Revised PPE regulation: a significant alteration

A ‘Regulation’ is a binding legislative act. It must be applied in its entirety across the EU, whilst a ‘Directive’ is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to individual countries to decide how they do this. 

Once the Regulation is passed, it will have immediate binding legal force throughout every member state.

The most significant changes to the original 1989 Directive are as follows:

The Regulation uses some new terminology. ‘Economic operator' encompasses the manufacturer, the authorised representative, the importer and the distributor. So all organisations involved with the production, supply, 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. 

All types of hearing protection against harmful noise will be re-classified to the Complex Category (or Cat 3), designed to protect against very serious risk, where the hazard is not immediately obvious. This will require EC type-examination plus ongoing surveillance.

The validity of EC type-examination certificates will be time-limited for all products, with a five-year expiry date on product approvals. 

Compatibility – all items that could be used on, or with, other manufacturers’ equipment must be examined and certified that they do so safely and effectively. 

Hopefully fewer low-specification and counterfeit products will get into the market place. When people buy PPE, they should reasonably expect it will meet the standards purported by the EO. All EOs will now be held to account, and they will have to ensure compliance to EN performance requirements.  Simplified, this means they will need to set up, maintain and keep records of batch testing of products they import and sell onto the market under a robust and audited quality management system (QMS).  As the Regulation specifically acknowledges, the changes are designed to level the playing field between importers and manufacturers who already carry the cost of operating such QMS systems.  It should be a big improvement and drive out fake and counterfeit PPE from the EU.

Hearing protection will have to be better controlled, since loss of hearing usually cannot be detected until it is too late. This will get rid of cheap ear defenders, leading to the design of improved products that wearers will look after better and be more prepared to use. 

The five-year expiry date on certificates is the biggest implication for end users. It will most likely result in EOs continually reviewing their products and producing better ones. It may also reduce counterfeit and illegal products and will remove inferior older products from the market. However, re-testing and reissuing certification is expensive for EOs, so will inevitably increase the cost of some PPE for the end user.

From the wearer’s point of view, ensuring compatibility of equipment can only be a good thing. For example, JSP’s industrial safety helmets must now be proven to work with other EOs’ ear defenders, so that protection is ensured. This means EOs will have to carry out extra tests and certification of recommended combinations where that is the case. However, this may be difficult to police.

Conclusions 

In general, these revisions to the old Directive will be constructive in helping to protect the health and safety of PPE users. Fly-by-night importers dumping containers full of inadequate PPE will hopefully become a thing of the past, and old, obsolete products will no longer hang around the market. The design and production of PPE is a competitive and fast-moving market, in which manufacturers continually strive to make improvements and innovations, all of which benefit the user in state-of-the-art products.

The current focus of the HSE on health as well as safety is tackling the issue of the long latency of some types of harm, which the re-categorisation of hearing protection acknowledges. Making sure equipment is legal, up-to-date and compatible can only be beneficial for the protection of the end-user.