BETA

166 Amendments of Manon AUBRY related to 2023/0226(COD)

Amendment 29 #
Draft legislative resolution
Citation -1 (new)
– The European Parliament rejects the Commission proposal.
2023/11/19
Committee: ENVI
Amendment 30 #
Draft legislative resolution
Citation 2
– having regard to Article 43(2), Article 114, Article 191 and Article 168(4)(b)of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9- 0238/2023),
2023/11/19
Committee: ENVI
Amendment 32 #
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain newer genomic manipulation techniques and their food and feed, and amending Regulation (EU) 2017/625products derived of these plants (Text with EEA relevance)
2023/11/19
Committee: ENVI
Amendment 34 #
Proposal for a regulation
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, 191 and 168(4) (b) thereof,
2023/11/19
Committee: ENVI
Amendment 36 #
Proposal for a regulation
Recital -1 (new)
(-1) Living organisms, whether released into the environment in large or small amounts for experimental purposes or as commercial products, may reproduce in the environment and cross national frontiers thereby affecting other Member States. The effects of such releases on the environment may be irreversible.
2023/11/19
Committee: ENVI
Amendment 38 #
Proposal for a regulation
Recital -1 a (new)
(-1a) The protection of health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of genetically modified organisms (GMOs). Under the Treaty, action by the European Union relating to the environment should be based on the principle that preventive action should be taken.
2023/11/19
Committee: ENVI
Amendment 39 #
Proposal for a regulation
Recital -1 b (new)
(-1b) The precautionary principle is a general principle of EU law requiring the authorities in question, in the particular context of the exercise of the powers conferred on them by the relevant rules, to take appropriate measures to prevent specific potential risks to public health, safety and the environment, by giving precedence to the requirements related to the protection of those interests over economic interests.
2023/11/19
Committee: ENVI
Amendment 40 #
Proposal for a regulation
Recital -1 b (new)
(-1b) Respect for ethical principles recognised in a Member State is particularly important. Member States may take into consideration ethical aspects when GMOs are deliberately released or placed on the market as or in products.
2023/11/19
Committee: ENVI
Amendment 41 #
Proposal for a regulation
Recital -1 c (new)
(-1c) A sustainable food system is at the heart of the European Green Deal. Agroecology can provide healthy food while maintaining productivity, increase soil fertility and biodiversity, and reduce the footprint of food production. Organic farming in particular holds great potential for farmers and consumers alike. The sector creates jobs and attracts young farmers. Organic farming also provides 10-20 % more jobs per hectare than conventional farms, and creates added value for agricultural products. To make the most of this potential, under the Green Deal’s Farm to Fork and Biodiversity Strategies, the European Commission has set a target of ‘at least 25% of the EU’s agricultural land under organic farming and a significant increase in organic aquaculture by 2030’.
2023/11/19
Committee: ENVI
Amendment 44 #
Proposal for a regulation
Recital 1
(1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the Council (32 ), on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted, significant progress in biotechnology has led to the development of newer genomic manipulation techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precise locations. However, also these newer techniques may lead to unexpected outcomes that cannot be fully predicted and that may be equivalent or different compared to plants obtained by conventional breeding. _________________ 32 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
2023/11/19
Committee: ENVI
Amendment 57 #
Proposal for a regulation
Recital 2
(2) NGTs constitute a diverse group of genomic techniques, and each of them can be used in various ways to achieve different results and products. They can result in organisms with modifications equivalent to what can be obtained by conventional breeding methods or in organisms with more complex modifications. Among NGTs, targeted mutagenesis and cisgenesis (including intragenesis) introduce genetic modifications without inserting genetic material from non-crossable species (transgenesis). They rely only on the breeders’ gene pool, i.e. the total genetic information that is theoretically available for conventional breeding including from distantly related plant species that can be crossed by advanced breeding techniques. Targeted mutagenesis techniques result in modification(s) of the DNA sequence at precise locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool.
2023/11/19
Committee: ENVI
Amendment 59 #
Proposal for a regulation
Recital 2 a (new)
(2a) However, the processes used in cisgenesis and intragenesis are the same as used in transgenesis, namely the insertion of additional gene sequences. Furthermore, the gene pool used by conventional breeders under practical conditions, may show restrictions that are absent in a gene pool that can be exploited by direct (and potentially repeated) gene transfer across all kinds of genetic backgrounds and therefore result in plants that are unlikely to be obtained by methods of conventional breeding.
2023/11/19
Committee: ENVI
Amendment 69 #
Proposal for a regulation
Recital 3
(3) There is ongoing public and private research using NGTs on a wider variety of crops and traits compared to those obtained through transgenic techniques authorised in the Union or globally(33 ). This includesleads to promises about the development of plants with improved tolerance or resistance to plant diseases and pests, plants with improved tolerance or resistance to climate change effects and environmental stresses, improved nutrient and water-use efficiency, plants with higher yields and resilience and improved quality characteristics. These types of new plants, coupled with the fairly easy and speedy applicability of those new techniques, could deliver benefits to farmers, consumers and to the environmentshould they indeed be developed in the future, coupled with appropriate risk assessment, traceability, labelling and co- existence measures, together with the necessary legal adaptations in the field of intellectual property protection in order to exclude risks of monipolisation in the food chain, could potentially deliver benefits to breeders. Thus, NGTs could have the potential to contribute to the innovation and sustainability goals of the European Green Deal (34 ) and of the ‘Farm to Fork’ (35 ), Biodiversity (36 ) and Adaptation to Climate Change(37 ) Strategies, to global food security (38 ), the Bioeconomy Strategy (39 ) and to the Union’s strategic autonomy (40 ). _________________ 33 Insights and solutions stemming from EU-funded research and innovation projects on plant breeding strategies may contribute to address detection challenges, ensure traceability and authenticity, and promote innovation in the area of new genomic techniques. More than 1,000 projects were funded under the Seventh Framework Programme and successor Horizon 2020 programme with an investment of over 3 billion Euros. Horizon Europe support to new collaborative research projects on plant breeding strategies is also ongoing, SWD(2021) 92. 34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final. 35 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, healthy and environmentally friendly food system, COM/2020/381 final. 36 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030: Bringing nature back into our lives, COM/2020/380 final. 37 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions forging a Climate-Resilient Europe - The New EU Strategy on Adaptation to Climate Change, COM(2021) 82 final 38 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, Safeguarding food security and reinforcing the resilience of food systems, COM (2022) 133 final; Food and Agriculture Organisation of the United Nations (FAO), 2022, Gene editing and agrifood systems, Rome, ISBN 978- 92-5-137417-7. 39 European Commission, Directorate- General for Research and Innovation, A sustainable bioeconomy for Europe – Strengthening the connection between economy, society and the environment: updated bioeconomy strategy, Publications Office, 2018, https://data.europa.eu/doi/10.2777/792130. 40 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Trade Policy Review - An Open, Sustainable and Assertive Trade Policy, COM(2021)66 final.
