Key Takeaways
- REACH obligations sit with the EU importer, not the non-EU manufacturer. Factory declarations shift no legal risk and should be treated as evidence, not as protection.
- The 0.1 percent SVHC threshold is calculated per component article, not per finished glove. A cuff band or printed label can trigger duties that whole-glove maths hides completely.
- Four Annex XVII entries cause most rejections: chromium VI in leather at 3 mg/kg, azo dyes at 30 mg/kg, eight PAHs at 1 mg/kg each, and dimethyl fumarate at 0.1 mg/kg.
- Chromium VI is a storage problem, not only a tanning problem. Leather that tests clean at the factory can exceed 3 mg/kg after eight weeks in a hot humid container.
- SCIP notification under the Waste Framework Directive has been mandatory since 5 January 2021 and is separate from Article 33 communication and Article 7(2) notification.
- Screen the full Candidate List once per compound at qualification, then run four or five targeted batch tests. Full-list testing on every batch spends money without reducing risk.
Why REACH Applies to Gloves at All
Buyers reasonably assume that REACH is a chemicals regulation and that a finished glove is not a chemical. That assumption is where the exposure begins. Regulation (EC) No 1907/2006 defines an "article" in Article 3(3) as an object which during production is given a special shape, surface or design determining its function to a greater degree than its chemical composition. A safety glove is unambiguously an article, and REACH regulates articles through three mechanisms: restrictions under Annex XVII, communication duties for substances of very high concern, and notification duties to the European Chemicals Agency.
This is also completely separate from PPE conformity. A glove can hold a valid EU type-examination certificate under Regulation (EU) 2016/425, carry a legitimate CE mark, satisfy every EN 388 mechanical requirement, and still be illegal to place on the EU market because the leather contains 12 mg/kg of chromium VI. The two regimes test different things and neither substitutes for the other. If you are new to the PPE side, our EU PPE Regulation 2016/425 guide covers that framework in detail; this article deals only with chemical compliance.
The commercial reality is that market surveillance authorities in the EU have become considerably more active on chemical restrictions in textiles and leather goods over the past several years, and gloves are an easy target: they are cheap, high volume, imported, and by definition in prolonged direct skin contact. Prolonged skin contact is the trigger condition for several of the most demanding limits.
Who Actually Carries the Obligation
Understanding role allocation resolves most of the confusion in supplier correspondence. REACH binds entities established in the EU. It does not bind a factory in Qingdao, Sialkot or Penang.
| Party | Direct REACH duties | What they can realistically provide | Risk carried |
|---|---|---|---|
| Non-EU manufacturer | None | Test reports, compound datasheets, material declarations, bill of materials by weight | Commercial only, via contract |
| EU importer | Full: Annex XVII compliance, Art. 33 communication, Art. 7(2) notification, SCIP | - | Legal and financial, including recall |
| EU distributor | Art. 33 communication, SCIP where applicable | Pass-through of importer documentation | Legal for information duties |
| Only Representative | Takes over registration duties for substances, appointed by non-EU manufacturer | Registration coverage, not article compliance | As agreed with appointing party |
| Non-EU seller shipping direct to EU consumer | None under REACH, but the consumer or platform may become importer | - | Shifts unpredictably; avoid this model |
Two practical consequences follow. First, when a supplier says "our gloves are REACH compliant", the useful response is not to accept or reject it but to ask what was tested, against which restriction entries, on which material components, by which laboratory, using which method, and on what date. A compliance claim without those five data points cannot be verified.
Second, because the importer carries the legal risk, the importer should specify the test package rather than accept whatever the factory happens to have. Factories test what their largest customer demanded three years ago. Your product, your colours and your destination may not match.
The 0.1 Percent SVHC Rule and Its Hidden Denominator
The Candidate List of substances of very high concern is maintained by ECHA and has grown past 240 entries, expanded roughly twice a year. Inclusion on the Candidate List does not ban a substance. It triggers information duties:
- Article 33(1) requires a supplier of an article containing a Candidate List substance above 0.1 percent by weight to give recipients sufficient information for safe use, including at minimum the substance name.
- Article 33(2) requires the same information to be given to a consumer on request, free of charge, within 45 days.
- Article 7(2) requires notification to ECHA where the substance is present above 0.1 percent and the total quantity of that substance in articles exceeds one tonne per importer per year, unless exposure can be excluded.
