REACH Regulation — EU Chemical Compliance for Pigments
EC 1907/2006 · Registration, Evaluation, Authorisation and Restriction of Chemicals
Overview
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), established under EC 1907/2006, is the European Union’s comprehensive regulatory framework for chemical substances. It applies to all chemical substances manufactured in or imported into the EU in quantities exceeding 1 tonne per year. For the pigment industry, REACH imposes obligations throughout the supply chain — from raw material sourcing to finished product import — and directly affects which pigments can legally be placed on the EU market.
Scope
REACH applies to:
- Manufacturers of chemical substances within the EU/EEA producing ≥1 tonne/year
- Importers bringing chemical substances, mixtures, or articles into the EU/EEA
- Downstream users (formulators, compounders, converters) who use registered substances
- Articles containing substances intended to be released under normal use
For pigments specifically, polymers are exempt from registration under Article 2(9). However, non-polymer organic pigments (low-molecular-weight colorants) may require registration if manufactured or imported ≥1 tonne/year. Inorganic pigments (oxides, sulfides, chromates) are substances and generally within REACH scope.
SVHC Candidate List — Updated Every 6 Months
The Substances of Very High Concern (SVHC) Candidate List is updated biannually by ECHA (January and July). Once a substance is listed on the Candidate List, importers and producers of articles containing that substance above 0.1% w/w have immediate notification obligations to ECHA and information obligations to customers. As of 2025, the Candidate List contains over 240 substances.
Restricted Substances in Pigments
Azo Pigments Releasing Carcinogenic Amines — Annex XVII Entry 43
Under Annex XVII Entry 43 of REACH, azo colorants that can release one or more of the 22 listed carcinogenic aromatic amines in concentrations above 30 mg/kg (30 ppm) are prohibited from use in textile and leather articles that come into prolonged contact with human skin or the oral cavity. The key regulated amines include:
- Benzidine (92-87-5) — Category 1 carcinogen
- 4-Aminobiphenyl (92-67-1) — Category 1 carcinogen
- 2-Naphthylamine (91-59-8) — Category 1 carcinogen
- 4-Chloro-o-toluidine (95-69-2) — Category 1B carcinogen
- 2,4-Toluenediamine (95-80-7), 4,4′-Methylenedianiline (101-77-9), o-Aminoazotoluene (97-56-3), and 15 others
Lead Chromate Pigments — Annex XVII Entries 16 & 63
Lead chromate and lead chromate molybdate pigments (including PY34 Lead Chromate Yellow, PR104 Molybdate Red) are restricted under Annex XVII. Their use is prohibited in paints, coatings, and most consumer applications. A limited number of industrial and professional uses may be subject to authorisation.
Cadmium Pigments — Annex XVII Entry 23
Cadmium and cadmium compounds are restricted under Annex XVII Entry 23. This directly affects cadmium sulfide (PY35), cadmium sulfoselenide (PO20), and cadmium zinc sulfide pigments. Use is prohibited in most applications with narrow exemptions for artist paints and certain industrial applications.
Affected Pigments
| Substance / Concern | CAS | Restriction Limit | Affected Pigment CIs | REACH Status |
|---|---|---|---|---|
| Benzidine-based azo pigments (release regulated amines) | Varies (22 amines) | 30 mg/kg per amine | PR3, PR48:1, PR48:2, PY12, PY13, PY14, PY17, PY83, PO13, PO34 | PROHIBITED |
| Lead chromate (PY34) | 7758-97-6 | 0.1% w/w (article notification) | PY34, PR104, Lead Molybdate Orange | RESTRICTED |
| Lead chromate molybdate sulfate (PR104) | 12656-85-8 | 0.1% w/w (article notification) | PR104 | RESTRICTED |
| Cadmium sulfide (PY35) | 1306-23-6 | 0.01% w/w | PY35, PO20 | RESTRICTED |
| Cadmium sulfoselenide (PO20) | 12656-57-4 | 0.01% w/w | PO20 | RESTRICTED |
| Diketopyrrolopyrrole (PR254) — polymer exempt | 84632-65-5 | N/A (polymer) | PR254 | COMPLIANT |
| Phthalocyanine Blue (PB15:3) — non-polymer; low hazard | 147-14-8 | No SVHC listing | PB15:3 | COMPLIANT |
| Phthalocyanine Green (PG7) | 1328-53-6 | No SVHC listing | PG7 | COMPLIANT |
| Quinacridone Violet (PV19) | 1047-16-1 | Polymer exempt | PV19 | COMPLIANT |
| Iron Oxide Red (PR101) | 1309-37-1 | Registration required if ≥1 t/yr | PR101 | COMPLIANT |
⚠ Critical: Azo Pigment Amine Release Under Reducing Conditions
Azo pigments such as PR3, PR48:2, PY12, PY13, PY14, and PY83 can release regulated carcinogenic amines when subjected to reducing conditions — common in textile finishing, leather processing, and even during toxicological metabolism. The limit of 30 mg/kg per amine is strictly enforced. Non-compliance can result in RAPEX alerts, product recalls, and market bans across all 27 EU member states. Always require EN 14362-1 test reports from your pigment supplier for any azo pigment intended for skin-contact applications.
How to Comply
- Identify substance status: Determine whether your pigment is a substance (registration-required) or polymer (exempt) under REACH Article 2(9).
- Pre-register or register: If manufacturing or importing ≥1 tonne/year of a non-polymer pigment, complete registration with ECHA including a Chemical Safety Report (CSR) for quantities ≥10 tonnes/year.
- Check the SVHC Candidate List: Verify that your pigment and all its constituents are not listed as SVHCs. Monitor ECHA’s biannual updates (January and July).
- Test for restricted substances: For azo pigments, conduct EN 14362-1:2017 testing for releasable amines. For inorganic pigments, test heavy metal content (Pb, Cd, Cr6+, Hg) by ICP-OES or XRF screening.
- Provide Safety Data Sheet (SDS): Issue compliant SDS in all required EU languages. Include exposure scenarios for registered substances ≥10 tonnes/year.
- Communicate down the supply chain: If your article contains SVHCs >0.1% w/w, inform recipients and consumers under Article 33. Notify ECHA via SCIP database for articles.
Documentation Required
| Document | Purpose | When Required |
|---|---|---|
| REACH Registration Certificate | Proof of substance registration with ECHA | Manufacturing/importing ≥1 t/yr of non-polymer substance |
| Safety Data Sheet (SDS) | Hazard communication per Annex II | All hazardous substances and mixtures |
| Chemical Safety Report (CSR) | Risk assessment for identified uses | Registered substances ≥10 t/yr |
| EN 14362-1 Test Report | Proof that azo pigments do not release regulated amines >30 ppm | All azo pigments for textile/leather skin-contact applications |
| SCIP Notification | Article SVHC content declaration | Articles containing SVHC >0.1% w/w |
| Certificate of Analysis (CoA) | Heavy metal content and purity verification | All regulated pigment shipments |
Need REACH-Compliant Pigments?
Our pigment portfolio is fully vetted against the SVHC Candidate List. Every shipment includes third-party EN 14362-1 and ICP-OES test reports.