PPE Regulation (EU) 2016/425 has started
The most important date for the European PPE industry for over 25 years; 21 April 2018 is upon us. The PPE Directive 89/686/EEC is repealed with effect from that date and the PPE Regulation (EU) 2016/425 applies going forward. A transition process has been outlined in Article 47 of the Regulation which states ‘without prejudice to Member States shall not impede the making available on the market of products covered by Directive 89/686/EEC which are in conformity with that Directive and which were placed on the market before 21 April 2019’ and also ‘EC type-examination certificates and approval decisions issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date.
But what does this mean?
Article 10’s to Module B’s
BSI has a very extensive scope for the Module’s B as well C2 and D under the PPE Regulation and has been issuing pre-dated Module B certificates that come effective on 21 April since July 2017. We are working to transition existing and new clients as seamlessly as possible for their current Article 10 certificates also offering guidance on the differences called up in the Regulation such as risk assessments and electronics schematics. Risk assessment is one of the areas we’ve been frequently asked about and some of the points that should go in to it are as follows:
Identification of hazards against which the PPE is designed to protect
Levels of protection e.g. nominal protection factors, chemical permeability levels, cut resistance, heat resistance
Evidence of verification of levels of protection against identified risks
Limitations of use
Identification of potential misuse and incorrect use
Either way we’ll guide you through this transition and ensure you have a compliant technical file.
Article 11A to Module C2 and Article 11B to Module D
During the audit year (April 2018 to April 2019) we’ll be transitioning our existing clients to Module C2 and D of the new Regulation and we’ll also be getting our clients who manufacture hearing protection and life jackets for either Module C2 or D; whichever they prefer. As the Module C2 and D are similar to the previous Article 11A or B, we’re giving our existing clients:
We can carry out a desktop review and if there are no outstanding issues, we can transition them to their new respective module so they’re ready for April 2018
Transition them at their next on-going surveillance activity be it a factory audit or laboratory test.
Either route, we’re looking at getting everyone ready for April 2019. Remember if you have ranges of life jackets or hearing protection, you’ll need to have a module C2 or D system in place by 21 April 2019.
I haven’t done anything yet!
If you’re a manufacturer and haven’t done any preparation yet for the new Regulation, don’t panic, here’s some tips:
Look at your current product range
- Look at your current products and identify which ones are current and need transitioning to the new Regulation
- Identify what standard they conform to and if they are current; we cannot issue PPE Regulation Module B certificates to withdrawn standards
Come up with a plan
Have a structured plan to manage your transition.
Take on board the new requirements
We have a number of documents available to guide you through constructing PPE Regulation compliant technical files; things to consider are:
- Including a risk assessment for the product
- Schematics if your product includes electronics
- Details on how you’re going to distribute your EU DOC
Again, we’ll guide you through the process and if you send in a file to us we’ll give you guidance on getting it compliant.
Recent interpretation of Article 47
There’s been a recent interpretation of Article 47 in a Commission Guidance Document which has stated that ‘PPE may be placed on the market after the full applicability of the PPE Regulation (21 April 2019) on the basis of an EC type-examination certificate and/or an approval decision in accordance with the PPE Directive, until 21 April 2023’. There are a couple of exceptions to this:
One or several applicable essential health and safety requirement(s) in the Regulation have changed on substance to the extent that a higher level of protection than the Directive is required
The design and/or manufacture of the PPE has changed since the last EC type-examination
The generally acknowledged state-of-the-art which is reflected by European harmonised (i.e. the product is certified to a withdrawn standard.
How specifiers and scrutineers are going to look at this in the market isn’t clear, so the fail-safe advice is to transition your certification from the Directive to the Regulation by 21 April 2019.
BSI and BREXIT
One question we’re getting more and more is what will happen to certificates issued by BSI as a UK Notified Body after the European Commission published a notice on 11 January 2018 regarding the future recognition of UK Notified Bodies in the EU. This article outlines the worst-case scenario where no withdrawal agreement is achieved. I’m pleased to say that BSI has a contingency in place and we’re in the process of establishing a Notified Body in the Netherlands to ensure the validity of our certifications. There will be more questions to come, but in the meantime you can find all the relevant information here >