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

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2011;9(9):2382 [18 pp.].
Possible conflict of interest
One member of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.
doi
10.2903/j.efsa.2011.2382
Panel members at the time of adoption
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the United Kingdom
Question Number
EFSA-Q-2010-01233
Adopted
16 September 2011
Published in the EFSA Journal
30 September 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

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 μg) 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 μg) of vitamin D from all sources should be consumed daily. The target population is men and women 60 years of age and older.

Keywords
Vitamin D, calcium, falls, risk of falling, bone fractures, health claim
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Number of Pages
18