Calcidiol Monohydrate Approved as Source of Vitamin D in the EU
European Union
Feb 26, 2025
With the implementation of Regulation (EU) 2025/352 of February 21, 2025, the Commission amending Directive 2002/46/EC of the European Parliament and of the Council as regards calcidiol monohydrate used in the manufacture of food supplements.
Following a request from the Commission to deliver an opinion on calcidiol monohydrate as a novel food pursuant to Regulation (EU) 2015/2283 of the European Parliament and of the Council and as a source of vitamin D in the context of Directive 2002/46/EC, on 25 May 2021, the Authority has adopted a scientific opinion on the matter
It follows from that opinion that there are no safety concerns about the use of calcidiol monohydrate in food supplements, provided that the conditions for its authorisation set out in Commission Implementing Regulation (EU) 2024/1052 are met. Based on the Authority’s favourable opinion and on its authorisation as a novel food ingredient in Implementing Regulation (EU) 2024/1052, calcidiol monohydrate should be included in the list of vitamin and mineral substances set out in Annex II to Directive 2002/46/EC, in order to allow its use as a source of vitamin D in food supplements.
Directive 2002/46/EC should therefore be amended accordingly.
For further information (in English), click on the Link
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