This case concerned an annulment of Commission Directive 2003/112/EC of 1 December 2003 amending Council Directive 91/414/EEC by Sweden before the Court of First Instance (Now the General Court). This case was brought by Sweden against the Commission’s decision to authorize paraquat as an active substance to be used as a herbicide[2].
In the instant case, the key issue is whether the scientific dossier relied on the Commission does not contain enough evidence to conclude that paraquat does not pose a significant risk to human health[3].
The Court in this case deeply engaged in scientific issues. In particular, it deeply examined whether the Commission failed to examine two important scientific studies. Although the Commission relied on the opinion of the Standing Committee to enact short-term exposure to paraquat at 0.005 milligrams per kilogram of body weight, by deeply reading the contents of the two scientific studies, the Court first pointed out that the Commission failed to explain why one of the studies shall be considered unrepresentative of application practice in Europe[4].
In addition, the Scientific Committee’s stated that only persons who had not followed the recommended work procedure had shown levels of exposure close to the limit is not corroborated. While the Guatemalan study generally followed the recommendations and complied with hygiene standards, the study is recounting a case where exposure to paraquat was problematic even though the recommended work procedures had been followed[5]. The Court thus concluded that, the Guatemalan study appears to constitute ‘solid’ evidence which may reasonably raise doubts as to the safety of paraquat for operators applying it[6].
Moreover, while the scientific studies the Commission relied on clearly indicated that, it remained opposed to the authorisation of paraquat-based preparations for any uses requiring application with a knapsack sprayer, the contested directive prohibits the use of knapsack or handheld sprayers merely in regard to ‘home gardens’, which means that applications with knapsack sprayers outside ‘home gardens’ are permitted, even though the CET indicated in the French study that it was against such applications. Therefore, based the above finding, the Court concluded that, the lack of sufficient evidence in the dossier to justify inclusion of paraquat in Annex I to Directive 91/414 must be accepted[7].
Although there is assessment of the literature concerning the possible link between paraquat and Parkinson’s disease, the Court annulled the decision on the ground of not satisfying the procedural requirements laid down by Article 7 of Regulation No 3600/92. The Court ruled that, the allegation of procedural irregularity in the consideration of a possible link between paraquat and Parkinson’s disease must therefore be accepted, without there being any need to rule on the other arguments put forward in support of that plea.[8].
1.1.1.2 Comments
It is rarely to find that the European Courts engage in scientific issues when reviewing risk regulation. Nevertheless, the uncertainty paradox remains. The Court was still keen to verify whether the scientific evident the parties invoked wad solid, instead of verifying the existence of scientific uncertainty through consulting the external experts.
On the other hand, at least, in the instant case, the Court required the Commission to take into account all available scientific studies when adopting the measures. Also, the Court indicated the gap the Commission failed to fulfill in the scope of prohibited use by examining the relation between the assessment report the Commission relied on and the regulatory measures the Commission adopted.
[2] A. Alemanno, ‘The Shaping of European Regulation by Community Courts’, Jean Monnet Working Report Paper 18/08, at p. 27.
[8] T-229/04, Sweden v Commission [2007] ECR II-2441, para. 110, A. Alemanno, ‘The Shaping of European Regulation by Community Courts’, Jean Monnet Working Report Paper 18/08, at p. 28.
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