Answer given by Ms Kyriakides on behalf of the European Commission
7.3.2024
The Commission is aware of the opinion published by the French agency ANSES[1] on the criteria in Annex I to the Commission’s proposal for a regulation on plants obtained by certain new genomic techniques (NGTs)[2].
The criteria have been developed by the Commission based on a scientific literature analysis about the changes in plants’ genome obtained by conventional breeding methods.
They are underpinned by the European Food Safety Authority’s (EFSA) conclusions about the safety of plants obtained by NGTs.
In line with EFSA’s mandate to provide independent scientific advice and scientific and technical support which serve as the scientific basis for the drafting and adoption of Union measures in the fields falling within its mission, the Commission has relied on several EFSA opinions adopted since 2012 and has given EFSA two specific mandates in preparation of the proposal[3].
National agencies, including ANSES, engaged with EFSA in the context of this work, in particular through the EFSA GMO Network[4] and the public consultations of the relevant EFSA scientific opinions.
The criteria proposed by the Commission are in line with and take into account EFSA’s scientific opinions. In this regard, the Commission does not consider there is a need to mandate EFSA to establish new equivalence criteria.
However, the Commission has proposed that the criteria can be reviewed in the future in the light of scientific and technical progress.
- [1] https://www.anses.fr/en/system/files/BIOT2023AUTO0189.pdf
- [2] Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 (COM(2023) 411 final).
- [3] EFSA Panel on Genetically Modified Organisms, Scientific opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease 3 and other Site-Directed Nucleases with similar function. EFSA Journal 2012;10(10):2943 (https://doi.org/10.2903/j.efsa.2012.2943); EFSA Panel on Genetically Modified Organisms, ‘Applicability of the EFSA Opinion on SDNs type 3 for the safety assessment of plants developed using SDNs type 1 and 2 and oligonucleotide-directed mutagenesis’, EFSA Journal 2020;18(11):6299 (https://doi.org/10.2903/j.efsa.2020.6299); EFSA Panel on Genetically Modified Organisms, 2012. Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. EFSA Journal 2012;10(2):2561 (https://doi.org/10.2903/j.efsa.2012.2561); EFSA Panel on Genetically Modified Organisms, 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); EFSA Panel on Genetically Modified Organisms, 2022. Statement on criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis. EFSA Journal 20(10):7618, 12 pp. (https://doi.org/10.2903/j.efsa.2022.7618).
- [4] The EFSA Scientific Network for Risk Assessment of Genetically Modified Organisms.