This week, the European Commission presented the Biotech Act, a new legislative proposal aimed at stimulating innovation in the biotechnology sector and strengthening biosecurity in Europe. The proposal contains a series of measures to reduce the risk of misuse of biotechnology and to enhance preparedness against biological threats.

Under the Biotech Act, suppliers of sensitive biotechnological materials, such as synthetic DNA and pathogen components, will be required to verify whether buyers have a legitimate reason for their purchase. In addition, companies that supply DNA and similar products must screen their products for risky or regulated genetic sequences. To this end, central European lists and guidelines will be established, ensuring that screening is carried out effectively and uniformly.

When a supplier receives a suspicious request or detects a risky sequence, they are subject to an immediate reporting obligation to both national authorities and a central EU reporting point. This enables swift action in response to potential threats. Furthermore, the Biotech Act requires companies and governments to invest in training and awareness programs, so that employees can recognize biosecurity risks in time and know how to act. Finally, the proposal aims to harmonize measures within the EU, ensuring uniform biosecurity requirements everywhere and improved supervision and enforcement.

It is still unclear what the Biotech Act will mean exactly for the Netherlands, but it is certain that biosecurity will receive more attention and that existing regulations may need to be tightened in some areas. For the field, there are proposals to invest more in training and awareness. The overarching idea of the Biotech Act is that harmonization will create a level playing field with other EU countries, facilitating European cooperation.

The Biosecurity Office is closely following developments and will provide further information as necessary.

https://commission.europa.eu/news-and-media/news/commission-proposes-new-measures-improve-health-and-healthcare-sector-2025-12-16_en