About
Amaranth (E123) is a synthetic red azo dye used as a food colourant to impart a deep red to purple hue in foods and beverages such as aperitif drinks and fish roe. It is among the oldest synthetic food dyes and is characterised by its water solubility and stability across a range of processing conditions.
Safety summary
EFSA's 2010 re-evaluation concluded that Amaranth is neither genotoxic nor carcinogenic at permitted levels, establishing an ADI of 0.5 mg/kg bw/day; however, adults consuming very large quantities of aperitif drinks at maximum permitted levels may exceed this ADI by up to six-fold. Animal studies at higher doses (1.5–15 mg/kg bw/day) have indicated possible reproductive toxicity, including reduced spermatozoid resistance and depression of the oestral cycle. The dye has been delisted in the United States (since 1976) and is prohibited in Japan, while remaining restricted to narrow food categories in the EU.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| MHLW (Ministry of Health, Labour and Welfare) (Japan) | Banned | Amaranth is not listed among Japan's approved food colour additives and is therefore prohibited for use in food and beverages sold in Japan. |
| FDA (Food and Drug Administration) (United States) | Banned | Provisional listing and certification of FD&C Red No. 2 (Amaranth) was terminated via Federal Register announcements of February 10 and 13, 1976. The colour is delisted and not permitted for domestic food use; export-only use is permitted under strict conditions per Section 801(e) of the Federal Food, Drug, and Cosmetic Act.source |
| EFSA (European Food Safety Authority) (European Union) | Restricted | Permitted only in aperitif drinks and fish roe under Regulation (EC) No 1333/2008. EFSA's 2010 re-evaluation lowered the ADI to 0.5 mg/kg bw/day. Adults consuming very high quantities of Americano cocktails or aperitif wines at maximum permitted levels may exceed the ADI by up to six times; children's exposure was estimated at approximately 30 times below the ADI.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Listed as a permitted synthetic food colour (INS 123) under FSS (Food Products Standards and Food Additives) Regulations 2011, Appendix A. General maximum limit for synthetic colours in food is 100 ppm (100 mg/kg) unless a lower product-specific limit applies.source |
Who should approach with care
Research citations
- 1other. Opinion on Toxicological Data on Colouring Agents for Medicinal Products: Amaranth (E123) – Scientific Committee on Medicinal Products and Medical Devices. health.ec.europa.eu
- 2PubMed. Food Safety and Health Concerns of Synthetic Food Colors: An Update, 2024. pmc.ncbi.nlm.nih.gov
- 3EFSA. Scientific Opinion on the re-evaluation of Amaranth (E 123) as a food additive, 2010. efsa.europa.eu
- 4PubMed. Cytogenetic evaluation and DNA interaction studies of the food colorants amaranth, erythrosine and tartrazine, 2010. pubmed.ncbi.nlm.nih.gov
- 5FDA. CPG Sec 587.200 – Uncertified or Delisted Colors in Foods for Export (e.g., FD&C Red No. 2), 1976. fda.gov
