PIGMENT RED 48
Official label name (INCIInternational name of cosmetic ingredients: the one printed on the pack. name, EU glossary of cosmetic ingredient names), No 21027
- Prohibited in hair dyes (Annex II)
- Colorant allowed under conditions (Annex IV)
PIGMENT RED 48: Prohibited in hair dyes (Annex II, entry 1348); colorant allowed under conditions (Annex IV, entry 28), 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Definitions of functions (decision repealed on 8 May 2020, cited for information).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.
An ingredient can be used as a colorant only if it appears on the list of Annex IV. PIGMENT RED 48 is on it, with no maximum concentration or restriction of use in this entry.
CosIng, Annex II of Regulation (EC) No 1223/2009 (prohibited substances), retrieved 23 October 2026, source updated 13 October 2026.
CosIng, Annex IV of Regulation (EC) No 1223/2009 (allowed colorants), retrieved 23 October 2026, source updated 13 October 2026.
Origin and odour
No natural occurrence recorded in Wikidata (LOTUS database); this does not prove that the ingredient is synthetic.
Basis: one CosIng CAS, with no natural occurrence recorded in this database.
Wikidata: names of substances in six languages and taxa in which they occur (largely from the LOTUS database), retrieved 23 October 2026.
Present in 0.0% of recorded cosmetics (0 out of 18 968).
Open Beauty Facts, export of cosmetic products, retrieved 23 October 2026.
Data “Open Beauty Facts and its contributors”, licensed under ODbL 1.0 (opendatacommons.org/licenses/odbl/1-0); derived table distributed under the same licence.
The text of the annexes
Prohibited in hair dyes
CosIng links the name PIGMENT RED 48 to this entry. The cases of prohibition are explained above, in “In plain words”; the official title is given below.
- Entry
- Annex II, No 1348
- Substance
- Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48; CI 15865) when used as a substance in hair dye products
- CAS
- 3564-21-4
- EC
- 222-642-2
Dates in the act (2)
- Entry into force on 15 May 2013
- Application from 11 July 2013
It shall apply from 11 July 2013.
Excerpts from the English text published in the Official Journal. A date may concern only some substances of the act: the excerpt says so.
Regulation (EC) No 1223/2009, Annex II, entry 1348. CosIng, Annex II of Regulation (EC) No 1223/2009 (prohibited substances), retrieved 23 October 2026, source updated 13 October 2026.
Entry from Regulation (EU) n° 344/2013, adopted on 4 April 2013.
Colorant allowed under conditions
This entry covers the same substance as PIGMENT RED 48 (same CAS number in the CosIng inventory): its conditions apply.
- Entry
- Annex IV, No 28
- Substance
- Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate and its insoluble barium, strontium and zirconium lakes, salts and pigments
- Glossary names
- CI 15865
- CAS
- 3564-21-4; 5280-66-0
- EC
- 222-642-2
Regulation (EC) No 1223/2009, Annex IV, entry 28. CosIng, Annex IV of Regulation (EC) No 1223/2009 (allowed colorants), retrieved 23 October 2026, source updated 13 October 2026.
Entry from Regulation (EC) No 1223/2009, adopted on 30 November 2009.
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.
Annex IV, entry 28: introduced or replaced by Regulation (EC) No 1223/2009
Annex II, entry 1348: introduced or replaced by Regulation (EU) n° 344/2013
Annex II, entry 1348: applies from this date
Annex IV, entry 28: applies from this date
Identity
- CosIng identifier
- 36569
- CAS (according to CosIng)
- 3564-21-4
- EC (according to CosIng)
- 222-642-2
- Declared functions
- Hair dyeing
The CAS number cited by CosIng also covers 1 other INCI name: it designates a family of substances, not this ingredient alone.
CosIng inventory. CosIng, inventory of cosmetic ingredients (INCI names, CAS, EC, functions), retrieved 21 October 2026.
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.
| Country | Rule | Maximum concentration cited |
|---|---|---|
| European Union | Prohibited in hair dyes | not cited |
| United Kingdom | Prohibited in hair dyes | not cited |
| Switzerland | EU Regulation applies | not cited |
| United States (federal) | No federal rule recorded | not cited |
| Japan | No entry in the lists recorded | not cited |
| South Korea | No entry in the lists recorded | not cited |
| China | Not on the prohibited lists recorded (lists of allowed substances are not recorded) | not cited |
| Australia | No entry in the lists recorded | not cited |
| Brazil | Prohibited differs from the EU | not cited |
United Kingdom (Great Britain)
- Prohibited in hair dyes (Annex II)
- Colorant allowed under conditions (Annex IV)
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).
Switzerland, FDHA Ordinance on Cosmetic Products (OCos, SR 817.023.31), consolidated version, retrieved 22 October 2026.
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.
Brazil
- Prohibited: 4-[(5-cloro-4-metil-2-sulfonatofenil)azo]-3-hidroxi-2-naftoato dissódico (CI 15865), quando usado como substância que entra na composição de corantes capilares
RDC 529/2021, Anexo (prohibited substances), entry 1348, page 46.
Conditions, source text, in Portuguese
N° UE: 1348
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.