Safety evaluation of the food enzyme mannan endo-1,4-β-mannosidase from the non-genetically modified Aspergillus niger strain AE-HCM

Abstract

The food enzyme mannan endo-1,4-β-mannosidase (1,4-β-d-mannan mannanohydrolase; EC 3.2.1.78) is produced with the non-genetically modified microorganism Aspergillus niger strain AE-HCM by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in three food manufacturing processes. Dietary exposure was calculated to be up to 0.568 mg total organic solids (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 728 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1282. A search for the homology of the amino acid sequence of the mannan endo-1,4-β-mannosidase to known allergens was made and a match with a 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.