Who this guide is for
This guide is written for brand owners, importers and sourcing managers who buy underwear from China and sell it into the United States, the European Union, or both. It is about the chemicals in the garment: which limits are statutory, which are contractual, and which are voluntary.
It is the companion to our guide to underwear label requirements, which covers what has to be printed on the label. That guide deliberately stops at the chemicals; this one starts there.
It is written from the buyer’s side of the table, because the exposure sits there. A restricted substance in a shipment is the importer’s problem: the brand pays for the recall, the brand answers the customs officer, and the brand appears in the market surveillance report.
The short answer: a test report and a compliance answer are two different things
Most chemical problems on an underwear programme are not caused by the wrong numbers on a lab report. They are caused by a report that answers a question nobody asked.
Three failures account for most of them, and none of the three is visible on the certificate:
- The certificate does not cover this order. A voluntary certificate names a certified article and a licence holder. It does not transfer to a different style, a different fabric, a different dye lot or a different supplier.
- The wrong regime was tested. A Chinese GB 18401 report handed to a European buyer does not demonstrate REACH conformity, and its aromatic-amine test method is not the one REACH references.
- The right regime was tested against the wrong component. REACH Articles 33 and REACH Annex XVII entry 43 do not both measure the garment whole. One measures each article; the other measures the article or its dyed parts.
Everything below is arranged to make those three failures checkable before the container leaves Xiamen, rather than at a customs desk or in a retailer’s compliance review.
Which chemical rules apply to underwear — by market
| Subject | European Union | United States | China |
|---|---|---|---|
| Azo dyes releasing listed aromatic amines | Restricted — REACH Annex XVII entry 43 | Not a federal textile rule | Restricted — GB 18401-2010, Appendix C list |
| Formaldehyde | Restricted — REACH Annex XVII entry 72, 75 mg/kg in textiles | Not a federal textile limit | Restricted by class — 20 / 75 / 300 mg/kg |
| Nickel release from metal parts | Restricted — REACH Annex XVII entry 27 | No federal limit | GB 28480-2012 mirrors the EU values |
| Lead | Covered by entry 72 and by the SVHC list | Children’s products — 100 ppm; coating 90 ppm | Covered by GB 18401 extractable metals |
| Phthalates | Covered by entry 72 and by the SVHC list | Children’s toys and child care articles — 0.1% | Covered by GB 18401 / GB 31701 |
| Substances of very high concern | Disclosure duty — REACH Article 33 | Not applicable | Not applicable |
| Flammability | Not harmonised for apparel | 16 CFR 1610; 1615 / 1616 for sleepwear | GB 18401 does not cover flammability |
Two things to read out of that table. China is the only one of the three with a single instrument carrying a formaldehyde limit, a pH limit, an odour requirement and a colour-fastness requirement at once. And the European Union has no federal flammability rule for general apparel, while the United States does — which is why a style can be chemically clean and still fail at the US border.
REACH: the four provisions that bite on underwear
REACH is not one rule, and the phrase “REACH compliant” is not a compliance statement. It is a statement that the supplier screened against something and found nothing. Four provisions do the actual work on a knitted underwear programme.
Entry 43 — azo dyes, 30 mg/kg, 22 amines
Azo dyes that can cleave, under reductive conditions, into one of the aromatic amines listed in Appendix 8 to Annex XVII must not be used in textile or leather articles that may come into direct and prolonged contact with human skin or the oral cavity. The limit is more than 30 mg/kg (0.003% by weight) of the article, or of the dyed parts of it.
Underwear is squarely inside that scope. The provision names clothing, bedding, towels and nappies among the covered articles, and the European market surveillance programmes that sample underwear list azo dyes among the first substances they test for.
Two details decide whether a test report actually answers entry 43:
- The unit is the article, or its dyed parts — not the average of the garment. A dark navy waistband elastic, a printed care patch and a dyed body panel are separate dyed parts with separate results. A single composite result hides the one part that fails.
- The reference method is EN 14362-1 for textiles, with EN ISO 17234 for leather. A report citing something else may be a perfectly good test of a different requirement.
Entry 72 — formaldehyde, 75 mg/kg, and the 2026 date you do not need to worry about
Annex XVII entry 72 is the CMR substance list for textiles, clothing and footwear intended for consumers. It sets a formaldehyde content limit of 75 mg/kg, and it has been in force since 1 November 2020.
This is where the most widespread error in current EU textile advice sits. The most recent addition under the REACH Annex XVII restrictions procedure, Regulation (EU) 2023/1464, introduced entry 77, restricting formaldehyde emissions at 0.062 mg/m³ for furniture and wood-based articles and 0.080 mg/m³ for other articles, applicable from 6 August 2026. That date is usually reported as a new formaldehyde limit for clothing.
