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

Abstract

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. KEY WORDSLutein, E 161b, CAS Registry Number 127-40-2, food colour, EINECS number 204-840-0. SUMMARYFollowing a request from the European Commission to the European Food Safety Authority (EFSA), the Scientific Panel on Food Additives and Nutrient Sources (ANS) added to Food was asked to provide a scientific opinion re-evaluating the safety of lutein (E 161b) when used as a food colour.Lutein (E 161b) is a natural carotenoid dye authorised as a food additive in the EU (E 161b) and 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 (SCF, 1975).Specifications have been defined in the EU legislation Directive 2008/128/EC and JECFA. EU specifica...

Bench-Scale Cultivation of Microalgae Scenedesmus almeriensis for CO2 Capture and Lutein Production

“…It acts as a light energy harvesting compound, which improves the photosynthesis efficiency and it prevents photodamage [16]. A daily lutein intake of 1 mg/kg body weight was suggested by the European Food Safely Authority (EFSA) [17], which could provide several health benefits. Moreover, lutein also acts as an antioxidant, anti-inflammatory, and colorant, which promotes its application for nutraceutical and pharmaceutical purposes [9].…”

Carotenoids: How Effective Are They to Prevent Age-Related Diseases?

“…The adverse outcomes are reversed after lutein intake discontinuation [203]. Although research has demonstrated a positive association between lutein and the risk of several diseases, the survey conducted by EFSA concluded that the data obtained were insufficient to show an adverse outcome [197]. Consistent with the data reported by EFSA, the Age-Related Eye Disease Study 2 (AREDS2) intervention study did not identify any risk of lung cancer after lutein supplementation [204,205].…”

“…Despite the fact that no toxic effect was observed during lutein supplementation in both intervention and epidemiological studies [195], the Joint Expert Committee on Food Additives established an upper safety limit for daily lutein consumption of 2 mg/kg [196]. Whereas the European Food Safety Authority (EFSA) indicated an upper safety limit of 1 mg/kg [197]. EFSA further established an upper limit for lutein-enriched milk for infants of 250 µg/L [198].…”

Safety and efficacy of lutein and lutein/zeaxanthin extracts from Tagetes erecta for poultry for fattening and laying (except turkeys)

“…The NDA EFSA Panel in 2012 updated its opinion on the safety of synthetic zeaxanthin as a novel food ingredient in food supplements in the light of additional information made available (EFSA NDA Panel, 2012). The re-evaluation of lutein (E 161b) as a food additive was carried by the EFSA Panel on Food Additives and Nutrient Sources added to Food (EFSA ANS Panel, 2010. The same EFSA Panel published a statement on the safety assessment of the exposure to lutein preparations based on new data on the use levels of lutein (EFSA ANS Panel, 2012).…”

“…The FEEDAP Panel noted that the toxicological profile of saponified and saponified/isomerised carotenoid extracts of T. erecta with similar specification has not been previously evaluated. However, the toxicological profile of lutein from Tagetes extracts and synthetic zeaxanthin has been evaluated by various committees (JECFA, 2004/WHO, 2006, 2014, 2016, 2018EFSA, 2008;EFSA ANS Panel, 2010EFSA NDA Panel, 2012).…”