Scientific Opinion on the re-evaluation of lutein (E 161b) as a food additive
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The Panel on Food Additives and Nutrient Sources added to Food provided a scientific opinion re-evaluating the safety of lutein (E 161b). Lutein had previously been evaluated by the EU Scientific Committee for Food (SCF) in 1975 and by 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, however, 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 therefore based its evaluation on previous assessments, additional literature that had become available since then, and data submitted following a public call for data. Among the new information was 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 standard regulatory studies, this study was too limited to identify a No Observed Adverse Effect Level (NOAEL) suitable for safety evaluation purposes.
The Panel concluded, based on a NOAEL of 200 mg/kg bw/day (the highest dose level tested) in a 90-day rat study, the absence of developmental toxicity at doses up to 1000 mg/kg bw/day (the highest dose tested), the lack of genotoxicity, the absence of effects on reproductive organs in 90-day studies, and the fact that lutein is a normal constituent of the diet, that an ADI could be derived.
Given the absence of a multigeneration reproductive toxicity study and of chronic toxicity/carcinogenicity studies, the Panel applied an uncertainty factor of 200 and established an ADI of 1 mg/kg bw/day.
The Panel noted that this ADI refers specifically to lutein derived from Tagetes erecta containing at least 80% carotenoids, consisting of lutein and zeaxanthin (79% and 5%, respectively). The Panel further concluded that, at the current levels of use, Tier 3 intake estimates may exceed the ADI at the upper end of the exposure range.