How Brexit impacts regulatory compliance and the product conformity assessment
02 okt. 2020
Impact on regulatory compliance and product conformity assessment.
When I was asked earlier this year to write a blog on topics related to my work as the chief certification officer for Intertek’s Swedish National Certification Body, I immediately thought of Brexit as a hot and up-to-date topic for my first post. Now, when the time has come to publish this first post, I am no longer so sure.
Almost four years after the UK referendum in 2016, there is still no signed Trade Agreement between the EU and the UK (or more specifically, the European Union and the European Atomic Energy Community and the United Kingdom of Great Britain and Northern Ireland). After lengthy discussions and negotiations between the parties, there is, however, an exit date set to December 31, 2020.
My understanding of the Brexit situation as of today (Oct 2, 2020) – and remember, this may change before the exit date – is this:
The UK left the EU on 31 January 2020, and entered the withdrawal transition period which ends on 31 December 2020, as negotiations continue to put in place a Free Trade Agreement, the outcome will be either a “DEAL” with an agreement in place or if not, alternative arrangements will be put in place (NO DEAL). On 01 September 2020, the UK Government announced the New UK Regulatory Framework effective from 01 January 2021 for Great Britain (GB) being (England, Wales and Northern Ireland). Northern Ireland (NI) has its own special rules and marking requirements. The new conformity mark for the GB market is called the UKCA mark, which in time will replace the CE mark. Northern Ireland has its own marking requirements for placing product onto the market such as the CE or UK(NI) mark, UKCA marking alone is not accepted.
UK based Notified Bodies will cease operating on 31 December 2020 with issued certificates not being accepted on the EU market. To mitigate business risk customers are being advised to transfer certificates to an EU 27 appointed Notified Body before 31 December 2020.
CE marking will still be accepted before 31 December 2020 for existing product placed on the GB market for a majority of goods till 01 January 2022 after which the CE mark will cease to be valid.
For new products placed on the GB market after 1st January 2021 the UKCA (UK Conformity Assessed) marking shall be applied. Special rules apply for Medical Devices which has an acceptance period for CE marking till 30 June 2023. From June 2023, the CE mark will be phased out and replaced by the UKCA mark.
Compliance for self-declared products, manufacturers will be required to draw up a separate DoC (Declaration of Conformity) for the UKCA mark, referencing UK legislations/regulations and British standards. UK legislation is based on EU directives, likelihood is that this will remain the same in the future. BSI (the British Standards Institute) will remain a member of CEN/CENELEC, at least for the next two years, and will, at least for the first year, continue to recognize EU standards without additional new national deviations. The UK version of the EU official journal is to be called the Designated Standards List, which will likely consist of International and National standards. (BS EN)
I recommend anyone exporting goods to the UK and Northern Ireland to prepare for a No Deal situation. If you want more detailed information, Intertek will be hosting a webinar (in Swedish) on Brexit and its impact on product compliance on Nov 3. More information on the webinar, as well as a white paper and an FAQ document for download can be found in the right column of this page.
If you have questions, please don't hesitate to reach out to your usual Intertek contact, or email info-sweden@intertek.com.
