BETA

Activities of Lydie MASSARD

Plenary speeches (6)

Situation of Ukrainian women refugees, including access to SRHR support (debate)
2023/10/17
EU/New Zealand Free Trade Agreement (debate)
2023/11/21
Dossiers: 2023/0038(NLE)
Improving the socio-economic situation of farmers and rural areas, ensuring fair incomes, food security as well as a just transition (debate)
2024/01/17
Plants obtained by certain new genomic techniques and their food and feed (debate)
2024/02/06
Dossiers: 2023/0226(COD)
EU/Chile Advanced Framework Agreement - EU/Chile Advanced Framework Agreement (Resolution) - Interim Agreement on Trade between the European Union and the Republic of Chile (joint debate - EU-Chile agreements)
2024/02/29
Substantiation and communication of explicit environmental claims (Green Claims Directive) (debate)
2024/03/11

Institutional motions (1)

MOTION FOR A RESOLUTION on Commission Delegated Regulation of 12 March 2024 amending Commission Delegated Regulation (EU) 2022/126 supplementing Regulation (EU) 2021/2115 of the European Parliament and of the Council as regards the rules on the ratio for the good agricultural and environmental condition (GAEC) standard 1
2024/04/17
Documents: PDF(146 KB) DOC(47 KB)

Written questions (6)

Acceptability of the NNRP-funded cableway project in Trieste in view of the environmental impacts and financial risks
2023/12/05
Documents: PDF(42 KB) DOC(10 KB)
Compatibility between the declaration of public interest for the ‘Cigéo’ radioactive waste disposal project in Bure, France, and Directive 2011/92/EU
2023/12/18
Documents: PDF(53 KB) DOC(10 KB)
Transparency concerning the Commission’s analysis of the conformity of France’s measures transposing Directive (EU) 2019/944
2023/12/18
Documents: PDF(40 KB) DOC(9 KB)
Member State’s intentional concealment of misleading commercial practices and potential risks to health and the environment
2024/01/30
Documents: PDF(43 KB) DOC(10 KB)
Atrocities committed by African Parks rangers against the Baka in the EU-funded Odzala-Kokoua National Park (Republic of Congo)
2024/03/12
Documents: PDF(45 KB) DOC(11 KB)
Slovak Beneš decrees and the right to property
2024/04/08
Documents: PDF(51 KB) DOC(11 KB)

Amendments (72)

Amendment 28 #

2023/0226(COD)

Proposal for a regulation
The European Parliament rejects the Commission proposal.
2023/11/19
Committee: ENVI
Amendment 65 #

2023/0226(COD)

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 includes 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 environment. Thus, NGTs 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 79 #

2023/0226(COD)

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 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 not be considered excluded from the scope of that Directive. The new genomic techniques and new mutagenesis methods do not have a long history of safe use. They would therefore have a comparable risk potential to the production of transgenic plants, in which foreign genetic material is introduced into the genome of organisms. In accordance with the precautionary principle, the GMO legislation would therefore have to be applied (Art.2 No.2 of Directive 2001/18; fourth, eighth and 25th recitals). These organisms and all products derived from them must therefore be subjected to a comprehensive safety assessment for humans, animals and the environment before being placed on the market. Likewise, they must be traceable and labelled. _________________ 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 111 #

2023/0226(COD)

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 annual agriculture plants , i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae, excluding microorganisms, fungi and animals for which the available knowledge is more limited. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter ‘NGT plants’), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non-crossable species (transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene. 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 120 #

2023/0226(COD)

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 plants and other products containing or consisting of NGT plants (‘NGT products’) so as to contribute to the innovation and sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and to enhance the competitiveness of the Union agri-food sector at Union and world level.
2023/11/19
Committee: ENVI
Amendment 128 #

2023/0226(COD)

Proposal for a regulation
Recital 12
(12) The potential risks of NGT plants vary, ranging from risk profiles similar to conventionally-bred plants to various types and degrees of hazards and risks that might be similar to those of plants obtained by transgenesis. This Regulation should therefore lay down special rules to adjust the risk assessment and risk management requirements according to the potential risks or lack thereof posed by NGT plants and NGT products.deleted
2023/11/19
Committee: ENVI
Amendment 134 #

2023/0226(COD)

