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 the UK, with the CE mark remaining temporarily valid to ease the changeover.
What does the UKCA mark mean?
The UK Conformity Assessed mark will be a mandatory mark on a product to indicate that it conforms to UK legislation. The manufacturer or their authorised representative will be responsible for affixing the UKCA mark to the product, which is the same principle as for CE marking but for the UK market.
Will the CE mark remain valid for products placed on the UK market?
For most products placed on the UK market, the CE mark will only remain valid until 31st December 2021. 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?
Many of the differences between the two systems are administrative in nature and reflect that UKCA only applies in the UK and only requires information in English. This simplifies some aspects, such as where the technical information must be kept and which language applies.
Other differences relate to the separation of UK conformity assessment bodies from the EU Notified Body System, described below.
What aspects are not changing?
Many facets are the same; the scope of products covered, technical requirements (essential requirements, standards) and conformity assessment procedures will all initially be alike. 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 will apply 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 will remain aligned with the EU single market in terms of trading goods. Products that are to be placed on the market throughout the UK will therefore need both UKCA and CE marking.
How will UKCA marking impact Northern Ireland?
Products placed on the market in Northern Ireland (and in the EU) must be CE marked, regardless of their origin. Products placed on the market in Great Britain will need to be UKCA marked as discussed above, regardless of their origin with one exception: businesses in Northern Ireland will be in the unique position of being able to ship products certified to EU (CE mark) or UK (UKCA mark) rules into Great Britain.
Can I put both CE and UKCA marks on my product?
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 the UKCA 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.
Further statutory instruments are expected in October, including one to restrict application of the amending regulations and UKCA marking to Great Britain, such that the CE marking regulations remain unamended for Northern Ireland.
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 to start with harmonised and designated standards lists will be the same. BSI is unlikely to withdraw EN standards but the UK designated list is likely to differ slightly in time as UK authorities such as HSE will bring their influence to bear on standards they do not like.
What do the changes mean for Notified Body certificates?
UK Notified Body accreditations will be withdrawn, and their CE marking will no longer be valid for products placed on the EU market after 31st December 2020. Many UK Notified Bodies are consequently transferring certificates to EU-established Notified Bodies and this usually requires product markings and Declarations of Conformity to be changed.
UK bodies that were Notified Bodies immediately before 31st December 2020 will automatically become UK Approved Bodies, and their certificates will remain valid only for products placed on the market in the UK, and for products CE marked and placed on the EU market before that day.
What needs immediate action?
Other aspects that have an immediate effect on manufacturers and importers are:
- From 1st January 2021, importers of products marketed in the UK must be established in the UK. Their product labelling obligations can be met by information on documents accompanying the product for a period of 18 months.
- Authorised Representatives already established in the EEA will continue to be recognized in the UK, but those established after 31st December 2020 must be in the UK.
- EU-based organisations that bring in UK products for marketing in the EU will become an “importer” with increased responsibility for compliance. Currently, these entities are classed as “distributors” with responsibility for checking declarations, instructions and markings. As importers they must also check that products have an adequate technical file, which is a significant extra obligation, and indicate their name and address on the product.
What can be expected next?
Further statutory instruments are expected in October, including one to restrict application of the amending regulations and UKCA marking to Great Britain, such that the CE marking regulations remain unamended for Northern Ireland. Products placed on the market in Northern Ireland (and in the EU) must be CE marked, regardless of their origin.
Guidance is also expected on the new UK(NI) mark, which will be used when a UK Approved Body is involved in the conformity assessment process of CE marked goods for placing on the Northern Ireland market.
Unrelated to the UK’s withdrawal from the EU, important changes to manufacturers’ obligations are being introduced in July 2021 by Regulation (EU)2019/1020, which is likely to impact 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, particular 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, the EU-based responsible economic operator must be one of the following:
- an importer
- an authorised representative appointed by the manufacturer
- a fulfilment service provider who handles the product, if neither of the above exist
For further information on the Regulation and obligations please visit our sister company’s website at www.authorisedrepresentativeservice.com