1 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (GFL). The GFL sets out general principles and requirements of EU food law and provides, as such, the general framework on which more detailed food legislation is based.

2 See further on EU food safety regulation and the GFL, e.g.: Alemanno, Alberto, Trade in Food. Regulatory and Judicial Approaches in the EC and the WTO, (London: Cameron May, 2007)Google Scholar; MacMaoláin, Caoimhín, EU Food Law. Protecting Consumers and Health in a Common Market, (Oxford – Portland Oregon: Hart Publishing, 2007)Google Scholar; van der Meulen, Bernd and van der Velde, Menno, European Food Law Handbook, (Wageningen: Wageningen Academic Publishers, 2008)Google Scholar; O’Rourke, Raymond, European Food Law, 3 ^rd ed (London: Sweet & Maxwell, 2005)Google Scholar; Szajkowska, Anna, Regulating Food Law (Wageningen: Wageningen Academic Publishers, 2012)CrossRefGoogle Scholar.

3 Art. 14(1) GFL.

4 See further on this issue: van der Meulen, Bernd, “The Core of Food Law. A Critical Reflection on the Single Most Important Provision in All of EU Food Law”, 3 European Food and Feed Law Review (2012), pp. 117–125, at p. 118Google Scholar.

5 Art. 3(10) GFL.

6 The main risk-related terms in the GFL are based on those provided by the Codex Alimentarius Commission (CAC), see: Codex Alimentarius Commission, Procedural Manual, 21th edition 2013, available on the internet at: ftp://ftp.fao.org/codex/Publications/ProcManuals/Manual_21e.pdf, at p. 121 (last accessed 13 October 2014). The CAC, in turn, was influenced by the terminology in the Agreement on the Application of Sanitary and Phytosanitary Measures under the WTO (SPS-Agreement). See for an overview: Yoe, Charles E., Principles of Risk Analysis, Decision Making Under Uncertainty (Boca Raton: Taylor & Francis Group LLC, 2012)Google Scholar. See further on risk analysis in general: Hood, Christopher, Rothstein, Henry and Baldwin, Robert, The Government of Risk – Understanding Risk Regulation Regimes, (Oxford: Oxford University Press, 2001)Google Scholar and specifically with respect to food safety risk analysis, e.g.: Alemanno, Trade in Food, supra note 2, at pp. 78 et sqq.; Majone, Giandomenico, “Foundations of Risk Regulation: Science, Decision-Making, Policy Learning and Institutional Reform”, 1 European Journal of Risk Regulation (2010), pp. 5–19 CrossRefGoogle Scholar; Szajkowska, Regulating Food Law, supra note 2, at pp. 61 et sqq; Vos, Ellen, “EU Food Safety Regulation in the Aftermath of the BSE Crisis”, 23 Journal of Consumer Policy (2000), pp. 227–255 CrossRefGoogle Scholar.

7 “Hazard” is defined in Art. 3(14) GFL as “a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect”.

8 See in this sense: Yoe, Principles of Risk Analysis, supra note 6, at p. 4.

9 A definition of “risk” can be found in Art. 3(9) in conjunction with Art. 3(14) GFL.

10 The risk concept in the GFL has been analysed in, e.g.: Alemanno, Trade in Food, supra note 2, at p. 82 et sqq. and Van der Meulen and Van der Velde, European Food Law Handbook, supra note 2, at p. 267. See for a more technical angle, e.g.: Tijhuis, M.J., de Jong, N., Pohjola, M.V. et al, “State of the Art in Risk–Benefit Analysis: Food and Nutrition”, 50 Food and Chemical Toxicology (2012), pp. 5 et sqq CrossRefGoogle ScholarPubMed, at p. 6. For a more theoretical perspective see, e.g.: Jensen, Karsten Klint and Sandøe, Peter, “Food Safety and Ethics: The Interplay between Science and Values”, (15) Journal of Agricultural and Environmental Ethics (2002), pp. 245–253, at p. 245CrossRefGoogle Scholar.

11 Bernd van der Meulen, “The Core of Food Law”, supra note 4, at p. 118; Van der Meulen and Van der Velde, European Food Law Handbook, supra note 2, at p. 261.

