Fermotein Does Not Exert Genotoxic Effects in Bacterial Reverse Mutation and in Vitro Mammalian Cell Micronucleus Tests
Marjolein Van Der Spiegel
Schuttelaar & Partners, Wageningen, Netherlands.
José J. Van Den Driessche
Schuttelaar & Partners, Wageningen, Netherlands.
Elisa Leune
The Protein Brewery, Breda, Netherlands.
Kirsten Knobel
The Protein Brewery, Breda, Netherlands.
Wim De Laat *
The Protein Brewery, Breda, Netherlands.
*Author to whom correspondence should be addressed.
Abstract
Aim: Fermotein is an innovative single-cell protein obtained from fermentation of the filamentous fungus Rhizomucor pusillus. Like other filamentous fungi, a lack of information on this species exists to assess its safety for human consumption. The capability to induce gene mutations or structural and numerical chromosomal aberrations of this fungus and derived products has never been studied before. The objective of the current study was to investigate the genotoxic effects of Fermotein using a bacterial reverse mutation test and an in vitro mammalian cell micronucleus test.
Methodology: The bacterial reverse mutation test and in vitro mammalian cell micronucleus test were performed in accordance with GLP and concurrent OECD guidelines. Dose-range finding tests were used to select appropriate doses of Fermotein Dry. The highest doses in the genotoxicity experiments were determined by the solubility of the mycoprotein.
Results: The bacterial reverse mutation test and in vitro mammalian cell micronucleus test were performed in accordance with GLP and concurrent OECD guidelines. Dose-range finding tests were used to select appropriate doses of Fermotein Dry. The highest doses in the genotoxicity experiments were determined by the solubility of the mycoprotein.
Conclusion: No safety concerns regarding genotoxicity were identified for Fermotein and no further in vivo genotoxicity testing is required. Information from the current study contributes to the body of evidence for a novel food authorisation of Fermotein in the EU and a GRAS notification in the US.
Keywords: Single-cell protein, safety, filamentous fungi, Rhizomucor pusillus, genotoxicity; bacterial reverse mutation (Ames) test, in vitro mammalian cell micronucleus test