CALL FOR INTEREST - UK BPR

Brexit transition period was completed on 31 December 2020 and the United Kingdom is no longer part of the European Union. This means that there will be changes for biocidal product authorisations and Biocidal Active Substance approvals, as the Biocidal Product Regulation in its adopted version only applies to the European Union. This means, that – if your company is present on the UK market with active chlorine generated from sodium chloride by electrolysis – you need a separate product authorisation according to UK BPR. Latest news reports the withdrawal of the active substance approval dossier for “active chlorine generated from sodium chloride by electrolysis” in the UK. 
 
HSE (the UK Authority for BPR) published an open invitation to provide an opportunity for a person, company or task force/consortium to notify an intention to take up or take over the role of participant in the GB Review Programme for “active chlorine generated from sodium chloride by electrolysis” in product types 2, 3, 4 and 5. A corresponding notification is due until 12 August 2023. If a notification to take over the role of participant is not received, these active substance/product type combinations will be subject to a GB non-approval decision. Biocidal products containing active substances with GB non-approval decisions for the relevant product types will have to be removed from the GB market. 

Please note that ISA Consortium will not be directly initiating any active substance approval procedures or future product authorisations in the UK.  
 
Therefore, please state you interest in a joined task force dedicated to that topic as soon as possible to info@figawaservice.de 

About ISA Consortium

Purpose 
According to the Biocidal Products Regulation (EU 528/2012), the in-situ generation of active chlorine from sodium chloride by electrolysis has to be authorised either by the user of the in-situ generated active substance or by other interested parties like the supplier of the sodium chloride or the producer of the device used for the in-situ generation. Moreover, the use of devices without corresponding authorisation is prohibited, although transitional provisions might still apply. 

The main purpose of ISA Consortium was to achieve suitable authorisations of a biocidal product and a biocidal product family for applications in water treatment in particular with respect to the product types 2, 4 and 5 according to the BPR. This milestone was achieved prior to the deadline of 1 July 2022.
Therefore, all members of ISA Consortium can ensure vis-à-vis customers that corresponding devices are considered in the application for product authorisation and the user is not obliged to apply for product authorisation.  

ISA Consortium also contributes to the development of the outstanding technical guidance by the responsible authorities on European level for the product authorisation of in-situ cases under the BPR and to the development of technical standards relating to the in-situ generation of active chlorine as the in-situ generated active substance.

Letter of Access 
ISA Consortium was able to submit the dossiers for application for Union product authorisation prior to the given deadline. The members of the Consortium generated device based data for the prepartion of those dossiers. These data include analyses of the in-situ generated active substance (IGAS) as well as information on devices and use case related technical and chemical parameters. 

Therefore the members of ISA Consortium are now in a position to grant Letters of Access (LoA) to interested parties for the purpose of fulfilling the data requirements of the authorities with regards to the product authorisation in the water treatment sector. 

If you are interested in a Letter of Access offered by ISA Consortium, please contact the Consortium Management for more details:
figawa Service GmbH
Mrs. Carina Janich
eMail:  isa@figawaservice.de
Phone +49 221 37668-59

Organisation

The Steering Committee consists of representatives of the Members of ISA Consortium according to Article 3 of the Consortium Agreement.

The Members of ISA Consortium are:

BAYROL Deutschland GmbH
BSV ELECTRONIC, SL
BWT Holding GmbH
CULLIGAN ITALIANA spa
ecotron GmbH
Elchem Water Treatment GmbH & Co. KG
FLUIDRA, SA
Grünbeck Wasseraufbereitung GmbH
Grundfos Water Treatment GmbH
Hans Sasserath GmbH & Co. KG
HYDROTEC GmbH
JUDO Wasseraufbereitung GmbH
Kinetico ApS
KOWITEC Ingenieurgesellschaft für Wassertechnik mbH
R. Nussbaum AG

ISA Consortium is an undisclosed partnership. Purpose of the consortium is to fulfill registration requirements of the Biocidal Products Regulation (EU) No 528/2012 (BPR) and to share emerged costs among users of data. According to the consortium agreement figawa Service GmbH is acting on behalf of the consortium members. The consortium is not acting in its own name.

All services are being provided by

figawa Service GmbH
Marienburger Str. 15
50968 Cologne
Germany

Contact:

Carina Janich
Project Manager
Phone +49 221 37668-59
Email janich@figawaservice.de
 

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67550 Worms
Germany

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