HOW TO RECONCILE MARKET AND NON-MARKET VALUES IN EU MARKET INTERGATION
—A Study of Precautionary Principle—
Abstract
Recognizing the limits of science and the possibility of facing unpredicted risks in modern society, this contribution aims to deal with the situation where there is scientific uncertainty, how the public authority could respond by relying upon the precautionary principle. The author starts to study the relevant WTO and EU cases and their academic comments, in order to answer the questions presented. The author finds that, first the demerits of the precautionary principle can be mitigated by requiring the authority to severely fulfill the procedural requirements in the process of decision-making. Second, the application of the precautionary principle did change the criteria of the proportionality principle in the EU cases. Finally, given the limits of the text of the SPS Agreement, it is hard to find a compromise between the precautionary principle and the SPS Agreement.
1. Introduction
This paper aims to explore how the EU institutions and the Member States shall apply precautionary principle in terms of the EU case law and how the EU courts have reviewed the preventative measure of the EU institutions and the protective acts of the Member States. In the former cases, the General Court (GC) needs to make a balance between private rights (the right to property, the freedom to pursue a business) and an EU public interest (a high level of protection of human health), in the latter case, the Court of Justice of the European Union (ECJ) has to weigh an EU public interest (free movement of goods, Article 34 of the TFEU) against a national public interest (the right to depart from the EU’s harmonized measures on the ground of human health protection)[1]. In both cases, the EU courts need to make a balance between trade interests and non-trade interests[2], when the institutions adopt the preventative measure under the precautionary principle.
In particular, the author would like to observe the relation between the proportionality principle and the precautionary principle and to see whether the application of the precautionary principle has changed the criteria of the proportionality principle in the relevant cases.
Apart from the internal interaction between the EU institutions, the Member States and the EU courts, it is also meaningful to observe the external relation between the precautionary principle under the EU law and the SPS Agreement under the WTO law, in order to examine whether there exists a compromise between both legal instruments.
In this contribution, the author mainly relies on the relevant EC and WTO case law to study and answer the question presented.
In the following sections, we would first describe what the precautionary principle is, its legal basis in EU law, and how the EU courts extend the scope of the precautionary principle into the area of the protection of human health. After explaining the precautionary principle, we would like to further illustrate how to apply the precautionary principle and to see how the EU courts would review the precautionary measures adopted by the EU institutions and the Member States. After that, we would turn to observe the relation between the precautionary principle and the SPS Agreement.
2. What is the Precautionary Principle
Article 191 of the Treaty on the Functioning of the European Union states that, Union policy on the environment shall be based on the precautionary principle. Thus, the precautionary principle is first to be used in the area of environmental policy.
Subsequently, in the landmark case, the Court of Justice ruled that, “where there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait the reality and seriousness of those risks becomes fully apparent[3]. Later, the General Court (GC) recalled the BSE judgment and explicitly referred to the precautionary principle[4]. Therefore, the European courts extended the precautionary principle to the area of human health. This view has also been shared by the Commission[5].
According to the case law, the precautionary principle allows the authority to adopt a preventative measure in a provisional manner, pending the availability of additional scientific evidence, provided that there is scientific uncertainty[6].
3. How to Apply the Precautionary Principle
3.1 The General Framework
A common regime of risk regulation often comprises two parts: risk assessment and risk management. First, using the procedure of risk assessment determines the probability of the occurrence of harm. The risk assessment procedure includes four steps: hazard identification, dose response assessment, exposure assessment, and risk characterization[7].
Once the procedure of risk assessment has been completed, the second step is for the politicians to make a political decision to determine whether the products concerned is safe to distribute or shall be restricted, taking into account the reports of the risk assessment as well as other societal, economic, ethical factors. Here, the precautionary principle requires that, on the one hand, the decision shall be based on the scientific evidence as rigorous as possible, and on the other hand, the politicians retain the autonomy when making such a decision[8].
3.2 The Risks Addressed
According to the wording of international treaty, here the risks addressed shall be serious, significant, and the harm shall be irreversible when the risks become reality[9]. Here, I agree with Cass Sunstein’s view that there has to exist a threshold of scientific plausibility, in order to prevent ‘palpable absurdity’[10].
In addition, a hypothetical risk cannot be seen as a risk under the precautionary principle[11]. According to WTO case law, the risk must be ascertainable’ and not ‘theoretical’, because science can never provide absolute certainty when assessing whether a given substance will never have an adverse impact on human health[12].
3.3 Risk Assessment
First, before taking a protective measure, it is necessary to conduct a risk assessment. The EC court expressly recognizes the need to perform risk assessments when facing uncertainties[13]. The General Court (GC) further indicated that, performing a risk assessment is a prerequisite for taking a protective measure[14].
Second, In Monsanto, the ECJ found that, when conducting the risk assessment, the national authorities shall provide specific evidence to demonstrate that the implementation of the preventative measures is ‘necessary’, in order to avoid the products posing potential risks to human health, by offering ‘the specific evidence’ to conclude the assessment on the basis of ‘the most reliable scientific evidence available and the most recent results of international research’[15].
Third, when conducting a risk assessment, it is not necessary to set up a ‘minimum magnitude of degree of risk’, according to the WTO case law[16].
Fourth, science itself does not have a majority rule[17]. The mainstream scientific opinions do not guarantee the correctness of the scientific opinion. The scientific history has demonstrated that the divergent opinion might be not commonly acceptable among the scientific community at the time when it first published, but its finding might be recognized later. The precautionary principle thus requires the authorities to search the divergent opinions.
Fifth, since the key issue here is the scientific uncertainty. The whole range of the uncertainty shall contain lack of full evidence, lack of causal mechanisms, incorrect assumptions, extrapolation uncertainty, indeterminacy, ambiguity, and ignorance[18]. In particular, the experts shall indicate the unknown unknowns, and the systematic searching for blind spots shall be encouraged[19].
Sixth, although a risk assessment shall be required to conduct, in order to reduce the uncertainty, it may be out of the question to conduct a full risk assessment at that time, due to the limits of the state of science. In fact, scientists are unable to offer the answer to every question. In contrary, their research results would often demonstrate that there is a high degree of scientific uncertainty[20].
Finally, the GC confirmed that, the scientific advice shall be based on principles of excellence, independence, and transparency, in order to maintain a high level of protection of human health[21].
3.4 Risk Management
From the outset, it is well-settled that it is for the institution to determine the level of protection, which it deems appropriate for the society, depending on the circumstances of the particular case. This has also been confirmed by the WTO case law[22].
Although science is the core stone when adopting the precautionary measure in the field of food safety, since scientists have neither democratic legitimacy nor political duty[23], thus, the opinions of the scientific committees or the relevant agencies are not binding[24]. Here, it is the duty of the politicians to determine the appropriate level of protection. Since to determine the appropriate level of protection is a political decision, the authorities are empowered to have a large degree of discretion regarding the means of achieving the objectives of safety, when facing uncertainty[25], provided that the authority has carefully and impartially examined all the relevant aspects of the case concerned[26].
