Designated Standards and the future of CE marking after the EU exit transition period

We are nearing the end of the EU exit transition period, on 31 December 2020, after which the UK, with exceptions in Northern Ireland, will no longer automatically align with EU rules or obligations. There will be no immediate changes to standards published by BSI, but the new UK regulatory regime does present some important differences that standards makers and users should be aware of.

From 1 January 2021, a new marking will begin to appear on products sold in Great Britain. Products sold in England, Scotland and Wales will be required to conform to UK regulatory requirements, rather than EU regulations (laws in Northern Ireland do not change, see below). Accordingly, the familiar CE marking will be phased out and replaced with the new UK Conformity Assessed (UKCA) marking.

What does all this mean for UK manufacturers, how will the change be implemented and how does it impact the use of standards?

What system did the UK follow until now?

Until the end of 2020, product manufacturers have to meet EU laws of performance and safety to sell goods in the UK. Using harmonised European standards that are cited in the EU’s Official Journal enables manufacturers to comply with these regulations. The CE marking is used to show this regulatory conformity.

Products with the CE marking can be sold throughout the European Economic Area without being subject to restrictions. The CE marking is required for many, but not all, products sold within the EU single market including medical devices, toys, electrical equipment, PPE and machinery.

What is changing?

With the end of the EU exit transition period, the UK will transfer from being under the jurisdiction of EU law to a new UK regulatory environment. New standalone UK product regulations transpose EU laws for Great Britain, and while the basic requirements remain the same it is possible that their interpretation and application may be different. The new UKCA marking indicates that this change has taken place.

Organizations will need to ensure they understand how the changes in the product regulatory system will affect them, and whether they need to take any actions in response. For example, while performance and safety requirements remain the same, declarations and responsibilities of suppliers are changing. 

Most standards have no relation to product regulation and their use will continue as now. For those British Standards used to show conformity with CE marking regulation (under 10% of BSs), they will be referenced in regulation in a different way for Great Britain. UK government will designate the standards that enable conformity with UKCA regulations.

To enable organizations to adjust to the new rules, in most cases a grace period of at least one year will apply in which the CE marking will still be valid to show regulatory conformity of products sold within Great Britain. For some products such as medical devices, a longer period applies. The CE marking will only remain valid where UK and EU rules remain the same and, if the rules diverge, UK organizations will need to use the UKCA marking when selling in Great Britain. 

In a few cases, the UKCA marking is required from 1 January 2021 so it is important to check how the regulations apply to your products. 

What about Northern Ireland?

Products sold within Northern Ireland will not be subject to the new UKCA regulatory regime; these goods will continue to use the CE marking system. Under the Withdrawal Agreement between the UK and the EU, certain legislation will continue to be implemented by the UK government for Northern Ireland, including all CE marking legislation.

Manufacturers will therefore continue to use harmonised European standards cited in the EU Official Journal to show conformity to these regulations.

What is the BSI’s role under the new regulatory regime?

As the UK’s National Standards Body, BSI will continue to play its role in the UK market structure through the development of standards and supplying business services to support regulatory conformity.

BSI is working with the UK government to support its system for the designation of standards. A page on the gov.uk website will contain the lists of designated standards.

While references to standards in regulation change, the standards themselves are not changing as the EU transition period ends.

BSI remains a member of the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), as these are private bodies and not agencies of the EU. BSI is working with CEN and CENELEC to establish a new membership model for BSI after the end of 2021.

BSI will therefore continue to enable UK stakeholders to influence the content of national, European and international standards that are used for market access and trade globally, in the same way as now.

Where can you find more information?

Further guidance on the new UK product regulation can be found on the BSI page on product regulation after 1 January 2021. There is also information on the UK Government’s web page explaining the new UKCA mark.

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