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Food Irradiation: The EU Regulatory Framework, Risk Assessment and International Trade Considerations

Published online by Cambridge University Press:  20 January 2017

Ignacio Carreño  and
Paolo R. Vergano
Ignacio Carreño
Affiliation:
FratiniVergano – European Lawyers
Paolo R. Vergano
Affiliation:
FratiniVergano – European Lawyers
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Abstract

This article looks at the different regulatory approaches on food irradiation, starting with international standards on food irradiation, describing the approach in the US and other third countries, and finally in the EU, where there has been a regulatory standstill since 1999. The current EU approach on food irradiation, which authorises irradiation of certain predefined product categories and sets upper dose limits, does not appear to be in line with the approach used under the relevant internationally-recognised standards, such as the Codex Alimentarius and the International Plant Protection Convention. There are potential legal conflicts between the current regulatory framework on food irradiation in the EU and the international trade framework of the World Trade Organization. Ultimately, the EU must base its measures on scientific principles, on relevant international standards, and choose the least trade-distortive measures that are available (i.e., ensure that they are applied only to the extent necessary to protect human, animal or plant life or health). In 2011, the European Food Safety Authority published new risk assessments on food irradiation, which the European Commission has requested in view of drafting new EU legislation on food irradiation, and which appear to open the way for a fundamental altering of the regulatory parameters (such that food irradiation regulations must be scientifically-justified and in line with the relevant international standards), and seem to weaken the EU stance vis-à-vis the possible instances where the current rules on food irradiation prevent (de jure or de facto) access to the EU market by third countries’ operators and products, particularly those of developing countries.

Type
Research Article
Information
European Journal of Risk Regulation , Volume 3 , Issue 3 , September 2012 , pp. 373 - 392
Copyright
Copyright © Cambridge University Press 2012

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References

1 This is what, according to a food irradiation specialist at the International Atomic Energy Agency, happened in the US, where irradiation was approved as a treatment for killing pathogens on spinach and lettuce following an E. coli scare in 2006. See Helen Glaberson, “E. coli crisis could prompt interest in irradiation for salads”, 28 June 2011, available on the Internet at <http://www.foodproductiondaily.com/Quality-Safety/E.coli-crisis-could-prompt-interest-in-irradiation-for-salads-IAEA> (last accessed on 28 August 2012).

2 For more details on the outbreak and its trade impact, see Commission Implementing Decision 2011/402/EU, OJ 2011 L 179/10, which introduced a ban on the release for free circulation in the EU of seeds and beans from Egypt.

3 Different technologies are currently available and used for the irradiation of food. As foreseen by the Codex General Standard for Irradiated Foods, such technologies are primarily based on the use of three different kinds of ionising radiation: gamma rays ( -rays ) from the radionuclides cobalt-60 (Co-60) or cesium-137 (Cs-137); X-rays generated from machine sources operated at or below an energy level of 5 MeV (i.e., 5 million electron volts); and electrons (e-beams) generated from machine sources operated at or below an energy level of 10 MeV. While the first type ( -rays) are produced from a radioactive source, the other two (X-rays and ebeams) are produced by specific equipment converting other energy sources, such as electric current, without the involvement of any radioactive substance.

4 See information of the UK Food Standards Authority on Irradiated food, available on the Internet at: <http://www.food.gov.uk/safereating/rad_in_food/irradfoodqa/> (last accessed on 28 August 2012).

5 International Consultative Group on Food Irradiation (Food and Environmental Protection Section Joint FAO/IAEA (International Atomic Energy Agency) Division of Nuclear Techniques in Food and Agriculture), “Facts about food irradiation”, 1999.

6 Institute of Food Science and Technology, The Use of Irradiation for Food Quality and Safety (February 2006); Nordion, The History of Food Irradiation, available on the Internet at <http://www.nordion.com/documents/The-History-of-Food-Irradiation.pdf> (last accessed on 28 August 2012).

7 Report of a Joint FAO/IAEA WHO Expert Committee, “Wholesomeness of Irradiated Food”, in Technical Report Series 659 (WHO: Geneva, 1981).

8 Report of a Joint FAO/IAEA/WHO Study Group, “High Dose Irradiation: Wholesomeness of Food Irradiated with Doses above 10 kGy”, in Technical Report Series 890 (WHO: Geneva, 1999).