With regard to the zero-risk approach, although the GC previously stated that the institutions may not base their decisions on zero risk[27], in practice, the GC upheld this approach by doubting that the plaintiff failed to conclude there was no link between the use of virginamycin and the development of streptogramin resistance. The GC further noted that, it was insufficient to merely demonstrate that the existence of such a link was ‘very unlikely[28]’. However, it also vital to note that, precluding a zero-risk approach does not seem to preclude the adoption of a preventative measure aiming to eliminate entirely a risk, which is more than a hypothetical risk and which has been scientific confirmed[29].
Due to the scientific evidence or results are insufficient, inconclusive, or imprecision, a Member may adopt a preventative measure. Also, when there are conflicts of scientific opinions regarding the safety of the products, a Member may also adopt a preventative measure.
It is vital to note that the authority’s decision shall be based on a sufficiently reliable and respect information[30], taking into account the scientific data available at the time when taking a precautionary measure[31], as well as the latest results of international research[32].
4. Judicial Review
The EU courts make a distinction between the EU institutions and the Member States when reviewing their precautionary measures. With regard to the protective measures adopted by the Member States, the ECJ tends to apply the strict test of the precautionary principle, when the measures at issue have impaired the functioning of the internal market[33]. While, where the EU institutions possess wide discretionary powers, the GC virtually tends to apply a slight test of the precautionary principle, and solely examines whether the Union measures concerned is invalid on the ground of manifest error, misuse of power, or ultra vires[34]. Being aware of the difficulties of regulating the controversial cases or determining where action is urgent, the EU courts tend to respect the decisions adopted by the EU institutions and only conduct the limited reviews. Here, the EU judicial organs choose not to substitute its assessment of the facts for that of the Union institutions[35].
4.1 Examining the Precautionary Measures by the Proportionality Principle
The ECJ previously admitted that, the precautionary principle is part of the proportionality principle[36]. In contrary, the GC treated the precautionary principle and the proportionality principle as two separate principles in its judgments[37]. The authors indicated that, the principles of proportionality and precaution are intertwined together in their application[38]. Here, my personal view is that the courts have virtually changed the criteria of the proportionality principle when applying the precautionary principle in the case[39]. Compared with the proportionality principle, the precautionary principle is used to cope with the uncertain situations and tends to enact a more restrictive measure to address the unknown risks. When the factual contexts are uncertain, it is very hard to establish the proportionality[40].
When applying the proportionality principle, the ECJ normally requires that, Union measures shall not exceed the limits of what is appropriate and necessary in order to attain the objectives pursued by the acts in question and, where there is a choice between several proper measures, recourse must be to the least restrictive, and the demerits caused must not be disproportionate to the objectives pursued[41]. Below we would like to separately examine each criterion.
4.1.1 The Necessity Test
This test first compares the various measures having the capacity of achieving the objectives pursued and picks the least restrictive one. However, in Pfizer case, the plaintiff party argued that, the Union authority shall wait until the scientific studies have shown ‘a sufficient likelihood of risk, instead of immediately taking the preventative measures. The GC replied that, the institutions cannot be criticized for having chosen to provisionally withdraw the authorization of virginiamycin, in order to prevent the risk from becoming reality, and at the same time, to continue the research. Here, we can observe that this approach is in line with the precautionary principle. Thus, the criterion of the necessity test has been loosened by the courts.
4.1.2 The Test of Weighing Interests
At this stage, the proportionality principle requires the courts to compare the importance of the objective pursued by the measure at issue and the interests that would be sacrificed by the measure[42]. However, both the ECJ and the GC have expressed that, the requirements of the protection of human health should take precedence over the economic interests[43]. Furthermore, in Artegodan, the GC even embraced a new general principle of Union law, by stating that the protection of human health ‘must undoubtedly’ take precedence over the economic considerations[44]. Here, again, the application of the precautionary principle has effectively changed the criterion of the proportionality principle, by placing the value of human health being prior to the economic interests.
Nonetheless, in Artegodan, the GC also equally emphasized the importance of applying the principles of proportionality and non-discrimination[45]. Likewise, in Bellio F.lli Srl, the ECJ stressed that, even the need to protect public health has been recognized as a primary concern, the proportionality principle still needs to be respected[46].
4.1.3 The Duty of Re-examination
In line with the WTO and the EU law[47], the proportionality principle also requires the EU institutions and the Member States to re-examine their preventative measures, when there has been new scientific information. It would be proportionate to loosen the requirements of the preventative measure when the new research shows that the suspected risk does not seem as serious as the previous evaluation. Here, since the application of the precautionary principle can be seen as the exception of the proportionality principle, the preventative measures adopted shall be provisional and the institutions shall continue its research and re-examine its preventative measures in time, in order to make a balance between the two principles.
4.2 Examining the Precautionary Measures by the Precautionary Principle
In 2000, the European Commission (hereafter referred to as ‘Commission’) produced a Communication seeking to inform all interested parties how the Commission would apply or intent to apply the precautionary principle when taking the preventative measures to confront with the risk, whose nature is scientific uncertainty. Although the communication is not binding, the EU judicial organs can examine whether an EU measure complies with the guidelines the Commission have presented. In other words, in accordance with the equal principle[48], the Commission shall adopt a communication-consistent measure[49].
It is quite observed that the EU courts are reluctant to conduct the substantive review of the precautionary measures adopted by the EU institutions. As mentioned before, the courts also admitted that it is the duty and competence of the institutions to make a political decision whether it is necessary to adopt a preventative measure under the precautionary principle. Thus, the institutions enjoy wide discretionary powers when enacting a precautionary measure[50]. However, also mentioned above, in order to avoid the abuse of the precautionary principle resulting from the view of the populist[51], several steps need to be fulfilled before adopting a preventive measure:
l The necessity of conducting a risk assessment;
l The risk assessment shall be based on the all scientific evidence available at the time when adopting preventative measures;
l The risk assessment shall contain the latest results of the international research;
l The risk assessment shall be conducted in an excellent, independent ,and transparent manner, in order to ensure the quality of the risk assessment;
l When the decision-makers want to disregard a scientific opinions issued by an EU relevant scientific committee or an agency, they shall provide the equal scientific opinion as the one they do not concern.
Whereas the institutions already have the wide discretionary powers to determine a preventative measure under the precautionary principle, it shall severely observe the procedural steps it enacted. While, the GC widely recognized the criteria presented by the Communication, it missed the chance to use those criteria to examine the institution’s decisions. Here, we do not see the court had examined whether the institutions have conducted an as thorough risk assessment as possible and required adequate guarantees of scientific objectivity[52]. A risk management decision without fulfilling the all procedural steps above-mentioned would not solve the controversial dispute, while bringing more problems.
On the other hand, despite its avoidance of entering to the substantively scientific detail, it did conduct several substantive examinations in the cases[53]. Therefore, we may wonder, first whether the courts themselves have the capacity to judge so, and second, whether the courts conducted those factual examinations based on the firmly scientific ground. The author thus suggested in case involving highly technical or controversial scientific evidence, the courts shall submit the evidence to the independent experts to assess the validity of the scientific arguments involved[54].
