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New PPE Regulations: What You Need to Know

Photo of a surgical team in an operating theatre - Integrity Cleanroom

Having just enjoyed an interesting session on the new PPE regulations at the Cleanroom Technology Conference 2017, we thought we’d share the key takeaways with you here, in bite-size form.

Key points of the New PPE Regulations:

  • 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 in 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.

Category I – Simple PPE

Personal Protective Equipment in this category is designed to protect people from minimal risks. Examples include:

  • Superficial mechanical injury
  • Contact with hot surfaces not exceeding 50° Celsius
  • Damage to the eyes due to exposure to sunlight
  • Atmospheric conditions that are not of an extreme nature
  • Contact with water or cleaning materials of weak action

There is one small change in this category, which is the final bullet covering the use of hot water and detergents.

Category II – Intermediate PPE

There are no changes to Category II within the new Regulation. As a reminder, this is the category that encompasses risks other than those listed in Category I or Category III. Examples include:

  • Safety spectacles and goggles
  • Industrial helmets and bump caps
  • High visibility clothing

Category III – Complex PPE

This category has seen more changes, covering risks which “may cause severe consequences such as death or irreversible damage to health.” Risks include:

  • Substances and mixtures hazardous to health
  • Harmful biological agents
  • Ionizing radiation
  • Atmospheres with oxygen deficiency
  • High-temperature environments, the effects of which are comparable to those of an air temperature of at least 100° Celsius
  • Low-temperature environments, the effects of which are comparable to those of an air temperature of -50° Celsius or less
  • Falling from a height, electric shock and live working
  • Drowning
  • Cuts by hand-held chainsaws
  • High-pressure jets
  • Bullet wounds or knife stabs
  • Harmful noise

Not all of these will apply to those working in Cleanrooms, but the breadth of the Regulations is interesting to see.

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 concerning the requirements of the Regulation
  • Ensure conformity assessment procedures have been carried out by the manufacturer, and that products bear the 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 can be contacted
  • Withdraw from the market any product where there is a 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 conformity
  • 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 conformity of PPE in a language which can be easily understood by the requesting authority

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 source.

See more on the Legislation Update Service website.