Is NEOTAME safe in cosmetics?
NEOTAME has a safety rating of "GOOD" in our database. EU status: permitted. 7 toxicological study endpoint(s) are available in our database.
NEOTAME
Also known as: E961, N-(N-(3,3-dimethylbutyl)-L-alpha-aspartyl)-L-phenylalanine 1-methyl ester, UNII-VJ597D52EX, N-[N-(3,3-dimethylbutyl)-L-alpha-aspartyl]-L-phenylalanine methyl ester
NEOTAME (CAS 165450-17-9) is a cosmetic cosmetic ingredient functioning as Fragrance. NOAEL 200 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 industrial chemical safety, pharmaceutical, and food safety data.
View industrial chemical safety profile for CAS 165450-17-9 →
Auto-generated CPSR Part A draft with source citations
Function
Fragrance
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
(3S)-3-(3,3-dimethylbutylamino)-4-[[(2S)-1-methoxy-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid
InChIKey
HLIAVLHNDJUHFG-HOTGVXAUSA-N
Regulatory Status
EU EU Status
permitted
US US Status
Not specifically regulated
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Toxicological Studies
7 study endpoints found for NEOTAME. 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 | Carcinogenicity | COSMOS_DB |
| NOAEL | 100 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 300 mg/kg bw/day | oral | mouse | Short Term Toxicity | COSMOS_DB |
| NOAEL | 500 mg/kg bw/day | oral | rabbit | Developmental | COSMOS_DB |
| NOAEL | 800 mg/kg bw/day | oral | dog | Chronic | COSMOS_DB |
| NOAEL | 956 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for NEOTAME across SCCS product categories, with measured dermal absorption where available.
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Regulatory (2)
JECFA Evaluation
NEOTAME | 2003 | 0-2 mg/kg bw | JECFA established an ADI of 0–2 mg/kg of body weight for neotame on the basis of a NOEL of 200 mg/kg of body weight per day in a 1-year study in dogs and a 100-fold safety factor. | TRS 922-JECFA 61/30 | FAS 52-JECFA 61/85
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
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 NEOTAME.
Regulatory Flags
cosing-sourced
eu-permitted
fragrance
needs-enrichment
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to NEOTAME by CAS number or substance name.
Studies
7
Lowest NOAEL
50 mg/kg bw/day
Highest NOAEL
1000 mg/kg bw/day
COSMOS_DB
Known Synonyms
E961
N-(N-(3,3-dimethylbutyl)-L-alpha-aspartyl)-L-phenylalanine 1-methyl ester
UNII-VJ597D52EX
N-[N-(3,3-dimethylbutyl)-L-alpha-aspartyl]-L-phenylalanine methyl ester
Chemical Function
Deodorizer
Flavouring and nutrient
Regulatory Lists
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
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.
ChEMBL ID
CHEMBL3718532
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Neotame
E Number
E961
ADI
2 mg/kg bw
Food Category
sweetener
Frequently Asked Questions
Is NEOTAME allowed in the EU?
NEOTAME EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does NEOTAME do in cosmetics?
NEOTAME functions as: Fragrance. It is classified as a cosmetic ingredient in our database. CAS number: 165450-17-9.
What is the NOAEL for NEOTAME?
The NOAEL (No Observed Adverse Effect Level) for NEOTAME is 50 mg/kg bw/day based on a Carcinogenicity study via oral route in rat. A total of 7 study endpoints are available. Source: COSMOS_DB.
Is NEOTAME used outside cosmetics?
NEOTAME also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check NEOTAME compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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