With regard to the precautionary measures adopted by the Member States, in cases of scientific uncertainty, Member States also enjoy wide discretion in deciding the adoption of the preventative measures. They shall also deliver some evidence of scientific uncertainty. The evidence presented shall be related to a specific, concrete risk and not a potential risk on the basis of a general preventative approach, and this special risk shall be assessed in terms of the specific eating habits of a nation[55].
5. The Precautionary Principle and the SPS Agreement
From the outset, the negotiators of the SPS Agreement did not intend to include the precautionary principle into the SPS Agreement[56].
Article 2, paragraph 2 of the SPS Agreement provides that, a SPS measure cannot be maintained without ‘sufficient scientific evidence’. The exception is to enact a provisional measure, in accordance with Article 5, paragraph 7 of the SPS Agreement[57], and this provision can be seen as the expression of the precautionary principle under the WTO law[58].
In Japan-Varietals, the Appellate Body ruled that, the ordinary meaning of 'sufficient' is 'of a quantity, extent, or scope adequate to certain purpose or object'. 'Sufficiency' requires the existence of a sufficient or adequate relationship between the SPS measure and the scientific evidence. Whether there is a rational relationship between an SPS measure and the scientific evidence is to be determined on a case-by-case basis and will depend upon the particular circumstances of the case, including the characteristics of the measure at issue and the quality and quantity of the scientific evidence[59].
Here, the Appellate Body clearly stated that, the requirement of sufficient scientific evidence is both determined by the quality and quantity of the scientific evidence.
According to Article 5, paragraph 7 of the SPS Agreement, A Member can enact a provisional measure provided that:
l in a situation where 'relevant scientific information is insufficient;
l the measure adopted is 'on the basis of available pertinent information'.
In addition, a provisional measure may not be maintained unless:
l the Member seeks to obtain the additional information necessary for a more objective assessment of risk;
l the Member reviews the provisional measure accordingly within a reasonable period of time.
The four criteria are cumulative[60]. With respect to the reasonable time limits of review, the Appellate Body noted that, in our view, what constitutes a 'reasonable period of time' has to be established on a case-by-case basis and depends on the specific circumstances of each case, including the difficulty of obtaining the additional information necessary for the review and the characteristics of the provisional SPS measure[61]. Thus, here the Appellate Body has taken into account the difficulty of obtaining the necessary scientific information, in order to complete the full risk assessment. The requirement of the reasonable time limits of review is not so strict and in line with the precautionary principle[62].
However, the core concept used in the text of Article 5, paragraph 7 of the SPS Agreement is ‘insufficient’, instead of ‘uncertainty’. At first glance, one may wonder the scope of precautionary principle under the WTO law has been significantly narrowed[63]. Nonetheless, recalling the ruling of the Appellate Body in Japan-Varietals, the ordinary meaning of 'sufficient' is 'of a quantity, extent, or scope adequate to certain purpose or object. If all available information is insufficient for the scientists to make a conclusion, or even the current state of scientific knowledge is insufficient to assess the suspected risk, Member shall be allowed to adopt a provisional measure to address the unknown risks or the urgent problems under the WTO law.
Therefore, Article 5, paragraph 7 of the SPS Agreement aims to deal with the situation where there is a lack of sufficient scientific evidence concerning the suspected risk, including the accumulated evidence is inconclusive or unreliable[64]. The standard for permitting to adopt a provisional measure under Article 5, paragraph 7 of the SPS Agreement is to test whether there is sufficient scientific evidence for completing a full risk assessment under Article 5, paragraph 1 of the SPS Agreement[65].
Furthermore, here I would like to emphasize that, science, per se, is an evolving process. It is not a stable concept, and every day, scientists would have new findings about the new potential risks. Thus, it is rationale for Members to enact a provisional measure to address a new risk found in the substances that had been used in the manufacture of specific products for many years. In other words, recognizing the limits of science and the dynamic nature of the science, today the food is safe, tomorrow it would be deemed as unsafe, and thus a rational measure shall be figured out.
Also, in EC-Hormones, with respect to the legal status of the precautionary principle under the international law, the Appellate Body stated that, whether the precautionary principle has been widely accepted by Members as a principle of general or customary international law appears less than clear. We note that the precautionary principle, at least outside the field of international environmental law, still awaits authoritative formulation[66].
Although, the Appellate refuse to recognize the legal status of the precautionary principle as the customary international law, and thus can be invoked to interpret Article 5, paragraph 1 of the SPS Agreement, considering that to become a principle of customary international law is also an evolving process, the precautionary principle may be recognized as a principle of customary international law in the future.
Nevertheless, in EC-Hormones, the Appellate Body explicitly stated that, the precautionary principle cannot override the requirements of Article 5, paragraph 1 and 2 of the SPS Agreement[67].
Finally, it is noteworthy that, despite the fact that the ECJ has denied the direct effect of the WTO Agreement[68], where the Union acts aimed to implement a specific WTO obligation, the European courts has expressed its willingness to review the legality of the Union measures under the WTO law[69].
6. Conclusion
In the end, we would like to review our findings in the previous sections. First, in line with the WTO case law, also considering the requirements of the Communication, the EU institutions shall severely obey the procedural requirements it enacted before adopting a preventative measure.
Second, after reviewing the relevant cases, the application of the precautionary principle did change the criteria of the proportionality principle. Therefore, it is vital to strike a balance between the two principles by requiring the institutions to completely fulfill all the relevant requirements when making decisions. In particular, the economic interests shall not be entirely sacrificed without goods reasons, and the measures adopted shall be provisional. Whereas science plays an important role in the decision-making of risk regulation, the advice shall be offered in an independent, excellence, and transparent manner, in order to well solve the disputes.
Third, it is pity to see that the General Court missed the opportunities to use those procedural requirements to review the institution’s decisions. The GC failed to examine whether the institutions had an as through risk assessment as possible and whether the adequate requirements of scientific objectivity had been guaranteed. Without a strict test performed by the judicial review, it would inevitably offer the incentive for the institutions to abuse the wide discretion they have. Furthermore, if the courts have conducted reviews in the area of scientific issues, it is rational for the courts to submit the evidence to the experts to assess the scientific arguments in question.
Finally, is there any possible to seek a compromise between the precautionary principle and the SPS Agreement? Limited by the texts of the current provisions of the SPS Agreement, also given the negative outcomes of the relevant WTO cases, the room of applying the precautionary principle under the WTO law is narrow and only can be sought by invoking Article 5, paragraph 7 of the SPS Agreement. Nonetheless, there is still room to include the precautionary principle by well interpretation.
[1] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 165.
[2] It is interesting to note that, it is also possible to invoke the precautionary principle as a sword to challenge the legality of acts of Member States, see Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 257.
[3] Case C-180/96 R United Kingdom v. Commission [1996] ECR I-3903, para. 93.
[4] Case T-13/99 Pfizer, [2002] ECR II-03305, para. 139.
[5] See COMMUNICATION FROM THE COMMISSION on the precautionary principle, Brussels 02.02.2000 COM (2000) 1 at p. 10. The legal basis can also be found in Article 114, paragraph 3 of the TFEU, see Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 256, J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at pp. 52-53.
[6] Case T-13/99 Pfizer, [2002] ECR II-03305, para 387.
