Changes from plenary report to plenary report

RemovedRecital 9: (9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae. Available knowledge on other organisms, such as microorganisms, fungi and animals, should be reviewed with a view to future legislative initiatives on them. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter ‘NGT plants’), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non-crossable species (transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene.

RemovedRecital 10: (10) With full regard to the precautionary principle, the legal framework for NGT plants should share the objectives of the Union GMO legislation to ensure a high level of protection of human and animal health and of the environment and the good functioning of the internal market for the concerned plants and products, while addressing the specificity of NGT plants. This legal framework should enable the development and placing on the market of plants, food and feed containing, consisting of or produced from NGT plants and other products containing or consisting of NGT plants (‘NGT products’) so as to contribute to the innovation and sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and to enhance the competitiveness of the Union agri-food sector at Union and world level.

RemovedRecital 11: (11) This Regulation constitutes lex specialis with regard to the Union GMO legislation. It introduces specific provisions for NGT plants and NGT products. However, where there are no specific rules in this Regulation, NGT plants and products obtained from them should remain subject to the requirements of the Union GMO legislation and the rules on GMOs in sectoral legislation, such as Regulation (EU) 2017/625 on official controls or the legislation on certain products like plant and forest reproductive material.

RemovedRecital 13 a (new): (13a) NGT plants with the potential to persist, reproduce or spread in the environment, within or beyond fields, should be evaluated with the highest level of scrutiny in respect of such plants’ impact on nature and the environment.

RemovedRecital 14: (14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny (‘category 1 NGT plants’) should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent and that their risks are comparable, thereby derogating in full from the Union GMO legislation and GMO related requirements in sectoral legislation. In order to ensure legal certainty, this Regulation should set out the criteria to ascertain if a NGT plant is equivalent to naturally occurring or conventionally bred plants and lay down a procedure for competent authorities to verify and take a decision on the fulfilment of those criteria, prior to the release or placing on the market of NGT plants or NGT products. Those criteria should be objective and based on science. They should cover the type and extent of genetic modifications that can be observed in nature or in organisms obtained with conventional breeding techniques and should include thresholds for both size and number of genetic modifications to the genome of NGT plants. Since scientific and technical knowledge evolves rapidly in this area, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to update these criteria in light of scientific and technical progress as regards the type and extent of genetic modifications that can occur in nature or through conventional …

RemovedRecital 14 a (new): (14a) Taking into account the high complexity of plant genomes, the criteria for considering that a NGT plant is equivalent to a naturally occurring or conventionally bred plant should reflect the diversity of plants genomic size and their characteristics. Polyploid plants contain more than two homologous chromosomes. Within that category of polyploid plants, tetraploid, hexaploid, and octoploid have 4, 6 and 8 sets of chromosomes respectively. Polyploid plants tend to exhibit greater numbers of genetic modifications compared to monoploid plants. For those reasons, any limit to the total number of individual modifications per plant should reflect the number of chromosomes set in a plant (“ploidy”).

RemovedRecital 18: (18) Since the criteria for considering that a NGT plant is equivalent to naturally occurring or conventionally bred plants are unrelated to the type of activity that requires the deliberate release of the NGT plant, a declaration of the category 1 NGT plant status made prior to its deliberate release for any other purpose than placing on the market in the territory of the Union should also be valid for the placing on the market of related NGT products. In view of the high uncertainty existing at the field trial stage about the product reaching the market and the likely involvement of smaller operators in such releases, the verification procedure of category 1 NGT plant status prior to field trials should be conducted by national competent authorities as this would be less administratively burdensome for operators, and a decision should be taken at Union level only in case there are comments to the verification report by other national competent authorities. Where verification request is submitted prior to the placing on the market of NGT products, and if there are reasoned objections by other Member States, the procedure should be conducted in consultation with the Commission and the European Food Safety Authority (‘the Authority’) in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.