Now the part that generates most under-reporting. The 0.1 percent is not calculated against the finished glove. Following the Court of Justice of the European Union ruling in case C-106/14 and the subsequent ECHA guidance revision, the threshold applies to each article incorporated into a complex object. A coated safety glove is a complex object assembled from several articles.
| Component | Component weight | SVHC content | Concentration in component | Concentration in whole glove | Duty triggered? |
|---|---|---|---|---|---|
| Knitted HPPE liner | 11.0 g | 0 mg | 0 percent | 0 percent | No |
| Nitrile palm coating | 6.5 g | 1.2 mg | 0.018 percent | 0.006 percent | No |
| Elasticated cuff band | 4.0 g | 6.0 mg | 0.150 percent | 0.030 percent | Yes |
| Printed size label | 0.4 g | 0.8 mg | 0.200 percent | 0.004 percent | Yes |
| Whole glove | 21.9 g | 8.0 mg | - | 0.037 percent | Whole-glove maths says no |
Read the bottom row against the two rows above it. Calculated against the whole glove, this product looks compliant at 0.037 percent and no duty appears to arise. Calculated correctly, per component, both the cuff band and the label exceed 0.1 percent and both Article 33 communication and potentially Article 7(2) notification are engaged.
This is why the single most valuable document to request at quotation stage is a bill of materials with component weights. Without component weights, no one in the chain can perform the calculation correctly, and a supplier who cannot produce component weights probably has not performed it.
Annex XVII: The Restrictions That Fail Glove Shipments
Annex XVII contains the hard limits. Unlike the Candidate List, these are prohibitions: exceed the limit and the article cannot lawfully be placed on the EU market. The following entries are the ones that apply to glove constructions in practice.
| Entry | Substance group | Limit | Applies to | Typical test method |
|---|---|---|---|---|
| 23 | Cadmium and compounds | 0.01 percent (100 mg/kg) by weight of plastic material | Plastic components, pigments in coatings | EN 1122 / ICP-OES |
| 27 | Nickel release | 0.5 microgram per square centimetre per week | Metal snaps, rivets, chain mail links in prolonged skin contact | EN 1811 |
| 43 | Azo dyes cleaving to 22 listed aromatic amines | 30 mg/kg | Dyed textile liners, dyed leather, coloured cuffs | EN ISO 14362-1 / -3 |
| 47 | Chromium VI in leather | 3 mg/kg of total dry weight of leather | Leather gloves, leather palm patches, rigger gloves, welding gauntlets | EN ISO 17075-1 |
| 50 | Eight polycyclic aromatic hydrocarbons | 1 mg/kg each | Rubber or plastic parts in prolonged skin contact: nitrile, latex, PVC coatings, TPR pads | GC-MS, AfPS GS 2019:01 PAK |
| 51 / 52 | Phthalates DEHP, DBP, BBP, DIBP | 0.1 percent each or in combination in plasticised material | PVC dipped gloves, PVC cuffs, soft plastic parts | EN ISO 14389 / GC-MS |
| 61 | Dimethyl fumarate (DMF) | 0.1 mg/kg | Any article or part; historically from anti-mould sachets in packaging | GC-MS after solvent extraction |
| 72 | 33 CMR substances in clothing and related accessories | Substance-specific, e.g. benzene 5 mg/kg, chromium VI 1 mg/kg for textiles | Textile components of gloves in skin contact | Method per substance |
Two clarifications matter when reading that table. Entry 72 has its own limits which can be stricter than the general entries for the same substance, so a textile component may need to satisfy both. And "prolonged skin contact" under Entry 50 is defined by contact duration in normal use, which for work gloves is always satisfied. There is no argument available that a glove is only in brief contact.
Chromium VI, Azo Dyes, PAHs and DMF in Practice
Knowing the limits is the easy part. Understanding how compliant product becomes non-compliant in transit is what actually prevents rejected containers.
Chromium VI is a storage phenomenon. Around 85 to 90 percent of world leather production is chrome tanned using chromium III salts, which are not restricted. Chromium VI is not intentionally added; it forms by oxidation of chromium III during storage, and formation accelerates with heat, humidity, high pH and the presence of unsaturated fats in the fatliquoring agents. The practical consequence is that a leather glove can test at 1.5 mg/kg at the factory gate and exceed 3 mg/kg after six to ten weeks in a container crossing the equator. Mitigation is chemical, not logistical: specify leather tanned with chromium VI suppressing agents such as vegetable tannin or synthetic antioxidant retanning, and require testing on a retained sample after accelerated ageing per EN ISO 17075 conditioning rather than only on fresh leather. Our leather work gloves guide covers tannage selection in more depth.