[7] Ellen Vos, Antibiotics, the Precautionary Principle and the Cout in First Instance. Maastricht Journal of European and Comparative Law,2004, at p. 193.
[8] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at pp. 146-147.
[9] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 148.
[10] Cass R. Sunstein, Beyond the Precautionary Principle, Public Law and Legal Theory Working Paper No. 38: the Law School, The University of Chicago, at: http://www.law.uchicago.edu/publications/papers/publiclaw/1-99 , p. 13.
[11] Case T-13/99 Pfizer [2002] ECR II-03305, para. 143. See also, J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at p. 60.
[12] Appellate Body Report, EC-Hormones, para. 186.
[13] Case C-236/01, Monsanto Agricoltura Italia, para. 113.
[14] Case T-13/99 Pfizer [2002] ECR II-03305, paras. 155-156.
[15] Case C-236/01, Monsanto, para. 113.
[16] Appellate Body Report, EC-Hormones, para. 186.
[17] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 153.
[18] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 154.
[19] See Article 10.1 of the Directive 2001/42/EC.
[20] Case C-192/01, Commission v. Denmark, para. 51.
[21] Case T-13/99 Pfizer [2002] ECR II-03305, para. 162.
[22] Appellate Body Report, Australia-Salmon, para. 199.
[23] Case T-13/99 Pfizer [2002] ECR II-03305, para. 201.
[24] Case C-405/92, Armand Mondiet, paras. 31-32.
[25] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 162.
[26] Case T-13/99 Pfizer [2002] ECR II-03305, para. 171.
[27] Case T-13/99 Pfizer [2002] ECR II-03305, para. 152.
[28] Case T-13/99 Pfizer [2002] ECR II-03305, para. 391.
[29] J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at p. 60.
[30] Case T-13/99 Pfizer [2002] ECR II-03305, para. 62.
[31] Case T-13/99 Pfizer [2002] ECR II-03305, para. 145.
[32] Case C-42.02, Commission v. Netherlands, para. 49.
[33] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 166.
[34] Ellen Vos, Antibiotics, the Precautionary Principle and the Court in First Instance, Maastricht Journal of European and Comparative Law, 2004, at p. 196.
[35] Case T-13/99 Pfizer [2002] ECR II-03305 para. 169.
[36] Case C-157/96 The Queen v. Ministery of Agriculture, Fisheries, and Food [1998] ECR I-2211, para. 63.
[37] Ellen Vos, Antibiotics, the Precautionary Principle and the Court in First Instance. Maastricht Journal of European and Comparative Law, 2004, at p. 195.
[38] Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 257.
[39] In contrary, the author indicated that, the proportionality principle would serve to temper precaution in a European Union setting, see J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at p. 62.
[40] Ellen Vos, Antibiotics, the Precautionary Principle and the Court in First Instance. Maastricht Journal of European and Comparative Law,2004, at p. 196, Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 260.
[41] Case T-13/99, Pfizer [2002] ECR II-03305, para. 411.
[42] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 168.
[43] Case C-180/96 P UK v Commission [1996] ECR I-3903, para. 93.
[44] Case T-74/00 Artegodan, para. 173. However, this sentence shall not be merely construed as a slogan. Instead, here the policy-makers are truly faced with hard choices and required to strike a balance between trade and non-trade interests, see J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at p. 66.
[45] Case T-74/00 Artegodan, para. 186.
[46] Case C-286/02 Bellio F. lli Srl. Para. 60.
[47] With regard to the WTO law, Article 5.7 of the SPS Agreement; with regard to the EU law, see paragraph 6.3.5 of COMMUNICATION FROM THE COMMISSION on the precautionary principle, Brussels 02.02.2000 COM (2000) 1.
[48] It is the administrative self-restraints principle in German administrative law.
[49] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at pp. 141-142.
[50] To note, in the absence of harmonization, Member States are also allowed considerable discretion, while, they must have regard to the requirement of free movement, see Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 261.
[51] With regard to the discussion between technocratic and populist, see Cass R. Sunstein, The Laws of Fear, JOHN M. OLIN LAW & ECONOMICS WORKING PAPER NO. 128, p. 3, at: http://www.law.uchicago.edu/Lawecon/wp101-150
[52] Ellen Vos, Antibiotics, the Precautionary Principle and the Court in First Instance. Maastricht Journal of European and Comparative Law, 2004, at p. 200.
[53] Ellen Vos, Antibiotics, the Precautionary Principle and the Court in First Instance. Maastricht Journal of European and Comparative Law, 2004, at pp. 198-199. A similar opinion, see J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at p. 62.
[54] Ellen Vos, Antibiotics, the Precautionary Principle and the Court in First Instance. Maastricht Journal of European and Comparative Law, 2004, at p. 200.
[55] Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 261.
[56] Appellate Body Report, EC-Hormones, para. 124. Denise Prévost, What Role for the Precautionary Principle in WTO Law After Japan-Apples, Ecolomic Policy and Law: Journal of Trade and Environmental Studies, Vol. 2 (4), June 2005, at pp. 2-3.
[57] Joost Pauwelyn, The WTO Agreement on Sanitary and Phytosanitary (SPS) Measures as Applied in the First Three SPS Dipsutes EC - Hormones, Australia - Salmon and Japan – Varietals, Journal of International Economic Law (1999), at p. 645, also see Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 273.
[58] Denise Prévost, What Role for the Precautionary Principle in WTO Law After Japan-Apples, Ecolomic Policy and Law: Journal of Trade and Environmental Studies, Vol. 2 (4), June 2005, at p. 13.
[59] Appellate Body Report, Japan-Varietals, paras. 73 and 84.
[60] Peter Van den Bossche, The Law and Policy of the World Trade Organization-Texts, Cases, and Materials, (Cambridge University Press, 2007), at p. 863.
[61] Appellate Body Report, Japan-Varietals, para. 93.
[62] Similarly, the author states that the requirement of reasonable time limit is flexible and allows a Member to maintain a measure as long as necessary for completing a full risk assessment, see Peter Van den Bossche, The Law and Policy of the World Trade Organization-Texts, Cases, and Materials, (Cambridge University Press, 2007), at p. 867.
[63] However, In Japan-Apples, the Appellate Body indicated that, Article 5, paragraph 7 of the SPS Agreement is not triggered by the existence of scientific uncertainty, but rather by the insufficiency of scientific evidence, see Appellate Body Report, Japan-Apples, para. 8.215.
[64] Peter Van den Bossche, The Law and Policy of the World Trade Organization-Texts, Cases, and Materials, (Cambridge University Press, 2007), at p. 865.
[65] Panel Report, EC-Approval and Marketing of Biotech Products, para. 7.3239.
[66] Panel Report, EC-Hormones, para. 8.610.
[67] Appellate Body Report, EC-Hormones, para. 124.
[68] Case C-149/96 Portugal v. Council [1999] ECR I-8395.
[69] J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at p. 69.
