Brexit FAQ

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.

• Chemicals 

The Annex seeks to facilitate trade in chemicals, ensure high levels of environmental and health protection and provide 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

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.

Yes, according to the U.K. government announcement of Nov. 14, 2022, until Jan. 1, 2025, suppliers (manufacturers, importers or authorized representatives) can continue to use the CE mark and the relevant supporting documentation. Manufacturers will be able to use the CE marking until Jan. 1, 2025, if any of the following apply:

• Manufacturer  currently apply the CE marking to your good on the basis of self-declaration
• Any mandatory third-party conformity assessment was carried out by an EU-recognized Notified Body (including a body in a country with which the EU has a relevant mutual recognition agreement)
• The certificate of conformity previously held by a UK approved body has been transferred to an EU-recognised notified body prior to 1 January 2021

The government intends to introduce legislation enabling the UKCA marking to be placed on a label affixed to the product or on a document accompanying the product until 11pm on 31 December 2027.

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.

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.
 

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.

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 Nobember 2022,  the U.K. announced that this limited time period will extend through to the end of 2024 for most legislation, including the U.K. equivalents of the LVD, EMCD, GAR, Machinery, ATEX, RoHS and RED etc.

Recognizing the impact of the new UKCA marking on businesses, on Nov. 14, 2022 the Government has announced the extension of the deadline to Dec. 31, 2024 to apply UKCA marks for certain products to demonstrate compliance with product safety regulations, superseding the previously announced deadline of 1 January 2023. The CE marked goods in scope of this document that meet EU requirements can continue to be placed on the GB market until 1 January 2025 where EU and U.K. requirements remain the same. This includes goods which have been assessed by an EU recognized notified body.

Until the end of December 2024, 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). 

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.

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. 

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 {https://www.legislation.gov.uk/uksi/2019/188/regulation/18}, SI 2019 No. 188, SI 2019 No. 492, SI 2019 No. 1078, SI 2020 No. 1647
• Ecodesign and Energy Labelling — Statutory Instrument 2010 No. 2617 The Ecodesign for Energy-Related Products Regulations 2010 and  Statutory Instrument 2011 No. 1524  The Energy Information Regulations 2011 
  • Amended by SI 2019 No. 539, SI 2020 No. 1568, SI 2020 No. 1528, SI 2021 No. 745, SI 2021 No. 1095

The latest version of all regulations can be found here: https://www.legislation.gov.uk/
 

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). 

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

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.
 

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.

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.

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.

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. To reduce labelling costs, The government will allow businesses to affix the UKCA marking and include importer information for products from EEA countries on an accompanying document or label until 31 December 2027. Businesses to be given UK product marking flexibility - GOV.UK

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.

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.

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.
 

Yes, and you can find the details here, UL International (U.K.) LTD -(www.gov.uk)

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.

From Jan. 1, 2021 until Dec. 31, 2024, you can continue to put products on the GB market using your existing and valid CE certificates issued by an EU-based Notified Body (based in any EU 27 member state). In Europe you will still need CE certificates issued by an EU Notified Body.

Starting from Jan. 1, 2025, you will need to get UKCA Certificates from a U.K. Approved Body since CE marking will not be acceptable anymore. However, on Nov. 14 , 2022 the government announced the intention to introduce legislation to allow conformity assessment activities undertaken by EU-recognised Conformity Assessment Bodies (CABs), for CE certification before 11pm on 31 December 2024, to be used by manufacturers to declare existing product types as compliant with UKCA requirements. Products must still bear the UKCA marking and will need to undergo conformity assessment with a UK Approved Body at the expiry of the certificate or after 31 December 2027, whichever is sooner.

Before 11pm on 31 December 2024, if an EU-recognised CAB has completed the relevant conformity assessment activities applying to a product, this would allow manufacturers to apply the UKCA mark without the need for any UK Approved Body involvement. They could continue to place their goods on the market on the basis of their existing CE certification following the end of this year, for the lifetime of the certificate issued, or until 31 December 2027 (whichever is sooner). https://www.gov.uk/guidance/ukca-marking-conformity-assessment-and-documentation#full-publication-update-history

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.

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.

No. You need to use the UKNI marking only if all the following apply:

• You are placing certain goods (mostly those goods subject to the CE marking) on the Northern Ireland market.
• Your goods require mandatory third-party conformity assessment.
• You are planning to use a UK body to carry out those conformity assessments.

If you are marking your goods based on a supplier’s declaration of conformity without the intervention of a third party, you will never need the UKNI marking on your goods.
 

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.

1. 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.
2. Many manufacturers use the Type Examination route even when harmonized standards have been fully applied as a confidence check or to support customer requirements

Yes. As the regulations for UKCA for “Ex”-products is based on the ATEX Directive 2014/34/EU, the UL Certification team will base their assessment of UKCA on this existing data.

Yes, some additional assessment may be required, but we will provide any additional evaluation needed to support the issuance of a UKCA mark certificate.

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.

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.

Yes, under the UKCA mark, there will be the Approved body number for UL International (U.K.) Ltd, which is 0843.

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.

Yes, more information can be found on the governmental website www.gov.uk

Not yet. It has been agreed among the current approved bodies.