2010 REPORT ON TECHNICAL BARRIERS TO TRADE 

I. Executive Summary

II. Introduction 

• Genesis of this Report

• Overview of Standards-Related Measures 

III. Overview of Trade Obligations on Standards-Related Measures

• TBT Agreement

• Operation of the TBT Agreement

• Standards-Related Provisions in U.S. Free Trade Agreements

IV. U.S. Statutory and Administrative Framework for Implementing Standards-Related Trade 

Obligations

V. Standards

VI. Conformity Assessment Procedures

VII. U.S. Process for Identifying Standards-Related Trade Barriers and Determining How to 

Address Them

VIII. U.S. Engagement on Standards-Related Measures in International, Regional, and 

Bilateral Fora

• Overview of U.S. Engagement on Standards-Related Measures

• TBT Committee

o Specific Trade Concerns

o The Fifth Triennial Review of the TBT Agreement

• APEC

o The APEC Toy Safety Initiative

o Partnership Training Institute Network of the Food Safety Cooperation Forum 
2

o Business Engagement in Standards and Conformance

o Trade Facilitation Task Force 

o Export Assistance Models for Small and Medium Sized Enterprises 

• North American Free Trade Agreement 

• Doha Round Negotiations Regarding Standards-Related Measures

• Organization for Economic Cooperation and Development

IX. Trends

X. Country-Specific Reports 

• Background on Trade Concerns Contained in the Country Reports 

• Argentina 

• Brazil 

• Canada 

• China 

• Colombia 

• Ecuador 

• The European Union and its Member States

• Gulf Cooperation Council and its Member States

• India 

• Indonesia 

• Israel 

• Japan 

• Korea

• Malaysia 

• Mexico 
3

• Russia 

• Taiwan

• Thailand 

• Turkey 

• Vietnam 

XI. Appendices 

• Appendix A: List of Commenters 

• Appendix B: List of Frequently Used Abbreviations and Acronyms
4

Acknowledgements

The Office of the United States Trade Representative (USTR) is responsible for the preparation 

of this report, which was written by USTR staff. U.S. Trade Representative Ron Kirk gratefully 

acknowledges the contributions of the Departments of Agriculture, Commerce, Labor, Justice, 

State, Transportation and Treasury, the U.S. Environmental Protection Agency, the U.S. Food 

and Drug Administration, the U.S. Consumer Product Safety Commission, the U.S. International 

Trade Commission, and the Office of Management and Budget. 

In preparing the report, substantial information was solicited from U.S. Embassies abroad.

Drafts of the report were circulated through the interagency Trade Policy Staff Committee. 

USTR is especially appreciative of the consistent support of the International Trade 

Administration and the National Institute of Standards and Technology of the U.S. Department 

of Commerce and the Foreign Agricultural Service of the U.S. Department of Agriculture with 

respect to standards-related matters, including this report.
5

I. Executive Summary

The 2010 Report on Technical Barriers to Trade (TBT Report) is a new, specialized report 

focused on significant foreign trade barriers in the form of product standards, technical 

regulations and testing, certification, and other procedures involved in determining whether 

products conform to standards and technical regulations (conformity assessment procedures). 

These standards-related trade measures, known in World Trade Organization (WTO) parlance as 

“technical barriers to trade,” play an increasingly critical role in shaping the flow of global trade.

Standards-related measures serve an important function in facilitating global trade, including by 

enabling greater access to international markets by small and medium sized enterprises (SMEs). 

Standards-related measures also enable governments to pursue legitimate objectives such as 

protecting human health and the environment and preventing deceptive practices. However, 

standards-related measures that are non-transparent, discriminatory, or otherwise unwarranted 

can act as significant barriers to U.S. trade. This report is intended to describe and advance U.S. 

efforts to identify and eliminate such barriers, which can also present particular challenges for 

SMEs that typically lack the resources to identify and address such barriers. The United States 

and other governments have a right to adopt and enforce measures to pursue legitimate 

objectives such as protecting human health and the environment and preventing deceptive 

practices. At the same time, it is appropriate to question standards-related measures that appear 

non-transparent, discriminatory, or otherwise act as unwarranted barriers to U.S. trade. The 

U.S. Government’s efforts to reduce and eliminate these barriers are fully consistent with 

pursuing legitimate objectives through standards-related measures.

The opening sections of this report present an overview of technical barriers to trade and the U.S. 

and international mechanisms for addressing them.1

 1 For readers seeking a deeper understanding of the specific topics covered in this report, references and hyperlinks 

to additional information are provided throughout the report. To access official documents of the WTO (such as 

those identified by the document symbol “G/TBT/...”) click on “simple search” and enter the document symbol at 

the WTO’s document retrieval website: http://docsonline.wto.org/gen_search.asp?searchmode=simple

 Section II provides an introduction to 

standards-related measures, including the genesis of this report and the growing importance of 

standards-related measures in global trade. Section III provides an overview of standards-related 

trade obligations, in particular rules governing standards-related measures under the WTO 

Agreement on Technical Barriers to Trade (TBT Agreement) and U.S. free trade agreements. 

Section IV describes the U.S. legal framework for implementing its standards-related trade 

obligations. Section V elaborates on standards, including the role of international standards in 

facilitating trade and fulfilling legitimate public policy objectives and Federal agencies’ 

participation in standards development. Section VI elaborates on conformity assessment 

procedures, including Federal agencies’ use of conformity assessment and the possibility for 

international systems of conformity assessment to facilitate trade. Section VII describes how the 

U.S. government identifies technical barriers to trade and the process of interagency and 

stakeholder consultation it employs to determine how to address them. Section VIII explains 

how the United States engages with its trading partners to address standards-related measures 
6

that act as barriers and prevent their creation through multilateral, regional, and bilateral 

channels, including the WTO’s Committee on Technical Barriers to Trade (TBT Committee), the 

North American Free Trade Agreement’s (NAFTA) Committee on Standards-Related Measures,

and cooperative activities under the Asia Pacific Economic Cooperation (APEC) Subcommittee 

on Standards and Conformance. Section IX summarizes current trends relating to standardsrelated measures.

The heart of this report is Section X, which identifies and describes significant standards-related 

trade barriers currently facing U.S. producers, along with U.S. government initiatives to 

eliminate or reduce the impact of these barriers. The report identifies TBT measures in 20 

countries or groups of countries: Argentina, Brazil, Canada, China, Colombia, Ecuador, the 

European Union (EU) and its Member States, the Gulf Cooperation Council (GCC) and its 

Member States, India, Indonesia, Israel, Japan, Korea, Malaysia, Mexico, Russia, Taiwan, 

Thailand, Turkey, and Vietnam. 

II. Introduction

Genesis of this Report

Shortly after taking office in 2009, President Obama reaffirmed America’s commitment to 

ensuring the effective implementation and enforcement of the WTO’s system of multilateral 

trading rules. The President’s 2009 Trade Policy Agenda vowed an aggressive and transparent 

program of defending U.S. rights and benefits under the rules-based trading system as a key 

element in his vision to restore the role of trade in leading economic growth and promoting

higher living standards. The President’s Agenda also recognized that “behind the border” 

measures and other non-tariff barriers have grown in significance for U.S. exporters seeking 

access to foreign markets. 

In a major policy speech delivered at the Edgar Thomson Plant of the Mon Valley Works in 

Pittsburgh, Pennsylvania in July 2009, the U.S. Trade Representative, Ambassador Ron Kirk, 

pledged more aggressive action to break down barriers to U.S. exports. Ambassador Kirk 

highlighted two kinds of non-tariff measures that pose increasing challenges to U.S. producers 

and businesses seeking to export products abroad: sanitary and phytosanitary (SPS) measures; 

and standards-related measures. Standards-related measures include government measures such 

as mandatory product standards and testing requirements. In the WTO, measures of this type are 

referred to as “technical barriers to trade” (TBT).

In his speech, Ambassador Kirk pledged stepped up monitoring of trading partners’ SPS and 

standards-related practices that act as obstacles to U.S. trade. He also vowed increased 

engagement to resolve trade issues and to help ensure that U.S. trading partners are complying 

with trade rules – particularly those relating to obligations under two WTO agreements: the 

Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the 

TBT Agreement. The goal of this intensified monitoring and engagement is to help to facilitate

and expand trade in safe, high quality U.S. products.
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Ambassador Kirk also relayed his determination to make USTR’s annual reports to Congress 

“more than paperwork.” To this end, he directed that the annual reports be used to bring new 

energy to the process of identifying non-tariff measures that act as significant barriers to U.S. 

exports; to provide a central focus for intensified engagement by U.S. agencies in resolving trade 

concerns related to non-tariff barriers; and to document the actions underway to give greater 

transparency and confidence to American workers, producers, businesses, and other stakeholders 

with regard to the actions this Administration is taking on their behalf. 

The 2010 Report on Technical Barriers to Trade (TBT Report) serves these goals for standardsrelated measures. The TBT Report is a new, specialized report dedicated to significant foreign 

barriers in the form of product standards, technical regulations, and conformity assessment 

procedures (standards-related measures). These measures previously have been addressed in the 

National Trade Estimate Report on Foreign Trade Barriers (NTE Report).2

The TBT Report includes country reports that identify specific standards-related trade barriers. 

The report also includes general information on standards-related measures, the processes and 

procedures the United States uses to implement these measures domestically and the tools the 

United States uses to address standards-related measures when they act as barriers to trade. This 

general information is provided to give the appropriate context that will enable better 

understanding of the trade concerns and issues described in the last two sections of the report. 

These last two sections review current trends relating to standards-related measures that can have 

a significant impact on trade and identify and describe significant standards-related trade barriers 

currently facing U.S. producers and businesses, along with U.S. government initiatives to 

eliminate or reduce these barriers. 

 The TBT Report 

broadens and deepens these past efforts. By addressing significant foreign trade barriers in the 

form of standards-related measures, the TBT Report meets the requirements under Section 181 of 

the Trade Act of 1974, as amended, to report on significant foreign trade barriers with respect to 

standards-related measures. Accordingly, the 2010 NTE itself does not contain information on 

these measures. A separate report addressing significant foreign trade barriers in the form of 

SPS measures (2010 Report on Sanitary and Phytosanitary Measures) is being released in 

parallel to this report.

Like the NTE Report, the source of the information for the TBT Report includes stakeholder 

comments that USTR solicited through a Federal Register notice, reports from U.S. Embassies 

abroad and from other Federal agencies, and USTR’s ongoing consultations with domestic 

stakeholders and trading partners. An appendix to this report includes a list of commenters that 

submitted comments in response to the Federal Register notice. 

 2 In accordance with section 181 of the Trade Act of 1974 (the 1974 Trade Act), as amended by section 303 of the 

Trade and Tariff Act of 1984 (the 1984 Trade Act), section 1304 of the Omnibus Trade and Competitiveness Act of 

1988 (the 1988 Trade Act), section 311 of the Uruguay Round Trade Agreements Act (1994 Trade Act), and section 

1202 of the Internet Tax Freedom Act, the Office of the U.S. Trade Representative is required to submit to the 

President, the Senate Finance Committee, and appropriate committees in the House of Representatives, an annual 

report on significant foreign trade barriers. The statute requires an inventory of the most important foreign barriers 

affecting U.S. exports of goods and services, foreign direct investment by U.S. persons, and protection of 

intellectual property rights.
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Overview of Standards-Related Measures

Today, standards-related measures play a critical role in shaping the flow of global trade. While

tariffs still constitute an important source of distortions and economic costs in international trade 

in some products, overall the relative role of tariffs in shaping global trade has declined due in 

large part to successful “rounds” of multilateral tariff reductions in the WTO and its predecessor, 

the General Agreement on Tariffs and Trade (GATT). Broadly speaking, standards-related 

measures are documents and procedures that set out specific technical or other requirements for 

products or processes and procedures to ensure that products and processes meet those 

requirements. The rise in importance of standards-related measures in international trade stems 

in large part from the desire to:

• ensure the connectivity and compatibility of inputs sourced in global markets, 

• manage the flow of product-related information through complex and increasingly 

global supply chains,

• organize manufacturing or other production processes around replicable routines and 

procedures to yield greater product quality assurance,

• meet important regulatory and societal objectives, such as ensuring product safety, 

preventing deceptive practices, and protecting the environment, and 

• promote more environmentally-sound or socially-conscious production methods. 

Standards-related measures also play a vital role in enabling greater competition by helping to 

ensure that producers and consumers can purchase components and end products from a wide 

variety of suppliers. These measures also enable more widespread access among producers to 

technical innovations. Standards-related measures can offer particularly pronounced benefits to 

small- and medium-sized enterprises (SMEs) from this perspective. By establishing a common 

set of technical requirements that producers can rely on in manufacturing components and end 

products, uniform standards and product testing procedures can facilitate the diffusion of 

technology and innovation, contribute to increasing buyer-seller confidence, and assist SMEs to 

participate in global supply chains. 

However, when outdated, overly burdensome, discriminatory, or otherwise inappropriate 

standards-related measures are used, they can reduce competition, stifle innovation, and create 

unnecessary obstacles to trade. Even when standards-related measures are used appropriately, 

firms – particularly SMEs – can face significant challenges in accessing information about, and 

complying with, diverse and evolving technical requirements in major export markets. This is 

particularly the case when technical requirements change rapidly or differ markedly across 

markets. 

Standards-related measures can be an effective and efficient means of achieving legitimate 

commercial and policy objectives. For policy makers, industry officials, and other stakeholders, 

the basic question is: how do we ensure that standards-related measures facilitate innovation, 
9

competition, consumer and environmental protection, and other public policy objectives –

without creating unnecessary obstacles to trade? As supply chains grow increasingly complex, 

governments and other stakeholders must also address the question of how to better align

standards and technical requirements across jurisdictions and markets both to help producers 

comply with those requirements and to help goods flow across borders.

The rules, procedures, and opportunities for engagement that international, regional, and bilateral 

trade agreements provide establish an important foundation for addressing many of these 

questions. The TBT Agreement is the principal agreement establishing multilateral rules 

governing standards-related measures. (Box 1 lays out definitions provided under the TBT 

Agreement for standards-related measures.) U.S. free trade agreements (FTAs) establish 

additional rules on standards-related measures with specific trading partners. The disciplines of 

the TBT Agreement are vital in setting the terms on which the United States engages with its

trading partners on standards-related measures, and U.S. FTAs build on these disciplines in 

important ways. These agreements are described in more detail in Section III below.

A broad and active agenda of U.S. engagement on many fronts is needed to ensure that foreign 

standards-related measures do not impose unwarranted barriers to trade. USTR leads Federal 

government policy deliberations on foreign standards-related measures through the interagency 

Trade Policy Staff Committee (TPSC). U.S. activities in the WTO are at the forefront of 

USTR’s efforts to prevent and resolve trade concerns arising from standards-related measures. 

Coordinating with relevant agencies through the TPSC, USTR engages with other governments 

on standards-related issues in many venues, including those established by U.S. FTAs and 

through regional and multilateral organizations, such as the WTO, Asia Pacific Economic 

Cooperation (APEC) and the Organization for Economic Cooperation and Development 

(OECD). USTR also regularly raises standards-related issues in bilateral dialogues with U.S. 

trading partners. These efforts are designed to ensure that U.S. trading partners adhere to 

internationally agreed rules governing standards-related measures and to reduce or eliminate 

unnecessary standards-related measures that can create barriers for U.S. producers and 

businesses.
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Box 1. Key Definitions in the WTO Agreement on Technical Barriers to Trade

Technical regulation

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, marking, or labeling requirements as 

they apply to a product, process, or production method.

Standard

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, marking, or 

labeling requirements as they apply to a product, process, or production method.

Conformity assessment procedures

Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations 

or standards are fulfilled.

Explanatory note: Conformity assessment procedures include, inter alia, procedures for sampling, testing 

and inspection; evaluation, verification and assurance of conformity; registration, accreditation, and 

approval as well as their combinations.

Source: Annex 1 of the TBT Agreement.

Note: These definitions apply only with respect to products and related processes and production methods, not to 

services.

III. Overview of Trade Obligations on Standards-Related Measures

TBT Agreement

The TBT Agreement is designed to ensure that standards-related measures serve legitimate

objectives, are transparent, and do not create unnecessary obstacles to trade. The TBT 

Agreement contains a comprehensive set of obligations for WTO Members on the development 

and use of standards-related measures. It establishes rules on developing, adopting, and applying

voluntary product standards and mandatory technical regulations – as well as for the conformity 

assessment procedures (such as testing or certification) used to determine whether a particular 

product meets such standards or regulations. These rules help distinguish legitimate standardsrelated measures from protectionist measures, as well as help ensure that testing and other 
11

procedures used to determine product conformance with applicable standards and technical 

regulations are fair and reasonable. 

The TBT Agreement recognizes that WTO Members have the right to take standards-related 

measures necessary to protect human health, safety and the environment at the levels they 

consider appropriate and to achieve other legitimate objectives. At the same time, the TBT 

Agreement imposes a series of disciplines regarding the development and application of those 

measures. For example, the TBT Agreement requires governmental standards-related measures 

to be developed through transparent processes and to be based on relevant international standards

(where effective and appropriate), as well as prohibits standards-related measures that 

discriminate against imported products or create unnecessary obstacles to trade. The TBT 

Agreement also sets out a Code of Good Practice for both governments and non-governmental 

standardizing bodies to guide the preparation, adoption, and application of voluntary standards. 

The Code is open to acceptance by any standardizing body located in the territory of any WTO 

Member. Box 2 outlines the key disciplines of the TBT Agreement.

Box 2. Key principles and provisions of the TBT Agreement 

Non-discrimination: The Agreement states that “in respect of their technical regulations, products imported from 

the territory of any Member [shall] be accorded treatment no less favorable than that accorded to like products of 

national origin and to like products originating in any other country.” (Art. 2.1) The Agreement requires Members 

to ensure that “conformity assessment procedures are prepared, adopted and applied so as to grant TBT Agreement 

access for suppliers of like products originating in the territories of other Members under conditions no less 

favorable than those accorded to suppliers of like products of national origin or originating in any other country, in a 

comparable situation.” (Art. 5.1.1) The Agreement also requires that Members ensure that related fees are equitable 

(Art. 5.2.5) and that they respect the confidentiality of information about the results of conformity assessment 

procedures for imported products in the same way they do for domestic products. (Art. 5.2.4)

Avoidance of unnecessary obstacles to trade: When preparing or applying a technical regulation, a Member must 

ensure that the regulation is not more trade-restrictive than necessary to fulfill the Member’s legitimate objective.

(Art. 2.2) The obligation to avoid unnecessary obstacles to trade applies also to conformity assessment procedures. 

They must not be stricter than necessary to provide adequate confidence that products conform with applicable 

requirements. (Art. 5.1.2)

Better alignment of technical regulations, standards, and conformity assessment procedures: The Agreement 

calls on Members to use relevant international standards, or the relevant parts of them, as a basis for their technical 

regulations and to use relevant international recommendations and guides, or relevant portions of them, as the basis 

for their conformity assessment procedures. The Agreement, however, does not require the use of relevant

international standards, guides and recommendations if they would be ineffective or inappropriate to fulfill the 

Member’s “legitimate objectives.” (Arts. 2.4 and 5.4) In addition, Members should participate, “within the limits of 

their resources,” in the preparation by international standardization bodies, of international standards for products 

for which they either have adopted, or expect to adopt, technical regulation, and in the elaboration of international 

guides and recommendations for conformity assessment procedures. (Arts.2.6 and 5.5).
12

Use of performance-based requirements: Whenever appropriate, product requirements should be set in terms of 

performance rather than design or descriptive characteristics. (Art. 2.8)

International systems of conformity assessment: Members shall, whenever practicable, formulate and adopt 

international systems for conformity assessment and become members thereof or participate therein.

Acceptance of technical regulations as equivalent: Alongside harmonization, the Agreement encourages Members 

to accept technical regulations that other Members adopt as “equivalent” to their own if these regulations adequately 

fulfill the objectives of their own regulations. (Art. 2.7)

Mutual recognition of conformity assessment: The Agreement requires each Member to recognize “whenever 

possible” the results of conformity assessment procedures (e.g. test results or certifications), provided the Member is 

satisfied that those procedures offer an assurance of conformity that is equivalent as its own. (Art. 6.1) (Without 

such recognition, products might have to be tested twice, first by the exporting country and then by the importing 

country.) The Agreement recognizes that Members may need to consult in advance to arrive at a “mutually 

satisfactory understanding” regarding the competences of their respective conformity assessment bodies. (Art. 6.1) 

The Agreement also encourages Members to enter into negotiations to conclude agreements providing for the 

mutual recognition of each other’s conformity assessment results (i.e., mutual recognition agreements or MRAs). 

(Art. 6.3)

Transparency: To help ensure transparency, the Agreement requires Members to publish a notice at an early stage 

and notify other Members through the WTO Secretariat when it proposes to adopt a technical regulation or 

conformity assessment procedure and to include in the notification a brief indication of the purpose of the proposed 

measure. These obligations apply whenever a relevant international standard, guide, or recommendation does not 

exist or the technical content of a proposed technical regulation or conformity assessment procedure is not in 

accordance with the technical content of relevant international standards, guides, or recommendations. In such 

circumstances, Members must allow “reasonable time” for other Members to comment on proposed technical 

regulations and conformity assessment procedures, which the TBT Committee has recommended to be “at least 60 

days,” and take comments it receives from other Members into account. (Arts. 2.9 and 5.6) The Agreement 

establishes a Code of Good Practice that is applicable to voluntary standards and obligates Members and 

standardizing bodies that have accepted it to publish every six months a work program containing the standards it is 

currently preparing and give interested parties at least 60 days to comment on a draft standard; once the standard is 

adopted it must be promptly published. (Annex 3) The Agreement also requires that all technical regulations and 

conformity assessment procedures be promptly published. (Art. 2.11 and 5.8) In addition, the Agreement requires 

each Member to establish an inquiry point to answer all reasonable inquires from other Members and interested 

parties. (Art. 10.1) 

Technical assistance: The Agreement calls on Members to provide technical assistance to other Members. (Art. 11) 

Technical assistance can be provided to help developing country Members in particular with such matters as 

preparing technical regulations, establishing national standardizing bodies, participating in international 

standardization bodies, and establishing bodies to assess conformity with technical regulations.

Enforcement and dispute settlement: The Agreement establishes the Committee on Technical Barriers to Trade as 

the major forum for WTO Members to consult on matters relating to the operation of the Agreement, including 

specific trade concerns about measures that Members have proposed or adopted. (Art. 13) The TBT Agreement 

provides for disputes under the Agreement to be resolved under the auspices of the WTO Dispute Settlement Body 

and in accordance with the terms of the WTO’s Dispute Settlement Understanding. (Art. 14)

Other: As noted above, the Agreement sets out a “Code of Good Practice” for preparing, adopting, and applying 

voluntary standards. (Annex 3). Standardizing bodies that Members establish at the central level of government 

must comply with the Code and Members must take reasonable measures to ensure that local government and 

private sector standardizing bodies within their territories also accept and comply with the Code. (Art. 4.1) The 
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Code is open to acceptance by any standardizing body in the territory of a WTO Member, including private sector 

bodies as well as public sector bodies. The Code requires Members and other standardizing bodies that have 

accepted it to adhere to obligations similar to those for technical regulations, for example, to ensure that the 

standards they adopt do not create unnecessary obstacles to trade and are based on relevant international standards, 

except where ineffective or inappropriate.

Note: The OECD and WTO have also developed summaries of the TBT Agreement. See Trade Policy Working 

Paper No. 58, Do Bilateral and Regional Approaches for Reducing Technical Barriers to Trade Converge Towards The 

Multilateral Trading System? (OECD (TAD/TC/WP(2007)12/FINAL), WTO Trade Gateway, and TBT Committee

reports and recommendations.

