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  • Technical notes for guidance in support of Annex VI Directive 98/8/EC � concerning the placing of biocidal products on the market. Common principles and practical procedures for the authorisation and registration of products

Abstract

This guidance document is intended for use by the competent authorities appointed by Member States under the provisions of Directive 98/8/EC. It is issued by the European Commission to help competent authorities carry out their obligations when considering applications for the authorisation or registration of products. The guidance is also intended to be useful to those making applications for authorisation or registration of products. It should help them understand how the risk and efficacy assessments are conducted and how decisions or conclusions are reached, including, on occasion, the need to request further data.

Annex VI of the Directive lays down harmonised principles ('Common Principles") for the appropriate evaluation of risk and efficacy for biocidal products, to enable decisions resulting in a high level of protection for humans, animals and the environment. This document is primarily intended to amplify and explain the Common Principles, and it gives detailed practical guidance about how to assess risks and efficacy for the purposes of authorisation or registration. In addition, it provides guidance on practical aspects of administration, in particular the use of frame formulations, data protection and confidentiality.

Additional information

Authors: RASMUSSEN K, European Commission, Joint Research Council, Institute for Health and Consumer Protection, Toxicology and Chemical Substances Unit, Ispra (IT);KAPPES D, European Commission, Joint Research Council, Institute for Health and Consumer Protection, Toxicology and Chemical Substances Unit, Ispra (IT);PEDERSEN F, European Commission, Joint Research Council, Institute for Health and Consumer Protection, Toxicology and Chemical Substances Unit, Ispra (IT);ASCHBERGER K (EDITORS), European Commission, Joint Research Council, Institute for Health and Consumer Protection, Toxicology and Chemical Substances Unit, Ispra (IT)
Bibliographic Reference: EUR 20683 EN (2003), 211pp. Free of charge
Availability: Available from European Commission, JRC Knowledge Management Unit, Ispra (IT) Tel: +39 033278 9843 or +39 033278 9864 Fax: +39 033278 9623 E-mail: jrc-publications-office@ec.europa.eu
Record Number: 200316481 / Last updated on: 2003-07-28
Category: PUBLICATION
Original language: en
Available languages: en