Following the United Kingdom’s (U.K.) departure from the European Union (EU) on Jan. 31, 2020, the EU and U.K. jointly agreed on a transition period that ended on Dec. 31, 2020. From Jan. 1, 2021, the relationship between U.K. and EU is defined by the Trade and Cooperation Agreement established on Dec. 24, 2020.
This information outlines the latest official U.K. guidance and answers commonly asked questions about market access requirements after the agreement.
Which goods and legislations are covered by this guidance?
- Electromagnetic compatibility – EMC
- Gas appliances
- Low voltage electrical equipment (LVD)
- Measuring instruments
- Non-automatic weighing instruments
- Outdoor noise
- Personal protective equipment (PPE)
- Pressure equipment
- Products used/installed in Hazardous Locations (ATEX)
- Radio equipment
- Recreational craft and personal watercraft
- Restriction of hazardous substances (RoHS)
- Simple pressure vessels
- What are the key points of the deal?
On Dec. 24, 2020, EU and U.K. negotiators reached an agreement in principle on the text of a new Trade and Cooperation Agreement to govern their relations now that the U.K. has left the EU.
The U.K.-EU trade Agreement entered into force on Dec. 31, 2020.
The full Agreement is 1,246 pages long and here are some of the key points:
- Trade in Goods
There will be no taxes on goods or limits on the amounts that can be traded between the U.K. and the EU from 1 January 2021. What does that mean? This means that there will be no tariffs or quotas on the movement of goods between the U.K. and the EU, where goods meet the relevant Rules of Origin.
- Small and Medium-sized Enterprises (SMEs)
The Agreement includes commitments to provide SMEs with clear and accessible online information about the Agreement, helping them to trade and do business in the U.K. and the EU. This covers customs procedures, intellectual property rights, and public procurement. The Agreement commits the U.K. and the EU to provide for searchable online database, on measures such as customs duties, taxes and rules of origin.
- Business Services
The Agreement includes provisions to support trade in services (including financial services and legal services). This will provide many U.K. service suppliers with legal guarantees that they will not face barriers to trade when selling into the EU and will support the mobility of U.K.
The Annex seeks to facilitate trade in chemicals, ensure high levels of environmental and health protection and provides for cooperation between authorities. It includes joint commitments to comprehensive implementation of international classification and labeling rules as well as commitments to ongoing cooperation and information.
- Motor Vehicles
The Annex confirms that both the U.K. and the EU will mutually recognize approvals based on UN regulations. It establishes dedicated cooperation mechanisms to address regulatory barriers.
- Digital Trade
These provisions will promote trade in digital services and facilitate new forms of trade in goods and services. The provision helps to facilitate the cross-border flow of data by prohibiting requirements to store or process data in a certain location. This prevents the imposition of costly requirements for British businesses.
Source: U.K.-EU TRADE AND COOPERATION AGREEMENT – Summary
- Does the Agreement change the new rules for UKCA marking?
No, the deal secures tariff-free access between U.K. and EU markets, but does not change the actual compliance process, so the UKCA and the conformity to the U.K. Legislations remain mandatory. The new rules apply from 11 p.m. Dec. 31, 2020.
- Is a grace period expected?
Yes, the implementation of the UKCA mark will be done in steps:
- Until Jan. 1, 2022, suppliers (manufacturers, importers or authorized representatives) can continue to use the CE mark and the relevant supporting documentation, unless the CE marking was using a U.K.-based EU Notified Body
- Until Jan. 1, 2023, suppliers (manufacturers, importers or authorized representatives) have the option to affix the UKCA marking on a label affixed to the product or on an accompanying document.
- What is the UKCA mark?
To replace CE marking, the U.K. introduced their own regulatory mark, the UKCA mark1. This marking will be required on products subject to the U.K. equivalent legislation to all of the EU directives that required CE marking, including the Radio Equipment Directive, EMC Directive, Low Voltage Directive, Gas Appliances Regulation and ATEX Directive. So if you are already CE marking products, then you will now need to add the UKCA Mark.
