Developing the technical guidance document on data requirements for biocidal products

IRG/WP 98-50101-02

P Karvinen, E Nikunen

Finland has been developing a discussion document for EC and the Member States concerning the specified data requirements for 23 biocidal product types, including wood preservatives, and their active substances. This data is required when applying for authorisation for a wood preservative according to the forthcoming Biocides Directive. The data requirements comprise of the core data set, which is common for all product types, and the product type specific additional data sets. The core data set has been outlined in the common position of Biocide Directive adopted by the EU Council and has only been complemented with some technical details. The data required in the additional data set is supplementary to the core data set and it takes into consideration the product type specific properties and direct and indirect human and environmental exposure. At the same time other guides have also been preparing: a guide for risk assessment of active substances by Sweden and a guide for risk assessment of biocidal products by UK. Close cooperation with these projects is an essential part of the preparatory work. After finalizing the draft discussion papers by the end of February 1998 the formal discussion on these will take place with EC and the Member States during 1998. The proposals on the data requirements will be circulated for comments to the EC, the Member States, industry and other interested parties. The final document will be addressed to the authorities and the applicants.


Keywords: BIOCIDES; AUTHORIZATION; TECHNICAL GUIDANCE

Conference: 98-02-02/03 Cannes-Mandelieu, France


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