Scientific Opinion on the substantiation of health claims related to lutein and maintenance of vision (ID 1603, 1604, 1931) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to lutein and the maintenance of normal vision. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claim is lutein. The Panel considers that lutein is sufficiently characterised. The claimed effects are “required for macular pigmentation in the eyes which helps maintenance of healthy eye functions”, “eye health” and “macular pigment blue light filter in eyes antioxidant activity”. From the data provided, it has not been established that a change in macular pigment in people with healthy eyes is related to eye function. Normal vision, however, is a function of the eye which can be assessed by established methods. The target population is assumed to be the general population. The Panel considers that the maintenance of normal vision is a beneficial physiological effect. In weighing the evidence, the Panel considered that the generally consistent epidemiological evidence indicating a possible role for lutein in vision was not supported by the weight of evidence from the human intervention studies. While it is established that lutein can increase macular pigment density in most but not all healthy subjects, it has not been established that such increases in macular density is related to vision. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of lutein and maintenance of normal vision.