¹ Agreement on Technical Barriers to Trade, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, opened for signature 15 April 1994, entered into force 1 January 1995.

² Agreement on Sanitary and Phyto-Sanitary Measures, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A opened for signature 15 April 1994, entered into force 1 January 1995.

³ Buthe, T, ‘The globalization of health and safety standards: delegation of regulatory authority in the SPS-Agreement of 1994 agreement establishing the World Trade Organization’ (2008) 71 L and Contemporary Problems 219Google Scholar.

⁴ The literature on this issue is vast. See, for instance, H Horn and JHH Weiler, ‘European Communities—Trade Description of Sardines: Textualism and its Discontent’ in H Horn and PC Mavroidis (eds), The American Law Institute Report 2002 (CUP 2005) 251, 260; Livermore, M, ‘Authority and Legitimacy in Global Governance: Deliberation, Institutional Differentiation and the Codex Alimentarius’ (2006) 81 New York UL Rev 766, 786–789Google Scholar; Bonzon, Y, ‘Institutionalizing Public Participation in WTO Decision Making: Some Conceptual Hurdles and Avenues’ (2008) 11 J of Intl Economic L 751, 775ffGoogle Scholar; Scott, J, ‘International Trade and Environmental Governance: Relating Rules (and Standards) in the EU and the WTO’ (2004) 15 Eur J of Intl L 307, 310Google Scholar; R Howse, ‘A New Device for Creating International Legal Normativity: The WTO Technical Barriers to Trade Agreement and ‘International Standards’’ in C Joerges and EU Petersmann (eds), Constitutionalism, Multilevel Trade Governance and Social Regulation (Hart Publishing 2006) 383, 391.

⁵ Vienna Convention on the Law of Treaties, adopted 23 May 1969, entered into force 27 January 1980, 115S UNTS 331 (‘VCLT’), preambles are listed in art 31(2) among the elements useful for the analysis of the context of a treaty, and often international courts and tribunals use them as a shortcut to determine what the purpose of an instrument is. See eg C Schreuer, ‘Diversity and Harmonization of Treaty Interpretation in Investment Arbitration’ in M Fitzmaurice, O Elias, P Merkouris (eds), Treaty Interpretation and the Vienna Convention on the Law of Treaties: 30 Years (BRILL 2010) 129, 131 (referring to investment arbitration): ‘The most frequent way to find a treaty's object and purpose was to look at the preamble.’ With respect to the purpose of the European Convention of Human Rights see, in the same book, G Letsas, ‘Intentionalism and the Interpretation of the ECHR’, ibid., 257, 260, referring to the seminal Golder case (Golder v United Kingdom [1975] 1 EHRR 524).

⁶ See Helfer, LR, ‘Regime Shifting in the International Intellectual Property System’ (2009) 7 Perspectives on Politics 39CrossRefGoogle Scholar; ‘Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual Property Lawmaking’ (2004) 29 Yale J of Intl L 1Google Scholar. Although some features of Helfer's model apply to the present study (eg the consequential importance of the differences between the regimes, with respect to the binding force of their norms or the design of their law-making procedures), in this study the regime-shift expression applies to the norms rather than to the actors, and merely depicts the migration of international standards into the realm of international trade law.

⁷ For a more detailed description of the Codex Commission and its activity, see Pereira, RA, ‘Why Would International Administrative Activity Be Any Less Legitimate? A Study of the Codex Alimentarius Commission’ (2008) 9 German LJ 1693Google Scholar, 1695ff.

⁸ The Conference of Food and Agriculture Organisation (FAO), in 1961, and the World Health Organization (WHO) Assembly, in 1963, adopted the resolutions establishing the Codex Commission. They also adopted the Statutes and Rules of Procedure for the Commission.

⁹ See art 1 of the Codex Statutes, available at <http://www.fao.org/DOCREP/005/Y2200E/y2200e02.htm>.

¹⁰ See ibid art 2.

¹¹ Under the Rules of Procedure, the Commission has one chairperson and three vice-chairpersons to be elected at each annual session, a secretary appointed by the FAO and the WHO, and some regional Coordinators (Rule V). The chairpersons, together with seven member representatives, form the Executive Committee, which shall report to the Commission (Rule VI). The Rules of the Commission can be amended with the vote of two-thirds of the members (Rule XIII). See the full text of the Rules at <http://www.fao.org/DOCREP/005/Y2200E/y2200e03.htm#TopOfPage>.

¹² The full procedures for the adoption of standards are encompassed in the Procedures for the Elaboration of Codex Standards and Related Texts adopted by the Commission, available at <http://www.fao.org/DOCREP/005/Y2200E/y2200e04.htm#TopOfPage>.

¹³ For a recent and comprehensive description of the process, see Henson, S and Humphrey, J, The Impacts of Private Food Safety Standards on the Food Chain and on Public Standard-Setting Processes (Paper for FAO/WHO May 2009)Google Scholar 24ff.

¹⁴ See the FAQ page of the Codex website <http://www.codexalimentarius.net/web/faq_gen.jsp#G11>: ‘General Question 11: Are Codex Standards mandatory? Answer: Codex texts are voluntary and non-binding …’.

¹⁵ Available at <http://www.fao.org/DOCREP/005/Y2200E/y2200e05.htm#TopOfPage>.

¹⁶ For instance, full acceptance of a standard implies that food not conforming therewith shall not be distributed under the name or description laid down in the standard (see Principle 4A.i).

¹⁷ According to the taxonomy of GK Hadfield, ‘The Public and the Private in the Provision of Law for Global Transactions’ in V Gessner (ed), Contractual Certainty in International Trade: Empirical Studies and Theoretical Debates on Institutional Support for Global Economic Exchanges (Hart Publishing 2009) 238, Codex standards would rank as public under some criteria, but they would still have a ‘private ordering’ aspect, since ‘legal obligations based in private ordering derive exclusively from the intent and consent of the obligated party to be bound.’ (240). See also Vogel, D, ‘Private Global Business Regulation’ (2008) 11 Annual Rev of Political Science 261, 265CrossRefGoogle Scholar (regarding ISO regulations). Similarly, Cafaggi, F, Product Safety, Private Standard Setting and Information Networks (Working Paper 2008/17 EUI 2008) 10Google Scholar, refers to technical standards as ‘privately produced’ when compliance is voluntary. For a distinction between private regulation, co-regulation and ex-post recognized self-regulation see Cafaggi, F, Rethinking Private Regulation in the European Regulatory Space (Working Paper 2006/13 EUI 2006)CrossRefGoogle Scholar. Not surprisingly, as Pereira (n 7) notes, there is no consensus regarding the nature of the Codex. See Kingsbury, B, Krisch, N and Stewart, RB, ‘The Emergence of Global Administrative Law’ (2005) 68 L and Contemporary Problems 15Google Scholar (CC is a hybrid body); A Herwig, ‘Transnational Governance Regimes for Foods Derived from Bio-Technology and their Legitimacy’ in C Joerges, I-J Sand and Gunther Teubner (eds), Transnational Governance and Constitutionalism (Hart Publishing 2004) 199, 204; J Pauwelyn, ‘Non-Traditional Patterns of Global Regulation: Is the WTO ‘Missing the Boat’?’ in Joerges and Petersmann (n 4) 199, 208–215(CC is essentially a public body).

¹⁸ Members can apply for full membership or for correspondent membership, which entitles them to an observer status during the sessions of the Technical Committees.

