5.6.6S
REGULATORY CHALLENGES FOR NEW FUNGICIDES IN THE EU

DD SLAWSON

Pesticides Safety Directorate, Mallard House, Kings Pool, 3, Peasholme Green, York Y01 2PX, UK

In order to place new plant protection products on the market in the European Union, a prospective applicant must satisfy the regulatory requirements specified in Council Directive 91/414/EEC. Many of the major regulatory challenges facing the EU involve the influence of national 'politics' on science-based decision-making and the conflicts with the open market philosophy. These are challenges are open to speculation, are generic across different types of plant protection product (e.g. fungicides, insecticides, herbicides, etc.), and as such, are beyond the scope of this paper.

The regulatory challenges that relate to fungicides in particular, arise from interpretation of either the efficacy requirements, which are specified in Commission Directive 93171/EEC [1] or of the 'Uniform Principles', which are specified in Council Directive 97/57/EC [2].

Under Commission Directive 93/71/EEC, applicants must provide evidence on a range of efficacy-related issues, including effectiveness, resistance, yield (quantity and quality, including effects on transformation processes), phytotoxicity, unintended side-effects (succeeding crops, adjacent crops and propagation) and impact on beneficial organisms. It is also a requirement that trials submitted in support of an authorisation must be conducted by an 'official' or 'officially recognised' testing organisation.

This evidence should be submitted to the regulatory authorities in the form of a 'Biological Assessment Dossier', in which the applicants themselves are required to summarise, evaluate and assess the data concerned in the light of the relevant evaluative and decision making criteria. They are also required to make proposals for the decision, which in their opinion, reflect the conclusions that can be derived from the data and information concerned.

The regulatory authorities are then required to evaluate the data submitted in accordance with the ' Uniform Principles'. These lay down detailed principles concerning the evaluation of this information so as to ensure consistency between Member States and to achieve a high level of protection of human and animal health and the environment.

Many of these requirements and procedures may be new to a Member State or may differ from any well-established national requirements. For these reasons, there are wide differences in the views of Member States on a number of issues, such as the acceptability of foreign data, acceptable trials numbers, acceptable levels of disease control and information on fungicide resistance. In addition, some novel regulatory challenges have been created by the new classes of fungicide (e.g. strobilurins and systemic acquired resistance enhancers).

This paper aims to describe some of the important features of the new system and to offer opinion on some of these major challenges as they relate to fungicides.

References
1. Anon., 1993. Official Journal of the European Community, L221, 31 August 1993, 27-36. 2. Anon., 1997. Official Journal of the European Community, L265, 22 September 1997, 87-110.