2023/11/19
Committee: ENVI
Amendment 78 #
Proposal for a regulation
Recital 4
(4) The deliberate release into the environment of organisms obtained by NGTsgenetic manipulation, including products containing or consisting of such organisms, as well as the placing on the market of food and feed produced from these organisms, are subject to Directive 2001/18/EC and, Regulation (EC) No 1830/2003 (41 ) of the European Parliament and of the Council and, in the case of food and feed, also to Regulation (EC) No 1829/2003 (42 ), while the contained use of plant cells is subject to Directive 2009/1/EC, and transboundary movements of NGTGM plants to third countries are regulated by Regulation (EC) No 1946/2003 (‘the Union GMO legislation’). _________________ 41 Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, p. 24). 42 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).
2023/11/19
Committee: ENVI
Amendment 82 #
Proposal for a regulation
Recital 5
(5) In its judgment in case C-528/16 Confédération paysanne and Others43 the Court of Justice of the European Union noted that the definition of a GMO in Article 2(2) of Directive 2001/18 is made clear by a distinction between techniques the use of which results in genetic modification and techniques which are not considered to result in such genetic modification, and the Court held that GMOs obtained by means of new techniques/methods of mutagenesis that had appeared or had been mostly developed since Directive 2001/18/EC was adopted could nomust be considered excluded from the scopeto be GMOs within the meaning of Article 2(2) of that Directive. _________________ 43 Judgement of the Court of Justice of 25 July 2018, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, C-528/16, ECLI:EU:C:2018:583.
2023/11/19
Committee: ENVI
Amendment 84 #
Proposal for a regulation
Recital 6 a (new)
(6a) The European Parliament, in its reaction to the Farm to Fork strategy for a fair, healthy and environmentally- friendly food system, highlighted the precautionary principle and the need to ensure transparency and freedom of choice to farmers, processors and consumers, and stressed that any policy action on NGTs should include risk assessments and a comprehensive overview and assessment of options for traceability and labelling with a view to achieving proper regulatory oversight and should provide consumers with relevant information, including for products from third countries in order to ensure a level playing field.
2023/11/19
Committee: ENVI
Amendment 85 #
Proposal for a regulation
Recital 6 b (new)
(6b) The European Parliament has called1a for a comprehensive analysis of the socioeconomic and environmental effects on the food system of patents on breeding processes, plant propagation material and parts thereof, including their potential to increase market concentration and monopolisation in the food chain, as well as their impact on the affordability and availability of food, and called for the EU and its Member States not to grant patents on biological material and to safeguard the freedom to operate and breeders’ exemption for varieties. It is therefore appropriate to ensure that patented plants are not subject to any exemptions of the Union GMO legislation. Furthermore, to address the threat patents pose to food security, the Commission should rapidly investigate the best route to ban the use of patents in the food chain. The Commission should present a legal proposal to achieve this by 31 December 2024. _________________ 1a European Parliament resolution of 14 June 2023 on ensuring food security and long-term resilience of the EU agriculture (2022/2183(INI)) P9_TA(2023)0238
2023/11/19
Committee: ENVI
Amendment 92 #
Proposal for a regulation
Recital 7 a (new)
(7a) Currently, the debate on using NGTs in plant breeding is held almost exclusively among scientists, scientific and industry organisations, and companies in the agri-food field, as well as a small number of NGOs. However, in shaping a new policy on NGTs, it is important to include the voice of citizens, not only because biotechnologies have the power to redesign life, but also because they offer the potential to reshape the practice of agriculture and the future of our food (system). The way we produce food involves questions of how we want to live on this planet and how we want to relate to other species. For purposes of democracy, citizens need to have a say on which public values are incorporated in a new policy for NGTs.
2023/11/19
Committee: ENVI
Amendment 94 #
Proposal for a regulation
Recital 7 b (new)
(7b) One of the few studies that have been performed to investigate the attitude of the public, concluded1a that in general, citizens’ views converged towards reservation and hesitation about the use of NGTs and genetic modification in crops. Citizens raised doubts mainly about the plausibility that these crops will contribute meaningfully to the solving of our current societal challenges in the food system, and whether they are indeed the right approach for dealing with these challenges. They wondered if alternative solutions may be better, and how these may come with less unforeseen, long-term risks for human health and ecosystems. Moreover, the citizens in this study questioned whether companies will in practice develop valuable varieties for society, as the logics of the corporate world tend to be focused on capital accumulation and on making profits. Citizens were unanimous in their view that regulation of NGT crops is necessary for diverse reasons: to prevent harms to the environment and human health, to give consumers freedom of choice, to guard against the potential of the technology to increase inequalities, and to ensure that the technology is directed towards contributing to solutions to societal problems. The latter is viewed as an important pre-condition for the introduction of NGT products onto the marketplace. According to citizens, NGTs should not be developed purely for commercial motives driven by the logic of the market. There needs to be a clear societal purpose for their introduction. In terms of policy, this would necessitate a case-by-case assessment of NGT crops for broader considerations such as purpose, and value to society. _________________ 1a Rathenau Instituut (2023). Editing under provision – Dutch citizens’ views on new genomic techniques in food crops. Den Haag. Authors: Habets, M., I. Pirson, P. Macnaghten and P. Verhoef.
2023/11/19
Committee: ENVI
Amendment 98 #
Proposal for a regulation
Recital 8
(8) It is therefore necessaryappropriate to adopt a specific legal frameworkprovisions for GMOs obtained by targeted mutagenesis and cisgenesis and related products when deliberately released into the environment or placed on the market.
2023/11/19
Committee: ENVI
Amendment 106 #
Proposal for a regulation
Recital 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, excluding microorganisms, fungi and animals for which the available knowledge is more limitedannual arable plants without the potential to persist, reproduce and propagate in the environment, excluding microorganisms, fungi and animals. 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 ((cisgenesis, intragenesis and transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.
2023/11/19
Committee: ENVI
Amendment 118 #
Proposal for a regulation
Recital 10
(10) 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, in line with the precautionary principle and the One Health principle, for the concerned 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, Zero Pollution and Climate Adaptation strategies and to enhance the competitiveness of the Union agri-food sector at Union and world levelhe Organic action plan.
2023/11/19
Committee: ENVI
Amendment 133 #
Proposal for a regulation
Recital 13
(13) This Regulation should distinguish between two categories of NGT plants.deleted
2023/11/19
Committee: ENVI
Amendment 144 #
Proposal for a regulation
Recital 14
(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘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 fulfillment 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 breeding.deleted
2023/11/19
Committee: ENVI
Amendment 161 #
Proposal for a regulation
Recital 15
(15) All NGT plants that are not category 1 (‘category 2 NGT plants’) should remain subject to the requirements of the Union GMO legislation because they feature more complex sets of modifications to the genome.
