Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
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.
Regulatory Flags
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.
Compliance Tools
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Related Ingredients
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