Biocide - Call of interest

Redebel Regulatory Affairs (RRA) is currently gathering interest of companies to prepare biocidal family product dossiers for PT3 and PT4 products based on the following combination of active substances:

  • Glutaraldehyde (CAS N°111-30-8) and DDAC (CAS N°7173-71-5; Didecyldimethylammonium chloride)
  • Glutaraldehyde (CAS N°111-30-8) and ADBAC (CAS N°68424-85-1; Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides)
Glutaraldehyde has already been approved for PT3 and PT4 ((EU)2015/1759). ADBAC and DDAC are currently planned at the agenda of the BPC for PT3 and 4 on June 2018, leading to a possible approval date on Mid-2020, deadline of the preparation of the BPR dossiers.
 
RRA has relevant experience in biocidal product dossiers preparation, including the compliance upgrade of biocidal products with the current legislation (BPR 528/2012), but also in consortium management. Indeed, RRA was involved in biocides legislation since the implementation of the BPD 98/8 on early 2000’s. This experience confirms the market structure (mainly SME’s) and the need to find efficient financial solution to comply with regulatory requirements. One of these solutions is to share the cost of regulatory dossiers by generating common family dossiers including similar products of several industrial working in Consortium.
 
Such strategy thus implies to firstly define legal aspects for Consortium work and then to work on technical aspects for biocidal products dossier preparation. The total process is estimated to take more than 2 years.
 
If you are interested in such initiative to work together with other companies to prepare biocidal products dossiers for PT3 and PT4 based on these active substances, please send us an email on the following address: consortium@redebel.com, by the 30th June 2018, with the following information:
  • Company name
  • Contact person (name, email, phone)
  • Product type and active substances combination
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