Is Levulinic Acid safe in cosmetics?
Levulinic Acid has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. This ingredient has been reviewed by CIR Safety Assessment.
Levulinic Acid
Also known as: 4-03-00-01560, Acetopropionic acid, beta-Acetylpropionic acid, BRN 0506796, EINECS 204-649-2 (+14 more)
INCI: LEVULINIC ACID
Levulinic Acid (CAS 123-76-2) is a cosmetic preservative functioning as Preservative (combination systems); antimicrobial contributor; pH adjuster. NOAEL 1000 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; 1 safety opinion reviewed (CIR Safety Assessment). 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.
Cross-Vertical Regulatory Divergence
Levulinic Acid is classified GHS Danger (H302, H315, H317, H318, H319) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu status; Chemicals: ghs classifications.signal word/hazard statement code
Function
Preservative (combination systems); antimicrobial contributor; pH adjuster (mild acidification)
Editorial assessment
EXCELLENT
Preliminary editorial note — not a computed safety verdict.
Chemistry & Identifiers
IUPAC Name
4-oxopentanoic acid
InChIKey
JOOXCMJARBKPKM-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permitted without restriction. Naturally derived from cellulose and starch hydrolysis — bio-renewable origin. No adverse FDA findings. Accepted for natural and COSMOS-certified formulations.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Levulinic Acid.
Calculate MoS for your specific formulation with the MoS Calculator.
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
CIR Safety Assessment
Verdict: safe
ormulations, and concluded that these ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-irritating. Keywords Cosmetic Ingredient Review, Expert Panel for Cosmetic Ingredient Safety, Safety, Cosmetics,
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Levulinic Acid across SCCS product categories, with measured dermal absorption where available.
HRIPT Human Patch Test Studies
1 human repeat insult patch test aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HMT | - | 0 | 2700 | - | - |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Regulatory (8)
JECFA Number
606
Source: WHO/JECFA
JECFA Evaluation
3-ACETYLPROPIONIC ACID | 2023 | Not evaluated | JECFA requests that updated exposure data (including both MSDI and SPET values) be provided for the flavouring agents citronelloxyacetaldehyde (No. 592), 1,3-nonanediol acetate (No. 605), levulinic acid (No. 606), hydroxycitronellal diethyl acetal (No. 613), diethyl malonate (No. 614), diethyl tartrate (No. 622) and triethyl citrate (No. 629) within…
Source: WHO/JECFA
JECFA Evaluation
beta-ACETYLPROPIONIC ACID | 2023 | Not evaluated | JECFA requests that updated exposure data (including both MSDI and SPET values) be provided for the flavouring agents citronelloxyacetaldehyde (No. 592), 1,3-nonanediol acetate (No. 605), levulinic acid (No. 606), hydroxycitronellal diethyl acetal (No. 613), diethyl malonate (No. 614), diethyl tartrate (No. 622) and triethyl citrate (No. 629)…
Source: WHO/JECFA
JECFA Evaluation
gamma-KETOVALERIC ACID | 2023 | Not evaluated | JECFA requests that updated exposure data (including both MSDI and SPET values) be provided for the flavouring agents citronelloxyacetaldehyde (No. 592), 1,3-nonanediol acetate (No. 605), levulinic acid (No. 606), hydroxycitronellal diethyl acetal (No. 613), diethyl malonate (No. 614), diethyl tartrate (No. 622) and triethyl citrate (No. 629) within…
Source: WHO/JECFA
JECFA Evaluation
4-OXOPENTANOIC ACID | 2023 | Not evaluated | JECFA requests that updated exposure data (including both MSDI and SPET values) be provided for the flavouring agents citronelloxyacetaldehyde (No. 592), 1,3-nonanediol acetate (No. 605), levulinic acid (No. 606), hydroxycitronellal diethyl acetal (No. 613), diethyl malonate (No. 614), diethyl tartrate (No. 622) and triethyl citrate (No. 629) within 2…
Source: WHO/JECFA
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Flavouring and nutrient
Fragrance
Softener and conditioner
Regulatory List Membership (4)
EU Regulated in Personal Care
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
Consumer Product Chemical
Editorial summary
Preliminary editorial summary for Levulinic Acid — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
cosmos-approved
natural-derived
bio-renewable
ph-dependent
pka-4.6
combination-systems
clean-label
p-anisic-acid-pair
not-annex-v
ifra_fragrance
fda_food_additive
jecfa_safe
Known Synonyms
4-03-00-01560
Acetopropionic acid
beta-Acetylpropionic acid
BRN 0506796
EINECS 204-649-2
FEMA No. 2627
3-Ketobutane-1-carboxylic acid
Laevulic acid
Propionic acid, 3-acetyl-
Valeric acid, 4-oxo-
3-Acetylpropionsaeure
Acidum laevulinicum
4-Oxopentansaeure
UNII-RYX5QG61EI
3-Acetylpropionate
4-Ketovalerate
4-Oxopentanoate
4-Oxovalerate
Laevulinate
Chemical Function
Softener and conditioner
Fragrance
Flavouring and nutrient
Regulatory Lists
pharmaceutical
Europe
pharmaceutical
Europe; Personal care
Europe; Personal care
Europe; Personal care
IFRA Transparency
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
consumer_product
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
LEVULINIC ACID
ChEMBL ID
CHEMBL1235931
Max Phase
3
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
LEVULINIC ACID
ADI
No safety concern at current levels of intake when used as a flavouring agent mg/kg bw
Food Category
flavoring
Frequently Asked Questions
Is Levulinic Acid allowed in the EU?
Levulinic Acid EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Levulinic Acid do in cosmetics?
Levulinic Acid functions as: Preservative (combination systems); antimicrobial contributor; pH adjuster (mild acidification). It is classified as a Preservative in our database. CAS number: 123-76-2.
Is Levulinic Acid used outside cosmetics?
Levulinic Acid 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.
Does Levulinic Acid have different safety status in cosmetics vs industrial chemicals?
Levulinic Acid is classified GHS Danger (H302, H315, H317, H318, H319) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check Levulinic Acid compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
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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