From January 1st, 2021, some UK businesses will need to use the new UKCA mark on their products, user guides, and documentation.
And with the Brexit transition period over, the full impact of the UK’s departure from the EU will come into force.
The transition from the CE Mark to the UKCA mark could be confusing for businesses that sell in multiple territories. We put together this guide to help you decide how urgent the change is for your business, and what you’ll need to do to update your user guides.
What is the UKCA mark?
The UKCA mark is a new compliance mark which comes into effect when the UK formally leaves the EU. UKCA stands for UK Conformity Assessed.
UKCA marks are a direct replacement for the EU-wide CE mark. The UKCA mark is specifically for goods sold in the UK, and is required if they are to be sold legally.
Assessment of whether goods meet the standards, and are therefore able to display the mark, is covered either by a process of self-declaration by the manufacturer or third-party accreditation by nominated assessment bodies.
When does the UKCA mark come into effect?
The UKCA Mark comes into force on 1st January 2021. From that date, the CE mark will no longer be valid on new goods being placed on the market for sale in the UK.
The good news is that the switch from the CE to the UKCA is largely technical and administrative. Both will be issued by a notified body in a similar way. And if you already have a CE mark, there is still a grace period to update your documentation, packaging, and product labels.
What’s the difference between the UKCA mark and the CE mark?
With Brexit, the jurisdiction for the standards, assessment, and accreditation processes has switched from EU to UK law.
The simplest way to put it is this: the UKCA is the new UK-only, post-Brexit equivalent of the CE mark.
“From 1 January 2021 the technical requirements (‘essential requirements’) you must meet – and the conformity assessment processes and standards that can be used to demonstrate conformity – will be largely the same as they are now… the UK standards will be the same in substance and with the same reference as the standards used in the EU. However, they will use the prefix ‘BS’ to indicate that they are standards adopted by the British Standards Institution as the UK’s national standards body.”gov.uk website
So if you sell goods in the UK at present under the CE mark, you will be able to continue doing so. You’ll just need to use the UKCA mark instead.
Is it compulsory to use the UKCA mark rather than the CE mark?
Yes. The UKCA mark is compulsory if you manufacture qualifying goods that you want to sell in the UK.
The criteria for which goods fall under the scheme relate to specified areas of conformity and compliance, including things like:
- Gas safety
- Control of hazardous substances
- ATEX appliance safety
- and so on.
In terms of specific products, the broad answer is that most goods already on sale in the UK using the CE mark do not need to be reassessed.
In fact, goods already on the market will be able to continue using the CE mark. But from January 1st onwards, all new accreditations must be made under the UKCA scheme in the UK.
What products does the UKCA cover?
Like the CE mark it replaces, the UKCA only applies to certain types of manufactured goods. Its purpose is to indicate conformity with health, safety and environmental protection standards.
The product classes which must use the new UKCA mark are defined on the gov.uk website. At the time of writing, they are:
- Recreational craft and personal watercraft
- Simple pressure vessels
- Electromagnetic instruments
- Non-automatic weighing instruments
- Measuring instruments
- ATEX equipment
- Radio equipment
- Pressure equipment
- Personal protective equipment (PPE)
- Gas appliances
- Low voltage electrical equipment
- Hazardous substances
- Medical devices
- Rail equipment
- Construction products
- Civil explosives.
Do I have to show the UKCA mark on my goods from January 1st, 2021?
Possibly. There are four main scenarios that apply to goods being sold in the UK.
1. Existing stock that was on the market before January 1st 2021
You don’t need to take any action yet, but it’s a good idea to start planning now to change your labels and user guides. The CE mark on these goods will be legally recognised until December 31st, 2021.
2. New stock that has been fully conformity assessed, but is not yet on sale
You can release these goods for sale with a CE mark after January 1st, 2021 as long as the conformity assessment was approved by EU authorities before December 31st, 2020.
After 31st December 2021, the CE mark will no longer be legally recognised in the UK. So if your business has a large stockpile of CE-marked goods, there will come a point where you will need to think about re-marking them with the UKCA mark.