12 Art. 14(2)(b) GFL.

13 Art. 14(2)(b) and (5) GFL. See also: Commission proposal of 8 November 2000 for a Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food, COM (2000)716 final, at p. 11.

14 See, for example, Teegala, Shyam M., Willett, Walter C. and Mozaffarian, Dariush, “Consumption and Health Effects of Trans Fatty Acids: a Review”, 92(5) Journal of the Associations of Official Analytical Chemists International (2009), pp. 1250-7Google Scholar.

15 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), “Scientific Opinion on Dietary Reference Values for fats, including saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, trans fatty acids, and cholesterol”, 8(3):1461 EFSA Journal 2010, at p. 54, available at: http://www.efsa.europa.eu/en/efsajournal/doc/1461.pdf, last accessed on 7 May 2014.

16 Denmark has successfully applied a maximum level of industrially produced trans fatty acids in processed foods (Order No. 160 of 11 March 2003). In 2005, the EU Commission initiated a lawsuit against Denmark contending that the legislation was a technical hindrance to trade (Commission Decision of 21 March 2005, SG(2005)D/201366). However, in 2007, after having received the scientific justification of the Danish legislation by the Danish authorities, the Commission, by Commission Decision of 21 March 2007, withdrew the lawsuit without specifying its grounds for withdrawal (PV(2007)1781 (see further on this subject the answer to the question of the Danish Parliament to the Ministry of Agriculture of 3 December 2007: http://www.eu-oplysningen.dk/upload/application/pdf/b7300e0d/2837sv2.pdf?download=1 (last accessed 13 October 2014)).

17 In view of Art. 30(7) of Regulation (EU) 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (the Food Information Regulation, FIR), it is currently being discussed whether the EU should adopt labelling requirements with respect to trans fats.

18 Recently, a paper was published in one of the world's most prestigious journals, Nature, pointing at a correlation between artificial sweeteners and glucose intolerance: Suez, Jotham, Korem, Tal, Zeevi, David et al, “Artificial Sweeteners Induce Glucose Intolerance by Altering the Gut Microbiota”, 514 Nature (2014), pp. 181–186 Google Scholar. See also: Malik, Vasanti, Schulze, Matthias and Hu, Frank, “Intake of Sugar-Sweetened Beverages and Weight Gain: a Systematic Review”, 84 (2) American Journal of Clinical Nutrition (2006), pp. 274–288 Google ScholarPubMed. See also the note addressed to the media by the World Health Organisation in relation to its launching, on 5 March 2014, of a public consultation concerning a revised sugars guideline, in which it proposes a further reduction of the intake of sugars from 10% to 5% of total energy intake per day because of “increasing concern that consumption of free sugars, particularly in sugar-sweetened beverages, may result in both reduced intake of foods containing more nutritionally adequate calories and an increase in total caloric intake, leading to an unhealthy diet, weight gain and increased risk of noncommunicable diseases (NCDs)”. Information on the public consultation available on the internet, at: http://www.who.int/mediacentre/news/notes/2014/consultation-sugar-guideline/en/, last accessed on 7 May 2014.

19 Commission proposal of a GFL, supra note 13, at p. 11.

20 Preamble to the Food Information Regulation, recital 3.

21 Much has been written on consumers’ ability and willingness to maximize their health and well-being and on how to respond to behavioural aspects from a policy perspective. See, for example: Alberto Alemanno and Alessandro Spina, “Nudging Legally. On the Checks and Balances of Behavioural Regulation”, Jean Monnet Working Paper 06/13, available on the internet, at: http://www.jean-monnetprogram.org/papers/13/documents/JMWP06AlemannoandSpina.pdf, last accessed on 8 May 2014; Howells, Geraint, “The Potential and Limits of Consumer Empowerment by Information”, 32(3) Journal of Law and Society (2005), pp. 349–370 CrossRefGoogle Scholar; Jacoby, Jacob, “Is it Rational to Assume Consumer Rationality?”, 6 Roger Williams University Law Review (2000), pp. 81–161 Google Scholar; Jolls, Christine, Sunstein, Cass R. and Thaler, Richard, “A Behavioral Approach to Law and Economics”, 50(5) Stanford Law Review (1998), pp. 1471–1550 CrossRefGoogle Scholar; Thaler, Richard, “Toward a Positive Theory of Consumer Choice”, 1 Journal of Economic Behaviour and Organisation (1980), pp. 39–60 CrossRefGoogle Scholar.

