March 2021

27 www.drivesncontrols.com March 2021 been assessed and CE-marked before 31 December 2020. The UKCA mark can be applied to accompanying documentation only until 1 January 2023, if preferred, but after that date the UKCA mark must be displayed on both a product and its documentation. At the time of writing, I am not aware of anything in the trade agreement that would countermand this advice. Changes to the documentation should not be too onerous. As we have already said, the documentation now needs to show the machine as being UKCA-marked instead of CE-marked. In addition, where a Declaration of Conformity (DoC) or Declaration of Incorporation (DoI) previously referred to harmonised standards with EN prefixes, they now need to refer to designated standards, and all standard numbers should be prefixed with BS to indicate they are British Standards. When preparing a DoC or DoI under the CE marking regime, the declaration requires a person established in the EEA (European Economic Area) to be named as authorised to compile the technical file. For UKCA marking, there is no such requirement and it would appear that the authorised person can be anywhere in the world. For British machine-builders supplying their home market, this difference will probably be immaterial. Similarly, the requirement for the technical file to be in English will not bother machine-builders in Great Britain. For Annex IV machinery, where CE marking requires a Notified Body to undertake the conformity assessment, the relevant bodies in the UK are now termed UK Market Conformity Assessment Bodies (UKMCABs). Most UK Notified Bodies are being converted automatically to Approved Bodies, but machine-builders should check this with their Notified/Approved Body and make sure the documentation is updated accordingly. Northern Ireland The Northern Ireland Protocol has been in place since 1 January 2021. This permits free trade between Northern Ireland and the Republic of Ireland for most manufactured products. It also ensures unfettered access to Great Britain for manufacturers in Northern Ireland. Because of the need for free trade across the Irish border, Northern Ireland is largely aligning with European rules rather than GB regulations when it comes to placing manufactured goods on the market. Machine-builders in Northern Ireland can therefore continue to CE-mark machines and sell them in Northern Ireland, the EU 27 member states and, thanks to unfettered access, Great Britain. Machines manufactured in GB for sale in Northern Ireland must be CE-marked (see the section on exporting to Europe). Note that UKCA marking is not accepted in Northern Ireland. If Annex IV machines are conformity assessed by a UK Approved Body, then the machine must display both the CE and UKNI mark (not the UNKI mark on its own). UK Approved Bodies can continue to act as Notified Bodies for products being CE/UKNI marked for Northern Ireland. Exporting to Europe As well as the EU 27 member states, the new trade deal effectively includes Iceland, Liechtenstein and Norway (members of the European Free Trade Association, EFTA), plus Switzerland, which has a Mutual Recognition Agreement (MRA) with the EU. In addition, Turkey, Andorra and San Marino have Customs Union Agreements with the EU. Northern Ireland can also be treated the same way by GB machine-builders, thanks to the protocol mentioned earlier. CE marking of machines destined for these markets continues almost exactly as before. The vital difference is that it is no longer acceptable to name a person in the UK as being authorised to compile the technical file. This is because the UK is no longer in the EU. The person named on the DoC or DoI must be established in the EEA (European Economic Area) and can be a person or a business. GB machine-builders may have a subsidiary, distributor or representative willing to undertake this role but, if these options are not available, then an alternative is to use an EU-based company offering such services (see below). Where Annex IV machinery has previously been conformity-assessed by a Notified Body based in the UK, the EU is no longer recognising these EC type-examination certificate. In most cases, UK Notified Bodies have already transferred accreditations to other EU-based Notified Bodies. Machine-builders should satisfy themselves that this has been done or, if not, obtain certification from an EU Notified Body as a matter of urgency. The points outlined above are very important for UK machine-builders exporting to the EU. Because there is no “CE police”, some machine-builders have previously taken the view that a minor non- compliance with the CE marking process would be unlikely to cause a problem. Now, however, incorrect documentation could easily result in machines, partly-completed machines and machine safety components being held up at customs and failing to reach customers on time. Rules of origin Aside from the technical aspects of CE marking, UK-based machine-builders exporting to the EU now need to consider the complex rules of origin. This relates to customs declarations and is outside the scope of this article. Nevertheless, it would be remiss not to draw machine-builders’ attention to the need for them to address this issue as well. European Regulation 2019/1020 on market surveillance and compliance of products comes into force on 16 July, 2021. The aim is to strengthen the requirements for market surveillance by member states, but there are important implications for machine-builders. The new regulation introduces requirements relating to an “economic operator” and machines cannot be placed on the market unless there is an economic operator established in the EU. n Irish company offers to hold files for UK machine-builders Hold Tech Files, based inWaterford in the Republic of Ireland, has created aWeb-based service for UK-based manufacturers of machines, partly completed machines and safety components covered by the Machinery Directive. It can act as the person authorised to compile Technical Files for the Machinery Directive and the Authorised Representative with respect to Regulation 2019/1020. The company also has a UK-based subsidiary that can hold files for machine-builders that sell to the UK. After signing a mandate and paying a fee, the relevant file can be uploaded to a secure server. Payment of a one-off fee entitles the manufacturer to name Hold Tech Files on the DoC or DoI for a period of ten years. As well as acting as the person authorised to compile Technical Files, Hold Tech Files can also act as the authorised representative to enable UK machine-builders to comply with the need for an EU- based economic operator from 16 July 2021. www.holdtechfiles.eu MACHINE-BUILDING n