Access to information on product-related technical requirements is critical for facilitating trade.

Producers, growers, manufacturers, and other supply chain participants need to know the 

requirements with which their products must comply in order to sell them in prospective 

markets. Accordingly, the TBT Agreement requires every WTO Member to establish a national 

Inquiry Point that is able to answer all reasonable questions from other Members as well as 

interested parties concerning its proposed or existing standards-related measures, and provide 

relevant documents related to those measures, as appropriate. It also requires each WTO 

Member to ensure all standards-related measures that it adopts are promptly published or 

otherwise made publicly available. 

In addition, the TBT Agreement requires Members to afford other Members the opportunity to 

participate in the development of proposed mandatory standards-related measures. Members and 

interested parties can take advantage of those opportunities to help ensure that other Members’ 

standards-related measures do not become unnecessary obstacles to trade.3 In particular, the 

TBT Agreement requires each WTO Member to publish a notice in advance that it proposes to 

adopt a technical regulation or conformity assessment procedure.4 It also requires each WTO 

Member to notify proposed technical regulations and conformity assessment procedures to the 

WTO so that other WTO Members may comment on them in writing. WTO Members are 

required, without discrimination, to take into account these written comments, plus the results of 

any requested discussions of those comments, when finalizing their measures.5

 3

 Depending on the WTO Member’s domestic processes, interested parties in other Members may participate 

directly in the Member’s process for developing new standards-related measures, for example, by submitting written 

comments to the Member, or indirectly by working with their own governments to submit comments.

 In 2009 alone, 

4 Members typically do this by publishing a notice in an official journal of national circulation or on a government 

website that they propose to adopt a technical regulation or conformity assessment procedure or by publishing the 

full text of the draft measure. 

5 The obligations described in this paragraph apply to measures that have a significant effect on trade and are not 

based on relevant international standards, guides, or recommendations or in circumstances where relevant 

international standards, guides, or recommendations do not exist. In many instances, however, Members, including 

the United States, notify proposed technical regulations and conformity assessment procedures regardless of whether 

they are based on relevant international standards. 
14

WTO Members notified 1,490 new or amended technical regulations and conformity assessment 

procedures to the WTO. Box 3 shows the growth in notifications since 1995.6

Article 13 of the TBT Agreement establishes a “Committee on Technical Barriers to Trade” to 

oversee the operation and implementation of the TBT Agreement. The TBT Committee is open 

to participation by all 153 WTO Members. The TBT Committee is one of over a dozen standing 

bodies (others include the Committees on Import Licensing, Antidumping and Rules of Origin, 

for example) that report to the WTO Council on Trade in Goods. The activities of the TBT 

Committee are described in detail below.

 

Box 3: Number of TBT Notifications to the WTO since 1995

Source: WTO, 

G/TBT/28

0

200

400

600

800

1000

1200

1400

1600

1800

2000

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Notification Addenda/Corrigenda

 6 WTO Members notify new measures, as well as addenda and corrigenda to previously notified measures. An 

addendum alerts WTO Members that substantive or technical changes have been made to a measure that has been 

previously notified. A corrigendum conveys editorial or administrative corrections to a previous notification. Many 

Members also notify adopted technical regulations and conformity assessment procedures (regardless of whether or 

not they are based on relevant international standards).
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Operation of the TBT Agreement

The TBT Agreement seeks to set out simple rules (including regarding transparency, 

nondiscrimination, use of international standards, and the avoidance of unnecessary trade 

restrictiveness) covering complex requirements (technical regulations, standards, and conformity 

assessment procedures) that are developed and implemented by disparate bodies (central and 

local governmental agencies; inter-governmental entities; and non-governmental, national and 

international standardizing organizations). WTO Members’ central government authorities have 

primary responsibility for ensuring compliance with the TBT Agreement, including by taking 

reasonable measures to ensure that local and non-governmental bodies, such as private sector 

standards developing organizations, adhere to the relevant provisions of the TBT Agreement. 

Further, each WTO Member must inform the TBT Committee of the laws, policies, and 

procedures it has adopted to implement and administer the TBT Agreement.7

The quality and coherence of these laws, policies, and procedures – as well as how they are put 

into practice – influence the extent to which standards-related measures in any particular country 

are transparent, non-discriminatory, and avoid creating unnecessary obstacles to trade, as the 

TBT Agreement requires. In practice, sound mechanisms for internal coordination among a 

WTO Member’s trade, regulatory, and standards officials are critical to ensuring that the WTO 

Member effectively implements the TBT Agreement. When interested agencies and officials 

coordinate their efforts in developing standards-related measures, it makes it more likely that the 

government will consider alternative technical specifications that may lessen any potential 

adverse effects on trade. 

Further, when governments take account in developing standards-related measures how the 

products they propose to regulate are traded, it can make the measures they adopt more effective

in fulfilling the objective of the regulation. The effectiveness of a WTO Member’s internal 

coordination also often determines the extent to which it is able to resolve specific trade concerns 

raised by other WTO Members. In some developing countries, ineffective internal coordination 

and a lack of established procedures for developing standards-related measures are a key 

concern. For these countries, technical assistance or cooperative efforts to improve internal 

coordination can be vital in helping U.S. exporters sell into these markets.

In discharging its responsibility in overseeing the TBT Agreement, the TBT Committee conducts 

triennial reviews of systemic issues affecting WTO Members’ policies and procedures for 

implementing specific TBT obligations.8

Good Regulatory 

Practice

 In the course of these reviews, Members adopt specific 

recommendations and decisions, and lay out a forward-looking work program to strengthen the 

implementation and operation of the TBT Agreement. To advance their understanding of 

systemic issues, Members share experiences and participate in special events and regional 

workshops to explore topics in depth. Recent Committee events have covered 

, Conformity Assessment, Information Exchange, and the Role of International 

 7 See G/TBT/GEN/1/Rev.8 for a list of Members submissions on the measures they have taken to implement and 

administer the TBT Agreement. 

8 The results of the most recent triennial review are discussed in Section V.
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Standards in Economic Development. Planned events include the 6th Special Meeting on 

Information Exchange in June 2010 and a Workshop on Regulatory Cooperation in March 2011.

In addition to its triennial reviews and the special events and workshops it convenes in 

connection with those reviews, the TBT Committee meets three times a year. At these meetings, 

WTO Members may raise any specific trade concerns they have with standards-related measures 

that other WTO Members have proposed or adopted. The TBT Committee’s discussion of 

specific trade concerns can serve to clarify the technical aspects of the measures concerned, 

promote greater understanding of how the measures might affect the trade of other WTO 

Members, and resolve the concerns that WTO Members have raised. In 2009, WTO Members 

raised 75 specific trade concerns in the TBT Committee, including, for example, concerns 

regarding measures relating to managing hazards arising from use of chemicals, conformity 

assessment systems for toys, and registration requirements for medical devices. Recently, WTO 

Members underscored the importance of the Committee’s regular discussions of specific trade 

concerns, and agreed that the Committee’s work has helped to clarify and resolve trade issues 

between WTO Members.9

Box 4 shows the number of specific trade concerns that WTO Members have raised in the TBT 

Committee since 1995. The rise in the number of concerns raised reflects several factors –

including an increase in the number of proposed measures that WTO Members have notified to 

the WTO, a heightened focus on standards-related activities, increased concern that standardsrelated measures may be used as a form of disguised protectionism, and an increasing perception 

that discussions in the TBT Committee, as well as bilateral discussions on the margins of 

Committee meetings, can lead to results in addressing trade concerns. At recent TBT Committee 

meetings, roughly a third of the specific trade concerns that Members have raised related to 

measures of the European Union. Concerns regarding Chinese measures have been the second 

most frequently cited. In a few cases, concerns have remained on the TBT Committee’s agenda 

for years, such as the European Union’s regulation on the Registration, Evaluation, and 

Authorization of Chemicals (REACH), which was first raised in March 2003.

 

10 Over this time, 

33 Members have taken the floor at various TBT Committee meetings to voice trade concerns 

over REACH.11

G/TBT/28

 For a full accounting of the concerns raised in the Committee since 1995, see 

.

 9 See the discussion of the Operation of the Committee in the “Fifth Triennial Review of the Operation and 

Implementation of the Agreement on Technical Barriers to Trade under Article 15.4” G/TBT/26. 10 The process the United States uses to identify and raise issues in the TBT Committee is elaborated in Section VI.

11 Specific trade concerns regarding REACH are addressed in Section X.
17

Box 4: Number of specific trade concerns raised per year in the TBT Committee

Source: WTO, G/TBT/28

0 0 0 2 7 5 8

16 16 17 16 14 18

26 28

4 6

11

13 5 13

15

20 16 14 12

23

27

33

47

0

10

20

30

40

50

60

70

80

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Previous concerns New concerns

Standards-Related Provisions in U.S. Free Trade Agreements12

In U.S. free trade agreements (FTAs), the parties reaffirm their commitment to the TBT 

Agreement, and agree to strengthen its key provisions. U.S. FTAs build on the disciplines in the 

TBT Agreement in important ways, including by providing for greater transparency, establishing 

mechanisms for more in-depth consultation on specific trade concerns, and facilitating 

cooperation and coordination with FTA partners on systemic issues. As a result, the U.S. 

approach to standards-related measures in its FTAs is commonly referred to as “TBT plus.”13

 12 This section describes TBT provisions of U.S. FTAs with Australia, Bahrain, Central America and the Dominican 

Republic, Chile, Morocco, Oman, and Peru, all concluded in 2003 or later. Pending FTAs with Panama, Korea, and 

Colombia contain similar TBT provisions. In addition to these FTAs, the North American Free Trade Agreement 

also includes provisions that go beyond those contained in the TBT Agreement, for example, with respect to 

transparency, cooperation with trading partners regarding standards-related measures, and national treatment for 

testing and certification bodies. The U.S. FTA with Singapore also includes TBT provisions that seek to enhance the 

parties’ cooperation on standards-related measures. 

 

For example, U.S. FTAs require governments to publish the full text of their proposed standardsrelated measures, rather than simply publish a notice that it proposes to adopt the measure. In 

13 For a discussion of agreements that promote divergence from multilateral approaches ( or “TBT minus”) see

Trade Policy Working Paper No. 58, Do Bilateral and Regional Approaches for Reducing Technical Barriers to 

Trade Converge Towards The Multilateral Trading System? (OECD (TAD/TC/WP(2007)12/FINAL).
18

addition, U.S. FTAs provide interested parties, as well governments, the opportunity to comment 

on proposed measures. This enables the United States and other FTA partners to engage and 

monitor each other’s proposed measures more closely. 

U.S. FTAs also contain substantive obligations that go beyond those in the TBT Agreement. For 

example, U.S. FTAs require FTA partners to accredit or otherwise recognize U.S. testing and

certification bodies under no less favorable terms than FTA partners afford their own testing and 

certification bodies. U.S. FTAs, as well as the earlier NAFTA, also build in mechanisms (such 

as special committees) for closer and more enduring engagement and cooperation on standardsrelated measures. These mechanisms can prevent specific trade concerns from arising and assist 

the FTA governments in resolving emerging problems. 

For example, by enhancing greater understanding of each Party’s’ respective rulemaking 

processes and standards and conformance infrastructure, these consultative mechanisms can 

enable early identification of potential trade problems and provide opportunities for the FTA 

partners to discuss technical alternatives before a measure is finalized. (See, for example,

G/TBT/W/317 for a discussion of the cooperative standards-related work on automobiles, 

chemicals, food, energy, and other issues under the NAFTA.) The provisions in U.S. FTAs that 

provide for more timely and robust consultations, enhance the notifications process, and provide 

for direct bilateral engagement on notified measures are particularly important in this regard. 

Like the TBT Agreement, the TBT provisions of U.S. FTAs recognize that FTA partners should 

not be prevented from taking measures necessary to protect public health and safety or the 

environment. At the same time, U.S. FTAs lay out ways in which FTA partners can reduce the 

impact on their bilateral trade stemming from differing regulatory regimes. Several U.S. FTAs 

also contain provisions designed to encourage FTA partners to accept each other’s regulations as 

equivalent to their own, where appropriate. 

Lastly, recent U.S. FTAs provide strong support for the U.S. Standards Strategy – which 

establishes a framework for developing voluntary product standards – by formally recognizing 

the TBT Committee’s 2000 Decision on Principles for the Development of International 

Standards.

14

G/TBT/W/305

The U.S. experience with the 2000 Committee Decision is described at length in 

. These issues are discussed in more detail in the section below on Standards.

 14 Decision on Principles for the Development of International Standards, Guides and Recommendations with 

Relation to Articles 2, 5 and Annex 3 of the TBT Agreement, contained in document G/TBT/1/Rev.9, Part I, Section 

III (pp. 10-12) and Annex B (pp. 37-39).
19

Box 5: Key Standards-Related Provisions in U.S. Free Trade Agreements

The United States has negotiated free trade agreements with a number of countries. While each agreement is 

unique, many of these free trade agreements share common provisions relating to standards-related measures. This 

box summarizes standards-related provisions common to U.S. FTAs with Australia, Bahrain, Central America and 

the Dominican Republic, Chile, Morocco, Oman, and Peru. Pending FTAs with Panama, Korea, and Colombia 

contain these provisions as well.

Affirmation of the TBT Agreement: The FTAs reaffirm the parties’ obligations under the TBT Agreement and use 

the TBT Agreement’s definitions of key terms, such as technical regulation, standard, and conformity assessment 

procedures.

International standards: The FTAs require FTA partners to apply the principles of the 2000 Committee Decision in 

determining whether an international standard, guide, or recommendation exists.

Conformity assessment procedures: The FTAs recognize the variety of mechanisms that exist for facilitating 

acceptance of each other’s conformity assessment procedures, and they list specific examples of those mechanisms. 

The agreements also call for FTA partners to intensify their exchange of information regarding these mechanisms; 

require an FTA partner to explain when it will not accept, or negotiate agreements to accept, another partner’s 

conformity assessment results; call for FTA partners to recognize conformity assessment bodies in another partner’s 

territory on a national treatment basis; and require FTA partners to explain any refusal to recognize another party’s 

conformity assessment body.

Transparency: The FTAs state that each party shall permit persons from the other party to participate in the 

development of standards-related measures on terms no less favorable than those it accords to its own persons. They 

also enhance TBT Agreement transparency provisions by requiring that proposals be notified directly to the other 

Party, that objectives be included when notifying proposals, that interested parties as well as the FTA partner be 

provided a meaningful opportunity to comment and to have their comments taken into account in finalizing the 

measure, that 60 days be allowed for comment, that proposals be published or otherwise made available, that 

responses be provided to significant comments received at the time a final measure is published, and that additional 

information be provided about the objectives when requested.

Cooperation: The FTAs provide for FTA partners to intensify their joint work on technical regulations, standards, 

and conformity assessment bodies. They also urge participating governments to identify bilateral initiatives for 

specific issues or sectors.

Information Exchange: The FTAs call on each FTA partner to provide information or explanations regarding 

proposed measures within a reasonable period following a request from another FTA partner.

Administration: Each FTA creates its own committee or subcommittee to monitor application of the agreement’s 

provisions, address specific issues that arise under the agreement, enhance cooperation, and exchange information 

on pertinent developments.

Note: For more information, see http://www.ustr.gov/trade-agreements/free-trade-agreements.
20

IV. U.S. Statutory and Administrative Framework for Implementing 

Standards-Related Trade Obligations

The United States maintains a robust system to support implementation of its trade obligations 

on standards-related measures through strong central management of its regulatory regime, an 

effective interagency trade policy mechanism, and public consultation. The legal framework for 

implementing U.S. obligations under the TBT Agreement and standards-related provisions in 

U.S. FTAs includes the Administrative Procedure Act of 1947 (APA) and the Trade Agreements 

Act of 1979, as amended (TAA).15

The Trade Agreements Act establishes USTR as the lead agency within the Federal government 

for coordinating and developing international trade policy related to standards-related activities, 

as well as in discussions and negotiations with foreign countries on standards-related matters. In 

carrying out this responsibility, USTR is required to inform and consult with Federal agencies 

having expertise in the matters under discussion and negotiation. The TAA also directs the 

Secretaries of Commerce and Agriculture to keep abreast of international standards activities, to 

identify those activities that may substantially affect U.S. commerce, and to inform, consult, and 

coordinate with USTR with respect to international standards-related activities.

 The APA establishes a process of public participation in 

rulemakings by U.S. agencies through a system of notice and comment. The TAA prohibits 

Federal agencies from engaging in any standards-related activity that creates unnecessary 

obstacles to trade and directs them to consider the use of international standards in rulemaking. 

The Administrative Procedure Act provides the foundation for transparency and accountability in 

developing Federal regulations. The APA requires agencies to undertake a notice and comment 

process open to all members of the public, both foreign and domestic, for all rulemakings, and to 

take these comments into account in the final rule.

16

The foundation for central regulatory review is 

 In accordance with the APA, agencies 

publish proposed technical regulations and conformity assessment procedures in the Federal 

Register and solicit public comment. To fulfill WTO obligations to notify proposed technical 

regulations and conformity assessment procedures, the National Institute of Standards and 

Technology (NIST) in the Department of Commerce serves as the U.S. notification authority. 

NIST officials review the Federal Register and other materials on a daily basis and notify the 

WTO of technical regulations and conformity assessment procedures that agencies propose to

adopt. NIST also serves as the U.S. Inquiry Point for purposes of the TBT Agreement.

Executive Order 12866 – Regulatory Planning 

and Review (E.O. 12866) and the implementing guidance of the Office and Management and 

Budget (OMB) Circular A-4. E.O. 12866 lays out the philosophy, principles, and actions that 

 15 The standards-related provisions of the TAA are codified at United Stated Code, Title 19, Chapter 13, Subchapter 

II, Technical Barriers to Trade (Standards). 

16The term “rule” refers to “an agency statement of general or particular applicability and future effect designed to 

implement, interpret, or prescribe law or policy....” 5 U.S.C. 551(4). “Rule making” means the “agency process for 

formulating, amending, or repealing a rule....” 5 U.S.C. 551(5). These definitions include rules or rulemakings 

regarding technical regulations and conformity assessment procedures. The APA makes exceptions for urgent 

matters, allowing Federal agencies to omit notice and comment, for example, where they find that notice and public 

procedures are impracticable or contrary to the public interest. 5 U.S.C. 553(b)(3). 
21

guide Federal agencies in planning, developing, and reviewing Federal regulations. E.O. 12866 

and Circular A-4 are the primary basis on which good regulatory practice (GRP) has been 

integrated into the Federal regulatory structure. These practices ensure openness, transparency,

and accountability of the regulatory processes and as a result help ensure that the United States 

fulfills key TBT Agreement and U.S. FTA obligations. GRP,

17

Under the procedures spelled out in E.O. 12866, prior to adopting any significant regulatory 

action (e.g., a proposed technical regulation) Federal agencies must submit it for review by 

OMB. Significant regulatory actions are defined as those with an estimated annual impact on the 

U.S. economy of at least $100 million. OMB reviews Federal agencies’ proposed regulatory 

actions and consults with USTR and other agencies as needed. This review is designed to 

ensure, inter alia, that proposed regulatory actions are not duplicative or inconsistent with other 

planned or existing Federal regulatory actions, are consistent with U.S. international trade 

obligations, and take into account the trade impact of proposed regulatory actions. At the 

conclusion of this process, OMB provides guidance to the pertinent agency to ensure that its 

regulatory actions are consistent with applicable law, Presidential priorities, and E.O. 12866’s 

regulatory principles. 

such as that embodied in E.O. 

12866 and OMB Circular A-4, enables government agencies to achieve their public policy 

objectives efficiently and effectively. GRP, as well as the processes and procedures that give it 

effect, is also critical in reducing the possibility that governments will adopt standards-related 

measures that create unnecessary obstacles to trade. 

In addition to the statutes and policies outlined above, the National Technology Transfer and 

Advancement Act (NTTAA) and OMB’s implementing guidance to Federal agencies, OMB 

Circular A-119, require Federal agencies to use18 voluntary consensus standards19 in their 

regulatory activities wherever possible and to avoid using “government-unique” standards.20

 17 For a discussion of good regulatory practices from the perspective of APEC and the OECD, see:

The purpose is to discourage Federal agencies from developing their own standards where 

suitable voluntary consensus standards already exist and their use can effectively achieve the 

regulatory objectives. The NTTAA and the TAA are complementary: The NTTAA directs 

Federal agencies to look to voluntary consensus standards to meet their regulatory objectives, 

while the TAA directs them to consider using relevant international standards. As elaborated in 

the next section, international standards are those that recognized bodies (either 

APEC, “Information Notes on Good Practice for Technical Regulation,” September 2000.

OECD, Cutting Red Tape: National Strategies for Administrative Simplification. Paris, 2006.

OECD, Background Document on Oversight Bodies for Regulatory Reform. Paris: OECD, 2007. 

OECD, Regulatory Impact Analyses: Best Practices in OECD Countries. Paris: OECD, 1997.

OECD, Regulatory Performance: Ex post Evaluation of Regulatory Policies. Paris: OECD, 2003. 

OECD and APEC, APEC-OECD Integrated Checklist on Regulatory Reform. Mexico City, 2005.

18 Circular A-119 defines “use” as the inclusion of a standard in whole, in part, or by reference in a regulation.

19 Circular A-119 states that the following attributes define bodies that develop voluntary consensus standards: 

openness, balance of interests, due process, an appeals process, and consensus. 

20 Circular A-119 defines “government-unique standards” as standards developed by the government for its own 

uses.
22

intergovernmental or non-governmental) develop in accordance with principles such as 

openness, transparency, and consensus.

For additional information on the laws, policies, and interagency processes through which the 

United States implements the TBT Agreement, see G/TBT/2/Add.2, G/TBT/W/285, and 

G/TBT/W/315. See also the Report on the Use of Voluntary Standards in Support of Regulation 

in the United States presented to the High Level Regulatory Cooperation Forum of the United 

States – European Union Transatlantic Economic Council (TEC) in October 2009. For 

additional information on the relationship between technical barriers to trade and GRP, see 

G/TBT/W/287 and USITC Working Paper No ID-24, The Role of Good Regulatory Practice in 

Reducing Technical Barriers to Trade.

V. Standards

Voluntary standards serve a variety of functions and their use supports world trade, for example 

by ensuring the connectivity and compatibility of inputs sourced in global markets. The TBT 

Agreement has a specific definition of “standard” – a 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 for which compliance is not mandatory. Voluntary 

standards can facilitate buyer-seller transactions, spur competition21 and innovation, increase the 

efficiency of production, unify markets, and promote societal goals. When used as the basis for 

establishing a technical requirement in a regulation, voluntary standards can help officials 

harness relevant technology to achieve regulatory goals in a cost effective manner. In the United 

States, responsibility for developing voluntary standards rests almost exclusively, and 

appropriately, with the private sector, as this is where the technical know-how for sophisticated 

products and complex processes resides.22

The TBT Agreement acknowledges the diversity of standardizing bodies, and seeks to minimize 

unnecessary obstacles to trade that can arise from multiple standards for the same product, 

specifications that favor domestic goods over imported ones, lack of transparency, or dominance 

by a region or government in standards development. To promote greater harmonization of the 

technical requirements that WTO Members impose, the TBT Agreement promotes the use of, 

and participation in the development of, international standards. 

To this end, the TBT Agreement requires Members to base technical regulations and conformity 

assessment procedures on relevant international standards, guides and recommendations, except 

where they would be inappropriate or ineffective in meeting a legitimate objective. The TBT 

Agreement affords technical regulations based on relevant international standards a rebuttable 

presumption that they are not unnecessary obstacles to trade under the TBT Agreement. The 

 21 See Standards & Competitiveness: Coordinating for Results: Removing Standards-Related Trade Barriers 

Through Effective Collaboration, International Trade Administration, 2005.

