regulation

Recital 28

Text proposed by the Commission

Amendment

(28) The European Union Reference Laboratory for GM Food and Feed (EURL), in collaboration with the European Network of GM Laboratories (ENGL), concluded that analytical testing is not considered feasible for all products obtained by targeted mutagenesis and cisgenesis51. When the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not allow the differentiation of the NGT plant from conventional plants. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier or the applicant, the modalities to comply with analytical method requirements should be adapted. This should be done in the implementing acts adopted pursuant to this Regulation. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants on the minimum performance requirements for analytical methods. Modalities for performing method validation may also be adapted.

(28) The European Union Reference Laboratory for GM Food and Feed (EURL), in collaboration with the European Network of GM Laboratories (ENGL), concluded that analytical testing is not considered feasible for all products obtained by targeted mutagenesis and cisgenesis51. When the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not allow the systematic differentiation of the NGT plant from conventional plants. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier or the applicant, the modalities to comply with analytical method requirements should be adapted. This should be done in the implementing acts adopted pursuant to this Regulation. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants on the minimum performance requirements for analytical methods. Modalities for performing method validation may also be adapted.

_________________

51 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)

Or. fr

Amendment 268

Jessica Polfjärd

Proposal for a regulation

Recital 28

Text proposed by the Commission

Amendment

(28) The European Union Reference Laboratory for GM Food and Feed (EURL), in collaboration with the European Network of GM Laboratories (ENGL), has identified challenges in analytical testing for some products obtained by targeted mutagenesis and cisgenesis (51 ). For example, when the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not allow the differentiation of the NGT plant from conventional plants. In cases like these, an analytical method should still be provided either by the applicant or notifier. However, if duly justified, the modalities to comply with analytical requirements for methods should be adapted. This should be done in the implementing acts adopted pursuant to this Regulation. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants on the minimum performance requirements for analytical methods. Modalities for performing method validation may also be adapted.

_________________

51 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)

Or. en

Amendment 269

Martin Häusling

Proposal for a regulation

Recital 28 a (new)

Text proposed by the Commission

Amendment

(28a) Member States should support the development of such analytical methods and acknowledge that the lack of detection methods for certain NGTs is merely an analytical research gap at the moment and that such detection methods will be developed in the coming years if given sufficient funding and political support.

Or. en

Amendment 270

João Pimenta Lopes

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.

deleted

Or. pt

Amendment 271

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 272

Günther Sidl

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 273

Lydie Massard

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

Or. en

Amendment 274

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

Or. en

Amendment 275

Martin Häusling

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

Or. en

Amendment 276

Stanislav Polčák

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. 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.

Or. cs

Amendment 277

Christophe Clergeau

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, the monitoring plan for environmental effects should be required although it may be adapted depending on whether or not the category 2 NGT plant is likely to pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment.

Or. fr

Amendment 278

Francesca Peppucci

Proposal for a regulation

Recital 29 a (new)

Text proposed by the Commission

Amendment

(29a) Once a category 1 NGT plant has been granted authorisation on the basis of scientific criteria, the authorisation should be valid for an unlimited period.

Or. en

Amendment 279

João Pimenta Lopes

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.

deleted

Or. pt

Amendment 280

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 281

Günther Sidl

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 282

Lydie Massard

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 283

Martin Häusling

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

(30) After a first renewal of the authorisation, the authorisation should be valid for a limited period of 10 years.

Or. en

Amendment 284

Norbert Lins

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

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

Or. en

Amendment 285

Francesca Peppucci

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. In the case of a category 2 NGT plant, 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.

Or. en

Amendment 286

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

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 a limited period, based on the risk assessment and the available information on the NGT plant concerned, subject to reassessment when new information has become available.

Or. en

Amendment 287

María Soraya Rodríguez Ramos, Michal Wiezik

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 a limited 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.

Or. en

Amendment 288

Martin Häusling

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.

deleted

Or. en

Amendment 289

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 32

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 290

Lydie Massard

Proposal for a regulation

Recital 32

Text proposed by the Commission

Amendment

(32) To increase transparency and consumers’ information, operators shall label all NGT products according to the requirements laid down existing EU law, Directive 2001/18 and Regulation (EC) No 1830/2003.

Or. en

Amendment 291

Günther Sidl

Proposal for a regulation

Recital 32

Text proposed by the Commission

Amendment

(32) To increase transparency and consumers’ information, operators should label all NGT products which comply with the requirements laid down existing EU law, Directive 2001/18 and Regulation (EC) No 1830/2003.

Or. en

Justification

In order to enable freedom of choice for consumers along the entire value chain, all food and feed produced using new genetic engineering methods has to be labelled as genetically modified products to enable consumers and all users along the value chain to make an informed choice. Consumer´s right to information is enshrined in EU food law (EU (VO) 178/2002) and the EU Treaties (Article 169).

Amendment 292

Martin Häusling

Proposal for a regulation

Recital 32 a (new)

Text proposed by the Commission

Amendment

(32a) The transmission and holding of information that products contain or consist of NGT plants and products, and the unique codes for those NGTs, at each stage of their placing on the market provide the basis for appropriate traceability and labelling for NGTs. The codes may be used to access specific information on NGT from a register, and to facilitate their identification, detection, and monitoring in accordance with Directive 2001/18/EC.

Or. en

Amendment 293

Christophe Clergeau

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

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

deleted

_________________

52 COM (2023) 414 final.

Or. fr

Amendment 294

Martin Häusling

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

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

deleted

_________________

52 COM(2023) 414 final

Or. en

Amendment 295

João Pimenta Lopes

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

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

(33) Regulatory incentives should be offered to potential notifiers or applicants for NGT plants and products containing traits with the potential to contribute to a sustainable agri-food system, in order to steer the development of NGT plants towards such traits. The criteria to trigger these incentives should focus on broad trait categories with the potential to contribute to sustainability (such as those linked to tolerance or resistance to biotic and abiotic stresses, improved nutritional characteristics or increased yield) and should be based on the contribution to the value for sustainable cultivation and use as defined in [Article 52(1) of the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union52 ].

_________________

52 COM(2023) 414 final.

Or. pt

Amendment 296

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

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

(33) Regulatory incentives could be offered to potential SME notifiers or applicants for certain NGT plants and products containing traits with the potential to contribute to a sustainable agri-food system, in order to steer the development of NGT plants towards such traits. The criteria to trigger these incentives should exclusively focus on broad trait categories with the evidence-based potential to contribute to sustainability (such as those linked to tolerance or resistance to biotic and abiotic stresses), and should be based on the contribution to the value for sustainable cultivation and use as defined in [Article 52(1) of the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union52 ].

_________________

52 COM(2023) 414 final

Or. en

Amendment 297

Günther Sidl

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

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

_________________

52 COM(2023) 414 final

Or. en

Justification

Amendment 298

Christophe Clergeau

Proposal for a regulation

Recital 34

Text proposed by the Commission

Amendment

(34) Incentives should consist in an accelerated procedure for risk assessment as regards applications handled by a fully centralised procedure (food and feed products) and enhanced pre-submission advice to help developers prepare the dossier for the purpose of the environmental and food and feed safety assessments, without affecting the general provisions on pre-submission advice, notification of studies and consultation of third parties pursuant to Articles 32a, 32b and 32c of Regulation (EC) No 178/2002(53).

deleted

_________________

53 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 031 1.2.2002, p. 1).

Or. fr

Amendment 299

Martin Häusling

Proposal for a regulation

Recital 34

Text proposed by the Commission

Amendment

deleted

_________________

Or. en

Amendment 300

João Pimenta Lopes

Proposal for a regulation

Recital 34

Text proposed by the Commission

Amendment

(34) Incentives should consist in enhanced pre-submission advice to help developers prepare the dossier for the purpose of the environmental and food and feed safety assessments, without affecting the general provisions on pre-submission advice, notification of studies and consultation of third parties pursuant to Articles 32a, 32b and 32c of Regulation (EC) No 178/2002(53).

_________________

Or. pt

Amendment 301

Stanislav Polčák

Proposal for a regulation

Recital 34

Text proposed by the Commission

Amendment

_________________

Or. cs

Amendment 302

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 34

Text proposed by the Commission

Amendment

(34) Incentives could consist in an accelerated procedure for risk assessment as regards enhanced pre-submission advice to help SME developers prepare the dossier for the purpose of the environmental and food and feed safety assessments, without affecting the general provisions on pre-submission advice, notification of studies and consultation of third parties pursuant to Articles 32a, 32b and 32c of Regulation (EC) No 178/2002(53 ).

