New PPE Regulation hitting the cleanroom market

08/02/2018 @ 15:25:00

It’s on everyone’s radar; the Personal Protective Equipment (PPE) Directive is being superseded by the new PPE Regulation. The PPE Regulation will be applied from 21st April 2018, and there is a one-year transition period until 21st April 2019. Although we first talked about this in September, with the impact on cleanroom clothing, gloves and masks, it bears repeating. 

The new PPE Regulations will have an impact on ways of working, regardless of your exact role. Whether you wear PPE, purchase on behalf of others, or even if you have a strategic operational responsibility, the Regulations and their impact across the supply chain will be felt. 

From 2018, all manufacturers, importers and distributors of PPE must:

  • Place only compliant PPE on the market, acting with due care in relation to the requirements of the Regulation
  • Ensure conformity assessment procedures have been carried out by the manufacturer, and that products bear the CE marking, and are accompanied by the required instructions in a language which can be understood by end-users
  • Indicate on the PPE their name, registered trade name / trademark and a postal address at which they can be contacted
  • Withdraw from market any product where there is reason to believe the PPE they have made available is not in conformity with the Regulation
  • Ensure that storage or transport conditions do not jeopardise its conformity
  • Keep a copy of the EU declaration of conformity for 10 years and ensure technical documentation can be made available to surveillance authorities upon request
  • Provide all information and documentation to demonstrate the conformity of PPE in a language which can be easily understood by the requesting authority 
  • The PPE regulation is mandatory, and it is a legal requirement to comply. 
  • Employers must therefore ensure that their providers are able to meet the new Regulation requirements. Reputable suppliers will be able to do this, so the key is to verify your supply chain and always buy from a trusted source. 

Key facts:

  • The Regulation text was adopted on 12th February 2016, was published on 31st March 2016 and was listed in the Official Journal on 21st April 2016. This started the two year transition period, so the current Directive will be re-issued as a Regulation on 21st April 2018. 
  • The PPE Regulation replaces the PPE Directive. It is a binding legislative act that must be applied in its entirety across the EU.
  • Although the Personal Protective Equipment (PPE) at Work Regulations 1992 will still stand, employers will be required to select appropriate PPE in line with The PPE Regulation (rather than the Personal Protective Equipment Regulations, 2002). 
  • The PPE Regulation applies to the whole supply chain, not just manufacturers. Everyone involved in the manufacture, supply and distribution of PPE (known within the Regulation as ‘Economic Operators’) must ensure their PPE meets with the standard requirements.

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