Guide to PPE Regulation

Guide to the PPE Regulation (EU) 2016/425

When and why is the PPE Directive changing?

As of April 2018, the new PPE Regulation 2016/425 repeals the PPE Directive 89/686/EEC. The PPE Regulation has been introduced to harmonise processes and reflect current practice for developing and bringing PPE to the market in Europe.


April 2018 to April 2019, is the transition phase between the regulation being published and applied. By April 2019 all CE marked PPE products placed on the market must be compliant with the PPE Regulation.


What are the main changes?

The PPE Regulation is a binding legislative act and imposes clear and detailed requirements which must be applied in their entirety across the EU member states. The regulation applies to all forms of PPE supply, including distance selling, and seeks to establish high levels of health and safety practice, protection of users, and fair competition.


There are several principle changes which are:

  • Change of categorisation from product related to risk related
  • Change of classification for certain product categories;
    Hearing protection, now categorised as ‘harmful noise’ (risk) is moving from Category II to Category III
  • EU Declaration of Conformity to be provided with each product (or a link to where it can be obtained)
  • Technical documentation and the EU declaration of conformity held for 10 years after the PPE has been placed on the market
  • 5-year validity / expiry date for new certificates
  • Outlined obligations for Economic Operators within the supply and distribution chain


Declarations of Conformity and Certificates

3M’s Declarations of Conformity and certificates can be located by the links below.

  • Safety Product Advisors Tool

    Safety Product Advisor Tool

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    For eye protection

    For hearing protection

  • Harmful Noise

    Harmful Noise

    The PPE Regulation recognises harmful noise as an irreversible health hazard. This puts hearing protection in the same level of high risk as respiratory protection and fall protection.