_________________

Or. en

Amendment 303

Christophe Clergeau

Proposal for a regulation

Recital 35

Text proposed by the Commission

Amendment

(35) Additional incentives should be afforded when the notifier or applicant is a small or medium-sized enterprise (SME), to promote access to the regulatory procedures by these enterprises, support diversification of developers of NGT plants and encourage the development by small breeders of crop species and traits by means of NGTs, by granting fee waivers for the validation of detection methods to SMEs and more extensive pre-submission advice covering also the design of studies to be carried out for the purpose of risk assessment.

deleted

Or. fr

Amendment 304

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 35

Text proposed by the Commission

Amendment

(35) Additional incentives could be afforded when the notifier or applicant is a small enterprise, to promote access to the regulatory procedures by these enterprises, support diversification of developers of NGT plants and encourage the development by small breeders of crop species and traits by means of NGTs, by granting fee waivers for the validation of detection methods to small enterprises and more extensive pre-submission advice covering also the design of studies to be carried out for the purpose of risk assessment.

Or. en

Amendment 305

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

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

Or. en

Amendment 306

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Recital 36

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 307

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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. Practice shows that such cultivation leads to development of weeds resistant to those herbicides and to the need to increase of quantities of herbicides applied, regardless of the breeding technique. For this reason, plants featuring herbicide-tolerant traits should not be regarded as NGT plants.

Or. en

Amendment 308

Martin Häusling

Proposal for a regulation

Recital 36

Text proposed by the Commission

Amendment

Or. en

Amendment 309

Christophe Clergeau

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 fall under category 1. The same applies to NGT plants whose genetic modification has enabled them to produce insecticides or other pesticides.

Or. fr

Amendment 310

Christophe Clergeau

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.

deleted

Or. fr

Amendment 311

João Pimenta Lopes

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

deleted

Or. pt

Amendment 312

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 313

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 314

Stanislav Polčák

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

deleted

Or. cs

Amendment 315

Anna Zalewska, Krzysztof Jurgiel

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. However, the Regulation should respect the right of Member States to apply measures restricting or prohibiting the cultivation of category 2 NGT plants in all or part of their territory, in accordance with Article 26b of Directive 2001/18/EC.

Or. pl

Amendment 316

Lydie Massard

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 regulated under existing EU law, in particular Directive 2001/18 and Regulation (EC) No 1830/2003 . This requires predictability for breeders and farmers as regards the possibility to cultivate such plants in the Union. Therefore, the possibility for Member States to adopt measures restricting or prohibiting the cultivation of NGT products in all or part of their territory, set out in Article 26b of Directive 2001/18/EC should remain.

Or. en

Amendment 317

Martin Häusling

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 regulated under existing EU law including Directive 2001/18 and Regulation (EC) No 1830/2003. This requires predictability for breeders and farmers as regards the possibility to cultivate such plants in the Union. Therefore, the possibility for Member States to adopt measures restricting or prohibiting the cultivation of NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC should remain.

Or. en

Amendment 318

Günther Sidl

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 regulated under existing EU law, in Directive 2001/18 and Regulation (EC) No 1830/2003. This requires predictability for breeders and farmers as regards the possibility to cultivate such plants in the Union. Therefore, the possibility for Member States to adopt measures restricting or prohibiting the cultivation of NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC should remain.

Or. en

Justification

The European Commission’s plan to ease market access for genetically modified plants also undermines its own Farm to Fork Strategy, which seeks to reduce pesticide use by 50 percent by 2030 and reverse biodiversity loss in the EU. The cultivation of genetically modified plants that are resistant to pesticides is rising worldwide. To date, the commercial distribution of plants is dominated by pesticide-resistant plants together with the large amounts of pesticides designed for them. The proportion of genetically modified plants with tolerance to herbicides was already 43 per-cent in 2020.

Amendment 319

Jan Huitema, Karin Karlsbro, Emma Wiesner

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, 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.

Or. en

Justification

Restricting or prohibiting the cultivation of category 2 NGT plants in the territory of Member States would undermine the goals set out in the Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy. Therefore, it should not be possible for Member States to adopt such measures.

Amendment 320

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

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

Or. en

Amendment 321

Günther Sidl

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.

deleted

Or. en

Justification

The approval procedure for NGT plants should differ from the approval procedure for conventional GMOs. Our advancing knowledge of molecular genetics informs us that the genome of an organism functions as a delicately balanced, integrated network (Gupta et al., 2022; Schaefer et al., 2017), with complex traits being omnigenic in nature having the function of the entire genome at their basis (Boyle et al., 2017; Mathieson, 2021). That genes function as networks, implies that any modification at this level can have major consequences with respect to patterns of gene expression and an organism’s biochemistry. Thus, the latest science actually suggests that the law governing genetic modification including NGT should be re-appraised and strengthened rather than weakened.

Amendment 322

Christophe Clergeau

Proposal for a regulation

Recital 38

Text proposed by the Commission

Amendment

Or. fr

Amendment 323

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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 NGT plants are expected to result in more cultivation in the Union of 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 protect the interests of producers of conventional and organic 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.

Or. en

Amendment 324

Lydie Massard

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 325

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 326

Günther Sidl

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Article 26b of Directive 2001/18 allows the total or partial exclusion of the cultivation of genetic engineering on the territory of the respective member state. In the sense of subsidiarity of the member states, this possibility is also to be maintained extensively for NGT plants.

Amendment 327

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

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 and the free movement of NGT plant products across the EU, 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 shall 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.

Or. en

Amendment 328

Pascal Canfin, Max Orville

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, unless a Member State decides not to authorize a category 2 NGT plant within its territory as provided by Regulation 2001/18/EC.

Or. en

Amendment 329

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner

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 for NGT plants and related products, the free movement of goods should be ensured, provided they comply with the requirements of other Union law.

Or. en

Justification

It is essential for the good functioning of the internal market and the free movement of NGT plant products across the EU, that the deliberate release of NGT plants and placing on the market of NGT products are 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. It is important that Member States do 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 330

Martin Häusling

Proposal for a regulation

Recital 39 a (new)

Text proposed by the Commission

Amendment

(39a) To achieve the goal of ensuring the effective functioning of the internal market, EU-wide legally binding coexistence measures for category 1 and category 2 NGTs should be adopted.

Or. en

Amendment 331

Ulrike Müller

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, including 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 SME. While a balance must be struck to ensure that patents do not unduly hinder the opportunities of SME in the market for NGT plants and products, it must be noted that patents play an important role for SME to facilitate access to finance, particularly in biotechnology. 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. With regard to the impacts of patents, the Commission should present a first assessment by 2026 in order to ensure that where necessary, changes to the framework for intellectual property rights can be discussed in due time before a significant number of NGT plants can be expected to be placed on the market. The assessment should include an analysis of the functioning of licensing platforms.

Or. en

Amendment 332

Günther Sidl

Proposal for a regulation

Recital 40

Text proposed by the Commission

Amendment

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

Or. en

Justification

In the Treaty on the Functioning of the EU (TFEU), Article 114 § 3 states: “The Commission, in its proposals envisaged in paragraph 1 concerning health, safety, environmental protection and consumer protection, will take as a base a high level of protection, taking account in particular of any new development based on scientific facts. Already, many problems have been documented for NGTs. For example, CRISPR applications have turned out to cause toxicity (Álvarez et al., 2022), mosaicism (Mehravar et al., 2019) and other unintended genomic abnormalities (Höijer et al., 2022; Chu and Agapito-Tenfen, 2022). See also the ENSSER position statement on CRISPR/Cas gene editing (ENSSER, 2023). Whereas these effects have been observed in organisms intentionally exposed to CRISPR/Cas, its impact and adverse effects on non-target and unintentionally exposed organisms are yet unknown (Schenke and Cai, 2020). Such knowledge is only generated when risk assessments are required and in place and both the impact and the uncertainties are estimated and acknowledged.

