From the CEO's desk - November 2020
15 October 2020
This month, Alan Murray provides an update on regulations for Covid related PPE and the future regulatory requirements as the UK moves to a new conformity assessment regime, under the UKCA marking protocol.
2020 HAS been for all, dominated by the sudden and dramatic upheavals caused by Covid 19 and the ensuing devastation to lives and the economy. In the Safety Industry we commonly discuss statistics, as they reflect health and safety performance at work. Well this year so far, we have seen a new statistic where the UK reported over 42,000 deaths from a virus where PPE and safety products had a vital role to play, in ensuring that that figure was not even a great deal higher.
I am sure that you do not need to read here of the circumstances that surrounded the PPE supply or dire lack of it, or hear more information on some of the shocking products that were placed on the market. Therefore, I plan in this column to update on regulations for Covid related PPE and the future regulatory requirements as the UK moves to a new conformity assessment regime, under the UKCA marking protocol.
Firstly I would like to deal with the apparently continual evolution of the guidance produced by BEIS / OPSS on the placing of, Covid 19 related, PPE on the market under the easement of conformity assessment to the Regulation (EU) 2016/425. The easement 2020/403 was raised as a recommendation by the EU in March and subsequently adopted by the UK. The recommendation stated, it must be remembered, that decisions on applying the easement is for individual EU countries and their regulators to determine the conditions on which it can be applied in each member state. Somewhat remarkably the UK has now published our 7th version of the guidance and while by its nature the easement is “temporary” it is clear that it remains relevant as the UK still needs to ensure adequate supply of Covid related PPE, as we face the winter and the potential second wave of the virus. The guidance is designed to make sure PPE is available, is safe for use and does not mean that we have a long term legacy threat of non - compliant PPE in the market for years into the future. This let us be clear, is a very obvious risk.
The latest guidance is available to download at whttps://www.bsif.co.uk/wp-content/uploads/2020/10/Guidance-for-businesses-high-volume-manufacture-of-ppe-version-7.pdf and I would like to draw your attention to Section 7 (page 5) perhaps the most significant change in the new guidance. The new guidance still requires the submission to and confirmation of acceptance by a Notified Body of PPE for conformity assessment. However if you wish to begin selling this product prior to the completion of the full CE conformity assessment process you must get the approval from the market surveillance authority (MSA), who are responsible for confirming that it meets the necessary essential health and safety requirements.
This approval must be obtained from the Health and Safety Executive (HSE) or HSENI in Northern Ireland. You can apply for this approval through e - mailing MarketSurvPPE@hse.gov.uk. (If PPE is exclusively for private consumers use Trading Standards are the relevant MSA).
This is clearly an important requirement and a key difference from previous guidance.
There are many other conditions carried over from previous versions which of course must also be adhered to, and there will be PPE that is at various stages of the easement assessment process. Guidance in this area can be found in Section 10 of the document which addresses actions now required under “Transitional arrangements”. Please pay particular attention to this Section as there may now be steps you need to take that were previously unforeseen.
The guidance is primarily for manufacturers of PPE but of course importers obligations are also laid out. These can be found in Section 9.
Moving into the very near future, we are all aware the UK has withdrawn from the EU and we will move forward with a UK specific conformity assessment regime for PPE. BEIS and OPSS have just published the guidance on the use of the UKCA mark.
The “Guidance” package published was quite involved, dealing with the status of Notified Bodies who in the UK will become known as Approved Bodies, all the way through to the application of the UKCA mark itself. There are also 5 separate pieces of guidance referring to the situation of trade in goods, in, out of, and through Northern Ireland.
As the situation remains fluid I will deal mainly with the use of the UKCA mark here, although full guidance pieces as published are available on the BSIF website. I will also try to restrict my information to areas that are not subject to the ongoing political negotiations.
Please be aware that my comments are made in good faith they should not be solely relied on for any decisions that you make.
The guidance published by BEIS / OPSS relates to 17 pieces of EU originated legislation which have now been adopted into UK legislation. These enactments, all from the EU’s “New Approach”, cover a very wide range of manufactured goods, including PPE, all now moving from the CE regime to the UKCA process.
Because of the number of items of legislation covered, the guidance published is very“ high level” and general in nature and for us in the PPE market it does, in no way answer all the detailed questions necessary to effect a successful and efficient migration to the new rules. The PPE regulations are of course arguably more complex than many of the other regulations that are coming across.
That said, the best and most obvious way to approach the changes is to know and understand, that for PPE the current Regulation (EU) 2016/425 will be applied but with amendments which overlay a UK “ised” presentation.
I would like to tell you that BSIF will host a webinar in November to ensure that we reach as wide an audience as possible and best inform on the details as they become clear. BEIS / OPSS will also participate in the webinar. Please watch out for details and ensure that you register!
At this point I would highlight the following:
The new UKCA mark regime will come into effect on January 1st 2021
Products in compliance and CE marked can still be place on the UK market during 2021. I highlight this as there has been some general misunderstanding on this point. Where there has been no change in the “standard”.
Current harmonised EN standards will become UK “Designated Standards”.
From January 1st 2022 product must (also) be in compliance with UKCA
Current Notified Bodies in the UK, responsible for conformity assessment decisions will become “Approved Bodies” and they will retain their current Notified Body number.
PPE can carry both UKCA and the CE mark as long as they are compliant with both processes.
As I have said previously full details of the process are not yet available but I can tell that there are no plans to change any technical requirements for products.
For information, included below is the link to UK guidance on using the UKCA mark as far as it goes:
In closing I would just remind you to look out for the BSIF UKCA mark webinar and sincerely wish you good health, in the uncertain months ahead.
Alan Murray is chief executive of BSIF. For more information, visit www.bsif.co.uk