EU Approves Calcidiol Monohydrate in Food Supplements

On February 24, 2025, the European Union (EU) authorized “Calcidiol Monohydrate as a Permitted Source of Vitamin D in Food Supplements” amending Directive 2002/46/EC.

The key points are as follows:

• Calcidiol monohydrate is now an approved Vitamin D source in food supplements under Directive 2002/46/EC, following European Food Safety Authority’s (EFSA) positive assessment; 
• The novel food ingredient has been added to Annex II of Directive 2002/46/EC as an approved Vitamin D source for food supplements;
• EFSA confirms the safety within the limits set by Commission Implementing Regulation (EU) 2024/1052;
• Annex II of Directive 2002/46/EC now includes calcidiol monohydrate alongside ergocalciferol and cholecalciferol;
• The amendment aligns with Regulation (EU) 2015/2283 on novel foods to meet EU safety standards.

The rule is effective March 16, 2025.

To view the complete regulation, check out the Food News Monitoring System