¹⁹ The mixed membership, the associational model and the voluntary nature of the standards adopted make it possible to consider ISO a hybrid regime, or even a private one. See for instance Clapp, J, ‘The Privatization of Global Environmental Governance: ISO 14000 and the Developing World’ (1998) 4 Global Governance 295Google Scholar, 301 (ISO is a hybrid body); Cafaggi, F, The Architecture of Transnational Private Regulation (EUI Working Paper 2011/12) 9Google Scholar (ISO is a private regulator).

²⁰ For a full account of standardization procedures, see the ISO/IEC Directives ‘Procedures for Technical Works’, available at <http://www.iso.org/directives>.

²¹ Shamir-Borer, E, The Evolution of Administrative Law-Type Principles, Mechanisms and Practices in the International Organization for Standardization (ISO) (Paper NYU Global Hauser Colloquim 2006) 21Google Scholar.

²² For a limited set of matters, typically linked with environmental protection and corporate social responsibility, the procedure has been gradually opened to include other stakeholders, see N Roht-Arriaza, ‘Soft Law’ in a ‘Hybrid’ organization: The International Organization for Standardization’ in D Shelton (ed), Commitment and Compliance: The Role of Non-Binding Norms in the International Legal System (OUP 2000) 265.

²³ See KW Abbott and D Snidal, ‘The Governance Triangle: Regulatory Standards Institution and the Shadow of the State’ in W Mattli and N Woods (eds), The Politis of Global Regulation (Princeton University Press 2009) 44, 63.

²⁴ See Rule V of the Rules of Procedure, (n 11).

²⁵ See ibid, Rule VI.

²⁶ Namely, when the standards incorporate a maximum limit for residues of pesticide or veterinary drugs, see Procedures for the Elaboration (n 12), Part 1, Step 2.

²⁷ See the Principles Concerning the Participation of International Non-Governmental Organizations in the Work of the Codex Alimentarius Commission, available at <http://www.fao.org/DOCREP/005/Y2200E/y2200e09.htm#TopOfPage>. Such principles establish an accreditation procedure, through which organizations having a particular connection with the matters covered by the standards (in terms of expertise, competence, aims or subject-field) can apply for the status of observers. See also the report International Non-governmental Organizations in Observer Status with the Codex Alimentarius Commission, Report by the Secretariat (CAC/30 INF/2), available at <ftp://ftp.fao.org/Codex/CAC/CAC30/if30_02e.pdf>. It must be noted that, according to official reports, industry-related NGOs hugely outnumber consumers' associations, see Pereira (n 7) 1709. See also, on participatory issues in the Codex, T Huller and ML Maier, ‘Fixing the Codex?: Global Food-Safety Governance under Review’ in Joerges and Petersmann (n 4) 267, 271 ff (acknowledging that the large majority of observer NGOs belong to the producers or traders’ community); Livermore (n 4) 783–786.

²⁸ See Henson and Humphrey (n 13) 15. On the ‘mixity’ of the Codex's original purpose see Huller and Maier (n 27) 269: ‘If several potentially conflicting goals are built into the mandate of an individual organization, as in the case of Codex, conceptualizing problem-solving capacity is [a] daunting task.’ See also Buthe (n 3) 223.

²⁹ See the Principles for Food Import and Export Inspection and Certification Cac/Gl 20–1995, adopted by the Codex Alimentarius Commission at its 21^st Session, 1995, available at <http://www.fao.org/docrep/009/y6396e/Y6396E01.htm#ch1>.

³⁰ See Chan, A G, ‘Qs-9000 and Its Legal Implications’ (1999) 64 J of Air L and Commerce 1123, 1147Google Scholar, describing plaintiffs' use of court claims founded on violations of voluntary standards.

³¹ Shamir-Borer, E, The Evolution of Administrative-Law Norms and Mechanisms in the International Organization for Standardization (ISO) (Paper GAL Conference—Viterbo 2006)Google Scholar, see, generally, ISO/IEC Directives (n 20).

³² Industries are encouraged to take part in the decision-making process, see, for instance, de Vries, HJ, ‘Standards for business—How companies benefit from participation in international standards setting’ in International Standardization as a strategic tool (International Electronical Commission 2006) 130Google Scholar.

³³ See the relevant clauses of the ISO Code of Ethics, (2004) <http://www.iso.org/iso/en/aboutiso/ethics/ethics.html>, and the ISO document ‘The Consumer and Standards: Guidance and Principles for Consumer Participation in Standards Development’, available at <http://www.iso.org/iso/standardsandconsumer.pdf>. For an extensive discussion of participatory issues, see Shamir-Borer (n 21); Zúñiga Schroder, H, ‘Definition of the Concept ‘International Standard’ in the TBT Agreement’ (2009) 43 J of World Trade 1223, 1233ffGoogle Scholar; BJ Farquhar, ‘Governance in the International Organization for standardization (ISO) and the International Electrotechnical Commission (IEC)’ in K Dawar (ed), Decision Making in the Global Market: Trade, Standards and the Consumer (Consumers International 2005) 45, 60–62.

³⁴ Winn, JK, ‘Globalization and Standards: the Logic of Two-Level Games’ (2009) 5 I/S: J of L and Policy for the Information Society 185, 210Google Scholar.

³⁵ Krisch, N, ‘The Emerging Global Administrative Law’ (2006) 17 European Journal International Law 265CrossRefGoogle Scholar. See also Baird, S, ‘The Government at the Standards Bazaar’ (2007) 18 Stanford L and Policy Rev 35Google Scholar, arguing for government's non-intervention in the setting of information technology standards.

³⁶ In the case of ISO, where standards are a product on sale, the confusion is further aggravated by marketing strategies: on the ISO website, standards are claimed to pursue a large number of purposes, ranging from quality of the production chain to consumers' health and safety, diffusion of innovations, harmonization of regulations and trade facilitation; see http://www.iso.org/iso/about/discover-iso_what-standards-do.htm.

³⁷ For instance, with respect to the environmental standards enshrined in the ISO 14000 series, it is estimated that self-certification still outnumbers third-party certification, though these standards were drafted with the purpose of being auditable and certifiable: see Wirth, DA, ‘The International Organization for Standardization: Private Voluntary Standards as Swords and Shields’ (2009) 36 Boston College Environmental Affairs L Rev 79, 85Google Scholar. See also Roht-Arriaza, N, ‘Shifting the Point of Regulation: the International Organization for Standardization and Global Lawmaking on Trade and the Environment’ (1995) 22 Ecology LQ 479, 499Google Scholar, describing the monitoring process with respect to the ISO 9000 standards (and how it applies also to the 14000 series), and Chan (n 30) 1132, describing the role of third-party registrars and accreditation bodies in the ISO 9000 compliance assessment procedure.

³⁸ See <www.iso.org/iso/resources/conformity_assessment/mechanisms_for_performing_conformity_assessment.htm>. ISO, however, adopted some guidelines containing the best practices for certifiers (ISO/IEC 17021) and accreditation bodies (ISO/IEC 17011).

³⁹ See Bruno, JC and Pynnonen, BD, ‘Legal Implications of ISO 9000 Under the UCC’ (1996) 75 Michigan Bar J 1076, 1077Google Scholar : ‘… if an ISO 9000 adoption statement is made, ISO 9000 could apply to the sale of the product and may be deemed a part of each supply contract’, as an express warranty.

