Personal Protective Equipment (PPE) Regulation
Please note: the PPE Regulation (EU) 2016/425 replaced the Personal Protective Equipment Directive (89/686/EEC) from 21 April 2018.
Number: Regulation (EU) 2016/425
Official Title:
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC
Description:
The PPE Regulation lays down the conditions governing its placing on the market and free movement within the Community and the basic safety requirements which PPE must satisfy in order to ensure the health protection and safety of users.
The PPE Regulation lays down the conditions governing its placing on the market and free movement within the Community and the basic safety requirements which PPE must satisfy in order to ensure the health protection and safety of users.
The PPE Regulation’s main objectives are to provide the Basic Health and Safety Requirements which the PPE must satisfy to preserve the health and ensure the safety of intended users, and to ensure free movement of PPE within the Community.
Which products are covered by the Personal Protective Equipment (PPE) Regulation?
Regulation (EU) 2016/425 applies to personal protective equipment (PPE) intended for use in domestic, leisure, and sports activities, as well as for professional use.
For the purposes of this Regulation, personal protective equipment (PPE) means ‘any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.’
- PPE also covers:
(a) a unit constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks; - (b) a protective device or appliance combined, separably or inseparably, with personal non-protective equipment worn or held by an individual for the execution of a specific activity;
- (c) interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment.

Which products are not covered by the Personal Protective Equipment (PPE) Regulation?
This PPE regulation does not apply to:
- PPE covered by another directive designed to achieve the same objectives as this Directive with regard to placing on the market, free movement of goods and safety
- PPE designed and manufactured specifically for use by the armed forces or in the maintenance of law and order (helmets, shields, etc.).
- PPE for self-defense (aerosol canisters, personal deterrent weapons, etc.)
- PPE designed and manufactured for private use against:
— adverse atmospheric conditions (headgear, seasonal clothing, footwear, umbrellas, etc.),
— damp and water (dish-washing gloves, etc.),
— heat (gloves etc.). - PPE intended for the protection or rescue of persons on vessels or aircraft, not worn all the time.
- Helmets and visors intended for users of two- or three-wheeled motor vehicles.
How to comply with the Personal Protective Equipment (PPE) Regulation:
Personal protective equipment covered by the PPE Directive are separated into three distinct groups and their relevant conformity assessment procedures. These are named in the Directive as “Simple design”, “Complex design” and neither of these, the last being the third Category. Whilst Regulation (EU) 2016/425 does not explicitly define these three groups as Categories, it is common practice to use the terms category I, III and II respectively.
The categories are:
- Category I (“simple design”): The manufacturer declares conformity by means of an EU declaration of conformity only;
- Category II (neither simple nor complex): subject to an EC-type examination by a Notified Body and an EC declaration of conformity is then produced;
- Category III (so-called “complex design”): subjected to EC-type examination and to one of the two Quality Assurance procedures before an EC declaration of conformity is produced.
Links/Downloads
- European Harmonised Standards Related to Personal Protective Equipment (PPE) Directive
- Text REGULATION (EU) 2016/425
Other articles that may be of interest
- Machinery Directive – 2006/42/EC
- Low Voltage Directive – 2014/35/EU
- EMC Directive – 2014/30/EU
- Medical Devices Directive – 93/42/EEC
- Construction Products Regulation – Regulation (EU) No 305/2011
- Pressure Equipment Directive – 97/23/EC
- REACH – Regulation (EC) No 1907/2006
- RoHS – Restriction of Hazardous Substances – Directive – 2011/65/EU
- Waste Electrical and Electronic Equipment Directive – 2012/19/EU
- ATEX Directive – 2014/34/EU
- Toy Directive – 2009/48/EC
- R&TTE Directive – 1999/5/EC
- Recreational Craft Directive – 94/25/EC
- Active Implantable Medical Devices Directive – 90/385/EEC
- Explosive for Civil Use Directive – 93/15/EEC
- Noise Emission in the Environment Directive – 2000/14/EC
- Gas Appliances Directive – 2009/142/EC
- Lifts Directive – 1995/16/EC
- Pyrotechnic Directive – 2007/23/EC
- Measuring Instruments Directive – 2004/22/EC
- What is CE marking?
- What does the CE mark mean? What do the initials CE stand for?
- Do your products need CE marking?
- How do you benefit from CE marking??
- In which countries is the CE marking required?
- What does CE certification cost?
- Do our products automatically qualify for the CE mark when they are UL/CSA approved?
- Who should undertake CE marking?
- Notified Bodies: What are they? What is their role?
- What is the CE marking process?
- What files/documentation must I keep?
- How and where must the CE mark appear?
- Other posts about CE Marking