22 Agriculture is a notable exception. USDA maintains several programs, such as the Agricultural Marketing 

Service, for the development of voluntary standards on the quality and identity of agricultural products sold in the 

U.S. market. 
23

TBT Agreement also strongly discourages standardizing bodies from developing standards 

where international standards already exist.

The TBT Agreement does not, however, designate specific standardizing bodies as 

“international.” Instead, in its 2000 Decision on the Principles for the Development of 

International Standards, Guides and Recommendations (2000 Committee Decision), the TBT 

Committee adopted a set of six principles for developing international standards.

23

It is the policy of the U.S. government to use the term “international standard” to refer to those 

standards developed in conformity with the 2000 Committee Decision principles.

 The Decision 

is designed to clarify the concept of “international standard” and to advance objectives such as 

greater harmonization of technical requirements across markets. The six principles are: (1) 

openness; (2) transparency; (3) impartiality and consensus; (4) relevance and effectiveness; (5) 

coherence; and (6) the development dimension. 

24

Annex 3 of the TBT Agreement contains a 

For example, 

U.S. FTAs require trading partners to apply the 2000 Committee Decision principles when 

determining whether a relevant international standard exists. When WTO Members use 

international standards developed in conformity with the 2000 Committee Decision in their 

technical regulations, it can promote greater global regulatory alignment and reduce the adverse 

trade effects that regulatory divergences can create. Application of principles such as consensus, 

openness, and transparency when developing standards helps ensure standards are globally 

relevant and respond to both technical and regulatory needs. The 2000 Committee Decision also 

helps ensure that all interested parties, including producers and consumers that may be affected 

by a particular standard, can participate in developing it. 

Code of Good Practice for WTO Members and nongovernmental standardizing bodies to follow in preparing, adopting, and applying standards. 

Central government standardizing bodies must adhere to the Code. WTO Members are required 

to take reasonable measures to ensure non-governmental standardizing bodies conform to the 

Code as well. In the United States, the American National Standards Institute (ANSI) has 

accepted the Code of Good Practice on behalf of the over 200 standards developing 

organizations (SDOs) that ANSI has accredited. ANSI, a private sector body, is the coordinator 

of the U.S. voluntary standards system with a membership that consists of standards developers, 

certification bodies, industry, government, and other stakeholders. In coordination with its 

membership, ANSI developed and implements the U.S. Standards Strategy. For more 

information on the ANSI system, see Overview of the U.S. Standards System. 

ANSI accredits SDOs based on its Essential Requirements. Many elements of these 

requirements mirror the 2000 Committee Decision. The Essential Requirements require each 

SDO to maintain procedures for developing standards that ensure openness, consensus, due 

process, and participation by materially affected interests. ANSI also serves as the U.S. national 

 23 Decision on Principles for the Development of International Standards, Guides and Recommendations with 

Relation to Articles 2, 5 and Annex 3 of the TBT Agreement, contained in document G/TBT/1/Rev.9, Part I, Section 

III (pp. 10-12) and Annex B (on pp. 37-39).

24 The U.S. experience with the 2000 Committee Decision is described in G/TBT/W/305. 
24

standards body member of the International Organization for Standardization (ISO) and the 

International Electrotechnical Commission (IEC). Federal agency representatives participate 

actively in ANSI policy forums, as well as in the technical committees of ANSI-accredited 

SDOs, on an equal basis as other ANSI members. 

OMB Circular A-119 contains guidance for Federal agencies in participating in the development 

of voluntary standards. Circular A-119 directs Federal agencies to participate in private sector 

standards developing organizations consistent with agency missions and priorities. The 

Interagency Committee for Standards Policy, which NIST chairs, coordinates implementation of 

this guidance. More than 4,000 Federal agency officials participate in the private sector 

standards development activities of 497 organizations25

VI. Conformity Assessment Procedures

to support regulatory needs, enable 

efficient procurement, and to help devise solutions to support emerging national priorities. It is 

notable, however, that the governments in some regions and countries take a non-technical and 

more commanding role in standards setting than Federal agencies generally do. For example, 

some governments direct their national standards bodies or central government bodies to develop 

voluntary standards to achieve specific regulatory needs.

Conformity assessment enables buyers, sellers, consumers, and regulators to have confidence 

that products sourced in global market meet specific requirements.26 Governments may mandate 

conformity assessment procedures – such as testing, sampling, and certification requirements –

to ensure that the requirements they have established in standards or regulations for a product, 

process, system, person, or body are fulfilled. Suppliers also use conformity assessment 

procedures to demonstrate to their customers that their products or related processes or systems 

meet particular specifications.

27

Yet, the costs and delays attributable to unnecessary, duplicative, and unclear conformity 

assessment requirements are frequently cited as a key concern for U.S. exporters.

 

28

 25 Source: NIST, 2008.

Indeed,

many specific trade concerns raised by the United States in the TBT Committee with respect to 

other WTO Members’ measures center on difficulties associated with the measures’ conformity 

26 Conformity assessment procedures take a variety of forms, including, for example, testing, certification, 

registration, inspection, accreditation, and verification. The entities that conduct these procedures are referred to as 

conformity assessment bodies and include such bodies as testing laboratories, certification bodies, and accreditation 

bodies. Testing laboratories, for example, test products to evaluate their performance or product characteristics 

while certification bodies certify that products conform to specific standards or requirements. Accreditation bodies, 

for example, evaluate the competency of testing and certification bodies and verify that they comply with specific 

standards or requirements.

27 For an introduction to conformity assessment, see Breitenberg, Maureen, The ABC’s of the U.S. Conformity 

Assessment System, NIST, 1997. 

28 See Johnson, Christopher, Technical Barriers to Trade: Reducing the Impact of Conformity Assessment Measures, U.S. International Trade Commission Working Paper, 2008.
25

assessment requirements. Governments can reduce or minimize such difficulties by taking into 

account the risks associated with a product’s failure to conform to an underlying standard or 

requirement when choosing the type of conformity assessment procedure to apply with respect to 

that standard or requirement. Governments can also reduce or minimize costs associated with 

conformity assessment by adopting approaches that facilitate the acceptance of the results of 

those procedures (e.g., approaches that allow products to be tested or certified in the country of 

export). The TBT Committee’s list of approaches that facilitate this acceptance is contained in 

G/TBT/1/Rev.9.

In the United States, the NTTAA directs NIST to coordinate the conformity assessment activities 

of Federal, state, and local entities with private sector technical standards activities and 

conformity assessment activities. The goal is to eliminate any unnecessary duplication of 

conformity assessment activities. Pursuant to this statutory directive, NIST issued a Federal 

Register notice in 2000 providing guidance to Federal agencies on conformity assessment. It 

calls for Federal agencies to provide sound rationales, seek public comments, look to the results 

of other government and private sector organizations, and use international guides and standards 

when incorporating conformity assessment procedures in their regulations and procurement 

processes. Today, the conformity assessment standards and guides published by ISO and IEC 

are known as the “CASCO toolbox.” 29

In addition to NIST’s efforts to inform and guide Federal agencies in adopting and applying 

conformity assessment procedures, Federal agencies and private sector organizations can look to 

guidance in ANSI’s National Conformity Assessment Principles for the United States. ANSI’s 

principles provide supplemental information designed to promote increased acceptance of U.S. 

products in international markets through the use of competently conducted conformity 

assessment procedures. The TBT Agreement, NIST’s guidance, and ANSI’s principles all 

emphasize the importance of international systems of conformity assessment in facilitating 

international trade. 

Participation and use of international systems of conformity assessment strengthens these 

international systems and produces global benefits. For example, international systems for 

accreditation play a vital role in allowing products to be tested and certified at sites that are 

convenient to production facilities and reducing duplicative testing and certification 

requirements. International systems for accreditation enable this by establishing procedures and 

criteria that accreditation bodies participating in the system agree to apply when accrediting 

testing, certification, or other conformity assessment bodies. Accreditations issued by such 

entities can, in appropriate circumstances, provide governments, as well as suppliers, assurances 

that a body – regardless of its location – is competent to test and certify products for relevant 

markets. 

Examples of international accreditation systems include the International Laboratory 

Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF). ILAC and 

IAF have established voluntary mutual recognition arrangements (MRAs). Under these MRAs, 

accreditation bodies agree to adhere to international standards and other procedures and criteria 

when accrediting testing and certification bodies and subject themselves to a system of peer-to-

 29 ISO/CASCO is the standards development and policy committee on conformity assessment of ISO. 
26

peer review to ensure that they continue to meet MRA requirements. In the United States, 

accreditation bodies that participate in these mutual recognition arrangements are predominately 

private sector entities. Increasingly, Federal agencies, such as the Consumer Product Safety 

Commission and the Nuclear Regulatory Commission, are using international systems such as 

ILAC in support of their conformity assessment requirements.

VII. U.S. Process for Identifying Standards-Related Trade Barriers and 

Determining How to Address Them

The United States also maintains rigorous, interagency processes and mechanisms for 

identifying, reviewing, analyzing, and addressing foreign government standards-related measures 

that act, or may act, as barriers to U.S. trade. USTR coordinates these processes and 

mechanisms through the TPSC and, more specifically, its specialized TBT subgroup, the TPSC

Subcommittee on Technical Barriers to Trade (TPSC Subcommittee). 

The TPSC Subcommittee, comprising representatives from Federal regulatory agencies and other 

agencies with an interest in foreign standards-related measures, meets formally at least three 

times a year, but maintains an ongoing process of informal consultation and coordination on all 

standards-related issues as they arise. Representatives of the Subcommittee include officials 

from the Departments of State, Agriculture and Commerce as well as officials from OMB and 

Federal regulatory agencies, such as the Food and Drug Administration and the Environmental 

Protection Agency. The Departments of Commerce and Agriculture serve as the primary 

conduits for communicating information between U.S. industry and agriculture export interests, 

respectively, and the TPSC Subcommittee. 

Information for the TPSC Subcommittee on foreign standards-related measures is collected and 

evaluated on a day to day basis through a variety of government channels including: the TBT 

Inquiry Point at NIST, the Trade Compliance Center (TCC), the Office of Standards Liaison, and 

the U.S. Commercial Service (UCS) in the Department of Commerce; the Foreign Agricultural 

Service (FAS) and its Office of Scientific and Technical Affairs (OSTA) in the Department of 

Agriculture; the State Department’s economic officers in U.S Embassies abroad; and USTR. 

U.S. government outreach and consultations with U.S. stakeholders generates much of the 

information supplied through these channels, which are further described below. 

To disseminate information to U.S. stakeholders on proposed foreign notifications, NIST 

operates a web-based service, NotifyUS, which automatically notifies registered stakeholders of 

measures proposed and adopted by other WTO Members in sectors of interest. These 

notifications alert U.S. firms and other interested stakeholders of their opportunity to comment 

on proposed foreign measures that may have an impact on their exports. U.S. stakeholders may 

provide their comments directly to the WTO Member concerned, if its domestic processes 

provide for that, or through NIST, which works with relevant Federal agencies to review, 

compile and submit comments to the WTO Member. By providing comments through NIST, 

U.S. stakeholders alert Federal agencies to their concerns and can enable advocacy by Federal 

agencies on their behalf. 
27

In 2009, the TBT Notification Authority and Inquiry Point at NIST processed and distributed 

155 U.S. government and industry comments to other WTO Members, and circulated 27 WTO 

Member comments on U.S. measures, as well as 67 WTO Member replies to U.S. comments, to 

relevant Federal agencies. NIST’s service NotifyUS has over 5,000 registered users. U.S.

stakeholders monitor notifications of new or revised measures of other WTO Members in sectors 

of interest through the NotifyUS alert program, and contact U.S. officials through the government 

channels listed above to obtain further information, to contribute to the submission of U.S. 

comments, and to coordinate follow-up actions.

The TCC administers the Department of Commerce’s Trade Agreements Compliance Program 

and coordinates efforts and resources within the Department to systematically monitor, 

investigate, and help ensure foreign governments’ compliance with trade agreements to which 

the United States is a party. The TCC offers an online trade complaint hotline at

www.trade.gov/tcc where exporters can report and obtain assistance in overcoming foreign trade 

barriers. The TCC helps assemble teams of specialists to investigate market access problems, 

including ones involving standards-related measures, and develop strategies to address them.

Compliance teams work with affected companies or industries to establish objectives and to craft 

and implement compliance action plans to achieve market access.

In addition, TCC regularly provides input to the TPSC based on the information on the specific 

trade concerns that it collects and analyzes through this process. This information informs the 

TPSC’s development of the appropriate U.S. position in the various multilateral and bilateral 

forums for addressing standards-related measures. On-the-ground assistance is also provided 

from Compliance Officers at U.S. Embassies in China, India, El Salvador, Japan, and at the U.S. 

Mission to the European Union in Brussels. Free, online tools include the texts of more than 270 

non-agricultural trade agreements plus a checklist of the kinds of trade barriers that the Program 

can help exporters overcome.

OSTA provides a conduit for queries and comments on foreign standards-related measures in the 

agricultural sector. OSTA monitors developments in relevant export markets, provides 

information on foreign standards-related measures through a range of publications, disseminates 

WTO TBT notifications from foreign governments to interested parties, and provides translation 

services on key export market requirements. OSTA works cooperatively with U.S. industry, as 

well as with technical specialists in its overseas offices and Federal regulatory agencies, to 

develop comments and positions on specific foreign standards-related measures. In addition, 

FAS works through relevant international organizations to resolve agriculture-related issues 

arising from foreign standards-related measures. 

In addition to these government channels, the TPSC Subcommittee receives information from 

the Industry and Agriculture Trade Advisory Committees (ITAC and ATAC, respectively). The 

ITAC and the ATAC help identify trade barriers and provide assessments regarding the practical 

realities that producers face in complying with technical regulations and conformity assessment 

procedures. USTR and Commerce officials meet at least quarterly with the ITAC on Standards 

and Technical Trade Barriers (ITAC 16), which is composed of cleared advisors from 

manufacturers, trade associations, standards developers, and conformity assessment bodies.30

 30 See

 

http://www.ustr.gov/Who_We_Are/List_of_USTR_Advisory_Committees.html. 
28

USTR also meets with other ITACs and advisory committees to receive advice on TBT issues 

affecting specific industry sectors, such as steel, chemicals, automobiles, processed foods, and 

textiles, or specific regulatory areas, such as labor and environment.

In developing the U.S. position on any foreign standards-related measure, the TPSC 

Subcommittee takes into account how the United States regulates the same or similar products. 

Regulatory agency officials on the TBT TPSC Subcommittee also provide important information 

on the technical and scientific aspects of particular foreign standards-related measures, as well as 

insights on cooperative efforts through international organizations that may be relevant to the 

issue. The TPSC Subcommittee factors the views that regulatory agencies express into the 

positions that the United States takes in multilateral, regional, and bilateral trade discussions 

regarding standards-related measures. Particularly in the area of emerging technologies where 

standards-related activities are nascent, the technical, scientific, and policy advice that regulatory 

agencies provide is critical in formulating U.S. views. 

Indeed, the need for greater coordination and policy attention to emerging technologies is 

critical. On March 12, 2010, the Office of Science and Technology Policy and the Office of 

Management and Budget and USTR sent a joint memorandum to the heads of Federal 

departments and agencies announcing the establishment of a high level interagency group to 

serve as a point of coordination for identifying, and where appropriate, addressing cross-cutting 

issues relating to emerging technologies that affect multiple agencies. This group, the 

“Emerging Technologies Interagency Policy Coordination Committee” (ETIPC), will 

complement the work of the TPSC and the National Science and Technology Council (NSTC), 

by providing a forum for appropriate and timely consideration of a broad range of policy 

questions and to coordinate positions that Federal agencies may take when engaging on these 

issues internationally. The goals of the ETIPC are to ensure that U.S. policy capitalizes on the 

potential of emerging technologies for spurring economic growth and breaks down barriers that 

could stifle innovation.

VIII. U.S. Engagement on Standards-Related Measures in International, 

Regional, and Bilateral Fora

Overview of U.S. Engagement on Standards-Related Measures

The United States maintains a broad and active agenda of engagement with foreign governments 

both to prevent unnecessary obstacles to trade and to resolve specific trade concerns arising from 

standards-related measures. As noted above, the TBT Committee is the principal multilateral 

forum for engagement on trade issues relating to standards-related measures. The mechanisms 

for cooperation on standards-related measures in U.S. FTAs also play a vital role in facilitating 

U.S. bilateral and regional efforts to prevent and resolve trade concerns. U.S. agencies also seek 

to prevent potential technical barriers from emerging by engaging in multilateral, regional, and 

bilateral cooperative activities, information exchanges, technical assistance, and negotiations on 

specific agreements. These efforts are aimed at helping other governments design effective and 

well-conceived standards-related measures, with the goal of producing better regulatory 

outcomes and facilitating trade. 
29

U.S. government cooperative efforts and information exchanges with developing countries can 

assist firms in those countries build their capacity to comply with foreign standards-related 

measures. As developing country producers increase their participation in global supply chains,

they need a better understanding of foreign technical requirements and strategies to consistently 

meet those requirements. Cooperative activities can also serve to prevent localized high-profile 

incidents of the type that can disrupt trade across all markets and damage both producer 

reputations and consumer confidence. Close coordination among trade, regulatory, and 

standards officials with highly specialized technical expertise is required in order to carry out 

cooperation and information exchange initiatives that successfully meet these objectives.

The United States provides bilateral technical assistance and capacity building to developing 

countries on standards-related activities through the U.S. Agency for International Development 

(USAID), the U.S. Trade and Development Agency (USTDA), and the Commerce Department’s 

Commercial Law Development Program (CLDP), Market Development Cooperator Program 

(NDCP), and NIST. USDA’s Foreign Agricultural Service (FAS) also provides technical 

assistance on standards related to food trade. These agencies have broader missions and 

generally provide standards-related capacity building assistance as a component of a specific 

project or mission.

To reduce the negative impact on trade of divergences in technical requirements across markets, 

USTR negotiates bilateral, regional, and multilateral mutual recognition agreements (MRAs) 

with U.S. trading partners. These agreements establish procedures for each party to accept the 

results of conformity assessment procedures for specified products carried out in the other 

party’s territory or to accept the other government’s technical specifications for those products as 

sufficient to meet its own requirements. MRAs with trading partners that have a regulatory 

approach compatible with that of the United States and a similar level of technical capacity can 

help facilitate trade in select sectors where trade flows are significant and technical requirements 

can be complex, such as in the telecommunication equipment sector. 

NIST maintains a complete inventory of the government-to-government MRAs to which the 

United States is a party. It also maintains a listing of the accreditation requirements for 

conformity assessment bodies under each MRA to which the United States is a party and a list of 

conformity assessment bodies that NIST has designated pursuant to each MRA as competent to 

perform tests or certify products to ensure they conform to the other MRA party’s technical 

requirements. (The Federal Communications Commission (FCC) website provides useful 

background information on U.S. MRAs and examples of how they work.) 

The United States also seeks to reduce foreign technical barriers by concluding “equivalency” 

arrangements with other governments. A recent example is the June 2009 exchange of 

equivalency determinations between USDA and Canada’s Food Inspection Agency on organic 

agricultural products. As a result of that exchange, U.S. producers that a USDA-accredited agent 

has certified as meeting U.S. National Organic Program standards do not need to be certified 

under the Canada’s National Organic Standard in order to market their products in Canada as 

“organic.” The exchange provides for Canadian producers to receive a similar accommodation 

for products they export to the United States. 
30

U.S. engagement on standards-related measures in various international and regional fora is 

detailed below. U.S. bilateral engagement with its trading partners on standards-related 

measures is detailed in individual Country Specific Reports in Section X.

TBT Committee

Specific Trade Concerns

The U.S. government actively seeks to prevent and eliminate technical barriers to trade through 

the TBT Committee, with its focused WTO Member-driven agenda. The Committee dedicates a 

significant portion of each of its three annual meetings to affording WTO Members the 

opportunity to raise specific trade concerns on measures that other Members have proposed or 

adopted. WTO Members may also use Committee sessions to share experiences, case studies, or 

concerns relating to cross-cutting issues regarding how WTO Members are implementing the 

TBT Agreement. The TBT Committee often holds workshops or other events on special topics 

alongside its formal meetings. On the margins of each meeting, Members engage in informal 

bilateral and plurilateral meetings to clarify and resolve specific trade concerns and to discuss 

how to resolve other issues of mutual interest. 

In 2009, the United States raised specific trade concerns regarding 20 to 30 foreign TBT 

measures at each TBT Committee meeting held during the year and in the informal meetings it 

held with individual or groups of WTO Members. The details and status of many of the specific 

trade concerns that the United States raised in, and on the margins of, the TBT Committee 

sessions are described in Section X of this report, Country Specific Reports. As elaborated in the 

Country Specific Reports, U.S. interventions in the TBT Committee, and on its margins, have 

helped resolved a number of standards-related concerns affecting U.S. trade.

The Committee’s annual review of its activities is contained in G/TBT/28, and includes a 

thumbnail description of the specific trade concerns that WTO Members raised, as well as 

identifies the Members that raised them. 

The Fifth Triennial Review of the TBT Agreement

The TBT Agreement calls for the TBT Committee to review the implementation and operation of 

the Agreement every three years. These triennial reviews provide an important opportunity for 

WTO Members to clarify particular provisions of the Agreement. Triennial reviews have 

resulted in a significant body of agreed recommendations and decisions, contained in 

G/TBT/1/Rev.9, which are intended to strengthen and improve the operation of the TBT 

Agreement. In November 2009, the TBT Committee completed its Fifth Triennial Review of the 

Operation and Implementation of the Agreement on Technical Barriers to Trade Under Article 

15.4. Suggestions that the United States put forward for purposes of the review on regulatory 

cooperation, good regulatory practice, internal coordination, transparency, and international 

standards figure prominently among the Committee’s recommendations in its report on the 

results of the review, which are set out in G/TBT/26. The Committee also established an 

important and ambitious work program on conformity assessment in the report on the review. 

The report and its recommendations establish the focus of the TBT Committee's work program.
31

Regulatory issues featured prominently in the discussions under the review. The United States 

advocated for greater regulatory cooperation in a joint submission with its NAFTA partners 

(G/TBT/W/317). Regulatory cooperation is an avenue for reducing unnecessary technical 

divergences as well as for achieving better regulatory outcomes – both of which can help to 

facilitate and expand trade. For example, regulatory efforts that effectively reduce the incidence 

of unsafe products benefit both the consumers who purchase those products as well as the 

producers that produce those products. The TBT Committee supported the proposal from the 

NAFTA countries, and agreed to hold a workshop to explore the variety of approaches to 

regulatory cooperation. The workshop is tentatively scheduled for March 2011. The Committee 

will be looking to use the workshop to identify whether there are avenues to promote greater 

regulatory alignment. 

During the review, a U.S. submission on how to identify the need to regulate, G/TBT/W/285, 

also factored into the TBT Committee’s discussions and recommendations as an important 

component of GRP discussions. Other Members showed significant interest in advancing work 

on GRP, with Brazil, Canada, China, Costa Rica, Jordan, Korea, Israel, and New Zealand 

submitting papers and comments relating to GRP issues. GRP carries the potential to help WTO 

Members: enhance their capacity for market surveillance; apply risk analysis in developing 

regulation; produce clarity in the definition of regulatory objectives; facilitate communication 

with industry and consumers; provide a basis for effective training; maximize the benefits of 

trade facilitation; and generally ensure policy integrity. Going forward, the TBT Committee will 

compile guidelines and discuss mechanisms for WTO Members to implement GRP. 

