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Putting Risk Management to the Test or Why it is Ineffectual to Separate Risk Assessment from Risk Management: The Story of Maximum Levels for Aflatoxins*

Published online by Cambridge University Press:  20 January 2017

Liana Giorgi  and
Annuradha Tandon
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Abstract

This article reviews the policy process of setting maximum levels for aflatoxins by the European Union and the Codex Alimentarius Commission. The differences between the two regulatory organizations and the difficulties entailed in the alignment of the two standards are illustrative of the problems inherent in risk analysis in the food sector. This case is also instructive with respect to the way in which scientific evidence is used when deciding on appropriate food safety standards.

Type
Articles
Information
European Journal of Risk Regulation , Volume 1 , Issue 2 , June 2010 , pp. 123 - 135
Copyright
Copyright © Cambridge University Press 2010

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Footnotes

*

This article is based on research carried out in the framework of the MoniQA Network of Excellence on ‘Monitoring and Quality Assurance in the Food Supply Chain’ supported by the Sixth Framework Programme of the European Commission. The opinions expressed in this article are solely those of the authors.

References

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5 This includes almonds, hazelnuts, pistachios, Brazil nuts, cashew nuts, walnuts, and pecan nuts.

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9 See Wagacha and Muthomi, “Mycotoxin Problem in Africa”, supra note 2; also, P. Bayman, J. L. Baker and N. E. Mahoney, “Aspergillus on Tree Nuts: Incidence and Associations”, 155 Mycopathologia (2002), pp. 161–169; T. Denizel, B. Jarvis, E. J. Rolfe, “A Field Survey of Pistachio (Pistacia vera) Nut Production and Storage in Turkey with Particular Reference to Aflatoxin Contamination”, 27(11) Journal of Scientific Food Agriculture (1976), pp. 1021–6.

10 See Ozay, G., “Factors Influencing Fungal and Aflatoxin Levels in Turkish Hazelnuts (Corylus avellana L.) during Growth, Harvest, Drying and Storage: A 3-year Study”, 25(2) Food Additives and Contaminants 2008, pp. 209–218 CrossRefGoogle ScholarPubMed.

11 See also Simsek, O., Arici, M. and Demir, C., “Mycoflora of Hazelnut (Corylus avellana L.) and Aflatoxin Content in Hazelnut Kernels Artificially Infected with Aspergillus parasiticus ”, 46 Nahrung (2002), pp. 194–196 3.0.CO;2-D>CrossRefGoogle ScholarPubMed.

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15 The Scientific Committee for Food (SCF) was originally established by Commission Decision (EC) 74/234/EEC (OJ 1974 L 136), replaced by Commission Decision (EC) 95/273/EC (OJ 1995 L 167), to advise the Commission on food safety issues. In 2003, following the establishment of EFSA, it was incorporated into the latter's structure.

16 European Commission Report of the Scientific Committee for Food (Thirty-Fifth Series), Directorate-General Industry (1996), p. 47.

17 Regulation (EC) 1525/98 amended Regulation (EC) 194/97 setting limits for them in groundnuts, certain cereals and milk. Regulation 1525 does not make explicit reference to the ALARA principle, but refers instead to “limits as low as possible” (OJ 1998 L 201/43). The subsequent amendment in 2001 refers explicitly to ALARA.

18 Commission Regulation (EC) No 466/2001 setting maximum levels for certain contaminants in foodstuffs (OJ 2001 L 77/1-13).

19 Commission Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs (OJ 2006 L 364/5-24). This regulation replaced the previous one from 2001 taking into account new scientific evidence for contaminants such as nitrates, ochratoxin A, T2 and HT-2 toxins as well as dioxins and mercury. For aflatoxins, limits were introduced for maize, spices, baby-food and processed cereal-based foods. Those for nuts, which are the subject of the present article, remained unchanged except for aflatoxin M1.

20 FAO, Worldwide Regulations for Mycotoxins in Food and Feed 2003 (Rome; United Nations FAO 2004).

21 Sum total of Aflatoxins – B1+B2+G1+G2.

22 Codex Standard CODEX STAN 193-1995, “Codex General Standard for Contaminants and Toxins in Food and Feed”, p. 13, available on the Internet at <http://www.codexalimentarius.net/download/standards/17/CXS_193e.pdf> (last accessed on 9 March, 2010).

23 For almonds, hazelnuts and pistachios, but not for peanuts.

24 These discussions are documented in the annual reports of the CAC Committee on Food Additives and Contaminants. The latter was reorganized into two separate committees, one on food additives and one on contaminants in 2007. This reflects the gradual realization within the CAC of the growing significance of chemical contaminants in food.

