Compoatlas

KETOCONAZOLE

Official label name (INCI name, EU glossary of cosmetic ingredient names), No 14153

KETOCONAZOLE: Prohibited in cosmetics (Annex II, entry 1528), under Regulation (EC) No 1223/2009.

In plain words

What the rules say

It is prohibited to use it in a cosmetic product sold in the European Union, whatever the dose. If it appears on the ingredient list of a recent product, this needs checking: the record may be old or wrong, or the product intended for another market.

Hazard and risk

The CLP Regulation classifies this substance as toxic for reproduction, category 1B (presumed effect, established mainly from animal studies).

This classification describes what the substance can cause (a hazard), not what happens when using a product (a risk): the risk depends on the dose, the form and the route of exposure (skin, inhalation, ingestion).

Already prohibited in cosmetics (Annex II).

The text of the annexes

Prohibited in cosmetics

CosIng links the name KETOCONAZOLE to this Annex II entry.

Entry
Annex II, No 1528
Substance
Ketoconazole; 1-[4-[4-[[(2SR,4RS)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone
CAS
65277-42-1
EC
265-667-4
CMR
Reprotoxic Cat. 1B()
Dates in the act (1)
  • Entry into force on 12 June 2019

Excerpts from the English text published in the Official Journal. A date may concern only some substances of the act: the excerpt says so.

Identity

CosIng identifier
105164
CAS (according to CosIng)
65277-42-1
EC (according to CosIng)
265-667-4

Classified hazard (CLP Regulation)

A classification describes an intrinsic hazard, not a risk: the risk depends on the dose, the form and the exposure.

ketoconazole; 1-[4-[4-[[(2SR, 4RS)-2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone

CMR Repr. 1B

Hazard classes
Repr. 1B
Acute Tox. 3 *
STOT RE 2 *
Aquatic Acute 1
Aquatic Chronic 1
Hazard statements
H360F*** H301 H373** H400 H410

Already prohibited in cosmetics (Annex II).

Elsewhere in the world

Information on other jurisdictions. What is covered, and what is not yet.

United Kingdom (Great Britain)

  • Prohibited in cosmetics (Annex II)

Same entries as in the European Union. Conditions (concentrations, warnings) may differ: they are not compared here.

Switzerland

Regulation (EC) No 1223/2009 applies in Switzerland (Article 54 of the Ordinance on Foodstuffs and Utility Articles).

United States, federal rules

None of the integrated sections of the federal code (21 CFR 700.11 to 700.27 and 250.250) targets this name. The FDA does not publish a list of allowed ingredients.

South Korea

  • Prohibited: 케토코나졸 (KETOCONAZOLE)

    별표 1 (prohibited substances), entry 710, page 37.

China

  • Prohibited: 抗感染类药物，包括但不限于三溴沙仑、抗生素类、二氢速甾醇、乙硫异烟胺、呋喃唑酮、酮康唑、甲硝唑、呋喃妥因、磺胺类药物（磺胺和其氨基的一个或多个氢原子被取代的衍生物）及其盐类、甲巯咪唑、短杆菌素等 (Anti-infectives, including but not limited to 3,4',5-Tribromosalicylanilide （Tribromsalan （INN） ）（CAS No. 87-10-5）, Antibiotics, Dihydrotachysterol （INN） （CAS No. 67-96-9）, Ethionamide （INN） （CAS No. 536-33-4）, Furazolidone （INN） （CAS No. 67-45-8）, Ketoconazole （CAS No. 65277-42-1）, Metronidazole （CAS No. 443-48-1）, Nitrofurantoin （INN） （CAS No. 67-20-9）, Sulphonamides （sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups） and their salts, Thiamazole （INN） （CAS No. 60-56-0）, Thyrothricine （CAS No. 1404-88-2）)

    表1 化妆品禁用原料目录 (prohibited substances, 2021年第74号), entry 299, page 附件2 (.doc) table row 299 ; TID reprint p.14.

Brazil

  • Prohibited: Cetoconazol; 1-[4-[4-[[(2SR,4RS)-2-(2,4-diclorofenil)-2-(imidazol-1-ilmetil)-1,3-dioxolan-4-il]metoxi]fenil] piperazin-1-il]etanona (KETOCONAZOLE; 1-[4-[4-[[(2SR,4RS)-2-(2,4-DICHLOROPHENYL)-2-(IMIDAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL]METHOXY]PHENYL]PIPERAZIN-1-YL]ETHANONE) (KETOCONAZOLE; 1-[4-[4-[[(2SR,4RS)-2-(2,4-DICHLOROPHENYL)-2-(IMIDAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL]METHOXY]PHENYL]PIPERAZIN-1-YL]ETHANONE)

    RDC 529/2021, Anexo (prohibited substances): inclusões by RDC 1.030/2026, Art. 2º, entry 1414, page 5. Conditions (source text, in Portuguese): Nº UE: 1528

Glossary: Commission Implementing Decision (EU) 2025/1175. Page updated on 21 October 2026.