2023/11/19
Committee: ENVI
Amendment 166 #
Proposal for a regulation
Recital 16
(16) Category 1 NGT plants and products should not be subject to the rules and requirements of the Union GMO legislation and to provisions in other Union legislation that apply to GMOs. For legal certainty for operators and transparency, a declaration of the category 1 NGT plant status should be obtained prior to deliberate release, including the placing on the market.deleted
2023/11/19
Committee: ENVI
Amendment 171 #
Proposal for a regulation
Recital 17
(17) This declaration should be obtained prior to any deliberate release of any category 1 NGT plants for any other purpose than placing on the market, such as for field trials that are to take place in the territory of the Union, since the criteria are based on data that is available before the field trials and does not depend on these field trials. When no field trials are to take place in the territory of the Union, operators should obtain that declaration before placing the category 1 NGT product on the market.deleted
2023/11/19
Committee: ENVI
Amendment 179 #
Proposal for a regulation
Recital 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 the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.deleted
2023/11/19
Committee: ENVI
Amendment 192 #
Proposal for a regulation
Recital 19
(19) The competent authorities of the Member States, the Commission and the European Food Safety Authority (‘the Authority’) should be subject to strict deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.deleted
2023/11/19
Committee: ENVI
Amendment 200 #
Proposal for a regulation
Recital 20
(20) The verification of category 1 NGT plant status is of technical nature and does not involve any risk assessment or risk management considerations and the decision on the status is only declaratory. Therefore, when the procedure is conducted at Union level, such implementing decisions should be adopted by the advisory procedure, supported by scientific and technical assistance by the Authority.deleted
2023/11/19
Committee: ENVI
Amendment 205 #
Proposal for a regulation
Recital 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 and for the purpose of labelling of plant reproductive material derived from them.deleted
2023/11/19
Committee: ENVI
Amendment 212 #
Proposal for a regulation
Recital 22
(22) Category 1 NGT plants should remain subject to any regulatory framework that applies to conventionally bred plants. As is the case for conventional plants and products, those NGT plants and their products will be subject to the applicable sectoral legislation on seed and other plant reproductive material, food, feed and other products, and horizontal frameworks, such as the nature conservation legislation and environmental liability. In this regard, category 1 NGT food featuring a significantly changed composition or structure that affects the nutritional value, metabolism or level of undesirable substances of the food will be considered as novel food and thus fall into the scope of Regulation (EU) 2015/2283 of the European Parliament and of the Council (46 ) and will be risk assessed in that context. _________________ 46 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).deleted
2023/11/19
Committee: ENVI
Amendment 230 #
Proposal for a regulation
Recital 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 NGT plants are and should remain banned in organic production. However, iIt is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. The use of new genomic techniques is currently incompatible with the concept of organic production in the Regulation (EC) 2018/848 and with consumers’ perception of organic products. The use of category 1 NGT plants should therefore be also prohibited in organic productionensure that the organic sector as a whole has the means to remain GMO-free. Member States should lay down rules to ensure and enforce sufficiently wide buffer zones between organic, conventional and NGT crops. Labelling and traceability shall remain in place on all NGT plants and products containing them to ensure cross- contamination to organic plants and products is not taking place. _________________ 47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).
2023/11/19
Committee: ENVI
Amendment 238 #
Proposal for a regulation
Recital 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. 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 1consumers, food producers, farmers and other operators, plant reproductive material, plants, food and feed and products of NGT plants should be labelled as category 1GMO and NGT.
2023/11/19
Committee: ENVI
Amendment 248 #
Proposal for a regulation
Recital 25
(25) Category 2 NGT plants should remain subject to the requirements of the Union GMO legislation given that on the basis of current scientific and technical knowledge, their risks need to be assessed. Special rules should be provided in order to adapt the procedures and certain other rules laid down in Directive 2001/18/EC and Regulation (EC) No 1829/2003 to the specific nature of category 2 NGT plants and the differing levels of risk that they may pose.
2023/11/19
Committee: ENVI
Amendment 257 #
Proposal for a regulation
Recital 26
(26) Category 2 NGT plants and products, in order to be released into the environment or placed on the market, should remain subject to a consent or authorisation in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. However, given the wide variety of those NGT plants, the amount of information necessary for the risk assessment will vary on a case-by-case basis. The Authority, in its scientific opinions on plants developed through cisgenesis and intragenesis48 and on plants developed through targeted mutagenesis49 recommended flexibility in data requirements for the risk assessment of these plants. Based on the Authority’s ‘Criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis’ (50 ), considerations on the history of safe use, familiarity for the environment and the function and structure of the modified/inserted sequence(s) should assist in determining the type and amount of data required to perform the risk assessment of those NGT plants. It is therefore necessary to establish general principles and criteria for the risk assessment of these plants, while providing for flexibility and possibility to adapt risk assessment methodologies to scientific and technical progress. _________________ 48 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta, J, Fernandez Dumont A, Gennaro A, Lenzi, P, Lewandowska A, Munoz Guajardo IP, Papadopoulou N and Rostoks N, 2022. Updated scientific opinion on plants developed through cisgenesis and intragenesis. EFSA Journal 2022;20(10):7621, 33 pp. https://doi.org/10.2903/j.efsa.2022.7621. 49 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Naegeli H, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Mullins E, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Gennaro A, Paraskevopoulos K, Raffaello T and Rostoks N, 2020. Applicability of the EFSA Opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis. EFSA Journal 2020;18(11):6299, 14 pp. https://doi. org/10.2903/j.efsa.2020.6299. 50 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Fernandez A, Gennaro A, Papadopoulou N, Raffaello T and Schoonjans R, 2022. Statement on criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis. EFSA Journal 2022;20(10):7618, 12 pp. https://doi.org/10.2903/j.efsa.2022.7618.
2023/11/19
Committee: ENVI
Amendment 260 #
Proposal for a regulation
Recital 27
(27) Requirements on the content of notifications for consent for the placing on the market of products containing or consisting of GMOs other than food or feed and on the content of applications for authorisation for the placing on the market of genetically modified food and feed are laid down in different pieces of legislation. To ensure consistency between the notifications for consent and applications for authorisation for category 2 NGT products, the content of such notifications and applications should be the same, except those concerning the assessment of food and feed safety assessment as these are only relevant to category 2 NGT food and feed.
2023/11/19
Committee: ENVI
Amendment 266 #
Proposal for a regulation
Recital 28
(28) The European Union Reference Laboratory for GM Food and Feed (EURL), in collaboration with the European Network of GM Laboratories (ENGL), concluded that analytical testing is not yet considered feasible for all products obtained by targeted mutagenesis and cisgenesis (51 ). When the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not allow the differentiation of the NGT plant from conventional plants. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier or the applicant, the modalities to comply with analytical method requirements should be adapted. This should be done in the implementing acts adopted pursuant to this Regulation should be required to ensure one, and provide the exact information needed for the laboratories to differentiate the specific NGT. Furthermore, the Commission and Member States should develop better analytical testing methods. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants on the minimum performance requirements for analytical methods. Modalities for performing method validation may also be adapted. _________________ 51 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)
2023/11/19
Committee: ENVI
Amendment 274 #
Proposal for a regulation
Recital 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 more 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 shcould 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. Therefore, a monitoring plan for environmental effects should not be required if the category 2 NGT plant is unlikely to pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment.
