Scientific Opinion on the re-evaluation of lutein (E 161b) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of lutein (E 161b). Lutein has been previously evaluated by the EU Scientific Committee for Food (SCF) in 1975 and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2006. JECFA established a group Acceptable Daily Intake (ADI) of 0-2 mg/kg body weight (bw) for lutein from Tagetes erecta and zeaxanthin. The SCF could not establish an ADI, but concluded that xanthophylls prepared from natural foods by physical processes are acceptable for use in food. 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 a 90-day study in rats in which no adverse effects were reported up to dose levels of 400 mg/kg bw/day. However, the Panel noted that, compared to the standard regulatory studies, the study is too limited to identify a NOAEL for the safety evaluation of lutein. The Panel concluded, based on the NOAEL of 200 mg/kg bw/day (the highest dose level tested) in a 90-day rat study, the absence of developmental toxicity at dose levels up to 1000 mg/kg bw/day (the highest dose level tested), the fact that lutein is not genotoxic, the fact that in 90-day studies no effects on reproductive organs were observed, and the fact that lutein is a normal constituent of the diet, that an ADI can be derived. Given the absence of a multigeneration reproductive toxicity study and of chronic toxicity/carcinogenicity studies the Panel applies an uncertainty factor of 200 and establishes an ADI of 1 mg/kg bw/day. The Panel noted that this ADI refers to lutein derived from Tagetes erecta containing at least 80% carotenoids consisting of lutein and zeaxanthin (79 and 5% respectively). The Panel concluded that at the current levels of use Tier 3 intake estimates are above the ADI at the upper end of the range.