Safety assessment of food enzymes

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.

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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BaseClear services for food enzyme safety assessment

  • Clear reports for dossier filing to regulatory agencies
  • Helping in getting data in the form required by the food enzyme safety authorities
  • Data analyses, interpretation of results (e.g. from WGS) and conclusions
  • Literature reviews, consultations and statements
  • Metagenomics analysis
  • Identification of microbes (bacteria, yeasts, filamentous fungi)
  • Whole genome sequencing (WGS), including genome assembly and annotation
  • Analysis of the presence of toxin genes and virulence factors
  • Analysis of the presence of antibiotic resistance genes
  • Analysis of genetic modifications
  • Assessment of genetic stability
  • Analysis of the absence of the production organism and residual DNA in the final product
  • Tailored bioinformatics for your specific needs

Regulatory Affairs for Microbial Strain Safety Assessment

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