New PPE Regulations for the Cleanroom Market

Photo of people in laboratory - Integrity Cleanroom

The new PPE Regulations are superseding the Personal Protective Equipment (PPE) Directive.

The PPE Regulations will apply from 21st April 2018, including a one-year transition period until 21st April 2019.

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

From 2018, PPE regulations are changing. All manufacturers, importers, and distributors of PPE must:

  • Distribute compliant PPE on the market, acting with due care concerning the requirements of the Regulation
  • Make sure conformity assessment procedures have been carried out by the manufacturer, and that products bear CE marking, and 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 are contactable
  • Withdraw from the 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 jeopardize its compliance
  • Keep a copy of the EU declaration of conformity for ten years and ensure technical documentation can be made available to surveillance authorities upon request
  • Provide all information and documentation to demonstrate the compliance 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 can 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 supplier.

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 that 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.


Further information can be found here