22 Artt. 6(1) and 14(1) GFL, respectively.

23 See further, e.g. Alemanno, Trade in Food, supra note 2, at p. 78 et sqq; Majone, “Foundations of Risk Regulation”, supra note 6; Van der Meulen and Van der Velde, European Food Law Handbook, supra note 2, at pp. 261 et sqq; Szajkowska, Regulating Food Law, supra note 2, at pp. 28 et sqq.; Vos, “EU Food Safety Regulation in the Aftermath of the BSE Crisis”, supra note 6, at p. 229; Yoe, Principles of Risk Analysis, Decision Making Under Uncertainty, supra note 6, at pp. 4 et sqq.

24 Art. 14(3) GFL. See also Commission proposal, supra note 13, at p. 11.

25 The Court of Justice of the European Union has consistently held that the “reference consumer” is an average consumer “who is reasonably well informed and reasonably observant and circumspect”. See, with regard to foodstuffs: Case C-210/96, Gut Spingenheide [1998] ECR I-4657, at para. 31 and Case C-358/01, Commission vs. Spain [2003] I-13145, at para. 53. The average consumer benchmark has been codified in several pieces of EU food legislation, e.g., the Food Information Regulation, (FIR) supra note 17, and Regulation (EC) No 1924/2006 of the Parliament and of the Council of 20 December 2006 on nutrition and health claims made on food (Claims Regulation).

26 See for a further discussion of the average consumer benchmark, for example: Weatherill, Stephen, “Who is the average consumer?”, in: Weatherill, Stephen and Bernitz, Ulf (eds), The Regulation of Unfair Commercial Practises under EC Directive 2005/29, (Oxford: Hart Publishing, 2007)Google Scholar and for an overview of Case Law: Unberath, Hannes and Johnston, Angus, “The Double-Headed Approach of the ECJ Concerning Consumer Protection”, 44 Common Market Law Review (2007), pp. 1237 et sqq Google Scholar. For a critical note on the average consumer benchmark, see: Garde, Amandine, EU Law and Obesity Prevention, (The Netherlands: Kluwer Law International B.V., 2010), at p. 156 Google Scholar.

27 See further on the integration of behavioural – or “lifestyle” – factors in risk analysis, e.g.: Planzer, Simon and Alemanno, Alberto, “Lifestyle Risks: Conceptualizing an Emerging Category of Research”, 4 European Journal of Risk Regulation, 2010, pp. 335–337 CrossRefGoogle Scholar; Thaler, Richard and Sunstein, Cass R., Nudge: Improving Decisions About Health, Wealth and Happiness (London: Penguin Books, 2009)Google Scholar.

28 Art. 5(1) and (2) GFL.

29 van der Meulen, Bernd, “The Function of Food Law. On the Objective of Food Law, Legitimate Factors and Interests Taken Into Account”, 2 European Food and Feed Law Review (2010), pp. 83–90, at p. 85Google Scholar.

30 See in this respect, for example, Negri, Stefania, “Food Safety and Global Health: An International Law Perspective”, 2 Global Health Governance (2009), pp. 1–26, at p. 7Google Scholar.

31 Set out in Art. 14 GFL.

32 Set out in Art. 8(1) GFL.

33 Since the adoption of Council Resolution of 14 April 1975 on a Preliminary Programme of the European Economic Community for a consumer protection and information policy, OJ 1975 C 092, at p. 0001, the provision of information to consumers has been a fundamental principle of the EU. See further on EU consumer policy: Micklitz, Hans-W., Reich, Norbert and Rott, Peter, Understanding EU Consumer Law (Antwerp: Intersentia, 2009)Google Scholar and Weatherill, Stephen, EU Consumer Law and Policy, 2 ^nd ed (Cheltenham: Edward Elgar Publishing Limited, 2013)CrossRefGoogle Scholar.

34 The consumer right to information is expressly recognised in Art. 169(1) of the Treaty on the Functioning of the European Union (TFEU).

