Essential planning for manufacture of ATEX certified products after Brexit.
Like all British manufacturers selling into Europe, we at Sarum Hydraulics have identified the risk that Brexit poses to our business. ATEX certified products pose a significant risk for businesses because the route to conformity assessment and CE marking is in a lot of cases multi-faceted.
To be clear, affixing the CE marking to a product, followed by the explosion protection symbol, the symbols of the equipment-group and category and any other required markings, denotes conformity to the ATEX Equipment Directive, which was implemented into UK law under The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016.
The three main aspects of selling ATEX products into the EU that concern us are as follows:
– EU-type examination of product to the relevant essential safety requirements of the Directive, as defined in Annex II and design standards relevant to the equipment.
-surveillance of production control, test, product verification and quality assurance, dependant on the Module within each Annex that is relevant to the product.
-obligations of the authorised representative and importer within the Eurozone.
We looked at each one and here’s our take.
It is arguably an advantage that many standards relating to design and construction of equipment for use in potentially explosive atmospheres are internationally recognised standards, rather than European compiled EN standards. Arguable because who is to say that some future UK government would not bring back a suite of BS designated standards to replace BS EN standards? Even if this is unlikely.
However, whilst the design standards may remain the same, EU-type examination certificates will not be valid post-Brexit unless issued by a notified body within the EU27 countries; that won’t be the UK. Many UK-based notified bodies have recognised this and now have EU-based partners to offer transfer of certificates. This then ticks the box.
If the classification of the product involves surveillance of production, product witness testing or quality assurance, this will also have to be performed by a notified body from within the EU27. Again, UK-based notified bodies have partnered with bodies from within the EU27, but it is worth checking costs in case personnel are having to travel from mainland Europe each time they attend site.
Authorised representative and importer
As part of the EU, this has not previously been a matter for concern. An authorised representative may typically hold technical and conformity documentation for the product and be required to provide any necessary conformity documentation to a national authority, including taking any action necessary to eliminate risks posed by product. At present, it would be the UK enforcing authority (HSE) that would take up any such actions direct with the UK manufacturer. But once outside the EU, the relevant EU national authority will take up any such actions either with the EU-based authorised representative or, if there isn’t one, the importer. This puts an added obligation onto the importer and may lead to one importer acting as the authorised representative, then selling on to other EU customers. We think it will force many manufacturing businesses to think hard about the way that they sell in the Eurozone. How large does a business have to be to have a permanent establishment in another EU country and who can then act as the importer? Even then, there may be issues with foreign ownership, implying partnership with another business. Deep stuff!
Brexit and trade
Preparing for Brexit incurs cost. Although it is now clear that we will exit the EU at the end of January 2020, what is much less clear is the path to a trade deal. Assuming this happens, there would be a transition period, currently running to December 2020, but in all likelihood, this would be extended to December 2022 (although the government needs to inform the EU by July if it wants an extension). This therefore still gives time for businesses to move type test certificates and surveillance arrangements over to an EU27-based notified body. Indeed, it is possible that UK-based notified bodies could retain their status in the event that a suitable free trade deal is concluded by December 2020, or December 2022, or beyond, given that history tells us lesser free trade deals between the EU and other trading nations have taken between 6 and 9 years to agree.
Waiting until the terms of a Brexit trade deal are known before acting on any of the above would avoid expense which could end up being wasted in the event of UK notified bodies continuing to be recognised by the EU. The one caveat here though is a ‘no trade deal Brexit’, where we suddenly find we get to December 2020 and there is no prospect of a trade deal happening. This could now easily lead us into immediate cessation of free trade and leave unprepared businesses exposed to being unable to export to Europe. It is then pretty fair to say that decisions taken in haste aren’t always the best judgements. So, it is really a case of weighing up the risks as events unfold over the coming months, but do be prepared for that sudden exit from free trade which is likely to become the elephant in the room as the year progresses. Suffice it to say that there may be other implications for selling within the UK if this scenario does arise e.g. UKCA (UK Conformity Assessed) marking of products.
Here at Sarum Hydraulics, we have been designing and manufacturing our Micropac specialist hydraulic hand pumps for over 35 years. Our equipment is typically used for hydrostatic testing, emergency backup systems, and cylinder operation. We supply equipment for use in potentially explosive atmospheres; our products conform to the ATEX Equipment Directive and we affix the CE marking. We have transferred our certificate files to a Netherlands- based notified body, but because of the product classification we do not have any requirement for surveillance. We have not as yet appointed a dedicated authorised representative within the EU.
Our European customers have been asking us for 3 years what is going on with Brexit. Now we can finally tell them that we are leaving, but we fear that conversations on trade will continue for a long time to come.