(EU) 2016/425
In forcePersonal Protective Equipment Regulation
CE framework for equipment worn or held for protection against health or safety risks — gloves, eyewear, helmets, respirators, fall protection. The conformity route depends on the risk category: self-assessment for Category I, notified-body type-examination for Categories II and III.
Applies to
Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety (Article 3(1)), sold to consumers or professionals. Exclusions include PPE specifically designed for the armed forces, for self-defence (except sporting), and products for private use protecting against atmospheric conditions that are not of an extreme nature (Article 2(2)).
Key obligations
- 01Ensure PPE is designed and manufactured in accordance with the essential health and safety requirements of Annex II, and carry out the conformity assessment procedure applicable to its risk category (Article 8).source
- 02Draw up the technical documentation (Annex III) and the EU Declaration of Conformity, and affix the CE marking (Article 8(2)).source
- 03Classify the PPE correctly per Annex I: Category I (minimal risks, e.g. superficial mechanical injury), Category II (risks that are neither minimal nor Category III), Category III (risks that may cause death or irreversible damage to health, e.g. harmful substances, falls from height).source
- 04Supply instructions and information (storage, use, cleaning, maintenance, performance limits) with each item of PPE, in the required language.sourceUnverified — check source
- 05For Category III PPE, ensure ongoing production control via a notified body (supervised product checks or quality assurance) and add the notified body's number after the CE marking (Article 17(3), Article 19(c)).source
Conformity routes
- Category I — internal production control (Module A)Minimal-risk PPE only (superficial mechanical injury, cleaning materials, atmospheric conditions that are not extreme, etc.). Pure self-assessment.source
- Category II — EU type-examination (Module B) + conformity to type (Module C)Intermediate risks (most work gloves, eyewear, helmets). A notified body examines and certifies the type before marketing.source
- Category III — Module B plus Module C2 or Module DRisks that may cause death or irreversible harm (respiratory protection, fall arrest, chemical protection): EU type-examination plus either supervised product checks at random intervals (C2) or quality assurance of the production process (D), both via a notified body.source
Documentation
- EU Declaration of ConformitySupplied with the PPE or via a web link indicated in the instructions; kept 10 years.source
- Technical documentation (Annex III)Risk analysis, design details, test reports, and the EU type-examination certificate where applicable.source
- Instructions and information of the manufacturerUse, storage, maintenance, performance limits, accessories/spare parts information.source
Marking requirements
- CE marking on the PPE (or packaging/documents where not possible); for Category III PPE the CE marking is followed by the identification number of the notified body involved in production control (Article 17(3)).source
Testing standards
Harmonised and designated standards lists change over time: confirm the currently cited version before testing.
Key dates
- 2018-04-21Regulation (EU) 2016/425 applies, repealing PPE Directive 89/686/EEC. Old-directive PPE could be made available until 21 April 2019; old EC type-examination certificates remained valid until 21 April 2023 at the latest.source
Penalties
Member States lay down the rules on penalties (Article 45(1)), which may include criminal penalties for serious infringements and must be effective, proportionate and dissuasive.source
Further guidance
Applies to these product types
Frequently asked
How do I know which PPE category my product is?+
Annex I defines it by risk protected against, not product type. Category I covers minimal risks only (e.g. superficial mechanical injury, contact with cleaning materials, non-extreme weather). Category III lists the gravest risks — harmful substances, falls from height, respiratory hazards, etc. Everything in between is Category II.
Do work gloves need a notified body?+
Gloves protecting against mechanical risks (tested to EN 388) are Category II, so yes — a notified body must issue an EU type-examination certificate before you can CE-mark and sell them. Only minimal-risk gloves (e.g. simple gardening gloves against superficial injury) are Category I self-assessed.
Why do FFP masks show a four-digit number after the CE mark?+
Filtering half masks protect against a Category III risk, so a notified body monitors ongoing production (Module C2 or D) and its identification number must follow the CE marking on the product.
Does the PPE Regulation cover consumer products like cycling helmets?+
Yes — the regulation covers PPE for both professional and private use. The main private-use exclusion is products against non-extreme atmospheric conditions (ordinary clothing/umbrellas); protective sports gear like helmets is in scope.
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