Personal protective equipment

• Regulation (EU) 2016/425 — Personal Protective Equipment
• Regulation (EU) 2019/1020 — Article 4
• Regulation (EU) 2023/988 — GPSR for aspects not covered

Who has to appoint one

Manufacturers outside the Union placing protective equipment on the EU market, including work gloves, helmets, harnesses, eye and hearing protection, respiratory masks, high-visibility clothing and safety footwear. Importers who sell under their own brand become manufacturers. Online sellers shipping directly to EU consumers or businesses need an EU-established operator under Article 4.

Thresholds and exemptions

None. Category I equipment covering minimal risks — gardening gloves, sunglasses, washing-up gloves — is fully in scope, with a lighter conformity route. Category II covers everything not in I or III. Category III covers equipment against risks that may cause very serious consequences: falls from height, chemicals, harmful biological agents, high-voltage electricity, drowning, cuts by chainsaw, high-pressure jets, bullet wounds, extreme temperatures and harmful noise.

What must appear on the label

CE marking, followed by the four-digit identification number of the notified body for Category III equipment subject to production surveillance. The manufacturer's name, registered trade name and postal address, and the same for the authorised representative or importer. Type, batch or serial number. The pictograms and performance levels required by the relevant harmonised standard — for example the four digits of EN 388 for mechanical risks on gloves. The internet address where the EU declaration of conformity can be accessed.

Marketplace fields

Marketplaces suppress PPE listings that show no CE marking, and specifically check for the notified body number on Category III items such as respirators and fall-arrest equipment. During the 2020 mask shortage this category attracted extensive enforcement, and the scrutiny has not relaxed: test reports and EU type-examination certificates are routinely demanded before reinstatement.

Documentation you must hold

EU declaration of conformity, supplied with the product or accessible at a stated internet address. Technical documentation with the design and manufacturing drawings, the risk analysis of the risks the PPE protects against, the list of standards applied, test reports and the notified body's EU type-examination certificate for Categories II and III. For Category III, evidence of the chosen production surveillance route — either supervised product checks or an audited quality system. Instructions for use, storage, cleaning, maintenance, obsolescence and the meaning of markings.

Standards and testing

EN 388 for mechanical risks in gloves, EN 374 for chemical and micro-organism protection, EN 166 for eye protection, EN 149 for filtering half masks, EN 361 and EN 355 for fall arrest, EN ISO 20345 for safety footwear, EN ISO 20471 for high-visibility clothing, EN 352 for hearing protectors. Categories II and III require EU type-examination by a notified body: self-declaration is available only for Category I.

Language requirements

Instructions and information must be in the official language of every member state where the PPE is made available, and this includes the explanation of pictograms and performance levels. Because PPE is often bought for workplaces, several member states enforce this through labour inspectorates as well as market surveillance.

When it applies

Documentation and, for Categories II and III, the type-examination certificate must exist before the first unit is placed on the market. EU type-examination certificates are valid for a maximum of five years and must be reviewed when the state of the art or the standard changes; an expired certificate means the product is no longer covered.

How long records are kept

Technical documentation and the EU declaration of conformity for ten years after the PPE was placed on the market. Production surveillance records for Category III for the duration of the certificate plus the statutory period.

What happens if you do not comply

Withdrawal, recall and Safety Gate alerts, which for PPE are frequent and public. Customs refusal at import. National fines, and workplace liability where an employer supplied non-conforming equipment: the employer is exposed as well as the seller, which is why professional buyers demand documentation before purchase.

Who enforces it

National market surveillance authorities, labour inspectorates, notified bodies for type examination and surveillance, and customs.

Where the boundary lies

Two edges matter. A face covering sold as a fashion accessory is not PPE, but any protective or filtration claim brings it into Regulation 2016/425; a mask with a medical purpose is instead a medical device under Regulation 2017/745. And PPE for private use against minor risks — ordinary sunglasses, dishwashing gloves — is Category I and self-declared, but still needs CE marking, documentation and an EU economic operator, which sellers of low-value goods routinely overlook.

Questions we are asked

Are simple work gloves really PPE?

Yes, in Category I if they protect only against minimal risks, in Category II if against mechanical risks with performance claims. The paperwork is lighter in Category I but the CE marking, the declaration and the EU operator are still required.

Our masks are certified in China to GB 2626 — is that enough?

No. EU conformity requires EU type-examination against EN 149 by a notified body listed in NANDO. Foreign certifications, and certificates from bodies not notified for this Regulation, have no legal effect in the Union.

Does the notified body number always appear next to CE?

Only where the notified body is involved in production surveillance, which is Category III. Category II carries CE marking without a number, since the notified body is involved only in type examination.

How do we check a notified body is genuine?

Look it up in the Commission's NANDO database under Regulation (EU) 2016/425. Certificates from bodies not listed there for this Regulation are worthless, and buying one is a common way sellers are defrauded.