Questions about the UKCA mark
Investigating the workings of the UK’s new legislation for PPE products.
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SATRA recently held a webinar in order to answer questions raised by our customers about the new UKCA certification process for personal protective equipment (PPE). This article features most of the information that was presented.
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 those products placed on the UK market that were previously covered by the CE mark. This includes EU PPE legislation written into law following the departure from the EU. 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 last day of December 2021, after which only UKCA-marked products can be placed on the UK market.
Q. Are the categories for PPE the same for the UKCA mark as they are in CE marking?
A. Yes – The UK government brought the EU PPE legislation in its entirety into UK law with only very minor changes that did not affect the categorisation of PPE. While we are not aware of any plans to change this at the current time, it is always possible that UK laws may diverge from EU law in future years.
Q. Why are SATRA UKCA certificates sometimes referred to as ‘transfers’ rather than ‘extensions’?
A. This is to simply reflect SATRA’s internal transfer of data from a previously issued CE certificate issued by our Ireland-based Notified Body to a UKCA certificate.
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.
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Q. How will the UKCA mark affect PPE items for military use?
A. PPE used exclusively by the military or for the maintenance of law and order do not need to be CE marked. Nevertheless, this is a common practice – especially when required by the procurement organisation during the tendering process, and UKCA certification is likely to be viewed in the same way.
Q. What is now the UK equivalent of the EU PPE Regulation?
A. The UK equivalent of the EU PPE Regulation is known as ‘The Personal Protective Equipment Regulations (Regulation (EU) 2016/425 as brought into UK law and amended and the Personal Protective Equipment (Enforcement) Regulations 2018’. This title may, of course, be shortened at some time in the future.
Q. Does UKCA labelling on products need to be in place on 1st January 2022?
A. 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 document) alone if it is not possible to mark the product during this time.
Q. Will the actual product need to be marked from 1st January 2023 following the one-year grace period, or can the UKCA mark then be printed on a swing tag or in user instructions?
A. Typically, 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. Can I still place CE marked products onto the UK market after the 31st December 2021?
A. New products can only be placed on the market in the UK after 31st December 2021 if they carry the UKCA mark. However, there may be some products in the supply chain that had been placed on the market prior to the 31st December deadline, including goods still on the shelves without the UKCA mark. It is not currently known how the UK government will deal with this situation.
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. Is the date for the end of CE marking in the UK not supposed to be in April 2023, as certificates need to conform with the PPE Regulation rather than the PPE Directive, which would have expired by then?
A. The original PPE Regulation had dates attached to it to allow for the transition from the PPE Directive. Certificates issued against the directive could (depending on certain criteria) remain valid until April 2023. That is still the case, provided the certificate was issued by an EU27 Notified Body. Certificates issued by UK-based Notified Bodies against the PPE Directive and, indeed, the EU PPE Regulation expired at the end of 2020 once the UK formally left the EU. These must now be transferred to an EU27 Notified Body, which would also require updating to the regulation – unless the product is not being sold in the EU – when this process would be conducted by an Approved Body and transferred to a UKCA certificate. The 2023 timescale originally assumed that those certificates remained valid. Obviously, if they were issued by UK-based Notified Bodies, they are now considered as expired. Therefore, the April 2023 date no longer has any bearing.
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 to the PPE Regulation, all that is normally required 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 another Notified Body other than SATRA, we will ask for the technical file, certificate and supporting documentation. Again, if relevant standards have changed, re-testing may be required.
If the product is new, it will need testing and 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.
Q. Can CE and UKCA certification processes run alongside each other for new products I want to market?
A. Yes – one of these processes can be taken to completion and the certification can then be transferred to the other. This is the most efficient and cost-effective way, as the common parts of the processes are not repeated.
Q. Is there any specific guidance with regard to labelling and marking of products?
A. The alteration of marking to meet with UKCA requirements is likely to be the addition of the UKCA logo and, if the product is category III PPE, the Module C2 or D Approved Body number. The rest of the marking is typically driven by the standards involved, so whether the product is certified against CE or UKCA, this information is unlikely to change.
Q. Can we label a product with the CE or UKCA mark and place it on the market once the application process is under way and a timeframe has been offered?
A. No. The CE or UKCA mark can only be placed on a product once it is in full compliance with the legislation. While there may be deadlines for the production of labels, packaging and instruction sheets, a product should not be considered compliant until the certificate has been issued. One of the aspects of the certification process is checking that the labelling and other documentation provided with the product meets all requirements, and amendments may be required as part of this process.
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 certification to CE and UKCA be combined in one Declaration of Conformity’?
