Disinfectants must be effective and safe to use. In Germany, the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, BAuA), and other national assessment bodies are equipped with statutory powers to assess whether this is the case from a technical point of view and draw on the results to conduct authorisation procedures. Fundamentally, the assessment of disinfectants - like that of other biocidal products too - is carried out in a two-stage procedure. The first stage sees the active substance’s properties, effectiveness, and risks assessed at the EU level. This stage ends with a decision on whether the active substance can be approved or not.

The second stage is the authorisation process. A product authorisation application must be submitted for disinfectants that contain approved active substances. Only once the application has been scrutinised exhaustively by the authorities is a decision taken about whether or not to authorise the product in question, which can be done at either the national or EU level.

Of the standard procedures begun to date for the approval of active ingredients and subsequent authorisation of disinfectants, however, not all have yet been concluded. At the moment, many disinfection products are therefore marketable in Germany on the basis of transitional arrangements, even though they have not actually been authorised. They still need to be assessed, with the consequence that it remains to be decided whether these products should be permanently authorised. Were it to be found in the course of such procedures that an active substance or product posed unacceptable risks to humans, animals, or the environment, that active substance or product would not be approved or authorised for disinfection purposes, even if it were highly effective.

The use of disinfectants helps decisively to prevent transmissible diseases among humans and animals. At the same time, these products can pose risks for employees, animals, and the environment. BAuA therefore assesses disinfectants and contributes to authorisation procedures in order to ensure a sensible balance is struck between effectiveness and safe use, and suitable products are available. Further information about the use of disinfectants in practice can be found in baua: Aktuell 04/2025 (p. 7, German).

A comprehensive understanding of disinfectants’ properties and uses is helpful in the search for alternatives to disinfectants that are to be substituted because they have particular properties. In view of this, BAuA engages actively in ongoing dialogue with industry and scientific associations, businesses, higher education institutions, and experts.

Furthermore, the Biocidal Products Regulation allows the authorities to adopt temporary derogations from the regulation’s requirements for substances or products that are absolutely essential from the perspective of infection control. Since temporary derogation does not involve an application procedure requiring the usual data to be supplied, it is necessary to have a good knowledge of the intended applications and possible alternatives.

A case in point: temporary derogations during the SARS-CoV-2 pandemic

At the end of February 2020, when the demand for effective disinfectants expanded dramatically in the health sector, this demand could be met in Germany thanks to a general administrative act on the placing on the market of hand sanitisers and surface disinfectants. This allowed the sale of products that would not have been marketable under the regular provisions of biocidal products law.

The last of the temporary derogations that dated back to the SARS-CoV-2 pandemic expired in April 2021 because the production capacities for disinfectants that had been marketable prior to the pandemic were enough to meet demand again.

In future too, it will remain important to be capable of responding appropriately to unusual events and potential shortages of specific disinfectants by having recourse to temporary derogations.