International Congress BIOLOGICAL PRODUCTS - Gruppo di ...

BIOPESTICIDES: EVALUATION PROCESS FOLLOWING THE APPLICATION
OF THE DIRECTIVE 91/414/CE
M. Rubbiani
Istituto Superiore di Sanità
Laboratorio di Tossicologia Applicata
Viale Regina Elena 299 - 00161 Roma - ITALIA
E mail: rubbiani@iss.it
Directive 91/414/CE for new and existing (revision) biopesticides requests the same kind of full evaluation, in terms of
risk assessment, provided for chemicals.
The first application of the guidelines immediately showed the obvious differences between the two types of products
(chemical and micro-organism based pesticides), and the need to distinguish within the critical end points addressed to
both of them.
This yielded to revise the data requirements for risk assessment (Annex II part B and Annex III part B of the Directive),
because of the foreseeable problems due to the specific nature of the micro-organisms based pesticides.
The different aspects regarding the critical end points of the evaluation process, such as mode of action,
characterisation, toxicological and microbiological features, as well as the possible risk for human and environment are
fairly highlighted.
Moreover, the problems raised in relation to the use and handling of these products, as well as the possibility to develop
new strategies for a more suitable toxicological and ecotoxicological evaluation (correctly hazard- and risk- based) are
reported.
The activity within Directive 91/414/CE evaluation procedures at EU level and the activity of the National Committee
for the registration of biopesticides are also shortly described.
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