UK conformity assessment
Information for businesses on the regulatory framework and transitional arrangements January 2023.
The transition period following the UK’s departure from the EU, during which EU rules continued to apply across the UK, has been extended until 31 December 2024.
This update uses the term conformity assessment body (CAB) to cover Approved Bodies, UK Notified Bodies (for bodies in Northern Ireland assessing to EU requirements), Recognised Third Party Organisations (RTPOs), User Inspectorates (UIs) and Technical Assessment Bodies (TABs).
Change in status of UK CABs previously notified under EU regulations
UK-based CABs have automatically acquired status as UK Approved Bodies for the purpose of certifying goods to be placed on the GB market for the same scope of products for which they were notified to the EU as of 31 December 2020. UK-based Recognised Third Party Organisations (RTPOs), User Inspectorates (UIs) and Technical Assessment Bodies (TABs) have become UK-recognised RTPOs, UIs and TABs.
Letters of appointment or designation are being issued by the relevant competent authorities to UK CABs notifying them of their status. UKAS has updated schedules of accreditation in support of this.
All UK-based bodies retain their status as CABs for the purpose of certifying goods to be placed on the Northern Ireland market (as per Article 7(3) of the Northern Ireland Protocol) – such goods are then marked with the UK(NI) marking alongside the relevant EU conformity mark.
UK-based bodies will keep the same 4-digit identification number as before.
The UK Market Conformity Assessment Bodies (UKMCAB) database on GOV.UK serves as the UK’s database of CABs, and the UK equivalent of the EU’s NANDO database. UKMCAB is the definitive source of UK CABs who can certify goods for both the GB and NI markets.
(Under the Northern Ireland Protocol EU recognised notified bodies can also certify goods for the NI market.)
Outcome of UK-EU trade agreement
The UK has successfully agreed a Technical Barriers to Trade (TBT) chapter which reaffirms, and builds on, the WTO TBT Agreement – and will help ensure that the respective regulatory regimes are not discriminatory and do not create unnecessary obstacles to trade for exporters.
While the UK secured a number of sector-specific annexes as part of the TBT offer, it was not possible to reach agreement with the EU on the UK’s proposal for a Mutual Recognition Agreement (MRA) on conformity assessment. While this was not the desired outcome, the UK Government’s focus is on implementing the deal helping prepare businesses for upcoming opportunities.
Without an MRA, UK CABs are no longer recognised as competent to perform conformity assessment against EU regulatory requirements, for example for the purposes of CE marking products to be placed on the EU market. Similarly, EU CABs are not recognised as competent to perform conformity assessment against GB requirements for the purposes of UKCA marking.
Transitional arrangements mean that for a finite period, in most cases until 31 December 2024, the CE marking will continue to be recognised for goods being placed on the GB market (including where assessment has been undertaken by an EU CAB). However, for the majority of goods currently subject to the CE marking, when placed on the GB market from 31 December 2024 they will be required to meet the GB requirements. This includes any mandatory third-party conformity assessment having been done by either a UK-based CAB or a body located outside of the UK but recognised under an MRA.
(For most product areas covered by this document, the end date to the transitional measure was introduced in the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020.)
These measures have been put in place to give businesses time to prepare for the introduction of the new regulatory arrangements. However, we will continue to stress to manufacturers that they should prepare to UKCA mark their products as soon as possible, including engaging a UK CAB where required.
Validity of existing certificates issued by UK bodies prior to the end of the transition period
As set out in UK law, certificates issued by UK bodies before the end of the transition period continue to be valid for the purposes of placing products on the GB market with UKCA marking. We recognise that some approved bodies and/ or their clients may nevertheless prefer updated certificates for the avoidance of any doubt, but they are not required to do so.
The above does not apply if the certificate has ceased to be the responsibility of the UK-based body, for example because it has been transferred to a non-UK body such as a Notified Body based in the EU. A certificate transferred in such a way may be valid for placing CE marked goods on the GB market for the duration of the current transitional period during which CE marking is recognised in GB, but it will not be valid beyond this.
