Good Cosmetic Ingredient NOAEL Data

Aspartame

Also known as: 3-Amino-N-(alpha-carboxyphenethyl)succinamic acid N-methyl ester, stereoisomer, 3-Amino-N-(alpha-methoxycarbonylphenethyl) succinamic acid, Aspartame, L,L-alpha-, N-L-alpha-Aspartyl-L-phenylalanine 1-methyl ester, EINECS 245-261-3 (+14 more)

INCI: ASPARTAME

Aspartame (CAS 22839-47-0) is a cosmetic cosmetic ingredient functioning as Flavouring used in oral care cosmetics such as toothpaste and mouthwash. NOAEL 2000 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical and food safety data.

View industrial chemical safety profile for CAS 22839-47-0 →

Auto-generated CPSR Part A draft with source citations
Function
Flavouring used in oral care cosmetics such as toothpaste and mouthwash
Safety Rating
GOOD

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes FDA-approved as food additive; not specifically restricted for cosmetic use

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Aspartame.

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 =50 mg/kg bw/day oral Rat Chronic toxicity WHO/JECFA
NOAEL =50 mg/kg bw/day oral Rat Chronic toxicity WHO/JECFA
NOAEL =119 mg/kg bw/day oral Human; Rat Subchronic toxicity WHO/JECFA
NOAEL =119 mg/kg bw/day oral Human; Rat Subchronic toxicity WHO/JECFA
NOAEL =220 mg/kg bw/day - - Toxicology study WHO/JECFA
NOAEL =220 mg/kg bw/day - - Toxicology study WHO/JECFA
NOAEL =1000 mg/kg bw/day - - Toxicology study WHO/JECFA
NOAEL =1000 mg/kg bw/day - - Toxicology study WHO/JECFA
NOAEL =4000 mg/kg bw/day oral Rat Toxicology study WHO/JECFA
NOAEL =4000 mg/kg bw/day oral Rat Toxicology study WHO/JECFA

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Aspartame across SCCS product categories, with measured dermal absorption where available.

EPA ToxValDB — Toxicity Values

4 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint Value Species Route Duration Source
ADI <=40 mg/kg Human oral - WHO/JECFA
NOEL =2000 mg/kg-day Mouse oral acute ECOTOX
LD50 >10000 mg/kg Mouse oral - ChemIDplus
LD50 >10000 mg/kg Rat oral - ChemIDplus

IARC Carcinogenicity

International Agency for Research on Cancer (WHO) monograph evaluation.

IARC Group
2B
Volume
134
Evaluation Year
2023

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Deodorizer Flavouring and nutrient
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)

Expert Verdict

Expert safety assessment and concern-level summary for Aspartame.

Regulatory Flags

fda_food_additive

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Aspartame by CAS number or substance name.

Studies
66
Lowest NOAEL
25
Highest NOAEL
5700

Units vary across source rows: mg/kg bw/day, mg/kg bw

WHO/JECFA WHO/JECFA

Known Synonyms

3-Amino-N-(alpha-carboxyphenethyl)succinamic acid N-methyl ester, stereoisomer 3-Amino-N-(alpha-methoxycarbonylphenethyl) succinamic acid Aspartame, L,L-alpha- N-L-alpha-Aspartyl-L-phenylalanine 1-methyl ester EINECS 245-261-3 Methyl L-alpha-aspartyl-L-phenylalanate Methyl N-L-alpha-aspartyl-L-phenylalaninate Methyl L-aspartyl-L-phenylalanine 1-Methyl N-L-alpha-aspartyl-L-phenylalanine Tri-sweet Aspartamum UNII-Z0H242BBR1 (3S)-3-amino-3-{[(2S)-1-methoxy-1-oxo-3-phenylpropan-2-yl]carbamoyl}propanoic acid 1-methyl N-L-alpha-aspartyl-L-phenylalanate 3-Amino-N-(alpha-carboxyphenethyl)succinamic acid N-methyl ester Asp-phe-ome E 951 L-Aspartyl-L-phenylalanine methyl ester Sweet dipeptide

Chemical Function

Flavouring and nutrient Deodorizer

Regulatory Lists

pharmaceutical food_additive; Substances Added to Food (formerly EAFUS) (2/2019) Canada; pharmaceutical Canada; pharmaceutical

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical and food safety data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound
ASPARTAME
ChEMBL ID
CHEMBL171679
Max Phase
3
Adverse Event Associations
3
View full pharmaceutical profile →
SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Aspartame (encapsulated/coated)
ADI
40 mg/kg bw
Food Category
sweetener
View full food safety profile →

Frequently Asked Questions

Is Aspartame safe in cosmetics?

Aspartame has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 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 NOAEL for Aspartame?

The NOAEL (No Observed Adverse Effect Level) for Aspartame is =50 mg/kg bw/day based on a Chronic toxicity study via oral route in Rat. A total of 10 study endpoints are available. Source: WHO/JECFA.

Is Aspartame used outside cosmetics?

Aspartame also appears in pharmaceutical and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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