Good Active Ingredient NOAEL Data

Folic Acid

INCI: FOLIC ACID

CAS Number
59-30-3
Function
Anti-aging; DNA synthesis/repair support; skin conditioning; wound healing
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No standalone CIR cosmetic safety assessment identified. FDA-GRAS for food use. Emerging anti-aging use for DNA repair activity. B9+B12 combination shows 25-30% wound closure improvement in clinical data. Critical stability issues: high heat and high light sensitivity require low-temperature manufacturing, opaque packaging, and neutral-alkaline pH formulation.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Folic 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 50 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 0.5 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 1.5 mg/kg bw/day oral mouse Developmental COSMOS_DB
NOAEL 92 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2.6 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 3.8 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
dose_tested 50 mg/kg bw/day oral rat Developmental COSMOS_DB
dose_tested 0.5 mg/kg bw/day oral rat Developmental COSMOS_DB
dose_tested 1.5 mg/kg bw/day oral mouse Developmental COSMOS_DB
dose_tested 92 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

Expert Verdict

Emerging but formulation-challenging vitamin in cosmetics with strong rationale for anti-aging and wound healing, though severe heat and light instability necessitates opaque packaging, neutral-alkaline pH, and low-temperature manufacturing. Best used in B9+B12 combination where clinical evidence is strongest.

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Concern Level: Low

Regulatory Flags

anti-aging dna-repair wound-healing high-heat-sensitivity high-light-sensitivity opaque-packaging-required formulation-challenge b9-b12-synergy emerging-ingredient fda_food_additive

Frequently Asked Questions

Is Folic Acid safe in cosmetics?

Emerging but formulation-challenging vitamin in cosmetics with strong rationale for anti-aging and wound healing, though severe heat and light instability necessitates opaque packaging, neutral-alkaline pH, and low-temperature manufacturing. Best used in B9+B12 combination where clinical evidence is strongest. The EU classifies Folic Acid as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Folic Acid allowed in the EU?

Folic Acid EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Folic Acid do in cosmetics?

Folic Acid functions as: Anti-aging; DNA synthesis/repair support; skin conditioning; wound healing. It is classified as a Active Ingredient in our database. CAS number: 59-30-3.

What is the Margin of Safety for Folic 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 Folic Acid?

The NOAEL (No Observed Adverse Effect Level) for Folic Acid is 50 mg/kg bw/day based on a Developmental study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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