The article 14 application was submitted by DSM Nutritional Products Europe. The ruling by the Panel on Dietetic Products Nutrition and Allergies (NDA Panel) concluded that vitamin D (D2 and D3) was sufficiently characterised and that daily vitamin D supplementation in combination with calcium (compared to calcium alone) significantly reduced the risk of falling.
Wouter Claerhout, head global marketing at DSM, said: “We have been working closely with the scientific community on the preparation of the dossier to meet the strict requirements of the European Commission - a process of more than four years.
“We are proud to have been able to contribute in such a meaningful way to public health – fall prevention has important psychological benefits to seniors and it helps to reduce osteoporotic fractures.”
Supporting studies
DSM submitted five human intervention studies which had falls as the primary outcome. They all showed a significant reduction in the risk of falling among men and women aged 60 or more taking vitamin D and calcium supplementation.
EFSA wrote in its opinion: “The Panel notes that all the studies which showed an effect of daily vitamin D supplementation on the risk of falling used supplemental calcium in combination.
“However, since physiological functions of calcium (except bone mineralisation) are unrelated to dietary calcium intake level, the Panel considers that it is unlikely that supplemental calcium is required for an effect of vitamin D on the risk of falling.”
It was estimated by scientists that more than one third of the global population may suffer from vitamin D deficiency. EFSA agreed that a reduction of the risk of falling could influence human health by reducing the risk of bone fractures.
The NDA Panel advised that 800 IU (international units) of vitamin D from all sources should be consumed daily to obtain the effect. At least 600 IU are required to make the claim on products, said EFSA.