The United Kingdom formally left the European Union on January 31, 2020 and the year-long transition period that allowed continuity of rules and regulations ends on December 31, 2020. This includes the rules surrounding the conformity of marking and assessment of products.
Although the UK and EU are attempting to negotiate an agreement in relation to the regulatory regime after the transition period, plans are also being implemented for the introduction of a United Kingdom Conformity Assessment (UKCA) Mark in the event that a deal is not reached.
The UKCA mark is a new conformity mark for goods intended to be placed on the market in England, Wales and Scotland. This compliance mark will replace the existing European CE mark. (Goods being sold on the Northern Ireland market fall under a slightly different jurisdiction. See the table below). UK regulations have been amended to broadly replace references to the CE mark with reference to the UKCA mark and the role of ‘Notified Bodies’ will be replaced with ‘UK Approved Bodies.’
The table below illustrates the accepted markings in each relevant market.
Whether you are a manufacturer, importer or distributor, it is important that you ensure that products brought into the UK have the new mark.
Businesses are encouraged to be ready for full implementation of the new UK regime as soon as possible after 1 January 2021. However, there will be a one year period where both the UKCA or CE mark will be accepted for products shipped before 1 January 2021. The UKCA mark will entirely replace the CE mark at the end of 2021.
Companies will need to use the new UKCA mark if all of the following apply:
This does not apply to existing stock, for example, if the product was fully manufactured and ready to place on the market before 1 January 2021. In these cases your goods can still be sold in Great Britain with a CE marking, even if covered by a certificate of conformity issued by a UK body.
In most cases, the UKCA mark must be applied 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.
The following general rules apply:
Note: This graphic does not include timescales for marine equipment, medical devices or IVDs.
Manufacturers will need to carefully consider the implications of Brexit on the conformity of their products and take appropriate action to ensure that all declarations are made correctly and on time. Although there is a transition period, it is essential that companies complete the new requirements as soon as possible. Manufacturers will also need to ensure that various partners within the supply chain are located in the correct territory.
On January 1, 2021, UK-based Notified Bodies will automatically become ‘Appointed Bodies’ under the UKCA legislation. Any UK Notified Body-issued certificates that have not been transferred to an EU27 Notified Body, will automatically become valid as a means for illustrating conformity under the UK Regulations to which they apply: Reaching out to Conformity Assessment Bodies is always recommended if there are questions.
This article was written by BSI. BSI is appointed by the UK Government as the national standards body, holds the Royal Charter, and represents UK interests at the International Organisation for Standardisation (ISO), the International Electrotechnical Commission (IEC) and the European Standards Organisations (CEN, CENELEC and ETSI).
BSI’s role as the UK National Standards Body is to help improve the quality and safety of products, services and systems by enabling the creation of standards and encouraging their use. We represent UK economic and social interests across all European and international standards organisations and in the development of business information solutions for British organisations of all sizes and sectors.
BSI is also a Certification Body and Notified Body. For UKCA Services, BSI is an approved body (0086) for the UKCA Mark and can work with you on the required conformity assessment procedures that will allow you to affix the UKCA marking under the following areas:
Learn more about BSI Services and the new UKCA Mark. At the time of writing, guidelines and timelines regarding UKCA marking for Medical Devices and IVD’s differ to those for the products listed above.
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