Safety evaluation of an extension of use of the food enzyme laccase from the non‐genetically modified Trametes hirsuta strain AE‐OR

TL;DR

This study evaluates the safety of extending the use of a food enzyme called laccase in additional food manufacturing processes.

Contribution

The study provides an updated safety assessment for laccase use in nine food processes, including revised use levels.

Findings

Dietary exposure to the enzyme was calculated as up to 0.030 mg TOS/kg body weight per day.

The margin of exposure was at least 28,733, indicating no safety concerns under the revised conditions.

Abstract

The food enzyme laccase (benzenediol:oxygen oxidoreductase, i.e. EC 1.10.3.2) is produced with the non‐genetically modified Trametes hirsuta strain AE‐OR by Amano Enzyme Inc. 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 six food manufacturing processes. Subsequently, the applicant has requested to extend its use to include three additional processes and to revise the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of nine food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was calculated to be up to 0.030 mg TOS/kg body weight (bw) per day in European populations. Using the no observed adverse effect level previously reported (862 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 28,733. Based on the data provided for the previous evaluation and the revised margin of exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.