UKCA vs CE MARK, PRODUCT SAFETY AND COMPLIANCE (OPSS) UPDATE PUBLISHED FEBRUARY 2022
After the Brexit, a transition period remained in effect. During this period, EU rules continued to apply throughout the UK. This period ended on December 31, 2020 (even though the UK government approved to extend the transition period for CE product marking in the UK until January 1, 2023). The regulations cover industrial products marketed in GB that were previously subject to EU CE marking.
Product Safety and Compliance Regulatory Framework: UK-EU Transitional Arrangements in 2021 and 2022
The UK Government Office for Product Safety and Standards (OPSS) published an update on 23 February 2022 on some of the forthcoming changes with respect to the time before the Brexit. Underneath, we describe a summary of them.
This update includes the term Conformity Assessment Body (CAB). It is used for:
- APPROVED BODIES,
- NOTIFIED BODIES IN THE UK (FOR NORTHERN IRELAND MARKET),
- APPROVED THIRD PARTY ORGANISATIONS (RTDS),
- USER INSPECTION BODIES (UIS), AND
- TECHNICAL ASSESSMENT BODIES (TBIS).
Change in Status of CABs in the UK Previously Notified Under EU Regulations
CABs based in the UK that have been approved and notified to the EU as of December 31, 2020, will retain the status of approved inspection bodies by the UK government. EU-recognized Third Parties, User Inspection Bodies and Technical Assessment Bodies based in the UK are also recognized in the UK.
All UK-based bodies retain their status as a CAB for certifying goods placed on the Northern Ireland market. These goods will then bear the UK(NI) mark in addition to the relevant EU conformity mark.
UK-based bodies will retain the same 4-digit identification number as before.
The UK Market Conformity Assessment Bodies (UKMCAB) database was launched at GOV.UK. This database is the UK database of CABs and the UK equivalent of the EU NANDO database.
Result of UK-EU trade Agreement Regarding UKCA vs CE Mark
The UK and EU have reached an agreement on technical trade barriers. This agreement should help to ensure that there are no discriminatory regulatory regimes. It also aims to eliminate unnecessary trade barriers for UK exporters.
This is called the "Technical Barriers to Trade" (TBT). The technical requirements for the UK and EU markets should not slow down the market.
Mutual Recognition Agreement
No commitment has been made, regarding the proposal to reach a mutual recognition agreement. As a result, CABs are no longer recognized in the UK as competent bodies to carry out conformity assessments based on EU regulatory requirements. This includes, for example, affixing a CE mark on products placed on the EU market.
Similarly, EU-based CABs are not recognized as competent to perform compliance assessments against GB regulations for UKCA marking.
In most cases, the CE mark will remain recognized until Jan. 1, 2023. This is for goods placed on the GB market (including where the assessment has been carried out by an EU CAB). After this date, the goods will have to comply with UK requirements. From then on, any mandatory third-party compliance assessments must have been carried out by a UK-based CAB. Where the third party is based outside the UK, it will have to be a body recognized under the PRA.
These measures have been introduced to give companies time to prepare for the introduction of the new regulations. However, we will continue to urge manufacturers to prepare to UKCA mark their products as soon as possible, if necessary by engaging a UK CAB.
Validity of Existing Certificates
This is about the validity of existing certificates issued by UK authorities before the end of the transition period. As stipulated in UK legislation, these remain valid for the marketing of UKCA marked products in GB. If the certificate is no longer the responsibility of the UK-based body, it will not apply. This may be, for example, because it has been transferred to a body outside the UK, such as an EU-based Notified Body.
A certificate that has been transferred in such a way will no longer be valid in the UK after the expiry of the current transition period.
Issuance of New Certificates Based on Previous Assessments
The Brexit provisions aim to facilitate the issuance of new certificates. At the request of a manufacturer, a CAB must share information on conformity assessments carried out before the end of the transition period with a body based in the other market (UK or EU).
Separate CABs in the UK issue certificates. It is also their responsibility to ensure that the products for which these certificates are issued comply with the relevant requirements. However, it is not necessarily necessary to retest or completely reassess a product before a UK body issues a new certificate.
Reviewing existing documentation by an EU-based CAB performed conformity assessment results to verify them may be sufficient. After all, the UK and EU essential requirements are currently the same.
It is not a condition of accreditation for UK CABs that they have directly performed all the assessments underlying the certificates for which they are responsible. Nor is it a condition that they conduct a full reassessment for clients they have taken on after the end of the transition period and who previously held a certification from an EU-recognized body.
It is not a condition of accreditation for UK CABs that they have directly carried out all the assessments underlying the certificates for which they are responsible. Nor is it a condition that they conduct a full reassessment for clients they have taken on after the end of the transition period and who previously held certification from an EU-recognized body. However, the CAB must ensure that the relevant requirements have been met, as it is ultimately responsible for the certification.
The receiving CAB must have a copy of the technical file. To effect a UKCA transition, the CAB must ensure that the technical file contains sufficient detail to demonstrate that the product is compliant. The UK CAB is not required to re-certify or issue the supporting certificates.
The receiving CAB must have a copy of the technical dossier which must contain evidence that the product complies with the essential requirements of the relevant regulations (including copies of all relevant supporting certificates). To effect a UKCA transition, the CAB must ensure that the technical file contains sufficient detail to demonstrate that the product complies with the regulations. The UK CAB is not required to re-certify or issue the supporting certificates.
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 in 2021 and 2022 for most areas), it is permissible for goods to be UKCA marked and placed on the GB market based on:
- a Module B / “type-examination” certificate issued by an EU body where there is a second module (e.g. 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 (e.g. of an individual component) issued by an EU CAB.
A certificate issued by the UK may stipulate that it is valid only when the product in question is used together with another product certified by a CAB recognized by the UK. If so, it is considered valid for use together with any product certified by one of the EU that was placed on the market before the end of the period of time-limited recognition of EU certification in GB.
From 2023 (in most cases), all certificates used for products marketed in GB, including module B certificates/type-examination as well as certification, and all other certificates for which legislation requires them to be issued by an approved CAB, must have been issued by the UK approved CABs. This does not apply to CABs from the EU.
Status of EU Based Bodies and Expansion to the Scope of Accreditation
To be eligible for appointment as a CAB for the GB market for the relevant regulations, an applicant must be a legal entity in the United Kingdom (or a country with which the UK has agreed on an MRA). After the transition period, CABs not based in the UK will no longer be able to certify goods for the GB market. This provides opportunities for UK CABs to expand their scope.
UKAS remains the UK's sole national accreditation body and retains its role in the accreditation of CABs. If, as a UK-based CAB, you require an addition or modification to your accreditation scheme, you must apply for an extension of scope. Before applying, you should contact UKAS to discuss your requirements and timelines.
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 recognized 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 compliance assessment body recognized by the UK as able to carry out conformity assessment activities for the GB market. Such bodies may be located outside of the UK e.g. if they are operating under a Mutual Recognition Agreement between the UK and another country.
A compliance assessment that is physically established in the UK (i.e. the legal entity which is recognized as a CAB by the UK is located in the UK even if some facilities are located elsewhere). EU CAB: A compliance assessment body recognized by the EU as able to carry out conformity assessment activities for the EU market. Such bodies may be located outside of the EU e.g. if they are operating under a Mutual Recognition Agreement between the EU and another country.
Annex 2 – List of legislation covered by OPSS update 16-02-2022
UKCA vs CE MARK, PRODUCT SAFETY AND COMPLIANCE (OPSS) UPDATE PUBLISHED FEBRUARY 2022, Source: OPSS