dsm-firmenich marks milestone in ampli-D authorisation with EU approval of calcidiol as a novel food

ampli-D has been supported in over 15 human studies as an ingredient supporting blood vitamin D

dsm-firmenich has announced the approval of its ampli-D calcidiol monohydrate ingredient as a novel food in the EU by the European Commission.

Clinically proven in more than 15 human studies, ampli-D is a calcifediol (calcidiol) ingredient that raises blood vitamin D levels 2.5 times faster and more effectively than conventional vitamin D3.1 Under the EU authorisation, ampli-D is approved for a maximum daily dose of 10µg in children over 11 years old and adults including pregnant and lactating women, and a maximum daily dose of 5µg for children aged three to 10.

The approval marks a major milestone in dsm-firmenich’s ambition to bring innovations to market and help consumers in the EU unlock the health benefits of the “sunshine vitamin” more rapidly – which include support for immunity, healthy ageing, mobility and more. A five-year exclusive use period has been granted for dsm-firmenich to place ampli-D on the market from 1 May 2024.

“With 88% of the global population having sub-optimal vitamin D levels,2 the approval of our game-changing ampli-D ingredient as a novel food in the EU means more people will have access to a solution that can raise levels of this essential vitamin in weeks, rather than months,” said Catherine Mignot, head of regulatory affairs HNC, EMEA at dsm-firmenich. “This landmark approval further demonstrates our role as an end-to-end partner for nutraceutical brands, with our scientific and regulatory expertise paving the way for the commercialisation of fast-acting, consumer-centric products that make the world a healthier place.”

Available as a market-ready solution, ampli-D supports nutraceutical brands in their innovation pipelines and delivers products targeting key health areas to market.