Our Verdict: SAFE

Lactose, Hydrolyzed

CAS977126-93-4FDA GRAS

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Lactose, Hydrolyzed — food additive

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.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
Not EvaluatedUK FSA
Canada
Not EvaluatedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

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.

Frequently Asked Questions

What is Lactose, Hydrolyzed?

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.

Is Lactose, Hydrolyzed safe?

Lactose, Hydrolyzed is currently rated "safe" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Lactose, Hydrolyzed banned in any country?

Lactose, Hydrolyzed is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.