COGEM advises on the European Biotech Act I

On 16 December 2025, the first part of the Biotech Act (Biotech Act I) was published by the European Commission (EC). With this, the EC aims to accelerate and simplify the regulations for biotechnological products for health in order to improve the competitive position of the European Union.

One of the proposed regulatory relaxations is to exempt certain groups of GMOs that are considered safe from environmental risk assessment in clinical studies. COGEM has issued advice on the implications of this specific article for safety of human health and the environment.

COGEM has previously remarked that GMO regulations are no longer in line with current scientific developments and considers it necessary to amend and streamline the regulations and authorisation procedures. However, with its current proposal, the EC is wrongly seeking to address the problem of excessive regulatory pressure by abolishing parts of the risk assessment based on overly generic criteria, thereby compromising the safety of human health and the environment.