BETA

60 Amendments of Pietro FIOCCHI related to 2023/0226(COD)

Amendment 31 #
Proposal for a regulation
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomicprecision breeding techniques and their food and feed, and amending Regulation (EU) 2017/625 (Text with EEA relevance)
2023/11/19
Committee: ENVI
Amendment 56 #
Proposal for a regulation
Recital 2
(2) NGTs constitute a diverse group of genomic techniques, and each of them can be used in various ways to achieve different results and products. They can result in organisms with modifications equivalent to what can be obtained by conventional breeding methods or in organisms with more complex modifications. Among NGTs, targeted mutagenesis and cisgenesis (including intragenesis) introduce genetic modifications without inserting genetic material from non-crossable species (transgenesis). They rely only on the breeders’ gene pool, i.e. the total genetic information that is available for conventional breeding including from distantly related plant species that can be crossed by advanced breeding techniquin one species. Targeted mutagenesis techniques result in modification(s) of the DNA sequence at precise locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool.
2023/11/19
Committee: ENVI
Amendment 63 #
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 potentially 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,us, NGTs might 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 ). However, most NGTs havein the potential to contribute to the innovation and sustainability goalre-commercial stage relate to pesticide tolerance. Increased herbicide use resulting from NGT cultivation in the European Union must be considered. Importantly, the different action pathways to fulfil the objectives of the European Green Deal (34 ) and of the ‘Farm to Fork’ (35 4), Biodiversity (36 5) and Adaptation to Climate Change(37 6) Strategies, to global food security (38 7), the Bioeconomy Strategy (39 8) and to the Union’s strategic autonomy (40 )9), must not undermine one another. _________________ 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 146 #
Proposal for a regulation
Recital 14
(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniques (‘category 1 NGT plants’) should be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equivalent and that their risks are comparable, thereby derogating in full from the Union GMO legislation and GMO related requirements in sectoral legislation. In order to ensure legal certainty, this Regulation should set out the criteriaapproach to ascertain if a NGT plant ismeets the condition of equivalentce 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 thosapplicable 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 numbers benchmark 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 approaches and any applicable criteria for the equivalence verification at least every three years 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. During the development of a NGT plant, genetic material originating from outside the breeders’ gene pool might have been temporarily inserted (transiently or stably in an intermediate plant). In order to verify the NGT status of a plant, information is necessary to show absence of such temporarily inserted sequences from outside the breeders’ gene pool.
2023/11/19
Committee: ENVI
Amendment 151 #
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 1and their progeny obtained by conventional breeding techniques (‘category 1 NGT plants’) shall not fall under the scope of the Union GMO legislation and GMO related requirements in sectoral legislation. Nonetheless, NGTs plants’) shoul, obtained bey treated as plants that have occurred naturally or haveargeted mutagenesis or cisgenesis, or a combination thereof, remain genetically modified plants. There is no scientific basis for assimilating NGTs to conventional breen 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 GMOding methods, nor products obtained by NGTs to conventional products. The genetic engineering process used to obtain NGT plants and products itself may lead to unintended effects that can entail potential risks. Whether a certain modification or trait could be obtained by other means than genetic engineering does not take away the need to assess and regulated requirements in sectoral legislation NGTs and products obtained by NGTs in accordance with the precautionary principle. 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 bredthe risk profile of an NGT 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 breedingThe adaptation of these criteria may have significant implications on the scale of the NGT plants and products which may fall under the scope of category 1 or 2 NGT plants and products, and therefore, should be adapted based on an ordinary legislative procedure.
2023/11/19
Committee: ENVI
Amendment 170 #
Proposal for a regulation
Recital 16
(16) Category 1 NGT plants and products shouldmust 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.
2023/11/19
Committee: ENVI
Amendment 217 #
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, 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).deleted
2023/11/19
Committee: ENVI
Amendment 232 #
Proposal for a regulation
Recital 23 a (new)
(23a) All European quality schemes and geographical indicators (GIs) should have the possibility to choose not to use NGTs in their standards.
2023/11/19
Committee: ENVI
Amendment 233 #
Proposal for a regulation
Recital 23 b (new)
(23b) Organic and conventional operators should have the right and freedom not to use NGTs in their production process and throughout their supply chain. This Regulation shall lay out adequate provisions to ensure the freedom of choice for operators not to use NGT plants and seeds, both category 1 and 2, in their production processes. Any additional financial and legal burden to ensure the GMO and NGT-free status of production should not fall on farmers and operators who do not wish to use NGTs. Economic losses incurred due to the adventitious presence of GMOs shall not fall on NGT-free conventional and organic operators. In most cases of adventitious presence, it is impossible to establish the causes, faults, and therefore responsibilities. Thus, this Regulation shall establish coexistence measures, laying the basis for national liability provisions and compensation funds.
