Changes from adopted text to adopted text

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

Added(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. ThereforeIn view of the precautionary principle, a monitoring plan for environmental effects should notalways be required ifwhen 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 is unlikely todoes not pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment. [Am. 17]

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

Added(30) For reasons of proportionality, after a first renewal of the authorisation, the authorisation should be valid for an unlimited period, unless decided differently at the time of that renewal based on the risk assessment and the available information on the NGT plant concerned, subject to reassessment when new information has become available.

RemovedArticle 10 – paragraph 1: Category 1 NGT plants, products containing or consisting of category 1 NGT plant(s) and plant reproductive material, including for breeding and scientific purposes that contains or consists of category 1 NGT plant(s) and is made available to third parties, whether in return for payment or free of charge, shall bear a label indicating the words ‘New Genomic Techniques’. In the case of plant reproductive material, it shall be followed by the identification number of the NGT plant(s) it has been derived from.

Added(31) For reasons of legal certainty and good administration, the timeline for the Authority to deliver its opinion on an application for authorisation should only be extended when additional information is necessary to carry out the assessment of the application, and the extension should not be longer than the originally foreseen time limit unless it is justified by the nature of the data or exceptional circumstances.

RemovedArticle 10 – paragraph 1 a (new): Appropriate document-based traceability for NGTs shall be provided by the transmission and holding of information that products contain or consist of NGT plants and product, and the unique codes for those NGTs, at each stage of their placing on the market.

Added(32) To increase transparency and consumers’ information, operators should be allowed to complement the labelling of category 2 NGT products as GMO with information on the trait conferred by the genetic modification. In order to avoid misleading or confusing indications, a proposal for such a labelling should be provided in the notification for consent or in the application for authorisation and should be specified in the consent or in the authorisation decision.

RemovedArticle 11 a (new): Article 11a / Withdrawal of the decision / If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis, the competent authority may withdraw its decision referred to in Article 6(8) or statement referred to in Article 7(5). The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who shall have 15 days in which to make observations. In that case, the marketing of the NGT plant or product shall be prohibited from the day following the date of receipt of the registered letter.

Added(33) Regulatory incentives should be offered to potential notifiers or applicants for category 2 NGT plants and products containing traits with the potential to contribute to a sustainable agri-food system, in order to steer the development of category 2 NGT plants towards such traits. The criteria to trigger these incentives should focus on broad trait categories with the potential to contribute to sustainability (such as those linked to tolerance or resistance to biotic and abiotic stresses, improved nutritional characteristics or increased yield) and should be based on the contribution to the value for sustainable cultivation and use as defined in [Article 52(1) of the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union]. The applicability of the criteria across the EU does not allow a narrower definition of traits to focus on specific issues or address local and regional specificities.

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

Added(34) Incentives should consist in an accelerated procedure for risk assessment as regards applications handled by a fully centralised procedure (food and feed products) and enhanced pre-submission advice to help developers prepare the dossier for the purpose of the environmental and food and feed safety assessments, without affecting the general provisions on pre-submission advice, notification of studies and consultation of third parties pursuant to Articles 32a, 32b and 32c of Regulation (EC) No 178/2002().

RemovedArticle 17 – paragraph 2 a (new): 2a. If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis, the competent authority may withdraw its decision. The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who shall have 15 days in which to make observations. In that case, the marketing of the NGT plant or product shall be prohibited from the day following the date of receipt of the registered letter.

Added(35) Additional incentives should be afforded when the notifier or applicant is a small or medium-sized enterprise (SME), to promote access to the regulatory procedures by these enterprises, support diversification of developers of NGT plants and encourage the development by small breeders of crop species and traits by means of NGTs, by granting fee waivers for the validation of detection methods to SMEs and more extensive pre-submission advice covering also the design of studies to be carried out for the purpose of risk assessment.

RemovedArticle 20 – paragraph 4: 4. The Union reference laboratory shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 19(2). If the applicant justifies the application of adapted modalities to comply with detection method requirements, the Union reference laboratory shall carry out its own research and analyses to confirm the claimed unfeasibility. In that case, the decision of the Union reference laboratory shall be motivated and be made public.

Added(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 be eligible for incentives under this framework. However, this Regulation should not take other specific measures on herbicide tolerantfall within the scope of the category 1 NGT plants, because such measures are taken horizontally in [the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union]. [Am. 18]

RemovedArticle 21 – paragraph 1 a (new): If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis or if the competent authority may withdraw its decision. The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who shall have 15 days in which to make observations. In that case, the marketing of the NGT plant or product shall be prohibited from the day following the date of receipt of the registered letter.

Added(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, the possibility 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 would undermine those goals. [Am. 239]

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)).

