20 Amendments of Daniel BUDA related to 2023/0226(COD)
Amendment 31 #
Proposal for a regulation
Recital 8
Recital 8
(8) It is therefore necessary to adopt a specific legal framework for GMOplants obtained by NGTs such as targeted mutagenesis and cisgenesis and related products when deliberately released into the environment or placed on the market. A periodic review of the approach to establishing equivalence to conventional breeding methods is mandated in order to reflect scientific and technological progress.
Amendment 97 #
Proposal for a regulation
Recital 21
Recital 21
(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 110 #
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, apart from category 1 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).
Amendment 115 #
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 NGT.
Amendment 172 #
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, provided they comply with the requirements of other Union law. Member States should adhere to this.
Amendment 178 #
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. 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 the aim of further improving the Regulation.
Amendment 189 #
Proposal for a regulation
Recital 46 a (new)
Recital 46 a (new)
(46 a) Member States should organise factual public information campaigns regarding the safety and the benefits of plants obtained thorough new genomic techniques, with a particular emphasis on category 1 NGT plants. Member States should aim to dispel myths and misconceptions about new genomic techniques as well as to counteract disinformation and misinformation on this subject via these public information campaigns or by other means. The European Commission should provide assistance and guidelines to Member States in this respect, upon request.
Amendment 200 #
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 261 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plants, with the exception of the techniques referred to in Annex IB to Directive 2001/18, which shall also apply to category 1 NGT plants.
Amendment 267 #
Amendment 280 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2 a. Category 1 NGT plants and products obtained from or by such plants, shall not be subject to coexistence measures with Regulation (EC) No 1829/2003 1829/2003.
Amendment 290 #
Proposal for a regulation
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3 a. Category 1 NGT plants shall not be patentable.
Amendment 316 #
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. Such reasoned objections shall solely refer to the criteria as set out in Annex I and shall include a scientific justification.
Amendment 335 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any commentsreasoned objection 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 348 #
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 the commentreasoned objection(s) to the Commission without undue delay.
Amendment 359 #
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 379 #
Proposal for a regulation
Article 7 a (new)
Article 7 a (new)
Article7a Free movement Member States shall not prohibit or restrict the deliberate release or placing on the market of type 1 NGT plants and related products referred to in Article 3 through requirements that are specific to type 1 NGT plants or related products.
Amendment 404 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Amendment 508 #
Proposal for a regulation
Annex I – paragraph 1
Annex I – paragraph 1
A NGT plant is considered equivalent to conventional plants when it contains only genetic modifications referred to in points 1 to 5 and when it differs from the recipient/parental plant by no more than 20 genetic modifications of the types referred to in points 1 to 54, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic toolsthe targeted site or sites in the monoploid genome.
Amendment 529 #
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 an intragenic plant: