/ Food Supplement Labeling: New Vitamin D Fortification

The new regulations impose new labeling requirements and affect manufacturers, importers, and distributors, who must adjust their formulations and labels to comply with the requirements and avoid penalties, delays, or a loss of consumer confidence.

Andrea Adasme
Patent Associate
Alessandri Abogados

In June 2026, Decree No. 29 took effect in Chile, amending the Food Sanitation Regulations and establishing mandatory fortification with vitamin D₃ in liquid milk, powdered milk for direct consumption, and wheat flour. This measure aims to reduce the high levels of vitamin D deficiency detected in various population groups, particularly among children, women of childbearing age, and older adults.

In addition to its public health benefits, this regulation introduces new regulatory requirements that directly impact manufacturers, importers, and distributors of food and dietary supplements. The accurate declaration and labeling of ingredients, nutrients, and fortifying agents are of fundamental importance to ensure regulatory compliance.

Incorrect or incomplete labeling can result in:

• Regulatory findings by the health authority.
• Delays in import and marketing processes.
• Risk of penalties or product recalls.
• Loss of trust among consumers and customers.

The changes required by the new regulations—which manufacturers of the aforementioned products must take into account—are as follows:

1. Mandatory fortification with vitamin D₃ in products defined by the regulations.
2. New labeling requirements, which mandate declaring the presence of vitamin D₃ in the list of ingredients and clearly indicating whether its source is animal or non-animal.
3. Adjustments for imported products, which must enter the Chilean market in compliance with the required fortification levels or be adjusted prior to marketing, which involves reviewing formulations, technical specifications, and labeling.

The implementation of this measure reflects the constant evolution of food regulations in response to public health challenges. Organizations that review and adapt their products and labels in a timely manner will be better positioned to comply with the regulations and maintain their competitiveness in the market.