⁴⁰ To list just a few, see Victor, DG, ‘The Sanitary and Phytosanitary Agreement of the WTO: An Assessment After Five Years’ (2000) 32 New York UJ of Intl L and Politics 865, 892Google Scholar; C Chinkin, ‘Normative Development in the International Legal System’ in D Shelton (ed), Commitment and Compliance: The Role of Non-Binding Norms in the International Legal System (OUP 2000) 21, 31–34; Bevilacqua, D, ‘Il principio di trasparenza come strumento di accountability nella Codex Alimentarius Commission’ (2007) 57 Rivista Trimestrale di Diritto Pubblico 651, 657Google Scholar; Picciotto, S, ‘Rights, Responsibilities and Regulation of International Business’ (2003) 42 Columbia J of Trantl L 131, 141Google Scholar.

⁴¹ See Howse, R, ‘The Sardines Panel and AB Ruling—Some Preliminary Reactions’ (2002) 29 L Issues of Economic Integration 247, 251Google Scholar, noting that since no formal incorporation occurred, panels and the AB do not enjoy an autonomous interpretive power on Codex standards as if they were WTO norms.

⁴² See Preamble and art 2(2) of the TBT. For a commentary on art 2 TBT see L Tamiotti, in R Wolfrum, PT Stoll and A Seibert-Fohr (eds), Technical Barriers and SPS Measures—Commentary (Martinus Nijhoff 2007) 210–234. The Preamble also mentions other interests (product quality, health, environment). For some remarks on the ‘double telos’ of the TBT, a concept that fits our purpose-shift discourse, see Du, MM, ‘Domestic Regulatory Autonomy under the TBT Agreement: From Non-discrimination to Harmonization’ (2007) 6 Chinese J of Intl L 269, 272Google Scholar.

⁴³ The full text reads: ‘Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfillment of the legitimate objectives pursued, for instance because of fundamental climatic or geographical factors or fundamental technological problems.’

⁴⁴ Reading, in the relevant part: ‘Whenever a technical regulation is prepared, adopted or applied for one of the legitimate objectives explicitly mentioned in paragraph 2 [national security requirements; the prevention of deceptive practices; protection of human health or safety, animal or plant life or health, or the environment] and is in accordance with relevant international standards, it shall be rebuttably presumed not to create an unnecessary obstacle to international trade.’

⁴⁵ Annex 1 to the TBT defines a technical regulation as a ‘document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marketing or labeling requirements as they apply to a product, production or processing method.’

⁴⁶ The illustrative list of art 2(4) TBT does not seem to leave much room for such justifications of deviation, as it refers to cases where the standards are not efficient ‘because of fundamental climatic or geographical factors or fundamental technological problems’.

⁴⁷ See the Preamble to the Agreement: ‘no country should be prevented from taking measures necessary to ensure the quality of its exports, or for the protection of human, animal or plant life or health, of the environment … at the levels it considers appropriate’.

⁴⁸ The onus of proof, indeed, rests with the complainant, see European Communities—Trade Description of Sardines (‘Sardines’), WT/DS231/AB/R, Appellate Body Report adopted 23 October 2002, DSR 2002:VIII, 3359, paras 274–275.

⁴⁹ Art 2(1) TBT. This requirement is covered by the (rebuttable) presumption of art 2(5) TBT.

⁵⁰ Art 2(2) TBT. This requirement being outside the scope of art 2(5) TBT, it is in principle possible to challenge on grounds of discrimination a measure adopted in accordance with a relevant international standards.

⁵¹ The issue is extensively discussed in Howse (n 41, n 4), J Pauwelyn, ‘Human Rights in WTO Dispute Settlement’ in T Cottier, J Pauwelyn and E Burgi (eds), Human Rights and International Trade (OUP 2005) 205; Pauwelyn (n 17) and Wolfrum, Stoll and Seibert-Fohr (n 42). The relevant AB reports are EC Measures Concerning Meat and Meat Products (‘Hormones’), WT/DS26/AB/R, WT/DS48/AB/R, Appellate Body Report adopted 13 February 1998, DSR 1998:III, 1033, see para 163 (stating that it is sufficient that a SPS measure is ‘founded’ or ‘built upon’ or ‘supported by’ the international standard) and Sardines (n 48), see para 245 (requiring that the international standard is the ‘principal constituent’, ‘determining principle’ or ‘fundamental principle’ of the TBT measure). At first glance, the ‘very close and very strong relationship’ deemed by Sardines (n 48) to meet the ‘based on’ criterion leaves little space for a more stringent requirement of ‘in accordance with’ under art 2(5) TBT, somehow conflating the two requirements. This result was correctly avoided in Hormones, where art 3(1) and art 3(2) SPS were interpreted by giving careful consideration to the difference between measures ‘based on’ and ‘conforming to’ relevant standards (see AB report, para 163).

⁵² The full definition contained in annex 1 to the TBT reads: ‘document approved by a recognized body that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marketing or labeling requirements as they apply to a product, process or production method’.

⁵³ The TBT agreement relies on ISO/IEC Guide 2:2004 for guidance, defining a standardizing body as a ‘body that has recognized activities in standardization’. However, this definition is too indeterminate to be of actual help.

⁵⁴ Decisions and Recommendations Adopted by the Committee since 1 January 1995, WTO Committee on Technical Barriers to Trade, G/ TBT/1/Rev 8, 23 May 2002.

⁵⁵ This is somewhat at odds with the very role of standards in the TBT framework, which is exactly to provide a sound justification for unilateral market distortion practices (a presumption of legality for domestic policies inconsistent with WTO policies). See Howse, R, A New Device for Creating International Legal Normativity: the WTO Technical Barriers to Trade Agreement and “International Standards (draft Paper IILJ Global Administrative Law Series 2004 available at <http://www.iilj.org/GAL/documents/HowsePaper.pdf>) 13Google Scholar.

⁵⁶ Annex 3 to the TBT: Code of Good Practice for the Preparation, Adoption and Application of Standards. A similar document is the non-binding Annex 4 of the TBT Committee's Second Triennial Review (2000), which also argues for a more inclusive process of decision-making, in which the largest range of interests should have representation.

⁵⁷ Other recommendations that similarly aim at building consistence within the standard multi-layered regimes are the duties to cooperate with international standardizing organizations, to avoid standard duplication, and to adopt performance-oriented standards: see the Code of Good Practice, General Provisions G, H and I.

⁵⁸ Zúñiga Schroder (n 33) 1226–1227, examines other GATT and WTO documents of an informal nature, including an Annex to the Second TBT Triennial Review, in which other organizations are listed, such as the World Health Organization, the International Organization of Legal Metrology and the Organization for Economic Co-operation and Development. This suggests that, at least in the TBT framework, the list of relevant bodies is open to expansion.

⁵⁹ ISO's position in certain areas can be effectively described by referring to the archetypical model of the ‘monopolist private regulator’, see Cafaggi (n 17) 41.

⁶⁰ Considerations of regulatory dominance and credibility were also decisive in the choice of Codex, OIE and IPPC under the SPS, see Zúñiga Schroder (n 33) 1225, fn 7, referring to the preparatory works of the SPS text.

⁶¹ For a full account of the ‘strategic partnership’ established between the WTO and ISO, see the ISO/IEC information sheet: ‘WTO, ISO, IEC and World Trade’, available at <http://www.standardsinfo.net/info/livelink/fetch/2000/148478/6301438/inttrade.html>.