2023/11/19
Committee: ENVI
Amendment 280 #
Proposal for a regulation
Recital 30
(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.deleted
2023/11/19
Committee: ENVI
Amendment 289 #
(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.deleted
2023/11/19
Committee: ENVI
Amendment 296 #
Proposal for a regulation
Recital 33
(33) Regulatory incentives shcould be offered to potential SME notifiers or applicants for category 2ertain 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 exclusively focus on broad trait categories with the evidence-based 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 Union52 ]. 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. _________________ 52 COM(2023) 414 final
2023/11/19
Committee: ENVI
Amendment 302 #
Proposal for a regulation
Recital 34
(34) Incentives shcould 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 SME 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(53 ). _________________ 53 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 031 1.2.2002, p. 1).
2023/11/19
Committee: ENVI
Amendment 304 #
Proposal for a regulation
Recital 35
(35) Additional incentives shcould 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 SMEsmall enterprises and more extensive pre-submission advice covering also the design of studies to be carried out for the purpose of risk assessment.
2023/11/19
Committee: ENVI
Amendment 307 #
Proposal for a regulation
Recital 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 mayPractice shows that such cultivation leads to development of weeds resistant to those herbicides orand 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 tolerant 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]regarded as NGT plants.
2023/11/19
Committee: ENVI
Amendment 312 #
Proposal for a regulation
Recital 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, 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.deleted
2023/11/19
Committee: ENVI
Amendment 323 #
Proposal for a regulation
Recital 38
(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 balanceprotect the interests of producers of conventional, and 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.
2023/11/19
Committee: ENVI
Amendment 334 #
Proposal for a regulation
Recital 40
(40) Given the novelty of the NGTs, it will be important to monitor closely the 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. Information should be collected regularly and within fivthree 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 evaluation of this Regulation to assess the possible negative effects on biodiversity, environment and health, the impact on the organic value chain, the trust and freedom of choice of citizens and measure the progress made towards the availability of NGT plants containing such actual favourable characteristics or properties on the EU market.
2023/11/19
Committee: ENVI
Amendment 346 #
Proposal for a regulation
Recital 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, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Uniontasked to evaluate the necessity 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.’ The Commission should present a legislative proposal if it deems it necessary to amend this list.
2023/11/19
Committee: ENVI
Amendment 347 #
Proposal for a regulation
Recital 43 a (new)
(43a) Member States and the Commission should ensure that systematic and independent research on the potential risks involved in the deliberate release or the placing on the market of NGTs is conducted. The necessary resources should be secured for such research by Member States and the Community in accordance with their budgetary procedures and independent researchers should be given access to all relevant material, while respecting intellectual property rights.
2023/11/19
Committee: ENVI
Amendment 351 #
Proposal for a regulation
Recital 45
(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 and NGT products, 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(55 ). _________________ 55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
2023/11/19
Committee: ENVI
Amendment 354 #
Proposal for a regulation
Recital 46
(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 identified56 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 freedom of choice, including their knowledge of and 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. _________________ 56 SWD(2023) 412
2023/11/19
Committee: ENVI
Amendment 356 #
Proposal for a regulation
Recital 47
(47) Certain references to provisions of the Union GMO legislation in Regulation (EU) 2017/625 of the European Parliament and of the Council (57 ) need to be amended to include the specific provisions in this legislation applicable to NGT plants. _________________ 57 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).deleted
2023/11/19
Committee: ENVI
Amendment 366 #
Proposal for a regulation
Article 1 – paragraph 1
This Regulation 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 plantsprovisions for certain newer genomic manipulation techniques (‘NGT plants’), while ensuring the protection of health and the environment and upholding the precautionary principle.
2023/11/19
Committee: ENVI
Amendment 369 #
Proposal for a regulation
Article 2 – paragraph 1 – point 1
(1) NGT plantsAnnual arable NGT plants that have no potential to persist, reproduce and spread in the environment;
2023/11/19
Committee: ENVI
Amendment 388 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
(2) ‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis or cisgenesis, orn a combination thereof, on thell of the following condition thats: (a) it does not contain any genetic material originating from outside the breeders’ gene pool that temporarily may have been inserted during the development of the NGT planprepared outside the cell, (b) it is not bred to be intentionally tolerant to herbicides, (c) there is no patent attached to the plant, its traits, properties or the technique used to create it;
2023/11/19
Committee: ENVI
Amendment 400 #
Proposal for a regulation
Article 3 – paragraph 1 – point 4
(4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at precisely defined locations in the genome of an organism;
2023/11/19
Committee: ENVI
Amendment 403 #
Proposal for a regulation
Article 3 – paragraph 1 – point 5
(5) ‘cisgenesis’ means techniques of genetic modification resulting in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool;deleted
2023/11/19
Committee: ENVI
Amendment 406 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6
(6) ‘breeders’ gene pool’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses;deleted
2023/11/19
Committee: ENVI
Amendment 416 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7
(7) ‘category 1 NGT plant’ means a NGT plant that: (a) fulfils the criteria of equivalence to conventional plants, set out in Annex I, or (b) is progeny of the NGT plant(s) referred to in point (a), including progeny derived by crossing of such plants, on the condition that there are no further modifications that would make it subject to Directive 2001/18/EC or Regulation 1829/2003;deleted
2023/11/19
Committee: ENVI
Amendment 436 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8
(8) ‘category 2 NGT plant’ means a NGT plant other than a category 1 NGT plant;deleted
2023/11/19
Committee: ENVI
Amendment 447 #
Proposal for a regulation
Article 3 – paragraph 1 – point 13
(13) ‘category 1 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 1 NGT plant;deleted
2023/11/19
Committee: ENVI
Amendment 450 #
Proposal for a regulation
Article 3 – paragraph 1 – point 14
(14) ‘category 2 NGT product’ means a NGT product where the NGT plant it contains, consists of or, in the cases of food or feed, is produced from, is a category 2 NGT plant;deleted
2023/11/19
Committee: ENVI
Amendment 458 #
Proposal for a regulation
Article 4
Deliberate release of NGT plants for any other purpose than placing on the market and placing on the market of NGT Without prejudice to other requirements of Union law, a NGT plant may only be deliberately released into the environment for any other purpose than placing on the market, and a NGT product may only be placed on the market, if: (1) the plant is a category 1 NGT plant and (a) has obtained a decision declaring that status in accordance with Article 6 or 7; or (b) is progeny of plant(s) referred to in point (a); or (2) the plant is a category 2 NGT plant and has been authorised in accordance with Chapter III.Article 4 deleted products
2023/11/19
Committee: ENVI
Amendment 481 #
Proposal for a regulation
Chapter II – title
II Category 1 NGT plants and category 1 NGT productsThe European Parliament deletes this chapter
2023/11/19
Committee: ENVI
Amendment 485 #
Proposal for a regulation
Article 5