Proposal for a regulation
Recital 13
(13) This Regulation should distinguish between two categories of NGT plants.deleted
2023/11/19
Committee: ENVI
Amendment 148 #

2023/0226(COD)

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 which includes that they are not patented and that their risks are comparable as a risk assessment has shown, 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.
2023/11/19
Committee: ENVI
Amendment 162 #

2023/0226(COD)

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 165 #

2023/0226(COD)

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 175 #

2023/0226(COD)

(17) This declaration should be obtained prior to any deliberate release of any category 1 NGT planNGT products 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.
2023/11/19
Committee: ENVI
Amendment 177 #

2023/0226(COD)

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 196 #

2023/0226(COD)

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 plantNGT products status declarations are made within a reasonable time.
2023/11/19
Committee: ENVI
Amendment 199 #

2023/0226(COD)

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 207 #

2023/0226(COD)

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 216 #

2023/0226(COD)

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).
2023/11/19
Committee: ENVI
Amendment 229 #

2023/0226(COD)

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 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 planNGT products should therefore be also prohibited 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).
2023/11/19
Committee: ENVI
Amendment 241 #

2023/0226(COD)

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 1 NGT plants should be labelled as category 1 NGT.
2023/11/19
Committee: ENVI
Amendment 252 #

2023/0226(COD)

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 253 #

2023/0226(COD)

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 261 #

2023/0226(COD)

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 273 #

2023/0226(COD)

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 limited risk assessment to complex alterations requiring a more thorough analysis of potential risks. Therefore, post-market monitoring requirements for environmental effects of category 2 NGT plants should be adapted in the light of the environmental risk assessment and the experience in field trials, the characteristics of the NGT plant concerned, the characteristics and scale of its expected use, in particular any history of safe use of the plant and the characteristics of the receiving environment. 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 282 #

2023/0226(COD)

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 290 #

2023/0226(COD)

Proposal for a regulation
Recital 32
(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 decisionall label all NGT products according to the requirements laid down existing EU law, Directive 2001/18 and Regulation (EC) No 1830/2003.
2023/11/19
Committee: ENVI
Amendment 316 #

2023/0226(COD)

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 facilitatedregulated under existing EU law, in particular Directive 2001/18 and Regulation (EC) No 1830/2003 . 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 planNGT products in all or part of their territory, set out in Article 26b of Directive 2001/18/EC wshould undermine those goalsremain.
2023/11/19
Committee: ENVI
Amendment 324 #

2023/0226(COD)

Proposal for a regulation
Recital 39
(39) To achieve the goal of ensuring the effective functioning of the internal market, NGT plants and related products should benefit from the free movement of goods, provided they comply with the requirements of other Union law.deleted
2023/11/19
Committee: ENVI
Amendment 333 #

2023/0226(COD)

Proposal for a regulation
Recital 40
(40) In its judgment of 25 July 2018, in case C-528/1610 the Court of Justice of the European Union held that organisms obtained by means of techniques/methods of mutagenesis which have not conventionally been used in a number of applications and do not have a long safety record come within the scope of Directive 2001/18 and are, therefore, subject to the obligations arising from that directive. 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 five years after the adoption of the first decision allowing the deliberate release or the marketing of NGT plants or NGT products in the Union, the Commission should carry out an evaluation of this Regulation to measure the progress made towards the availability of NGT plants containing such characteristics or properties on the EU market.
2023/11/19
Committee: ENVI
Amendment 367 #

2023/0226(COD)

Proposal for a regulation
Article 1 – paragraph 1
TIn accordance with the precautionary principle, and with the primary objective of ensuring a high level of protection of human and animal health and the environment, 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 plants.
2023/11/19
Committee: ENVI
Amendment 373 #

2023/0226(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 1
(1) annual agricultural NGT plants;
2023/11/19
Committee: ENVI
Amendment 378 #

2023/0226(COD)

Proposal for a regulation
Article 2 – paragraph 1 a (new)
This regulation does not apply to: (1) patented material or material for which a patent application is being processed; (2) herbicide-tolerant plants; (3) Wild plants, trees and algae.
2023/11/19
Committee: ENVI
Amendment 386 #

2023/0226(COD)

Proposal for a regulation
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 conditions that: (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 plant and; (b) there are no patents or exclusive rights covering the process used to develop the plant, and there are no patents or exclusive rights covering the plant or parts thereof, and no application has been tabled for such patents or exclusive rights to be granted;
2023/11/19
Committee: ENVI
Amendment 418 #

