199 Amendments of Anja HAZEKAMP related to 2023/0226(COD)
Amendment 5 #
Proposal for a regulation
Citation -1 (new)
Citation -1 (new)
– The European Parliament rejects the Commission proposal.
Amendment 23 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6 a) 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;
Amendment 24 #
Proposal for a regulation
Recital 6 b (new)
Recital 6 b (new)
(6 b) 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. _________________ 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
Amendment 26 #
Proposal for a regulation
Recital 7
Recital 7
Amendment 29 #
Proposal for a regulation
Recital 8
Recital 8
Amendment 29 #
Draft legislative resolution
Citation -1 (new)
Citation -1 (new)
– The European Parliament rejects the Commission proposal.
Amendment 30 #
Draft legislative resolution
Citation 2
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),
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)
Amendment 34 #
Proposal for a regulation
Citation 1
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,
Amendment 36 #
Proposal for a regulation
Recital -1 (new)
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.
Amendment 37 #
Proposal for a regulation
Recital 10
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 level.
Amendment 38 #
Proposal for a regulation
Recital -1 a (new)
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.
Amendment 39 #
Proposal for a regulation
Recital -1 b (new)
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.
Amendment 40 #
Proposal for a regulation
Recital -1 b (new)
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.
Amendment 41 #
Proposal for a regulation
Recital -1 c (new)
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’.
Amendment 44 #
Proposal for a regulation
Recital 13
Recital 13
Amendment 44 #
Proposal for a regulation
Recital 1
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).
Amendment 49 #
Proposal for a regulation
Recital 14
Recital 14
Amendment 57 #
Proposal for a regulation
Recital 2
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.
Amendment 59 #
Proposal for a regulation
Recital 2 a (new)
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.
Amendment 61 #
Proposal for a regulation
Recital 15
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.
Amendment 64 #
Proposal for a regulation
Recital 16
Recital 16
Amendment 69 #
Proposal for a regulation
Recital 3
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.
Amendment 71 #
Proposal for a regulation
Recital 17
Recital 17
Amendment 74 #
Proposal for a regulation
Recital 18
Recital 18
Amendment 78 #
Proposal for a regulation
Recital 4
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).
Amendment 82 #
Proposal for a regulation
Recital 5
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.
Amendment 83 #
Proposal for a regulation
Recital 19
Recital 19
Amendment 84 #
Proposal for a regulation
Recital 6 a (new)
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.
Amendment 85 #
Proposal for a regulation
Recital 6 b (new)
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
Amendment 88 #
Proposal for a regulation
Recital 20
Recital 20
Amendment 92 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 92 #
Proposal for a regulation
Recital 7 a (new)
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.
Amendment 94 #
Proposal for a regulation
Recital 7 b (new)
Recital 7 b (new)
Amendment 98 #
Proposal for a regulation
Recital 8
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.
Amendment 101 #
Proposal for a regulation
Recital 22
Recital 22
Amendment 106 #
Proposal for a regulation
Recital 9
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.
Amendment 108 #
Proposal for a regulation
Recital 23
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 banned in organic production. However, it 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 prohibitNGT plants are banned in organic production. _________________ 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).
Amendment 118 #
Proposal for a regulation
Recital 10
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.
Amendment 121 #
Proposal for a regulation
Recital 24
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 1 NGT plants should be labelled as category 1 NGT.
Amendment 124 #
Proposal for a regulation
Recital 25
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.
Amendment 133 #
Proposal for a regulation
Recital 13
Recital 13
Amendment 144 #
Proposal for a regulation
Recital 14
Recital 14
Amendment 161 #
Proposal for a regulation
Recital 15
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.
Amendment 166 #
Proposal for a regulation
Recital 16
Recital 16
Amendment 171 #
Proposal for a regulation
Recital 17
Recital 17
Amendment 179 #
Proposal for a regulation
Recital 18
Recital 18
Amendment 192 #
Proposal for a regulation
Recital 19
Recital 19
Amendment 200 #
Proposal for a regulation
Recital 20
Recital 20
Amendment 202 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) ‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, on the condition that it does not contain any genetic material originating from outside the breeders’ gene pool that temporarily may have been inserted during the development of the NGT planprepared outside the cell, and there is no intellectual property right of any kind attached to the plant, its properties or the technique used to create it;
Amendment 205 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 212 #
Proposal for a regulation
Recital 22
Recital 22
Amendment 213 #
Proposal for a regulation
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
Amendment 216 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
Amendment 224 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
Amendment 230 #
Proposal for a regulation
Recital 23
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).
Amendment 235 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
Amendment 238 #
Proposal for a regulation
Recital 24
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.