⁶² As well as with the SPS Committee and the Committee on Trade and Environment (CTE).

⁶³ See provisions C, J and K of annex 3 to the TBT.

⁶⁴ In the case of the Codex, its definition as ‘recognized body’ under the TBT is not controversial, since it is expressly recognized in the SPS Agreement: see below. However, the AB makes clear that not all Codex standards are automatically relevant under art 2(4) TBT, and that a case by case assessment is necessary.

⁶⁵ Council Regulation No 2136/89 of 21 June 1989 laying down common marketing standards for preserved sardines, OJ 1989 L 212.

⁶⁶ Codex Alimentarius Commission, Codex Standard for Canned Sardines and Sardine-Type Products (Codex Stan 94–1981), art 2(1). EC regulation allowed the use of the word ‘sardines’ only for the species Sardina pichardus, whereas the Codex standard permitted other species such as the Sardina sagax to be called ‘sardines’ as well (subject to the attachment of an origin prefix, such as ‘Pacific sardines’).

⁶⁷ See Sardines, AB Report (n 48), para 225. See also EC Measures Concerning Meat and Meat Products (‘Hormones panel’), Panel Report adopted 18 August 1997, WT/DS26/R /USA 1998:III, 699, para 8.69.

⁶⁸ In only a few disputes TBT matters were litigated, and sometimes the TBT part of the claim was disregarded by the panel. As of October 2011, only a handful of cases are to be mentioned. A case similar to Sardines was EC—Scallops. However, the parties settled the dispute, thus the panel report remained unadopted see European Communities—Trade Description of Scallops—Request by Canada, WT/DS7/R, 5 August 1996, unadopted, DSR 1996:I, 89; WTO Panel Report, European Communities—Trade Description of Scallops—Requests by Peru and Chile, WT/DS12/R, WT/DS14/R, 5 August 1996, unadopted, DSR 1996:I, 93. In EC—Asbestos the panel considered complaints under GATT and overlooked the TBT claims. See WTO Panel Report, European Communities—Measures Affecting Asbestos and Asbestos-Containing Products, WT/DS135/R and Add.1, adopted 5 April 2001, modified by Appellate Body Report, WT/DS135/AB/R, DSR 2001:VIII, 3305. On 2 September 2011 a panel report was circulated, regarding the dispute United States—Measures Affecting the Production and Sale of Clove Cigarettes WT/DS406/R. Although TBT-related claims are central and in particular art 2(5) TBT is discussed at length, the case did not hinge upon the role of international standards. See para 7.458, and footnote 813: ‘In response to a question from the Panel, both parties agreed that there is no relevant “international standard” within the meaning of the second sentence of Article 2.5 of the TBT Agreement.’ It is possible to monitor the status of TBT-related disputes at <http://www.wto.org/english/tratop_e/dispu_e/dispu_agreements_index_e.htm?id=A22#selected_agreement>.

⁶⁹ See art 2(2) SPS: ‘Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence.’ The risk assessment requirement (art 5(1) SPS) is the main pillar of the scientific basis for a SPS measure.

⁷⁰ Art 2(3) SPS.

⁷¹ Art 5(4) and 5(6) SPS.

⁷² Art 3(3) SPS.

⁷³ Art 5(5) SPS. Whereas there is no obligation to ensure internal regulatory consistency (States are free to regulate similar risks differently), States are encouraged to adopt homogeneous measures, and are not allowed to use their right to set a higher level of protection in order to implement unjustified discriminations or disguised restrictions, see Hormones (n 51) para 213. On these consistency requirements, see also the Appellate Body Report, Australia —Measures Affecting Importation of Salmon (Australia–Salmon), WT/DS18/AB/R, adopted 6 November 1998, DSR 1998:VIII, 3327, para 178.

⁷⁴ See art 3(1), reading in the relevant part: ‘Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist’.

⁷⁵ See annex A to the SPS Agreement, art 3. The IOE and the IPPC are, respectively, the reference bodies for animal health and plant protection. Art 3(d) is an open clause, stating that for matters not covered by the Codex, the IOE and the IPPC, a TBT-like method applies, and States can rely on standards developed by international organizations whose membership is open to all WTO members. This explicit reference can be read as an ‘ex post recognition of [the] ‘public functions’ [of these bodies] which extends the scope of legal effect to third parties,’ see Cafaggi (n 17) 29. For recent qualification of the Codex Commission as a ‘relevant international organization’ see United States–Continued Suspension of Obligations in the EC–Hormones Dispute, WT/DS320/R, Panel Report adopted 31 March 2008, para 7.446.

⁷⁶ In fact, this presumption is wider, since art 2(5) TBT, as seen above, provides for an expressly rebuttable presumption, and only with respect to the requirement of no unnecessary trade restrictiveness.

⁷⁷ Under which regulations stricter than those based on standards are permitted ‘if there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a Member determines to be appropriate’.

⁷⁸ The Parties added a footnote to art 3(3) SPS to clarify the meaning of scientific justification, which reads: ‘there is a scientific justification if, on the basis of an examination and evaluation of available scientific information in conformity with the relevant provisions of this Agreement, a Member determines that the relevant international standards, guidelines or recommendations are not sufficient to achieve its appropriate level of sanitary or phytosanitary protection’.

⁷⁹ This specification has a central role in the allocation of the onus probandi regarding the violation of trade rules. Whereas the Panel had found that art 3(3) SPS works as an exception (see Hormones panel (n 67), paras 8.51 to 8.54), in fact, the AB ruled instead that it rests with the complainant, alleging a violation of art 3(3) SPS, to show at least a prima facie lack of scientific basis for the challenged measure. In other words, deviation from the standards ‘is not penalized’ with a shift of the burden of proof on the defendant. See the AB report in Hormones (n 51) para 171 and Sardines (n 48). This is consistent with the above remark that deviation from the standards does not trigger a presumption of illegality, in which case the defendant should have the burden of rebutting the presumption. On the difference between this doctrine and the one adopted with respect to the exceptional rules of art XX GATT and the Enabling Clause, see Matsushita, M, ‘Human Health Issues in Major WTO Dispute Cases’ (2009) 4 Asian Journal of WTO and International Health Law and Policy, 1Google Scholar. See Howse (n 4) 388, as regards the similar provision of art 2(4) TBT.

⁸⁰ Guzman, A, ‘Global Governance and the WTO’ (2004) 45 Harvard Intl LJ 303Google Scholar.

⁸¹ Ruggie, JG, ‘International Regimes, Transactions, and Change: Embedded Liberalism in the Postwar Economic Order’ (1982) 36 Intl Organization 379, 398CrossRefGoogle Scholar.

⁸² Ming Du, M, ‘Domestic Regulatory Autonomy under the TBT Agreement: From Non-discrimination to Harmonization’ (2007) 6 Chinese J of Intl L 269, 272Google Scholar.

⁸³ Cassese, S, Shrimps, Turtles and Procedure: Global Standards for National Administrations (Working Paper 2004/4 IILJ Global Administrative Law Series 2004)Google Scholar : ‘[standards] do not create direct, legally binding obligations upon the States.’ See also Hormones AB Report (n 51) para 165.

