The impact of Brexit on conformity assessment

The United Kingdom left the European Union on 1 January 2021. For the purposes of testing and certification, the UK first amended the previous national implementation of EU Directives using UK Statutory Instrument (SI) 2019 No 696 Exiting the EU.

UK Conformity Assessment logo post Brexit (Photo: gov.uk)

This document amended 28 UK Regulations including the safety of electrical equipment (LVD), electromagnetic compatibility (EMC), radio equipment devices (RED), and equipment for potentially explosive atmospheres (ATEX). Other EU Directives including those for construction products and medical devices were covered by individual rules. Whilst this UK Statutory Instrument first implemented the changes, there have now been further amending Instruments containing clarifications and corrections for specific Regulations.

For UK businesses trading with the EU and vice versa, this means a number of changes to the testing and certification process for electrical and electronic products and components, which ensure they are fit for purpose in both markets.

To find out more about the implications of Brexit on conformity assessment, e-tech spoke with Simon Barrowcliff, UK alternate member of the IEC Conformity Assessment Board (CAB). Barrowcliff is General Manager for Certification and Approvals at Element, an independent UK global provider of testing, inspection and certification services to diverse industries, including global aerospace, fire and building products, infrastructure and environmental, transportation and oil and gas.

What are the key changes as of 1 January 2021?

All new rules for conformity assessment (CA) in the UK come into force on 1 January 2021 and there is a new UKCA mark for Great Britain (UK less Northern Ireland). Different rules apply for Northern Ireland which will continue to follow CE marking for product conformity assessment. Because the UKCA Regulations are based on EU Directives there is a high degree of commonality between the technical requirements. This includes the situations where conformity assessment is based on a manufacturer’s declaration or on a notified body certificate.

After 31 Dec 2020 there is a time limited measure (until the end of 2021) where goods placed on the Great Britain (GB) market can continue to be sold with the CE mark which is deemed equivalent to the UKCA mark. For this period either mark can be used. The UKCA mark has no validity in the EU. As of January 2022, UK products to be sold in the GB and EU will require dual marking.

When the CE mark ceases to be valid in GB and the UKCA mark must be applied, then conformity assessment for GB by an EU notified body becomes the responsibility of UK approved body. UK approved bodies may be based in the UK or in other states with a conformity assessment agreement with the UK (e.g. the radio equipment MRA with the USA). Element in the UK is such a body and is now known as the UKCA approved body 0891.

During the transition phase over the past year (2020), third party assessments for CE marking, certified by a former UK notified body, should have been transferred to an EU 27 country notified body prior to 31 December 2020. If this was not done, the UK conformity assessment marking process will need to be initiated with a UK recognized approved body in 2021.

For example, Element has transferred its files pertaining to the minimum safety requirements of the workplace and equipment used in explosive atmosphere (ATEX) to Element in the Netherlands (NB 2812) and those for radio equipment and electromagnetic compatibility (EMC) to Element in the US (NB 0981).

What is your experience of the transfer process?

Practically speaking I have just gone through the process of completing several approved body transfer of certificates. There is more administration, but technically, there are only some minor changes required to ensure clients are using the correct up-to-date standards. Old certificates with out-of-date standards that are not on the UK designated standards list will need refreshing and that is where the work will be.

However, if clients start new projects now, they will most likely want CE and UKCA markings. In this case you would do exactly the same testing and check all requirements are included for both the UK and EU certificates. What has changed is that you end up with two certificates and a different checking process, but there is usually little extra technical work.

How does this impact CA declarations and paperwork?

EU declaration of conformity (DoC)

  • If your conformity to CE marking did not use a former UK notified body, there is no change to the EU declaration of conformity.
  • If it did use a former UK notified body then start the process with an EU recognized notified body.

UK declaration of conformity (UKDoC)

  • If you want to use the UKCA mark after 1 January 2021 it is valid for the UK market providing the UKCA mark is applied. It is worth noting that the UK DoC is based on the EU DoC, with similar content.
  • The UKCA mark does not cover EU 27 market. Hence, if you apply the UKCA mark you will need a UK DoC, while the EU DoC covers you for the EU 27 market.
  • Most significant change on the UK DoC is the declaration to the UK Statutory Instrument and UK designated standards, rather than an EU Directive or EU harmonized standards.
  • The current list of UK designated standards is the same as the CE equivalent lists in the EU Official Journal as of December 2020. Hence, EN standards are permitted for the UKCA mark.

Importers

Now that the UK is a third party to the EU 27, any goods entering the EU from the UK, or entering the UK from the EU, will be the responsibility of an importer or authorized agent. This may entail identifying some importer details on packaging or in documentation.

If the product is UK manufactured or the importer or authorized agent is in the UK, the importer role in the EU 27 may need to be clarified and documents and markings changed accordingly, depending on the EU Directive.

For the EU market, the implications of EU Market Surveillance Regulation (EU) 2019/1020 should be applied from July 2021.

What will the impact be on international standards and certification?

The UK uses standards from the European Committee for Standardization and the European Committee for Electrotechnical Standardization CEN/CENELEC. The British Standards Institution (BSI) is a member of CEN/CENELEC and produces joint BS EN documents. BSI plans to remain closely associated with CEN/CENELEC and the expectation is that the UK standards model will continue much as it has in recent years.

ISO, IEC and its conformity assessment schemes will be unaffected by Brexit, as will international standards development, since BSI is a member of IEC and ISO and will continue to participate as normal.

Regarding UK Accreditation Service (UKAS) test reports, for example on safety of electrical equipment, these are accredited under the International Laboratory accreditation (ILAC) and are internationally recognized. They have always been global, rather than just for UK or European markets. UKAS has also retained accreditation with European Accreditation (EA) for at least two years, however, UKAS accredited reports will remain valid for most CE marking after 2020 for most electrotechnical products. Similarly EU accredited test reports will be recognised for most UKCA marking.

How UKCA ready is industry?

There is a broad range of readiness. Some manufacturers have completed the process using either the self-declaration or approved body route, and have already started applying the UKCA mark. Others are aiming for completion towards the end of 2021, when the UKCA process has been practically tried and tested, and any inconsistencies in the regulations addressed.

Do you have any advice for companies considering UKCA marking?

Firstly the UK Government web pages for UKCA are very good, and there is a lot of useful information to be found there. Secondly, understand that the intent of the UKCA regime is to replicate the CE process wherever possible. If companies are unsure of the approach to UKCA, then the starting point is look at what they do for CE and follow that process whilst noting the different marking and declaration document.