65 Amendments of Asger CHRISTENSEN related to 2023/0226(COD)
Amendment 30 #
Proposal for a regulation
Recital 8
Recital 8
(8) It is tTherefore necessary to adopt a specific legal framework for GMO, category 1 NGT plants and products obtained by targeted mutagenesis and cisgenesis and related products when deliberatelyshall not be subject to the reuleased into the environment or placed on s and requirements of the Union GMO legislation and to provisions in other Union legislation that apply to GMOs. Targeted mutagenesis Category 1 NGT plants and products shall be exempted in Directive 2001/18/EC Annex 1 B like other marketutagenecis methods.
Amendment 35 #
(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 other organisms, such as microorganisms, the available knowledge will be reviewed in view of a future proposal. 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 time wider GMO legislation should be examined in view of the Commission conclusion that it is no longer fit purpose to ensure that requirements are science-based and proportional to the risk.
Amendment 57 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14 a) In view of the high complexity of plant genomes, the criteria for considering that a NGT plant is equivalent to naturally occurring or conventionally bred plants should reflect the diversity of plants genomic size and their characteristics. Polyploid plants contain more than two homologous chromosomes. Within this, tetraploid, hexaploid, and octoploid have 4, 6 and 8 sets of chromosomes respectively. Polyploid plants tend to exhibit greater numbers of genetic modifications compared to monoploid plants. Based on this any limit to the total number of individual modifications per plant should reflect the plants “ploidy”, meaning the number of chromosomes set in a plant.
Amendment 97 #
Proposal for a regulation
Recital 8
Recital 8
(8) It is therefore necessary to adopt a specific legal framework for GMOCategory 1 NGT plants and products obtained by targeted mutagenesis and cisgenesis and related products when deliberatelyshall not be subject to the reuleased into the environment or placed on s and requirements of the Union GMO legislation and to provisions in other Union legislation that apply to GMOs. Targeted mutagenesis Category 1 NGT plants and products shall be exempted in Directive 2001/18/EC Annex 1 B like other marketutagenecis methods.
Amendment 98 #
Proposal for a regulation
Recital 21
Recital 21
(21) Decisions declaring the category 1 NGT plant status should assign an identification number to the NGT plant concerned in order to ensure transparency and traceability of such plants when they are listed in the database and for the purpose of labe. The information listed shall ing of plant reproductive material derived from themclude information on the technique(s) used to obtain the trait(s).
Amendment 109 #
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, excluding microorganisms, fungi and animals for which the available knowledge is more limited. For other organisms, such as microorganisms, the available knowledge will be reviewed in view of a future proposal. 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 time wider GMO legislation should be examined in view of the Commission conclusion that it is no longer fit purpose to ensure that requirements are science-based and proportional to the risk.
Amendment 112 #
Proposal for a regulation
Recital 23
Recital 23
(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(47 ) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. As a result, category 2 NGT plants will be banned in organic production. However, it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. The use of new genomic techniques is currently incompatible with the concept of organic production in the Regulation (EC) 2018/848 and with consumers’ perception of organic products. The use of category 1 NGT plants should therefore be also prohibited in organic production. _________________ 47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1)techniques used in category 1 NGT plants are by their definition comparable with conventional breeding techniques and should therefore be accessible for organic production.
Amendment 118 #
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, including information on the technique(s) used to obtain the trait(s), to ensure traceability, transparency and choice for operators.
Amendment 158 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) In view of the high complexity of plant genomes, the criteria for considering that a NGT plant is equivalent to naturally occurring or conventionally bred plants should reflect the diversity of plants genomic size and their characteristics. Polyploid plants contain more than two homologous chromosomes. Within this, tetraploid, hexaploid, and octoploid have 4, 6 and 8 sets of chromosomes respectively. Polyploid plants tend to exhibit greater numbers of genetic modifications compared to monoploid plants. Based on this any limit to the total number of individual modifications per plant should reflect the plants “ploidy”, meaning the number of chromosomes set in a plant.
Amendment 209 #
Proposal for a regulation
Recital 21
Recital 21
(21) Decisions declaring the category 1 NGT plant status should assign an identification number to the NGT plant concerned in order to ensure transparency and traceability of such plants when they are listed in the database and for the purpose of labe. The information listed shall ing of plant reproductive material derived from themclude information on the technique(s) used to obtain the trait(s).
Amendment 222 #
Proposal for a regulation
Recital 23
Recital 23
(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(47 ) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. As a result, category 2 NGT plants will be banned in organic production. However, it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. The use of new genomic techniques is currently incompatible with the concept of organic production in the Regulation (EC) 2018/848 and with consumers’ perception of organic products. The use of category 1 NGT plants should therefore be also prohibiAs category 1 NGT plants could also have been obtained with conventional breeding techniques, their use should be permitted in organic production. _________________ 47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).
