On your marks
12 August 2021
Darren Roberts has compiled this handy FAQ addressing the PPE industry’s key concerns and questions regarding the introduction of the UKCA mark.
Q. What is the UKCA mark?
A. UKCA stands for ‘United Kingdom Conformity Assessed’. It is the UK’s version of the European CE mark and is to be used for products placed on the UK market that were previously covered by the CE mark, including EU PPE legislation. UKCA certification entered UK legislation on 1st January 2021. We are currently in a ‘transition year’ in which products can be either CE or UKCA marked. This period ends on the 31st December 2021, after which only UKCA-marked products can be placed on the UK market.
Q. Are PPE categories the same for the UKCA mark as they are in CE marking?
A. Yes – The UK government brought EU PPE legislation in its entirety into UK law with only very minor changes that did not affect categorisation. While we are not aware of any plans to change this at the current time, it is possible that UK laws may diverge from EU law in the future.
Q. Can SATRA issue the Northern Ireland version of the UKCA mark?
A. Customers should be aware that the CE mark is accepted in Northern Ireland, so SATRA’s provision of certification to either the CE mark or the UKCA mark will offer complete coverage of the UK – including Northern Ireland. However, should a customer specifically require a certificate issued against the CE+UKNI mark, SATRA is able to provide this service.
Q. What are the deadlines for labelling products with the UKCA mark?
If a product conforms to UKCA legislation, it can be UKCA marked now. From 1st January 2022, it will require UKCA labelling. However, a one-year ‘grace’ period until 1st January 2023 will permit UKCA marking to be used on packaging, or accompanying documentation, alone if it is not possible to mark the product during this time. After this date, the product itself should be marked. However, if it is not practical to do this (for example, on single-use earplugs or disposable gloves), it will be the manufacturer’s responsibility to justify why the mark cannot be placed directly on the product.
Q. What does the term ‘placed on the UK market’ mean?
A. A fully manufactured (individual) good is ‘placed on the market’ when a written or verbal agreement (or offer of an agreement) to transfer ownership or possession or other property rights in the product is exchanged. The UK Government has published guidance on placing personal protective equipment on the market from 1st January 2021, which can be found on the www.gov.uk website.
Q. What documentation should I submit to support any application for UKCA certification?
A. If SATRA has previously issued a CE certificate for the product is a completed application form to confirm that there have been no changes and confirmation of the new labelling and marking, upon which certification to indicate conformity with UK legislation can be issued. If the original CE mark certificate was issued prior to the updating of a relevant standard, re-testing may be necessary.
When the previous certificate had been issued by a Notified Body other than SATRA, we will ask for the technical file, certificate and supporting documentation. If relevant standards have changed, re-testing may be required. If the product is new, it will need testing and other technical documentation will be requested.
Q. Do I need to re-test all my products to obtain UKCA certification when they already have a CE mark?
A. This depends on whether or not the standards used as part of the initial type-examination are still current and the claims made about the protection offered by the product have not changed. In all cases, it is worth checking with SATRA’s product certification team. There has been no change to SATRA’s acceptance criteria for product testing. CE and UKCA certification processes can run alongside each other for new products.
Q. Can I dual mark my product with CE and UKCA marks after completion of the certification process?
A. Absolutely. We anticipate that many products will be dual marked with information relating to the CE and UKCA marks being included on a single set of labels, packaging and user instructions, the product can then be placed on both the EU and UK markets, including Northern Ireland.
Q. At what stage of the supply chain does the labelling need to be actioned? For instance, products may be kept in UK distribution centre storage or even stay on retailers’ shelves for two years. It may be very difficult to track whether a product has been sold. What level of product recall and re-labelling would be necessary, if any?
A. The UK Government accepts that supply chains are often lengthy and the time taken from a product being ‘placed on the market’ to being sold to the end user may be some years. Rather than having to recall or re-label, the issue would be to prove the date on which the product was placed on the market – for example, by a sales order or other document showing transfer of ownership.
Q. Will the UKCA mark be issued against current EU harmonised standards?
A. The UK government has issued a list of what it considers to be ‘UK designated standards’. This was the list of harmonised standards published at the end of 2020 by the European Commission and thereafter transposed into UK law. Over time, there may well be a time lag between standards being harmonised and then designated or vice versa, and even the possibility that a standard many be accepted as one but not the other.
A new list of harmonised standards was published on 8th March 2021 and, as far as we are aware, this has yet to be reflected in the list of designated standards published by the UK. However, we understand that the update process has been started.
Q. Can we continue to sell self-certified category I products and apply the UKCA mark if the requirements are already met by CE certification?
A. Yes – the categories and the products that are in each category have not currently changed. If you were able to self-certify your products as a manufacturer under EU legislation, you can currently do the same thing under UK law. However, any technical documentation used to support the certification may need to be reviewed to ensure that it refers to the UKCA legislation, as well as updating any marking and user information.
Q. What do I need to do in order to transfer my CE certificates?
A. Contact SATRA with a list of the certificates you wish to transfer. The information required will be: the certificate number, the name of the issuing Notified Body and the issue date.
We can then review the work required and provide a quote. If SATRA transfers certificates we have previously issued, the process be quicker than if we transfer CE certificates issued by another Notified Body, and the cost may be lower. This is because we may not need to carry out a full reassessment of the technical file and test reports.
Q. Can non-UK-based Notified Bodies issue a UKCA mark?
A. No. at the current time there are no Mutual Recognition Agreements (MRAs) in place with other countries, so UKCA certification can only be issued by UK-based Approved Bodies.
Q. Can legacy-compliant CE-marked products (with UKCA on the packaging) that were in the market pre-2023 still be sold afterwards?
A. Goods placed on the market after 1st January 2022 will need to be in compliance with the requirements of the UKCA mark and have documentation (certificates) to prove this. It should be noted that the legislation applies at the time the product is ‘placed on the market’ and not retrospectively to anything already on the market.
Q. In connection to the UKCA mark, the manufacturer (which holds the technical file) should include an address in the product marking. Must this address include both the name and address of the EU manufacturer and the address of the importer/or distributor (neither of which holds the technical file)?
A. The address needs to be that of the company that is assuming the responsibility of the manufacture. If the product is branded in the name of the importer or distributor, by doing this they take on the responsibility of the manufacturer – even if they do not actually manufacture the product themselves – and their name is required to be on the packaging. However, where the product is simply imported, the manufacturer’s name can remain. Article 10(3) of the UK legislation requires importers to indicate on the PPE their name or trade mark and postal address or, where this is not possible, to include this on the packaging or documentation.
Darren Roberts is head of footwear testing at SATRA Technology Centre. For more information, visit www.satra.com