Press release

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

Kaiseraugst (Switzerland), Heerlen (Netherlands), May 7 2024

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 leves 2.5 times faster and more effectively than conventional D3.1 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,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,” 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.”

Available as a Market-Ready Solution, ampli-D® can help nutraceutical brands fast-track innovation pipelines and quickly bring meaningful products targeting key health areas to market. 

dsm-firmenich will showcase ampli-D® in a range of new concepts on booth #D90 at Vitafoods Europe 2024 in Geneva, Switzerland.  To learn more about how ampli-D® can help brands tackle low vitamin D status faster and more effectively, book at meeting with dsm-firmenich at Vitafoods Europe click here.


About dsm-firmenich
As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people.

 

References

1 EFSA. Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate. July 2023.

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

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Forward-looking statements
This press release may contain forward-looking statements with respect to dsm-firmenich’s future (financial) performance and position. Such statements are based on current expectations, estimates and projections of dsm-firmenich and information currently available to the company. dsm-firmenich cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. dsm-firmenich has no obligation to update the statements contained in this press release, unless required by law. The English language version of this press release prevails over other language versions.