Safety evaluation of the food enzyme arabinan endo‐1,5‐α‐L‐arabinanase from the non‐genetically modified Aspergillus aculeatinus strain CBS 148915

The food enzyme arabinan endo‐1,5‐α‐L‐arabinanase (5‐α‐L‐arabinan 5‐α‐L‐arabinanohydrolase; EC 3.2.1.99) is produced with the non‐genetically modified Aspergillus aculeatinus strain CBS 148915 by Solyve. The food enzyme was considered free from viable cells of the production organism. The applicant proposed the use of the food enzyme in 12 food manufacturing processes. Since the use of the enzyme in one proposed use is not allowed in the European Union and residual amounts of food enzyme–total organic solids (TOS) are removed in four processes, dietary exposure was calculated for the remaining seven food manufacturing processes. It was estimated to be up to 1.499 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 301 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 201. A search for the homology of the amino acid sequence of the arabinan endo‐1,5‐α‐L‐arabinanase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure 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 in 11 food manufacturing processes (excluding the use in the production of juices).