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 scientist 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.
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...
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 aquire a safety assessment dossier on microorganisms used as production strains, probiotics, live biotherapeutics, novel foods, feed additive production and fermentation among...
Adalberto is our Product Managers Genomics & Regulatory Affairs. Adalberto graduated in Medical Biotechnology at the University of Trieste. He specialised in molecular biology and next-generation sequencing during his PhD at the Radboud University in Nijmegen, where he studied the transcriptonal mechanisms of cancer cells. Adalberto is BaseClear’s technical expert on short and long read NGS platforms, including the latest nanopore-based technologies, and how to best use them for specific applications.
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