European Biotech Act

This procedure concerns the European Biotech Act, a regulation to strengthen the sustainability, safety and competitiveness of health biotechnology in the Union, anchored in the One Health principle and based on Articles 114, 168(4), 173(3) and 191 TFEU. Amendments define health biotechnology strategic projects, attach conditions to public support, require environmental impact assessments, and provide penalties for non-compliance affecting availability or affordability. They address Union funding and State aid, AI use in development and authorisation procedures, biosimilars, veterinary medicinal products and GMO clinical trials, phasing out animal testing with EMA guidance, the mandate of EFSA, regulatory sandboxes for novel foods under Regulation (EU) 2015/2283, and a Commission review five years after application.