Regulation (EU) 2016/425 on personal protective equipment
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 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
- Risk categories of PPE
- Essential health and safety requirements
- Technical documentation for PPE
- Internal production control
- EU type-examination
- Conformity to type based on internal production control
- Conformity to type based on internal production control plus supervised product checks at random
- Conformity to type based on quality assurance of the production process
- EU declaration of conformity No … (form)
- Correlation table (regarding Directive 89/686/EEC)
See also information of the European Commission:
Commission communication in the framework of the implementation of Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (Publication of titles and references of harmonised standards under Union harmonisation legislation)
This legal act is a regulation thus applying directly in the Member States - no national implementing measures are required.