Status of category 1 NGT plants 1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plants. 2. For the purposes of Regulation (EU) 2018/848, the rules set out in its Articles 5 (f) (iii) and 11 shall apply to category 1 NGT plants and to products produced from or by such plants. 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 in order to adapt them to scientific and technological progress as regards the types and extent of modifications which can occur naturally or through conventional breeding.deleted
2023/11/19
Committee: ENVI
Amendment 511 #
Proposal for a regulation
Article 6
[...]deleted
2023/11/19
Committee: ENVI
Amendment 608 #
Proposal for a regulation
Article 7
[...]deleted
2023/11/19
Committee: ENVI
Amendment 657 #
Proposal for a regulation
Article 8
between Member States, the Commission The Commission shall set up and maintain an electronic system for the submission of verification requests in accordance with Articles 6 and 7 and theArticle 8 deleted System of exchange of the information uander this Title.e Authority
2023/11/19
Committee: ENVI
Amendment 666 #
Proposal for a regulation
Article 9
Database of decisions declaring the 1. The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6). The database shall contain the following information: (a) name and the address of the requester; (b) the designation of the category 1 NGT plant; (c) a summarised description of the technique(s) used to obtain the genetic modification; (d) a description of the trait(s) and characteristics which have been introduced or modified; (e) an identification number, and (f) the decision referred to in Article 6(8) or (10), and Article 7(6), as appropriate. 2. The database shall be publicly available.Article 9 deleted category 1 NGT plant status
2023/11/19
Committee: ENVI
Amendment 699 #
Proposal for a regulation
Article 10
reproductive material, including breeding 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 ‘cat 1 NGT’, followed by the identification number of the NGT plant(s) it has been derived from.Article 10 deleted Labelling of category 1 NGT plant material
2023/11/19
Committee: ENVI
Amendment 728 #
Proposal for a regulation
Article 11
1. The requester referred to in Articles 6 and 7 may submit a request to the Member State competent authority or to the Authority, as appropriate, to treat certain parts of the information submitted under this Title as confidential, accompanied by verifiable justification, in accordance with paragraphs 3 and 6. 2. The competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1. 3. The competent authority or the Authority, as appropriate, may grant confidential treatment only with respect to the following items of information, upon verifiable justification, where the disclosure of such information is demonstrated by the requester to potentially harm its interests to a significant degree: (a) items of information referred to in points (a), (b) and (c) of Article 39(2) of Regulation (EC) No 178/2002; (b) DNA sequence information; and (c) breeding patterns and strategies. 4. The competent authority or the Authority, as appropriate, shall, after consultation with the requester, decide which information is to be treated as confidential and shall inform the requester of its decision. 5. Member States, the Commission and the Authority shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public. 6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis. 7. In the event of a withdrawal of the verification request by the requester, Member States, the Commission and the Authority shall respect the confidentiality as granted by the competent authority or the Authority in accordance with this Article. Where the withdrawal of the verification request takes place before the competent authority or the Authority has decided on the relevant confidentiality request, Member States, the Commission and the Authority shall not make public the information for which confidentiality has been requested.Article 11 deleted Confidentiality
2023/11/19
Committee: ENVI
Amendment 744 #
Proposal for a regulation
Chapter III – title
III Category 2 NGT plants and category 2 NGT products
2023/11/19
Committee: ENVI
Amendment 746 #
Status of Category 2 NGT plants and category 2 NGT products
2023/11/19
Committee: ENVI
Amendment 749 #
The rules which apply to GMOs in Union legislation in so far as they are not derogated from by this Regulation, shall apply to category 2 NGT plants and category 2 NGT products.
2023/11/19
Committee: ENVI
Amendment 751 #
Proposal for a regulation
Chapter III – Section 1 – title
1 Deliberate release of category 2 NGT plants for any other purpose than for placing on the market
2023/11/19
Committee: ENVI
Amendment 755 #
Proposal for a regulation
Article 13 – paragraph 1 – introductory part
As regards the deliberate release of a category 2 NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:
2023/11/19
Committee: ENVI
Amendment 758 #
Proposal for a regulation
Article 13 – paragraph 1 – point b
(b) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene poocell where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);
2023/11/19
Committee: ENVI
Amendment 760 #
Proposal for a regulation
Article 13 – paragraph 1 – point c – point ii
(ii) information relating to the category 2 NGT plant(s);
2023/11/19
Committee: ENVI
Amendment 762 #
(iv) information on the interactions between the category 2 NGT plant(s) and the environment;
2023/11/19
Committee: ENVI
Amendment 763 #
Proposal for a regulation
Article 13 – paragraph 1 – point c – point v
(v) a plan for monitoring in order to identify effects of the category 2 NGT plant(s) on human health or the environment;
2023/11/19
Committee: ENVI
Amendment 772 #
Proposal for a regulation
Chapter III – Section 2 – title
2 Placing on the market of category 2 NGT products other than food or feed
2023/11/19
Committee: ENVI
Amendment 774 #
Proposal for a regulation
Article 14 – paragraph 1 – introductory part
1. As regards the placing on the market of category 2 NGT products other than food and feed, the notification referred to in Article 13(2) of Directive 2001/18/EC, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, shall contain:
2023/11/19
Committee: ENVI
Amendment 777 #
Proposal for a regulation
Article 14 – paragraph 1 – point b
(b) designation and specification of the category 2 NGT plant;
2023/11/19
Committee: ENVI
Amendment 780 #
Proposal for a regulation
Article 14 – paragraph 1 – point d
(d) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene poocell where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);
2023/11/19
Committee: ENVI
Amendment 787 #
Proposal for a regulation
Article 14 – paragraph 1 – point h
(h) where appropriate, a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the notifier considers that the NGT plant does notonly needs a limited monitoring plan, the notifier may propose not to suba limit aed monitoring plan;
2023/11/19
Committee: ENVI
Amendment 789 #
Proposal for a regulation
Article 14 – paragraph 1 – point j
(j) proposed commercial names of the products and names of category 2 NGT plants contained therein, and a proposal for a unique identifier for the category 2 NGT plant, developed in accordance with Commission Regulation (EC) No 65/2004 (60 ). After the consent any new commercial names should be provided to the competent authority; _________________ 60 Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004, p. 5).
2023/11/19
Committee: ENVI
Amendment 790 #
Proposal for a regulation
Article 14 – paragraph 1 – point l
(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier, the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);
2023/11/19
Committee: ENVI
Amendment 796 #
Proposal for a regulation
Article 14 – paragraph 1 – point m
(m) samples of the category 2 NGT plant and their control samples, and information as to the place where the reference material can be accessed;
2023/11/19
Committee: ENVI
Amendment 800 #
Proposal for a regulation
Article 14 – paragraph 2
2. The notifier shall include in this notification information on data or results from releases of the same category 2 NGT plant or the same combination of category 2 NGT plants previously or currently notified and/or carried out by the notifier either inside or outside the Union.
2023/11/19
Committee: ENVI
Amendment 801 #
Proposal for a regulation
Article 14 – paragraph 3 a (new)
3 a. The assessment report as well as all information provided by the applicant shall be made publicly available on a website without undue delay.
2023/11/19
Committee: ENVI
Amendment 805 #
Proposal for a regulation
Article 15 – paragraph 1
The written consent referred to in Article 19 of Directive 2001/18/EC shall either specify monitoring requirements, as described in Article 19(3) point (f) or state that monitoring is not required. Article 17(2), point (b), of Directive 2001/18/EC shall not apply if monitoring is not required by the consent.
