About
Bromelain is a group of sulfhydryl-containing proteolytic (protein-digesting) enzymes extracted from the stem and fruit of the pineapple plant (Ananas comosus). It is used in food processing as a meat tenderizer and as an enzyme preparation in bakery products, and is widely marketed as a dietary supplement with anti-inflammatory and digestive properties.
Safety summary
Bromelain is generally recognized as safe (GRAS) by the FDA and JECFA assigns an ADI of 'not limited', with no evidence of carcinogenicity or hepatotoxicity in authoritative reviews. The most commonly reported side effects are gastrointestinal (stomach upset, nausea, diarrhea), and allergic reactions can occur particularly in individuals sensitive to pineapple, latex, or related pollens. Its anticoagulant properties present a potential bleeding risk in people taking antiplatelet or anticoagulant drugs, and safety during pregnancy and lactation has not been established.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Used as a food enzyme and processing aid in the EU; food enzymes are regulated under Regulation (EC) No 1332/2008. No E-number is assigned as bromelain is classified as a food enzyme (not a food additive in the EU framework). EMA confirmed JECFA's ADI of 'not limited'. Naturally present in pineapple; also used as a meat tenderizer. Enzyme activity is largely destroyed at 80°C within 8 minutes.source |
| FDA (Food and Drug Administration) (United States) | Approved | In 2022, FDA approved a prescription drug product containing bromelain (NexoBrid) for topical debridement of severe burns in adults — a pharmaceutical use separate from its food additive status.source |
Who should approach with care
Research citations
- 1WHO. JECFA Food Additives and Contaminants Database — Bromelain (INS 1101iii, CAS 9001-00-7). apps.who.int
- 2other. Bromelain: Usefulness and Safety — National Center for Complementary and Integrative Health (NCCIH/NIH). nccih.nih.gov
- 3FDA. Food Additive Status List — Bromelain (Bromelin), 2026. fda.gov
- 4other. Bromelain — LiverTox: Clinical and Research Information on Drug-Induced Liver Injury (NIH/NCBI), 2024. ncbi.nlm.nih.gov
- 5PubMed. Current Uses of Bromelain in Children: A Narrative Review, 2024. pmc.ncbi.nlm.nih.gov
- 6PubMed. Efficacy and safety of bromelain: A systematic review and meta-analysis, 2023. pubmed.ncbi.nlm.nih.gov
