Scientific Opinion on the substantiation of a health claim related to vitamin D and risk of falling pursuant to Article 14 of Regulation (EC) No 1924/2006

Following an application from DSM Nutritional Products Europe AG, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to vitamin D and risk of falling. Vitamin D (D2 and D3) is sufficiently characterised. A reduction in the risk of falling among men and women 60 years of age and older is beneficial to human health by reducing the risk of bone fractures. Daily vitamin D supplementation (800-1000 I. U.; 20-25 mu g) in combination with calcium, when compared to calcium alone, significantly reduced the risk of falling (i.e. risk of falls, risk of falling at least once, or both) in elderly subjects in the five human intervention studies provided by the applicant which had falls as the primary outcome. Statistical pooling of the data from these randomised controlled trials consistently shows a significant reduction in the risk of falling. The available data do not provide information about the lowest effective dose of vitamin D needed to obtain the claimed effect. On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the intake of vitamin D and a reduction in the risk of falling. In order to obtain the claimed effect, 800 I. U. (20 mu g) of vitamin D from all sources should be consumed daily. The target population is men and women 60 years of age and older. (C) European Food Safety Authority, 2011.