2023/11/19
Committee: ENVI
Amendment 234 #
Proposal for a regulation
Recital 24
(24) Provision should be made to ensure transparencceability 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. Category 1 NGT plants tshat 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 farmersll be subject to the traceability system laid out in Regulation (EC) 1830/2003. Traceability measures are needed throughout the whole supply chain to enable food processors and operators to avoid the accidental or unavoidable adventitious presence of NGTs in their production process. These traceability requirements should facilitate both the withdrawal of products where unforeseen adverse effects on human health, animal health or the environment, including ecosystems, are established, and the targeting orf 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 NGTonitoring to examine potential effects, particularly on the environment. Traceability should also facilitate the implementation of risk management measures in accordance with the precautionary principle.
2023/11/19
Committee: ENVI
Amendment 244 #
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 NGTall be indicated by a mention in the national and EU variety registers.
2023/11/19
Committee: ENVI
Amendment 306 #
Proposal for a regulation
Recital 36
(36) Herbicide tolerant plants are bred to be intentionally tolerant to herbicides, in order to be cultivated in combination with the use of those herbicides. If such cultivation is not done under appropriate conditions, it may lead to development of weeds resistant to those herbicides or to the need to increase of quantities of herbicides applied, regardless of the breeding technique. For this reason, NGT plants featuring herbicide-tolerant traits should not be eligible for incentives under this framework. However, this Regulation should not take other specific measures on herbicide tolerant NGT plants, because such measures are taken horizontally in [the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union].deleted
2023/11/19
Committee: ENVI
Amendment 320 #
Proposal for a regulation
Recital 37
(37) In order to enable NGT plants to contribute to the sustainability objectives of the Green Deal and the Farm to Fork and Biodiversity Strategies, cultivation of NGT plants in the Union should be facilitated. This requires predictability for breeders and farmers as regards the possibility to cultivate such plants in the Union. Therefore, the possibility for Member States to adopt measures restricting or prohibiting the cultivation of both category 2ies of NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC would undermine those goals.
2023/11/19
Committee: ENVI
Amendment 327 #
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, provi and the free movement of NGT plant products across the EU, the deliberate release of NGT plants and placing on the market of NGT products should be based on the harmonized requirements and procedures laid down in this Regulation, leading to the adoption of a decision uniformly applicable to all Member States. Member States shall not unilaterally derogate from the provisions set out in this Regulation in a way that would restrict, prohibit or hindedr they comply with the requirements of other free movement, placing on the market and deliberate release of NGT plants or related products within the territory of the Union law.
2023/11/19
Committee: ENVI
Amendment 393 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
(2) ‘NGT plant’ means a genetically modified plantplant as set out in Regulation (EU) 2016/2031 of the European Parliament and of the Council(2), 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;
2023/11/19
Committee: ENVI
Amendment 394 #
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 condition that it does not contain any genetic material originating from outside the breeders’ gene pool that temporarily (transiently or stably in an intermediate plant) may have been inserted during the development of the NGT plant;
2023/11/19
Committee: ENVI
Amendment 402 #
Proposal for a regulation
Article 3 – paragraph 1 – point 4
(4) ‘targeted mutagenesis’ means mutagenesis techniques resulting in modification(s) of the DNA sequence at precisetargeted locations in the genome of an organism;
2023/11/19
Committee: ENVI
Amendment 411 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6
(6) ‘breeders’ gene poolgene pool for breeding purposes’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses;
2023/11/19
Committee: ENVI
Amendment 433 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 a (new)
(7a) Therefore, these plants are subject to Community Plant Variety Rights (CPVR);
2023/11/19
Committee: ENVI
Amendment 434 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 b (new)
(7b) Products for which it is not feasible to provide an analytical method that detects, identifies and quantifies;
2023/11/19
Committee: ENVI
Amendment 475 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
(2) the plant is a category 2 NGT plant and has been granted consent or has been authorised in accordance with Chapter III.