In the course of the review, the United States also spearheaded in-depth discussions on the 

benefits and challenges of greater use of international standards. Worldwide use of international 

standards facilitates trade by helping firms achieve economies of scale in production, source lowcost global inputs, and achieve greater acceptance for their products across countries. In March 

2009, the Committee held a workshop on overcoming challenges and instituting best practices 

relating to the development and use of international standards to help firms in developing 

countries participate more fully in global markets. Experts from Peru, Pakistan, Brazil, 

Colombia, Chile, Egypt, and Kenya presented practical case studies illustrating how the use of 

international standards yielded positive economic benefits to their economies. Several 

developing country Members stressed the challenges confronting their producers in complying 

with multiple or conflicting standards around the world. Many U.S. exporters strongly support 

the principle that governments should avoid mandating unnecessary local specifications for 

globally traded products. 

Members also reaffirmed the importance during the review of both the TBT Agreement’s Code 

of Good Practice for developing, adopting, and using standards and the 2000 Committee 

Decision on the development of international standards. The Code calls on Members to ensure 

that their standardizing bodies at the central level of government do not adopt standards that 

create unnecessary obstacles to trade, and to take reasonable measures to ensure that 

standardizing bodies at sub-central levels of government as well as private standardizing bodies 

do not produce standards that create unnecessary obstacles to trade. The 2000 Committee 

Decision states that processes for developing international standards should be transparent, 

consensus-based, and open to all interested parties. Both the Code and the 2000 Committee 

Decision seek to avoid duplication in standards development. At the conclusion of the review, 
32

the TBT Committee agreed to share experiences and examine more closely the ways in which 

Members implement both the Code and the 2000 Committee Decision. 

In previous triennial reviews, the Committee’s work on conformity assessment focused on 

information exchange. In the course of those reviews, the Committee held several events 

addressing conformity assessment31

G/TBT/1/Rev.9

and developed an indicative list of approaches that Members 

can use to facilitate the acceptance of results of conformity assessment procedures performed in 

other countries (see ). In the Fifth Triennial Review, Members agreed to 

continue to exchange information on this subject, but broadened the scope of that exchange to 

include the criteria, methods of analysis, and concepts that Members use to inform their 

evaluation and choose conformity assessment procedures for specific purposes, including in the 

context of a risk management framework. Further, based on these exchanges, the TBT 

Committee agreed to initiate work on developing practical guidelines on how to choose and 

design efficient and effective mechanisms aimed at strengthening the implementation of the 

conformity assessment provisions of the TBT Agreement.

Finally, during the Fifth Review, the Committee continued its focus on how Members are 

carrying out those provisions of the TBT Agreement that provide for Members to give notice and 

comment on proposed technical regulations and conformity assessment procedures. The TBT’s 

notice and comment rules and the requirement for Members to take comments into account in 

finalizing the measure they notify are fundamental to preventing and minimizing unnecessary 

obstacle to trade. During the Fifth Review, Members discussed and reaffirmed the significant 

body of recommendations and decisions on these transparency procedures that the Committee 

had established in earlier reviews. In addition, reflecting the increase in standards-related 

regulatory activity of local governments (e.g., at the state and provincial level) affecting trade, 

the Committee called for better coordination between central and local governments to improve 

Members’ implementation of the TBT Agreement’s transparency provisions.

APEC

In 1994, APEC32

 31 These events were: (i) a Symposium on Conformity Assessment Procedures was held on 8-9 June 1999 (G/TBT/9, 

13 November 2000, Annex 1); (ii) a Special Meeting dedicated to Conformity Assessment Procedures was held on 

29 June 2004 (G/TBT/M/33/Add.1, 21 October 2004); (iii) a Workshop on Supplier's Declaration of Conformity 

(SDoC) was held on 21 March 2005 (Annex 1 of G/TBT/M/35, 24 May 2005); and, (iv) a Workshop on the 

Different Approaches to Conformity Assessment, including on the Acceptance of Conformity Assessment Results, 

was held on 16-17 March 2006 (G/TBT/M/38/Add.1, 6 June 2006).

established the Subcommittee on Standards and Conformance (SCSC) with the 

goal of better aligning the divergent approaches to standards and conformance issues that 

economies in the region have adopted. The SCSC works to reduce the negative impact of these 

divergences on trade and investment, as well as to facilitate increased market access through 

improved standards and conformance procedures. The SCSC seeks to improve these measures 

by promoting approaches that embody the APEC principles of market-driven interdependence 

32 The APEC members are Australia, Brunei Darussalam, Canada, Chile, China, Hong Kong China, Indonesia, 

Japan, Korea, Malaysia, Mexico, New Zealand, Papua New Guinea, Peru, the Philippines, Russia, Singapore, 

Taiwan, Thailand, Vietnam, and the United States.
33

and open regionalism. The SCSC does not develop standards and does not support the use of 

regional standards. Rather, the SCSC seeks to encourage APEC economies to align their 

standards-related measures with international standards. 

The SCSC is unique among inter-governmental forums in that it regularly brings together trade 

policy officials, representatives of national standards bodies, and other technical specialists33

The SCSC is a valuable forum for garnering support for policy priorities, conducting capacity 

building activities, and building consensus among APEC economies on standards-related 

measures. The Committee makes use of studies, surveys, workshops, training, and other events

to achieve these objectives. The SCSC work is member-driven, with officials of different APEC 

countries working collaboratively to develop and implement projects and initiatives. These 

efforts are designed to promote greater alignment to international standards, pursue recognition 

arrangements for conformity assessments, encourage cooperation to develop “technical 

infrastructure,” and improve implementation of good regulatory practices, including through 

activities to promote greater understanding and cooperation on regulatory issues. The SCSC 

addresses both TBT and SPS issues.

to 

advance standards-related goals through cooperation. Regulatory officials often participate in 

SCSC special events and initiatives. The SCSC often invites private sector representatives with 

specific expertise to participate in its special events. The United States has established several 

public-private partnerships to advance priority issues in the SCSC. These partnerships provide 

the SCSC with invaluable access to technical expertise and resources – and provide critical 

information on the practical realities that producers face in complying with technical regulations, 

and that governments confront in developing standards and using conformity assessment 

procedures. 

Over the years, the SCSC has made important contributions to advancing progress and 

understanding on the trade aspects of standards-related matters, both in the region and 

internationally. In its work on conformity assessments, the SCSC has published reports and 

surveys on topics such as suppliers’ declaration of conformity, market surveillance, and the 

effectiveness of MRAs. The SCSC established a “Voluntary Alignment Program” that has 

identified priority areas for member economies to align their measures with international 

standards and monitored the progress of each economy has made in adopting international 

standards. The SCSC has also adopted a strategic plan for improving technical infrastructure 

that identifies capacity building priorities for each developing APEC economy in the areas of 

standards, accreditation, laboratory accreditation, metrology, and legal metrology. 

The United States has led several important standards-related initiatives in APEC, including the 

APEC Toy Safety Initiative, the Partnership Training Institute Network (PTIN) of the Food

Safety Cooperation Forum (FSCF), and the Strategy on Business Engagement in Standards and 

 33 Representatives from the APEC “Specialized Regional Bodies” (SRBs) participate in the SCSC as technical 

experts. The five APEC SRBs are: the Pacific Area Standards Congress (PASC), the Asia-Pacific Metrology 

Program (APMP), the Pacific Accreditation Cooperation (PAC), the Asia Pacific Legal Metrology Forum (APLMF) 

and the Asia-Pacific Laboratory Accreditation Cooperation (APLAC). For a summary of work of the SRBs, see 

“The Role of the APEC Specialist Regional Bodies: Elements of the Standards and Conformance Infrastructure” 

March 2008.
34

Conformance. All three of these initiatives were developed and are being implemented as 

public-private partnerships. The United States also co-chairs the SCSC’s Trade Facilitation Task 

Force (TFTF), which brings trade and technical experts together on a regular basis to share 

information and cooperate on product-related environmental standards-related measures. The 

United States recently co-sponsored a project led by Singapore on models of assistance in 

helping SMEs overcome technical barriers to their exports. 

The APEC Toy Safety Initiative

Following high-profile incidents involving recalls of unsafe toys in 2007, APEC Leaders 

directed their officials to work to strengthen product safety standards and practices in the region 

without creating unnecessary obstacles to trade. The SCSC responded in 2008 by launching the 

U.S.-led APEC Toy Safety Initiative. Co-sponsored by the U.S. Toy Industry Association, the 

goals of the APEC Toy Safety Initiative are to strengthen toy safety, increase transparency, 

promote better regulatory alignment, and reduce unnecessary obstacles to trade that may arise as 

a result of toy safety systems. The Initiative sought to advance these goals through the 

“Regulator Dialogue on Toy Safety” held in Singapore in August 2009 and the Survey of Toy 

Safety Regulators delivered at the “Open Dialogue on Toy Safety for All Stakeholders” held in 

conjunction with the Hong Kong Toy Fair in January 2010.34

The APEC Toy Safety Initiative was critical. First, of course, the safety of children is a 

paramount concern among APEC economies. Second, trade in toys is vital to prosperity in the 

region. APEC economies are home to 85 percent of the world’s toy manufacturers and 

exporters. Further, technical requirements related to toy safety have been changing rapidly and 

these new requirements differ markedly across markets around the globe. In APEC alone, 11 of 

the 21 member economies had notified the WTO of changes to their regulatory practices 

regarding toys in the previous three years.

 

35

Chairman Inez Tenenbaum of the U.S. Consumer Product Safety Commission gave the keynote 

address to Regulator Dialogue, which brought together regulators from 20 APEC economies. 

Regulators from 10 economies provided detailed information on their regulatory schemes, and 

the leading technical experts from standards developing organizations discussed the similarities 

and divergences among three toy standards, ASTM F-963,

 Further, over recent years WTO Members have 

increasingly raised trade concerns in the TBT Committee regarding new toy safety measures that 

other Members have proposed. 

36 EN-71,37

 34 All of the agendas, presentations and reports on the APEC Toy Safety Initiative’s activities are available on the 

website of the Toy Industry Association: 

and ISO 8124. Five 

http://www.toyassociation.org.

35 WTO Members that have notified the TBT Committee of toy safety measures include Chile, China, Japan, Korea, 

Mexico, New Zealand, Peru, the Philippines, Taiwan, the United States, and Vietnam.

36 ASTM International is non-governmental organization that develops voluntary standards for materials, products, 

systems, and services. ASTM-F963 is its Standard Consumer Safety Specification for Toy Safety.

37 EN-71 is the European standard that specifies the safety requirements for all toys sold in the European market. 

EN-71 is developed by CEN, the European Committee for Standardization (Comitée Européen de Normalisation).
35

economies presented information on their procedures for export inspections, compulsory 

certifications, pre-market inspections, and mandatory third party testing, and the role their 

customs authorities play in identifying unsafe toys. 

A consensus emerged from the Regulator Dialogue that ensuring toys are safe is a responsibility 

that no single economy can undertake on its own, and that safety solutions must have global 

currency. Regulators agreed to consider ways to improve conformity assessment procedures for 

toys by strengthening and expanding dialogue on best practices with key stakeholders. 

Participants also concurred on the need to promote greater alignment of technical requirements,

including by exploring ways to “expand the common set” of reference standards for toys and 

redoubling efforts to harmonize approaches to emerging hazards.

The Open Dialogue on Toy Safety among All Stakeholders, sponsored by APEC, the U.S. Toy 

Industry Association, and the Hong Kong Trade Development Council brought together officials 

from 19 economies38 (11 served as speakers)

39

The APEC Toy Safety Initiative has advanced regulatory cooperation both within and beyond

APEC, and helped to initiate relationships between regulators, standards experts, and 

stakeholders that will further the project’s goals. Regulators that participated in the Initiative 

agreed to continue this cooperation in other international organizations, and to collaborate in a 

project to identify successful market surveillance practices. The Initiative resulted in greater 

collaboration and coordination among the standards developers. ASTM and ISO pledged to 

support greater technical cooperation in developing toy standards and agreed to hold future joint 

meetings when possible. 

to discuss advancing trade in safe toys with 

representatives of consumer groups, manufacturers, retailers, standards organizations, and 

conformity assessment bodies. Keynote addresses affirming the commitment to seek to align toy 

standards were given by Chinese Vice Minister Wei of AQSIQ, CPSC Chairman Tenenbaum,

and EU Consumer Commissioner Kuneva. The United States also presented the results of the 

Survey of Toy Safety Regulators, which showed the wide diversity of the regulatory regimes in 

the region. Eighteen of the 21 APEC economies mandate toy safety standards: 13 reference ISO 

8124; 10 reference EN-71; and 7 reference ASTM F-963. (In some instances, APEC economies 

reference all three standards in their regulatory regimes.)

In particular, ASTM International invited delegates to the ISO Technical Committee on Toy 

Safety (ISO TC/181) to attend and participate in reviewing proposed changes to ASTM F-963. 

Representatives from 17 countries, including some APEC economies, joined with members of 

the ASTM F15.22 committee on toy safety to explore enhancements to technical standards that 

could address potential toy hazards related to impaction, magnets, and projectiles. Further, the 

ISO Technical Committee on Toy Safety adopted a resolution to establish an advisory panel to 

determine priorities for the ISO Technical Committee that will facilitate increased cooperation 

 38 Brunei Darussalam and Russia did not send representatives.

39 Australia, Canada, China, Hong Kong, China, Indonesia, Japan, Malaysia, Mexico, New Zealand, United States, 

and Vietnam, plus European representatives from the European Commission, the ISO 8124 Technical Committee, 

Chairman of the CEN Technical Committee 52, and the World Trade Organization.
36

among toy standard setting bodies in the interest of promoting standards alignment and avoiding 

development of further divergences among major toy standards. Experts from CEN will 

participate in the advisory panel.

Partnership Training Institute Network of the Food Safety Cooperation Forum 

Concerns about food safety in the Asia Pacific region have risen sharply in recent years and have 

spurred a collective mandate from APEC Leaders to improve food safety standards and practices

in the region without creating unnecessary impediments to trade. In response, the SCSC 

established the Food Safety Cooperation Forum (FSCF) in 2007 with the goal of improving food 

safety regulatory systems in APEC economies, including food inspection, assurance, and 

certification systems that are consistent with WTO Members’ rights and obligations under both 

the SPS and TBT Agreements.40

The FSCF, co-chaired by Australia and China and composed of high-level regulatory officials 

responsible for food safety – including Dr. Steven Sundlof of FDA’s Center for Food Safety and 

Nutrition and Dr. David Goldman of USDA’s Food Safety and Inspection Service – set about to 

address this direction by identifying the capacity building priority needs in each developing 

APEC economy. The FSCF initiated 25 different capacity building activities, held in five cities 

across the region. In 2008, the United States in collaboration with the Grocery Manufacturers 

Association and the Joint Institute for Food Safety and Nutrition (JIFSAN) of the University of 

Maryland, spearheaded the establishment of the Partnership Training Institute Network under the 

FSCF (FSCF PTIN) to combine the expertise and resources of industry and academia to 

strengthen and augment the FSCF’s efforts in addressing the capacity building needs in the 

region. The FSCF PTIN initiative was endorsed by APEC Leaders in 2008, launched in July 

2009, and has now entered the implementation phase. 

 The FSCF seeks to advance food safety and facilitate trade in 

safe food by addressing capacity building opportunities for APEC member economies in priority 

areas such as information sharing, food safety regulatory systems, and food inspection. In 2008, 

Leaders called for increased capacity building to improve technical competence and 

understanding of food safety management among stakeholders in the food supply chain, which 

include regulators, growers, packers, handlers, storage providers, processors, manufacturers, 

retailers, and food service providers. 

The goal of the FSCF PTIN is to facilitate trade and protect public health by building the 

capacity of stakeholders in the food supply chain to use international standards and best practices 

in food safety management from production to consumption. To this end, the FSCF PTIN will 

help APEC economies anticipate, prevent, and manage food safety incidents, and thus better 

assure the safety of the food supply chain in the APEC region. The FSCF PTIN will seek to 

fulfill this goal by creating a network of food safety institutes, trainers, and practitioners in the 

APEC region. This network will communicate and exchange scientific and technical 

information related to food safety, as well as strengthen and expand food safety management 

training by developing a set of curricula and training tools that support the use and understanding 

of international standards and best practices. 

 40 The FSCF covers both SPS and TBT issues. For convenience, the activities of the FSCF are included in the 2010 

TBT Report rather than 2010 SPS Report. 
37

The FSCF PTIN will support training on food safety in a manner consistent with the rights and 

obligations of the WTO SPS and TBT Agreements. The FSCF PTIN is not intended to be an 

actual “bricks and mortar” facility, but instead will build on existing resources in the region to 

create a network of institutes with the capacity to conduct training in international best practices 

in food safety. FSCF PTIN training programs will draw on expert faculty and experienced 

practitioners from academia, industry, consulting firms, and government agencies.

Business Engagement in Standards and Conformance

The SCSC has long recognized the importance of the engagement of business and industry 

stakeholders from APEC economies on key topics in order to enhance cooperation on standardsrelated measures and facilitate trade in the region. By working together, policy makers, 

standards developers, and business leaders can maximize the positive contribution that standards 

and conformance procedures make in promoting trade and investment in the region. When 

APEC economies use market-relevant international standards and conformance procedures they 

help to expedite trade transactions, reduce costs, encourage broader product acceptance, and 

promote greater integration of supply networks. The SCSC seeks to promote greater 

participation by APEC economies in international standardization activities to ensure that the 

international standards adequately reflect the region’s trade interests. Moreover, when those 

standards take into account the market considerations in the region, APEC economies will be 

more likely to adopt them, and result in greater alignment of technical requirements in the APEC 

region.

The SCSC is seeking through this initiative, co-led by Vietnam and the United States, to develop 

a long term strategy to increase business involvement with the SCSC in support of these goals. 

In August 2009, business and industry representatives with expertise in standards and conformity 

assessment joined the SCSC to discuss potential areas for facilitating trade in the region through 

on-going cooperative activities. Participants discussed current engagement by APEC economies 

in developing standards for such products as smart cards, Information Technology (IT)-based 

vehicle control logic for intelligent transport systems, and mobile technologies for e-commerce, 

as well as product safety design in IT products. 

Participants stressed how important it is for governments to establish market relevant conformity 

assessment procedures and for businesses to develop strategies to monitor and comply with 

emerging technical regulations. The SCSC convened a Conference on Business Engagement, 

co-sponsored by ANSI, the U.S. Chamber of Commerce, and the National Association of 

Manufacturers. Mr. Teng Theng Dar, 2009 Chair of the APEC Business Advisory Council and 

CEO of the Singapore Business Federation, provided the keynote address. The Conference 

resulted in over 50 recommendations to the SCSC for possible future collaboration with 

businesses in the APEC region to promote further progress on ensuring trade-facilitative 

approaches to standards and conformity assessment procedures in the region.

Trade Facilitation Task Force (TFTF)

The proliferation and diversity of product-related environmental regulations, particularly those of 

the European Union, prompted the need for an APEC forum to promote information exchange 
38

and cooperation to reduce the potential adverse trade impact on APEC economies of these 

emerging technical requirements. In 2006, the SCSC established the Trade Facilitation Task 

Force (TFTF). The TFTF, co-chaired by Korea and the United States, brings together trade and 

technical experts to exchange information on specific trade concerns affecting APEC economies 

(whether imposed by other APEC economies or countries outside the APEC region) and to 

promote cooperation in international standardization activities associated with product-specific 

environmental regulations. Experts from industry, academia, international or regional bodies,

and other relevant authorities participate in TFTF activities.

In February 2009, the TFTF met in Singapore to exchange information and promote cooperation

on several topics. First, the TFTF reviewed technical work on standards under way in various 

standardizing bodies, such as IEC and ASTM International, to help producers implement and 

comply with material declaration aspects of product-specific environmental regulations (such as 

the EU Directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and 

Electronic Equipment (RoHS), the EU Directive on Energy Using Products (EuP), and EU

REACH.) The TFTF also explored new areas of work including trade and technical aspects of 

current work related to carbon emission estimation and sustainability. 

Carbon footprinting is one method that can assist governments, industry, and consumers in 

promoting the use and development of low carbon products. During the TFTF meeting, experts 

from government, academia, and standards organizations exchanged information on the 

methodological and conceptual challenges involved in developing estimates of a product’s 

“carbon footprint.” The TFTF also discussed the challenges associated with carbon footprint 

labeling programs – particularly difficulties relating to comparability of estimates across 

products and to the ability to communicate complex information to consumers in an 

understandable, reliable, and concise form. 

The TFTF also reviewed the status of international standardization activities related to carbon 

footprinting, such as through ISO TC 207/SC7/WG2 (an ISO working group that develops 

standards addressing greenhouse gas management in the value or supply chain). Participants 

noted that few APEC economies have been involved in these activities to date, and questions 

were raised regarding the representation of trade perspectives in this work and the potential 

implications for the market relevance of the standards being developed.

The TFTF also regularly collaborates with experts from the APEC Chemical Dialogue Steering 

Group and the APEC Energy Working Group’s Expert Group on Energy Efficiency and 

Conservation on work underway in those bodies related to regulatory practices and standards 

development.

Export Assistance Models for Small and Medium Sized Enterprises (ETAM)

Businesses, in particular SMEs, that seek to export overseas, often face difficulties in learning 

about and understanding foreign regulatory requirements applicable to their products. Finding 

effective ways to assist SMEs overcome TBTs as they seek to export is a priority for the United 

States. Accordingly, the U.S. Department of Commerce took on a leadership role in cosponsoring an initiative that Singapore is leading in the SCSC to study the existing models in the 
39

various APEC economies for providing this type of assistance, with a view to gaining insights 

into working models and learning best practices to inform policy makers in all APEC economies.

U.S. programs to assist SMEs will be featured in the final report of this initiative. Many APEC 

economies have launched initiatives to help their businesses address this problem. Singapore 

would also like to help develop a network of APEC member agencies that provide these services 

to share information and work together, especially when dealing with new and existing technical 

regulations in major export markets around the world. The SCSC will review this study and 

develop recommendations in 2010.

North American Free Trade Agreement 

Under NAFTA, the parties established the CSRM and related subcommittees. This forum is an 

important venue for discussing standards-related matters affecting North American trade. In 

addition, the three NAFTA governments have long acknowledged the positive effects of 

improved trilateral regulatory cooperation, which acts to lower costs for North American 

businesses, producers, governments and consumers; maximize trade in goods and services across 

North American borders; and protect health, safety, and the environment. In March 2005, the 

Leaders of Canada, Mexico and United States launched a Regulatory Cooperation Framework 

(RCF) in the context of the Security and Prosperity Partnership of North America, with three 

general goals: (1) to strengthen regulatory cooperation, including at the outset of the regulatory 

process; (2) to streamline regulations and regulatory processes; and (3) to encourage 

compatibility of regulations, promote the use or adoption of relevant international standards in 

regulations, and eliminate redundant testing and certification requirements, consistent with each 

country’s WTO obligations. While the work of the RCF extends beyond standards-related 

measures, many key areas of the RCF’s work concern or relate to standards-related measures. 

Under the RCF, the United States, Canada, and Mexico agreed to a set of common regulatory 

principles to guide North American regulators as they develop regulations.

41 These common 

principles are rooted in WTO rules and mirror closely OECD principles. They include 

minimizing the adverse impact of regulations on fair and competitive market economies; 

minimizing unnecessary duplicative requirements within North America; identifying alternatives 

to addressing public policy objectives, including non-regulatory options; and ensuring that 

regulations are developed and implemented in a transparent fashion. The three governments also 

established a list of illustrative “best practices” that provide concrete guidance, in each of the 

three countries, on how to achieve these common principles.42

In addition, the NAFTA governments established a trilateral forum on Regulatory Impact 

Analysis (RIA)

 These best practices encompass 

government efforts to streamline the regulatory process, increase the use of regulatory impact 

assessments, and improve transparency through effective public consultations throughout the 

rulemaking process. 