2023/0226(COD)

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 439 #

2023/0226(COD)

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 448 #

2023/0226(COD)

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 451 #

2023/0226(COD)

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 460 #

2023/0226(COD)

Proposal for a regulation
Article 4 – paragraph 1 – introductory part
Without prejudice to other requirements of Union law, and with strict regard to the precautionary principle for a purpose intentionally 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: the plant is a NGT plant and has been authorized in accordance with Chapter III.
2023/11/19
Committee: ENVI
Amendment 463 #

2023/0226(COD)

Proposal for a regulation
Article 4 – paragraph 1 – point 1
(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); ordeleted
2023/11/19
Committee: ENVI
Amendment 465 #

2023/0226(COD)

Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point a
(a) has obtained a decision declaring that status in accordance with Article 6 or 7; ordeleted
2023/11/19
Committee: ENVI
Amendment 469 #

2023/0226(COD)

Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
(b) is progeny of plant(s) referred to in point (a); ordeleted
2023/11/19
Committee: ENVI
Amendment 472 #

2023/0226(COD)

Proposal for a regulation
Article 4 – paragraph 1 – point 2
(2) the plant is a category 2 NGT plant and has been authorised in accordance with Chapter III.deleted
2023/11/19
Committee: ENVI
Amendment 489 #

2023/0226(COD)

Proposal for a regulation
Article 5 – paragraph 1
1. The rules which apply to GMOs in Union legislation shall not apply to category 1all NGT plants.
2023/11/19
Committee: ENVI
Amendment 496 #

2023/0226(COD)

Proposal for a regulation
Article 5 – paragraph 2
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.deleted
2023/11/19
Committee: ENVI
Amendment 502 #

2023/0226(COD)

Proposal for a regulation
Article 5 – paragraph 3
3. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the criteria of equivalence of NGT plants to conventional plants laid down in Annex I 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.
2023/11/19
Committee: ENVI
Amendment 512 #

2023/0226(COD)

Proposal for a regulation
Article 6
[...]deleted
2023/11/19
Committee: ENVI
Amendment 610 #

2023/0226(COD)

Proposal for a regulation
Article 7
[...]deleted
2023/11/19
Committee: ENVI
Amendment 659 #

2023/0226(COD)

Proposal for a regulation
Article 8 – paragraph 1
The Commission shall set up and maintain an electronic system for the submission of verifapplication requests in accordance with Articles 6 and 7 ands for registration and all necessary data and studies for the exchange of the information under this Titlpursuant to this title and shall maintain that system. All data shall be promptly displayed to the public in a publicly viewable register and shall be sent immediately upon request without charge.
2023/11/19
Committee: ENVI
Amendment 663 #

2023/0226(COD)

Proposal for a regulation
Article 8 a (new)
Article 8a The Commission shall publish the detection method and make reference material of the NGT plant available to the European GMO reference laboratories.
2023/11/19
Committee: ENVI
Amendment 669 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1
The Commission shall establish and maintain a public database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6).
2023/11/19
Committee: ENVI
Amendment 687 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point e a (new)
(ea) information about the genetic modification and the site;
2023/11/19
Committee: ENVI
Amendment 688 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point f
(f) the decision referred to in Article 6(8) or (10), and Article 7(6), as appropriconfirmation that the NGT plant is not subject to any patent.
2023/11/19
Committee: ENVI
Amendment 691 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point f a (new)
(fa) risk assessment according to Directive 2001/18.
2023/11/19
Committee: ENVI
Amendment 693 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point f b (new)
(fb) detection methods.
2023/11/19
Committee: ENVI
Amendment 695 #

2023/0226(COD)

Proposal for a regulation
Article 9 – paragraph 2
2. The database and all information contained in it shall be publicly available.
2023/11/19
Committee: ENVI
Amendment 714 #

2023/0226(COD)

Proposal for a regulation
Article 10 – paragraph 1
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 fromNGT plant for food and feed use, NGT product and produced from an NGT plant shall fulfil the labelling requirements as set out in Directive 2001/18 and Regulation (EC) No 1830/2003.
2023/11/19
Committee: ENVI
Amendment 738 #

2023/0226(COD)

