1.1.1 The Gowan[1]Case
Gowan challenged those ministerial decrees in an action before the Tribunale amministrativo regionale del Lazio (TAR Lazio) seeking the annulment of them. In that action, Gowan contested the illegality of Directive 2006/134[2]. It argued essentially that the severity of the restrictions on the use of fenarimol is not justified by the scientific studies carried out during the assessment procedure. The terms of the inclusion of fenarimol in Annex I to Directive 91/414 restricted the use of that substance for a period of 18 months to certain crops of marginal importance compared with those which hitherto constituted its main market[3].
The referring court found that the scientific assessment procedure resulted in positive conclusions and that the Commission had initially proposed the inclusion of fenarimol in Annex I to Directive 91/414 without restrictions. Therefore, it decided to stay proceedings and to refer the following question to the Court:
‘In view of the fact that the conclusion of the technical and scientific assessment carried out by the rapporteur State appears to be that the risk arising from the use of fenarimol is acceptable, is Directive 2006/134/EC, which significantly limited such use, valid[4]?’
1.1.1.2 The Judgment
The Court first noted that, the Organisation for Economic Cooperation and Development (OECD) is developing test guidelines to further refine the assessment of potential endocrine disrupting properties. Hence, it is appropriate to require that fenarimol should be subjected to such further testing as soon as agreed OECD Test Guidelines exist and that such studies should be presented by the notifier[5].
Second, recalling recitals 7 and 8 in the preamble to Directive 2006/134, since several Members showed their concerns that additional restriction is necessary to reduce the risk to a level that can be considered acceptable and consistent with the high level of protection that is sought within the Community, the Commission re-considered its position. It considered it appropriate, in addition to the principles set out in recital 6, to further reduce the period of inclusion to 18 months instead of seven years. That reduction also reduces any risk by ensuring a priority re-assessment of this substance[6].
1.1.1.2.1 Manifest Error of Assessment
With regard to manifest error of assessment, when conducting complex assessments, although the Commission must be allowed a wide discretion, the exercise of that discretion is not, however, excluded from review by the Court. In addition, under Directive 91/414, although the Commission is required to take into account the scientific assessment prepared by the rapporteur Member State, that assessment is not binding on the Commission, or the Council. They remain entitled, in the procedure provided for by Article 19 of that directive, to adopt different risk management measures from those proposed by the rapporteur Member State[7].
Concerning the decision to include fenarimol in Annex I to Directive 91/414, it must be pointed out that Directive 2006/134 does not undermine the results of the scientific assessment of risks posed by that active substance since the latter directive serves to authorise its use in plant protection products. Therefore, it cannot be claimed that the Commission failed to take into account with care and impartiality the scientific evidence produced by the rapporteur Member State at the stage of assessment of the risks posed by the use of fenarimol. The Court thus concluded that in the light of the scientific evidence resulting from the assessment of the risks posed by the uses of fenarimol envisaged by the notifier, examination of the file has revealed nothing to suggest that Directive 2006/134 is vitiated by a manifest error of assessment on the part of the Commission[8].
1.1.1.2.2 Breach of the Precautionary Principle
Recalling its ruling in Commission v France[9], the Court first noted that, a correct application of the precautionary principle presupposes, first, identification of the potentially negative consequences for health of the proposed use of the substance at issue, and, secondly, a comprehensive assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research[10].
Second, the Court found that, where it proves to be ‘impossible’ to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures, provided they are non-discriminatory and objective[11]
Apart from to the scientific evidence put forward by certain Member States during the work of the Standing Committee on the Food Chain and Animal Health, in its written observations the Commission also referred to several studies and reports on the question of the effect of disruption of the endocrine system produced by certain substances, and the Communication from the Commission to the Council and the European Parliament - Community strategy for endocrine disrupters - A range of substances suspected of interfering with the hormone systems of humans and wildlife of 17 December 199 (COM (1999) 706 final), in particular. Furthermore, as pointed out in recital 10 in the preamble to Directive 2006/134, the work of the OECD on the development of test guidelines in order to further refine the assessment of potential endocrine disrupting properties was not yet completed by the date of the adoption of Directive 2006/134[12].
