Regulatory affairs

BaseClear can help you acquire a safety assessment dossier on microorganisms used as production strains, probiotics, live biotherapeutics, novel foods, feed additive production and fermentation among other food & feed applications. Our solution is to generate appropriate whole genome sequencing & bioinformatics data compliant with regulatory requirements and help build the dossier with rigorous scientific justification to support the safety of strains introduced intentionally into the food chain. 

The European (EU/EFSA) and USA (FDA) regulatory bodies have now strict guidelines for submitting products. Obtaining regulatory approval for the use of microorganisms as a food or feed additive or production strain can thus be challenging. Applying the strict guidelines and rules to e.g. the genomic data generated when analysing these microbial strains often presents both technical and interpretation challenges. BaseClear offers full solutions to meet the regulatory requirements. We help you overcome challenges and can facilitate the complete project, including the genomic characterisation of microbial strains and writing dossier reports ready for EU/EFSA and/or FDA submission.

Case study: Proving a negative with genomics

Getting a new animal feed product approved for sale in the European Union can be a minefield. Trouw Nutrition approached BaseClear: to support in specific guidance on proving the non-GMO status of a strain used to make a vitamin for the organic feed market.

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