The German Chemicals Act appoints the Federal Office for Chemicals at the Federal Institute for Occupational Safety and Health as the authorisation unit for biocides. In the course of implementing Regulation (EU) No. 528/2012, it regulates the authorisation and making available on the market of biocidal products.
The tasks of Unit 5.4 in the biocide procedure focus on the authorisation procedures for the disinfectants (product types PT 1 - PT 5). The tasks of Unit 5.4 for the aforementioned product types consist in detail of:
- Design and coordination of the authorisation procedure for biocidal products and the mutual recognition procedure of authorisations
- Processing applications for Union authorisation, national authorisation, mutual recognition of authorisations and notifications under the Biocidal Products Regulation
- Granting of authorisations for biocidal products specifying the conditions of use and risk mitigation measures for making them available on the market and for use
- Processing of applications for research and development
- Authorisation of biocidal products in cases of unforeseen danger (Exception: Decontamination measures (RKI, BVL))
- Exchange of information with state authorities regarding notifications and authorisation decisions as well as the associated directions for use
- Providing advice prior to an application's submission and during the authorisation procedure
- Providing information material for industry, authorities, ministries and the general public
- Holding symposia on specific topics relating to product authorisation
- Participation in working groups of the European Commission and the European Chemicals Agency (ECHA) on the authorisation of biocidal products as well as on specific topics of the authorisation procedure
- Participation in the REACH-CLP Biocide Helpdesk