From the CEO's desk - October 19

WHILE PENNING this article the talks go on between the UK and the EU in an attempt to uncover a way forward which will avoid the UK leaving the EU without a deal. BSIF have written extensively on the potential consequences of a no deal and what that may mean for the Personal Protective Equipment (PPE) industry, let us hope that by the time you are reading this the issue has been decided and we have a better understanding of our ongoing relationship.

As we all know the PPE industry has operated for many years under EU directives and regulations. The latest major change being PPE Regulation (EU) 2016/425 which has been in operation since April 2018. Regardless of Brexit this regulation heralded changes which the market has adjusted to over the last few years. On October the 2^nd the European Safety Federation (of which I through the BSIF am President) held an open workshop on the implementation of the regulation. 
The workshop was attended by over 60 stakeholders from the industry and heard a presentation from the EU Commission Officer responsible, covering the current state of play with the implementation of the regulation.

The agenda of the workshop enabled 3 distinct workshop groups to break out and share experiences and concerns covering the important topics of 1. Market Surveillance 2. Notified Bodies and 3. Product Standards. All of these breakout groups had the opportunity to have concerns debated and have them directly addressed by the Commission. Following the individual workshops there was a panel session where the audience was able to air questions to experts.

Given that in the event of a Brexit deal we will continue to use the Regulation and even in the event of a “no deal” the UK conformity assessment process will mirror the existing EU regulation I think it is useful for you to share in what was discussed in the workshop.

On Market Surveillance – The experience across the EU markets is broadly similar to the experience in the UK. That is, that the authorities are under - resourced and do not prioritise PPE. It is all relative of course and hearing from the Belgium authorities I can tell you that they have an proactive annual plan for PPE inspection, but that is the exception. The regulation and the legal frameworks delegate the responsibility for market surveillance to national authorities in each member state. This by its nature means that there will be differences. What is clearly consistent is that whatever each member state is doing is seen as inadequate, to prevent sub standard and non compliant product from entering the market. The Commission accepted the situation is not good enough but reassured the audience that the new EU Regulation (EU) 2019/1020 on Market Surveillance and Compliance of Products will go some way to addressing this. Within market surveillance there are always technical, legal and political elements to consider, however the new regulation (EU) 2019/1020 will provide financial resource and a new network to address issues with energy and dynamism. We shall see!

On Standards – The workshop recognised that there were strengths and weaknesses in the current situation. Strengths cited were that harmonised standards did provide a statement on “state of the art” , they provide a useful means to compare PPE performance and are a useful tool in enabling end user selection. Weaknesses agreed, were that uncertainty of test measurements were unclear and a source of confusion and further that some member states require PPE to be to the latest standard when placed on the market. It was agreed by all that improvements can be realised by simplifying the revision process and only allowing changes to test methods if they closer reflect “real life use” as opposed to laboratory tests. It was universally agreed that we must move away or find a solution to non value adding requirements such as the need for hard copy instructions for use. All agreed that the production of instructions for use and the need for them to accompany each item of PPE was expensive, wasteful and unnecessary. The Commission acknowledged the points raised.

On Notified Bodies – The workshops raised concerns that within the C2 and D modules for quality assurance there is a need to make sure this is being carried out consistently – it is not currently, which can lead to problems. In the implementation of the Regulation there was concern expressed at the delay in providing product certification. The concern over the view that sub contracting of testing by Notified Bodies should not be allowed (except in certain circumstances) was also raised as this would fracture the existing model and lead to significant delays. Once again the problem of different test results from different test labs was raised and is was noted that while there are round - robin processes to establish commonality the results of these are never shared.

The workshop was a great success enabling the Commission to hear at first hand the concerns of the market and it was clear that inconsistencies in the areas covered have the potential to undermine the effectiveness of the Regulation and the industry.

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