35 See further on the “informed consumer” concept, e.g.: Reich, Norbert, Goddard, Christopher and Vasiljeva, Ksenija, Understanding EU Law, 2 ^nd ed (Antwerp: Intersentia, 2005), at pp. 297–298 Google Scholar and Weatherill, Stephen, “The Role of the Informed Consumer in EC Law and Policy”, 2 Consumer Law Journal (1994), pp. 49–62 Google Scholar.

36 Preamble to the GFL, recitals 1, 9 and 23.

37 Wilhelmsson, Thomas, “The Abuse of the ‘Confident Consumer’”, 27 Journal of Consumer Policy (2004), pp. 317–337, at p. 320CrossRefGoogle Scholar. See for an overview of the developments in EU consumer law and policy: Stuyck, Jules, “European Consumer Law After the Treaty of Amsterdam: Consumer Policy in or beyond the Internal Market”, 37 Common Market Law Review (2000), pp. 367–400 CrossRefGoogle Scholar; Micklitz, Reich and Rott, Understanding EU Consumer Law, supra note 33; Weatherill, EU Consumer Law and Policy, supra note 33.

38 Van der Meulen and Van der Velde, European Food Law Handbook, supra note 2, at p. 261.

39 Art. 1(1) and 5(1) GFL.

40 MacMaoláin argues that nutritional value should be included in the factors that are taken into account in determining what qualifies as safe or high quality food, in: EU Food Law, supra note 2, at p. 224.

41 The main food information rules are set out in the Food Information Regulation (FIR), supra note 17.

42 See for a commentary on the FIR: Sosnitza, Olaf, “Challenges of the Food Information Regulation: Revision and Simplification of Food Labelling Legislation?”, 1 European Food and Feed Law Review (2011), pp. 16–26 Google Scholar. See further on EU food information legislation, e.g.,: Cheyne, Ilona, “Consumer Labelling in EU and WTO law”, in Gaines, Sanford, Olsen, Brigitte Egelund and Sørensen, Karsten Engsig ed, Trade in the EU and the WTO, A Legal Comparison (Cambridge: Cambridge University Press, 2012), pp. 310 et sqq Google Scholar.

43 Klompenhouwer, Tatiana and van den Belt, Henk, “Regulating Functional Foods in the European Union: Informed Choice Versus Consumer Protection?”, 16 Journal of Agricultural and Environmental Ethics (2003), pp. 545–556, at p. 546CrossRefGoogle Scholar.

44 After the acceptance of the principle of mutual recognition in the seminal Cassis de Dijon judgment (Case 120/78, Rewe-Zentrale AG v Bundesmonopolverwaltung für Brantwein [1979] ECR 649), the Commission left the idea of adopting detailed “recipe legislation” in favour of a well-developed and clear system of labelling, presentation and advertising of foodstuffs, see: Commission Communication of 8 November 1985 on the completion of the internal market: Community legislation on foodstuffs, COM(85) 603 final, at p. 8.

45 Art. 3(1) Food Information Regulation, supra note 17. See also the Regulation's preamble, recital 4.

46 Art. 11(1) of the Charter of Fundamental Rights of the European Union.

47 See further: Van der Meulen and Van der Velde, European Food Law Handbook, supra note 2, at p. 371.

48 Art. 17(1) GFL.

49 Art. 14(1) and (2) GFL.

50 Art. 3(1) GFL.

51 For an interpretation of the scope of Art. 6 GFL see: Van der Meulen and Van der Velde, European Food Law Handbook, supra note 2, at p. 269. See further: Alemanno, Trade in Food, supra note 2, at pp. 78 et sqq; Vos, Ellen and Everson, Michelle, Uncertain Risks Regulated, (Oxon: Routledge-Cavendish, 2009), at pp. 96–97 Google Scholar.

52 Commission proposal for a GFL, supra note 13, at p. 9.

53 This does not mean that consumer information cannot be opted for as a means to regulate risks. In those situations food information legislation is a risk management tool rather than (just) an information tool.

54 Art. 3(10) GFL.

55 See further on the phases of risk analysis , e.g. Alemanno, Trade in Food, supra note 2, at p. 78 et sqq; Van der Meulen and Van der Velde, European Food Law Handbook, supra note 2, at pp. 261 et sqq; Szajkowska, Regulating food law, supra note 2, at pp. 28 et sqq; Vos, “EU Food Safety Regulation in the Aftermath of the BSE Crisis”, supra note 6, at p. 229; Yoe, Principles of Risk Analysis, supra note 6, at pp. 4 et sqq. See further on risk analysis from an international perspective: FAO and WHO, Food safety risk analysis: A guide for national food safety authorities, 87 FAO Food and Nutrition Paper (2006), available on the internet at: http://www.who.int/foodsafety/publications/micro/riskanalysis06.pdf?ua=1, last accessed 13 October 2014.

