About
Indigo Carmine (E132) is a synthetic indigoid blue food dye derived from indigo, used to impart a deep blue or blue-green colour to foods, beverages, confectionery, and pharmaceutical products. It is widely employed across the food, textile, pharmaceutical, and medical industries.
Safety summary
EFSA and JECFA have established an ADI of 5 mg/kg body weight per day; EFSA confirmed in its 2023 follow-up that there is no safety concern at reported use levels, noting the dye is poorly absorbed and does not raise concern for genotoxicity or developmental toxicity. Some in vitro studies suggest potential cytotoxicity at high concentrations, but these are difficult to extrapolate to normal human dietary exposure. Trace unsulfonated aromatic amines may be present as impurities depending on purity grade, and the dye has been reported to cause hypertension, hypotension, skin irritation, or gastrointestinal disorders in case reports, particularly at high non-dietary doses.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Authorised under Regulation (EC) No 1333/2008 on food additives; maximum permitted level is 500 mg/kg food. ADI of 5 mg/kg bw/day confirmed in 2023 follow-up opinion. EU specifications require minimum 85% colouring matter. EU label must declare E132 or 'Indigotine, indigo carmine'.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Listed as a permitted synthetic food colour under FSS (Food Products Standards and Food Additives) Regulations, 2011. Minimum total dye content of 85% required. Final concentration in foods and beverages should not exceed 100 ppm (mg/kg) as per FSSAI general limits for synthetic colours.source |
| FDA (Food and Drug Administration) (United States) | Approved | Approved as FD&C Blue No. 2 (Indigotine); listed in 21 CFR Part 74 as a certified color additive subject to batch certification by FDA. Approved for general use in food, drugs, and cosmetics. No US-specific ADI set; batches must be certified before use in marketed products.source |
Who should approach with care
Research citations
- 1FDA. Color Additives in Foods – Summary of Color Additives for Use in the United States. fda.gov
- 2PubMed. Food Safety and Health Concerns of Synthetic Food Colors: An Update, 2024. pmc.ncbi.nlm.nih.gov
- 3PubMed. Indigo Carmine: Between Necessity and Concern, 2023. pmc.ncbi.nlm.nih.gov
- 4FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations – Chapter 3: Substances Added to Food, 2023. fssai.gov.in
- 5EFSA. Follow-up of the re-evaluation of indigo carmine (E 132) as a food additive, 2023. efsa.europa.eu
- 6PubMed. Follow-up of the re-evaluation of indigo carmine (E 132) as a food additive, 2023. pubmed.ncbi.nlm.nih.gov