—A Study of Precautionary Principle—
Abstract
Recognizing the limits of science and the possibility of facing unpredicted risks in modern society, this contribution aims to deal with the situation where there is scientific uncertainty, how the public authority could respond by relying upon the precautionary principle. The author starts to study the relevant WTO and EU cases and their academic comments, in order to answer the questions presented. The author finds that, first the demerits of the precautionary principle can be mitigated by requiring the authority to severely fulfill the procedural requirements in the process of decision-making. Second, the application of the precautionary principle did change the criteria of the proportionality principle in the EU cases. Finally, given the limits of the text of the SPS Agreement, it is hard to find a compromise between the precautionary principle and the SPS Agreement.
1. Introduction
This paper aims to explore how the EU institutions and the Member States shall apply precautionary principle in terms of the EU case law and how the EU courts have reviewed the preventative measure of the EU institutions and the protective acts of the Member States. In the former cases, the General Court (GC) needs to make a balance between private rights (the right to property, the freedom to pursue a business) and an EU public interest (a high level of protection of human health), in the latter case, the Court of Justice of the European Union (ECJ) has to weigh an EU public interest (free movement of goods, Article 34 of the TFEU) against a national public interest (the right to depart from the EU’s harmonized measures on the ground of human health protection)[1]. In both cases, the EU courts need to make a balance between trade interests and non-trade interests[2], when the institutions adopt the preventative measure under the precautionary principle.
In particular, the author would like to observe the relation between the proportionality principle and the precautionary principle and to see whether the application of the precautionary principle has changed the criteria of the proportionality principle in the relevant cases.
Apart from the internal interaction between the EU institutions, the Member States and the EU courts, it is also meaningful to observe the external relation between the precautionary principle under the EU law and the SPS Agreement under the WTO law, in order to examine whether there exists a compromise between both legal instruments.
In this contribution, the author mainly relies on the relevant EC and WTO case law to study and answer the question presented.
In the following sections, we would first describe what the precautionary principle is, its legal basis in EU law, and how the EU courts extend the scope of the precautionary principle into the area of the protection of human health. After explaining the precautionary principle, we would like to further illustrate how to apply the precautionary principle and to see how the EU courts would review the precautionary measures adopted by the EU institutions and the Member States. After that, we would turn to observe the relation between the precautionary principle and the SPS Agreement.
2. What is the Precautionary Principle
Article 191 of the Treaty on the Functioning of the European Union states that, Union policy on the environment shall be based on the precautionary principle. Thus, the precautionary principle is first to be used in the area of environmental policy.
Subsequently, in the landmark case, the Court of Justice ruled that, “where there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait the reality and seriousness of those risks becomes fully apparent[3]. Later, the General Court (GC) recalled the BSE judgment and explicitly referred to the precautionary principle[4]. Therefore, the European courts extended the precautionary principle to the area of human health. This view has also been shared by the Commission[5].
According to the case law, the precautionary principle allows the authority to adopt a preventative measure in a provisional manner, pending the availability of additional scientific evidence, provided that there is scientific uncertainty[6].
3. How to Apply the Precautionary Principle
3.1 The General Framework
A common regime of risk regulation often comprises two parts: risk assessment and risk management. First, using the procedure of risk assessment determines the probability of the occurrence of harm. The risk assessment procedure includes four steps: hazard identification, dose response assessment, exposure assessment, and risk characterization[7].
Once the procedure of risk assessment has been completed, the second step is for the politicians to make a political decision to determine whether the products concerned is safe to distribute or shall be restricted, taking into account the reports of the risk assessment as well as other societal, economic, ethical factors. Here, the precautionary principle requires that, on the one hand, the decision shall be based on the scientific evidence as rigorous as possible, and on the other hand, the politicians retain the autonomy when making such a decision[8].
3.2 The Risks Addressed
According to the wording of international treaty, here the risks addressed shall be serious, significant, and the harm shall be irreversible when the risks become reality[9]. Here, I agree with Cass Sunstein’s view that there has to exist a threshold of scientific plausibility, in order to prevent ‘palpable absurdity’[10].
In addition, a hypothetical risk cannot be seen as a risk under the precautionary principle[11]. According to WTO case law, the risk must be ascertainable’ and not ‘theoretical’, because science can never provide absolute certainty when assessing whether a given substance will never have an adverse impact on human health[12].
3.3 Risk Assessment
First, before taking a protective measure, it is necessary to conduct a risk assessment. The EC court expressly recognizes the need to perform risk assessments when facing uncertainties[13]. The General Court (GC) further indicated that, performing a risk assessment is a prerequisite for taking a protective measure[14].
Second, In Monsanto, the ECJ found that, when conducting the risk assessment, the national authorities shall provide specific evidence to demonstrate that the implementation of the preventative measures is ‘necessary’, in order to avoid the products posing potential risks to human health, by offering ‘the specific evidence’ to conclude the assessment on the basis of ‘the most reliable scientific evidence available and the most recent results of international research’[15].
Third, when conducting a risk assessment, it is not necessary to set up a ‘minimum magnitude of degree of risk’, according to the WTO case law[16].
Fourth, science itself does not have a majority rule[17]. The mainstream scientific opinions do not guarantee the correctness of the scientific opinion. The scientific history has demonstrated that the divergent opinion might be not commonly acceptable among the scientific community at the time when it first published, but its finding might be recognized later. The precautionary principle thus requires the authorities to search the divergent opinions.
Fifth, since the key issue here is the scientific uncertainty. The whole range of the uncertainty shall contain lack of full evidence, lack of causal mechanisms, incorrect assumptions, extrapolation uncertainty, indeterminacy, ambiguity, and ignorance[18]. In particular, the experts shall indicate the unknown unknowns, and the systematic searching for blind spots shall be encouraged[19].
Sixth, although a risk assessment shall be required to conduct, in order to reduce the uncertainty, it may be out of the question to conduct a full risk assessment at that time, due to the limits of the state of science. In fact, scientists are unable to offer the answer to every question. In contrary, their research results would often demonstrate that there is a high degree of scientific uncertainty[20].
Finally, the GC confirmed that, the scientific advice shall be based on principles of excellence, independence, and transparency, in order to maintain a high level of protection of human health[21].
3.4 Risk Management
From the outset, it is well-settled that it is for the institution to determine the level of protection, which it deems appropriate for the society, depending on the circumstances of the particular case. This has also been confirmed by the WTO case law[22].
Although science is the core stone when adopting the precautionary measure in the field of food safety, since scientists have neither democratic legitimacy nor political duty[23], thus, the opinions of the scientific committees or the relevant agencies are not binding[24]. Here, it is the duty of the politicians to determine the appropriate level of protection. Since to determine the appropriate level of protection is a political decision, the authorities are empowered to have a large degree of discretion regarding the means of achieving the objectives of safety, when facing uncertainty[25], provided that the authority has carefully and impartially examined all the relevant aspects of the case concerned[26].
With regard to the zero-risk approach, although the GC previously stated that the institutions may not base their decisions on zero risk[27], in practice, the GC upheld this approach by doubting that the plaintiff failed to conclude there was no link between the use of virginamycin and the development of streptogramin resistance. The GC further noted that, it was insufficient to merely demonstrate that the existence of such a link was ‘very unlikely[28]’. However, it also vital to note that, precluding a zero-risk approach does not seem to preclude the adoption of a preventative measure aiming to eliminate entirely a risk, which is more than a hypothetical risk and which has been scientific confirmed[29].