RemovedRecital 18 a (new): (18a) In order to effectively select new varieties that help the agricultural sector increase food security, as well as sustainability, adaptation and resilience in relation to the consequences of climate change, it is necessary to consider the specificity of polyploid plants, which are plants that contain more than two genomes. For such plants, the maximum number of genetic modifications allowed for inclusion in category 1 NGT should be proportionate to the number of genomes they contain.

RemovedRecital 19: (19) The competent authorities of the Member States, the Commission and the Authorityshould be subject to appropriate deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.

RemovedRecital 21: (21) Decisions declaring the category 1 NGT plant status should assign an identification number to the NGT plant concerned in order to ensure transparency and traceability of such plants when they are listed in the database. The information listed should include information on the techniqueor techniques used to obtain the trait or traits.

RemovedRecital 23: (23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(47) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. As a result, category 2 NGT plants will be banned in organic production. However, it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. Currently, the compatibility of the use of new genomic techniques with the principles of organic production requires further consideration. The use of category 1 NGT plants should therefore be prohibited in organic production, until such further consideration takes place.

RemovedRecital 24: (24) Provision should be made to ensure transparency as regards the use of category 1 NGT plant varieties, to ensure that production chains that wish to remain free from NGTs can do so and thereby safeguard consumer trust. NGT plants that have obtained a category 1 NGT plant status declaration should be listed in a publicly available database including information on the techniqueor techniques used to obtain the trait or traits. To ensure traceability, transparency and choice for operators, during research and plant breeding, when selling seed to farmers or making plant reproductive material available to third parties in any other way, plant reproductive material of category 1 NGT plants should be labelled as category 1 NGT.

RemovedRecital 29: (29) Directive 2001/18/EC requires a monitoring plan for environmental effects of GMOs after their deliberate release or placing on the market but provides for flexibility as to the design of the plan taking into account the environmental risk assessment, the characteristics of the GMO, of its expected use and of the receiving environment. Genetic modifications in category 2 NGT plants may range from changes only needing a limited risk assessment to complex alterations requiring a more thorough analysis of potential risks. Therefore, post-market monitoring requirements for environmental effects of category 2 NGT plants should be adapted in the light of the environmental risk assessment and the experience in field trials, the characteristics of the NGT plant concerned, the characteristics and scale of its expected use, in particular any history of safe use of the plant and the characteristics of the receiving environment. In view of the precautionary principle, a monitoring plan for environmental effects should always be required when consent is first given. It should only be possible to waive the requirement for monitoring upon the renewal of consent, provided that it has been demonstrated that the category 2 NGT plant does not pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment.

RemovedRecital 36: (36) Herbicide tolerant plants are bred to be intentionally tolerant to herbicides, in order to be cultivated in combination with the use of those herbicides. If such cultivation is not done under appropriate conditions, it may lead to development of weeds resistant to those herbicides or to the need to increase of quantities of herbicides applied, regardless of the breeding technique. For this reason, NGT plants featuring herbicide-tolerant traits should not fall within the scope of the category 1 NGT plants.

RemovedRecital 37: (37) In order to enable NGT plants to contribute to the sustainability objectives of the Green Deal and the Farm to Fork and Biodiversity Strategies, cultivation of NGT plants in the Union should be facilitated. This requires predictability for breeders and farmers as regards the possibility to cultivate such plants in the Union. Therefore, it should not be possible for Member States to adopt measures restricting or prohibiting the cultivation of category 2 NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC, as this would undermine those goals.

RemovedRecital 39: (39) To achieve the goal of ensuring the effective functioning of the internal market and the free movement of NGT plant and NGT products across the Union, the deliberate release of NGT plants and placing on the market of NGT products should be based on the harmonised requirements and procedures laid down in this Regulation, leading to the adoption of a decision uniformly applicable to all Member States. Member States should not unilaterally derogate from the provisions set out in this Regulation in a way that would restrict, prohibit or hinder the free movement, placing on the market and deliberate release of NGT plants or NGT products within the territory of the Union.

