76 Amendments of María Soraya RODRÍGUEZ RAMOS related to 2023/0226(COD)
Amendment 46 #
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 new genomic techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precise locations while experimental evidence confirms occurrence of off- target mutations. _________________ 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 54 #
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 available for conventional breeding including from distantly related plant species that can be crossed by advanced breeding techniques. At the same time, the techniques used in cisgenesis are equal to those of transgenesis. Moreover, under practical conditions, the breeder's gene pool may prove restrictive in comparison with direct gene transfer and consequently result in new products unlikely to be obtained by conventional methods. 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 poolfrom a theoretically crossable species. It can however not be assumed that such changes result in plants equivalent to conventionally bred plants, and establishing the safety and risk of these NGT plants requires a direct comparison with isogenic, non-modified parental plant lines on a molecular level as well as on a physiological and anatomical level, established from actual evidence.
Amendment 60 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) Therefore, a case-by-case risk assessment has to be obtained for NGT plants in order to generate sufficient data on their intended and unintended genetic changes and related effects. The risk assessment shall require experiments under contained conditions and shall be undertaken in order to make informed decisions on NGT plant's status.
Amendment 71 #
(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 after their risk and safety is established on a case-by-case basis, 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.
Amendment 72 #
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 includes plants with improved tolerance or resistance to plant diseases and pests, tolerance to herbicides, 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.
Amendment 107 #
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 gcategorized as annual arable croups Archaeplastida or Phaeophyceae, excluding microorganisms, fungi and animals for which the available knowledge is more limitedwith no potential to persist, reproduce and spread in the environment. 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 including 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.
Amendment 121 #
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, based on the precautionary principle, and to ensure the good functioning of the internal market for the concerned plants and products, while addressing the specificity of NGT plants. The precautionary principle should be implemented as regards to adequate risk assessment and monitoring frameworks for the release of NGT plants into the environment. 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.
Amendment 122 #
Proposal for a regulation
Recital 10
Recital 10
(10) TWith full regard to the precautionary principle, the legal framework for NGT plants should share the objectives of the Union GMO legislation to ensure a high level of protection of human and animal health and of the environment and the good functioning of the internal market for the concerned plants and products, while addressing the specificity of NGT plants. This legal framework should enable the development and placing on the market of plants, food and feed containing, consisting of or produced from NGT plants and other products containing or consisting of NGT plants (‘NGT products’) so as to contribute to the innovation and sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and to enhance the competitiveness of the Union agri-food sector at Union and world level.
Amendment 131 #
Proposal for a regulation
Recital 12
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 with full regard to the precautionary principle.
Amendment 136 #
Proposal for a regulation
Recital 13
Recital 13
(13) This Regulation should distinguish between two categories of NGT plants. The status of each NGT plant is verified case by case by adequate data showing equivalence (category 2 NGT plants) or significant difference to plants derived from conventional breeding (category 2 NGT plants).
Amendment 139 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) Since significant number of NGT plants may be released into a shared environment clear methodologies must be developed in order to study potential interactions and carrying capacity of an environment related to organisms not adapted by evolutionary processes.
Amendment 140 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) NGT plants with the potential to persist, reproduce or spread in the environment, within or beyond the fields, should be evaluated with highest scrutiny in respect to their impact on nature and the environment.
Amendment 153 #
Proposal for a regulation
Recital 14
Recital 14
(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘category 1 NGT plants’) should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent and that their risks are comparable, thereby derogating in full from the Union GMO legislation and GMO related requirements in sectoral legislation. In order to ensure legal certainty, this Regulation should set out the criteria and safety for health and the environment, adequate methodology shall be defined 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.
Amendment 198 #
Proposal for a regulation
Recital 20
Recital 20
Amendment 214 #
Proposal for a regulation
Recital 22
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, metabolism or structure that affects the nutritional value, metabolism or level of undesirable substances of the food, inter alia novel toxins or allergens 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).
Amendment 223 #
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, which have been exempted from the legal requirement on the ground of their 'long history of use'. 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, with the precautionary approach on the use of inputs allowed in organic production, and with consumers’ perception and expectations of organic products. The use of category 1 NGT plants 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).
Amendment 224 #
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 prohibited in organic production. The rules of the Regulation must allow for identification of source of contamination, and the applicability of the polluter pays principle. _________________ 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 231 #
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) This regulatory framework does not provide certainty on the issue of patents on genetic material, plant traits and characteristics associated with genetic engineering. Mandatory traceability provisions for both category 1 and 2 NGT plants and products are important temporary safeguards as they contribute to the identification of NGTs throughout the entire supply chain.
Amendment 243 #
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, transparNGT plants, reproductive material, progency and choice for operators,products duering 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 NGTved from it shall be equally labelled to ensure traceability, transparency and freedom of choice for producers, operators and consumers throughout the whole food chain.