Issuing of new certificates based on previous assessments
The terms of the UK-EU Withdrawal Agreement (Article 46) mean that upon request by a manufacturer, a CAB located in the UK or EU should share with a body located in the other market information they hold in relation to conformity assessments carried out before the end of the Transition Period. This is intended to facilitate the issuing of new certificates.
It is the responsibility of individual UK CABs to assure themselves that products for which they are issuing certificates are compliant with the relevant requirements. However, it is not necessarily required to retest or fully re-assess a product or process before a UK body issues a new certificate. As UK and EU essential requirements are currently the same, during the current period of transition to the new UK regime we encourage UK CABs to consider alternatives including reviewing existing documentation and/or performing targeted activities to verify conformity assessment results carried out previously by an EU CAB where a review of available documentation is not sufficient to provide confidence in the product’s conformity.
We have confirmed with the United Kingdom Accreditation Service (UKAS) that it is not a condition of UK CABs’ accreditation that they have directly conducted all assessments that underpin certificates for which they are responsible nor that they conduct full reassessments for clients they have taken on after the end of the transition period who previously held certification from an EU recognised body. However, in taking on such cases the CAB must satisfy itself that the relevant requirements have been met as it will ultimately be responsible for the certification.
The receiving CAB must have a copy of the technical file which should contain evidence of the product’s compliance with the essential requirements of the relevant regulations (including copies of all relevant supporting certificates). To progress a UKCA transition it is for the CAB to satisfy itself that the technical file contains sufficient detail to demonstrate the compliance of the product. The UK CAB is not required to re-certify or re-issue the supporting certificates.
Please note that separate guidance will be published by UKAS, following discussions with the Department for Levelling Up, Housing and Communities, in relation to AVCP System 3 for construction products.
Combining EU and UK certification
During the period of time-limited recognition of certification by EU CABs only (limited to goods being placed on the GB market until 31 December 2024 for most areas), it is permissible for goods to be UKCA marked and placed on the GB market on the basis of:
- a Module B / ‘type-examination’ certificate issued by an EU body where there is a second module (such as Module D) which has been carried out by a UK CAB
- a certificate issued by a UK CAB that relies in part on a separate certification (for example, of an individual component) issued by an EU CAB
Where a UK issued certificate stipulates that it is only valid where the product covered is being used along with another product that has been certified by a UK recognised CAB, it shall be considered valid for use with any product certified by an EU CAB that has been placed on the market before the end of the period of time-limited recognition of EU certification in GB.
From 31 December 2024 (in most cases) all certificates used for products being placed on the GB market, including Module B / type-examination certificates as well as certification, and any other certificates where the legislation requires certificates to be issued by a recognised CAB, must have been issued by UK-recognised CABs. This will not include EU CABs.
Reducing re-certification/re-testing costs for UKCA marking
The government has introduced legislation to allow completed conformity assessment activities carried out under EU requirements (including existing testing, certification, and contractual arrangements relating to the quality control or auditing of existing certificates) undertaken by non-UK CABs (accredited by their national accreditation body) for CE certification before 31 December 2024 to be used by manufactures to declare existing product types as compliant with UKCA. Products must still bear UKCA marking and will need to undergo conformity assessment with a UK Approved Body at the expiry of the certificate, or until 31 December 2027, whichever is sooner.
This will allow manufacturers to apply the UKCA mark without the need for any UK-recognised CAB involvement and continue to place their goods on the market on the basis of their existing CE type examination completed before 31 December 2024, until the expiry of the certificate issued, or until 31 December 2027, whichever is sooner.
Where manufacturers are using existing CE certification completed before 31 January 2024 as the basis to demonstrate compliance with UKCA for their products, we recommend that they include in the UK Declaration of Conformity the list of relevant UK designated standards and equivalent EU harmonised standards that apply to their product, as well as details of the EU CAB (or CAB recognised under an EU Mutual Recognition Agreement) which carried out the conformity assessment procedures.
