Summary Experts Meeting Human Microbiome & Applications in Therapies
On March 19th, 2021 BaseClear has organised an online experts meeting on Human Microbiome & Applications in Therapies. With 100+ attendees, this public event was …Read more
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.
Download the whitepaper by completing the form below.
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