RemovedRecital 40: (40) Given the ongoing development of new genomic techniques, the Commission should carry out an evaluation within five years after the adoption of the first decision allowing the deliberate release or the marketing of NGT plants or NGT products in the Union. That evaluation should measure the progress made towards the availability of NGT plants or NGT products containing such characteristics or properties on the EU market, with the aim of further improving this Regulation.

RemovedRecital 43: (43) The types of NGT plants developed and the impact of certain traits on environmental, social and economic sustainability are continuously evolving. Therefore, based on the available evidence of such developments and impacts, fully taking into account the precautionary principle, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to adapt the list of traits that should be incentivized or discouraged to achieve the goals of the Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies.’

RemovedRecital 45 a (new): (45a) The European Parliament has called for the Union and its Member States not to grant patents on biological material and to safeguard the freedom to operate and the breeders’ exemption for varieties. It should be ensured that breeders have full access to the genetic material of NGT plants, which by definition are not transgenic plants. 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). As current provisions in patent law do not provide for a full breeder’s exemption, it should be ensured that patents should not restrict the use of NGT plants by breeders and farmers. Hence, NGT plants should not be subject to patent legislation, but should for the protection of intellectual property solely be subject to the Community Plant Variety Rights (CPVR) system, as laid down in Council Regulation (EC) No 2100/94, which allows the use of the breeder’s exemption. NGT plants, their derived seeds, their plant material, associated genetic material such as genes and gene sequences, and plant traits should therefore be excluded from patentability. The exclusion from patentability should be applied in a consistent manner across legislation. Furthermore, in order to avoid patents being granted or patent applications being submitted between the date of the entry into force of this Regulation and the application of its provisions, it should be ensured that plant material is excluded from patentability …

RemovedArticle 1 – paragraph 1: This Regulation, in accordance with the precautionary principle lays down specific rules for the deliberate release into the environment for any other purpose than placing on the market of plants obtained by certain new genomic techniques (‘NGT plants’) and for the placing on the market of food and feed containing, consisting of or produced from such plants, and of products, other than food or feed, containing or consisting of such plants, ensuring a high level of protection of human and animal health and the environment.

RemovedArticle 3 – paragraph 1 – point 2: (2) ‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the condition that it does not contain any genetic material originating from outside the gene pool for conventional breeding purposes that temporarily may have been inserted during the development of the NGT plant;

RemovedArticle 3 – paragraph 1 – point 4: (4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at targeted locations in the genome of an organism;

RemovedArticle 3 – paragraph 1 – point 6: (6) ‘gene pool for conventional breeding purposes’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses;

RemovedArticle 3 – paragraph 1 – point 15 a (new): (15a) ‘One Health Approach’ means an integrated, unifying approach that aims to sustainably balance and optimise the health of people, animals, plants and ecosystems and recognises that the health of humans, domestic and wild animals, plants, and the wider environment including ecosystems are closely interlinked and inter-dependent;

RemovedArticle 3 – paragraph 1 – point 15 b (new): (15b) “Chimeric protein” means proteins created through the joining of two or more genes or parts of genes that originally coded for separate proteins.

RemovedArticle 4 – paragraph 1 – point 1 – point b: (b) is progeny of plant(s) referred to in point (a) on condition that the criteria of equivalence set out in Annex I are still satisfied ; or

RemovedArticle 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.

RemovedArticle 4 – paragraph 1 a (new): 1a. The implementation, enforcement and application of this Regulation shall not have the object or effect of preventing or impeding imports from third countries of NGT plants and products that meet the same standards as those laid down in this Regulation.

RemovedArticle 4 a (new): Article 4a / Exclusion from patentability / NGT plants, plant material, parts thereof, genetic information and the process features they contain shall not be patentable.

RemovedArticle 5 – paragraph 2: 2. For the purposes of Regulation (EU) 2018/848, the rules set out in its Article 5 (f), (iii), and Article 11 shall apply to category 1 NGT plants and to products produced from or by such plants. [7 years after the entry into force of this Regulation], the Commission shall present a report on the evolution of the consumers' and producers' perception, accompanied, where appropriate, by a legislative proposal.

