Biocide focus addresses news about general regulatory issues related to Biocide world. A special section is dedicated to further steps inside BPF consortia ReachCentrum is launching, to keep you up-to-date with the latest news. A further section is also dedicated to upcoming Biocides events, where you will be able to meet your ReachCentrum referent, and information about tailored Biocide trainings ReachCentrum is organising in Brussels.
Brussels, October 5, 2017 – ERM’s biocide team, strengthen by the acquisition of ReachCentrum and JSC Consulting, has been contracted by OXENA to set up a consortium for the preparation of a dossier for product authorisation under the Biocidal Products Regulation (EU) 528/2012, for those products containing the active substance Active Chlorine released by Sodium Hypoclorite CAS 7681-52-9. The aim is to provide producers, distributors and formulators interested in placing biocidal products on the market for PT 2 anti-lichen, PT 4 and PT 5, with an environment in which they can cooperate to meet their obligations under the legislation for what concerns product authorization, sharing data and costs. Consortium’s kick off meeting will take place on October 16 in Paris. Meeting will be conducted in French, with a translation service organized upon request.
Other companies who are willing to attend the meeting and join the consortium are kindly requested to express their interest by contacting Cécile Rousseau or Magdalena Urbanowska by 15 October 2017.
Biocides: mise en place d’un consortium pour l’Hypochlorite de Sodium CAS 7681-52-9 PT 2 anti-lichen, PT 4 et PT 5
ERM, leader du conseil en management environnemental, impacts sociaux, santé, sécurité et développement durable, rassemble les parties intéressées afin de collaborer pour la mise en place d’une organisation de type consortium concernant les demandes d’autorisation de mise sur le marché de produits biocides contenant de l’Hypochlorite de Sodium.
Bruxelles – L’équipe Biocides d’ERM, renforcée par l’acquisition de ReachCentrum et de JSC Consulting, a été contractée par OXENA afin de mettre en place une structure coopérative pour la préparation d’un dossier d’autorisation de produit sous le Règlement sur les Produits Biocides (EU) 528/2012, pour les produits contenant comme substance active le Chlore Actif libéré par l’Hypochlorite de Sodium CAS 7681-52-9.
L’objectif est de fournir aux producteurs, distributeurs et formulateurs qui souhaitent mettre sur le marché des produits biocides pour TP 2, TP 2 anti-lichen, TP 4 and TP 5, un environnement dans lequel ils pourront coopérer afin de répondre à leurs obligations réglementaires concernant l’autorisation de ces produits, le partage des données et des coûts. La réunion d’information aura lieu le 16 octobre à Paris. La réunion se tiendra en français, avec un service de traduction organisé selon la demande.
Les autres sociétés qui souhaitent participer à la réunion et se joindre à cette initiative sont priées d’exprimer leur intérêt en contactant Cécile Rousseau ou Magdalena Urbanowska avant le 15 octobre 2017.
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In accordance with art. 95 of the BPR, a substance supplier or product supplier needs to be included in the list of authorised suppliers by September 1st, 2015. Amendment to the BPR introduced by Regulation n. 334/2014 also allows product suppliers to apply to be included in the art. 95 list. Sodium Chloride is concerned as it is used to generate active chlorine via electrolysis for water disinfection, e.g. swimming pool water.
A pre-consortium phase to organise the joint dossier for Sodium Chloride generating active chlorine is currently under preparation, in order, for suppliers, to be listed in Art. 95 for the product-types 1 to 5, and 11. The grouping of companies interested in the authorisation procedure of Biocidal Products is also under preparation.
The signing of pre-Consortium agreement will take place in early March 2015, once the cost of the letters of access is known. Therefore, it is still time for companies (salt manufacturers or importers, but also electrolysis device manufacturers and users of salt for biocidal purposes) to join the pre-Consortium and state their interest, by contacting Ms. Leondina Della Pietra ([email protected]) and Ms. Sandrine Lauret ([email protected]).
Next steps will be:
Consortia for Biocidal Products Containing Certain Active Substances.
Brussels - ERM and ReachCentrum are collecting interest in the setting up of consortia. These consortia will facilitate cooperation between producers, distributors and formulators wishing to authorise biocidal products on the EU market according to the rules and procedures required by the Biocidal Products Regulation (EU 528/2012 –the ‘BPR’).
ReachCentrum is the chemical industry recognised expert in the delivery of consortium management services. ERM is a leading global provider of environmental, health, safety, regulatory and sustainability related services, with many years of biocide experience helping companies approve active substances and biocidal products in a wide range of chemistries and product types. Together, they have experts in all disciplines with skills to provide scientific and regulatory knowledge to help gain the required authorisations.
From launching this call of interest to final product authorisation, ERM and ReachCentrum will coordinate all aspects of the proposed consortia and provide the technical and regulatory support necessary to ensure consortia members achieve their goals.
ERM and ReachCentrum are planning to launch consortia to support biocidal products containing the following active substances, within the listed Product Types. Biocidal Product Committee decisions to approve these active substances are likely during 2020 meaning that deadlines to submit applications for product authorisation in EU Member States will likely occur during 2022.
In case you would be interested in joining one of these biocidal product consortia, we kindly ask you to express your interest by sending an email to our Team - see contacts below.
|Active Substance||CAS n°||Product Type|
|Active chlorine released from sodium hypochlorite||7681-52-9||11, 12|
|Benzalkonium chloride (BKC)||68424-85-1||1, 2, 3, 4|
|Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents||89997-63-7||18|
|Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide||89997-63-7||18|
|Didecyldimethylammonium chloride (DDAC)||7173-51-5||1, 2, 3, 4|
|Hydrogen peroxide||7722-84-1||11, 12|
|Sodium Chloride (NaCl)||7647-14-5||11|
|Symclosene||87-90-1||2, 3, 4, 5, 11|
|Troclosene sodium (NaDCC)||2893-78-9||2, 3, 4, 5, 11|
|Peroxyoctanoic acid||33734-57-5||2, 3, 4|
To discuss your regulatory support requirements, please contact:
Dr Richard Elsmore, Partner & Global Biocide Lead at [email protected]
Dr Sam Wright, Regulatory Affairs Lead at [email protected]
Dr Cecile Rousseau, Partnerat [email protected]
Andrew Goodyear, Partner at [email protected]
Magdalena Urbanowska, Partner (ReachCentrum) at [email protected]
ReachCentrum is proud to announce that our project manager Magdalena Kornacka will present a case study on preparing and submitting an application for in situ substances at the annual Biocides Stakeholders' Day organised by ECHA, the European Chemicals Agency. The event will be held in Helsinki on September 1st, providing participants with the latest information about the Biocidal Products Regulation (BPR), tools and support available for companies, and experiences from ECHA, the European Commission and companies complying with the Regulation.
Visit the ECHA website for further information and registration.