A. Declarations of Conformity covering each piece of legislation will be required. For two pieces of European legislation (for instance, an item of PPE that includes electrical components) the Commission requires the declarations to all appear in a single EU declaration. However, in this case, it is a piece of European legislation and a legislation from a third country, so ideally these should be two separate declarations. Feasibly, though, a combined version could be made if the requirements of each legislation were met and each item of both legislations was referred to. The information would need to be very clear to ensure that the correct body could be contacted in the event of a problem.
Q. If we have a CE certificate issued by a UK-based Notified Body, will this cover both CE and UKCA marking on the packaging until the end of the transition period?
A. If the CE certificate was issued by a UK-based Notified Body, it is now considered as invalid because those UK-based Notified Bodies have ceased to exist, having been removed from the EU register at the end of 2020. SATRA CE certificates issued from our Dublin-based Notified Body are fully valid. If the Notified Body number on the certificate is ‘2777’, it is an EU-issued certificate and remains valid. However, if the number is ‘0321’, it was issued by our UK-based Notified Body – it is now invalid and cannot be used to place a product on the market in either the EU or the UK.
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.
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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: i) the certificate number, ii) the name of the issuing Notified Body and iii) 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, and 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.
Q. How does the equivalent of modules C2/D for the UKCA market work for category III products? How will the module C2 inspection for products with both certificates take place if they are only in one warehouse?
A. The same requirements currently apply for the UKCA mark as it does for the EU PPE Regulation. Where a product is category III, either module C2 or module D will be required. Where a customer holds both an EU and a UKCA certificate issued by SATRA for the same category III product, it is our intention as far as possible to carry out one assessment (module D audit or module C2 test programme), and then use the data for both assessments. At the current time, we believe that separate reports and/or certificates will be required, which will incur some administrative costs.
Q. We hold a one-year certificate issued for the COVID threat under recommendation sheet 2020/403. Is the UK also issuing one-year certificates?
A. The length of time for which any certificate remains valid is generally at the discretion of the body that issues it. 2020/403 has not been adopted by the UK, but at SATRA we will continue to allow the issue of one-year certificates for the UKCA as we have done for EU certificates.
Q. Where can I find dimensions for the UKCA logo?
A. The minimum height for the whole logo is 5 mm. This requirement can be found on the UK government website (www.gov.uk) under ‘Using the UKCA marking’.
Q. The UK government has published a list of designated standards to be used for the UKCA mark. In this list, the ‘old’ EN 420 is mentioned, so does this mean we are still able to show compliance to EN 420, and not have to re-test to EN 21420?
A. Where a standard is listed as being designated, we will accept test data against that standard as a means of showing conformance against the requirements of the UKCA legislation. Where a newer version has been published but not designated, we may also accept this newer version – but this will be on a case-by-case basis and will depend on the reason for non-designation of the newer version.
Once the new version has been designated, we will allow a transition period from the old version. This will usually be a period of six months from the date of publication based on the date of submission and receipt of a completed application.
Q. Who forms the UK panel that will decide what changes to the EU PPE Regulation to adopt and the impact to revisions to harmonised EN standards?
A. With regard to changes to the PPE Regulation as adopted in UK law then this would be the remit of the UK government via its department for Business, Energy and Industrial Strategy (BEIS). Changes to standards will be through the UK standards committees.
Q. Is an EU-based company required to include the address of its UK-based subsidiary (the ‘importer’) on products that are branded with a registered trademark registered in both the UK and the EU?
A. Where a product is rebranded, the obligations of the manufacturer transfer to that of the brand owner. In this case, the brand is registered in both the EU and the UK, so the UK address will need to be shown on products sold within the UK. Article 10(3) of the Regulation 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.
Q. Users and buyers will not know what is ‘placed on the market’ by 31st December 2021 and what is not. Will that not lead to confusion, with consumers asking for UKCA markings on an existing product that is CE-marked?
A. Unfortunately, given the length of modern supply chains, this is something that is going to happen and may require suppliers to be able to explain and/or prove the date when a product was placed on the market.
Q. Has any UK Declaration of Conformity format been issued that a manufacturer can follow, providing information according to each EU directive/regulation?
A. The UK has currently adopted the EU PPE Regulation without change, so the requirements for the Declaration of Conformity will be as listed within Annex IX of the PPE Regulation, with the exception that it will reference the UK legislation.
Q. Does the user manual/technical file need to be updated to explain the UKCA marking for 2022, when the marking is on the packaging only? Would it not defeat the purpose of simplified marking?
A. If the technical file was created to conform with the EU Regulation, it will need to be updated to refer to the UKCA mark and UK legislation. This will include the user information and any labelling. A UKCA Approved Body should be able to advise of the changes required for specific products.
How can we help?
SATRA members are invited to contact SATRA’s PPE team (email@example.com) for assistance with certification against the new UKCA legislation.
This article was originally published on page 10 of the June 2021 issue of SATRA Bulletin.