But before we do that, there’s one important concept to understand. It’s ‘Presumption of conformity’. That means if a product or process meets the requirements of a specific standard, it is assumed to also meet the corresponding legal requirements of the territory concerned.
For the purposes of this article, the territories we will compare, and contrast are England, Wales and Scotland, versus the EU. (Different rules apply in Northern Ireland.)
Different marks, the same idea
Post-Brexit, the terminology and framework for standards that can be used to show ‘presumption of conformity’ changed.
To confirm that a product or services does conform, it carries an officially designated mark. With different ones for the UK and the EU.
Let’s begin with what is required to place goods on the market in the EU. Regulations may require a CE mark as a declaration of conformity to essential requirements of the regulation. On the other hand, for similar goods being placed on the market in England, Scotland, and Wales, a UKCA mark may now be required.
To complicate matters a little in this regard, there has been an indefinite extension of CE mark recognition for some products coming to the UK.
What’s behind these markings?
Let’s start with the EU. Here we run into what are called ‘harmonized and ‘cited’ standards.
Harmonized standards are those that have been written following a request from the European Commission to the European regional standards organizations. They are designed to support essential requirements of certain pieces of European legislation.
These standards are developed by a recognized European Standards Organization (ESO), i.e. CEN, CENELEC, or ETSI, all of which are independent of the EU.
The references of harmonized standards must be published (or cited) in the Official Journal of the European Union (OJEU) before the standard can be used to provide a presumption of conformity with essential requirements of EU legislation.
A full list can be found on the website of the European Commission here.
In the UK, it’s the UK Government that designates standards for use in Great Britain to help manufacturers demonstrate their products or processes comply with UK law.
All standards cited in the EU Official Journal for relevant regulations were ‘designated’ by the UK government back in 2021, and the list has continued to be developed since that time. A full list of designated standards can be found on the UK Government website here. By following these designated standards (and any subsequent ones), manufacturers can claim their ‘presumption of conformity’.
So, by following harmonised (EU and Northern Ireland) and designated standards (England, Scotland and Wales), you can use the relevant CE or CA marking that signals your compliance with the standards demanded. Essential for cross border trade.
At a glance: the difference between harmonized and designated standards
Harmonized standards:
Developed by European standards organizations (e.g., CEN, Cenelec) and are used to underpin EU product legislation.
When a product is manufactured in accordance with a harmonized standard, it is presumed to meet the relevant essential requirements of the EU legislation.
The references of harmonised standards must be published in the Official Journal of the European Union (OJEU).
A key part of the CE marking process.
Designated standards
A standard adopted by any of the recognised standardisation bodies (the British Standards Institution (BSI), European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardisation (CENELEC) and European Telecommunications Standards Institute (ETSI)) or by international standardising bodies (including the International Organization for Standardization (ISO), International Electrotechnical Commission (IEC) and International Telecommunication Union (ITU)).
Designated standards allow manufacturers to demonstrate that their products meet the essential requirements of UK product regulations
The UK government recognizes and publishes the references of designated standards on GOV.UK.
A key part of the UKCA marking process
Why the differences matter for your business
Knowing which standards to follow is essential for making compliance and international trade as simple as possible, with multiple benefits:
Faster market access as compliance doesn’t need to be proven from scratch
Reduced risk of non-compliance (if something goes wrong, businesses can also demonstrate they followed best practices)
Easier trade across borders thanks to a removal of technical barriers and consistency across borders. This also cuts down on duplicate testing
Enhanced consumer protection and confidence that comes with all standards
We hope this article provides you with a clearer picture of what can be a very complicated subject.
Remember, our team of research professionals at the BSI Member Enquiry Service are on hand to help you with standards-related queries. If you are a BSI member, contact us on knowledgecentre@bsigroup.com or +44 20 8996 7004
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