56 Art. 6(2) GFL.

57 Art. 22 and 23 GFL.

58 Art. 3(11) GFL.

59 Art. 3(12) GFL.

60 Commission White Paper of 12 January 2000 on Food Safety, COM (1999) 719 final, at p. 13.

61 See on the question whether risk assessment and risk management can indeed be viewed as separate processes, e.g.: Jasanoff, Sheila, “Relating Risk Assessment and Risk Management. Complete separation of the two processes is a misconception”, 1 EPA Journal (1993), pp. 35–37 Google Scholar; Majone, “Foundations of Risk Regulation”, supra note 6, at p. 18; Millstone, Erik, “Science, Risk and Governance: Radical Rhetorics and the Realities of Reform in Food Safety Governance”, 38 Research Policy (2009), pp. 624–636, at p. 626CrossRefGoogle Scholar.

62 Art. 3(13) GFL, see also the Commission proposal for a GFL; supra note 15, at p. 9.

63 Alemanno, Trade in Food, supra note 2, at p. 86.

64 See also: Alemanno, Alberto, “Risk vs Hazard and the Two Souls of EU Risk Regulation - A reply to Ragnar Löfstedt”, 2 European Journal of Risk Regulation (2011), pp. 169–171, at p. 171CrossRefGoogle Scholar; Alemanno, Trade in Food, supra note 2, at pp. 395 et sqq.; Szajkowska, Regulation Food Law, supra note 2, at pp. 125 et sqq. See for a US perspective on the role of “other legitimate factors” in EU and US legislation: Echols, Marsha A., “Food Safety Regulation in The European Union and the United States: Different Cultures, Different Laws”, 4 Colombia Journal of European Law (1998), pp. 525–543 Google Scholar.

65 See further on the role of the precautionary principle in EU food safety law: Alemanno, Trade in Food, supra note 2, at pp. 407 et sqq; Van der Meulen and Van der Velde, European Food Law Handbook, supra note 2, at pp. 269 et sqq; Szajkowska, Regulating Food Law, supra note 2, at pp. 61 et sqq. See for an overview of the origin and functioning of the precautionary principle: Anker, Helle Tegner and Grossman, Margaret Rosso, “Authorization of Genetically Modified Organisms: Precaution in US and EC Law”, 1 European Food and Feed Law Review (2009), pp. 3–22 Google Scholar.

66 Art. 7(1) GFL lays down the conditions for the application of the precautionary principle.

67 Szajkowska, Regulating Food Law, supra note 2, at pp. 125 et sqq.

68 Preamble to the GFL, recital 19.

69 Alemanno, Trade in Food, supra note 2 at p. 89.

70 Ibid. See further: Szajkowska, Regulating Food Law, supra note 2, at p. 91.

71 Alemanno, Trade in Food, supra note 2, at p. 88.

72 Numerous scholars have contested that risk assessment can ever be value-free, e.g., Alemanno, “Risk vs Hazard and the Two Souls of EU Risk Regulation”, supra note 64; Jasanoff, Sheila, “Contested Boundaries in Policy-Relevant Science”, 17 Social Studies of Science (1987), pp. 195–230 CrossRefGoogle Scholar; Jensen and Sandøe, “Food safety and Ethics”, supra note 10, at p. 247; Millstone, “Science, Risk and Governance”, supra note 61.

73 However, EFSA may also issue scientific opinions on its own initiatives (Art. 29 (1)(b) GFL).

74 Jensen and Sandøe, “Food Safety and Ethics”, supra note 10, at p. 247. See further: Jasanoff, “Contested Boundaries in Policy- Relevant Science”, supra note 72; Millstone, “Science, Risk and Governance”, supra note 61, at p. 626.

