The recent BSIF webinar on the UKCA Mark and what it means for the PPE industry was very well attended and yielded a lot of questions. BSIF have now provided answers to those questions, please see below, all questions are answered based upon current understanding and may be subject to change. Some questions have been edited for clarity purposes only:
| Question | BSIF | Answer |
| What is the official reference for UKCA / NI PPE documentation? | For GB Market ‘Regulation 2016/425 on Personal Protective Equipment as brought into UK law and amended’ For NI Market ‘Regulation EU 2016/425 on Personal Protective Equipment’ | |
| Is there a scenario whereby UKCA does not come to pass, eg. a deal that makes continuation of the status quo possible? | Potentially, yes. | |
| Is there a chance of the UK Notified Bodies and the EU putting in place MRA’s after 1st January 2021 as part of any future trade agreements if there is no deal before the end of the year? | Our understanding is that any deal must be done by the end of 2021. | |
| Would you still require a UKCA marking/approval if any PPE has been through the CE marking process? | Yes you will if you wish to sell product in the GB market. | |
| Who will process the UKCA mark | It will be processed through an application by a manufacturer to a UK Approved Body | |
| Can we start to apply for UKCA examination certificates now – or do we need to wait until Jan 1st, 2021? | My understanding is that you can apply now. The UK Approved Bodies will be those currently established as UK established Notified Bodies. | |
| When are the UK approved bodies ready to process UK CA assessment ? | My understanding is that you can apply now. The UK Approved Bodies will be those currently established as UK established Notified Bodies. | |
| Can product testing done by an EU based test facility still be used for conformity assessment for sale of the product in the UK? | This will depend upon the UK Approved Body – however, the likelihood is that providing the test result comes from a suitably approved laboratory then yes. | |
| Accreditated test institutes; can we still use the test reports issued by the EU when applying for the UKCA type-examination certificate? | This will depend upon the UK Approved Body – however, the likelihood is that providing the test result comes from a suitably approved laboratory then yes. | |
| For Category I PPE: – will test reports issued by an accredited laboratory (outside UK) according to an ISO standard still be considered valid according to the equivalent British Standard (e.g. ISO 12312 vs BS EN ISO 12312)? – will test reports issued by an accredited laboratory (outside UK) according to an UNI standard still be considered valid according to the equivalent British Standard (e.g. EN 16128 vs BS EN 16128)? | It will be for the UKAB to determine what testing is required. They will also determine what reports are necessary and acceptable. | |
| In order to be able to keep on “placing on UK market” PPE from 2021 January the 1st as a EEA Manufacturer are we bound to -Appoint a responsible person in UK? -Adjust current EU Type-Declaration of Conformity starting already from 2021 January the 1st even though articles concerned are already EU Certified the same articles might not have been already assessed by a UK Approved Body? | Until January 2022 CE approvals and documentation will suffice | |
| Can an NB outside of GB or NI be approved also for examination of UKCA type certificates? | No at this present moment approval for UKCA (and UKNI) will come from a UK Approved Body. For CE this will be from an EU 27 established Notified Body | |
| To which recipient should the company send information relating to its role (manufacturer, importer, distributor, branch, retailer …)? Which is the deadline? If the manufacturer is an extra UK company, shall the company have its own authorized representative based in UK? | It will depend what information is required and for what purpose. For approvals this would go to the Approved Body. | |
| Please confirm, that a category 2 product, which has been through EU NB assessment, can be sold in UK under CE marking until Jan 22. After that, it should have a UK CA Mark and the product technical documents should have been assessed by a UK NB. | I confirm, however the product can be marked with both UKCA and CE. | |
| Is it correct that the new UK AB only have 12 months to issue the new UKCA certificates? For products sold in GB, will the labelling and user instructions on production manufactured in January – Dec 2021 remain the same until the UKCA certificates are issued? i.e with only the CE mark and without the UKCA mark? | In answer to the 1st point, yes. The answer to the subsequent point depends if the product is considered as “placed on the market” or not. | |
| Do all Category II products require the module B to be checked by a UKAB? | Yes that would likely be part of the UKAB conformity assessment process | |
| Does this mean that as a Manufacturer that manufactures outside the UK already compies with the CE markings, do they then also need to also apply a UKCA | Yes, if they wish to sell into the UK following Jan 2021 they should look to have products assessed/certified to UKCA by a UK based Approved Body – this needs to be completed by Jan 2022 | |
| Do I understand well that without MRA the CE only is not allowed and UKCA will be needed as from january? | You can continue to sell CE marked product during 2021 as long as the standards remain the same. By Jan 2022 the products must have been assessed/certified/marked to UKCA (you can continue to mark with CE as well if selling into Europe) | |
