Safety evaluation of an extension of use of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Aspergillus niger strain XEA

TL;DR

This paper evaluates the safety of expanding the use of a food enzyme produced by a genetically modified fungus in six food manufacturing processes.

Contribution

The study provides a safety evaluation for extending the use of endo-1,4-β-xylanase in additional food processes.

Findings

The dietary exposure was calculated to be up to 0.316 mg TOS/kg body weight per day.

The margin of exposure was determined to be at least 5861, indicating no safety concerns.

EFSA concluded the enzyme is safe under the revised intended conditions of use.

Abstract

The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Aspergillus niger strain XEA by DSM Food Specialties B.V. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include four additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of six food manufacturing processes. The dietary exposure was calculated to be up to 0.316 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1852 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 5861. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.