Therefore, in the light of this evidence which tends to demonstrate that there was still some scientific uncertainty regarding the assessment of the effects on the endocrine system of substances such as fenarimol, the Commission cannot be considered to have applied the precautionary principle in a manifestly erroneous manner in attaching restrictions on use to the authorisation of that substance[13].
1.1.1.3 Comments
1.1.1.3.1 Manifest Error of Assessment
Although the Court confirmed that, a wide discretion owned by the Commission does not exclude the review by the Court. It only found that the contested directive does not undermine the results of the scientific assessment posed by fenerimol since the contested directive serves to authorize its use in plant protection products.
As Alemanno argued, the Court failed to address Gowan’s main concerns that following the adoption of the favorable rapporteur assessment report, whether the Commission can go back on its initial assessment and adopt unjustified restrictions on the use of fenerimol without any reason or scientific justification[14].
Again, the Court failed to require the EU institutions to provide a statement of reasons with a scientific level at least commensurate with the opinions offered by its committees, when departing from the scientific opinions of its committees[15]. However, is it really necessary to require new evidence produced before adopting a preventive measure departing from the opinions of the EU scientific committees as suggested by Alemanno[16]? Or it may be suffice that the Commission take into account other scientific evidence presented by several Member States, with a scientific level at least commensurate with the opinions offered by the EU scientific committees before decision.
Back to the starting point of applying the precautionary principle, it requires the existence of scientific uncertainty of the risk at issue when adopting the precaution measures. As long as this scientific uncertainty has been confirmed by the scientific experts in the decision-making processes of the administration and the court, the wide discretion owned by the administration can be compensated with the scientific justification. Therefore, the key question here is not the requirement of new evidence. Instead, it is how to urge the Court to use expert evidence, in order to assist them to deal with scientific uncertainty when confronting conflicting opinions between the opinions of the EU scientific committee and the evidence presented by Member States[17]. By appointing or accepting expert evidence, the Court can avoid the situation to pretend to be scientists when assessing the scientific issues.
1.1.1.3.2 Breach of the Precautionary Principle
The Court correctly point out that, the uncertainty is the impossibility of determining with certainty the existence or extent of the alleged risk, due to the insufficiency, inconclusiveness or imprecision of the results of studies conducted[18].
However, the Court constructed scientific uncertainty by relying upon the scientific evidence presented by Member States, several studies invoked by the Commission in the documents, and the incomplete guideline which is developing by the OECD[19].
With regard to the conflicting scientific opinions presented by Member States, like Pfizer[20], the Court still lack the capacity to judge the conflicts, as a typical example of uncertainty paradox.
With regard to several studies invoked by the Commission in the documents, at least this time, the Commission sought several studies to support its decision, instead of picking the uncertain parts of the scientific committee’s opinion to construct uncertainty as it did in Pfizer[21].
With regard to the incomplete guideline which is developing by the OECD, it may be seen as a good reason for the Commission to trigger the precautionary principle and to wait the agreed guideline developed by OECD, in order to fully assess potential endocrine disrupting properties[22]. Nevertheless, without consulting with the experts, the Court still lack the capacity to judge whether the lack of agreed guidelines is due to the scientific constraints or another differing political and economic concerns among Member States.
Since the concern about endocrine disrupting only appeared after the adoption of the risk assessment, it is also necessary to question whether the Commission, as the risk manager, can trigger the precautionary principle by constructing scientific uncertainty without further seeking the external advices. Since the Commission reconsidered its position after hearing the concerns expressed by several Member States, it would be necessary for Court to examine whether public concern or scientific evidence changed the Commission’s position[23].
Recalling the ruling of the CFI (now the General Court) in Pfizer, while admitting the EU institutions are entitled to enjoy a wide discretion under the precautionary principle, in such circumstances, the guarantees conferred by the Community legal order in administrative proceedings are of even fundamental importance[24]. Alemanno asserted that, in the instant case, by failing to counterweight the broadening of EU discretionary powers stemming from the application of precaution with an effectively procedural scrutiny by the judicial organ, the Court seems to surrender its function of gatekeeper of precautionary function[25]. As a result, by failing to require the EU institutions to complete procedural guarantees, the Court allowed the Commission to dress up as a public concern, in the instant case the risk of endocrine disruption, in the clothing of scientific uncertainty[26].
