Why this is important to Wisconsin businesses: After Brexit, companies selling products into the UK must follow different compliance and labeling procedures distinct from those in use for EU markets.
No longer a member of the European Union, the UK is working to establish new trade relationships, import/export procedures, and related product testing and approval requirements. As of Jan. 1, 2021, U.S. exporters now need to address these requirements for the UK separately from their procedures for doing business in the EU.
On Jan. 1, 2021, the new UK Conformity Assessed (UKCA) mark replaced the CE product marking for a range of products being sold into Great Britain (comprising England, Scotland and Wales). The CE mark will continue to be recognized in the UK until the end of 2021 for products subject to the same regulations in the UK as the EU. Starting in 2022, only products with the UKCA marking will be sold in Great Britain. Products can still display both the UKCA and the CE marks, as long as they meet both sets of regulations, or the regulations are identical. Some goods (e.g., medical devices) will have an extended transition period through 2023, and the Medical Device Regulation has its ow special requirements.
The UKCA marking applies to most of the products previously subject to the CE marking, and the technical evaluation procedures and requirements are largely the same as they were for CE evaluation, including the conditions for self-declaration of conformity. Where a self-declaration is not appropriate, the product destined for Great Britain will now require a mandatory third-party conformity assessment by a UK-based authority, formerly called a notified body. These organizations are now called UK approved bodies (UKABs), and their purview will cover the UK regulations that have replaced the EU directives for which they were notified bodies.
In cases where a U.S.-made product is also destined for any of the EU 27 countries, a separate assessment by an EU-based notified body is required—although the evaluation procedures, test data, risk assessment and technical files are the same, and therefore, one set can be applied to both applications. The UKCA marking will not be recognized in EU markets.
Notified body and approved body certificates operate under separate accreditations and legal jurisdictions; hence, different certificate numbers will apply in addition to any product marking associated with the body. Most UK-based approved bodies have opened offices in the EU and have had these offices appointed as EU notified bodies so they can continue to provide “one-stop” service to their clients for both UKCA and CE markings.
Manufacturers based outside the UK wishing to sell within the UK must appoint a UK-based authorized body as their representative. This can be a distributor or a specialist company, and the appointee must be identified on the product or its associated documentation or packaging. The representative is also required to ensure that the correct conformity assessment procedures have been conducted and the UKCA mark is properly applied, and that technical documentation is in order and available to the UK compliance authorities.