31 Amendments of Silvia SARDONE related to 2023/0226(COD)
Amendment 124 #
Proposal for a regulation
Recital 10
Recital 10
(10) The legal framework for NGT plants should share the objectives of the Union GMO legislation to ensure a high level of protection of human and animal health and of the environment and the good functioning of the internal market for the concerned plants and products, while addressing the specificity of NGT plants. This legal framework should enable theallow for flexibility and adaptation to ensure the continued yet monitored development and placing on the market of plants, food and feed containing, consisting of or produced from NGT plants and other products containing or consisting of NGT plants (‘NGT products’) so as to contribute to the innovation and sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and to enhance the competitiveness ofin order to enhance the competitiveness and profitability of companies especially small and medium- sized enterprises in the Union agri-food sector at Union and world level.
Amendment 182 #
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 188 #
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 and to adapt to and ensure resilience to the consequences of climate change, the specific nature of polyploid plants – those containing more than two genomes – needs 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 255 #
Proposal for a regulation
Recital 26
Recital 26
(26) Category 2 NGT plants and products, in order to be released into the environment or placed on the market, should remain subject to a consent or authorisation in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. However, given the wide variety of those NGT plants, the amount of information necessary for the risk assessment will vary on a case-by-case basis. The Authority, in its scientific opinions on plants developed through cisgenesis and intragenesis48 and on plants developed through targeted mutagenesis49 recommended flexibility in data requirements for the risk assessment of these plants. Based on the Authority’s ‘Criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis’ (50 ), considerations on the history of safe use, familiarity for the environment and the function and structure of the modified/inserted sequence(s) should assist in determining the type and amount of data required to perform the risk assessment of those NGT plants. It is therefore necessary to establish general principles and criteria for the risk assessment of these plants, while providing for flexibility and possibility to adapt risk assessment methodologies to scientific and technical progress. As per EFSA’s considerations in the above-mentioned document on criteria for risk assessment, the concept and utility of the history of safe use should be clarified, giving recognition of safety records in third countries. _________________ 48 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta, J, Fernandez Dumont A, Gennaro A, Lenzi, P, Lewandowska A, Munoz Guajardo IP, Papadopoulou N and Rostoks N, 2022. Updated scientific opinion on plants developed through cisgenesis and intragenesis. EFSA Journal 2022;20(10):7621, 33 pp. https://doi.org/10.2903/j.efsa.2022.7621. 49 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Naegeli H, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Mullins E, Nogué F, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Gennaro A, Paraskevopoulos K, Raffaello T and Rostoks N, 2020. Applicability of the EFSA Opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis. EFSA Journal 2020;18(11):6299, 14 pp. https://doi. org/10.2903/j.efsa.2020.6299. 50 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J-L, Dalmay T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Fernandez A, Gennaro A, Papadopoulou N, Raffaello T and Schoonjans R, 2022. Statement on criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis. EFSA Journal 2022;20(10):7618, 12 pp. https://doi.org/10.2903/j.efsa.2022.7618.
Amendment 305 #
Proposal for a regulation
Recital 36
Recital 36
Amendment 339 #
Proposal for a regulation
Recital 40 a (new)
Recital 40 a (new)
(40a) NGT plants and products imported into the Union shall be subject to the same obligations as those originating in the Union.
Amendment 410 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘breeders’ gene poolgene pool for breeding purposes’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses;
Amendment 414 #
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 486 #
Proposal for a regulation
Article 5 – title
Article 5 – title
Status of category 1 NGT plants and category 1 NGT products
Amendment 506 #
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 567 #
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 571 #
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make commentsreasoned scientific opinion to the verification report within 20 days from the date of receipt of that report.
Amendment 580 #
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 581 #
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any comments from a Member State or the Commissionreasoned objections from the Commission or Member States, 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 587 #
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 Commissionupon request make the reasoned objections available to the other Member States without undue delay.
Amendment 589 #
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) toobjections and their justifications to the Member States and the Commission without undue delay.
Amendment 596 #
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), 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 599 #
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, taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
Amendment 707 #
Proposal for a regulation
Article 10 – title
Article 10 – title
Amendment 933 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
Member States and the European Commission shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003.
Amendment 1001 #
2a. The report shall also address progress achieved regarding regulatory cooperation with trade partners and include information on the impact of divergent legislative approaches in third countries on EU international trade. In that regard, the following elements should be included in the report: - progress achieved in developing (private- public) Databases on NGT plants at global or third country level, in order to foster open dialogue with third countries. - overview of outcome of risk assessment (including environmental) in main trade partners’ countries, and how this can feed into the EU regulatory framework.
Amendment 1008 #
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, and economic, environmental and social sustainability. The analysis should also cover the successes and limitations of the Regulation and include proposals to enable fair access of farmers to NGT 1 products.
Amendment 1051 #
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 1064 #
Proposal for a regulation
Annex I – point 1
Annex I – point 1
(1) targeted substitution or insertion of no more than 20 nucleotides;
Amendment 1071 #
Proposal for a regulation
Annex I – point 2
Annex I – point 2
(2) targeted deletion of any number of nucleotides;
Amendment 1079 #
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 1081 #
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 1088 #
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;
Amendment 1101 #
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 on the condition that the genetic modification does not interrupt an endogenous gene.
Amendment 1177 #
Proposal for a regulation
Annex III – Part 1 – paragraph 1 – point 3
Annex III – Part 1 – paragraph 1 – point 3
(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change conditions;
Amendment 1187 #
Proposal for a regulation
Annex III – Part 2
Annex III – Part 2