Good Active Ingredient NOAEL Data SCCS/CIR Reviewed

Biotin

INCI: BIOTIN

CAS Number

58-85-5

Function

Scalp conditioning; hair care active

Safety Rating

GOOD

Regulatory Status

🇪🇺 EU Status permitted

🇺🇸 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)

not established

Dermal Absorption

negligible

Sensitization

none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Biotin. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint	Value	Route	Species	Study Type	Source
NOAEL	35 mg/kg bw/day	oral	rat	Subchronic	COSMOS_DB
NOAEL	50 mg/kg bw/day	oral	mouse	Short Term Toxicity	COSMOS_DB
NOAEL	50 mg/kg bw/day	oral	mouse	Short Term Toxicity	COSMOS_DB
NOAEL	360 mg/kg bw/day	oral	rat	Short Term Toxicity	COSMOS_DB
NOAEL	35 mg/kg bw/day	oral	rat	Subchronic	COSMOS_DB
NOAEL	1 mg/kg bw/day	oral	rat	Special Toxicology Study	COSMOS_DB
NOAEL	1 mg/kg bw/day	oral	gerbil	Short Term Toxicity	COSMOS_DB
NOAEL	150 mg/kg bw/day	oral	mouse	Developmental	COSMOS_DB
NOAEL	2.8 mg/kg bw/day	oral	swine	Reproductive	COSMOS_DB
NOAEL	4.4 mg/kg bw/day	oral	swine	Reproductive	COSMOS_DB

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir 19 September 2001

Verdict: unknown

Expert Verdict

Biotin (CAS 58-85-5) is a water-soluble B-complex vitamin (Vitamin B7/H) with CIR safe as used status, first assessed in 2001 and reaffirmed in the 2017 re-review, unrestricted across all major markets including EU, US, UK, Canada, Japan, Korea, China, and ASEAN with no Annex listings under EU Cosmetics Regulation EC No 1223/2009. No formal MoS was calculated due to absent dermal absorption data; safety is justified by low use concentrations (max leave-on 0.1% per 2015 industry survey) and comparison to dietary intake. The critical regulatory risk is claims-related, not safety-related: the FDA explicitly classifies topical biotin as NOT GRAS for hair growth or hair loss prevention drug claims under 21 CFR 310.527, meaning such labeling converts a cosmetic into an unapproved drug.

⚠️

Concern Level: Low

Regulatory Flags

eu-unrestricted cir-approved gras-fda natural-origin no-sccs-opinion fda_food_additive

Frequently Asked Questions

Is Biotin safe in cosmetics?

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.

What is the Margin of Safety for Biotin?

not established 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.

What is the NOAEL for Biotin?

The NOAEL (No Observed Adverse Effect Level) for Biotin is 35 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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 55 jurisdictions

🧮

MoS Calculator

Calculate Margin of Safety using SCCS methodology

⚗️

Heavy Metal Limits

Compare limits across jurisdictions

Related Ingredients

Oligopeptide-68

Good

Gluconic Acid

Good

Citric Acid R

Good

Ashwagandha (Withania Somnifera) Root Ext

Good

Palmitoyl Dipeptide-6 Diaminohydroxybutyr

Moderate

Browse all 30,000+ ingredients →

📱

Is Biotin in Your Products?

Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free →

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Biotin in your formulation.

Ingredient Decoder MoS Calculator