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Authorisation of surface disinfectants by way of exception

Details on the authorisation of surface disinfectants by way of exception

Due to the global spread of coronavirus SARS-CoV-2, there is an increased demand for disinfectants. With the current regulations, it had become apparent that it was not possible to make available sufficient quantities of raw materials. Therefore, the BAuA [German Federal Institute for Occupational Safety and Health] has issued authorisations by way of exception pursuant to Article 55, paragraph 1 of the biocidal products regulation. These decisions were made in close consultation with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety and the Federal Ministry of Health and are based on the topically available information.

On 2 April 2020, a general decision regarding the authorisation of biocidal products containing ethanol, chloramine-T and sodium hypochlorite for surface disinfection for distribution to and use by professional users due to a danger to public health was issued to avoid shortages in the area of surface disinfection also.

General decision issued 02/04/2020

After consultation with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, the Federal Office for Chemicals as the competent authority has issued the “general decision on the authorisation of biocidal products containing ethanol, chloramine-T and sodium hypochlorite for surface disinfection for distribution to and use by professional users due to a danger to public health” according to Article 55 (1) of Regulation (EU) 528/2012. The general decision is intended to ensure supply of surface disinfectants in the further course of the pandemic also.

To support the manufacturers of hand and surface disinfectants, the Federal Office for Chemicals has prepared FAQs in German for both, which you can download here.