In 2024, the European Commission launched a legislative initiative to establish the “EU Biotech Act,” with the ambitious goal of accelerating the transition of biotechnology products from research to market, while maintaining high safety standards for people and the environment. The initiative seeks to strengthen Europe’s competitiveness in biotechnology, support innovation, and align biotech development with key EU priorities, such as health, sustainability, and resilience.
As part of this process, the Commission opened a Call for Evidence for an Impact Assessment, inviting stakeholders to help define the scope and focus of this politically significant legislation. This call aims to shape how future biotech laws and policies are designed and evaluated across the EU.
PRI recognised this as a critical moment. Given that the definition of biotechnology includes the application of science and technology to living organisms and their components, PRI believes that microbiome technologies, spanning health, agriculture, food, and the environment, must be explicitly included in this policy framework.
PRI prepared and submitted a formal response to the Commission’s call, emphasising the unique needs and strategic value of microbiome-based products. These innovations, often based on complex living systems, require tailored regulatory approaches that current frameworks do not yet fully support. In preparing this response, PRI reached out to its members, and we are grateful for the feedback received, which helped shape and strengthen the final submission.
You can read PRI Submission to the EU Biotech Act Call for Evidence here.
