BSIF : How EU Brexit Deal Affects PPE?

As a member of The British Safety Industry Federation (BSIF), Troy is dedicated to bringing members important up-to-the-minute information and changes to PPE standards & legislation now the UK has left the EU.  Please see below important information direct from PPE experts at BSIF…

BSIF EU Brexit Deal Summary

You will doubtless have heard that the UK and the EU have reached agreement on a “trade deal”. The “deal” of course includes Personal Protective Equipment and I wanted to make it clear to all, that while the deal is welcome, in that it includes no new tariffs or quotas, it does not include mutual recognition of product conformity assessment.

Therefore the UKCA and UKNI conformity assessment regime, replacing CE marking has now come into force under the guidance that we have communicated over the past 2 months, the latest of which can be found at https://www.gov.uk/government/publications/personal-protective-equipment-enforcement-regulations-2018

The UK Government has not yet published much detail on the deal itself but you may find the brief EU summary highlighting no mutual recognition on conformity assessment useful. It can be found at https://www.bsif.co.uk/wp-content/uploads/2021/01/Brexit-Deal-and-absence-of-mutual-recognition-on-conformity-assessment.pdf


Member Bulletin Update in Easement 2020/403

“BSIF would like to make you aware that the Office for Product Safety and Standards (OPSS) have just published further guidance on the application of the EU Easement Recommendation 2020/403.

This time the guidance does not differentiate on “scale” it is for all manufacturers, large and small interested, and involved in the placing on the market of COVID 19 related “PPE”.

Essentially the guidance gives notice on the termination of the easement arrangements and the requirement for full resumption of conformity assessment, type approvals and quality assurance procedures in line with EU Regulation 2016/425.

In summary, for PPE placed on the GB market the easement arrangements end on the 31st of March 2021 and for product sold or donated to the NHS in England, Scotland and Wales easement arrangements end on the 30th June 2021.

For Northern Ireland, which will remain in regulatory alignment with the EU, the Recommendation remains in place.

Guidance can be found on the BSIF website

Please note: if you are a manufacturer based in Scotland placing PPE on the GB market, then full conformity assessment will apply and be required from January 1st 2021. I do not in any way pretend to be a constitutional expert but this anomaly arises because the legislation laid before the UK parliament on the 9th of December in order to extend easement 2020/403 beyond the end of the UK / EU transition period, (The Personal Protective Equipment (Temporary Arrangements) (Coronavirus) (England) Regulations 2020) was done under devolved powers. The Government legislated for England and the Welsh Government followed for Wales. The Scottish Government is considering following, but has not at this point done so. Therefore for economic operators in Scotland different rules apply.”

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