It is not. Entry 77’s own derogation list excludes, verbatim, articles to which the entry 72 restriction applies. Consumer clothing is governed by entry 72, so entry 77 excludes clothing by its own text. The binding number for underwear is 75 mg/kg of content, and it is not new.
The practical cost of the mistake runs in one direction only: emission testing that the garment does not require, quoted at a price, against a deadline that does not exist. If a supplier or a consultancy tells you a new EU formaldehyde limit lands on clothing in August 2026, ask which entry number they mean. The answer settles it.
Entry 27 — nickel release, and why the metal trim is not a detail
Nickel release is regulated by migration, not by content. Entry 27 sets 0.2 µg/cm²/week for post assemblies inserted into pierced body parts, and 0.5 µg/cm²/week for articles in direct and prolonged contact with the skin. The legal text lists the relevant items for garments explicitly: rivet buttons, tighteners, rivets, zippers and metal marks when used in garments.
On a bra programme that list is not abstract. Hook-and-eye closures, strap sliders and rings, and any metal badge sit inside it. Three points follow:
- Coated metal is tested after simulated wear. A nickel-free-looking plating is not evidence on its own; the reference method for coated articles is EN 12472, a wear-and-corrosion simulation applied before the release test (EN 1811).
- “Prolonged contact” has been defined. ECHA’s interpretation is contact of potentially more than 10 minutes on three or more occasions within two weeks, or more than 30 minutes on one or more occasions within two weeks. A bra satisfies that by a wide margin.
- The failure mode is invisible on a spec sheet. A plated component can pass on content and fail on release. This is the one entry where asking for a test report rather than a material declaration is not optional.
Article 33 — SVHC above 0.1% of an article, not of the garment
If an article you supply contains a substance on the Candidate List above 0.1% by weight, REACH Article 33 requires you to pass enough information downstream for safe use — at minimum the substance name — and to give the same information to a consumer who asks, free of charge, within 45 days. There is no tonnage threshold on that duty.
What 0.1% is measured against is where programmes get caught. Following the Court of Justice ruling in case C-106/14, each component that is itself an article is assessed separately: an object does not stop being an article when it is assembled with others into a complex product. The industry shorthand is “once an article, always an article”.
For an underwear programme that means the metal closure, the plastic slider and the printed transfer are each measured against 0.1% on their own, not against the weight of the finished bra. A component can be far below 0.1% of the garment and still trigger the duty. If a supplier’s only SVHC document is a declaration about the finished product, it does not answer Article 33.
There is a second clock running alongside it. Since 5 January 2021, suppliers placing articles containing Candidate List substances above 0.1% on the EU market also submit data to ECHA’s SCIP database. The Candidate List itself is revised roughly twice a year and now runs to a few hundred substances, which is why a substance declaration dated eighteen months ago is evidence about the past, not about the shipment.
GB 18401-2010: three classes, and the two numbers buyers get wrong
GB 18401-2010 is the mandatory Chinese national standard for textile products, and it is the standard your partner factory will test to by default, whether or not you asked. It was reviewed in 2022 and remains in force.
It applies to textiles produced and sold inside China. That sentence has a consequence worth reading carefully: export products may follow the terms agreed in the contract. In other words, GB 18401 is the factory’s baseline, not your legal obligation in Hamburg or Los Angeles. Where it matters most to a buyer is as the starting point you are upgrading from, and as the standard behind the report you were probably sent.
The classes
| Requirement | A | B | C |
|---|---|---|---|
| Applies to | Infants’ textiles | Textiles with direct skin contact | Textiles with no direct skin contact |
| Formaldehyde, mg/kg | ≤ 20 | ≤ 75 | ≤ 300 |
| pH | 4.0–7.5 | 4.0–8.5 | 4.0–9.0 |
| Colour fastness, water and perspiration, grade | ≥ 3–4 | ≥ 3 | ≥ 3 |
| Colour fastness to saliva | Required | — | — |
| Cleavable carcinogenic aromatic amines | Not permitted — 24 substances listed, limit 20 mg/kg | ||
| Odour | No odour | ||
Infants’ textiles must meet class A, direct-skin-contact textiles at least class B, and non-contact textiles at least class C. For underwear, that means class B at minimum, and class A for infant sizes.
The first number buyers get wrong is class A’s formaldehyde limit. It is often quoted as 16 mg/kg, which is the OEKO-TEX figure for the same class, not the Chinese one. GB 18401 sets 20 mg/kg.
