# Safety evaluation of a second extension of use of the food enzyme triacylglycerol lipase from the non‐genetically modified Rhizopus arrhizus strain AE‐TL(B)

## TL;DR

This paper evaluates the safety of extending the use of a food enzyme in infant oil production and confirms it remains safe.

## Contribution

The study provides an updated safety evaluation for a revised use of triacylglycerol lipase in infant nutrition.

## Key findings

- Dietary exposure to the enzyme was estimated at up to 0.33 mg TOS/kg body weight per day.
- The margin of exposure was calculated to be at least 5939, indicating no safety concerns.
- EFSA concluded the enzyme is safe under the revised intended conditions of use.

## Abstract

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the non‐genetically modified Rhizopus arrhizus strain AE‐TL(B) by Amano Enzymes Inc. Two safety evaluations of this food enzyme were 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 the production of 2‐palmitic acid‐enriched vegetable oil intended for infants aged 0–3 months, to withdraw one food manufacturing process and to revise one use level. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of five food manufacturing processes. Dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.33 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1960 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 5939. 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.