Safety evaluation of the food enzyme containing β‐fructofuranosidase and β‐glucosidase activities from the non‐genetically modified Aspergillus tubingensis strain IN 319

TL;DR

This paper evaluates the safety of a food enzyme from Aspergillus tubingensis, concluding it is safe for use in food manufacturing.

Contribution

A safety assessment of a novel food enzyme from a non-genetically modified fungal strain is presented.

Findings

The enzyme is free from viable cells and safe for six food manufacturing processes.

Dietary exposure was estimated up to 1.832 mg TOS/kg body weight per day.

Genotoxicity tests showed no safety concerns, and a margin of exposure of at least 582 was found.

Abstract

The food enzyme containing β‐fructofuranosidase (β‐d‐fructofuranoside fructohydrolase; EC 3.2.1.26) and β‐glucosidase (β‐d‐glucoside glucohydrolase; EC 3.2.1.21) activities is produced with the non‐genetically modified Aspergillus tubingensis strain IN 319 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in six food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in one process, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 1.832 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The Panel identified a no observed adverse effect level of 1067 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 582. A search for the homology of the amino acid sequence of the β‐fructofuranosidase and β‐glucosidase to known allergens was made and matches with one food and one respiratory allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. 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.