Safety evaluation of the food enzyme papain, a cysteine endopeptidase complex from the latex of Carica papaya L

TL;DR

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

Contribution

The study provides a safety evaluation of a food enzyme complex from Carica papaya L. for use in nine food processes.

Findings

Dietary exposure to the enzyme was estimated at up to 0.409 mg TOS/kg body weight per day.

The enzyme complex contains known allergens, raising potential allergic reaction risks.

The enzyme is considered safe for use in food manufacturing under the evaluated conditions.

Abstract

The food enzyme is a cysteine endopeptidase complex, containing papain (EC 3.4.22.2), chymopapain (EC 3.4.22.6), caricain (EC 3.4.22.30) and glycyl endopeptidase (EC 3.4.22.25), obtained from the latex of unripe Carica papaya L. by Enzybel International SA. It is intended to be used in nine food manufacturing processes. Since residual amounts of the food enzyme‐total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining eight food manufacturing processes. It was estimated to be up to 0.409 mg TOS/kg body weight per day. This exposure is in the same order of magnitude as 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, they were evaluated as supporting evidence. Among the four proteins in the cysteine endopeptidase complex, papain and chymopapain are known food allergens. Homology searches of the amino acid sequences of the four proteins in the complex to known allergens identified matches with six food and eight 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.

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