Scaling precision fermentation food innovations in Europe: the role of regulatory sandboxes

Abstract

Precision fermentation is food innovation based on biotechnology with potential to support more sustainable, resource-efficient, and animal-free food production. In the European Union, many precision fermentation-derived food ingredients fall under the Novel Food Regulation and may also raise questions linked to GMO-related production processes. While these regulatory frameworks are essential for food safety and consumer protection, they may also create uncertainty for companies seeking to move from laboratory or pilot scale to commercialisation. This thesis examines how regulatory sandboxes, which are controlled regulatory testing environments, could be designed in Europe to support the scaling-up of precision fermentation food innovations while maintaining safety and public trust. The study aims to identify the main regulatory barriers faced by precision fermentation companies, the sandbox models most suitable for this sector, and how sandbox outcomes could contribute to regulatory learning. The research is based on a literature review, analysis of policy and industry documents, and four semi-structured interviews with relevant experts. The findings suggest that the main regulatory barriers relate to uncertainty over evidence requirements, approval timelines, and limited opportunities for early dialogue with authorities. Regulatory sandboxes could provide value by creating a structured environment for interaction between innovators and regulators, improving the quality of applications, clarifying expectations, and generating evidence for future regulatory guidance. However, all stakeholders agreed that sandboxes should not weaken food safety standards. For precision fermentation, the most appropriate model appears to be a carefully controlled EU-level or EU-coordinated sandbox focused on regulatory learning. The thesis concludes that regulatory sandboxes should be understood not only as tools to support individual companies, but as mechanisms for institutional learning. If designed with clear entry criteria, transparency safeguards, EFSA and Member State involvement, and mechanisms for translating lessons into guidance or policy reform, sandboxes could help Europe build a more predictable, adaptive, and innovation-sensitive regulatory environment for precision fermentation.