PPE Regulation (EU) 2016/425

Last reviewed: May 2026 · Legal status verified against EUR-Lex.

Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment — the "PPE Regulation" — replaced Council Directive 89/686/EEC and has applied since 21 April 2018. PPE covers equipment designed and manufactured to be worn or held by a person for protection against one or more risks to their health or safety. The Regulation classifies PPE into three categories by risk severity, with conformity assessment requirements scaled accordingly. The Regulation was published in the OJEU as OJ L 81, 31.3.2016, p. 51.

Legal status and timeline

• Adoption: 9 March 2016.
• Entry into force: 21 April 2016.
• Date of application: 21 April 2018.
• Repeal of Directive 89/686/EEC: 21 April 2018.
• Status in May 2026: applies; no replacement under preparation.

Scope: products covered

Article 3(1) defines PPE as "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", interchangeable components essential to the equipment's protective function, and connection systems that are not held or worn by a person but are designed to connect that equipment to an external device or to a reliable anchorage point.

Exclusions (Annex I)

• PPE designed specifically for use by armed forces or maintenance of law and order;
• PPE designed for self-defence (with the exception of equipment intended for sporting activities);
• PPE designed for private use to protect against atmospheric conditions of a non-extreme nature (e.g., umbrellas, ordinary gardening gloves), dampness, and water in the context of washing-up;
• PPE intended exclusively for use on seagoing vessels or aircraft covered by international agreements applicable in Member States;
• Helmets and visors for users of two- and three-wheel motor vehicles, subject to relevant UNECE Regulation.

Risk categories (Annex I, Section II)

Annex I divides PPE into three categories based on the severity of the risks the equipment is intended to protect against:

• Category I — Minimal risks. Examples: superficial mechanical injury, contact with cleaning materials of weak action or prolonged contact with water, hot surfaces below 50°C, damage to the eyes by sunlight (where not used for observing intense light sources), atmospheric conditions of non-extreme nature. Sunglasses for everyday use, gardening gloves, household rubber gloves.
• Category II — Risks not in Category I or III. Includes most general-purpose PPE — safety helmets, hi-vis clothing, hearing protection (against noise damaging hearing but not at chronic risk levels in Category III), most safety gloves, safety footwear.
• Category III — Serious risks with irreversible consequences or fatal outcomes. Twelve specific risk areas listed: substances and mixtures hazardous to health; atmospheres with oxygen deficiency; harmful biological agents; ionising radiation; high-temperature environments (≥100°C); low-temperature environments (≤−50°C); falls from a height; electric shock and live work; drowning; cuts by hand-held chainsaws; high-pressure jets; bullet wounds or knife stabs; harmful noise; PPE for cold environments.

Essential health and safety requirements (Annex II)

Annex II sets out the essential health and safety requirements:

• 1. General requirements applicable to all PPE. Design principles, harmlessness of materials, comfort, marking, user information.
• 2. Additional requirements common to several types of PPE. PPE that incorporates adjustment systems, that envelopes parts of the body, with face, eye, or respiratory protection, with limited service life, used in very dangerous situations, with an electrical circuit, exposed to internal heat sources.
• 3. Specific risk requirements. Protection against mechanical impacts, prevention of static electricity, prevention of drowning, against high voltages, against ionising radiation, against high temperatures, against low temperatures, against falls from heights, against noise, against hot or cold liquid splashes, against cuts by hand-held chainsaws, against high-pressure jets.

Conformity assessment procedures

Articles 18–20 and Annexes V–VIII assign conformity assessment routes by category:

• Category I — Module A (Internal production control), Annex IV. The manufacturer self-declares. No Notified Body.
• Category II — Module B (EU type-examination) + Module C (Conformity to type based on internal production control), Annexes V + VI. A Notified Body issues an EU type-examination certificate; the manufacturer manages production conformity.
• Category III — Module B + Module C2 (random product checks) or Module D (production quality assurance), Annexes V + VII or VIII. Notified Body involvement in both design and production.

The four-digit Notified Body identification number appears next to the CE marking for Category II products only where Module C is supplemented by Notified Body verification, and always for Category III products. See Notified Bodies.

