Food enzyme safety: an extensive lineage of safe Aspergillus niger production strains.

Aspergillus niger has been used for decades in the production of food enzymes and other fermented food ingredients. Ensuring the safety of microbially produced enzymes requires comprehensive safety assessments, supported by manufacturing best practices that consistently prevent the presence of fungal toxins at toxicologically relevant levels. This paper corroborates the safety of dsm-firmenich's Aspergillus niger production strain lineage, to support safety evaluations of enzymes produced by strains within this lineage. Toxicological data, including a full battery of genotoxicity tests and a 90-day repeated dose oral toxicity study conducted with ten different food enzymes derived from multiple strains of our lineage, are integrated in this manuscript with the outcomes of historical studies. All enzymes were non-genotoxic, and the systemic safety of all ten enzymes was demonstrated for their intended use in human food applications. The data confirm that the genetic modifications did not increase the toxigenic potential or the systemic toxicity within the lineage. These findings support the use of the dsm-firmenich's Aspergillus niger lineage strains as safe hosts for the production of food enzymes. Furthermore, the outcome provides a scientific foundation for safe strain lineage and read-across approaches that reduce reliance on animal testing.