Mandelic Acid
Description
Benzeneacetic acid, .alpha.-hydroxy-
Function
Properties
Regulatory Status
Mandelic Acid (CAS 90-64-2) is an alpha-hydroxy acid permitted without restriction under EU Regulation (EC) No. 1223/2009 and US FD&C Act. Non-irritating to skin, LLNA negative, non-mutagenic. Key concerns: H318 serious eye damage classification; AHA-class photosensitivity (~18% increase in UV-induced skin sensitivity). Data gaps exist for NOAEL from repeated dose studies and reproductive/developmental toxicity.
Permitted cosmetic ingredient under FD&C Act. Not GRAS classified for OTC drug use. FDA 2005 AHA labeling guidance applies: products must include sun protection advisory (daily SPF use recommended). CIR 1998 report (reaffirmed 2017) evaluated glycolic and lactic acids but not mandelic acid specifically; comparable AHA safety conditions suggested (≤10% consumer, pH ≥3.5, sun protection). Not subject to any FDA concentration restriction as a cosmetic.