Positive EFSA opinion opens vitamin D innovation potential

By:  Talking Nutrition Editors

  • DSM has received a positive EFSA opinion for the Novel Food assessment of calcidiol, also known as calcifediol.
  • DSM’s ampli-D® calcifediol product is already commercially available in Australia, Singapore and New Zealand as an advanced, fast-acting vitamin D solution.
  • Vitamin D, the so-called ‘sunshine vitamin’, is well-recognized for its role in bone and muscle health as well as the maintenance of a normal immune system. ampli-D® can help quickly tackle low vitamin D status to achieve the optimal level more efficiently than vitamin D31.

The recognition by the European Food Safety Authority (EFSA) of the safety and bioavailability of calcidiol – or calcifediol – for the intended use is an important milestone in the authorization of DSM’s ampli-D® product for sale across the European Union. EFSA recognized the more efficient absorption of calcidiol compared to regular vitamin D3 to increase the level of vitamin D in the blood and hence improve the vitamin D status of an individual.

The positive EFSA opinion confirms the safe use of calcidiol in food supplements for children above 11 years old and for the adult population including pregnant and lactating women2. The future inclusion of calcidiol on the Union list of novel foods for use in food supplements will take DSM a step closer to supporting its customers as an end-to-end partner in vitamin D innovation.  

A potent vitamin D form

DSM’s ampli-D® is already approved for use in food supplements in Australia, Singapore and New Zealand. The European Commission must now provide the final authorization and, once this is received, ampli-D® will be launched in Europe too where it will be commercially available as a market-ready solution. The future authorization will include a five-year data protection for the proprietary ingredient.

Few foods naturally provide the required intake of vitamin D. Up to 90% of vitamin D in the body is produced when our skin is exposed to sunlight. However, in winter especially, many people spend a lot of time indoors and this makes it difficult to achieve the optimal vitamin D status. Other factors that limit vitamin D production in the body include age, sun protection and darker skin tones. It is now estimated that 88% of individuals globally have sub-optimal vitamin D levels (<75 nmol/L)3.

With fortified foods and regular dietary supplements, it can take months to build up vitamin D levels. As a bioavailable active form of vitamin D, ampli-D® can quickly tackle low vitamin D status – achieving optimal levels in the body in a matter of weeks, or even days.

Immunity and more

Vitamin D is well-known for its role in bone and muscle health as well as for the maintenance of a normal immune system. 62% of consumers worldwide already associate vitamin D with ‘boosting’ immunity4 and a growing bank of scientific evidence also shows that vitamin D could reduce the risk of acute respiratory infections. In today’s environment, immune health remains a top worry for consumers of all ages and 65% of global consumers state that it is currently a concern5. The launch of ampli-D® further strengthens the position of DSM as an innovation partner, supporting its customers from concept to consumer in the creation of purpose-led food, beverage and dietary supplement products targeting a variety of trending health concerns. 

 

Published on

13 July 2021

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References

  1. Clinical studies show that sufficient Vitamin D status is achieved on average 3 times faster and more efficiently compared to D3 on an equal dose basis.
  2. EFSA Panel on Nutrition, Novel Foods and Food Allergens. Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, vol. 19, issue 7, July 2021
  3. Hilger et al. A systematic review of vitamin D status in populations worldwide. Br J Nutr 2014, 111, 23-45.
  4. DSM Consumer Immunity Panel, September 2020.
  5. Ibid

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