BETA

62 Amendments of Maria NOICHL related to 2023/0226(COD)

Proposal for a regulation
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The Committee on Agriculture and Rural Development calls on the Committee on Environment, Public Health and Food Safety, as the committee responsible, to propose the rejection of 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.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Recital 5

(5) In its judgment in case C-528/16 Confédération paysanne and Others43 the Court of Justice of the European Union held that GMOs obtained by means of new techniques/methods of mutagenesis that had appeared or had been mostly developed since Directive 2001/18/EC was adopted could not be considered excluded from the scope of that Directive~~. _________________ 43 Judgement of the Court of Justice of 25 July 2018, Confédération paysanne an~~, as the new mutagenesis techniques/methods have a comparable risk potential to the production of transgenic plants, in which foreign genetic material is introduced into the genome of organisms. In accordance with the precautionary principle, the regulations of the Genetic Engineering Law would Other~~s v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, C-528/16, ECLI:EU:C:2018:583~~efore have to be applied (Art.2 No.2 of Directive 2001/18; fourth, eighth and 25th recitals). These organisms and all products derived from them must therefore be subjected to a comprehensive safety assessment for humans, animals and the environment before being placed on the market. Likewise, they must be traceable and labelled.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 8

(8) It is therefore not necessary to adopt a specific legal framework for GMOs obtained by targeted mutagenesis and cisgenesis and related products when deliberately released into the environment or placed on the market, as the current legal framework 2001/18 is appropriate.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 9

(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation should be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae, excluding microorganisms, fungi and animals for which the available knowledge is more limited. For the same reason, this Regulation should only cover plants obtained by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter ‘NGT plants’), but not by other new genomic techniques. Such NGT plants do not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non- crossable species (transgenesis) should remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgene. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present timeall GMOs, and therefore also NGT plants, should remain regulated under the existing Directive 2001/18.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 11

(11) This Regulation constitutes lex specialis with regard to the Union GMO legislation. 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.deleted

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 13

~~(13) This Regulation should distinguish between two categories of NGT plants.~~deleted

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

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 criteria to ascertain if a NGT plant is equivalent to naturally occurring or conventionally bred plants and lay down a procedure for competent authorities to verify and take a decision on the fulfillment of those criteria, prior to the release or placing on the market of NGT plants or NGT products. Those criteria should be objective and based on science. They should cover the type and extent of genetic modifications that can be observed in nature or in organisms obtained with conventional breeding techniques and should include thresholds for both size and number of genetic modifications to the genome of NGT plants. Since scientific and technical knowledge evolves rapidly in this area, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to update these criteria in light of scientific and technical progress as regards the type and extent of genetic modifications that can occur in nature or through conventional breeding.deleted

2023/11/14
Committee: AGRI

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 criteria to ascertain if a NGT plant is equivalent to naturally occurring or conventionally bred plants and lay down a procedure for competent authorities to verify and take a decision on the fulfillment of those criteria, prior to the release or placing on the market of NGT plants or NGT products. Those criteria should be objective and based on science. They should cover the type and extent of genetic modifications that can be observed in nature or in organisms obtained with conventional breeding techniques and should include thresholds for both size and number of genetic modifications to the genome of NGT plants. Since scientific and technical knowledge evolves rapidly in this area, the Commission should be empowered in accordance with Article 290 of the Treaty on the Functioning of the European Union to update these criteria in light of scientific and technical progress as regards the type and extent of genetic modifications that can occur in nature or through conventional breeding.deleted

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 15

(15) All NGT plants that are not category 1 (‘category 2 NGT plants’) should remain subject to the requirements of the Union GMO legislation because they feature more complex sets of modifications to the genome.deleted

