Activities of Stanislav POLČÁK related to 2023/0226(COD)
Plenary speeches (1)
Plants obtained by certain new genomic techniques and their food and feed (A9-0014/2024 - Jessica Polfjärd)
Amendments (32)
Amendment 33 #
Proposal for a regulation
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114 and, 168(4) (b) and 191(2) thereof,
Amendment 70 #
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[1]). 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 supp, provided that they are used wisely and do not, on the contrary, lead to a disregard for the suitability of individual agricultural areas and plots of land fort 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 sustainablhe cultivation of certain crops, 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 ([2]) and of the ‘Farm to Fork’ ([3]), Biodiversity ([4]) and Adaptation to Climate Change([5]) Strategies, to global food security ([6]), the bBioeconomy 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 finalStrategy ([7]) and to the Union’s strategic autonomy ([8]).
Amendment 113 #
Proposal for a regulation
Recital 9
Recital 9
(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae, excludingand should not apply to microorganisms, fungi and animals for which the available knowledge is more limited. For the same reason, this Regulation should only cover plants obtained only by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter ‘NGT plants’), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non-crossable species (transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.
Amendment 155 #
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 in the same way 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 essentially 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 184 #
Proposal for a regulation
Recital 18
Recital 18
(18) Since the criteria for considering that a NGT plant is essentially equivalent to naturally occurring or conventionally bred plants are unrelated to the type of activity that requires the deliberate release of the NGT plant, a declaration of the category 1 NGT plant status made prior to its deliberate release for any other purpose than placing on the market in the territory of the Union should also be valid for the placing on the market of related NGT products. In view of the high uncertainty existing at the field trial stage about the product reaching the market and the likely involvement of smaller operators in such releases, the verification procedure of category 1 NGT plant status prior to field trials should be conducted by national competent authorities as this would be less administratively burdensome for operators, and a decision should be taken at Union level only in case there are comments to the verification report by other national competent authorities of other Member States. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.
Amendment 195 #
Proposal for a regulation
Recital 19
Recital 19
(19) The competent authorities of the Member States, the Commission and the European Food Safety Authority (‘the Authority’) should be subject to strict deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.
Amendment 215 #
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 or structure that affects the nutritional value, metabolism or level of undesirable substances of the food will be considered as novel food and thus fall into the scope of Regulation (EU) 2015/2283 of the European Parliament and of the Council (46[1]) 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 239 #
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. Similarly, NGT products placed on the market should also be labelled so that consumers have a choice.
Amendment 276 #
Proposal for a regulation
Recital 29
Recital 29
(29) Directive 2001/18/EC requires a monitoring plan for environmental effects of GMOs after their deliberate release or placing on the market but provides for flexibility as to the design of the plan taking into account the environmental risk assessment, the characteristics of the GMO, of its expected use and of the receiving environment. Genetic modifications in category 2 NGT plants may range from changes only needing a limited risk assessment to complex alterations requiring a more thorough analysis of potential risks. Therefore, post- market monitoring requirements for environmental effects of category 2 NGT plants should be adapted in the light of the environmental risk assessment and the experience in field trials, the characteristics of the NGT plant concerned, the characteristics and scale of its expected use, in particular any history of safe use of the plant and the characteristics of the receiving environment. ThereforIn view of the precautionary principle, a monitoring plan for environmental effects should not be required ifalways be required when consent is first given. It should only be possible to waive the requirement for monitoring upon the renewal of consent, provided that it has been demonstrated that the category 2 NGT plant is unlikely todoes not pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment.
Amendment 301 #
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 314 #
Proposal for a regulation
Recital 37
Recital 37
Amendment 337 #
Proposal for a regulation
Recital 40
Recital 40
(40) Given the novelty of the NGTs, it will be important to monitor closely the development and presence on the market of NGT plants and products and evaluate any accompanying impact on human and animal health, the environment and environmental, economic and social sustainability. Information should be collected regularly and within five years after the adoption of the first decision allowing the deliberate release or the marketing of NGT plants or NGT products in the Union, and then on a regular basis at least every five years, the Commission should carry out an evaluation of this Regulation to measure the progress made towards the availability of NGT plants containing such characteristics or properties on the EU market.
Amendment 345 #
Proposal for a regulation
Recital 43
Recital 43
(43) The types of NGT plants developed and the impact of certain traits on environmental, social and economic sustainability are continuously evolving. Therefore, based on the available evidence of such developments and impacts, fully taking into account the precautionary principle, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to adapt the list of traits that should be incentivized or discouraged to achieve the goals of the Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies.’
Amendment 395 #
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 plantnor has it been created with the use of such material;
Amendment 408 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘breeders’ gene pool’ 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, using regular breeding techniques, cross-bred;
Amendment 504 #
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 to adapt them to scientific and technological progress, fully taking into account the precautionary principle, as regards the types and extent of modifications which can occur naturally or through conventional breeding.
Amendment 528 #
Proposal for a regulation
Article 6 – paragraph 3 – point c
Article 6 – paragraph 3 – point c
(c) a description of the trait(s) and characteristics which have been introduced, removed or modified;
Amendment 534 #
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 plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);
Amendment 563 #
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 582 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any comments from a Member State or the Commission, within 120 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.
Amendment 601 #
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. The Commission, 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 plant within 4560 working days from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
Amendment 619 #
Proposal for a regulation
Article 7 – paragraph 2 – point c
Article 7 – paragraph 2 – point c
(c) a description of the trait(s) and characteristics which have been introduced, removed or modified;
Amendment 623 #
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 plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);
Amendment 675 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d
Article 9 – paragraph 1 – subparagraph 2 – point d
(d) a description of the trait(s) and characteristics which have been introduced , removed or modified;
Amendment 696 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The database shall be publicly available free of charge online.
Amendment 702 #
Proposal for a regulation
Article 10 – title
Article 10 – title
Labelling of category 1 NGT plant reproductive material, including breeding material, and labelling of NGT products
Amendment 713 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Plant reproductive material, including for breeding and scientific purposes, that contains or consists of category 1 NGT plant(s) and is made available to third parties, whether in return for payment or free of charge, shall bear a label indicating the words ‘cat 1 NGT’, followed by the identification number of the NGT plant(s) it has been derived from. Similarly, any NGT product placed on the market shall bear a label indicating the words ‘cat 1 NGT’.
Amendment 757 #
Proposal for a regulation
Article 13 – paragraph 1 – point b
Article 13 – paragraph 1 – point b
(b) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);
Amendment 779 #
Proposal for a regulation
Article 14 – paragraph 1 – point d
Article 14 – paragraph 1 – point d
(d) a copy of the studies, which have been carried out and any other available material to demonstrate that the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);
Amendment 804 #
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 c. The requirement for monitoring can only be waived upon the renewal of consent, provided that it has been demonstrated that the category 2 NGT plant does not pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environsment.
Amendment 836 #
Proposal for a regulation
Article 19 – paragraph 1 – point a
Article 19 – paragraph 1 – point a
(a) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementing act adopted in accordance with Article 27, point (a);
Amendment 943 #
Proposal for a regulation
Article 25
Article 25
Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.5 deleted Cultivation