⁸⁴ Reich, A, ‘The WTO as a Law-Harmonizing Institution’ (2004) 25 U of Pennsylvania J of Intl Economic L 362Google Scholar. For an accurate account of the concept of negative integration and its application in economic communities, see Ortino, F, Basic Legal Instruments for the Liberalisation of Trade: a Comparative Analysis of EC and WTO Law (Hart Publishing 2004)Google Scholar 18 and bibliography referred to therein, in particular FW Scharpf, ‘Negative and Positive Integration in the Political Economy of European Welfare States’ in G Marks, FW Scharpf, PC Schmitter and W Streeck (eds), Governance in the European Union (SAGE 1996) 15.

⁸⁵ In other words, the WTO does not try to bring about regulatory convergence. It is disinterested in national policies, as long as they do not affect international trade, and whenever they do, it just makes sure that the least restriction to trade is provoked. PC Mavroidis Market Access in the GATT (Research Paper 7/2008 STALS 2008 available at <http://www.stals.sssup.it/site/files/stals_Mavroidis.pdf>) 7: ‘national policies are being unilaterally defined and, to the extent that there is an international spillover, it will be internalized through nondiscrimination. … Trade will not harmonize societal preferences. Trade is not the overarching value in the WTO contract. Trade comes after respect of regulatory diversity.’ On mutual recognition, harmonization and regulatory authority, see JP Trachtman, ‘Regulatory Jurisdiction and the WTO’ in WJ Davey and JH Jackson (eds), The Future of International Economic Law (OUP 2008) 193.

⁸⁶ This species of harmonization is purported to be the one that negotiators of the SPS had in mind: see Buthe (n 3) 242: ‘International harmonization would force countries with stringent standards to justify those standards, providing opportunities for agricultural exporters to expose and potentially block protectionist measures.’

⁸⁷ For a definition of the ‘terms of trade’ expression see the Deardoff's Glossary of International Economics, available at <http://www-personal.umich.edu/~alandear/glossary>: ‘1. The relative price, on world markets, of a country's exports compared to its imports.’

⁸⁸ An accurate description and distinction of these two trade-policy goals is contained in Regan, DH, ‘What Are Trade Agreements for?—Two Conflicting Stories Told by Economists, with a Lesson for Lawyers’ (2006) 9 J of Intl Economic L 951CrossRefGoogle Scholar.

⁸⁹ Staiger, RW and Sykes, AO, International Trade and Domestic Regulation (Working Paper 15541 NBER 2009) 19–22CrossRefGoogle Scholar.

⁹⁰ For instance, governments pursue terms-of-trade purposes when they try to safeguard exporters' revenues at the expense of global efficiency.

⁹¹ Staiger and Sykes (n 89) 29; Trachtman (n 85) 195; G Marceau and JP Trachtman, ‘Responding to national concerns’ in D Bethlehem and others (eds), Oxford Handbook of International Trade Law (OUP 2009) 209, 235.

⁹² Hudec, RE, ‘Science and Post-Discriminatory WTO Law’ (2003) 26 Boston College Intl and Comparative L Rev 185, 187Google Scholar.

⁹³ Note that according to DH Regan (n 88) 980–981, SPS and TBT's requirements for efficient standards (and trade agreements in general) are aimed only at preventing protectionism, and are not designed to exorcise terms-of-trade manipulation, a goal that is rarely used as an actual regulatory purpose by State authorities. However, this conclusion is in consequence of Regan's persuasion (at 986–988) that the SPS and TBT are solely concerned with hidden protectionist measures and should not be used to strike down merely inefficient or unnecessarily restrictive measures, to the point of doubting ‘whether the substantive provisions of the SPS and TBT Agreements—about the use of international standards, and risk assessment, and the avoidance of unnecessarily trade-restrictive measures—are a good thing.’

⁹⁴ See PC Mavroidis, ‘Come together?: Producer Welfare, Consumer Welfare and WTO Rules’ in EU Petersmann (ed), Reforming the world trading system: legitimacy, efficiency and democratic governance (OUP 2005) 277, 285; Buthe (n 3) 246, stressing that resort to standards was a device through which SPS negotiators intended to simplify the scientific review of national measures, avoiding costly case by case risk assessment procedures.

⁹⁵ See US—Hormones suspension, panel report (n 75), para 7.644: ‘standards, guidelines or recommendations … are based on risk assessments that meet the requirements of the SPS Agreement. This means, therefore, that there was sufficient evidence for [the standard-setting body] to undertake the appropriate risk assessments’.

⁹⁶ Marceau, G and Trachtman, JP, ‘The Technical Barriers to Trade Agreement, the Sanitary and Phytosanitary Measures Agreement and the General Agreement on Tariffs and Trade’ (2002) 36 J of World Trade 811, 838CrossRefGoogle Scholar; Buthe (n 3).

⁹⁷ Pereira (n 7) 1704.

⁹⁸ Allegedly, Japan lowered its domestic pesticide standards which provided greater public health protection than was required by Codex standards, in order to prevent WTO litigation with New Zealand or the US, see Wallach, LM, ‘Accountable Governance in the Era of Globalization: The WTO, Nafta, and International Harmonization of Standards’ (2002) 50 U of Kansas L Rev 823, 838Google Scholar; Naiki, Y, ‘Accountability and Legitimacy in Global Health and Safety Governance: The World Trade Organization, the SPS Committee and International Standard setting Organizations’ (2009) 43 J of World Trade 1255, 1276Google Scholar; Victor (n 40) 879. See Hormones AB Report (n 51) para 177.

⁹⁹ Pauwelyn (n 17) 213 succinctly phrases this interpretation as: ‘the incentive to harmonize is limited to the safe-haven offered by conforming to the standard.’ Note that the Panel, when analyzing the structure of art 2 TBT and 3 SPS, excluded the possibility that departure from a standard could be construed as an exception: ‘the Appellate Body found no general rule-exception relationship even though the word ‘except’ was used in both Article 3.1 of the SPS Agreement and Article 2.4 of the TBT Agreement.’ See EC—Tariff Preferences, report of 1 December 2003, WT/DS246/R, fn 452.

¹⁰⁰ Namely, art 5(1) and 3(3) SPS.

¹⁰¹ See Hormones (n 51) paras 208–209.

¹⁰² See Buthe (n 3) 228: ‘the freedom to adopt more stringent standards is subject to more, not fewer constraints.’

¹⁰³ See Wouters, J, Marx, A and Hachez, N, Private Standards, Global Governance and Transatlantic Cooperation, the Case of Global Food Safety Governance (Working Paper Leuven Centre for Global Governance Studies 2009) 14–15Google Scholar : ‘Any food safety regulation which is more lenient than a Codex Alimentarius Standard does not violate the SPS Agreement.’ See also Kalderimis, D, ‘Problems of WTO Harmonization and the Virtues of Shields Over Swords’ (2004) 13 Minnesota J of Global Trade 305, 337–341Google Scholar : ‘SPS and TBT Agreements … do not prescribe any essential requirements because they do not promote any non-trade values. The WTO does not provide minimum standards of health protection, or specify minimum levels of technical regulations’. See also Wirth (n 37) 95. Contra, arguing that the obligation not to deviate from standards is enforceable also in case of looser regulations, see Howse (n 4) 395. See also Hormones (n 51) para 165, noting that it would be excessive to assume that SPS signatories intended to vest more stringent voluntary international standards with obligatory force and that, under the in dubio pro mitius general principle of international law, States should be allowed to maintain their ‘less burdensome’ obligations. The AB refers to ‘sovereign states’ as a whole, failing to grasp the core of the issue: technical requirements that are burdensome for some States (exporters) might be beneficial for others (importers). The AB's remark, thus, should be read in the sense that exporters could not deliberately give up the voluntary nature of international standards, to their own detriment.

