Biocidal products are intended to destroy, deter, render harmless, prevent the action of, or control the effect on any harmful organism by chemical or biological means. The Biocidal Product Directive (BPD 98/8/EC) aims at harmonising the European market for biocidal products and their active substances, while providing a high level of protection for humans, animals and the environment.
The BPD covers 23 different product types. Any biocidal products that fall into these 23 product types are within the scope of BPD.
Annex I of the Directive lists active substances considered acceptable for use in biocidal products. The BPD establishes a two-step process of approval. First, the evaluation of the active substance takes place at EU level and, then, the product authorisation at Member State level is carried out.
Several active substances covered by IMA-Europe are or are in the process of being included in Annex I.
Revision of the BPD
After eleven years of implementation, a proposal to revise the directive was introduced – this time in form of a regulation – in order to tackle identified weaknesses of the regulatory framework, as well as to improve and to update certain elements of the system, especially within the authorisation process. The Regulation No 528/2012 concerning the making available on the market and use of biocidal products (BPR) was adopted on 22 May 2012. It will repeal and replace Directive 98/8/EC, and will be applicable as of 1 September 2013.
One of the fundamental changes in the BPR is the introduction of the so-called “union authorisation” or mutual recognition, which gives the possibility for some biocidal products to be fully authorised at EU level giving them direct access to the entire EU market.
Other new aspects of the regulation are the extended scope to cover articles and materials treated with biocidal products and the European Chemicals Agency’s (ECHA) involvement in the scientific work.