Safety evaluation of an extension of use of the food enzyme endo‐polygalacturonase from the genetically modified Aspergillus oryzae strain AR‐183

TL;DR

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

Contribution

The study provides an updated safety assessment for the extended use of endo-polygalacturonase in seven food processes.

Findings

Dietary exposure to the enzyme was estimated at up to 0.087 mg TOS/kg body weight per day.

The margin of exposure was calculated to be at least 11,494, indicating no safety concerns.

The enzyme is considered safe under the revised intended conditions of use.

Abstract

The food enzyme endo‐polygalacturonase ((1 → 4)‐α‐d‐galacturonan glycanohydrolase EC 3.2.1.15) is produced with the genetically modified Aspergillus oryzae strain AR‐183 by AB ENZYMES GmbH. 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 five food manufacturing processes. Subsequently, the applicant requested to extend its use to two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme for use in a total of seven food manufacturing processes. As the food enzyme‐total organic solids (TOS) is removed from the final foods in three food manufacturing processes, the dietary exposure to the food enzyme‐TOS was estimated only for the remaining four processes. Dietary exposure was up to 0.087 mg TOS/kg body weight (bw) per day in European populations. When combined with the NOAEL reported in the previous opinion (1000 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 11,494. Based on the data provided for the previous evaluation and the revised margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.