1 Hood, Christopher, Rothstein, Henry, and Baldwin, Robert, The Government of Risk: Understanding Risk Regulation Regimes (Oxford: Oxford University Press, 2001), at p. 4 CrossRefGoogle Scholar. Some authors refer to “social regulation” to describe this process – see Joerges, Christian, “Scientific Expertise in Social Regulation and the European Court of Justice”, in Joerges, Christian, Ladeur, Karl-Heinz, and Vos, Ellen (eds), Integrating Scientific Expertise into Regulatory Decision-Making: National Traditions and European Innovations (Baden-Baden: Nomos, 1997)Google Scholar.

2 OJ 2002 L 31/1.

3 See Case C-47/90, Delhaize [1992] ECR I-3669, at para. 26; Case C-315/92, Clinique [1994] ECR-317, at para. 12.

4 Case 120/78, Rewe-Zentral AG v. Bundesmonopolverwaltung für Branntwein [1979] ECR 649.

5 The other exceptions are: public morality, public policy or public security; the protection of national treasures possessing artistic, historic or archaeological value; and the protection of industrial and commercial property.

6 On Art. 114 TFEU see Michael Dougan, “Minimum harmonisation and the internal market”, 37 CML Rev. (2000), pp. 853 et sqq.; Hanf, Dominik, “Flexibility Clauses in the Founding Treaties, from Rome to Nice”, in De Witte, Bruno, Hanf, Dominik, and Vos, Ellen (eds), The Many Faces of Differentiation in EU Law (Antwerp: Intersentia, 2001)Google Scholar; Vos, Ellen, “Differentiation, Harmonisation and Governance”, in De Witte, Bruno, Hanf, Dominik, and Vos, Ellen (eds), The Many Faces of Differentiation in EU Law (Antwerp: Intersentia, 2001)Google Scholar; and de Sadeleer, Nicolas, “Procedures for Derogation from the Principle of Approximation of Laws under Article 95 EC”, 40 CML Rev. (2003), pp. 889 et sqq Google Scholar. In 2002 the Commission issued a Communication concerning Article 95 EC (COM (2002)760).

7 The paragraph runs as follows: “4. If, after the adoption of a harmonisation measure by the European Parliament and the Council, by the Council or by the Commission, a Member State deems it necessary to maintain national provisions on grounds of major needs referred to in Article 36, or relating to the protection of the environment or the working environment, it shall notify the Commission of these provisions as well as the grounds for maintaining them.”

8 The paragraph reads: “5. Moreover, without prejudice to paragraph 4, if, after the adoption of a harmonisation measure by the European Parliament and the Council, by the Council or by the Commission, a Member State deems it necessary to introduce national provisions based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmonisation measure, it shall notify the Commission of the envisaged provisions as well as the grounds for introducing them.”

9 See, e.g., Dec. 1999/5/EC, OJ 1999 L 3/13, at para. 15; Dec. 1999/830/EC, OJ 1999 L 329/1, at para. 18.

10 See, e.g., Pescatore, Pierre, “Some Critical Remarks on the ‘Single European Act’”, 24 CML Rev. (1987), pp. 9 et sqq Google Scholar.

11 Opinion of A.G. Tizzano of 30 May 2002 in Case 3/00.

12 Ibid., at para. 76.

13 Case 3/00, Denmark v. Commission [2003] ECR I-2643, at para. 59.

14 For an overview of national derogations see Onida, Marco, “The Practical Application of Article 95(4) and 95(5) EC Treaty: What Lessons Can We Learn About the Division of Competences Between the EC and Member States in Product-Related Matters?”, in Pallemaerts, Marc (ed.), EU and WTO Law: How tight is the Legal Straitjacket for Environmental Product Regulation? (Brussels: VUB Brussels University Press, 2006)Google Scholar.

15 Dominik Hanf, supra note 6, at p. 12.

16 The title refers to Tsunehiro Otsuki, John S. Wilson, and Mirvat Sewadeh, A Race to the Top? A Case Study of Food Safety Standards and African Exports (The World Bank Policy Research Working Paper WPS2563, 2001).

17 Grey, Paul, “Food law and the internal market: Taking stock”, 15 Food Policy (1990), pp. 111 et sqq., at p. 111CrossRefGoogle Scholar.

