Navigation and service

Hinweis zur Verwendung von Cookies

Cookies help us to provide our services. By using our website you agree that we can use cookies. Read more about our Privacy Policy and visit the following link: Privacy Policy

OK

Authorisations for disinfectants for hygienic hand disinfection by way of exception

Details on the authorisation of hand disinfectants by way of exception

Due to the spread of coronavirus SARS-CoV-2 in Germany, the Federal Government has observed an increased demand for disinfectants for disinfection of the hands which could not be met sufficiently by the resources available so far with the applicable regulations. Therefore, the BAuA [German Federal Institute for Occupational Safety and Health] was asked to issue authorisations by way of exception pursuant to Article 55 (1) of the biocidal products regulation for the short term by means of general decision to allow pharmacies, the pharmaceutical and chemical industry and entities under public law to manufacture additional hand disinfectants and make them available on the market.

On 04 March 2020, the BAuA issued a “general decision on the authorisation of biocidal products containing 2-propanol for hygienic hand disinfection”. On 13 March 2020, it was supplemented by another general decision on the authorisation of biocidal products containing 2-propanol, 1-propanol and ethanol for hygienic hand disinfection. On 20 March 2020, the second general decision was updated, enlarging the circle of addressees. Both general decisions were replaced by the “general decision on the authorisation of biocidal products containing 2-propanol and ethanol for hygienic hand disinfection for distribution to and use by professional users and consumers and on authorisation of biocidal products containing 1-propanol and ethanol for hygienic hand disinfection for distribution to and use by professional users due to a danger to public health and on annulment of the general decision dated 4 and 20 March 2020” dated 09 April 2020.

General decision issued 09 April 2020 (last updated on 15 April 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 2-propanol and ethanol for hygienic hand disinfection for distribution to and use by professional users and consumers and on authorisation of biocidal products containing 1-propanol and ethanol for hygienic hand disinfection for distribution to and use by professional users due to a danger to public health and on annulment

Significant amendments:

  • Pharmacies and the chemical and pharmaceutical industry may now manufacture biocidal products containing 2-propanol and ethanol for distribution to and use by consumers also.
  • Additional compositions with a higher content of the active substance were added.
  • The general decision now also applies for certain compositions for which an application for authorisation pursuant to article 89 (3) of the biocidal products regulation had been submitted in time.

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. Additional supporting information regarding classification and labelling of hand disinfectants as well as sample labels are provided in German.

Downloads