18 Amendments of Daniela RONDINELLI related to 2023/0226(COD)
Amendment 55 #
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, dimensions and number of genetic modifications that can occur in nature or through conventional breeding.
Amendment 79 #
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 level. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted in consultation with the Commission and the European Food Safety Authority (‘the Authority’) only if there are reasoned scientific objections by other Member States in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.
Amendment 81 #
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
Amendment 141 #
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
(29a) After the successful authorisation of a category 1 NGT plant based on scientific criteria, the authorisation should be valid for an unlimited period.
Amendment 147 #
Proposal for a regulation
Recital 30
Recital 30
(30) For reasons of proportionality, after a first renewal of the authorisation of a category 2 NGT plant, the authorisation should be valid for an unlimited period, unless decided differently at the time of that renewal based on the risk assessment and the available information on the category 2 NGT plant concerned, subject to reassessment when new information has become available.
Amendment 177 #
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 category 2 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 category 2 NGT plants or category 2 NGT products in the Union, the Commission should carry out an evaluation of this Regulation to measure the progress made towards the availability of category 2 NGT plants containing such characteristics or properties on the EU market.
Amendment 212 #
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 222 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6 a (new)
Article 3 – paragraph 1 – point 6 a (new)
(6a) 'Polyploidy' means the presence of more than two genomes in a single cell;
Amendment 288 #
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 of, dimensions and number of genetic modifications which can occur naturally or through conventional breeding.
Amendment 319 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make comments to the verification reporreasoned scientific objections to the verification report with regard to whether the criteria set out in Annex I have been met within 20 days from the date of receipt of that report.
Amendment 329 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any commentreasoned scientific 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 340 #
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. In cases where a commentreasoned scientific 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 comment(s) toobjections and their justifications to the Member States and the Commission without undue delay.
Amendment 351 #
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 latterreasoned scientific objections and their justifications, taking that information into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
Amendment 382 #
Proposal for a regulation
Article 7 a (new)
Article 7 a (new)
Article 7a Free movement Member States shall not prohibit or restrict the deliberate release or placing on the market of Category 1 NGT plants or Category 1 NGT products.
Amendment 503 #
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 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 toolsplants obtained by means of conventional selection methods when it contains only the genetic modifications referred to in points 1 to 5 and when it differs from the recipient/parental plant by no more than 20 genetic modifications, excluding off-target modifications, of the types referred to in points 1, 2 and 4, in the targeted site or sites in the monoploid genome.
Amendment 518 #
Proposal for a regulation
Annex I – point 1
Annex I – point 1
(1) targeted substitution or insertion of no more than 20 nucleotides;
Amendment 523 #
Proposal for a regulation
Annex I – point 2
Annex I – point 2
(2) targeted deletion of any number of nucleotides;
Amendment 533 #
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;