Product Compliance in United Kingdom

The so called UK Designated standards can help manufacturers demonstrate their products, services or processes comply with GB law. By following designated standards, manufacturers can claim, ‘presumption of conformity’ (which can be countered by evidence) with the corresponding essential requirements of UK product regulations.  However, designated standards do not replace the essential requirements and manufacturers retain full responsibility for ensuring the applicable GB law is met.

For the GB market, and depending on the product, a designated standard can be a standard adopted by any of the recognised standardisation bodies (the British Standards Institution (BSI), European Committee for Standardisation (CEN), European Committee for Electrotechnical Standardisation (CENELEC) and European Telecommunications Standards Institute (ETSI)) or by international standardising bodies (including the International Organization for Standardization (ISO), International Electrotechnical Commission (IEC) and International Telecommunication Union (ITU))

Designated standards are prefixed “BS”, “EN”, “EN ISO” or “EN IEC”. The “EN” prefix indicates that the standard has been adopted by a regional European standardising body. Where the designated standard specified in the notice of publication is prefixed “EN” it is acceptable to reference this version in technical documentation, or a version of the same standard with a national prefix. This is because regional European standards are adopted identically by the 34 national members of CEN and CENELEC.

The UKCA (UK Conformity Assessed) marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods which previously required the CE marking in the European Union, known as ‘new approach’ goods.

The UKCA marking came into effect on 1 January 2021. The UKCA marking was an effort to distinguish the UK’s domestic market from the European one, the UK initially pledged to gradually eliminate the use of CE marks for products sold in England, Scotland, and Wales (collectively known as Great Britain or “GB”).  However, this initiative encountered numerous delays, leading to several extensions of the transition deadline from CE to UKCA marks..

However, on 1 August 2023 the UK Government announced that it will indefinitely recognize the EU’s product conformity assessment mark (the “Conformité Européenne” or “CE” mark), with respect to a range of manufactured goods placed on the UK market.  The move was a significant reversal of the UK’s previous, post‑Brexit policy.  Despite this change, the UK has not completely abandoned the UKCA mark, and manufacturers still have the option to utilize it.

The UKCA conformity assessment process can be summarized by the following steps:

• Step 1: Check if your product needs UKCA marking
• Step 2: Check the appropriate route for conformity assessment
• Step 3: Draft technical file and ensure compliance
• Step 4: Draw up draft UK Declaration of Conformity
• Step 5: Affixing the UKCA marking and preparing to place your goods on the market

For products requiring the UKCA marking, the technical requirements (‘essential requirements’) they must meet – and the conformity assessment processes and standards that can be used to demonstrate conformity – are largely the same as they were for the CE marking.

The circumstances in which a self-declaration of conformity can be used for UKCA marking are the same as for CE marking. If you were able to self-declare conformity for the CE marking, you will be able to do the same for the UKCA marking.

On the other hand, where mandatory third-party conformity assessment was required for CE marked goods, it is also required for UKCA marked goods.  This conformity assessment needs to be carried out by a UK-recognised conformity assessment body in order to be marked with the UKCA marking. The type of conformity assessment procedures are the same that were required for the CE marking.

Another requirement linked with UKCA is that the manufacturer of his authorised representative (where allowed for in the relevant legislation), must create and/or keep technical documentation to demonstrate that your product conforms with the regulatory requirements. This must be kept for up to 10 years after the product is placed on the market.  The documentation should comprise among others information about how the product is designed and manufactured, how the product has been shown to conform to the relevant requirements and the addresses of the manufacturer and any storage facilities.

The CE marking is only valid in Great Britain for areas where GB and EU rules remain the same. If the EU changes its rules and you CE mark your product on the basis of those new rules you will not be able to use the CE marking to sell in Great Britain, even before 31 December 2022.

2.1 UKCA marking

In most cases, you must apply the UKCA marking to the product itself or to the packaging. In some cases, it may be placed on the manuals or on other supporting literature. This will vary depending on the specific regulations that apply to the product.  However, the British government introduced legislation so that the UKCA marking can be placed on a label affixed to the product or on a document accompanying the product until 31 December 2023.  This label or accompanying document must stay with the individual good until it reaches its end user.

The UKCA marking must be clearly visible and legible when you affix it to the product. Only if this is not possible, you must attach it to the packaging (if any) or accompanying documents.

When affixing the UKCA marking, you take full responsibility for your product’s conformity with the requirements of the relevant legislation.  You must only use the UKCA marking to demonstrate conformity with the relevant UK legislation.  The UKCA marking cannot be placed on products unless there is a specific requirement to do so in the legislation.

2.2 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. We recommend that manufacturers have a separate UK Declaration of Conformity to their EU Declaration of Conformity.

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

• declare that the product is in conformity with the relevant statutory requirements applicable to the specific product
• 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 Declaration of Conformity is largely the same as what was required on an EU Declaration of Conformity. This can vary depending on the application legislation but generally should include:

• your name and full business address or that of your authorised representative
• 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
• your name and signature
• the date the declaration was issued
• supplementary information (if applicable)

However, in the UK Declaration of Conformity you will need to mention:

• relevant UK legislation (rather than EU legislation)
• UK designated standards rather than standards cited in the Official Journal of the European Union

Product areas covered by the UKCA marking are:

• Toy safety
• Pyrotechnics
• Recreational craft and personal watercraft
• Simple pressure vessels
• Electromagnetic compatibility
• Non-automatic weighing instruments
• Measuring instruments
• Lifts
• ATEX
• Radio equipment
• Pressure equipment
• Personal protective equipment
• Gas appliances
• Machinery
• Equipment for use outdoors
• Ecodesign
• Aerosols
• Low voltage electrical equipment
• Restriction of hazardous substances

Products covered by the UKCA marking but additionally have some special rules are:

• medical devices
• rail interoperability
• construction products
• civil explosives