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The German Chemicals Act (ChemG) designates the Federal Institute for Occupational Safety and Health as both the Federal Office for Chemicals (Registration Office for Biocides) and the Risk Assessment Unit for Occupational Safety and Health for the purposes of implementing the Biocidal Products Regulation (EU) No 528/2012. The duties of the Risk Assessment Unit are coordinated by the group 'Process lead and coordination of biocides' within Division 4. The Biocidal Products Regulation establishes a two-step procedure for the distribution of biocidal products on the European market. First, biocidal active substances are assessed in a European process and if an approval is possible the active substances are incorporated into a positive list. When a biocidal active substance is approved, biocidal products containing these actives go through a second step - an authorisation procedure.
During active substance evaluation, the unit assesses the risks associated with the use of active substances and products at workplaces. This includes the evaluation of exposure and risks for professional users and the specification of risk mitigation measures to ensure a safe handling at the workplace.
During product authorisation the Risk Assessment Unit formulates risk reduction measures for identified risks on the basis of national regulations. This includes forwarding hazard information and measures to protect employees which can apply to the product or specific types of intended uses.
To enable a safe use of biocidal products, specific occupational safety and health measures need to be formulated. This requires realistic modelling of exposure scenarios and protective measures proven in practice. In various projects, Division 4 has determined safe tasks applying different biocides. Among others, activities with expected high levels of exposure as spraying or handling concentrated products were determined. In addition, individual biocidal product types and related exposure scenarios were investigated in detail. These projects covered the product types insecticides, antifoulings and wood preservatives. Besides a comprehensive presentation of the various exposure scenarios, workplace measurements investigating spray processes and wood treatment were performed. In another project on wood preservation, the level of dermal exposure during the application of creosote was determined. Based on the projects' results, Division 4 develops concepts for the assessment of biocides. This also includes the development of an IT model for the evaluation of dermal and inhalation exposure when spraying biocides: the SprayExpo model.
In addition, Control Guidance Sheets are developed, which summarise the most important steps to ensure a safe handling at the workplace in a brief, comprehensible form. The aim is to improve the communication between the authorities and the applicant as well as between the employer and his biocides-using employees.
The units involved in the Risk Assessment Unit Biocides for Occupational Safety and Health are unit 4.1 'Exposure Scenarios', 4.3 'Toxicology' and 4.7 'Biological Agents'.