20 Amendments of Martin HLAVÁČEK related to 2023/0226(COD)
Amendment 273 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 276 #
Proposal for a regulation
Article 5 – paragraph 2 – point 1 (new)
Article 5 – paragraph 2 – point 1 (new)
(1) Plant varieties that may arise and occur naturally or may be produced by conventional breeding or are considered to be conventional plants (such NGT plants) shall not be subject to Patent legislation but to Plant Variety Rights legislation, which allows the use of the so- called Plant breeders ‘exemption and Farm saved Seeds exemption‘.
Amendment 282 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
Amendment 303 #
Proposal for a regulation
Article 6 – title
Article 6 – title
Verification procedure of category 1 NGT plant status prior to the deliberate release for any other purpose than placing on the market(merged Articles 6 and 7)
Amendment 309 #
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working days from the date of receipt of a verification request. The competent authority shall make available the verification reportasks the European Food Safety Authority (‘the Authority’) for scientific opinion on the verification report and shall make it available to the other Member States and to the Commission without undue delay.
Amendment 317 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make commentsreasoned comments together with a scientific justification as regards the fulfilment of the criteria set out in Annex 1, to the verification report within 20 days from the date of receipt of that report.
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 327 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
Amendment 339 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
Amendment 353 #
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. The Ccommission, 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 plantpetent authority shall adopt its decision based on the EFSA´s opinion within 4520 working days from the date of receipt of the comment(s), taking the latter iEFSA´s opinion. The competento account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2)uthority shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.
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 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 504 #
A NGT plant prepared by new genomic techniques is considered equivalent to a conventional plants when if it differs from the recipient/parental plant by no more than 20only by 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 tools4 which can be combined with each other.
Amendment 510 #
Proposal for a regulation
Annex I – paragraph 1 – point 1 (new)
Annex I – paragraph 1 – point 1 (new)
(1) Criteria specific for the use of targeted mutagenesis on the condition that the number of modifications per any gene cannot exceed 3:
Amendment 511 #
Proposal for a regulation
Annex I – paragraph 1 – point 2 (new)
Annex I – paragraph 1 – point 2 (new)
(2) Criteria specific for the use of cisgenesis on the condition that only one modification can occur per one genome site:
Amendment 528 #
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 gene or that the resulting DNA sequences context in the recipient plant already occurs in a species from the breeders’ gene pool:
Amendment 536 #
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 542 #
Proposal for a regulation
Annex I – point 3 – point b
Annex I – point 3 – point b
(b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool;
Amendment 544 #
Proposal for a regulation
Annex I – point 3 – point b – point i (new)
Annex I – point 3 – point b – point i (new)
i) translocation of a continuous endogenous DNA sequence existing in the breeders’ gene pool;
Amendment 551 #