Personal protective equipment

The overall purpose of the Personal Protective Equipment (PPE) Regulation is to define rules for equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety.

From PPE Directive 89/686/EEC to PPE Regulation (EU) 2016/425: The regulation superseded the old PPE Directive 89/686/EEC on 21 April 2018. The new regulation reflects new technologies and processes for developing and bringing PPE to the market. As well as reflecting new technology, the new regulation has been shaped to enhance consumer safety and ensure fair competition between companies and markets.

The new regulation will not have to be transposed into each member state’s national law as it is a binding legislative act. It will be applied in its entirety across the EU without the need for separate national legislation. It also covers EEA/EFTA members (Liechtenstein, Norway, Iceland). Countries under specific acquis communautaire agreements (Switzerland, Turkey) are also required to apply the regulation.

The main changes with the new regulation are:

  • Responsibilities outlined for importers and distributors, including online.

  • An EU declaration of conformity must accompany the product, or user information must include corresponding information and must also display the website address where the EU declaration of conformity can be accessed.

  • Technical documentation and EU declaration of conformity must be available for 10 years after the product has been placed on the market.

  • Mandatory maximum five-year certificate validity period.

  • The manufacturer must declare their (1) name, (2) registered trading name or brand, and (3) a single contact postal address at which they can be contacted, on the product or, where not possible due to the size or physical characteristics of the product, on its packaging and/or on the accompanying documentation.

  • Products must be marked with type, serial or batch number.

  • Any competent market supervisory authority is permitted and advised to contact the economic operator directly, even if they are based in a different member state.

The regulation specifies different categories of PPE, such as work clothes, regulated by EN ISO 13688:2013; work gloves, regulated by EN 420:2003+A1:2009; and eye, ear and foot protection.

More information at European Commission