2023/11/19
Committee: ENVI
Amendment 494 #
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 500 #
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 516 #
Proposal for a regulation
Article 6 – title
Verification procedure of category 1 NGT plant status prior to the deliberate release for any other purpose than placing on the market
2023/11/19
Committee: ENVI
Amendment 561 #
Proposal for a regulation
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 30 working days from the date of receipt of a verification request. The competent authority shall make available the verification reportasks the European Food Safety Authority (‘the Authority’) for scientific opinion on the verification report and shall make it available to the other Member States and to the Commission without undue delay.
2023/11/19
Committee: ENVI
Amendment 573 #
Proposal for a regulation
Article 6 – paragraph 7
7. The other Member States and the Commission may make commentsAuthority shall issue its scientific opinion to the verification report within 230 days from the date of receipt of that report.
2023/11/19
Committee: ENVI
Amendment 575 #
Proposal for a regulation
Article 6 – paragraph 8
8. In the absence of any comments from a Member State or the Commission, within 10 working days from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.deleted
2023/11/19
Committee: ENVI
Amendment 585 #
Proposal for a regulation
Article 6 – paragraph 9
9. In cases where a comment is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the comment(s) to the Commission without undue delay.deleted
2023/11/19
Committee: ENVI
Amendment 595 #
Proposal for a regulation
Article 6 – paragraph 10
10. The Ccommission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plantpetent authority shall adopt its decision based on the EFSA´s opinion within 4520 working days from the date of receipt of the comment(s), taking the latter iEFSA´s opinion. The competento account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2)uthority shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.
2023/11/19
Committee: ENVI
Amendment 607 #
Proposal for a regulation
Article 7
[...]deleted
2023/11/19
Committee: ENVI
Amendment 661 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Free movement Member States shall not prohibit, restrict or impede the deliberate release or the placing on the market of category 1 NGT plants and related products, which comply with the requirements of this Regulation.
2023/11/19
Committee: ENVI
Amendment 708 #
Proposal for a regulation
Article 10 – title
LabellingTransparency of category 1 NGT plant reproductive material, including breeding material
2023/11/19
Committee: ENVI
Amendment 712 #
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 labelmention in national variety register automatically transmitted in the EU common register provided for in PRM/FRM indicating the words ‘cat 1 NGT’, followed by the identification number of the NGT plant(s) it has been derived from.
2023/11/19
Committee: ENVI
Amendment 791 #
Proposal for a regulation
Article 14 – paragraph 1 – point l
(l) methods for sampling (including references to existing official or standardised sampling methods), detection, identification and quantification of the NGT plant. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier, the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2)f the specificities of the modification do not allow for the identification or quantification, methods for detection, identification and quantification do not need to be provided this is duly justified;
2023/11/19
Committee: ENVI
Amendment 811 #
Proposal for a regulation
Article 16 – paragraph 1
In addition to Article 19(3) of Directive 2001/18/EC, the written consent shall specify the labelling in accordance with Article 23 of this Regulation.deleted
2023/11/19
Committee: ENVI
Amendment 813 #
Proposal for a regulation
Article 16 – paragraph 1
In addition to Article 19(3) of Directive 2001/18/EC, to be adapted to include the designation ‘new genomic techniques’ or ‘NGT’, the written consent shall specify the labelling in accordance with Article 23 of this Regulation.
2023/11/19
Committee: ENVI
Amendment 843 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2
In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant or concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the modalities to comply with analytical method requirements shall be adapted as specifapplication for authorisation shall be accompanied inby the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2)at justification;
2023/11/19
Committee: ENVI
Amendment 917 #
Proposal for a regulation
Article 23 – paragraph 1
In addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003, and without prejudice to the requirements under other Union legislation, the labelling of authorised category 2 NGT products may also mention the trait(s) conveyed by the genetic modification, as specified in the consent or the authorisation pursuant to Sections 2 or 3 of Chapter III of this Regulation.deleted
2023/11/19
Committee: ENVI
Amendment 920 #
Proposal for a regulation
Article 23 – paragraph 1
In addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of Regulation (EC) No 1830/2003, to be adapted to include the designation ‘new genomic techniques’ or ‘NGT’, 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. The name and mention of the trait(s) conferred by the amendment may be indicated on the label using a QR code and/or link.
2023/11/19
Committee: ENVI
Amendment 927 #
Proposal for a regulation
Article 24 – paragraph 1
Member StatesThe Commission 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 , only where NGT Category 2 plants can be detected, identified and quantified by analytical methods. 2(a). The burden of proof for the unintentional presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation (EC) No 1829/2003 should not be placed on the users of category 2 NGT plants.
