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European Biotech Act II

In “A new plan for Europe's sustainable prosperity and competitiveness”

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In its work programme 2026, the Commission announced to prepare a legislative initiative on a European Biotech, to be released during the third quarter of 2026.

Its indicative legal basis should be Article 114 TFEU. 

In its Communication on a strategic framework for a competitive and sustainable EU bioeconomy adopted on 27 November 2025, the Commission provides the policy framework in which the upcoming biotech Acts are embedded, as well as an indicative outline of possible key elements such as sectoral and horizontal enablers (for example regulatory sandboxes, fast-track authorisation procedures for microbial solutions for industrial use in the bioeconomy and streamlined permitting for biomanufacturing projects).

References:

Author: Clément Thierry Évroux, Members' Research Service: legislative-train@europarl.europa.eu

As of 20/02/2026.