Beeswax/Cera Alba

Beeswax (Cera Alba, CAS 8012-89-3) is a natural animal-derived wax produced by honeybees with over four decades of documented cosmetic safety history. The CIR Expert Panel concluded it is safe as used in cosmetics in 1984, reaffirmed in 2005, with routine re-review completed in 2025. EU status is fully unrestricted under Regulation (EC) 1223/2009 with no SCCS opinion required. While broadly safe, sensitization potential of approximately 18% has been documented in patients with pre-existing cheilitis or facial dermatitis, primarily driven by propolis cross-reactivity; formulators should consider propolis-free beeswax specifications for susceptible populations.

GRAS status under 21 CFR 184.1973 (direct food additive). Permitted as OTC drug ingredient under 21 CFR 310.545 (skin protectants, ophthalmic products); permitted up to 5% in ophthalmic preparations with emollients per 21 CFR 349.13. For cosmetics, permitted without restrictions under FD&C Act and maintains compliance under MoCRA (Modernization of Cosmetics Regulation Act, 2022). Not classified as an active sunscreen ingredient. Registered in >8,800 cosmetic formulations per 2024 FDA Voluntary Cosmetic Reporting Program (VCRP) data.