UK accreditation post EU-exit
UKAS as the National Accreditation Body
Accreditation in the UK following our exit from the European Union
Following the outcome of the UK referendum on EU membership in 2016, the United Kingdom left the EU on 31st January 2020 although the impact of this could only start to be realised with the conclusion of the EU Exit transition period on 31st December 2020. During the intervening period UKAS worked closely with Government departments in a number of areas to ensure that the impact on accreditation and conformity assessment within the UK were fully considered. Although there is still work to be done to fully understand how our new relationship with the European Union will operate, there are a number of important points that are now clear, and which are covered below.
- Accreditation regulations following Exit from the EU
From 1st January 2021 the regulatory landscape regarding accreditation within the UK changed:
- The legislative framework for accreditation in Great Britain is set out in the Regulation on Accreditation and Market Surveillance No 765/2008 (“RAMS”) which became incorporated into GB law by the EU (Withdrawal) Act 2018 and deficiencies were corrected by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 UK Statutory Instruments 2019 No. 696 (as amended). This is hereon referred to as GB RAMS).
- In Northern Ireland, Regulation (EC) No. 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance (as it applies in EU law, through the Northern Ireland Protocol) will continue to apply. It is hereon referred to as “RAMS NI”.
- Both regulations require Government to appoint a single not for profit UK National Accreditation Body (NAB) to operate accreditation as a public authority activity.
See government guidance: Regulation 765/2008 on Accreditation and Market Surveillance – What’s changed?
- The United Kingdom’s National Accreditation Body
In accordance with the requirements of both GB RAMS and RAMS NI the Secretary of State formally appointed the United Kingdom Accreditation Service as the UK’s National Accreditation Body via The Accreditation Regulations 2009 (S.I. 2009/3155).
As the UK’s National Accreditation Body, the government will only recognise accreditation of UK CABs by UKAS in the voluntary and mandatory sectors.
- Memorandum of Understanding between BEIS and UKAS
The initial Memorandum of understanding (MoU) explaining how the UK Government and UKAS would work together to maintain and promote a strong national accreditation service in the UK was first signed in 1995. Following the UK’s exit from the EU and confirmation of UKAS’s ongoing status as the UK’s National Accreditation Body, the MoU was updated on 1st January 2021 and signed by the Secretary of State for Business, Energy and Industrial Strategy (BEIS), on behalf of Government as a whole, and the United Kingdom Accreditation Service (UKAS).
Paragraph 9.2 of the MoU confirms “where testing, inspection or certification is required to demonstrate compliance with national legislation or guidance, or any similar rules or recommendations of any international institutions, Government will specify the use of laboratories, inspection bodies or certification bodies accredited by UKAS. In line with UKAS’ appointment as the sole national accreditation body for the UK as defined in the Accreditation Regulations 2009, the Secretary of State will only recognise accreditation of UK CABs by UKAS in the voluntary and mandatory sectors”.
- Government policy on accreditation
The government published its updated Conformity Assessment and Accreditation Policy in the UK on 1st January 2021, setting out its policy principles and how it will be apply those principles.
The principles on accreditation are as follows:
- Accreditation is applicable to both the regulated and non-regulated sectors.
- Accreditation being at the topmost level of control should provide an authoritative statement of the technical competence of CABs.
- The legislative framework for accreditation in Great Britain is GB RAMS.
- In Northern Ireland the legislative framework is RAMS NI.
- The National Accreditation Body (NAB) shall operate in accordance with GB RAMS and RAMS NI as relevant.
- Accreditation is considered to be a public authority activity and should therefore operate in the public interest. It should be self-supporting but run as a not for profit activity.
- Accreditation should be operated with integrity; independent of the organisations it accredits and impartial, and free from commercial pressure. The NAB shall operate to recognised standards or other transparent criteria and be compliant with applicable technical requirements, demonstrated, where appropriate, through peer evaluation.
In applying these principles, the Department for Business, Energy & Industrial Strategy:
- appoints on behalf of government as a whole, a single NAB for the UK. By means of The Accreditation Regulations 2009 (SI 2009 No. 3155), the United Kingdom Accreditation Service (UKAS) is appointed as the NAB for the UK;
- works with UKAS to ensure that it operates in the public interest and meets the obligations imposed by the Regulation on accreditation and market surveillance (765/2008) as it has effect in Great Britain and to Regulation (EC) 765/2008 as it applies to Northern Ireland, as well as those accepted under the Memorandum of Understanding UKAS has with government;
- requires that where a UK CAB requests accreditation, it shall do so from UKAS as the sole NAB for the UK;
- recommends UK businesses, government and local authorities requiring third party conformity assessment services to source such services, where they exist, from conformity assessment bodies accredited by the UK NAB; and
- recognises the equivalence of the services delivered by those accreditation bodies that are members of the European or international multilateral agreements (i.e. those operated by EA, ILAC and IAF).
See government guidance: Conformity assessment and accreditation
- UKAS Membership of the European co-operation for Accreditation (EA)
UKAS was a founder member of EA, the association of European national accreditation bodies, at the turn of the 21st Century, and has been an active and influential member and supporter during the following two decades.