18 European Economic and Social Committee, Opinion on “The single market and the protection of the environment: coherence or conflict (Single Market Observatory)”, OJ C 019 21/1/1998, at para. 1.4.

19 Vogel, David, Trading Up: Consumer and Environmental Regulation in a Global Economy (Cambridge, MA: Harvard University Press, 1995), at p. 259 Google Scholar.

20 Creosote is principally used for railway sleepers, poles for electricity transport, hydraulic constructions or fences. It is highly toxic and its release to the environment can cause harm to animals and wildlife. Exposure to creosote is also dangerous to human health as it can be carcinogenic.

21 OJ 1994 L 365/1. Creosote was not permitted for wood treatment if it contained benzo[a]pyrene above a concentration of 0,005% by mass and water extractable phenols at a concentration greater than 3% by mass. By way of derogation, in industrial installations creosote containing benzo[a]pyrene of a concentration of less than 0,05% was allowed.

22 Dec. 1999/832/EC, OJ 1999 L 329/25; Dec. 1999/833/EC, OJ 1999 L 329/43; Dec. 1999/834/EC, OJ 1999 L 329/63; Dec. 1999/835/EC, OJ 1999 L 329/82.

23 Dir. 2001/90/EC, OJ 2001 L 283/41.

24 I.e., creosote containing benzo[a]pyrene at a concentration of less than 0,005% by mass and water extractable phenols at a concentration of less than 3% by mass.

25 Dec. 2002/884/EC, OJ 2002 L 308/30, at para. 80.

26 See, e.g., Dec. 1999/833/EC, supra note 23, at paras. 32–34.

27 A special Committee of Inquiry set up by the European Parliament severely criticized the Commission for protecting the market and putting business interests over public health concerns (European Parliament, Report on the alleged contraventions or maladministration in the implementation of Community law in relation to BSE, without prejudice to the jurisdiction of the Community and the national courts, 1997, A4-0020/97/A, PE 220.544/fin/A). On the BSE crisis see Vos, Ellen, “EU Food Safety Regulation in the Aftermath of the BSE Crisis”, 23 Journal of Consumer Policy (2000), pp. 227 et sqq CrossRefGoogle Scholar.; Sebastian Krapohl, Thalomide, BSE and the Single Market: A Historical-Institutionalist Approach to Regulatory Regimes in the European Union (EUI Working Paper LAW No. 2005/03).

28 Supra note 2.

29 European Commission, White Paper on Food Safety, COM (1999)719 final.

30 These Committees were: Scientific Committee on Food, Scientific Committee on Animal Nutrition, Scientific Veterinary Committee, Scientific Committee on Pesticides, Scientific Committee on Plants, and Scientific Steering Committee.

31 See, e.g., Reg. 1829/2003 on genetically modified food and feed, OJ 2003 L 268/1; Reg. 1924/2006 on nutrition and health claims made on foods, OJ 2007 L 12/3; Reg. 1331/2008 establishing a common authorization procedure for food additives, food enzymes and food flavourings, OJ 2008 L 354/1.

32 See, e.g., Art. 7(3) Reg. 1331/2008, supra note 31.

33 See, e.g., Alemanno, Alberto, Trade in Food: Regulatory and Judicial Approaches in the EC and the WTO (Cambridge: Cameron May, 2007), at p. 194 Google Scholar.

34 Art. 36(3) GFL and Reg. 2230/2004 laying down detailed rules with regard to the network of organizations operating in the fields within EFSA's mission, OJ 2004 L 379/64.

35 Art. 30 GFL.

36 David Byrne, “EFSA: Excellence, integrity and openness”, Inaugural meeting of the Management Board of the European Food Safety Authority, Brussels, 18 September 2002.

37 Szajkowska, Anna, “From mutual recognition to mutual scientific opinion? Constitutional framework for risk analysis in EU food safety law”, 34 Food Policy (2009), pp. 529 et sqq., at p. 531CrossRefGoogle Scholar.

