WRITTEN QUESTION E-3553/97 by Jan Sonneveld (PPE) and Jan Mulder (ELDR) to the Commission (12 November 1997)

Subject: Small producers of generic plant-protection products in the European Union

Can the Commission provide substantiated answers to the following questions:

1. Is it aware that as a consequence of Council Directive 91/414/EEC ((OJ L 230, 19.8.1991, p. 1.)), smaller European producers of generic plant-protection products are experiencing great difficulties, since they neither have access to the required data that are necessary for securing approval of the plant-protection products produced by them, nor are they able to refer to data already known to larger producers owing to obstruction by the latter, and cannot afford the very high research costs involved in deriving such data?

2. Is it aware that larger producers are taking advantage of this situation and are likely to recover their monopoly or oligopoly on the Community market in protection products, including generic ones?

3. Is it aware that the smaller producers are prepared, provided that they are still admitted to the re-evaluation programme, to pay a reasonable fee for the right to refer to the studies already completed by the bigger producers?

4. Does it not take the view that, as regards the active substance in future lists, all producers should be compelled to cooperate, so that only one dossier would need to be submitted for each active substance?

5. Does it agree that an independent body could arbitrate in that process?

6. Does it agree that such a system would prevent waste of resources and maintain competition?

7. Is it aware that detailed plans for such a system have been drawn up by smaller producers and that such a system has worked to the complete satisfaction of all parties for some years now in the United States?

Answer given by Mr Fischler on behalf of the Commission (5 January 199!)

The Commission is fully aware of the extensive requirements in Directive 91/414/EEC with regard to the delivery of data necessary for the evaluation of pesticide active substances and of plant protection products, and with regard to the protection of these data to the benefit of the companies that submitted these data.

Plant protection products are known as products with high potential risks for human health and the environment. It is normal therefore that they are extensively tested for all known possible effects they may have in relation to human and environmental safety. This implies the presentation of detailed study reports by the industry concerned on each of the multiple safety aspects which need to be addressed.

Given the high costs of many of the required study reports, the Council, in adopting Directive 91/414/EEC, provided for an extensive regime of protection of the data to the benefit of those companies which financed the studies concerned. In this way companies are encouraged to bring forward the required data with the consequence that new or existing products for which these studies demonstrate that the current high safety requirements for human health and the environment are satisfied for the products concerned, can come to the market or remain on the market to the benefit of Community agriculture.

Council Directive 91/414/EEC, in its Article 13(7), provides, with regard to data requested with a view to inclusion of an active substance in Annex I to the Directive, the principle of encouraging data holders to cooperate in the provision of data. In line with this principle, Commission Regulation (EEC) No 3600/92, laying down the detailes rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/14/EEC concerning the placing of plant protection products on the market ((OJ L 366, 15.12.1992. )), provided that all notifiers for active substances have to take all reasonable steps to present collective dossiers. For many, but regrettably not all, active substances this led to the formation of task forces where several companies worked together for a collective dossier. For those cases where the presentation of collective dossiers was not realized, the Commission, by its Regulation (EC) No 1199/97 of 27 June 1997 amending Regulation (EEC) No 3600/92 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market ((OJ L 170, 28.6.1997. )), provided that the notifiers concerned can, at an early stage, obtain information on the studies for which protection is claimed. In this way these notifiers can take any steps to bring forward adequate data, if need be, by producing the studies independently or in co-operation with other notifiers.

The Commission is willing to consider, in the framework of a future proposal for amendment of the basic Directive 91/414/EEC, the possibility for reviewing the provisions in question, taking into account the experience gained with the current provisions, and also considering any proposals organizations representing the industries concerned may bring forward.