Scientific Opinion on the re-evaluation of lutein preparations other than lutein with high concentrations of total saponified carotenoids at levels of at least 80%

Lutein is a carotenoid colour authorised as a food additive in the EU (E 161b) and reevaluated by the Panel on Food Additives and Nutrient Sources added to Food (ANS) in 2010. The ANS Panel established an ADI of 1 mg/kg bw/day and noted that this ADI refers to lutein derived from Tagetes erecta containing at least 80% carotenoids. In the present opinion the Panel considered whether additional studies made available address the gaps identified by the Panel in the toxicological database for lutein preparations other than lutein with high concentrations of total saponified carotenoids at levels of at least 80%. The Panel noted that in all additional studies made available, a specific lutein ester preparation extracted from Tagetes erecta was tested, containing > 60% carotenoid esters (>93% lutein esters, remainder zeaxanthin esters). No additional data were provided on lutein with levels of ~5-12% total carotenoids. The Panel concluded that lutein esters are not of concern with respect to genotoxicity. The additional data also included a 90-day toxicity study and a reproductive and developmental toxicity study. The Panel established for both studies a NOAEL of 1000 mg/kg bw/day, the highest dose level tested (equivalent to 538 mg lutein equivalents/kg bw/day). The Panel noted that this NOAEL of 538 mg lutein equivalents/kg bw/day is higher than the NOAEL of 200 mg/kg bw/day (the highest dose level tested) in the 90-day rat study with lutein from which the ADI has been derived. Based on these results, the Panel concluded that the additional database supports the conclusion that the ADI of 1 mg/kg bw/day also refers to lutein with high concentrations of total carotenoids extracted from Tagetes erecta and present as esters at levels of ≥ 60%. The Panel concluded that the toxicological data-base available is too limited to conclude that the ADI also applies to lutein preparations of lower purity or from other sources.