Scientific opinion on the re-evaluation of caramel colours (E 150 a,b,c,d) as food additives

The ANS Panel provides a scientific opinion re-evaluating the safety of the caramel colours (E150a (Class I), E150b (Class II), E150c (Class III), E150d (Class IV)) used as food additives. The caramel colours are a complex mixture of compounds produced by heating carbohydrates under controlled heat and chemical processing conditions; they are divided into four classes according to the manufacturing reactants used. The caramel colours were previously evaluated by the SCF and by JECFA, which concluded that a numerical ADI was not necessary for Class I, but established ADIs for the other classes of caramels, ranging from160-200 mg/kg bw/day. Given the consistency in the toxicological database, the Panel establishes a group ADI of 300 mg/kg bw/day for the caramel colours, by applying an uncertainty factor of 100 to a NOAEL of 30 g/kg bw/day (highest dose tested) identified in 13-week rat studies with Class IV and a similar NOAEL identified in a rat reproductive toxicity study, also with Class IV. Comparable NOAELS for Classes II, III and IV were reported in the SCF and JECFA evaluations. Within this group ADI, the Panel establishes an individual ADI of 100 mg/kg bw/day for Class III due to new information regarding the immunotoxicity of THI. The Panel concludes that the anticipated dietary exposure of child and adult populations may exceed the ADIs for Classes I, III and IV caramels, but exposure estimates to Class II were below the ADI. Exposure estimates for the caramel constituents THI, 4-MEI and SO2 are not of concern, but the Panel welcomes additional studies to clarify remaining uncertainties regarding effects of THI on the immune system. The Panel notes that other constituents of caramel colours including 5-HMF and furan may be present at levels that may be of concern, and considers that the specifications should include maximum levels for these constituents.