Statement on the safety of synthetic zeaxanthin as an ingredient in food supplements

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinion on the safety of synthetic zeaxanthin as a novel food ingredient in food supplements in the light of additional information provided by the applicant. In its previous opinion of 2008, the Panel concluded that based on the available data, the safety of zeaxanthin as an ingredient in food supplements at the proposed use level of up to 20 mg/person per day has not been established. In response to the EFSA Opinion of 2008, the applicant provided a two-generation reproduction toxicity study with synthetic zeaxanthin in rats and twenty-two additional references including some mechanistic studies related to carotenoids and lung cancer risk. Although neither animal nor human data on the lung cancer risk of zeaxanthin are available, on the current data available the Panel considers it is unlikely that supplemental intake of zeaxanthin would increase the risk of lung cancer in heavy smokers. The Panel identifies a NOAEL at 150 mg/kg bw per day in the two-generation reproduction toxicity study and has no concerns with regard to genotoxicity. Given the absence of a chronic toxicity/carcinogenicity study, the Panel applies an uncertainty factor of 200 on the NOAEL in the two-generation study. This results in 0.75 mg/kg bw per day for synthetic zeaxanthin corresponding to a daily intake of 53 mg for a person with a body weight of 70 kg. The Panel concludes that based on the available data, intakes of 0.75 mg/kg bw per day for synthetic zeaxanthin, corresponding to a daily intake of 53 mg for a person with a body weight of 70 kg, do not raise safety concerns. Therefore, the use levels proposed by the applicant do not raise safety concerns.