Scientific Opinion on the substantiation of health claims related to zeaxanthin and maintenance of normal vision (ID 1684, 2169, 2888) 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 zeaxanthin and 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 zeaxanthin. The Panel considers that zeaxanthin is sufficiently characterised. The claimed effects are “eye health and vision”, “helps to preserve elasticity and permeability of capillaries of retina and supports good blood circulation in eyes” and “required for macular pigmentation in the eyes for maintaining healthy eye functions”. The target population is assumed to be the general population. The Panel considers that maintenance of normal vision is a beneficial physiological effect. In weighing the evidence, the Panel noted that the only pertinent intervention study in humans did not indicate a benefit of zeaxanthin supplementation on a functional measure of vision. The epidemiological evidence was strongly in favour of no relationship between dietary or plasma zeaxanthin and risk of age-related macular degeneration. The Panel considers that the evidence provided in the animal studies does not predict an effect of zeaxanthin consumption on vision in humans. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of zeaxanthin and the maintenance of normal vision.