Whitepaper: Decoding the EFSA and FDA requirements for microbial strain safety assessment

Obtaining approval to use microbes as feed or food additive or as a production strain can be challenging. The European (EU / EFSA) and US (US-FDA) regulatory agencies now have strict guidelines for submitting dossiers. Applying the regulatory guidelines and rules to generated genomic and other data often presents both technical and interpretative challenges.

This whitepaper is your guide for safety assessments on microorganism used as production strains, probiotics, live biotherapeutics, novel food, feed additives and fermentation products. This document contains an  overview of these regulatory requirements and the challenges that you can encounter in the process, and summarizes the differences between the EFSA and FDA approached to this subject.

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