2023/11/19
Committee: ENVI
Amendment 815 #
Proposal for a regulation
Article 17
Duration of the validity of the consent 1. The consent granted under Part C of Directive 2001/18/EC shall, after the first renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for an unlimited period, unless the decision referred to in Article 17(6) or (8) provides that the renewal is for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the consent. 2. The last sentence in Article 17(6) and (8) of Directive 2001/18/EC shall not apply.Article 17 deleted after renewal
2023/11/19
Committee: ENVI
Amendment 826 #
Proposal for a regulation
Chapter III – Section 3 – title
3 Placing on the market of category 2 NGT plants for food or feed use and of category 2 NGT food and feed
2023/11/19
Committee: ENVI
Amendment 828 #
Proposal for a regulation
Article 18 – paragraph 1 – point a
(a) category 2 NGT plants for food use or for feed use;
2023/11/19
Committee: ENVI
Amendment 829 #
Proposal for a regulation
Article 18 – paragraph 1 – point b
(b) food containing, consisting or produced from category 2 NGT plants or containing ingredients produced from category 2 NGT plants (‘category 2 NGT food’);
2023/11/19
Committee: ENVI
Amendment 832 #
Proposal for a regulation
Article 18 – paragraph 1 – point c
(c) feed containing, consisting or produced from category 2 NGT plants (‘category 2 NGT feed’).
2023/11/19
Committee: ENVI
Amendment 833 #
Proposal for a regulation
Article 19 – title
Specific provisions on the application for authorisation referred to in Articles 5 and 17 of Regulation (EC) No 1829/2003
2023/11/19
Committee: ENVI
Amendment 834 #
Proposal for a regulation
Article 19 – paragraph 1 – introductory part
1. By way of derogation fromWithout prejudice to Articles 5(3), point (e), and 17(3), point (e), of Regulation (EC) No 1829/2003, and without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, an application for authorisation of a category 2 NGT plant for food or feed use, or category 2 NGT food or feed shall be accompanied by a copy of the studies, including, where available, independent, peer- reviewed studies, which have been carried out and any other available material to demonstrate that:
2023/11/19
Committee: ENVI
Amendment 837 #
Proposal for a regulation
Article 19 – paragraph 1 – point a
(a) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene poocell where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);
2023/11/19
Committee: ENVI
Amendment 840 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1
By way of derogation fromWithout prejudice to Articles 5(3), point (i), and 17(3), point (i), of Regulation (EC) No 1829/2003, an application for authorisation shall be accompanied by methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant and, where applicable, for the detection and identification of the NGT plant in the NGT food or feed.
2023/11/19
Committee: ENVI
Amendment 841 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2
In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant or concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);deleted
2023/11/19
Committee: ENVI
Amendment 849 #
Proposal for a regulation
Article 19 – paragraph 3 – introductory part
3. By way of derogation fromWithout prejudice to Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, in the case of category 2 NGT plants or food or feed containing or consisting of category 2 NGT plants, the application shall also be accompanied by:
2023/11/19
Committee: ENVI
Amendment 855 #
Proposal for a regulation
Article 19 – paragraph 3 – point b
(b) where appropriate, a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan. This duration may be different from the duration of the authorisation. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the applicant considers that the NGT plant doesonly needs a limited monitoring plan, the applicant may propose not to submit a limited monitoring plan.
2023/11/19
Committee: ENVI
Amendment 863 #
Proposal for a regulation
Article 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) or assess whether the information provided by the applicant justifies the application of adapted modalities to comply with detection method requirements referred to in that paragraph.
2023/11/19
Committee: ENVI
Amendment 866 #
Proposal for a regulation
Article 20 a (new)
Article20a Specific provisions on refusing NGT plants, food, feed and products Without prejudice to the criteria in Regulation (EC) No 1829/2003 and Directive 2001/18/EC, the deliberate release of NGT plants and the placing on the market of NGT food, feed and products shall be refused if a Member States deems it probable that it would jeopardise health, the environment or the sustainability of the food chain.
2023/11/19
Committee: ENVI
Amendment 868 #
Proposal for a regulation
Article 21
Duration of the validity of the authorisation after renewal By way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) No 1829/2003, after the first renewal, the authorisation shall be valid for an unlimited period, unless the Commission decides to renew the authorisation for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.Article 21 deleted
2023/11/19
Committee: ENVI
Amendment 880 #
Proposal for a regulation
Chapter III – Section 4 – title
4 Common provisions for category 2 NGT plants and category 2 NGT products
2023/11/19
Committee: ENVI
Amendment 882 #
Proposal for a regulation
Article 22 – title
Incentives for category 2 NGT plants and category 2 NGT products containing traits relevant for sustainability
2023/11/19
Committee: ENVI
Amendment 887 #
Proposal for a regulation
Article 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 trait(s) of the NGT plant conveyed by the genetic modification is contained in Part 1 of Annex III and it does not have any traits referred to in Part 2 of that Annex.
2023/11/19
Committee: ENVI
Amendment 890 #
Proposal for a regulation
Article 22 – paragraph 2 – point a
(a) where the applicant is a SME, and by way of derogation from Article 20(1), subsection (1) of this Regulation, the Authority shall deliver its opinion on the application within 4 months from the receipt of a valid application, unless the complexity of the product requires application of the time limit referred to in Article 20(1). The time limit shall be extendable under the conditions set out in Article 20(1), subsection (2);
2023/11/19
Committee: ENVI
Amendment 892 #
Proposal for a regulation
Article 22 – paragraph 2 – point b
(b) where the applicant is a SMEmicro or small enterprise, it shall be exempted from the payment of the financial contributions to the Union Reference Laboratory and to the European Network of GMO Laboratories referred to in Article 32 of Regulation (EC) No 1829/2003.
2023/11/19
Committee: ENVI
Amendment 894 #
Proposal for a regulation
Article 22 – paragraph 3 – point a
(a) the staff of the Authority shall, at the request of a potential applicant or notifier where that is a SME, provide advice on plausible risk hypotheses that the potential applicant or notifier has identified based on the properties of a plant, product or hypothetical plant or product, that need to be addressed by providing the information under Parts 2 and 3 of Annex II. The advice shall not, however, cover the design of studies to address the risk hypotheses;
2023/11/19
Committee: ENVI
Amendment 895 #
Proposal for a regulation
Article 22 – paragraph 3 – point b
(b) where the potential applicant or notifier is a SMEmicro or small enterprise, it may notify the Authority of how it intends to address the plausible risk hypotheses referred to in point (a) that it has identified based on the properties of a plant, product or hypothetical plant or product, including the design of the studies it intends to perform in accordance with the requirements laid down Parts 2 and 3 of Annex II. The Authority shall provide advice on the notified information, including on the design of the studies.
