CEO's Desk - Feb 21

THIS ARTICLE is the first that I have written since the new year of 2021 began, and it is often typical that it would be a forward looking piece, but it is difficult to create a view without it being through the joint prism of Covid 19 and the Brexit deal. 

Currently our horizons remain controlled by these factors and outlooks remain somewhat short and narrow and as I put pen to paper this morning the first information on the route out of the country’s 3^rd lockdown is beginning to come through. It is at first glance understandably cautious with what appears to be a progressive “step” plan being put in place to return the country to anything like our normal way of life. In writing this I am of course conscious that these arrangements are devolved and that the 4 countries of the UK will have slightly different timeframes in place, but on a very positive front we are heading towards 20 million vaccinations, which is great progress in the health and wellbeing challenge.

It is difficult to forecast the months ahead and it is clear that the impact of “economic shocks” caused by the pandemic remain largely unknown, and just a few short weeks ago the details of the UK EU Trade and Cooperation Agreement (TCA) were published. These highlighted the fact that it did not deliver a mutual recognition agreement (MRA) on conformity assessment regimes for manufactured product. This includes personal protective equipment (PPE) and confirms that after December 2021 and the end of the “standstill period” the CE mark, on its own, will no longer be acceptable for the placing on the market of products in GB. The era of the UKCA (United Kingdom Conformity Assessment) mark has begun.

The responsible government dept is the Department of Business Energy and Industrial Strategy (BEIS) through its Office for Product Safety and Standards (OPSS) and the UKCA regime immediately impacts 17 pieces of legislation where product was previously overseen within the CE marking regime. The general structural guidance was first published in September 2020 to be followed by industry specific guidance, including PPE, in November and December.The rules that now apply are in some respects little different, while on the other hand the process is a sea change.

Under the CE regime approval decisions for PPE were granted by Notified Bodies (NB) but from 2021 approval decisions for placing product on the market under the UKCA regime will be the responsibility of Approved Bodies. Approved Bodies are the UK established businesses that were formerly Notified Bodies. An up to date list of the PPE Approved Bodies can be accessed on the link below.

https://www.gov.uk/uk-market-conformity-assessment-bodies?uk_market_conformity_assessment_body_type%5B%5D=approved-body&uk_market_conformity_assessment_body_legislative_area%5B%5D=personal-protective-equipment

While the UKCA regime is now in force placing product on the market using CE is still acceptable throughout 2021 but the application of the UKCA process will become mandatory from January 1^st 2022. There is an abundance of guidance on the new process already published on the BSIF website and we are very happy to answer specific questions to support the membership. The fact remains that the applicable Regulation is in substance unchanged. Where we previously worked with “Regulation (EU) 2016/425” the industry and the Approved Bodies will work with “Regulation 2016/425 on Personal Protective Equipment as brought into UK law and amended”. Within the UK Regulation there are a suite of product performance standards and these are now known as UK Designated Standards. These standards for PPE have been produced from the listing of product standards that pre existed in the Official Journal of the European Union as at December 2020, but there is not yet a functioning mechanism for adopting developing or newly published EN standards into the UK designated process. A link to the list of UK Designated Standards can be found below.

https://www.bsif.co.uk/wp-content/uploads/2020/12/PPE-Designated-Standards-Dec-9th-2020.pdf

There are however, outline plans being worked on by BEIS to accommodate all of this and BSIF whose membership includes all of the UK Approved Bodies will be involved. So bearing the above in mind manufacturers should now be making sure that their applications are submitted to UK Approved Bodies. It almost goes without saying, but of course the vast majority of PPE product which will be submitted to Approved Bodies for UKCA will be product which already carries a CE mark and approval. In these cases the Approved Bodies are being encouraged by the authorities to take a practical and pragmatic view when making UKCA decisions but, as of now no “common approach” exists and the process of granting an approval decision will ultimately rest with the Approved Body.BSIF, BEIS –OPSS and the UK Approved Bodies are conscious of this position and will endeavour to create a consistent process for the industry. With all of the above being said, it is hopefully apparent that we will be front and centre of trying to ensure an effective and efficient transition to the new regime. However, with the amount of work anticipated and only the remaining months of 2021 for completion, we anticipate potential bottlenecks at the Approved Bodies, so please do not delay in setting the UKCA process in motion.

While we are confident that we have been able support the membership to the point that UKCA is understood we all face a considerable task in ensuring that the end users of PPE understand the changes and what they mean. I believe we share a collective responsibility in taking the message of UKCA to the users and ensure that they understand the information. 2020 has taught is many lessons, not least that end users do not always understand the regulations or how to tell the difference between good and bad PPE. It is never beeen more important that users are well informed and able to be discerning in their sourcing of these crucial products.

While all of these conformity assessment changes are being accommodated the economic operators in the PPE market are coming to terms with the fact that, while the TCA was touted as an agreement without any new tariffs and quotas, this is entirely dependant on “Product Rules of Origin”. We have now seen many examples of surprise and confusion on product costings as members have attempted to import and export PPE. Sadly it looks like this will result in increased costs for the supply chain and ultimately for users.

I remain optimistic and anticipate that as the new arrangements bed in much of the confusion will dissipate and BSIF will endeavour to support wherever and whenever we can.

Alan Murray is chief executive of BSIF. For more information, visit www.bsif.co.uk