Scientific Opinion on the re-evaluation of Sunset Yellow FCF (E 110) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Sunset Yellow FCF (E 110). Sunset Yellow FCF has been previously evaluated by JECFA and the SCF. Both committees established an Acceptable Daily Intake (ADI) of 0-2.5 mg/kg bw/day. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. New studies included studies by Mathur et al. reporting significant effects on the testes in rats exposed for 90 days to 250 and 1500 mg Sunset Yellow FCF/kg bw/day. The Panel notes that the Sunset Yellow FCF administered in these studies was obtained at the local market and that its specifications or purity were not defined. The Panel also notes that the 90 day rat study used by JECFA to derive the ADI also reported effects on testes weight, occurring without accompanying histological changes, although sperm morphology and sperm mobility were not analysed. The Panel concludes that these findings do give reason for re-definition of the ADI. The Panel decided to reduce the ADI, by an extra uncertainty factor of 2.5, to 1 mg/kg bw/day and to make the ADI temporary for 2 years. Within this period, clarification of the effects of Sunset Yellow FCF on the testis, sperm morphology and sperm mobility should be provided, based on a 28-day study performed according to the recently updated OECD test guideline 407. The Panel concludes that at the maximum reported levels of use of Sunset Yellow FCF, refined intake estimates are generally below the temporary ADI of 1 mg/kg bw/day, although in 1- to10-year old children the mean and the high percentiles of exposure (95th/97.5th) can be higher than this ADI, at the upper end of the range.