Brexit has provided a lot of regulatory detail for businesses to grapple with. However, there are some important changes to how the government refers to standards that are easy to understand.
As a consequence of Brexit, the UK government has introduced its own system to recognize standards for conformity to regulations in England, Scotland and Wales. EU regulation continues to apply in Northern Ireland.
This transition has changed the terminology and framework around standards that can be followed for a presumption of conformity to regulation in England, Scotland and Wales.
To help you understand the new landscape, we’ve prepared this quick primer on what the situation was before Brexit and what it looks like now.
What was the situation before Brexit?
The EU has rules to make the single market work for member states and to help to ease trade across national borders. These rules are set out in Directives, which are implemented by legislation in each individual member state or in Regulations, which are directly applicable in member states.
The European Commission sends requests to the European standards-making bodies (CEN, CENELEC and ETSI) to develop standards in support of “essential requirements” set out in the legislation or regulation. These are known as “harmonized standards”.
Before Brexit, the UK was also subject to this system, covering many aspects of product performance and safety.
However, it is only when the harmonized standards are referenced or ‘cited’ in the Official Journal of the European Union (OJEU) that they have legal consequences. This OJEU citing shows that by complying with the standard’s requirements for products, services or processes, a presumption of conformity to relevant EU legislative requirements can be claimed.
Pre-Brexit, the UK (along with the rest of the EU) used the references to standards cited in the OJEU to evidence conformity to EU regulations, and CE marking was used by manufacturers to show they met the requirements of the relevant regulations.
Following the UK’s departure from the EU in 2020 and the end of the Brexit transition period, there have been some important changes to this system.
What is the situation post-Brexit?
Following Brexit, the UK government now has regulatory autonomy. Regulations, including those mentioned above, were all “on-shored’ to function on a UK-only basis. As of 1 January 2021, the standards cited in the OJEU were also ‘designated’ by the UK government for conformity to UK regulations.
Standards designated by the UK Government work in the same way as the harmonized and other standards cited in the OJEU.
As a result of the Northern Ireland Protocol agreed between the UK government and the EU, Northern Ireland has, effectively remained within the EU single market and is subject to EU regulation. For standards, in effect this means that designated standards can be used for conformity to UK regulations in England, Scotland and Wales, and harmonized standards and other standards cited in OJEU continue to be used in Northern Ireland.
Designated standards. Meeting UK regulations
Designated UK standards can carry prefixes BS, EN, EN ISO, or EN IEC. The UK government decides which standards to designate. Importantly, standards cited in the OJEU will not automatically be designated by the UK government, and those operating in UK and EU markets should check both the UK and EU listings.
New or revised standards for designation published after 1 January 2021 contain information relevant to UK regulations within the national foreword of the standard. This foreword will also direct you to check the latest listing of designated standards on the gov.uk website.
Incidentally, designated standards can be identified and obtained through the BSI Shop by selecting ‘designated standards’ among search filters on the left-hand column.
The role of UKCA product marking
UKCA marking was introduced on 1 January 2021 as a declaration of conformity to UK regulations. This will effectively replace CE marking in England, Scotland and Wales.
However, CE marking will continue to be recognized in the UK until 31 December 2022 (or 30 June 2023 for medical devices).
CE marking will continue for relevant products in Northern Ireland and the rest of Europe. In Northern Ireland, there is also a new UKNI mark which is explained here.
Trading in the EU from the UK?
If your company is based in England, Scotland and Wales and is trading in the EU, then applicable standards cited within the OJEU can be used to evidence conformity to EU regulations. But the UKCA and UNKI marks will not be recognised in the EU.
Therefore, if your products are going to be placed on the EU market and require CE marking, they must have that CE marking, irrespective of whether they also meet UK requirements and are UKCA marked.
Practically speaking, manufacturers seeking to place their products on the market in both the UK and the EU will need to ensure that those products comply with both UK and EU product safety requirements and carry both UKCA and CE marks. Although the underpinning technical requirements and standards are the same, where marking requires third-party testing, it may be necessary to carry out two tests, one for each market.
There is no restriction on marking products with both a CE mark and a UKCA mark, as long as the respective requirements to properly place such marks on the product are met under both regimes.
Preparing for change
These developments are well underway and it is important you understand how the changes will impact your organization.
The earlier you begin to prepare and adapt, the smoother the transition will be. If you need further guidance, BSI members can seek advice from the Knowledge Centre research team.
Find out more:
Please note that all dates and deadlines were correct at the time this article was published.