Activities of Sandra PEREIRA related to 2023/0226(COD)
Plenary speeches (1)
Plants obtained by certain new genomic techniques and their food and feed (debate)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625
Amendments (105)
Amendment 2 #
Proposal for a regulation
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The Committee on Agriculture and Rural Development calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to propose rejection of the Commission proposal.
Amendment 6 #
Proposal for a regulation
Recital -1 (new)
Recital -1 (new)
(-1) Biotechnology is one of the most important technologies for the future and should be supported by a suitable policy framework, with ethical, environmental and health aspects also being taken into account. However, life should under no circumstances be patented, either in the form of reproductive techniques or by privatising genome sequences, because knowledge is of benefit to all.
Amendment 7 #
Proposal for a regulation
Recital -1 a (new)
Recital -1 a (new)
(-1a) Ethical questions relating to the use and practice of science in the field of genetic engineering are a fundamental issue. First and foremost, the short-, medium- and long-term consequences of using such technologies must be examined. It will be undeniably important to gain further knowledge about the impact on the environment, climate, farming, biodiversity and food security. It will also be important to build bridges between science and the advances it produces and the development of agriculture and production in general avoiding sacrificing the future and ensuring that such choices follow the precautionary principle.
Amendment 8 #
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, however, the results cannot be fully foreseen and may be equivalent to or different from plants obtained using conventional selection. _________________ 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 10 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) Trade in genetically modified organism varieties cannot directly or indirectly rely solely on monopolistic private multinational companies, which benefit the most from the mass use of those patented varieties, a situation that leaves farmers more dependent on seed producers and, therefore, reduces the Member States' food and production sovereignty.
Amendment 11 #
Proposal for a regulation
Recital 1 b (new)
Recital 1 b (new)
(1b) Since knowledge about the properties of each gene is incomplete and the number of variables is considerable, the impact of using such genetic techniques and their subsequent large- scale roll-out is not yet fully understood. Natural or organic crops, i.e. crops that have not been genetically modified by humans, existing alongside genetically modified crops poses the issue of gene flow, since pollination is often anemophilous, by way of the wind.
Amendment 12 #
Proposal for a regulation
Recital 1 d (new)
Recital 1 d (new)
(1d) The use of genetically modified organisms has led to an excessive use of pesticides and persistent fertilisers, which can lead to reduced soil fertility, aridity and low water holding capacity. Defending the genetic integrity of natural crops is therefore fundamental, given that the impact of large-scale agriculture on soil properties affects the hydrosphere, biosphere, atmosphere and climate and, over time, contributes to desertification, which poses a threat to long-term food security. The precautionary principle should therefore be followed with the introduction of new NGT varieties.
Amendment 13 #
Proposal for a regulation
Recital 1 e (new)
Recital 1 e (new)
(1e) The impact that consumption of GMOs and NGTs may have on animal feed and human food has not been sufficiently weighed up, particularly in the long term. There are no studies in the European Union that assess with any certainty the true impact on farming and food of introducing such plant varieties.
Amendment 15 #
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 theoretically 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. However, the processes used in cisgenesis (and in intragenesis) are the same as those used to carry out transgenesis (insertion of additional gene sequences). Moreover, the gene pool used by conventional breeders in practical conditions may include variations not present in a gene pool that can be harnessed through the direct (and potentially reproducible) transfer of genes through all types of genetic backgrounds and can therefore produce plants that are difficult to obtain through conventional breeding 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. However, the results in terms of intentional and unintentional genetic alterations and biological effects cannot be predicted. 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. However, the processes used in cisgenesis (and in intragenesis) are the same as those used to achieve transgenesis (insertion of additional gene sequences). Moreover, the gene pool used by conventional breeders, when taking practical decisions, may include restrictions absent from a gene pool that can be harnessed through the direct (and potentially repeated) transfer of genes through all genetic backgrounds and can therefore produce plants that will be difficult to obtain through conventional breeding methods.
