Glove CE Marking and REACH: Category III and the DMF Story

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So far we looked at “how well a glove protects” (performance). Now two different things: whether it is legal to sell in Europe (CE), and what the glove is made of (REACH). Performance, legality and material are three separate stories. (← continued from Work Glove Certifications: The Full Map)

Summary

A CE mark is not a quality or performance grade. It is the manufacturer’s declaration that “this product meets EU rules.”

The EU PPE Regulation (EU 2016/425) sorts hazards into Categories I·II·III. Lethal hazards like chemical, electrical and high-heat gloves are Category III, and only then does a 4-digit notified-body number appear beside CE. Separately, REACH regulates not performance but what the glove is made of.

CE is not a performance grade

Start with the most common myth. “It has CE, so it’s a good glove” is wrong. CE is not a score.

CE is the manufacturer’s own declaration that the product meets the essential safety requirements of EU rules. It is not a quality grade or a third-party mark. Performance is shown separately, by pictogram numbers like EN388 and EN374.

A common trap follows. Two kinds of numbers get stamped on a glove. The EN388 4-digit performance code sits under the hammer/anvil pictogram. The 4-digit notified-body number sits beside CE. One is performance, the other a regulator’s ID.

Categories I·II·III: the size of the risk

The EU PPE Regulation (EU 2016/425, replacing 89/686/EEC) splits gloves into three by hazard size. The bigger the risk, the stricter the check.

Category Risk Verification Example
I minimal maker self-declaration garden cotton glove
II intermediate type-exam by a notified body general mechanical (EN388)
III lethal/irreversible type-exam + ongoing surveillance chemical, electrical, high heat

The key: only Category III carries the 4-digit notified-body number beside CE. These gloves cannot be undone if they fail, so a notified body keeps watching even after sale. So a 4-digit number beside CE means “this is a high-risk Category III glove.”

CE Categories I, II, III: the bigger the risk, the stricter the check Three boxes rise like stairs. Category I: minimal risk, maker self-declaration, e.g. a garden cotton glove; CE only, no number. Category II: intermediate risk, type-exam by a notified body, e.g. a general mechanical EN388 glove; also no number. Category III: lethal or irreversible risk, type-exam plus ongoing surveillance by a notified body even after sale, e.g. chemical, electrical and high-heat gloves. Only Category III carries a 4-digit notified-body number beside CE. The higher the category, the stricter the check CE (no number) CE (no number) CE + 4-digit notified-body no. Category I Risk: minimal Maker self-declaration e.g. garden cotton glove Category II Risk: intermediate Type-exam by a notified body e.g. general mechanical (EN388) Category III Risk: lethal/irreversible Type-exam + ongoing surveillance (notified body keeps watching after sale) e.g. chemical, electrical, high heat Size of the risk, and strictness of the check
Figure 1. Glove categories under the EU PPE Regulation (EU 2016/425). The 4-digit notified-body number beside CE appears only on Category III.

REACH: what the glove is made of

If CE asks “is the performance right,” REACH asks “is the material safe.” REACH (the EU chemicals regulation, 1907/2006) controls hazardous substances in products.

A glove is legally an “article,” so it falls under REACH. If a substance of very high concern (SVHC) exceeds 0.1%, that must be communicated. Substances on Annex XVII (the restriction list) face outright limits. Even with every performance certificate, a glove cannot be sold if its material breaks REACH.

The two confusing ‘DMF’ chemicals

In glove talk, “DMF” points to two completely different chemicals. The names look alike and are often confused, so let’s pin them down.

① Dimethyl fumarate (DMFu, CAS 624-49-7) is an anti-mould biocide. Around 2008 it sat in sofa and shoe desiccant sachets and caused mass contact dermatitis in Europe — the “toxic sofa” cases.

It became REACH Annex XVII entry 61, banning more than 0.1 mg/kg (0.1 ppm) in articles.

