EN Official Journal of the European Union CE 88/556

(2004/C 88 E/0568)

WRITTEN QUESTION E-0997/04

by Dominique Souchet (NI) to the Commission

(31 March 2004)

Subject: Placing on the market of plant protection products

The Community system for the approval of plant protection products introduced by Directive 91/414/EEC (1) is chiefly based on a system for evaluating the active substances, with a reporting Member State being designated for each substance. This evaluation phase involves collecting studies carried out by plant protection firms themselves and forwarding them to the European Food Safety Authority.

Does the Commission consider that this one-way evaluation procedure makes it possible to ensure that the decision to approve a substance is taken in a sufficiently objective manner?

Furthermore, the protocols envisaged in the studies with a view to assessing the degree of toxicity of substances have not been updated in line with the appearance of new molecules on the market.

Should their specifications not be adjusted to take account of the performance and modes of action of these new substances, as otherwise it will not be possible to ascertain all the potential toxic effects of a new molecule?

The process for evaluating active substances is based on a four-stage system corresponding to four lists of substances.

Given that it is the undertakings concerned that choose which studies are to be carried out as a priority in each of the stages, does the Commission believe that this is the best system for guaranteeing compliance with health and environmental requirements?

Answer given by Mr Byrne on behalf of the Commission

(30 April 2004)

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market is based on the principle that the burden of proof of compliance with the Directive's main requirements rests with the applicant. Hence it is usual for the applicant to prepare, collate and submit the requisite studies supporting the application. The rapporteur Member State is required to check whether the file is complete, and only after that is the assessment proper started. The next stage comprises sending the draft assessment report to the other Member States for peer review. The Commission takes the final decision, in accordance with the procedures described in the Directive and its implementing rules. The Commission is required to consult the Standing Committee on the Food Chain and Animal Health and may also obtain scientific opinions from the European Food Safety Authority, which now carries out the tasks assigned in the past to a number of scientific committees, including the Scientific Committee for Pesticides and the Scientific Committee for Plants. Relevant comments from third parties may also be taken into account. In addition to Member States, the applicant is requested to answer technical questions. The discussions are clearly confined to scientific and technical matters relating directly to risk assessment.

In the light of the various aspects of the dossier (including, if necessary, the opinion of the European Food Safety Authority), the Commission refers it to the Standing Committee on the Food Chain and Animal Health, which gives its opinion on measures to be taken. Those measures may comprise inclusion of the substance in Annex I to the Directive, accompanied by the requisite instructions to ensure correct use, or non-inclusion. In both cases, a formal instrument is adopted.

The Commission therefore considers that the current procedure ensures a sufficient degree of transparency and independence, while providing the requisite mechanisms for interested parties to express their views.

With regard to the second part of the question it is worth noting that, under Article 7 of Directive 91/414/EEC, the applicant must immediately notify the competent authority of all new information on a potential risk. The competent authority is to notify that information immediately to the other Member States and to the Commission, which is to refer it to the Committee.

This case is different from the question relating to the speed of scientific and technological progress and hence the obsolescence of studies supplied. The Commission is aware that, in the course of evaluation procedures taking several years, studies supplied may be overtaken even before evaluation has been completed. However, experience shows that these cases are exceptional. Although additional studies are sometimes required during the procedure, it seems reasonable not to subject the applicant to constantly renewed requirements and to confine retroactivity to cases where new facts have recently invalidated existing data.

In general, decisions of this type can be taken only on a case-by-case basis, having regard to the high level of protection which Community measures must reflect, the significance of the risk involved and the need to provide legal certainty for the applicant.

The Commission nevertheless stresses that the cases referred to above may arise while substances are being evaluated, but also after they have been authorised. That is why authorisations are valid for a limited period and their renewal is subject to a fresh evaluation. In addition, Member States always have the possibility of recourse to safeguard procedures for products which, for various reasons, do not or no longer meet the required safety standard.

Lastly, Annexes II and III to the Directive — which list the requirements for dossiers to be submitted — are currently being amended to reflect the latest scientific and technological developments.

With regard to the division of substance evaluation into four stages, it should be noted that the differentiation is based firstly on safety considerations (priority being given to substances which are widely used and/or whose toxic and ecotoxic characteristics call for particular care) and then on efficient deployment of resources.

The Commission stresses that, at whichever stage a given substance is classified, the dossier will have to contain the studies specified by Community legislation. Exemption from that rule, for example in cases where the regulatory requirements are considered irrelevant, is subject to express acceptance by the Commission.

In addition, unsubstantiated absence or inadequacy of data constitutes grounds for the Commission to decide automatically not to include the substances concerned.

The Commission therefore takes the view that the applicant's margins of manœuvre are well-defined with regard to the studies to be supplied.

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