Testing for efficacy and potential risks

Uses and usage categories of biocidal products can be very diverse. Thus the EU Biocidal Products Directive (BPD) distinguishes between 23 product types in 4 main groups (disinfectants and general biocidal products; preservatives; pest control; other biocidal products).

As of 2009, biocidal products will be subject to a national authorisation or registration procedure in the Member States according to harmonised standards (see Austrian Act on Biocidal Products). The authorisation and registration is based on a detailed evaluation by the competent authorities with regard to the efficacy of the biocidal product and the risks it poses to humans, animals and the environment under the conditions of use. Thus insufficient efficacy and unacceptable effects shall be avoided, provided the biocidal products are properly used for the intended purpose. An official authorisation notice for a biocidal product also contains binding provisions for e.g. labelling and, where appropriate, detailed conditions of use.

Biocidal products with a low risk potential are subject to a registration procedure that is considerably less comprehensive with regard to the details and dossiers to be submitted to the authorities than the authorisation procedure. The fact that the risks arising from these products largely depend on the active substance is taken into account here. The active substance(s) contained in these biocidal products must all be listed in Annex IA of the Biocidal Products Directive (active substances listed in Annex IA have a lower risk potential; therefore they must be free from certain dangerous properties).

General provisions for the placing on the market and the use of biocidal products are stipulated in section 4 of the Act on Biocidal Products.

The principle of the Biocidal Products Directive - that only biocidal products authorised or registered according to the general provisions of the BPD may be placed on the market in the EU Member States - cannot be complied with in the case of existing active substances as long as a detailed evaluation of these active substances under the EU Review Programme has not been completed. This applies to biocidal products containing (an) existing active substance(s) that has (have) not been included in Annex I/IA. In Austria, these biocidal products are subject to notification according to section 27 (3) of the Act on Biocidal Products. Biocidal products that contain an existing active substance and have not been on the market in Austria before the date of inclusion of the active substance in Annex I/IA may not be placed on the market in Austria until authorisation or registration has been obtained (section 7 of the Biocides Act-Ordinance on Existing Active Substances). For products already on the Austrian market before the inclusion of the active substance they contain in Annex I/IA of the BPD, which are intended to remain on the Austrian market, the obligation to make an application applies from the date of inclusion of the active substance.

For a biocidal product containing a new active substance an application according to section 21 of the Act on Biocidal Products must be submitted: The application for authorisation has to be submitted to the competent authority, together with an application for inclusion of the new active substance in Annex I/IA of the BPD 98/8/EC and the details and dossier required according to Annex II and III of the BPD.

Furthermore, the sale of very toxic, toxic, carcinogenic, mutagenic or toxic for reproduction (categories 1 and 2) biocidal products is now confined only to professional users. Biocidal products used for the control of birds or fish (product types 15 and 17) are not allowed in Austria.