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 16

(16) Category 1 NGT plants and products should ~~not~~ be subject to the rules and requirements of the Union GMO legislation and to provisions in other Union legislation that apply to GMOs. For legal certainty for operators and transparency, a ~~declaration of the category 1 NGT plant status should be obtained~~comprehensive risk assessment and evaluation within an authorisation procedure, including the provision of a specific detection method, as well as reference and control material should be obtained. Without authorisation, zero tolerance applies. After authorisation, NGT-1 products are subject to mandatory labelling along the entire value chain and at legal level, coexistence regulations (such as a parcel-specific site register, distance and liability regulations in accordance with the polluter principle) that reliably prevent contamination need to be implemented. NGT plants should be subject to monitoring. Member states should be given the option of opt-out in order to protect people from health hazards, prior to deliberate release, including the placing on the market.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Recital 18

(18) Since the criteria for considering that a NGT plant is equivalent to naturally occurring or conventionally bred plants are unrelated to the type of activity that requires the deliberate release of the NGT plant, a declaration of the category 1 NGT plant status made prior to its deliberate release for any other purpose than placing on the market in the territory of the Union should also be valid for the placing on the market of related NGT products. In view of the high uncertainty existing at the field trial stage about the product reaching the market and the likely involvement of smaller operators in such releases, the verification procedure of category 1 NGT plant status prior to field trials should be conducted by national competent authorities as this would be less administratively burdensome for operators, and a decision should be taken at Union level only in case there are comments to the verification report by other national competent authorities. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.deleted

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Recital 19

(19) The competent authorities of the Member States, the Commission and the European Food Safety Authority (‘the Authority’) should be subject to ~~strict~~feasible deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 20

(20) The verification of category 1 NGT plant status is of technical nature and does not involve any risk assessment or risk management considerations and the decision on the status is only declaratory. Therefore, when the procedure is conducted at Union level, such implementing decisions should be adopted by the advisory procedure, supported by scientific and technical assistance by the AuthorityAll NGT plants should be tested and assessed for their risks before being put on the market and prior to authorisation for cultivation.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

(20) The verification of category 1 NGT plant status ~~is of technical nature and does not involve any~~needs a risk assessment or risk management considerations ~~and the decision on the status is only declaratory~~. Therefore, when the procedure is conducted at Union level, such implementing decisions should be adopted by the advisory procedure, supported by scientific and technical assistance by the Authority.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 21

(21) Decisions declaring the category 1 NGT plant status should assign an identification number to the NGT plant concerned i. In order to ensure transparency and traceability of such plants ~~when~~, they ~~are listed in the database and for the purpose of labelling of plant reproductive material derived from them~~must undergo an authorisation procedure in accordance with Directive 2001/18.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Recital 24

(24) Provision should be made to ensure transparency as regards the use of ~~category 1~~all in EU approved NGT plant varieties, to ensure that production chains that wish to remain free from NGTs can do so and thereby safeguard consumer trust. All NGT plant~~s that have obtained a category 1 NGT plant status declaration~~ varieties approved in the EU 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 NGTconsumers and farmers, all NGT verified and authorised in the EU should be labelled according to existing EU law, namely Directive 2001/18 and Regulation (EC) No 1830/2003.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 25

(25) ~~Category 2~~All 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 ot~~ as well as possible expected and unexpected outcomes, their risks need to be assessed. Ther 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~~should serve in order to assess risks that ~~they~~NGT plants may pose.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 26

(26) ~~Category 2~~All NGT plants and products, in order to be released into the environment or placed on the market, should remain subject to a consent or authorisation in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. However, given the wide variety of those NGT plants, the amount of information necessary for the risk assessment will vary on a case-by-case basis. The Authority, in its scientific opinions on plants developed through cisgenesis and intragenesis48 and on plants developed through targeted mutagenesis49 recommended flexibility in data requirements for the risk assessment of these plants. Based on the Authority’s ‘Criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis’ (50 ), considerations on the history of safe use, familiarity for the environment and the function and structure of the modified/inserted sequence(s) should assist in determining the type and amount of data required to perform the risk assessment of those NGT plants. It is therefore necessary to establish general principles and criteria for the risk assessment of these plants, while providing for flexibility and possibility to adapt risk assessment methodologies to scientific and technical progress. _________________ 48 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta, J, Fernandez Dumont A, Gennaro A, Lenzi, P, Lewandowska A, Munoz Guajardo IP, Papadopoulou N and Rostoks N, 2022. Updated scientific opinion on plants developed through cisgenesis and intragenesis. EFSA Journal 2022;20(10):7621, 33 pp. https://doi.org/10.2903/j.efsa.2022.7621. 49 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Naegeli H, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Mullins E, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Gennaro A, Paraskevopoulos K, Raffaello T and Rostoks N, 2020. Applicability of the EFSA Opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis. EFSA Journal 2020;18(11):6299, 14 pp. https://doi. org/10.2903/j.efsa.2020.6299. 50 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Fernandez A, Gennaro A, Papadopoulou N, Raffaello T and Schoonjans R, 2022. Statement on criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis. EFSA Journal 2022;20(10):7618, 12 pp. https://doi.org/10.2903/j.efsa.2022.7618in data requirements for the risk assessment of these plants should increase respectively.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 27