RemovedArticle 5 – paragraph 3: 3. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the criteria of equivalence of NGT plants to conventional plants laid down in Annex I, taking into account potential associated risks and functional consequences in the verification procedure in order to adapt those criteria to the latest scientific and technological developments as regards the types and extent of modifications which can occur naturally or through conventional breeding.

RemovedArticle 5 – paragraph 3 a (new): 3a. The adventitious or technically unavoidable presence of category 1 NGT plants, reproductive material or parts thereof in organic production, or in non-organic products authorised in organic production in accordance with Articles 24 and 25 of Regulation (EU) 2018/848, shall not constitute non-compliance with that Regulation.

RemovedArticle 6 – paragraph 1: 1. To obtain the declaration of category 1 NGT plant status referred to in Article 4(1), point (a), before undertaking a deliberate release of a NGT plant for any other purpose than placing on the market, the person intending to undertake the deliberate release shall submit a request to verify whether the criteria set out in Annex I at least one of the traits referred to in Annex III, Part 1, and the exclusion criteria in Annex III, Part 2, are met (‘verification request’). That verification request shall be submitted to the competent authority designated in accordance with Article 4(4) of Directive 2001/18/EC of the Member State within whose territory the release is to take place in accordance with paragraphs 2 and 3 and the delegated act adopted in accordance with Article 6(11a), point (b).

RemovedArticle 6 – paragraph 3 – point c: (c) a description of the trait or traits and characteristics which have been introduced or modified, including information on the technique or techniques used to obtain the trait or the traits and including disclosure of the sequence of genetic modification;

RemovedArticle 6 – paragraph 3 – point d – point i: (i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the gene pool for conventional breeding purposes where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the delegated act adopted in accordance with Article 6(11a), point (a);

RemovedArticle 6 – paragraph 3 – point d – point ii: (ii) the NGT plant meets the criteria set out in Annex I, at least one of the traits in Annex III, Part 1, and the exclusion criteria of Annex III, Part 2;

RemovedArticle 6 – paragraph 3 – point d a (new): (da) the denomination of the variety

RemovedArticle 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 may, where appropriate, consult with the European Food Safety Authority ('EFSA') while preparing the verification report. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.

RemovedArticle 6 – paragraph 7: 7. The other Member States and the Commission may make reasoned objections to the verification report, as regards the fulfilment of the criteria set out in Annex I, within 20 days from the date of receipt of that report. Such reasoned objections shall solely refer to the criteria as set out in Annex I and Annex III and shall include a scientific justification.

RemovedArticle 6 – paragraph 8: 8. In the absence of any reasoned 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.

RemovedArticle 6 – paragraph 9: 9. In cases where a reasoned 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 make the reasoned objections publicly available without undue delay.

RemovedArticle 6 – paragraph 10: 10. The Commission, after having consulted 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 reasoned objections, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).

RemovedArticle 6 – paragraph 11 a (new): 11a. The Commission is empowered to adopt delegated acts in accordance with Article 26 supplementing this Regulation concerning: / (a) the information required to demonstrate that a plant is a NGT plant; / (b) the preparation and the presentation of the verification requests referred to in Articles 6 and 7.

RemovedArticle 7 – paragraph 2 – point b a (new): (ba) the denomination of the variety;

RemovedArticle 7 – paragraph 2 – point c: (c) a description of the trait(s) and characteristics which have been introduced or modified including information on the technique or techniques used to obtain the trait or the traits and on disclosure of the sequence of genetic modification;

RemovedArticle 7 – paragraph 7: 7. The Commission shall publish the final decision in the Official Journal of the European Union and shall publish, in a dedicated and publicly available webpage, its draft decision and the reasoned objections referred to in Article 6.

RemovedArticle 9 – paragraph 1 – subparagraph 2 – point b: (b) the designation and specification of the category 1 NGT plant;

RemovedArticle 9 – paragraph 1 – subparagraph 2 – point b a (new): (ba) the denomination of the variety;

RemovedArticle 9 – paragraph 1 – subparagraph 2 – point e a (new): (ea) if provided, the opinion or statement of EFSA, as referred to in Article 6 (10) and Article 7(5); and

RemovedArticle 9 – paragraph 2: 2. The database shall be publicly available, and in an online format.