¹⁰⁴ Wouters, Marx and Hachez (n 103) 15 notes that SPS uses the standards as ‘upper limits’. Likewise, Landwehr in Wolfrum, Soll and Seibert-Fohr (n 42) 414: ‘the [SPS] Agreement has effectively changed the nature of these standards: while the standards were originally developed as minimum standards, they are now used in dispute settlement proceedings as ceilings which—in principle—have to be observed.’ Similarly, Wirth (n 37) 96.

¹⁰⁵ Curiously, the ISO itself, on its website, refers to the ‘floor’ concept of common standards, even precisely in connection with their trade function: ‘International Standards create ‘a level playing field’ for all competitors on those markets. The existence of divergent national or regional standards can create technical barriers to trade.’ On Codex standards as minimum quality standards, see Livermore (n 4) 768, 771.

¹⁰⁶ Pauwelyn (n 17) 213ff raises the question whether TBT and SPS could be used to ratchet-up national policies or solely to use international standards as a ceiling. His accurate reading of the TBT and SPS provisions seems to leave space for the ‘upward harmonizing’ view: since members ‘shall’ use standards as a basis for regulations (art 2(4) TBT and 3(1) SPS), it would seem that there is an actual WTO obligation not to pierce the floor of standard protection by adopting looser regulations. Even though it could be formally true, some normative elements and a factual consideration virtually make this reading unlikely, or irrelevant. First, as Pauwelyn concedes, looser domestic regulations would hardly meet the requirements of art 1(1) SPS (the Agreement applies only to measures that are likely to affect international trade), and the TBT repeatedly links the function of standards with the risk of trade distortion (implicitly ignoring their supposed relevance as minimum protection floor), in the preamble and in art 2(1), 2(2), 2(4), 2(5), 2(9). Moreover, more pragmatically, it is highly unlikely that a member would challenges a domestic regulation of another member imposing looser standards, as this measure could not (negatively) affect its interests (as an exporter); as Pauwelyn states: ‘The odd result of this is that the WTO would then essentially grant a request to restrict trade more (that is, ask the defendant to impose stricter SPS measures).’ Likewise Victor (n 40) 883–884 acknowledges that in the SPS looser national regulations may still be challenged, but not so much in that they deviate from standards, but only under art 5 tests (risk assessment and scientific justification). For instance, low-protection national regulations may prove burdensome just because they were only adopted in one country, making it relatively expensive for companies to adapt their activity just to gain access on that market. In any event, Victor concedes that the hypothesis is unlikely, ‘because demonstrating the existence of a trade effect from weak SPS measures is difficult and bringing disputes is costly’.

¹⁰⁷ VCLT (n 9), art 31(1).

¹⁰⁸ See Howse (n 4) 387.

¹⁰⁹ See Hormones (n 51) para 171, emphasis added.

¹¹⁰ Reading, in the relevant part: ‘Members shall ensure that technical regulations are not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. For this purpose, technical regulations shall not be more trade-restrictive than necessary to fulfill a legitimate objective, taking account of the risks non-fulfillment would create.’

¹¹¹ This burden is additional to the one typically reserved to complainants, that is, proving the existence of trade impairment subsequent to the adoption of the challenged measure.

¹¹² This hypothesis must nevertheless be taken into account, at least to maintain a distinction between the two benefits granted by art 3(2) SPS. On one hand, the necessity requirement is irrefutably satisfied (‘shall be deemed to be necessary’), on the other hand, every other provision of the SPS and the GATT is simply ‘presumed’ to be complied with.

¹¹³ See Howse (n 4) 388–389.

¹¹⁴ To the contrary, if any importance were attached to the dynamics of the burden of proof in the treatment of standards, it would be clear that the hardest task is assigned to States that want to ‘surpass’ the standards: they have to prove the standards' inefficiency and inappropriateness.

¹¹⁵ To date, only five disputes hinging upon the application of the SPS have been brought before the panels and the AB: EC—Measures Concerning Meat and Meat Products, Panel Report WT/DS26/R/USA adopted 18 August 1997; AB Report WT/DS26/AB/R adopted 16 January 1998. Australia—Measures Affecting Importation of Salmon, Panel Report WT/DS18/R adopted 12 June 1998; Appellate Body Report WT/DS18/AB/R adopted 20 October 1998. Japan—Measures Affecting Agricultural Products (Apples), Panel Report WT/DS76/R adopted 27 October 1998; Appellate Body Report WT/DS76/AB/R adopted 22 February 1999. Japan—Measures Affecting the Importation of Apples, Panel Report WT/DS245/R adopted 15 July 2003; Appellate Body Report WT/DS245/AB/R adopted 26 November 2003. For a full description of this case law, see Matsushita (n 79). Other disputes were filed relating to SPS provisions without triggering the adoption of a panel report, see WT/DS3 Korea—Measures Concerning the Testing and Inspection of Agricultural Products; WT/DS144, United States—Certain Measures Affecting the Import of Cattle, Swine and Grain from Canada and WT/DS100, United States—Measures Affecting Imports of Poultry Products. The GMO disputes against the EC (WT/DS291, 292 & 293, European Communities—Measures Affecting the Approval and Marketing of Biotech Products) were not appealed before the AB. In 2010, SPS norms were discussed by the panel in US—Certain Measures Affecting Imports of Poultry from China Panel Report WT/DS392/R adopted 29 September 2010, but the dispute did not touch upon relevant international standards. Similarly, in the New Zealand Apples dispute art 3 SPS was not invoked nor applied (see Australia—Measures Affecting the Importation of Apples from New Zealand, Panel Report WT/DS367/R adopted 9 August 2010; Appellate Body Report WT/DS367/AB/R adopted 29 November 2010). As for TBT-cases, see cases above (n 69).

¹¹⁶ See the data provided in Naiki (n 98) 1265–1266. In fact, in the case of TBT, China is also a frequent target of trade concerns, presumably due to the difficulty of exporters to adapt their business to new China-specific registration or verification requirements, quite apart from their stringency. As for SPS trade concerns, see the data available in Epps, T, International Trade and Health Protection (Elgar Northampton 2008) 32–33CrossRefGoogle Scholar, and Zahrnt, V ‘Transparency of complex regulation: how should WTO trade policy reviews deal with sanitary and phytosanitary policies? (2010) World Trade Rev—FirstView 13Google Scholar: ‘What [exporters] target is poor risk assessment, overly trade-restrictive measures, and levels of protection that are well above the implementing country's average level as well as above international standards.’

¹¹⁷ A study of the negotiation process leading to the adoption of the SPS (Buthe (n 3) 239–241) seems to confirm that the only rationale for the proposals to take into account international standards was that of ‘minimizing the adverse effects that [safety] regulations and barriers can have on trade’. Excerpt from WTO, Ministerial Declaration of 20 September 1986, MIN(86(/W/19, 25 ILM 1623, 1626 (1986). See also the dictum of the panel in US Poultry (n 115) para 5.75: ‘it is clear that an SPS measure can only be introduced provided that it is based on international standards, guidelines and recommendations where they exist … This is to ensure that measures are not taken arbitrarily and are not used as a tool for manipulating international trade.’ (emphasis added)

¹¹⁸ See supra, nn (102 to 104 and 106) for a sample of the available studies on this point. However, these sparse remarks have not been used against the ‘hardening’ narrative, as this article seeks to do.