2023/11/19
Committee: ENVI
Amendment 899 #
Proposal for a regulation
Article 22 – paragraph 4 – point c
(c) the Authority shall make public without delay a summary of the pre- submission advice once an application or notification has been considered valid. Articles 38(1a) shall apply mutatis mutandis;
2023/11/19
Committee: ENVI
Amendment 902 #
Proposal for a regulation
Article 22 – paragraph 5 – point a
(a) the information necessary to establish that the intended trait(s) conveyed by the genetic modification of the category 2 NGT plant meet the conditions referred to in paragraph 1;
2023/11/19
Committee: ENVI
Amendment 903 #
Proposal for a regulation
Article 22 – paragraph 5 – point b
(b) where applicable, the information necessary to demonstrate the (potential) applicant or notifier is a SMEmicro, small or medium enterprise;
2023/11/19
Committee: ENVI
Amendment 909 #
Proposal for a regulation
Article 22 – paragraph 8 – introductory part
8. The Commission is empowered tomay adopt dea legated acts in accordance with Article 26islative proposal amending the lists of traits of NGT plants laid down in Annex III in order to adapt them to scientific and technological progress and to new evidence relating to the impact on sustainability of those traits, subject to the following conditions:
2023/11/19
Committee: ENVI
Amendment 914 #
Proposal for a regulation
Article 23 – title
Labelling of authorised category 2 NGT products
2023/11/19
Committee: ENVI
Amendment 921 #
In addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003, and without prejudice to the requirements under other Union legislation, the labelling of authorised category 2 NGT products may also mention the trait(s) conveyed by the genetic modification, as specified in the consent or the authorisation pursuant to Sections 2 or 3 of Chapter III of this Regulation. This information needs to be evidence-based and needs to be accompanied by the statement that sustainable agriculture needs to be seen in a holistic manner and sustainability cannot be captured in a specific trait.
2023/11/19
Committee: ENVI
Amendment 923 #
Proposal for a regulation
Article 24 – title
Measures to avoid the unintended presence of category 2 NGT plants
2023/11/19
Committee: ENVI
Amendment 928 #
Proposal for a regulation
Article 24 – paragraph 1
Member States shall 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. This shall include legally binding buffer zones of no less than 2 kilometre between NGT crops and conventional crops and of no less than 5 kilometre between NGT crops and organic crops. It shall also include detailed legally binding measure to avoid cross contamination further in the food chain, an enforcement plan and appropriately dissuasive penalties.
2023/11/19
Committee: ENVI
Amendment 934 #
Proposal for a regulation
Article 24 – paragraph 1 a (new)
Member States shall set up a public register in which the all locations where NGT plants are bred or cultivated are shown, described by means of latitude and longitude coordinates corresponding to at least one latitude and one longitude point and using at least six decimal digits.
2023/11/19
Committee: ENVI
Amendment 936 #
Proposal for a regulation
Article 24 – paragraph 1 b (new)
Member States shall introduce liability schemes in order to ensure that the costs of cross-contamination of conventional and organic operators with NGTs are born by the operator that released the NGT into the environment. The latter shall also bear the burden of proof.
2023/11/19
Committee: ENVI
Amendment 937 #
Proposal for a regulation
Article 24 – paragraph 1 c (new)
Where operators cultivate NGT crops, they will make this visible to the public by putting up information signs in their field which should be clearly legible.
2023/11/19
Committee: ENVI
Amendment 940 #
Proposal for a regulation
Article 25
Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.5 deleted Cultivation
2023/11/19
Committee: ENVI
Amendment 955 #
Proposal for a regulation
Article 26
1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt the delegated acts referred to in Article 5(3) 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. 3. The delegations of power referred to in Article 5(3) 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. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(61 ). 5. As soon as it adopts aArticle 26 delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles Article 5(3) 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. _________________ 61 OJ L 123, 12.5.2016, p. 1.Exercise of the delegation
2023/11/19
Committee: ENVI
Amendment 976 #
Proposal for a regulation
Article 27 – paragraph 1 – point b
(b) the preparation and the presentation of the verification requests referred to in Articles 6 and 7;deleted
2023/11/19
Committee: ENVI
Amendment 981 #
Proposal for a regulation
Article 27 – paragraph 1 – point c
(c) the methodology and information requirements for the environmental risk assessment of category 2 NGT plants and the safety assessments of category 2 NGT food and feed, in accordance with the principles and criteria laid down in Annex II;
2023/11/19
Committee: ENVI
Amendment 983 #
Proposal for a regulation
Article 27 – paragraph 1 – point e
(e) adapted modalities to comply with analytical method requirements referred to in Article 14(1), point (l), and Article 19(2).deleted
2023/11/19
Committee: ENVI
Amendment 992 #
Proposal for a regulation
Article 28 – paragraph 2
2. Where reference is made to this paragraph, Article 4 of Regulation (EC) No 182/2011 shall apply.deleted
2023/11/19
Committee: ENVI
Amendment 995 #
Proposal for a regulation
Article 30 – paragraph -1 (new)
-1. By 31 December 2024, the Commission shall present a report on the issue of patents in the food chain, and their effects on food security, freedom of choice for farmers and consumers, increased corporate control in the plant breeding sector and monopolisation of our food. The Commission shall accompany this report with a legislative proposal to amend the intellectual property legislation to prohibit the use of patents on living organisms, genes, traits and breeding techniques.
2023/11/19
Committee: ENVI
Amendment 998 #
Proposal for a regulation
Article 30 – paragraph 1
1. No soonlater 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 fivthree 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.
2023/11/19
Committee: ENVI
Amendment 1002 #
Proposal for a regulation
Article 30 – paragraph 2 a (new)
2a. The report shall address the possible negative effects on biodiversity, environment and health, the impact on the organic value chain, the trust and freedom of choice of citizens.
2023/11/19
Committee: ENVI
Amendment 1003 #
Proposal for a regulation
Article 30 – paragraph 2 b (new)
2b. The report shall address invasiveness, allergenic potential, impacts on non targeted organisms and the effects of NGTs in the use and risk of pesticides and fertilisers.
2023/11/19
Committee: ENVI
Amendment 1017 #
Proposal for a regulation
Article 31 – paragraph 1
With 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.
2023/11/19
Committee: ENVI
Amendment 1021 #
Proposal for a regulation
Article 32 – paragraph 1
Any 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 concernednatural or legal person with sufficient interest. Any non- governmental organisation promoting environmental protection and the protection of health, and meeting any requirements under national law shall be deemed to have sufficient interest.
2023/11/19
Committee: ENVI
Amendment 1022 #
Proposal for a regulation
Article 32 – paragraph 3
The Commission shall prepare a draft decision within twoone months requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to act.
2023/11/19
Committee: ENVI
Amendment 1031 #
Proposal for a regulation
Article 32 a (new)
Article 32a Access to justice 1. Any natural or legal person having sufficient interest shall have access to a court or other independent and impartial public body competent to review the procedural and substantive legality of the decisions, plans, permits, acts or failure to act of the competent authority under this Regulation. Any non-governmental organisation promoting environmental protection and the protection of human health, and meeting any requirements under national law shall be deemed to have sufficient interest. 2. Access to a court or other independent and impartial public body pursuant to paragraph 1 shall be fair, equitable, timely and not prohibitively expensive and provide adequate and effective remedies, including injunctive relief where appropriate. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.