The second is the amine list. GB 18401 lists 24 cleavable carcinogenic aromatic amines at a limit of 20 mg/kg. REACH entry 43 lists 22 at 30 mg/kg. The lists overlap heavily and are not identical in length, so a Chinese report showing 0 mg/kg against 24 substances is strong evidence — but it is not a REACH entry 43 report, and treating it as one is the single most common documentary failure we see on EU-bound programmes.
The test method is not interchangeable
Aromatic amines are tested to GB/T 17592 in the Chinese standard, with GB/T 23344 for 4-aminoazobenzene. REACH entry 43 references EN 14362 for textiles. The two extraction and detection procedures are not the same method, and a lab cannot convert one result into the other on paper.
This is a procurement issue, not a chemistry one. If your European buyer’s specification says “EN 14362” and the factory’s routine test order says “GB/T 17592”, you will receive a document that looks like compliance and fails the specification — and you will discover it at the point where the report is checked. Naming the method on the purchase order is cheaper than re-testing at the port.
CPSIA: what applies to children’s underwear — and what does not
Children’s apparel in the United States is regulated on three axes at once: lead, phthalates and flammability. Which of them applies is decided by the age grading of the style and by whether the item is a child care article, not by the fact that it is children’s clothing.
Lead: 100 ppm substrate, 90 ppm coating, and an exemption that does not cover buttons
All accessible components of a children’s product must meet a total lead content limit of 100 ppm. There is a material determination for dyed and undyed textiles that are not treated or adulterated, which means the fabric itself generally does not need third-party lead testing.
That exemption is where programmes relax too early. It does not extend to metal or plastic components — buttons, snaps and zippers must be tested — and it does not extend to surface coatings. Painted component parts, and screen-printing inks used on the garment, fall under the lead in paint requirement of 16 CFR part 1303 at 90 ppm.
Read as a whole, the rule draws a line that is easy to misread: the soft part of the garment is exempt from third-party testing, and every hard part of it is not. On a kids’ underwear programme the printed logo on the waistband and the metal-free snap are the two items that carry the lead question.
Phthalates: not all children’s clothing, but sleepwear for the under-threes
Section 108 of the CPSIA restricts eight phthalates — DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP and DCHP — to 0.1% (1000 ppm) in an accessible plasticised component of children’s toys and child care articles, codified at 16 CFR part 1307.
Children’s clothing generally is not certified to that requirement. But a child care article is defined by function — a product designed or intended to facilitate sleep, feeding, sucking or teething in children aged three and younger — and children’s sleepwear falls inside that definition. So a children’s pyjama set sized for the under-threes carries the phthalate requirement, while a plain children’s brief does not.
For a programme that runs both underwear and sleepwear, this is the point at which the two product lines stop sharing a test plan. The component most likely to matter is a plasticised print, a soft PVC badge or a soft plastic zipper pull.
Flammability: 1610 everywhere, 1615 and 1616 for sleepwear
| Product | Standard | What it covers |
|---|---|---|
| Clothing textiles generally | 16 CFR 1610 | Three flammability classes; the base requirement for wearing apparel |
| Vinyl plastic film used in apparel | 16 CFR 1611 | Non-rigid vinyl film, including the film used in disposable diapers |
| Children’s sleepwear, sizes 0 to 6X | 16 CFR 1615 | Fabric and finished garment vertical flame test |
| Children’s sleepwear, sizes 7 to 14 | 16 CFR 1616 | Fabric and finished garment vertical flame test |
| Infant garments and tight-fitting sleepwear | 16 CFR 1615.1(c), 1615.1(o), 1616.2(m) | Excepted from 1615 and 1616 — but still subject to 1610 or 1611 |
Two consequences. First, the sleepwear exemption is a sizing, measurement, tagging and labelling exemption, not a free pass: an excepted garment still has to meet 1610. Second, there is no general certificate of conformity required for adult wearing apparel that is exempt from testing under 16 CFR § 1610.1(d) — a distinction that matters to importers who have been told to produce a certificate for an adult brief that does not owe one.
Certification and tracking labels
Children’s products subject to a CPSC-enforced rule require a Children’s Product Certificate, supported by testing at a CPSC-accepted third-party laboratory. Where an exemption or determination makes testing unnecessary, the rule citation still has to be listed on the certificate. Children’s products and their packaging also require a tracking label carrying the manufacturer or private labeler, the location and date of production, and batch or run information.
The practical implication for a sourcing programme is that the order file, not the factory’s general capability, is what an auditor asks to see. We cover the age-grading side of this in our guide to kids’ underwear safety standards.