¹¹⁹ Scott, J, The WTO Agreement on Sanitary and Phytosanitary Measures (OUP 2007) 261–266Google Scholar.

¹²⁰ ibid 262.

¹²¹ ibid 263.

¹²² See Hormones (n 51) para 165, and the analysis supra (n 103).

¹²³ Scott (n 119) 264.

¹²⁴ ibid 265–266. These conclusions are replicated and agreed upon in L Gruszczynski, Regulating Health and Environmental Risks under WTO Law (OUP 2010) 102–104. On the flexibility devices of TBT and SPS designed to accommodate developing countries’ needs see Mayeda, G, ‘Developing Disharmony? The SPS and TBT Agreements and the Impact of Harmonization on Developing Countries’ (2004) 7 J of Intl Economic L 737, 746ffGoogle Scholar.

¹²⁵ See Hormones (n 51) para 163.

¹²⁶ See Sardines (n 48) para 248.

¹²⁷ See Charnovitz, S, ‘The Supervision of Health and Biosafety Regulation by World Trade Rules’ (2000) 13 Tulane Environmental LJ 271, 287Google Scholar, noting that looser regulations would not be illegal for the very fact that they deviate in peius from standards, since they would still be expected to meet the other requirements (scientific justification, non-discrimination, least-restrictiveness). We just note that not only is compliance with such requirements easier to achieve in the case of less stringent regulations (with the only possible exception of the alignment obligation under art 5(5) SPS), but—primarily—it seems unlikely that such regulations are ever challenged by foreign exporting countries, if only in that they could hardly entail any detrimental trade effect.

¹²⁸ Compliance with the measure, instead, might result in a deviation from the Codex standards, but their voluntary nature would imply little consequence in case of violation, at least outside the Codex regime.

¹²⁹ See, for instance, the table of cases and complaints included in the Fifteenth Annual Review of the Implementation and Operation of the TBT Agreement, prepared by the TBT Committee and published on 5 February 2010, document No G/TBT/28, and the detailed ‘trade concerns’ raised at the June and November 2009 sessions by the Member States (see the respective Minutes of each session in documents G/TBT/M/48 of 29 September 2009 and G/TBT/M/49 of 22 December 2009). The only concerns which do not squarely deal with the stringency of the standards deal with their unreasonableness. For instance, the EC expressed some concern on the possibility that Brazil introduced a verification procedure on imported health products based on requirements other than those already included in an ISO standard. The EC insists that these procedures be based on the ISO standards (see the Minutes of the November meeting, para 142) not so much because they are more lenient (in fact, it does not transpire that they are) but because, by their very divergence from the standards, they are unreasonably burdensome.

Likewise, in the SPS framework, concerns reflect the awareness that standards are likely to be used to foster trade more than health concerns. See, for instance, the debate about the possible adoption of a Codex standard setting the maximum residue of ractopamine in pork and swine feed. It is significant that those who push for the adoption of the Codex standard are indeed the States willing to market meat administered with ractopamine, whereas the EC and China, who had concerns about the harmfulness of this substance, appear reluctant to accelerate the standard-setting activity. Under a very candid cost-benefit perspective, it transpires that it is preferable for States that are relatively more concerned with health protection not to have the standard at all, than to have it used in the SPS system as an anti-regulation device enforceable by the DSB (see Summary of the Meeting of the SPS Committee of 28–29 October 2009, document G/SPS/R/56 of 28 January 2010, particularly paras 141ff.

¹³⁰ See the Minutes of the June 2009 meeting of the TBT Committee (n 129), particularly para 326. On the issue of private regulation regimes and the WTO, see Bernstein, S and Hannah, E, ‘Non-State Global Standard Setting and The WTO: Legitimacy and the Need for Regulatory Space’ (2008) 11 J of Intl Economic L 575CrossRefGoogle Scholar; Vogel (n 17) 264–265.

¹³¹ These measures would be challengeable under SPS and TBT to the extent that it is relatively easier for the complainant to show that, whatever the interest they are alleged to protect, less restrictive alternative measures are available. In this extreme case, however, it would be less a matter of protection than of mere unreasonableness and inefficiency of the policy adopted.

¹³² See Codex General Principles, ‘Purpose of the Codex Alimentarius,’ available at <http://www.fao.org/DOCREP/005/Y2200E/y2200e05.htm#bm05>. See the statement of WTO Director-General Pascal Lamy: ‘[the SPS Agreement] was not primarily conceived with consumers in mind.’ Address at the Assembly of Consumers Associations in Europe Conference (18–19 November 1999), available at <http://ec.europa.eu/dgs/health_consumer/library/speeches/speech25_en.html>.

¹³³ See <http://www.iso.org/iso/about/discovers-iso_who-standards-benefits.htm>.

¹³⁴ United Nations General Assembly Resolution A/RES/39/248 of 16 April 1985, mentioned in Henson and Humphrey (n 13) 23, emphasis added.

¹³⁵ Wouters, Marx and Hachez (n 103) 14. See the remarks expressed above about the ambiguity of the SPS Preamble.

¹³⁶ In the TBT and SPS, national technical regulations are treated as NTB (non-tariff barriers), and can be reviewed to prevent national practices of ‘regulatory protectionism’. See Buthe (n 3) 222; Sykes, AO, ‘Regulatory Protectionism and the Law of International Trade’ (1999) 66 U of Chicago L Rev 1CrossRefGoogle Scholar.

¹³⁷ The possibility that legal elements are transformed when they are used in a different regime is a classic example of interplay between legal orders, see for instance how Romano, Santi, L'ordinamento giuridico (Sansoni Firenze 1946)Google Scholar n 96bis described the possible ways in which one legal order (or part thereof) can be relevant to another legal order: ‘[i]t can disregard or refuse another order's existence; it can take another order into consideration, but providing it with a different nature than the one this latter would attribute to itself. Likewise, a legal order can equate another legal order to a mere fact, ignoring his legal nature, or acknowledge it as a legal system, but only to a certain extent and to certain effects, perhaps subject to the conditions that it deems opportune to impose’ (emphasis added). Note that the use of standards as facts (ie, as static units of measurement) has little to do with the well known issue of the proof of foreign law (regarding the difficulties arising when the law of one order has to be proved and applied before a court of another legal system), which is generally summarized with the maxim that the proof of foreign law is proof of fact (see, for instance, Miller, A, ‘Federal Rule 44.1 and the ‘Fact’ Approach to Determining Foreign Law: Death Knell for Die-Hard Doctrine’ (1967) 65 Michigan L Rev 613)CrossRefGoogle Scholar.

¹³⁸ Shamir-Borer (n 31) 23.

¹³⁹ Pauwelyn (n 51) 226: ‘knowing that standards are no longer voluntary but at least partially enforceable at the WTO, countries may be wary to issue new standards’. See Victor (n 40) 931: ‘the agenda and standards in the Codex are determined heavily by the SPS policies in the advanced industrialized countries’.

¹⁴⁰ S Maljean-Dubois and É Etchelar, ‘World Trade and International Normalisations: Codex Alimentarius’ in K Byttebier and K Van der Borght (eds), WTO Obligations and Opportunities: Challenges of Implementation (Cameron May London 2007) 121, 141: ‘By making the Codex adopt its point of view, a state of a group of states is (almost) totally sheltered from being sanctioned by the WTO’.