As with CE marking, the UKCA mark will need to be a minimum of 5 mm high and included on both device label and packaging (although an additional transition period allowing markings to be on the documentation and not the product may be available for some products. The UKCA mark will need to be supported by a Declaration of Conformity (DoC). Also on the label will need to be the manufacturer’s name and address, which isn’t a change from EU requirements. Additionally, the U.K. importer, not the EU importer, will need to be on the label and/or packaging. There is nothing in the rules yet that would allow for electronic labeling of devices, but the U.K. could be in a position to adopt e-labeling sooner than the EU.
1 Image files can be found on the U.K. Government site here.
- Will I need a UKCA certificate to mark my products and place them on the market in U.K.?
The U.K. adopted EU directives and regulations and modified them to introduce:
- Different marking, the UKCA
- Different references to legislation, which are U.K. statutory instruments
- Different conformity assessment bodies, the Approved Bodies
This means that the basic approach to the conformity assessment is the same as the one in place in the EU for CE marking: same essential requirements and same conformity modules, both for the design phase and for the production phase. Due to this, the requirement to get certificates from an Approved Body depends on the applicable regulation.
For example, to carry out the conformity assessment according to the Electrical Equipment (Safety) Regulations 2016 - SI 2016 No. 1101 (corresponding to the EU Low Voltage Directive 2014/35/EU), the involvement of an Approved Body is never required and the manufacturer can complete the whole process alone until the final self-declaration. Based on their self-declaration, they will then affix the UKCA marking on the products.
- Can the CE marking and the UKCA marking both be used on the same product?
Yes, both marks can be used on the same products at the same time provided that the product complies with both EU and U.K. legislation.
- When do I need to start UKCA marking?
After the IP, the U.K. will adopt a limited time period to allow manufacturers to transition to UKCA marking and the U.K.’s regulatory scheme for electrical/electronic products, etc. In September 2020, the U.K. announced that this limited time period will extend through to the end of 2021 for most legislation, including the U.K. equivalents of the LVD, EMCD, GAR, Machinery, ATEX, RoHS and RED etc.
Until the end of December 2021, you can choose to continue CE marking or use the UKCA mark to support shipment and sales in the U.K. In addition, for many devices except medical devices and some other categories (refer to www.gov.uk), an additional one-year transition period allows the UKCA mark to be placed in a document accompanying the product rather than on the product itself. But, device labeling will be mandatory after Jan. 1, 2023.
- What does SI mean?
SI stands for statutory instrument. A statutory instrument is a regulatory instrument and can be affirmative or negative. The affirmative or negative refers to the parliamentary procedure for their adoption. Affirmative means that both the House of Commons and House of Lords need to approve the text. Negative means that unless a house blocks the text under a certain timeline, it gets automatically approved. Most SIs are adopted with the negative procedure.
- What are the new directives for UKCA marking?
The U.K. transposed the EU directives into U.K. law when the directives were introduced, so the good news is that, for now at least, the core requirements will remain the same as the corresponding EU directives. Changes have been — and will continue to be — made to update references from EU to U.K., Notified Body to Approved Body, Harmonized Standard to Designated Standard, etc.
The U.K.’s equivalents to the main EU directives are listed in the following table.
