Biocides | Background

The Biocidal Products Directive

The prerequisite for marketing of biocidal products is the inclusion of their active substance(s) into Annex I of the Directive. For new active substances, applications for Annex I inclusion can be submitted at any time. Existing active substances (key date 14th May 2000, i.e. entry into force of the Directive) either had to be notified for the "existing substances review programme" (see below) if intended to be further marketed, or to be identified if not further supported.

According to the intended use of a biocidal product, Directive 98/8/EC defines 23 different product types (PDF, 194 kB).

New and existing active substances

Existing active substances (i.e., actives that were already on the market before 14 May 2000) are subject to a ten-year review programme in order to evaluate if they can be included in Annex I of the Directive. Existing active substances had to be notified until March 2002 ( list of notified substances, PDF, 1.1 MB) in order to qualify for the review programme. Dossiers on existing active substances had to be submitted until October 2008. This first phase of the review programme (notification and identification) was regulated by the Commission Regulation (EC) 1896/2000 (PDF, 74 kB).

Active substances not notified are considered as new active substances. Dossiers on new active substances can be submitted at any time.

Substances not notified, but only identified had to be phased out until 01 September 2006.

The evaluation phase for notified actives (second phase) is split into four periods, as regulated by the so-called "Review Regulations".

Biocidal Products Regulation

The current Directive 98/8/EC is foreseen to be replaced by a new Commission Regulation – see the European Commission website.