¹⁴¹ See Sardines (n 48) 275.

¹⁴² As for standards in the TBT, it is significant to note how the Russian-doll-like inextricable definition of standards betrays to some extent this shift (from common good to trade). Whereas the Agreement in itself is consistent in referring to standards as an element of trade facilitation, compare the text of a footnote with the definition of standards contained in the ISO/IEC Guide 2:2004 referred to by annex 1.2 to the TBT, whose definitions are, in turn, recalled by art 1(2) TBT: ‘Standards should be based on the consolidated results of science, technology and experience, and aimed at the promotion of optimum community benefits’ (emphasis added). In relation to the implementation of Codex standards, see Henson and Humphrey (n 13) 5, stressing that the implementation of standards is not compliance by firms, but rather adoption by States: ‘Codex does not implement or assess conformity with the international standards, guidelines and recommendations it develops. Rather, implementation is dependent on adoption by Codex members, in whole or in part and formally or informally, and/or incorporation into the standards of other bodies, including private standards setters.’

¹⁴³ Pereira (n 7) 1703.

¹⁴⁴ See the wording of the SPS Committee decision revising the monitoring procedure established in 1997 (G/SPS/11/Rev.1 of 15 November 2004): ‘5. The international standards, guidelines or recommendations proposed by a Member to be monitored … should be limited to those which have a major trade impact. The trade impact of an international standard, guideline or recommendation should be determined primarily on the basis of the extent to which Members use the standard (apply it to imports) and the frequency or severity of problems experienced in the trade of the goods covered by the standard’. See Joint FAO/WHO Food Standard Programme Codex Alimentarius Commission, Thirtieth Session Rome, Italy, 2–7 July 2007, Activities of the SPS Committee and Other Relevant WTO Activities from 2006 to the Present, Report by the WTO Secretariat: ‘Monitoring the Use of International Standards 12. The procedure adopted by the SPS Committee to monitor the use of international standards invites countries to identify specific trade problems they have experienced due to the use or non-use of relevant international standards, guidelines or recommendations’ (available at <ftp://ftp.fao.org/codex/CAC/CAC30/if30_05e.pdf>). See Naiki (n 98) 1274, noting that the procedure is not used substantively, and targets only standards with a major trade impact.

¹⁴⁵ Under DSU art 21(5).

¹⁴⁶ See the Arbor Drugs case (Baker v Arbor Drugs, Inc., 544 NW2d 727, 731; (Mich Ct App) 1996) described in Chan (n 30) 1147–1148: ‘[the] defendant voluntarily assumed a duty of care when it implemented [a ISO 9000 certified software system for the management of drug prescriptions] and then advertised that this system would detect harmful drug interactions for its customers’ (emphasis added). This example is particularly significant because it displays how ISO standards can be interpreted before a non-WTO court, and serve as foundation of a due diligence defence that has nothing to do with the presumption of WTO-compliance provided in the TBT Agreement. ibid 1153–1160, see how additional self-failure assessment requirements (Failure Mode and Effects Analysis) enshrined in the QS 9000 standards for designers and manufacturers (the US version of ISO 9000) could end by substantiating plaintiffs’ claims for product liability: ‘FMEAs inherently provide all the basic ammunition to a plaintiff to establish a design [or manufacturing] defect, [or a] a marketing defect or failure to warn.’ See also Bruno and Pynnonen (n 39) 1080: ‘Even if ISO 9000 adoption statements are not interpreted to give rise to independent obligations, they may be sufficient under the UCC to render the seller's warranty disclaimers unreasonable, and thus ineffective’.

¹⁴⁷ For an appraisal of the relationship between standards and liability in the area of product safety, see Cafaggi (n 17) 10. See for instance Preamble, point no 14, arts 3(2) and 3(3) of the Product Safety EC Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001, OJ L 11, 15.1.2002, p 4–17, setting forth a presumption of safety for the products conforming to national standards transposing European safety standards. This is a telling example of the ‘New Approach’ adopted by the EU, whereby the Commission sets the general requirements for products and services, leaving it to voluntary standards the task of providing detailed specifics. In this framework, the main standardization body is the CEN (Comité Européen de Normalisation), an organization comprised of all EU members national standardization bodies. See J Morrison and N Roht Arriaza, ‘Private and Quasi-private Standard Setting’ in D Bodansky and others (eds), Oxford Handbook of International Environmental Law (OUP 2007) 498, 520.

¹⁴⁸ Bruno and Pynnonen (n 39) 1076: ‘The ISO 9000 series is a set of standardized procedures and principles that sellers can adopt to ensure customer satisfaction. … Customer satisfaction, both with the product and with the system developed to create the product, is the ultimate goal’.

¹⁴⁹ This is somewhat different from the EC approach to technical standardization. Although many of the principles underpinning this ‘new approach to technical harmonisation’ (see at <http://europa.eu/legislation_summaries/internal_market/single_market_for_goods/technical_harmonisation/l21001a_en.htm>) recall those laid down in the TBT and professed by the TBT Committee, yet compliance with the standards is not a mere defence against the charge of trade-restrictiveness, but creates a presumption of good faith in that it creates a link between the technical regulation and the ‘essential requirements’ and public interest it pursues. See Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards (Council Resolution (85/C 136/01), Official Journal C 136 of 4 June 1985; referring to the Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations, Official Journal L 109 of 26 April 1983.

¹⁵⁰ See Shapiro, SA, ‘International Trade Agreements, Regulatory Protection, and Public Accountability’ (2002) 54 Administrative L Rev 435, 451Google Scholar: ‘when international standard-setting organizations issue standards that are less stringent than similar regulations in the United States, it opens the door for other countries to challenge more stringent American regulations.’

¹⁵¹ See JH Mathis, ‘The WTO Agreement on Technical Barriers to Trade (TBT) Interaction with international standards and implications for consumers’ in K Dawar (n 33) 105, 124: ‘From a national consumer perspective, it seems that the substance question turns upon whether a standard is posing as a floor or as a ceiling.’ To the extent that the ceiling-argument has been proved, above, it follows that consumers are indeed worse off.

¹⁵² See Henson and Humphrey (n 13), noting that the slow process guided by WTO case law would be ineffective in any event in influencing the regulatory regime timely.

¹⁵³ For instance, by including a reference to the standards in government procurement instructions, see eg Chan (n 30) 1216: ‘the U.S. Federal Acquisition Regulations specify ISO 9000 and QS-9000 as examples of quality standards that may be required for compliance with higher-level contract quality requirements’.

¹⁵⁴ Victor (n 40) 920.

¹⁵⁵ ibid (2000) 924. Charnovitz (n 127) 284–285; see also WTO Committee on Sanitary and Phytosanitary Measures, Proposed Guidelines to Further the Practical Implementation of Article 5.5, G/SPS/W/104, para A.4 (20 March 2000).

¹⁵⁶ Wirth (n 37) 96: ‘operating through the TBT Agreement, non-binding ISO standards may acquire international legal significance, may be transformed from minimum standards of performance into regulatory ceilings from which governments must justify departure in terms of greater rigor.’

¹⁵⁷ Roht-Arriaza (n 37) 510, describing ISO practices: ‘the global standard serves only as a floor.’

¹⁵⁸ Staiger and Sykes (n 89) 40.