| I thought you previously said that we can continue to use CE marked until january 2022? | Products only carrying the CE mark are acceptable until January 2022 | |
| Just for clarification. A product being placed on the UK market is determined by this being a new product, or a product placed on the GB market which previously had not been? Any product currently placed on the UK market with CE approvals and being sold currently then does not need UKCA marking until 2022? | There are a couple of questions in this I believe but valid CE will be acceptable through the standstill period of 2021 . From the start of 2022 UKCA will be required for the GB market. | |
| Is there any time limitation for use of currently issued products, i.e. does current ppe need to be replaced by 2022? | No if product is not already placed on the market then nothing else needs done but if not already placed on the market it would need to comply with UKCA regime by that date (in addition to CE) | |
| The majority of our gas detection products are manufactured in Germany, all CE approved and a number are ATEX certified. Is it just a matter of using these to state it is UKCA approved? | No a UKAB is required to give a UKCA conformity assessment decision | |
| What is the plan with OBL (Own Brand Label) / Extension CE Certificates? | The same process would apply as it exists under CE. Extension certificates could be granted from the “master” UKCA certificate. | |
| As a UK distributor purchasing products from European companies for their Own Branded products to sell on the UK market, who is responsible for having the UKCA mark applied? | If they are Own Brand Product you assume the responsibilities of the manufacturer. However there is likely to be the certificate extension process as in CE. | |
| What’s the BSiF’s view of in terms of notified (approved) body capacity to handle UKCA transition along side the change from PPE Directive to Regulation. | Covid 19 and the Easement 2020/403 has probably been responsible for bottlenecking in capacity. For UKCA marking the AB is being encouraged to take a pragmatic view of how they arrive at their decision and whether any further testing is required. I know that the ABs are making arrangements now. | |
| Are the UKAB’s ready for assessing all documents? Or will we as manufacturers once again be obstructed like with the transition from the PPE Directive to the PPE Regulation? | Some will – I would imagine – be more ready than others. | |
| If you’re selling a product to GB and NI, do you have to get UKCA marked and UKNI marked? | CE will suffice until the start of January 2022 in GB. CE on its own will suffiice in NI as long as the NI Protocol is in place. | |
| If we bring gloves in from Thailand and place them on the UK market, does this mean we will be the importer and need to place our details on the packaging after December 2022? | Yes, but if you are bringing gloves that are PPE in directly at the moment the details should be on the packaging now. | |
| We have already imported some goods from the EU, does the new legislation apply to these goods? Or what legislation apply to these? | They are therefore already placed on the market and the current legislation applies – the PPE Regulation (EU) 2016/425 | |
| For products we have in our warehouse – or currently at our factories – that are currently makred with a CE mark – what do we have to do with this? Some of it is slow moving lines – so we may have this for a number of years – can we still sell it or does it need to be stickered after 1 January 2022? | If it is already considered as placed on the market then you do not need to do anything further. | |
| If an item of PPE is only CE marked and within its serviceable life, can it still be used past the January 2022 grace period for products not having a UKCA mark? | Yes if already placed on the market | |
| Will a PPE product ( a glove for instance ) that has a valid current CE certificate which expires in 2023 and is currently on the ground in the UK, have to have external UKCA markings and documentation added to the outer packaging ( case ) and will it as a result, remain available to be sold legally in the UK for the duration of this period even though the product itself does not include UKCA markings / UKCA User Instructions etc..?? | from this description I would consider that the product is already “placed on the market” and no further action is required. | |
| In regards to ‘products placed on the market’ before 1st January 2021. If we have a product an existing one but we have re-ordered on a new PO and this isn’t due until say March 2021 would this need a UKCA mark or if the EU standard is exactly the same and no change is this product OK to just have the EC mark until 31st December 2021? | This would be considered as already placed on the market. | |
| If I have a procurement contract for three years – continuing into 2023, and the product specification does not change in that time, is that product classed as already on the market even if they are manufactured at the point of ordering? | To be considered as “placed on the market” product must already have been manufactured. | |
| If we have a EU type certificate for a new product in the beginning of January 2021, can we sell this product in 2021 in UK with the CE marking and with EU certification? | Yes you can through until the end of 2021. | |
| If the product is on the market already, when do we have to changed all the packaging, DOC and technical files by? | If the product is already on the market you do not need to take additional action. | |
| If we’re a manufacturer or gloves and decide to bring in a new glove brand after Jan 2021, does this mean we will need to go through the UKCA process in order to place this new brand on the UK market? Or can we just affix a CE mark on the product as we currently hold a valid EC certificate? | CE will suffice until the start of January 2022. | |