Due to the scientific evidence or results are insufficient, inconclusive, or imprecision, a Member may adopt a preventative measure. Also, when there are conflicts of scientific opinions regarding the safety of the products, a Member may also adopt a preventative measure.
It is vital to note that the authority’s decision shall be based on a sufficiently reliable and respect information[30], taking into account the scientific data available at the time when taking a precautionary measure[31], as well as the latest results of international research[32].
4. Judicial Review
The EU courts make a distinction between the EU institutions and the Member States when reviewing their precautionary measures. With regard to the protective measures adopted by the Member States, the ECJ tends to apply the strict test of the precautionary principle, when the measures at issue have impaired the functioning of the internal market[33]. While, where the EU institutions possess wide discretionary powers, the GC virtually tends to apply a slight test of the precautionary principle, and solely examines whether the Union measures concerned is invalid on the ground of manifest error, misuse of power, or ultra vires[34]. Being aware of the difficulties of regulating the controversial cases or determining where action is urgent, the EU courts tend to respect the decisions adopted by the EU institutions and only conduct the limited reviews. Here, the EU judicial organs choose not to substitute its assessment of the facts for that of the Union institutions[35].
4.1 Examining the Precautionary Measures by the Proportionality Principle
The ECJ previously admitted that, the precautionary principle is part of the proportionality principle[36]. In contrary, the GC treated the precautionary principle and the proportionality principle as two separate principles in its judgments[37]. The authors indicated that, the principles of proportionality and precaution are intertwined together in their application[38]. Here, my personal view is that the courts have virtually changed the criteria of the proportionality principle when applying the precautionary principle in the case[39]. Compared with the proportionality principle, the precautionary principle is used to cope with the uncertain situations and tends to enact a more restrictive measure to address the unknown risks. When the factual contexts are uncertain, it is very hard to establish the proportionality[40].
When applying the proportionality principle, the ECJ normally requires that, Union measures shall not exceed the limits of what is appropriate and necessary in order to attain the objectives pursued by the acts in question and, where there is a choice between several proper measures, recourse must be to the least restrictive, and the demerits caused must not be disproportionate to the objectives pursued[41]. Below we would like to separately examine each criterion.
4.1.1 The Necessity Test
This test first compares the various measures having the capacity of achieving the objectives pursued and picks the least restrictive one. However, in Pfizer case, the plaintiff party argued that, the Union authority shall wait until the scientific studies have shown ‘a sufficient likelihood of risk, instead of immediately taking the preventative measures. The GC replied that, the institutions cannot be criticized for having chosen to provisionally withdraw the authorization of virginiamycin, in order to prevent the risk from becoming reality, and at the same time, to continue the research. Here, we can observe that this approach is in line with the precautionary principle. Thus, the criterion of the necessity test has been loosened by the courts.
4.1.2 The Test of Weighing Interests
At this stage, the proportionality principle requires the courts to compare the importance of the objective pursued by the measure at issue and the interests that would be sacrificed by the measure[42]. However, both the ECJ and the GC have expressed that, the requirements of the protection of human health should take precedence over the economic interests[43]. Furthermore, in Artegodan, the GC even embraced a new general principle of Union law, by stating that the protection of human health ‘must undoubtedly’ take precedence over the economic considerations[44]. Here, again, the application of the precautionary principle has effectively changed the criterion of the proportionality principle, by placing the value of human health being prior to the economic interests.
Nonetheless, in Artegodan, the GC also equally emphasized the importance of applying the principles of proportionality and non-discrimination[45]. Likewise, in Bellio F.lli Srl, the ECJ stressed that, even the need to protect public health has been recognized as a primary concern, the proportionality principle still needs to be respected[46].
4.1.3 The Duty of Re-examination
In line with the WTO and the EU law[47], the proportionality principle also requires the EU institutions and the Member States to re-examine their preventative measures, when there has been new scientific information. It would be proportionate to loosen the requirements of the preventative measure when the new research shows that the suspected risk does not seem as serious as the previous evaluation. Here, since the application of the precautionary principle can be seen as the exception of the proportionality principle, the preventative measures adopted shall be provisional and the institutions shall continue its research and re-examine its preventative measures in time, in order to make a balance between the two principles.
4.2 Examining the Precautionary Measures by the Precautionary Principle
In 2000, the European Commission (hereafter referred to as ‘Commission’) produced a Communication seeking to inform all interested parties how the Commission would apply or intent to apply the precautionary principle when taking the preventative measures to confront with the risk, whose nature is scientific uncertainty. Although the communication is not binding, the EU judicial organs can examine whether an EU measure complies with the guidelines the Commission have presented. In other words, in accordance with the equal principle[48], the Commission shall adopt a communication-consistent measure[49].
It is quite observed that the EU courts are reluctant to conduct the substantive review of the precautionary measures adopted by the EU institutions. As mentioned before, the courts also admitted that it is the duty and competence of the institutions to make a political decision whether it is necessary to adopt a preventative measure under the precautionary principle. Thus, the institutions enjoy wide discretionary powers when enacting a precautionary measure[50]. However, also mentioned above, in order to avoid the abuse of the precautionary principle resulting from the view of the populist[51], several steps need to be fulfilled before adopting a preventive measure:
l The necessity of conducting a risk assessment;
l The risk assessment shall be based on the all scientific evidence available at the time when adopting preventative measures;
l The risk assessment shall contain the latest results of the international research;
l The risk assessment shall be conducted in an excellent, independent ,and transparent manner, in order to ensure the quality of the risk assessment;
l When the decision-makers want to disregard a scientific opinions issued by an EU relevant scientific committee or an agency, they shall provide the equal scientific opinion as the one they do not concern.
Whereas the institutions already have the wide discretionary powers to determine a preventative measure under the precautionary principle, it shall severely observe the procedural steps it enacted. While, the GC widely recognized the criteria presented by the Communication, it missed the chance to use those criteria to examine the institution’s decisions. Here, we do not see the court had examined whether the institutions have conducted an as thorough risk assessment as possible and required adequate guarantees of scientific objectivity[52]. A risk management decision without fulfilling the all procedural steps above-mentioned would not solve the controversial dispute, while bringing more problems.
On the other hand, despite its avoidance of entering to the substantively scientific detail, it did conduct several substantive examinations in the cases[53]. Therefore, we may wonder, first whether the courts themselves have the capacity to judge so, and second, whether the courts conducted those factual examinations based on the firmly scientific ground. The author thus suggested in case involving highly technical or controversial scientific evidence, the courts shall submit the evidence to the independent experts to assess the validity of the scientific arguments involved[54].
With regard to the precautionary measures adopted by the Member States, in cases of scientific uncertainty, Member States also enjoy wide discretion in deciding the adoption of the preventative measures. They shall also deliver some evidence of scientific uncertainty. The evidence presented shall be related to a specific, concrete risk and not a potential risk on the basis of a general preventative approach, and this special risk shall be assessed in terms of the specific eating habits of a nation[55].
5. The Precautionary Principle and the SPS Agreement
From the outset, the negotiators of the SPS Agreement did not intend to include the precautionary principle into the SPS Agreement[56].
