Niveau juridique : Union européenne
Texte de la question
« The ruling of the European Court of Justice in Case C-528/16 means that organisms whose genome is edited by means of new breeding techniques are subject to European GMO legislation.
1. This ruling will cause problems for SMEs and start-ups wishing to apply these techniques, as they often do not have the means to complete the approval process. How will the Commission ensure that small and medium-sized plant-breeding companies can also use precision breeding techniques such as CRISPR?
2. A major challenge in applying GMO legislation to new breeding techniques is its enforcement. The minor changes made to the heritable material of organisms by genome editing can also occur spontaneously in nature. Therefore, if a minor change is found in a genome, it could be the consequence of spontaneous change, traditional breeding or genome editing. In other words, GMO legislation is not enforceable for this type of organism. How can GMO legislation be amended in such a way that only those organisms fall within the scope of the legislation for which that legislation can also be enforced? »
Texte de la réponse
« The objective of Directive 2001/18/EC (1) is to protect human health and the environment in case of releases of genetically modified organisms (GMOs) into the environment. The authorisation procedure requires a science-based case-by-case risk assessment of potential adverse effects for humans, animals and the environment.
One of the key objectives of the Commission’s policies related to Small and medium-sized enterprises and start-ups (2) is to promote a business environment conducive to sustainable growth and competitiveness of small businesses across the EU.
Member States are responsible for the enforcement of the GMO legislation. The Commission has requested the European Union Reference Laboratory for Genetically Modified Food and Feed and the European Network of GMO laboratories to prepare a report on the current and future possibilities and limitations regarding the detection of food or feed obtained by new mutagenesis techniques. The report should be finalised by mid 2019. The Commission and the Member States’ competent authorities are currently discussing the implications of the Court ruling in terms of implementation, with a view to a harmonised enforcement. At this stage, there are no plans to put forward new legislative proposals concerning the GMO legislation.
Finally, products placed on the market in the EU, whether imported or produced in the EU, have to fulfil the requirements of the EU legislation. The burden of proof is on economic operators, including verification that unauthorised GMOs are not placed on the market and that traceability and labelling rules for authorised GMOs (as set by the EU legislation) are fulfilled ».
(1) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, OJ L 106, 17.4.2001, p. 1-39.
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