CEO's desk - June 24

SO, AS I sit to write my column the Government has just announced a general election and with that comes the proroguing of parliament and a wholesale halt to the working of government. One piece of legislation that made it over the line before Westminster was wound up was the amendment which confirms ongoing recognition of the CE mark in law, alongside the UKCA/UKNI mark and processes. See link to the amendment www.legislation.gov.uk/uksi/2024/696/contents/made

Specific guidance on how this will apply will be produced shortly, when all the pertinent details are available.  

The application of the amendment had been a formality and we already knew that the intention was to maintain recognition of CE into the future anyway, but it is however an important confirmation laid down ahead of any new government coming into power in July as, I think we all appreciate, their agendas will be full and their priority list overflowing, with the any desire to focus in this area unlikely to materialise!  

So, what does the future hold for UKCA/UKNI? As we are all aware the referendum vote of 2016 saw the UK leave the EU and the institutions of union. One of the consequences being, that it was felt necessary that we had our own independent product conformity assessment regime, embodied in and by the UKCA mark. The rationale for the UKCA mark was that it would transition us away from CE and establish a separate and respected mark for the UK. The motivation in this was two-fold, on a practical side a separate mark was felt to be useful in the processes of negotiating trade deals (beyond the EU) in that we had a stand-alone product safety and conformity regime and on the political/ideological side it was it was seen as proof-positive that we do longer did the bidding of the EU.
However, the government has never really invested in the UKCA/UKNI process and has continually changed the goal posts on it when it will be “required” as a replacement for CE. Originally it was announced that it was effective from January 2021 but there would be a year of transition when CE will still be accepted. At this point all the responsible manufacturers of PPE set about engaging with Approved Bodies to have their products UKCA certified and approved. Bodies previously operating as Notified Bodies under CE became UKCA Approved Bodies right away, with a further 12 bodies going through the rigorous UKAS and government approval system. In the interim period we have seen multiple announcements moving the dates out as to when UKCA/UKNI must be applied in place of CE. In parallel we saw announcements making it easier to comply with UKCA/UKNI by (in effect) using existing CE credentials as the basis of demonstrating compliance. The impact of the changes has been that a manufacturer does not need UKCA/UKNI or a UK Approved Body to place PPE on the market and confirmed by the Product Safety and Metrology (amendment) which completed its’ parliamentary passage on the 20 May 2024. As a consequence, the declining demand for UKCA/UKNI has dropped off the cliff. 

You should remember that when UKCA announced it was clear that only UK approved Conformity Assessment Bodies could provide product approval decisions (and this goes well beyond PPE taking in some 21 different sectors) at the same time they were no longer able to provide approval decisions under CE, as they were pre-Brexit, while they were EU Notified Bodies. In short, with little or no demand for UKCA our UK test and certification industry is in peril.
This was notionally recognised by the Department of Business and Trade and all affected Approved Bodies were invited to a series of meetings last August/September to air the challenges and discuss with the Department how support could be extended. No material support was forthcoming, with a subsequent meeting called for the 1^st of May 2024, at which it was clear that no support was on the table.
It has to be remembered that the UK has never actually published a stand-alone version of the PPE Regulation (EU) 2016/425 nor any versions of a “Blue Guide” simply relying on the original EU Regulation, cosmetically altered to remove references to the commission and member states. In short, we have always used the EU Regulation as the basis for our own rules, so with the political imperatives gone, it seems that they have defaulted to just relying on what we had before under CE but being content to condone the millions already spent and sanction the failure of the UK Test and Certification industry. 

Setting aside for a moment the jeopardy put upon the Test and Certification industry, is all of this a missed opportunity for the country and control of our product safety regime? In December 2020 when the UKCA processes began all of the EU PPE Harmonised Product Standards (for design and performance) were copy pasted as UK Designated Standards so providing continuity for the market. Since the establishment of the PPE Designated Standards, the UK has created restrictions on EN149 and EN 469 on respiratory protection and firefighters clothing respectively. These restrictions arguably create safeguards on the standards and are very much a positive step. The restrictions were welcomed, and the Department of Business and Trade are to be commended for taking these actions. The restrictions mentioned above are evidence of the UK taking appropriate independent actions which make a contribution to safety and health, therefore, one could argue that in these particular examples the UKCA mark is an indication of a better and safer product. However, and while of course the potential to create restrictions still exists, the continual neglect, the existential threat to test and certification bodies and rapidly diminishing profile of UKCA will surely mean that the rationale for the UKCA mark as a mechanism to transition us away from CE and establish a separate and respected mark for the UK will not be realised within any reasonable time horizon. Perhaps a lost opportunity and a great deal of money wasted if the government does not provide a reason and an incentive for all stakeholders to get behind UKCA.