Data requirements for wood preservatives in the EU Biocides Directive

IRG/WP 01-50166-08

H Braunschweiler

Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products (the Biocidal Products Directive, BPD) lays down the requirements on data needed for authorisation of a biocidal product and approval of its active substance(s). The dossier must contain data needed for the proper risk assessment of the biocidal product. A detailed technical guidance document on data requirements for biocides has been produced to ensure the harmonised decision making according to the BPD. The purpose of the guidance is to give detailed testing strategies e.g. for toxicology, ecotoxicology and efficacy of different biocidal products and active substances, including wood preservatives. The data requirements for biocides are divided in two parts: the common core data set lists the studies which are always required, and the additional data set lists the studies which may be required in certain cases e.g. on basis of the results of the tests in the common core data set, and proposed uses and the potential exposure for a biocidal product. The common core data set contains a very comprehensive list of toxicological studies and, therefore, their additional data set is very limited. Instead, for ecotoxicological studies the common core data set is very limited, but the additional data set is very broad. Therefore, the guidance document on data requirement lists those additional ecotoxicological studies that are usually always required for certain biocidal product types - also for wood preservatives - in the application for approval. Waiving for some toxicological studies may be needed to minimise the need for animal testing and to reduce the costs of testing. The technical guidance document for data requirements gives some guidance on such a possibility on exemptions on the data requirements. The need for additional ecotoxicological testing depends on the product type and potential exposure for a product. In addition, the environmental risk found as a result from common core data set is the basic criterion when deciding testing strategy and the need for the additional ecotoxicological testing on e.g. adsorption, degradation and bioconcentration. Issues important for wood preservatives are data required on efficacy and on leaching from treated wood.


Keywords: BIOCIDES DIRECTIVE; DATA REQUIREMENTS; TOXICOLOGY; ECOTOXICOLOGY; RISK ASSESSMENT; WAIVING; TESTING STRATEGIES

Conference: 01-05-06/02 Cannes-Mandelieu, France


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