1 Wiener, Jonathan, “Precaution”, in Bodansky, Daniel, Brunnée, Jutta und Hey, Ellen (eds), The Oxford Handbook of International Environmental Law, (Oxford: Oxford University Press, 2007), pp. 597 et sqq., at p. 554Google Scholar.

2 Cafaggi, Fabrizio, “New Foundations of Transnational Private Regulation”, 38 Journal of Law and Society (2011), pp. 20 et sqq CrossRefGoogle Scholar.

3 Article 191 (2) of the Treaty on the Functioning of the European Union, OJ 2010 C 83/49 states: “Union policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Union. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay”.

4 The core element of the general food law definition of the PP, namely decision making under scientific uncertainty and a margin of appreciation associated with it – already emerged in rulings dating back to 1980, before such concept was included in the EC Treaty. In particular in Case C-174/1982, Criminal proceedings against Sandoz BV [1983] ECR 2445, at para. 16, the court affirmed: “In so far as there are uncertainties at the present state of scientific research, it is for the MS, in the absence of harmonization, to decide what degree of protection of the health and life of humans they intend to assure, having regard however for the requirements of the free movement of goods within the Community”.

5 Sunstein, Cass, Laws of Fear: Beyond the Precautionary Principle (Cambridge: Cambridge University Press, 2005), pp. 89 et sqq CrossRefGoogle Scholar. See the ruling of the ECJ in the so called BSE cases, namely Case C-157/96, The Queen v Ministry of Agriculture, Fisheries and Food and Commissioners of Customs & Excise, ex parte National Farmers’ Union and Others [1998] ECR I-02211, at para. 63 where the Court, evaluating the Commission adoption of emergency measure banning all exports of British beef, found the measure not to be in breach of the principle of proportionality, affirming 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 until the reality and seriousness of those risks become fully apparent”. See also Case C-180/96 United Kingdom of Great Britain and Northern Ireland v Commission of the European Communities [1998] ECR I-02265.

6 Majone, Giandomenico, “Political Institutions and the Principle of Precaution”, in Wiener, Jonathan, Rogers, Michael, Hammitt, James, et al. (eds), The Reality of Precaution - Comparing Risk Regulation in the US and Europe (Washington: Resource for the Future Press, 2011), pp. 411 et sqq., at p. 431Google Scholar.

7 Berkamp, Lucas and Smith, Turner Jr., “Legal and Administrative Systems: Implications for Precautionary Regulation”, in Wiener, Jonathan, Rogers, Michael, Hammitt, James, et al. (eds), The Reality of Precaution - Comparing Risk Regulation in the US and Europe (Washington: Resource for the Future Press, 2011), pp. 434 et sqq Google Scholar., at p. 470. Judicial review in EU has a more limited scope due to a voluntary restrain adopted by courts on their own discretion. A clear example is Case C- 331/88, The Queen v Minister of Agriculture, Fisheries and Food and Secretary of State for Health, ex parte: Fedesa and others, [1990] ECR I-04023, at para. 8, where the ECJ was asked to make a preliminary ruling on the validity of national regulations which aimed to implement Directive 88/146/EC prohibiting the use of a number of hormones in livestock. In particular the claimant, Fedesa had held that anxieties of consumers related to the hormones in question lacked any foundation in science, and that as a consequence the principle of legal certainty for traders of hormones was violated. The court declined to make a judgment with regard to scientific evidence stating that: “Even if it were to be held, as the applicants in the main proceedings have argued, that the principle of legal certainty requires any measures adopted by the Community institutions to be founded on a rational and objective basis, judicial review must, having regard to the discretionary power conferred on the Council in the implementation of the common agricultural policy, be limited to examining whether the measures in question is vitiated by a manifest error or misuse of powers, or whether the authority in question has manifestly exceeded the limits of its discretion”.

8 See Case T-229/2004, Kingdom of Sweden v Commission of the European Communities [2007] ECR II-02437, where the CFI revoked a decision to authorize the pesticide Paraquat upon the basis that the Commission had not acted in a sufficiently precautionary manner when issuing the authorization.