EU legislation U.K. legislation LVD
Statutory Instrument 2016 No. 1101 The Electrical Equipment (Safety) Regulations 2016 EMCD
Statutory Instrument 2016 No. 1091 Electromagnetic Compatibility Regulations 2016 Machinery
Statutory Instrument 2008 No. 1597 The Supply of Machinery (Safety) Regulations 2008 GAR
Regulation (EU) 2016/426
Regulation (EU) 2016/426 is Gas Appliances Regulation (Regulation (EU) 2016/426 as brought into U.K. law and amended) and the Gas Appliances (Enforcement) and Miscellaneous Amendment Regulations 2018
Statutory Instrument 2017 No.1206 The Radio Equipment Regulations 2017 PED
Statutory Instrument SI 2016 No. 1105 Pressure Equipment (Safety) Regulations 2016 ATEX
Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 General Product Safety
General Product Safety Regulations 2005
All the U.K. regulations listed have been amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 and 2020: S.I. 2019/696, S.I. 2019/1246, SI 2020 No. 676, SI 2020 No. 852, SI 2020 No.1460 in order to fix any deficiencies that arose from the U.K. leaving the EU. Also included, as this is a common regulation for devices covered by the above directives, is the RoHS Directive and the Ecodesign Directive:
- RoHS — Statutory Instrument 2012 No. 3032 Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012
- Amended by SI 2019 No. 188, SI 2019 No. 492, SI 2019 No. 1078, SI 2020 No. 1647
- Ecodesign and Energy Labeling — Directive 2009/125/EC and Directive 92/42/EEC and Regulation (EU) 2017/1369 is The Ecodesign for Energy-Related Products Regulations 2010
- Amended by SI 2019 No. 539, SI 2020 No. 1568
The latest version of all regulations can be found here: https://www.legislation.gov.uk/
- RoHS — Statutory Instrument 2012 No. 3032 Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012
- What standards are used for UKCA marking?
The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 – S.I. 2019/696 introduced Designated Standards as the standards giving presumption of conformity to the essential requirements included in the U.K. legislation.
A designated standard is a technical specification which may be recognized by government in part or in full by publishing the reference on GOV.UK. Depending on the product, it can be a standard adopted by any of the following recognized standardization bodies:
- British Standards Institution (BSI)
- European Committee for Standardization (CEN)
- European Committee for Electrotechnical Standardization (Cenelec)
- European Telecommunications Standards Institute (ETSI)
- International Organization for Standardization (ISO)
- International Electrotechnical Commission (IEC)
- International Telecommunication Union (ITU)
Designated standards will be prefixed “BS,” “EN,” “EN ISO” or “EN IEC,” for example: EN 71-1:2014+A1:2018.
The government has recently updated the list of designated standards and created a similar document to EU Official Journal: Designated standards (www.gov.uk).
Documents and Process
- What format is the DoC for the UKCA marking?
The DoC to support UKCA marking will follow the format of the EU Directive. The main changes will be to:
- Replace the references to the EU directives with the U.K. Regulations
- Replace, where applicable, the standards with the designated standards
- Remove or, where applicable, replace references to an EU Type Examination Certificate and EU Notified Body with a reference to a U.K. Type Examination and Approved Body
- What about Energy Labeling requirements?
From Jan. 1, 2021, products placed on the Great Britain market must comply with relevant U.K. legislation, which includes U.K. branding and English language text. Where QR codes are present, they must link to the required product information on a publicly accessible website. Compliant products placed on the market up to Dec. 31, 2020, with EU flags on their energy labels, may continue to remain in circulation following the end of the transition period.
U.K. Label Generator
Products placed on the Northern Ireland market must comply with relevant EU legislation. This includes the EU flag and QR codes that link to the required product information on the European Product Registry for Energy Labeling (EPREL) database.
- Will there be changes for U.K. and EU suppliers regarding the EU product database (EPREL)?
Yes. U.K. and EU suppliers placing relevant energy-using products on the EU or Northern Ireland markets will have to enter relevant information into the EPREL database. Suppliers based in Great Britain will need to access EPREL via an authorized representative or importer based in the EU. Suppliers in Northern Ireland will be able to access EPREL directly. U.K. and EU suppliers placing relevant energy-using products on the Great Britain market will not be required, under domestic law, to enter relevant information into the EPREL database from Jan. 1, 2021.
- What shall I do to comply with my wireless product if I apply ETS standards?
You shall get a U.K. Approved Body Type Examination Certificate if designated standards are not used for demonstrating compliance with the essential requirements related to use of radio spectrum or special features. This means that you cannot UKCA mark a product until either the standards you used have been listed as Designated Standards or you have a UKCA Type Examination Certificate.
