About
Astaxanthin is a xanthophyll carotenoid (molecular mass 596.85 Da) found naturally in microalgae (especially Haematococcus pluvialis), bacteria, yeast, and marine animals such as salmon, trout, shrimp, and crabs. It is used as a red-orange food colourant, a feed additive to impart characteristic pigmentation in farmed salmonids and crustaceans, and as a nutraceutical/food supplement prized for its potent antioxidant activity.
Safety summary
EFSA confirmed that astaxanthin is neither mutagenic nor carcinogenic, and the current ADI is 0.2 mg/kg body weight per day (established by the EFSA FEEDAP Panel in 2019, replacing the earlier 0.034 mg/kg bw/day). Combined dietary and supplement exposure at authorised levels (up to 8 mg/day from food supplements) is safe for adults, but adolescents aged 14–18 approach the ADI, and children under 14 and infants can substantially exceed it. Synthetic astaxanthin is not authorised for direct human food use in the EU and does not hold GRAS status in the US.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Restricted | Authorised as a Novel Food (oleoresin from H. pluvialis) for use in food supplements only at up to 40–80 mg oleoresin/day (≤8 mg astaxanthin/day) under Commission Implementing Regulation (EU) 2017/2470. Synthetic astaxanthin is prohibited in foods for human consumption under EC Regulation No. 1925/2006. ADI is 0.2 mg ATX/kg bw/day. Use in other food categories (dairy, fruit juice) under assessment as of 2025.source |
| Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom) | Restricted | Post-Brexit, the FSA/FSS retained the EU novel food authorisation for ATX-rich oleoresin in food supplements. The ADI under active consideration remains 0.034 mg/kg bw/day (pre-2019 EFSA figure) pending GB-specific scientific review; use is currently limited to food supplements and excludes infants, toddlers, children, and adolescents under 14 years.source |
| FDA (Food and Drug Administration) (United States) | Restricted | Natural astaxanthin (from H. pluvialis and Phaffia yeast) is approved as a colour additive specifically for use in salmonid fish feed under 21 CFR 73.35 and 73.355. Astaxanthin-rich carotenoid extracts from Paracoccus carotinifaciens received a GRAS Notice (GRN 000700) but FDA raised concerns about colour additive classification for human food use; there is no GRAS provision for colour additives. Synthetic astaxanthin does not hold GRAS status.source |
Who should approach with care
Research citations
- 1EFSA. Safety of the extension of use of oleoresin from Haematococcus pluvialis containing astaxanthin as a novel food pursuant to Regulation (EU) 2015/2283, 2025. efsa.europa.eu
- 2PubMed. Production and therapeutic use of astaxanthin in the nanotechnology era, 2023. pmc.ncbi.nlm.nih.gov
- 3FSSAI. List of product(s)/ingredient(s) applications Approved under FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017, 2022. fssai.gov.in
- 4PubMed. Safety of astaxanthin for its use as a novel food in food supplements, 2020. pubmed.ncbi.nlm.nih.gov
- 5EFSA. Safety of astaxanthin for its use as a novel food in food supplements, 2020. efsa.europa.eu
- 6EFSA. Safety and efficacy of astaxanthin-dimethyldisuccinate (Carophyll® Stay-Pink 10%-CWS) for salmonids, crustaceans and other fish, 2019. efsa.europa.eu