Changes from adopted text to adopted text

AddedBefore adopting the implementing acts referred to in points (a) to (d), the Commission shall consult the Authority. The implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).

AddedArticle 28 Committee procedure

Added1. The Commission shall be assisted by the committee set up by Article 58 of Regulation (EC) No 178/2002.

Added2. Where reference is made to this paragraph, Article 4 of Regulation (EC) No 182/2011 shall apply.

Added3. Where reference is made to this paragraph, Article 5 of Regulation (EC) No 182/2011 shall apply.

AddedArticle 29 Guidance

Added1. Before the date of application of this Regulation, the Authority shall publish detailed guidance to assist the notifier or the applicant in the preparation and the presentation of the notifications and the application referred to in Chapters II and III and for the implementation of Annex II.

Added2. Before the date of application of this Regulation, the European Union Reference Laboratory for Genetically Modified Food and Feed established pursuant to Article 32 of Regulation (EC) No 1829/2003, assisted by the European Network of GMO Laboratories, shall publish detailed guidance to assist the notifier or the applicant for the application of Article 14(1), point (l), and Article 19(2).

AddedArticle 30 Monitoring, reporting and evaluation

Added1. No sooner than three years after the first decision is adopted in accordance with Article 6(8) or (10) or Article 7(6) or in accordance with Sections 2 or 3 of Chapter III, whichever is the earliest, and thereafter every five years, the Commission shall forward to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Regulation.

Added2. 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. [Am. 64]

Added3. 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. [Am. 65]

Added4. No sooner than two years after the publication of the first report referred to in paragraph 1 the Commission shall carry out an evaluation of the implementation of this Regulation and its impact on human and animal health, the environment, consumer information, the functioning of the internal market, and economic, environmental and social sustainability.

Added5. The Commission shall present a report on the main findings of the evaluation referred to in paragraph 4 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

Added5a. 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. [Am. 66]

Added5b. 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. [Am. 67]

Added5c. 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). [Am. 68]

AddedArticle 31 References in other Union legislation

AddedWith regard to category 2 NGT plants, references in other Union legislation to Annex II or Annex III to Directive 2001/18/EC shall be construed as references to Parts 1 and 2 of Annex II to this Regulation.

AddedArticle 32 Administrative review

AddedAny decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a Member State or from any person directly and individually concerned.

AddedTo this effect a request shall be submitted to the Commission within two months from the day on which the party concerned became aware of the act or omission in question.

AddedThe Commission shall prepare a draft decision within two months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.

AddedArticle 33 Amendments to Regulation (EU) 2017/625

AddedArticle 23 of Regulation (EU) 2017/625 is amended as follows:

Added(1) in paragraph 2, point (a)(ii) is replaced by the following:

Added‘(ii) the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];;’

Added(2) in paragraph 3, point (b) is replaced by the following:

Added‘(b) the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];.’

AddedArticle 33a Amendments to Directive 98/44/EC

Added1. Article 4 of Directive 98/44/EC on the legal protection of biotechnological inventions is amended as follows:

Added(a) In paragraph 1, the following points are added:

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];

Added(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.’

Added(b) the following paragraph 4 is added:

Added‘4. Paragraphs 2 and 3 shall be without prejudice to the exclusions from patentability covered in paragraph 1.’

Added2. In Article 8, the following paragraph is added:

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.’

Added3. In Article 9, the following paragraphs are added:

Added‘2. By way of derogation from paragraph 1, a plant product containing or consisting of genetic information obtained by a patentable technical process shall not be patentable if it is not distinguishable from plant products containing or consisting of the same genetic information obtained by an essentially biological process.

Added3. By way of derogation from paragraph 1, the protection conferred by a patent on a product containing or consisting of genetic information shall not extend to plant material in which the product is incorporated and in which the genetic information is contained and performs its function but which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process.

Added4. The protection conferred by a patent on a technical process that enables the production of a product containing or consisting of genetic information shall not extend to plant material in which the product is incorporated and in which the genetic information is contained and performs its function but which is not distinguishable from plant material obtained or which can be obtained by an essentially biological process.’ [Ams. 69, 291cp1, 230/rev1 and 291cp3]

AddedArticle 34 Entry into force and application

Added1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Added2. 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. [Am. 70]

AddedThis Regulation shall be binding in its entirety and directly applicable in all Member States.

AddedDone at …,

AddedFor the European Parliament For the Council

AddedThe President The President

AddedAnnex I

AddedCriteria of equivalence of NGT plants to conventional plants

AddedA 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 typesif the following conditions referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.and 1a are met: [Am. 71]

Added(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:

Added(a) substitution or insertion of no more than 20 nucleotides;

Added(b) deletion of any number of nucleotides; [Am. 72]

Added(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;

Added(a) insertion of continuous DNA sequences existing in the gene pool for breeding purposes;

Added(b) substitution of endogenous DNA sequences with continuous DNA sequences existing in the gene pool for breeding purposes;

Added(c) inversion or translocation of continuous endogenous DNA sequences existing in the gene pool for breeding purposes. [Am. 73]

Added(2) deletion of any number of nucleotides; [Am. 74]