Compoatlas

HC BLUE NO. 4

Official label name (INCIInternational name of cosmetic ingredients: the one printed on the pack. name, EU glossary of cosmetic ingredient names), No 11580

HC BLUE NO. 4: Prohibited in hair dyes (Annex II, entry 1256), under Regulation (EC) No 1223/2009. Annexes of the Regulation consulted on 23 October 2026.

Who it concerns

What official classifications and rules say for each group. A classification describes the hazard of the pure substance, not the risk of a product that contains it, which depends on the dose and the exposure.

Prohibition or serious classificationThe text prohibits the substance for this use, or ranks it among the most serious hazards (known or presumed carcinogenic, mutagenic or reprotoxic, identified endocrine disruptor).Worth watchingThe text sets a condition or flags a hazard worth knowing: allergen, suspected effect, condition for children, hazard to the aquatic environment.For informationOfficial information with no condition on a finished product: warning to read, irritation of the pure substance.

  • Pregnancy and breastfeeding

    No classification harmonised by the European Union covers reproduction, the unborn child or breastfeeding for this substance. This does not mean it has been judged to have no effect during pregnancy.

  • Babies and children

    The Cosmetics Regulation sets no age-related condition for this ingredient.

  • Skin, eyes and allergies

    No harmonised classification for sensitisation, irritation or eye damage, and no obligation to label it as an allergen.

  • Environment

    No harmonised classification as hazardous to the aquatic environment, and it is not on ECHAEuropean Chemicals Agency.'s Candidate List as an endocrine disruptor for the environment.

  • Read on the label

    The Cosmetics Regulation requires no warning to be printed for this ingredient.

In plain words

What it is used for

Functions declared by manufacturers:

Hair dyeing: colours hair.

Functions declared in the CosIngThe European Commission's database of cosmetic ingredients. inventory. CosIng, inventory of cosmetic ingredients (INCI names, CAS, EC, functions), retrieved 21 October 2026.

Definitions of functions (decision repealed on 8 May 2020, cited for information). Decision 2006/257/EC, inventory of cosmetic ingredients (definitions of functions), retrieved 22 October 2026.

What the rules say

Prohibited as a substance in hair dye products. This entry does not cover other uses, which may fall under another annex.

CosIng, Annex II of Regulation (EC) No 1223/2009 (prohibited substances), retrieved 23 October 2026, source updated 13 October 2026.

The text of the annexes

Prohibited in hair dyes

CosIng links the name HC BLUE NO. 4 to this entry. The cases of prohibition are explained above, in “In plain words”; the official title is given below.

Entry
Annex II, No 1256
Substance
N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethanolamine (HC Blue No 4) and its salts, when used as a substance in hair dye products
CAS
158571-57-4

Regulation (EC) No 1223/2009, Annex II, entry 1256. CosIng, Annex II of Regulation (EC) No 1223/2009 (prohibited substances), retrieved 23 October 2026, source updated 13 October 2026.

Entry from Regulation (EC) No 1223/2009, adopted on 30 November 2009.

SCCSEU Scientific Committee on Consumer Safety: it assesses cosmetic ingredients. opinions cited: Opinion concerning Use of Permanent Hair Dyes and Bladder Cancer - Updated 2004; Opinion concerning Hair Dyes without File submitted; Opinion on Personal Use of Hair Dyes and Cancer Risk; Opinion on the Use of Permanent Hair Dyes and Bladder Cancer Risk; Assessment Strategies for Hair Dyes.

What has changed, and what will change

Dates of the texts that cover this ingredient. A text date may cover several substances: the details of each entry are below.

  1. Annex II, entry 1256: introduced or replaced by Regulation (EC) No 1223/2009

  2. Annex II, entry 1256: applies from this date

Identity

CosIng identifier
34192
CAS (according to CosIng)
158571-57-4
Declared functions
Hair dyeing

Elsewhere in the world

Information on other jurisdictions, with no effect on sale in France. What is covered, and what is not yet.

Comparison between countries

Most restrictive status in each country, and the maximum concentration cited. The details and the source of each rule follow.

Comparison between countries: HC BLUE NO 4
CountryRuleMaximum concentration cited
European UnionProhibited in hair dyesnot cited
United KingdomProhibited in hair dyesnot cited
SwitzerlandEU Regulation appliesnot cited
United States (federal)No federal rule recordednot cited
JapanNo entry in the lists recordednot cited
South KoreaProhibited differs from the EUnot cited
ChinaProhibited differs from the EUnot cited
AustraliaNo entry in the lists recordednot cited
BrazilProhibited differs from the EUnot cited

United Kingdom (Great Britain)

  • Prohibited in hair dyes (Annex II)

Same entries as in the European Union. Their maximum concentrations are compared in the “Comparison between countries” table; other conditions (product types, warnings) may differ.

Annexes II to VI in force. United Kingdom, Annexes II to VI of Regulation (EC) No 1223/2009 as retained and amended, retrieved 21 October 2026.

Contains public sector information licensed under the Open Government Licence v3.0.

Northern Ireland applies EU law.

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.

United States, 21 CFR part 700 and section 250.250 (FDA rules on cosmetic ingredients), eCFR, retrieved 21 October 2026.

The eCFR is not an official legal edition of the Code of Federal Regulations.

South Korea

  • Prohibited: N-메칠-1,4-디아미노안트라퀴논, 에피클로히드린 및 모노에탄올아민의 반응생성물(에이치시 청색 No. 4) 및 그 염류

    별표 1 (prohibited substances), entry 238, page 12.

    Conditions, source text, in Korean

    화학물질명: 에이치시 청색No.4 (CAS No. 158571-57-4)

South Korea, MFDS Regulation on Safety Standards for Cosmetics, Notification 2026-19, retrieved 22 October 2026.

Source: 식품의약품안전처 (MFDS), 화장품 안전기준 등에 관한 규정, via law.go.kr; table formatted by the publisher of this site.

China

  • Prohibited: HC 蓝 NO. 4 (N-甲基-1,4-二氨基蒽醌和乙醇胺、表氯醇的反应产物) 及其盐类 (N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethanolamine (HC Blue No. 4) (CAS No. 158571-57-4) and its salts)

    表1 化妆品禁用原料目录 (prohibited substances, 2021年第74号), entry 978, page 附件2 (.doc) table row 978 ; TID reprint p.38.

China, NMPA catalogues of prohibited cosmetic ingredients (2021 No. 74, revised up to 2026), retrieved 22 October 2026.

Source: 国家药品监督管理局 (NMPA); plant catalogue as reprinted by the Trade and Industry Department of Hong Kong; table formatted by the publisher of this site.

Brazil

  • Prohibited: N-metil-1,4-diaminoantraquinona, produtos da reação com epicloridrina e monoetanolamina (HC azul n.º 4) e seus sais, quando usado como substância que entra na composição de corantes capilares

    RDC 529/2021, Anexo (prohibited substances), entry 1256, page 43.

    Conditions, source text, in Portuguese

    N° UE: 1256

Brazil, ANVISA resolutions RDC 529/2021, 528/2021, 600/2022 and 628/2022, retrieved 22 October 2026.

Source: ANVISA. Text of the adopted draft resolutions, as the Official Journal could not be accessed; the 2021 lists of prohibited substances and preservatives were compared with the copy of the published text distributed by the State of Paraná, the 2022 lists of UV filters and colorants were not.

Glossary: Commission Implementing Decision (EU) 2025/1175. Page updated on 23 October 2026.

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