About
Papain is a cysteine endopeptidase complex extracted from the latex of unripe Carica papaya L. fruit, comprising four proteolytic enzymes — 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). It is used as a food-processing enzyme for meat tenderising, brewing, baking, cheese and dairy production, and manufacture of protein hydrolysates.
Safety summary
EFSA (2026) concluded the food enzyme raises no safety concern under its intended conditions of use, and toxicological studies were waived given its edible-plant origin and dietary-exposure profile. However, papain and chymopapain are recognised food allergens with demonstrated homology to multiple food and respiratory allergens, and EFSA noted that a risk of allergic reactions upon dietary exposure cannot be excluded. Occupational inhalation exposure is well documented to cause rhinitis and asthma in industrial workers; no specific ADI has been formally established by EFSA or JECFA.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Recognised as a permitted food enzyme under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011; use governed by GMP.source |
| FDA (Food and Drug Administration) (United States) | Approved | Listed as GRAS under 21 CFR 184.1585; permitted as a food enzyme/meat-tenderising agent under Good Manufacturing Practice (GMP) with no specified numerical limit.source |
| EFSA (European Food Safety Authority) (European Union) | Under_review | EFSA FEZ Panel published favourable safety opinions in 2026 (EFSA-Q-2023-00441 and EFSA-Q-2023-00275); pending formal inclusion on the EU authorised list of food enzymes under Regulation (EC) No 1332/2008. Until the Union list is established, national rules of EU Member States continue to apply.source |
Who should approach with care
Research citations
- 1FDA. Code of Federal Regulations Title 21, Part 184.1585 – Papain. ecfr.gov
- 2EFSA. Safety evaluation of the food enzyme papain, a cysteine endopeptidase complex from the latex of Carica papaya L. (EFSA-Q-2023-00441), 2026. efsa.europa.eu
- 3PubMed. Safety evaluation of the food enzyme papain, a cysteine endopeptidase complex from the latex of Carica papaya L., 2026. pubmed.ncbi.nlm.nih.gov
- 4EFSA. Safety evaluation of the food enzyme papain, a cysteine endopeptidase complex from the latex of Carica papaya L. (EFSA-Q-2023-00275, Enzybel International SA), 2026. efsa.europa.eu
- 5FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 — Compendium (March 2022), 2022. fssai.gov.in