② N,N-Dimethylformamide (DMF, CAS 68-12-2) is a solvent used to make PU/nitrile-coated gloves. It is reprotoxic and liver-toxic.

It was restricted under REACH Annex XVII entry 76 — a 0.3% limit in substances/mixtures, generally from 12 December 2023.

In plain terms, ① is “the desiccant that rubbed off and caused dermatitis.” ② is “the toxic solvent used to make the glove.” Both are abbreviated DMF, but the entry numbers and limits differ.

The two DMFs compared: dimethyl fumarate and N,N-dimethylformamide A side-by-side comparison. Dimethyl fumarate (DMFu, CAS 624-49-7) is an anti-mould biocide; around 2008 it sat in sofa and shoe desiccants and caused contact dermatitis in Europe. It is REACH Annex XVII entry 61, introduced by Regulation (EU) 412/2012, banning more than 0.1 mg/kg in articles. N,N-dimethylformamide (DMF, CAS 68-12-2) is a solvent used to make PU/nitrile-coated gloves; it is reprotoxic and liver-toxic, and residue can permeate through the glove to the skin. It is REACH Annex XVII entry 76, introduced by Regulation (EU) 2021/2030, a 0.3% restriction in substances and mixtures rather than an article-content limit, generally applying from 12 December 2023. Both abbreviated ‘DMF’, two different chemicals ① Dimethyl fumarate (DMFu) ② N,N-Dimethylformamide (DMF) CAS No. 624-49-7 68-12-2 What it is Anti-mould biocide Solvent for PU/nitrile-coated gloves Why it mattered Sofa/shoe desiccant → dermatitis (around 2008, “toxic sofa” cases) Reprotoxic, liver-toxic residue permeates glove to skin REACH Annex XVII Entry 61 Entry 76 Introduced by Reg (EU) 412/2012 Reg (EU) 2021/2030 Limit and scope Over 0.1 mg/kg banned content in the article itself 0.3% restriction substances/mixtures, not an article limit generally from 12 December 2023 Only the abbreviation is shared. Entry, limit and scope all differ.
Figure 2. The two ‘DMF’ chemicals in glove talk. ① is an article-content limit; ② is a substance/mixture restriction.

Solvent DMF can come off the glove

The ② solvent DMF is not just history. Residual DMF in a PU coating can permeate through the glove to the skin.

A study (Chao et al., Science of the Total Environment 2011) found DMF permeated through gloves used in the synthetic-leather industry. Simple aeration did not decontaminate them enough to reuse. So it is not “wear a glove and you’re safe” — it is “which glove.”

So what do you check

When choosing imported gloves, the order is simple. First, the CE mark and (if Category III) the 4-digit notified-body number. Second, performance separately, via pictogram numbers like EN388/EN374. Third, REACH compliance (SVHC / Annex XVII) if the material concerns you.

Don’t call a glove “good” on CE alone. CE is an entry ticket, not a report card. Pictograms speak for performance; REACH speaks for material safety.

Sources

Law (primary):
– PPE Regulation (EU) 2016/425 (EUR-Lex)
– REACH Regulation (EC) 1907/2006 (EUR-Lex)
– REACH Annex XVII entry 61 — Reg (EU) 412/2012 (dimethyl fumarate)
– REACH Annex XVII entry 76 — Reg (EU) 2021/2030 (DMF solvent)

Academic: skin exposure to DMF permeating gloves (Chao et al., Sci Total Environ 2011, PMID 21194731)

Test body (secondary): PPE categories and conformity modules (SATRA)

⚠ Claude Opus 4.8 (2026-06-28): Regulation numbers, limits and dates are cross-checked against EUR-Lex texts and multiple authoritative sources. The ECHA restriction-detail page was not read directly, and note that entry 76 (solvent DMF) is a 0.3% substance/mixture restriction, not an article-content limit. Verify against the consolidated EUR-Lex text before relying on it.

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