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  • Regulatory Update

UK and EU Market Access for PPE Products Update November 2022

The U.K. government has announced that it intends to introduce legislation to extend the recognition of the CE marking for PPE products placed on the GB market until Dec. 31, 2024.

Life jacket in water

December 12, 2022

The U.K. government announced on Nov. 14, 2022, that it intends to introduce legislation to extend the recognition of the CE marking for PPE products placed on the GB market until Dec. 31, 2024. This will provide businesses placing goods on the GB market with flexibility to use the UKCA or CE marking until Dec. 31, 2024.

Starting on Jan. 1, 2020, the U.K. officially exited the European Union (EU); that was the start of the implementation period (IP) to allow both the EU and the U.K. to establish the processes to handle the changes for customs and immigration, etc. The IP ended on Dec. 31, 2020. The transition period began on Jan. 1, 2021, and was expected to last until Jan. 1, 2023.

The process will depend on where the end products are sold — either in the U.K. or the EU — and whether European conformity assessment documentation already covers them.

On June 20, 2022, the U.K. government released several easements of access of PPE goods into the U.K. market (updated Nov. 14, 2022). This article intends to provide an update on the easements.

Easements

The U.K. government has implemented the following with the intention of implementing them into U.K. law through the statutory instrument “Product Safety and Metrology (Amendment and Transitional Provisions) Regulations 2022.”

Easement 1 – Labelling

The UKCA marking does not have to be permanently attached until Dec. 31, 2027; until this time, it can be placed on the product using a sticky label or on an accompanying document.

For goods imported from the European Economic Area (EEA), the importer details can be affixed to the product via a sticky label or accompanying document until Dec. 31, 2027.

If the UKCA or importer details use the accompanying document, this document must be kept with the goods until it reaches the end user.

Easement 2 – Spare parts

Spare parts will continue to be accepted onto the U.K. market to repair, replace and maintain products to the same conformity requirements that were in place when the original product was placed on the GB market.

Therefore, if a product was placed on the GB market using the CE marking previously, any spare parts for this product may continue to be placed on the GB market using only the CE marking.

However, businesses will be required to have documentary evidence to demonstrate the use of the product as a spare part.

Easement 3 – Imported products

Stock imported into GB before the end of 2022 will not need retesting and remarking with the UKCA marking.

However, imported products that require further manufacturing or processing in GB will not be considered as placed on the market.

Easement 4 – Conformity assessment

Manufacturers may use CE certificates issued before 11 p.m. on Dec. 31, 2024, by non-UK conformity assessment bodies as the basis for the UK Declaration of Conformity (DoC) and may apply the UKCA marking to products.

Manufacturers can use certificates issued before 11 p.m. on Dec. 31, 2024, by European notified bodies to issue a U.K. DoC and apply the UKCA marking to the product without having to obtain U.K. type certificates from a UK Approved Body.

The goods must still bear the UKCA marking and are required to undergo conformity assessment (where required) with a UK Approved Body at the natural expiry of the CE certificate or after Dec. 31, 2027, whichever is sooner.

The manufacturer cannot make any changes to the CE certificate after Dec. 31, 2024. Otherwise, the product will need to undergo conformity assessment with a UK Approved Body as the basis for the UKCA marking.

Additional information: www.gov.uk/ukca

Customers now have a longer period to place the UKCA marking on their products and can continue to use the CE marking to sell products until Dec. 31, 2024.

UL Solutions** is an EU notified body for the Personal Protective Equipment Regulation and the Marine Equipment Directive for life jackets, buoyancy aids, immersion suits and thermal protective aids, and can issue certificates for the CE marking and the Wheel mark.

UL Solutions*** is also a UK Approved Body (UKCA) for the Personal Protective Equipment Regulation and the Merchant Shipping (Marine Equipment) Regulations for life jackets, buoyancy aids, immersion suits and thermal protective aids. We can issue certificates for the UKCA marking and the Red Ensign mark. Please get in touch to find out how we can help you with your global market access needs.

For details on UL Solutions’ scope of accreditation, please see below:

**UL International (Netherlands) B.V. is accredited by RvA and appointed by the Dutch government to work as a notified body under Notified Body No. 2821. EUROPA - European Commission - Growth - Regulatory policy - NANDO

***UL International UK Ltd. is accredited by UKAS and appointed by the U.K. secretary of state to work as an Approved Body under Approved Body No. 0843. UL International (UK) LTD - GOV.UK (www.gov.uk)