OEKO-TEX Standard 100: what it is
STANDARD 100 is a voluntary testing and certification scheme for textiles, run by the OEKO-TEX association. It tests articles against a criteria catalogue that is updated at least annually, covering more than a thousand regulated and non-regulated substances, and it assigns the article to one of four product classes by intended use and degree of skin contact.
| Product class | Intended use | Formaldehyde, mg/kg |
|---|---|---|
| I | Articles for babies and toddlers | Not detectable (< 16) |
| II | Articles with direct skin contact | ≤ 75 |
| III | Articles with no direct skin contact | ≤ 150 |
| IV | Decoration material | ≤ 300 |
Those are the current edition’s figures, and they are worth checking against the edition you were sent, because classes III and IV were once both 300 mg/kg and some published tables still show the older pairing. There is also a stricter option, Annex 6, which applies tighter thresholds and additional environmental criteria.
Class II is the class an underwear programme would normally sit in. Class I applies to baby and toddler articles.
What an OEKO-TEX certificate does not do
This is the part that matters commercially, and it is a statement about the scheme’s scope rather than about its quality. STANDARD 100 is a strong and useful instrument. It is nevertheless not a compliance document for your order, for three reasons that are built into how it works.
- It does not replace the statutory requirement. A fabric carrying a STANDARD 100 certificate still has to meet REACH Annex XVII, and a product destined for the Chinese market still has to carry its GB 18401 class declaration. The certificate is additive to the law, not a substitute for it, and treating it as the answer to a REACH question leaves the entry 43 and entry 27 obligations untouched.
- It covers a certified article, not your shipment. The certificate attaches to a specific article — a defined composition, from a defined production route — and to a licence holder. A change of fabric, of dye lot, of trim supplier or of factory takes the order outside the certified article. This is the mechanism behind the most expensive version of the mistake: a certificate that is entirely genuine, and a shipment that is not covered by it.
- The holder is the certificate holder. On a sourcing programme the licence holder is the partner factory, not the brand and not the trading company. The certificate is theirs to authorise the use of, and the mark may only be applied as the licence permits — which is why “we have OEKO-TEX” is a misleading sentence in a supplier quote unless it also names whose certificate it is and what it covers.
There is a fourth point that only applies to some buyers, and it is a category error worth naming: an OEKO-TEX certificate does not demonstrate CPSIA compliance for children’s products. The US requirements for children’s underwear are lead, phthalate and flammability requirements with their own test methods and their own certificate. A chemical certification of any kind does not produce a Children’s Product Certificate.
The five questions that decide whether a certificate is worth anything
Before a certificate goes into an order file, five questions establish what it actually covers. They take a few minutes and they are the whole difference between evidence and decoration.
- Which entry, or which rule, does this report address? “REACH tested” is not an answer. Entry 43, entry 72 and Article 33 are different requirements with different limits, and a broad SVHC screen does not answer any of them specifically.
- Which certificate holder, and which article? Match the holder to the factory in the order, and the certified article to the fabric and trims actually being used.
- Which market? A GB 18401 report does not serve an EU buyer; an OEKO-TEX certificate does not serve a US children’s product requirement.
- Which test method, and which laboratory? EN 14362 rather than GB/T 17592 for EU-bound textiles; an ISO 17025-accredited laboratory where the US children’s product rules require one.
- How old is it? The OEKO-TEX criteria catalogue is revised at least annually and the REACH Candidate List roughly twice a year. A report older than one cycle describes a product as it was, not as it is.
How we handle chemical compliance on an order
Unitex Underwear is a sourcing and supply-chain management company. We place, follow and inspect underwear orders in partner factories across the Xiamen–Quanzhou–Jinjiang knitwear cluster in Fujian, China. The partner factories we work with hold amfori BSCI and OEKO-TEX Standard 100 certification. Our own role on chemicals is to plan the testing, place it against the right entry, and keep the evidence with the order.
What we need from you
- The markets each style will be sold in, and whether any style is children’s sleepwear sized for the under-threes — that single fact changes which US requirements apply.
- The buyer’s test specification, including the standard numbers named in it. If it names EN 14362 rather than GB/T 17592, we need to know before the test order is placed.
- The component list for trims: closures, sliders, snaps, zips, badges and prints, since these are what entry 27, entry 43 and the US lead rules attach to.
What we do
- We build the test plan against the entries and rules in your markets, and name the method and the component in writing before sampling, so the report comes back answering the question that was asked.
- We coordinate the testing with accredited laboratories, including nickel release testing on metal trims after simulated wear where the component is coated.