38 Art. 4(1) GFL.

39 Art. 3(1) GFL.

40 Codex Alimentarius Commission, Procedural Manual, 19th ed. (Rome: FAO/WHO, 2010)Google ScholarPubMed.

41 The risk analysis methodology is limited to measures aimed at the protection of human health (food safety law). Technical food standards not having as their objective the protection of human health are excluded from the scope of application of risk analysis. See also Szajkowska, Anna, “The Impact of the Definition of the Precautionary Principle in EU Food Law”, 47 CML Rev. (2010), pp. 173 et sqq., at p. 189Google Scholar. On risk analysis see National Research Council, Risk Assessment in Federal Government: Managing the Process (National Academy Press, 1983)Google Scholar; American Chemical Society, Understanding Risk Analysis: A Short Guide for Health, Safety, and Environmental Policy Making (Washington DC, 1998)Google Scholar; FAO, “Risk Management and Food Safety”, Report of a Joint FAO/WHO Consultation – Rome, 27–31 January 1997, FAO Food and Nutrition Paper 65.

42 The definition of risk analysis, strictly speaking, consists of three components: risk assessment, risk management and risk communication. Risk communication is the interactive exchange of information concerning risks throughout the risk analysis process among risk assessors, risk managers, but also consumers, food businesses and other stakeholders (Art. 3(13) GFL). This element of risk analysis, however, is outside the scope of this study.

43 Risk assessment comprises four steps: hazard identification, hazard characterisation, exposure assessment and risk characterization (Art. 3(11) GFL). On the application of risk assessment to food safety see McKone, Thomas E., “Overview of the risk analysis approach and terminology: the merging of science, judgment and values”, 7(2) Food Control (1996), pp. 69 et sqq CrossRefGoogle Scholar.

44 Art. 3(12) GFL.

45 As an example, Vogel describes the reaction to the Ruling of the Court of Justice concerning the German “Reinheitsgebot” (Case 178/84, Commission v. Germany [1987] ECR 1227). A petition to maintain the national purity decree was signed by 2.5 million German citizens. David Vogel, supra note 19, at p. 40.

46 See Ansell, Christopher and Vogel, David (eds), What's the Beef? The Contested Governance of European Food Safety (Massachusetts: The MIT Press, 2006)Google Scholar.

47 See European Commission, Report of the working group “Democratising expertise and establishing scientific reference systems” (Group 1b) R. Gerold, pilot; A. Liberatore, rapporteur (White Paper on Governance, Work Area 1 – Broadening and enriching the public debate on European matters), 2001; Christoforou, Theofanis, “The precautionary principle and democratizing expertise: a European legal perspective”, 30(3) Science and Public Policy (2003), pp. 205 et sqq CrossRefGoogle Scholar.; De Marchi, Bruna, “Public participation and risk governance”, 30(3) Science and Public Policy (2003), at pp. 171 et sqq CrossRefGoogle Scholar.; Grundmann, Reiner and Stehr, Nico, “Social control and knowledge in democratic societies”, 30(3) Science and Public Policy (2003), pp. 183 et sqq Google Scholar.; Liberatore, Angela and Funtowicz, Silvio, “‘Democratising’ expertise, ‘expertising’ democracy: what does this mean, and why bother?”, 30(3) Science and Public Policy (2003), pp. 146 et sqq CrossRefGoogle Scholar.; Millstone, Erik, “Can food safety policy-making be both scientifically and democratically legitimated? If so, how?”, 20 Journal of Agricultural and Environmental Ethics (2007), pp. 483 et sqq CrossRefGoogle Scholar.

48 Rec. 19 GFL.

49 Art. Art. 3(12) GFL.

50 Jasanoff, Sheila, The Fifth Branch: Science Advisers and Policymakers (Cambridge, MA: Harvard University Press, 1994), at pp. 53–54 Google Scholar.

51 Emiliou, Nicholas, The Principle of Proportionality in European Law: A Comparative Study (London: Kluwer Law International, 1996)Google Scholar; de Búrca, Gráinne, “Proportionality and Subsidiarity as General Principles of Law”, in Bernitz, Ulf and Nergelius, Joakim (eds), The General Principles of European Community Law (Kluwer Law International, 2000)Google Scholar; Jans, Jan H., “Proportionality Revisited”, 27(3) Legal Issues of Economic Integration (2000), pp. 239 et sqq CrossRefGoogle Scholar.

