Changes from report parliamentary committee draft to plenary report

AddedArticle 26 – paragraph 2: 2. The power to adopt the delegated acts referred to in Article 5(3), Article 6(11a) and Article 22(8) shall be conferred on the Commission for a period of 5 years from [date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period.

AddedArticle 26 – paragraph 3: 3. The delegations of power referred to in Article 5(3), Article 6(11a) and Article 22(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

AddedArticle 26 – paragraph 6: 6. A delegated act adopted pursuant to Articles Article 5(3), Article 6(11a) and Article 22(8) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.

AddedArticle 27 – paragraph 1 – point a: deleted

AddedArticle 27 – paragraph 1 – point b: deleted

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).

AddedDirective 98/44/EC

AddedArticle 33 a (new), Article 4: 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. Paragraph 2 and 3 shall be without prejudice to the exclusions from patentability covered in paragraph 1.’ / 1a Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ L 213, 30.7.1998, p. 13).

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.

AddedAnnex III a (new): ANNEX IIIa / In-door safety assessment / A Cat.1 NGT plant is considered safe if, when compared to the non modified parent of the same species, through confined experiments evidence is provided that: / (1) the whole genome sequencing and profiling shows that the intended and unintended genetic modifications have not adversely modified the function of one or more genes; and / (2) the whole transcriptome sequencing carried out on the relevant part of the plant shows that the intended and unintended genetic modifications have not adversely modified biochemical pathways, leading in particular to adverse compositional consequences, verified for instancethrough gene ontology analysis; and / (3) biochemical metabolite (metabolomics) and protein (proteomics) profiling realised on the relevant part of the plant shows that the intended and unintended genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of toxic or allergenic novel biochemicals or proteins other than those sought after and tested .