WRITTEN QUESTION P-2921/01

by Phillip Whitehead (PSE) to the Commission

(17 October 2001)

Subject: Plant Protection Products Directive 91/414/EEC and Regulation 451/2000

Does the Commission accept that a failure to notify an active substance under the second and third stages of the work programme (Commission Regulation 451/2000(1)) may be due to the inability of small and medium-sized enterprises to meet the considerable costs involved in the notification and evaluation of the active substance, and not to their lack of interest or knowledge?

Does the Commission not agree that this may lead to a perverse situation where safer and more effective pesticides are compulsorily taken off the market while less safe and less effective pesticides are allowed to remain on the market, simply because they are supported by larger firms who can afford the very large sums which are charged for evaluation and notification?

In light of the ongoing review of the work programme as required by Article 8(2) of Directive 91/414/EEC(2), will the Commission consider allowing derogations on active substances that have not been notified by the date set out in Regulation 451/2000, where it can be proved that the lack of notification was due to the inability of reputable small firms, which are supposed to be at the heart of the EU's strategy for economic growth, to meet the substantial costs of notification and evaluation which may exceed their actual annual turnover?

(1) OJ L 55, 29.2.2000, p. 25.

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

Answer given by Mr Byrne on behalf of the Commission

(20 November 2001)

The Commission is aware that pesticide manufacturers took many factors into consideration when reaching decisions on whether to notify individual substances under the second and third stages of

the work programme under Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC. It acknowledges that economic reasons could have driven decisions by manufacturers, including small and medium enterprises (SMEs), not to notify certain active substances even though the Directive encourages the formation of industry task forces and the submission of joint dossiers to reduce the costs of defending substances in the review.

In the absence of assessments of the safety of individual substances, the Commission has no basis on which it could agree with the hypothesis that this may lead to a situation where safer and more effective pesticides are taken off the market. Application of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market will lead to a situation where only the safe and effective use of pesticides will be permitted in the Community. Nevertheless, the Commission is aware of the enormous challenge faced, in particular by SMEs with regard to their capacity for innovation through the very comprehensive regulatory requirements that aim at guaranteeing health and environmental safety and effective crop protection.

The Directive placed the protection of health and the environment above the needs of agricultural production and provided for a Commission Decision not to include in Annex I those active substances for which the requisite information and data were not submitted within prescribed time periods. Recital 15 of Regulation (EC) No 451/2000 acknowledged that, if necessary, it may be appropriate to re-examine these provisions for certain uses which are essential and for which there is no alternative available in order to efficiently protect plants or plant products or to allow the development of alternatives replacing the use of withdrawn products. It also recognised that the necessity of re-examining those provisions would have to be demonstrated on a case-by-case basis. Recital 16 of the Regulation states that if, for a particular active substance, the requirements concerning notification and submission of complete dossiers are not satisfied, interested parties are not prevented from seeking inclusion of such active substances in Annex I to the Directive at a later date in accordance with the procedures under Article 6(2) of the Directive.