3. New stock that has not yet completed conformity assessment
Any manufactured products that are currently undergoing mandatory conformity assessments that are not completed by December 31st, 2020 must carry the UKCA mark straight away.
This applies even if the relevant assessment body in the UK completes the process before the end of the year. That’s because the documentary evidence of approval used to be passed on to authorities in the EU who then grant the mark, but government guidance is that that route is now closed.
UK conformity assessment bodies should now be working to approve the UKCA mark only.
4. Goods manufactured after January 1st, 2021
From January 1st 2021, the UKCA will apply to all conformity assessments for domestic goods. The CE mark will no longer be eligible for new goods manufactured for sale in the UK.
How do I display the UKCA mark?
The UKCA mark is a graphic which must be displayed on qualifying products. You can download the image files for the UKCA mark from the gov.uk website.
It can be printed directly on the product itself or the packaging.
In some cases where it isn’t appropriate to show the mark in either of these ways (for example, on industrial equipment), it should be printed in the user guides and documentation.
Can I just stick the UKCA mark over the old CE mark in my user guide?
You can leave the old CE mark on your products without penalty.
If you want to remove it:
- You can use a label to cover up the old CE mark on some items until January 1st, 2023.
- Labels are not allowed for certain classes of goods that are subject to special rules, such as construction products, medical devices, and transportable pressure equipment.
- From January 1st, 2023, all manufacturers will have to incorporate the UKCA graphic within the print design of their products or user guides so it is permanently attached.
Are there any rules for using the UKCA image in a user guide?
Yes, there are a number of rules and conditions relating to the use of the UKCA image which we can help with if you need assistance.
The basic design guidelines are:
- The UKCA mark should only be placed on a product by the manufacturer or an authorised representative
- As the manufacturer, you are legally responsible a) for declaring conformity with the right standards and b) guaranteeing compliance. You must be able to provide evidence for compliance, including a written Declaration of Conformity.
- The UKCA mark should only be used on products that meet the qualifying criteria. If your products are not covered by one of the relevant compliance areas, you should not use the mark. So if you have multiple user guides, your technical writer will need to be sure to exclude it when it isn’t relevant.
- The UKCA mark must be visible and legible. It cannot be hidden by graphics, stickers, or labels.
- The user guide or product must show the UKCA mark at least 5mm high when displayed.
- If the image is resized, the proportions must be the same as the original.
Keep in mind that documentation for the UK, EU, and NI may potentially need different marks. You don’t need to manually maintain these different versions. Red Robot can produce different iterations of your user guide with the right marks automatically. Don’t hesitate to contact us if you need help with this.
Can I still use the CE mark as well as the UKCA mark?
Yes, you can use both CE and UKCA as long as the goods conform to the same standards.
In detail, this means:
- The CE mark will still be legally recognised in the UK up until 31st December 2021. So until then, you can continue to use the CE mark (alone) for goods sold in the UK as long as EU and UK regulations for those products are the same. If you continue to use the CE mark during this time, make sure that the accreditation is still in date and valid. This is not an issue if you supply goods that are certified on the basis of self-declaration only.
- If your products have to undergo mandatory assessment, you can only continue to use the CE mark for as long as the last certificate of conformity issued by an EU-recognised body remains valid. Once an assessment is required again, you must then submit for certification under the new UKCA instead.
- From January 1st 2022 onwards, you can still continue to display the CE mark on goods sold in the UK if you wish, but this must then be alongside the UKCA mark. This makes things easier if you’re selling products in both UK and EU markets, but the main condition is that goods must conform to both UK and EU standards in order to legally carry both marks. This is likely to become more of an issue further down the line if and when standards across more and more categories diverge in the wake of Brexit.
Can I remove the CE mark and just use UKCA if I sell goods in Northern Ireland?
The precise rules on conformity certification will depend on the final details of the Northern Ireland protocol, but as things stand:
- Products will have to carry the CE mark to facilitate the movement of goods across the border with the Republic of Ireland (and therefore the wider EU).
- That means qualifying goods sold in Northern Ireland, the rest of the UK and the Republic of Ireland (and/or the rest of the EU) will therefore have to carry both the UKCA and CE marks after December 31st 2021.
