What is CE marking?

CE marking refers to the obligation on manufacturers to affix the letters “CE” to certain products traded in the European Economic Area (EEA). It serves as a declaration that the product is in conformity with applicable rules and meets certain health, safety and environmental requirements.

For some products, CE marking is mandatory (typically when products are subject to sector-specific regulation such as electrical equipment, radio equipment and toys). The CE marking process applies to a wide variety of products and must be completed by manufacturers located in the EU or importers of goods into the EU.

The CE mark must be affixed to the product or in some cases, its packaging, although guidance from the European Commission indicates that the CE mark must appear on the product itself unless there are good reasons why this is not possible (for example, due to the product being too small). The rules may depend on the specific product in scope, so applicable legislation should be checked.

The “CE mark” is affixed at the final stage of the conformity assessment process. The conformity assessment process involves the preparation and signing of a “Declaration of Conformity”, which must include the following information:

  • The name/address of the manufacturer (and of the responsible person, where applicable)
  • The model and/or serial number of the product/equipment
  • A list of the relevant Directives
  • A list of standards used (with dates plus amendments)
  • A declaration statement
  • Notified Body details (if required)
  • The name and position of the person signing the Declaration of Conformity (and their dated signature)

Application of the CE mark and signing the Declaration of Conformity is, effectively, a statement from the manufacturer (or importer) that the product in question meets the essential requirements of the relevant CE marking Directive(s).

Some products (typically those that present higher safety risks) require an independent assessment by a Notified Body. The European Commission website has a section where manufacturers can check the rules by product category (linked here). If mandatory third-party testing is required, the manufacturer may only affix the CE marking once this testing has been completed, and the CE marking must be accompanied by the identification number of the Notified Body. If a product does not need to be verified by an independent third-party, then it is the manufacturer’s responsibility to complete the above conformity assessment process, and check that its product complies with the relevant technical requirements.

What is UKCA / UKNI marking?

Now that the UK has left the EU, it has introduced its own “United Kingdom Conformity Assessed” mark (“UKCA” mark) in place of the CE mark. The EU and UK undertook to ensure a common approach to future technical requirements for EU and UK goods and to simplify access to each other’s markets. The UKCA mark regime mirrors the equivalent regime in the EU, and the mark is required on those goods that would have previously required a CE mark. There is currently a grace period in place, and further detail on timings is set out below.

In relation to conformity assessments, the EU and UK have agreed to continue to accept self-certification of conformity by a manufacturer as proof of compliance where this was allowed under applicable EU and UK rules as of 1 January 2021.

“UKNI” marking is a new conformity marking for products placed on the market in Northern Ireland, which have undergone mandatory third-party conformity assessment by a body based in the UK. The UKNI marking is not used if you are able to self-declare your goods are compliant, under the relevant EU legislation that applies in Northern Ireland, or if you use an EU Notified Body for any mandatory conformity assessment/testing. In these cases, you can still use the CE marking to place goods on the Northern Ireland market.

Where does the UKCA/UKNI marking regime apply?

UKCA marking applies in Great Britain (England, Scotland and Wales).

The position in Northern Ireland is more complicated and can be summarised as follows:

  • if mandatory testing is required and you are a manufacturer using a UK Notified Body, you need to apply a UKNI marking, in addition to the CE marking;
  • however, the UKNI marking is not recognised on the EU market – if you intend to place a product on both the Northern Ireland and EU markets, you must use the CE marking and an EU-recognised Notified Body (as the UKNI marking and conformity assessment by UK based Notified Bodies are not valid in the EU).

Is the UKCA/UKNI marking regime in force?

The UKCA regime currently applies, but the UK government has announced a grace period to allow businesses to adjust to the new rules. It will continue to accept CE marked products for goods placed on the market in Great Britain before 1 January 2023, provided the goods are covered by a certificate of conformity issued by a UK body before 1 January 2021.

An important factor to keep in mind is that CE marking is only valid in Great Britain while the law remains the same as the EU. If the EU makes changes within this grace period, and a product is CE marked on the basis of new EU law, it will not be possible to use CE marking to sell that product in Great Britain, even before 31 December 2022. The UK government has said there are no plans to diverge from the EU rules, but this remains a possibility.

After the grace period expires, the UKCA mark will be a mandatory mark on a product to indicate that it conforms to UK legislation. Guidance from the Department for Business, Energy and Industrial Strategy recommends that manufacturers have a separate UK Declaration of Conformity to their EU Declaration of Conformity.

The UKNI marking regime is now in force.

What is the process for affixing the CE, UKCA or UKNI mark?

There are six key steps to CE, UKCA or UKNI marking:

  1. Find the EU/UK law(s) that apply to your product.
  2. Understand the essential requirements/standards for your product.
  3. Determine if you need third-party certification.
  4. Assess product conformity.
  5. Create and maintain technical documentation.
  6. Sign the applicable Declaration of Conformity and affix the CE/UKCA/UKNI mark.

What are the latest proposals?

Last year, the UK’s Office of Product Safety and Standards consulted on a revision to the UK’s regulatory regime for product safety and included the UKCA mark in its scope. The regulator published its analysis of respondents’ comments in November 2021, stating that that the results “highlighted the importance of continuing to build capacity and capability in the UK among conformity assessment bodies”. It was further reported that respondents want “the UK to maintain a global outlook, aligning with international practices to raise product quality and benefit trade”. See the full call for evidence response here.

Links

For more information on CE marking, the Europa website has guidance here, and gov.uk has guidance here.

For further details on using UKCA marking, the Department for Business, Energy and Industrial Strategy has published guidance here.

For further information on using UNKI marking, the Department for Business, Energy and Industrial Strategy has published guidance here.