Amendment 240 #
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 including information on the technique(s) used to obtain the trait(s). To ensure traceability, transparency and choice for operators, during research and plant breeding, when selling seed to farmers or making plant reproductive material available to third parties in any other way, plant reproductive material of category 1 NGT plants should be labelled as category 1 NGT.
Amendment 262 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The rules which apply to GMOs in Union legislationthe techniques referred to in Annex 1B to Directive 2001/18 shall notalso apply to category 1 NGT plants.
Amendment 269 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 305 #
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 or modified including information on the technique(s) used to obtain the trait(s);
Amendment 306 #
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. The competent authority shall acknowledge receipt of the verification request to the requester without undue delin 10 working days, stating the date of receipt. It shall make available the request to the other Member States and to the Commission without undue delin 10 working days.
Amendment 307 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the competent authority within 30 working days within the date of receipt of a verification request. The competent authority shall inform the requester, the other Member States and the Commission without undue delin 10 working days of the inadmissibility of the verification request and shall provide the reasons of its decision.
Amendment 310 #
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 30 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 delin 10 working days.
Amendment 311 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make commentreasoned objections to the verification report within 20 days from the date of receipt of that report, as regards the fulfilment of the criteria set out in Annex I, within 20 days from the date of receipt of that report. Such reasoned objections shall solely refer to the criteria as set out in Annex I and shall include a scientific justification.
Amendment 329 #
Proposal for a regulation
Recital 39
Recital 39
(39) To achieve the goal of ensuring the effective functioning of the internal market, for NGT plants and related products should benefit from, the free movement of goods should be ensured, provided they comply with the requirements of other Union law.
Amendment 330 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any commentreasonable objections 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 delin 10 working days to the requester, the other Member States and to the Commission.
Amendment 335 #
(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 andongoing development of new genomic techniques, the Commission should carry out an evaluation 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. This evaluation should measure the progress made towards the availability of NGT plants or NGT products containing such characteristics or properties on the EU market, with the aim of further improving this Regulation.
Amendment 346 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. In cases where a commentreasonable objection 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 the commentreasonable objection(s) to the Commission without undue delin 10 working days.
Amendment 350 #
Proposal for a regulation
Article 6 – paragraph 9 a (new)
Article 6 – paragraph 9 a (new)
9 a. The national competent authority can decide to take the reasoned objection(s) into account in the verification report or decide to reject the objection(s) for not being based on justified and scientific grounds. If the national authority considers that a decision on the question is necessary, it may request a decision from the Commission and forward the reasoned objection(s) to the Commission.
Amendment 356 #
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’)Authority, shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days from the date of receipt of the comment(s), taking the latterrequest of a decision from the competent authority, taking the reasoned objection(s) into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
Amendment 374 #
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 or modified including information on the technique(s) used to obtain the trait(s);
Amendment 376 #
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The Authority shall acknowledge receipt of the verification request to the requester without delin 5 working day,s stating the date of receipt. It shall make available the verification request to the Member States and to the Commission without undue delin 10 working days and make public the verification request, relevant supporting information and any supplementary information supplied by the requester, in accordance with article 38(1) of Regulation (EC) No 178/2002, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.
Amendment 377 #
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the Authority within 30 working days within the date of receipt of a verification request. The Authority shall inform the requester, the Member States and the Commission without undue delin 10 working days of the inadmissibility of the verification request and shall provide the reasons of its decision.
Amendment 392 #
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 plant;
Amendment 401 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Amendment 401 #
Proposal for a regulation
Article 3 – paragraph 1 – point 4
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;
Amendment 408 #
Proposal for a regulation
Article 10 – paragraph 1 a (new)
Article 10 – paragraph 1 a (new)
Amendment 429 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b
Article 3 – paragraph 1 – point 7 – point b
(b) is progeny of the NGT plant(s) referred to in point (a), including progeny derived by crossing of such plants, on the condition that there are no further modifications that would make it subject to Directive 2001/18/EC orr progeny that has undergone further modifications and fulfils the criteria of equivalence to conventional plants, as set out in Annex I of this Regulation 1829/2003;
Amendment 431 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b a (new)
Article 3 – paragraph 1 – point 7 – point b a (new)
(ba) products for which it is not possible to provide an analytical method to detect, identify and quantify a genetic change made by an new genomic technique.
Amendment 443 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12
Article 3 – paragraph 1 – point 12
(12) ‘NGT product’ means a product, other than food and feed, containing or, consisting of aor produced from NGT plants and food and feedother products containing, or consisting of or produced from such a plants;
Amendment 474 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
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.
