But how does this affect you?
Posted on: 22/08/2018 By: Lee Rance
Well, if you are responsible for the purchase of PPE (Personal Protective Equipment), you must now ensure your suppliers are able to meet the new regulatory requirements.
Importers and Distributors also have new obligations and can now only place compliant PPE on the market.
The PPE Directive (89/686/EEC), which came into force in 1989, has been now repealed by the PPE Regulations (EU) 2016/425 with effect from 21 April 2018.
The new PPE Regulations ((EU) 2016/425) have been in transition since April 2016 and on 21 April 2018 the Regulation came into effect. There is a further transition period until 21 April 2019 where both the old Directive and the new Regulation will remain valid however after that date any products that are CE marked Directive 89/686/EEC will need to be re-certified. However, EC type-examination certificates issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date . The EC type-examination is the part of a conformity assessment procedure in which a Notified Body examines the technical design of PPE and verifies and attests that the technical design of the PPE meets the requirements of this Regulation that apply to it. These usually have a 5-year validity.
What are the PPE Regulations?
They basically lay down the conditions governing PPE placed on the market and the basic safety requirements which the manufacturers must satisfy in order to ensure the health, safety and protection of the user.
The new PPE Regulations introduce a shift in responsibility within the PPE supply chain. Previously, with the PPE Directive, it was the Manufacturers and their Authorised Representatives who were responsible for compliance. Now all organisations involved with the production, importation, supply, distribution, marketing and sale of PPE will have the same responsibilities as the manufacturer, including getting product approval, making sure it conforms to the Regulation and keeping technical files and records. This will level the playing field between manufacturers and importers and means that fewer low-specification and counterfeit products will get into the EU marketplace.
PPE products are classified into one of three categories, depending upon the level of risk associated with their use:
- Category I – products of simple structure, used in a low-risk environment. The user is able to independently assess the PPE protection effectiveness. (e.g. gardening gloves, aprons, sunglasses)
- Category II – products protecting against hazards which can cause injuries. The hazard for injury is determined as “not very low and not very high”. (e.g. warning clothing and clothing for use in welding, protective helmets, safety goggles)
- Category III – products of complex structure, protecting in the situations of serious or permanent hazard which can affect the user’s life and health. (e.g. respiratory devices, safety harnesses, fire-protective clothing)
Hearing protection which was previously Category II has been re-classified as Category III which means all hearing protection will require EC Type examination plus ongoing surveillance. The hazard category was increased, due to the potential for life changing injuries. These changes will help to get rid of cheap ear defenders. The World Health Organization (WHO) has identified noise-induced hearing loss as being the most common permanent and preventable injury in the world and tinnitus as the third most serious non-fatal medical condition.
To check if the PPE your purchasing is compliant with the new regulations then an EU Declaration of Conformity must either accompany each item of PPE or a web link to the digital version must be clearly shown on the product or user instructions. If it doesn’t then you need contact your supplier immediately. It’s their responsibility to ensure the product they are supplying is compliant.
If you need any help or advice on your responsibilities under the new regulations, then please contact us on 01908 632418 | Email: firstname.lastname@example.org.
Until next time.