Safety evaluation of the food enzyme mannan endo-1,4-β-mannosidase from the non-genetically modified Aspergillus niger strain ACH 12-525

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 Aspergillus niger strain ACH 12-525 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to be used in three food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.579 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 1331 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 2299. A search for the homology of the amino acid sequence of the mannan endo-1,4-β-mannosidase to known allergens was made and no match 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.