Changes from plenary report to adopted text

AddedArticle 30 – paragraph 2: 2. The report shall also identify and address any issues regarding biodiversity and environmental, human and animal health, changes to agronomic practices as well as socio-economic and ethical issues that may have arisen with the application of this Regulation.

AddedArticle 30 – paragraph 3: 3. For the purpose of the reporting referred to in paragraph 1, the Commission, by [24 months after the date of entry into force of this Regulation] at the latest, shall establish, after consulting the competent authorities of the Member States in accordance with Directive 2001/18/EC and Regulation (EC) No 1829/2003, a detailed programme for monitoring, based on indicators, the impact of this Regulation, including the intended and unintended effects and systematic effects on the environment, biodiversity and ecosystems. It shall specify the action to be taken by the Commission and by the Member States in collecting and analysing the data and other evidence.

AddedArticle 30 – paragraph 5 a (new): 5a. By June 2025 the Commission shall submit 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, in particular, on opportunities for SMEs. The report shall assess whether further legal provisions are necessary in addition to those provided for in Article 4a and Article 33a of this Regulation. Where appropriate to ensure breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, the report shall be accompanied by a legislative proposal to address further necessary adjustments in the intellectual property rights framework.

AddedArticle 30 – paragraph 5 b (new): 5b. By 2024, the Commission shall submit a report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions evaluating the specificities of and needs for other sectors not covered in this legislation, such as microorganisms, including a proposal for further policy actions.

AddedArticle 30 – paragraph 5 c (new): 5c. Every four years, the Commission shall assess the criteria of equivalence established in Annex I and, if necessary, update them through a delegated act as referred to in Article 5(3).

AddedAmendments 69, 291cp1, 230/rev1 and 291cp3

AddedArticle 33 a (new)

AddedDirective 98/44/EC

AddedArticle 4, Article 8 and Article 9

AddedAmendment: Article 33a / Amendments to Directive 98/44/EC1a / 1. Article 4 of Directive 98/44/EC on the legal protection of biotechnological inventions is amended as follows: / (a) In paragraph 1, the following points are added: / '(c) NGT plants, plant material, parts thereof, genetic information and process features they contain, as defined in Regulation (EU) .../... [O.J. please insert the number of this Regulation]; / (d) plants, plant material, parts thereof, genetic information and process features they contain that can be yielded by techniques excluded from the scope of Directive 2001/18/EC as listed in Annex I B to that directive.' / (b) the following paragraph 4 is added: / ‘4. Paragraphs 2 and 3 shall be without prejudice to the exclusions from patentability covered in paragraph 1.’ / 2. In Article 8, the following paragraph is added: / ‘3. By way of derogation from paragraphs 1 and 2, the protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall not extend to biological material possessing the same characteristics that is obtained independently of the patented biological material and from essentially biological processes, or to biological material obtained from such material through propagation or multiplication.’ / 3. In Article 9, the following paragraphs are added: / '2. By way of derogation from paragraph 1, a plant product containing or consisting of genetic information obtained by a patentable techni…

AddedArticle 34 – paragraph 2 – subparagraph 1: It shall apply from [24 months from the date of entry into force of this Regulation]. Article 4a and Article 33a shall apply from the date of entry into force.

AddedAnnex I – paragraph 1: A NGT plant is considered equivalent to conventional plants if the following conditions referred to in points 1 and 1a are met:

AddedAnnex I – point 1: (1) The number of the following genetic modifications, which can be combined with each other, does not exceed 3 per any protein-coding sequence taking into account that mutations in introns and regulatory sequences are excluded from this limit: / (a) substitution or insertion of no more than 20 nucleotides; / (b) deletion of any number of nucleotides;

AddedAnnex I – point 1 a (new): (1a) The following genetic modifications, which can be combined with each other, do not create a chimeric protein that is not present in species from the gene pool for breeding purposes or does not interrupt an endogenous gene; / (a) insertion of continuous DNA sequences existing in the gene pool for breeding purposes; / (b) substitution of endogenous DNA sequences with continuous DNA sequences existing in the gene pool for breeding purposes; / (c) inversion or translocation of continuous endogenous DNA sequences existing in the gene pool for breeding purposes.

AddedAnnex I – point 2: deleted

AddedAnnex I – point 3: deleted / (deleted) / (deleted)

AddedAnnex I – point 4: deleted

AddedAnnex I – point 5: deleted

AddedAnnex II – Part 1 – paragraph 2 – point a a (new): (aa) the characteristics of the recipient plant like allergenicity, potential for gene flow, weed potential, ecological function;

AddedAnnex II – Part 2 – point 6 a (new): (6a) Impacts on organic cultivation

AddedAnnex II – Part 2 – point 8 a (new): (8a) Effects on protecting and conserving biodiversity

AddedAnnex III – title 1: Traits referred to in Article 6 and Article 22

AddedAnnex III – Part 1 – paragraph 1 – point 1: (1) yield, including yield stability and yield under low-input conditions, provided that those traits also contribute to either point (2), (3) or (4) of this Annex;

AddedAnnex III – Part 1 – paragraph 1 – point 7: (7) reduced need for external inputs, such as fertilisers, if it does not contradict with Annex III, part 2.