BSIF - BRITISH SAFETY INDUSTRY FEDERATION
BREXIT AND THE EU COMMISSION LETTER ON CONSEQUENCES OF WITHDRAWAL FROM THE
EUROPEAN UNION
Spring 2018 will see the Safety and PPE Industry across Europe become fully absorbed with implementing the new PPE Regulation 2016 / 425 , while at the same time , the UK is preoccupied with Brexit negotiations and the potential impacts which may result from our leaving the EU .
The transition to the new Regulation , which has little impact on the performance of product , has involved a great deal of effort 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 ’ s been a great deal of negotiation on the details to ensure preparatory work is , as far as it can be , targeted effectively .
After literally years , 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 . It was finally confirmed that they would remain valid until 2023 , unless they had an earlier expiry date , unless the standard had been superseded , or indeed the product itself was placed into a higher risk category ( as was the case with hearing protection ).
BSIF has lobbied intensely 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 for us , post UK withdrawal on 30th March 2019 .
On 11 January 2018 , the European Commission issued a Notice to stakeholders :
Notice to stakeholders - Withdrawal of the United Kingdom and EU rules in the field of industrial products .
The Notice outlines impacts on UK “ economic operators ” and UK Notified
Bodies , and suggests that product certificates issued by UK Notified Bodies would need to be replaced – while this is clearly antagonistic , there is no reason to believe , on the face of it , that they are bluffing .
The UK Notified Bodies are world leading and this would affect all of industry ; specifically within the PPE sector , there is a large amount of crossover with medical devices .
While always a key focus for the Federation , this work has been driven front and centre with the EU Commission issuing this notice concerning the effect of Brexit .
The European Commission details 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 Agreements that may yet be arrived at , and while I am writing this from a Safety Industry perspective , the letter refers to all industries .
The Notice from the Commission lays out explicitly that 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 . This element of the Notice was really , in many ways , stating the obvious .
However , the latter part of the Notice , which deals with consequences of Brexit for Notified Bodies , was extremely problematic , and BSIF are in communication with The Department for Business Energy and Industrial Strategy ( BEIS ) for their official interpretation of this notice . It states that product placed on the EU market will require certification issued by a Notified Body from within the EU , and that product certification by a UK Notified Body would no longer be valid . Brand owners are :
Alan Murray , BSIF CEO
“... advised to consider either applying for a new certificate issued by an EU- 27 Notified Body or arranging for a transfer – on the basis of a contractual arrangement between the manufacturer , the UK Notified Body , and the EU- 27 Notified Body - of the file and the corresponding certificate from the UK Notified Body to an EU-27 Notified Body , which would then take over the responsibility for that certificate .”
The impact of this would be that product 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 agreed 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 .
The BSIF is , through the European Safety Federation , in touch with the EU Commission to seek immediate clarification of this interpretation .
Alan Murray , BSIF CEO
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