36 Amendments of Annie SCHREIJER-PIERIK related to 2023/0226(COD)
Amendment 9 #
Proposal for a regulation
Recital 1
Recital 1
(1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the Council (32 ), on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted, significant progress in biotechnology has led to the development of new genomic techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precisetargeted locations. _________________ 32 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
Amendment 16 #
Proposal for a regulation
Recital 2
Recital 2
(2) NGTs constitute a diverse group of genomic techniques, and each of them can be used in various ways to achieve different results and products. They can result in organisms with modifications equivalent to what can be obtained by conventional breeding methods or in organisms with more complex modifications. Among NGTs, targeted mutagenesis and cisgenesis (including intragenesis) introduce genetic modifications without inserting genetic material from non-crossable species (transgenesis). They rely only on the breeders’ gene pool, i.e. the total genetic information that is available for conventional breeding including from distantly related plant species that can be crossed by advanced breeding techniques. Targeted mutagenesis techniques result in modification(s) of the DNA sequence at precisetargeted locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool.
Amendment 207 #
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 228 #
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 236 #
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, product containing or, consisting of or produced from a NGT plant and food and feedother products containing, consisting of or produced from such a plant;
Amendment 250 #
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 263 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The rules which apply to GMOs in Union legislationlisted in Annex I B to Directive 2001/18/EC shall notalso apply to category 1 NGT plants.
Amendment 271 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 277 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2 a. For the purposes of Regulation (EU) 2018/848, the rules set out in its Articles 5 (f) (iii) and 11 shall only apply to category 2 NGT plants and to products produced from or by such plants.
Amendment 283 #
Proposal for a regulation
Article 5 – paragraph 2 b (new)
Article 5 – paragraph 2 b (new)
2 b. Category 1 NGT plants and category 1 NGT products (conventional- like) shall not be subject to provisions like as established in Article 24 of this Regulation or Regulation (EC) 1829/2003.
Amendment 285 #
Proposal for a regulation
Article 5 – paragraph 2 c (new)
Article 5 – paragraph 2 c (new)
2 c. Category 1 NGT plants and category 1 NGT products (conventional- like) are not subject to provisions established in Article 26b of Directive 2001/18/EC.
Amendment 301 #
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 313 #
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. These reasoned objections must solely refer to the fulfilment of the criteria as set out in Annex I and must include a scientific justification.
Amendment 332 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any commentreasoned 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 342 #
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 comment(s) to thereasoned objection(s) to the requester, other Member States and to Commission without undue delay.
Amendment 361 #
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 372 #
Proposal for a regulation
Article 7 – title
Article 7 – title
Verification procedure of category 1 NGT plant status for requests submitted prior to the placing on the market of NGT products
Amendment 378 #
Proposal for a regulation
Article 7 a (new)
Article 7 a (new)
Article7a Free movement of category 1 NGT plants and category 1 NGT products Member States shall not prohibit, restrict or impede the deliberate release or the placing on the European single market of category 1 NGT plants and products produced from or by such plants.
Amendment 395 #
Proposal for a regulation
Article 10
Article 10
Amendment 438 #
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(2category 2 NGT plant should then be considered to fall under category 1 NGT plant as per Art 3 (7)(ba new);
Amendment 466 #
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 IIIthe Regulation on Plant Reproductive Material and it does not have any traits referred to in Part 2 of that Annex.
Amendment 479 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003. These provisions shall not apply to category 1 NGT plants and category 1 NGT products.
Amendment 498 #
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 breeder’s gene pools.
Amendment 514 #
Proposal for a regulation
Annex I – point 1
Annex I – point 1
Amendment 520 #
Proposal for a regulation
Annex I – point 2
Annex I – point 2
Amendment 527 #
Amendment 546 #
Proposal for a regulation
Annex I – point 4
Annex I – point 4
Amendment 552 #
Proposal for a regulation
Annex I – point 5
Annex I – point 5
Amendment 564 #
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) .../... ( of Plant Reproductive Material).
Amendment 566 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 1
Annex III – Part 1 – paragraph 1 – point 1
Amendment 567 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 2
Annex III – Part 1 – paragraph 1 – point 2
Amendment 570 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 3
Annex III – Part 1 – paragraph 1 – point 3
Amendment 572 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 4
Annex III – Part 1 – paragraph 1 – point 4
Amendment 574 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 5
Annex III – Part 1 – paragraph 1 – point 5
Amendment 577 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 6
Annex III – Part 1 – paragraph 1 – point 6
Amendment 579 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 7
Annex III – Part 1 – paragraph 1 – point 7