25 WHO Technical Report Series 884, “Evaluation of Certain Food Additives and Contaminants: Forty-Ninth Report of the Joint FAO/WHO Expert Committee on Additives”, 1999, pp. 69–77. Specifically, the study reported that the estimated risk at 20 μg/kg is 0.0041 cancer cases per 100,000 populations annually and at 10ppb there are 0.0039 cancer cases per 100,000 populations annually. In other words, the upward adjustment of the standard from 10 to 20 μg/kg would bring an increase of the estimated cancer risk by approximately 2 cancer cases annually per 1 billion population (p. 76).

26 See European Community Comments for CAC 28th Session (2005), ALINORM 05/28/12, Circular Letter CL 2005/22-FAC, Point 9, 1 p.

27 Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, 31st Session, 2008 (ALINORM 08/31/41), pp. 13–14.

28 See EFSA, “Opinion of the Scientific Panel on Contaminants in the Food Chain on a Request from the Commission related to the Potential Increase of Consumer Health Risk by a Possible Increase of the Existing Maximum Levels for Aflatoxins in Almonds, Hazelnuts and Pistachios and Derived Products”, Question EFSAQ-2006-174, 446 The EFSA Journal, pp. 1–127.

29 Samples of other foodstuffs were also considered – a total of around 40,000. However several thousand samples could not be used since the information records were incomplete.

30 See http://www.who.int/foodsafety/chem/gems/en/index1.html (last accessed on 31 January 2010).

31 See JEFCA, “Evaluation of Certain Food Additives and Contaminants”, Sixty-Eighth Report of the Joint FAO/WHO Expert Committee on Food Additives (JEFCA), WHO Technical report series 947, (WHO 2007).

32 Ibid., p. 168.

33 Commission Regulation (EU) No. 165/2010 (OJ 2010 L50/8-12) amending Regulation (EC) No. 1881/2006 (OJ 2006 L364/5-30) setting maximum levels for certain contaminants in foodstuffs as regards aflatoxins. The regulation went through the comitology procedure and was passed by the Council on 15–16 October 2009 (SANCO-D1(2009)411740).

34 OJ (2004 L 191/1-52).

35 European Commission, RASFF – Annual Report on the Functioning of the RASFF 2004 (Brussels: DG-SANCO 2004). Specifically with respect to Turkey, the decision was further based on the results of an official FVO mission to Turkey which found out that official laboratories, i.e., laboratories in charge of carrying out official controls, are not obliged to be accredited with the ISO 17025:2005 standard, which is the standard required within the EU for certifying competence in sampling and testing. See Commission of the European Communities, “Final Report of a mission carried out in Turkey from 28 February to 10 March 2006 in order to assess the control systems in place to prevent mycotoxin contamination in hazelnuts, pistachios and dried figs and to assess the use of additives in dried fruits intended for exports to the European Community”, DG (SANCO)/8101/2006 – MR Final.

36 Commission Decision (EC) No 2006/504 (OJ 2006 L 199/21-32) on special conditions governing certain foodstuffs imported from certain third countries due to contamination risks of these products by aflatoxins.

37 The cost for assessing each sample is around €250. AGES costs for tests for aflatoxins – total aflatoxin: €83 for a single test (Einfach-bestimmung) and €166 for a double test (Doppelbestimmung). Source: Personal Communication with C. Alien, Quality Manager at Manner AG, December 2009.

38 Cited in the EFSA, “Opinion of the Scientific Panel”, supra note 28.

39 See Wu, Felicia, “Mycotoxin Risk Assessment for the Purpose of Setting International Regulatory Standards”, 38(15) Environmental Science and Technology (2004), pp. 4049–4055 CrossRefGoogle ScholarPubMed.

40 Ibid. on Sub-Saharan Africa and China. In South Africa, the differentiation of controls according to whether the commodities are meant for export or for domestic consumption is shown by the way in which the Department of Agriculture tests unprocessed food for trade, but the Department of Health tests the same contaminants only for processed food for the domestic market, see Chanda, R. R., Fincham, R. J. and Venter, P., “A Review of South African Food Control System: Challenges of Fragmentation”, 21 Food Control, 2010, pp. 816–824 CrossRefGoogle Scholar. For the lack of compliance with maximum tolerated levels in Morocco which is counted as ‘best-practice’ among North African countries, see Zinedine, Abdellah and Maries, Jordi, “Occurrence and Legislation of Mycotoxin in Food and Feed from Morocco”, 20 Food Control (2010), pp. 334–344 CrossRefGoogle Scholar.

41 The second-largest producer of hazelnuts is Italy with 15% of the market, followed by Spain and the US with 3% each.

42 According to data from Eurostat, world hazelnut production increased from 665 metric tons in 1996 (of which 420 came from Turkey) to 859 tonnes in 2007 (of which 625 originated from Turkey). 80–90% of the Turkish hazelnut production is exported.

