Papain | whatsinit

About

What it is and where it shows up.

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

The regulatory and scientific consensus.

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

What food-safety regulators have decided.

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

Whose guidance would steer them away.

Other — Individuals with papaya allergy or latex-fruit syndrome should avoid papain, as papain and chymopapain are recognised Carica papaya food allergens with documented IgE-mediated reactions (EFSA, 2026).

Pregnancy — Concentrated papain from unripe papaya latex has historically been associated with concerns about uterine contractility; while food-additive quantities are low, caution is advised during pregnancy pending robust clinical data.

Children — EFSA dietary exposure modelling indicated relatively higher per-body-weight exposure in children; children with pre-existing fruit or latex allergy are at elevated risk of allergic reaction.

Ibd — As a broad-spectrum proteolytic enzyme, papain may alter intestinal mucosal integrity or exacerbate inflammation in individuals with inflammatory bowel disease; medical consultation is advisable.

Research citations

The sources behind this verdict.

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

Independently researched5 citations