- What is the format I need to use for my U.K. DoC?
The format for your Declaration of Conformity for UKCA will be the same as the existing CE DoC except for replacing the references to the EU standards and directives with the U.K. regulations and designated standards, where applicable. If a Notified Body is determined to be needed, you will need to reference your U.K. Type Examination Certificate and U.K. Approved Body instead.
- I am a manufacturer located in the U.K. and I am responsible to sign EU Declarations of Conformity. Starting from Jan. 1, 2021, will I still be allowed to sign EU Declarations of Conformity?
According to EU regulations, the manufacturer is the one putting their brand on the product wherever the company is located. The only difference is that starting from Jan. 1, 2021, you will be a non-EU manufacturer and the company importing the products in the EU will assume the role and responsibilities of the importer, including the obligation to put their name and contact address on the product.
- I have tested my products for CE marking according to EN standards. Can I use the same test reports for UKCA or shall I re-test?
If your test reports already include the relevant U.K. conditions and deviations, if any, you may continue to use the same reports to self-declare your products. If you need to submit the reports to a UKCA Approved Body, you need to check the acceptance of your reports obtained for EU type examination with the body you select. Of course, if you keep the same provider, for example UL, for the approval for both markets, EU and U.K., the acceptance for both markets will be easier.
U.K. Approved Bodies and EU Notified Bodies
- What About Notified Bodies?
Under U.K. regulations, an Approved Body will have the equivalent role for the U.K. Statutory Instruments as the EU Notified Bodies have for the EU Directives. Requirements for using an Approved Body will follow the EU Directives.
Current U.K.-based EU Notified Bodies will be designated as Approved Bodies in January 2021 and will be able to issue Type Examination Certificates to support the applicable regulations. As noted in the earlier sections, unless a mutual recognition agreement (MRA) is established between the EU and the U.K., the U.K. Approved Bodies will cease to be Notified Bodies for EU CE marking. The U.K. Government has recently published the list of Approved Body: U.K. Market Conformity Assessment Bodies - (www.gov.uk)
We expect that U.S.-based Notified Bodies will also be designated as Approved Bodies to support UKCA marking for the applicable regulations as the U.S. and the U.K. have an MRA in place. The procedures for designation have yet to be established but we hope/expect that it will be a quick transition. UL’s U.S.-based Notified Body will be seeking designation as an Approved Body.
- Is UL a Market Conformity Assessment Body (MCAB)?
- When the intervention of a Notified Body is required, shall the label bear the U.K. Approved Body number?
The U.K. Department of Business, Energy and Industrial Strategy (BEIS) Secretary of State will compile a register of Approved Bodies, their Approved Body identification numbers, the activities for which they have been approved and any restrictions on those activities. When the U.K. Approved Body will be involved in the production phase, in the same way as for CE marking and EU directives, they would need to add the U.K. Approved Body number.
Northern Ireland and EU
- What is the impact on CE marking?
CE marking and the EU Directives will remain unaffected by Brexit. Manufacturers shall continue to:
- Use the CE mark on their products
- Issue Declarations of Conformity (DoC)
- Label products and packaging with the appropriate manufacturer names and addresses
- Label radio equipment with Article 10(10) information related to restrictions on use
The EU will no longer recognize U.K. Notified Bodies after the implementation period ends on Dec. 31, 2020. Beginning Jan. 1, 2021, any Type Examination Certificates issued by a U.K. Notified Body will not be valid and cannot be used to support an EU DoC.
When the U.K. is no longer a part of the EU, importer information on packaging may need to be updated with an EU importer. While labeling is usually the responsibility of the importer, some manufacturers may prelabel packaging.
- Does Northern Ireland follow the same rules as Great Britain?
No. After the end of the transition period, the CE mark will continue to be the conformity assessment mark for most goods to show they meet EU rules. You may also need to apply the UKNI mark if you choose to use U.K. bodies for approvals or certification. Harmonized goods carrying only the UKCA mark will not be allowed in the Northern Ireland market.
