Scientific Opinion on the re-evaluation of Green S (E 142) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Green S (E 142). Green S is a triarylmethane dye authorised as a food additive in the EU. Green S has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1970 and 1975, and the EU Scientific Committee on Food (SCF) in 1984. JECFA has established a Temporary ADI of 25 mg/kg bw/day in 1970 but withdrew it in 1975. Up till now JECFA has not allocated an ADI to Green S. The SCF has established an ADI of 5 mg/kg bw/day. The Panel considered that the present dataset on the absorption, distribution, metabolism and excretion, subchronic, reproductive, developmental and long-term toxicity and carcinogenicity do not give reason to revise the ADI of 5 mg/kg bw/day allocated by the SCF in 1984. For Green S, the lack of adequate genotoxicity data is balanced by the negative results from carcinogenicity and reproductive toxicity studies. The Panel noted that the issue whether lacking genotoxicity data could be balanced by carcinogenicity and reproductive toxicity studies is currently a matter of discussion in the Scientific Committee. The Panel concluded that at the maximum levels of use of Green S, intake estimates for children at the high percentiles (95th/97.5th) are above the ADI of 5 mg/kg bw/day at Tier 2, but not at the refined intake estimate at Tier 3. The Panel noted that the ADI for adults is not exceeded at Tier 2 and 3.