The UK is no longer a member of the European Union. This brings about allsorts of problems for manufacturers selling products in the UK, especially for those outside the UK who always relied on applying the CE mark to their products for sale anywhere in the EU.
According to Conformance, a leading UK consulting
company specializing in product safety regulations and CE marking in the UK,
trading between the UK and Europe, as well as trading inside the UK, has just
got more complicated. The trade deals between the UK and the EU focuses on the
elimination of trading tariffs and the equalization of customs rules. As far as
the rules for CE marking is concerned, the UK is now split into two parts: Northern
Ireland who is remaining with the single market while Great Britain (England,
Scotland and Wales) are leaving the single market and started to set its own
rules.
Great Britain has opted for a new mark to be applied to products being placed on the market, known as the UKCA Mark (UKCA = UK Conformity Assessed). From 1 January 2021 the UKCA mark has started to replace the CE marking for goods sold within Great Britain, but the CE marking will remain acceptable for goods sold in Northern Ireland. Manufacturers based outside the UK will also have to apply the UKCA mark, while for goods sold in Northern Ireland they can apply the CE mark or the UK(NI) mark, which is also accepted in Northern Ireland.
For CE marked goods there is a one year transition period. This period started on 1 Jan 2021, and will end on 31 Dec 2021. The UK has accepted 17 EU directives and regulations as a basis for this. For some goods, including certain medical devices, the transition period has been extended to 2023. For all other goods, the UKCA mark becomes mandatory at the end of 2021.
Good news for manufacturers exporting to the UK and the rest of Europe, products can carry both the CE mark and the UKCA mark, provided that the product complies with the requirements for both. Fortunately, at this stage, there is for the most part not too much divergence between the two sets of requirements, but be aware that this can happen in future. The EU may change its requirements or the UK may change its requirements.
Products requiring third party involvement (Notified Bodies) as part of the CE marking process will have one big difference for products going to the UK. The third party will have to be a UK approved body, which can only be organizations residing inside the UK. The problem is that if those products are also sold in the member states of the EU, manufacturers will have to involve a body notified by the European Parliament, which now cannot be a body residing in the UK, it must be in an EU member state. In other words, in some cases two third party bodies may have to be involved separately.
Manufacturers for outside the UK will now also need to have a UK based representative. Where a UK based representative has been appointed for products going to the EU member states, this representative will now have to be replaced with an EU based representative.
The UKCA mark
The UKCA mark replaces the CE mark in England, Scotland and Wales. It is applied in the same manner as the CE logo. The regulations and directives which create the legal structure for CE marking have now been adopted into UK law and has been updated to change terminology and to bring them completely within the control of the UK government.
To apply the UKCA mark, manufacturers follow exactly the same process as for CE marking. In most cases at present, the same standards apply. What changes is the logo and the wording of the Declaration of Conformity. Products can have both logos if sold in Great Britain and in the EU member states.
If we take Machinery Directive (2006/42/EC) as an example, in the UK the directive has been replaced by the “Supply of Machinery (Safety) Regulations 2008”. Machines or machine assemblies that are operating in the UK will now have to comply with PUWER legislation (Provision of Work Equipment Regulations 1998).
Similar changes are made in terms of other EU directives and regulations. Manufacturers will have to ensure that they use the UK legislation in all cases, also those that replace other directives and regulations.
Standards
We have used standards (mostly EN standards) as a basis for the design of products that had to be CE marked. This is still applicable for the UKCA mark. A list of British standards (BS standards) has been published by the British authorities. We now have to apply those standards when the UKCA mark is applied. (I have looked at the current list, and it seems as if nothing has changed – yet!).
Standards in the UK are published by the British Standards Institute (BSI). The BSI remains a member of CEN and CENELEC until the end of 2021, but as an EEA member, not a full EU member. It gives the BSI less influence over drafting new or updated harmonized standards.
We are currently not sure what will happen to the UK’s obligation to withdraw conflicting national standards and replace them with harmonized EU standards once the BSI is no longer a full member of CEN/CENELEC. The UK-EU agreement talks about the fact that the UK will focus on standardization at an ‘international’ level, but what this means is not clear. Maybe ISO standards will become more prominent in the EU as well as in the UK? We do not know. What we do know is that some EN standards are already also available as ISO standards.
Notified bodies
Where notified bodies had to be involved in CE marking, they had to be established in the EU member states, including the UK. With BREXIT, notified bodies outside the UK are no longer accepted by the UK authorities. And UK approved bodies (as they are now known) are no longer accepted as notified bodies in the EU member states. It is, however, possible that a Mutual Recognition Agreement between the EU and the UK could be drawn up, but that is not yet the case.
Authorized
representative
The UK is no longer part of the EU. Authorized representatives based elsewhere in the EU are no longer accepted by the UK authorities. UK based authorized representatives are now also no longer accepted in EU member states. This has a direct impact on manufacturers based outside the UK.
Conclusion
Little change will be experienced until the end of December 2021. The technical requirements remain the same for the UK and the EU member states for the time being. Currently changes are more of an administrative nature.
For more information or assistance with exports to the UK (and the EU), feel free to contact me at koosgouws10@gmail.com. Please visit our website at www.sheqmanagementsystem.co.za, or at www.sheq-management-systems.webnode.com.
Feel free to let me have your thoughts on this article!
Regards
Koos
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