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3.1.1 Technical Regulations and Standards
As defined in Annex 1.1 of the TBT Agreement, technical regulations are mandatory,
written rules applying to identifiable products that set out product characteristics or
their related processes and production methods. They include rules dealing with
terminology, symbols, packaging, marking and labelling requirements. The definition
of a standard is broadly similar, with one important difference – the Agreement
defines standards as “not mandatory”. The terminology is somewhat confusing, as in
common parlance mandatory regulations are often referred to as “standards”.
Until recently the distinction seemed clear-cut. However, a recent decision by the
under U.S. or applicable copyright law.
Appellate Body, described in the text box below, blurred the distinction, and many
measures that were regarded as standards because they were voluntary may now be
classified as technical regulations. While an interesting issue for lawyers to debate, the
change of categorisation makes little difference in practice, as the TBT rules applicable
to standards are generally the same as those applicable to technical regulations.
labelled with their nutritional content, are clearly technical regulations within
the meaning of the TBT Agreement. But what about a labelling system that
permitted
allows, but does not require statements to be made about the product if it
meets certain criteria? US – Tuna II determined that a US programme
uses of
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the TBT Agreement, even though the label was not required.39 The decision
was based on the following factors:
The TBT Agreement requires that technical regulations, standards and conformity
assessment procedures:
Do not discriminate (most-favoured-nation and national treatment);42
Do not create unnecessary obstacles to international trade (“necessity”);43
Are based on international standards when they exist and when they are
effective and appropriate (“harmonisation”);44 and
Are transparent.45
Most challenges under the TBT Agreement also invoke the GATT. This
strategy proved successful in the EC – Seal Products dispute,46 where the
AB found a violation of Article XI of the GATT after ruling that the TBT
Agreement did not apply.47
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The principal TBT obligations are discussed below from the perspective of technical
regulations, but similar rules apply to standards and conformity assessment procedures.
3.2.1 Non-discrimination
Like the GATT, the TBT Agreement contains both national treatment and most-
favoured-nation obligations. Unlike the GATT, the TBT Agreement does not set forth
exceptions. This drafting oversight poses a problem for the business community. The
Appellate Body had to find a way to reconcile the need to fulfil a Member’s legitimate
regulatory objectives with the need to assure that a Member does not apply technical
regulations for protectionist purposes. The Appellate Body solved the problem by
“creating” the concepts of a “legitimate regulatory distinction” and “even-handedness”
as part of the four-part test set out below.48 Although the formal analysis may be
somewhat different, it is likely that the result in a TBT dispute alleging a violation of
the non-discrimination obligation would be the same as the result in a GATT dispute
predicated on a non-discrimination violation (MFN or national treatment) were a party
to invoke Article XX to justify the discrimination.
All recent TBT decisions have found that there was no legitimate regulatory distinction
behind the discrimination, and that there was therefore a violation of Article 2.1 – the
TBT Agreement’s non-discrimination obligation.
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US – Tuna II: Dolphins swim with tuna in certain parts of the Pacific Ocean.
The United States regulates the use of a “dolphin-safe” label that manu-
facturers can apply to tuna products to indicate that the tuna is caught
in a manner that avoids dolphin deaths. The Appellate Body found that
the US labelling regulations discriminated against Mexico. The US label-
ling scheme applied to tuna caught with purse-seine nets in the eastern
tropical Pacific Ocean where the US and Mexico both fish. Tuna coming
from the western tropical Pacific Ocean where Mexico does not fish were
subjected to laxer requirements (despite the fact that tuna also swim with
dolphins in that region).
livestock were born, raised and slaughtered. The Appellate Body found
that the COOL programme discriminated against Canadian and Mexican
livestock by imposing increased costs on their livestock, both in in the
slaughtering process, and through the collection of information that was
never provided to consumers. This case is discussed in Chapter 13, Case
Study A.
3.2.2 Necessity
Pursuant to the TBT Agreement, technical regulations, standards and conformity
assessment procedures must not create “unnecessary” obstacles to international trade
(as explained above, measures based on international standards are presumed to
meet this requirement). This language is clarified in Article 2.2: “For this purpose,
technical regulations shall not be more trade-restrictive than necessary to fulfil a
legitimate objective, taking account of the risks non-fulfilment would create.”52
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“INEFFECTIVE OR INAPPROPRIATE”
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3.2.4 Transparency
3.2.4.1 General Provisions
The transparency provisions of the TBT Agreement are similar to those in the SPS
Agreement, although as will be seen below, they are more business friendly. TBT
transparency requirements take several forms. Most apply when a relevant
international standard does not exist or a proposed technical regulation is “not in
accordance with the technical content of relevant international standards” and “may
have a significant effect on trade”. They can be broken down into measures applicable
pre-adoption and post-adoption.
