EFSA issues positive opinion for novel food assessment of calcidiol

Published: 7-Jul-2021

DSM is celebrating the notice as a key milestone towards European authorisation of its ampli-D vitamin D product

Royal DSM, a nutrition, health and sustainable living company, has received a positive EFSA opinion for the novel food assessment of calcidiol, also known as calcifediol. The recognition of the safety and bioavailability of calcidiol for the intended use is a key milestone, the company says, in the authorisation of its 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.

Recognised for its role in bone and muscle health as well as for the maintenance of a normal immune system, a growing bank of evidence reportedly also shows vitamin D may reduce the risk of acute respiratory infections. The future inclusion of calcidiol on the Union list of novel foods for use in food supplements will take DSM a step closer to enabling its customers to bring fast-acting vitamin D solutions to market serving various health benefits.

Consumers increasingly recognise the association between vitamin D and immunity, yet globally 88% of individuals are reported to have sub-optimal vitamin D levels1. The company describes ampli-D as a highly bioavailable form of vitamin D2, positioned to support dietary supplement brands in product development.

André Rhoen, Regional VP EMEA at DSM said: “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 authorisation 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.


1. Hilger et al. A systematic review of vitamin D status in populations worldwide. Br J Nutr 2014, 111, 23-45.

2. Clinical studies show that sufficient Vitamin D status is achieved on average 3 times faster and more efficiently compared to D3 on an equal dose basis.

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