43

 41 See

under the RCF, which brings together regulatory policy experts from the three 

http://www.spp.gov/docs/RCF_Common_Regulatory_Principles_Inventory_Best_Practices_FINAL.doc.

42 Ibid.

43 For an explanation of regulatory impact analysis, see OECD. Regulatory Impact Analyses: Best Practices in 

OECD Countries. Paris: OECD, 1997.
40

countries to strengthen their collaboration on procedures, practices, and tools that underpin new 

regulatory proposals. In 2008, this forum undertook a trilateral review of an existing U.S. 

Department of Transportation RIA on electronic stability control for motor vehicles, allowing 

Canada and Mexico the opportunity to provide comments on the analysis. This joint pilot project 

also allowed representatives from regulatory agencies and departments, as well as representatives 

from federal agencies in the three governments that are responsible for regulatory policy in the 

three countries, to discuss the similarities and differences between the analyses and 

methodologies each country applies in developing regulations. The participants found the 

discussion to be highly instructive and the three governments intend to pursue similar reviews in 

the future. The United States believes that this type of analytical work and dialogue are key for

developing compatible approaches to technical regulations.

In the food and agricultural sector, the United States, Canada, and Mexico have been working 

together for many years to improve sector-related product regulations and practices. The three 

governments have established NAFTA technical working groups (TWGs) to address issues such 

as food labeling and packaging. TWGs and forums such as the North American Biotechnology 

Initiative play a significant role in enhancing regulatory cooperation in this sector, in particular 

through collaboration on a wide range of regulatory projects. One such project, for example, 

sought to enhance cooperation between the three countries regarding food laboratories by: (1) 

establishing a procedure to share information on laboratory methods; (2) exchanging information 

on proficiency testing programs in each country; and (3) identifying gaps where programs are not 

available. In another project, the three countries have agreed on a harmonized approach to the 

scientific basis they use to update dietary reference values for labeling food products. 

The United States, Canada, and Mexico are also undertaking several joint activities with the goal 

of reducing air pollution and greenhouse gas emissions from vehicles and engines and ensuring

that significantly cleaner vehicles and fuels are marketed throughout North America while 

enhancing regulatory cooperation among the three countries. The three governments have 

shared information on policies and programs on standards for vehicle fuel efficiency, standby 

power consumption, and the potential for natural gas to support optimal energy use for the 

future. The three governments undertook a comprehensive analysis of various emissions 

inventories of the three countries to prepare a trilateral strategy to make them more compatible. 

Additional areas for future cooperation could include activities such as exchanging of 

information on vehicle and engine testing, as well as sharing information on developing and 

using voluntary partnerships to reduce in-use fleet emissions. 

The United States, Canada, and Mexico have also collaborated to enhance auto safety, guard 

against vehicle theft, and promote fuel economy. The three countries are also working towards 

harmonizing regulations and streamlining the regulatory process for the auto sector in order to 

help the North American auto industry remain competitive. Specifically, the U.S. Department of 

Transportation (DOT) and Transport Canada (TC) signed a bilateral Memorandum of 

Cooperation (MOC) in the area of motor vehicle safety regulation. The Mexican Ministry of 

Communications and Transportation and Ministry of Economy have agreed to commence 

negotiations to join in this effort and conclude a trilateral North American MOC.

The United States, Canada, and Mexico have also developed a trilateral approach to apply the 

results of ongoing efforts to: (1) assess, prioritize, and take appropriate action on existing 
41

chemicals in the United States; (2) update information on inventories of such chemicals in 

Canada’s Chemicals Management Plan; and (3) assist Mexico in developing a chemical 

inventory. The objective of this work is to achieve the following by 2020: (1) establishing or 

updating inventories of chemicals in commerce in all three countries;(2) enhancing capacity in 

Mexico to assess and manage chemicals; and (3) achieving sound management of chemicals in 

North America as articulated by the World Summit on Sustainable Development Johannesburg 

Plan of Implementation and reinforced by the Strategic Approach to International Chemicals 

Management. These efforts are designed to contribute to improving regulation to protect human 

health and the environment, while avoiding unnecessary obstacles to trade, through a practical 

and focused approach to strengthen chemical management in North America over the long term. 

In July 2007, the three countries also concluded an agreement on energy science and technology 

– a framework designed to stimulate innovation and to share and help build capacity in all three 

countries. Ministers emphasized that developing cleaner and more efficient ways to produce and 

use conventional energy and advancing knowledge of renewable energy, science, and technology 

were fundamental to increasing energy security, sustaining economic prosperity, and protecting 

the environment, and that greater regulatory cooperation increased the potential return on 

investment in energy science and technology. 

The three NAFTA countries have also harmonized their energy efficiency performance standards 

for freezers and refrigerators, three-phase motors, and room air conditioners as part of a larger 

effort under the RCF to systematize energy efficiency harmonization among the three countries. 

The three governments have also held workshops on Standby Power and Transportation 

Efficiency. The NAFTA governments are also committed to further aligning their energy 

efficiency standards on key consumer products, and identifying specific ways to increase 

cooperation on research and development and to reduce barriers to deployment of new 

technologies in a wide variety of areas, including biofuels, gas hydrates, hydrogen, carbon 

capture and storage, clean coal, and electricity transmission.

In short, the NAFTA approach to regulatory cooperation emphasizes the importance of 

regulatory alignment (including reduction of regulatory inconsistencies and redundancies), 

administrative simplification, and the use of practical, science- and risk-based tools, to attain 

critical health, safety, environmental, and security goals in a way that avoids unnecessary 

obstacles to trade. Such an approach enables the NAFTA partners to attain their legitimate 

regulatory objectives while reducing rather than increasing the burden on businesses and 

consumers.

Doha Round Negotiations Regarding Standards-Related Measures

The United States has tabled three proposals in the WTO’s Doha Round of Trade Negotiations 

on Non-Agricultural Market Access (NAMA) aimed at reducing standards-related non-tariff 

barriers (NTBs). These proposals cover: (1) textiles, apparel, footwear, and travel goods

(TAFT);

44 (2) electronic goods;45 and (3) automotive goods.46

 44 Understanding on the Interpretation of the Agreement on Technical Barriers to Trade with respect to the Labelling 

of Textiles, Clothing, Footwear, and Travel Goods (TN/MA/W/93/Rev.1, 15 September 2009).

 WTO Member “senior officials” 
42

have set all three of these proposals for priority negotiations as part of the overall NAMA NTB 

negotiations and the proposals were included in the NAMA Chair’s December 2008 negotiating 

text.47

Each of the three proposals seeks to facilitate trade in specific sectors for which U.S. industry has 

expressed particular concern about standards-related NTBs. For example, the TAFT proposal 

grew out of U.S. industry concern that the differing approaches that WTO Members take to 

labeling requirements and sudden changes in those requirements can impose substantial costs 

and burdens on producers and delay time to market for these products, which are often seasonal. 

In many cases, these costs are then passed on to importers and consumers. The three proposals 

aim to build on existing TBT Agreement disciplines to create new or enhanced disciplines for 

these specific sectors in areas such as transparency, good regulatory practice, international 

standards, and conformity assessment procedures, while at the same time ensuring that regulators 

retain the ability to meet legitimate policy objectives, such as protecting health, safety, and the 

environment, at levels they consider appropriate. 

The U.S. NAMA proposals contain a number of provisions similar to the standards-related 

provisions of U.S. free trade agreements. In particular, the U.S. proposals seek to ensure that 

U.S. exporters and other relevant stakeholders have the right to participate on a nondiscriminatory basis in the process by which other WTO Members develop standards-related 

measures. The proposals would guarantee these stakeholders a right to submit comments on 

proposed measures (including voluntary standards that central government bodies develop), to 

have other WTO Members take their comments into account, and to see a response to their 

comments no later than the date the WTO Member publishes the final measure. 

The U.S. autos and electronics proposals also contain provisions to encourage standardizing 

bodies in the territories of WTO Members to develop standards in accordance with principles 

designed to ensure that they are globally and technically relevant and that the processes these 

bodies use to develop them include a meaningful opportunity for U.S. exporters and other 

stakeholders to participate. The proposals would do this by directing WTO Members to base 

their decisions on whether a standard is “international” on whether the body that developed the 

standard did so in accordance with the six principles of the 2000 Committee Decision discussed 

in Section V of this report. 

The autos and electronics proposals also seek to require WTO Members to provide national 

treatment with respect to the criteria and procedures they use to accredit or otherwise approve 

conformity assessment bodies to test and certify products for their markets and to accept test 

results performed by competent facilities outside a WTO Member’s territory. In addition, the 

autos and electronics proposal would require WTO Members to review their existing technical 

 45 Agreement on Non-Tariff Barriers Pertaining to the Electrical Safety and Electromagnetic Compatibility (EMC) 

of Electronic Goods (TN/MA/W/105/Rev.2, 15 September 2009).

46 Agreement on Non-Tariff Barriers Pertaining to Standards, Technical Regulations, and Conformity Assessment 

Procedures for Automotive Products (TN/MA/W/120, 15 September 2009).

47 Fourth Revision of the Draft Modalities for Non-Agricultural Market Access (TN/MA/W/103/Rev.3, 6 December

2008. The list of proposals is in paragraph 24.
43

regulations and conformity assessment procedures in these sectors at regularly-scheduled 

intervals and ensure that they have adequate domestic procedures in place to review the actions 

their regulators take in applying technical regulations and conformity assessment procedures in 

these sectors.

In addition, the U.S. autos and electronics proposals would require WTO Members that are 

preparing or proposing to adopt a technical regulation or conformity assessment procedure to 

consider the costs of complying with the proposed measure, recognizing that considering the cost 

of compliance can both inform Members’ regulatory analyses and help them ensure that the 

requirements they adopt do not create unnecessary obstacles to trade. Further, the U.S. autos 

proposal would require Members to assess, when they prepare or propose to adopt a technical 

regulation or conformity assessment procedure, whether regulatory and non-regulatory 

alternatives are available. 

The provisions in the U.S. proposals to enhance transparency, good regulatory practice, and 

reliance on the 2000 Committee Decision principles seek to help U.S. stakeholders influence the 

development standards-related measures in WTO Member countries in ways that minimize their 

effect on trade. These provisions also promote greater alignment of standards-related measures 

across WTO Members. If adopted, these provisions will help ensure, for example, that as 

regulators in various WTO Members develop standards-related measures to address common 

problems, stakeholders have the opportunity to provide relevant information and to advocate for 

solutions that are consistent across jurisdictions (e.g., that rely on a common standard or 

conformity assessment approach). These provisions also help hold regulators accountable by 

requiring them to take into account and respond to such comments. These provisions will

increase the likelihood that regulators in different countries will reach similar conclusions, such 

as on the risks associated with a particular product and appropriate measures to mitigate those 

risks, and develop and adopt more efficient and effective measures. 

In addition to these provisions, the U.S. TAFT proposal seeks to facilitate trade in textiles, 

apparel, footwear, and travel goods through provisions that would promote greater alignment of 

labeling requirements, which should, in turn, reduce costs for suppliers, exporters, and 

consumers. The proposal would promote greater alignment of labeling requirements by 

presumptively deeming that certain types of labeling requirements (such as requirements to 

include care instructions or fiber content on a label) comply with the TBT Agreement’s rule that 

technical regulations should be “no more trade restrictive than necessary to meet a legitimate 

objective” and by prohibiting other requirements (such as requirements for labels to be certified 

or made of certain materials). The proposal would also encourage Members to use nonpermanent labels. Under the proposal, regulators would retain their ability to require information 

on permanent labels needed to inform and protect consumers (e.g., flammability information on 

labels for children’s sleepwear). 

The U.S. proposal on electronic goods seeks to commit WTO Members to one of two forms of 

conformity assessment procedures in the areas of electrical safety and electro-magnetic 

compatibility – third party certification or a suppliers’ declaration of conformity. The proposal 

would establish disciplines for both types of procedures that ensure, for example, any product 
44

testing a Member requires can be performed in the exporting country and that U.S. testing and 

certification bodies are treated no less favorably than equivalent bodies in other WTO Members. 

Finally, the U.S. proposal on automotive products seeks to encourage Members to (a) participate

in the work of international standardizing bodies as a way of harmonizing technical regulations 

and conformity assessment procedures for those products; (b) consider other Members’ 

automotive technical regulations and conformity assessment procedures when they determine 

that there is a need to regulate and explain any proposed deviations in substance from relevant 

international standards; and (c) provide at least 18 months for producers to comply with a new 

technical regulation that would require substantial change in automobile design or technology. 

Organization for Economic Cooperation and Development

The OECD is an organization comprising 30 governments that seeks to support sustainable 

economic growth, boost employment, raise living standards, maintain financial stability, assist 

other countries develop economically, and contribute to growth in world trade. As part of its

work program on non-tariff barriers to trade, the OECD conducts a variety of activities and 

studies to deepen understanding of the nature and magnitude of the trade effects that standardsrelated measures can produce. The United States actively supports this research by facilitating 

the exchange of information between U.S. and OECD experts through papers, discussions, and 

workshops. The OECD Secretariat has work underway or recently completed on several TBT 

topics. 

The OECD is currently looking at the extent to which WTO Members use relevant international 

standards when they establish technical regulations, as the TBT Agreement generally requires. 

The Secretariat is also pursuing work in the area of product labeling, where government 

requirements have grown more complex and divergent in recent years with potentially negative 

implications for trade. Other recent current studies include an assessment of trade problems 

related to the use of conformity assessment procedures and a comparison of TBT provisions in 

regional trade agreements. The OECD also regularly holds workshops on the nexus of trade 

policy and standards-related activities. 

IX. Trends

The U.S. government actively seeks to prevent and eliminate technical barriers to trade through a 

variety of venues and on many levels. Previous sections of this report reviewed U.S. government 

engagement in bilateral and multilateral venues on specific trade concerns and on systemic 

issues. Section X provides a summary of the specific concerns of the United States with 

standards-related activities in specific countries or groups of countries. This section reviews 

trends that appear across various U.S. trading partners’ markets as well as trends, or systemic

issues, observed within a single trading partners’ market. These trends concern standards-related 

measures or policies that can significantly affect the ability of U.S. businesses and producers to 

access foreign markets.
45

European Union’s Approach to Standards and Conformity Assessment

Several years after the completion of the 1992 European single market initiative, the European

Commission announced its intention to encourage its trading partners to adopt standards and 

regulatory approaches based on, or compatible with, European practice.48 The European 

Commission noted in a 2007 strategy paper submitted to the European Council and Parliament 

that its single market can act as a global standard setter to enhance the competitiveness of 

European industry. This strategy paper recommended that the EU “promote greater global 

regulatory convergence – including where appropriate the adoption of European standards –

internationally through international organizations and bilateral agreements.”49 This section lays 

outs several ways in which the European Commission promotes European standards and how 

this provides an advantage to European industry.

One way the EU promotes use of European standards is through its New Approach Directive. 

Under the EU New Approach, the European Commission requests European standards bodies

CEN, CENELEC and ETSI50 to develop standards to meet “essential requirements” of various 

other EU directives. Non-EU persons cannot vote in the CEN and CENELEC technical 

committees. These EU directives then identify CEN, CENELEC or ETSI standards that, if 

complied with, create a “presumption of compliance” with the essential requirements of the 

corresponding EU directive. 

While the New Approach allows other standards to be used to meet essential requirements, U.S. 

producers report that in practice the costs and uncertainty associated with not using a CEN or 

CENELEC standard51

 48 European Commission, "Community External Trade Policy in the Assessment" (COM(96)564 final, 13.11.96), 

Jan. 13, 1997, p. 1.

and attempting to demonstrate that their use of alternative standards will 

fulfill the essential requirements can be prohibitive. As a result, U.S. producers often feel 

49 Commission of the European Communities, “Communication from the Commission to the Council, The European 

Parliament, The European Economic and Social Committee and the Committee of the Regions: A Single Market for 

Citizens,” COM (2007) 60 Final, Brussels, 21.2.2007, p. 7.

50 CEN – the European Committee for Standardization – and CENELEC– the European Committee for 

Electrotechnical Standardization – are the two primary European standardizing bodies. ETSI, the European 

Telecommunications Standards Institute, a recognized body, operates differently than CEN and CENELEC.

51 An example of the costs and uncertainties with using non-European standards is U.S. stakeholders’ experience 

with the EU Pressure Equipment Directive (97/23/EC). The PED provides a presumption of compliance with the 

PED’s essential requirements for products that conform to certain CEN standards; products that conform to other 

standards do not enjoy that presumption. Under the PED, a producer seeking to use other standards has two options: 

(1) obtain a “particular material appraisal” (PMA) from the Commission indicating that when a particular 

manufacturer uses a particular material in a particular product it meets the relevant PED essential requirement; or 

obtain a European Approval of Materials (EAM) indicating that when any pressure equipment is made of a 

particular material by any manufacturer it meets the relevant PED essential requirements. However, industry reports 

that both options demand significant time and resources. Moreover, PMAs are limited to a particular manufacturer’s 

use of a particular material in a particular product and, while EAMs apply more broadly, they are difficult to obtain 

in practice inter alia because they include review by the Member States. In the case of the PED, industry estimates 

that only about a third of industry EAM applications have been approved through 2008.
46

compelled to use the relevant CEN or CENELEC standard for products they seek to sell on the 

EU market. 

However, because non-EU persons cannot vote in the CEN or CENELEC technical committee,

when a U.S. producer uses a CEN or CENELEC standard it may be using a standard that has 

been developed through a process in which it had no meaningful opportunity to participate. This 

is particularly the case for SMEs and other companies that do not have a European presence. 

The opportunity for U.S. stakeholders to influence the technical content of EU directives setting 

out essential requirements (i.e., technical regulations) is also limited. This is because when the 

EU notifies proposed directives containing essential requirements to the WTO, the EU does not 

identify the specific CEN or CENELEC standards for which the presumption of compliance will 

be given. As a consequence, U.S. stakeholders often do not have the opportunity to comment on 

critical technical elements of proposed technical regulations and conformity assessment 

procedures contained in EU directives. 

The EU also promotes adoption of European standards in other markets – and often requires the 

subrogation of non-EU standards to EU standards as a condition of providing assistance to, or 

affiliation with, other countries – which can give EU companies commercial advantages in those 

markets. The EU and some Member States have established standards initiatives as part of 

foreign-aid programs. European entities promote the use of EU directives and European 

standards to developing countries through technical training. European entities are known to link

provision of technical assistance to the adoption of European standards and legislation. At a 

recent TBT Committee workshop on standards, one developing country stated that the EU had 

conditioned roughly 2 million Euros in technical assistance on the country’s adoption of 10,000 

European standards. 

The EU promotes European standards through its use of Partnership Standardization Body (PSB) 

agreements with national standards bodies. Negotiated by CEN and CENELEC with their 

counterpart organizations in developing countries that have an FTA or other links with the EU, 

such agreements provide developing country standards authorities with free access to European

standards but oblige them to use those standards and delete any standards that conflict with such 

standards from their national codes. The deleted standards can be standards that U.S. producers 

use and that may be of equal or superior quality to the CEN or CENELEC standards that 

replaced them. U.S. producers would then need to choose between the cost of redesigning or 

reconfiguring the product or exiting the market. CEN has 20 affiliate members, while

CENELEC has eleven, including the national standards bodies Israel, Turkey, and the Ukraine. 

U.S. companies report that European standards are incorporated into other countries’ legal codes, 

affecting U.S. exports to those markets as well. 

The EU strategy is evident in its influence on the development of international standards and 

guides as well. Through the Vienna Agreement between CEN and ISO and the Dresden 

Agreement between CENELEC and IEC, the EU is able to bypass a portion of the deliberative 

and consensus building processes that generally characterize translation of new standards 

proposals into international standards through ISO and IEC. For example, when standards are 

developed through those agreements with a CEN or CENELEC lead, the CEN and CENELEC 

technical committees do not need to submit their standards to ISO and IEC for a vote until the 
47

standards reach the “draft International Standard” stage – at which point it is often difficult to 

make substantive changes to the standard. If the parallel ISO or IEC committee disagrees with 

the technical content of a draft standard, the CEN or CENELEC technical committee may choose 

to develop a regional standard rather than participate in technical work of ISO or IEC. 

In some instances, this choice may influence ISO and IEC technical committees to agree to 

develop standards under the Vienna and Dresden Agreements. It can also dampen opposition to 

provisions of CEN or CENELEC-drafted standards by non-EU members of the ISO and IEC 

technical committees when those provisions eventually come before those committees for review 

and voting. For example, after a French ride-on lawnmower standard failed to gain support in 

ISO, France sought to have the standard developed in CEN. The United States has expressed 

concerns with this standard, including its deviation from standards used in the United States and 

other EU Member States. (See the European Union Country Report in Section X for further 

details on concerns the United States has raised with respect to the French lawnmower 

requirement.) Similarly, the ISO technical committee on nanotechnologies, TC229, agreed to 

develop jointly a nanotechnology labeling standard that some committee members believed was 

unnecessary because the alternative was that CEN would develop the standard on its own. 

Even where a standard is not developed through the Vienna or Dresden Agreements, the 

participation of 27 EU Member States can result in the EU having greater influence in ISO and 

IEC technical committees than other countries. This influence can facilitate the incorporation of 

EU standards and technical requirements into ISO and IEC standards. To counter this regional 

influence, ISO and IEC have in recent years adopted policies to promote the “global relevance” 

of their standards. Under this policy, the technical content of ISO and IEC standards should be 

able to be implemented anywhere in the world, and not give preference to the characteristics of a 

particular country or region. The adoption of these global relevance policies should help ensure 

that ISO and IEC standards support global trade and do not create trade barriers. In some 

instances, however, implementation of global relevance policies at the technical level, 

particularly with respect to the incorporation of “essential differences,” has been inadequate. 

For example, several IEC standards for wireless devices contain provisions accounting for 

differences in the electrical infrastructures of several EU Member States. However, U.S. 

producers report that their proposals to modify these standards to take into account the electrical 

infrastructures of countries outside the EU were not supported by European members of the 

relevant technical committees. As a result, U.S. and other non-EU competitors in the electrical 

equipment business cannot claim that their products comply with the IEC standards or utilize the 

IECEE CB scheme.52 Compliance with IEC standards can give companies a competitive 

advantage in emerging markets that are developing electrical infrastructure and regulations to 

support that infrastructure. In a few cases, U.S. producers report that EU companies have urged 

other countries to adopt these IEC standards and to delete the standards used by U.S. companies 

from their national codes, which could push U.S. products out of those markets. 

 52 The IECEE CB Scheme is international system for mutual acceptance of test reports and certificates dealing with 

the safety of electrical and electronic components, equipment and products.
48

With respect to the Codex Alimentarius Commission,53 the participation of 27 EU Member 

States and the EU’s special status as a Regional Economic Integration Organization has in some 

cases enabled European standards and regulatory approaches at odds with those of other 

countries to influence Codex work. For instance, the EU maintains a mandatory biotechnology 

labeling regime and has been pressing for over a decade to have Codex develop a biotechnology

labeling standard that reflects the EU approach. The United States and other trading partners 

have consistently voiced concerns about the EU’s mandatory biotechnology labeling requirement 

and its negative impact on U.S. and other foreign producers’ ability to export safe biotechnology 

products to the EU.

There are other examples as well. Some EU Member States are attempting to obtain a 

modification to one of the parameters for extra virgin olive oil, linolenic acid, in the Codex 

standard for extra virgin olive oil. If they are successful, olives grown in Europe could be used 

to produce olive oil to be labeled “extra virgin.” However, due to differences in climatic and 

geographic conditions, the levels of linolenic acid in authentic extra virgin olive oils produced in 

other countries – e.g., Argentina, Australia, Chile, Mexico, New Zealand, South Africa, and the 

United States – may not meet the levels set out in the modification proposed by the EU. EU 

Members States have also previously successfully advocated for the inclusion of annexes setting 

out European cheese-making standards and practices in 1654 separate Codex cheese standards 

and, most recently, successfully lobbied to maintain these annexes within these standards. 

