67 Amendments of Veronika VRECIONOVÁ related to 2023/0226(COD)
Amendment 4 #
Proposal for a regulation
Title 1
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomicprecision breeding techniques and their food and feed, and amending Regulation (EU) 2017/625 (Text with EEA relevance)
Amendment 31 #
Proposal for a regulation
Title 1
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomicprecision breeding techniques and their food and feed, and amending Regulation (EU) 2017/625 (Text with EEA relevance)
Amendment 67 #
Proposal for a regulation
Recital 16
Recital 16
(16) Category 1 NGT plants and products shouldmust not be subject to the rules and requirements of the Union GMO legislation and to provisions in other Union legislation that apply to GMOs. For legal certainty for operators and transparency, a declaration of the category 1 NGT plant status should be obtained prior to deliberate release, including the placing on the market.
Amendment 103 #
Proposal for a regulation
Recital 23
Recital 23
Amendment 120 #
Proposal for a regulation
Recital 24
Recital 24
(24) Provision should be made to ensure transparency as regards the use of category 1 NGT plant varieties, to ensure that production chains that wish to remain free from NGTs can do so and thereby safeguard consumer trust. NGT plants that have obtained a category 1 NGT plant status declaration should be listed in a publicly available database. To ensure traceability, transparency and choice for operators, during research and plant breeding, when selling seed to farmers or making plant reproductive material available to third parties in any other way, plant reproductive material of category 1 NGT plants should be labelled as category 1 NGTindicated by a mention in the national and EU variety registers.
Amendment 157 #
Proposal for a regulation
Recital 36
Recital 36
Amendment 165 #
Proposal for a regulation
Recital 37
Recital 37
(37) In order to enable NGT plants to contribute to the sustainability objectives of the Green Deal and the Farm to Fork and Biodiversity Strategies, cultivation of NGT plants in the Union should be facilitated. 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 category 2ies of NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC would undermine those goals.
Amendment 170 #
Proposal for a regulation
Recital 39
Recital 39
(39) To achieve the goal of ensuring the effective functioning of the internal market, NGT plants and related products should benefit from the free movement of goods, provi 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 should not unilaterally derogate from the provisions set out in this Regulation in a way that would restrict, prohibit or hindedr they comply with the requirements of other free movement, placing on the market and deliberate release of NGT plants or related products within the territory of the Union law.
Amendment 170 #
Proposal for a regulation
Recital 16
Recital 16
(16) Category 1 NGT plants and products shouldmust not be subject to the rules and requirements of the Union GMO legislation and to provisions in other Union legislation that apply to GMOs. For legal certainty for operators and transparency, a declaration of the category 1 NGT plant status should be obtained prior to deliberate release, including the placing on the market.
Amendment 198 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) ‘NGT plant’ means a genetically modified plantplant 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;
Amendment 209 #
Proposal for a regulation
Article 3 – paragraph 1 – point 4
Article 3 – paragraph 1 – point 4
(4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at precisetargeted locations in the genome of an organism;
Amendment 217 #
Proposal for a regulation
Recital 23
Recital 23
Amendment 219 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘breeders’ gene poolgene pool for breeding purposes’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses;
Amendment 231 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 a (new)
Article 3 – paragraph 1 – point 7 a (new)
(7 a) This plant shall be subject to Community Plant Variety Rights (CPVR).
Amendment 232 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 b (new)
Article 3 – paragraph 1 – point 7 b (new)
(7 b) for which it is not feasible to provide an analytical method that detects, identifies and quantifies.
Amendment 244 #
Proposal for a regulation
Recital 24
Recital 24
(24) Provision should be made to ensure transparency as regards the use of category 1 NGT plant varieties, to ensure that production chains that wish to remain free from NGTs can do so and thereby safeguard consumer trust. NGT plants that have obtained a category 1 NGT plant status declaration should be listed in a publicly available database. To ensure traceability, transparency and choice for operators, during research and plant breeding, when selling seed to farmers or making plant reproductive material available to third parties in any other way, plant reproductive material of category 1 NGT plants should be labelled as category 1 NGTall be indicated by a mention in the national and EU variety registers.
Amendment 251 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
(2) the plant is a category 2 NGT plant and has been granted consent or has been authorised in accordance with Chapter III.
