Everything you need to know about the UKCA Mark

Latest Information

As of November 2022 The UK government has for the third time delayed the requirement for firms to adopt the UK Conformity Assessment (UKCA) mark for their goods to be placed in the UK market. The UKCA mark can already be used for goods traded in the UK and the government’s intention is for it to eventually replace the EU’s CE mark. Both marks are used to verify that manufactured goods meet the safety standards of their respective markets. The government has given businesses two additional years to prepare for a new deadline of 31 December 2024, at which point the UKCA mark will be legally required for affected goods placed in the UK market. The UK will continue to recognise the CE mark for this period, with the EU certificate remaining valid until the end of 2027. Industry bodies have repeatedly raised concerns about the requirement for goods to be re-tested to ensure they meet the UK’s post-Brexit safety standards and have said that the UK would not have sufficient capacity to meet the surge in demand for this. Firms have also warned that some EU suppliers would not bother with the additional administrative requirements for getting the new certification, potentially stopping supplying the UK market. In June this year, the UK government announced a series of easements to make the application process easier. This included allowing certificates issued by EU assessment bodies before the end of 2022 to be used as the basis for a UKCA mark application, as well as the removal of the need to relabel permitted existing goods imported before January 2023.

Product areas covered by the UKCA marking

You will need to use the UKCA marking if you manufacture or handle products in the following areas:

• 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
• ecodesign
• aerosols
• low voltage electrical equipment

Some products are covered by the UKCA marking but have some special rules. You should consult the sector specific guidance for more information;

• Medical devices
• Rail interoperability
• Construction products
• Civil explosives
• Marine equipment
• Cableways
• Energy using products
• Transportable pressure equipment
• Hazardous substances (RoHS)

Roles & Responsibilities
If the UKCA marking applies to products you manufacture or handle, you will have specific obligations and responsibilities for compliance, depending on your role. Economic operators under the relevant legislation are:

• manufacturers
• importers
• authorised representatives
• distributors

Manufacturers
A manufacturer is normally an individual or business who manufactures a product, or has a product designed or manufactured and markets that product under their own name or trademark. For instance, an importer who markets a good under their name and trademark is usually considered to be the manufacturer and assumes the responsibilities of a manufacturer.

Before placing a product on the GB market, the manufacturer must ensure that the product has been designed and manufactured in accordance with the relevant safety requirements in the legislation.

Next, the manufacturer must draw up a declaration of conformity and place the UKCA marking visibly, legibly, and indelibly to the product. However, legislation in certain product sectors may allow the UKCA marking to be alternatively affixed to a label placed on the product, to the product’s packaging or to a document accompanying the product. These exceptions may require certain conditions to be met, such as the nature of the product making it impossible for the UKCA marking to be placed on it directly.

Manufacturers must draw up technical documentation and a UK declaration of conformity and keep both for 10 years after a product has been placed on the GB market. Manufacturers must indicate their name, registered trade name or registered trademark, and postal address on the product. There may also be other product specific indications that manufacturers should include, such as a type, batch, serial, or model number. Where it is not possible to indicate this on the product, the manufacturer must ensure the information is indicated on the packaging or in a document accompanying the product.

Manufacturers must ensure that the product is accompanied by instructions. The precise content and nature of the instructions will be product specific, but they generally should be clear, legible and in easily understandable English.
Manufacturers must also make certain that procedures are in place to ensure that any products in series production remain in conformity with the relevant product regulations. For example, ensuring series products are bought into compliance when product regulations change. You must take account of any changes in the product’s design, characteristics, and designated standards or technical specifications to which the declaration of conformity was drawn up.

Manufacturers must act where they have reason to believe that the product(s) they have placed on the GB market are not in conformity with the legal requirements of the relevant regulations and must immediately take the corrective measures necessary to bring the product into conformity or withdraw or recall it. Where the product presents a risk, the manufacturer must immediately inform the market surveillance authority.

Importers

An importer is anybody (individual or business) established in the UK who supplies a product from outside the UK for distribution, consumption or use on the GB market in the course of a commercial activity.

