Safety evaluation of the food enzyme cellulose 1,4-β-cellobiosidase (non-reducing end) from the non-genetically modified strain C1-5-2.

The food enzyme cellulose 1,4-β-cellobiosidase (non-reducing end) (EC 3.2.1.91) is produced with the non-genetically modified strain C1-5-2 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in ten food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two processes, dietary exposure was calculated only for the remaining eight food manufacturing processes. It was estimated to be up to 0.568 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 1962 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 3454. A search for the homology of the amino acid sequence of the cellulose 1,4-β-cellobiosidase (non-reducing end) 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 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.