# Vitamin D-3

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**Safety rating:** SAFE
**CAS number:** 67-97-0
**Category:** nutrient
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-04

## Summary

Vitamin D-3 (cholecalciferol) is a fat-soluble nutrient naturally produced in skin when exposed to sunlight and obtained from animal-based food sources. It is added to foods as a nutritional fortification to support calcium absorption and bone health.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | approved |
| Canada | approved |
| Australia | approved |
| Japan | approved |
| South Korea | approved |
| Brazil | approved |
| China | approved |
| India | approved |

## Detailed analysis

## What is Vitamin D-3?

Vitamin D-3, chemically known as cholecalciferol (CAS Number: 67-97-0), is a fat-soluble vitamin essential for human health. Unlike most vitamins, vitamin D functions as both a nutrient and a hormone precursor in the body. It is naturally synthesized in human skin upon exposure to ultraviolet B (UVB) radiation from sunlight and is also found naturally in fatty fish, egg yolks, and mushrooms exposed to sunlight.

## Common Uses

Vitamin D-3 is extensively used as a nutritional supplement in food fortification programs. Common food applications include milk and dairy products, plant-based milk alternatives, breakfast cereals, orange juice, and various functional foods. It is also available as a standalone dietary supplement. The fortification of milk with vitamin D has been a public health standard in many countries since the early 20th century and remains one of the most effective methods of ensuring adequate vitamin D intake in populations with limited sun exposure.

## Safety Assessment

Vitamin D-3 has been designated as Generally Recognized as Safe (GRAS) by the FDA for use in food fortification at established levels. The FDA has recorded zero adverse events specifically linked to vitamin D-3 fortification in foods and zero recalls associated with this nutrient as of current database records.

Toxicity from vitamin D-3 is possible only at very high supplemental doses, typically exceeding 4,000 IU daily over extended periods, which can lead to hypercalcemia (excessive blood calcium). However, toxicity from food fortification and normal dietary intake is virtually impossible to achieve. The European Food Safety Authority (EFSA) established an upper tolerable intake level of 100 micrograms (4,000 IU) daily for adults, though this refers to supplemental intake rather than food fortification levels.

The Institute of Medicine's Dietary Reference Intakes recommend 600-800 IU daily for most adults, with requirements increasing slightly for adults over 70 years old. Fortification levels in food products are carefully controlled to support nutritional adequacy without creating excessive intake.

## Regulatory Status

Vitamin D-3 is approved for use as a nutrient supplement in food fortification by regulatory agencies worldwide, including the FDA, EFSA, and Health Canada. It is listed on the FDA's GRAS list for use in specified food categories. The FDA does not classify it under GRAS designation in the traditional sense because nutrients have a separate regulatory pathway; however, it is recognized as safe and appropriate for food fortification.

Different countries maintain slightly different maximum fortification limits based on their population health assessments and dietary patterns. The United States permits vitamin D fortification in milk at levels of 40 IU per 100 mL, with flexibility for other food categories.

## Key Studies

Numerous clinical studies have documented the effectiveness of vitamin D-3 fortification in raising serum vitamin D levels and supporting bone health. Large epidemiological studies, including data from the National Health and Nutrition Examination Survey (NHANES), demonstrate that vitamin D-3 fortification has successfully reduced vitamin D deficiency prevalence in fortified-food consuming populations. Research consistently shows that vitamin D-3, whether from sunlight, food, or fortification, is metabolized identically in the human body, serving as a precursor for active vitamin D hormone (calcitriol) in the kidneys.

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "Vitamin D-3 — Safety, regulation, and evidence." https://additivefacts.com/additives/vitamin-d-3. Accessed 2026-05-20.