bretox

Some biocidal products are still in a ‘transition period’. This means that their active ingredient(s) are included in the European review program, but a final decision has not yet been taken. As such these products are authorized according to national law until there is a decision taken at European level on its active ingredient(s). BReTox has over 20 years experience with applications to the Dutch competent authority (Ctgb) and knows the details of the so-called ‘overgangsrecht’ for biocides.

When the active ingredient of a biocidal product has reached a final decision at European level and is included in the so-called ‘union list – register’ all biocidal products containing this ingredient have to follow the BPR procedure.  For a number of product types you can follow the union application procedure and apply for union approval in the entire EU. For other product types (or if you intend to market your product only in a few member states), you need to follow the national 528/2012 procedure, followed by mutual recognition application in case you intend to include additional member states. BReTox can advise you on the choice of application procedure and assist with the full application according to the EU procedures. This includes submission through R4BP register and preparation IUCLID dossier, SPC document and compiling the PAR summary document including the required risk assessments.

Additionally, all other formulants present in the biocidal product can be checked for being a substance of concern and a screening for endocrine disrupting properties can be done by BReTox.