From the CEO's desk: Brexit, the EU Commission and PPE Regulation (EU) 2016/425
26 January 2018
The safety and health industry took its first steps into 2018 in the knowledge that the new Regulation becomes effective from the 21st April 2018. For the last three years BSIF and our member companies, active in marketing PPE, have been absorbed in all of the preparation.
The transition to the new Regulation, which has little impact on the performance of product, has involved a great deal of background work to provide accurate interpretation covering what was new in the document, changes in product categorisation, the timescales involved, and the expanded obligations on “economic operators”.
Within this body of work there has been a great deal of negotiation on the details to ensure preparatory work, as far as it could be, has been targeted effectively. One of the final items for which crucial clarity was sought, and achieved last November / December was the interpretation of the validity of existing EC Product Type Certificates, where it was confirmed that they would remain valid until 2023 unless they had an earlier expiry date or the standard had been superseded.
BSIF has been lobbying very hard with Westminster and The Department for Exiting the EU (DexEU) making the case to protect the status of the UK’s Notified Bodies who provide UK product testing and CE certification. Notified Body status within the EU depends on being part of an EU Member State and of course with Brexit that would not be the case, post the UK withdrawal on the 30th March 2019. BSIF has always promoted the benefits of achieving a mutual recognition agreement to support both the Notified Bodies and the UK safety and health industry.
While always a key focus for the Federation this work has been driven front and centre in January 2018 with the EU Commission issuing a notice concerning the effect of Brexit.
The European Commission detailed the effect of the UK leaving the European Union on all economic operators within the remaining 27 members, and the implications for UK Notified Bodies and future product certification. Please be clear that this notice does not take account of any transitional or ongoing Mutual Recognition Agreement that may yet be arrived at.
As of the date of withdrawal (00.00h 30th March 2019) distributors based in the remaining 27 EU countries that wish to place on the market PPE products sourced from the UK will become “Importers” into the EU, and will then take on the additional obligations of an importer. For products supplied into the UK it should be remembered that in the event that we do not reach any separate agreement, then the reality is that they (the EU) will not determine the conditions under which PPE is placed on the UK market. This would of course be the responsibility of UK authorities alone.
BSIF are in communication with The Department for Business Energy and Industrial Strategy (BEIS) for their official interpretation of this notice as it also states that products placed on the EU market will require certification issued by a Notified Body from within the EU. It states that for products currently certified by a UK Notified Body this can be done by applying for a new certificate (from an EU NB), or by an arrangement to transfer the current certificate to an EU NB, which will then take on future responsibility for it.
The impact of this would be that product which has been certified under the PPE Directive 89/686 or after April 2018 under Regulation (EU) 2016 / 425 by a UK based Notified Body would require to be re-certified by a non UK Notified Body where previously this was not articulated and the interpretation was that these certificates would unless otherwise detailed be valid until 2023. We believe that this will cause major disruption for members who hold certificates for product that they currently sell into the EU market. It will also cause unnecessary disruption for commercial operators, manufacturers and brand owners based outside of the UK who have chosen to use UK Notified Bodies for their product certification.
We are through the European Safety Federation in touch with the EU Commission to seek immediate clarification of this interpretation. We will continue with increased urgency to lobby the UK Government and the Department for Exiting the EU for a Mutual Recognition Agreement to be in place in time for our withdrawal from the EU to address these points, during the time remaining. We will keep you informed as the situation develops.
The Commission document which we recommend you read can be downloaded from the BSIF website through this link http://www.bsif.co.uk/economic-operators-and-ppe-certification-after-brexit/