The EU also seeks to promote its approach to the accreditation of testing and certification bodies. 

The EU has explained for example that it seeks to “promote, in its international relations, the 

European model of accreditation.”55 Under the EU approach, each Member State must designate 

a single, not-for-profit entity that may accredit conformity assessment bodies in Europe. The EU 

approach provides for recognition of accreditation bodies in other countries, provided they have 

been designated by their governments as the country’s single, not-for-profit accreditation body. 

In the United States alone there are over 200 accreditation bodies; choosing a single body to 

accredit all conformity assessment bodies in the United States would be impracticable and 

inappropriate. 

As a result, the United States is concerned that U.S. accreditation bodies may no longer be 

recognized in the European Union, irrespective of their competence and status under ILAC or 

 53 The Codex Alimentarius Commission is an intergovernmental body established in 1963 by the Food and 

Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). The 

Commission's main aims are to protect the health of consumers and ensure fair practices in the international food 

trade. The SPS Agreement recognizes the Codex Alimentarius Commission as a source of international standards for 

the purposes of the SPS Agreement.

54 Codex standards for Cheddar (C-1), Danbo (C-3), Edam (C-4), Gouda (C-5), Havarti C-6, Samso (C-7), 

Emmental (C-9), Tilsiter (C-11), Saint-Paulin (C-13), Provolone (C-15), cottage cheese (C-16), Coulommiers (C18), cream cheese (C-31), Camembert (C-33), Brie (C-34), and mozzarella (c-46).

55 See “General Guidelines for Cooperation between the European co-operation for Accreditation and the European 

Commission, the European Free Trade Area and the competent national authorities,” European Commission 

Enterprise and Industry Directorate-General, Certif doc 2009-01, pages 4, 7-8.
49

IAF. There is also significant concern in the United States and elsewhere that the EU approach 

may undermine the ILAC and IAF international accreditation systems. In particular, by leaving 

to Members States’ discretion whether to recognize these systems, conformity assessment bodies

in other countries accredited by ILAC and IAF signatories may no longer be recognized in 

Europe. Other countries, particularly developing countries, may find that the only way to have 

their accreditation bodies recognized in Europe is to adopt the EU approach. (See the EU 

Country Report in Section X for further details on this issue.)

The EU approach to promoting its standards and conformance system also includes efforts to 

establish ISO, IEC and other bodies in which Europe is represented by its 27 member states as 

the exclusive developers of “international standards” and to require its trading partners to use 

these particular standards as the basis for their technical regulations. For example, in several 

venues the EU has sought to establish that the relevant international standards for a particular 

sector or sectors are developed exclusively by these bodies. Thus, for example, the EU-Korea 

FTA and the EU’s electronics proposal in the WTO NAMA NTB negotiations identify ISO, IEC, 

and the International Telecommunications Union (ITU) as the exclusive international 

standardizing bodies for the electronics sector and seek to commit trading partners to base their 

technical requirements for electronics on standards developed by these bodies. 

The EU’s autos proposal in the WTO NAMA NTB negotiations is another example. That 

proposal identifies the World Forum for the Harmonization of Vehicle Regulations, within the 

framework of the United Nations Economic Commission for Europe (UNECE), as the “main 

international standardizing body” for automotive products and would require that WTO 

Members adopt all standards developed by this body within ten years. The vast majority of autos 

standards developed under the UNECE framework have been developed pursuant to procedures 

established in an agreement known as the “1958 Agreement.” Under the 1958 Agreement 

procedures, a standard can be adopted by a two-thirds vote and each of the 27 EU Member States 

votes individually. As a result, the majority of 1958 Agreement standards were developed 

through a process dominated by EU Member States. Thus, the standards resulting from the 1958 

Agreement process arguably resemble EU regional standards rather than “international 

standards.” 

Although the United States was the only non-European founder of the UNECE and its subsidiary 

body WP-29, it is not a signatory to the 1958 Agreement due to the “closed door” practice of 

developing standards and regulations under that Agreement. In 1995, the United States 

spearheaded the development of a new agreement and pushed for its conclusion in 1998. The 

1998 Agreement – which entered into force in 2002 – established a more open, transparent, and 

consensus-based process for the development of “global technical regulations” (GTRs) under the 

UNECE. The 1998 Agreement established the protocols and standards development 

mechanisms that have led to the development of several GTRs. 

The United States raises concerns with the EU’s standards-related activities as they arise in the 

context of particular market access issues, including as they affect SMEs which, because of their 

more limited resources may be less able to manage the problems presented by the EU’s 

approach. In 2010, U.S. officials intend to work to develop a more comprehensive strategy for 
50

addressing the negative impact of the EU’s approach on standards and conformance on U.S. 

exports to the EU as well as third countries. 

China’s Development and Use of Standards and Technical Regulations in the 

Information Technology Sector 

Since its accession, China has devoted significant energy to reforming its standards, testing, and 

certification regimes following its WTO accession. In general, China has worked towards 

aligning its standards system with international practices and developing procedures for 

notifying its proposed technical regulations and conformity assessment procedures to the WTO. 

The United States remains concerned, however, about China's current approach to developing 

and using standards and technical regulations in the information technology sector, which in too 

many instances appears designed to favor China-specific approaches. Many of the standards are 

developed absent meaningful (if any) foreign input and tend to favor domestic producers. 

First, China still does not notify some proposed technical regulations and conformity assessment 

procedures to the WTO, provide WTO Members an opportunity to comment, take those 

comments into account, or provide a reasonable time period for compliance. For instance, 

during bilateral talks in September 2009, the United States learned from officials from China’s 

Ministry of Industry and Information Technology (MIIT) that China would approve hand held 

devices that employ the widely-used WiFi standard, but only if those devices are also enabled 

with the Chinese standard – the WAPI (WLAN authentication and privacy infrastructure) 

encryption algorithm for secure communications. MIIT officials acknowledged that there is no 

published or written measure setting out this requirement, and that China had not notified this 

requirement to the WTO. Thus, WTO Members and private sector stakeholders were unable to 

comment on the technical merits of the measure. 

Similarly, in May 2009, China’s MIIT issued a proposed measure mandating that all computers

sold in China be pre-installed or packaged with the Chinese-produced “Green Dam – Escort of 

the Youth Flowers” Internet filtering software by July 2009. China never notified the measure to 

the WTO and provided a very short (i.e., less than two months) implementation period. When 

global technology companies, worldwide media, and Chinese citizens learned of the measure, 

they expressed serious concerns about the stability of the Chinese software, the scope and extent 

of the filtering activities, and its security weaknesses. In June 2009, China announced that it was 

suspending the measure indefinitely. 

Second, China’s standards-setting process lacks openness and transparency. The vast majority of 

Chinese technical committees have not been fully open to foreign participation. In some cases, 

Chinese technical committees refuse membership to foreign firms. In other cases, the 

committees may permit companies with majority foreign ownership to attend but deny them the 

right to vote. In instances where the committees allow foreign firms to have non-voting observer 

status, these firms reportedly may be required to pay membership fees far in excess of those the 

domestic voting members pay.

The lack of openness and transparency in Chinese standards-setting processes appears to be part 

of China’s broader strategy, outlined in the Standards Administration of China’s September 2004 
51

strategy report, to promote China’s development of standards and technical regulations as a 

means of protecting its domestic industry as its tariff rates fall. Chinese regulators often favor

the use of Chinese-developed standards despite the existence of relevant international standards, 

and these policies may serve to protect domestic companies from competing foreign standards 

and technologies. 

The following examples highlight how the lack of transparency and openness in China’s 

processes for developing technical regulations and standards have promoted China-specific 

approaches that may adversely impact access to the Chinese market for U.S. companies. 

With respect to the WAPI standard mentioned above, China has made several attempts over the 

years to require incorporation of this standard in information technology products used in China, 

even though there is a relevant international standard – WiFi. China first sought to enforce the 

use of WAPI in China by mandating its use and providing a necessary algorithm only to a 

limited number of Chinese companies. Later, China began requiring all government agencies, 

quasi-government bodies, and government-affiliated organizations to give priority to WAPIcompliant products when procuring WLAN and related products using government funds. Most 

recently (as discussed above), China indicated that it will only approve mobile handsets sold in 

China incorporating the WiFi standard for WLAN technology if they are also enabled with 

WAPI.

China also attempted to develop a standard for mobile phone batteries that would have specified

requirements for size, electrical performance, safety performance, and labeling. The proposed 

battery sizes were too large for many phones, especially newer, smaller phones, would have 

raised questions about the ability of suppliers to sell mobile phones with a built-in battery in 

China, and would have limited innovation in battery design, performance, and safety. China 

suspended development of the standard after domestic and international stakeholders, including 

the United States, the European Union, and Japan, raised concerns. 

In addition, in 2007 China proposed to require that thirteen categories of commercially available 

information technology products to be tested and certified to Chinese standards for information 

security functions. No other country had imposed such requirements in the commercial sphere 

or for non-sensitive government functions. China eventually rolled back the proposal, but the 

compulsory certification requirement in the final measure still applies when suppliers sell certain 

specified information technology products to Chinese government agencies. Thus, U.S. hightech companies are being forced to decide whether to develop one set of products for the Chinese 

public sector and another for the rest of the world or entirely forego the Chinese government 

market. The United States remains concerns about this measure and will continue to engage 

with China on this issue. 

See Section X below for further information on U.S. efforts to address these issues. 
52

Mandatory Biotech Labeling

A growing number of markets around the world either require or have proposed mandatory retail 

labeling for food products that contain or are derived from biotechnology. Details, as well as 

implementation, of the regimes vary from market to market. However, the mandatory nature of 

these regimes has impeded or, in some cases, completely blocked U.S. exports of such food 

products to several countries. These countries include Australia, Brazil, China, EU Member 

States, Indonesia, Japan, Korea, Malaysia, New Zealand, Russia, Saudi Arabia, Thailand, and 

Taiwan. U.S. biotechnology crops are ubiquitous and include corn, cotton, and soybeans, as well 

as food produced or processed from these crops. Biotechnology crops are the core of U.S. 

agricultural exports, which totaled $98.6 billion in 2009. Proposed mandatory biotechnology 

labeling measures in Korea, Turkey, and Vietnam are discussed in Section X.

 

For three reasons, the mandatory labeling of food products containing or derived from 

biotechnology negatively affects trade. First, mandatory labeling affects the consumer’s 

impression of a product subject to the labeling requirement. As a general matter, no 

requirements exist that all food be labeled to indicate the breeding technique used to produce it. 

A mandatory method-of-production regime that applies only to products containing or derived 

from biotechnology creates the impression that the labeled food is in some way different from, or 

less safe, than a comparable, unlabeled food not containing or derived from biotechnology. 

Second, mandatory biotechnology labeling for such food products has unnecessarily increased 

costs for consumers and industry stakeholders. It has also raised costs and presented other 

challenges for government officials who implement and enforce mandatory biotechnology 

labeling regimes. Third, the negative impact on trade of mandatory biotechnology labeling is 

compounded where countries lack adequate infrastructure or mechanisms to implement and 

enforce these regimes in a consistent and transparent manner. 

In many markets, the combined effect of these three problems has caused companies to 

reformulate their products to eliminate the use of ingredients containing or derived from 

biotechnology. These companies bear additional costs of searching for alternative ingredients, 

some of which may be expensive or in limited supply. Many of these costs are ultimately passed 

on to the consumer. 

Recognition of Conformity Assessment Bodies

Some governments do not permit U.S. suppliers to use competent conformity assessment bodies 

(e.g., testing laboratories or product certifiers) located in the United States to demonstrate that 

their products comply with their technical regulations. Rather, U.S. exporters are required to use 

conformity assessment services provided by bodies in the destination market. Requiring 

conformity assessment procedures to be performed by conformity assessment bodies in the 

destination market can impose additional costs and burdens on U.S. exporters, particularly 

SMEs. These costs and burdens can be compounded by significant delays when the foreign 

market lacks sufficient domestic testing, inspection, or certification capacity. 
53

The TBT Agreement includes several provisions relevant to this issue. First, it encourages WTO 

Members to permit foreign conformity assessment bodies to participate in their conformity 

assessment procedures on terms no less favorable than those accorded to domestic or other 

foreign conformity assessment bodies. The Agreement also requires Members to accept, 

whenever possible, test results, certifications and other forms of assurance performed in other 

Members’ territories provided they are satisfied that they offer an assurance of conformity 

equivalent to their own. To advance that possibility, the Agreement encourages Member to 

negotiate agreements with other WTO Members to mutually recognize the results of each other's

conformity assessment procedures (MRA).56 

Further, the TBT Agreement calls on Members to use, wherever practicable, international 

systems of conformity assessment. As discussed in Section VI, two such systems are the ILAC

and the IAF57 international accreditation systems. These systems enable WTO Members to rely 

on them as a basis for recognizing conformity assessment bodies, including bodies located 

outside their territories, to test, certify, and perform other forms of conformity assessment on 

products destined for their markets. 

In 2009, the United States raised concerns in bilateral, regional and multilateral venues regarding 

the testing, certification, or accreditation procedures of several trading partners in cases where

the trading partner’s system does not provide for recognition of foreign conformity assessment 

bodies including bodies that have been accredited under the ILAC or IAF systems. As a result to 

sell their products in those markets, U.S. exporters must have their products tested or certified 

there and U.S. conformity assessment bodies have lost opportunities to provide conformity 

assessment services for those markets: 

Argentina and Brazil: In September 2009, Brazil’s toy regulator (INMETRO) announced that it 

would allow laboratories that have been accredited by an ILAC MRA signatory to conduct 

required testing of toys and other children’s article in certain instances. Its previous position was 

that all testing would have to be conducted in Brazil, which industry feared would lead to delays 

to the Brazilian market. In response to similar industry concerns, Argentina is working to 

identify additional testing capacity, which U.S. officials hope will include recognizing 

laboratories outside Argentina that have been accredited by an ILAC MRA signatory to perform 

phthalates testing for toys to be sold on the Argentine market. In Argentina’s case, suppliers are 

concerned that if Argentina does not identify such additional capacity and requires imported toys 

to be tested by a single designated Argentine laboratory, exports of toys to Argentina would face 

significant delays due to that laboratory’s insufficient capacity. 

China: One U.S.-based conformity assessment body has entered into a memorandum of 

understanding (MOU) with China allowing it to conduct follow-up factory inspections (but not 

primary inspections) of manufacturing facilities that make products for export to China that

 56 In addition, U.S. FTAs require each party to afford conformity assessment bodies of the other party treatment no 

less favorable than it affords its own conformity assessment bodies with respect to criteria and procedures to 

accredit, recognize or otherwise approve conformity assessment bodies to test, certify or perform other conformity 

assessment procedures.

57 See Section VI for a discussion of the ILAC and IAF MRAs.
54

require the China Compulsory Certification mark (CCC mark). However, China allows only one 

MOU per country, so other U.S.-based conformity assessment bodies have not been granted 

similar rights. China has rejected suggestions that it recognize laboratories that have been 

accredited by ILAC MRA signatories or develop other procedures to recognize foreign 

conformity assessment bodies, insisting that it will accept conformity assessment bodies

domiciled abroad only if their governments negotiate MRAs with China, a condition that in this 

instance is both unnecessary and impracticable.

European Union: The EU’s system for conformity assessment is set out in its “Global Approach 

to Certification and Testing.” The EU Member States have the authority to designate conformity 

assessment bodies – known as Notified Bodies – as competent to test, inspect, and certify 

products for conformance with EU mandatory requirements. Products meeting EU requirements 

must bear the European mark (CE mark); the EU requires the CE mark for a wide range of 

products sold in the EU. EU Member States, however, are not permitted to designate conformity 

assessment bodies outside their territories as Notified Bodies. As a result, U.S. conformity 

assessment bodies cannot provide conformity assessment services for the EU market unless there 

is a government-to-government MRA or U.S. conformity assessment bodies act as 

subcontractors to Notified Bodies. 

The United States is also concerned that the new EU accreditation regime could disrupt the 

ability of U.S. accreditation bodies to accredit conformity assessment bodies to test, inspect, and 

certify products for compliance with EU requirements, as is now being done under the ILAC and 

IAF arrangements. Regulation (EC) No 765/2008, which became effective on January 1, 2010 

and applies to all sectors, requires each Member State to appoint a single national accreditation 

body and prohibits competition among Member States’ national accreditation bodies. The 

regulation further specifies that national accreditation bodies shall operate as public, not-forprofit entities. This means that only a single government-recognized entity in each Member 

State will be permitted to accredit conformity assessment bodies in the EU. 

In addition, the regulation appears to give discretion to Member States regarding whether to 

recognize non-European accreditation bodies, as well as the discretion concerning whether to 

accept conformity assessments issued by ILAC MRA and IAF MLA accredited bodies.58 The

European Commission, however, has not issued guidance to the EU Member States on this issue.

There is significant concern that absent clear guidance from the Commission, EU Member States 

will refuse to recognize non-European accreditation bodies and conformity assessments issued 

by non-European testing and certification bodies. 

While the EU advocates that authorities in key emerging markets liberalize their approaches to 

conformity assessment, including acceptance of ILAC and IAF accreditations, the EU continues 

to maintain a non-reciprocal approach to conformity assessment that other countries, such as 

China, have adopted. 

India: Since 2007, the United States has raised concerns, both directly with India and in the 

TBT Committee, about a proposed Bureau of Indian Standards (BIS) conformity assessment 

procedure for tires. The BIS conformity assessment system for tires is a “type approval” system. 

 58 See Section VI which describes the ILAC MRA and IAF MLA.
55

India published the final version of this measure in November 2009, with an effective date of 

180 days from date of publication. The measure requires suppliers seeking to export tires to 

India to apply for approval for each tire family from each tire plant and send sample tires for 

each family to India for compliance testing at the Central Institute for Road Transport (CIRT). 

CIRT is currently the only laboratory BIS has authorized to conduct the testing. Given CIRT’s 

limited capacity, industry believes that this could lead to testing backlogs and disrupt U.S. 

exports of tires to India. The United States continues to urge India to recognize additional test 

laboratories, such as foreign test laboratories that have been accredited by ILAC MRA 

signatories, wherever they may be located, to avoid backlogs. 

Korea: In Korea, electrical safety testing and certification for the Korean market must be 

conducted by designated certification bodies, which must be “domestic nonprofit organizations 

equipped with suitable testing equipment and qualified testing personnel...” This requirement 

means that conformity assessment bodies located outside Korea cannot provide certification for 

the Korean market. In addition, Korea has not allowed foreign conformity assessment bodies

with a presence in Korea to be designated as nonprofits, even those that are registered as 

nonprofits in the United States. Therefore, even U.S. conformity assessment bodies with a 

presence in Korea are denied the opportunity to test and certify products for the Korean market. 

While there were positive developments in Korea in 2009 in the areas of lithium ion batteries and 

energy efficiency testing, U.S. conformity assessment bodies are still precluded from testing and 

certifying products for electrical safety for the Korean market, and U.S. suppliers continue to 

incur additional burdens and expense caused by the requirement to have their products tested and 

certified in Korea. 

Mexico: Under Article 908.2 of the NAFTA, Mexico is required to accredit, approve, license, or 

otherwise recognize U.S. conformity assessment bodies on terms no less favorable than those 

applied to conformity assessment bodies in Mexico. Yet action on applications that two U.S. 

conformity assessment bodies submitted for accreditation by the Entidad Mexicana de 

Acreditación (EMA), the body responsible for accrediting conformity assessment bodies to 

Mexican official standards, was delayed for years until the end of 2007/early 2008 when the two 

U.S. conformity assessment bodies were finally accredited to offer conformity assessment 

services for a limited range of products for the Mexican market. Because these and other 

conformity assessment bodies may want to apply for additional accreditations in the future, 

however, the United States has urged Mexico to: clarify whether a conformity assessment body 

can apply for accreditations at any time or if it must wait (as happened in the case mentioned 

above) until Mexican government officials request applications for specific accreditations before 

applying; set out a reasonable timeline for the accreditation process; and modify its accreditation 

rules to ensure that the application fees charged by Mexican authorities to accredit conformity 

assessment bodies are set in a fair and transparent manner. 

Under NAFTA Article 1304.6 of the NAFTA, Mexico committed to adopt, as part of its 

conformity assessment procedures for telecommunications equipment, provisions necessary to 

accept test results from test laboratories in the United States. Mexico could meet this 

commitment by implementing the Inter-American Telecommunications Commission’s Mutual 

Recognition Agreement for Conformity Assessment of Telecommunications Equipment (CITEL 

Telecom MRA) or the APEC Mutual Recognition Arrangement for Conformity Assessment of 
56

Telecommunications Equipment (APEC Telecom MRA) with respect to the United States. 

These MRAs contain procedures for each party to recognize laboratories located in the other 

party’s territory as competent to test or certify equipment for compliance with the party’s 

technical requirements. If Mexico implemented the CITEL or APEC Telecom MRA with the 

United States with respect to testing of telecommunications equipment, U.S. laboratories could 

test telecommunications equipment for the Mexican market, saving them the expense and burden 

of having to send their products to Mexico for testing. The United States has continued to press 

Mexico to implement the APEC or CITEL Telecom MRAs with the United States and recently 

progress was made in this regard, as explained in the Mexico country report in Section X. 

In all of these cases, recognition of additional conformity assessment bodies could provide 

adequate assurances of conformity that would facilitate trade while ensuring that WTO Members 

can still achieve their legitimate objectives. In 2010, the United States will continue to pursue 

bilateral engagement as well as support ongoing multilateral efforts to urge its trading partners to

recognize U.S. conformity assessment bodies under their conformity assessment regimes and 

enhance the prospect that U.S. manufacturers are able to have their products tested and certified 

by competent bodies wherever they are located. 

Distilled Spirits

Divergences in how governments in different regions regulate distilled spirits have also created 

trade problems for U.S. exporters. For instance, the EU maintains a three-year minimum aging 

requirement for whiskey. The EU’s age threshold is based on the climatic conditions in Scotland 

and Ireland, where three years of aging may be necessary to produce Scotch Whiskey and Irish 

Whiskey. By contrast, the climatic conditions in Kentucky, Tennessee, Indiana, and other U.S. 

states are different, so U.S.-produced whiskey need not be aged three years to achieve the same 

result. The EU requirement acts to restrict U.S. exports to the EU of whiskies that are aged less 

than three years or are blended with neutral spirits. 

The ramifications of the U.S.-EU divergence on whiskey aging adversely affect U.S. whiskey 

producers when they export to other markets as well. Israel has recently adopted the same 

minimum aging requirement as the EU – even though Israel does not produce whiskey – and 

Colombia is considering doing the same. Further, Colombia is proposing that brandy be aged 

solely through the solera method, a system of aging that was developed in Europe. This would 

restrict exports to Colombia of U.S. brandy, most of which is aged using the barrel aging 

method. 

 

In addition, Brazil and Colombia have proposed quality and identity requirements for vodka, gin, 

rum, and whiskey that differ in important respects from how North American and European 

regulators have traditionally regulated these beverages. North American and European 

regulations are based primarily on differences in the raw materials used and the process that 

producers use to make them. The Brazilian and Colombian proposals would define these 

products based primarily on whether they meet certain analytical parameters for alcohol content, 

congener levels, and other factors. 
57

Whereas Brazil has clarified that its proposal would only apply to domestically-produced spirits, 

Colombia’s proposal would apply to both domestic and imported products. As a result, if 

finalized in its present form, Colombia’s proposal could effectively bar some U.S. spirits from 

the Colombian market, such as those with alcohol content levels that fall above or below the 

ranges specified in the proposed Colombian requirements. U.S. and Colombian regulators and 

trade officials continue to discuss these issues bilaterally. Recently, U.S. producers have also 

raised concerns about labeling requirements adopted by Brazil that could potentially prohibit 

U.S. exports of distilled spirits to Brazil. See the country reports on Brazil and Colombia in 

Section X for more details.

