September 28, 2021

Volume XI, Number 271

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September 28, 2021

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September 27, 2021

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EU Considers Benefits of New Genomic Techniques

On April 29, 2021, the European Commission published a study considering the status of “new genomic techniques” (NGTs) under EU law. The study defined NGTs as techniques  for altering genetic material that have been developed since 2001 and considered the use of NGTs in plants, animals, and microorganisms in food, industrial, and pharmaceutical applications. The report concluded that the EU’s 2001 legislation on genetically modified organisms (GMOs) “is not fit for purpose for these innovative technologies” and that NGTs, such as CRISPR/Cas, have the potential to contribute to sustainable agriculture initiatives like the European Green Deal and the Farm to Fork Strategy.

The Council of the European Union commissioned the study following a controversial 2018 Court of Justice of the European Union (CJEU) ruling in Case C-528/16 that found organisms obtained by any technique that induces DNA mutagenesis are GMOs subject to the restrictions in its 2001 legislation. The ruling said that while techniques that have a long safety record can be exempt from the 2001 obligations, individual member states can decide for themselves whether to require these to be compliant with the law. Although the case did not directly address gene editing (which encompasses CRISPR/Cas), a distinct technology from mutagenesis, regulation over gene editing techniques was called into question.

The study clarifies that while organisms obtained through NGTs are subject to the 2001 GMO legislation, the current regulatory framework will stymie innovation, inhibit the EU from reaching its goals for a more resilient and sustainable food system, and put the EU at a competitive disadvantage. It explains that NGTs cover a diverse group of techniques and that a targeted regulatory framework considering the safety, risks, and uses of each technique will better serve the EU. While maintaining a cautionary tone, the report shed a more positive outlook on innovation in gene editing than past publications.

The Commission outlined its next steps in a letter to the Portuguese Presidency of the EU, which include initiation of a policy action on plants derived from targeted mutagenesis and cisgenesis and an accompanying impact assessment. It also stated that it will begin meeting with the European Parliament and stakeholders in meetings to gather opinions on proposed changes to the current regulatory framework. We will continue to monitor and report on developments.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 120
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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