# Lactose, Hydrolyzed

> Source URL: https://additivefacts.com/additives/lactose-hydrolyzed
> Markdown URL: https://additivefacts.com/additives/lactose-hydrolyzed.md

**Safety rating:** SAFE
**CAS number:** 977126-93-4
**Category:** sweetener
**FDA GRAS:** yes
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

Hydrolyzed lactose is a nutritive sweetener created by breaking down lactose (milk sugar) into its simpler components, glucose and galactose. It is used in food products as a sweetening agent and is recognized as safe by the FDA.

## Regulatory status

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

## Detailed analysis

## What is Hydrolyzed Lactose?

Hydrolyzed lactose is a sweetener derived from lactose, the naturally occurring disaccharide found in milk. The hydrolysis process breaks the glycosidic bond between glucose and galactose molecules, converting lactose into these two simple monosaccharides. This enzymatic or acid-catalyzed process increases the sweetness profile compared to intact lactose and improves solubility in food applications.

## Common Uses

Hydrolyzed lactose is used as a nutritive sweetener in various food and beverage products. Its primary applications include:

- Dairy products and yogurts
- Confectionery and chocolate products
- Baked goods and desserts
- Processed foods and condiments
- Nutritional supplements and meal replacement products

The ingredient provides approximately 4 calories per gram, similar to other carbohydrate-based sweeteners. Its use allows manufacturers to maintain sweetness while utilizing dairy-derived ingredients, which may appeal to consumers seeking more natural sweetening sources.

## Safety Assessment

Hydrolyzed lactose has been designated as Generally Recognized as Safe (GRAS) by the FDA, indicating it meets safety standards for use in food. The ingredient has not been associated with any reported adverse events in FDA databases and has not been subject to any recalls related to safety concerns.

For individuals with lactose intolerance, hydrolyzed lactose presents a different safety profile than intact lactose. Since the lactose has been broken down into glucose and galactose, it may be better tolerated by lactose-intolerant individuals, though sensitivity can vary. However, those with galactosemia, a rare genetic condition affecting galactose metabolism, should avoid this ingredient.

The sweetener does not provide the caloric reduction associated with non-nutritive sweeteners, making it suitable for applications where caloric content is not a primary concern. Like other simple sugars, it can contribute to dental caries and should be considered in the context of overall sugar intake.

## Regulatory Status

Hydrolyzed lactose is approved for use in food in the United States under FDA regulations. Its GRAS status permits its use in various food categories without pre-market approval requirements, provided use levels are consistent with safe food manufacturing practices.

In the European Union, hydrolyzed lactose is listed among permitted food additives and is subject to EFSA (European Food Safety Authority) oversight. It is approved for use in various food categories with specified purity and labeling requirements.

Labeling requirements in the United States require that hydrolyzed lactose be identified by its common name in ingredient lists. Products containing this ingredient should be clearly labeled for consumer awareness, particularly for those with lactose sensitivity.

## Key Studies

The safety profile of hydrolyzed lactose is supported by its long history of use in dairy products, where enzymatic lactose hydrolysis has been employed for decades. The component monosaccharides (glucose and galactose) are well-established food components with extensive safety data.

Research on lactose hydrolysis demonstrates that enzymatic treatment effectively reduces lactose content while maintaining nutritional value. Studies examining the digestibility of hydrolyzed lactose products confirm improved tolerance compared to intact lactose in sensitive populations.

The FDA's GRAS designation reflects the ingredient's established safety record and the absence of adverse event reports. Continued monitoring through post-market surveillance maintains oversight of this ingredient's safety profile in food applications.

## 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. "Lactose, Hydrolyzed — Safety, regulation, and evidence." https://additivefacts.com/additives/lactose-hydrolyzed. Accessed 2026-05-19.