43 These were introduced to constrain the large accumulation of stocks. Presently, hazelnut plantations are only possible in areas that are less than 750m above sea level, with at least 12% gradient and composed of high-class soil. See Meral, Uznon, “An Investigation of the Recent Hazelnut Policies on the Producers Side in Turkey”, 2(8) Journal of Applied Sciences Research 2006, pp. 451–455 Google Scholar.

44 In 2000, the Turkish government granted direct income support to farmers willing to shift away from hazelnut production. Within this framework, hazelnut plantations with less than 6% slope were subject to closure and compensated for lost income through subsidies and removal costs. See Meral, op. cit.

45 Information provided by TUBITAK in the framework of the MoniQA project.

46 Wu, “Mycotoxin Risk Assessment”, supra note 39.

47 Luz B. Diaz Rios and Steven Jaffee, “Barrier, Catalyst or Distraction? Standards, Competitiveness and Africa's Groundnut Exports to Europe”, 39 The World Bank, Agricultural and Rural Development Discussion Paper (2008).

48 Moreu, C., Moulds, Toxins and Food, 2nd ed. (London: Wiley 1979), p. 477 Google Scholar.

49 Otsuki, T., Wilson, J. S. and Sewadeh, M., “Saving Two in a Billion: Quantifying the Trade Effect of European Food Safety Trade Standards on African Exports”, 26 Food Policy (2001), pp. 495–514 CrossRefGoogle Scholar.

50 See Otsuki, T., Wilson, J. S. and Sewadeh, M., “What Price Precaution? European Harmonisation of Aflatoxin Regulations and African Groundnuts Exports”, 28(2) European Review of Agricultural Economics (2001), pp. 263–283 CrossRefGoogle Scholar.

51 Indeed, the gravity model developed by Otsuki et al. showed that, of the factors significantly impacting on the value of trade between Africa and the EU, the aflatoxin maximum levels had the lowest effect, accounting for the smallest explained variance. The t-value of the aflatoxin levels was found to be 4.008 and compared with 11.618 for the effect of the European GDP (indicator of buyers’ wealth), -7.323 for the effect of geographical distance and 14.316 for the effect of colonization ties between the trading partners. The estimations made thereafter by the authors are nevertheless reported as if only related to the change in maximum aflatoxin levels.

52 Data was extracted from the Eurostat Comext database on foreign trade.

53 The nine African countries comprise Egypt, Gambia, Mali, Nigeria, Sudan, Chad, Senegal, South Africa and Zimbabwe.

54 These estimations were made by the authors on the basis of the Eurostat Comext trade data.

55 Fruits and nuts include SITC 057 (fruits and nuts – fresh & dried) and SITC 05892 (nuts, groundnuts and other seeds).

56 According to data reported by the FAO, the price of a tonne of shelled hazelnuts went down from 1896 USD in 1999 and 1665 USD in 2000 to 1090 USD in 2001, 1108 USD in 2002 and 1263 USD in 2003. The prices only began to bounce back in 2004, when they stood at 1744 USD/tonne. In 2007, they skyrocketed to 3503 USD per tonne. (See http://faostat.fao.org/site/567/DesktopDefault.aspx?PageID=567#ancor (last accessed on 30 November 2009)).

57 S. Jaffee and S. Henson, “Standards and Agro-Food Exports from Developing Countries: Rebalancing the Debate”, World Bank Policy Research Working Paper 3348, 2004.

58 Diaz Rios and Jaffee, “Barrier, Catalyst or Distraction?”, supra note 47, especially pp. 2, 6, 11–12.

59 Franz Verstraete, “Influence of Global Food Regulations on Regional/National Food Regulations – The Case of Aflatoxins in EC”, presentation held at the 3rd International Congress on “Food and Nutrition”, Antalya, 22–25 April 2009.

60 An ex-post analysis using the RASFF data carried out by Diaz Rios and Jaffee (supra note 47) and concentrating on groundnuts showed that 52% of the groundnut consignments intercepted by the EU also did not comply with Codex standards, this share rising to 83% in the case of Sub-Saharan African countries (see pp. 47–49).

61 The situation is somewhat different in the case of almonds and pistachios, especially, where aflatoxin B1 contamination is more prevalent, thus accounting for a higher share of total aflatoxin contamination.

62 EFSA, “Opinion of the Scientific Panel”, supra note 28.

63 JEFCA, “Evaluation of Certain Food Additives”, supra note 31.

64 EFSA, “Opinion of the Scientific Panel”, supra note 28, p. 22, emphasis added.

65 Ibid., p. 23.

66 Ibid., emphasis added.

67 Ibid., p. 49.

68 Ibid., p. 23, emphasis added.

69 Ibid., p. 61, emphasis added.

70 EFSA, “Opinion of the Scientific Panel”, supra note 28, p. 72.

71 Paraphrasing from a famous quotation by the astronomer Carl Sagan.