PPE categories I, II and III — which product belongs where?
Technically reviewed: 2026-07-31
In short
Regulation (EU) 2016/425 categorises PPE by risk. Category I: minimal risks (e.g. garden gloves) — the manufacturer self-assesses. Category II: everything neither I nor III (e.g. safety footwear, mechanical-risk gloves) — EU type-examination is required. Category III: risks causing death or irreversible harm (e.g. chemical-protective gloves, firefighter footwear) — type-examination PLUS ongoing production surveillance.
Why categories?
The Regulation’s logic is simple: the greater the risk the equipment protects against, the more independent verification its conformity needs. The category is not a quality ranking — it is the grade of procedural rigour.
Category I — minimal risks
Superficial injury, mild chemical action, heat below 50 °C, weather: garden gloves, washing-up gloves, sunglasses. The manufacturer itself demonstrates conformity through internal production control (Module A).
Category II — everything neither I nor III
The broad middle of protective equipment: safety footwear, mechanical-risk gloves, helmets, high-visibility clothing. The mandatory element is EU type-examination by a notified body (Module B), followed by the manufacturer’s internal production control (Module C).
Category III — fatal or irreversible risks
Chemicals, falls from height, heat and fire, electricity: chemical-protective gloves, firefighter footwear and gloves, fall-arrest harnesses. Beyond type-examination, ongoing production surveillance is mandatory — through supervised product checks (Module C2) or quality assurance of production (Module D). Next to the CE marking, these products carry the four-digit number of the surveillance notified body.
The practical consequence
The category determines the route, the timeline and the participants of market access. Clarifying the classification at the start of development is cheap; discovering it at the end is expensive — especially when the product’s functions place it a category higher than assumed.
Frequently asked questions
- Who decides which category a product belongs to?
- The classification follows from Annex I of the Regulation, based on the product's intended purpose and the nature of the risk. Correct classification is the manufacturer's responsibility — the notified body checks during the procedure that the chosen route matches the category.
- Can a product be in several categories?
- A product is in one category, always determined by its highest-risk protective function. If a glove protects both mechanically and chemically, the Category III chemical function takes the whole product into Category III.
- Does a Category I product need a notified body?
- No. In Category I the manufacturer issues the EU declaration of conformity through internal production control (Module A). A notified body is mandatory from Category II upward.
Related standards
Where next?
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