Authorisation of Biocidal Products

The actual focus of our work is on applications for authorisation of biocidal products according to the Biocidal Products Regulation (Regulation (EU) No 528/2012). Main part of an application for authorisation is the product dossier (IUCLID 6) including Product Assessment Report. The dossier is supported by a Letter of Access to the biocidal active substance dossier which has been evaluated in the EU Review Programme. As a sometimes more cost-efficient solution, the applicant can submit his own (third-party) active substance dossier.

In coordination with you, we arrange a pre-submission meeting with Competent Authorities, and appropriately regard the special requirements for the authorization of your product and the applications. A network of laboratories and consultants allows addressing also very special issues as the verification of efficacy of a biocidal product. In case you are a manufacturer of a biocidal active substance, we take over the inclusion in the list according to article 95 of the Biocidal Products Regulation on your behalf.

Expert knowledge and e xperience in this regulatory area for many years results from employment in the department of product development and authorisation of a disinfectant manufacturer (product types 2,3,4), as well as client consulting regarding the authorisation procedure for several other product types (1, 8, 11, 17), with exposure calculation and risk characterization for humans and the environment (Exposure Scenario Documents, EUSES, ConsExpo).