FAQ
Here you can find frequently asked questions related to disinfectants.
I would like to sell a disinfectant in Austria that contains an active substance which is still going through the approval process. May I advertise this biocidal product as a virucidal disinfectant?
According to BPR, promoting a disinfectant that is marketable in Austria as a virucidal product is possible if a virucidal effect exists and can be proved (e.g. by a study according to international standards) and as long as the active substances in question are being evaluated. This rule applies until authorisation is granted in accordance with BPR.
I would like to sell a disinfectant in Austria for which an application for authorisation has been submitted in accordance with BPR and for which the product evaluation process is still ongoing, and advertise it as a virucidal product, although the virucidal effect is not part of the application for authorisation. May I advertise this biocidal product as a virucidal product?
According to BPR, it is possible to promote a disinfectant as a virucidal product if that disinfectant can be marketed in Austria on the basis of an ongoing authorisation procedure and if a virucidal effect exists (i.e. if the applicant can demonstrate the minimum level of efficacy) and as long as the products in question are being evaluated. This rule applies until authorisation is granted in accordance with BPR.
Note: An application for inclusion of the respective use after the marketing authorisation has been granted can be made by submitting a request for an amendment (providing relevant studies).
What should I know about alternative biocidal products or “home remedies” such as vinegar before using them as disinfectants?
Basically, a biocide assessment consists of an estimate of the efficacy of the product and of the risk it poses to humans, animals and the environment, using harmonised study data generated for a particular biocidal product and the active substances it contains.
For the minimum level of efficacy, parameters have been established that a product must comply with in order to qualify for approval.
In the case of biocides offered as alternatives, such as vinegar, it should be noted that although acetic acid has been approved as a biocidal active substance no authorisation has as yet been granted for a product. The active substance has been shown to have certain biocidal effects which, however, depend on the type of use and on the target organism.
As an organic acid, vinegar has been shown to have a biocidal effect on bacteria. As this is also known from the literature, it has served as the basis for its approval as an active substance, but there is no clear evidence in the literature of a virucidal activity.
It should be noted that, in order to demonstrate the minimum level of efficacy, studies and tests must be carried out according to the EN standard and under clearly defined conditions. So far, it has been shown that vinegar has a certain virucidal effect, but this effect does not correspond to the minimum efficacy requirements. This means that the reduction in the amount of virus particles in a short space of time is not enough.
Therefore, on the basis of the available data, it cannot be concluded that these alternative products are sufficiently effective against viruses and especially against enveloped viruses, which include the coronavirus.
It is therefore not advisable to use such products as an alternative to disinfectants that have been evaluated and approved.
What do I have to consider when labelling biocidal products?
First, it should be noted that harmless or misleading names such as "natural" are not allowed for biocidal products according to Art. 72 of the Biocidal Products Regulation.
In order to be able to adequately assess the obligations and the marketability of a biocidal product, it is essential that the active substance is clearly identified and named by the company that places the biocidal product on the market. The names to be used for the active substance must be those that are listed in the Review Regulation or on the Art. 95 list. These names must be shown on the label in accordance with Art. 69 of the BPR and in the safety data sheet, if necessary.
Depending on which active substance is used, the marketability of the biocidal product must be assessed. As a first step, this decision is the responsibility of the person placing the product on the market.
In general, the following applies:
For biocidal products that contain active substances that are listed in the Review Regulation (EU) No. 1062/2014, but have not yet been included in the Union list of approved active substances or in Annex I to the Biocidal Products Regulation (EU) 512/2012, marketing in Austria is still permitted for the notified product types until the active substances are included in the Union list or else until there is a decision for non-inclusion.
After the inclusion of (an) active substance(s) in the Union list of approved active substances, biocidal products containing this/these active substance(s) must be authorised for making them available on the market in accordance with the Biocidal Products Regulation.
The Austrian Biocidal Products Act does not require any registration or notification for biocidal products that are as yet not subject to the EU approval process. Therefore, in Austria biocidal products do not have to be registered or notified in the transitional phase in order to be marketed. Therefore, no biocide registration or notification number is issued. In case, the biocidal product comes within the scope of Art. 45 CLP, emergency health information has to be provided.
Provided that all other relevant provisions of the BPR (e.g. labelling provisions, prohibition and restriction provisions, marketing provisions according to the Review Regulation, biocidal products with approved active substances etc.) and the relevant Austrian and European regulations (e.g. chemicals law, REACH and CLP Regulation) are complied with, the products in question are allowed to be made available on the market in Austria.
In particular, reference should be made to Art. 95 of the BPR, which states that only active ingredients from a source that is listed in the so-called "Art. 95 list" may be used.
Note: If a company intends to place a biocidal product on the market in Austria or in the EU, it can only do so by complying with complex legal provisions which are essentially based on the REACH, CLP and BPR regulations. It is recommended that you carefully examine the basic requirements of these regulations in order to be able to guarantee legal marketing compliance.