Biocides regulated since 1998

With the promulgation of the Biocidal Products Directive 98/8/EC (BPD), the EU created an instrument for the estimation, limitation and - eventually - the sustainable reduction of risks that may arise from the use of biocidal products. In order to accommodate experiences from 10 years of the Directive's implementation as well as current requirements, an amendment to the Biocidal Products Directive is currently underway. This amendment will take effect in two stages. Urgent updates will be adopted in 2009; the second stage which involves extensive amendments will take more time.

For the purpose of harmonisation of the EU single market for biocidal products and in order to provide a basis for harmonised product evaluation within the EU, existing biocidal substances are tested under a multi-stage working programme (EU Review Programme) for the risks they pose to humans, animals and the environment, as well as for their efficacy. In the First EU Review Regulation, a notification procedure was laid down for existing active substances. The following Second EU Review Regulation gave a list of all identified or notified active substances, with only those contained in biocidal products to be allowed to remain on the market in the long term, which had been notified for use in a product type under the EU Review Programme. At the same time, the detailed evaluation of active substances by means of four priority lists was stipulated, and the individual member states responsible - initially limited to the first two priority lists - specified.

To provide an improved overview of the latest updates for active substances under review, and in order to keep up to date with the progress and changes made under the EU Review Programme, the EU Commission adopted Regulation (EC) No 1451/2007, thereby repealing Regulation (EC) No 2032/2003 (2nd EU Review Regulation).

For some substance/product type combinations a new deadline for the submission of a dossier was established in 2010 by the Commission Decision 2010/84/EU.

Through the EU evaluation process and BPD Annex I/IA inclusion procedure, new active substances are subject directly to the provisions of the Biocidal Products Directive.

Once the evaluation of an active substance has been completed with a positive decision and the substance included in Annex I/IA of the Directive ("exhaustive list"), the national product authorisation or registration procedure for biocidal products containing this substance may start, on the basis of applications submitted to the competent authorities of the member states. As part of this procedure, the product-specific risks are evaluated.

In Austria, the Act on Biocidal Products, implementing the BPD, applies. The Biocidal Products Act and the Biocides Act-Ordinance on Existing Active Substances specify the requirements for the placing on the market of biocidal products subject to authorisation/registration and containing those active substances which have already been included in Annex I/IA of the Directive. Every Directive of the EU Commission amending the BPD for the purpose of the inclusion of an active substance in Annex I or IA requests the Member States, in Article 2, to adopt national laws, regulations and administrative provisions as required by the relevant date as stipulated. Implementing the Inclusion Directives at national level entails the obligatory transition from different national rules for placing biocidal products on the market to EU-wide harmonisation (see Article 16 (3) of the BPD).

A biocidal product containing a new active substance may not be placed on the market for the first time until its authorisation or registration has been obtained. Products containing an existing active substance listed in Annex II of Regulation (EC) No 1451/2007 for the relevant product type, but not included in Annex I/IA of the Biocidal Products Directive, are not subject to application, but to notification requirements.

Furthermore, the Biocidal Products Act contains inter alia provisions concerning labelling, advertising and notification requirements, as well as detailed monitoring measures. For all application-based evaluations a relevant fee - as stipulated in the Biocides Act-Ordinances on Mandatory Fees - has to be paid by the applicant.