Latest update: 20/10/2023

Regulation (EU) 2016/425 on personal protective equipment

The Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) to ensure the health and safety of users and to allow the equipment to be sold and used throughout the EU.


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 Regulation includes obligations for economic operators such as manufacturers and importers of PPE. They are responsible for the compliance of PPE with the essential safety and health requirements laid down in the Regulation to ensure a high level of protection of the users of PPE and to guarantee fair competition on the Union market. The Regulation is not aimed at employers. Obligations for employers are set out in occupational safety and health (OSH) legislation and, more specifically, in Directive 89/656/EEC on the use of personal protective equipment.
The Regulation repealed Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment. A ‘regulation’ is a directly binding legislative act and applies in its entirety across the EU. Its provisions do not require national implementing measures. 


The aim of this regulation is to ensure common standards for personal protective equipment (PPE) in all Member States in terms of protection of health and the safety of users, while enabling the free movement of PPE within the Union. The Regulation applies to all sorts of PPE except, for example, for those used by armed forces, certain private uses of PPE, and the ones subject to other rules (e.g. PPE on seagoing vessels, motorcycle helmets, etc.).


The Regulation includes definitions for the following terms: personal protective equipment, making available on the market, placing on the market, manufacturer, authorised representative, importer, distributor, economic operators, technical specification, harmonised standard, accreditation, national accreditation body, conformity assessment, conformity assessment body, recall, withdrawal, Union harmonisation legislation, CE marking.


All PPE shall comply with the Regulation and shall not endanger persons and properties. All PPE shall meet the essential health and safety requirements (Annex II) that need to be specified in the PPE’s “EU declaration of conformity”. Member States shall ensure free movement on the market but may lay down special requirements for the use of the PPE. Conformity assessment is the obligation of the manufacturer, which applies to imported PPE, as well. PPE must be accompanied by instructions and contact details in the user’s language.

Specific rules governing CE mark on PPEs are set out in this Regulation.

Accreditation of conformity assessment bodies, market surveillance and controls, and the general principles of the CE marking are laid down in Regulation (EC) No 765/2008.

There are three risk categories (annex I) that establish different applicable conformity assessment procedures.

Further provisions in the Regulation are the following:

  • Notification of conformity assessment bodies
  • Union market surveillance, control of PPE entering the union market and union safeguard procedure
  • Delegated and implementing acts
  • Transitional and final provisions


  1. Risk categories of PPE
  2. Essential health and safety requirements
  3. Technical documentation for PPE
  4. Internal production control
  5. EU type-examination
  6. Conformity to type based on internal production control
  7. Conformity to type based on internal production control plus supervised product checks at random
  8. Conformity to type based on quality assurance of the production process
  9. EU declaration of conformity No … (form)
  10. Correlation table (regarding Directive 89/686/EEC)

Read the full text of Regulation 2016/425/EU


Further information

This legal act is a regulation thus applying directly in the Member States - no national implementing measures are required.