Added(38) The special rules laid down in this Regulation concerning the authorisation procedure for category 2 NGT plants are expected to result in more cultivation in the Union of category 2 NGT plants compared to the situation so far under the current Union GMO legislation. That renders necessary for Member States’ public authorities to define coexistence measures to balance the interests of producers of conventional, organic and GM plants and thereby allow producers a choice between different types of production, in line with the Farm to Fork Strategy’s target of 25 % of agricultural land under organic farming by 2030.

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.

Added(39) To achieve the goal of ensuring the effective functioning of the internal market, NGT plants and related products should benefit from and the free movement of goods, provided they comply with theNGT 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 Statesof other Union law. [Am. 20]

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.

Added(40) Given the novelty of the NGTs, it will be important to monitor closely theongoing development and presence on the market of NGT plants and products and evaluate any accompanying impact on human and animal health, the environment and environmental, economic and social sustainability. Informationof new genomic techniques, the Commission should be collected regularly andcarry 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, the Commission should carry out an. That evaluation of this Regulation toshould 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. [Am. 21]

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.

Added(41) In order to provide a high level of protection of health and environmental protection in relation to NGT plants and NGT products, requirements arising from this Regulation should apply in a non-discriminatory manner to products originating in the Union and imported from third countries.

RemovedArticle 27 – paragraph 1 – point a: deleted

Added(42) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can be better achieved at Union level, so that NGT plants and NGT products may circulate freely within the internal market, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

RemovedArticle 27 – paragraph 1 – point b: deleted

Added(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. [Am. 22]

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.

Added(44) It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

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.

Added(45) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the information required to demonstrate that a NGT plant is a category 1 NGT plant, as regards the preparation and the presentation of the notification for that determination, and as regards the methodology and information requirements for the environmental risk assessments of category 2 NGT plants and of NGT food and NGT feed, in accordance with the principles and criteria laid down in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council().

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.

Added(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 from the day of entry into force of this Regulation. For patents already granted or pending patent applications covering plant material, the effects of patents should be further limited. In addition, the Commission should assess and address, in the forthcoming study, how the broader problem of patents being granted, directly or indirectly, on plant material despite previous efforts to close loopholes, should be further addressed. The assessment should address in particular the role and impact of patents on breeders' and farmers' access to plant reproductive material, seed diversity and affordable prices, as well as on innovation and in particular on opportunities for SMEs. The report of the Commission should be accompanied by the appropriate legislative proposals in order to ensure further necessary adjustments are made to the intellectual property rights framework. [Am. 23]

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.

Added(46) The Commission should regularly collect information in order to assess the performance of the legislation in achieving the development and availability of NGT plants and NGT products in the market that can contribute to the objectives of the Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and in order to inform an evaluation of the legislation. A broad set of indicators have been identified and should be periodically reviewed by the Commission. The indicators should support monitoring of potential risks to health or the environment of category 2 NGT plants and related NGT products, impact of NGT plants on environmental, economic and social sustainability as well as impact on organic agriculture and on consumers acceptance of NGT products. A first monitoring report should be presented three years after the first products have been notified/authorised, to ensure that enough data is available after full implementation of the new legislation, and at regular intervals thereafter. The Commission should carry out an evaluation of this Regulation two years after the first monitoring report has been published, in order to allow for the impact of the first products going through the verification or authorisation to fully materialise.

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).

Added(47) Certain references to provisions of the Union GMO legislation in Regulation (EU) 2017/625 of the European Parliament and of the Council () need to be amended to include the specific provisions in this legislation applicable to NGT plants.

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

Added(47a) The European Green Deal, the ‘Farm to Fork’, and the EU Biodiversity Strategies put organic farming at the core of a transition to sustainable food systems, with a target to expand European agricultural land under organic production to 25 % by 2030. This is a clear recognition of the environmental benefits of organic farming, for less dependency on inputs for farmers, and a resilient food supply and food sovereignty. This Regulation must not adversely undermine the pathway to a transition of European food systems to organic farming to 25 % by 2030. [Am. 241]

RemovedArticle 33 a (new)

Added(47b) Traceability requirements for food and feed produced from NGTs should be established to facilitate the accurate labelling of such products, in accordance with the requirements of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, so as to ensure that accurate information is available to operators and consumers to enable them to exercise their freedom of choice in an effective manner, as well as to enable control and verification of labelling claims. Requirements for food and feed produced from NGTs should be similar in order to avoid discontinuity of information in cases of change in end use. [Am. 243]

RemovedDirective 98/44/EC

Added(48) Since the application of this Regulation requires the adoption of implementing acts, it should be deferred in time to allow for the adoption of such measures,

RemovedArticle 4, Article 8 and Article 9

AddedHAVE ADOPTED THIS REGULATION:

RemovedAmendment: 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…

AddedCHAPTER I GENERAL PROVISIONS

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.

AddedArticle 1 Subject matter

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:

AddedThis 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. [Am. 24]

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;

AddedArticle 2 Scope

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.

AddedThis Regulation shall apply to:

RemovedAnnex I – point 2: deleted

Added(1) NGT plants;