Azo dyes fail on cheap colour, not on cheap leather. The 22 restricted aromatic amines come from a specific family of low-cost dyestuffs long since abandoned by reputable dye houses but still circulating in secondary markets. Failures cluster in bright colours on knitted liners and in dyed cuff bands, particularly in orange, red and yellow. A dye house certificate covering the specific dye lot is more informative than a finished-glove test, because the finished-glove test only tells you about the sample you cut up.
PAHs come from the extender oils and carbon black. Highly aromatic extender oils are cheap plasticisers for rubber compounds and are heavily loaded with the eight restricted PAHs. Carbon black grades vary widely in PAH content. This is a compound formulation issue that is invisible in the finished glove appearance and cannot be inspected out. Specify low-PAH carbon black and non-aromatic or treated distillate aromatic extract oils in the compound specification, then verify once per compound at qualification.
DMF is a warehousing shortcut. Dimethyl fumarate sachets were used as anti-mould agents in humid storage, principally for leather goods. The 0.1 mg/kg limit is effectively a ban and it applies to the article, so contamination migrating from packaging into the glove is a violation. Prohibit anti-mould sachets explicitly in the packaging specification and substitute controlled humidity, silica gel or desiccant clay.
SCIP Notification and the Waste Framework Directive
SCIP is the ECHA database of Substances of Concern In articles as such or in complex objects (Products). The legal basis is Article 9(1)(i) of the Waste Framework Directive as amended by Directive (EU) 2018/851, and the duty has applied since 5 January 2021. Any supplier of an article containing a Candidate List substance above 0.1 percent by weight must submit a SCIP notification before placing the article on the EU market.
Three points of confusion recur:
- SCIP is additional, not alternative. It does not replace Article 33 communication to customers, nor Article 7(2) notification to ECHA. A single glove line above threshold can trigger all three.
- The waste angle explains the data fields. SCIP exists so waste operators can identify substances of concern at end of life, which is why it asks for article identifiers, material category, concentration range and safe use instructions rather than exposure assessments.
- Nothing above threshold means no SCIP duty. This is the strongest commercial argument for specifying SVHC-free compounds up front. Avoiding the substance costs a few cents; managing notification, communication and customer questionnaires forever costs administrative time on every order.
For buyers supplying industrial customers, expect SVHC questionnaires from any client with an ISO 14001 or a supply chain due diligence programme. Being able to answer "no Candidate List substance exceeds 0.1 percent in any component, here is the test report and the bill of materials" converts a procurement obstacle into a differentiator.
REACH vs POPs vs RoHS vs Prop 65
Glove importers frequently conflate four separate regimes. They have different scopes, different substances and different consequences, and a compliance package built for one will not satisfy another.
| Regime | Legal instrument | Scope for gloves | Key glove-relevant substances | Consequence of failure |
|---|---|---|---|---|
| REACH | Regulation (EC) 1907/2006 | All gloves placed on EU market | Chromium VI, azo amines, PAHs, phthalates, DMF, cadmium, SVHC list | Withdrawal, Safety Gate notification, national penalties |
| POPs | Regulation (EU) 2019/1021 | Water-repellent and stain-resistant finishes | PFOA and related compounds at 25 ppb, PFOS, PFHxS | Prohibition on placing on market |
| RoHS | Directive 2011/65/EU | Only gloves incorporating electrical or electronic components | Lead, mercury, cadmium, chromium VI, PBB, PBDE, four phthalates | Non-conformity of the EEE product |
| California Prop 65 | California Health & Safety Code 25249.6 | Gloves sold into California | Lead, DEHP, DINP, BPA, PAHs, chromium VI | Private enforcement litigation, warning label demands |
| Food contact | Reg. (EC) 1935/2004, Reg. (EU) 10/2011 | Food-handling gloves only | Overall migration 10 mg/dm2, specific migration limits | Withdrawal from food sector use |
PFAS deserves specific attention because it is the fastest-moving area. Durable water repellent finishes on winter and waterproof gloves have historically relied on fluorochemistry. PFOA and its related compounds are restricted under the POPs Regulation with a limit of 25 parts per billion for PFOA itself, and the regulatory direction of travel across the EU is toward broader PFAS restriction. If you are sourcing water-repellent gloves, specify a non-fluorinated DWR chemistry now rather than requalifying the product later under commercial pressure.
