Regulatory Status
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Safety Data
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Dermal Penetration Profile
Skin absorption and penetration characteristics of Bisabolol, relevant to systemic exposure and MoS calculations.
Source: Int J Cosmet Sci 2011
Expert Verdict
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 โ 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.
Regulatory Flags
Frequently Asked Questions
Is Bisabolol safe in cosmetics?
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 โ 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. The EU classifies Bisabolol as "permitted". Safety rating: EXCELLENT.
Is Bisabolol allowed in the EU?
Bisabolol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Bisabolol do in cosmetics?
Bisabolol functions as: Synthetic (nature-identical) (-)-alpha-bisabolol. Sesquiterpene alcohol; anti-inflammatory via 5-lipoxygenase and cyclooxygenase inhibition; skin-conditioning and soothing. Chemically identical to plant-derived bisabolol but produced by total synthesis (ISO 16128 NI=0 โ synthetic). Lacks the companion terpenoids present in plant-derived chamomile-extracted bisabolol (chamazulene, apigenin, alpha-bisabolol oxides) that may contribute synergistic anti-inflammatory effects. Pharmaceutical-grade batch consistency and purity. Penetration enhancer.. It is classified as a Active Ingredient in our database. CAS number: 515-69-5.
What is the Margin of Safety for Bisabolol?
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.
Compliance Tools
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