The Biocidal Products Directive 98/8/EC (BPD) seeks to
establish a high level of protection for humans and the
environment, and to eliminate barriers to trade by
harmonizing the processes involved in placing biocidal products on
the European market. But it will also dramatically transform the
biocidal industry, since it will have far-reaching effects on those
who produce, distribute and use active substances.
The new Biocidal Products Regulation EU/528/2012
(BPR) was adopted on the 22nd of May 2012, and will
enter into force on the 1st of September 2013. This
regulation will repeal and replace the BPD, and introduces a range
of changes. Responsibility for the management of the biocidal
active substance approval and product registration will be moved to
the European Chemicals Agency (ECHA). More information on
other specific changes can be found on the websites of DG Environment of the European Commission and
ECHA. Given the timelines of the active
substance approval, it seems likely that the products based on our
active substances will be registered under this new regime.
The BPR describes biocides as chemical preparations containing
one or more active substances that are intended to control harmful
organisms by either chemical or biological means.
The classification of biocides is broken down into 22
Product Types (i.e. application categories), with
several comprising different subgroups.
Under the BPR, the system of product authorisation requires
two regulatory steps before a biocidal product can be
marketed. The first step is approval of the active
substance and the second step is on the specific formulated
biocidal products. Each requires a dossier per product type that
contains information on its biocidal efficacy, toxicological and
ecotoxicological properties, etc.
Read more information on the submitted
product types page.
Progress thus far
The dossiers submitted in 2007 have passed the evaluation period
and are currently subject to review by the Technical
See the Draft
competent authority report on circa.europa.eu
The dossiers submitted in 2008 are currently undergoing
evaluation by the Rapporteur Member State.
At the next step we are updating the dossiers according to
requests from the Technical Meetings. There will be further
discussions in 2013.
On the agency website you can follow the annex I entries by
clicking on these links:
Last Update: 11/2012