,The EFSA CEP Panel has published its scientific opinion on a cysteine endopeptidase complex obtained from the latex of unripe Carica papaya L., produced by Troplandis BVBA. The enzyme preparation comprises 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) and is intended for use across multiple food manufacturing processes.
Based on the data assessed, EFSA concluded that the food enzyme does not raise safety concerns under the proposed conditions of use. However, the Panel highlighted quality assurance deficiencies, noting the presence of multiple mycotoxins in all enzyme batches tested.
Dietary Exposure Assessment
Dietary exposure to the enzymes Total Organic Solids (TOS) was evaluated for seven food manufacturing processes. The estimated exposure reached up to 6.104 mg TOS/kg body weight per day at the high end.
EFSA noted that this level of exposure is of the same order of magnitude as the intake of the corresponding enzyme fraction naturally present in unripe C. papaya latex, supporting the safety conclusion given the edible plant origin of the source material.
Toxicology and Safety Considerations
In line with current EFSA guidance, toxicological studies were not required, considering:
The edible plant origin of the enzyme source
The nature of the manufacturing process
The estimated dietary exposure, which is comparable to natural dietary intake
Allergenicity Assessment
The enzyme complex contains proteins with known allergenic potential:
Papain and chymopapain are established food allergens.
Amino acid sequence homology analyses identified matches with six known food allergens and eight respiratory allergens across the four enzyme proteins.
Consequently, the Panel concluded that the risk of allergic reactions upon dietary exposure cannot be excluded, particularly for sensitised individuals.
Quality and Manufacturing Concerns
Despite the favorable safety conclusion, EFSA raised a significant concern regarding manufacturing quality. The detection of multiple mycotoxins in all tested batches indicates deficiencies in the quality assurance system. While these findings did not alter the overall safety conclusion under the intended use, the Panel emphasized the need for improvements in raw material control and manufacturing oversight.
Regulatory Implications
The opinion supports the safety of the papaya-derived cysteine endopeptidase complex for use in food processing within the EU, subject to the intended conditions of use. However, EFSAs observations on mycotoxin contamination underscore the importance of robust quality management systems to ensure ongoing compliance and consumer protection.