CEO's desk - September 23

ON THE 1 August 2023 the Department for Business and Trade (DBT) announced that it will continue to recognise CE marking indefinitely. This continuing, indefinite recognition covers all of the product categories and regulations that fall under the DBT, including of course PPE.

The announcement came with the normal “newspeak” bordering on “doublethink” of …..cutting red tape, reducing burden, enabling firms to focus on creating jobs and growing the economy. Overall, as we have come to expect the spin was that yet again these steps were being taken “support for business”. This rhetoric is hollow, even mendacious, especially for those in the PPE industry who moved heaven and earth to provide good product during the pandemic and invested massively in being ready for UKCA. It is also a body blow for PPE Approved Bodies who invested to provide conformity assessment capacity for UKCA. 

Setting aside any politics this is one expensive debacle, with the costs borne by the industry.

Let me remind readers of the events…..

• 2016. From the result of the EU referendum in June of that year BSIF lobbied the UK Government to maintain the CE regime for PPE, arguing that the existing Regulation was fit for purpose, well understood and it was supported by a robust conformity assessment infrastructure. We made it clear that the PPE market was international in nature and that neither safety nor industry would benefit from creating a different system.

• 2020. September. While the market was reeling from the pandemic and the PPE crisis, accommodating the easements and derogations for product against Regulation 2016/425, the announcement came that we were moving away from CE and that the new UKCA regime would come into force from January 2021 with a standstill period of one year applied until the end of 2022, thus enabling CE marked product still to be placed on the market. The announcement also created a structure of “Approved Bodies” by automatically recognising those former EU Notified Bodies established in the UK, as being “Approved” to provide product approval decisions for placing PPE on the market under the UKCA regime. Despite the reduction in capacity, from over 100 Notified Bodies (throughout the EU) to some 9 Approved Bodies, the market had a means of moving forward and certifying these safety critical products in GB. During this period the department (then BEIS) encouraged the establishment of additional Approved Bodies in the UK to ensure demand for approval and certification was able to be met. At the time of writing this has led to a total of 18 Approved Bodies, scoped to give approval decisions on PPE under UKCA, with 6 EU Notified Bodies and 3 entirely new business investing heavily and establishing themselves in the UK. After much hard work, a balance of supply and forecast demand was achieved. 
  From the initial announcement of the UKCA requirements PPE manufacturers invested immediately and very significantly (in the millions) to ensure their products were compliant, against, it has to be said, a technically unchanged but new parallel GB Regulation. The UKCA regime was, let it not be forgotten, an additional requirement for the vast, vast majority of manufacturers who already held CE certifications and approvals. So from the outset a duplication!

• 2021. June. BEIS announced that it would be acceptable to use existing CE certification as a basis for manufacturers to apply the UKCA mark, meaning much of the money already invested by manufacturers had been needless! At the same time this ability to base UKCA marking on existing CE certification undermined and diminished the role of existing and new Approved Bodies. The deadline date for UKCA compliance however, remained as the end of December 2022.

• 2021. November. Within five short months of the June announcement, referenced above, BEIS created a further easement pushing back the requirement for UKCA to replace CE until the end of 2024, exaggerating the waste of manufacturer investment and the creation of a precipitous decline in demand at UK Approved Bodies.

• 2023. August. The Department for Business and Trade (DBT) announces their “indefinite postponement” further amplifying the wasted cost of compliance by PPE manufacturers and it renders UKCA Approved Bodies in the PPE sector all but redundant. Within three days of the announcement there was the first notice of an Approved Body ceasing trading.

Given the story so far, am I surprised? In truth no! Am I shocked? Yes I am, we should all be!

From the outset the stated objective in establishing the UKCA regime was to transition away from CE and make UKCA a meaningful international mark. The problem was and is, that there was never any joined up-reformist strategy to support this. 
What is the future of UKCA? Without wishing to politicise it, my opinion is that ideologically you cannot have driven the leaving of the EU with the whole concept of “taking back control” and concede to formally retaining the constructs of EU conformity assessment. Therefore, UKCA will remain as a parallel option into the future. However, with the potential damage done to domestic testing and approval institutions the structure will not be there!

BSIF have, of course, engaged with Government to make our concerns clear and to seek compensation for the wasted investment. We will continue, in collaboration with others, to try and establish a way forward.

In other news ….the much, much delayed Product Safety Review Consultation (PSR) was published on August 2 2023. This will examine opportunities to reform existing legislation and controls, including on-line selling responsibilities. I will not go into this now, as it is a very important consultation, worthy of comment and discussion which I will deal with over the coming months, but I mention it here as there are also potentially significant impacts on the future shape of product Regulation, including of course PPE, which relate closely to the situation on CE and UKCA.

If I may beg your indulgence though, I talked about language used earlier in the announcement on the “indefinite extension of CE”, well the PSR commentary also includes phrases again drifting into “doublethink” where it states that reforming Product Safety Legislation will “reduce burden on business” and “unleash innovation”. Really!

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