Key takeaways
- REACH entry 43 limits each listed amine released from azo dyes to 30 mg/kg in skin-contact textile and leather articles, including chair covers and bedding.
- REACH entry 72 sets limits for 33 CMR substances in clothing, footwear and textiles with similar skin contact, such as bed linen and upholstery.
- India has prohibited the handling of 112 benzidine-based and azo dyes, and imported textiles must not contain them.
- Buyer restricted substance lists (RSLs) are often stricter than the law and are written into purchase contracts.
- Only a lab can measure amines and CMR substances. An inspection checks that the tested materials are the ones in production.
REACH entry 43: the EU azo dye restriction
Entry 43 of Annex XVII to the EU REACH Regulation (EC) No 1907/2006 restricts azo colourants. Its current wording was set by Regulation (EC) No 552/2009. It has three parts.
- Articles. Azo dyes that can release one or more of the aromatic amines listed in Appendix 8, in concentrations above 30 mg/kg (0.003% by weight) in the article or its dyed parts, must not be used in textile and leather articles that may come into direct and prolonged contact with the skin or the mouth. Such articles cannot be placed on the EU market.
- Examples named in the law. Clothing, bedding, towels, hats, nappies, sleeping bags, footwear, gloves, wristwatch straps, handbags, purses and wallets, briefcases, chair covers, textile or leather toys, and yarn and fabrics sold to the final consumer.
- Dyes as substances. The azo dyes listed in Appendix 9 must not be placed on the market or used in mixtures above 0.1% by weight to colour textile and leather articles.
| Material | Test method listed in Appendix 10 |
|---|---|
| Textiles | EN ISO 14362-1:2017 (amines from azo colourants, with and without extracting the fibres) and EN ISO 14362-3:2017 (azo colourants that may release 4-aminoazobenzene) |
| Leather | EN ISO 17234-1:2015 (aromatic amines from azo colourants) and EN ISO 17234-2:2011 (4-aminoazobenzene) |
The rule reaches home furnishings as well as apparel. A cushion cover, a dyed cotton throw or a leather chair cover sold in the EU is in scope.
REACH entry 72: CMR substances in textiles and footwear
Regulation (EU) 2018/1513 added entry 72 to Annex XVII. From 1 November 2020, 33 substances or groups classed as carcinogenic, mutagenic or toxic for reproduction (CMR) must not exceed set limits in clothing and related accessories, footwear, and other textiles that touch the skin to a similar extent, when these are for consumers. The recitals give bed linen, blankets, upholstery and reusable nappies as examples. Limits are measured in homogeneous material.
| Substance or group | Limit |
|---|---|
| Cadmium, chromium VI, arsenic and lead compounds | 1 mg/kg after extraction, each |
| Listed polycyclic aromatic hydrocarbons (PAHs), for example benzo[a]pyrene | 1 mg/kg each |
| Benzene | 5 mg/kg |
| Formaldehyde | 75 mg/kg (300 mg/kg was allowed in jackets, coats and upholstery until 1 Nov 2023) |
| Listed phthalates | 1,000 mg/kg, alone or combined with other CMR phthalates |
| Solvents NMP, DMAC and DMF | 3,000 mg/kg each |
| Dyes C.I. Disperse Blue 1, Basic Red 9 and Basic Violet 3; quinoline | 50 mg/kg each |
Entry 72 does not apply to items made only of natural leather, fur or hide, to non-textile fasteners and decorations, to second-hand goods, to wall-to-wall carpets, rugs and runners, or to disposable textiles. Personal protective equipment and medical devices are also excluded.
India's own ban on hazardous dyes, and what it means for exporters
India restricts the same chemistry at home. The Ministry of Environment and Forests prohibited the handling of 42 benzidine-based dyes by a notification of January 1990, effective from 1993. A Gazette notification of 26 March 1997 added 70 azo dyes, bringing the total to 112 dyes that can release harmful amines. The legal basis is clause (d) of section 6(2) of the Environment (Protection) Act, 1986.
