35 Amendments of Carmen AVRAM related to 2023/0226(COD)
Amendment 56 #
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 68 #
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 78 #
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 commentreasoned scientific objections to the verification report by other national competent authorities. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.
Amendment 94 #
(21) Decisions declaring the category 1 NGT plant status should assign an identification number to the NGT plant concerned in order to ensure transparency and traceability of such plants when they are listed in the database and for the purpose of labelling of plant reproductive material derived from them.
Amendment 109 #
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. The use of new genomic techniques is currently incompatible with the concept of organic production in the Regulation (EC) 2018/848 and with consumers’ perception of organic products. The use of category 1 NGT plants should therefore be also prohibited in organic production. _________________ 47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).
Amendment 116 #
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 167 #
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 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.
Amendment 171 #
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 204 #
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 208 #
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 220 #
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 230 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b a (new)
Article 3 – paragraph 1 – point 7 – point b a (new)
(b a) for which it is not feasible to provide an analytical method that detects, identifies and quantifies.
Amendment 239 #
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 a NGT plant and food and feed containing, consisting of or produced from such a plant, and other products containing or consisting of such plants;
Amendment 264 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The rules which apply to Annex IB GMOs in Union legislation shall notalso apply to category 1 NGT plants.
Amendment 270 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 279 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2 a. 2a. Category 1 NGT plants and the products from such plants, are not subject to provisions established in Article 24 of this Regulation or Regulation 1829/2003.
Amendment 284 #
Proposal for a regulation
Article 5 – paragraph 2 b (new)
Article 5 – paragraph 2 b (new)
2 b. Category 1 NGT plants and products from such plants are not subject to provisions established in Article 26b of Directive 2001/18/EC.
Amendment 300 #
Proposal for a regulation
Article 6 – title
Article 6 – title
Verification procedure of category 1 NGT plant status for requests submitted prior to the deliberate release for any other purpose than placing on the market
Amendment 312 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make commentreasoned scientific objections to the verification report within 20 days from the date of receipt of that report. These objections must solely refer to the fulfilment of the criteria as set out in Annex I and must include a scientific justification.
Amendment 328 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any commentreasoned scientific objections from a Member State or the Commission, within 10 working days from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.
Amendment 347 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. In cases where a commentreasoned scientific 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 the commentobjection(s) to the Commission without undue delay.
Amendment 355 #
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 commentresoned scientific objection(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
Amendment 402 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Amendment 436 #
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);the NGT plant should fall under category 1 as to Art 3 (7)(c)
Amendment 464 #
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 IIIicle 52(1) of Regulation (EU) …/… (reference to Plant Reproductive Material) and it does not have any traits referred to in Part 2 of that Annex.
Amendment 477 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
Amendment 485 #
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.
Amendment 500 #
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 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 toes not include foreign genetic material from outside the breeders’ gene pools.
Amendment 512 #
Proposal for a regulation
Annex I – point 1
Annex I – point 1
Amendment 521 #
Proposal for a regulation
Annex I – point 2
Annex I – point 2
Amendment 525 #
Proposal for a regulation
Annex I – point 3
Annex I – point 3
Amendment 530 #
Proposal for a regulation
Annex I – point 3 – point a
Annex I – point 3 – point a
Amendment 537 #
Proposal for a regulation
Annex I – point 3 – point b
Annex I – point 3 – point b
Amendment 548 #
Proposal for a regulation
Annex I – point 4
Annex I – point 4
Amendment 553 #
Proposal for a regulation
Annex I – point 5
Annex I – point 5