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Unit 5.4 Authorisation of Biocidal Products
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.
Unit 5.4 has the following responsibilities with regard to the authorisation procedure:
- Conception and coordination of the procedure for authorisation of biocidal products and mutual recognition of authorisations
- Processing of applications for Union authorisation, national authorisation, mutual recognition of authorisations and notifications within the context of the Biocidal Product Regulation
- Authorisation of biocidal products laying down directions for use and mitigation measures for the making available on the market and use
- Processing of applications for research and development
- Authorisation of biocidal products in cases of unforeseen danger (Exceptions: Decontamination (Robert Koch-Institut, RKI) and disinfestation (Federal Office of Consumer Protection and Food Safety, BVL)
- Exchange of information with state authorities with regard to 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 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 ECHA on the authorisation of biocidal products, as well as on specific topics relating to the authorisation procedure
- Participation in the REACH-CLP-Biozid Helpdesk