On December 16, 2025, the European Commission introduced a proposal to amend EU Directive 2001/18/EC. This directive regulates the deliberate release of genetically modified organisms into the environment. The proposal is being considered in conjunction with a European biotechnology regulation that is being developed in parallel.

With this amendment, the European Commission aims, among other things, to simplify the process of placing genetically modified microorganisms on the market. The BfN has examined what consequences the planned amendments could have from the perspective of nature conservation and environmental protection. In its assessment, the BfN took particular account of the central ecological role of microorganisms, their specific biological properties, and significant current gaps in knowledge. These gaps primarily concern microbial diversity and its specific functions in various environments.

The BfN reaches the following conclusion, among others:

• Greater consideration should be given to the precautionary principle: In the BfN’s view, there are doubts as to whether the proposal will satisfy the EU’s precautionary principle and the requirement for a high level of environmental protection. In particular, long-term environmental impacts have not been adequately taken into account thus far.
• Indefinite approval of GMMs is problematic: In the BfN's view, it is concerning that the proposal would permit potential unlimited approval for GMMs.
• Requirements for "low risk" GMMs are too weak: The proposal introduces a new category of GMMs considered low risk, but the requirements for this category are inadequate. For example, even for GMMs in this category, it should not be possible to waive the mandatory monitoring of environmental impacts.
• GMMs can vary greatly and spread widely in the environment: The proposed regulation covers a wide range of possible GMM applications in the environment. These include genetically modified bacteria, microalgae, certain fungi, viruses, and animal protozoa such as amoebas. Because microorganisms can spread widely once released, these applications are associated with environmental impacts that may be far reaching and difficult to reverse.
• Nature conservation and environmental protection are increasingly impacted: GMMs are not limited to agricultural contexts, but can also enter semi-natural and natural habitats. Furthermore, GMMs are specifically developed for use outside of farmland.

Options for regulating GMMs are derived from the analysis. The key message is: As long as there are uncertainties in the risk assessment of GMMs, special care and adherence to the EU precautionary principle are necessary.