(27) Requirements on the content of notifications for consent for the placing on the market of products containing or consisting of GMOs other than food or feed and on the content of applications for authorisation for the placing on the market of genetically modified food and feed are laid down in different pieces of legislation. To ensure consistency ~~between the notifications for consent and applications for authorisation for category 2 NGT products, the content of such notifications and applic~~these pieces of legislations 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~~apply to NGT plants as well.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 28

(28) ~~The European Union Reference Laboratory for GM Food and Feed (EURL), in collaboration with the European Network of GM Laboratories (ENGL), concluded tha~~In order to ensure the necessary traceability and to at least aena~~lytical testing is not considered feasible for all products obtained by targeted mutagenesis and cisgenesis (51 ). When the introduced modifications of the genetic material~~ble retrievability, specific verification procedures are a basic requirement. As the DNA changes are knot specific to the NGT plant in question, they do not allow the differentiation of the NGT plant from conventional plants. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier or the applicant, the modalities to comply with analytical method requirements should be adapted. This should be done in the implementing acts adopted pursuant to this Regulation. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants on the minimum performance requirements for analyticwn when the product is known, it is not a problem for the applicants to submit detection methods as well as reference and control material. If the distributors do not submit modalities to fulfil the requirements for the analytical method, authorisation shall be refused. In addition, financial support for investments in the development of general mdethods. Modalities for performing method validation may also be adapted. _________________ 51 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)ection methods in order to be able to detect NGTs in imports, should be provided on EU level.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 29

(29) Directive 2001/18/EC requires a monitoring plan for environmental effects of GMOs after their deliberate release or placing on the market but provides for flexibility as to the design of the plan taking into account the environmental risk assessment, the characteristics of the GMO, of its expected use and of the receiving environment. Genetic modifications in category 2 NGT plants may range from changes only needing a limited risk assessment to complex alterations requiring a more thorough analysis of potential risks. Therefore, post-market monitoring requirements for environmental effects of category 2 NGT plants should be adapted in the light of the environmental risk assessment and the experience in field trials, the characteristics of the NGT plant concerned, the characteristics and scale of its expected use, in particular any history of safe use of the plant and the characteristics of the receiving environment. Therefore, a monitoring plan for environmental effects should not be required if the category 2 NGT plant is unlikely to pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment, which should be valid for all NGT plants.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 32

(32) To increase transparency and consumers’ information, ~~operators should be allow~~there needs 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 decisionbe clear labelling of all NGTs in accordance with Directive 2001/18 up to the end product.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Recital 32

(32) To increase transparency and consumers’ information, operators should be allowed to complement the labelling of category 2 NGT products as GMO with information on the trait conferred by the genetic modification. In order to avoid misleading or confusing indications, a proposal for such a labelling should be provided in the notification for consent or in the application for authorisation and should be specified in the consent or in the authorisation decisionlabel all NGT products which comply with the requirements laid down in existing EU law, namely Directive 2001/18 and Regulation (EC) No 1830/2003.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 34

~~(34) Incentives should consist in an acc~~delerated 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).

