37 Amendments of Ulrike MÜLLER related to 2023/0226(COD)
Amendment 104 #
Proposal for a regulation
Recital 23
Recital 23
(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(47 ) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. As a result, category 2 NGT plants will be banned in organic production. However, it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. TWhile category 1 NGT plants are indistinguishable from plants obtained from conventional breeding including chemical and radiation induced mutagenesis which are accepted in organic production, and while relevant science bodies point out the particular potential of NGT plants in organic farming47a, it should be respected that the use of new genomic techniques is currently considered incompatible with the concept of organic production in the Regulation (EC) 2018/848 by a large majority of the organic farming and food sector and with consumers’ perception of organic products. The use of category 1 NGT plants should therefore be also prohibited in organic production. The prohibition of category 1 NGT plants in organic production further will ensure freedom of choice for consumers who wish to opt for products free from NGT plants. _________________ 47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1). 47a https://www.dfg.de/download/pdf/dfg_im_ profil/geschaeftsstelle/publikationen/stellu ngnahmen_papiere/2023/statement_geno mic_techniques.pdf
Amendment 156 #
Proposal for a regulation
Recital 14
Recital 14
(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘category 1 NGT plants’) should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent and that their risks are comparable, thereby derogating in full from the Union GMO legislation and GMO related requirements in sectoral legislation. In order to ensure legal certainty, this Regulation should set out the criteria to ascertain if a NGT plant is equivalent to naturally occurring or conventionally bred plants and lay down a procedure for competent authorities to verify and take a decision on the fulfillment of those criteria, prior to the release or placing on the market of NGT plants or NGT products. Those criteria should be objective and based on science. They should cover the type and extent of genetic modifications that can be observed in nature or in organisms obtained with conventional breeding techniques and should include thresholds for both size and number of genetic modifications to the genome of NGT plants. Since scientific and technical knowledge evolves rapidly in this area, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to update these criteria in light of scientific and technical progress as regards the type and extent of genetic modifications that can occur in nature or through conventional breeding.
Amendment 175 #
Proposal for a regulation
Recital 40
Recital 40
(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.
Amendment 183 #
Proposal for a regulation
Recital 18
Recital 18
(18) Since the criteria for considering that a NGT plant is equivalent to naturally occurring or conventionally bred plants are unrelated to the type of activity that requires the deliberate release of the NGT plant, a declaration of the category 1 NGT plant status made prior to its deliberate release for any other purpose than placing on the market in the territory of the Union should also be valid for the placing on the market of related NGT products. In view of the high uncertainty existing at the field trial stage about the product reaching the market and the likely involvement of smaller operators in such releases, the verification procedure of category 1 NGT plant status prior to field trials should be conducted by national competent authorities as this would be less administratively burdensome for operators, and a decision should be taken at Union level only in case there are comments to the verification report by other national competent authorities. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union levelin consultation with the Commission and the European Food Safety Authority ('EFSA') only if there are reasoned objections by other Member States in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.
Amendment 219 #
Proposal for a regulation
Recital 23
Recital 23
(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(47 ) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. As a result, category 2 NGT plants will be banned in organic production. However, it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. TWhile category 1 NGT plants are indistinguishable from plants obtained from conventional breeding including chemical and radiation induced mutagenesis which are accepted in organic production, and while relevant science bodies point out the particular potential of NGT plants in organic farming47a, it should be respected that the use of new genomic techniques is currently considered incompatible with the concept of organic production in the Regulation (EC) 2018/848 by a large majority of the organic farming and food sector and with consumers’ perception of organic products. The use of category 1 NGT plants should therefore be also prohibited in organic production. The prohibition of category 1 NGT plants in organic production further will ensure freedom of choice for consumers who wish to opt for products free from NGT plants. _________________ 47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1). 47a https://www.dfg.de/download/pdf/dfg_im_ profil/geschaeftsstelle/publikationen/stellu ngnahmen_papiere/2023/statement_geno mic_techniques.pdf
Amendment 318 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make scientifically justified comments to the verification report, with regard to the compliance with criteria set out in Annex I, within 20 days from the date of receipt of that report.
Amendment 331 #
Proposal for a regulation
Recital 40
Recital 40
(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.
Amendment 363 #
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 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).
