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

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 Enzyme Development Corporation. It is intended to be used in 13 food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining 12 food manufacturing processes. It was estimated to be up to 20.963 mg TOS/kg body weight per day. This exposure is up to one order of magnitude higher than the intake of the corresponding fraction from unripe C. papaya L. latex. Considering the overestimation of the exposure to the food enzyme-TOS, in a realistic exposure scenario, both values can be expected to be within the same order of magnitude. Toxicological studies were not required according to the current guidance. Among the four proteins in the cysteine endopeptidase complex, papain and chymopapain are known food allergens. Homology searches with 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.