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October 11, 2023

EC Recommends Carrying Out Risk Assessment on Biotechnologies

Lynn L. Bergeson Carla N. Hutton

The European Commission (EC) announced on October 3, 2023, that it adopted a Recommendation on critical technology areas for the European Union’s (EU) economic security, for further risk assessment with EU member states. According to the EC, the Recommendation relates to the assessment of technology risk and technology leakage. The EC states that the risk assessment “will be objective in character, and neither its results nor any follow-up measures can be anticipated at this stage.” In the Recommendation, the EC put forward a list of ten critical technology areas, including biotechnologies. The EC selected these technology areas based on the following criteria:

  • Enabling and transformative nature of the technology: The technologies’ potential and relevance for driving significant increases of performance and efficiency and/or radical changes for sectors and/or capabilities;
  • The risk of civil and military fusion: The technologies’ relevance for both the civil and military sectors and their potential to advance both domains, as well as risk of uses of certain technologies to undermine peace and security; and
  • The risk the technology could be used in violation of human rights: The technologies’ potential misuse in violation of human rights, including restricting fundamental freedoms.

Out of the ten critical technology areas, the Recommendation identifies four technology areas that are considered “highly likely to present the most sensitive and immediate risks related to technology security and technology leakage,” including biotechnologies (techniques of genetic modification, new genomic techniques, gene-drive, and synthetic biology). The EC recommends that EU member states, together with the EC, initially conduct collective risk assessments of these four areas by the end of 2023. The Recommendation includes some guiding principles to structure the collective risk assessments, including consultation of the private sector and protection of confidentiality.