Personal Protective Equipment Regulation

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
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.
Gloves are PPE that are covered by the PPE Regulation (2016/425).
Gloves are PPE that are covered by the PPE Regulation (2016/425).

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.


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