9 Ibid., at p. 3.

10 The recently-adopted ISO Standard 14470:2011 Food irradiation – Requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food specifies requirements for the development, validation and routine control of the process of irradiation using ionizing radiation for the treatment of food, and establishes guidelines for meeting the requirements.

11 Codex General Standard for Irradiated Foods No. 106-1983, Rev 1-2003, available on the Internet at <http://www.codexalimentarius.net/web/more_info.jsp?id_sta=16> (last accessed on 28 August 2012).

12 Common European Community Position for the Codex Alimentarius Commission, 24th session, 2-7 July 2001, Geneva, Switzerland – Agenda Item 10 b) Consideration of Standards and related Texts at Step 5 – Proposed Draft Revision to the Codex General Standard for Irradiated Foods at step 5.

13 Codex Alimentarius, CAC/RCP 19-1979, Revision 2-2003.

14 “Hazard Analysis and Critical Control Points”.

15 Codex Alimentarius, CAC/RCP 1-1969, Revision 3-1997, Amendment 1-1999.

16 This standard was endorsed by the Commission on Phytosanitary Measures in March 2007.

17 USA, Code of Federal Regulations, 21 CFR 179, as revised on 1 April 2010.

18 Irradiation is permitted for 1) for control of Trichinella spiralis in pork carcasses or fresh, non-heat-processed cuts of pork carcasses; 2) for growth and maturation inhibition of fresh foods; 3) for deinfestation of arthropod pests in food; 4) for microbial disinfection of dry or dehydrated enzyme preparations; 5) for microbial disinfection of certain dry or dehydrated aromatic vegetable substances (i.e., herbs and spices) when used as ingredients in small amounts solely for flavouring or aroma; 6) for control of foodborne pathogens in fresh or frozen, uncooked poultry products; 7) for the sterilisation of frozen, packaged meats used solely in the NASA space flight programs; 8) for control of foodborne pathogens in, and extension of the shelf-life of, certain refrigerated or frozen, uncooked meat products; 9) for control of Salmonella in fresh shell eggs; 10) for control of microbial pathogens on seeds for sprouting; 11) for the control of Vibrio bacteria and other foodborne microorganisms in or on fresh or frozen molluscan shellfish; and 12) for control of foodborne pathogens and extension of shelf-life in fresh iceberg lettuce and fresh spinach.

19 The “Radura” is the international symbol indicating that a food product has been irradiated. The Radura is usually green and resembles a plant in circle. The use of the logo for irradiated food is required under the Codex Alimentarius Standard on Labelling of Prepacked Food.

20 USA, Code of Federal Regulations, CFR, Title 7: Agriculture, Part 305-Phytosanitary treatments; § 305.9 Irradiation treatment requirements.

21 According to the German Max Rubner–Institut of the Federal Research Institute of Nutrition and Food (Bundesforschungsanstalt für Ernährung und Lebensmittel), available at <http://www.bfa-ernaehrung.de/bestrahlung/>, irradiation is authorised in the following European countries: Croatia, Montenegro, Norway, Russian Federation, Serbia, Turkey and Ukraine; in Asia: Bangladesh, China, India, Indonesia, Iran, Israel, Japan, Korea, Pakistan, Philippines, Saudi-Arabia, Syria, Thailand and Vietnam; in Central-, North-, and South America: Argentina, Brazil, Canada, Chile, Costa Rica, Cuba, Mexico, Paraguay, Peru, Uruguay and the US; in Africa: Algeria, Egypt, Ghana, Libya, South Africa, Tunisia and Zambia; and in Australia and New Zealand.

22 Kume, T., Todoriki, S., and Uenoyama, N. et al., “Status of food irradiation in the world”, 78 Radiation Physics and Chemistry (2009), pp.222 et sqq CrossRefGoogle Scholar. As to the products irradiated, the 405,000 tonnes comprised 186,000 tonnes of spices and dry vegetables, 82,000 tonnes of grains and fruits, 32,000 tonnes of meat and fish, 88,000 tonnes of garlic and potatoes, and 17,000 tonnes of other food items including food supplements, mushroom and honey.

23 Directive 1999/2/EC of the European Parliament and of the Council on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation, OJ 1999 L 66/16, last amended by Regulation (EC) No 1137/2008 of the European Parliament and of the Council, OJ 2008 L 311/1.

