24 Amendments of Herbert DORFMANN related to 2023/0226(COD)
Amendment 54 #
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 77 #
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 the European Food Safety Authority (‘the Authority’) only if there are reasoned 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 80 #
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18a) With a view to effectively selecting new varieties that help the agricultural sector to increase food security and sustainability as well as to adopt to and ensure resilience to the consequences of climate change, the specific characteristics of polyploid plants – those containing more than two genomes – need to be considered. This is the case, for instance, with wheat, potato, sugar beet, banana, kiwi, peanut, rapeseed, etc. For polyploid 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 95 #
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 labelling of plant reproductive material derived from them.
Amendment 142 #
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
Amendment 146 #
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 158 #
Proposal for a regulation
Recital 36
Recital 36
Amendment 200 #
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 211 #
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 221 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6 – point a (new)
Article 3 – paragraph 1 – point 6 – point a (new)
(a) 'Polyploidy' means the presence of more than two genomes in a single cell;
Amendment 287 #
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, dimensions and number of modifications which can occur naturally or through conventional breeding.
Amendment 290 #
Proposal for a regulation
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3 a. Category 1 NGT plants shall not be patentable.
Amendment 320 #
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 whether the criteria set out in Annex I have been met within 20 days from the date of receipt of that report.
Amendment 337 #
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 343 #
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 the comment(s) toobjections and their justifications to the Member States and the Commission without undue delay.
Amendment 354 #
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 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 381 #
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 442 #
Proposal for a regulation
Article 16
Article 16
Amendment 472 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
Amendment 507 #
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 per haploid, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.
Amendment 516 #
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 532 #
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 breeding purposes;
Amendment 539 #
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 breeding purposes;
Amendment 556 #
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 poolgene pool for breeding purposes.