26 Amendments of Francesca PEPPUCCI related to 2023/0226(COD)
Amendment 154 #
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 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, size and number of genetic modifications that can occur in nature or through conventional breeding.
Amendment 186 #
Proposal for a regulation
Recital 18
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 levelin consultation with the Commission and EFSA, only if there are reasoned objections from other Member States, in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.
Amendment 189 #
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18a) In order to effectively select new varieties that help the agricultural sector increase food security, as well as sustainability, adaptation and resilience to the consequences of climate change, it is necessary to consider the specificity of polyploid plants, i.e. those that contain more than two genomes. For such plants, the maximum number of genetic modifications allowed for inclusion in category 1 NGT should be proportionate to the number of genomes they contain.
Amendment 228 #
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. This prohibition, in any case, should not hinder the application of Category 1 NGT. _________________ 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 278 #
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
(29a) Once a category 1 NGT plant has been granted authorisation on the basis of scientific criteria, the authorisation should be valid for an unlimited period.
Amendment 285 #
Proposal for a regulation
Recital 30
Recital 30
(30) For reasons of proportionality, after a first renewal of the authorisation, the authorisation should be valid for an unlimited period. In the case of a category 2 NGT plant, unless decided differently at the time of that renewal based on the risk assessment and the available information on the NGT plant concerned, subject to reassessment when new information has become available.
Amendment 336 #
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. IWith reference to category 2 NGT plants, information should be collected regularly and within five years after the adoption of the first decision allowing the deliberate release or the marketing of NGTsuch plants or NGTsuch products in the Union, the Commission should carry out an evaluation of this Regulation to measure the progress made towards the availability of NGTsuch plants containing such characteristics or properties on the EU market.
Amendment 413 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6 a (new)
Article 3 – paragraph 1 – point 6 a (new)
Amendment 497 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2a. Category 1 NGT plants and products from such plants are not subject to the provisions laid down in Article 24 of this Regulation or Regulation 1829/2003.
Amendment 507 #
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 as regards the types and, extent, size and number of modifications which can occur naturally or through conventional breeding.
Amendment 568 #
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 with regard to compliance with the criteria in the Annex I within 20 days from the date of receipt of that report.
Amendment 578 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any commentreasoned 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 delay to the requester, the other Member States and to the Commission.
Amendment 588 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. In cases where a commentreasoned objections 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)objections and their justifications to Member States to the Commission without undue delay.
Amendment 597 #
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 comment(s)reasoned objections and their justifications, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
Amendment 655 #
Proposal for a regulation
Article 7 a (new)
Article 7 a (new)
Article 7a Freedom of movement Member States do not prohibit or restrict the intentional release or placing on the market of Category 1 NGT plants and Category 1 NGT products.
Amendment 809 #
Proposal for a regulation
Article 16
Article 16
Amendment 844 #
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2
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)application for authorisation is accompanied by such justification;
Amendment 912 #
Proposal for a regulation
Article 23
Article 23
Amendment 931 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
Amendment 935 #
Proposal for a regulation
Article 24 – paragraph 1 a (new)
Article 24 – paragraph 1 a (new)
Amendment 962 #
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
3. The delegations of power referred to in Article 5(3) and Article 22(8) may only be exercised to adapt to scientific and technological progress, and the non- regression clause must be applied. Delegations of power may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 1056 #
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 20 genetic modifications per haploid of the types referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.
Amendment 1062 #
Proposal for a regulation
Annex I – point 1
Annex I – point 1
(1) substitution or insertion of no more than 20 nucleotides per haploid;
Amendment 1077 #
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 for reproductive purposes;
Amendment 1087 #
Proposal for a regulation
Annex I – point 3 – point b
Annex I – point 3 – point b
(b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool for reproductive purposes;
Amendment 1102 #
Proposal for a regulation
Annex I – point 5
Annex I – point 5
(5) any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (possibly with modifications as accepted under points (1) and/or (2)) in a species from the breeders’ gene pool for reproductive purposes.