EFSA's recognition of the safety and bioavailability of calcidiol (aka calcifediol) is a key milestone in the authorization of DSM’s ampli-D product for sale across the European Union. EFSA recognised the more efficient absorption of calcidiol compared to regular vitamin D3 to increase the level of vitamin D in the blood and hence improve the vitamin D status of an individual.
DSM's ampli-D product is currently only approved for use in food supplements in Australia, Singapore and New Zealand. Following the positive EFSA opinion, the European Commission must now provide the final authorisation and once this is received, ampli-D will be launched in Europe.
A growing bank of scientific evidence shows that vitamin D could reduce the risk of acute respiratory infections and even reduce COVID-19 infections and deaths.
With 65% of global consumers currently concerned about their immune health (DSM Consumer Immunity Panel, September 2020), consumers are increasingly recognising the growing associations between the so-called ‘sunshine vitamin’ and immunity.
Despite this increased awareness, 88% of individuals globally are reported to have sub-optimal vitamin D levels.
At the moment, commercially available products contain cholecalciferol – another form of vitamin D3 - and DSM says it can take months to bring the body to optimum sufficiency using some Vitamin D2 and D3 supplements.
Calcifediol (25-hydroxyvitamin D3) is another form of vitamin D naturally present in food sources like fish, milk and eggs and it is the most common form of vitamin D in our body.
Research has found this form of the vitamin as a supplement is three to five times more efficient than cholecalciferol and that it has a higher rate of intestinal absorption and thereby can improve vitamin D status in days to weeks.
Peter Van Dael, senior vice president of nutrition science & advocacy at DSM, says the ability to raise vitamin D levels quickly is more important than ever, helping to support people’s immunity during the current global pandemic as fast as possible.
“Although current practices such as vaccinations, hygiene measures, wearing face masks, and social distancing are still extremely important in limiting the spread of viral infections, like the highly contagious COVID-19 disease caused by the SARS-CoV-2 virus, additional focus on the role of nutrition and its positive impact on immunity is also critical.
"Given the supporting evidence, nutritional supplementation is strongly advised as part of future public health strategies. Complementing a healthy, balanced diet with a nutritional supplement – like vitamin D, preferably calcifediol – is a safe, effective and low-cost way to support healthier futures across the world, as it helps to promote an optimal immune response and manage the risk and severity of infectious diseases.”
André Rhoen, regional vice president EMEA at DSM, adds: “This positive EFSA opinion opens up exciting potential in vitamin D innovation, with the addition of an advanced and potent form to our portfolio. This important landmark is testament to the role that DSM plays as an end-to-end partner to our customers – from scientific and regulatory services, right through to the market-ready solutions that will be commercially available as soon as we receive authorization from the European Commission.”
The positive EFSA opinion confirms the safe use of calcidiol in food supplements for children above 11 years old and for the adult population including pregnant and lactating women.
