# Safety evaluation of the food enzyme ribonuclease P from the non‐genetically modified Penicillium citrinum strain AE‐RPE

## TL;DR

This study evaluates the safety of a food enzyme produced by a non-genetically modified fungus and concludes it is safe for use in yeast processing.

## Contribution

The study provides a comprehensive safety assessment of a novel food enzyme from Penicillium citrinum.

## Key findings

- Genotoxicity tests showed no safety concerns for the food enzyme.
- The no observed adverse effect level was 984 mg TOS/kg bw per day.
- The likelihood of allergic reactions is considered low.

## Abstract

The food enzyme ribonuclease P (EC 3.1.26.5) is produced with the non‐genetically modified Penicillium citrinum strain AE‐RPE by Amano Enzyme Inc. It was considered free from viable cells of the production organism. It is intended to be used in the processing of yeast and yeast products. Dietary exposure was estimated to be up to 0.0014 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 984 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 702,857. A search for the homology of the amino acid sequence of the ribonuclease P to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but that the likelihood is low. 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.