Test Package, Methods and Realistic Costs
Blanket testing is the most common way importers waste compliance budget. The correct approach is a two-tier structure: a broad screen once per compound and colour at qualification, then a narrow high-risk panel per production batch.
| Test | Method | Applies to | Indicative cost (USD) | Turnaround | Frequency |
|---|---|---|---|---|---|
| Chromium VI in leather | EN ISO 17075-1 | Leather components | 60 to 90 | 5 to 7 days | Every batch |
| Azo dyes / aromatic amines | EN ISO 14362-1 and -3 | Dyed textile and leather | 80 to 150 per colour | 5 to 8 days | Every new dye lot |
| PAH screen, 18 substances | GC-MS, AfPS GS 2019:01 PAK | Rubber and plastic parts | 120 to 200 | 7 to 10 days | Per compound, then annually |
| Phthalates, 6 substances | EN ISO 14389 / GC-MS | PVC and plasticised parts | 90 to 140 | 5 to 8 days | Per compound |
| Dimethyl fumarate | GC-MS after extraction | Whole glove and packaging | 50 to 70 | 4 to 6 days | Every batch if humid route |
| Nickel release | EN 1811 | Metal fittings, chain mail | 80 to 120 | 7 to 14 days | Per metal component |
| Cadmium and heavy metals | ICP-OES after digestion | Pigmented coatings | 70 to 110 | 5 to 8 days | Per pigment |
| Full SVHC Candidate List screen | Multi-method, 240-plus substances | All distinct materials | 500 to 1,500 | 10 to 15 days | Once per compound at qualification |
The economics are straightforward. A qualification screen at 900 USD amortised over a 500,000-pair annual programme is 0.0018 USD per pair. A rejected container is a five-figure loss plus the customer relationship. Buyers who resist qualification testing are optimising the wrong number.
One methodological point worth insisting on: submit separated materials to the laboratory, not whole gloves. If the lab has to test a composite, dilution across components can mask a component that individually exceeds the per-article threshold, and the report will be worthless for the Article 33 calculation described earlier. Sampling discipline here mirrors the AQL discipline covered in our QC and AQL inspection guide.
Contract Clauses That Transfer Risk Correctly
You cannot transfer the legal obligation away from the EU importer, but you can transfer the financial consequence to the party that caused it. Four clauses do most of the work:
- Specification by restriction entry. Do not write "REACH compliant". Write the entries and limits: "leather shall not exceed 3 mg/kg chromium VI per EN ISO 17075-1 tested after conditioning; rubber components shall not exceed 1 mg/kg for each of the eight PAHs listed in Annex XVII entry 50."
- Bill of materials with component weights. Make it a contractual deliverable at sample approval, and make any change to the BOM a change requiring written approval. Silent compound substitution is the root cause of most repeat failures.
- Retained sample obligation. Require the factory to retain sealed samples from each production batch for 24 months. Without a retained sample you cannot establish whether a failure originated in production or in transit, and the negotiation becomes unwinnable.
- Cost allocation on failure. State explicitly that testing, re-testing, re-work, storage, return freight and destruction costs arising from a restriction failure are for the seller's account, and tie a retention of 5 to 10 percent of contract value to the passing batch report.
Also state the packaging prohibition in the contract, not only in an email: no dimethyl fumarate or other anti-mould sachets, desiccant only. This clause has prevented more failures per word than any other.
Pre-Order Compliance Checklist
- Confirm which legal entity is the EU importer of record, and therefore who carries REACH liability.
- Obtain a bill of materials with component weights for every distinct material in the glove.
- Identify which Annex XVII entries apply to each component from the construction, not from a generic list.
- Commission a qualification test package covering the applicable entries plus a full Candidate List screen per compound and colour.
- Determine whether any component exceeds 0.1 percent for a Candidate List substance; if so, prepare Article 33 wording and submit SCIP before first shipment.
- Check whether the destination market adds requirements: POPs for water-repellent finishes, food contact for food-handling lines, Prop 65 for California.
- Write the specification, BOM control, retained sample and cost allocation clauses into the purchase contract.
- Set batch-level testing on the high-risk panel only, and prohibit anti-mould sachets in the packaging specification.
Buyers who work through this list before the first purchase order typically add a week to their qualification timeline and remove the largest single source of unplanned cost in imported PPE. It also pairs naturally with duty and classification planning, covered in our HS code and import duty guide, and with the wider sourcing decisions set out in the 2026 buyer's guide.