- If goods are sold in Northern Ireland but not in the EU, a special UK(NI) conformity mark must be obtained from an NI notified body.
Which notified body should I use to obtain my CE or UKCA marks?
If your CE mark was issued by an EU notified body, it will need to be renewed by one in the UK. Some notified bodies have opened up UK branches to make this easier (and vice versa).
Which goods are covered by ‘special’ UKCA rules?
Some types of goods are subject to special rules under the UKCA regime which create exceptions to the normal timeframe. These chiefly apply to products where new UK conformity regulations differ from the EU rules that have previously applied, or where UK national laws have always been slightly different to those of the EU.
This includes categories of goods like:
- Medical equipment
- Construction products
- Civil explosives
- Products requiring environmental conformity labelling.
This is because of existing differences between EU and UK compliance standards, or differences that will emerge on January 1st 2021.
The key point is that all goods must now comply with UK rules. So if you have goods in the above categories that have previously carried the CE mark, you won’t be able to automatically switch to using the UKCA mark. You will need to have your goods accredited against the UK standards, and you will also have to start using the UKCA straight away.
If this applies to you, please consult a solicitor before contacting us to change your marks.
How does UKCA apply to British firms exporting goods to the EU?
How the UKCA will impact exporters to the EU depends on whether you also sell goods in the UK or not. If you do, you’ll eventually having to use two different marks, either side by side or on products differentiated for the different markets. We can help you to develop documentation that is suitable for each market easily.
If you only export goods for the EU market, and you have your goods certified through a UK body, then the main consideration is whether that organisation will be continuing to offer CE accreditation services. If not, you will have to find an alternative provider in the EU.
How does UKCA apply to firms importing goods to sell in the UK?
From January 1st 2021, if your business is involved in importing qualifying goods into the UK for sale, you will have a legal responsibility for ensuring the goods display the UKCA mark (in England, Scotland and Wales) and conform to the relevant standards.
These responsibilities will include ensuring that the manufacturer has supplied the correct technical documentation (see below) and that the correct conformity assessments have been carried out, if required.
Imported goods carrying the UKCA mark must also be labelled with the importer’s company name and address, although until December 31st 2022, it is sufficient to supply this on the documentation.
What evidence do I need to support use of the UKCA mark?
The UKCA mark is a declaration that goods placed on the market for sale in the UK conform to relevant standards. But while the mark is the outward sign of conformity, it must be backed up with documentary evidence.
Conformity and use of the UKCA is determined either by self-declaration or via a formal assessment and accreditation process carried out by an authorised body. Which method can be used depends on the type of goods and the standards that apply – for some, independent testing is mandatory.
Whichever method is used, it is a legal requirement to keep documentation that details how the product conforms with the relevant standards. This documentation should include full details of how the product is designed and manufactured, any technical evidence and / or testing results demonstrating conformity with the relevant standards, and a legal pronouncement known as The UK Declaration of Conformity which must include:
- Your name and full business address or that of your authorised representative
- The product’s serial number, model or type
- A statement of responsibility for guaranteeing the product’s compliance
- The details of the approved body which carried out the conformity assessment (if applicable)
- The relevant UK legislation and standards
- Your name and signature
- The date the declaration was issued
- Any supplementary information (if applicable)
All of this documentation must be kept for up to 10 years after the product is placed on the market and made available to market surveillance or enforcement authorities on request.
We’ll also ask to see it before we update your UKCA marks, although we don’t make decisions on which mark you should be using.
Next Step: Update Your User Guides for UKCA
Manufacturing firms, retailers, importers, exporters, any business that depends on a supply chain that at some point extends into Europe, will feel the impact of Brexit – trade deal or not.
Domestically, too, as the UK plots its own independent regulatory course after half a century of following EU trade rules and customs, things will change. It might take longer for many of these effects to filter through, but it will come.
If you need help updating your documentation over the next few months, Red Robot can assist. We carry out user guide updates and maintenance to ensure that each version of your user guide is compliant for each area.
If you need assistance in changing the marking in your manuals, please get in touch with us for a fixed quote.