The UK left the EU single market at 11PM on 31st December 2020. The United Kingdom Conformity Assessed or UKCA mark is being phased in from 1st January 2021 to replace the CE mark in Great Britain, although for most goods the CE mark will remain acceptable for a transition period ending on 31 December 2022.
What does the UKCA mark mean?
The UK Conformity Assessed mark is a mandatory mark on a product to indicate that it conforms to GB legislation. The manufacturer or, if mandated, their authorised representative will be responsible for affixing the UKCA mark to the product, which is the same principle as CE marking but for the GB market.
Will the CE mark remain valid for products placed on the UK market?
For most products placed on the GB market, the CE mark will only remain valid until 31st December 2022. Some exceptions are Medical Devices and Construction Products and information has been published on the gov.uk website for these.
What are the differences between UKCA and CE marking?
In technical terms, the differences between the requirements for CE marking and for UKCA marking are slight. Products which meet the technical requirements for one will mostly meet the requirements for the other for the foreseeable future. Most of the differences between the two systems are administrative in nature and reflect the fact that the UKCA mark only applies in Great Britain.
Other differences relate to the separation of UK conformity assessment bodies from the EU Notified Body system, described below.
What aspects are not changing?
For the moment, many facets are the same; the scope of products covered, technical requirements (essential requirements, standards) and conformity assessment procedures are all initially identical for the two different markets. If your product is sold in both the EU and the UK, the technical file to show that it meets these requirements will also be the same.
Will UKCA marking apply throughout the UK?
No, UKCA marking applies only in Great Britain (comprising England, Scotland and Wales), so it may be helpful to think of it more as a GBCA mark. CE marking continues in Northern Ireland, which remains aligned with the EU single market for goods. Products that are to be placed on the market in both GB and NI therefore need both UKCA and CE marking unless they are "Qualifying Northern Ireland Goods" in which case they can be sold in GB with a CE mark and do not need a UKCA mark.
How will UKCA marking impact Northern Ireland?
Products placed on the market in Northern Ireland must be CE marked, regardless of their origin. Products placed on the market in Great Britain must be UKCA marked, regardless of their origin with one exception: businesses in Northern Ireland will be in the unique position of being able to ship Qualifying Northern Ireland Goods certified to either the EU (CE mark) or UK (UKCA mark) rules into Great Britain.
Can I put both CE and UKCA marks on my products?
Yes, provided they fulfil the associated requirements. It is already common to see multiple conformity marks on internationally sold products.
What is the specific UK legislation that needs to be followed?
To implement the new regime, the UK government has issued several Statutory Instruments to amend current legislation. The main regulations are The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, which runs to 659 pages. These regulations amend most of the UK CE marking regulations for products placed on the UK market and stipulate that the UKCA mark replaces the CE mark. Where a directive required CE marking and UK regulations were already detailed, the amendments are limited to:
- replacing the CE mark with the UKCA mark,
- limiting applicability to products for the UK market,
- changing references to Notified Bodies to Approved Bodies,
- changing language references to English.
Where an EU CE marking Regulation is being amended rather than a directive, more substantial amendments have been necessary similar to the regulations that implement the directives.
Are standards changing?
The British Standards Institution (BSI) emphatically maintains its commitment to the EN and international standards systems and ‘harmonised standards’ remain best practice for both CE and UKCA marking. The UK regulations term them ‘designated standards’ and the lists of harmonised and designated standards are largely the same. BSI is unlikely to withdraw EN standards but in time the UK designated list is likely to differ slightly as UK authorities such as HSE bring their influence to bear on standards which they do not like.
What do the changes mean for Notified Body certificates?
UK based Notified Bodies ceased to be able to issue Notified Body certificates on 31 December 2020 and all certificates they had previously issued became invalid on that date. Manufacturers relying on those certificates to CE mark their products have had to find a new Notified Body, based within the EU, to certify their products and procedures.
For the UKCA mark, Notified Bodies based in the UK were automatically granted status as 'UK Approved Bodies' when their Notified Body status expired. A UK Approved Body has exactly the same role as an EU Notified Body but only for products which are UKCA marked. UK Approved Bodies cannot issue certificates on which the manufacturer can base their CE marking (with one exception, see the details of the UKNI mark below), and EU Notified Bodies cannot issue certificates which can be used as the basis of UKCA marking.
What is the UKNI mark?
Products which require certification by a Notified Body before they can be CE marked cannot rely on a certificate from a UK Approved Body. However, there is an exception to this which comes about because of the desire for there to be no barriers to trade between GB and NI. This special arrangement allows goods which are CE marked for sale in NI, and only NI, to be certified by a UK Approved Body instead of a Notified Body.
The purpose of the UKNI mark is to identify products which have a CE mark based on certification by a UK Approved Body. Such products are only eligible for sale in Northern Ireland and cannot legally be sold anywhere else in the EU Single Market.
Do I need to put the UKNI mark on my products before I can sell them in Northern Ireland?
Few products will actually have to carry the UKNI mark, since it only applies to products which require independent certification. It does not apply to products which are self-certified by the manufacturer. Even where independent certification is required, most manufacturers will go to an EU Notified Body since this will give them a CE mark which they can use anywhere in Europe.
What needs immediate action?
- If you are based in (and selling into) the UK and your products are already properly CE marked then the only action you need to take before 2023 is to ensure that your UK name and address is on the product or its accompanying documentation.
- If you are based outside the UK and you sell CE marked or UKCA marked products within the UK then in many cases you also need to identify a UK address (importer or Authorised Representative) on the product or its accompanying documentation.
- If you relied on a Notified Body certificate from a UK based organisation before Brexit then you must get that certificate re-issued by an EU based Notified Body in order for your CE mark to remain valid.
- By the end of 2022, you will need to have updated the markings on products you sell within the UK to include the UKCA mark.
- If your product requires EU Notified Body certification then you will also need a UK Approved Body certificate before you can legally UKCA mark it.
- From 1 January 2023, the address of the UK based manufacturer /importer / authorised representative must* be permanently marked on the product, and not just on the documentation or in the form of a sticky label on the product.
*For a detailed discussion about the appointment of Authorised Representatives and the names and addresses which must go on products being sold in the UK, please see our web page "Brexit and Authorised Representatives in the UK".
Unrelated to the UK’s withdrawal from the EU, important changes to manufacturers’ obligations were introduced in July 2021 by Regulation (EU)2019/1020, which impacts UK and other non-EU based manufacturers wishing to sell into the EU single market. This regulation has been introduced with the intention of better defending the EU single market against non-compliant products and avoiding gaps in the enforcement system, particularly in view of the increasing number of products being offered for sale online to end users within the EU. It states that for manufacturers based outside the EU, there must be a responsible economic operator who is based in the EU and who is either:
- an importer
- an authorised representative appointed by the manufacturer
- a fulfilment service provider who handles the product, if neither of the above exist
A detailed discussion of the legal background to these changes can be found on our web page "The Requirement for an Authorised Representative within the EU"
For further information on the Regulation and obligations please also visit our sister company’s website at www.authorisedrepresentativeservice.com