Frequently Asked Questions
Does a non-EU safety glove manufacturer have REACH obligations?
No. REACH, Regulation (EC) No 1907/2006, places obligations on legal entities established in the European Union. A factory in China, Malaysia or Pakistan has no direct REACH duties, which is why a supplier declaration alone carries no legal weight. The EU importer becomes the responsible party and inherits the full obligation set: SVHC communication under Article 33, ECHA notification under Article 7(2) where thresholds are met, SCIP notification under the Waste Framework Directive, and compliance with every applicable Annex XVII restriction. A non-EU manufacturer can appoint an Only Representative established in the EU to take over registration duties, but for finished gloves, which are articles rather than substances, the practical position is that the importer carries the risk. This is the single most misunderstood point in glove procurement: a Chinese REACH certificate proves testing was done, not that anyone in the chain has assumed liability.
What is the 0.1 percent SVHC threshold and how is it calculated for a glove?
The 0.1 percent by weight threshold under REACH Articles 7(2) and 33 triggers notification and communication duties when a Candidate List substance of very high concern is present above that level. The critical detail is the denominator. Following the 2015 ECHA guidance revision after the Court of Justice ruling in case C-106/14, the threshold is calculated per component article, not against the total weight of the assembled product. A coated safety glove is typically a complex object made of several articles: the knitted liner, the polymer coating, an elasticated cuff band and any printed label. If the cuff band weighs 4 grams and contains 6 milligrams of a Candidate List phthalate, that component is at 0.15 percent and the duty is triggered, even though the phthalate is only 0.03 percent of the 20 gram glove. Suppliers who calculate against whole-glove weight systematically under-report, so always ask for the calculation basis in writing.
Which REACH Annex XVII restrictions most often fail imported safety gloves?
Four restrictions account for most failures. Entry 47 limits chromium VI in leather in skin contact to 3 mg per kg of total dry leather weight, and it is the leading cause of rejected leather and rigger glove shipments because chromium VI forms during storage from chromium III tanning agents even when the glove tested clean at the factory. Entry 43 limits azo dyes that cleave to 22 listed aromatic amines to 30 mg per kg in textiles and leather in direct skin contact, which catches cheap dyed liners and coloured cuffs. Entry 50 limits each of eight polycyclic aromatic hydrocarbons to 1 mg per kg in rubber or plastic parts in prolonged skin contact, which catches carbon-black-loaded and extender-oil-loaded nitrile and PVC compounds. Entry 61 limits dimethyl fumarate to 0.1 mg per kg and still appears where anti-mould sachets are used in humid warehouses. Entry 72 adds a list of CMR substances with individual limits for clothing and related accessories in skin contact, and gloves fall within related accessories.
Do I need a SCIP notification for imported safety gloves?
Yes, if you are an EU importer or distributor placing gloves on the EU market that contain a Candidate List substance above 0.1 percent by weight in any component article. The obligation comes from Article 9(1)(i) of the Waste Framework Directive as amended by Directive (EU) 2018/851 and has applied since 5 January 2021. Notification goes to the ECHA SCIP database and must identify the article, the substance, its concentration range and safe use instructions. It is separate from and additional to the Article 33 communication duty to your customers and the Article 7(2) notification duty. In practice the workflow is: test, determine whether any component exceeds 0.1 percent, and if so submit SCIP before first placing on the market. If nothing exceeds the threshold there is no SCIP duty, which is a strong commercial argument for specifying SVHC-free compounds at the quotation stage rather than managing notifications later.
How much does a REACH test package for safety gloves cost and how long does it take?
A targeted package appropriate to the glove construction is far cheaper than a blanket screen. For leather gloves budget roughly 60 to 90 USD for chromium VI to EN ISO 17075, 80 to 150 USD for azo dyes to EN ISO 14362-1, and 60 USD for dimethyl fumarate, with a 5 to 8 working day turnaround. For coated knit gloves budget 120 to 200 USD for an 18-substance PAH screen by GC-MS, plus azo dyes on the dyed liner. A full Candidate List screen covering the current 240-plus substances runs 500 to 1,500 USD depending on the number of distinct materials submitted and takes 10 to 15 working days. The cost-effective approach is to run the full screen once per compound at qualification, then run the four or five high-risk targeted tests on each production batch. Testing every batch against the full list is a waste of money because the compound recipe, not the batch, determines the result.
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