European Union - Personal Protective Equipment (PPE) Regulation (EU) 2016/425 has officially replaced the old PPE Directive 89/686 EEC. While the old Directive was enforced by national statutory instruments, the new regulation is a legally binding legislative act that must be observed across the EU. This change will affect health and safety professionals, as well as suppliers, distributors, and importers of PPE.
Over the past few years, the old PPE Directive has become insufficient, in that it has failed to prevent hazardous and non-compliant products from being sold in European markets. Recent advances in technology have also increased the need for an updated policy, and there have been concerns about the uniformity of product compliance, and the efficiency of product monitoring. The law has now been changed to address these concerns.
Under the new PPE Regulation, all parties involved with PPE are legally responsible for ensuring that products comply with safety standards. It is no longer the sole job of manufacturers; it falls under the remit of all ‘Economic Operators’ (those who produce, import, distribute or sell PPE). Widening accountability will hopefully lower the number of non-compliant and poor-quality products available.
Economic Operators must ensure that they adhere to the following requirements:
- Comply with the health and safety obligations
- After demonstrating compliance, draw up an EU declaration of conformity and attach a CE mark
- Keep relevant documents for up to 10 years
- Assess samples under rigorous conditions, and provide evidence of testing
- Take appropriate action in cases of non-conforming or ineffective PPE
- Label PPE accurately and provide clear instructions
- Cooperate with national authorities
If Economic Operators find that products do not conform to the guidelines, they cannot be sold.
Changes are to be made to the classification of some products, such as hearing protection and life jackets. Many intermediate (category 2) products will become complex (category 3) products, thus requiring stricter surveillance. This reflects the exacting procedures ushered in by these revisions to legislation, and should help to eliminate risks from low-quality PPE.
There will now be a transition period until 20th April 2019, during which time both Directive 89/686/EEC and the new Regulation will be lawful. This also means that EC Type Examination certificates and approval decisions issued under the old Directive are valid until 21st April 2023, unless they expire before that date.
The new PPE Regulation will hopefully improve the quality of Personal Protective Equipment, eliminate sub-standard products, and encourage innovation.