Amendment 333

Lydie Massard

Proposal for a regulation

Recital 40

Text proposed by the Commission

Amendment

Or. en

Amendment 334

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 40

Text proposed by the Commission

Amendment

Or. en

Amendment 335

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner

Proposal for a regulation

Recital 40

Text proposed by the Commission

Amendment

(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. This 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.

Or. en

Justification

Impacts of NGT plants on human and animal health, the environment and environmental, economic and social sustainability will be monitored and verified by the Commission as per Article 30(4) of this Regulation, so wording here is redundant. What should be emphasized however, is that the field of plant biotechnology is generally characterized by a steady pace of scientific advancements. Regular revisions of this Regulation are therefore essential to keep the legislative framework for NGTs in the Union future-proof.

Amendment 336

Francesca Peppucci

Proposal for a regulation

Recital 40

Text proposed by the Commission

Amendment

Or. en

Amendment 337

Stanislav Polčák

Proposal for a regulation

Recital 40

Text proposed by the Commission

Amendment

Or. cs

Amendment 338

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Recital 40

Text proposed by the Commission

Amendment

Or. fr

Amendment 339

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Recital 40 a (new)

Text proposed by the Commission

Amendment

(40a) NGT plants and products imported into the Union shall be subject to the same obligations as those originating in the Union.

Or. it

Amendment 340

Catherine Griset, Aurélia Beigneux

Proposal for a regulation

Recital 41 a (new)

Text proposed by the Commission

Amendment

(41a) Consequently, all NGT plants and products imported into the EU should be subject to the same requirements as products originating in the Union and those requirements should be systematically incorporated in trade agreements (‘mirror clause’).

Or. fr

Amendment 341

João Pimenta Lopes

Proposal for a regulation

Recital 42

Text proposed by the Commission

Amendment

(42) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can be better achieved at Union level, so that NGT plants and NGT products may circulate freely within the internal market, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

deleted

Or. pt

Amendment 342

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Recital 42

Text proposed by the Commission

Amendment

(42) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

Or. en

Amendment 343

João Pimenta Lopes

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.’

deleted

Or. pt

Amendment 344

Martin Häusling

Proposal for a regulation

Recital 43

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 345

Stanislav Polčák

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, 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.’

Or. cs

Amendment 346

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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 tasked to evaluate the necessity 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.’ The Commission should present a legislative proposal if it deems it necessary to amend this list.

Or. en

Amendment 347

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 43 a (new)

Text proposed by the Commission

Amendment

(43a) Member States and the Commission should ensure that systematic and independent research on the potential risks involved in the deliberate release or the placing on the market of NGTs is conducted. The necessary resources should be secured for such research by Member States and the Community in accordance with their budgetary procedures and independent researchers should be given access to all relevant material, while respecting intellectual property rights.

Or. en

Amendment 348

João Pimenta Lopes

Proposal for a regulation

Recital 45

Text proposed by the Commission

Amendment

(45) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the information required to demonstrate that a NGT plant is a category 1 NGT plant, as regards the preparation and the presentation of the notification for that determination, and as regards the methodology and information requirements for the environmental risk assessments of category 2 NGT plants and of NGT food and NGT feed, in accordance with the principles and criteria laid down in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council().

deleted

_________________

55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

Or. pt

Amendment 349

Günther Sidl

Proposal for a regulation

Recital 45

Text proposed by the Commission

Amendment

deleted

_________________

55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

Or. en

Justification

Since NGT plants should be treated like conventional GMOs, this paragraph is not necessary.

Amendment 350

Martin Häusling

Proposal for a regulation

Recital 45

Text proposed by the Commission

Amendment

(45) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the preparation and the presentation of the authorisation of category NGT 1 in accordance with the principles and criteria laid down in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(55 ).

_________________

55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

Or. en

Amendment 351

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 45

Text proposed by the Commission

Amendment

(45) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the methodology and information requirements for the environmental risk assessments of NGT plants and of NGT food and NGT feed and NGT products, in accordance with the principles and criteria laid down in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(55 ).

_________________

55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

Or. en

Amendment 352

Christophe Clergeau

Proposal for a regulation

Recital 45

Text proposed by the Commission

Amendment

(45) In order to ensure uniform conditions for the implementation of this Regulation, delegated powers should be conferred on the Commission as regards the information required to demonstrate that a NGT plant is a category 1 NGT plant, as regards the preparation and the presentation of the notification for that determination, and as regards the methodology and information requirements for the environmental risk assessments of category 2 NGT plants and of NGT food and NGT feed, in accordance with the principles and criteria laid down in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council55.

_________________

55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

Or. fr

Amendment 353

Pascal Canfin, Max Orville

Proposal for a regulation

Recital 45 a (new)

Text proposed by the Commission

Amendment

(45a) In order to ensure the proper functioning of the seed market, it is necessary that seed breeders keep having easy access to plant reproductive material for cross breeding activities and benefit therefore from the breeder's exemption.

Or. en

Amendment 354

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 46

Text proposed by the Commission

Amendment

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

(46) The Commission should regularly collect information in order to assess the performance of the legislation in achieving the objectives of the Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and in order to inform an evaluation of the legislation. A broad set of indicators have been identified56 and should be periodically reviewed by the Commission. The indicators should support monitoring of potential risks to health or the environment of NGT plants and related NGT products, impact of NGT plants on environmental, economic and social sustainability as well as impact on organic agriculture and on consumers freedom of choice, including their knowledge of and acceptance of NGT products. A first monitoring report should be presented three years after the first products have been notified/authorised, to ensure that enough data is available after full implementation of the new legislation, and at regular intervals thereafter. The Commission should carry out an evaluation of this Regulation two years after the first monitoring report has been published.

_________________

56 SWD(2023) 412

Or. en

Amendment 355

Günther Sidl

Proposal for a regulation

Recital 46

Text proposed by the Commission

Amendment

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

_________________

56 SWD(2023) 412

Or. en

Justification

A distinction between category 1 and category 2 NGT plants is not necessary

Amendment 356

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Recital 47

Text proposed by the Commission

Amendment

(47) Certain references to provisions of the Union GMO legislation in Regulation (EU) 2017/625 of the European Parliament and of the Council (57 ) need to be amended to include the specific provisions in this legislation applicable to NGT plants.

deleted

_________________

57 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).

Or. en

Amendment 357

Martin Häusling

Proposal for a regulation

Recital 47 a (new)

Text proposed by the Commission

Amendment

(47a) The European Green Deal, the ‘Farm to Fork’, and the EU Biodiversity Strategies put organic farming at the core of a transition to sustainable food systems, with a target to expand European agricultural land under organic production to 25% by 2030. This is a clear recognition of the environmental benefits of organic farming, for less dependency on inputs for farmers, and a resilient food supply and food sovereignty. This Regulation must not adversely undermine the pathway to a transition of European food systems to organic farming to 25% by 2030.

Or. en

Amendment 358

Martin Häusling

Proposal for a regulation

Recital 47 b (new)

Text proposed by the Commission

Amendment

(47b) According to a 2021 JRC study, 6 out of 16 pre-commercial NGT products are modified for herbicide tolerance. However, this Regulation should contribute to delivering on the objectives set out in the European Green Deal and Union and international pesticide reduction targets. Thus, this Regulation should ensure that herbicide tolerant NGT plants cannot be considered at NGT category 1.

Or. en

Amendment 359

Martin Häusling

Proposal for a regulation

Recital 47 c (new)

Text proposed by the Commission

Amendment

(47c) The precautionary principle, enshrined in Article 191 of the Treaty on the Functioning of the European Union, aims at ensuring a higher level of environmental protection and consumer health, in the context of food and human, animal and plant health, through preventative decision-taking in the case of risk. This Regulation needs to be in accordance with the precautionary principle as NGT plants shall be released and cultivated in the environment.

Or. en

Justification

It is important to add the precautionary principle in this Regulation, as the release and cultivation of genetically engineered plants into the environment may have significant impacts on human, animal, and environmental health. Healthy and prospering ecosystems are fundamental for resilient food production in Europe and thus, the new regulatory framework must adhere to strong standards of precaution and preventative decision-taking.

Amendment 360

Martin Häusling

Proposal for a regulation

Recital 47 e (new)

Text proposed by the Commission

Amendment

(47e) Traceability requirements for food and feed produced from NGTs should be established to facilitate accurate labelling of such products, in accordance with the requirements of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, so as to ensure that accurate information is available to operators and consumers to enable them to exercise their freedom of choice in an effective manner as well as to enable control and verification of labelling claims. Requirements for food and feed produced from NGTs should be similar in order to avoid discontinuity of information in cases of change in end use.