24 Directive 1999/3/EC of the European Parliament and of the Council on the establishment of a Community list of foods and food ingredients treated with ionising radiation, OJ 1999 L 66/24.

25 Annex I point 1 of Directive 1999/2/EC of the European Parliament and of the Council on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation, OJ 1999 L 66/16, last amended by Regulation (EC) No 1137/2008 of the European Parliament and of the Council, OJ 2008 L 311/1.

26 Article 4(3) of Directive 99/2/EC, supra note 23, refers to Article 100a of the Treaty (i.e. Article 114 of the TFEU).

27 See Communication from the Commission on foods and food ingredients authorised for treatment with ionising radiation in the Community, OJ 2001 C 241/06.

28 In May 2003, the five Scientific Committees providing the Commission with scientific advice on food safety were transferred to the EFSA.

29 OJ 2009/C 283/5.

30 List of approved facilities for the treatment of foods and food ingredients with ionising radiation in the Member States, OJ 2011 C 336/14.

31 COM(2011) 359 final, Report from the Commission on food irradiation for the year 2008 of 27 June 2011.

32 See data compiled in the following sources: Scientific Opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) on the Chemical Safety of Irradiation of Food, adopted on 25 November 2010, and Published on 6 April 2011 in 9:4 EFSA Journal (2011), 1930 pp.15 et ssq.

33 Röcke, Timo, “The Law on Treatment of Food with Ionising Radiation – Legislative Silence”, 4 European Food and Feed Law Review (2006), pp.203 et sqq, at p. 208Google Scholar.

34 OJ 2009/C 242/02, Report from the Commission on food irradiation for the year 2007. For the latest available figures on the frequency of testing and number of incompliant samples in the EU Member States, see the last report available at supra note 31.

35 See: Final report of a mission carried out in China from 24 February to 2 March 2009 in order to evaluate food irradiation facilities, DG(SANCO)/2009-8144 – MR – FINAL.

36 Röcke, “The Law on Treatment of Food with Ionising Radiation”, supra note 33 at p. 208.

37 Lebensmittel- und Futtermittelgesetzbuch of 01.09.2005 in der Fassung der Bekanntmachung vom 22. August 2011 (BGBl. I S. 1770).

38 In a further opinion, the Revision of the opinion of the Scientific Committee on Food on the irradiation of food of 4 April 2003 (SCF/CS/NF/IRR/24 Final), the SCF concluded that it is not possible to accept at present the suggested removal of the upper limit of 10 kGy for the production of safe and wholesome irradiated foods. On the basis of the information presently supplied to it, the Committee argued that it is appropriate to specify a maximum dose for the treatment of certain food products by ionising radiation and that irradiated foodstuffs should continue to be evaluated individually, taking into account the technological need and their safety.

39 OJ 2002 L 31/1–24, last amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council, OJ 2009 L 188/14-92.

40 Ibid., at para 34.

41 Ibid., at para 17.

42 Ibid., at para 18.

43 Ibid., at para 19.

44 9:4 EFSA Journal (2011), 2107 pp.1 et sqq.

45 Ibid., at p. 10.

46 9:4 EFSA Journal (2011), 1930 at p. 3.

47 Codex Alimentarius, Codex General Standard for Irradiated Foods No. 106-1983, Rev 1-2003, available on the Internet at <http://www.codexalimentarius.net/web/more_info.jsp?id_sta=16> (last accessed on 28 August 2012).

48 Various terms are used for defining radiation dose and the CEF Panel agrees with the approach of the Codex Standard which no longer uses the concept of overall average dose (which is still used in EU law). Therefore it is considered that the limits should be expressed in terms of a maximum dose. In order to convert the overall average dose into a maximum dose, the conversion factor should not exceed 1.5, which corresponds to the currently maximum allowed dose uniformity ratio of 3.0. 9:4 EFSA Journal (2011), at p. 7.

49 See, e.g., Open Letter of Food and Water Watch, French collective against food irradiation and other organisations of 11 October 2010 to EFSA, the European Commission and the European Parliament, and statement of the French collective against food irradiation of 8 April 2011 ‘Food Irradiation: let us ban it under the precautionary principle!.’ Both documents are available on the internet at <http://www.foodandwaterwatch.org/europe/questionable-technologies/food-irradiation/> (last visited on 28 August 2012).

