UK product certification post Brexit
11 May 2021
A consequence of the UK leaving the EU which has perhaps attracted less attention than other areas, such as border checks, is the new regime for product certification. Under EU law, many products must carry the CE mark to show that they are safe and comply with relevant laws.
Until the end of the transition period, the UK continued to use the EU CE mark on those products to confirm safety and legal compliance.
The UKCA (UK Conformity Assessed) marking is a new UK product marking for goods being placed on the market in England, Wales and Scotland (see later for Northern Ireland). It applies from 1 January 2021 and covers most goods which previously required the CE marking. The technical requirements and the conformity assessment processes and standards that can be used to demonstrate conformity are largely the same as they were for the CE marking (which will still be needed if you are putting goods on the market in the EEA).
A fully manufactured (individual) good is ‘placed on the market’ when a written or verbal agreement (or offer of an agreement) to transfer ownership or possession or other property rights in the product is exchanged. This does not require physical transfer of the good.
The marking is a key indicator of a product's compliance with UK legislation. By affixing the UKCA mark on a product a manufacturer is declaring conformity with the legal requirements to achieve UKCA marking. There may be more than one set of legal requirements that apply to a product.
UKCA marking may be achieved in two different ways, depending on the product concerned:
- examination by UK-approved bodies. This means that the manufacturer must use an approved body (such as the British Standards Institution) to test or review the product to enable the application of the UKCA mark; or
- self-declaration. This does not require any independent testing or review and it is therefore the manufacturer's own statement that they believe the product meets the relevant regulations.
Placing the UKCA marking
In most cases, you must apply the UKCA marking to the product itself or to the packaging. In some cases, it may be placed on the manuals or on other supporting literature (until 2023, when in most cases it will need to be affixed directly to the product). It must also be 5mm high and easily visible. This will vary depending on the specific regulations that apply to the product.
What products are caught?
The key sectors caught are:
- Toy safety
- Recreational craft and personal watercraft
- Simple pressure vessels
- Electromagnetic compatibility
- Non-automatic weighing instruments
- Measuring instruments
- ATEX (Atmospheres Explosibles)
- Radio equipment
- Pressure equipment
- Personal protective equipment
- Gas appliances
- Equipment for use outdoors
- Low voltage electrical equipment
- Restriction of hazardous substances
There are other products covered by the UKCA marking but which have some special rules, such as medical devices and construction products. The rules for those categories are largely the same but are due to be updated by mid-2021.
Other sectors such as automotive or aerospace have special rules.
Manufacturer’s responsibility, but distributors need to take care too
It is the manufacturer's responsibility to carry out the conformity assessment in accordance with the relevant safety legislation, bearing in mind that some safety legislation is product specific - for example, the Electrical Equipment (Safety) Regulations 2016 and the Toys (Safety) Regulations 2011.
It is also the manufacturer's responsibility to set up the technical file (including test reports and risk assessments), to issue the declaration of conformity and to affix the UKCA mark. There is no visual difference between a mandatory or self-declared UKCA mark and so a small business or consumer cannot tell whether the product has been tested or not.
If you are distributing products, you must verify the presence of both the UKCA mark and the necessary supporting documentation.
What happens if I don’t apply the mark?
If a product requires a UKCA mark but does not have one, it is illegal to place it on the UK market. However, not all products sold in the UK need to bear UKCA marking (for instance, cosmetic products which do not require a CE mark either), so distributors must have a basic knowledge of the legal requirements. They are expected to know what products must bear the UKCA mark and the accompanying documents required and should be able to identify products that are clearly not compliant.
What about Northern Ireland?
For Northern Ireland, a further mark is used: the UKNI mark. The product list is slightly different from the list using UKCA. This is a result of the Northern Ireland Protocol, which came into force on 1 January 2021. For as long as the Protocol is in force, Northern Ireland will align with all relevant EU rules relating to placing manufactured goods on the market. If your goods require third party assessment and you use a UK conformity body you use the UKNI mark and if you use an EU conformity body you use the CE mark.
There will be a crossover period for the UKCA and UKNI marks, and in most cases the CE mark can still be used until 31 December 2021.
And what happens if EU and GB law diverge?
CE marking will only be valid in Great Britain if GB and EU legislation stays the same. If EU law changes and GB law doesn't, and you place the CE mark on your product on the basis of the new EU law, you will not be able to use the CE marking to sell in GB even before the end of 2021. However, although the UK government is consulting on new product safety rules, which could potentially lead to changes to product labelling, nothing will change overnight.
So what, in a nutshell, do I need to do?
The following table sets out the rules for each territory:
Type of good
Placing goods on the market in Great Britain
Manufactured goods being placed on the GB market until the end of 2021
UKCA or CE
Manufactured goods placed on the GB market from 1 Jan 2022
Placing qualifying Northern Ireland goods on the market in Great Britain (unfettered access)
Qualifying Northern Ireland goods being placed on the GB market under unfettered access
CE or CE and UKNI
Placing goods on the market in Northern Ireland
Manufactured goods being placed on the market in NI using an EU conformity assessment body
Manufactured goods being placed on the market in NI using a UK-based body
CE and UKNI
You only need to use the new UKCA marking before 1 January 2022 if your product is covered by legislation which requires the UKCA marking AND requires mandatory third-party conformity assessment AND conformity assessment has been carried out by a UK conformity assessment body. This does not apply to existing stock.
From 1 January 2022, the CE marking will not be recognised in Great Britain on its own. However, a product bearing the CE marking would still be valid for sale in the UK so long as it was also UKCA marked and complied with the relevant UK rules.
Consequences of non-compliance
Many bodies enforce marking legislation to prevent misuse of the CE and UKCA marking and to ensure that product safety is maintained to a high standard. These include bodies such trading standards authorities, the Health and Safety Executive, the Medicines and Healthcare products Regulatory Agency and the National Measurement office.
If an enforcement body finds your product does not meet marking requirements, they will often provide you with an opportunity to ensure it is correctly marked. If you fail to comply with this, you will be obliged to take your product off the market. You may also be liable for a fine and even imprisonment.