Niveau juridique : Union européenne
Texte de la question :
« New genetic engineering techniques produce mutations. Such mutations cause specific genetic patterns (genotypes) giving rise to new traits (phenotypes) that can go beyond the limits of genomic organisation.
Using those techniques on plants carries an element of risk, not only in terms of the predicted traits but also the complexity of the process itself, for example, the imprecision of genetic scissors or the use of older techniques to insert DNA from those scissors into plant cells, provoking undesired genome changes. Consequently, the overall safety of the plants produced by these techniques cannot be determined without a detailed, product-based risk assessment and if only the predicted traits are taken into account.
1. The initial impact assessment on the legislation governing plants modified by particular new genomic techniques suggests that the Commission intends to deregulate those plants on a large scale. Is this the Commission’s intention ?
2. How will it manage the risks associated with the techniques and complexity of new genetic engineering ?
3. These techniques are very likely to pose new and specific risks. How will it address this ? »
Réponse de Mme Kyriakides au nom de la Commission européenne du 5 janvier 2022
« 1. The Commission’s decision to initiate a policy action for plants produced by certain new genomic techniques is not a proposal to deregulate, but to design a proportionate regulatory framework that is adapted to scientific and technological progress. Its aim is to ensure a high level of protection of human and animal health and the environment, as well as enable innovation and the contribution of new genomic techniques to the objectives of the European Green Deal and the Farm to Fork Strategy.
2. Certain new genomic techniques, namely targeted mutagenesis and cisgenesis techniques, can be used to produce alterations of the genetic material that can also be obtained by natural mutations and conventional breeding techniques, or can be used to produce alterations that are more complex. The current regulatory framework is not adapted to the resulting diverse risk profiles and needs adaptation to scientific and technological progress. Therefore, an impact assessment will be carried out in 2022 to assess different policy options. These options will include risk assessment and approval requirements proportionate to the risk involved, e.g. in terms of data and studies, taking into account elements such as the specific technique used, the type of modifications or the novelty of the trait. These risk assessment and approval requirements will be assessed in the impact assessment.
3. The European Food Safety Authority (1), replying to a mandate from the Commission, did not identify new hazards specifically linked to the techniques in the scope of the policy initiative, compared with both conventional breeding and transgenesis.
(1) EFSA Panel on Genetically Modified Organisms, 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. efsa.onlinelibrary.wiley.com/doi/full/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, 33 pp. efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2012.2561 »
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