PPE Regulation (EU) 2016/425

Last reviewed: October 2026 · Sources listed at the end of this page.

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: 20 April 2016.
• Date of application: 21 April 2018.
• Repeal of Directive 89/686/EEC: 21 April 2018.
• Transition (Article 47), now over: products under Directive 89/686/EEC could be placed on the market until 21 April 2019, and certificates under that Directive remained valid until 21 April 2023 at the latest.
• Status (October 2026): applies, as amended by Regulation (EU) 2024/2748 (emergency procedures for an internal market emergency, applicable from 29 May 2026).

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 (Article 2(2))

• 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 that are not of an extreme nature, or against damp and water during dishwashing;
• PPE intended exclusively for use on seagoing vessels or aircraft covered by international agreements applicable in Member States;
• PPE for head, face or eye protection covered by UNECE Regulation No 22 (protective helmets and visors for drivers and passengers of motorcycles and mopeds).

Risk categories (Article 18 and Annex I)

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 not exceeding 50°C, damage to the eyes due to sunlight (other than during observation of the sun), atmospheric conditions of non-extreme nature. Sunglasses for everyday use, gardening gloves, household rubber gloves.
• Category II — Risks not in Category I or III. Often includes general-purpose PPE such as safety helmets, hi-vis clothing, many safety gloves and safety footwear; the category follows the risk the manufacturer intends to protect against. Hearing protectors are Category III (harmful noise).
• Category III — Serious risks with irreversible consequences or fatal outcomes. Thirteen specific risk areas listed: substances and mixtures hazardous to health; atmospheres with oxygen deficiency; harmful biological agents; ionising radiation; high-temperature environments (effects comparable to an air temperature of at least 100°C); low-temperature environments (effects comparable to an air temperature of −50°C or less); falling from a height; electric shock and live working; drowning; cuts by hand-held chainsaws; high-pressure jets; bullet wounds or knife stabs; harmful noise.

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, innocuousness, comfort and effectiveness, and the manufacturer's instructions and information (point 1.4).
• 2. Additional requirements common to several types of PPE. For example adjustment systems, PPE enclosing parts of the body, PPE for the face, eyes and respiratory system, PPE subject to ageing, PPE for potentially explosive atmospheres, PPE for very dangerous situations, and multi-risk PPE.
• 3. Requirements specific to particular risks. For example mechanical impact, falls, mechanical injuries, drowning, harmful noise and other risks listed in the Annex.

Conformity assessment procedures

Article 19 and Annexes IV–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.

EU-type examination certificates are valid for no more than five years (Annex V). Under Article 17(3), the four-digit Notified Body identification number appears next to the CE marking only for Category III products; Category II products (Module B + C) bear the CE marking without a Notified Body number. By derogation, Category III PPE produced as a single unit to fit an individual user may follow the Category II procedure (Article 19). See Notified Bodies and CE number lookup.

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 after the PPE has been placed on the market (Article 8(3)). 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 manufacturer must either provide the Declaration with the PPE or include in the instructions the internet address at which it can be accessed (Article 8(8)).

Marking, labelling, instructions

Articles 16 and 17 govern the CE marking. Articles 8 and 10 require the PPE to bear or be accompanied by:

• Type, batch, or serial number, or other identifier (Article 8(5));
• Manufacturer's name, registered trade name or trade mark, postal address (Article 8(6));
• Importer's contact details where applicable (Article 10(3));
• The instructions and information set out in Annex II, Section 1.4, in a language easily understood by consumers and other end-users, as determined by the Member State concerned (Article 8(7)).

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

• Regulation (EU) 2024/2748 — added emergency procedures that operate only when an internal market emergency is activated; applicable from 29 May 2026. It is the only amendment recorded in the consolidated text.
• Omnibus IV — the provisional agreement of 9 June 2026 on digital compliance information for product legislation is reported to cover PPE. We found no publication in the Official Journal as of October 2026, so it does not yet apply.

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.
• 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 — applies to consumer products for aspects not covered by specific Union harmonisation legislation.

Common errors

• Mis-categorisation. Treating Category II PPE as Category I skips the required EU-type examination by a Notified Body.
• 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 III products. The four-digit number of the Notified Body involved in Module C2 or D must appear next to the CE mark (Article 17(3)); Category II products do not carry a Notified Body number.
• User instructions only in English. Article 8(7) requires the Annex II Section 1.4 instructions in a language easily understood by end-users, as determined by the Member State concerned.
• 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.

Frequently asked questions

What are the three PPE categories?

Category I covers only the minimal risks listed in Annex I. Category III covers only the 13 listed risks that may cause very serious consequences such as death or irreversible damage to health. Category II covers everything else.

Does Category II PPE carry a Notified Body number?

No. Category II PPE needs an EU-type examination certificate from a Notified Body, but the CE marking carries no number. Only Category III PPE has one, identifying the body involved in Module C2 or Module D (Article 17(3)).

How long is a PPE certificate valid?

An EU-type examination certificate is valid for no more than five years (Annex V). Certificates issued under the old Directive 89/686/EEC ceased to be valid by 21 April 2023 at the latest.

Is a face mask PPE or a medical device?

It depends on intended use. A medical mask intended for a medical purpose falls under the Medical Devices Regulation, while a respirator intended to protect the wearer falls under the PPE Regulation. A product claimed for both purposes needs to be assessed against both regimes.

Sources

• Regulation (EU) 2016/425 on personal protective equipment — EUR-Lex consolidated text.
• European Commission — PPE sector page.
• Regulation (EU) 2024/2748 — EUR-Lex.
• 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.