- We keep test reports, declarations and component evidence with the order file, dated, so that a compliance review or a customs query has something to read.
What we do not do
We are not the responsible operator on your label and we do not absorb your compliance obligation — the product is placed on the market by your company, and the duty follows the product.
The same applies to social audits. If your programme requires a SMETA report, we do not claim to hold one; we help confirm the partner factory’s Sedex membership and pass the report to you directly. Our comparison of underwear certifications sets out which scheme is held by whom, and what each one does and does not prove.
Compliance & verification
Every limit in this guide traces to a published instrument, and each one is linked in the sources below so you can check it rather than take our word for it. The four that carry the most weight in practice:
- REACH Annex XVII — entry 43 on azo dyes and the 22 aromatic amines, entry 72 on CMR substances in textiles including formaldehyde at 75 mg/kg, entry 27 on nickel release, and Article 33 on SVHC disclosure.
- Regulation (EU) 2023/1464 — entry 77 on formaldehyde emissions, applicable from 6 August 2026, and its derogation excluding articles covered by entry 72.
- CPSIA and 16 CFR parts 1303, 1307, 1610, 1615 and 1616 — US lead, phthalate and flammability requirements for children’s apparel.
- GB 18401-2010 — the Chinese mandatory standard, its class A, B and C limits, and the GB/T 17592 test method.
Chemical compliance is testable, and the question to put to a supplier is not whether they are compliant but which entry they tested, on which components, to which method, and when. Buyers who want the equivalent check on the supplier rather than the garment will find it in our B2B sourcing FAQ.
· Xiamen Unitex Trade Co., Ltd. — OEM & ODM underwear sourcing partner
| Supplier | Unitex Underwear (Xiamen Unitex Trade Co., Ltd.) — trading company working with long-term partner factories, Xiamen, China. |
|---|---|
| EU — azo dyes | REACH Annex XVII entry 43: above 30 mg/kg, 22 aromatic amines, article or dyed parts |
| EU — formaldehyde | REACH Annex XVII entry 72: 75 mg/kg in textiles, clothing and footwear |
| EU — formaldehyde emissions | Entry 77 from 6 August 2026; excludes articles covered by entry 72 |
| EU — nickel release | Entry 27: 0.2 µg/cm²/week pierced parts; 0.5 µg/cm²/week skin contact |
| EU — SVHC disclosure | Article 33: above 0.1% w/w of each article; 45 days to answer a consumer |
| China — formaldehyde | GB 18401-2010: class A 20 / B 75 / C 300 mg/kg |
| China — aromatic amines | GB 18401-2010: 24 substances, limit 20 mg/kg, tested to GB/T 17592 |
| China — class assignment | Infants class A; direct skin contact at least class B; non-contact at least class C |
| US — total lead | CPSIA: 100 ppm accessible substrate; 90 ppm paint or coating under 16 CFR 1303 |
| US — phthalates | 16 CFR 1307: eight phthalates at 0.1%, toys and child care articles |
| US — flammability | 16 CFR 1610 apparel; 1615 for sizes 0-6X and 1616 for 7-14 sleepwear |
| OEKO-TEX Standard 100 | Voluntary; classes I-IV; formaldehyde n.d. / 75 / 150 / 300 mg/kg |
Buyer checklist
- The report names the entry or rule it addresses — entry 43, entry 72, entry 27 or Article 33 — rather than a generic REACH screen.
- The certificate holder matches the factory in the order, and the certified article matches the fabric and trims actually being used.
- EU-bound textiles were tested to EN 14362 for aromatic amines, not to GB/T 17592 alone.
- Metal trims — closures, sliders, snaps, zips — carry a nickel release result, and coated parts were tested after simulated wear.
- SVHC information is given per component article, not as one declaration covering the finished garment.
- Children's styles have a total lead result for every metal and plastic component, and a coating lead result for painted or printed parts.
- Children's sleepwear sized for the under-threes has a phthalate result against 16 CFR 1307.
- Flammability was tested to the right standard: 1610 for apparel, 1615 or 1616 for sizes 0-6X and 7-14.
- The report date falls inside the current OEKO-TEX criteria year and the current REACH Candidate List cycle.
- Product for the Chinese market carries a GB 18401 class declaration stating A, B or C.
Unitex Underwear (Xiamen Unitex Trade Co., Ltd.)
Unitex Underwear (Xiamen Unitex Trade Co., Ltd.) — OEM/ODM underwear sourcing and supply-chain partner in Xiamen, China; in the trade since 2009, incorporated in 2013. Based in the Xiamen–Quanzhou–Jinjiang knitwear cluster, Fujian Province, south-east China.