On January 31, 2020, the United Kingdom bid farewell to the European Union, four years after the referendum of June 2016. Brexit has been a difficult journey for both the UK and the EU, but the parties finally reached an agreement setting out the rules of this new partnership. And, as of January 2021, the terms of the EU-UK Trade and Cooperation Agreement are in effect.
One important change resulting from Brexit is the new marking for goods sold in Great Britain (England, Wales, and Scotland). In this article, we will explore the UK Conformity Assessed marking (UKCA), how it will affect manufacturers, and how to comply to keep products on the market.
What to Know About The UKCA
Who needs to obtain the UKCA marking?
Most products that previously required the CE marking will now need the UK Conformity Assessed (UKCA) marking. The UKCA marking requirement took effect in January 2021 and a one-year transition period has been granted for products placed on the market before January 1, 2021.
A product is said to have been placed on the market when an agreement for the transfer of ownership or property rights exists. Goods placed on the market in Northern Ireland still require the CE marking; no change for Ireland (the Republic of Ireland), which has been an EU member state since 1973.
The manufacturer, importer, or distributor bears the burden of proof. Typically, documents such as a sale contract, invoices, or shipping documents suffice to demonstrate the date of placement.
When does the UKCA go into effect?
The UKCA becomes mandatory at the end of 2021, meaning a double marking process will be necessary. Displaying both logos remains acceptable for goods already in the supply chain unless rules diverge between the two markets. It’s important to note that some goods like medical devices benefit from a grace period up to 2023.
Manufacturers’ Location, Third-Party Conformity Assessment, And Self-Declaration
If based outside of the UK and selling in the UK, manufacturers need a representative based in Great Britain (GB).
If the manufacturing operations are based in GB and sell within the EU, you will have to retain a representative in Europe. This rep will be the contact point for Market Surveillance Authorities whose address goes on the product.
For products needing a third-party conformity assessment for CE marked goods, such a requirement will also apply to obtain the UKCA label. The assessment will be carried out by a UK-approved body. To date, procedures are the same as they are in the EU.
Whenever the EU permits CE marking based on self-declaration of conformity, so is the case for the UK Conformity Assessment.
Different rules apply depending on whether the products are harmonized or not, and to certain goods like medical devices and civil explosives.
For existing and new products, you will need to maintain two files, each with the appropriate certificate, declaration of conformity, and technical documentation.
Steps To Obtaining The UK Conformity Assessment Certificate
CE marking and UKCA marking requirements are nearly identical twins, so the process to keep or place your products on the British market is the same:
- Identify the requirements that apply to your products
- Ascertain the products meet the requirements
- Assess the needs for testing
- Test the product
- Compile the technical dossier
- Issue a declaration of conformity
- Submit for approval in the proper format
- Affix the UKCA marking on the product upon approval by the authorities
Note: if a product is not compliant with harmonized standards, a UK Conformity Assessment Body must be involved.
What will you need to collect/address during the process?
The UKCA label ensures the products are in conformity with health, safety, and environmental standards. Several areas require your attention, such as:
- Compatibility tests
- Safety tests
- Product design examination
- Appraisal reports
- Certification of quality systems
UKCA Compliance With Source Intelligence
Considering the complexity of global value chains, it can be challenging to reach suppliers scattered across the globe and make sure they understand what you request from them, and why. While the EU directives and UK regulations for certification are nearly identical twins, there can be some changes impacting compliance.
Source Intelligence is dedicated to simplifying and automating compliance processes. Through an AI-powered solution, you can easily engage suppliers and collect data.
We can also help you identify any gaps or changes affecting your current certifications.
Our compliance platform offers:
- Automated Supply Chain Data
- Supply Chain Data Management
- Dynamic Reporting
- Internal Collaboration
- Supplier Engagement
By working with us, you benefit from a personal connection, the knowledge of regulatory experts, and the assistance of a multilingual supplier engagement team 24/7.
The UKCA marking fully kicks in on January 1st, 2022. We strongly encourage you to get started as soon as possible.
Don’t miss the train on UK Conformity Assessment. Request a demo of our compliance solution to see how we can mitigate the risk of product removal and supply chain disruptions.
