A more detailed review of the provisions of the Biocidal Products Directive than that appearing at  EELR 204. The position in the Member States. The background to the Directive. Scope; definitions. Procedures for EU authorizations of active substances and for Member State authorizations of products containing active substances; data to be included in application dossiers - basic and specific data.
Procedure for the inclusion of an active substance in Annex I, I A or IB: who may apply; the dossier on the active substance and on at least one product containing the active substance; evaluation by the reviewing Member State - completeness check, evaluation, report; Commission proposal and decision on the application; duration and renewal of listing; terms of listing; consequences of refusal of an application. Comparative assessment of active substances leading to refusal of listing or de-listing of an active substance where an alternative substance, posing less risk, is already listed - a shift from risk assessment to risk management; proposed technical guidance on comparative assessment.
Product authorization by Member States. Mutual recognition of product authorizations; procedure; refusal to grant mutual recognition; recognition subject to restrictions; modifications to original authorization.
Technical aspects: principles for the evaluation of active substances and products; extensive data requirements; risk assessment based on the identification of hazards, assessment of exposure and likelihood that hazards will arise. Classification, packaging, labelling and safety data sheets in respect of biocidal products and active substances.
The expense of meeting the data requirements for listing; confidentiality to be observed by the competent authorities if so requested by the applicant; justification for such a request; data protection and its consequences; differences between confidentiality and data protection; periods of data protection; access to the data of other applicants by agreement. "Task forces" and cooperation in the use and development of data - advantages and disadvantages.
Ten-year transitional period and review of existing active substances; Enforcement by the Member States; their discretion; interpretation of the Directive, which is based on Article 100(a), EC Treaty (the internal market).European Energy and Environmental Law Review