A recent safety assessment published on EFSA Journal has concluded that a food enzyme produced from the non-genetically modified fungus Aspergillus oryzae strain HBI-POP01 does not raise safety concerns under its intended conditions of use. The enzyme preparation, containing metalloendopeptidase and leucyl aminopeptidase activities, is designed for use in four food manufacturing processes.
Researchers found no viable production organism cells in the final enzyme product. Dietary exposure across European populations was estimated at up to 1.821 mg total organic solids (TOS) per kilogram of body weight per day. Toxicological studies, including genotoxicity and a 90-day oral toxicity study in rats, showed no adverse effects, establishing a significant margin of exposure.
Read the abstract of the paper here:
Abstract
The food enzyme containing metalloendopeptidase (EC 3.4.24) and leucyl aminopeptidase (EC 3.4.11.1) activities is produced with the non-genetically modified Aspergillus oryzae strain HBI-POP01 by HBI Enzymes Inc. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to be used in four food manufacturing processes. Since residual amounts of total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining three food manufacturing processes. It was estimated to be up to 1.821 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 500 mg TOS/kg bw per day which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 275. A search for the homology of the two amino acid sequences to known allergens was made and a match with one respiratory allergen was 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.
