Pressure Equipment Directive 2014/68/EU (PED)
October 1, 2026
Toy Safety Directive 2009/48/EC
October 1, 2026
Regulation (EU) 2016/425 sets the design and manufacturing requirements for personal protective equipment (PPE) and the rules for placing it on the market. It replaced Directive 89/686/EEC and has applied since 21 April 2018. PPE in scope must carry the CE marking and be accompanied by an EU Declaration of Conformity on the EU and the Turkish market.
For CE marking of personal protective equipment, apply to CE Danışmanı (CE Consultant); we manage the whole process for you.
What is PPE?
- Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to health or safety
- Interchangeable components of such equipment that are essential for its protective function
- Connection systems that are not held or worn, that link the equipment to an external device or a reliable anchorage point, that are not permanently fixed and that need no fastening work before use
Typical products
| Protection | Examples |
|---|---|
| Head | Safety helmets, bump caps, hair nets |
| Hearing | Ear muffs, ear plugs, helmets with hearing protection |
| Eyes and face | Welding masks, face shields, goggles |
| Respiratory system | Gas masks, dust masks, breathing apparatus, diving equipment |
| Hands and arms | Protective gloves |
| Feet and legs | Safety footwear, gaiters, knee protectors, insoles |
| Trunk and body | Protective clothing against chemicals, puncture and splashes |
| Falls from a height | Fall prevention and fall arrest harness systems |
What is excluded
- PPE designed specifically for the armed forces or for maintaining law and order
- PPE for self-defence, except PPE intended for sporting activities
- PPE for private use against atmospheric conditions that are not of an extreme nature
- PPE for private use against damp and water during dishwashing
- PPE used exclusively on seagoing vessels or aircraft that are subject to international treaties
- Helmets and visors for motorcycle and moped users covered by the relevant UNECE regulation
Surgical masks and work clothes
A product that its manufacturer intends to protect the wearer is PPE, even when it is used in a hospital. Filtering masks against gases or dust are an example. A surgical mask or gown, intended for a medical purpose, is a medical device and falls under the Medical Device Regulation. Ordinary work clothes and uniforms that are not designed to protect the wearer’s health or safety are not PPE.
Risk categories
| Category | Risks | Conformity assessment |
|---|---|---|
| I | Minimal risks that the user can assess and notice in good time, such as superficial mechanical injury or contact with weak cleaning materials | Internal production control by the manufacturer |
| II | All risks that are not listed under Category I or III | EU type-examination by a notified body, then conformity to type based on internal production control |
| III | Risks that may cause death or irreversible damage to health, such as falls from a height, harmful substances or oxygen-deficient atmospheres | EU type-examination by a notified body, plus supervised product checks at random intervals or quality assurance of the production process |
For Category III, the identification number of the notified body follows the CE marking.
Risks the equipment addresses
- Physical: mechanical, thermal, electrical, radiation, noise
- Chemical: aerosols, liquids, gases, vapours
- Biological: bacteria, viruses, fungi, non-microbial biological antigens
The equipment must protect against the risk without creating a risk itself, suit the conditions of use, and fit the wearer’s body and ergonomic needs.
EU Declaration of Conformity
- Identification of the PPE
- Name and address of the manufacturer or the authorised representative
- Object of the declaration
- The legislation the product complies with
- References of the harmonised standards used
- The notified body, the EU type-examination certificate and, for Category III, the module applied
The CE marking is affixed to the PPE visibly, legibly and indelibly. The manufacturer keeps the technical documentation and the declaration for 10 years.
PPE in Turkey
Turkey applies the Regulation through its own Personal Protective Equipment Regulation, published in the Official Gazette of 1 May 2019 and aligned with (EU) 2016/425. PPE is among the product groups checked at import through TAREKS. A separate Turkish regulation covers how employers select and use PPE at the workplace, based on a risk assessment by body part and type of risk.
