A calcidiol monohydrate ingredient from dsm-firmenich has received novel food authorization in Europe

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The authorization by the EU allows the use of ampli-D at 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.

Photo © AdobeStock.com/Katsiaryna Hatsak

Photo © AdobeStock.com/Katsiaryna Hatsak

Dsm-firmenich has announced the approval of its ampli-D calcidiol monohydrate ingredient as a novel food by the European Commission in the European Union (EU). According to the company, the ingredient has been subject to 15 human studies, which has shown that it can help raise blood vitamin D levels 2.5 times faster than conventional vitamin D3. The authorization by the EU allows the use of ampli-D at 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. Dsm-firmenich has been granted an exclusive five-year use period to place ampli-D on the market from May 1, 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,” said Catherine Mignot, head of regulatory affairs HNC, EMEA at dsm-firmenich, in a press release. “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.”

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