Regulations for new genomic techniques: change is closer

“The current legislation on GMOs [genetically modified organisms], adopted in 2001, is not suitable for the new genomic techniques (NTG),” says the long-awaited study published by the European Commission (EC) at the request of the Council of the European Union (EU). O document led the EC to announce which will “initiate a broad and open consultation process to discuss the design of a new legal framework for these biotechnologies”.

“The study shows that NTG, which are techniques for altering the genome of an organism, have the potential to contribute to a more sustainable food system within the framework of the objectives of the European Green Deal and Farm to Fork Strategy“, says the EC statement. “With consumer and environmental safety as the guiding principle, the time has come to establish an open dialogue with citizens, Member States and the European Parliament in order to decide together on the way forward for the use of these biotechnologies in the EU,” stresses Stella Kyriakides, Commissioner for Health and Food Safety.

The report identifies limitations to the legislation's ability to keep up with scientific developments, causing implementation challenges and illegal uncertainties, which need to be resolved. It recognizes that it may not be justifiable to apply different levels of regulatory oversight to products with similar degrees of risk, as in the case of conventionally improved plants and those obtained from certain NTGs.

“Future regulatory actions will need to address the knowledge gaps and limitations identified in this study.” In addition, “a greater effort should be made to inform and involve the public regarding NGTs, and to assess their opinions,” admits the EC.

Entitled ‘Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16’, the study examines the current state of NTG, “taking into account the ‘state of the art’ of knowledge and the views of EU countries and stakeholders”. The Council of the EU requested this state of play on NTG under European law (Directive 2001/18/EC, Regulation (EC) 1829/2003, Directive 2009/41/EC e Regulation (EC) 1830/2003), in the light of the judgment of the Court of Justice in Case C-528/16.

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