Amendment 246 #
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 NGTas well as to facilitate the potential implementation of risk management measures, category 1 NGT plants and products shall be subject to traceability and labelling requirements throughout the whole supply chain.
Amendment 271 #
Proposal for a regulation
Recital 29
Recital 29
Amendment 286 #
Proposal for a regulation
Recital 30
Recital 30
(30) For reasons of proportionality, after a first renewal of the authorisation, the authorisation should be valid for an un limited 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.
Amendment 287 #
Proposal for a regulation
Recital 30
Recital 30
(30) For reasons of proportionality, after a first renewal of the authorisation, the authorisation should be valid for an un limited 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.
Amendment 313 #
Proposal for a regulation
Recital 37
Recital 37
Amendment 325 #
Proposal for a regulation
Recital 39
Recital 39
Amendment 342 #
Proposal for a regulation
Recital 42
Recital 42
(42) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can be better achieved at Union level, so that NGT plants and NGT products may circulate freely within the internal market, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
Amendment 368 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
Amendment 371 #
Proposal for a regulation
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
(1) NGT plants classified as annual crop plants with no capability to persist, reproduce and spread in the environment;
Amendment 391 #
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 plant, excluding CRISPR-Cas9- based mutagenesis;
Amendment 420 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – introductory part
Article 3 – paragraph 1 – point 7 – introductory part
(7) ‘category 1 NGT plant’ means a NGT plant that:categorized as annual crop plant and proven equivalent to conventionally bred plants on the basis of data acquired from in-door risk assessment;
Amendment 421 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point a
Article 3 – paragraph 1 – point 7 – point a
Amendment 426 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b
Article 3 – paragraph 1 – point 7 – point b
Amendment 440 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘category 2 NGT plant’ means a NGT plant categorized as annual crop plant other than a category 1 NGT plant;
Amendment 455 #
Proposal for a regulation
Article 3 – paragraph 1 – point 15 a (new)
Article 3 – paragraph 1 – point 15 a (new)
(15a) ‘in-door risk assessment’ means risk assessment based on experiments in contained environment including data on molecular, physiological and anatomical characterisation of the product.
Amendment 467 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point a
Article 4 – paragraph 1 – point 1 – point a
(a) has obtained a decision declaring that status and authorisation in accordance with Article 6 or 7; or
Amendment 468 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
Article 4 – paragraph 1 – point 1 – point b
Amendment 488 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plants. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 501 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 505 #
Proposal for a regulation
Article 5 – paragraph 3
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 toBy [OP: Please insert the date = 18 months after the date of entry into force of this Regulation], the Commission based on recommendations from the Authority, shall adaopt them to scientific and technological progress as regards the types and extent of modifications which can occur naturally or throughdelegated act defining the methodology to be used to assess equivalence of NGT plants to conventional breedingplants.
Amendment 520 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. To obtain the declaration of category 1 NGT plant status referred to in Article 4(1), point (a), before undertaking a deliberate release of a NGT plant for any other purpose than placing on the market, the person intending to undertake the deliberate release shall submit a request accompanied with data from in-door risk assessment to verify whether the criteria set out in Annex I are met (‘verification request’) to the competent authority designated in accordance with Article 4(4) of Directive 2001/18/EC of the Member State within whose territory the release is to take place in accordance with paragraphs 2 and 3 and the implementing act adopted in accordance with Article 27, point (b).
Amendment 522 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
Amendment 533 #
Proposal for a regulation
Article 6 – paragraph 3 – point d – point i
Article 6 – paragraph 3 – point d – point i
(i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plantof the cell, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);
Amendment 540 #
Proposal for a regulation
Article 6 – paragraph 3 – point d – point ii
Article 6 – paragraph 3 – point d – point ii
(ii) the NGT plant meets the criteria set out in Annex Iis equivalent to plants derived from conventional breeding methods or natural processes based on the data collected from in-door risk assessment;
Amendment 548 #
Proposal for a regulation
Article 6 – paragraph 3 – point e
Article 6 – paragraph 3 – point e
Amendment 564 #
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 360 working days from the date of receipt of a verification request. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.
Amendment 574 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make comments to the verification report within 240 days from the date of receipt of that report.
Amendment 622 #
Proposal for a regulation
Article 7 – paragraph 2 – point d – point i
Article 7 – paragraph 2 – point d – point i
(i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plantcell, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);
Amendment 627 #
Proposal for a regulation
Article 7 – paragraph 2 – point d – point ii
Article 7 – paragraph 2 – point d – point ii
(ii) the NGT plant meets the criteria set out in Annex Iis equivalent to plants derived from conventional breeding methods or natural processes based on the data collected from in-door risk assessment;
Amendment 648 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. If the verification request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its statement on whether the NGT plant fulfils the criteria set out in Annex I within 360 working days from the date of receipt of a verification request. The Authority shall make available the statement to the Commission and the Member States. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.
