Microbes and ingredients safety assessment

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.

Our PhD-level experts have a unique combination of strong background in regulatory affairs, microbiology and molecular biology and understand what it takes to submit applications to EFSA or FDA agencies.

Proving a negative with genomics: a case study in an animal feed product

Getting a new animal feed product approved for sale in the European Union can be a minefield. In particular, organic feed products require proof they have not been produced by a genetically modified organism (GMO) for approval. It is not so difficult to show that a production strain contains specific DNA fragments in its genome, but troublesome to prove their absence. This is why Trouw Nutrition approached BaseClear: they needed 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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Meet Hua Zhu!

With her unwavering passion for microorganism and over 15 years dedicated research experience, Hua Zhu brings her expertise to BaseClear as Regulatory Affairs Product Manager. “I am consistently fascinated by the invisible microbial world,” Says Hua. “My diverse experiences with various microorganisms, including bacteria, yeast, fungi and phage, enable me to perceive our customers’ needs and provide assistance across a broad spectrum of microbial topics.”

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