dsm-firmenich, a player in the nutrition, health and beauty industries, has gained approval from the European Commission to term its ampli-D calcidiol monohydrate ingredient as a food.
Clinically proven in more than 15 human studies, ampli-D is a calcifediol (calcidiol) ingredient that helps raise blood vitamin D levels 2.5x faster and more effectively than conventional vitamin D3.1 Under the EU authorisation, 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.
Bolstering vitamin D levels quickly
“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 commercialisation 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.
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.