If conformity assessment procedures have not been completed and a supporting CE certificate issued before 31 December 2024, these products are considered ‘new’ products. This also includes where goods are subject to important changes, overhauling its original performance, purpose, or type requiring new certification. Any ‘new’ good must comply with GB regulatory requirements, including the requirement for conformity assessment by a UK approved body from 31 December 2024.
The retesting measure applies across all module types for the following regulations:
- Noise Emission in the Environment by Equipment for Outdoor Use Regulations 2001
- Supply of Machinery (Safety) Regulations 2008
- Ecodesign for Energy-Related Products Regulations 2010 (with respect to boilers in accordance with Article 4 of Commission Regulation (EU) No 813/2013)
- Toys (Safety) Regulations 2011
- Explosives Regulations 2014
- Pyrotechnic Articles (Safety) Regulations 2015
- Electromagnetic Compatibility Regulations 2016
- Simple Pressure Vessels (Safety) Regulations 2016
- Lifts Regulations 2016
- Pressure Equipment (Safety) Regulations 2016
- Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016
- Non-automatic Weighing Instruments Regulations 2016
- Measuring Instruments Regulations 2016
- Recreational Craft Regulations 2017
- Radio Equipment Regulations 2017
- Regulation 2016/425 on personal protective equipment as it applies in GB
- Regulation 2016/426 on gas appliances as it applies in GB
Status of EU based bodies and expansion to scope of accreditation
To be eligible for appointment as a CAB for the GB market for the purposes of the relevant regulations, an applicant must be a legal entity in the United Kingdom (or a country with which the UK has agreed an MRA).
Following the end of the transitional measures above, EU based entities will therefore not be able to certify goods for the GB market. This presents opportunities for UK CABs to expand their scope into new areas to fill potential gaps in the market and develop the UK CAB industry further. We strongly encourage UK CABs to consider whether there are new areas they may be able to expand into.
As there are currently no UK-based CABs for pyrotechnics and given the relatively small size of the sector, a third-party CAB can exceptionally be established in a country outside of the UK without the existence of an MRA, but will still need to meet the necessary remaining requirements for appointment as an Approved Body for the GB market and go through UKAS’ accreditation process. This exception applies only to pyrotechnics – in all other cases (as set out in legislation) CABs assessing against UK regulations must be based in the UK or in a country with which the UK has an MRA. UK bodies are encouraged to consider the opportunities to expand into this sector, where there is demand for conformity assessment covering a range of products from fireworks to airbags and seatbelt pretensioners for the automotive industry. We would also highlight that there are no UK CABs offering conformity assessment for cableway installations.
CABs may also want to consider opportunities to expand their services to cover specific product categories within existing legislation. For example, while there are a number of CABs offering conformity assessment services for areas such as Personal Protective Equipment (PPE), construction products and equipment for use outdoors there may be specific product categories within these areas where there will be opportunities for UK CABs to expand the scope of their accreditation to provide assessments for products previously covered primarily by EU CABs.
To aid CABs in making commercial decisions about expansion, the Department for Business, Energy and Industrial Strategy (BEIS) and the Office for Product Safety and Standards (OPSS) published a document setting out the product categories currently covered by UK registered Approved Bodies:
BEIS and OPSS also published updated guidance on GOV.UK on gaining approved body status:
Read guidance on how to apply to be a UK CAB for product safety and metrology
UKAS continues to be the UK’s sole national accreditation body and maintains its role in the accreditation of CABs. If you as a UK-based CAB require any addition or change to your accreditation schedule you will need to apply for an extension to scope. You should contact UKAS in advance of applying to discuss your requirement and timescales.
We are also interested in understanding any potential barriers to expansion that you might foresee. If you or your organisation are considering expanding the scope of activities covered, please do contact us via our mailbox: goods.regulation@businessandtrade.gov.uk.
Further information and questions
If you have any questions about the above or any related matters please contact goods.regulation@businessandtrade.gov.uk.