Proposal for a regulation
Article 11 a (new)
Article 11a Member States shall take the appropriate measures to avoid the unintended presence of category 1 plants not subject to Directive 2001/18 or Regulation 1829/2003, based on an implementing regulation to be presented by the EU Commission.
2023/11/19
Committee: ENVI
Amendment 740 #

2023/0226(COD)

Proposal for a regulation
Article 11 b (new)
Article 11b During the authorisation procedure of a given category 1 NGT or during the renewal of consent/authorisation, a Member State may demand that the geographical scope of the written consent or authorisation be adjusted to the effect that all or part of the territory of that Member State is to be excluded from cultivation, according to article 26b of Directive 2001/18/EC.
2023/11/19
Committee: ENVI
Amendment 742 #

2023/0226(COD)

Proposal for a regulation
Chapter III – title
III Category 2 NGT plants and category 2 NGT products
2023/11/19
Committee: ENVI
Amendment 745 #

2023/0226(COD)

Proposal for a regulation
Article 12 – title
Status of Category 2 NGT plants and category 2 NGT products
2023/11/19
Committee: ENVI
Amendment 754 #

2023/0226(COD)

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 769 #

2023/0226(COD)

Proposal for a regulation
Article 13 – paragraph 1 – point d a (new)
(da) the proof that: (i) there are no patents or exclusive rights covering the process used to develop the plant; (ii) there are no patents or exclusive rights covering the plant or parts thereof; (iii) no application has been tabled for such patents or exclusive rights to be granted;
2023/11/19
Committee: ENVI
Amendment 773 #

2023/0226(COD)

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 802 #

2023/0226(COD)

Proposal for a regulation
Article 15
Specific provisions on monitoring 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.Article 15 deleted
2023/11/19
Committee: ENVI
Amendment 821 #

2023/0226(COD)

Proposal for a regulation
Article 17 – paragraph 1
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 period10 years, 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.
2023/11/19
Committee: ENVI
Amendment 874 #

2023/0226(COD)

Proposal for a regulation
Article 21 – paragraph 1
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 period10 years, 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.
2023/11/19
Committee: ENVI
Amendment 878 #

2023/0226(COD)

Proposal for a regulation
Article 21 a (new)
Article 21a Safeguard clause 1. Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a NGT as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory. The Member State shall ensure that in the event of a severe risk, emergency measures, such as suspension or termination of the placing on the market, shall be applied, including information to the public. The Member State shall immediately inform the Commission and the other Member States of actions taken under this Article and give reasons for its decision, supplying its review of the environmental risk assessment, indicating whether and how the conditions of the consent should be amended or the consent should be terminated, and, where appropriate, the new or additional information on which its decision is based. 2. Within 60 days of the date of receipt of the information trans mitted by the Member State, a decision shall be taken on the measure taken by that Member State in accordance with the regulatory procedure referred to in Article 30(2). For the purpose of calculating the 60-day period, any period of time during which the Commission is awaiting further information which it may have requested from the notifier or is seeking the opinion of the Scientific Committee or Committees which has or have been consulted shall not be taken into account. The period of time during which the Commission is awaiting the opinion of the Scientific Committee or Committees consulted shall not exceed 60 days. Likewise, the period of time the Council takes to act in accordance with the regulatory procedure referred to in Article 30(2) shall not be taken into account.
2023/11/19
Committee: ENVI
Amendment 886 #

2023/0226(COD)

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 913 #

2023/0226(COD)

Proposal for a regulation
Article 23 – title
Labelling of authorised category 2 NGT products
2023/11/19
Committee: ENVI
Amendment 919 #

2023/0226(COD)

Proposal for a regulation
Article 23 – paragraph 1
In addition to tThe 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 shall apply to NGT products .
2023/11/19
Committee: ENVI
Amendment 925 #

2023/0226(COD)

Proposal for a regulation
Article 24 – title
Measures to avoid the unintended presence of category 2 NGT plants
2023/11/19
Committee: ENVI
Amendment 929 #

2023/0226(COD)

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. A public register about the location where NGT are grown plus detection methods for NGT are obligatory. Member states will introduce liability schemes that producers of NGT burden the costs for contamination in neighbour fields as well as contamination caused by joint use of machineries, storages and processing entities.
2023/11/19
Committee: ENVI
Amendment 941 #

2023/0226(COD)

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 1041 #

2023/0226(COD)

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