50 It is argued that the fact that the Codex Alimentarius allows food irradiation at virtually unlimited doses presents a risk to countries refusing imports of food because they are irradiated and that this could lead to a complaint before the Dispute Settlement Body of WTO, which could then lead to trade retaliation, as was the case concerning EU measures prohibiting imports of meat from animals treated with hormones in the late 90s. See, Open Letter of Food and Water Watch, French collective against food irradiation and other organisations of 11 October 2010 to EFSA, the European Commission and the European Parliament, available on the internet at <http://www.foodandwaterwatch.org/europe/questionable-technologies/food-irradiation/> (last accessed on 28 August 2012).

51 On the relation of EFS with the European Commission, see: Alberto Alemanno, The European Food Safety Authority at Five, 1 European Food and Feed Law Review (2008), pp.2 et sqq

52 EFSA's scientific independence has been questioned over the last years, arguing that too often it is not independent science that underlies EFSA opinions. See, e.g., Conflicts on the menu. A decade of industry influence at the European Food Safety Authority (EFSA), report by Corporate Europe Observatory (CEO) and Earth Open Source (EOS), February 2012. Available on the internet at <http://www.corporateeurope.org> (last accessed on 28 August 2012).

53 Ibid. Article 14(4)a) of Regulation (EC) No 178/2002 even establishes that “In determining whether any food is injurious to health, regard shall be had: (a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations.”

54 See Case T-13/99, Pfizer v. Council [2002] ECR p. II-3305, paras 143-144. For a review of the jurisprudence of the EU and EFTA courts on the precautionary principle, see Alberto Alemanno, The Shaping of the Precautionary Principle by European Courts: From Scientific Uncertainty to Legal Certainty, Valori Costituzionali E Nuove Politiche Del Diritto, L. Cuocolo, L. Luparia, eds., Cahiers Europèens, Halley, 2007.

55 ‘Case C-79/09, Gowan Comércio Internacional e Serviços Lda v. Ministero della Salute, Judgment of the Court of Justice (Second Chamber) of 22 December 2010.’ In the case at stake, following a favourable assessment of a pesticide and a favourable draft proposal by the European Commission, the authorisation procedure for fenarimol, a fungicide, ended with a Directive restricting its use, relying on the precautionary principle. The Court concluded that since there was still “some scientific uncertainty regarding the assessment of the effects on the endocrine system” at the time the draft decision was drawn up, the Commission cannot be considered to have erroneously applied the precautionary principle.

56 For a detailed analysis of the Gowan judgment, see: Alberto Alemanno, ‘Case C-79/09, Gowan Comércio Internacional e Serviços Lda v. Ministero della Salute, Judgment of the Court of Justice (Second Chamber) of 22 December 2010’ (2011), 48 Common Market Law Review pp.1329–1348.

57 Alemanno, Alberto, “Case C-79/09, Gowan Comércio Internacional e Serviços Lda v. Ministero della Salute, Judgment of the Court of Justice (Second Chamber) of 22 December 2010”, 48 Common Market Law Review (2011), pp.1329–1348 Google Scholar.

58 Röcke, “The Law on Treatment of Food with Ionising Radiation”, supra note 33 at p. 204.

59 In relation to the issue that, apart from science, decision makers should take into account other legitimate factors, such as societal, ethical or traditional concerns, see: Szajkowska, Anna, “Different Actors, Different Factors – Science and Other Legitimate Factors in the EU and National Food Safety Regulation”, 4 European Journal of Risk Regulation (2011), pp.523 et sqq CrossRefGoogle Scholar.

60 See European Commission, Directorate General for Health & Consumers, Rapid Alert System for Food and Feed, available on the Internet at <http://ec.europa.eu/food/food/rapidalert/index_en.htm> (last accessed on 28 August 2012).

61 Paisan Loaharanu, “Food irradiation in developing countries: A practical alternative”, IAEA Bulletin, 1/1994, pp.30 et sqq..

62 Contributions to Global Food Security by the Joint Division of the Food and Agriculture Organization and the International Atomic Energy Agency, Atoms for Food – a global partnership (IAEA and FAO, October 2008), at p. 11, available on the Internet at <http://www-naweb.iaea.org/nafa/fao1008.pdf> (last accessed on 28 August 2012).