RemovedArticle 10 – paragraph 1: Plant reproductive material, including for breeding and scientific purposes that contains or consists of category 1 NGT plant or plants and is made available to third parties, whether in return for payment or free of charge, shall bear a label and a reference to a variety register automatically transmitted to the EU common register indicating the words ‘cat 1 NGT’, followed by the identification number of the NGT plant or plants it has been derived from.

RemovedArticle 16: deleted / (deleted) / (deleted)

RemovedArticle 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 traits of the NGT plant conveyed by the genetic modification is contained in Article 51(1) of Regulation (EU/…)* and it does not have any traits referred to in Part 2 of that Annex. / * Commission proposal for a Regulation on plant reproductive material (COM/2023/414), (2023/0227(COD)).

RemovedArticle 24: Member States may take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003, only in the event that the category 2 NGT plants are able to be detected, identified and quantified by analytical methods. These provisions shall not apply to category 1 NGT plants and category 1 NGT products.

RemovedArticle 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.

RemovedArticle 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.

RemovedArticle 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.

RemovedArticle 27 – paragraph 1 – point a: deleted

RemovedArticle 27 – paragraph 1 – point b: deleted

RemovedArticle 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.

RemovedArticle 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.

RemovedArticle 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.

RemovedArticle 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.

RemovedArticle 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).

RemovedDirective 98/44/EC

RemovedArticle 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).

RemovedArticle 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.

RemovedAnnex 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:

RemovedAnnex 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;

RemovedAnnex 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.

RemovedAnnex I – point 2: deleted

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

RemovedAnnex I – point 4: deleted

RemovedAnnex I – point 5: deleted

RemovedAnnex 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;

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

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

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

RemovedAnnex 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;

RemovedAnnex 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.

RemovedAnnex 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 .

RemovedNew genomic techniques (NGTs) provide unprecedented opportunities for European agriculture and food production. These techniques enable us to alter the genetic materials of a certain organism providing swift development of different plant varieties with certain characteristics. NGTs are not limited to one specific technique but rather represent a diverse group of techniques that can contribute to a more tailored modification of the genome in comparison to conventional plant breeding. The achieved modification of the genome could or could not be produced in nature or obtained by conventional breeding techniques.

RemovedInnovative technologies such as CRISPR/Cas9, which was awarded the Nobel Prize in Chemistry in 2020, have the ability to improve plant breeding by strengthening various crops through more targeted changes and without the need to add anything new in the genetic composition of a crop.

RemovedNGTs therefore have the ability to enhance agriculture by making crops and harvests more resilient and sustainable. Given their low operating and entry costs, these techniques could also contribute to improving the Union´s trade policy and competitiveness.

RemovedUnfortunately, the European Union currently cannot utilize this potential.

RemovedIn its judgment of 25 July 2018, the Court of Justice of the European Union held that Directive 2001/18 cannot be interpreted as excluding from its scope genetically modified organisms (GMOs) obtained by certain new techniques.

RemovedThe practical implication of this has been significant, as NGTs have still not been introduced within the Union.

RemovedAs the European Commission concluded in a 30 April 2021 study delivered at the request of the Council on 8 November 2019, EU legislation should be adapted in line with scientific and technical progress in this area.

RemovedA new, adapted, legislation is essential to enable the use of these new techniques. It is essential to have adequate risk assessment requirements and authorisation procedures to ensure that a variety of potential plant products can be introduced within the EU. The current requirements and processes for genetically modified crops are not enabling the new techniques or a variety of plant products.

RemovedWithout an enabling framework in line with the scientific and technical progress, these problems continue to affect operators affected by the current regulations across the agri-food system. Consumers, farmers and the innovative sector cannot currently benefit from NGTs.