Imports are covered too. Under DGFT Notification No. 19/2015-2020 of 4 September 2015, textiles and textile articles may be imported only if they contain none of these prohibited dyes, backed by a certificate from an accredited textile testing laboratory in the country of origin.
For an overseas buyer, the Indian ban is a useful baseline but not proof. It governs what Indian dye houses may handle, not the amine content of a finished article. The REACH limits apply to the article as sold. In practice the risks in an Indian supply chain are:
- Unbranded or repacked dyes bought by small dye houses and printers, with no safety data sheet or supplier declaration.
- Job-work processing. Yarn or fabric may be dyed or printed by a sub-contractor the buyer has never seen.
- Leather tanned and dyed elsewhere, with no test report linking the hide lot to the finished bag or chair cover.
- Colour changes after approval. A new shade can mean a new dye recipe that was never tested.
Buyer restricted substance lists: AFIRM and ZDHC
Most brands and importers go beyond the law with their own restricted substance list (RSL), written into the purchase contract. Two industry references are common:
| List | What it controls | Who uses it |
|---|---|---|
| Legal limits (REACH entries 43 and 72) | Substances in the finished article sold in the EU | Required by law for every EU sale |
| AFIRM RSL | Substances in finished apparel and footwear products and materials; updated each year by 1 February | Brands that adopt it as their RSL or base their own list on it |
| ZDHC MRSL | Substances in the chemical formulations used in production, such as dyes and auxiliaries, with limits for each | Brands that require mills and dye houses to use compliant chemicals |
The difference matters. An RSL is checked by testing the product. A manufacturing RSL (MRSL) is checked by looking at the chemicals in the dye house store and their declarations. A supplier can pass one and fail the other. OEKO-TEX STANDARD 100 is another common buyer requirement; see OEKO-TEX and GOTS.
What an inspection can verify, and what needs a lab
| An inspector at the factory can check | Only a lab can establish |
|---|---|
| Test reports exist for each fabric, colourway and leather article, and name the material, shade and supplier actually in production | Whether any listed amine is released above 30 mg/kg (EN ISO 14362, EN ISO 17234) |
| Dye house records: dye names, batch numbers and supplier declarations for the shades in the order | Formaldehyde, heavy metals, PAHs, phthalates and other entry 72 substances |
| The colour and fabric of production match the approved and tested sample | Compliance with a buyer RSL or MRSL limit |
| Labels, hangtags and claims such as “azo-free” are backed by a current report | Whether a substituted dye or leather lot still passes |
A report dated before a shade change, or issued for a different mill, does not cover the goods. Ask for a new test when the dye recipe, fabric mill or tannery changes.
How Clear To Load checks this in India
On a home textiles inspection in India, the inspector compares the fabric, shade and leather in production with your approved samples and test reports, and photographs dye house records and supplier declarations where the factory provides them. Where you need a test, we pull and seal samples from the production lot and send them to an ISO/IEC 17025-accredited lab you choose or we suggest, through lab testing coordination. We have no partner labs and take no lab commissions.
The report ends in a verdict: Cleared to load, Hold or Not cleared. An inspection does not certify chemical compliance; that rests on the lab reports. To add these checks to an order, book an inspection.
Sources
- Regulation (EC) No 552/2009, Annex XVII entry 43 (EUR-Lex)
- Regulation (EU) 2018/1513, entry 72 and Appendix 12 (EUR-Lex)
- Regulation (EU) 2020/2096, Appendix 10 test methods (EUR-Lex)
- ECHA: Substances restricted under REACH
- JNCH Customs Public Notice No. 81/2015: testing of imported textiles for hazardous dyes
- Central Coir Research Institute: banned dyes and amines in India
- AFIRM Restricted Substances List
- ZDHC Manufacturing Restricted Substances List