Amendment 678 #
(da) relevant data from in-door risk assessment;
Amendment 689 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point f a (new)
Article 9 – paragraph 1 – subparagraph 2 – point f a (new)
(fa) information on whether a given NGT plant or part of its genetic material is covered by a granted patent or by a patent application in the EU.
Amendment 701 #
Proposal for a regulation
Article 10 – title
Article 10 – title
Amendment 705 #
Proposal for a regulation
Article 10 – title
Article 10 – title
Amendment 709 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Amendment 715 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Amendment 719 #
Proposal for a regulation
Article 10 – paragraph 1 a (new)
Article 10 – paragraph 1 a (new)
Category 1 NGT plants and products shall be subject to the rules and requirements of the Union GMO legislation with regard to traceability and labelling and to provisions in other Union legislation that apply to GMOs.
Amendment 720 #
Proposal for a regulation
Article 10 – paragraph 1 b (new)
Article 10 – paragraph 1 b (new)
Member States shall take appropriate measures to avoid the unintended presence of category 1 NGT plants in products not subject to this Regulation, Directive 2001/18 or Regulation 1829/2003, including by the possibility of opt-out.
Amendment 750 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
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. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 783 #
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 not need a monitoring plan, the notifier may propose not to submit a monitoring plan;
Amendment 806 #
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 818 #
Proposal for a regulation
Article 17 – paragraph 1
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 period, unless the decision referred to in Article 17(6) or (8) provides that the renewal is for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the consent.
Amendment 819 #
Proposal for a regulation
Article 17 – paragraph 1
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 period, unless the decision referred to in Article 17(6) or (8) provides that the renewal is for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the consent.
Amendment 822 #
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 851 #
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 does need a monitoring plan, the applicant may propose not to submit a monitoring plan.
Amendment 859 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1
Article 20 – paragraph 1 – subparagraph 1
By way of derogation from Article 6(1) and (2) and Article 18(1) and (2) of Regulation (EC) No 1829/2003, the Authority shall deliver an opinion on the application for authorisation referred to in Article 19 of this Regulation within sixnine months as from the receipt of a valid application.
Amendment 861 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 2
Article 20 – paragraph 1 – subparagraph 2
Where the Authority or the competent authority of the Member State carrying out the environmental risk assessment or the safety assessment of the food or feed pursuant to Article 6(3), points (b) and (c) and Article 18(3), points (b) and (c) of Regulation (EC) No 1829/2003 considers that additional information is necessary, the Authority, or the national competent authority through the Authority, shall ask the applicant to submit that information within a specified time limit. In that case, the six months period shall be extended by that additional period. The extension shall not exceed six months unless it is justified by the nature of the data requested or by exceptional circumstances.
Amendment 872 #
Proposal for a regulation
Article 21 – paragraph 1
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 period, unless the Commission decides to renew the authorisation for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.
Amendment 873 #
Proposal for a regulation
Article 21 – paragraph 1
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 period, unless the Commission decides to renew the authorisation for a limited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.
Amendment 891 #
Proposal for a regulation
Article 22 – paragraph 2 – point a
Article 22 – paragraph 2 – point a
(a) by way of derogation from Article 20(1), subsection (1) of this Regulation, the Authority shall deliver its opinion on the application within 46 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 932 #
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, including by the possibility of opt-out.
Amendment 949 #
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.
Amendment 978 #
Proposal for a regulation
Article 27 – paragraph 1 – point b a (new)
Article 27 – paragraph 1 – point b a (new)
(ba) methodology and information requirements for in-door risk assessment in accordance with the principles and criteria laid down in Annex I;
Amendment 982 #
Proposal for a regulation
Article 27 – paragraph 1 – point c a (new)
Article 27 – paragraph 1 – point c a (new)
(ca) methodology, processes and criteria for assessment of systemic effects on the environment, biodiversity and ecosystems, including combinatorial, cumulative and long-term effects, taking into account opinion of the Authority;
Amendment 1005 #
Proposal for a regulation
Article 30 – paragraph 3
Article 30 – paragraph 3
3. For the purpose of the reporting referred to in paragraph 1, the Commission, by [24 months after the date of entry into force of this Regulation] at the latest, shall establish, after consulting the competent authorities of the Member States in accordance with Directive 2001/18/EC and Regulation (EC) No 1829/2003, a detailed programme for monitoring, based on indicators, the impact of this Regulation, including the intended and unintended effects and systematic effects on the environment, biodiversity and ecosystems. It shall specify the action to be taken by the Commission and by the Member States in collecting and analysing the data and other evidence.
Amendment 1042 #
Proposal for a regulation
Annex I
Annex I
Amendment 1170 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – introductory part
Annex III – Part 1 – paragraph 1 – introductory part
Traits justifying the incentives referred to in Article 22, provided that such trait has been identified in the risk assessment: