Moderate Cosmetic Ingredient NOAEL Data

Casein

CAS Number
9000-71-9
Function
Anti-static agent; Emulsifier; Flavouring and nutrient; Processing aids not otherwise specified; Softener and conditioner; Surface modifier; Thickening agent
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes GRAS for food use (21 CFR); permitted in cosmetics if safe under FD&C Act

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.

Toxicological Studies

10 study endpoints found for Casein. 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 37000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 16500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 37500 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 rat Short Term Toxicity COSMOS_DB
NOAEL 6330 mg/kg bw/day oral rabbit Special Toxicology Study COSMOS_DB
NOAEL 9000 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 32000 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
dose_tested 37000 mg/kg bw/day oral rat Chronic COSMOS_DB
dose_tested 6330 mg/kg bw/day oral rabbit Special Toxicology Study COSMOS_DB

Expert Verdict

Major allergen (milk protein) requiring declaration due to cross-reactivity risk for individuals with cow's milk allergy; not suitable for vegan-labeled products.

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Concern Level: High

Regulatory Flags

potential-allergen fda_food_additive

Frequently Asked Questions

Is Casein safe in cosmetics?

Major allergen (milk protein) requiring declaration due to cross-reactivity risk for individuals with cow's milk allergy; not suitable for vegan-labeled products. The EU classifies Casein as "permitted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is Casein allowed in the EU?

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

What does Casein do in cosmetics?

Casein functions as: Anti-static agent; Emulsifier; Flavouring and nutrient; Processing aids not otherwise specified; Softener and conditioner; Surface modifier; Thickening agent. It is classified as a cosmetic ingredient in our database. CAS number: 9000-71-9.

What is the Margin of Safety for Casein?

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.

What is the NOAEL for Casein?

The NOAEL (No Observed Adverse Effect Level) for Casein is 37000 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.

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