# Lactase From Saccharomyces (kluyveromyces) Lactis

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**Safety rating:** UNKNOWN
**CAS number:** 977090-11-1
**Category:** other
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

Lactase from Saccharomyces (Kluyveromyces) lactis is an enzyme derived from yeast that breaks down lactose into glucose and galactose. It is used in food processing to reduce lactose content in dairy products, making them suitable for lactose-intolerant consumers.

## Regulatory status

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

## Detailed analysis

## What is Lactase From Saccharomyces (Kluyveromyces) Lactis?

Lactase from Saccharomyces (Kluyveromyces) lactis is an enzyme preparation derived from the yeast species Kluyveromyces lactis (formerly classified as Saccharomyces lactis). This enzyme catalyzes the hydrolysis of lactose, a disaccharide naturally present in milk and dairy products, into its constituent monosaccharides: glucose and galactose. The enzyme is produced through fermentation processes and is widely utilized in the dairy industry.

## Common Uses

This lactase enzyme is primarily used in the production of lactose-free and reduced-lactose dairy products. Applications include:

- Treatment of fluid milk to produce lactose-free milk
- Processing of whey and whey-based products
- Production of lactose-free yogurt and frozen desserts
- Manufacture of cheese and other fermented dairy products
- Use in nutritional and supplementary products

The enzyme allows manufacturers to create dairy products that are more digestible for individuals with lactose intolerance or lactose malabsorption, expanding the potential consumer base for dairy products.

## Safety Assessment

Lactase from Kluyveromyces lactis has been evaluated for safety in food applications. The enzyme is produced from a food-grade yeast strain with a long history of safe use in fermentation. The final enzyme preparation used in food typically undergoes purification to remove most microbial biomass, with only the active enzyme component remaining in food products at functional levels.

According to available FDA records, there have been zero reported adverse events associated with this additive and zero product recalls. The enzyme itself is a protein that is subject to digestion in the human gastrointestinal tract, similar to other food proteins. Lactase is also naturally produced by the human body in the small intestine, though production decreases in many individuals after childhood.

The safety profile is further supported by the fact that lactase enzymes derived from various microbial sources have been used in food processing for decades without documented safety concerns at typical usage levels.

## Regulatory Status

Lactase from Saccharomyces (Kluyveromyces) lactis does not currently hold FDA GRAS (Generally Recognized as Safe) status. However, this does not indicate a safety concern; rather, it reflects regulatory classification and approval pathways. The enzyme may be used in food under FDA Food Additive Regulations if it has received appropriate authorization, or it may be subject to specific limitations depending on intended use and product category.

In the European Union, lactase enzymes from various sources, including fungal and yeast-derived preparations, are authorized for use in food processing under EC Regulation 1332/2008 on food enzymes. The enzyme is listed in the European Union Register of Food Enzymes, indicating compliance with European safety assessments.

Regulatory requirements vary by jurisdiction, and manufacturers must comply with applicable regulations in each country where products are marketed.

## Key Studies

Research on lactase enzymes supports their effectiveness and safety in dairy processing. Studies demonstrate that:

- Lactase effectively hydrolyzes lactose in milk, reducing lactose content by 70-99% depending on treatment conditions
- The enzyme remains active under standard dairy processing conditions
- Heat treatment during subsequent processing inactivates the enzyme protein
- Enzyme-treated products show improved digestibility for lactose-intolerant individuals

The Kluyveromyces lactis organism itself has been extensively studied in food fermentation research and is recognized as safe for food applications by major regulatory bodies. Published research in food chemistry and dairy science journals confirms the technical efficacy of lactase in various dairy 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. "Lactase From Saccharomyces (kluyveromyces) Lactis — Safety, regulation, and evidence." https://additivefacts.com/additives/lactase-from-saccharomyces-kluyveromyces-lactis. Accessed 2026-05-12.