Excellent Cosmetic Ingredient NOAEL Data

Lactose

INCI: LACTOSE

CAS Number
63-42-3
Function
Skin conditioning agent; humectant; bulking agent; filler
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Permitted — GRAS food substance (21 CFR 184.1(b)(2)); widely used pharmaceutical excipient; no cosmetic restrictions under 21 CFR 700

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Lactose. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL 15000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 15000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 10000 mg/kg bw/day oral mouse Developmental COSMOS_DB
NOAEL 24868 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 24868 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 82500 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 12500 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 10000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 10000 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 35000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

Expert Verdict

Ensure milk protein-free grade if targeting milk-allergic consumers (trace casein/whey may persist in crude lactose); hygroscopic—may affect formulation stability; not a concern for lactose intolerance via topical route (enzyme deficiency is GI-specific)

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Concern Level: Low

Regulatory Flags

ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Lactose safe in cosmetics?

Ensure milk protein-free grade if targeting milk-allergic consumers (trace casein/whey may persist in crude lactose); hygroscopic—may affect formulation stability; not a concern for lactose intolerance via topical route (enzyme deficiency is GI-specific) The EU classifies Lactose as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

Is Lactose allowed in the EU?

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

What does Lactose do in cosmetics?

Lactose functions as: Skin conditioning agent; humectant; bulking agent; filler. It is classified as a cosmetic ingredient in our database. CAS number: 63-42-3.

What is the Margin of Safety for Lactose?

adequate 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.

What is the NOAEL for Lactose?

The NOAEL (No Observed Adverse Effect Level) for Lactose is 15000 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Lactose compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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