SAFETY & HAZARDOUS AREAS
Currently the process is moving from conformance with EU Directives to a virtually identical regime under UK statute. However, it does place greater onus on importers compared to distributors, especially in relation to compliance. “Although the changes are subtle, there are some definite shifts in legal responsibilities on the horizon,” said Flowers (pictured left)
aligned to the EU CE marking. Coulson said: “Machine builders exporting to
Ireland from the EU, as Sumitomo (SHI) Demag does, will continue to CE mark their machines exactly as before with the technical files compiled by an EU person. If an EU-based subsidiary, importer, representative or distributor is prepared to take on this role then the documentation can simply be updated accordingly. The manufacturer must trust any importer, as the Technical File contains Intellectual Property.” In instances where EU machine builders
previously using a UK Notified Body for the conformity assessment of Annex IV machines, this should have been transferred to an EU Notified Body. Most of the UK Notified Bodies now have EU subsidiaries or parent companies. However, where a CE marked product is put into service in Northern Ireland, if it has been assessed by a UK Authorised Body, the UKNI marking must also be used with the CE Marking. Serving a large and expanding injection moulding customer base across North and
Southern Ireland, Flowers clarifies that having a new registered office in Ireland helps. Additionally, having a nominated signatory in Germany, provides Sumitomo (SHI) Demag customers with reassurance that all future DoC or DoI documents will comply with all these new certification regimes. For most new injection moulding systems
commissioned for UK customers, Sumitomo (SHI) Demag will aim to import entire cells, including robotics and periphery equipment like runners and cooling systems from Germany or Japan. As the importer, the UK team accepts the responsibility of the Technical Files, making the issuing of a UKCA Mark seamless. Incorporating equipment, such as robotics,
from a different machinery supplier does raise further certification complications. With the onus of responsibilities potentially shifting to the end user - the moulding company, or the integrator. Flowers explained: “Under the scope of the Supply of Machinery (Safety) Regulations 2008 and amendments, it became mandatory for a complete robotic
cell to carry the CE marking. Providing it was added to a safe machine a Declaration of Incorporation could be issued. However, the duty of certification, even before Brexit, rested with the customer or integrator. That still applies.”
Additionally, creating a complex assembly of machinery may present other safety hazards. In effect creating a new cell. “It’s not enough to assume that having the CE or UKCA Mark affixed to each piece of equipment means the entire cell is certified,” observed Coulson.
Sumitomo (SHI) Demag
uk.sumitomo-shi-demag.eu
Being based in Ireland, Coulson’s organisation (above) – Hold Tech Files Ltd – is well- placed to assist manufacturers to navigate the different certification processes
Non-invasive ultrasonic flow measurement from the clamp-on specialists
+44 (0) 2476 714 111 •
info@katronic.com •
www.katronic.com OCTOBER 2021 | PROCESS & CONTROL 11
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