2023/11/19
Committee: ENVI
Amendment 953 #
Proposal for a regulation
Article 25 a (new)
Article 25a Category 2 NGT plants for which a detection method, which can detect, identify and quantify, cannot be provided shall not be subject to the requirements laid down in Article 23 of Regulation (EU) 2017/625 , Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4 and 5 of Regulation (EC) No 1830/2003.
2023/11/19
Committee: ENVI
Amendment 961 #
Proposal for a regulation
Article 26 – paragraph 3
3. The delegations of power referred to in Article 5(3) and Article 22(8) may be exercised only for the purpose of adapting to scientific and technological progress, on the understanding that the non- regression clause must apply. The delegations of power may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
2023/11/19
Committee: ENVI
Amendment 1050 #
Proposal for a regulation
Annex I – paragraph 1
A NGT plant is considered equivalent to conventional plants when it contains only genetic modifications referred to in points 1 to 5 and when it differs from the recipient/parental plant by no more than 20 genetic modifications, excluded off target modifications, of the types referred to in points 1 to 54, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic toolsthe targeted site or sites in the monoploid genome.
2023/11/19
Committee: ENVI
Amendment 1053 #
Proposal for a regulation
Annex I – paragraph 1
A NGT plant prepared by new genomic techniques is considered equivalent to a conventional plants when if it differs from the recipient/parental plant by no more than 20only by 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 tools2 which can be combined with each other.
2023/11/19
Committee: ENVI
Amendment 1055 #
Proposal for a regulation
Annex I – paragraph 1
A NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications per haploid 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.
2023/11/19
Committee: ENVI
Amendment 1063 #
Proposal for a regulation
Annex I – point 1
(1) substitution or insertion of no more than 20 nucleotides per haploid;
2023/11/19
Committee: ENVI
Amendment 1065 #
Proposal for a regulation
Annex I – point 1 a (new)
(1a) Criteria specific for the use of targeted mutagenesis on the condition that the number of mutations events per any protein-coding sequence does not exceed 3: (a) substitution or insertion of no more than 20 nucleotides; (b) deletion of any number of nucleotides; (2) Criteria specific for the use of cisgenesis on the condition that the genetic modification does not create a chimeric protein that is not already present in a species from the breeders’ gene pool: (a) insertion of a continuous DNA sequence existing in the breeders’ gene pool; (b) substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeders’ gene pool; (c) inversion or translocation of a continuous endogenous DNA sequence existing in the breeders’ gene pool.
2023/11/19
Committee: ENVI
Amendment 1068 #
Proposal for a regulation
Annex I – point 2
(2) deletion of any number of nucleotides;ed
2023/11/19
Committee: ENVI
Amendment 1073 #
Proposal for a regulation
Annex I – point 3
(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;deleted
2023/11/19
Committee: ENVI
Amendment 1076 #
Proposal for a regulation
Annex I – point 3 – point a
(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool;deleted
2023/11/19
Committee: ENVI
Amendment 1078 #
Proposal for a regulation
Annex I – point 3 – point a
(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool; for reproductive purposes
2023/11/19
Committee: ENVI
Amendment 1082 #
Proposal for a regulation
Annex I – point 3 – point a
(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool;
2023/11/19
Committee: ENVI
Amendment 1084 #
Proposal for a regulation
Annex I – point 3 – point b
(b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool;deleted
2023/11/19
Committee: ENVI
Amendment 1086 #
Proposal for a regulation
Annex I – point 3 – point b
(b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool for reproductive purposes;
2023/11/19
Committee: ENVI
Amendment 1090 #
Proposal for a regulation
Annex I – point 3 – point b
(b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool;
2023/11/19
Committee: ENVI
Amendment 1093 #
Proposal for a regulation
Annex I – point 4
(4) targeted inversion of a sequence of any number of nucleotides;deleted
2023/11/19
Committee: ENVI
Amendment 1098 #
Proposal for a regulation
Annex I – point 5
(5) any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (possibly with modifications as accepted under points (1) and/or (2)) in a species from the breeders’ gene pool.deleted
2023/11/19
Committee: ENVI
Amendment 1100 #
Proposal for a regulation
Annex I – point 5
(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 on the condition that the genetic modification does not interrupt an endogenous gene.
2023/11/19
Committee: ENVI
Amendment 1103 #
Proposal for a regulation
Annex I – point 5
(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. for reproductive purposes.
2023/11/19
Committee: ENVI
Amendment 1178 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 3
(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change conditions;
2023/11/19
Committee: ENVI