The importer’s obligations build on from the obligations of the manufacturer and authorised representative.
As an importer, you have legal obligations which go beyond those of distributors when placing a product on the GB market.

Importers must not place a non-compliant product on the market. They must ensure the manufacturer has carried out the correct conformity assessment procedures, subject to the requirements of the relevant legislation. If the manufacturer has appeared to have supplied non-compliant products, then the importer must take the necessary corrective actions (for example, recalling products from the market) to prevent the products from being placed on the GB market, until they are compliant with the appropriate legislative requirements.

An importer who markets a good under their name and trademark is usually considered to be the manufacturer and assumes the responsibilities of a manufacturer.

Where the product presents a risk, the importer must immediately inform the relevant enforcement authority.
The importer must ensure the manufacturer has drawn up the correct technical documentation in English, affixed conformity markings, and has fulfilled their identification obligations.

Before placing products on the market, the importer must indicate their details (name, registered trade name or registered trademark, and postal address – usually a number, street, and postcode) on the product. Where this is unwarranted due to the nature of the product, the product specific legislation sometimes permits placing these details on packaging, or placing them on accompanying documentation, as an alternative to placing them to products themselves.

There are also special rules for products imported from an EEA state or Switzerland before 11pm on 31 December 2027. In these cases, to smooth the transition, the importer’s details can be set out elsewhere instead of being affixed to the product itself. This will typically be in an accompanying document or on the product’s packaging. This measure applies to the following regulations:

• Electrical Equipment (Safety) Regulations 2016
• Electromagnetic Compatibility Regulations 2016
• Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016
• Explosives Regulations 2014
• Lifts Regulations 2016
• Measuring Instruments Regulations 2016
• Non-automatic Weighing Instruments Regulations 2016
• Pyrotechnic Articles (Safety) Regulations 2015
• Simple Pressure Vessels (Safety) Regulations 2016
• Supply of Machinery (Safety) Regulations 2008
• The Pressure Equipment (Safety) Regulations 2016
• Toys (Safety) Regulations 2011
• Radio Equipment Regulations 2017
• Recreational Craft Regulations 2017
• Regulation (EU) 2016/426 and the Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018
• Regulation (EU) 2016/425 and the Personal Protective Equipment (Enforcement) Regulations 2018
• The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012
• Weights and Measures (Packaged Goods) Regulations 2006

Importers must ensure that, while the product is under their responsibility, the storage or transport conditions do not jeopardise its compliance with the relevant UK products regulations.

Importers must retain a copy of the Declaration of Conformity and technical documentation for 10 years after the product has been placed on the market.

Under certain UK product regulations and depending on which specific regulations apply to you, market surveillance authorities may conduct sample testing of products, if they suspect products are non-compliant.

You should check the relevant legislation to understand your full obligations, however there may be specific responsibilities exclusively required of you.

There are no importer obligations for products falling under both the Supply of Machinery (Safety) Regulations 2008, and the Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001. It is the ‘responsible person’ who will need to ensure products are compliant and bear the UKCA marking (when placed on the market or put into service). The ‘responsible person’ is either the manufacturer or their authorised representative (and in specific circumstances can include the person placing the product on the GB market or the person putting the product into service in GB).

Authorised representatives

An authorised representative (AR) is anybody (an individual or company) who is appointed by a manufacturer to carry out certain agreed specified tasks (for example, drawing up a UK Declaration of Conformity for a manufacturer) on their behalf, as defined in the relevant product legislation.

The delegation of tasks from the manufacturer to the authorised representative must be explicit and set out in writing. If an AR is importing a product, then they also adopt the obligations of the importer too. The manufacturer in some cases could appoint an importer to carry out the delegated duties of the authorised representative, alongside the importer’s legal obligations. There is a limit as to what the authorised representative can do. They are not responsible for safety and compliance, for example.

If used, ARs must be established in the UK.

