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

dsm-firmenich, innovators in nutrition, health, and beauty, 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 helps raise blood vitamin D levels 2.5 times faster and more effectively than conventional vitamin D3. Under the EU authorization, ampli-D® is approved for a maximum daily dose of 10 µg in children over 11 years old and adults including pregnant and lactating women, and a maximum daily dose of 5 µg for children aged 3-10.

The approval marks a major milestone in dsm-firmenich’s ambition to bring breakthrough 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 aging, 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, 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,” says 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 commercialization of fast-acting, consumer-centric products that make the world a healthier place.”