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 | 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’ | |
| People are being encouraged & required to wear masks which are not certified. How is this helping protect against COVID virus spread. | Non-Compliant RPE should not be issued or sold in the UK. Only RPE approved to the PPE Regulation (EU) 2016/425 or the Covid19 ‘Easement’ Process (EU) 2020/403 should be used | |
| Can PPE that has assessed and certified by a Chinese notified body be used in the UK. | No. Currently Notified Bodies need approval by NANDO. After January 1st 2021 UK Approved Bodies are only ones who can approve to UKCA. Chinese Regulations/standards for PPE are not recognised in the EU or the UK | |
| Will there be an equivalent to NANDO in the UK? | Yes, details are to follow from Government in due course | |
| Are original versions of the 5 guidances of the conformity assessment available on OPSS website ? | The latest versions are available online via Gov.UK | |
| Is there still a risk that there is unidentified unsafe, non-compliant PPE in circulation? | Yes, there are still numerous instances of Non-Compliant PPE making its way to the market. All in the PPE Supply Chain have an obligation to highlight any product they believe is Non-Compliant to the Market Surveillance Authorities. BSIF stand ready to help – email enquiries@bsif.co.uk | |
| Is there any expectation that the 1 year transition will be extended? | The 1 year period 2021-2022 is a Standstill period rather than a transition, it is not expected that this will be extended | |
| what do OPSS and MRA mean ? | OPSS is the Office for Product Safety & Standards a Government Department. MRA is a Mutual Recognition Agreement – an agreement between 2 or more countries relating to the sale of goods/services across borders | |
| As an end user of PPE what do we need to look out for? | As always, you will need to ensure that the products are marked correctly and the documentation is correct for the area in which the product is being sold (UK, NI or CE). We at the BSIF will be publishing further guidance on this in due course | |
| Are all the questions and answers available for all following this or only the person who asked? | As you can see we have provided all Questions/answers | |
| Our organisation has approached several Notified Body organisations in the UK however have had no response to our requests for testing. Can you please advise? | I believe they will be ready to support UKCA but if you need further support please get in touch at enquiries@bsif.co.uk | |
| Please confirm – ‘placing goods on the market’ would have taken place if a company buys in goods from outside UK but didn’t sell them, used the goods only for that company’s operations and employees – or does ‘placing on the market’ only happen if the importing company sells the goods – many thanks | placing on the market need not have a requirement for onward selling of the product. | |
| EN standards and UK designated standards – what would the process be if the UK wanted to raise a safe guard/formal objection action against a EN standard? | We believe that this will happen in the normal way of a Foreword or communication through BSI to CEN. BSI are currently still members of CEN. | |
| Any advice for importers how to ensure that the oem manufacturer is up to speed with UKCA requirements? | That will be through your relationship with the OEM I am afraid. | |
| Is there likely to be a change in the current (non) position on fit test products for hearing protection? | That will be for the HSE to determine. | |
| To work out the changes to Regulation (EU) 2016/425 as a result of Brexit you have to look to part of the Product Safety Metrology etc. (EU Exit) Regs 2019 viz. Part 5, Reg 38 (which takes you to Schedule 35) – and the PPE Enforcement Regs 2018. Is that correct? | Guidance has now been published by BEIS/OPSS – https://www.gov.uk/guidance/product-safety-and-metrology-from-1-january-2021-great-britain#personal-protective-equipment and https://www.gov.uk/guidance/product-safety-and-metrology-from-1-january-2021-northern-ireland#personal-protective-equipment | |
| Could there be a significant impact on the supplies of Cat3 PPE (and FRSM II) to the NHS and other healthcare organisations who are currently receiving ‘push’ deliveries from central govt sourcing. These supplies are sent directly to NHS organisations from stockpiles and there is little to no control over what is received. | I would hope not. I would hope further that normalisation of supply chains will return very soon. | |
| Looking to understand the route to becoming a notified body, we are currently a UKAS accredited test laboratory to ISO 17025 | I believe you need to apply through UKAS to BEIS. | |
| Are there any implications for Laundry suppliers who are currently washing CE marked garments which may stay in service for a number of years after the change? | They would be considered as “already placed on the market”. | |
| I thought you previously said that we can continue to use CE marked until January 2022? | That is correct. |