Safety evaluation of the food enzyme abstract aspergillopepsin I from the non‐genetically modified Aspergillus niger strain CCTCC M 2023234

TL;DR

This study evaluates the safety of aspergillopepsin I, a food enzyme produced by a non-genetically modified fungus, for use in food manufacturing.

Contribution

The study provides a comprehensive safety assessment of aspergillopepsin I, including toxicity and allergenicity evaluations.

Findings

Genotoxicity tests showed no safety concerns for the food enzyme.

The no observed adverse effect level was 2000 mg TOS/kg bw per day, with a margin of exposure of at least 300.

A low likelihood of allergic reactions was identified despite matches with some allergens.

Abstract

The food enzyme aspergillopepsin I (EC 3.4.23.18) is produced with the non‐genetically modified Aspergillus niger strain CCTCC M 2023234 by Suntaq International Limited. The food enzyme was free from viable cells of the production organism. The food enzyme is intended to be used in eight food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining seven food manufacturing processes. It was estimated to be up to 6.664 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 300. A search for the homology of the amino acid sequence of the aspergillopepsin I to known allergens was made and matches with two respiratory allergens and one injected allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.