| Will there be a British standard issued regarding the new UKCA compliance? | No, as this relates to UK legislation rather than Standards which are focused on products/services/procedures that individual businesses are involved with.The Personal Protective Equipment Regulations (Regulation (EU) 2016/425 as brought into UK law and amended) – will be the document that details what is required | |
| As of January 2022 if the UKCA is required on items placed on markets, what about end user requirements i.e. An operative has an item of PPE issued in 2018 with CE mark is that end user still allowed to use that item if it remains fit for purpose past 2022? | Yes, if the product was suitably certified at the time of purchase and is still considered suitable for use based upon a suitable risk assessment of the hazard(s) then it is still OK to use, providing suitable care/use instructions are followed | |
| When sending work teams into the EU they will not be able to use UKCA only approved items from what date, and items to be used in both area will need to be both UKCA and CE marked | I would say that they will require both CE and UKCA at the appropriate time. | |
| After application of UKCA, can a company without any representative in UK be authorized to apply for UKCA ? | Unsure of this question as it seems to suggest applying for UKCA “after application”. If the question is can a manufacturer without a UK presence apply for a UKCA then the answer is yes. However to sell without a UK entity they would need an authorised person or body based in the UK or each customer would be an impoorter. | |
| As a UK distributor of PPE buying directly from European source we become the importer. The product we bring in is also brought into the UK by a number of other UK distributors, can one UKCA conformity document be applied by all of those distributors ? | The DoC is the responsibility of the manufacturer. | |
| As an importer, does the company detail required a UK address? | Yes, or a UK authorised person’s address | |
| What do you mean with: ‘any responsible people… must be based in the UK’, linked placing PPE on the market. We are operating as selling LE (Sales, Product Management, Reg. Affairs,…) outside of UK, only local Sales People are in the UK. What kind of positions needs the be in place in the UK? | There would need to be an individual or a company to whom the Market Surveillance Authority could address any product related concerns. | |
| Hello, any limitation in the number of “importers” of a specific product or not? | No there is not. | |
| We’ve been advised by a supplier that they intend to bring goods from outside UK/EU in to their EU bonded warehouse with onward delivery to the UK which means that the goods will arrive in to the UK outside any customs control in the EU, does this then make the distributor an importer by default. Similarly if we are taking deliveries from a compamny for example in Belgium does this make the distributor an importer? | If the goods are being invoiced from a UK company then that company would be the importer. Regardless of the physical handling of the goods. If goods are being invoiced from outside of the UK you would be the importer. | |
| What does “appointing an importer” means when selling from EU to UK? should it be only one importer or each dealer shall be appointed as an imported? | Each company bringing the product in will (de facto) be acting as an importer. | |
| If a distributor is based in Europe and is supplied with products from Europe but is invoiced from the UK will they still be classed as importers? | Yes (importing into the EU) | |
| What is accompanying documentation – can this be the Declaration of Conformity? | Yes, although it is permissible for the Declaration Of Conformity to be downloadable from a website – the link must be included with the Instructions for Use. The Instructions for Use MUST accompany the smallest commercial unit of sale of each product. | |
| Can you have one DoC covering both CE and UKCA if we are dual marking? | If you have products that are being sold in the UK and carry the UKCA, you need a UKCA DoC. If you are selling in EU, you will need an EU D of C as well. | |
| Hi, will the change in reference to the PPE Regulation (additional wording) be required in the user information or just the master Declaration. Also will it be necessary to have two Declarations or can a UKCA and CE combined Declaration be used? | If you have products that are being sold in the UK and carry the UKCA, you need a UKCA DoC. If you are selling in EU, you will need an EU D of C as well. | |
| Can the DOC and IFU be a combined UK and EU documents? | If you have products that are being sold in the UK and carry the UKCA, you need a UKCA DoC. If you are selling in EU, you will need an EU D of C as well. Dual use user instructions would I believe suffice. | |
| Do you require to have a UK Declaration of Conformity as well as an EU DoC? | If you have products that are being sold in the UK and carry the UKCA, you need a UKCA DoC. If you are selling in EU, you will need an EU D of C as well. | |
| On our website can we put the CE and UKCA declarations of conformity into a single 2-page PDF document rather than needing separate PDFs? | If you have products that are being sold in the UK and carry the UKCA, you need a UKCA DoC. If you are selling in EU, you will need an EU D of C as well – so separate DoC’s | |
| Can the DoC be a combined one CE and UKCA? | If you have products that are being sold in the UK and carry the UKCA, you need a UKCA DoC. If you are selling in EU, you will need an EU D of C as well. | |