Organic Products

Divergences in how countries regulate organic products can make exporting U.S. organic 

products a more costly and burdensome endeavor – in some instances, prohibitively so. In the 

organics sector, the United States has negotiated three types of agreements, alone or in 

combination, with major trading partners in an attempt to facilitate trade in organic products and 

overcome such divergences. 

Under a “recognition agreement,” an importing country agrees to recognize USDA’s National 

Organic Program (NOP) to accredit certifying agents within the United States to certify products 

as organic under the importing country’s requirements. (The United States has negotiated such 

an agreement with the European Union.) Similarly, USDA has accredited certifying agents in 

other countries to certify products as organic under the NOP. 

Under an “equivalency arrangement,” the United States and another country agree to allow some 

or all products produced and certified to the exporting country’s organic requirements to be sold 

as organic in the importing country. The United States concluded its first equivalency 

arrangement with Canada, the largest U.S. organics trading partner, in 2009. In addition, the 

United States and the EU have begun discussions for possible equivalence negotiations to begin 

in 2010. 

Under an “export arrangement,” U.S. organics producers can sell their products as organic in 

another market (e.g., Japan, Taiwan), provided that their products meet specific requirements of 

the importing country. 

These efforts have been highly effective in facilitating trade in organic products. However, in 

some instances it has not been possible to bridge some, or all, of the differences between U.S. 

and foreign organics requirements using these tools. 

U.S. organics exports to Japan are limited by Japan's zero tolerance policy for pesticide and 

herbicide residues on organic products. U.S. organics exports to Japan are also limited by 

Japan's ban on alkali extracted humic acid, a substance that USDA permits for use on U.S. 

organic crops. 

In addition, U.S. organics exports to Korea can potentially be limited by Korea’s zero tolerance 

policy for adventitious presence of biotechnology content in organic products. U.S. organics
58

exports to Korea could be further restricted beginning in January 2011 if Korea does not quickly 

adopt regulations allowing it to negotiate one or more of the arrangements outlined above. 

U.S. officials continue to engage with trading partners in an attempt to resolve these issues. 

Toys and Children’s Products

Following high-profile recalls of unsafe toys in 2007, many WTO Members – including the 

United States and ten other APEC member economies – adopted new or improved toy safety 

measures to protect their children from potential hazards posed by certain toys and children’s 

articles. This is a critical policy goal and demonstrates the ability of individual countries to 

respond swiftly to address emerging safety hazards. While fully supporting the objective of 

protecting children from exposure to potentially dangerous substances in toys and other 

children’s articles, the United States and other WTO Members have raised trade concerns in the 

TBT Committee with new testing requirements for toys and children’s articles that Argentina, 

Brazil and other countries have adopted. Discussion of these new measures in the TBT 

Committee has sought to ensure that they do not provide less favorable treatment for imported 

products than for domestically-produced products and provide sufficient availability of testing 

facilities to ensure timely market access for toys and children’s articles that fulfill such 

requirements.

Argentina’s measure initially required that imports of toy and children’s articles be accompanied 

upon entry by a test report issued by a single government Argentine laboratory; the measure does 

not require that domestic manufacturers provide such a report. In response to concerns 

expressed by the United States and other trading partners, Argentina suspended the requirement 

that imported toys be accompanied at the time of import by a test report while it develops 

additional testing options. In addition, at the November 2009 TBT Committee meeting, 

Argentina indicated that it does recognize test results in certain circumstances from conformity 

assessment bodies that had been accredited by an ILAC MRA signatory.

Brazil’s measure initially gave domestic producers two options for demonstrating that their 

products conform with Brazilian requirements, while it gave foreign producers only one option. 

In addition, Brazil’s measure subjected imported toys and children’s articles to two sets of 

testing – the second of which had to be performed in Brazil – while domestic products were only 

subject to one set of testing. In response to concerns expressed by the United States and other 

trading partners, Brazil eventually allowed importers to choose from both conformance options 

and eliminated the second testing requirement for imports. Brazil also indicated that it would 

recognize test results in certain circumstances from conformity assessment bodies that had been 

accredited by an ILAC MRA signatory.

The United States held bilateral discussions with Malaysia in 2009 on its proposed conformity 

assessment procedures for toys and children’s articles, seeking to clarify how several aspects of 

the procedures would operate. In early 2010, Malaysia announced a new conformity assessment 

system that resolved these concerns. Among other things, the new system does not require that 

suppliers obtain test results solely from Malaysian laboratories.
59

Some elements of these countries’ revised regulatory approaches appear similar to elements of 

the conformity assessment system that the U.S. Consumer Product Safety Commission is 

implementing pursuant to the Consumer Product Safety Improvement Act enacted in 2008. This 

illustrates the propensity of U.S. trading partners to look to the United States and the measures 

the United States has in place when adopting their own standards-related measures. When the 

United States adopts measures that facilitate trade, while ensuring that legitimate health, safety, 

and other objectives are met and similar approaches are adopted by U.S. trading partners, the 

ability of U.S. exporters to sell their products abroad is enhanced. 

In 2008 at the initiative of the United States, APEC economies launched the Toy Safety Initiative. 

The United States led this project, which was co-sponsored by the U.S. Toy Industry 

Association. The goals of the APEC Toy Safety Initiative are to strengthen toy safety, increase 

transparency, promote better regulatory alignment and reduce unnecessary obstacles to trade that 

can arise from toy and children’s article safety systems. The initiative has advanced regulatory 

cooperation both within and beyond APEC, and helped to establish relationships between 

regulators, standards experts, and industry stakeholders that will further the project’s goals in 

other international fora. Regulators agreed to continue this cooperation in other international 

organizations and collaborate on a project to identify successful market surveillance practices.

The APEC Toy Safety Initiative also resulted in greater collaboration and coordination among the 

standards developers. Section XIII contains additional information on the APEC Toy Safety 

Initiative.

Developments in the toys and children’s products sector demonstrate the importance to the 

global trading system of U.S. leadership in (1) developing regulatory approaches that facilitate 

trade in safe, high-quality products while also ensuring that legitimate public policy objectives 

are achieved, and (2) encouraging other governments to adopt those approaches. 

X. Country Reports 

Background on Trade Concerns Contained in the Country Reports 

This section sets out specific TBT concerns in individual country reports. The issues included in 

these reports are a product of U.S. government engagement at home and abroad with U.S. 

stakeholders concerning specific standards-related barriers that U.S. stakeholders have 

encountered. The selection of issues for inclusion in the TBT Report reflects a considered 

process that is based on the USTR’s along with other Federal agencies’ understanding and 

analysis of the measures and practices that give rise to those issues. The measures and practices 

that the country reports identify raise significant trade concerns and, in some instances, give rise 

to questions concerning whether a trading partner is complying with its obligations under trade 

agreements to which the United States is a party.59

In each instance, USTR’s goal is to work as vigorously and expeditiously as possible to resolve 

the concern. The tools the U.S. government uses vary depending on the particular issue and 

 59 Nothing in this report should be construed as a legal determination that a measure included in the report falls 

within the scope of any particular WTO Agreement (e.g., whether the measure is subject to the TBT as opposed to 

the SPS Agreement). 
60

circumstances. As reflected in the country reports, in many instances USTR seeks to resolve 

specific concerns through dialogue with the pertinent trading partner – either bilaterally or 

through multilateral fora – and working collaboratively to obtain changes that result in improved 

market access for U.S. exporters. In appropriate instances, dispute settlement under the WTO or 

in another relevant forum can be a tool to address specific concerns. 

In response to USTR’s outreach in compiling this report, stakeholders raised a number of new 

standards-related concerns. In several cases, USTR lacked sufficient information about those 

concerns at the time of publication to include them in the report. For those issues, USTR will 

seek to compile additional information, including by following up with stakeholders, U.S. 

Embassies and other Federal agencies. Stakeholders should not view the absence of an issue in 

the report as a sign that USTR does not believe the matter raises significant concerns; it may 

simply reflect the fact that we need additional time or information to consider it.

The TBT Report provides more focused and structured reporting on country-specific standardsrelated issues than appeared in past years’ NTE reports, and past years’ NTE reports may have 

included standards-related issues that USTR has not included in the TBT Report. The TBT 

Report describes USTR’s and other Federal agencies’ current understanding of a measure or 

practice, why it is a concern, and how the United States is seeking to address that concern. The 

report is not simply a recounting of all outstanding issues that stakeholders have brought to 

USTR’s attention this year or in the past. For purposes of the TBT Report, USTR determined 

that the report would include measures and practices that USTR knows more about, while 

continuing to gather information about others. Regardless, USTR will continue to follow those 

concerns and pursue them, as appropriate, with the trading partners concerned, in the same 

manner as those listed below. 

Argentina 

Bilateral engagement

The United States discusses TBT matters with Argentina both bilaterally and during meetings of 

the TBT Committee. The next bilateral meeting between Argentina and the United States is 

tentatively scheduled for April 2010.

Toys – testing and accreditation requirements

On June 4, 2008, Argentina’s Ministry of Health (MoH) issued Resolution 583/2008 limiting the

amount of phthalates that toys and other children’s articles may contain. While this is in itself 

not problematic, the resolution’s requirement that products be tested for compliance with the 

phthalate limit is limited to imported products. In addition, the resolution initially required that 

imported toys and children’s articles be accompanied at the time of import by a technical report

by a single designated Argentine government laboratory, the Center of Investigation and 

Technological Development for the Plastics Industry (INTI). INTI is a part of the Argentine 

National Institute of Industrial Technology. 
61

At the time, MoH indicated that it would not accept technical reports from other laboratories, 

including accredited laboratories in the country of production. U.S. industry expressed concern 

that Argentina lacked sufficient testing capacity to perform the required testing and that this 

coupled with the inability to test these products in the country of production gave rise to a high 

probability of significant delays, costs, and burdens for exports of toys and children’s articles to 

Argentina. Some U.S. stakeholders exporting toys to Argentina did, in fact, experience delays, 

with one reporting that complying with the in-country test requirement added more than 90 days 

to the process of placing its products on the market in Argentina. 

The United States raised this issue with Argentina in the TBT Committee in June and November 

2009. The United States noted its strong support for Argentina’s objective to protect children 

from exposure to potentially dangerous substances in toys and other children’s articles, and 

posed several questions to Argentina, including the rationale for requiring test reports for 

imported, but not domestic, products. The United States noted that the resolution applies the 

testing requirement only to imports and asked Argentina whether any testing requirements apply 

to domestic toys and children’s products. Argentina stated that testing requirements apply to 

both domestic and imported products; however, it has not provided a copy of any Argentine

measure that requires domestic products to be tested. The United States also noted concerns

about the requirement to perform the testing in Argentina and the overall lack of testing capacity 

there, which could increase costs and create substantial delays to market for exports to 

Argentina.

 

U.S. officials explained that the U.S. system for testing toys and children’s articles, established 

pursuant to the Consumer Product Safety Improvement Act and related implementing 

regulations, requires mandatory third party testing of toys and children’s articles, but permits 

such testing to be performed by any private laboratory – including one in the country of 

production – that has been accredited by an ILAC MRA signatory. While still fulfilling 

Argentina’s objective to ensure that toys and children’s articles are safe, U.S. officials urged 

Argentina to consider something similar as one potential option for its phthalates testing regime 

as this could be less burdensome and costly for U.S. exporters. The United States also asked 

Argentina to clarify in writing that domestic producers will be required to supply testing results 

as well. 

Lastly, U.S. officials offered to facilitate discussions on this matter between Argentine regulators 

and officials of the U.S. Consumer Product Safety Commission which has recently implemented 

an ILAC-based testing regime for many toys and children’s articles, including, among other 

things, with respect to chemical content testing. U.S. officials also noted new opportunities for 

Argentina to participate in APEC toy safety activities, which would enable Argentine regulators

to learn how other regulators around the world are addressing these safety issues and share best 

practices. 

 

Following these discussions, Argentina has indicated its willingness to work to develop technical 

solutions to the issues the United States has raised, including by taking steps to identify 

additional laboratories to perform phthalates testing, such as the possibility of recognizing 

laboratories accredited by ILAC MRA signatories. 
62

Following U.S. engagement, Argentina revised Resolution 583 in October 2009 to allow 

producers to market toys and children’s articles in Argentina if the supplier: (1) certified that the 

products meet Argentine product safety requirements; and (2) indicated that the producer had 

requested a test report from INTI prior to September 23, 2009. This revision was issued several 

weeks after September 23, 2009. Because Argentina issued the revision several weeks after that 

date, the United States raised concerns during the November 2009 TBT Committee meeting that 

many suppliers were likely unaware of Argentina’s new flexibility and suggested that Argentina 

consider adopting a cut-off date that is later than September 23, 2009. The United States 

suggested that this could act as a short-term measure to address the current marketing delays 

while Argentina considered whether to modify Resolution 583 further to allow for recognition of 

additional test laboratories, including ones located outside Argentina, and ways to expand its 

domestic testing capacity. 

Following this U.S. intervention, Argentina noted that it recognizes test results from laboratories 

that have been accredited by an ILAC MRA signatory, but that it also requires such laboratories 

to comply with other requirements. The United States has requested a copy of these other 

requirements and will engage further with Argentine officials to understand the extent to which 

Argentina recognizes test results from laboratories that an ILAC MRA signatory has accredited 

(i.e., to understand whether Argentina accepts such test results in lieu of INTI test results).

In December 2009, Argentina issued Resolution 1078/2009. This resolution allows suppliers of 

toys and children’s products to export their products to Argentina without a test report from INTI

if the products are accompanied by written proof that samples of the products have been 

presented to, and are being analyzed by, INTI. This is a positive development that should help 

reduce delays while Argentina considers further revisions to its testing requirement for toys and 

children’s products (e.g., by recognizing laboratories outside of Argentina) and determines how 

best to expand laboratory capacity to ensure that producers can obtain test results before their 

products are imported into Argentina. The United States will continue to raise this issue with 

Argentina. 

Brazil 

Bilateral engagement

The United States and Brazil discuss TBT-related matters at various bilateral fora, including the 

Bilateral Consultative Mechanism (led by Brazil’s Ministry of External Relations and USTR), 

the Commercial Dialogue (led by Brazil’s Ministry of Development, Industry, and Commerce 

and the U.S. Department of Commerce) and the Economic Partnership Dialogue (led by Brazil’s 

Ministry of External Relations and the U.S. Department of State). At the most recent meeting of 

the Economic Partnership Dialogue in December 2009, the U.S. and Brazilian governments

welcomed further cooperation on regulatory issues, noting the importance of working together to 

share information. They also agreed to continue discussing memoranda of understanding

(MOUs) outlining a framework for cooperation, including a proposed MOU between the U.S. 

Alcohol and Tobacco Tax and Trade Bureau (TTB) and Brazil’s Ministry of Agriculture 

(MAPA). The United States also discusses TBT matters with Brazil during, and on the margins 

of, TBT Committee meetings.
63

Distilled spirits – quality and identity requirements

In spring 2008, Brazil notified the WTO of numerous proposed changes to its technical 

requirements for distilled spirits. U.S. industry raised concerns that the requirements differed 

from international practices, were not justified by health and safety considerations, and could bar 

exports of a number of U.S. spirits to Brazil. 

In particular, the proposed Brazilian requirements make use of analytical parameters or chemical 

composition limits to define products that can be marketed as distilled spirits, liqueurs, or

cordials in Brazil. In the United States, by contrast, rules of identity for spirits are based solely 

on the raw materials and production processes that producers use to make these products, not 

their chemical composition. The minimum and maximum alcohol content requirements set out 

in Brazil’s proposal also do not conform to global practices for most spirit categories. For 

example, the proposal would establish a maximum alcohol content level of 54 percent alcohol by 

volume for distilled spirits. Yet none of the major spirits trading countries (e.g., the United 

States, Canada, or EU Member States) establishes maximum limits for alcohol content. As

certain U.S. spirits are bottled at significantly higher strengths than the proposed 54 percent 

limit, the proposal could bar many U.S. spirits from the Brazilian market. Lastly, Brazil’s 

proposal would not recognize Bourbon and Tennessee Whiskey as distinctive products of the 

United States that can only be produced in the United States in conformity with U.S. 

requirements. 

In 2009, the United States, joined by Mexico and the EU, expressed concerns in the TBT 

Committee that differences between the proposed Brazilian identity and quality requirements and 

requirements in other major markets could restrict trade in wine and spirits. In response, Brazil 

clarified that Article 34 of Brazil’s Decree 2314 provides that beverages that are produced 

abroad and do not comply with Brazilian requirements can continue to be imported, provided 

that a certificate is presented attesting that: (1) the beverage is a typical product from its country 

of origin; (2) the beverage was produced in accordance with that country’s laws and regulations; 

and (3) the beverage is regularly consumed in that country. Thus far, U.S. industry has not 

reported any disruption of shipments of distilled spirits to Brazil. 

In October of 2009, Brazil notified additional amendments to its technical regulations 

establishing criteria for the labeling of beverages and products of acetic fermentations. U.S. 

industry raised concerns that some of the requirements could potentially prohibit imports of 

specific U.S. –origin, internationally-traded spirits. Specifically, their concerns include a 

prohibition on using abbreviations for common terms on labels, an explicit requirement for 

product names to be printed on the main label in bold face and upper case letters, a requirement 

for a large decal to be placed on the label including the importer’s registration number, as well as 

a prohibition of the use of certain expressions on labels (such as “home-made”, “hand-crafted”, 

“reserve” and “special reserve”), even if these are associated with the company’s name or 

trademark, among others.

Thus far, U.S. industry has not reported any disruption of shipments of distilled spirits to Brazil.
64

Medical devices – inspection requirements

Resolution 25, which Brazil notified to the WTO on May 18, 2009, requires ANVISA (Brazil’s 

medical device inspection agency) to inspect facilities that produce certain “high risk” medical 

devices to be sold in the Brazilian market by May 22, 2010. The United States does not contest 

Brazil’s right to inspect U.S. facilities, as the U.S. Food and Drug Administration (FDA) has 

analogous authority to conduct inspections of Brazilian facilities. However, the United States is 

concerned that ANVISA may not have sufficient resources to inspect all overseas facilities that 

ship these devices to the Brazilian market by the May 22, 2010 deadline that the Resolution sets, 

which could disrupt hundreds of millions of dollars in U.S. exports of medical devices to Brazil 

and jeopardize the adequate supply of essential medical devices to the Brazilian market. 

In September 2009, ANVISA and the U.S. Department of Commerce co-sponsored an event on 

medical device regulation – the Medical Device Information Exchange Forum – in Brasilia that 

U.S. industry and FDA’s regional representative attended, where the two sides discussed the

inspection issue. In addition, on November 4, 2009, ANVISA representatives participated in a 

seminar that the American Chamber of Commerce hosted in São Paolo to explain Brazil’s new 

inspection requirement to local representatives of foreign manufacturers, including how 

companies can apply for an inspection and what the inspections will entail. At the November 

2009 TBT Committee meeting, the United States, the EU, Mexico, Canada, and Switzerland 

raised concerns about the inspection requirement, requesting assurances from Brazil that trade in 

medical devices will not be disrupted after May 2010 if ANVISA cannot complete all of the 

inspections (and related registrations) in time, and noting that companies still had questions 

about the registration and inspection processes, including how to apply for an inspection and the 

coverage of such inspections. 

The meetings that FDA and ANVISA had during the Medical Device Information Exchange 

Forum were productive, and that FDA has agreed to hold follow-up technical discussions with 

ANVISA so that respective regulators in each country can learn more about the other’s

regulatory systems. This is a positive development that the United States hopes will increase the 

opportunities for increased dialogue on this and other issues. In addition, Brazil has now 

clarified that class I medical devices (e.g., tongue depressors, bedpans) and class II devices (e.g., 

powered wheelchairs, surgical drapes) are exempted from the inspection requirement, and that 

ANVISA’s inspections will apply only to the last place of manufacture (as opposed to all the 

supplier facilities). In addition, only plants that manufacture devices subject to re-registrations 

or new registrations will need to be inspected by the May 2010 deadline. The United States

understands that ANVISA has also been hiring additional inspectors and has started scheduling 

inspections, and will be issuing a technical note answering many of industry’s questions in the 

coming weeks. The United States will continue to engage with Brazil on the inspection issue 

and work with Brazil to resolve the matter in such a way that avoids a disruption in trade in safe 

and effective medical devices. 

 

Medical devices – data requirements for registration

Resolution 185 of 2001 sets out ANVISA’s registration requirements for medical devices. The 

measure, which Brazil has not notified to the WTO, requires manufacturers to submit detailed 
65

economic data, such as the prices they charge in other markets, advertising budgets, and 

distributor mark-ups, with each product registration or re-registration. The Resolution’s 

registration requirements do not appear related to evaluating the safety or efficacy of medical 

devices, they lack clarity and transparency, and they seem excessively burdensome and intrusive.

Moreover, they could require producers to submit information that either does not exist, could be 

business confidential or proprietary, or could not be obtained without giving rise to antitrust 

concerns since producers would have no way of obtaining the information without contacting 

each other. 

The United States has raised these concerns with Brazil on repeated occasions, both bilaterally 

and in the TBT Committee. As a consequence of those discussions, ANVISA recently published 

a resolution that clarifies the registration requirements in Resolution 185. U.S. and industry 

officials have welcomed this development and are reviewing the new measure to determine 

whether it resolves the concerns or if additional follow-up with Brazil is necessary. 

Additionally, industry did not report any trade disruptions in 2009 due to the registration 

requirements. Brazil and the United States are currently engaged in discussions aimed at finding 

a long-term resolution to the issue. 

Telecommunications – acceptance of test results

Brazil’s National Telecommunications Regulatory Agency (ANATEL) does not accept test data 

generated outside Brazil (except in cases where the equipment is too physically large or costly to 

transport). Accordingly, U.S. suppliers must submit virtually all of their information technology 

and telecommunications equipment (e.g., cell phones and optic cables) for testing to laboratories 

located in Brazil. This requirement results in redundant testing, higher costs for importers, and 

delayed time to market in Brazil. 

There was some progress in 2009 in informal discussions with Brazil on this issue. However, the 

United States continues to urge Brazil to implement the CITEL (Inter-American 

Telecommunication Commission) Mutual Recognition Agreement (MRA), noting that if 

ANATEL implements the CITEL MRA, it would also benefit Brazilian suppliers who would 

then be free to use test results from Brazilian laboratories to certify that their telecommunications 

products meet U.S. FCC requirements. 

Toys and children’s articles – conformity assessment procedures

U.S. industry raised concerns about a proposed National Institute of Metrology, Standardization, 

and Industrial Quality (INMETRO) measure amending Brazil’s existing conformity assessment 

procedures for toys and children’s articles. The proposed measure would have permitted foreign 

manufacturers to test their toys for compliance with Brazilian toy safety requirements in the 

country of manufacture. At the same time, however, it would have required imported toys that 

had been tested abroad to undergo a second round of testing in Brazil. This measure would not 

have required domestically-produced toys to be tested twice. Industry also raised concerns about 

proposed procedures for placing INMETRO conformity assessment seals on conforming 

products and whether, similar to domestic producers, U.S. producers could use either the System 
66

5 (“Compliance Imprint Certification Model”) or System 7 (“Lot Certification Model”)

conformity assessment procedures for their products. 