It is submitted that, by clearly indicating the policy choices adopted and separating them from the scientific results, this may facilitate the Court to scrutinize the contested measures[27]. However, the fundamental problem remains unsolved. Without effectively consulting with the scientific experts, the Court lack the capacity to deal with scientific issues and thus avoid engaging in scientific issues by constructing the scientific uncertainty, in order to uphold the application of the precautionary actions by the EU institutions. Even it is questionable for the Court to conduct the so-called procedural scrutiny without the needs to seek the external advice from the scientific experts.
[1] Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, not yet reported.
[2] Commission Directive 2006/134/EC of 11 December 2006 amending Council Directive 91/414/EEC to include fenarimol as active substance (OJ 2006 L 349, p. 32),
[3] Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, para. 20.
[4] Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, paras. 21-22.
[5] Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, para. 41.
[6] Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, para. 43.
[7] Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, paras. 56, 60.
[8] Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, paras. 63, 65, 67.
[10] Case C‑333/08 Commission v France [2010] ECR I‑0000, para. 92; Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, para. 75.
[11] Case C‑333/08 Commission v France [2010] ECR I‑0000, para. 93; Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, para. 76.
[12] Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, para. 78.
[13] Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, para. 79.
[14] A. Alemanno, Annotation of European Court of Justice, Case C-79/09, Gowan Comércio Internacional e Serviços Lda v. Ministero Della Salute (Precautionary Principle), 48 CMLR 4, 2011, at p. 9.
[15] Case T-13/99, Pfizer Animal Health SA v. Council of the European Union [2002] ECR II-03305, para. 199.
[16] A. Alemanno, Annotation of European Court of Justice, Case C-79/09, Gowan Comércio Internacional e Serviços Lda v. Ministero Della Salute (Precautionary Principle), 48 CMLR 4, 2011, at p. 9. This position requiring new evidence is also supported by the Court in Artegodan, see Cases T-74. 76. 83-85, 132, 137, and 141/00, Artegodan GmbH v Commission [2002] ECR II-4945, para. 194, P. Craig, EU Administrative Law, Oxford 2006, at p. 730.
[17] As mentioned before, what scientific experts can provide is such uncertainty information, and what they cannot provide is certainty about uncertain risks, see Van Asselt, Vos and Rooijackers, ‘Science, Knowledge and Uncertainty in EU Risk Regulation’, in Eversion and Vos (eds.), Uncertain Risks Regulated, Routledge Cavendish 2009, at. p. 363.
[18] Case C‑333/08 Commission v France [2010] ECR I‑0000, para. 93; Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, para. 76.
[19] Case C-77/09, Gowan Comércio Internacional e Serviços Lda v Ministero della Salute, Judgment of the Court (Second Chamber) of 22 December 2010, para. 78.
[22] Alemanno has the different opinion and asserts that, reference to the lack of the OECD document as an evidence of scientific uncertainty would lead to open the Pandora’s box represented by the notion of scientific uncertainty, an area where epistemological knowledge and regulatory consensus often diverge, see A. Alemanno, Annotation of European Court of Justice, Case C-79/09, Gowan Comércio Internacional e Serviços Lda v. Ministero Della Salute (Precautionary Principle), 48 CMLR 4, 2011, at p. 11, T. Christoforou, ‘The Precautionary Principle and Democratizing Expertise: A European Legal Perspective’, Science and Public Policy, Vol. 30, number 3, 2004, at p. 206.
[23] A. Alemanno, Annotation of European Court of Justice, Case C-79/09, Gowan Comércio Internacional e Serviços Lda v. Ministero Della Salute (Precautionary Principle), 48 CMLR 4, 2011, at p. 12.
[24] Case T-13/99, Pfizer Animal Health SA v. Council of the European Union [2002] ECR II-03305, para. 171.
[25] A. Alemanno, Annotation of European Court of Justice, Case C-79/09, Gowan Comércio Internacional e Serviços Lda v. Ministero Della Salute (Precautionary Principle), 48 CMLR 4, 2011, at p. 2.
[26] A. Alemanno, Annotation of European Court of Justice, Case C-79/09, Gowan Comércio Internacional e Serviços Lda v. Ministero Della Salute (Precautionary Principle), 48 CMLR 4, 2011, at p. 14.
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