52 See Case 104/75, De Peijper [1976] ECR 613, at paras 16–17.

53 Jan H. Jans, “Proportionality Revisited”, supra note 51, at p. 241.

54 See, e.g., Case 302/86, Commission v. Denmark [1988] ECR 4607 (Danish bottles). In this case, the ECJ found that “the system for returning non-approved containers is capable of protecting the environment and, as far as imports are concerned, affects only limited quantities of beverages compared with the quantity of beverages consumed in Denmark… In those circumstances, a restriction of the quantity of products which may be marketed by importers is disproportionate to the objective pursued” (para. 21).

55 Case T-326/07, Cheminova v. Commission [2009] ECR II-02685, at para. 106.

56 Ibid., at para. 107. See also Joined Cases T-74/00, T-76/00, T-83/00, T-84/00, T-85/00, T-132/00, T-137/00 and T-141/00, Artegodan and Others v. Commission [2002] ECR II-4945, at para. 200.

57 Case C-405/07 P, Netherlands v. Commission [2008] ECR I-8301, at para. 55.

58 Case T-13/99, Pfizer Animal Health SA v. Council [2002] ECR II-3305, at para. 169.

59 See, e.g., Case 178/84, supra note 45, at para. 44. On EFSA's de facto superiority over national scientific advice, see also Alemanno, Alberto, “The European Food Safety Authority at Five”, 1 European Food and Feed Law Review (2008), pp. 19 et sqq Google Scholar.

60 Case T-326/07, supra note 55, at para. 146.

61 Trachtman, Joel P., “Trade and … Problems, Cost-Benefit Analysis and Subsidiarity”, 9 EJIL (1998), pp. 32 et sqq CrossRefGoogle Scholar.

62 Ibid., at p. 74.

63 Case T-13/99, supra note 58, at para. 411.

64 Ibid., at paras. 420–429.

65 Ibid., at paras. 464–474.

66 See, e.g., Case 157/96, National Farmers’ Union [1998] ECR I-2211, at para. 61.

67 Case T-13/99, supra note 58, at para. 471, and case law referred to therein.

68 Case C-333/08, Commission v. France [2010] ECR 0000, at para. 87 and case-law referred to therein.

69 Dir. 88/344/EEC, OJ 1988 L 157/28.

70 Case C-333/08, supra note 68, at para. 103.

71 Case C-333/08, supra note 68, at para. 92.

72 Case C-333/08, supra note 68, at para. 85. See also van der Meulen, Bernd, “Prior Authorisation Schemes: Trade Barriers in Need of Scientific Justification”, 4 EJRR (2010), pp. 465 et sqq Google Scholar.

73 Jan H. Jans, “Proportionality Revisited”, supra note 51, at p. 249.

74 See, in this regard, Dec. 2009/726/EC concerning interim protection measures taken by France as regards milk products coming from a holding where a scrapie case is confirmed, OJ 2009 L 258/27, at paras. 22–25.

75 See Opinion of A.G. Tizzano, supra note 11, at para. 99.

76 Case 3/00, supra note 13, at para. 93.

77 See Opinion of A.G. Tizzano, supra note 11. In this regard he states that “[i]f it were a problem common to all or the majority of Member States, it would presumably already have been resolved by the directive, but if that were not so, it would be necessary to verify whether the conditions for challenging the directive were met, given that the directive must ensure not just general protection but a high level of protection; in any case, the problem would be of a general nature and it is not therefore possible to understand why it should be resolved only for the fortunate citizens of a single meticulous Member State, to the detriment of the uniform application of the harmonized rules and hence of the functioning of the internal market” (para. 77).

78 Dec. 1999/5/EC, supra note 9.

79 Supra note 11, at para. 82.

80 OJ 1995 L 61/1.

81 Dec. 1999/830/EC, OJ 1999 L 329/1.

82 Case 3/00, supra note 13.

83 Ibid., at para. 111. The SCF in its second opinion noted that the residual amounts of nitrites allowed by the directive were much higher than those to be expected from the addition justified by technological needs. The Danish government claimed that if the levels of nitrate residues were as high as those authorised by the harmonisation measure, the ADI would be exceeded.