Article 2, paragraph 2 of the SPS Agreement provides that, a SPS measure cannot be maintained without ‘sufficient scientific evidence’. The exception is to enact a provisional measure, in accordance with Article 5, paragraph 7 of the SPS Agreement[57], and this provision can be seen as the expression of the precautionary principle under the WTO law[58].
In Japan-Varietals, the Appellate Body ruled that, the ordinary meaning of 'sufficient' is 'of a quantity, extent, or scope adequate to certain purpose or object'. 'Sufficiency' requires the existence of a sufficient or adequate relationship between the SPS measure and the scientific evidence. Whether there is a rational relationship between an SPS measure and the scientific evidence is to be determined on a case-by-case basis and will depend upon the particular circumstances of the case, including the characteristics of the measure at issue and the quality and quantity of the scientific evidence[59].
Here, the Appellate Body clearly stated that, the requirement of sufficient scientific evidence is both determined by the quality and quantity of the scientific evidence.
According to Article 5, paragraph 7 of the SPS Agreement, A Member can enact a provisional measure provided that:
l in a situation where 'relevant scientific information is insufficient;
l the measure adopted is 'on the basis of available pertinent information'.
In addition, a provisional measure may not be maintained unless:
l the Member seeks to obtain the additional information necessary for a more objective assessment of risk;
l the Member reviews the provisional measure accordingly within a reasonable period of time.
The four criteria are cumulative[60]. With respect to the reasonable time limits of review, the Appellate Body noted that, in our view, what constitutes a 'reasonable period of time' has to be established on a case-by-case basis and depends on the specific circumstances of each case, including the difficulty of obtaining the additional information necessary for the review and the characteristics of the provisional SPS measure[61]. Thus, here the Appellate Body has taken into account the difficulty of obtaining the necessary scientific information, in order to complete the full risk assessment. The requirement of the reasonable time limits of review is not so strict and in line with the precautionary principle[62].
However, the core concept used in the text of Article 5, paragraph 7 of the SPS Agreement is ‘insufficient’, instead of ‘uncertainty’. At first glance, one may wonder the scope of precautionary principle under the WTO law has been significantly narrowed[63]. Nonetheless, recalling the ruling of the Appellate Body in Japan-Varietals, the ordinary meaning of 'sufficient' is 'of a quantity, extent, or scope adequate to certain purpose or object. If all available information is insufficient for the scientists to make a conclusion, or even the current state of scientific knowledge is insufficient to assess the suspected risk, Member shall be allowed to adopt a provisional measure to address the unknown risks or the urgent problems under the WTO law.
Therefore, Article 5, paragraph 7 of the SPS Agreement aims to deal with the situation where there is a lack of sufficient scientific evidence concerning the suspected risk, including the accumulated evidence is inconclusive or unreliable[64]. The standard for permitting to adopt a provisional measure under Article 5, paragraph 7 of the SPS Agreement is to test whether there is sufficient scientific evidence for completing a full risk assessment under Article 5, paragraph 1 of the SPS Agreement[65].
Furthermore, here I would like to emphasize that, science, per se, is an evolving process. It is not a stable concept, and every day, scientists would have new findings about the new potential risks. Thus, it is rationale for Members to enact a provisional measure to address a new risk found in the substances that had been used in the manufacture of specific products for many years. In other words, recognizing the limits of science and the dynamic nature of the science, today the food is safe, tomorrow it would be deemed as unsafe, and thus a rational measure shall be figured out.
Also, in EC-Hormones, with respect to the legal status of the precautionary principle under the international law, the Appellate Body stated that, whether the precautionary principle has been widely accepted by Members as a principle of general or customary international law appears less than clear. We note that the precautionary principle, at least outside the field of international environmental law, still awaits authoritative formulation[66].
Although, the Appellate refuse to recognize the legal status of the precautionary principle as the customary international law, and thus can be invoked to interpret Article 5, paragraph 1 of the SPS Agreement, considering that to become a principle of customary international law is also an evolving process, the precautionary principle may be recognized as a principle of customary international law in the future.
Nevertheless, in EC-Hormones, the Appellate Body explicitly stated that, the precautionary principle cannot override the requirements of Article 5, paragraph 1 and 2 of the SPS Agreement[67].
Finally, it is noteworthy that, despite the fact that the ECJ has denied the direct effect of the WTO Agreement[68], where the Union acts aimed to implement a specific WTO obligation, the European courts has expressed its willingness to review the legality of the Union measures under the WTO law[69].
6. Conclusion
In the end, we would like to review our findings in the previous sections. First, in line with the WTO case law, also considering the requirements of the Communication, the EU institutions shall severely obey the procedural requirements it enacted before adopting a preventative measure.
Second, after reviewing the relevant cases, the application of the precautionary principle did change the criteria of the proportionality principle. Therefore, it is vital to strike a balance between the two principles by requiring the institutions to completely fulfill all the relevant requirements when making decisions. In particular, the economic interests shall not be entirely sacrificed without goods reasons, and the measures adopted shall be provisional. Whereas science plays an important role in the decision-making of risk regulation, the advice shall be offered in an independent, excellence, and transparent manner, in order to well solve the disputes.
Third, it is pity to see that the General Court missed the opportunities to use those procedural requirements to review the institution’s decisions. The GC failed to examine whether the institutions had an as through risk assessment as possible and whether the adequate requirements of scientific objectivity had been guaranteed. Without a strict test performed by the judicial review, it would inevitably offer the incentive for the institutions to abuse the wide discretion they have. Furthermore, if the courts have conducted reviews in the area of scientific issues, it is rational for the courts to submit the evidence to the experts to assess the scientific arguments in question.
Finally, is there any possible to seek a compromise between the precautionary principle and the SPS Agreement? Limited by the texts of the current provisions of the SPS Agreement, also given the negative outcomes of the relevant WTO cases, the room of applying the precautionary principle under the WTO law is narrow and only can be sought by invoking Article 5, paragraph 7 of the SPS Agreement. Nonetheless, there is still room to include the precautionary principle by well interpretation.
[1] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 165.
[2] It is interesting to note that, it is also possible to invoke the precautionary principle as a sword to challenge the legality of acts of Member States, see Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 257.
[3] Case C-180/96 R United Kingdom v. Commission [1996] ECR I-3903, para. 93.
[4] Case T-13/99 Pfizer, [2002] ECR II-03305, para. 139.
[5] See COMMUNICATION FROM THE COMMISSION on the precautionary principle, Brussels 02.02.2000 COM (2000) 1 at p. 10. The legal basis can also be found in Article 114, paragraph 3 of the TFEU, see Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 256, J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at pp. 52-53.
[6] Case T-13/99 Pfizer, [2002] ECR II-03305, para 387.
[7] Ellen Vos, Antibiotics, the Precautionary Principle and the Cout in First Instance. Maastricht Journal of European and Comparative Law,2004, at p. 193.
[8] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at pp. 146-147.
[9] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 148.
[10] Cass R. Sunstein, Beyond the Precautionary Principle, Public Law and Legal Theory Working Paper No. 38: the Law School, The University of Chicago, at: http://www.law.uchicago.edu/publications/papers/publiclaw/1-99 , p. 13.