Or. en

Amendment 361

Martin Häusling

Proposal for a regulation

Recital 47 f (new)

Text proposed by the Commission

Amendment

(47f) All European quality schemes and geographical indicators (GIs), which are important sectors in Europe which consumers have certain expectations of, should have the possibility to choose not to use NGTs in their standards.

Or. en

Amendment 362

Ivan David

Proposal for a regulation

Recital 48 a (new)

Text proposed by the Commission

Amendment

(48a) Category 1 NGT plants, as well as plants and varieties that can be produced and occur in nature, or can be produced by conventional breeding, or are considered conventional plants, should not be subject to a patent but rather to plant variety rights. Plant variety rights allow the use of the ‘breeder’s exemption’, which promotes innovation and the creation of new varieties. It should be possible to continue to use the ‘farmer’s exemption’ for these plants. The protection of the intellectual property of the breeders of these plants should continue in accordance with the COUNCIL DECISION of 30 May 2005 approving the accession of the European Community to the International Convention for the Protection of New Varieties of Plants, as revised at Geneva on 19 March 1991 and the Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights, as amended.

Or. cs

Amendment 363

Jan Huitema, Karin Karlsbro, Emma Wiesner, Andreas Glueck, Ulrike Müller

Proposal for a regulation

Recital 48 a (new)

Text proposed by the Commission

Amendment

(48a) Although not covered by the scope of this Regulation, it is crucially important that the framework for intellectual property rights for plants, whether obtained through NGTs or classical breeding, is fit for purpose. To that end, the Commission should put forward a study to evaluate the effects of patenting plants on advancements in plant breeding, the influence of patents on breeders' accessibility to genetic resources and methods, the availability of seeds for farmers and the EU's competitiveness in the field of plant biotechnology. Findings from this study shall be delivered by December 2026 and shall, where appropriate, be accompanied by a legislative proposal.

Or. en

Amendment 364

Martin Häusling

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.

With the primary objective of ensuring a high level of protection of human and animal health and the environment, this Regulation lays down derogations from the provisions of Directive 2001/18 and other existing Union legislation on GMOs regarding 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. These derogations shall only apply insofar as they can ensure a high level of protection of human and animal health and the environment, in accordance with the precautionary principle.

Or. en

Amendment 365

Günther Sidl

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

This Regulation corresponds to the provisions of Directive 2001/18 and extends these provisions to the deliberate release of plants obtained by certain new genomic techniques (hereinafter "NGT plants").

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

Or. en

Justification

Amendment 366

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

This Regulation lays down specific provisions for certain newer genomic manipulation techniques (‘NGT plants’), while ensuring the protection of health and the environment and upholding the precautionary principle.

Or. en

Amendment 367

Lydie Massard

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 368

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

With full regard to the precautionary principle, this Regulation lays down specific rules for the deliberate release into the environment for any other purpose than placing on the market of annual arable crop 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.

Or. en

Amendment 369

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 2 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

(1) NGT plants;

(1) Annual arable NGT plants that have no potential to persist, reproduce and spread in the environment;

Or. en

Amendment 370

Martin Häusling

Proposal for a regulation

Article 2 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

(1) NGT plants;

(1) Annual arable agricultural NGT plants that do not have the potential to persist, reproduce or spread in the environment;

Or. en

Justification

The public debate and the reasoning of the European Commission focuses entirely on agricultural NGT plants. In addition, NGT plants that have the potential to persist, reproduce or spread in the environment (within or beyond the fields) need to be evaluated in accordance with the current GMO legislation.

Amendment 371

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 2 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

(1) NGT plants;

(1) NGT plants classified as annual crop plants with no capability to persist, reproduce and spread in the environment;

Or. en

Amendment 372

Günther Sidl

Proposal for a regulation

Article 2 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

(1) NGT plants;

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

Or. en

Amendment 373

Lydie Massard

Proposal for a regulation

Article 2 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

(1) NGT plants;

(1) annual agricultural NGT plants;

Or. en

Amendment 374

João Pimenta Lopes

Proposal for a regulation

Article 2 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

(1) NGT plants;

(1) NGT agricultural plants;

Or. pt

Amendment 375

Martin Häusling

Proposal for a regulation

Article 2 – paragraph 1 – point 4

Text proposed by the Commission

Amendment

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

deleted

Or. en

Justification

Only food and feed from agricultural NGT plants should be covered.

Amendment 376

João Pimenta Lopes

Proposal for a regulation

Article 2 – paragraph 1 – point 4 a (new)

Text proposed by the Commission

Amendment

(4a) Wild plants, trees and algae fall outside the scope of this Regulation.

Or. pt

Amendment 377

Martin Häusling

Proposal for a regulation

Article 2 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The rules in Union legislation which apply to GMOs and in Union legislation on environmental protection and food safety, in so far that they are not derogated from by this Regulation, shall continue to apply to these plants and products.

Or. en

Amendment 378

Lydie Massard

Proposal for a regulation

Article 2 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

This regulation does not apply to:

(1) patented material or material for which a patent application is being processed;

(2) herbicide-tolerant plants;

(3) Wild plants, trees and algae.

Or. en

Amendment 379

Günther Sidl

Proposal for a regulation

Article 2 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

This regulation does not apply to:

(1) patented material or material for which a patent application is being processed;

(2) Wild plants and trees.

Or. en

Amendment 380

Martin Häusling

Proposal for a regulation

Article 2 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

This Regulation shall not apply to transgenic plants or to progeny of transgenic plants.

Or. en

Justification

The intention of the Commission proposal is to keep transgenic plants subject to the existing GMO legislation.

Amendment 381

Martin Häusling

Proposal for a regulation

Article 2 – paragraph 1 d (new)

Text proposed by the Commission

Amendment

This Regulation shall not apply to NGT plants which are herbicide tolerant, insecticidal, antimicrobial, fungicidal or which have a changed composition.

Or. en

Justification

NGT plants with these traits should be assessed for their full environmental impacts before being placed on the market or being released into the environment. A number of studies demonstrate the negative impact that these traits may have. For example, changed oil content of NGT oilseed rape crops may negatively impact pollinators, whilst herbicide tolerance can lead to an increased use of complementary herbicides which would not be in line with the ambition to reduce pesticide use. Insecticidal, antimicrobial (as well as NGTs containing antibiotic marker genes) and fungicidal traits may also impact non-target organisms, and the wider ecosystem, in a negative way. Given that the EC proposal does not foresee impact assessment, monitoring detection or labelling for the vast majority of NGTs (category 1), there is no way to identify if these traits are indeed problematic before they are released into the environment and placed on the market. These NGTs should therefore remain subject to the current GMO legislation.

Amendment 382

Martin Häusling

Proposal for a regulation

Article 2 – paragraph 1 e (new)

Text proposed by the Commission

Amendment

This Regulation shall not apply to gene technology which aims to modify the genome outside of the laboratory.

Or. en

Amendment 383

Martin Häusling

Proposal for a regulation

Article 2 – paragraph 1 f (new)

Text proposed by the Commission

Amendment

This Regulation shall not apply to plants which have been modified with RNA interference technologies.

Or. en

Amendment 384

Martin Häusling

Proposal for a regulation

Article 2 – paragraph 1 g (new)

Text proposed by the Commission

Amendment

This regulation does not apply to patented material or material for which a patent application is being processed.

Or. en

Justification

The Commission proposal aims to facilitate the commercialisation of NGT plants in Europe. In the absence of specific safeguards, this could lead to an increased number of patented seeds in the EU.

As a result, breeders and farmers could find themselves at a heightened risk of legal action from NGT developers if they inadvertently use their patented genetic sequences.

Specifically with regards to CRISPRC/Cas products, researchers have warned of a "patent thicket" that could be extremely hard to navigate for the majority of plant breeders and farmers.

