PPE Regulation (EU 2016/425)

INSPEC offers PPE certification against:  

  • Module B, Type-examination
  • Module C2, Product control 
  • Module D, Quality control

The Personal Protective Equipment Regulation (EU 2016/425) becomes effective on 21st April 2018, and, from that date, repeals the PPE Directive. There will be a one-year transition period, during which time both the PPE Directive and the PPE Regulation can be used to CE mark products.  However, from 21st April 2019 all Personal Protective Equipment (PPE) being placed on the EU market must comply with the Regulation, including existing PPE certified against the Directive.

PPE is defined in the Regulation as: ‘Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that persons health or safety, or interchangeable components for such equipment; or connection systems for such equipment that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, but are not designed to be permanently fixed and that do not require fastening works before use’.


In order for PPE legally to be placed on the market in member states of the European Union (EU), it must bear the CE mark.  The CE mark must be of the form specified in Regulation 765/2008 and should be at least 5 mm high.  It has to be affixed to the product, or, if the item is very small, shown on the packaging.  For certain categories of PPE, the manufacturer must apply to a Notified Body for the PPE to undergo EC type-examination, followed, in some cases, by elements of quality control. 


The Regulation provides for three categories of PPE – Minimal Risks (Category I), Other Risks (Category II) and Serious Risks (Category III).  The extent of control on the manufacturer's production and quality system, and the degree of involvement of a Notified Body, is determined by the category.  The categorisation of PPE is subject to regular review and a corresponding list is maintained up-to-date and published by the European Commission.


The Regulation also requires EU member states to nominate to the European Commission (EC) the names of those organisations (certification bodies) that the member state has deemed competent to perform the actions required by the Directive.  These organisations are called Notified Bodies


Click here for more information about the process of CE marking.


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The Personal Protective Equipment Regulation (EU 2016/425) becomes applicable from 21st April 2018, and, from that date, repeals the PPE Directive. There will be a one-year transition, during which time both the PPE Directive and the PPE Regulation can be used to CE mark products. However, from 21st April 2019 all Personal Protective Equipment (PPE) being placed on the EU market must comply with the Regulation, including existing PPE certified against the Directive. 

PPE is defined in the Regulation as: ‘Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that persons health or safety, or interchangeable components for such equipment; or connection systems for such equipment that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, but are not designed to be permanently fixed and that do not require fastening works before use’.

In order for PPE legally to be placed on the market in member states of the European Union (EU), it must bear the CE mark.  The CE mark must be of the form specified in Regulation 765/2008 and should be at least 5 mm high.  It has to be affixed to the product, or, if the item is very small, shown on the packaging.  For certain categories of PPE, the manufacturer must apply to a Notified Body for the PPE to undergo EC type-examination, followed, in some cases, by elements of quality control. 

The Regulation provides for three categories of PPE – Minimal Risks (Category I), Other Risks (Category II) and Serious Risks (Category III).  The extent of control on the manufacturer's production and quality system, and the degree of involvement of a Notified Body, is determined by the category.  The categorisation of PPE is subject to regular review and a corresponding list is maintained up-to-date and published by the European Commission. 

The Regulation also requires EU member states to nominate to the European Commission (EC) the names of those organisations (certification bodies) that the member state has deemed competent to perform the actions required by the Directive.  These organisations are called Notified Bodies

 

Click here for more information about the process of CE marking.