Safety evaluation of the food enzyme catalase from the non-genetically modified Aspergillus niger strain CTS 2093

The food enzyme catalase (hydrogen-peroxide:hydrogen-peroxide oxidoreductase; EC 1.11.1.6) is produced with the non-genetically modified Aspergillus niger strain CTS 2093 by Shin Nihon Chemical Co., Ltd. It is considered free from viable cells of the production organism. The food enzyme is intended to be used in eight food manufacturing processes: baking processes, cereal-based processes, coffee processing, egg processing, vegetable processing for juice production, processing of tea, herbal and fruit infusions, herring roe processing and milk processing for cheese production. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 3.61 mg TOS/kg body weight (bw) per day in European populations. In addition, it is used in the production of acacia gum with the highest dietary exposure at the 95th percentile of 0.018 mg TOS/kg bw per day in infants, when acacia gum is used as a food additive. 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 56 mg TOS/kg bw per day, the mid-dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of 16. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. Based on the data provided, the Panel considered the margin of exposure as insufficient to exclude safety concerns under the intended conditions of use.

Automated summary

The food enzyme catalase is produced by a non-genetically modified strain of Aspergillus niger and is used in eight food manufacturing processes. Dietary exposure to the food enzyme was estimated to be up to 3.61 mg TOS/kg bw per day in European populations. Based on the data provided, the risk of exposure cannot be completely excluded.