Of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC
Directive 89/686/EEC is repealed with effect from 21 April 2018.
Objective
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.).
Defintions
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.
Contents
All PPE shall comply with the Regulation and shall not endanger persons and properties. All PPE shall meet certain 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 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