Amendment 363 #
Proposal for a regulation
Recital 48 a (new)
Recital 48 a (new)
Amendment 392 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) ‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the 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 401 #
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 429 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b
Article 3 – paragraph 1 – point 7 – point b
(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 orr progeny that has undergone further modifications and fulfils the criteria of equivalence to conventional plants, as set out in Annex I of this Regulation 1829/2003;
Amendment 431 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b a (new)
Article 3 – paragraph 1 – point 7 – point b a (new)
(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.
Amendment 443 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12
Article 3 – paragraph 1 – point 12
(12) ‘NGT product’ means a product, other than food and feed, containing or, consisting of aor produced from NGT plants and food and feedother products containing, or consisting of or produced from such a plants;
Amendment 474 #
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 487 #
Proposal for a regulation
Article 5 – title
Article 5 – title
Status of category 1 NGT plants and products
Amendment 491 #
5 a. No later than 2026, the Commission shall present a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the role and impact of patents on breeders' and farmers' access to varied plant reproductive material, as well as on innovation and particularly on the opportunities for SME. Where appropriate to ensure breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, as well as the ongoing promotion of innovation, particularly with a view to opportunities for SME, the report shall be accompanied by a roadmap to address necessary adjustments in the intellectial property framework.
Amendment 565 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make commentreasoned objections to the verification report within 20 days from the date of receipt of that report regard to the fulfilment of the criteria set out in Annex I, within 20 days from the date of receipt of that report. A reasoned objection by a Member State shall be science-based and shall directly refer to the criteria as set out in Annex I.
Amendment 590 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. In cases where a commentreasoned objection is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the comment(s) to the Commissionreasoned objection to the Commission and the other Member States without undue delay.
Amendment 598 #
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the commentreasoned objection(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
Amendment 602 #
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 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).
Amendment 662 #
Proposal for a regulation
Article 8 a (new)
Article 8 a (new)
Article 8a 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 792 #
Proposal for a regulation
Article 14 – paragraph 1 – point l
Article 14 – paragraph 1 – point l
(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier, the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2)plant should be considered as category 1 NGT plant in accordance with Article 3(7)(c) of this Regulation;
Amendment 885 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. The incentives in this Article shall apply to category 2 NGT plants and category 2 NGT products, where at least one of the intended trait(s) of the NGT plant conveyed by the genetic modification is contained in Part 1 of Annex IIIArticle 51(1) of Regulation (2023/0227) and it does not have any traits referred to in Part 2 of that Annex.
Amendment 1012 #
Proposal for a regulation
Article 30 – paragraph 5 a (new)
Article 30 – paragraph 5 a (new)
5a. Every three years, the Commission shall review the criteria listed in Annex I and Annex III of this Regulation and, where appropriate, amend them by means of a delegated act, in order to ensure adaptation to the latest scientific and technological progress.
Amendment 1014 #
Proposal for a regulation
Article 30 – paragraph 5 b (new)
Article 30 – paragraph 5 b (new)
5b. No later than December 2026, the Commission shall present a study to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the effects of patenting plants on advancement 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. Where appropriate, the report shall be accompanied by a legislative proposal amending the framework for intellectual property rights for plants.
Amendment 1049 #
Proposal for a regulation
Annex I – paragraph 1
Annex I – paragraph 1
A NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications per haploid genome of the types referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.
Amendment 1075 #
Proposal for a regulation
Annex I – point 3 – introductory part
Annex I – point 3 – introductory part
(3) on the condition that the genetic modification does not interrupt an endogenous genecreate a chimeric protein:
Amendment 1083 #
Proposal for a regulation
Annex I – point 3 – point a
Annex I – point 3 – point a
(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool;
Amendment 1169 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – introductory part
Annex III – Part 1 – paragraph 1 – introductory part
Traits justifying the incentives referred to in Article 22: are listed in Article 52(1) of Regulation (EU) 2023/0227.
Amendment 1172 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 1
Annex III – Part 1 – paragraph 1 – point 1
Amendment 1175 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 2
Annex III – Part 1 – paragraph 1 – point 2
Amendment 1176 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 3
Annex III – Part 1 – paragraph 1 – point 3
Amendment 1179 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 4
Annex III – Part 1 – paragraph 1 – point 4
Amendment 1181 #
Amendment 1183 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 6
Annex III – Part 1 – paragraph 1 – point 6
Amendment 1184 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 7
Annex III – Part 1 – paragraph 1 – point 7