Technical documentation

Annex III sets the technical documentation contents — a complete description of the PPE and its intended use; an assessment of the risks against which the PPE is intended to protect; a list of essential requirements applicable; design and manufacturing drawings; references to harmonised standards applied; results of design calculations and examinations; test reports; for Category III PPE, supplementary documentation supporting the Notified Body's assessment under Module B and the production-phase module. Retention: 10 years (Article 8(7)). See technical documentation.

EU Declaration of Conformity

Article 15 and Annex IX set the Declaration's contents. A single Declaration covers all applicable Union acts. See EU Declaration of Conformity. The Declaration must accompany the PPE or be made available at an internet address printed on the product or its packaging (Article 15(2)).

Marking, labelling, instructions

Article 16 requires the CE marking. Article 8(2) requires the PPE to bear:

• Type, batch, or serial number, or other identifier;
• Manufacturer's name, registered trade name or trade mark, postal address;
• Importer's contact details where applicable (Article 10(3));
• Instructions for use, maintenance, storage, and disposal in the language(s) of the Member State of destination — required by Annex II, Section 1.4.

Notified Body number for Category III

For Category III PPE, the Notified Body identification number for the production-phase module (C2 or D) appears next to the CE mark. The identification number for the Module B Notified Body does not appear separately on the product.

Harmonised standards

The PPE Regulation has a large set of harmonised standards organised by protective function:

• EN ISO 20471 — hi-vis warning clothing;
• EN ISO 20345 / 20346 / 20347 — safety, protective, and occupational footwear;
• EN 388 — protective gloves against mechanical risks;
• EN 374 series — protective gloves against chemicals and microorganisms;
• EN 397 — industrial safety helmets;
• EN 166 — eye and face protection;
• EN 149 — filtering half-masks (FFP1, FFP2, FFP3);
• EN 361 — full-body harnesses for fall protection;
• EN ISO 13688 — protective clothing general requirements;
• EN ISO 11611 / 11612 — protective clothing for welding and against heat and flame.

See harmonised standards.

Recent and upcoming changes

• The Commission has been working on adjustments to the harmonised standards list in response to lessons learned during COVID-19 (especially FFP respirators).
• The PPE Regulation's relationship with the Medical Devices Regulation for products used in healthcare (e.g., medical face masks vs. respirators) has been clarified by repeated Commission and MDCG guidance.
• No structural amendment to the Regulation is currently in preparation.

Related legislation

• Medical Devices Regulation 2017/745 — medical face masks and gowns intended for medical purposes are medical devices, not PPE. Respirators for healthcare use can be PPE, medical devices, or both depending on intended use.
• Machinery Regulation 2023/1230 — for PPE incorporated as a safety component of machinery (rare).
• Directive 89/656/EEC (employer obligations to use PPE) — sets the framework for employer use of PPE in the workplace, distinct from the PPE Regulation that governs the equipment itself.
• GPSR 2023/988 — fallback for products marketed as protective but outside Annex I.

Common errors

• Mis-categorisation. Treating Category II PPE as Category I (no Notified Body) is a frequent finding in market surveillance.
• Missing periodic Notified Body involvement for Category III. Module B + C2 / D involves continuing Notified Body engagement; a one-off type-examination certificate is not sufficient.
• Use of CE mark without Notified Body number on Category II/III products. The four-digit number must appear next to the CE mark for Category III, and for Category II where production checks are conducted by the Notified Body.
• User instructions only in English. Annex II Section 1.4 requires instructions in the official language(s) of the Member State of destination.
• Confusion with medical devices. A face mask marketed for healthcare use may be a medical device under the MDR; the same physical mask marketed for industrial use is PPE. The intended use determines the applicable regime.

Sources

• Regulation (EU) 2016/425 on personal protective equipment — EUR-Lex consolidated text.
• European Commission — PPE sector page.
• European Commission — Harmonised standards for PPE.
• Council Directive 89/656/EEC on use of PPE by workers — EUR-Lex.
• Commission Notice — Blue Guide 2022 — EUR-Lex.