In September 2019, the European Parliament called for “free access to plant material (including plant traits)” saying this was “absolutely essential for the innovative capacity of the European plant-breeding and farming sectors, their competitiveness and the development of new plant varieties in order to guarantee global food security, tackle climate change and prevent monopolies within the breeding sector” and warning that “any restriction or attempt to hamper access to genetic resources may lead to an excessive market concentration in the field of plant breeding, to the detriment of market competition, consumers and the European internal market and food security”(https://www.europarl.europa.eu/doceo/document/TA-9-2019-0020_EN.html)

This amendment, in line with the Parliament’s position, aims to ensure that the NGT Regulation will not hamper free access to plant material for farmers and plant breeders.

Amendment 385

Günther Sidl

Proposal for a regulation

Article 3 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

(1) the definitions of ‘organism’, ‘deliberate release’ and ‘placing on the market’ set out in Directive 2001/18/EC, those of ‘food’ and ‘feed’ set out in Regulation (EC) No 178/2002, that of ‘traceability’ set out in Regulation (EC) No 1830/2003, that of ‘plant’ set out in Regulation (EU) 2016/2031 of the European Parliament and of the Council(58 ) and that of ‘plant reproductive material’ set out in [the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union59 ];

(1) the definitions of ‘organism’ set out in Directive 2001/18/EC

(1a), ‘deliberate release’ set out in Directive 2001/18/EC

(1b) and ‘placing on the market’ set out in Directive 2001/18/EC,

(1e) those of ‘food’ and ‘feed’ set out in Regulation (EC) No 178/2002,

(1f) that of ‘traceability’ set out in Regulation (EC) No 1830/2003

(1e) that of ‘plant’ set out in Regulation (EU) 2016/2031 of the European Parliament and of the Council(58 )

(1f) ‘plant reproductive material’ set out in [the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union59 ];

_________________

58 Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p. 4).

59 COM(2023) 414 final

Or. en

Amendment 386

Lydie Massard

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 conditions that:

(a) it does not contain any genetic material originating from outside the breeders’ gene pool that temporarily may have been inserted during the development of the NGT plant and;

(b) there are no patents or exclusive rights covering the process used to develop the plant, and there are no patents or exclusive rights covering the plant or parts thereof, and no application has been tabled for such patents or exclusive rights to be granted;

Or. en

Amendment 387

Günther Sidl

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 conditions that:

(a) it does not contain any genetic material originating from outside the breeders’ gene pool that temporarily may have been inserted during the development of the NGT plant,

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

Or. en

Amendment 388

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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, on all of the following conditions:

(a) it does not contain any genetic material prepared outside the cell,

(b) it is not bred to be intentionally tolerant to herbicides,

Or. en

Amendment 389

João Pimenta Lopes

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 or prepared outside cells that temporarily may have been inserted during the development of the NGT plant, and there is no type of intellectual property associated with the plant, its properties or the technique used to create it;

Or. pt

Amendment 390

Martin Häusling

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 on the condition that it does not contain any genetic material prepared outside of the cells and that there are no patents or exclusive rights covering the process used to develop the plant, and there are no patents or exclusive rights covering the plant or parts thereof, and no application has been tabled for such patents or exclusive rights to be granted;

Or. en

Justification

Cisgenesis involves the insertion of large DNA sequences and, as with transgensis, it should be covered by the existing GMO legislation. In addition, The Commission proposal aims to facilitate the commercialisation of NGT plants in Europe. In the absence of specific safeguards, this could lead to an increased number of patented seeds in the EU.

As a result, breeders and farmers could find themselves at a heightened risk of legal action from NGT developers if they inadvertently use their patented genetic sequences.

Specifically with regards to CRISPRC/Cas products, researchers have warned of a "patent thicket" that could be extremely hard to navigate for the majority of plant breeders and farmers.

This amendment, in line with the Parliament’s position, aims to ensure that the NGT Regulation will not hamper free access to plant material for farmers and plant breeders.

Amendment 391

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

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, excluding CRISPR-Cas9-based mutagenesis;

Or. en

Amendment 392

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Nils Torvalds, Emma Wiesner, Ulrike Müller

Proposal for a regulation

Article 3 – paragraph 1 – point 2

Text proposed by the Commission

Amendment

(2) ‘NGT plant’ means a 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;

Or. en

Amendment 393

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 3 – paragraph 1 – point 2

Text proposed by the Commission

Amendment

(2) ‘NGT plant’ means a plant as set out in Regulation (EU) 2016/2031 of the European Parliament and of the Council(2), 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;

Or. en

Justification

Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p. 4).

Amendment 394

Pietro Fiocchi

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 (transiently or stably in an intermediate plant) may have been inserted during the development of the NGT plant;

Or. en

Amendment 395

Stanislav Polčák

Proposal for a regulation

Article 3 – paragraph 1 – point 2

Text proposed by the Commission

Amendment

Or. cs

Amendment 396

Martin Häusling

Proposal for a regulation

Article 3 – paragraph 1 – point 3

Text proposed by the Commission

Amendment

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

deleted

Or. en

Justification

The definition of GMO is already laid down in the existing legislation.

Amendment 397

Günther Sidl

Proposal for a regulation

Article 3 – paragraph 1 – point 3

Text proposed by the Commission

Amendment

(3) ‘genetically modified organism’ or ‘GMO’ means a genetically modified organism as defined in Article 2(2) of Directive 2001/18/EC;

Or. en

Amendment 398

Christophe Clergeau

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(3a) 'conventional plants' means plants obtained by conventional breeding techniques excluding genetic modifications and techniques of genetic modification listed in Annex IB to Directive 2001/18/EC like mutagenesis and cell fusion;

Or. en

Amendment 399

Martin Häusling

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 precisely defined locations in the genome of an organism, and in which no unintended changes take place elsewhere in the genome as verified by a full unbiased screening of the whole of the genome;

Or. en

Amendment 400

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

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 precisely defined locations in the genome of an organism;

Or. en

Amendment 401

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Ulrike Müller

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;

Or. en

Justification

'Targeted' is a more appropriate word here. The aim of the mutagenesis techniques resulting in modifications of the DNA sequence could be a specific part of the genome of an organism, but not necessarily an exact location in that specific part of the genome.

Amendment 402

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

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;

Or. en

Justification

Clarification to the EC text

Amendment 403

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 404

Martin Häusling

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

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

deleted

Or. en

Justification

Cisgenesis involves the insertion of large DNA sequences and, as with transgensis, it should be covered by the existing GMO legislation.

Amendment 405

Günther Sidl

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;

deleted

Or. en

Justification

The term "gene pool" is probably intended to mark the boundary between transgenesis and cisgenesis, but is widely extended to include the entire genetic information of other taxonomic species with which crosses can be made or brought about by techniques not yet known.

Amendment 406

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 3 – paragraph 1 – point 6

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 407

Martin Häusling

Proposal for a regulation

Article 3 – paragraph 1 – point 6

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

There is no need for this definition

Amendment 408

Stanislav Polčák

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, using regular breeding techniques, cross-bred;

Or. cs

Amendment 409

Christophe Clergeau

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 naturally be cross-pollinated;

Or. en

Justification

This definition of the breeders' gene pool should not allow the introduction of other foreign genes than the ones that can be naturally hosted by the target species through natural cross-pollination. This definition will be more easily applicable and verifiable by competent authorities.

Amendment 410

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Article 3 – paragraph 1 – point 6

Text proposed by the Commission

Amendment

(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;

Or. en

Justification

Plant DNA belongs to nature and the PVR/UPOV system must be preserved, whereby the proliferation of a variety, growing, harvesting and further breeding of the variety is free of charge, which stimulates maximum innovation and development for the benefit of society, farmers and breeders.

Amendment 411

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 3 – paragraph 1 – point 6

Text proposed by the Commission

Amendment

Or. en

Amendment 412

Christophe Clergeau

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 embryo rescue and induced polyploidy;

Or. en

Justification

The bridge crossing techniques which moves a gene from outside the ‘crossable’ gene pool into the breeder’s gene pool via sequential crosses with intermediates species, allows for the introduction of virtually any foreign genes into the target species, from totally unrelated species. This technique pushes the borders of the breeder’s gene pool beyond any limits and will enable transgenesis-like genetic modifications.

