Food supplements: calcidiol monohydrate
- Food additives
Summary
The European Union (EU) has included calcidiol monohydrate as a source of vitamin D in its list of vitamins and minerals allowed for use in food supplements.
EU lists calcidiol monohydrate as vitamin D source allowed in food supplements
Commission Regulation (EU) 2025/352 of 21 February 2025 amending Directive 2002/46/EC of the European Parliament and of the Council as regards calcidiol monohydrate used in the manufacture of food supplements
Update
The European Union (EU) has included calcidiol monohydrate as a source of vitamin D in its list of vitamins and minerals allowed for use in food supplements.
Impacted Products
Food supplements
What is changing?
Following its authorisation as a novel food in 2024, the EU has now added calcidiol monohydrate, a source of vitamin D, to the list of vitamin and mineral substances that may be used in the manufacture of food supplements (Annex II to Directive 2002/46/EC).
Why?
The European Food Safety Authority has concluded that the use of calcidiol monohydrate as a source of vitamin D in food supplements is safe (EFSA 2021).
Timeline
Applies from 16 March 2025.
Background
Previously, Regulation 2024/1052 authorised calcidiol monohydrate as a novel food ingredient in food supplements excluding those for infants and young children.
Resources
EFSA (2021) Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 19(6): 6660.
Regulation (EU) 2024/1052 authorising the placing on the market of calcidiol monohydrate as a novel food
Sources
Regulation (EU) 2025/352 as regards calcidiol monohydrate used in the manufacture of food supplements
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EU lists calcidiol monohydrate as vitamin D source allowed in food supplements
Regulation (EU) 2025/352 as regards calcidiol monohydrate used in the manufacture of food supplements
What is changing and why?
Following the authorisation in 2024 of calcidiol monohydrate as a novel food ingredient, the EU has now authorised this substance as a source of vitamin D that may be used in food supplements.
Timeline
Applies from 16 March 2025.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.