Amendment 17 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) The introduction of plant varieties into the environment and/or into foodstuffs or feed for animals that may be different in their intended or unintended genotypes and phenotypes from those obtained by conventional breeding processes poses challenges to the regulatory authority, which must ensure safety for health and the environment. Such differences may not always be obvious or predictable and suitable data therefore is needed before conclusions about their safety can be drawn.
Amendment 18 #
Proposal for a regulation
Recital 2 b (new)
Recital 2 b (new)
(2b) A risk assessment must be carried out on all NGT plants in order to produce adequate data on their intended and unintended genetic alterations and the effects that may arise from those alterations. This first stage of the risk assessment, which simply requires experiments under contained use conditions, should be used to take decisions about their status and the amount of data that will be needed for an overall risk assessment.
Amendment 19 #
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, 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 20 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) Given that sustainability comprises many degrees of complexity, clear and transparent criteria are needed for a suitable technological assessment before conclusions can be drawn on the potential benefits of NGTs' specific characteristics.
Amendment 25 #
Amendment 28 #
Proposal for a regulation
Recital 8
Recital 8
Amendment 34 #
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 Phaeophyceaeannual agricultural crops with no potential to persist, reproduce and spread in the environment, excluding microother organisms, 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 or insertions of additional genetic material prepared outside cells. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non- crossable species (transgenesis) or that contain additional genetic material prepared outside cells should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene or the inserted additional genetic material. 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 36 #
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 plants and o but without undermining ther 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 levelecautionary principle.
Amendment 41 #
Proposal for a regulation
Recital 11
Recital 11
(11) This Regulation constitutes lex specialis with regard to the Union GMO legislation, based on the precautionary principle. It introduces specific provisions for NGT plants and NGT products. However, where there are no specific rules in this Regulation, NGT plants and products (including food and feed) obtained from them should remain subject to the requirements of the Union GMO legislation and the rules on GMOs in sectoral legislation, such as Regulation (EU) 2017/625 on official controls or the legislation on certain products like plant and forest reproductive material.
Amendment 46 #
(13a) To evaluate the status of NGT plants, it is necessary to know the 'indoor risk assessment' data (which requires experiments under contained conditions involving molecular characterisation and greenhouse experiments) to check the two categories of NGT plants. Given that field trials or food consumption trials are not required for the 'indoor risk assessment' (which requires experiments in contained conditions), such data can be supplied and evaluated without excessive costs in a shorter period of time.
Amendment 47 #
Proposal for a regulation
Recital 13 b (new)
Recital 13 b (new)
(13b) Given that many NGT plants with different characteristics and from a variety of species may be released into the same environment, clear criteria and methods should be established to assess potential interactions and avoid overloading ecosystems with organisms that have not adapted through evolutionary processes. NGT plants that have the potential to persist, reproduce or spread in the environment (within or outside fields) must have their impact on nature and the environment assessed with greater scrutiny. In the event of any doubts, their release into the environment should be banned.
Amendment 48 #
Proposal for a regulation
Recital 13 c (new)
Recital 13 c (new)
(13c) The status of each NGT plant should be checked by clearly establishing what makes it considerably different from plants derived from conventional reproductive methods.
Amendment 53 #
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 to ascertain if a NGT plant is equivalent toIn order to ensure legal certainty and safety for health and the environment, this Regulation should set out the criteria and establish suitable methods to ascertain the impact that a NGT plant has on the reproduction of 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. TheyDecision-making 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 regardsthe site of the intended or unintended genetic alterations and associated biological effects. The methods needed for the 'indoor risk assessment' (for example for whole genome sequencing and to carry out omics, greenhouse and environmental chamber experiments) must be proposed by the European Food Safety Authority (EFSA) and established by an implementing regulation. They should cover the type and extent of genetic modifications that can occurbe observed in nature or througin organisms obtained with conventional breeding techniques.
Amendment 59 #
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 and the overall risk assessment because they feature more complex sets of modifications to the genome or have a genotype and/or phenotype that is unlikely to be obtained through conventional or natural reproductive processes. The amount of additional data needed to draw a conclusion about the safety of those plants can be decided based on data in their 'indoor risk assessment' as the first step in the approval process.
