Good Active Ingredient NOAEL Data Dermal Penetration

Malic Acid

INCI: MALIC ACID

CAS Number
617-48-1
Function
Dicarboxylic AHA from apples (Pyrus Malus). Lacks the exfoliating potency of glycolic or lactic acid and is typically used in combination with other AHAs, particularly in brightening and anti-hyperpigmentation formulations. Contributes mild exfoliation, pH buffering, and chelation in multi-acid blends.
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes GRAS affirmed under 21 CFR 184.1069 (both DL- and L-forms) as food additive (pH control, flavor enhancer, antimicrobial). Not permitted in baby food. FDA recommends ≤10% concentration at pH ≥3.5 for consumer OTC cosmetics. Professional/salon use up to 30% at pH ≥3.0. Mandatory Sunburn Alert labeling recommended per FDA 2005 AHA guidance. Not a GRASE sunscreen ingredient.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Malic 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 200 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 1400 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 40 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 266 mg/kg bw/day oral mouse Developmental COSMOS_DB
NOAEL 350 mg/kg bw/day oral rat Developmental COSMOS_DB
dose_tested 200 mg/kg bw/day oral rat Chronic COSMOS_DB
dose_tested 1400 mg/kg bw/day oral dog Chronic COSMOS_DB
dose_tested 40 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
dose_tested 266 mg/kg bw/day oral mouse Developmental COSMOS_DB
dose_tested 350 mg/kg bw/day oral rat Developmental COSMOS_DB

Dermal Penetration Profile

Skin absorption and penetration characteristics of Malic Acid, relevant to systemic exposure and MoS calculations.

Absorption %
6-10%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum/epidermis
Molecular Weight
134.1 Da
Log P
-1.26
Systemic Absorption
minimal
Topical Bioavailability
4-8%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation

Source: Int J Cosmet Sci 2009

Expert Verdict

Malic Acid is an AHA concluded safe by CIR Expert Panel (2022) in present practices of use and concentration. EU unrestricted — not listed on Annex II, III, V, or VI of Regulation (EC) No. 1223/2009. pH-dependent irritation profile; less irritating at higher pH. Key concern: AHA class UV photosensitivity risk increases skin sensitivity to sun and sunburn potential. FDA recommends Sunburn Alert labeling for AHA-containing cosmetics. In vitro ocular irritation predicted severe at 2.27% pH 3.0-3.6.

⚠️
Concern Level: Moderate

Regulatory Flags

eu-unrestricted cir-approved no-sccs-opinion gras-fda phototoxic epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Malic Acid safe in cosmetics?

Malic Acid is an AHA concluded safe by CIR Expert Panel (2022) in present practices of use and concentration. EU unrestricted — not listed on Annex II, III, V, or VI of Regulation (EC) No. 1223/2009. pH-dependent irritation profile; less irritating at higher pH. Key concern: AHA class UV photosensitivity risk increases skin sensitivity to sun and sunburn potential. FDA recommends Sunburn Alert labeling for AHA-containing cosmetics. In vitro ocular irritation predicted severe at 2.27% pH 3.0-3.6. The EU classifies Malic Acid as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Malic Acid allowed in the EU?

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

What does Malic Acid do in cosmetics?

Malic Acid functions as: Dicarboxylic AHA from apples (Pyrus Malus). Lacks the exfoliating potency of glycolic or lactic acid and is typically used in combination with other AHAs, particularly in brightening and anti-hyperpigmentation formulations. Contributes mild exfoliation, pH buffering, and chelation in multi-acid blends.. It is classified as a Active Ingredient in our database. CAS number: 617-48-1.

What is the Margin of Safety for Malic 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 Malic Acid?

The NOAEL (No Observed Adverse Effect Level) for Malic Acid is 200 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Malic Acid compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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