Good Cosmetic Ingredient NOAEL Data

Aspartame

INCI: ASPARTAME

CAS Number
22839-47-0
Function
Flavouring used in oral care cosmetics such as toothpaste and mouthwash
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA-approved as food additive; not specifically restricted for cosmetic use

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Aspartame. 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 11000 mg/kg bw/day oral rat Neurotoxicity COSMOS_DB
NOAEL 125 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 125 mg/kg bw/day oral dog Short Term Toxicity COSMOS_DB
NOAEL 8000 mg/kg bw/day oral hamster Chronic COSMOS_DB
NOAEL 4000 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 3000 mg/kg bw/day oral monkey Chronic COSMOS_DB
NOAEL 8000 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 3125 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 3325 mg/kg bw/day oral rat Reproductive COSMOS_DB
NOAEL 3225 mg/kg bw/day oral rat Reproductive COSMOS_DB

Expert Verdict

Contains phenylalanine requiring declaration for phenylketonuria patients; IARC classified as possibly carcinogenic (Group 2B) in 2023, though EFSA maintained its safety assessment.

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Concern Level: Moderate

Regulatory Flags

fda_food_additive

Frequently Asked Questions

Is Aspartame safe in cosmetics?

Contains phenylalanine requiring declaration for phenylketonuria patients; IARC classified as possibly carcinogenic (Group 2B) in 2023, though EFSA maintained its safety assessment. The EU classifies Aspartame as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Aspartame allowed in the EU?

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

What does Aspartame do in cosmetics?

Aspartame functions as: Flavouring used in oral care cosmetics such as toothpaste and mouthwash. It is classified as a cosmetic ingredient in our database. CAS number: 22839-47-0.

What is the Margin of Safety for Aspartame?

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 Aspartame?

The NOAEL (No Observed Adverse Effect Level) for Aspartame is 11000 mg/kg bw/day based on a Neurotoxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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