Scientific Opinion on the substantiation of a health claim related to a combination of lutein and zeaxanthin and improved vision under bright light conditions pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from DSM Nutritional Products and Kemin Foods, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a combination of lutein and zeaxanthin and improved vision under bright light conditions. The Panel considers that the food is sufficiently characterised. Improved vision under bright light conditions is a beneficial physiological effect. The applicant provided a total of 10 published and one unpublished human intervention studies as being pertinent to the health claim. Five studies investigated the effects of lutein and/or zeaxanthin on macular pigment optical density, but did not assess vision, whereas two studies investigated the effects of lutein only. Two further studies had already been evaluated by the Panel in a previous assessment. No conclusions could be drawn from one further small (no effect) study. In a further trial with a large number of missing data owing to drop-out/non-compliance of study subjects, a combination of lutein and zeaxanthin had no effect on any outcomes of visual function in the population of subjects completing the protocol as planned. In weighing the evidence, the Panel took into account that the one study from which conclusions could be drawn did not show an effect of lutein plus zeaxanthin on vision. The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of lutein and zeaxanthin and improved vision under bright light conditions.

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