Managing exceptional situations safely
In a pandemic there tends to be enormous demand for effective, safe disinfectants. Authorisation bodies therefore require particular knowledge about common disinfectants, possible alternatives, and their safe usage.
When the volumes of effective disinfectants needed in the healthcare sector rose sharply at the end of February 2020, it was only possible to satisfy the demand for them by issuing a general administrative act on the placing of hand sanitisers and surface disinfectants on the market. The products this covered would not have been marketable under the regular provisions of biocides law. These exceptional authorisations expired in April 2021 at the latest because production capacities were sufficient to meet requirements once again.
Despite not having been authorised, various products used for disinfection purposes can still be placed on the market in Germany at the moment on the basis of transitional provisions .
A two-stage procedure is followed for the assessment of biocides. In the first stage, active substances’ properties, effectiveness, and risks are assessed at the EU level. This stage ends with a decision on whether or not an active substance should be approved. The second stage is premised on the general requirement that biocidal products containing approved active substances have to be authorised before they can go on sale. Only following examination by the authorities is it decided at the national or EU level whether such products should be authorised or not.
The procedures for the approval of active substances contained in a number of disinfectants and those disinfectants’ subsequent authorisation have, however, still not been concluded.
These procedures sometimes result in the finding that an active substance or product poses unacceptable risks to humans, animals, or the environment. Even if it is highly effective, it will not then be approved or authorised for use as a disinfectant. With regard to substances or products that are absolutely essential from the point of view of infection control, the Biocidal Products Regulation provides for the instrument of derogation, under which the competent authorities may exceptionally permit products to be placed on the market. Since derogation is not a procedure triggered by the submission of an application, it presupposes knowledge about the essential uses envisaged and any possible alternatives. The Disinfectants Thematic Cluster is especially intended to illuminate the issues around such essential uses and alternatives.