75 Van der Meulen, “The Core of Food Law”, supra note 4, at p. 117.

76 Recommended International Code of Practice General Principles of Food Hygiene (CAC/RCP 1-1969), available on the internet at: http://www.codexalimentarius.org/standards/list-of-standards/en/?provide=standards&orderField=fullReference&sort=asc&num1=CAC/RCP, last accessed 14 October 2014.

77 Commission proposal for a GFL, supra note 13. The Commission’s amended proposal for a GFL of 7 August 2001, COM(2001) 475 final, does not give a reason for this shift, nor is the amendment based on an amendment from the European Parliament. See also Van der Meulen, “The Core of Food Law”, supra note 4, at p. 118.

78 Ibid.

79 Ibid, at p. 119.

80 Food law comprises, apart from the GFL, a multitude of EU and national instruments regulating aspects of food and food production and distribution. See for an overview of subjects also: Hersey, Tamara K. and McHale, Jean V., Health Law and the European Union, (Cambridge: Cambridge University Press, 2004), at p. 348Google Scholar; MacMaoláin, EU Food Law, supra note 2; Van der Meulen and Van der Velde, European Food Law Handbook, supra note 2; O’Rourke, European Food Law, supra note 2.

81 See on the “presumption of safety” and its limits: Van der Meulen, “The Core of Food Law.” supra note 4, at p. 122-124.

82 Art. 14(4) GFL.

83 Commission proposal for a GFL, supra note 13, at p. 11.

84 Ibid.

85 See also: Van der Meulen, “The Core of Food Law”, supra note 4, at p. 120.

86 According to De la Peña, the weight conscious public often considers foods containing artificial sweeteners to be “healthy food”: de la Peña, Carolyn, “Artificial Sweetener as a Historical Window to Culturally Situated Health”, 1190 Annals of the New York Academy of Science (2010), at pp. 159-65Google Scholar. See also Bakker, Dirk J.G., “Consumer Behaviour and Attitudes toward Low-Calorie Products in Europe”, 85 World Review of Nutrition and Dietics (1999), pp. 146–158 CrossRefGoogle Scholar and Tandel, Kirtida R., “Sugar Substitutes: Health Controversy over Perceived Benefits”, 2(4) Journal of Pharmacology & Pharmacotherapeutics (2011), pp. 236–243, at p. 237CrossRefGoogle Scholar.

87 A Eurobarometer survey on food risk issues undertaken in 2005 showed that of the people that had changed their consumptive habits within the last twelve months before the survey, 34% had done so in order to lose weight. Of the respondents, 39% had opted to reduce sugar-intake, while 38% ate fewer calories. European Commission, 246/Wave 64.3 Special Eurobarometer, Health and Food (2006), at pp. 36 et sqq, available on the internet, at: http://ec.europa.eu/health/ph_publications/eb_food_en.pdf, last accessed on 22 May 2014.

88 Scientific Committee for Food, Sweeteners, Reports of the Scientific Committee for Food, (Sixteenth Series) EUR 10210 EN, Commission of the European Communities, Luxembourg.

89 Scientific Committee for Food, Sweeteners, Reports of the Scientific Committee for Food, (Twenty-first Series) EUR 11617 EN, Commission of the European Communities, Luxembourg.

90 Scientific Committee for Food, Minutes of the 107th Meeting of the Scientific Committee for Food held on 12-13 June 1997 in Brussels, available at: http://europa.eu.int/comm/food/fs/sc/oldcomm7/out13_en.html, last accessed on 19 May 2014; Scientific Committee on Food, Opinion of 4 December 2002 holding an Update on the Safety of Aspartame, SCF/ADD/EDUL/222/ Final, available on the internet, at: http://ec.europa.eu/food/fs/sc/scf/out155_en.pdf, last accessed on 21 October 2014; EFSA Panel of Food additives, flavourings, processing aids and materials in contact with food (AFC), Opinion of 3 May 2006 related to a new long-term carcinogenicity study on aspartame, 356 EFSA Journal (2006), at pp. 1-44; EFSA Panel on Food Additives and Nutrient Sources added to Food, Updated opinion of 19 March 2009 on a request from the European Commission related to the 2nd carcinogenicity study on aspartame, taking into consideration study data submitted by the Ramazzini Foundation in February 2009, 1015 EFSA Journal (2009), at pp. 1-18; EFSA ANS Panel, Statement of 8 February 2011 on two recent scientific articles on the safety of artificial sweeteners, 9(2):1996 EFSA Journal (2011); EFSA ANS Panel, Scientific Opinion of 10 December 2013, on the re-evaluation of aspartame (E 951) as a food additive, 11(12):3496 EFSA Journal (2013), at p. 263.