Annex 1 – terms used in this document
Conformity assessment body (CAB): An Approved Body, Notified Body, Recognised Third Party Organisation, User Inspectorate or Technical Assessment Body formally recognised as able to assess conformity against a particular set of regulations. In this document, CAB does not generally refer to conformity assessment bodies undertaking activities not required by legislation.
UK CAB / UK-recognised CAB: A conformity assessment body recognised by the UK as able to carry out conformity assessment activities for the GB market. Such bodies may be located outside of the UK, for example, if they are operating under a Mutual Recognition Agreement between the UK and another country.
UK-based CAB: A conformity assessment body which is physically established in the UK (meaning the legal entity which is recognised as a CAB by the UK is located in the UK even if some facilities are located elsewhere).
EU CAB: A conformity assessment body recognised by the EU as able to carry out conformity assessment activities for the EU market. Such bodies may be located outside of the EU, for example, if they are operating under a Mutual Recognition Agreement between the EU and another country.
Annex 2 – list of legislation covered by this update
We are working to update the detailed guidance to reflect the new measures as soon as possible. However, until amended, in reading the guidance you should bear in mind the new dates as set out in the new measures.
EU legislation | UK legislation |
---|---|
Toy Safety – Directive 2009/48/EC | Toys (Safety) Regulations 2011 |
Recreational craft and personal watercraft – Directive 2013/53/EU | Recreational Craft Regulations 2017 |
Simple Pressure Vessels – Directive 2014/29/EU | Simple Pressure Vessels (Safety) Regulations 2016 |
Electromagnetic Compatibility – Directive 2014/30/EU | Electromagnetic Compatibility Regulations 2016 |
Non–automatic Weighing Instruments – Directive 2014/31/EU | Non–automatic Weighing Instruments Regulations 2016 |
Measuring Instruments – Directive 2014/32/EU | Measuring Instruments Regulations 2016 |
Lifts – Directive 2014/33/EU | Lifts Regulations 2016 |
ATEX – Directive 2014/34/EU | Equipment and Protective Systems Intended for use in Potentially Explosive Atmospheres Regulations 2016 |
Radio equipment – Directive 2014/53/EU | Radio Equipment Regulations 2017 |
Pressure equipment – Directive 2014/68/EU | Pressure Equipment (Safety) Regulations 2016 |
Personal protective equipment – Regulation (EU) 2016/425 | Regulation 2016/425 on personal protective equipment as it applies in GB |
Gas appliances – Regulation (EU) 2016/426 | Regulation 2016/426 on gas appliances as it applies in GB |
Machinery – Directive 2006/42/EC | Supply of Machinery (Safety) Regulations 2008 |
Outdoor Noise – Directive 2000/14/EC | Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001 |
Hot-water boilers and Ecodesign – Directives 92/42/EEC and 2009/125/EC | Boiler (Efficiency) Regulations 1993 |
Pyrotechnic articles – Directive 2013/29/EU | Pyrotechnic Articles (Safety) Regulations 2015 |
Cableway installations – Regulation (EU) 2016/424 | Regulation (EU) 2016/424 on cableway installation (as retained in UK law and amended) |
Marine equipment – Directive 2014/90/EU | Merchant Shipping (Marine Equipment) Regulations 2016 |
Explosives for civil uses – Directive 2014/28/EU | Explosives Regulations 2014 |
Construction products – Regulation (EU) 305/2011 | Construction Products Regulations (Regulation (EU) 305/2011 as brought into UK law and amended) |
Boiler Efficiency – Directive 92/42/EC | Boiler (Efficiency) Regulations 1993 |
Updates to this page
Last updated 27 January 2023 + show all updates
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Page updated to reflect the further extension of the transition period.
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Updated list of product categories covered by UK registered Approved Bodies.
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The government is introducing legislation to reduce re-certification/re-testing costs for UKCA marking.
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Added list of product categories covered by UK registered Approved Bodies.
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First published.