Amendment 272 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 296 #
Proposal for a regulation
Article 6 – title
Article 6 – title
Verification procedure of category 1 NGT plant status prior to the deliberate release for any other purpose than placing on the market
Amendment 298 #
Proposal for a regulation
Article 6 – title
Article 6 – title
Verification procedure of category 1 NGT plant status prior to the deliberate release for any other purpose than placing on the market
Amendment 306 #
Proposal for a regulation
Recital 36
Recital 36
Amendment 308 #
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working days from the date of receipt of a verification request. The competent authority shall make available the verification report to asks the European Food Safety Authority (‘the Authority’) for scientific opinion on the verification report and shall make it available to the other Member States and to the Commission without undue delay.
Amendment 320 #
Proposal for a regulation
Recital 37
Recital 37
(37) In order to enable NGT plants to contribute to the sustainability objectives of the Green Deal and the Farm to Fork and Biodiversity Strategies, cultivation of NGT plants in the Union should be facilitated. 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 category 2ies of NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC would undermine those goals.
Amendment 324 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make commentsAuthority shall issue its scientific opinion to the verification report within 230 days from the date of receipt of that report.
Amendment 326 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
Amendment 327 #
Proposal for a regulation
Recital 39
Recital 39
(39) To achieve the goal of ensuring the effective functioning of the internal market, NGT plants and related products should benefit from the free movement of goods, provi 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 hindedr they comply with the requirements of other free movement, placing on the market and deliberate release of NGT plants or related products within the territory of the Union law.
Amendment 338 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
Amendment 352 #
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. The Ccommission, after having consulted the European Food Safety Apetent authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plantshall adopt its decision based on the EFSA´s opinion within 4520 working days from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2)EFSA´s opinion. The competent authority shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.
Amendment 369 #
Proposal for a regulation
Article 7
Article 7
Amendment 386 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
Member States shall not prohibit, restrict or impede the deliberate release or the placing on the market of category 1 NGT plants and related products, which comply with the requirements of this Regulation.
Amendment 393 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) ‘NGT plant’ means a genetically modified plantplant 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;
Amendment 399 #
Proposal for a regulation
Article 10 – title
Article 10 – title
Amendment 402 #
Proposal for a regulation
Article 3 – paragraph 1 – point 4
Article 3 – paragraph 1 – point 4
(4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at precisetargeted locations in the genome of an organism;
Amendment 405 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Plant reproductive material, including for breeding and scientific purposes, that contains or consists of category 1 NGT plant(s) and is made available to third parties, whether in return for payment or free of charge, shall bear a labelmention in national variety register automatically transmitted in the EU common register provided for in PRM/FRM indicating the words ‘cat 1 NGT’, followed by the identification number of the NGT plant(s) it has been derived from.
Amendment 411 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘breeders’ gene poolgene pool for breeding purposes’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses;
Amendment 433 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 a (new)
Article 3 – paragraph 1 – point 7 a (new)
(7a) Therefore, these plants are subject to Community Plant Variety Rights (CPVR);
Amendment 434 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 b (new)
Article 3 – paragraph 1 – point 7 b (new)
(7b) Products for which it is not feasible to provide an analytical method that detects, identifies and quantifies;
Amendment 475 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
(2) the plant is a category 2 NGT plant and has been granted consent or has been authorised in accordance with Chapter III.
Amendment 494 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 502 #
Proposal for a regulation
Annex I – paragraph 1
Annex I – paragraph 1
A NGT plant prepared by new genomic techniques is considered equivalent to a conventional plants when if it differs from the recipient/parental plant by no more than 20only by genetic modifications of the types referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic toolsand 2 which can be combined with each other.
