Lactulose

INCI: LACTULOSE

CAS Number
4618-18-2 (EINECS: 225-027-7)
Function
Humectant, skin conditioning
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Allowed for cosmetic use; also an FDA-approved pharmaceutical (laxative for constipation/hepatic encephalopathy)

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Very well-characterized safety profile due to extensive pharmaceutical use; no significant topical safety issues; synthetic disaccharide (galactose + fructose). Synthetic galactosylfructose disaccharide; white powder, highly water-soluble (76.4 g/100 mL at 30°C); acts as a prebiotic that can support beneficial skin microbiome balance alongside its humectant function

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Concern Level: Moderate

Frequently Asked Questions

Is Lactulose safe in cosmetics?

Very well-characterized safety profile due to extensive pharmaceutical use; no significant topical safety issues; synthetic disaccharide (galactose + fructose). Synthetic galactosylfructose disaccharide; white powder, highly water-soluble (76.4 g/100 mL at 30°C); acts as a prebiotic that can support beneficial skin microbiome balance alongside its humectant function The EU classifies Lactulose as "permitted". Safety rating: MODERATE.

Is Lactulose allowed in the EU?

Lactulose EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Lactulose do in cosmetics?

Lactulose functions as: Humectant, skin conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 4618-18-2 (EINECS: 225-027-7).

What is the Margin of Safety for Lactulose?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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