First application for authorisation/registration

The placing on the market of biocidal products is harmonised under the Biocidal Products Directive 98/8/EC (BPD). Biocidal products (BP) within the EU are thus subject to authorisation/registration (abbreviated A/R) according to Community principles. In Austria, the BPD (along with its provisions for the placing on the market of biocidal products) has been transposed into national legislation with the Biocidal Products Act and the Biocides Act-Ordinance on Existing Active Substances (see Regulations).

In principle, for a biocidal product that is subject to A/R an application for first A/R must be submitted in one or several of the EU Member States. In all other Member States where the placing on the market of the product is also intended or where it should remain on the market, an application for mutual recognition has to be submitted. A new biocidal product that is subject to A/R must not be placed on the market before A or R has been granted.

In order for A/R to be granted according to EU principles, all active substances contained in the biocidal product must have been evaluated and included in Annex I or IA of the BPD (transposed into Austrian law through the Biocides Act-Ordinance on Existing Active Substances).

For a first A/R the following three cases (with different applicable deadlines and provisions) can be distinguished:

a) New biocidal product containing new active substances

b) New biodical product containing existing active substances

c) Existing biocidal product containing existing active substances

Definitions:

“existing” or “new active substances”: See Biocidal Products Act Section 2 (1) 16 and 17.

“new biocidal products”: See Biocides Act-Ordinance on Existing Active Substances Section 7

a) In the case of a new biocidal product containing one or several new active substance(s), the inclusion of the new active substance(s) in Annex I/IA of the Biocidal Products Directive 98/8/EC first has to be applied for. If the authority has decided that the criteria for inclusion have been fulfilled for the (last of the) active substance(s), an application for temporary A/R of the product can be accepted, making the product marketable before the inclusion of the (last) new active substance in Annex I/IA. Actual A/R will be granted upon inclusion in Annex I/IA, following the positive result of the respective EU decision-making process.

b) A biocidal product containing one or several existing active substances is regarded as a new biocidal product if it has not been placed on the market in Austria before the date of inclusion in Annex I/IA of the BPD of the first active substance contained in the product. A new biodical product must not be placed on the market until A or R has been granted.

c) A biocidal product containing one or several existing active substance(s) is regarded as existing biocidal product if it has been placed on the marked in Austria before the date of inclusion in Annex I/IA of the BPD of the first active substance contained in the product. Before the inclusion of the (first) active substance in Annex I/IA, the Austrian biocidal products authority has to be notified of the placing on the market of the respective biocidal product by submission of a Safety Data Sheet in German. Upon inclusion in Annex I, existing biocidal products become subject to application; they may nevertheless remain on the market until the A/R procedure has been completed. If a biocidal product contains several active substances, the date of the inclusion of the last active substance in Annex I/IA is the reference date for the obligatory submission of an application for A/R.

Use of BP not covered by Annex I/IA inclusion

If the use of a BP for which an application for A/R has been submitted is not covered by the conditions for including the active substance contained in the product in Annex I/IA of the BPD (see “specific provisions” in the Annex of the relevant active substance Inclusion Directive and the conditions in the Assessment Report), an additional evaluation of the active substance has to be performed and the entry Annex I/IA of the BPD has to be changed accordingly.

Specific requirements for authorisation and registration

Biocidal products which are classified as toxic, very toxic, carcinogenic, mutagenic or toxic for reproduction (category 1 or 2) shall only be authorised for use by professional users. Authorisation of biocidal products of the product types avicides (PT 15), piscicides (PT 17) and control of other vertebrates (PT 23) is not allowed in Austria.

Biocidal products authorised/registered according to EU rules and regulations in Austria can be accessed in the Austrian biocidal products register.