Is Biotin safe in cosmetics?
Biotin has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. This ingredient has been reviewed by cir.
Biotin
Also known as: D-(+)-Biotin, D-Biotin, Biotin (Vitamin H), EINECS 200-399-3, Hexahydro-2-oxo-1H-thieno(3,4-d)imidazole-4-pentanoic acid, (3aS-(3aalpha,4beta,6aalpha))- (+15 more)
INCI: BIOTIN
Biotin (CAS 58-85-5) is a cosmetic active ingredient functioning as Scalp conditioning; hair care active. EU Regulation 1223/2009 status: permitted; 1 safety opinion reviewed (cir). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 58-85-5 →
Auto-generated CPSR Part A draft with source citations
Function
Scalp conditioning; hair care active
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Dual regulatory identity in the US. (1) GRAS as a food/dietary nutrient under 21 CFR 182.8159; RDI 30 ug/day for adults. (2) CIR concluded safe as used in cosmetics (2001, reaffirmed 2017); reported cosmetic uses grew from 71 (1998) to 506 (2017); max leave-on concentration 0.1% (2015 industry data); spray/aerosol use at 0.009-0.1% with minimal inhalation risk (95-99% of particles >10 um). (3) CRITICAL: Under 21 CFR 310.527, biotin is explicitly listed as NOT GRAS for external OTC use as a hair grower or hair loss prevention drug — topical hair growth claims trigger unapproved drug status. (4) FDA issued safety communications in 2017 and 2019 warning that high-dose biotin supplementation (5-10 mg/day) can interfere with immunoassay-based lab tests causing false-positive or false-negative results; at least one death reported from a missed MI diagnosis due to falsely low troponin; cessation recommended at least 2 days before blood tests (up to 1 week for high-dose therapy). Standard multivitamin doses (30-60 ug/day) generally below interference thresholds. No VCRP-specific concentration restrictions apply to cosmetic use.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Biotin.
Calculate MoS for your specific formulation with the MoS Calculator.
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
cir
19 September 2001
Verdict: unknown
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1 - 10 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Additional Ingredient Properties
5 property records from structured ingredient metadata.
baby_pediatric
{"cas_number": "58-85-5", "ingredient_class": "other", "pediatric_safety_rating": "excellent", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "Vitamin B7", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern": "Appropriate dosing important", "skin…
concentration
{"min_concentration_pct": "0.001", "max_concentration_pct": "0.05", "typical_concentration_pct": "0.01", "product_type": "Hair Mask", "function_at_concentration": "Hair strengthening", "source": "Clinical literature"}
hair_care
{"hair_function": "strengthening", "hair_type_suitability": "all", "curl_pattern_suitability": "all", "porosity_suitability": "all", "protein_sensitivity": "protein", "moisture_protein_balance": "yes", "cg_method_approved": "not-a-silicone", "silicone_type": "not-a-sulfate", "sulfate_type": "no", "drying_alcohol": "no", "fatty_alcohol": "no", "heat_protectant": "yes", "color_safe": "strengthens", …
regulatory
{"eu_status": "allowed", "us_status": "allowed"}
solubility_hlb
{"water_soluble": "partial", "oil_soluble": "no", "soluble_in": "water, ethanol", "insoluble_in": "oils, glycerin, silicones", "log_p": "-1.6", "melting_point_c": "232-233", "appearance": "white powder", "source": "DSM"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Chelating agent
Flavouring and nutrient
Pharmaceutical
Softener and conditioner
Regulatory List Membership (2)
EU Regulated in Personal Care
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Biotin.
Regulatory Flags
eu-unrestricted
cir-approved
gras-fda
natural-origin
no-sccs-opinion
fda_food_additive
Known Synonyms
D-(+)-Biotin
D-Biotin
Biotin (Vitamin H)
EINECS 200-399-3
Hexahydro-2-oxo-1H-thieno(3,4-d)imidazole-4-pentanoic acid, (3aS-(3aalpha,4beta,6aalpha))-
Injacom H
2'-Keto-3,4-imidazolido-2-tetrahydrothiophene-N-valeric acid
cis-Tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric acid
1H-Thieno(3,4-d)imidazole-4-pentanoic acid, hexahydro-2-oxo-, (3aS-(3aalpha,4beta,6aalpha))-
Vitamin Bw
beta-Biotin
Medebiotin
Biotinum
UNII-6SO6U10H04
(+)-cis-Hexahydro-2-oxo-1H-thieno[3,4]imidazole-4-valerate
(3aS,4S,6aR)-Hexahydro-2-oxo-1H-thieno[3,4-D]imidazole-4-valerate
(3aS,4S,6aR)-Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-valeric acid
-(+)-biotin
1swk
1swn
Chemical Function
Softener and conditioner
Pharmaceutical
Regulatory Lists
inert_ingredient; non_food_use; Pesticides
pharmaceutical
active_ingredient; animal_products; Europe; pharmaceutical; residue
Europe; supplements
Europe; Personal care
Europe; Personal care
Europe; Personal care
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; pharmaceutical
Canada; pharmaceutical
Canada; pharmaceutical
Europe; supplements
Europe; food_additive; supplements
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
BIOTIN
ChEMBL ID
CHEMBL857
Max Phase
4
Adverse Event Associations
3120
Frequently Asked Questions
Is Biotin allowed in the EU?
Biotin EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Biotin do in cosmetics?
Biotin functions as: Scalp conditioning; hair care active. It is classified as a Active Ingredient in our database. CAS number: 58-85-5.
Is Biotin used outside cosmetics?
Biotin also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Biotin compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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