WRITTEN QUESTION E-1761/97 by Jan Mulder (ELDR) to the Commission (27 May 1997)

Subject: Use of biological crop protection products in the European Union

1. Does the Commission agree that the use of biological crop protection products should be encouraged, from the environmental point of view and from the point of view of consumers? In this connection can the Commission state how many biological and how many chemical crop protection products have been registered since July 1993?

2. Does the Commission take the view that the existing directive for the registration of biological crop protection products based on bacteria, viruses and other micro-organisms can adequately satisfy the requirements of the market and, in particular, that such products are rapid and cost the same as comparable chemical products?

3. If the Commission believes that this is not the case, what action is it considering in order to facilitate the use of biological products in the future?

4. Is the Commission of the opinion that from the economic point of view the systems for registering biological crop protection products in the European Union and in the United States are broadly comparable, and that the two trading organizations provide their businesses with the same encouragement to take part in international competition? If not, what action is the Commission considering to improve the competitive position of European businesses?

Answer given by Mr Fischler on behalf of the Commission (16 July 1997)

1. The use and authorization of plant protection products is regulated by Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ((OJ L 230, 19.8.1991. )). This Directive provides a Community decision for both chemical substances and micro-organisms (inclusion in a positive list) used in plant protection products and for national authorizations of the preparations containing them. In principle the criteria for both chemical substances and micro-organisms are the same, i.e. the use of the preparation and residues resulting may not have, in accordance with the envisaged conditions of use, any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment.

Since July 1993, 18 dossiers for chemical active substances and 3 dossiers for micro-organisms have been accepted as complete at Community level. A final decision for inclusion in the positive list can only be taken after a detailed evaluation on the basis of a report prepared by a Member State. Currently no chemical active substance nor micro-organism has been included in the positive list, as the examination procedures are still ongoing.

2. to 4. The requirements for the dossier to be submitted are different for chemical and microbial preparations. The data requirements for microbial preparations have so far only been established in general terms. Moreover, the Directive provides a certain flexibility when the applicant can justify that certain studies are not necessary to demonstrate that for particular aspects human health or the environment are not at risk. The costs for the preparation of a dossier for micro-organisms are normally lower than for chemical preparations but, in cases where there is reason for concern, costly testing may be required to demonstrate the absence of any harmful effects.

The Commission is currently preparing a working document in order to establish in detail the data requirements for micro-organisms. This document will be discussed in the framework of the Organization for economic cooperation and development (OECD) in order to establish harmonised data requirements for micro-organisms in all OECD coutries.

Moreover the Commission is considering whether to propose a fast track procedure for the authorization of certain low risk plant protection products, including biological plant protection products.