Advice Categories of genetically modified organisms exempted from an environmental risk assessment in the Biotech Act I

The Ministry of Infrastructure and Water Management has asked COGEM for advice on the first part of the Biotech Act (Biotech Act I), which was published by the European Commission on 16 December 2025. The aim of Biotech Act I is to accelerate and relax regulations so that innovation is not unnecessarily hampered, and European companies can bring products from the laboratory to the market more quickly. One element of the proposal is that, in clinical trials, four categories of genetically modified organisms (GMOs) will be exempt from the requirements of GMO regulations and will no longer be subject to an environmental risk assessment.
Firstly, COGEM notes that these four categories of GMOs are defined very broadly in the proposal, which means that they can be interpreted in various ways. Secondly, COGEM notes that – partly due to the broad definitions – GMOs that may pose a potential risk to human health and the environment are exempt from environmental risk assessment.
COGEM is therefore of the opinion that the safety of human health and the environment cannot be  guaranteed when GMOs classified in one of the four categories, as described in the Biotech Act I, are used in clinical trials without an environmental risk assessment.