CASE-STUDY - ERYTHROSINE

Erythrosine (FD & C Red No.3) is an iodine-containing food colour whic h was used as an example in the application of the proposed approach o f data-derived safety factors. The effect of erythrosine on the thyroi d and the mechanism by which the effect is induced has been central to the discussion of the establishment of an Acceptable Daily Intake (AD I), or not, and a short account is given of the effect of erythrosine on the thyroid. The evaluation of erythrosine as a secondary tumorigen ic agent was based on the evaluations of the Joint FAO/WHO Expert Comm ittee on Food Additives (JECFA) and the Scientific Committee for Food of the Commission of the European Communities (SCF). In the proposed d ecision tree scheme, three different possibilities were examined. One was based on the long-term data and the second on the hormone data in the rat; the third was based on the NOEL for hormonal changes in human s. The three approaches with different NOEL and default values resulte d in the following ADIs: 0.25, 0.3 and 0.1 mg/kg bw. The cases are dis cussed and it is concluded that the ADI based on the NOEL in human stu dies seems most appropriate. As there is most uncertainty about the de fault value for human pharmacokinetic variability, it is suggested tha t further human studies might elucidate this point.