Under some product legislation an authorised representative is mandatory, but in most cases it is voluntary. For instance, the supply of medical devices for the GB market will require a UK-based responsible person to be appointed by the manufacturer. Check your respective product regulations to determine whether the use of an authorised representative is mandatory.

Where a manufacturer appoints an authorised representative, they may, among other things, ask them to:

• Affix the UKCA marking
• Draw up and sign a UK Declaration of Conformity
• Keep the necessary technical documentation and to cooperate with market surveillance authorities

If an authorised representative is also acting as an importer, or distributor, they will also need to fulfil the obligations of those economic operators under the legislation. An AR cannot act as a manufacturer, although as above, they may perform tasks on the manufacturer’s behalf.

GB-established authorised representatives are not recognised in the EU.

Distributors
A distributor is a person in the supply chain, other than the manufacturer or importer, who makes products available on the GB market. If a person is bringing in a product from outside of the UK and placing it on the market, they will be considered an importer under the legislation and therefore these persons cannot be distributors.

Please note that this guidance to distributors is non-exhaustive. You should check the relevant legislation to understand your full responsibilities and whether there are specific obligations depending on the products you are placing on the GB market.

Before making a product available on the GB market, a distributor must take due care to ensure that it is in conformity with product regulations as they apply in GB. The distributor must verify that the manufacturer and importer (if relevant) have indicated their name, registered trade name or registered trademark, postal address, and any other required indications on the product.

Distributors must ensure that products bear the UKCA marking and are accompanied by the required documentation, instructions, and safety information.

Distributors must not make a product available if they have reason to believe it is not in conformity with the essential safety requirements. If there is reason to believe the products are non-compliant, then the distributor must not make products available and take corrective actions to prevent them from being placed on the GB market until the product has been brought into conformity. Where the product presents a risk, the distributor must immediately inform the relevant enforcement authority.

Distributors must ensure that while the products are under their responsibility within the supply chain, the products storage and transport conditions do not jeopardise their conformity with the legislation.

Distributors must cooperate with and provide information to the market surveillance authorities following a request.
There are no distributor obligations for products falling under either the Supply of Machinery (Safety) Regulations 2008, and the Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001.

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 UKCA requirements have been met.

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.

The government will bring forward legislation that will require conformity assessment for new product types after 11pm on 31 December 2024 to be carried out by a UK Approved Body. The conformity assessment procedures and modules applicable are the same as those that were required for the CE marking.

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

The government will be introducing 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).

Where manufacturers are using conformity assessment under existing CE certification before 11pm on 31 December 2024 as the basis to ensure compliance with UKCA requirements for their products, it is recommended 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-recognised CAB (or CAB recognised under an EU Mutual Recognition Agreement with a third country) which carried out the conformity assessment procedures. This 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
• 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.

This information can be requested at any time by market surveillance or enforcement authorities to check that your product conforms with the regulatory requirements.

The information manufacturers must keep will vary depending on the specific legislation relevant to your product.
You must keep general records of:

• how the product is designed and manufactured
• how the product has been shown to conform to the relevant requirements
• the address 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. It is recommended that manufacturers have their UK Declaration of Conformity and their EU Declaration of Conformity in separate documents.

In the document you as the manufacturer, or your authorised representative (where allowed for in the relevant legislation), should (among other things):

• declare that the product is in conformity with the relevant regulatory requirements
• make sure the document has the name and address of the manufacturer (or your authorised representative) together with information about the product and the conformity assessment body (where relevant)
• The UK Declaration of Conformity should be available to market surveillance 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:
• your (the manufacturer’s) name and full business address and that of your authorised representative (if applicable)
• the product’s serial number, model or type identification
• a statement, stating you 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
• 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 legislation (rather than EU legislation). This can be listed as a reference to the base statutory instrument or the full title.
• UK designated standards rather than standards cited in the Official Journal of the European Union

Relevant UK and EU legislation

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

For more information about the latest UKCA mark requirements and how to comply email info@theinternationaltradeconsultancy.com or call +44(0)7966514511

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