Amendment 62 #
Proposal for a regulation
Recital 16
Recital 16
Amendment 72 #
Proposal for a regulation
Recital 17
Recital 17
Amendment 73 #
Proposal for a regulation
Recital 18
Recital 18
Amendment 82 #
Proposal for a regulation
Recital 19
Recital 19
Amendment 86 #
Proposal for a regulation
Recital 20
Recital 20
Amendment 91 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 100 #
Proposal for a regulation
Recital 22
Recital 22
Amendment 107 #
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. _________________ 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 119 #
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 123 #
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24a) Labelling must be used on NGT plants, their progeny and derived products in order to guarantee transparency and traceability throughout the food production chain right up to the consumer.
Amendment 126 #
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 128 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) The Member States cannot be restricted or prevented from establishing themselves as countries free from GMO and NGT varieties.
Amendment 129 #
Proposal for a regulation
Recital 25 b (new)
Recital 25 b (new)
(25b) The release of GMOs or organisms obtained by way of NGTs into the environment is irreversible/uncontrollable, has incalculable effects on ecosystems and biodiversity and poses a serious risk of polluting organic/conventional crops, thus making it impossible for those farmers to have freedom of choice.
Amendment 131 #
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 intragenesis48and on plants developed through targeted mutagenesis49recommended 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.2022.7618It 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.
Amendment 134 #
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 138 #
Proposal for a regulation
Recital 29
Recital 29
Amendment 143 #
Proposal for a regulation
Recital 30
Recital 30
Amendment 152 #
Proposal for a regulation
Recital 32
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 decision.
Amendment 153 #
Proposal for a regulation
Recital 33
Recital 33
(33) Regulatory incentives should be offered to potential notifiers or applicants for category 2 NGT plants and products containing traits with the potential to contribute to a sustainable agri-food system, in order to steer the development of category 2 NGT plants towards such traits. The criteria to trigger these incentives should focus on broad trait categories with the potential to contribute to sustainability (such as those linked to tolerance or resistance to biotic and abiotic stresses, improved nutritional characteristics or increased yield) and should be based on the contribution to the value for sustainable cultivation and use as defined in [Article 52(1) of the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the 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 155 #
Proposal for a regulation
Recital 34
Recital 34
(34) Incentives should consist in an accelerated procedure for risk assessment as regards applications handled by a fully centralised procedure (food and feed products) and enhanced pre-submission advice to help developers prepare the dossier for the purpose of the environmental and food and feed safety assessments, without affecting the general provisions on pre-submission advice, notification of studies and consultation of third parties pursuant to Articles 32a, 32b and 32c of Regulation (EC) No 178/2002(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 160 #
Proposal for a regulation
Recital 37
Recital 37
Amendment 180 #
Proposal for a regulation
Recital 42
Recital 42
Amendment 182 #
Proposal for a regulation
Recital 43
Recital 43
Amendment 185 #
Proposal for a regulation
Recital 45
Recital 45
Amendment 193 #
Proposal for a regulation
Article 2.º – paragraph 1 – point 1
Article 2.º – paragraph 1 – point 1
(1) NGT agricultural plants;
Amendment 194 #
Proposal for a regulation
Article 2.º – paragraph 1 – point 4 a (new)
Article 2.º – paragraph 1 – point 4 a (new)
(4a) Wild plants, trees and algae fall outside the scope of this Regulation.
