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 Troplandis BVBA. Dietary exposure was evaluated for seven food manufacturing processes and was estimated to be up to 6.104 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. 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 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. However, the Panel notes the presence of multiple mycotoxins in all food enzyme batches indicating deficiencies in the quality assurance system.