RemovedIn the absence of a modern regulatory framework in the EU, other countries in the world have already undertaken measures to enable the usage of NGTs. The EU therefore risks falling behind in both competitiveness and scientific and technological research. This would negatively impact European food safety as well as resilience in European food production.

RemovedObjectives and ambitions of the draft proposal

RemovedThe rapporteur supports the overall approach of the European Commission and welcomes its proposal to introduce a new regulation on plants obtained by certain new genomic techniques and their food and feed. Taking into account that the current regulatory framework is not in line with the latest scientific and technological development, the rapporteur welcomes this proposal with its objectives set out in the food safety-strategy Farm to fork. The proposal goes in line with the Farm to fork-strategy and its aim to transform European agriculture and food production towards sustainability and strengthen European competitiveness.

RemovedThe COVID-19 pandemic and Russia´s war of aggression against Ukraine have both aggravated the situation for European agriculture and food production by showing the Union´s external dependencies on critical inputs for agriculture.

RemovedWhile the rapporteur believes that the Commission proposal is a solid starting point, she believes that some further improvements and additions are required to ensure the best possible usage of the techniques.

RemovedClarification and improvement of the criteria for NGT 1-plants

RemovedThe rapporteur is of the opinion that the provisions related to category 1 (NGT 1) should be further improved. She believes that the criteria in annex I that defines an NGT 1 plant should be further clarified and improved. The Commission proposes a threshold of 20 genetically modified changes that cannot be exceeded if a plant were to be defined as an NGT 1.

RemovedConcerning the criteria set out in annex I to fall under NGT 1: the threshold of 20 genetically modified changes should be specified by ensuring that each change in a plant and/or a crop must be relative to the ploidity status in the crop. If, for example, a plant has a duplication of chromosomes and one modification de facto makes two changes, 10 modifications can already make up to 20 potential changes. This would risk going beyond its purpose. The particular change in a crop or a plant must be based on a single copy of a gene.

RemovedOrganic farming

RemovedThe rapporteur also believes that NGTs should be allowed and enabled in organic farming. The purpose of this draft report is to ensure that any operators without discrimination can use the techniques. Thus, the proposed ban by the Commission for the techniques to be used in organic farming is lifted to ensure a fair playing field without imposing the technique on any operator.

RemovedThe proposal should ensure that every operator could have access to these new technologies. The freedom of choice is essential for operators and the technique should remain available.

RemovedEnsuring science-based verification processes

RemovedThe proposed regulation also introduces verification procedures for NGT 1 prior to the deliberate release of plants for this category. The rapporteur believes that is important to ensure full compliance with the regulation. However, she believes that the verification process should be for the competent authority in a Member State where the application is submitted and without additional Member States able to challenge a certain decision of approval without a reasoned objection.

RemovedThe verification process should be based on the scientifically approved criteria set out in the annex defining a category 1 plant and, where appropriate, in close consultation with the European Commission and the European Food Safety Authority.

RemovedTraceability and labelling

RemovedAs regards the traceability and labelling of NGT 1 plants, the rapporteur supports the proposal by the commission by making information about the use of NGTs publicly available in the proposed public database. This ensures transparency and consumer choice. However, the rapporteur does not support seed bag labelling for verified conventional-like NGT plants as that would be discriminatory. Conventional-like NGT plants should be treated conventionally; this extra requirement is creating unjustified distinctions and administrative burden

RemovedPatents and patentability

RemovedThe rapporteur also takes note of the concerns expressed with regard to the patent on NGTs by breeders and farmers. The rapporteur believes that this should be regulated in existing separate regulations where they are currently regulated to avoid having this proposal go beyond its scope. The rapporteur therefore supports the proposed approach by the commission to assess on a regular basis and submit a report on how to address this after the legislation has worked in practice in order to assess if a technique is subject to be patentable.

RemovedThe Committee on Agriculture and Rural Development (AGRI) also has shared competencies on some provisions pursuant to Rule 57 with the Committee on the Environment, Public Health and Food Safety (ENVI). The rapporteur is therefore committed to working constructively with the rapporteur from the AGRI committee to find a good and balanced proposal for these techniques.