Regulations of Biotin

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Identifiers

FormulaC₁₀H₁₆N₂O₃S·CAS58-85-5·EC200-399-3·HS2936.29

Functions

HAIR ConditioningSKIN Conditioning - Miscellaneous

Which United States federal regulations apply to Biotin?

3 regulations

EPA TSCA Regulatory Flag

1H-Thieno[3,4-d]imidazole-4-pentanoic acid, hexahydro-2-oxo-, (3aS,4S,6aR)-: ACTIVE

FDA Direct Food Additives

Regulatory records

Entry	Regulation	Type	Status	Source
182.8159	21 CFR 182.8159	Food Additive	authorized	View
101.9	21 CFR 101.9	Labeling Standards	authorized	View
107.100	21 CFR 107.100	Labeling Standards	authorized	View

FDA Technical Effects

Regulatory records

Regulation	Status
FDA Technical Effect: NUTRIENT SUPPLEMENT	authorized
FDA Technical Effect: SEQUESTRANT	authorized

What EU regulatory requirements apply to Biotin?

2 regulations

EFSA Legal Basis

Regulation (EC) No 178/2002 (amended)

Status Regulation (EC)

Regulation (EC) No 178/2002 (amended)

What regulations apply to Biotin in Canada?

1 regulation

DSL / NDSL

Published: 04 May 1994
Effective: 04 May 1994

Regulatory records

Entry	Regulation	Type	Status
58-85-5	SOR/94-311	DSL	authorized

Conditions

This substance is on the Domestic Substances List (DSL). This substance was added to the DSL as an “Existing Substance” given that it meets the criteria set out in CEPA for substances that were in commerce in Canada between 1984 and 1986.

Record details

SOR/94-311

professional use only: No

What regulations apply to Biotin in China?

1 regulation

IECIC Listed Ingredients (List I)

Published: 24 Jun 2025
Effective: 24 Jun 2025

Regulatory records

Entry	Regulation	Type	Status
6024	Inventory of Existing Cosmetic Ingredients in China (IECIC) I	List I	authorized

Record details

Inventory of Existing Cosmetic Ingredients in China (IECIC) I

professional use only: No

What regulations apply to Biotin in Australia?

1 regulation

The Australian Inventory of Industrial Chemicals

Chemical: 1H-Thieno[3,4-d]imidazole-4-pentanoic acid, hexahydro-2-oxo-, (3aS,4S,6aR)-

What regulations apply to Biotin in New Zealand?

1 regulation

New Zealand EPA Inventory of Chemical Status

Biotin: Does not have an individual approval but may be used under an appropriate group standard