UKCA marking: conformity assessment and documentation

Guide

Last updated 24 January 2024

Applies to England, Scotland and Wales

The government intends to legislate to continue recognition of EU requirements, including the CE marking, indefinitely for a range of product regulations this spring. This will mean businesses have the flexibility to use either the UKCA or CE marking to sell products in Great Britain.

The government is introducing a new Fast-Track provision which will allow manufacturers to place products on the GB market where they meet the EU essential requirements and, where required, have been conformity assessed by an EU recognised conformity assessment body.

To benefit from this provision manufacturers will need to affix the UKCA marking (in a way that is allowed) and draw up the UK declaration of conformity, listing compliance with the relevant EU legislation. This also means that where products fall within multiple regulations, a mixture of both UKCA and CE conformity assessment procedures can be used.

This is designed to provide longer-term certainty and flexibility for businesses should the UK mandate UKCA for certain regulations in the future. Find out more about placing products on the market in Great Britain using UK or EU product markings.

Continued recognition of current EU requirements, including the CE and reversed epsilon markings, will apply to 21 product regulations, including the 18 product regulations owned by the Department of Business and Trade, previously announced on 1 August 2023. Following feedback from industry, we are also continuing recognition for a further 3 regulations covering: ecodesign, civil explosives, and in most circumstances restriction of hazardous substances (in electrical equipment).

This announcement does not apply to regulations for medical devicesconstruction productsmarine equipmentrail productscablewaystransportable pressure equipment and unmanned aircraft systems regulations.

There are specific arrangements in place for these sectors.

Separately, following feedback from businesses, the government also intends to bring forward an additional statutory instrument to legislate for further measures in Spring 2024.

This will provide permanent labelling flexibility, allowing:

  1. The UKCA marking to be placed on a sticky label or accompanying document.
  2. Importers of goods from any country outside the UK to provide their details either on the product itself, on an accompanying document, the packaging or on an adhesive label. This means all businesses placing products on the GB market will benefit from this measure and have the option to provide their details either indelibly on the product itself, on an accompanying document, the packaging or on an adhesive label.
  3. The voluntary option to use digital labelling. Businesses will be able to apply the UKCA marking, manufacturer details and importer details digitally.

Additional details for these measures will be provided in due course, including which regulations the measures will apply to.

The DBT regulations in scope of this announcement are:

  • Equipment for use in potentially explosive atmospheres Regulations 2016/1107
  • Electromagnetic compatibility Regulations 2016/1091
  • Lifts Regulations 2016/1093
  • Electrical Equipment (Safety) Regulations 2016/1101
  • Pressure Equipment (Safety) Regulations 2016/1105
  • Pyrotechnic Articles (Safety) Regulations 2015/1553
  • Recreational Craft Regulations 2017/737
  • Radio Equipment Regulations 2017/1206
  • Simple Pressure Vessels (Safety) Regulations 2016/1092
  • Toys (Safety) Regulations 2011/1881
  • Aerosol Dispensers Regulations 2009/ 2824
  • Gas Appliances ( EU Regulation) 2016/426
  • Supply of Machinery (Safety) Regulations 2008/1597
  • Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001/1701
  • Personal Protective Equipment ( EU Regulation) 2016/425
  • Measuring Instruments Regulations 2016/1153
  • Non-automatic weighing instruments Regulations 2016/1152
  • Measuring Container Bottles (EEC Requirements) Regulations 1977

For Department for Environment, Food and Rural Affairs (DEFRA):

  • Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (‘The RoHS Regulations’)

For Department for Energy Security and Net Zero (DESNZ):

  • Ecodesign for Energy-Related Products Regulations 2010

For Department for Work and Pensions (DWP) [HSE]:

  • Explosives Regulations 2014

This page will be updated to reflect the changes in due course.

The government intends to introduce legislation to extend recognition of goods that meet EU requirements (including the CE marking), indefinitely, beyond 31 December 2024 for many products.

