EN Official Journal of the European Union CE 84/942

(2004/C 84 E/1041)

WRITTEN QUESTION P-1085/04

by Paul Lannoye (Verts/ALE) to the Commission

(1 April 2004)

Subject: Evaluation of plant health products under Directive 91/414/EEC

The evaluation of plant health products under Directive 91/414/EEC (1) is confined to that of the active substances forming part of their composition.

Research carried out by a team headed by Gilles-Eric Séralini at the University of Caen has proved beyond all doubt that the product Roundup® inhibits the action of aromatase, while for glyphosate, an active substance forming part of the composition of that herbicide, the effect is visibly weaker, Research by the same team on the viability of placenta cells has shown that Roundup® is toxic in small doses and that its toxicity is approximately five times that of glyphosate.

Research into sea-urchins by the cell cycle and development laboratory at the biological station in Roskoff (France) has drawn attention to the action of Roundup® on a cell division regulator, whereas glyphosate, used alone and without the additives of the commercial formula of Roundup®, does not have that effect. It therefore appears clear that glyphosate, an active substance included in Annex I to Directive 91/414/EEC, does not have the same properties as Roundup® and that the latter is considerably more dangerous than its active substance.

Another example of pesticides being more toxic than the active substances forming part of their composition is the case of pyrethrinoids. Piperonyl butoxide is generally added to these as a synergist, reinforcing the action of pyrethrinoids by inhibiting an enzyme capable of degrading those active substances. These pesticides therefore visibly have toxicological properties that are different from those of the active substances of which they are composed.

It is more than clear from these two examples that it is a serious methodological error to limit evaluation to the active substances forming part of the composition of plant health products.

What measures does the Commission intend to introduce to put an end to this practice of incomplete evaluation, which can occlude the existence of severe effects on health or ecosystems?

Answer given by Mr Byrne on behalf of the Commission

(23 April 2004)

While unable to comment on the validity of the studies the Honourable Member mentions, we consider his question apposite, but wish to make some qualifications.

It is correct that only the active substance is included in Annex I to Directive 91/414/EEC (2). Inclusion follows a safety evaluation in line with the requirements set out in Annex II.

However Annex III sets out specific requirements that have to be met for plant protection products, i.e. for the actual product formulas. These have to be given a similar evaluation to that for active substances.

Detailed quantitative and qualitative information has to be provided on the product's composition. The additives, the amounts of these and their technical function must be correctly identified. Additives can in specific cases be made subject to the same rules as those covering active substances.

It is accepted that the formulas authorised at national level can differ in order to take account of intended use and of specific conditions, in particular climatic and geological. But this cannot be allowed to lead to any decline in the high level of safety and protection required in the Union. Accordingly Annex VI to Directive 91/414/EEC sets out the uniform principles that Member States must apply when evaluating products and deciding whether they can be marketed.

We intend drawing up a proposal for amendment of Directive 91/414/EEC that will be submitted to Parliament and the Council. In preparation for doing so we shall be reconsidering the legal position of the various types of additive, in particular synergists, solvents and diluents, and if appropriate proposing that in future they be subjected to specific requirements.

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

(2) 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.