2023/11/14
Committee: AGRI

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. Thereforesure the sovereignty of the Member States and regions, the possibility for Member States to adopt measures restricting or prohibiting the cultivation of ~~category 2~~ NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC ~~would undermine those goals~~needs to be kept.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

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~~regulated under existing EU law, in Directive 2001/18 and Regulation (EC) No 1830/2003. This requires predictability for breeders and farmers as regards the possibility to cultivate such plants in the Union. Therefore, the possibility for Member States to adopt measures restricting or prohibiting the cultivation of ~~category 2~~ NGT plants in all or part of their territory, set out in Article 26b of Directive 2001/18/EC wshould ~~undermine those goals~~remain.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Recital 39

(39) To achieve the goal of ensuring the effective functioning of the internal market, NGT plants and related products should benefit from the free movement of goods, provided they comply with the requirements of other Union law.deleted

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 39

(39) To achieve the goal of ensuring the effective functioning of the internal market, the EU-wide rules for the regulation of NGT plants and related products should be~~nefit from the free movement of goods, provided they comply with the requirements of other Union law~~ maintained. Accordingly, EU-wide strict coexistence rules should be introduced across the EU.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Recital 39 a (new)

(39 a) To achieve the goal of ensuring the effective functioning of the internal market, EU-wide legally binding coexistence measures for category 1 and category 2 NGTs have to be adopted.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Recital 40

(40) In its judgment of 25 July 2018, in case C-528/1610 the Court of Justice of the European Union held that organisms obtained by means of techniques/methods of mutagenesis which have not conventionally been used in a number of applications and do not have a long safety record come within the scope of Directive 2001/18 and are, therefore, subject to the obligations arising from that directive. Given the novelty of the NGTs, it will be important to monitor closely the development and presence on the market of NGT plants and products and evaluate any accompanying impact on human and animal health, the environment and environmental, economic and social sustainability. Information should be collected regularly and within five years after the adoption of the first decision allowing the deliberate release or the marketing of NGT plants or NGT products in the Union, the Commission should carry out an evaluation of this Regulation to measure the progress made towards the availability of NGT plants containing such characteristics or properties on the EU market.

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 42

(42) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can be better achieved at Union level, so that NGT plants and NGT products may circulate freely within the internal market, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.deleted

2023/11/14
Committee: AGRI

Proposal for a regulation
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, 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.’deleted

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 44

(44) It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (54 ). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 54 OJ L 123, 12.5.2016, p. 1deleted

2023/11/14
Committee: AGRI

Proposal for a regulation
Recital 45

(45) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the information required to demonstrate that a NGT plant is a category 1 NGT plant, as regards the preparation and the presentation of the notification for that determination, and as regards the methodology and information requirements for the environmental risk assessments of category 2 NGT plants and of NGT food and NGT feed, in accordance with the principles and criteria laid down in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(55 ). _________________ 55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).deleted

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 1 – paragraph 1

This Regulation corresponds to the provisions of Directive 2001/18 and extends these provisions to the deliberate release of plants obtained by certain new genomic techniques (hereinafter "NGT plants"). In accordance with the precautionary principle, and with the primary objective of ensuring a high level of protection of human and animal health and the environment, this Regulation lays down specific rules for the deliberate release into the environment for any other purpose than placing on the market of plants obtained by certain new genomic techniques (‘NGT plants’) and for the placing on the market of food and feed containing, consisting of or produced from such plants, and of products, other than food or feed, containing or consisting of such plants.

2023/11/14
Committee: AGRI

Proposal for a regulation
Article 1 – paragraph 1

This Regulation ~~lays down specific rules for the deliberate release into the environment for any other purpose than placing on the market~~contains derogations from the provisions of Directive 2001/18 for the deliberate release of plants obtained by certain new genomic techniques (‘hereinafter "NGT plants’") ~~and for the~~into the environment for purposes other than placing on the market of food and feed containing, consisting of or produced from such plants, and of products, other than food or feed, containing or consisting of such plants. The derogations apply insofar as at least equivalent requirements to those laid down in Directive 2001/18 in accordance with the precautionary principle for the protection of human and animal health and the environment are fulfilled.

