US Publishes Direct Addition of Vitamin D3 to Food for Human Consumption

On January 05, 2023, the U.S Food and Drug Administration published a regulation on the “Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3”. 

The scope of the document outlines the following points:

• To ensure the food additive is not harmful under the intended condition of use; 
• Amendment of the food additive regulations to provide the safe use of vitamin D3 as a nutrient supplement;
• Applicable on the food categories of breakfast cereals and grain-based bars to update the reference for the Vitamin D3 specifications;
• The maximum limit set for Breakfast Cereals is 560 IU of vitamin D3 per 100 g and in Grain-based bars at a level up to 400 IU of vitamin D3 per 100 g;
• Toxicological data and dietary exposure studies indicate the safe use of Vitamin D3 under the proposed food uses. 

The regulation is effective from January 05, 2023. 

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