Scientific Opinion on the re-evaluation of Erythrosine (E 127) as a food additive

The Scientific Panel on Food Additives and Nutrient Sources added to Food has re-evaluated the safety of Erythrosine (E 127) when used as a food colouring substance. Erythrosine (E 127) is a xanthene-dye which has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1990 and the EU Scientific Committee for Food (SCF) in 1989. Both committees have established an Acceptable Daily Intake (ADI) of 0-0.1 mg/kg bw/day. Erythrosine is exclusively authorised for use in cocktail and candied cherries, and Bigarreaux cherries (94/36/EC). The Panel considered the weight-of-evidence still showed that the tumorigenic effects of Erythrosine in the thyroid gland of rats are secondary to its effects on thyroid function and not related to any genotoxic activity. Erythrosine-induced rodent thyroid tumours may be considered of limited relevance to humans; an approach which is consistent with previous evaluation of Erythrosine. The Panel considered Erythrosine has a minimal effect in humans at a clinical oral dose of 200 mg daily over 14 days, while a dose of 60 mg daily was without effect (Gardner et al., 1987). The current ADI adopted by the JECFA and the SCF is based on this study. The Panel concurred with their identification of this as the critical study. The 60 mg dose was taken to be the equivalent of 1 mg/kg bw/day. By applying a safety factor of 10 to allow for the small number of subjects used in the study and its relatively short duration, an ADI of 0-0.1 mg/kg bw per day was derived. The Panel concludes that the present database does not provide a basis to revise the ADI of 0.1 mg/kg bw/day. The Panel concluded that at the current levels of use intake estimates for adults on average is 0.0031 mg/kg bw/day and 0.01 mg/kg bw/day at the 95^th percentile, and consequently are below the ADI of 0.1 mg/kg bw/day. The Panel considered there would be no safety concerns at current levels of exposure including other sources of exposure.