Differences in risk and usage

Biocidal active substances exert a harmful or controlling effect on harmful organisms. The necessity to draw up a positive list of assessed active substances which may be contained in biocidal products within the European Economic Area resulted in the development and utilization of uniform principles (Annex VI of the Biocidal Products Directive).

The status of active substances (see flowchart) in the EU Review Programme has major consequences for the biocidal product.

In order to take into account the fact that not all active substances pose a high risk when used in biocidal products, the positive list of the Bioicdal Products Directive (BPD) 98/8/EC was divided into Annex I, IA and IB:

Annex I comprises all active substances which pose a higher risk under the conditions of use.

The active substances listed in Annex IA are intended for use in low-risk biocidal products. Under the conditions of use, these biocidal products shall pose only a low risk to humans, animals and the environment. An active substance may not be included in Annex IA if it is classified according to Directive 67/548/EEC as carcinogenic, mutagenic, toxic for reproduction, sensitising or bioaccumulative and does not readily degrade.

Substances whose major use is not biocidal but which have a minor biocidal use (either directly or in a product with a simple diluent) are included in Annex IB.

To date no application for inclusion of a basic substance in Annex IB has been submitted within the EU.