Bisabolol

Bisabolol (CAS 515-69-5 racemic; 23089-26-1 natural (-)-alpha-Bisabolol / levomenol) is one of the safest and most well-established cosmetic ingredients globally. CIR confirmed safe as used in cosmetic formulations (1999 original opinion plus subsequent re-review); no EU Annex II/III/V/VI restrictions apply, and no pending reclassifications exist in any major market. Typical industry use is 0.1-1.0% in leave-on formulations with no regulatory concentration limit. The critical formulation caveat is Bisabolol's penetration enhancement effect — MoS calculations for co-formulated actives must account for increased dermal absorption, particularly in baby products. Natural (-)-alpha-Bisabolol (CAS 23089-26-1) is COSMOS/ECOCERT certifiable and approximately 2.24x more potent than the synthetic racemic form on an actives basis.

No FDA-specific regulation; manufacturer self-regulation applies. German chamomile (primary natural source of Bisabolol) is classified as GRAS for essential oils and extractives. CIR panel confirmed safe as used in cosmetic formulations (1999 + re-review). No FDA-imposed concentration limits; typical use 0.1-1.0%. No special listing or notification requirements under MoCRA beyond standard obligations.