Amendment 413

Francesca Peppucci

Proposal for a regulation

Article 3 – paragraph 1 – point 6 a (new)

Text proposed by the Commission

Amendment

(6a) 'polyploidy': means the presence of more than two genomes in one cell;

Or. en

Amendment 414

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Article 3 – paragraph 1 – point 6 a (new)

Text proposed by the Commission

Amendment

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

Or. it

Amendment 415

João Pimenta Lopes

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

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

deleted

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

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

Or. pt

Amendment 416

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

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

deleted

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

Or. en

Amendment 417

Günther Sidl

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

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

deleted

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

Or. en

Amendment 418

Lydie Massard

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

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

deleted

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

Or. en

Amendment 419

Marie Toussaint

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

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

deleted

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

Or. en

Justification

This amendment forms part of a set of amendments deleting NGT category 1. By exempting category 1 NGTs, which will be make up the vast majority of NGTs, from GMO risk assessment, monitoring, traceability and consumer labelling, the Commission proposal fails to respect consumer rights as well as the precautionary principle, as laid down in the TFEU. Furthermore, there is no scientific basis underlying the criteria in Annex I which ‘determines’ 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.

Amendment 420

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 3 – paragraph 1 – point 7 – introductory part

Text proposed by the Commission

Amendment

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

(7) ‘category 1 NGT plant’ means a NGT plant categorized as annual crop plant and proven equivalent to conventionally bred plants on the basis of data acquired from in-door risk assessment;

Or. en

Amendment 421

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 3 – paragraph 1 – point 7 – point a

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 422

Martin Häusling

Proposal for a regulation

Article 3 – paragraph 1 – point 7 – point a

Text proposed by the Commission

Amendment

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

(a) has been authorised in accordance with Chapter II, and

Or. en

Justification

This change is to ensure that NGT cat 1 plants are only recognised as such once authorised.

Amendment 423

Christophe Clergeau

Proposal for a regulation

Article 3 – paragraph 1 – point 7 – point a

Text proposed by the Commission

Amendment

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

(a) fulfils the criteria of equivalence to conventional plants, set out in Annex I and Annex IV, and has at least one of the intended characteristic(s) conveyed by the genetic modification that is contained in Part 1 of Annex III and does not have any one of those listed in Part 2 of Annex III, or

Or. en

Justification

The Category 1 NGT is an advantageous derogation to Directive 2001/18 acceptable on the condition that it brings real benefits in terms of sustainability.

Amendment 424

Martin Häusling

Proposal for a regulation

Article 3 – paragraph 1 – point 7 – point a a (new)

Text proposed by the Commission

Amendment

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

Or. en

Justification

The Commission proposal aims to facilitate the commercialisation of NGT plants in Europe. In the absence of specific safeguards, this could lead to an increased number of patented seeds in the EU.

As a result, breeders and farmers could find themselves at a heightened risk of legal action from NGT developers if they inadvertently use their patented genetic sequences.

Specifically with regards to CRISPRC/Cas products, researchers have warned of a "patent thicket" that could be extremely hard to navigate for the majority of plant breeders and farmers.

This amendment, in line with the Parliament’s position, aims to ensure that the NGT Regulation will not hamper free access to plant material for farmers and plant breeders.

Amendment 425

Martin Häusling

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ab) does not have one or more of the traits listed in part 2 of Annex III;

Or. en

Amendment 426

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 3 – paragraph 1 – point 7 – point b

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 427

Martin Häusling

Proposal for a regulation

Article 3 – paragraph 1 – point 7 – point b

Text proposed by the Commission

Amendment

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

Or. en

Justification

The crossing of several different NGT plants could lead to a violation of the criteria in Annex I.

Amendment 428

Christophe Clergeau

Proposal for a regulation

Article 3 – paragraph 1 – 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 the criteria of equivalence set out in Annex 1 and Annex 4 are still satisfied;

Or. en

Amendment 429

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Nils Torvalds, Emma Wiesner, Andreas Glueck, Ulrike Müller

Proposal for a regulation

Article 3 – paragraph 1 – 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, or progeny that has undergone further modifications and fulfils the criteria of equivalence to conventional plants, as set out in Annex I of this Regulation;

Or. en

Justification

Breeders constantly improve on commercial varieties, in order to reach incremental productivity gains over time. If the limit of 20 genetic modifications for category 1 NGT plants is cumulative over generations, it will limit the possibility for breeders to introduce new modifications using NGTs at a later time in future breeding programmes. This is not future-proof and will greatly limit the range of what could be achieved when combining complex traits, like drought tolerance with disease resistance.

Amendment 430

Jessica Polfjärd

Proposal for a regulation

Article 3 – paragraph 1 – 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 or progeny that has been subject to further modifications and deemed to fulfil the criteria of equivalence to conventional plants as set out in Annex I;

Or. en

Justification

Progeny of Category 1 NGT plants should still be considered as NGT 1 if additional modifications fulfil the equivalence criteria set out in annex I (without prejudice to previous modifications). Breeders improve on commercial varieties, in order to reach gradual result in productivity over time. If the threshold of 20 genetic modifications for NGT 1 plants are cumulative over generations, it will aggravate for the breeders to introduce new modifications using NGTs at a later time in future breeding programmes. This risks limiting the range of what could be achieved when combining complex traits (e.g. disease resistance).

Amendment 431

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Nils Torvalds, Emma Wiesner, Andreas Glueck, Ulrike Müller

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ba) products for which it is not possible to provide an analytical method to detect, identify and quantify a genetic change made by an new genomic technique.

Or. en

Justification

The proposal suggests that for certain category 2 NGT plants no or only an adapted identification method can be developed (yet). While these plants will consequently be regulated as GMOs, they are in fact not distinguishable from conventional plants. This is a specific challenge for imports. If for imports it is not possible to identify unauthorized NGTs with category 2 changes, it is discriminatory to require traceability and labelling of such products within the EU. Consequently, category 2 NGT plants for which no identification method can be developed should logically be treated as category 1 NGT plants.

Amendment 432

Christophe Clergeau

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ba) is not presented as having properties for treating or preventing diseases in human beings and may not be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, within the meaning of Article 1-2.(a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use.

Or. en

Justification

In that case it should be considered as Cat 2 NGT, and duly submitted to the Cat. 2 NGT procedure as well as the authorization procedure provided for in the medicinal products legislation.

Amendment 433

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 3 – paragraph 1 – point 7 a (new)

Text proposed by the Commission

Amendment

(7a) Therefore, these plants are subject to Community Plant Variety Rights (CPVR);

Or. en

Amendment 434

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

Proposal for a regulation

Article 3 – paragraph 1 – point 7 b (new)

Text proposed by the Commission

Amendment

(7b) Products for which it is not feasible to provide an analytical method that detects, identifies and quantifies;

Or. en

Amendment 435

João Pimenta Lopes

Proposal for a regulation

Article 3.º – paragraph 1 – point 8

Text proposed by the Commission

Amendment

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

deleted

Or. pt

Amendment 436

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 3 – paragraph 1 – point 8

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 437

Marie Toussaint

Proposal for a regulation

Article 3 – paragraph 1 – point 8

Text proposed by the Commission

Amendment

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

deleted

Or. en

Justification

Amendment 438

Günther Sidl

Proposal for a regulation

Article 3 – paragraph 1 – point 8

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 439

Lydie Massard

Proposal for a regulation

Article 3 – paragraph 1 – point 8

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 440

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 3 – paragraph 1 – point 8

Text proposed by the Commission

Amendment

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

(8) ‘category 2 NGT plant’ means a NGT plant categorized as annual crop plant other than a category 1 NGT plant;

Or. en

Amendment 441

Günther Sidl

Proposal for a regulation

Article 3 – paragraph 1 – point 9

Text proposed by the Commission

Amendment

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

(9) ‘NGT plant for food use’ means a NGT plant that may be used as food or as a source material for the production of food in line with the One Health approach;

Or. en

Amendment 442

Günther Sidl

Proposal for a regulation

Article 3 – paragraph 1 – point 10

Text proposed by the Commission

Amendment

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

(10) ‘NGT plant for feed use’ means a NGT plant that may be used as feed or as a source material for the production of feed in line with the One Health approach;

Or. en

Amendment 443

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Nils Torvalds, Emma Wiesner, Ulrike Müller

Proposal for a regulation

Article 3 – paragraph 1 – 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;