63 International Consultative Group on Food Irradiation – Food and Environmental Protection Section, Facts about food irradiation (Joint FAO/IAEA Programme, Division of Nuclear Techniques in Food and Agriculture, 1999).

64 USA, Federal Register/Vol. 75, No. 166/27 August 2010/Notices, at p.52712.

65 USA, Department of Agriculture, Animal and Plant Health Inspection Service, Importation of Fresh Mango Fruit (Mangifera indica L.) from Pakistan into the Continental United States, Risk Management Document, 2 March 2010, available on the Internet at <http://www.regulations.gov/#!docketDetail;rpp=10;po=0;D=APHIS-2010-0065> (last accessed on 28 August 2012).

66 400 Gy = 0.4 kGy.

67 USA, Code of Federal Regulations-CFR, Title 7: Agriculture, Part 305-Phytosanitary treatments; § 305.9 Irradiation treatment requirements).

68 The importation of irradiated dragon fruit from Thailand is permitted according to a recent decision of 4 October 2011.

69 USA, Department of Agriculture Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Fresh Fruits and Vegetables Import Manual, May 2011, available at <http://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/fv.pdf> (last accessed on 28 August 2012).

70 USA, Federal Register, Vol. 76, No. 206 of 25 October 2011, at p.65988.

71 Directive 1999/2/EC of the European Parliament and of the Council on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation, OJ 1999 L 66/16, last amended by Regulation (EC) No 1137/2008 of the European Parliament and of the Council, OJ 2008 L 311/1.

72 Directive 1999/3/EC of the European Parliament and of the Council on the establishment of a Community list of foods and food ingredients treated with ionising radiation, OJ 1999 L 66/24.

73 In general in relation to uncertainty of science and the application of the precautionary principle, see: Lukasz Gruszczynski, “The Role of Science in Risk Regulation under the SPS Agreement, European University Institute”, EUI Working Paper Law No. 2006/03; Gruszczynski, Lukasz, “SPS Measures Adopted in Case of Insufficiency of Scientific Evidence”, in Chaisse, Julien and Balmelli, Tiziano (eds) Essays on the Future of the World Trade Organization Volume II, The WTO Judicial System: Contributions and Challenges (Editions interuniversitaires suisses – Edis 2008), p.91 et sqq Google Scholar.

74 See Appellate Body Report, Japan–Measures Affecting Agriculture Products, WT/DS76/AB/R, adopted on March 19, 1999, para. 89; Appellate Body Report, Japan – Measures Affecting the Importation of Apples, WT/DS245/AB/R, adopted December 10, 2003 [hereinafter Japan-Apples] para. 176; Panel Report, European Communities – Measures Affecting The Approval And Marketing Of Biotech Products, AWT/DS291/R, WT/DS292/R, WT/DS293/R, adopted on of 29 September 2006, at para, 7.2973.

75 Japan-Apples para. 179.

76 Japan-Apples para. 185.

77 Appellate Body Report, EC Measures Concerning Meat And Meat Products (Hormones), WT/DS26/AB/R, WT/DS48/AB/R, adopted on 16 January 1998, para. 124.

78 Panel Report, European Communities – Measures Affecting The Approval And Marketing Of Biotech Products, AWT/DS291/R, WT/DS292/R, WT/DS293/R, adopted on of 29 September 2006, at para, 7.1520.

79 WTO, Committee on Sanitary and Phytosanitary Measures – Specific Trade Concerns – Submission by the United States Regarding G/SPS/GEN/204/Rev.1, document number G/SPS/GEN/265.

80 WTO, Committee on Sanitary and Phytosanitary Measures – Summary of the Meeting Held on 15-16 September 1998 – Note by the Secretariat, document number G/SPS/R/12, at paras. 37-38. See also WTO, Committee on Sanitary and Phytosanitary Measures – Summary of the Meeting Held on 10 – 11 July 2001 – Note by the Secretariat, document number G/SPS/R/22, at para. 127.

81 WTO, Committee on Sanitary and Phytosanitary Measures – Notification of Two Common Positions for: (a) A Framework Directive (FD) and (b) An Implementation Directive (ID), document number G/SPS/N/EEC/61.

82 WTO, Committee on Sanitary and Phytosanitary Measures – Specific trade concerns – Note by the Secretariat – Issues not considered in 2010 – Addendum, document number G/SPS/GEN/204/Rev.11/Add.2, at paras. 216 and 217.