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 Betaine. 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 | >5771 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | >812 mg/kg bw/day | oral | rat | oral | REACH |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Betaine, relevant to systemic exposure and MoS calculations.
Source: Cosmetic Science
Expert Verdict
CIR 2018 concluded safe at up to 8.7% (rinse-off). Oral LD50 rat >11,179 mg/kg (OECD 401). Dermal absorption ~0.1% (OECD 428). NOAEL >5,771 mg/kg/day (104-week rat). Negative genotoxicity (Ames, chromosome aberration, micronucleus). Non-irritating; anti-irritant at 4-5% (reduces SLS-induced erythema). No SCCS restrictions. CosIng Ref 74520. GRAS (FDA, FEMA 4223). MoS estimated >230,000. COSMOS/ECOCERT approved.
Regulatory Flags
Frequently Asked Questions
Is Betaine safe in cosmetics?
CIR 2018 concluded safe at up to 8.7% (rinse-off). Oral LD50 rat >11,179 mg/kg (OECD 401). Dermal absorption ~0.1% (OECD 428). NOAEL >5,771 mg/kg/day (104-week rat). Negative genotoxicity (Ames, chromosome aberration, micronucleus). Non-irritating; anti-irritant at 4-5% (reduces SLS-induced erythema). No SCCS restrictions. CosIng Ref 74520. GRAS (FDA, FEMA 4223). MoS estimated >230,000. COSMOS/ECOCERT approved. The EU classifies Betaine as "permitted". Safety rating: EXCELLENT. 2 toxicological study endpoint(s) are available in our database.
Is Betaine allowed in the EU?
Betaine EU regulatory status: permitted. Maximum allowed concentration: 8.7% (rinse-off). This is based on EU Regulation 1223/2009 and its amendments.
What does Betaine do in cosmetics?
Betaine functions as: Humectant, osmolyte, osmoprotectant; zwitterionic; stabilizes cellular protein structure under osmotic stress; non-tacky sensory profile; derived from sugar beet (Beta vulgaris) processing. It is classified as a Humectant in our database. CAS number: 107-43-7.
What is the Margin of Safety for Betaine?
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 Betaine?
The NOAEL (No Observed Adverse Effect Level) for Betaine is >5771 mg/kg bw/day based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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