Or. en

Amendment 444

João Pimenta Lopes

Proposal for a regulation

Article 3 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(13) ‘category 1 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 1 NGT plant;

deleted

Or. pt

Amendment 445

Marie Toussaint

Proposal for a regulation

Article 3 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(13) ‘category 1 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 1 NGT plant;

deleted

Or. en

Justification

Amendment 446

Günther Sidl

Proposal for a regulation

Article 3 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(13) ‘category 1 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 1 NGT plant;

deleted

Or. en

Amendment 447

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 3 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(13) ‘category 1 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 1 NGT plant;

deleted

Or. en

Amendment 448

Lydie Massard

Proposal for a regulation

Article 3 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(13) ‘category 1 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 1 NGT plant;

deleted

Or. en

Amendment 449

João Pimenta Lopes

Proposal for a regulation

Article 3 – paragraph 1 – point 14

Text proposed by the Commission

Amendment

(14) ‘category 2 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 2 NGT plant;

deleted

Or. pt

Amendment 450

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 3 – paragraph 1 – point 14

Text proposed by the Commission

Amendment

(14) ‘category 2 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 2 NGT plant;

deleted

Or. en

Amendment 451

Lydie Massard

Proposal for a regulation

Article 3 – paragraph 1 – point 14

Text proposed by the Commission

Amendment

(14) ‘category 2 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 2 NGT plant;

deleted

Or. en

Amendment 452

Günther Sidl

Proposal for a regulation

Article 3 – paragraph 1 – point 14

Text proposed by the Commission

Amendment

(14) ‘category 2 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 2 NGT plant;

deleted

Or. en

Amendment 453

Marie Toussaint

Proposal for a regulation

Article 3 – paragraph 1 – point 14

Text proposed by the Commission

Amendment

(14) ‘category 2 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 2 NGT plant;

deleted

Or. en

Justification

Amendment 454

Günther Sidl

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. It recognises that the health of humans, domestic and wild animals, plants, and the wider environment including ecosystems are closely interlinked and inter-dependent;

Or. en

Amendment 455

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(15a) ‘in-door risk assessment’ means risk assessment based on experiments in contained environment including data on molecular, physiological and anatomical characterisation of the product.

Or. en

Amendment 456

Christophe Clergeau

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(15a) 'variety' means a variety as defined in Article 5(2) of Regulation (EC) 2100/94.

Or. en

Amendment 457

Günther Sidl

Proposal for a regulation

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

Text proposed by the Commission

Amendment

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

Or. en

Amendment 458

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 4

Text proposed by the Commission

Amendment

Article 4

deleted

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

Without prejudice to other requirements of Union law, a NGT plant may only be deliberately released into the environment for any other purpose than placing on the market, and a NGT product may only be placed on the market, if:

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

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

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

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

Or. en

Amendment 459

Marie Toussaint

Proposal for a regulation

Article 4

Text proposed by the Commission

Amendment

Article 4

deleted

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

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

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

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

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

Or. en

Justification

Amendment 460

Lydie Massard

Proposal for a regulation

Article 4 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Without prejudice to other requirements of Union law, and with strict regard to the precautionary principle for a purpose intentionally a NGT plant may only be deliberately released into the environment for any other purpose placing on the market, and a NGT product may only be placed on the market if the plant is a NGT plant and has been authorized in accordance with Chapter III.

Or. en

Amendment 461

Günther Sidl

Proposal for a regulation

Article 4 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Without prejudice to other requirements of Union law and with strict regard to the precautionary principle, an NGT plant may only be deliberately released into the environment for any other purpose other than placing on the market, and an NGT product may only be placed on the market if the plant has been authorised in accordance with Chapter III.

Or. en

Amendment 462

João Pimenta Lopes

Proposal for a regulation

Article 4 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

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

deleted

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

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

Or. pt

Amendment 463

Lydie Massard

Proposal for a regulation

Article 4 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

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

deleted

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

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

Or. en

Amendment 464

Günther Sidl

Proposal for a regulation

Article 4 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

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

deleted

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

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

Or. en

Amendment 465

Lydie Massard

Proposal for a regulation

Article 4 – paragraph 1 – point 1 – point a

Text proposed by the Commission

Amendment

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

deleted

Or. en

Amendment 466

Martin Häusling

Proposal for a regulation

Article 4 – paragraph 1 – point 1 – point a

Text proposed by the Commission

Amendment

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

(a) has been authorised in accordance with Chapter II; or

Or. en

Amendment 467

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 4 – paragraph 1 – point 1 – point a

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 468

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

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

deleted

Or. en

Amendment 469

Lydie Massard

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

deleted

Or. en

Amendment 470

Martin Häusling

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

deleted

Or. en

Amendment 471

Christophe Clergeau

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 the condition that the criteria of equivalence set out in Annex 1 and Annex 4 are still satisfied ; or

Or. en

Amendment 472

Lydie Massard

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.

deleted

Or. en

Amendment 473

Günther Sidl

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 an NGT plant and has been authorised in accordance with Chapter III and is front-labelled as “NGT food” or “NGT feed”.

Or. en

Amendment 474

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Emma Wiesner, Ulrike Müller

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.

Or. en

Justification

Further clarification to the text proposed by the European Commission.

Amendment 475

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

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.

Or. en

Amendment 476

João Pimenta Lopes

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 an NGT plant authorised in accordance with Chapter III.

Or. pt

Amendment 477

Christophe Clergeau

Proposal for a regulation

Article 4 – paragraph 1 – point 2 a (new)

Text proposed by the Commission

Amendment

(2a) an extended producer responsibility (EPR) scheme has been settled at European or national level to ensure the financing of risks and possible future damages of human health, animal health or the environment or cross-contamination of organic food and non GMO-food are financed in line with the polluter pays principle.

Or. en

Amendment 478

Günther Sidl

Proposal for a regulation

Article 4 – paragraph 1 – point 2 a (new)

Text proposed by the Commission

Amendment

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

Or. en

Amendment 479

Günther Sidl

Proposal for a regulation

Article 4 – paragraph 1 – point 2 b (new)

Text proposed by the Commission

Amendment

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

Or. en

Amendment 480

Günther Sidl

Proposal for a regulation

Chapter II – title

Text proposed by the Commission

Amendment

II Category 1 NGT plants and category 1 NGT products

II The European Parliament deletes this chapter

Or. en

Amendment 481

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Chapter II – title

Text proposed by the Commission

Amendment

II Category 1 NGT plants and category 1 NGT products

II The European Parliament deletes this chapter

Or. en

Amendment 482

João Pimenta Lopes

Proposal for a regulation

Article 5

Text proposed by the Commission

Amendment

Article 5

deleted

Status of category 1 NGT plants

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

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

3. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the criteria of equivalence of NGT plants to conventional plants laid down in Annex I in order to adapt them to scientific and technological progress as regards the types and extent of modifications which can occur naturally or through conventional breeding.

Or. pt

Amendment 483

Günther Sidl

Proposal for a regulation

Article 5

Text proposed by the Commission

Amendment

Article 5

deleted

Status of category 1 NGT plants

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

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

Or. en

Amendment 484

Marie Toussaint

Proposal for a regulation

Article 5

Text proposed by the Commission

Amendment

Article 5

deleted

Status of category 1 NGT plants

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

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

Or. en

Justification

Amendment 485

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 5

Text proposed by the Commission

Amendment

Article 5

deleted

Status of category 1 NGT plants

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

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

Or. en

Amendment 486

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

Proposal for a regulation

Article 5 – title

Text proposed by the Commission

Amendment

Status of category 1 NGT plants

Status of category 1 NGT plants and category 1 NGT products

Or. en

Amendment 487

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Nils Torvalds, Emma Wiesner, Ulrike Müller

Proposal for a regulation

Article 5 – title

Text proposed by the Commission

Amendment

Status of category 1 NGT plants

Status of category 1 NGT plants and products

Or. en

Justification

Clarification in line with the title of the Article.

Amendment 488

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

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 GMOs in Union legislation shall apply to category 1 NGT plants.

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Or. en

Amendment 489

Lydie Massard

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 GMOs in Union legislation shall apply to all NGT plants.

Or. en

Amendment 490

Erik Poulsen, Asger Christensen, Emma Wiesner

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. Category 1 NGT plants should be included in the techniques referred to in Annex 1B of Directive 2001/18.

Or. en

Justification

By including 1 NGT among the techniques in Annex 1B of Directive 2001/18, it will be possible to use these plants in organic agriculture unless via the organic farming regulation specifies otherwise. Organic agriculture should also have access to category 1 NGT plants as this sector is also challenged by climate change and needs access to new and better plants. Therefore, if any regulation is made it should be done via the organic farming regulation.