Amendment 509 #
Proposal for a regulation
Annex I – paragraph 1 – indent 1 (new)
Annex I – paragraph 1 – indent 1 (new)
– Criteria specific for the use of targeted mutagenesis on the condition that the number of modification events per any protein-coding sequence does not exceed 3:
Amendment 516 #
Proposal for a regulation
Article 6 – title
Article 6 – title
Verification procedure of category 1 NGT plant status prior to the deliberate release for any other purpose than placing on the market
Amendment 524 #
Proposal for a regulation
Annex I – point 2 – indent 1 (new)
Annex I – point 2 – indent 1 (new)
– Criteria specific for the use of cisgenesis on the condition that the genetic modification does not create a chimeric protein that is not already present in a species from the breeders’ gene pool:
Amendment 535 #
Proposal for a regulation
Annex I – point 3 – point a
Annex I – point 3 – point a
(a) targeted insertion of a contignuous DNA sequence existing in the breeder’s gene pool;
Amendment 540 #
Proposal for a regulation
Annex I – point 3 – point b
Annex I – point 3 – point b
(b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s’ gene pool;
Amendment 543 #
Proposal for a regulation
Annex I – point 3 – point b – point i (new)
Annex I – point 3 – point b – point i (new)
i) c) inversion or translocation of a continuous endogenous DNA sequence existing in the breeders’ gene pool;
Amendment 549 #
Proposal for a regulation
Annex I – point 4
Annex I – point 4
Amendment 550 #
Proposal for a regulation
Annex I – point 5
Annex I – point 5
Amendment 561 #
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working days from the date of receipt of a verification request. The competent authority shall make available the verification reportasks the European Food Safety Authority (‘the Authority’) for scientific opinion on the verification report and shall make it available to the other Member States and to the Commission without undue delay.
Amendment 571 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 3
Annex III – Part 1 – paragraph 1 – point 3
(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change conditions;
Amendment 573 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make commentsAuthority shall issue its scientific opinion to the verification report within 230 days from the date of receipt of that report.
Amendment 575 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
Amendment 585 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
Amendment 595 #
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. The Ccommission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plantpetent authority shall adopt its decision based on the EFSA´s opinion within 4520 working days from the date of receipt of the comment(s), taking the latter iEFSA´s opinion. The competento account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2)uthority shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.
Amendment 607 #
Proposal for a regulation
Article 7
Article 7
Amendment 661 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
Free movement Member States shall not prohibit, restrict or impede the deliberate release or the placing on the market of category 1 NGT plants and related products, which comply with the requirements of this Regulation.
Amendment 708 #
Proposal for a regulation
Article 10 – title
Article 10 – title
Amendment 712 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Plant reproductive material, including for breeding and scientific purposes, that contains or consists of category 1 NGT plant(s) and is made available to third parties, whether in return for payment or free of charge, shall bear a labelmention in national variety register automatically transmitted in the EU common register provided for in PRM/FRM indicating the words ‘cat 1 NGT’, followed by the identification number of the NGT plant(s) it has been derived from.
Amendment 1053 #
Proposal for a regulation
Annex I – paragraph 1
Annex I – paragraph 1
A NGT plant prepared by new genomic techniques is considered equivalent to a conventional plants when if it differs from the recipient/parental plant by no more than 20only by genetic modifications of the types referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools2 which can be combined with each other.
Amendment 1065 #
Proposal for a regulation
Annex I – point 1 a (new)
Annex I – point 1 a (new)
(1a) Criteria specific for the use of targeted mutagenesis on the condition that the number of mutations events per any protein-coding sequence does not exceed 3: (a) substitution or insertion of no more than 20 nucleotides; (b) deletion of any number of nucleotides; (2) Criteria specific for the use of cisgenesis on the condition that the genetic modification does not create a chimeric protein that is not already present in a species from the breeders’ gene pool: (a) insertion of a continuous DNA sequence existing in the breeders’ gene pool; (b) substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeders’ gene pool; (c) inversion or translocation of a continuous endogenous DNA sequence existing in the breeders’ gene pool.
Amendment 1068 #
Proposal for a regulation
Annex I – point 2
Annex I – point 2
Amendment 1073 #
Proposal for a regulation
Annex I – point 3
Annex I – point 3
Amendment 1076 #
Proposal for a regulation
Annex I – point 3 – point a
Annex I – point 3 – point a
Amendment 1084 #
Proposal for a regulation
Annex I – point 3 – point b
Annex I – point 3 – point b
Amendment 1093 #
Proposal for a regulation
Annex I – point 4
Annex I – point 4
Amendment 1098 #
Proposal for a regulation
Annex I – point 5
Annex I – point 5
Amendment 1178 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 3
Annex III – Part 1 – paragraph 1 – point 3
(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change conditions;