With this year’s distractions, the headlines have moved away from Brexit but the prospect remains of leaving the single market without a trade deal. For a while, the CE mark will still be valid in the UK and it will certainly still be required within the EU. The UKCA (UK Conformity Assessed) mark will be phased in over a period of time that is currently undefined to replace the CE mark in the UK.
Statutory Instrument 2020 No. 852, which was laid before parliament on 12th August 2020, recently amended the 2019 regulations. It replaces the term “exit day” with “IP completion day” (IP stands for Implementation Period), still meaning 11pm on 31st December 2020. After IP completion day:
- Importers must be established in the UK but their product labelling obligations can be met by information on documents accompanying the product for a period of 18 months, rather than on the product itself.
- Authorised Representatives who were established in the EEA prior to IP completion day can continue, but authorised representatives established after IP day must be in the UK.
- Notified Bodies become “approved bodies”, and those that were notified bodies immediately before IP completion day automatically become approved bodies.
Further statutory instruments are expected in the coming months, including one to restrict the the amendments made by the 2019 Regulations to Great Britain, such that the regulations remain unamended for Northern Ireland.
What does the UKCA mark mean?
It will be the manufacturer’s statement that the product conforms to UK legislation and will be placed on the product by the manufacturer or authorised representative. This is in essence the same principle as that of the CE mark, but for the UK market.
What are the differences between UKCA and CE marking?
Many of the differences between the two systems are to reflect that UKCA only applies to the UK and only requires information in English. This simplifies 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?
As the UK leaves the single market, the scope, essential requirements, standards and conformity assessment procedures will be the same. 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.
What is the specific UK legislation that needs to be followed?
The UK government has issued The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019. They amend most of the UK CE marking regulations for products placed on the UK market and require 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.
The amending regulations were issued in 2019 but only come into force on “IP completion day." This is the day the UK leaves the single market (currently scheduled for 31st December 2020) not the day EU membership ended.
Consolidated versions of the amended UKCA marking regulations have not yet been produced but the Department for Business, Energy and Industrial Strategy has issued guidance in: UK product safety and metrology guidance from 1 January 2021. This document predates Brexit, an update is expected in Autumn 2020.
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 call 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 as UK authorities such as HSE will bring their influence to bear on standards they do not like.
What needs immediate action?
The aspects that have an immediate effect on manufacturers in a no-deal Brexit are:
- UK Notified Body accreditations will be withdrawn and their CE marking will no longer be valid for products placed on the EU market after exit day. Their certificates will remain valid only for UKCA marking of products for the UK and for products CE marked and placed on the EU market before exit day.
- Anyone based in the EU bringing in UK products that are placed on the EU market will become an “importer” and bear more responsibility for compliance. Currently, these people 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.
What should I do with UK Notified Body certificates?
Many UK Notified Bodies are transferring these certificates to EU-established Notified Bodies and this usually requires product markings and declarations to be changed. If your product requires Notified Body certification, it is worth checking this with your Notified Body and the gov.uk website which has more detail on UK bodies.
Will the CE mark remain valid for products placed on the UK market?
The CE mark will remain valid for most products placed on the UK market for a limited period, which is currently of unknown length. Some exceptions are Medical Devices and Construction Products and information has been published on the gov.uk website for these.
Can I put both CE and UKCA marks on my product?
Yes, it is already common to see numerous conformity marks on products sold internationally alongside the CE mark. We would recommend leaving enough space on the product label for the UKCA mark.
Other important changes to manufactures obligations are being introduced in July 2021 by Regulation (EU)2019/1020. Although unrelated to Brexit, they are likely to impact UK 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 website at www.authorisedrepresentativeservice.com