Amendment 197 #
Proposal for a regulation
Article 3.º – paragraph 1 – point 2
Article 3.º – 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 or prepared outside cells that temporarily may have been inserted during the development of the NGT plant; , and there is no type of intellectual property associated with the plant, its properties or the technique used to create it;
Amendment 223 #
Proposal for a regulation
Article 3.º – paragraph 1 – point 7
Article 3.º – paragraph 1 – point 7
Amendment 233 #
Proposal for a regulation
Article 3.º – paragraph 1 – point 8
Article 3.º – paragraph 1 – point 8
Amendment 240 #
Proposal for a regulation
Article 3.º – paragraph 1 – point 13
Article 3.º – paragraph 1 – point 13
Amendment 243 #
Proposal for a regulation
Article 3.º – paragraph 1 – point 14
Article 3.º – paragraph 1 – point 14
Amendment 256 #
Amendment 291 #
Proposal for a regulation
Article 6.º
Article 6.º
Amendment 365 #
Proposal for a regulation
Article 7.º
Article 7.º
Amendment 383 #
Proposal for a regulation
Article 8.º
Article 8.º
Amendment 387 #
Proposal for a regulation
Article 9.º
Article 9.º
Amendment 400 #
Proposal for a regulation
Article 10.º – title
Article 10.º – title
Labelling of category 1 NGT plant reproductive material, including breeding material
Amendment 407 #
Proposal for a regulation
Article 10.º – paragraph 1
Article 10.º – paragraph 1
Plant reproductive material, its descendants and derived products, including for breeding and scientific purposes, that containsing or consists of category 1ing of 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 abbreviation ‘NGT’, followed by the identification number of the NGT plant(s) it has been derived from.
Amendment 410 #
Proposal for a regulation
Article 11.º
Article 11.º
Amendment 413 #
Proposal for a regulation
Chapter III – title
Chapter III – title
III Category 2 NGT pPlants and category 2 NGT products
Amendment 415 #
Proposal for a regulation
Article 12.º – title
Article 12.º – title
Status of Category 2 NGT plants and category 2 NGT products
Amendment 419 #
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 422 #
Proposal for a regulation
Article 13.º – paragraph 1 – introductory part
Article 13.º – paragraph 1 – introductory part
As regards the deliberate release of a category 2n 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 423 #
Proposal for a regulation
Article 13.º – paragraph 1 – point c – point ii
Article 13.º – paragraph 1 – point c – point ii
(ii) information relating to the category 2 NGT plant(s);
Amendment 424 #
Proposal for a regulation
Article 13.º – paragraph 1 – point c – point iv
Article 13.º – paragraph 1 – point c – point iv
(iv) information on the interactions between the category 2 NGT plant(s) and the environment;
Amendment 425 #
Proposal for a regulation
Article 13.º – paragraph 1 – point c – point v
Article 13.º – 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 429 #
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 430 #
Proposal for a regulation
Article 14.º – paragraph 1 – introductory part
Article 14.º – 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 431 #
Proposal for a regulation
Article 14.º – paragraph 1 – point b
Article 14.º – paragraph 1 – point b
(b) designation and specification of the category 2 NGT plant;
Amendment 432 #
Proposal for a regulation
Article 14.º – paragraph 1 – point e
Article 14.º – paragraph 1 – point e
(e) the environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);.
Amendment 433 #
Proposal for a regulation
Article 14.º – paragraph 1 – point h
Article 14.º – 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 434 #
Proposal for a regulation
Article 14.º – paragraph 1 – point j
Article 14.º – 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 435 #
Proposal for a regulation
Article 14.º – paragraph 1 – point l
Article 14.º – 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 439 #
Proposal for a regulation
Article 14.º – paragraph 1 – point m
Article 14.º – 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 440 #
Proposal for a regulation
Article 14.º – paragraph 2
Article 14.º – 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 444 #
Proposal for a regulation
Article 17.º
Article 17.º
Amendment 446 #
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 447 #
Proposal for a regulation
Article 18.º – paragraph 1 – point a
Article 18.º – paragraph 1 – point a
(a) category 2 NGT plants for food use or for feed use;
Amendment 448 #
Proposal for a regulation
Article 18.º – paragraph 1 – point b
Article 18.º – paragraph 1 – point b
(b) food containing, consisting of or produced from category 2 NGT plants, or containing ingredients produced from category 2 NGT plants (‘category 2 NGT food’)NGT plants;
Amendment 449 #
Proposal for a regulation
Article 18.º – paragraph 1 – point c
Article 18.º – paragraph 1 – point c
(c) feed containing, consisting of or produced from category 2 NGT plants (‘category 2 NGT feed’).NGT plants;
Amendment 450 #
Proposal for a regulation
Article 19.º – paragraph 1 – introductory part
Article 19.º – paragraph 1 – introductory part
1. By way of derogation from 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 451 #
Proposal for a regulation
Article 19.º – paragraph 1 – point b
Article 19.º – paragraph 1 – point b
(b) the food or the feed complies with the criteria referred to in Article 4(1) or Article 16(1) of Regulation (EC) No 1829/2003, respectively, based on a safety assessmentn assessment of the risk to biodiversity and of the safety of the food or feed carried out in accordance with the principles and criteria laid down in Parts 1 and 3 of Annex II to this Regulation and with the implementing act adopted in accordance with Article 27, point (c).
