The mutual recognition procedureor biocidal products in EU Principles, challenges and problems!

摘要

The Biocide Product Directive (BPD, 98/8/EEC) of ttie European Union is intended to balance the efficacy of biocides in their intended use(s) for their impact on human/animal health and the environment. The Directive gives the criteria to regulate the process of putting a biocide on the market and harmonizes the regulation of the EU Member States. Only biocidal commercial products that contain on active substance included in Annex I of lA of the BPD will be authorized for use. Active substances have to be evaluated to assess whether or not they will be included in Annex I or lA. Once on active substance has been included in such annexes, National Competent Authorities of Member States can authorize commercial products (mixture) containing such active. Once a product has been authorized in the first Member State, it will be possible to have it mutually recognized and authorized by other Member States (providing relevant conditions of use are similar) but specific application from other Member States is needed by the authorisation holder.