# Safety evaluation of the food enzyme papain from the latex of Carica papaya L

## TL;DR

This study evaluates the safety of papain, an enzyme from unripe papaya latex, used in food manufacturing and concludes it is safe under intended conditions.

## Contribution

The study provides a safety evaluation of papain as a food enzyme, including allergenicity and dietary exposure assessments.

## Key findings

- Dietary exposure to papain is up to 1.112 mg TOS/kg body weight per day.
- Papain and chymopapain are known food allergens, and sequence homology suggests potential allergenicity.
- The enzyme is considered safe for use in food manufacturing under the evaluated conditions.

## Abstract

The food enzyme papain (EC 3.4.22.2) is extracted from the latex of unripe Carica papaya L. by Nagase (Europe) GmbH. It is intended to be used in six food manufacturing processes. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.112 mg TOS/kg body weight per day. This exposure is up to one order of magnitude lower than the intake of the corresponding fraction from unripe C. papaya L. latex. The toxicological studies provided were not required according to the current guidance, nevertheless, were evaluated as supporting evidence. For the allergenicity assessment, the Panel considered the papain as well as three other cysteine endopeptidases known to be present in the food enzyme. Papain and chymopapain are known food allergens. In addition, homology searches of the amino acid sequences of the four proteins to known allergens identified matches with 6 food and 8 respiratory allergens. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. Based on the data provided, the origin of the food enzyme being an edible plant source and the estimated dietary exposure, the Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.