2023/11/19
Committee: ENVI
Amendment 1032 #
Proposal for a regulation
Article 32 b (new)
Article 32b Compensation 1. Member States shall ensure that, where damage to health, the environment or GMO-free food and feed chains has occurred as a result of a violation of the provisions of this Regulation, the individuals affected have the right to claim and obtain compensation for that damage from the relevant natural or legal persons and, where appropriate, from the relevant competent authorities responsible for the violation. 2. Member States shall ensure that, as part of the public concerned, non- governmental organisations promoting the protection of health or the environment and meeting any requirements under national law are allowed to represent the individuals affected and bring collective actions for compensation. Member States shall ensure that a claim for a violation leading to a damage cannot be pursued twice, by the individuals affected and by the non- governmental organisations referred to in this paragraph.
2023/11/19
Committee: ENVI
Amendment 1033 #
Proposal for a regulation
Article 33
Regulation (EU) 2017/625
Article 23
Article 23 of Regulation (EU) 2017/625 is amended as follows: (1) in paragraph 2, point (a)(ii) is replaced by the following: ‘(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), of33 deleted Amendments to Regulation (ECU) No 1829/2003 and in Articles 14(1), point (h) and 19(3), point (b) of Regulation [reference to this Regulation];; ‘(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];.2017/625
2023/11/19
Committee: ENVI
Amendment 1038 #
Proposal for a regulation
Article 34 – paragraph 2 – subparagraph 1
It shall apply from [248 months from the date of entry into force of this Regulation].
2023/11/19
Committee: ENVI
Amendment 1043 #
Proposal for a regulation
Annex I
Criteria of equivalence of NGT plants to conventional plants A 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 types 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. (1) substitution or insertion of no more than 20 nucleotides; (2) deletion of any number of nucleotides; (3) on the condition that the genetic modification does not interrupt an endogenous gene: (a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool; (b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool; (4) targeted inversion of a sequence of any number of nucleotides; (5) any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (possibly with modifications as accepted under points (1) and/or (2)) in a species from the breeders’ gene pool.deleted
2023/11/19
Committee: ENVI
Amendment 1105 #
Proposal for a regulation
Annex II – subheading 1
Risk assessment of category 2 NGT plants and category 2 NGT food and feed
2023/11/19
Committee: ENVI
Amendment 1106 #
Proposal for a regulation
Annex II – paragraph 1
Part 1 of this Annex describes the general principles to be followed to perform the environmental risk assessment of category 2 NGT plants referred to in Article 13, points (c) and (d), Article 14(1), point (e), and Article 19(3), point (a), and the safety assessment of category 2 NGT food and feed referred to in Article 19(1), point (b). Part 2 describes specific information for the environmental risk assessment of category 2 NGT plants and Part 3 describes specific information for the safety assessment of category 2 NGT food and feed.
2023/11/19
Committee: ENVI
Amendment 1112 #
Proposal for a regulation
Annex II – Part 1 – paragraph 2 – introductory part
The type and amount of information necessary for the environmental risk assessment of category 2 NGT plants laid down in Annex III of Directive 2001/18/EC and for the food and feed safety assessment of category 2 NGT food and feed shallcould be adapted to their risk profile. Factors to be considered include:
2023/11/19
Committee: ENVI
Amendment 1115 #
Proposal for a regulation
Annex II – Part 1 – paragraph 2 – point e a (new)
(ea) The cultivation in the European Union of similar non-GMO plants and the risks of cross-contamination;
2023/11/19
Committee: ENVI
Amendment 1116 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – introductory part
The environmental risk assessment of category 2 NGT plants and the risk assessment of category 2 NGT food and NGT feed shall consist of the following:
2023/11/19
Committee: ENVI
Amendment 1119 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point a
(a) problem formulation including hazard identification and characterisation;
2023/11/19
Committee: ENVI
Amendment 1123 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point b
(b) exposure characterisation and assessment;
2023/11/19
Committee: ENVI
Amendment 1124 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point c a (new)
(ca) socio-economic assessment of the consequences of cross-contamination of the NGT plant to non-GMO plants and products thereof
2023/11/19
Committee: ENVI
Amendment 1127 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point c b (new)
(cb) risk management strategies
2023/11/19
Committee: ENVI
Amendment 1130 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point c c (new)
(cc) overall risk evaluation
2023/11/19
Committee: ENVI
Amendment 1138 #
Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point a – paragraph 1
The information shall be provided by collating already available data from scientific literature orand from other sources or, generating scientific data where necessary by performing appropriate experimental or bioinformatic studies.
2023/11/19
Committee: ENVI
Amendment 1140 #
Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point b – paragraph 1
Information shall be provided on the likelihood of each identified potential adverse effect, for all expose routes to humans, animals and the environment. This shall be evaluated taking into consideration, as relevant, the characteristics of the receiving environment(s), the intended function, the dietary role, the expected level of use of the food and feed in the EU and the scope of the application for authorisation.
2023/11/19
Committee: ENVI
Amendment 1144 #
Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point c – paragraph 1
The applicant shall base its risk characterisation of NGT plants and foods and feed on information from hazard identification, hazard characterisation and exposure assessment. The risk shall be characterised by combining, for each potential adverse effect and for each specific protection goal, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk. Where relevant, tThe uncertainty for each identified risk shall be described.
2023/11/19
Committee: ENVI
Amendment 1148 #
Proposal for a regulation
Annex II – Part 1 – paragraph 5
Any information on hazard identification and characterisation specified under Parts 2 and 3 shall only be required if the specific characteristics and the intended use of the category 2 NGT plant or category 2 NGT food or feed give rise to a plausible risk hypothesis that can be addressed utilising the specified information.deleted
2023/11/19
Committee: ENVI
Amendment 1152 #
Proposal for a regulation
Annex II – Part 2 – point 6 a (new)
(6a) Impacts on organic cultivation
2023/11/19
Committee: ENVI
Amendment 1155 #
Proposal for a regulation
Annex II – Part 2 – point 8 a (new)
(8a) Effects on protecting and conserving biodiversity
2023/11/19
Committee: ENVI
Amendment 1156 #
(8b) Effects on protecting ecologically sensitive areas
2023/11/19
Committee: ENVI
Amendment 1157 #
Proposal for a regulation
Annex II – Part 2 – point 8 c (new)
(8c) Socio-economic effects on the food chain
2023/11/19
Committee: ENVI
Amendment 1160 #
Proposal for a regulation
Annex II – Part 3 – point 1 a (new)
(1a) Analysis of the potential for persistence and invasiveness resulting from transport, loss, and spillage
2023/11/19
Committee: ENVI
Amendment 1164 #
Proposal for a regulation
Annex II – Part 3 – point 2
(2) Toxicology and ecotoxicology
2023/11/19
Committee: ENVI
Amendment 1180 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 4
(4) evidence-based more efficient use of resources, such as water and nutrients;
2023/11/19
Committee: ENVI
Amendment 1186 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 7
(7) a proven reduced need for external inputs, such as plant protection productchemical pesticides and fertilisers.
2023/11/19
Committee: ENVI
Amendment 1188 #
Proposal for a regulation
Annex III – Part 2 – paragraph 1
Traits excluding the application of the incentives referred to in Article 22: - tolerance to herbicides. , - tolerance to antimicrobials, - plants containing the endospore (or crystal) toxins of the Bacillus thuringiensis (Bt) be resistant to certain insect pests - patents on the plant, trait(s) or technique used,
2023/11/19
Committee: ENVI