Retinal crystal deposits
At high cumulative doses, canthaxanthin deposits as crystalline particles in the inner layers of the retina, particularly around the macula. This was first documented in people taking large doses of canthaxanthin as a tanning supplement. Crystals are visible as a 'donut' ring of gold-yellow flecks on eye examination. Most people with deposits have no symptoms, but some develop reduced visual acuity or visual field loss. The condition is generally reversible after stopping intake, though crystals can persist for years.
Retinal crystal deposits were found in 50% of people who had taken a cumulative total dose of more than 37g of canthaxanthin, and in 100% of those who had taken more than 60g. All cases involved tanning-pill use, not food additive exposure.
2013ObservationalBeaulieu et al., Case Reports in Ophthalmological Medicine (review of published case series)
EFSA set the acceptable daily intake (ADI) at 0.03 mg per kilogram of body weight per day, based directly on the formation of crystalline deposits in the retina observed in both monkeys and humans. The ADI was derived from a no-observed-adverse-effect level of 0.25 mg/kg bw/day for changes in night-vision function (scotopic b-wave).
2010Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources, Scientific Opinion on the re-evaluation of canthaxanthin (E 161 g) as a food additive, EFSA Journal
The EU Scientific Committee on Food reduced the ADI from 0.05 to 0.03 mg/kg bw/day after concluding that high-dose intake induced reversible retinal crystal deposits and electroretinogram changes in humans.
1997RegulatoryEU Scientific Committee on Food, Opinion on Canthaxanthin
Aplastic anaemia: one fatal case report
A single published case reported fatal aplastic anaemia in a previously healthy young woman who took high-dose canthaxanthin tanning tablets. The authors noted that human safety data for oral canthaxanthin were limited and that the cosmetic use did not justify the risk. No further fatal cases have been attributed to food additive doses in the published literature. The frequency of this adverse effect is unknown.
Aplastic anaemia with a fatal outcome occurred in a previously healthy young woman after ingesting canthaxanthin provided by a commercial tanning salon. The authors concluded that the risk, however rare, could not be justified for cosmetic purposes.
1990ObservationalBluhm R et al., Aplastic Anemia Associated with Canthaxanthin Ingested for Tanning Purposes, JAMA
Residues in farmed fish and poultry
Canthaxanthin remains authorised as a feed additive for farmed salmon, trout, and poultry. EFSA reviewed this and concluded that residues reaching consumers through farmed fish and eggs are unlikely to push combined exposure above the ADI at current permitted feed levels. Residue limits in salmon muscle are set at 25 mg per kilogram in the EU.
EFSA's 2010 review concluded that combined exposure from food and feed additive use was unlikely to exceed the ADI of 0.03 mg/kg bw/day for either adults or children, on the basis of estimated residues in farmed fish and eggs.
2010Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources, Scientific Opinion on the re-evaluation of canthaxanthin (E 161 g) as a food additive, EFSA Journal