Amendment 452 #
Proposal for a regulation
Article 19.º – paragraph 2 – subparagraph 2
Article 19.º – paragraph 2 – subparagraph 2
Amendment 455 #
Proposal for a regulation
Article 19.º – paragraph 3 – introductory part
Article 19.º – paragraph 3 – introductory part
3. By way of derogation from 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 456 #
Proposal for a regulation
Article 19.º – paragraph 3 – point b
Article 19.º – 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 457 #
Proposal for a regulation
Article 21.º
Article 21.º
Amendment 460 #
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 467 #
Proposal for a regulation
Article 22.º – paragraph 1
Article 22.º – 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 468 #
Proposal for a regulation
Article 22.º – paragraph 2 – point a
Article 22.º – 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 469 #
Proposal for a regulation
Article 22.º – paragraph 8 – point b
Article 22.º – paragraph 8 – point b
(b) the Commission shall conduct an up-to-date scientific literature review of the impact on environmental, social and economic sustainability, as well as the impact on health, of the trait(s) it intends to add to or delete from the list in Annex III;
Amendment 471 #
Proposal for a regulation
Article 23.º – title
Article 23.º – title
Labelling of authorised category 2 NGT products
Amendment 476 #
Proposal for a regulation
Article 24.º – title
Article 24.º – title
Measures to avoid the unintended presence of category 2 NGT plants
Amendment 482 #
Proposal for a regulation
Article 25.º
Article 25.º
Amendment 492 #
Proposal for a regulation
Article 31.º
Article 31.º
Amendment 495 #
Proposal for a regulation
Annex I
Annex I
Amendment 557 #
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 558 #
Proposal for a regulation
Annex II – paragraph 1
Annex II – paragraph 1
Amendment 559 #
Proposal for a regulation
Annex II – paragraph 1 a (new)
Annex II – paragraph 1 a (new)
The type and amount of information necessary for the environmental risk assessment of NGT plants laid down in Annex III of Directive 2001/18/EC and for the food and feed safety assessment of NGT food and feed shall apply.
Amendment 560 #
Proposal for a regulation
Annex II – Part 1
Annex II – Part 1
Amendment 561 #
Proposal for a regulation
Annex III
Annex III
Amendment 582 #
Proposal for a regulation
Annex III a (new)
Annex III a (new)
ANNEX III a Technological assessment: A technological assessment will be introduced to evaluate the potential benefits of NGT plants in terms of reducing pesticides, adapting to climate change or other aspects of sustainability, in order to verify the potential advantages, also in comparison with conventional reproduction.In addition, the technological assessment will also be implemented to address potential adverse effects that cannot be examined at the level of individual events, such as combinatorial, cumulative and long-term effects. The technological assessment should address the characteristics of specific traits, as well as aspects that could, at an early stage, have an impact on future technological development in the field of NGT plants in general. The criteria to be taken into account in the technological assessment are: use of pesticides, greenhouse gas emissions, effects on biodiversity, effects on agroecology, interactions between genetically modified plants sharing the same environment, spatial and temporal control, less risky alternatives and reversibility of releases.
Amendment 583 #
Proposal for a regulation
Annex III b (new)
Annex III b (new)
Annex III b Detection and traceability methods In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant or decided on by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) 1829/2003 under the procedure referred to in Article 20(4), the modalities for the fulfilment of the requirements of the analytical method shall be adapted. Methods of documentation that do not rely on analysis but rather on documentation should also be defined for relevant cases.