Is Berberine safe in cosmetics?
Berberine has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted.
Good
Cosmetic Ingredient
Berberine
Also known as: EC No.: 218-229-1, BRN 3570374, 9,10-Dimethoxy-2,3-(methylenedioxy)-7,8,13,13a-tetrahydroberbinium, EINECS 218-229-1, UNII-0I8Y3P32UF (+6 more)
INCI: BERBERINE
Berberine (CAS 2086-83-1) is a cosmetic cosmetic ingredient functioning as Antioxidant, anti-inflammatory, antimicrobial, skin-conditioning,. EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 2086-83-1 →
Auto-generated CPSR Part A draft with source citations
Function
Antioxidant, anti-inflammatory, antimicrobial, skin-conditioning, pigmentation-modulating agent
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
16,17-dimethoxy-5,7-dioxa-13-azoniapentacyclo[11.8.0.02,10.04,8.015,20]henicosa-1(13),2,4(8),9,14,16,18,20-octaene
InChIKey
YBHILYKTIRIUTE-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
No CIR safety assessment published to date; used in cosmetic formulations at low concentrations (typically 0.1–1%); GRAS considerations based on botanical history
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Berberine.
Calculate MoS for your specific formulation with the MoS Calculator.
Additional Ingredient Properties
2 property records from structured ingredient metadata.
acne
{"cas_number": "2086-83-1", "anti_acne_mechanism": "antibacterial/anti_inflammatory", "comedogenicity_rating_0_to_5": "0", "acne_type_efficacy": "inflammatory", "p_acnes_mic_ug_per_ml": "50-200", "sebum_reduction_pct_clinical": "10-15", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct": "No limit", "japan_quasi_drug_anti_acne": "No", "korea_functio…
anti_aging
{"anti_aging_claim": "anti-inflammatory, antimicrobial", "mechanism_of_action": "Bioactive compound, specialized mechanism", "target_skin_layer": "epidermis, dermis", "collagen_stimulation": "Mild", "elastin_protection": "Mild", "wrinkle_reduction_pct": "6-12", "clinical_study_duration_weeks": "12", "sample_size": "35", "double_blind": "No", "placebo_controlled": "Yes", "published_journal": "JAAD,…
Expert Verdict
Expert safety assessment and concern-level summary for Berberine.
Regulatory Flags
phototoxicity-risk
photosensitizer
no-cir-assessment
botanical-alkaloid
melanin-modulating
anti-inflammatory
antimicrobial
antioxidant
leave-on-caution
Known Synonyms
EC No.: 218-229-1
BRN 3570374
9,10-Dimethoxy-2,3-(methylenedioxy)-7,8,13,13a-tetrahydroberbinium
EINECS 218-229-1
UNII-0I8Y3P32UF
16,17-dimethoxy-5,7-dioxa-13l5-azapentacyclo[11.8.0.02,10.04,8.015,20]henicosa-1(13),2,4(8),9,14,16,18,20-octaen-13-ylium
7,8,13,13a-tetradehydro-9,10-dimethoxy-2,3-[methylenebis(oxy)]berbinium
9,10-dimethoxy-2,3-(methylenedioxy)-7,8,13,13a-tetradehydroberbinium
Benzo(g)-1,3-benzodioxolo(5,6-a)quinolizinium, 5,6-dihydro-9,10-dimethoxy-
Berberal
Coptis rhizome
Regulatory Lists
Canada; pharmaceutical
Canada; pharmaceutical
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
BERBERINE
ChEMBL ID
CHEMBL295124
Max Phase
4
Adverse Event Associations
380
Frequently Asked Questions
Is Berberine allowed in the EU?
Berberine EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Berberine do in cosmetics?
Berberine functions as: Antioxidant, anti-inflammatory, antimicrobial, skin-conditioning, pigmentation-modulating agent. It is classified as a cosmetic ingredient in our database. CAS number: 2086-83-1.
Is Berberine used outside cosmetics?
Berberine also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Berberine compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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