Safety assessment of food enzymes

Food enzyme safety for use in foodstuffs for human consumption must be assessed before it is placed on the Community market. The application submitted to the European Commission in support of the enzyme should normally contain a data package, which includes technical and toxicological data.

Biosafe provides support at all steps in the process, whether early-stage research or seeking approval for an already developed food enzyme. We have extensive experience in academic research, in developing detailed guidelines for applicants, and in assessing the food enzyme safety of the products. In addition to the analytical methods available in Biosafe laboratory, we have an extensive network of partners and collaborators in Finland and abroad. This guarantees customer-friendly and cost-effective planning and performing of the studies required.

(1) Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings

Analytical and other services provided by Biosafe for food enzyme producers

Microbiology and molecular biology

  • Analysis of both aerobic and anaerobic microbes
  • Identification of microbes (bacteria, yeasts, filamentous fungi)
  • Antimicrobial resistance and sensitivity studies
  • Assessment of genetic stability
  • Analysis of the absence of the production organism and DNA in the product
  • Assessment of antimicrobial activity
  • Other tailor-made studies

In vitro toxicity testing

  • Analysis of toxigenic potential of Bacillus species and subsequent analysis of toxins produced
  • Cytotoxicity tests: ISO 10993; Boar sperm motility and RNA synthesis inhibition tests; EROD and LDH assays
  • Genotoxicity tests: AMES; Micro Ames; in vitro micronucleus assay and Comet tests
  • Chemical composition – NMR, GC-MS, LC-MS
  • Endocrine disruption tests

Sequencing and bioinformatics

  • Whole genome sequencing (WGS)
  • Genome assembly and annotation
  • Species identification using the WGS data
  • Analysis of the presence of toxin genes, virulence factors, and antibiotic resistance genes
  • Detection and description of genetic modifications
  • Analysis of secondary metabolite biosynthesis genes
  • Metagenomics
  • Tailored bioinformatics for your specific needs


  • For unknown metabolites
  • Help focus the toxicological studies for relevant compounds


  • Interpretation of results from WGS
  • Literature reviews, consultations and statements
  • Data analyses and conclusions from customer consultations
  • Helping in getting data in the form required by the food enzyme safety authorities

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