91 EFSA Scientific Opinion on the re-evaluation of aspartame, supra note 90, at p. 152.

92 See, e.g.: Christopher Gardner, Judith Wylie-Rosette, Samuel S. Giddings et al, “Nutritive Sweeteners: Current Use and Health Perspectives, A Scientific Statement from the American Heart Association and the American Diabetes Association”, available on the internet, at: http://circ.ahajournals.org, DOI: 10.1161/CIR.=b=13e31825c42ee, last accessed on 19 May 2014.

93 See, e.g., Fowler, Sharon P., Williams, Ken, Resendez, Roy G. et al, “Fueling the Obesity Epidemic? Artificially Sweetened Beverage Use and Long-term Weight Gain”. 16 Obesity (2008), pp. 1894–1900 CrossRefGoogle ScholarPubMed.

94 See further: Yang, Qing, “Gain Weight by ‘Going Diet?’ Artificial Sweeteners and the Neurobiology of Sugar Cravings”, 83 Yale Journal of Biology and Medicine (2010), pp. 101–108, at p. 104Google ScholarPubMed.

95 van Wymelbeke, V., Béridot-Thérond, M.E., de la Guéronnière, V. et al, “Influence of Repeated Consumption of Beverages Containing Sucrose or Intense Sweeteners on Food Intake”, 58 European Journal for Clinical Nutrition (2004), pp. 425-34CrossRefGoogle ScholarPubMed. See for an overview, Tandel, “Sugar substitutes: Health Controversy over Perceived Benefits”, supra note 86. Tandel suggests that welldesigned large-scale studies in the general population are necessary in order to settle the controversy.

96 EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), Scientific Opinion on the substantiation of health claims related to intense sweeteners and contribution to the maintenance or achievement of a normal body weight (ID 1136, 1444, 4299), reduction of post-prandial glycaemic responses (ID 4298), maintenance of normal blood glucose concentrations (ID 1221, 4298), and maintenance of tooth mineralisation by decreasing tooth demineralisation (ID 1134, 1167, 1283) pursuant to Art. 13(1) of Regulation (EC) No 1924/2006, 9(6):2229 EFSA Journal (2011), pp. 26, at p. 11.

97 Supra note 25.

98 The Eurobarometer survey on health and food from 2005 showed that 28% of the European consumers consider that “healthy eating” means avoiding too much sugary food, European Commission, Special Eurobarometer, Health and Food, supra note 87.

99 See in this respect: Bakker, “Consumer Behaviour and Attitudes toward Low-Calorie Products in Europe, supra note 86; De la Peña, “Artificial Sweetener as a Historical Window to Culturally Situated Health”, supra note 86; Tandel, “Sugar Substitutes”, supra note 86.

100 EFSA Scientific Opinion on the re-evaluation of aspartame, supra note 90, at p. 151.

101 Ibid, at p. 100.

102 Article 3(14) GFL. The GFL definitions of “risk” and “hazard” are based on the Codex Alimentarius definition of 2003, see: Codex Alimentarius Commission, Procedural Manual, 21th edition 2013, supra note 6.

103 Besides the technical definition in the GFL, there is no commonly accepted definition of “food safety risk”, or even “risk”. Many authors have attempted to provide a definition, e.g., Alemanno, Trade in Food, supra note 2, at p. 81 et sqq; Beck, Ulrich, Risk Society: toward a New Modernity, (London, Sage, 1992), at p. 21 Google Scholar; Jasanoff, Sheila, “Bridging the Two Cultures of Risk Analysis”, 13(2) Risk Analysis (1993), pp. 123–129, at p. 124CrossRefGoogle Scholar; Renn, Ortwin, “The Role of Risk Perception for Risk Management”, 59 Reliability Engineering and System Safety (1998), pp. 49–62, at p. 51CrossRefGoogle Scholar.

104 WHO, “Global status report on noncommunicable diseases 2010”, April 2011, available on the internet at <http://www.who.int/nmh/publications/ncd_report2010/en/>, at p. vi (last accessed on 26 May 2014).

105 According to Tijhuis, De Jong, Pohjola et al “the health loss due to unhealthy food and nutrition is many times greater than that attributable to unsafe food”. Tijhuis, De Jong, Pohjola et al, “State of the Art in Risk–Benefit Analysis: Food and Nutrition”, supra note 10, at p. 6.

106 Van der Meulen and Van der Velde, European Food Law Handbook, supra note 2, at p. 269; Szajkowska, Regulating Food Law, supra note 2, at p. 100.

107 In 2003, the Codex Alimentarius Commission added to its Procedural Manual, which is one of main guidance documents for EFSA (see: Technical report of EFSA prepared by the Secretariat of the Scientific Committee on List of guidance documents, guidelines and working documents developed or in use by EFSA. EFSA Technical Report (2009) 294, 1-13), Nutritional Risk Analysis Principles and Guidelines for Application to the Work of the Committee on Nutrition and Foods for Special Dietary Uses. These principles are meant to be applied broader than in the context of the aforementioned committee, alone, which results in the assessment of risks to human health from inadequate and/or excessive intake of nutrients and related substances becoming an integral part of a broader food safety risk analysis (see: Procedural Manual, p. 120). This is, however, not reflected in the GFL.

108 Tijhuis, De Jong, Pohjola et al, “State of the Art in Risk–Benefit Analysis: Food and Nutrition”, supra note 10, at p. 7.

109 Jasanoff, “Bridging the Two Cultures of Risk Analysis”, supra note 103, at pp. 123 and 130.

110 Erik Millstone, “Science, Risk and Governance”: supra note 61, at p. 627 et sqq.

111 Alemanno, “Risk vs Hazard and the Two Souls of EU Risk Regulation”, supra note 64, at p. 171.

112 van Asselt, Marjolein B.A. and Renn, Ortwin, “Risk Governance”, 14(4) Journal of Risk Research (2011), pp. 431–449, at pp. 442 et sqq CrossRefGoogle Scholar.

113 Jasanoff, “Bridging the Two Cultures of Risk Analysis”, supra note 103, at p. 123.

114 Alemanno, “Risk vs Hazard and the Two Souls of EU Risk Regulation”, supra note 64, at p. 171.

115 See for example the “case of BPA”: in Alemanno, “Risk vs Hazard and the Two Souls of EU Risk Regulation”, supra note 64, at p. 172 and the “Hormones case”: Szajkowska, Regulating Food Law, supra note 2, at p. 128. According to Tegner Anker and Rosso Grossman “the explicit reliance - and perhaps over-reliance - on the precautionary principle in the EC could be seen as a surrogate for policy decisions that consider broader consumer concerns about GMOs”. See: Tegner Anker and Rosso Grossman, “Authorization of Genetically Modified Organisms”, supra note 65, pp. 3-22, at p. 21-22. See for the role of the WTO SPS-Agreement in this respect, e.g.: Flett, James, “If In Doubt, Leave It Out? EU Precaution in WTO Regulatory Space”, 1 European Journal of Risk Regulation (2010), pp. 20–31 CrossRefGoogle Scholar.

116 Art. 4(b)(ii) FIR, supra note 17.

117 Commission proposal of a GFL, supra note 13, at p. 11.

118 See for a study on how nutrition labelling affects consumer choice: George Baltas, “The Effects of Nutrition Information on Consumer Choice”, March/April Journal of Advertising Research 2001, at pp. 57-63.

119 See further on the subject of consumer understanding of food information: Howells, “The Potential and Limits of Consumer Empowerment by Information”, supra note 21, pp. 349-370; Garde, EU Law and Obesity prevention, supra note 26, at pp. 12-14 and 155-157; Thaler, “Toward a Positive Theory of Consumer Choice”, supra note 21, pp. 39-60.

120 Annex to the Claims Regulation, supra note 25.

121 Fowler, Williams, Resendez et al, “Fueling the Obesity Epidemic?”, supra note 93. See further: Tandel, “Sugar Substitutes”, supra note 86; Yang, “Gain Weight by ‘Going Diet?’”, supra note 94.

122 Commission proposal of a GFL, supra note 13, at p. 11.