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New Personal Protective Equipment Regulation

Posted on April 9, 2018 at 3:36 pm

On the 21st April 2018, Regulation (EU) 2016/425 on Personal Protective Equipment (PPE) will come into force and replace the old PPE Directive 89/686/EEC.

PPE are products that the user can wear or hold, in order to be protected against hazards either at home, at work or whilst engaging in leisure activities.

Main changes

The new Regulation now applies to the whole supply chain rather than just manufacturers. Everyone involved in the manufacture, supply and distribution of PPE must ensure their PPE meets with the standard requirements.  

Some of the standard requirements are outlined below:

  • making sure PPE complies with the essential health and safety requirements;
  • making sure technical documentation has be drawn up;
  • when compliance has been demonstrated the EU declaration of conformity has been drawn up and a CE mark affixed;
  • retention of documents for 10 years;
  • sample testing;
  • duty to take action in relation to non-conforming PPE;
  • labelling requirements;
  • providing instructions; and
  • cooperating with the national authority.

 

In certain cases, the manufacturer’s obligations can now apply to importers and distributors. An importer or distributor who markets a product in Europe under their own name, brand or trademark becomes liable for the full manufacturer’s obligations.

The new Regulation slightly modifies the risk categorisation of products.  Life Jackets and hearing protection are moved from Category II (Intermediate PPE) to Category III (Complex PPE). This means that they are now subject to stricter conformity assessment procedures and ongoing surveillance.

Transitional period

There is a transition period of 1 year (21st April 2018 to 20th April 2019) where both the old Directive and the new Regulation are applicable. Therefore PPE designed and manufactured in accordance with Directive 89/686/EEC can still be placed on the market until 21st April 2019.

EC type-examination certificates and approval decisions issued under the old Directive shall remain valid until 21st April 2023 unless they expire before that date.

Purchasing PPE

Regulation (EU) 2016/425 does not apply any duties directly to end users of PPE. Employers who are selecting and using PPE within their own organisation are covered by the Personal Protective Equipment at Work Regulations 1992 which are unaltered by this Regulation. Those involved in specifying, sourcing or purchasing PPE for use within their own organisation should continue to select appropriate PPE which has been CE marked.  

UK legislation

In the UK The Personal Protective Equipment (Enforcement) Regulations 2018 (SI 2018/390) provide an enforcement and penalty regime for Regulation (EU) 2016/425.

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