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
2 study endpoints found for Levulinic Acid. 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 | 500 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | oral | REACH |
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
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,
Expert Verdict
Levulinic acid is a bio-renewable, naturally derived organic acid preservative obtained from cellulose and starch hydrolysis, qualifying for COSMOS certification and clean-label positioning. It disrupts microbial energy metabolism and membrane integrity at low pH (pKa ~4.6; effective pH 3.0–5.0), rarely used as sole preservative but effective in combination systems with reduced component concentrations, improving safety and sensory profiles. Emerging ingredient in clean-beauty formulations as natural alternative to synthetic acid preservatives.
Regulatory Flags
Frequently Asked Questions
Is Levulinic Acid safe in cosmetics?
Levulinic acid is a bio-renewable, naturally derived organic acid preservative obtained from cellulose and starch hydrolysis, qualifying for COSMOS certification and clean-label positioning. It disrupts microbial energy metabolism and membrane integrity at low pH (pKa ~4.6; effective pH 3.0–5.0), rarely used as sole preservative but effective in combination systems with reduced component concentrations, improving safety and sensory profiles. Emerging ingredient in clean-beauty formulations as natural alternative to synthetic acid preservatives. The EU classifies Levulinic Acid as "permitted". Safety rating: EXCELLENT. 2 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.
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.
What is the Margin of Safety for Levulinic Acid?
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 Levulinic Acid?
The NOAEL (No Observed Adverse Effect Level) for Levulinic Acid is 500 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 2 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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