In the past, European Parliament issued Directives that were turned into national law in each Member State (MS). Little (if no) harmonisation exsisted as each MS interpreted the Directive in their own way resulting in products authorised in one MS not being authorised in another.
The Biocidal Product Directive (BPD) is European Union Directive (98/8/EC) that has three main objectives:
1. to harmonise the European market for biocidal products and their active substances so that the product authorisation content in one Member state (MS) can be recognised by other MSs;
2. to provide a high level of protection for people, animals and the environment through risk assessment of the use of biocidal products. This requires the submission and evaluation of data relating to substances', chemistry, toxicity to humans and ecotoxicity and fate in the environment;
3.To ensure Products are sufficiently effective against target species.
Revision of the BPD
On 12 June 2009, the European Commission adopted a proposal for a Regulation concerning the placing on the market and use of biocidal products (COM(2009)267). It will repeal and replace Directive 98/8/EC.
The Regulation aims to improve the functioning of the internal market in biocidal products while maintaining the high level of the environmental and human health protection. The proposal will build on the principles laid down in Directive 98/8/EC, in particular the two-tier authorisation process: firstly, the inclusion of the active substance in Annex I and secondly, the authorisation of the biocidal product. The regulation entered into force on 1 January 2013.
Further information on the EU Biocidal Products Directive/Regulations can be obtained here
As well as a core data set required for registration, there are specific additional data requirements depending on the biocidal product type. Brixham Environmental Laboratory is experienced in designing the appropriate testing strategy for a particular biocidal product and in agreeing that strategy with the regulatory authorities.
Brixham Environmental Laboratory is able deliver all studies required for the environmental component of the submission.