1 This deadlock was somewhat unusual within Codex as this UNsponsored body adopts dozens of food safety standards each year by consensus, with well over a hundred countries participating.

2 Panel Report, European Communities — Trade Description of Sardines, WT/DS231, paragraph 7.138.

3 Press Release by the EU following the adoption of an international food safety standard for ractopamine, July 6, 2012, available at on the Internet at <http://ec.europa.eu/food/international/organisations/codex_en.htm> (last accessed on 16 August 2012).

4 As compared with clenbuterol, ractopamine has a much shorter half-life in blood. In addition, it is more readily inactivated in the liver, eliminated faster and has lower potential for bioaccumulation in general. When administered orally to a number of animal species, ractopamine is more rapidly absorbed and rapidly excreted with very low level of tissue residues.

5 See, e.g., Apple, J.K. et al., “Meta-analysis of the ractopamine response in finishing swine”. 23 Prof. Anim. Sci. (2007), pp.179–196 Google Scholar.

6 The U.S. Food and Drug Administration (FDA) determined that ractopamine was safe for use in pigs 13 years ago - in 1999 - and has since approved it for use in cattle and turkeys as well. The agency set a threshold for residues of the drug. Sale of any meat with levels below this amount are legal and no meat in the United States has been found with ractopamine above the acceptable tolerances.

7 Australia New Zealand Food Standards Code 1.4.1 (MLs) and 1.4.2 (MRLs) (Australia only), up to Amendment 119, September 2010 available on the FSANZ website.

8 For New Zealand purposes, maximum residue limits for agricultural compounds are regulated in the New Zealand (Maximum Residue Limits of Agricultural Compounds Mandatory Food Standard 1999 - and subsequent amendments) issued under sections 11C and 11Z of the Food Act 1981.

9 Specifications and Standards for Foods and Food additives. See the Food Sanitation Law, MHW Notification, No. 370, 1959, amendment No.499 2005 MRLs list updated 28 Nov 2008, available on the MHLW website.

10 Currently, different β-agonist substances are authorised for use as growth promoters in around 25 countries worldwide. See EFSA, Opinion of Safety Evaluation of Ractopamine, The EFSA Journal (2009) 1041, 5–52.

11 Codex does not address the authorisation of use of veterinary drugs in food producing animals but establishes Maximum Residue Levels (MRLs) for veterinary drugs in foods, as recommendation for national authorities. Codex has developed the Guidelines for the Design and Implementation of National Regulatory Food Safety Assurance Programmes Associated with the Use of Veterinary Drugs in Food Producing Animals, which provide governments with adequate criteria for the selection of drugs and their use in food producing animals and the subsequent determination of related residues in their products.

12 Authorization been allowed by the Ministry of Agriculture, Livestock and Supply – MAPA.

13 Schaefer, A.L., Jones, S.D.M., Tong, A.K.W. et al., “The effect of feeding the beta-adrenergic agonist ractopamine on the behavior of market-weight pigs”, 72(1) Can. J. Anim. Sci. (1992), pp. 15–21 CrossRefGoogle Scholar.

14 Marchant-Forde, J.N., Lay, D.C. Jr., Pajor, E.A. et al., “The effects of ractopamine on the behavior and physiology of finishing pigs”, 81(2) J. Anim. Sci. (2003), pp.416–422 CrossRefGoogle ScholarPubMed.

15 Poletto, R., Cheng, H.W., Meisel, R.L. et al., “Aggressiveness and brain amine concentration in dominant and subordinate finishing pigs fed the β-adrenoreceptor agonist ractopamine” 88(9) J. Anim. Sci. (2010), pp.3107–3120 CrossRefGoogle ScholarPubMed.

16 The Codex Alimentarius Commission was created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this Programme are protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations.

17 The first vote saw that 64 voted in favor of a secret vote, with 54 against and 6 abstentions. Japan, one of the 27 countries that permits ractopamine residues, did not side with the US, which voted in favor of a vote on the draft MRLs being held by a secret vote. In the second vote, 59 voted in favor of holding a secret vote on the draft MRLs, but 68 voted against, with 9 abstentions.

18 For its recommendations on residues of veterinary drugs in food, Codex relies on the scientific assessment of the FAO/WHO Expert Committee on Food Additives (JECFA) and the recommendations of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF).

19 An ADI, along with data on how much meat consumers are likely to eat, allows the scientists to set safe drug residue limits. In particular, an ADI is an estimate of the amount of a substance in food or drinking water, expressed on a body-weight basis, that can be ingested daily over a lifetime without appreciable risk (standard human = 60 kg). The ADI is listed in units of mg per kg of body weight (JECFA Glossary of terms).

20 The published JECFA risk assessments and reviews are available in the WHO Technical Report Series available on the Internet at <http://www.who.int/foodsafety/chem/jecfa/publications/reports/en/index.html> (last accessed on 16 August 2012) and in FAO Residue Monographs available on the Internet at <http://www.fao.org/ag/agn/jecfa-vetdrugs/search.html> (last accessed on 16 August 2012).

21 The proposal to adopt the Ractopamine standards held at 34th Session of the Codex Alimentarius Commission (4–9 July 201) is based upon scientific advice from the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the recommendation of the Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF), and the current Codex step process. It acknowledges the validity of JECFA’s risk assessments undertaken in 2004, 2006 and 2010 and their recommended MRLs for Ractopamine (Ractopamine hydrochloride) in the target tissues (muscle, fat, liver and kidney) for cattle and pigs, as advanced through the Codex step process.

22 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) provides independent scientific advice on the safety and/or efficacy of additives and products or substances used in animal feed. The Panel evaluates their safety and/or efficacy for the target species, the user, the consumer of products of animal origin and the environment. It also looks at the efficacy of biological and chemical products/substances intended for deliberate use in animal feed.

23 Taiwan announced on August 15 a preview of official notice of allowable levels of ractopamine in beef imports and of requirements for labeling of product origin, which could open the country's doors to imported beef containing the leanness-enhancing drug next month at the earliest. See <http://www.taipeitimes.com/News/taiwan/archives/2012/08/16/2003540431> (last accessed on 16 August 2012).

24 Veggeland, F. and Borgen, S.O., Changing the Codex: The Role of International Institutions (Oslo: Norwegian Agricultural Economics Research Institute, 2002)Google Scholar.

25 For an analysis of the SPS impact on the Codex's activities, see David Jukes, “The Codex Alimentarius Commission – Current Status”, available on the Internet at <http://www.reading.ac.uk/foodlaw/codex-1.htm> (last accessed on 16 August 2012).

26 Appellate Body Report, European Communities — Trade Description of Sardines, WT/DS231/AB/R, adopted 23 October 2002.

27 Although the AB came to this conclusion in a case involving the application of an international standard under the TBT, there are good reasons to believe that this answer could be extended to the interpretation of the SPS Agreement.

28 Appellate Body Report, US-Continued Suspension, WT/DS230/AB, para 685.

29 Ibid., para 1413.

30 Alemanno, Alberto, “Derecho Internacional de la Seguridad Alimentaria”, in Recuerda, Miguel (ed.), Tratado de Derecho Alimentario, (Aranzi, 2011)Google Scholar.

31 Alemanno, Alberto, Trade in Food – Regulatory and Judicial Approaches in the EC and the WTO (London: Cameron May, 2007), p.263 et sqq Google Scholar.