BAuA: Exemption for hand disinfectants

Infections with the new coronavirus (SARS-CoV-2) have been confirmed in all 16 Bundesländer. Due to the spread of the coronavirus, there is an increased demand for antiseptic products for hand disinfection in Germany. Such preparations are currently practically no longer available in pharmacies and drugstores.

For this reason, the Federal Agency for Chemicals as the competent authority announced on 4.3.2020 the general ruling for the approval of biocidal products containing 2-propanol for hygienic hand disinfection in accordance with Article 55 (1) of Regulation (EU) No. 528/2012. The derogation is valid until 31.08.2020.

Thus, pharmacists and the pharmaceutical industry are now allowed to produce isopropanol-based hand disinfectants without an authorisation in order to counteract the shortage of disinfectants.

The manufacturers are responsible for the products and the compliance with the regulation – both those in the order itself and with additional regulations!

We can support you in the following areas:

  • Questions regarding the differentiation of pharmaceutical products, biocides and medical devices regarding disinfectants containing isopropanol
  • Regular application for product approval for sale at a later date
  • Advice on effectiveness, areas of application, restrictions, listings
  • Review of label designs against the requirements of the BPR and CLP
  • Review of advertising for compliance with the provisions of Article 72 of the Biocides Regulation
  • Notification of hand disinfectants based on old active substances (e.g. ethanol, active chlorine) in accordance with the transitional regulation at BAuA and BfR

Questions about safety data sheets and emergency numbers

Get in touch with us: <biocides@cfcsconsult.onmicrosoft.com>.  We will be pleased to provide you with a non-binding quotation.