What the PPE Regulation covers

The PPE Regulation (EU) 2016/425 sets the legal requirements for the design, manufacture, and placing on the EU/EEA market of personal protective equipment—equipment designed to be worn or held for protection against one or more risks to health or safety. It also covers essential interchangeable components and certain connection systems used with PPE.

Typical PPE in our store includes safety helmets, hearing and eye protection, protective gloves and footwear, high‑visibility clothing, fall‑protection, and respiratory protection. Some items are outside the Regulation’s scope (for example, products for non‑extreme weather used privately), while many professional and consumer PPE products are fully covered.

PPE risk categories (I–III)

PPE is classified by the severity of the risk addressed. The category determines the assessment route before a product can be sold.

Category I – Minimal risks

• Examples: superficial mechanical injury, contact with cleaning materials of weak action or prolonged contact with water, contact with hot surfaces ≤ 50 °C, sunlight (not solar observation), non‑extreme weather.
• Typical products: basic gardening gloves, simple rainwear, everyday sunglasses.
• Assessment: internal production control by the manufacturer (self‑declaration) and CE marking.

Category II – Intermediate risks

• PPE that is not Category I or III (e.g., many protective garments, safety eyewear, helmets depending on use).
• Assessment: EU type‑examination by a Notified Body (Module B), plus ongoing conformity to type via internal production control (Module C), then CE marking.

Category III – Very serious risks

• Risks with potential for death or irreversible health damage (for example: harmful biological agents, high/low temperatures, electric shock/live working, drowning, falls from height, chainsaw cuts, high‑pressure jets, stab/bullet wounds, harmful noise).
• Assessment: EU type‑examination (Module B), plus ongoing surveillance either via product checks (Module C2) or a quality‑assured production process (Module D). CE marking applies, with the Notified Body’s 4‑digit ID adjacent to the CE mark.

Conformity assessment & CE marking

• CE marking: Required on all PPE before it’s placed on the EU/EEA market. For Category III, the CE mark is followed by the Notified Body’s 4‑digit number.
• EU type‑examination certificates (Module B): Generally valid for five (5) years. Certificates are reviewed sooner if the product or applicable standards change.
• Presumption of conformity: Applying relevant EN standards is a recognized route to meet the Regulation’s Essential Health & Safety Requirements (EHSRs).

Documentation, labeling & languages

• EU Declaration of Conformity (DoC): Each PPE must be accompanied by a DoC or a clear reference with the product (e.g., link on packaging/manual) to where the DoC is available online.
• User instructions: Must be provided in the official language(s) of the EU country where the PPE is made available.
• Traceability: Labeling must include the manufacturer’s name and address (and importer details if applicable), product identification (model/batch/serial), CE marking, and for Cat III the Notified Body number.
• Retention: Manufacturers keep the technical file and DoC for at least 10 years after the product is placed on the market.

EU market surveillance & online sales

Within the EU, product safety and compliance are enforced by market surveillance authorities. For many harmonised products sold to EU consumers (including online), there must be an economic operator established in the EU (e.g., manufacturer, importer, authorised representative, or certain fulfilment service providers) to cooperate with authorities and hold compliance documentation.

Shopping with e‑workwear.eu: what we verify

• We prioritise suppliers whose products carry a valid CE marking and, for Category III PPE, a visible Notified Body ID with the CE mark.
• We request and archive current EU type‑examination certificates (where applicable) and ensure they are within their validity period.
• We ensure a DoC accompanies the product or is referenced on the product/packaging/manual for customer access.
• We check that user instructions and safety information are provided in the correct language(s) for the destination EU country.
• We work only with partners who maintain traceability (manufacturer/importer details, batch/serial identification) and uphold quality controls for ongoing compliance.

Frequently asked questions

Is CE marking required for all PPE in the EU?

Yes. All PPE placed on the EU/EEA market must bear the CE mark. For Category III, the CE mark is followed by the 4‑digit Notified Body number.

How are PPE categories determined?

By the risk addressed. Category I covers minimal risks; Category III covers very serious risks. Everything else sits in Category II.

What is an EU Declaration of Conformity (DoC)?

A legal statement by the manufacturer confirming that the PPE meets all applicable requirements. It must accompany each product or be accessible via a clear reference provided with the product.

How long is the EU type‑examination certificate valid?

Typically five years, with earlier review required if the product changes or relevant standards are revised.

Which language must be provided with PPE sold in the EU?

User instructions and safety information must be available in the official language(s) of the EU Member State where the product is made available to users.

Do you supply to all EU/EEA countries?

Yes. We deliver across the EU/EEA and ensure that instructions and labeling comply with the language and regulatory requirements of the destination market.

Disclaimer: This page is for general information only and is not legal advice. Always consult the product’s documentation and your safety professional for selection and use.

Last updated: 23 January 2026