Production of Disinfectants during Corona-Crisis

Due to the Covid-19 pandemic, companies wish to support the increased demand for disinfectants.
Please note that ISA Consortium is not in a position to grant access to data incorporated in the dossier submitted for the approval of the active substance “active chlorine generated from sodium chloride by electrolysis”. We would, thus, recommend to contact the applicant of the active substance to request a further outline on the process for purchasing an Letter of Access or send a request to ECHA on basis of Article 62 BPR.

About ISA Consortium

ISA stands for In-Situ-Applications and therefore for a safe, efficient and environmentally friendly technology. The consortium was established in 2018 and continues the successful work of a joint initiative of the German industry association in the gas and water sector figawa e.V. 
It consists of device manufacturing companies placing electrolysing devices for the in-situ generation of active chlorine on the market of the EU.

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.

The main purpose of ISA Consortium is to achieve one or more suitable authorisations of biocidal products or biocidal product families for applications in water treatment in particular with respect to the product types 1, 2, 3, 4 and 5 according to the BPR.

ISA Consortium also contributes to the development of regulatory and 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.

In particular ISA Consortium and its predecessor, the figawa Biocides Steering Committee substantially contributed to the Regulatory Guidance “Management of product authorisation for in-situ cases” agreed by the Competent Authoritites on 4 July 2019 and published under CA July 19 Doc 4.1 final in-situ.

ISA Consortium is by now not only preparing applications for the product authorisation of “Active Chlorine generated from sodium chloride by electrolysis" as defined by CA-March15-Doc.5.1- Final - Substances generated in situ. ISA Consortium will also contribute to the more detailed complementary Technical Guidance for in-situ cases under development by the European Chemicals Agency to support applicants in identifying the data necessary to support the risk/efficacy assessment.

While ISA Consortium and its Members are prepared to grant letters of access (LoAs) regarding data included in the application for biocidal product authorisation, neither ISA Consortium nor its Members are in a position to grant LoAs with respect to data contained in a dossier for the active substance “active chlorine generated from sodium chloride by electrolysis” to support applications for inclusion in the list established on basis of Article 95 BPR. We recommend to contact the Review Programme (RP) participant or dossier submitters instead.

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-Aktiengesellschaft
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
Kinetico Deutschland GmbH
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
 

Chemservice GmbH
Herrnsheimer Hauptstr. 1b
67550 Worms
Germany

Produktkanzlei – Ahlhaus Handorn Niermeier Schucht Rechtsanwaltsgesellschaft mbH
Provinostraße 52
86153 Augsburg
Germany