| Would it be possible to have both the EU and UKCA on the same Declaration of Conformity and the User Instructions? So there’s only one sheet for each product? | Separate DoCs will be required but dual use user instructions would I believe suffice. | |
| If you have a product that it is both UKCA marked and CE marked with the required documentation. can you have just 1 user information sheet with both mention to the UKCA requirements and uk approved body and the EU27 notified body , thus avoiding 2 user information sheets | Separate DoCs will be required but dual use user instructions would I believe suffice. | |
| Do I understand right that even though the product can still wear the CE mark (without UKCA till end 2021) even from January a UKCA declaration of conformity is needed? | No valid CE documentation is adequate. | |
| Is the DoC to UK regulation mandatory to be put in place on 1st january 2022 as soon as UKCA mark is implemented on the product ? | It would be required at least from January 2022. | |
| Will the DoC of a PPE-Cat.III to the EU2016/425 be enough until end 2021 for sales in UK market if the product is only claimed under PPE regulation with CE marking ? | Yes, but during 2021 the UKCA assessment willneed to be undertaken with a UK Approved Body and then you must issue a DoC relating to the UKCA approval | |
| If purchasing PPE from the EU (For use – not for sale) do we need an EORI Registration (Economic Operators Registration and Identification) number. | I do not believe so. | |
| Do we need to have double certifications for PPE? Once CE type examination from European NB and one from AB from the UK? If we have a CE type examination from NB – is it an easier process for the AB in the UK to have the technical file approved? | The final details are yet to be confirmed and will be part of a proposal from UK Approved Bodies through BSIF to BEIS / OPSS | |
| If a product is certified as CE with an EU NB and UKCA with a UK NB, does the surveillance have to be done with both? | Arguably yes it has to be carried out to the terms of each regime. However, in practice I believe the Approved and Notified Bodies will come to a practical & pragmatic solution. | |
| We hold PED Pressure Equipment Directive certification for cylinder assy’s sold for use with SCBA systems. We currently place the CE mark and NB number on the cylinder assy’s as part of our current PED approval so going forward when we want to sell these products in the UK what is the Directive / Regulation we will need to use specific to the UK? and also what changes will be necessary to the markings i.e. will a UK specific marking be required alongside the UK approved body number? | Pressure Equipment (Safety) Regulations 2016 and the UK Approved Body number will be required. | |
| If a European Manufacturer sells PPE into say four different UK Distributors then my understanding is that the four Distribution partners would then all have to individually recertify the Products to UKCA standard and not the European Manufacturer? Surely the sensible approach would be for the AB in Europe to be able to joint certify to CE and UKCA? It looks like non-UK Manufacturers will now have to open a UK Office to be the sole importers to avoid Distributors having to certify product. A seemingly obvious way around this would be to simply open a Northern Ireland postal office address and then sell into the GB and Northern Irish markets as they currently do and therefore avoiding the complexity of Distributors having to certify PPE to UKCA? | The distributors would not be responsible for certifying the products that would be the manufacturer. Distributors would become importers and be required to discharge their obligations, part of which is to ensure they sell compliant PPE. But it is the manufacturer who would have the product approved. | |
| Where will we be able to get the new UK product standards from and by when? | To be confirmed but the UK Government has committed to their publication by 31st December 2021 | |
| Would you please advise on status of UKCA for reusable masks? | If you require a specific body for “reusable masks” the list will be published by December 31st 2020 | |
| Please can you expand on your thoughts on notified (approved) bodies in terms of the process/procedure when there are changes to the state of art for EN standards after Brexit and the UK’s adoption of these. | This is an interesting question and I believe that the answer is that if an EN standard changes (reviewed and updated) it will come into the UK designation process. | |
| Will the UK keep the same interpretation of the PPE regulation? for example is welding products become CAT II to Cat III at the EU how will this be interpreted in the UK? | At this time the UK will continue with the current interpretation. Should things change as per status or standards the UK will take a case by case basis as to whether we adopt EU driven changes. | |
| Will CE marked Cat 3 PPE be outlawed in the UK after June 2023? | No not to my knowledge, but all PPE will require UKCA or UKNI approval/marking if it is to be sold in the GB or Northern Ireland Region respectively – dual CE marking is permitted | |
| Who or how will it be determined when it is or is not possible to place the UKCA mark on the product? Is there definitive guidance in this respect, as this could have significant ramifications for manufacturing processes and therefore (ultimately) the price the end user pays for the product | There is no definitive guidance on this question at this time. The understanding is that the interpretation that currently applied as part of CE will continue. |