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DE 
Exemption for hand disinfectants updated
Due to the spread of the SARS-CoV-2 coronavirus in Germany, there was an increased demand for disinfectants for hygienic hand disinfection in spring 2020. As this demand could not be met by the authorised manufacturers under the existing legal regulations for biocidal products, the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, BAuA) issued a short-term exceptional authorisation by general decree, invoking Article 55 (1) of the Biocidal Products Ordinance, which allowed the production of additional hand disinfectants based on 2-propanol and ethanol by pharmacies and the pharmaceutical and chemical industry.
This general ruling of 09 April 2020 expires on 06 October 2020. Due to a renewed increase in the number of COVID-19 cases and because of the use of hand disinfectants in hygiene concepts in public life, there is still an increased demand for hand disinfectants that cannot be covered by the authorised manufacturers. Therefore, a new general decree, valid from 07 October 2020, was published on 16 September 2020, which continues to allow manufacture by pharmacies and the chemical and pharmaceutical industry. Except for the formulations containing 1-propanol, all previous formulations from April will only be continued under new names. The previous formulations 1 - 7 now become formulations A - G.
Formulations A - C are preparations containing 2-propanol with a 2-propanol content of at least 70 vol.-%. Formulations D - G are ethanol-containing preparations with an ethanol content of more than 70 vol.-%. In formulations A, B, D and E, in addition to the alcohol and purified water, small amounts of hydrogen peroxide and glycerol are contained.
It should be noted that formulations B (> 80 vol.-% 2-propanol, hydrogen peroxide, glycerol), C (70 vol.-% 2-propanol), E (> 85 vol.-% ethanol, hydrogen peroxide, glycerol) and G (80 vol.-% ethanol) meet the requirements of EN 1500 for bactericidal activity within 30 seconds in addition to limited virucidal activity. In the case of formulations A, D and F, these efficacy requirements are only met after two uses of 3 ml each and an exposure time of 30 seconds in each case.
Although hand hygiene through thorough hand washing is sufficient for the general population in everyday life to prevent the transmission of infections with the SARS-CoV-2 coronavirus via the hands, hygiene concepts of facilities and companies often provide for the offer and use of disinfectants for personal hand hygiene.
The production of hand disinfectants containing ethanol according to formulations D - F for internal use is permissible for any company, irrespective of the addressees of the general ruling, as long as these preparations are not placed on the market. Labelling with the hazard statements H225 "Highly flammable liquid and vapour" and H319 "Causes serious eye irritation" according to the CLP Directive as well as the statement "Not for human consumption" is also required for in-house use.
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