Amendment 491

Ondřej Knotek

Proposal for a regulation

Article 5 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. Plant varieties that may arise and occur naturally or may be produced by conventional breeding or are considered to be conventional plants (such NGT plants) should not be subject to Patent legislation but to Plant Variety Rights legislation, which allows the use of the so-called Plant breeders ‘exemption and Farm saved Seeds exemption‘.

Or. en

Amendment 492

Norbert Lins

Proposal for a regulation

Article 5 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

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

Or. de

Amendment 493

Ondřej Knotek

Proposal for a regulation

Article 5 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1b. Category 1 NGT plants shall not be patentable.

Or. en

Amendment 494

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

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.

deleted

Or. en

Justification

This Regulation is not a place to regulate bans in organic farming.

Amendment 495

Jan Huitema, Karin Karlsbro, Erik Poulsen, Asger Christensen, Nils Torvalds, Emma Wiesner, Ondřej Knotek

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.

deleted

Or. en

Justification

As category 1 NGT plants are equivalent to conventionally bred plants, they should be accessible for organic production. Whether to use these plants or reproductive material thereof would be up the respective breeders and farmers. Next to this general rationale, any limitations related to the use of category 1 NGT plants for organic production should be decided within the framework of Regulation (EU) 2018/848 on organic farming for the purpose of legal consistency.

Amendment 496

Lydie Massard

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.

deleted

Or. en

Amendment 497

Francesca Peppucci

Proposal for a regulation

Article 5 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Category 1 NGT plants and products from such plants are not subject to the provisions laid down in Article 24 of this Regulation or Regulation 1829/2003.

Or. en

Amendment 498

Christophe Clergeau

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 499

Sirpa Pietikäinen

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

The purpose of Annex I is to create a new legal definition to categorize certain NGTs into falling into the regulatory scope of category 1 or category 2 NGTs, which is based on a policy choice, rather than science-based criteria, as the number of modifications cannot be equated with the resulting risk profile of a crop. This policy choice, i.e., the content of Annex I is of central importance to this legislative proposal, as it can have significant practical implications on how many NGTs would fall under each category. As such, this central feature must not be listed in the Annex and in consequence be amendable by the Commission through a simple delegated act. Instead, this important aspect must follow an ordinary legislative procedure to ensure thorough and democratic decision-making.

Amendment 500

Pietro Fiocchi

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 501

María Soraya Rodríguez Ramos, Michal Wiezik

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

The purpose of Annex I is to create a new legal definition to categorise NGTs into falling into the regulatory scope of category 1 or category 2 NGTs, which is based on a policy choice, as the number of modifications cannot be equated with the resulting risk profile of a crop. This important aspect must follow an ordinary legislative procedure.

Amendment 502

Lydie Massard

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 503

Martin Häusling

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

3. Where scientific studies show the need to update the criteria in Annex I in order to ensure the highest possible levels of protection of human and animal health and for the environment, the Commission shall come forward with a legislative procedure.

Or. en

Justification

A legislative act may delegate to the Commission the power to adopt non-legislative acts of general application to supplement or amend certain non- essential elements of the legislative act. However, the criterion of equivalence seem to be the most essential element of this legislative proposal, as both definitions of cat 1 NGT and cat 2 NGT are based on this criterion.

Amendment 504

Stanislav Polčák

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, fully taking into account the precautionary principle, as regards the types and extent of modifications which can occur naturally or through conventional breeding.

Or. cs

Amendment 505

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 5 – paragraph 3

Text proposed by the Commission

Amendment

3. By [OP: Please insert the date = 18 months after the date of entry into force of this Regulation], the Commission based on recommendations from the Authority, shall adopt delegated act defining the methodology to be used to assess equivalence of NGT plants to conventional plants.

Or. en

Amendment 506

Silvia Sardone, Maria Veronica Rossi, Rosanna Conte, Danilo Oscar Lancini

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

Or. it

Amendment 507

Francesca Peppucci

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, extent, size and number of modifications which can occur naturally or through conventional breeding.

Or. en

Amendment 508

Norbert Lins

Proposal for a regulation

Article 5 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. By way of derogation, category 1 plants and their derived seeds cannot be patented.

Or. en

Amendment 509

João Pimenta Lopes

Proposal for a regulation

Article 6

Text proposed by the Commission

Amendment

[...]

deleted

Or. pt

Amendment 510

Marie Toussaint

Proposal for a regulation

Article 6

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Justification

Amendment 511

Anja Hazekamp, Clare Daly, Manon Aubry, Marina Mesure, Mick Wallace

Proposal for a regulation

Article 6

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 512

Lydie Massard

Proposal for a regulation

Article 6

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 513

Günther Sidl

Proposal for a regulation

Article 6

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 514

Martin Häusling

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

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

Or. en

Amendment 515

Ondřej Knotek

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

Or. en

Amendment 516

Pietro Fiocchi, Veronika Vrecionová, Alexandr Vondra

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

Or. en

Justification

(merged Articles 6 and 7)

Amendment 517

Martin Häusling

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 an application request to verify whether the criteria set out in Annex I and conditions in this article are met (‘authorisation 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 paragraph 3 and the implementing act adopted in accordance with Article 27, point (b).

Or. en

Amendment 518

Christophe Clergeau

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 delegated act adopted in accordance with Article 26.

Or. en

Amendment 519

Pascal Canfin, Max Orville

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, 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’) 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).

Or. en

Amendment 520

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

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 accompanied with data from in-door risk assessment 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).

Or. en

Amendment 521

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 2

Text proposed by the Commission

Amendment

2. Where a person intends to undertake such a deliberate release simultaneously in more than one Member State, that person shall submit the verification request to the competent authority of one of those Member States.

deleted

Or. en

Justification

There should not be the possibility that applicants target the least strict or most over-burdened Member State competent authorities.

Amendment 522

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

Proposal for a regulation

Article 6 – paragraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 523

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 524

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3. The verification request referred to in paragraph 1 shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and shall include, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002:

3. The authorisation request referred to in paragraph 1 shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and shall include, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002:

Or. en

Amendment 525

Christophe Clergeau

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ba) the denomination of the variety;

Or. en

Amendment 526

Christophe Clergeau

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, including disclosure of the sequence of the genetic modification;

Or. en

Amendment 527

Erik Poulsen, Asger Christensen, Jan Huitema, Emma Wiesner

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 including information on the technique(s) used to obtain the trait(s);

Or. en

Justification

aligned with previous AMs

Amendment 528

Stanislav Polčák

Proposal for a regulation

Article 6 – paragraph 3 – point c

Text proposed by the Commission

Amendment

Or. cs

Amendment 529

Christophe Clergeau

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ca) a declaration on possible properties for treating or preventing disease in human beings or possible use or administration to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, within the meaning of Article 1-2. (a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use;

Or. en

Amendment 530

Christophe Clergeau

Proposal for a regulation

Article 6 – paragraph 3 – point c b (new)

Text proposed by the Commission

Amendment

(cb) any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it;

Or. en

Amendment 531

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 3 – point d – introductory part

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 532

Christophe Clergeau

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 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 delegated act adopted in accordance with Article 26;

Or. en

Amendment 533

Michal Wiezik, María Soraya Rodríguez Ramos, Martin Hojsík

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 of the cell, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. en

Amendment 534

Stanislav Polčák

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, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. cs

Amendment 535

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 3 – point d – point i

Text proposed by the Commission

Amendment

(i) the entire genome sequence, performed via an unbiased long-read sequencing with the most accurate and up to date techniques to show that, among other things, the plant does not contain any transgenic material or transgenes, such as those which may have been inserted as part of the development of the plant;

Or. en

Amendment 536

Martin Häusling

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ia) information in accordance with the requirements specified in the implementing act adopted in accordance with Article 27, point (a);

Or. en

Amendment 537

Martin Häusling

Proposal for a regulation

Article 6 – paragraph 3 – point d – point i b (new)

Text proposed by the Commission

Amendment

(ib) an environmental risk assessment, carried out in accordance with Directive 2001/18;

Or. en

Amendment 538

Martin Häusling

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, including through the submission of independent studies verifying the safety of the modifications outlined in annex I, paragraph 1, points 1 and 2;

Or. en