9 Cafaggi, Fabrizio, “A Coordinated Approach to Regulation and Civil Liability in European Law: Rethinking Institutional Complementarities”, in Cafaggi, Fabrizio (ed.) The Institutional Framework of European Private Law, (Oxford: Oxford University Press, 2006), pp.191 et sqq Google Scholar.

10 Whittaker, Simon, Product Liability: English Law, French Law, and European Harmonisation, (Oxford: Oxford University Press, 2005)CrossRefGoogle Scholar. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, OJ 2003 L 33/30 followed the blood contamination scandals such as HIV-infected blood in France, Germany and Portugal. However, given that the Directive sets minimum standards, it does not prevent MS from maintaining or introducing more stringent national protective measures, for instance relating to requirements for voluntary and unpaid blood donations.

11 For example Berkamp and Smith Jr., “Legal and Administrative Systems”, supra, note 7, at p. 475 state: “we do not see a clear indication, in either the US or the EU legal or administrative system, of any actual significant impact on the degree of precaution in the resulting risk regulation”.

12 Gray, George, Rogers, Michael and Wiener, Jonathan, “Beef Hormones, and Mad Cows, in Wiener, Jonathan, Rogers, Michael, Hammitt, James, et al. (eds), The Reality of Precaution - Comparing Risk Regulation in the US and Europe (Washington: Resource for the Future Press, 2011), pp. 65 et sqq Google Scholar., at p. 68 et sqq.; Alemanno, Alberto , “How to Get Out of the Transatlantic Regulatory Deadlock over Genetically Modified Organisms?”, in Vogel, David and Swinnen, Johan (eds), Transatlantic Regulatory Cooperation (Cheltenham: Edward Elgar Publishing Ltd., 2011) pp. 200 et sqq Google Scholar.

13 See Case C-6/1999, Association Greenpeace France and Others v Ministère de l’Agriculture et de la Pêche and Others [2000] ECR I-1651, at para. 44, where in relation to a question of a French Court regarding whether the MS is bound to follow the decision of the Commission regarding the authorization of GMO product, or it does still retain come discretion, the ECJ found that some discretion still remained, with the MS stating that “Observance of the precautionary principle is reflected in the right of any MS provisionally to restrict or prohibit the use or sale on its territory of a product which has received consent where it has justifiable reasons to consider that it constitutes a risk to human health or the environment”.

14 Berkamp and Smith Jr., “Legal and Administrative Systems” supra, note 7, at p. 474.

15 Reinmann, M., “Beyond National Systems: A Comparative Law for the International Age”, 75 Tulane Law Review (2001), pp. 1103 et sqq Google Scholar.

16 Michaels, Ralf and Jansen, Nils, “Private Law Beyond the State? Europeanization, Globalization, Privatization”, 54 American Journal of Comparative Law (2006), pp. 843 et sqq. CrossRefGoogle Scholar, Michaels, Ralf, “Comparative Law by Numbers? Legal Origins Thesis, Doing Business Reports, and the Silence of Traditional Comparative Law”, 57 American Journal of Comparative Law (2009), pp. 765 et sqq CrossRefGoogle Scholar.

17 Wiener, Jonathan, “The Real Pattern of Precaution”, in Wiener, Jonathan, Rogers, Michael, Hammitt, James, et al. (eds), The Reality of Precaution - Comparing Risk Regulation in the US and Europe (Washington: Resource for the Future Press, 2011), pp. 552 et sqq., at p. 553Google Scholar

18 As general examples in this regard one can mention the ISEAL Alliance or the Global Harmonization Initiative with regard to food safety standards; furthermore WTO Workshop on Regulatory Practices provides for such a forum (http://www.wto.org/english/tratop_e/serv_e/workshop_apr11_e/workshop_apr11_e.htm).

19 Sunstein, Laws of Fear, supra, note 5.

20 Cafaggi, “A Coordinated Approach to Regulation”, supra, note 9.

21 Stewart, Richard, “Instrument Choice”, in Bodansky, Daniel, Brunnée, Jutta und Hey, Ellen (eds), The Oxford Handbook of International Environmental Law, (Oxford: Oxford University Press, 2007), pp. 147 et sqq Google Scholar.

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