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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

Personal Protective Equipment (PPE) Regulation

The Personal Protective Equipment (PPE) Regulation establishes designing and manufacturing requirements for personal protective equipment (PPE) placed in the EU market for the purpose of protecting the health and safety of the user, either on worksites or other places that present potential physical danger.

The regulation classifies PPE into Category I, II, or III, depending on the level of risk of the environment associated with their use. The hazardous levels are arranged in ascending order.

Note that PPE that is classified as either Category II or III requires Notified Body involvement.

Product Examples

Here we list some examples of products that fall under the Personal Protective Equipment (PPE) Regulation:

  • Sunglasses
  • Face masks and respirators
  • Helmets
  • Working gloves
  • Safety goggles
  • Earmuffs
  • Earplugs

Protective equipment that is intended for military use, self-defense, and resistance to non-extreme climate conditions are often exempted from the PPE Regulation, although there are some exemptions, which you can find in the text of the regulation itself.

Learn More

a. List of Products Covered by the PPE Regulation

b. Official Text of the Regulation