Safety assessment of cell culture -derived novel food

The safety of novel foods must be assessed before they are placed on the market within the European Union (1). The application submitted to the European Commission should include description and detailed composition of the novel food, the production process, and scientific evidence demonstrating that the novel food does not pose safety risk to human health.

Of the ten novel food categories, Biosafe provides services in particular to category (ii) food consisting of, isolated from or produced from microorganism, fungi or algae; and category (vi) food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, microorganisms, fungi or algae.

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

(1) Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001

Analytical and other services provided by Biosafe for novel food producers

Microbiology

  • Studies on 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 genetically modified production organism and contaminating recombinant DNA
  • Assessment of antimicrobial activity
  • In vitro efficacy studies and 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

Metabolomics

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

Consultations

  • 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 authorities

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