[11] Case T-13/99 Pfizer [2002] ECR II-03305, para. 143. See also, J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at p. 60.
[12] Appellate Body Report, EC-Hormones, para. 186.
[13] Case C-236/01, Monsanto Agricoltura Italia, para. 113.
[14] Case T-13/99 Pfizer [2002] ECR II-03305, paras. 155-156.
[15] Case C-236/01, Monsanto, para. 113.
[16] Appellate Body Report, EC-Hormones, para. 186.
[17] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 153.
[18] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 154.
[19] See Article 10.1 of the Directive 2001/42/EC.
[20] Case C-192/01, Commission v. Denmark, para. 51.
[21] Case T-13/99 Pfizer [2002] ECR II-03305, para. 162.
[22] Appellate Body Report, Australia-Salmon, para. 199.
[23] Case T-13/99 Pfizer [2002] ECR II-03305, para. 201.
[24] Case C-405/92, Armand Mondiet, paras. 31-32.
[25] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 162.
[26] Case T-13/99 Pfizer [2002] ECR II-03305, para. 171.
[27] Case T-13/99 Pfizer [2002] ECR II-03305, para. 152.
[28] Case T-13/99 Pfizer [2002] ECR II-03305, para. 391.
[29] J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at p. 60.
[30] Case T-13/99 Pfizer [2002] ECR II-03305, para. 62.
[31] Case T-13/99 Pfizer [2002] ECR II-03305, para. 145.
[32] Case C-42.02, Commission v. Netherlands, para. 49.
[33] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 166.
[34] Ellen Vos, Antibiotics, the Precautionary Principle and the Court in First Instance, Maastricht Journal of European and Comparative Law, 2004, at p. 196.
[35] Case T-13/99 Pfizer [2002] ECR II-03305 para. 169.
[36] Case C-157/96 The Queen v. Ministery of Agriculture, Fisheries, and Food [1998] ECR I-2211, para. 63.
[37] Ellen Vos, Antibiotics, the Precautionary Principle and the Court in First Instance. Maastricht Journal of European and Comparative Law, 2004, at p. 195.
[38] Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 257.
[39] In contrary, the author indicated that, the proportionality principle would serve to temper precaution in a European Union setting, see J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at p. 62.
[40] Ellen Vos, Antibiotics, the Precautionary Principle and the Court in First Instance. Maastricht Journal of European and Comparative Law,2004, at p. 196, Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 260.
[41] Case T-13/99, Pfizer [2002] ECR II-03305, para. 411.
[42] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at p. 168.
[43] Case C-180/96 P UK v Commission [1996] ECR I-3903, para. 93.
[44] Case T-74/00 Artegodan, para. 173. However, this sentence shall not be merely construed as a slogan. Instead, here the policy-makers are truly faced with hard choices and required to strike a balance between trade and non-trade interests, see J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at p. 66.
[45] Case T-74/00 Artegodan, para. 186.
[46] Case C-286/02 Bellio F. lli Srl. Para. 60.
[47] With regard to the WTO law, Article 5.7 of the SPS Agreement; with regard to the EU law, see paragraph 6.3.5 of COMMUNICATION FROM THE COMMISSION on the precautionary principle, Brussels 02.02.2000 COM (2000) 1.
[48] It is the administrative self-restraints principle in German administrative law.
[49] Nicolas de Sadeleer, The Precautionary Principle in EC Health and Environmental Law, European Law Journal, Vol. 12, No. 2, March 2006, at pp. 141-142.
[50] To note, in the absence of harmonization, Member States are also allowed considerable discretion, while, they must have regard to the requirement of free movement, see Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 261.
[51] With regard to the discussion between technocratic and populist, see Cass R. Sunstein, The Laws of Fear, JOHN M. OLIN LAW & ECONOMICS WORKING PAPER NO. 128, p. 3, at: http://www.law.uchicago.edu/Lawecon/wp101-150
[52] Ellen Vos, Antibiotics, the Precautionary Principle and the Court in First Instance. Maastricht Journal of European and Comparative Law, 2004, at p. 200.
[53] Ellen Vos, Antibiotics, the Precautionary Principle and the Court in First Instance. Maastricht Journal of European and Comparative Law, 2004, at pp. 198-199. A similar opinion, see J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at p. 62.
[54] Ellen Vos, Antibiotics, the Precautionary Principle and the Court in First Instance. Maastricht Journal of European and Comparative Law, 2004, at p. 200.
[55] Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 261.
[56] Appellate Body Report, EC-Hormones, para. 124. Denise Prévost, What Role for the Precautionary Principle in WTO Law After Japan-Apples, Ecolomic Policy and Law: Journal of Trade and Environmental Studies, Vol. 2 (4), June 2005, at pp. 2-3.
[57] Joost Pauwelyn, The WTO Agreement on Sanitary and Phytosanitary (SPS) Measures as Applied in the First Three SPS Dipsutes EC - Hormones, Australia - Salmon and Japan – Varietals, Journal of International Economic Law (1999), at p. 645, also see Joanne Scott and Ellen Vos, ‘The Justification of Uncertainty: Observations of the Ambivalence of the Precautionary Principle within the EU and the WTO’, in C, Joerges and R. Dehousse (eds.), Good Governance in Europe’s Integrated Market (Oxford University Press: 2002), at p. 273.
[58] Denise Prévost, What Role for the Precautionary Principle in WTO Law After Japan-Apples, Ecolomic Policy and Law: Journal of Trade and Environmental Studies, Vol. 2 (4), June 2005, at p. 13.
[59] Appellate Body Report, Japan-Varietals, paras. 73 and 84.
[60] Peter Van den Bossche, The Law and Policy of the World Trade Organization-Texts, Cases, and Materials, (Cambridge University Press, 2007), at p. 863.
[61] Appellate Body Report, Japan-Varietals, para. 93.
[62] Similarly, the author states that the requirement of reasonable time limit is flexible and allows a Member to maintain a measure as long as necessary for completing a full risk assessment, see Peter Van den Bossche, The Law and Policy of the World Trade Organization-Texts, Cases, and Materials, (Cambridge University Press, 2007), at p. 867.
[63] However, In Japan-Apples, the Appellate Body indicated that, Article 5, paragraph 7 of the SPS Agreement is not triggered by the existence of scientific uncertainty, but rather by the insufficiency of scientific evidence, see Appellate Body Report, Japan-Apples, para. 8.215.
[64] Peter Van den Bossche, The Law and Policy of the World Trade Organization-Texts, Cases, and Materials, (Cambridge University Press, 2007), at p. 865.
[65] Panel Report, EC-Approval and Marketing of Biotech Products, para. 7.3239.
[66] Panel Report, EC-Hormones, para. 8.610.
[67] Appellate Body Report, EC-Hormones, para. 124.
[68] Case C-149/96 Portugal v. Council [1999] ECR I-8395.
[69] J. Scott, ‘The Precautionary Principle Before the European Courts’, in: R. Macrory (eds.), Principles in Environmental Law, (Europa Law Publishing, 2004), at p. 69.
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