WRITTEN QUESTION E-0722/00

by Carles-Alfred Gasòliba i Böhm (ELDR) to the Commission

(17 March 2000)

Subject: Community procedure for the recording and placing on the market of active substances and plant protection products

Council Directive 91/414/EEC(1) of 15 July 1991 introduced a new system for the recording and placing on the market of plant protection products, together with a non-standard procedure for the recording of active substances and products containing those substances, which hitherto had been produced and circulated freely. SMEs are now feeling the severe impact of this unusual state of affairs as the number of substances added to Annex I of the Directive grows. In some instances, a party which gives notification of an active substance included in Annex I interprets Article 13(3)(d) of the Directive for its own ends rather than in keeping with Community principles and allows a third party to gain access to supplies of the substance and to the protected data it has requested, but charges outrageous prices in the process and attaches unreasonable conditions, given the market concerned. Those with exclusive rights take this course of action to force small and medium-sized competitors which have been working with such substances until their inclusion under Annex I of the Directive off the market.

Is the Commission aware of the threat which the aforementioned practice, based on a specific reading of the Directive, poses to SMEs in the plant protection sector? Likewise, is it aware of the danger which might emerge for traditional producers of active substances or manufacturers of plant protection products which use certain active substances in their products?

Is it the Commission's intention to permit such a practice?

Does the Commission intend to ensure that third parties seeking access to protected data should pay fixed amounts based exclusively on the cost of the file drawn up by the first notifying party, irrespective of the intended use of the data, and on the nature of applicants' products, their share of the market and their capacity and potential in terms of distribution and marketing? What measures does it intend to adopt to counteract the adverse effects of the Directive on SMEs in the sector?

(1) OJ L 230, 19.8.1991, p. 1.

Answer given by Mr Byrne on behalf of the Commission

(28 April 2000)

The use of plant protection products is regulated by Council Directive 91/414/EEC of 15 July 1991(1) concerning the placing of plant protection products on the market. The main objectives of this Directive are to (a) ensure a high level of protection of human health, for the consumer and for the producers of agricultural commodities, (b) ensure a high level of protection of the environment and resources and (c) ensure free circulation of plant protection products and agricultural produce in the Community.

The Directive provides for a positive list of accepted active substances that are considered as safe for human and animal health and the environment after a thorough evaluation. Member States can only authorise a plant protection product if the active substances it contains

are listed in the positive list and provided certain criteria concerning efficacy and safety for humans and the environment are satisfied. These criteria are harmonised (the so-called uniform principles). Also the Directive harmonises the data industry has to submit when applying for an authorisation. The data required from industry in order to demonstrate acceptable uses are much more demanding which implies that for products already on the market before the implementation of the Directive sometimes an important number of additional studies have to be provided.

The Directive contains provisions on data protection which have to be applied by Member States when granting authorisations. These provisions constitute a balance between the interests of those companies which are generating the necessary studies in order to demonstrate the acceptability of the use of a plant protection product and the active substance it contains and the interest of free competition on the market.

The Directive does not provide for a general system whereby applicants are obliged to share data at a fixed price with other interested applicants. On the contrary, it provides that, after inclusion of an active substance in the positive list, Member States may introduce national measures obliging applicants to share the data involving testing on vertebrate animals with a view to avoiding duplicative testing on vertebrate animals and determine the procedure for utilising information, and the reasonable balance of interests of the parties concerned. The Commission is aware that only a very limited number of Member States have made use of this possibility.

(1) OJ L 230, 19.8.1991.