- Who will issue the EU Type Examination Certificate for products falling within the scope of EMC or Radio Equipment Directives or under the Gas Appliances Regulation?
For manufacturers that currently support their DoC through Type Examination by a U.K. based EU Notified Body, the options depend on whether the certificate is a requirement or optional. Under the EMC Directive, Type Examination is never mandatory, and manufacturers can decide to either:
- Remove references to the Type Examination Certificate and associated Notified Body from the EU DoC
- Obtain a new Type Examination Certificate from a EU 27 Notified Body, i.e., one established in the EU or in a country with a mutual recognition agreement with the EU such as the U.S., and update the EU DoC to reference the new certificate and Notified Body
For the Radio Equipment Directive, a Type Examination Certificate is required when harmonized standards are not fully applied to cover Articles 3.2 and 3.3 (1). When using the Type Examination Certificate from a U.K. Notified Body because harmonized standards have not been applied in full, the process described in the second bullet point must be used. If the use of the Type Examination Certificate was optional (2), i.e., harmonized standards have been fully applied to cover Articles 3.2 and 3.3, then either of the above options may be used.
For the Gas Appliances Regulation, the Type Examination Certificate is always required for series-manufactured appliances and fittings and therefore, the second bullet point is the only option.
- In some cases, for example where you have used the latest version of a standard that is not yet harmonized but the testing performed demonstrates full compliance with the current harmonized version, you may be able to follow the first option by adding the reference to the harmonized version of the standard to your DoC, updating your risk assessment to explain how testing to the newer version is equivalent to applying the harmonized version in full and removing the Notified Body references from the DoC.
- Many manufacturers use the Type Examination route even when harmonized standards have been fully applied as a confidence check or to support customer requirements
Products used/installed in Hazardous Locations
- Can I use the assessment data in my UL ATEX certification in support of the issue of a UKCA equivalent?
Yes. As the regulations for UKCA for “Ex”-products is based on the ATEX Directive 2014/34/EU, UL´s Certification team will base their assessment of UKCA on this existing data.
- Can existing ATEX certificates issued by other test bodies be used as supporting documentation for UL to issue certification for UKCA?
Yes, some additional assessment may be required, but we will provide any additional evaluation needed to support the issuance of a UKCA mark certificate.
- Do OEMs require additional quality system certification in addition to QAN/QARs?
Yes, manufacturers will require an additional quality audit to manufacture products with the UKCA mark. It follows the exact same structure as a QAN/QAR but will result in an additional certificate and control of production checks, so may require additional time for the audit depending on the number of certificates held.
- Does UKCA mark require the “Ex” mark like ATEX?
Yes, coding and Ex is unchanged. It is only required once and not duplicated on the label. The label will require the UKCA mark, the Approved body number and the UKCA certificate number.
- Should the U.K. accredited body No. be marked like ATEX NB No.?
Yes, under the UKCA mark, there will be the Approved body number for UL International (U.K.) Ltd, which is 0843.
- Is the Ex component treated in the same way as the ATEX component? Does that mean it requires evaluation by a U.K. accredited body but no marking is required?
Yes, components will be required to be UKCA approved. And if relied upon for an equipment certificate, these components will need to have UKCA certification before being referenced in the equipment reports/certificates.
- Is a manufacturer representative required in U.K.?
Importer (representative can be importer) is required, and importer information should be revealed on the product or attached document (manual, etc.). For more details, read the UKCA Guidance Document
- Is there any U.K. designated standard list available, like EU harmonized standards, on NANDO’s database?
Yes, more information can be found on the governmental website www.gov.uk
- Is there an UKCA/Ex U.K. equivalent to the ATEX Guidelines / Bluebook?
Not yet. It has been agreed among the current approved bodies.
The information provided may change based on the ongoing negotiations between the EU and the U.K. Visit the U.K. Government website www.gov.uk for additional guidance.
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