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3.4.1 Equivalence
A WTO Member is required to give “positive consideration” to accepting the technical
regulations of other Members as equivalent, even if different from its own, if the
Member is satisfied that the foreign regulation adequately fulfils the objectives of its
own regulation. As this “requirement” gives members discretion to determine when a
foreign regulation is equivalent, its enforceability may be difficult. Nevertheless,
equivalency agreements do exist. For example, since 2014, the United States and
Japan have recognised the equivalence of their organic food regulations, and as a
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result “all certified organic plant and plant based processed products that are
produced in the United States and Japan, or which have final processing, packaging,
or labelling in the United States or Japan, may access either market.”65
3.4.3 Design of Technical Regulations
“When appropriate”, Members are to specify technical regulations based on
performance characteristics as opposed to design characteristics. For example, the
regulation of a fire door should be specified based on its ability to withstand a certain
temperature for a specified length of time, as opposed to its physical characteristics,
which could be defined more easily in a way that favours domestic products over
imports. WTO Members intended that regulations based on performance
characteristics would unleash the creativity of the business community by allowing
space for new means of solving problems – for example the development of new
materials to design a fire door. In fact, the trend in developed countries is to base
regulations increasingly on performance characteristics, unless the matter is so vital
(for example automobile safety) that regulations based on design characteristics are
necessary (such as mandatory airbag and seatbelt requirements).
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discussed above, makes clear that such standards are outside the WTO Agreement as
they are set by private parties whose standard-setting activities are not open to all
WTO Members at all stages of their activity.
To the extent feasible, TPP focuses in large part on equivalence – both product-
specific equivalence, and also equivalence on a system-wide basis (for example use of
accredited laboratories). The goal is to prevent parties from relying on small
differences that would prevent a party’s recognition that a SPS measure or an SPS
system is equivalent. TPP also tries to accelerate the import inspection process and
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TPP also curbs potential abuse of the precautionary approach provided for in Article
5.7 of the SPS Agreement by requiring that precautionary measures be reviewed
within six months, instead of the reasonable period of time specified in Article 5.7.
TPP also seeks to limit a party’s ability to restrict trade in animal and animal products
by setting forth strict disciplines that are applicable to the veterinary certificates used
for trade in such products.
With respect to pest-free and disease-free zones, TPP requires greater respect for
regional and local conditions than that set forth in the WTO SPS Agreement. It favours
trade from “compartments” (zones) with high levels of bio-security. An importing
party must provide a rationale when it refuses to recognise a “compartment” as
disease or pest-free.
parties must utilise before resorting to the TPP’s formal dispute settlement system.
As with the SPS chapter of TPP, the TBT chapter mandates transparency. It requires
public consultations before new TBT measures are adopted. This allows both businesses
and consumers (“stakeholders”) time to comment on draft measures. In most cases,
TPP also requires a six-month waiting period between publication and entry into force
of new TBT measures so that the business community has time to adapt its products.
TPP parties are also required to make regulatory decisions public. This includes
disclosure of the criteria employed by a conformity assessment body when it refuses
to recognise the decision of a foreign body.
TPP limits the fees assessed for conformity assessment to the cost of the service
provided. It also provides for increased protection of proprietary information in the
processed food sector. In general, all information disclosure requirements are limited
to what is necessary to achieve a legitimate objective.
Finally the TBT chapter of the TPP Agreement includes a series of sectoral annexes
that business should consult, assuming ratification, if operating in a covered sector.
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1 See Report (2015) of the Committee on Sanitary and Phytosanitary Measures, G/L/1129 (28 October 2015); Committee on
Technical Barriers to Trade, Twenty-First Annual Review of the Implementation and Operation of the TBT Agreement, Report
by the Secretariat, G/TBT/38/Rev.1 (24 March 2016).
2 See http://www.iso.org/iso/home/standards.htm.
3 See http://www.iec.ch/about/annual_report/pdf/IEC_Annual_Report_2015.pdf at pp. 7 and 2 respectively.
4 See Okun-Kozlowicki, “Standards and Regulations: Measuring the Link to Goods Trade”, US Department of Commerce (2016), at p.3.
5 See Alisson, “The Nontariff Trade Barrier Challenge: Development and Distortion in the Age of Interdependence”, 12 Tulsa Law
Journal 1, at p.3, n.10 (1976), available at http://digitalcommons.law.utulsa.edu/tlr/vol12/iss1/1/.