Amendment 241 #
Proposal for a regulation
Article 3 – paragraph 1 – point 13
Article 3 – paragraph 1 – point 13
Amendment 245 #
Proposal for a regulation
Article 3 – paragraph 1 – point 14
Article 3 – paragraph 1 – point 14
Amendment 248 #
Proposal for a regulation
Recital 25
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.
Amendment 255 #
Proposal for a regulation
Chapter II – title
Chapter II – title
II Category 1 NGT plants and category 1 NGT productsDeleted.
Amendment 257 #
Proposal for a regulation
Article 5
Article 5
Amendment 257 #
Proposal for a regulation
Recital 26
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.
Amendment 260 #
Proposal for a regulation
Recital 27
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.
Amendment 266 #
Proposal for a regulation
Recital 28
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)
Amendment 274 #
Proposal for a regulation
Recital 29
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.
Amendment 280 #
Proposal for a regulation
Recital 30
Recital 30
Amendment 289 #
Amendment 292 #
Proposal for a regulation
Article 6
Article 6
Amendment 296 #
Proposal for a regulation
Recital 33
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
Amendment 302 #
Proposal for a regulation
Recital 34
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).
Amendment 304 #
Proposal for a regulation
Recital 35
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.
Amendment 307 #
Proposal for a regulation
Recital 36
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.
Amendment 312 #
Proposal for a regulation
Recital 37
Recital 37
Amendment 323 #
Proposal for a regulation
Recital 38
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.
Amendment 334 #
Proposal for a regulation
Recital 40
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.
Amendment 346 #
Proposal for a regulation
Recital 43
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.
Amendment 347 #
Proposal for a regulation
Recital 43 a (new)
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.
Amendment 351 #
Proposal for a regulation
Recital 45
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).
Amendment 354 #
Proposal for a regulation
Recital 46
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
Amendment 356 #
Proposal for a regulation
Recital 47
Recital 47
Amendment 366 #
Proposal for a regulation
Article 7
Article 7
Amendment 366 #
Proposal for a regulation
Article 1 – paragraph 1
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.
Amendment 369 #
Proposal for a regulation
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
(1) NGT plantsAnnual arable NGT plants that have no potential to persist, reproduce and spread in the environment;
Amendment 385 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Amendment 388 #
Proposal for a regulation
Article 9
Article 9
Amendment 388 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
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;
Amendment 393 #
Proposal for a regulation
Article 10
Article 10
Amendment 400 #
Proposal for a regulation
Article 3 – paragraph 1 – point 4
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;
Amendment 403 #
Proposal for a regulation
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
Amendment 406 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
Amendment 412 #
Proposal for a regulation
Article 11
Article 11
Amendment 416 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
Amendment 436 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
Amendment 447 #
Proposal for a regulation
Article 3 – paragraph 1 – point 13
Article 3 – paragraph 1 – point 13
Amendment 450 #
Proposal for a regulation
Article 3 – paragraph 1 – point 14
Article 3 – paragraph 1 – point 14
Amendment 458 #
Proposal for a regulation
Article 4
Article 4
Amendment 481 #
Proposal for a regulation
Chapter II – title
Chapter II – title
II Category 1 NGT plants and category 1 NGT productsThe European Parliament deletes this chapter
Amendment 485 #
Proposal for a regulation
Article 5
Article 5
Amendment 511 #
Proposal for a regulation
Article 6
Article 6
Amendment 608 #
Proposal for a regulation
Article 7
Article 7
Amendment 657 #
Proposal for a regulation
Article 8
Article 8
Amendment 666 #
Proposal for a regulation
Article 9
Article 9
Amendment 699 #
Proposal for a regulation
Article 10
Article 10
Amendment 728 #
Proposal for a regulation
Article 11
Article 11
Amendment 744 #
Proposal for a regulation
Chapter III – title
Chapter III – title
III Category 2 NGT plants and category 2 NGT products
Amendment 746 #
Status of Category 2 NGT plants and category 2 NGT products
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.
Amendment 751 #
Proposal for a regulation
Chapter III – Section 1 – title
Chapter III – Section 1 – title
1 Deliberate release of category 2 NGT plants for any other purpose than for placing on the market
Amendment 755 #
Proposal for a regulation
Article 13 – paragraph 1 – introductory part
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:
Amendment 758 #
Proposal for a regulation
Article 13 – paragraph 1 – point b
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);
Amendment 760 #
Proposal for a regulation
Article 13 – paragraph 1 – point c – point ii
Article 13 – paragraph 1 – point c – point ii
(ii) information relating to the category 2 NGT plant(s);
Amendment 762 #
(iv) information on the interactions between the category 2 NGT plant(s) and the environment;
Amendment 763 #
Proposal for a regulation
Article 13 – paragraph 1 – point c – point v
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;
Amendment 772 #
Proposal for a regulation
Chapter III – Section 2 – title
Chapter III – Section 2 – title
2 Placing on the market of category 2 NGT products other than food or feed
Amendment 774 #
Proposal for a regulation
Article 14 – paragraph 1 – introductory part
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:
Amendment 777 #
Proposal for a regulation
Article 14 – paragraph 1 – point b
Article 14 – paragraph 1 – point b
(b) designation and specification of the category 2 NGT plant;
Amendment 780 #
Proposal for a regulation
Article 14 – paragraph 1 – point d
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);
Amendment 787 #
Proposal for a regulation
Article 14 – paragraph 1 – point h
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;
Amendment 789 #
Proposal for a regulation
Article 14 – paragraph 1 – point j
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).
