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26 Amendments of Theresa BIELOWSKI related to 2023/0226(COD)

Amendment 22 #
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 Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, C-528/16, ECLI:EU:C:2018:583efore 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
Amendment 51 #
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
Amendment 76 #
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
Amendment 85 #
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 strictfeasible deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.
2023/11/14
Committee: AGRI
Amendment 90 #
Theresa BIELOWSKI, Maria NOICHL
(20) The verification of category 1 NGT plant status is of technical nature and does not involve anyneeds 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
Amendment 117 #
Theresa BIELOWSKI, Maria NOICHL
Proposal for a regulation
Recital 24
(24) Provision should be made to ensure transparency as regards the use of category 1all 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 plants 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
Amendment 150 #
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
Amendment 164 #
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 facilitatedregulated 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 goalsremain.
2023/11/14
Committee: AGRI
Amendment 169 #
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
Amendment 174 #
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
Amendment 176 #
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
Amendment 191 #
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
Amendment 258 #
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
Amendment 293 #
Theresa BIELOWSKI, Maria NOICHL
Proposal for a regulation
Article 6
[...]deleted
2023/11/14
Committee: AGRI
Amendment 364 #
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
Amendment 390 #
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
Amendment 391 #
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
Amendment 398 #
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
Amendment 406 #
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
Amendment 453 #
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
Amendment 461 #
Theresa BIELOWSKI, Maria NOICHL
Proposal for a regulation
Article 22
[...]deleted
2023/11/14
Committee: AGRI
Amendment 473 #
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
Amendment 487 #
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
Amendment 488 #
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
Amendment 489 #
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
Amendment 490 #
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
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