6 The SPS Agreement also allows a Member to prevent or limit other damage within its territory from the entry, establishment
or spread of pests, such as weeds.
7 SPS Measures are defined and examples are provided in Annex A(1) of the SPS Agreement.
8 See SPS Agreement, Annex C, para. 2.
9 Article XX(b) of the GATT permits exceptions to the GATT rules where “necessary” for the protection of human, animal, or
plant life or health. See Chapter Two, Secton 8.1.
10 EC – Measures Concerning Meat and Meat Products (Hormones), WT/DS26,48/AB/R (1998) (EC – Hormones), para. 170.
11 Canada/United States – Continued Suspension Of Obligations in the EC – Hormones Dispute, WT/DS320,321/AB/R (2008), para. 591.
12 Japan – Measures Affecting the Importation of Apples, WT/DS245/AB/R (2003) (Japan-Apples).
13 Japan – Measures Affecting Agricultural Products, WT/DS76/AB/R (1999).
14 Japan – Apples, paras. 147, 162-168.
15 European Communities – Measures concerning Meat and Meat Products (Hormones), DS26, para. 8.107.
16 Article 5.2 SPS.
17 EC – Hormones, paras. 207-209.
18 Id. para. 193.
19 Id. para. 190.
20 Article 5.6 and footnote 3 SPS (emphasis added).
21 Australia – Measures Affecting Importation of Salmon (Article 21.5 – Canada), WT/DS18/R/W (2000), para 7.111.
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and “inappropriate” means not suitable for the fulfilment of the legitimate objective pursued. Id. para. 285.
57 Article 2.9 – 2.11 TBT Agreement.
58 Transparency provisions for standardising bodies are somewhat different. In particular, Paragraph J of Annex 3:C of the
Agreement requires that standardising bodies notify their work programmes to the ISO/IEC Information Centre rather than
the WTO. Annex 3:C also requires standardising bodies that have accepted or withdrawn from the Code of Good Practice (an
Annex that sets forth the requirements applicable to standardising bodies) to notify the ISO/IEC Information Centre.
59 The Member must also provide copies of the regulation upon request to other Members, allow Members to comment in
writing, discuss the comments with other Members, and take the comments into consideration.
60 See http://ec.europa.eu/growth/tools-databases/tbt/en/, and https://tsapps.nist.gov/notifyus/data/index/index.cfm.
61 http://tbtims.wto.org/.
62 The training course is available at: https://ecampus.wto.org/search.asp?lang=En. The Guide, entitled WTO Agreements Series:
Technical Barriers to Trade (2014), is available at: https://www.wto.org/english/res_e/publications_e/tbttotrade_e.pdf.
63 https://www.wto.org/english/tratop_e/tbt_e/tbt_work_docs_test_e.htm.
64 Van den Bossche and Zdouc list the Associação Brasileira de Normas Técnicas, the American National Standards Institute and
the European Committee for Standardization as examples of non-governmental standardising bodies. The Law and Policy of
the World Trade Organization (Cambridge University Press, 3rd ed. 2013), at p. 860. This point has, however, never been tested
in a WTO dispute.
65 See https://www.ams.usda.gov/services/organic-certification/international-trade/Japan.
66 See generally United States – Import Prohibition of Certain Shrimp and Shrimp Products (Recourse to Article 21.5 of the DSU
by Malaysia), WT/DS58/AB/RW (2001).
67 In the US – Shrimp case, the Appellate Body required the United States to first try to negotiate a multilateral agreement in
good faith that would protect endangered sea turtles.
68 US – Tuna II (Mexico).
69 See http://www.globalgap.org/uk_en/who-we-are/about-us/.
70 See World Economic Forum, “What are Mega-Regional Trade Agreements?” https://www.weforum.org/agenda/2014/07/
trade-what-are-megaregionals/. As noted earlier, at the time of writing there was considerable doubt as to whether the TPP
or the TTIP would come into effect.
71 Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.
72 Australia, China, India, Japan, South Korea and New Zealand.
73 The SPS Agreement does not use the term “risk management”.
74 The USTR has provided a brief summary of the annexes on its website: https://ustr.gov/sites/default/files/TPP-Chapter-Sum-
mary-Technical-Barriers-to-Trade.pdf. The full text of the TPP is also available on the United States Trade Representative’s
website: https://ustr.gov/trade-agreements/free-trade-agreements/trans-pacific-partnership/tpp-full-text. Despite US with-
drawal from TPP, these documents were still available at the time of writing (April 2017).
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