Personal protective equipment is regulated as a safety product, not ordinary merchandise. In most markets a defined conformity assessment, the resulting file and the correct marking are legal preconditions to sale. Get it wrong and the failure is not one of quality: the goods cannot legally be sold.
Why PPE is regulated differently
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For most industrial goods, conformity is contractual. For PPE, the importer takes on statutory duties. In the EU, an importer must verify that the manufacturer carried out the correct conformity assessment, keep a copy of the EU declaration of conformity for 10 years, and be able to make the technical documentation available on request. Put your own brand on the product and you are treated in law as the manufacturer.
Requirements scale with consequence, not with price. Under Regulation (EU) 2016/425, PPE falls into three categories: Category I for minimal risks, which the manufacturer may self-assess; Category II, which requires EU type-examination by a notified body; and Category III, covering risks of death or irreversible damage to health, which requires type-examination plus ongoing third-party surveillance of production. Category III includes respiratory protection, fall arrest and hearing protectors, so a cheap earplug carries a heavier burden than general-purpose work gloves.
The documents that must exist before you pay
- Declaration of conformity naming the product, the legislation and the standards applied. For the EU it must be supplied with the product, or the instructions must give the internet address where it can be accessed.
- The third-party certificate above the self-declared tier — for the EU, an EU type-examination certificate from a notified body. Under 2016/425 these have a maximum validity of five years.
- Evidence of production surveillance for Category III: a current certificate for supervised product checks or an approved quality system. A type certificate alone is not sufficient.
- Test reports from a laboratory accredited to ISO/IEC 17025 with that test method in its scope, traceable to the certified design.
- The technical file — design data, bill of materials, material specifications, risk assessment, test evidence. You need not hold it, but you must be able to obtain it.
- Instructions for use in the languages each market requires, plus label artwork for approval before printing.
- Market-entry appointments: Article 4 of Regulation (EU) 2019/1020 requires an economic operator established in the Union for PPE; in the US, a NIOSH approval label and TC number for respirators.
What must physically appear on the item and the packaging
- Manufacturer’s name, registered trade name or trademark and postal address on the product; the importer’s name and address added on the product where possible, otherwise on the packaging or an accompanying document.
- Type, batch or serial number tracing the item to a production lot.
- The standard number, pictogram and performance codes, matching the certificate exactly. EN 388 performance, ANSI/ISEA Z87.1 markings and the marking required inside footwear to ASTM F2413 go on the product, not the carton.
- Conformity marking: CE for the EU, with the four-digit notified body number alongside it for Category III only. A notified body number on Category II product, or a CE mark with no supporting certificate, are both defects.
- Size, date of manufacture and obsolescence date where the standard requires it; instructions, storage conditions and origin marking on the packaging.
Third-party certification vs a factory test report
A factory test report records what one sample did on one day, often in an in-house laboratory. It is useful for pre-screening a supplier and worthless as legal cover. Third-party assessment differs: the body is independent and accredited or designated for that scope, and where the route includes production surveillance it re-examines production, not only the prototype.
Check the certificate itself, not a scan in a catalogue. EU notified bodies are listed publicly with an identification number and scope, and will confirm a certificate number on request. Confirm that the holder is the entity you contract with, that the annex lists the exact model and variant ordered, that the standard edition is current, and that the certificate has not expired. A certificate covering a different coating, lens tint, sole or filter media is a common scope mismatch.
How requirements differ by destination market
Europe and the UK
The EU operates the category system, CE marking and declaration of conformity described above, with instructions in a language determined by the Member State concerned. Great Britain has its own regime using UKCA marking and UK approved bodies, and the period during which CE-marked goods remain acceptable there has been extended more than once, so confirm the current position before committing artwork. Northern Ireland follows EU rules.
United States
Most PPE is not pre-approved by a federal agency. OSHA regulates the employer’s use of PPE and incorporates consensus standards by reference, so the specification burden falls on you: ANSI/ISEA Z87.1 for eye and face protection, Z89.1 for head protection, ANSI/ISEA 107 for high-visibility apparel, ANSI/ISEA 105 for cut resistance and ASTM F2413 for protective footwear. Respirators for occupational use are the exception: they must be approved by NIOSH under 42 CFR Part 84, and that approval is issued to a named holder for a specific product and production site. Goods sold with a medical claim may also fall under FDA device regulation, and imported articles must generally carry origin marking.
Elsewhere
Canada relies on CSA standards, made mandatory through occupational health and safety regulation. Australia and New Zealand specify AS/NZS standards, with third-party certification available through recognised schemes. Brazil requires an approval certificate number issued by the labour authority and held by a locally registered entity. Scales are not interchangeable: ANSI/ISEA 105 cut levels A1–A9 and the EN 388 cut classifications use different test protocols, so do not convert between them by eye. Chemical rules apply too: REACH Annex XVII restricts certain azo dyes and polycyclic aromatic hydrocarbons in articles with prolonged skin contact.
What a Chinese factory needs from you
- Every destination market, and the conformity route for each: self-declared, notified body certified or agency approved.
- The exact standard, its edition year, and the required performance levels or marking codes, not just “CE”.
- Whether the goods are private label. If your brand goes on the product, say so at RFQ stage: it changes who must hold the certificate.
- Whose name the certificate is issued in, and whether an existing one will be extended to your model.
- Confirmation that the certified production site, the audited factory and the invoicing entity are the same organisation.
- Label, pictogram and instruction artwork, the languages required, and the importer details to print.
- Acceptance criteria: inspection level and AQL, which laboratory will test, and who pays for retesting.