With the withdrawal of the UK from the European Union, UKAS no longer meets the EA membership criteria as we are not a NAB in an EU or EFTA Member State or candidate country. EA has expressed the importance of having UKAS as a member, even after the withdrawal of the UK from the EU. Accordingly, EA revised its Articles of Association and introduced the option of a transition period, which allowed UKAS to maintain its membership for a further 2 years from when the UK left the EU (i.e. until 31 January 2022). During this transition period UKAS is working with EA to analyse the Trade & Coordination Agreement between the EU and the UK and then revise the EA membership criteria with the aim that UKAS remains an EA member. Both parties are confident that a satisfactory resolution shall be reached during 2021.
In support of this the EA has recently issued a clarifying statement on ‘continuing recognition of UKAS under the EA MLA’ which can be read here. This statement applies to all UKAS accredited work covered under the scope of the EA MLA, no matter where the accredited body is located or operating.
UKAS’s membership of both the International Laboratory Accreditation Cooperation (ILAC) and International Accreditation Forum (IAF), including full signatory status of their mutual recognition agreements) have been unaffected by the UKs exit from the EU.
- Accreditation for the purposes of placing goods on the GB and NI Markets – UKCA and CE UKNI Marking
From 1st January 2021 the work of UK-based Notified Bodies is no longer recognised within the EU and therefore, unless a UK-based entity has already relocated its Notified Body operations to one of the 27 EU Member States and received accreditation from the local accreditation body then it will no longer be able to undertake notified body work for the purposes of placing goods on the EU single market.
With respect to the UK from 2021 onwards, the UK government has implemented its own Conformity Assessed (UKCA) Marking scheme for products to be placed on the GB (England, Scotland & Wales) market – The arrangements for Northern Ireland are different and are explained below. UK-based Notified Bodies automatically had their appointment for existing scopes changed from Notified Body for the purposes of CE marking to UK Approved Bodies for the purposes of UKCA marking. In support of this UKAS updated all Notified Body Schedules of Accreditation to reflect this transition, and to reference the UK legislation that underpin the UKCA Mark: This was completed by Christmas 2020.
Under the Northern Ireland protocol NI continues to abide by EU Directives relating to placing certain products on the NI market. As a consequence, NI continues to recognise the CE Mark but does not recognise the UKCA Mark. For producers and importers wishing to place goods on the NI market they have two options for attaining the CE Mark, either through (a) conformity assessment activities undertaken by a Notified Body from one of the EU Member States, or (b) conformity assessment activities undertaken by a UK-based Notified Body. If the second option is followed, then the product must be marked with a UKNI Mark in addition to the CE Mark denoting that the conformity assessment activities were undertaken within the UK. Products bearing the combined CE UKNI Marks shall not be accepted on the EU market.
Please note that the arrangements for Carriage of Dangerous Good / Transportable Pressure Equipment within Northern Ireland differs to other Notified Body work due to this area being covered by specific Northern Ireland legislation. UKAS is still in discussions with the Department for Transport & VCA with respect to this, but the expectation is that only bodies established in Northern Ireland (rather than the whole UK) shall be able to undertake related conformity assessment activities for the Northern Ireland market.
The product legislation for both the EU and UK shall be the same from the beginning of 2021, as will the requirements on performance of Notified Bodies and Approved Bodies. Therefore, there shall be no need for additional assessment effort required by UKAS in order to accredit an organisation as an Approved Body or as a joint Approved Body / UK Notified Body.
The government has set up a website that lists all UK Approved Bodies and UK Notified Bodies (for NI), the UK Market Conformity Assessment Bodies (UKMCAB) database, which is maintained by the Department for Business, Energy & Industrial Strategy (BEIS).
For more information on this topic please refer to the information provided in the following documents and websites:
- UKAS Publications GEN 5 – Accreditation for the Purposes of Appointment as an Approved Body under the UKCA System
- EA-2/17M – EA Document on Accreditation for Notification Purposes
Government Guidance on accreditation:
- Accreditation within the EU-UK Trade and Cooperation Agreement
In December 2020 the EU and the UK reached an agreement in principle on the EU-UK Trade and Cooperation Agreement (TCA). This Agreement includes a Technical Barriers to Trade (TBT) Chapter which addresses regulatory barriers to trade between the UK and EU, while allowing both Parties the freedom to regulate goods in the way most appropriate for their own market. This Chapter builds on the WTO TBT agreement and includes provisions on technical regulation, conformity assessment, standardisation, accreditation, market surveillance and marking and labelling.
Part 3 of the TCA covers law enforcement and judicial cooperation in criminal matters. This includes an article on accreditation of forensic service providers stating that “the States shall ensure that their forensic service providers carrying out laboratory activities are accredited by a domestic accreditation body as complying with EN ISO/IEC 17025”. A domestic accreditation body is defined within the TCA as the sole national accreditation body: Within the UK this is UKAS as appointed via The Accreditation Regulations 2009 (S.I. 2009/3155).
For further details see here