Product assessment

Biocidal products: assessment of efficacy and potential risks

A biocidal product is any substance or mixture

a)  in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, or

b) which is generated from substances or mixtures,

with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

A treated article that has a primary biocidal function shall also be considered a biocidal product.

According to the BPR, biocidal products are subject to an authorisation procedure which is based on a competent authority assessment of their efficacy and of the risks they pose to humans, animals and the environment, in order to avoid insufficient effectiveness and unacceptable effects. A decision authorising a biocidal product also contains mandatory requirements for labelling and terms and conditions imposed on the use of the biocidal product if appropriate.

For biocidal product authorisations, a distinction should be drawn between existing and new active substances. (see Product marketability).

Biocidal products used for the control of birds, fish or other vertebrates (product types 15, 17 and 20) are prohibited in Austria in accordance with paragraph 4 of section 14 of the Biocidal Products Act.

A biocidal product may not be made available to the general public (consumers) if it meets the following criteria for classification: highly toxic, toxic, carcinogenic, mutagenic or toxic for reproduction (category 1 or 2). (see BPR, paragraph 4 of Article 19)

Information on product types on ECHA homepage

Product authorisation – different procedures

Several procedures can be considered for the authorisation of biocidal products. A biocidal product can be authorised nationally in an EU Member State, and then authorised in other EU Member States under a mutual recognition procedure (in parallel or in sequence). There is also the possibility of a Union authorisation which is valid throughout the European Union. A certain number of products are eligible for a simplified authorisation procedure. Detailed descriptions of these procedures can be found on the following pages.

For Norway, Iceland and Liechtenstein, the validity of the Biocidal Products Regulation (BPR) has been incorporated in the Agreement on the European Area, and the above mentioned procedures can be applied in these states as well. An agreement with Switzerland on the BPR came into force in April 2014.

Authorisation procedures on ECHA homepage

For more information on applicable fees have a look on the Ordinance of fee tariffs:

Legal basis - fees