Safety assessment of food microbes
The safety of novel foods must be assessed before they are placed on the market within the European Union or USA. The application submitted to the regulatory agencies must include description and...
Food enzymes used in human nutrition are generally produced by microorganisms. Safety must be assessed before the enzymes can be offered to the market. The application submitted to the regulatory agencies (EFSA and/or FDA) in support of the enzyme should include a detailed characterisation and safety assessment of the production organism. Applying the regulatory guidelines and rules to the genomic data generated when analysing the microbial strains often presents both technical and interpretation challenges.
BaseClear can be of service for all steps needed in the process, whether early-stage research or seeking approval for an already developed food enzyme. BaseClear has a number of PhD-level scientists ready to take up on the next challenge. In addition, we have an extensive network of partners and collaborators on the Leiden Bio Science Park – the leading biomedical hotspot of Europe. With this we can offer our client an all-inclusive package, planning and performing of the studies required.
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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The safety of novel foods must be assessed before they are placed on the market within the European Union or USA. The application submitted to the regulatory agencies must include description and...
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For nutrition or health claims, the Food Safety Authority (EFSA or FDA) requires full knowledge of the organism you are working with. BaseClear can facilitate this with a complete solution including...
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...