2023/11/14
Committee: AGRI

Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point a

(a) ~~has obtained a decision declaring that status in accordance with Article 6 or 7; or~~the requirements of Article 6 of Directive 2001/18 are fulfilled.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 5

~~1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plants. 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. 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.deleted Status of category 1 NGT plants

2023/11/14
Committee: AGRI

Proposal for a regulation
Article 5 – paragraph 1

1. The rules which apply to GMOs in Union legislation shall ~~not~~ apply to ~~category 1~~all NGT plants.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 6

~~[...]~~deleted

2023/11/14
Committee: AGRI

Proposal for a regulation
Article 6

~~[...]~~deleted

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 6 a (new)

Article6a Verification procedure of category 1 NGT plant status prior to the deliberate release for any other purpose than placing on the market A permit for the release of NGTs has to be applied for according to Directive 2001/18.

2023/11/14
Committee: AGRI

Proposal for a regulation
Article 7

~~[...]~~deleted

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 9 – paragraph 1 a (new)

1 a. a description of a risk assessment according to Directive 2001/18.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 9 – paragraph 1 b (new)

1 b. a description of methods for sampling and detection identification of the NGT plant

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 10 – title

Labelling of category 1 NGT plant reproductive material, including breeding material. NGT plant for food and feed use, NGT product and produced from an NGT plant.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 10 – paragraph 1

Plant reproductive material, including for breeding and scientific purposes, that contains or consists of category 1 NGT plant(s) and is made available to third parties, whether in return for payment or free of charge, shall bear a label indicating the words ‘cat 1 NGT’, followed by the identification number of the NGT plant(s) it has been derived fromNGT plant for food and feed use, NGT product and produced from an NGT plant shall fulfill the labelling requirements as set out in Directive 2001/18 and Regulation (EC) No 1830/2003.

2023/11/14
Committee: AGRI

The rules which apply to GMOs in Union legislation ~~in so far as they are not derogated from by this Regulation,~~ shall apply to ~~category 2~~ NGT plants and ~~category 2 NGT~~their products.

2023/11/14
Committee: AGRI

Proposal for a regulation
Article 13 – paragraph 1 – introductory part

~~As regards the deliberate release of a category 2 NGT plant for any other purpose than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:~~To obtain an authorisation for the release of NGTs, authorisation must be requested in accordance with Directive 2001/18.

2023/11/14
Committee: AGRI

Proposal for a regulation
Chapter III – Section 2

~~[...]~~deleted

2023/11/14
Committee: AGRI

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 Regulatio~~The labelling must be clear and unambiguous using the term "genetic engineering" along the entire value chain.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

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 specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);deleted

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 22

~~[...]~~deleted

2023/11/14
Committee: AGRI

Proposal for a regulation
Article 22

~~[...]~~deleted

2023/11/14
Committee: AGRI

Proposal for a regulation
Article 23

Labelling of authorised category 2 NGT 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.Article 23 deleted products

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

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

2023/11/14
Committee: AGRI

Proposal for a regulation
Article 24 – title

Measures to avoid the unintended presence of ~~category 2~~ NGT plants

2023/11/14
Committee: AGRI

Proposal for a regulation
Article 24 – paragraph 1

Member States shall take appropriate measures to avoid the unintended presence of ~~category 2~~ NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 25 – paragraph 1

Article 26b of Directive 2001/18/EC shall ~~not~~ apply to category 2 NGT plants.

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 26 – paragraph 1

~~1. The power to adopt the~~ delegated ~~acts is conferred on the Commission subject to the conditions laid down in this Article.~~

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 27 – paragraph 1 – point a

~~(a) the information required to demonstrate that a plant is a NGT plant;~~deleted

2023/11/14
Committee: AGRI

Theresa BIELOWSKI, Maria NOICHL

Proposal for a regulation
Article 27 – paragraph 1 – point c

(c) the methodology and information requirements for the environmental risk assessment of category 2 NGT plants and the safety assessments of category 2 NGT food and feed, in accordance with the principles and criteria laid down in Annex II;deleted

2023/11/14
Committee: AGRI