21 Amendments of Bert-Jan RUISSEN related to 2023/0226(COD)
Amendment 188 #
Proposal for a regulation
Recital 45 a (new)
Recital 45 a (new)
(45 a) The issue of patents on NGTs was raised by many stakeholders during the consultation. It should be ensured that breeders have full access to the genetic material of NGT plants. As current provisions do not provide for a full breeders exemption in patent law, it should be ensured that patents should not restrict the use of NGT plants by breeders and farmers. Access to genetic materials can best be secured when the right of patent holders is exhausted in the hand of the breeder (Breeder’s exemption). It should furthermore be avoided that patents are being granted or patent applications can be submitted while further legal provisions on the issue would be postponed following the study that the Commission intends to do. It should therefore be ensured that NGT plant material is excluded from patentability from the day of entry into force of this Regulation. In addition, the Commission in the announced forthcoming study should assess how the broader problem of patents being granted, directly or indirectly, on plant material despite previous efforts to close loopholes, should be further addressed.
Amendment 210 #
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 238 #
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 253 #
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 299 #
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 315 #
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 334 #
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 344 #
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) toreasoned objection(s) to the other Member States and the Commission without undue delay.
Amendment 358 #
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 371 #
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 396 #
Proposal for a regulation
Article 10
Article 10
Amendment 463 #
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 52(1) of Regulation (EU) .../... [reference to the Regulation on the production and marketing of plant reproductive material] and it does not have any traits referred to in Part 2 of that Annex III.
Amendment 493 #
Proposal for a regulation
Article 31 a (new)
Article 31 a (new)
Article 31a Exclusion from patentability NGT plant material shall not be patentable.
Amendment 494 #
Proposal for a regulation
Article 33 a (new)
Article 33 a (new)
Article33a Amendments to Directive (EU) 98/44/EC Article 4 of Directive (EU) 98/44/EC is amended as follows: In paragraph 1, the following points (c) and (d) are added: '(c) NGT plant material as defined in Regulation (EU) .../... [insert reference to this Regulation]. (d) plant material that can be yielded by techniques excluded from the scope of Directive 2001/18/EC as listed in Annex IB of that directive'
Amendment 499 #
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 513 #
Proposal for a regulation
Annex I – point 1
Annex I – point 1
Amendment 519 #
Proposal for a regulation
Annex I – point 2
Annex I – point 2
Amendment 526 #
Proposal for a regulation
Annex I – point 3
Annex I – point 3
Amendment 547 #
Proposal for a regulation
Annex I – point 4
Annex I – point 4
Amendment 554 #
Proposal for a regulation
Annex I – point 5
Annex I – point 5
Amendment 563 #
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) .../... [reference to Regulation on plant reproductive material].