The placing on the EU market of biocidal products is regulated by Directive 98/8/EC (in force since 14.05.2000).
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 (cut-off date 14.05. 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.
A comprehensive programme was developed to evaluate all biocidal active substances already on the market, and to subsequently subject all biocidal products to a national product authorisation procedure:
The evaluation phase for notified actives (second phase) is split into four periods, as regulated by the so-called “Review Regulations”:
Within each of the four review periods, a set of biocidal product types is reviewed:
