1 See Anonymous, “Food safety spawns public concern”, China Daily, 26 March 2005, p. 3.

2 In China, commonly used methods for protein analysis cannot distinguish between nitrogen from protein sources and nitrogen from non-protein sources. Adulteration practices associated with melamine occur when non-protein nitrogen sources like melamine are intentionally added to milk products containing low protein to make them incorrectly appear to contain high protein. This type of adulteration practice is based on economic incentives. According to data from the relevant Chinese authorities, dietary exposure at the median levels of melamine reported in the most contaminated infant milk brand was estimated to range from 8.6 to 23.4 mg/kg body weight per day — this is about 40–120 times the Tolerable Daily Intake (TDI) of 0.2 mg/kg body weight, as later established by the WHO. Even worse cases were reported, as Chinese inspection results found one milk product to contain a record 2563 mg/kg. This caused dramatic health problems in Chinese infants. See World Health Organization, Toxicological and Health Aspects of Melamine and Cyanuric Acid, Report of a WHO Expert Meeting In collaboration with FAO Supported by Health Canada, Health Canada, Ottawa, Canada, 1–4 December 2008 (Geneva: World Health Organization, 2009), at pp. 1–4.Google Scholar

3 Ibid.

4 More than twenty countries were affected, prompting product recalls for all products containing milk ingredients originating from China under precautionary rules, or bans on milk products of Chinese origin. Among the countries and regions affected were Australia, the EU, Hong Kong, Japan, Malaysia, and South Korea. See Xiao, Pinghui, “Chinese Food Regulation: Institutional Perspectives” (LL.M. thesis on file at the Maastricht University, 2009), p. 57 Google Scholar; see also Willy Lam,”Milk scandal sours China's ‘soft power’”, available on the Internet at <http://www.atimes.com/atimes/China/JJ10Ad02.html> (last accessed on 13 July 2011).

5 A number of commentators view the melamine milk scandal as a man-made disaster; see Wu Zhong,”China struggles to cap milk crisis”, available on the Internet at <http://www.atimes.com/atimes/China/JI24Ad01.html> (last accessed on 13 July 2011); see also Willy Lam, “Milk scandal sours China's ‘soft power’”, supra note 4.

6 Calvin, Linda, Gale, Fred, Hu, Dinghuan et al., “Food safety improvements underway in China”, 4 Amber Waves (2006), pp. 16 et sqq.Google Scholar; see also Xinhua Net, “Chinese consumers concerned about food safety”, available on the Internet at <http://www.chinadaily.com.cn/china/2009-03/27/content_7624158.htm> (last accessed on 13 July 2011).

7 The Law on the Quality and Safety of Agricultural Products was promulgated by the Standing Committee of the National People's Congress on 29/04/2006, and became effective on 01/11/2006.

8 The Food Safety Law was adopted by the Standing Committee of the National People's Congress on 28/2/2009, and became effective on 1/6/2009. The passing of the Food Safety Law was a lengthy process in three stages. The first stage attracted a great deal of input from food law scholars and Ministries involved in food regulation. Closed door discussions resulted in different draft versions of the law. The third stage was a particularly time-consuming process. While bills tabled before the National People's Congress and its Standing Committee are normally passed within three readings, the Food Safety Law bill went through four readings, reflecting the heated debate it provoked. It was ultimately passed in February 2009. See Zhe Zhu, “Draft Food Safety Law approved”, China Daily, 1 November 2007, at pp. 1 et sqq.; see also Xiaopeng Liu and Qingchang Huang,”Eight revisions to avoid food safety loopholes (Bachu Xiugai Fengdu Shipin Anquan Loudong)”, available on the Internet at <http://www.npc.gov.cn/npc/xinwen/lfgz/2008-10/24/content_1454537.htm> (last accessed on 13 July 2011).

9 They are considered as the basic food laws for several reasons. Firstly, they are formulated by the National People's Congress, China's legislature and highest state body, and its Standing Committee — strictly speaking, in Chinese legal practice only regulations from this source are referred to as law and nationally applied, unless specified otherwise. Secondly, these two laws are comprehensive in their nature and focus on institutional and industry policy associated with food.

10 The Legislation Law and the Constitution of the People's Republic of China set out China's law-making framework and stipulate four categories of Chinese legislation: basic laws, administrative regulations, local regulations, and administrative and local rules. Chinese food legislation is classified accordingly.

11 Actually, as readers might be aware, in the latter text, the author tends to believe that China's model is quite unique though bearing similar features from different jurisdictions.

12 The Implementation Regulation of the Food Safety Law was promulgated by the State Council on 20/07/2009 and became effective on the same date. Most laws adopted by the National People's Congress are implemented via regulations formulated by the State Council or local government, as relevant.

13 The Food Hygiene Law was promulgated by the Standing Committee of the National People's Congress on 30/10/1995 and became effective on the same date. For a more general overview of this law, see Yongmin Bian, “The Challenges for food safety in China: Current legislation is unable to protect consumers from the consequences of unscrupulous food production”, China Perspectives (2004), pp. 4 et sqq.

14 It is understandable that the Food Hygiene Law did not feature any elements of risk assessment and analysis is understandable given that it was formulated in 1995 and replaced by the Food Safety Law in 2009. It should be noted that risk assessment and analysis were officially recognized by the Codex Alimentarius Commission (CAC) in the 1990s. Although China became a full member of CAC in 1986, China seriously started observing the relevant food standards and principles formulated by this institution only after its WTO entry in 2001. This was due to the fact that the provisions of the SPS and the TBT within the WTO Agreements directly or indirectly refer to the food standards of, among others, the CAC as benchmarks for international food trade. The inclusion of risk analysis into the recent Food Safety Law is another example of this trend. See Jiang, Shiqiang, Cai, Chunhe, Zhou, Yong et al., “Influence and Inspiration of our Attendance to Codex Alimentarius Commission (CAC)”, Modern Scientific Instruments (2006), pp. 9 et sqq.Google Scholar; Zhang, Rentang, Qian, Xuguang, Wei, Liu et al., “The challenge and replying strategy to China foodsafety system after entry to WTO”, 5 Journal of Shandong Agricultural University (2003), pp. 37 et sqq.Google Scholar; and Josling, Timothy, Roberts, Donna and Orden, David, Food regulation and trade: Toward a safe and open global system (Washington, DC: Peterson Institute, 2004), p. 35.Google Scholar

15 Food and Agriculture Organization, Strengthening national food control systems: A quick guide to assess capacity building needs (Rome: Food and Agriculture Organization, 2007), at footnote 3.Google Scholar

16 Food and Agriculture Organization and World Health Organization, The application of risk communication to food standards and safety matters: Report of a Joint FAO/WHO Expert Consultation (Rome: Food and Agriculture Organization, 1999), p. 5.Google ScholarPubMed

17 HACCP is a system of ensuring food safety and pharmaceutical safety by addressing physical, chemical, and biological hazards through prevention rather than finished product inspection. Though it shares a philosophy similar to risk analysis, they are not necessarily interchangeable concepts. This article, for instance, focuses on risk analysis rather than HACCP. For application of HACCP in the food industry, see Suwanrangsi, Sirilak and Keerativiriyaporn, Suwimon, How official services forster and enforce the implementation of HACCP by industry and trade (Second FAO/WHO Global Forum for Food Safety Regulators, Bangkok, Thailand, 12–14 October 2004) (Rome: the Food and Agriculture Organization and the World Health Organization, 2004)Google Scholar; see also Mayes, T., “Risk analysis in HACCP: burden or benefit?”, 9 Food control (1998), pp. 171 et sqq CrossRefGoogle Scholar. For the public perception of HACCP in China, see Zhigang Wanga, Yanna Maoa and Fred Gale, “Chinese consumer demand for food safety attributes in milk products”, 33 Food policy (2008), pp. 27 et sqq.

18 This figure is taken from the WHO's website, see World Health Organization,”About risk analysis in food”, available on the Internet at <http://www.who.int/foodsafety/micro/riskanalysis/en/> (last accessed on 13 July 2011). For a more informative description of risk analysis and its components, see Food and Agriculture Organization and World Health Organization, Food Safety Risk Analysis: A Guide for National Food Safety Authorities (Rome: Food and Agriculture Organization, 2006).Google ScholarPubMed

19 See The Food and Agriculture Organization and The World Health Organization, Application of Risk Analysis to Food Standards Issues: Report of the Joint FAO/WHO Expert Consultation (Geneva: World Health Organization, 1995), p. 7.Google Scholar

20 Ibid.

21 Food Standards Australia New Zealand (FSANZ), “The application of risk analysis in food control — challenges and benefits”, FAO/WHO Regional Conference on Food Safety for Asia and the Pacific, 2004.

22 BBC,”1990: Gummer enlists daughter in BSE fight”, available on the Internet at <http://news.bbc.co.uk/onthisday/hi/dates/stories/may/16/newsid_2913000/2913807.stm> (last accessed on 13 July 2011).

23 See Xindao Huanqiu Wang,”CCTV had a comprehensive field trip to Sanlu and noted more than 1,000 tests for dairy products prior to distribution (CCTV Ceng Shenru Diaocha Sanlu Naifen: Jing Qianxiang Jiance Cai Chuchang)”, available on the Internet at <http://www.stnn.cc/society_focus/200809/t20080912_863502.html> (last accessed on 13 July 2011).

24 Chen, Shumei, “Sham or shame: Rethinking China's milk powder scandal from a legal perspective”, 12 Journal of Risk Research (2009), pp. 725 et sqq., p. 726.CrossRefGoogle Scholar

25 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 establishing procedures in matters of food safety, OJ 2002 L 31/1.

26 White Paper on Food Safety, COM (1999) 719.

27 For a further historical account of the evolution of EU food law, see, for instance, Alemanno, Alberto, “Food Safety and the Single European Market”, in Ansell, Chris and Vogel, David (eds), What's the beef? The contested governance of European food safety (Cambridge: MIT Press, 2006), pp. 237 et sqq.Google Scholar; or van der Meulen, Bernd, “The System of Food Law in the European Union”, 14 Deakin Law Review (2009), pp. 305 et sqq.CrossRefGoogle Scholar

28 Art. 6 of the Law on the Quality and Safety of Agricultural Products stipulates that risk analysis and assessment shall be conducted to identify the potential hazards of agricultural products. There is, however, a lack of any further provisions regarding the so-called risk analysis.

29 Risk assessment is elaborated in Arts. 6 and 12 of the Law on the Quality and Safety of Agricultural Products on the one hand, and in Arts. 4, 13–17, 23, 45, and 81 of the Food Safety Law on the other.

30 Para. 1 of Art. 6 of the Law on the Quality and Safety of Agricultural Products.

31 Para. 2. of Art. 6 and Art. 7 of the Law on the Quality and Safety of Agricultural Products.

32 Para. 1 of Art. 13 of the Food Safety Law.

33 Para. 2 of Art. 2 and para. 2 of Art. 13 of the Food Safety Law.

34 Para. 3 of Art. 2 and para. 2 of Art. 13 of the Food Safety Law.

35 Para. 4 of Art. 2 and para. 2 of Art. 13 of the Food Safety Law.

36 Art. 16 and Art. 21 of the Food Safety Law.

37 According to Art. 2 of the Law on the Quality and Safety of Agricultural Products, “Agricultural products are those that originate from primary production, and specifically plants, animal and other organisms and the products derived from them.” Agricultural foodstuffs are not defined in this law, so their description has to be inferred from the definition of agricultural products — not an easy task given that the primary production is not defined. The Food Safety Law does not clarify matters at all — by not distinguishing agricultural foods from processed foods, it only provides a definition for general foods, which Article 19 describes as “any finished products or raw materials intended for people to eat or drink, as well as any product that has traditionally served as both food and medicament, with the exception of products used solely for medical purposes”. See Pinghui Xiao, “Chinese Food Safety Regulation: Institutional Perspective”, supra note 4, p. 3.

38 Drawing on the lessons of risk assessment consolidation and reforms in several European countries and the EU as a whole, a recent report suggested that an independent agency, tentatively named the Federal Institute for Food Safety Risk Analysis, which “would serve as the primary point of advice on scientific matters”, be established to improve on the current piecemeal approach to food risk assessment in the US. See Batz, Michael and Morris, Glenn, Building the science foundation of a modern food safety system: Lessons from Denmark, The Netherlands, and the United Kingdom on creating a more coordinated and integrated approach to food safety information (Washington D.C.: Georgetown University, 2010), p. 37 Google Scholar; see also Lofstedt, Ragnar and Vogel, David, “The changing character of regulation: A comparison of Europe and the United States”, 21 Risk analysis (2001), pp. 399 et sqq.CrossRefGoogle ScholarPubMed

39 For a general view of Australian food safety regulation and reform thereof, see Food Regulation Review Committee, Food: A growth industry report of the Food Regulation Review (Canberra: Commonwealth of Australia, 1998)Google Scholar; see also Taskforce, Regulation, Rethinking regulation: Report of the taskforce on reducing regulatory burdens on business, report to the Prime Minister and the Treasurer (Canberra: Commonwealth of Australia, 2006)Google Scholar. For details about different Australian states’ approaches to food regulation, see Kerin, John, Integration of the NSW food safety system: final report: review required by Section 73 Food Production (Safety) Act 1998 (Sydney: State of NSW, 2002)Google Scholar; see also Victorian Competition and Efficiency Commission, Simplifying the menu: Food regulation in Victoria, final report (Melbourne: State of Victoria, 2007).Google Scholar

40 Art. 13 of the Food Safety Law.

41 Art. 21 of the Food Safety Law.

42 Art. 13 of the Food Standards Australia New Zealand Act 1991 lists all the food standardization functions of the Authority, and Art. 18 para. (2) (a) states that to develop or review food regulatory measures and variations of food regulatory measures, the Authority must consider, among others, the need for standards to be based on risk analysis using the best available scientific evidence.

43 Para. 1 of Art. 23 of the Food Safety Law.

44 Para. 2 of Art. 23 of the Food Safety Law. Though risk assessment mainly serves the purpose of setting food standards, it has various other roles as well. According to Article 23 of the Implementation Regulation of the Food Safety Law, risk assessment programs can be launched in five types of situations, 1) if new national food safety standards are to be formulated or old ones reviewed; 2) at the request of various food regulators, to identify types of foods needing priority attention from regulators and provide them with a point of reference; 3) in the event a new potential risk arises; 4) to assess whether or not a given factor amounts to a potential food safety hazard; 5) in any other circumstances at the discretion of the Ministry of Health.

45 To date, there are no provisions within the Food Safety Law or any other food legislation specifying what their interaction with each other could be and how they can influence each other.

46 Art. 11A of the Food Standards Australia New Zealand Act 1991.

47 For an historical overview of the period prior to the establishment of the EFSA, 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; for the legal background of the EFSA, see Buonanno, Laurie, “The Creation of the European Food Safety Authority”, in Ansell, Chris and Vogel, David (eds), What's the beef? The contested governance of European food safety (Cambridge: MIT Press, 2006), pp. 259 et sqq.Google Scholar; see also Macmaolain, Caoimhin, EU Food Law: Protecting Consumers and Health in a Common Market (Oxford: Hart Publishing, 2007)Google Scholar; for a detailed account of the structure of the EFSA, see Ellen Vos and Wendler, Frank, Food safety regulation in Europe: A comparative institutional analysis (Mortsel: Intersentia Publishing, 2006).Google Scholar

48 For the purposes of a focused discussion regarding Chinese food risk assessment, only non-agricultural food risk assessment under the auspices of the FRAEC of the Ministry of Health is illustrated in this section.

49 Ellen Vos, “EU food safety regulation in the aftermath of the BSE crisis”, supra note 47, p. 229; see also, White Paper on Food Safety, supra note 26, p. 12.

50 For a constitutional analysis of comitology, see Joerges, Christian and Neyer, Jürgen, “From intergovernmental bargaining to deliberative political processes: the constitutionalisation of comitology”, 3 European Law Journal (1997), pp. 273 et sqq.CrossRefGoogle Scholar; for its implementation in EU food regulation and recent reforms, see Muchna, D., “The Importance of Comitology for the Decision-making Process in the Foodstuffs Sector – Implications of the 2006 Comitology Reform”, 31 Nutrition (2007), pp. 175 et sqq.Google Scholar

51 See Westlake, Martin, “Keynote article: ‘Mad cows and Englishmen’ — the institutional consequences of the BSE crisis”, 35 Journal of Common Market Studies (United Kingdom) (1997), pp. 11 et sqq.Google Scholar; and Laurie Buonanno, Sharon Zablotney and Richard Keefer,”Politics versus science in the making of a new regulatory regime for food in Europe”, available on the Internet at <http://eiop.or.at/eiop/texte/2001-012.htm> (last accessed on 13 July 2011).

52 Vincent, Keith, “‘Mad Cows’ and Eurocrats — Community Responses to the BSE Crisis”, 10 European Law Journal (2004), pp. 499 et sqq., p. 507.CrossRefGoogle Scholar

53 Temporary committee of inquiry into BSE,”Report on alleged contraventions or maladministration in the implementation of Community law in relation to BSE, without prejudice to the jurisdiction of the Community and national courts”, available on the Internet at <http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+REPORT+A4-1997-0020+0+DOC+XML+V0//EN#top> (last accessed on 13 July 2011).

54 This could occur due to pressure from Member States. As the ultimate authority over all committees affiliated with it, the European Commission could — albeit temporarily — guide the committees and push them to certain conclusions. As a political organ, it could direct the committees to work in a certain way or screen particular information, say, affecting the committees’ findings.

55 Jürgen Neyer, “The Regulation of Risks and the Power of the People: Lessons from the BSE Crisis”, 4 European Integration online Papers (EIoP) (2000), available on the Internet at <http://eiop.or.at/eiop/pdf/2000-006.pdf> (last accessed on 13 July 2011).

56 Art. 24 of the General Food Law.

57 Para. 4 of Art. 26 of the General Food Law.

58 See White Paper on Food Safety, supra note 26, p. 17. It should be noted that EFSA has been given no regulatory power in the form of risk management not only because of the BSE crisis but also due to the fact that the current European Parliament treaties do not allow any regulatory power to be assigned to an independent agency like the EFSA. In other words, the allocation of regulatory power to the independent EFSA might require a modification of the existing provisions of the European Parliament treaties.

59 Seguin, Eve, “The UK BSE crisis: strengths and weaknesses of existing conceptual approaches”, 27 Science and Public Policy (2000), pp. 293 et sqq., p. 300.CrossRefGoogle Scholar

60 Pinghui Xiao, “Chinese Food Safety Regulation: Institutional Perspective”, supra note 4, at pp. 7–15.

61 See Wu Zhong,”China struggles to cap milk crisis”, available on the Internet at <http://www.atimes.com/atimes/China/JI24Ad01.html> (last accessed on 13 July 2011); see also “China's baby-milk scandal, formula for disaster, the politics of an unconscionable delay”, available at <http://www.economist.com/node/12262271?story_ id=12262271> (last accessed on 13 July 2011).

62 A close examination into the censorship activities of the Propaganda Department of the CCP during the melamine milk scandal provides a footnote for this conclusion. The Ordinance on Managing Online News Publishing Associated with Sanlu Milk Contamination was published by the Propaganda Department, an internal division in charge of media censorship and control in China, even though state law does not explicitly give it such authority, and the division is not even formally considered to be part of the Chinese administration. The Ordinance ordered that media were not to publish any negative news or criticize the Party or the government, and were to strictly follow dispatches from Xinhua, People's Daily and other central media outlets controlled by the CCP. Given China's institutional approach, in which Chinese media are required to be in line with the CCP's policy and politics, it is questionable whether food assessment could ever be truly independent from political influence. It is unlikely that the Chinese government would implement full institutional separation of risk assessment and management and allow full independence in risk assessment to a free body speaking on behalf of the public. See “Milk Powder Contamination Discovered in August But Made Public Now?”, available at <http://chinadigitaltimes.net/2008/09/contaminationdiscovered-in-aug-but-made-public-now/> (last accessed on 13 July 2011); Jim Yardley and David Barboza, “Despite Warnings, China's Regulators Failed to Stop Tainted Milk”, New York Times, at A1 et sqq.; and Blecher, Marc, “China in 2008: Meeting Olympian Challenges”, 49 Asian Survey (2009), pp. 74 et sqq., p. 83.CrossRefGoogle Scholar