Amendment 790 #
Proposal for a regulation
Article 14 – paragraph 1 – point l
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);
Amendment 796 #
Proposal for a regulation
Article 14 – paragraph 1 – point m
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;
Amendment 800 #
Proposal for a regulation
Article 14 – paragraph 2
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.
Amendment 801 #
Proposal for a regulation
Article 14 – paragraph 3 a (new)
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.
Amendment 805 #
Proposal for a regulation
Article 15 – paragraph 1
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.
Amendment 815 #
Proposal for a regulation
Article 17
Article 17
Amendment 826 #
Proposal for a regulation
Chapter III – Section 3 – title
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
Amendment 828 #
Proposal for a regulation
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
(a) category 2 NGT plants for food use or for feed use;
Amendment 829 #
Proposal for a regulation
Article 18 – paragraph 1 – point b
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’);
Amendment 832 #
Proposal for a regulation
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
(c) feed containing, consisting or produced from category 2 NGT plants (‘category 2 NGT feed’).
Amendment 833 #
Proposal for a regulation
Article 19 – title
Article 19 – title
Specific provisions on the application for authorisation referred to in Articles 5 and 17 of Regulation (EC) No 1829/2003
Amendment 834 #
Proposal for a regulation
Article 19 – paragraph 1 – introductory part
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:
Amendment 837 #
Proposal for a regulation
Article 19 – paragraph 1 – point a
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);
Amendment 840 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1
Article 19 – paragraph 2 – subparagraph 1
Amendment 841 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2
Article 19 – paragraph 2 – subparagraph 2
Amendment 849 #
Proposal for a regulation
Article 19 – paragraph 3 – introductory part
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:
Amendment 855 #
Proposal for a regulation
Article 19 – paragraph 3 – point b
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.
Amendment 863 #
Proposal for a regulation
Article 20 – paragraph 4
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.
Amendment 866 #
Proposal for a regulation
Article 20 a (new)
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.
Amendment 868 #
Proposal for a regulation
Article 21
Article 21
Amendment 880 #
Proposal for a regulation
Chapter III – Section 4 – title
Chapter III – Section 4 – title
4 Common provisions for category 2 NGT plants and category 2 NGT products
Amendment 882 #
Proposal for a regulation
Article 22 – title
Article 22 – title
Incentives for category 2 NGT plants and category 2 NGT products containing traits relevant for sustainability
Amendment 887 #
Proposal for a regulation
Article 22 – paragraph 1
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.
Amendment 890 #
Proposal for a regulation
Article 22 – paragraph 2 – point a
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);
Amendment 892 #
Proposal for a regulation
Article 22 – paragraph 2 – point b
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.
Amendment 894 #
Proposal for a regulation
Article 22 – paragraph 3 – point a
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;
Amendment 895 #
Proposal for a regulation
Article 22 – paragraph 3 – point b
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.
Amendment 899 #
Proposal for a regulation
Article 22 – paragraph 4 – point c
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;
Amendment 902 #
Proposal for a regulation
Article 22 – paragraph 5 – point a
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;
Amendment 903 #
Proposal for a regulation
Article 22 – paragraph 5 – point b
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;
Amendment 909 #
Proposal for a regulation
Article 22 – paragraph 8 – introductory part
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:
Amendment 914 #
Proposal for a regulation
Article 23 – title
Article 23 – title
Labelling of authorised category 2 NGT products
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.
Amendment 923 #
Proposal for a regulation
Article 24 – title
Article 24 – title
Measures to avoid the unintended presence of category 2 NGT plants
Amendment 928 #
Proposal for a regulation
Article 24 – paragraph 1
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.
Amendment 934 #
Proposal for a regulation
Article 24 – paragraph 1 a (new)
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.
Amendment 936 #
Proposal for a regulation
Article 24 – paragraph 1 b (new)
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.
Amendment 937 #
Proposal for a regulation
Article 24 – paragraph 1 c (new)
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.