Amendment 487 #
Proposal for a regulation
Article 5 – title
Article 5 – title
Status of category 1 NGT plants and products
Amendment 490 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plantsCategory 1 NGT plants should be included in the techniques referred to in Annex 1B of Directive 2001/18.
Amendment 495 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 505 #
Proposal for a regulation
Annex I – paragraph 1
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 230 genetic modifications per haploid genome 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.
Amendment 527 #
(c) a description of the trait(s) and characteristics which have been introduced or modified including information on the technique(s) used to obtain the trait(s);
Amendment 545 #
Proposal for a regulation
Annex I – point 3 a (new)
Annex I – point 3 a (new)
(3 a) On the condition that NGTs are not used with the purpose of developing herbicide tolerant plants;
Amendment 565 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make commentreasoned objections to the verification report within 20 days from the date of receipt of that report regard to the fulfilment of the criteria set out in Annex I, within 20 days from the date of receipt of that report. A reasoned objection by a Member State shall be science-based and shall directly refer to the criteria as set out in Annex I.
Amendment 579 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any commentsreasoned objection 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.
Amendment 590 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. In cases where a commentreasoned objection 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 Commissionreasoned objection to the Commission and the other Member States without undue delay.
Amendment 598 #
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 45 working days from the date of receipt of the commentreasoned objection(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
Amendment 617 #
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 or modified including information on the technique(s) used to obtain the trait(s);
Amendment 718 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 (new)
Article 10 – paragraph 1 – subparagraph 1 (new)
It shall be prohibited to label consumer products as containing NGT products or having been developed using NGT. It shall furthermore be prohibited to use ‘negative labelling’ by labelling products as not containing NGT products (non- NGT, free of NGT etc)
Amendment 792 #
Proposal for a regulation
Article 14 – paragraph 1 – point l
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)plant should be considered as category 1 NGT plant in accordance with Article 3(7)(c) of this Regulation;
Amendment 885 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. The incentives in this Article shall apply to category 2 NGT plants and category 2 NGT products, where at least one of the intended trait(s) of the NGT plant conveyed by the genetic modification is contained in Part 1 of Annex IIIArticle 51(1) of Regulation (2023/0227) and it does not have any traits referred to in Part 2 of that Annex.
Amendment 1009 #
Proposal for a regulation
Article 30 – paragraph 4
Article 30 – paragraph 4
4. No sooner than two years after the publication of the first report referred to in paragraph 1 the Commission shall carry out an evaluation of the implementation of this Regulation and its impact on human and animal health, the environment, consumer information, the functioning of the internal market herein the organic production, and economic, environmental and social sustainability.
Amendment 1012 #
Proposal for a regulation
Article 30 – paragraph 5 a (new)
Article 30 – paragraph 5 a (new)
5a. Every three years, the Commission shall review the criteria listed in Annex I and Annex III of this Regulation and, where appropriate, amend them by means of a delegated act, in order to ensure adaptation to the latest scientific and technological progress.
Amendment 1013 #
Proposal for a regulation
Article 30 – paragraph 5 a (new)
Article 30 – paragraph 5 a (new)
5a. By 2024, the Commission shall produce a report evaluating the specificities and needs for other sectors not covered in this legislation, such as microorganisms, including a proposal for further policy action.
Amendment 1054 #
Proposal for a regulation
Annex I – paragraph 1
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 230 genetic modifications per haploid genome 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.
Amendment 1075 #
Proposal for a regulation
Annex I – point 3 – introductory part
Annex I – point 3 – introductory part
(3) on the condition that the genetic modification does not interrupt an endogenous genecreate a chimeric protein:
Amendment 1083 #
Proposal for a regulation
Annex I – point 3 – point a
Annex I – point 3 – point a
(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool;
Amendment 1092 #
Proposal for a regulation
Annex I – point 3 a (new)
Annex I – point 3 a (new)
(3a) On the condition that NGTs are not used with the purpose of developing herbicide tolerant plants as described in recital 36;
Amendment 1169 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – introductory part
Annex III – Part 1 – paragraph 1 – introductory part
Traits justifying the incentives referred to in Article 22: are listed in Article 52(1) of Regulation (EU) 2023/0227.
Amendment 1172 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 1
Annex III – Part 1 – paragraph 1 – point 1
Amendment 1175 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 2
Annex III – Part 1 – paragraph 1 – point 2
Amendment 1176 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 3
Annex III – Part 1 – paragraph 1 – point 3
Amendment 1179 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 4
Annex III – Part 1 – paragraph 1 – point 4
Amendment 1181 #
Amendment 1183 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 6
Annex III – Part 1 – paragraph 1 – point 6
Amendment 1184 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 7
Annex III – Part 1 – paragraph 1 – point 7