This will mean that certain goods that meet EU requirements can be placed on the GB market. These updates apply to the 18 regulations that fall under the Department for Business and Trade (DBT). These are:

  • toys
  • pyrotechnics
  • recreational craft and personal watercraft
  • simple pressure vessels
  • electromagnetic compatibility
  • non-automatic weighing instruments
  • measuring instruments
  • measuring container bottles
  • lifts
  • equipment for potentially explosive atmospheres (UKEX)
  • radio equipment
  • pressure equipment
  • personal protective equipment (PPE)
  • gas appliances
  • machinery
  • equipment for use outdoors
  • aerosol dispensers
  • low voltage electrical equipment

There are specific rules for: medical devices, rail productsconstruction products, civil explosivesmarine equipmentcableways, ecodesigntransportable pressure equipment, and hazardous substances (RoHS).

Conformity assessment routes

Certain conformity assessment procedures allow for self-declaration of conformity by the manufacturer.

Other regulations, for those typically more ‘high-risk’ products, may require third-party conformity assessment.

You should check the sector specific guidance which applies to your product to find out whether you can self-declare or need to use a third-party conformity assessment to show the UK essential requirements have been met.

CE marked products

Currently, the law provides that certain products that meet EU requirements, including CE marking, can be placed on the GB market until 31 December 2024. As set out above, the government is intending to extend this recognition of goods that meet EU requirements indefinitely, beyond 31 December 2024.

If you are following European harmonised standards to demonstrate that your product meets the EU essential requirements in the relevant EU legislation, and you want to place that product on the GB market, you should also note the following:

  1. Where UK law allows for a product to meet the EU essential requirements, there is no specific reference to harmonised standards giving rise to a ‘presumption of conformity’ with the essential requirements. However, where both EU harmonised standards and UK designated standards remain aligned, manufacturers may still rely on the harmonised standard to demonstrate they have met the relevant EU essential requirements to place a product on the GB market.
  2. In a small number of cases where there is a difference between designated standards and European harmonised standards, the conformity assessment procedures that need to be complied with before the CE marked product can be placed on the GB market, may be affected.
  3. If a designated standard has a restriction which the equivalent European harmonised standard used does not, you may need to take additional steps to bring that product into compliance with the safety requirements before placing the product on the GB market.

You should consult the sector-specific guidance for your product. You can speak to your solicitor or trade association if you’re unsure which regulations apply to your products.

Self-declaration for the UKCA marking

If you self-declare for the CE marking, you can still self-declare for the UKCA marking.

Legislative areas where self-declaration of conformity for UKCA marking is permitted, and in some, instances may be required:

Legislation Scope of products which can be self-declared
Electromagnetic Compatibility Regulations 2016 All products
Toy (Safety) Regulations 2011 All products except where designated standards covering the essential requirements either do not exist or have not been applied (either in full or in part) by the manufacturer. Or where one or more of the designated standards has been published with a restriction.
The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 All products
Medical Devices Regulations 2002 Some Class 1 devices
Radio Equipment Regulations 2017 All products except where designated standards covering the essential requirements either do not exist or have not been applied (either in full or in part) by the manufacturer.
The Pressure Equipment (Safety) Regulations 2016 Category I pressure equipment
Construction Products Regulations (Regulation (EU) 305/2011 as brought into UK law and amended) Products within scope of System 4
Recreational Craft Regulations 2017 Certain categories of recreational craft as specified in the legislation
The Electrical Equipment (Safety) Regulations 2016 All products
The Supply of Machinery (Safety) Regulations 2008 Any machinery which is not in Schedule 2, Part 4 of the Regulations. Any machinery that is in Schedule 2, Part 4 where the requirements of all relevant designated standards have been applied in full and where those standards cover all the applicable essential requirements.
The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 Equipment-group II, equipment category 3
Personal Protective Equipment Regulations (Regulation (EU) 2016/425 as brought into UK law and amended) Category I personal protective equipment
Ecodesign for Energy-Related Products Regulations 2010 All products listed in Schedule 1 with the exception of boilers as specified in retained Commission Regulation (EU) 813/2013

Mandatory third-party conformity assessment for the UKCA marking

Where mandatory third-party conformity assessment was required for  CE marked products, it’s also required for  UKCA marked products.