Amendment 940 #
Proposal for a regulation
Article 25
Article 25
Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.5 deleted Cultivation
Amendment 955 #
Proposal for a regulation
Article 26
Article 26
Amendment 976 #
Proposal for a regulation
Article 27 – paragraph 1 – point b
Article 27 – paragraph 1 – point b
Amendment 981 #
Proposal for a regulation
Article 27 – paragraph 1 – point c
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;
Amendment 983 #
Proposal for a regulation
Article 27 – paragraph 1 – point e
Article 27 – paragraph 1 – point e
Amendment 992 #
Proposal for a regulation
Article 28 – paragraph 2
Article 28 – paragraph 2
Amendment 995 #
Proposal for a regulation
Article 30 – paragraph -1 (new)
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.
Amendment 998 #
Proposal for a regulation
Article 30 – paragraph 1
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.
Amendment 1002 #
Proposal for a regulation
Article 30 – paragraph 2 a (new)
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.
Amendment 1003 #
Proposal for a regulation
Article 30 – paragraph 2 b (new)
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.
Amendment 1017 #
Proposal for a regulation
Article 31 – paragraph 1
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.
Amendment 1021 #
Proposal for a regulation
Article 32 – paragraph 1
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.
Amendment 1022 #
Proposal for a regulation
Article 32 – paragraph 3
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.
Amendment 1031 #
Proposal for a regulation
Article 32 a (new)
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.
Amendment 1032 #
Proposal for a regulation
Article 32 b (new)
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.
Amendment 1033 #
Proposal for a regulation
Article 33
Article 33
Regulation (EU) 2017/625
Article 23
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
Amendment 1038 #
Proposal for a regulation
Article 34 – paragraph 2 – subparagraph 1
Article 34 – paragraph 2 – subparagraph 1
It shall apply from [248 months from the date of entry into force of this Regulation].
Amendment 1043 #
Proposal for a regulation
Annex I
Annex I
Amendment 1105 #
Proposal for a regulation
Annex II – subheading 1
Annex II – subheading 1
Risk assessment of category 2 NGT plants and category 2 NGT food and feed
Amendment 1106 #
Proposal for a regulation
Annex II – paragraph 1
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.
Amendment 1112 #
Proposal for a regulation
Annex II – Part 1 – paragraph 2 – introductory part
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:
Amendment 1115 #
Proposal for a regulation
Annex II – Part 1 – paragraph 2 – point e a (new)
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;
Amendment 1116 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – introductory part
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:
Amendment 1119 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point a
Annex II – Part 1 – paragraph 3 – point a
(a) problem formulation including hazard identification and characterisation;
Amendment 1123 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point b
Annex II – Part 1 – paragraph 3 – point b
(b) exposure characterisation and assessment;
Amendment 1124 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point c a (new)
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
Amendment 1127 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point c b (new)
Annex II – Part 1 – paragraph 3 – point c b (new)
(cb) risk management strategies
Amendment 1130 #
Proposal for a regulation
Annex II – Part 1 – paragraph 3 – point c c (new)
Annex II – Part 1 – paragraph 3 – point c c (new)
(cc) overall risk evaluation
Amendment 1138 #
Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point a – paragraph 1
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.
Amendment 1140 #
Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point b – paragraph 1
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.
Amendment 1144 #
Proposal for a regulation
Annex II – Part 1 – paragraph 4 – point c – paragraph 1
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.
Amendment 1148 #
Proposal for a regulation
Annex II – Part 1 – paragraph 5
Annex II – Part 1 – paragraph 5
Amendment 1152 #
Proposal for a regulation
Annex II – Part 2 – point 6 a (new)
Annex II – Part 2 – point 6 a (new)
(6a) Impacts on organic cultivation
Amendment 1155 #
Proposal for a regulation
Annex II – Part 2 – point 8 a (new)
Annex II – Part 2 – point 8 a (new)
(8a) Effects on protecting and conserving biodiversity
Amendment 1156 #
(8b) Effects on protecting ecologically sensitive areas
Amendment 1157 #
Proposal for a regulation
Annex II – Part 2 – point 8 c (new)
Annex II – Part 2 – point 8 c (new)
(8c) Socio-economic effects on the food chain
Amendment 1160 #
Proposal for a regulation
Annex II – Part 3 – point 1 a (new)
Annex II – Part 3 – point 1 a (new)
(1a) Analysis of the potential for persistence and invasiveness resulting from transport, loss, and spillage
Amendment 1164 #
Proposal for a regulation
Annex II – Part 3 – point 2
Annex II – Part 3 – point 2
(2) Toxicology and ecotoxicology
Amendment 1186 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 7
Annex III – Part 1 – paragraph 1 – point 7
(7) a proven reduced need for external inputs, such as plant protection productchemical pesticides and fertilisers.
Amendment 1188 #
Proposal for a regulation
Annex III – Part 2 – paragraph 1
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,