Green S, also known as Wool Green, is a triarylmethane dye that has been used in a wide range of foods and beverages in Europe since the 1960s. Its original temporary ADI of 25mg/kg bw/day, set by JECFA in 1969, was withdrawn six years later. In 1984 the then Scientific Committee on Food (SFC) established an ADI of 5mg/kg bw/day.
The European Food Safety Authority (EFSA)’s Panel on Food Additives and Nutrient Sources (ANS) is currently re-evaluating the safety of all food additives used in the EU.
The ANS panel said that there are no adequate genotoxicity data available by modern standards, so the genotoxicity of Green S could not be assessed. Carcinogenicity and reproductive toxicity studies were found to be negative, and these were deemed to balance out the lack of adequate genotoxicity data.
The panel pointed out that the Scientific Committee is currently discussing whether it is appropriate for negative data on potential impacts to balance out lacking genotoxicity data.
No cases of intolerance or allergenicity have been reported, and the panel concluded that at current levels of exposure there would be very low incidence of allergenicity – if any at all.
Dietary incidence was estimated based on maximum permitted levels of use, and the theoretical maximum daily exposure for adults was estimated to be 8.1mg/kg bw/day for adults and 13.1 mg/kg bw/day for a typical three-year old child.
The panel said that some updates to the specifications may be required, as the material unaccounted for may represent sodium chloride and/or sodium sulphate as the main uncoloured components.
It also suggested that specifications on the maximum level of aluminium in the colour lakes may need to be updated, as the aluminium may add to the daily intake, which has a tolerable weekly intake of 1mg/kg bw/week.
A difference was also seen in between the JECFA and EC specifications for lead, with JECFA’s limit being 2mg/kg or less and the EC’s 10mg/kg or less.
EFSA’s opinion is available online here. http://www.efsa.europa.eu/en/scdocs/scdoc/1851.htm