Safety evaluation of a food enzyme containing phospholipase activity produced by a strain of Fusariumcommune

Phospholipases are commonly used food enzymes, e.g. to improve bread-making properties. For organic food certifications, enzymes need to be produced by non-genetically modified organisms, but no such 'classical' phospholipases are currently available. To this aim, a phospholipase product was developed with a Fusarium commune strain, a microorganism having no reported uses in the food industry. The safety of microbially-derived food enzymes depends largely on the safety of the production strain. Strain F. commune LFC was obtained by classical strain improvement. Whole-Genome Sequencing and literature search allowed to identify potential gene clusters for the mycotoxins beauvericin (BEA), moniliformin (MON), and fusaric acid (FA). Analysis of these mycotoxins revealed that no toxicologically relevant levels were produced during controlled submerged fermentation. The enzyme concentrate was assessed in a range of toxicity studies. The Ames test (OECD 471) was concluded to be equivocal, but the ToxTracker® AO assay suggested an indirect mode of action, induced by dose-dependent oxidative stress. The in vitro micronucleus test (OECD 487) and the in vivo follow-up Comet assay (OECD 489) confirmed that the food enzyme was not genotoxic. The repeated-dose oral toxicity study (OECD 408) showed no adverse effects in any of the treatment groups and allowed to derive a NOAEL of 1124 mg TOS/kg bw/day. The Margin of Exposure with estimated dietary intakes in human food applications was determined to be > 2500. It is therefore concluded that the use of the phospholipase enzyme LFC as processing aid in baking and other cereal-based applications is safe.