The Authorisation of Biocidal Products under the BPR
Over recent years the legislation concerning the placing of biocidal products on the market within the EU has changed significantly. We are seeing the gradual transition from national requirements to a harmonised European system of regulation. While the new EU wide system is based on a two phase approach, initially focussing on active substances, the second phase of this process is now impacting many companies who place formulated biocidal products, such as disinfectants, on the market. The change over from the diverse national approval systems to the BPR product authorisation process is triggered by the approval of the active substances that a product contains and product authorisation will now become essential if existing products are to remain on the market or before new products can be launched.
While certain biocidal products have traditionally been regulated under the old national rules in some Member States, the BPR requirement for product authorisation will impact all biocidal products that fall within scope of the BPR and represents a major change particularly for some products that may only have been lightly regulated in the past. As such, the requirements for BPR product authorisation can represent a significant challenge for companies who market these types of products. This article examines the process of product authorisation and some important considerations when planning to place a biocidal product on the market.
Historically the regulation of biocidal products has varied considerably within the various Member States of the EU. Nationally some groups of product such as rodenticides and insecticides have been regulated in most Member States, other types of biocide such as disinfectants and preservatives have been regulated in some Member States but not in others. Even where different Member States have had systems in place for biocidal products, the requirements have not been consistent and have varied considerably from country to country.
Because of this lack of a level playing field within the EU a harmonised system of control was proposed in the early 1990’s along the same lines as the harmonised system for agricultural pesticides (1). This draft non-agricultural legislation was introduced as the Biocidal Products Directive (2), or BPD, which was published in 1998 and implemented in Member States on 14 May 2000. The BPD was subsequently repealed and replaced by the Biocidal Products Regulation, or BPR (3),
in 2012. The BPD and the BPR are both based on a two phase process. The first phase involves the evaluation and ass ...