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European Commission Approves of dsm-firmenich’s ampli-D Calcidiol Monohydrate as Novel Food

The novel form of vitamin D3 is evidenced to raise blood concentrations of vitamin D faster than conventional forms.

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By: Mike Montemarano

Associate Editor, Nutraceuticals World

The European Commission has approved of dsm-firmenich’s amplid-D calcidiol monohydrate ingredient as a novel food in the EU.
 
The ingredient is calcifediol, a type of calcidiol which is clinically evidenced across 15 human studies to raise blood concentrations of vitamin D 2.5 times faster than conventional forms of vitamin D3, according to the company.
 
Under the EU authorization, ampli-D is approved for a maximum daily dose of 10 mcg in children and adults over 11 years, including pregnant and lactating women, and a maximum daily dose of 5 mcg for children between the ages of three and 10.
 
The authorization grants dsm-firmenich a five-year exclusive use period to place ampli-D on the market, beginning this month.
 
“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. “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.”
 
The company will be showcasing ampli-D in a range of new concepts at booth #D90 at Vitafoods Europe 2024 in Geneva, Switzerland.

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