Safety evaluation of the food enzyme non-reducing end α-l-arabinofuranosidase from the non-genetically modified Aspergillus tubingensis strain ARF

Abstract

The food enzyme non-reducing end α-l-arabinofuranosidase (α-l-arabinofuranoside non-reducing end-α-l-arabinofuranosidase; EC 3.2.1.55) is produced with the non-genetically modified Aspergillus tubingensis strain ARF by DSM Food Specialties B.V. The food enzyme was free from viable cells of the production organism. The food enzyme is intended to be used in five food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.455 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 234 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 514. A search for the homology of the amino acid sequences of the non-reducing end α-l-arabinofuranosidase 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.