Whilst the current position is that after 11pm on 31 December 2024 all products must be UKCA marked, which requires conformity assessment by a UK Approved body, the government intends to bring forward legislation before this date to extend recognition of goods that meet EU requirements (including CE marking), indefinitely for many products.

This means that goods that meet EU requirements, including the applicable conformity assessment procedures (which in some cases must be undertaken by EU recognised bodies) can continue to be placed on the GB market.

Reducing re-certification and re-testing costs for UKCA marking

The current position is that where a manufacturer has taken steps under an EU conformity assessment procedure prior to 31 December 2024 but the product has not been placed on the GB market by that date, those steps will be recognised and will count towards the equivalent conformity assessment procedure required under the UKCA regime (until any certificate expires or until December 2027, whichever is the sooner).

This provision was aimed at ensuring that manufacturers do not have to undertake expensive re-testing, once goods that meet EU requirements were no longer recognised on the GB market. However, as part of the process for extending the recognition of goods that meet EU requirements, indefinitely, beyond 31 December 2024, the government will also be considering this provision, since it may no longer have any value in its current form.

This measure applies across all module types for the following regulations as they apply in GB:

  • 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

The UK Market Conformity Assessment Bodies (UKMCAB) database lists all bodies which can provide conformity assessment for the UK market.

Technical documentation

Record keeping

You, or your authorised representative (where allowed for in the relevant legislation), must keep documentation to demonstrate that your product conforms with the regulatory requirements.

This must generally be kept for 10 years after the product is placed on the market. The relevant period is specified in the applicable legislation.

This information can be requested at any time (within the time period set out by legislation) by market surveillance or enforcement authorities to check that your product conforms with the regulatory requirements.

The information you must keep will vary depending on the specific legislation relevant to your product, but if requested you must provide enforcement authorities with all information and documentation necessary to demonstrate that a product is in conformity. This information must be provided in English.

This could include, but is not necessarily limited to, the following:

  • how the product is designed and manufactured
  • how the product has been shown to conform to the relevant requirements
  • the addresses of the manufacturer and any storage facilities

You should keep the information in the form of a technical file which can be supplied if requested by a market surveillance authority.

UK Declaration of Conformity

The UK Declaration of Conformity is a document which must be drawn up for most products lawfully bearing a UKCA marking before they are placed on the market. We recommend that manufacturers have their UK Declaration of Conformity and their EU Declaration of Conformity in separate documents.

The UK Declaration of Conformity should be available to market surveillance or enforcement authorities on request.

The information required on the UK Declaration of Conformity is largely the same as what was required on an EU Declaration of Conformity. This can vary depending on the applicable legislation but generally should include:

  • the name and full business address of the manufacturer and that of your authorised representative (if applicable)
  • the product’s serial number, model or type identification
  • a statement, stating you (the manufacturer) take full responsibility for the product’s compliance
  • the details of the approved body which carried out the conformity assessment procedure (if applicable)
  • the relevant legislation with which the product complies
  • references to the relevant designated standards, including the date of the standard or references to other technical specifications
  • the name and signature of the person authorised to sign on behalf of the manufacturer or their authorised representative
  • the date the declaration was issued
  • supplementary information (if applicable)

You will need to list:

Relevant UK and EU legislation

In many areas the current EU legislation for specific products has corresponding UK legislation:

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
Low Voltage Directive 2014/35/EU Electrical Equipment (Safety) 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
Ecodesign of energy-related products - Directive 2009/125/EC Ecodesign for Energy-Related Products Regulations 2010

First published 11 August 2022