Starting in February 2025, updates will apply to all novel food applications submitted to the European Commission. The European Commission tasked the European Food Safety Authority (EFSA) with updating the guidance on how to prepare and submit applications to market novel foods in the EU. This update consists of two key documents:
The first is scientific guidance, detailing the necessary scientific data that applicants must submit. The second, administrative guidance, outlines the step-by-step process for submitting applications, managed by EFSA’s front-desk support team.
These changes are crucial for businesses, including those in the emerging sector of cell culture-derived foods. Since the initial rollout of novel food regulations in 2018, substantial data has been gathered, enabling EFSA to refine its approach and specify clearer definitions and data requirements. This evolution aims to enhance the quality of applications and improve efficiency in the review process.
EFSA maintains a nine-month timeframe for completing risk assessments. By providing more comprehensive guidance at the outset, the hope is to reduce the need for further back-and-forth between applicants and EFSA, thereby expediting approvals.
Once EFSA grants approval, companies will need to consult with the European Commission and relevant national or local authorities to ensure compliance with marketing and labelling requirements.