84 Ibid., at para. 63.

85 EFSA, “The effects of Nitrites/Nitrates on the Microbiological Safety of Meat Products”, 14 The EFSA Journal (2003), pp. 1 et sqq Google Scholar.

86 According to the Commission, for these products, due to the nature of the manufacturing process, it was not possible to control the ingoing amount of curing salts absorbed by the meat.

87 European Parliament, Draft Report on the proposal for a Directive amending Directive 95/2/EC on food additives other than colours and sweeteners and Directive 94/35/EC on sweeteners for use in foodstuffs (COM(2004)0650 – C6-0139/2004 – 2004/0237(COD)).

88 Dir. 2006/52/EC, OJ 2006 L 204/10.

89 The Danish authorities highlighted the fact that the residual nitrite is not a reliable indicator because residual values may not reveal even very high additions of nitrites, which may in turn lead to a very high formation of nitrosamines.

90 Dec. 2008/448/EC, OJ 2008 L 157/98. The approval was temporary – until 23 May 2010 (2 years).

91 Ibid., at para. 41.

92 Case T-13/99, supra note 58, at para. 152.

93 Art. 1(1) GFL.

94 Mortelmans, Kamiel, “The Relationship between the Treaty Rules and Community Measures for the Establishment and Functioning of the Internal Market – Towards a Concordance Rule”, 39 CML Rev. (2002), pp. 1303 et sqq Google Scholar.

95 Dir. 81/602/EEC banned the use of substances having hormonal action, but the use of oestradiol-17β, progesterone, testosterone, trenbolone acetate and zeranol was left to be regulated in accordance with the individual regulatory schemes in Member States and other countries, pending further research. Dir. 85/649/EEC extended the ban to include these five hormones, but it was annulled by the Court of Justice on procedural grounds. The same provisions were re-introduced by Dir. 88/146/EEC. The ban was a reaction to “hormone scandals” in Italy in the late 1970s. Premature development of schoolchildren was suspected to be linked to illegal hormones in meat from school canteens. See Roberts, Donna, “Preliminary Assessment of the Effects of the WTO Agreement on Sanitary and Phytosanitary Trade Regulations”, 1(3) JIEL (1998), pp. 377 et sqq., at p. 386CrossRefGoogle Scholar.

96 Case C-331/88, Fedesa [1990] ECR I-4023.

97 Ibid., at para. 7.

98 Ibid., at para. 9.

99 Kamiel Mortelmans, supra note 94, at p. 1338, refers in this regard to the BSE case, where the UK argued against the Commission measure prohibiting exports of UK beef (Case C-180/96, UK v. Commission [1998] ECR I-2288).

100 Dec. 2003/653/EC, OJ 2003 L 230/24.

101 Cases T-366/03 and T-235/04, Land Oberösterreich and Austria v. Commission [2005] ECR II-4005.

102 Cases C-439/05 P and C-454/05 P, Land Oberösterreich and Austria v. Commission [2007] ECR I-7141.

103 Dec. 2003/653/EC, supra note 100, at para. 34.

104 Cases T-366/03 and T-235/04, supra note 101, at para. 67. See also Dec. 2008/62/EC, OJ 2008 L 16/17, concerning Polish provisions derogating from Dir. 2001/18/EC on the deliberate release into the environment of GMOs. The rejected national derogations referred to similar justifications, i.e. the need to fulfil the expectations of Polish society, a high level of fragmentation of agriculture and interest in organic production.

105 Cases T-366/03 and T-235/04, supra note 101, at para. 73.

106 See Case C-333/08, supra note 68, at para. 101.

107 OJ 2004 L 226/22 (Corrigendum).

108 “Foods with traditional characteristics” are defined in Art. 7 Reg. 2074/2005 laying down implementing measures for certain products under Reg. 853/2004 as “foods that, in the Member State in which they are traditionally manufactured, are:

1. a)

   a) recognized historically as traditional products, or

2. b)

   b) manufactured according to codified or registered technical references to the traditional process, or according to traditional production methods,

3. c)

   c) or protected as traditional food products by a Community, national, regional or local law. (OJ 2005 L 338/27).”