In the TBT Committee, the United States, joined by the EU, Thailand, and China, noted that it 

strongly shares Brazil’s objective of protecting children from exposure to potentially dangerous 

substances in toys and other children’s articles, but questioned the basis for Brazil’s requirement 

that imported toys would be subject to two sets of tests, while domestic toys would only be 

subject to only one. 

In September 2009, INMETRO announced that it would: (1) eliminate the second test 

requirement on imports; (2) allow laboratories that have been accredited by an ILAC MRA 

signatory to conduct the testing in certain instances; (3) provide foreign producers with the 

option of importing under System 5 or System 7; (4) provide a transition period of a few months 

to one year from the date INMETRO publishes its final measure for producers to comply; (5) 

permit foreign producers utilizing System 5 to add the INMETRO seal at the place of 

manufacture; and (6) eliminate a proposed number sequencing system for the seal, which 

INMETRO determined would not have been efficient or practical.

 

In early November 2009, INMETRO published a revised measure incorporating these 

improvements and notified it to the WTO. The United States welcomed the new measure, which 

addressed most of U.S. concerns, but posed additional questions about how the new system 

would operate in practice, including: (1) what criteria INMETRO would use for accrediting test 

laboratories in cases where it found that accreditation by an ILAC MRA signatory was 

insufficient; (2) whether the six-month transition period for compliance that the revised measure 

provides is sufficient, given that INMETRO accreditation of an ISO 9001 certification body 

takes, on average, six months; (3) whether INMETRO would consider recognizing certification 

bodies that are accredited by IAF signatories; (4) whether Brazil would consider accepting 

toxicological evaluations by Board Certified Toxicologists instead of requiring animal testing;

and (5) why Body of Product Certification (OCP) would need to select test samples rather than 

allowing an accredited laboratory to select its own samples. U.S. officials are following up with 

Brazilian authorities on these issues in 2010.

Wine – alcohol content levels and conformity assessment procedures

In mid 2008, Brazil notified proposed changes to its import procedures and other technical 

requirements for wine to the WTO. The U.S. government and industry raised concerns that the 

requirements were unjustified by health and safety considerations and could bar certain U.S. 

wine exports to Brazil. 

For example, Brazil’s proposal, which would require foreign wineries to register with the 

Ministry of Agriculture, Livestock, and Food Supply (MAPA) before exporting to Brazil, 

appeared to be duplicative since wine importers in Brazil were already required to register. The 

proposal would permit MAPA to inspect foreign wineries to verify their “technological, 

hygienic-sanitary, and documentation conditions” – even though the TTB already thoroughly 

inspects U.S. wineries through its process of implementing statutory permit requirements needed 

prior to initiating operations, and upholds a set of comprehensive regulations regarding the safety 
67

and security of wineries and wine products. The proposal would also require suppliers to reregister wine products each time they make even minor modifications to their wine labels, such 

as a change in a label’s color. 

Further, the proposal would limit the wine alcohol content to 14 percent by volume, unless a 

wine is accompanied by a statement clarifying it has “typical” or “distinctive” characteristics of a 

particular region (e.g., wines with a geographical indication or appellation of origin). 

Geographic and regional factors can influence wine alcohol content, which U.S. regulations

recognize by providing that wine may vary in alcohol content from 7 to 24 percent alcohol by 

volume. By contrast, Brazil’s proposed measure does not take account of regional differences 

and, if applied to U.S. imports, could have blocked access to its market for many U.S. wines with 

an alcohol content of greater than 14 percent alcohol by volume. Thus far, Brazilian authorities 

have been accepting TTB-issued certificates for such wine indicating that the product is a wine, 

or a byproduct of grapes and wine, with typical, regional, and peculiar characteristics from the 

United States; or the product is a wine, or a byproduct of grapes and wine, in conformity with 

U.S. requirements. 

In December 2009, Brazil notified a new measure that eliminated the winery registration 

requirement to the WTO. However, the measure also instituted a new certificate of origin and 

product analysis requirement for foreign wines. At present, U.S. industry is not reporting any 

disruption of wine shipments to Brazil. 

Canada 

Bilateral engagement

The United States discusses TBT matters with Canada during, and on the margins, of TBT 

Committee meetings, as well as bilaterally, such as in the United States-Canada Consultative 

Committee on Agriculture. The United States also discusses specific trade concerns and 

systemic issues with Canada together with Mexico in the NAFTA CSRM and subordinate 

Technical Working Groups (TWGs) established to address particular standards-related issues. 

For example, the NAFTA TWG established to address food labeling and packaging led to 

enhanced cooperation among the three NAFTA parties regarding food laboratories and 

nutritional labeling. The NAFTA parties also address standards-related measures in the context 

of the NAFTA RCF. For details on these fora and other trialateral cooperation regarding 

standards-related measures between the NAFTA parties, see Section VIII.

Cheese – compositional requirements

On June 16, 2007, Canada published proposed amendments to its Food and Drug Regulations 

and Dairy Products Regulations that altered the compositional requirements for cheese. The 

final requirements, which were published in December 2007 and entered into force in December 

2008, mandate that a certain percentage of a cheese’s protein content must be casein derived 

from raw milk rather than reintroduced whey, thereby limiting the protein content of cheese that 

may be derived from milk protein concentrates (MPCs). The raw milk used in Canadian cheese

is primarily supplied by Canadian producers. According to U.S. industry, Canada implemented 
68

the requirements as a means to increase demand for Canadian fluid milk and hence limit the use 

of MPCs, which are imported from the United States and other countries. While the regulations 

were under development, the United States and other trading partners raised concerns both 

bilaterally and in the TBT Committee that the requirements could significantly reduce access for 

exports of MPCs to the Canadian market. 

In October 2008, several U.S. companies, in cooperation with the Canadian dairy processing 

industry, petitioned the Federal Court of Canada for judicial review of the cheese compositional 

requirements. The plaintiffs asked the Court to invalidate the regulations, contending, inter alia, 

that the regulations were promulgated for the purpose of providing an economic benefit to dairy 

producers at the expense of dairy processors and others. On October 7, 2009, the Court issued an 

opinion upholding the Canadian government’s authority to issue the requirements. 

In 2010, the United States will continue to monitor trade flows of dairy products between the 

United States and Canada as well as any additional regulatory developments in Canada. 

Provincial notifications

In 2009, Canada did not notify two provincial measures to the WTO that raised potential TBT 

concerns for U.S. exporters: the British Columbia Recycling Regulation (B.C. Reg. 449/2004) 

and the Ontario Electrical Safety Authority’s product safety registration process for electrical 

products. As a result of Canada’s failure to notify these measures to the WTO in draft form, the 

views expressed by some U.S. stakeholders were not taken into account by Canadian provincial 

authorities until late in the regulatory process. The United States believes that this may be 

evidence of a systemic problem. In 2010, the United States hopes that Canada will take steps to 

improve its WTO notification practice for sub-central government technical regulations and 

conformity assessment procedures. 

Tobacco products – restrictions on additives

In 2009, Canada enacted amendments to its Tobacco Act relating to the use of additives in 

cigarettes and other tobacco products. The United States strongly supports the objective of 

deterring youth from tobacco use. In connection with this goal, U.S. officials have sought 

additional information on the approach taken in Canada’s measure, as well as additional 

information on any regulations that may be necessary to implement the amendments to Canada’s 

Tobacco Act. 

At the November 2009 TBT Committee meeting, the United States asked Canada to confirm 

when sections 4 and 5 of the Act relating to use of additives in the manufacture and sale of 

tobacco products would enter into effect, and whether the Canadian government has the authority 

to amend the schedule of additives that are regulated. At the meeting, U.S. officials asked 

whether Canada was considering any amendments to the schedule of additives. The United 

States also asked if Canada could provide information on the criteria used to develop the list of 

prohibited additives, and the specific efforts it made to identify the relationship in general 

between prohibited additives and products marketed to or that are innately attractive to youth. 
69

Canada said that it would consider the comments and indicated that it would notify any 

implementing regulations to the WTO for comment. During the March 2010 TBT Committee 

meeting, Canada provided written responses to the U.S. questions. The United States stated that 

it would consider those responses, together with Canada’s responses to questions and comments 

from other WTO Members, in reflecting further on the matter.

China 

Bilateral engagement

The United States and China regularly engage on TBT-related issues through the U.S.-China 

Joint Commission on Commerce and Trade (JCCT) and bilaterally on a case-by-case basis, when 

specific market access issues arise. Established in 1983, the JCCT is the main forum for 

addressing bilateral trade matters and promoting commercial opportunities between the United 

States and China. The JCCT has played a key role in helping to resolve bilateral TBT issues, 

including those related to medical device recalls and registration, certification of IT products, 

and cotton registration requirements. At the October 2009 JCCT meeting, in an effort to increase

collaboration on standards and conformity issues, the two sides agreed to convene a publicprivate meeting on standards and conformity assessment procedures in the first quarter of 2010. 

Conformity assessment procedures 

In August 2003, China required the China Compulsory Certification (CCC) mark to be applied to 

Chinese and foreign goods covering more than 159 product categories – including electrical 

machinery, IT equipment, household appliances, and their components. Since then, U.S. 

companies have continued to raise concerns that the regulations are unclear regarding which

products require a CCC mark. Industry has also reported that China is applying the CCC mark 

regulation in an inconsistent manner. In addition, U.S. officials understand that small and 

medium-sized U.S. companies without a presence in China find it particularly burdensome to 

apply for CCC mark exemptions, such as for replacement and re-export, because China requires 

the applications to be submitted in China’s Certification Accreditation Administration (CNCA) 

Beijing offices. 

To date, CNCA has accredited 14 certification and 153 testing bodies to test and certify products 

for purposes of the CCC mark. Despite China’s commitment that qualifying minority foreignowned (upon China’s accession to the WTO), and majority foreign-owned (two years later) joint 

venture conformity assessment bodies would be eligible for accreditation and would be accorded 

national treatment, China has so far accredited only six foreign-invested conformity assessment 

bodies. It is not clear whether these six foreign-invested conformity assessment bodies play a 

sizeable role in accrediting products sold in China. 

As a result, exporters to China are often required to submit their products to Chinese laboratories 

for tests that have already been performed abroad, resulting in greater expense and a longer time 

to market. One U.S.-based conformity assessment body has entered into a MOU with China 

allowing the conformity assessment body to conduct follow-up factory inspections (but not 

primary inspections) of manufacturing facilities that make products for export to China requiring 

the CCC mark. However, U.S. officials understand that China has not been willing to grant 
70

similar rights to other U.S.-based conformity assessment bodies, claiming that it is only allowing 

one MOU per country, the rationale for which has not been provided. 

Cotton supplier registration requirements

In August 2008, China’s General Administration of Quality Supervision, Inspection and 

Quarantine (AQSIQ) issued Announcement No. 87, which proposed to establish a new 

registration process for foreign cotton suppliers (domestic cotton suppliers were already subject 

to an inspection system), and notified it to the WTO. A related AQSIQ measure issued in 

November 2008 addressed quality assessment of cotton shipments and set out many of the details 

to implement Announcement No. 87. China did not notify this measure to the WTO. Under 

these measures, effective March 2009, consignees of foreign cotton are subject to foreign 

inspection at the border. Foreign suppliers that do not register under this system are 

automatically subject to a lower “quality credit assessment grade” and are required to include a 

pre-shipment inspection clause in their contracts.

At the September 2008 JCCT meeting and the March 2009 TBT Committee meeting, the United 

States identified these measures as a potential trade issue and began holding bilateral meetings 

with AQSIQ officials to discuss U.S. concerns. U.S. cotton exporters, as well as government 

officials and exporters from Australia, Brazil and other countries, also raised concerns. The 

United States noted that, by establishing a government-run regime to grade foreign exporters of 

cotton to China, the proposed registration and quality assessment system appeared to depart from

prevailing commercial practice within the cotton trade. By contrast, in other countries, cotton 

quality and related issues are addressed through private contract and arbitration. 

China claimed that registration was voluntary. The United States noted that exporters that did

not register would be subject to pre-shipment inspection and automatically assigned the lowest 

rating. Because Chinese cotton mills began refusing to do business with unregistered U.S. 

producers, a number of exporters felt compelled to register out of economic necessity. Finally, 

U.S. officials expressed concern that AQSIQ was seeking confidential business information on

the trading volume, value, and history of an exporter’s shipments to China and requested that 

China explain its purpose in requiring such information. In response to these concerns, AQSIQ 

agreed to consider suggestions for revising particular provisions of the measure that it had 

received from the interested governments and foreign industry representatives. 

Active dialogue continues between U.S. and Chinese experts on registration and testing 

requirements. In 2010, the United States will continue to monitor how AQSIQ implements these

measures at issue in order to ensure that China’s cotton registration requirements do not create a 

market access barrier for U.S. cotton exporters. 

“Excessive packaging” requirements

In November 2007, China notified the WTO of proposed restrictions on “excessive packaging” 

for six commodities, including alcoholic beverages, cake, grains, health food, and cosmetics. 

The United States noted its support of China’s objective of protecting the environment and 

conserving resources, noting that other countries, as well as some U.S. states, have chosen to 
71

reduce the effect of waste on the environment by linking packaging cost to specific targets for 

recyclable content and reuse materials. 

However, during TBT Committee meetings in 2008 and 2009, the United States expressed 

concerns about the efficacy of restricting total packaging cost in relation to product cost, as 

China had done, to meet its objective. U.S. officials pointed out that the cost of environmentally 

friendly packaging (i.e., packaging with the highest recyclable content or reuse percentage) often 

far exceeds that of traditional packaging. Thus, if China were to limits the total cost of 

packaging, the result may be that industry will be forced to package more products in cheaper 

materials that cannot be recycled or reused. U.S. officials also noted that less expensive 

packaging may also contain higher levels of heavy metal contaminants and other potentially 

hazardous materials, and that packaging enhancements designed to protect safety, such as child 

safety seals, often increase packaging costs. Further, they noted that China’s proposed measure 

may also discourage innovations in packaging, such as smart shelf life packaging, which may be 

more costly than cheaper packaging. The United States asked China to re-evaluate its approach 

to this technical issue and encouraged it to consider some of the methods that other WTO 

Members employ that could more effectively assist China in meeting its environmental 

objectives while at the same time not creating new safety and environmental issues and 

potentially disrupting trade.

 

While it did not alter its overall regulatory approach on this issue, China took steps to respond to 

many of the U.S. concerns with a view to enabling foreign suppliers to comply with the 

requirements. With respect to China’s requirements regarding the “inter space ratio” of 

packaging, China clarified its calculation methodology in a manner that was acceptable to U.S. 

industry. Second, under China’s original proposal, the packaging cost could not exceed 15 

percent of the commodity’s ex-factory price. China eventually raised the limit to 20 percent, 

clarified that the original package is the package in direct contact with the product and does not 

include the label, and indicated that the cost of the original package should not be counted in the 

calculation of packaging cost. Lastly, China delayed enforcement until April 1, 2010. Thus far, 

U.S. industry has not reported concerns with the modified requirements. 

IT products – mandatory testing and certification

In August 2007, China notified to the WTO a series of thirteen proposed measures requiring

certain IT products to be certified for information security functions. The proposed measures 

appeared to require testing and certification to certain Chinese national standards for information 

security which, in some areas, may differ from international standards used in the global market. 

In some cases, the Chinese standards require access to algorithms held by Chinese regulators, 

and it is unclear on what basis those algorithms will be made available. AQSIQ indicated that 

the thirteen proposed measures would be mandatory for all covered products as of May 1, 2009. 

The United States and other WTO Members expressed serious concerns to China about these 

proposed measures in numerous bilateral and multilateral meetings. At the September 2008 

JCCT meeting, China announced that it would delay publication of final implementing 

regulations while Chinese and foreign experts continued to discuss the best ways to ensure 

information security in China. In April 2009, CNCA, AQSIQ, and the Ministry of Finance 
72

announced that implementation of the measures would be delayed until May 2010, and 

subsequently, in September 2009, China confirmed that the compulsory certification requirement 

will apply only when products are sold to government agencies, and not to state-owned 

enterprises or in other sectors of China’s economy, representing a significant reduction in the 

scope of the requirements from China’s original plan. At the October 2009 JCCT meeting, 

China also agreed to a dialogue with the United States regarding global best practices for trade in 

information security products. The United States will continue to monitor this issue in 2010. 

Internet filtering software –“Green Dam”

In May 2009, China’s Ministry of Industry and Information Technology (MIIT) proposed a

measure that would have required imported or domestically-produced computers sold in China to

be pre-installed or packaged with the Chinese-produced “Green Dam – Escort of the Youth 

Flowers” Internet filtering software, effective July 2009. The software regularly connects to the 

Internet to download a current list of content to be blocked. 

U.S. government officials, as well as a broad coalition of global industry groups and officials 

from other countries, expressed serious concerns about this proposed measure shortly after it was 

made public and urged China to revoke it. Among other things, China never notified the 

measure to the WTO for review and comment and did not provide a reasonable period of time 

for manufacturers to comply. Additionally, global technology companies, Chinese citizens, and 

worldwide media expressed serious concerns about the stability of the software, the scope and 

extent of its filtering activities, and its security weaknesses. 

In June 2009, China announced that it was suspending the measure indefinitely. 

Medical devices – conformity assessment procedures 

The United States has expressed concerns that China maintains two separate authorities — the 

State Food and Drug Administration (SFDA) and AQSIQ — to enforce regulations with similar, 

but not identical, requirements for selected medical devices. This potential overlapping and 

unclear delineation of responsibilities can result in additional and unnecessary regulatory 

procedures with no demonstrable public health benefit. For example, Decree 95, issued by 

AQSIQ in June 2007, would have imposed an onerous examination and supervision regime on 

imported medical devices, introducing additional testing and inspection redundancy to the 

certification schemes administered by SFDA and, in some cases, CNCA. 

The United States, working closely with U.S. industry, raised these concerns as part of JCCTrelated meetings with AQSIQ and China’s Ministry of Commerce (MOFCOM). In November 

2007, AQSIQ issued a notice suspending implementation of Decree 95. In a further step to 

streamline the registration process, in September 2008 SFDA and AQSIQ jointly announced that 

they would require only one test, one report, one fee, and one factory inspection for medical 

devices. Industry welcomed this commitment, projecting that by reducing redundancies this step

could cut medical device approval times in half, which would provide U.S. industry with more 

timely access to China’s medical device market. 
73

In April 2009, SFDA circulated for public comment a draft measure intended to supersede the 

Administrative Measures on Medical Device Registration, originally issued in 2004, but did not 

notify the draft measure to the WTO. The United States subsequently expressed concerns about 

this draft measure in bilateral discussions with SFDA during the October 2009 JCCT meeting, 

and before the TBT Committee as part of China’s Transitional Review Mechanism (TRM). Of 

particular concern was a proposal to require all medical devices to be registered in the country of 

export or in the manufacturer’s legal residence before they could be accepted for registration in 

China. 

This requirement had the potential to block, or inordinately delay, sales of safe, high-quality 

medical devices to the Chinese market, as manufacturers may decide, for reasons unconnected 

with the quality or safety of their products, not to seek to have their devices approved in the 

countries in which they are produced or in the producers’ home countries. For example, 

producers may design particular medical devices specifically for patients in a third country, such 

as China, or may choose to produce them in a third country for export only. In these situations, a 

manufacturer would have no business reason to seek to have a particular device approved in its 

home country or the country of export and would likely forego that process in order to avoid the 

associated burdens of time and money. 

Also in April 2009, AQSIQ circulated draft Regulations on the Recall of Defective Products, 

which would apply to medical devices. Given that China’s Ministry of Health and SFDA had 

begun a process in 2008 to develop a recall system that would also cover medical devices, the 

United States became concerned about the possibility of redundant recall procedures. The 

United States raised its concerns in bilateral JCCT-related discussions, as well as during the 

WTO’s China TRM process. 

At the October 2009 JCCT meeting, China indicated that it would not require a medical device to 

be registered in the country of export or in the country of legal residence of the manufacturer as 

part of its prior approval process for medical devices. China also pledged to ensure that its 

product recall procedures for medical devices would not be redundant, and that the Ministry of 

Health and SFDA would be the relevant regulatory authorities for medical device recalls. The 

United States will monitor developments in this area in 2010.

Mobile phones – WAPI standard

In May 2003, China issued two standards for encryption over WLANs, applicable to domestic 

and imported equipment containing WLAN technologies. Conformance to these standards was 

scheduled to become mandatory in June 2004. The standards incorporated the WAPI encryption 

algorithm for secure communications. China sought to enforce the use of WAPI by mandating a 

particular algorithm (rather than mandating the need for encryption, and leaving the choice of the 

algorithm to market factors) and providing the necessary algorithm only to a limited number of 

Chinese companies. Had the standards become mandatory, U.S. and other foreign manufacturers 

would have been compelled to work with and through these companies, some of which were 

competitors, and provide them with their proprietary technical product specifications. Following 

high-level bilateral engagement, China agreed in April 2004 to postpone indefinitely 

implementing WAPI and to work within international standards processes in developing future 
74

wireless standards. This commitment led China to submit WAPI for consideration in ISO and 

IEC’s Joint Technical Committee 1 (JTC1). In 2006 ballot of ISO/IEC JTC1 members, the 

proposed WAPI amendment did not receive enough votes to be accepted as an ISO/IEC 

standard. 

Concerns regarding WAPI have recently re-emerged as China moved forward with plans to 

require the WAPI standard to be used in mobile handsets, despite the growing commercial 

success of computer products in China that comply with the internationally recognized standard, 

ISO/IEC 8802-11, otherwise known as WiFi. In this regard, over the past several years, global 

mobile handset makers have increasingly added WLAN/Internet capability into their mobile 

handsets, thus expanding the use of WLAN equipment beyond laptops and home computers to 

mobile handsets. The operative standard for this expansion of WLAN/Internet capability across 

the world has uniformly been the WiFi standard. However, until recently (as noted below) China 

had not issued type approvals for handsets that connect to the Internet through WLAN 

equipment, and instead had only issued type approvals for handsets that connect to the Internet 

through cellular networks, a practice that has required foreign equipment makers to disable 

WLAN/Internet capability before their handsets could be marketed in China. 

In 2009, in concert with its plan for encouraging an aggressive roll-out of third generation (3G) 

mobile handsets by Chinese telecommunications operators, many of which are Internet-enabled 

via WLAN networks, MIIT established a process for approving hand-held wireless devices such 

as Internet- enabled cell phones and smart phones. During bilateral talks in September 2009, 

MIIT indicated to U.S. government officials that it will approve devices that use the WiFi 

standard, but only if those devices are also enabled with the WAPI standard. MIIT officials 

acknowledged that there is no published or written measure setting out this requirement and that 

China has not notified this requirement to the WTO. 

Notification issues

China has designated MOFCOM as its authority for purposes of notifying proposed technical 

regulations and conformity assessment procedures to the WTO and MOFCOM has notified the 

WTO of a large number of these measures. This is a positive step. Almost all of the measures 

that MOFCOM has notified to the WTO, however, have been proposals issued by the AQSIQ, 

SAC, or CNCA. By contrast, MOFCOM has not notified several important trade-related 

measures that other agencies (e.g., Green Dam, information security, WAPI) and sub-federal 

agencies have drafted (e.g., provincial restrictions on plastic bag thickness). 

Patents used in Chinese national standards 

In recent years, concerns have arisen regarding China’s proposed treatment of patented 

technology in connection with domestic standards development processes. 

First, in late 2004, concerns arose after the Standardization Commission of China (SAC) issued

draft Provisional Regulations for National Standards Relating to Patents (Provisional 

Regulations) and public statements by key Chinese government officials that appeared to 

contemplate compulsory licensing of patented technologies that are used for national standards in 
75

China. In November 2009, SAC circulated a new draft of the Provisional Rules Regarding 

Administration of the Establishment and Revision of National Standards Involving Patents for 

public comment. This draft measure would implement China’s vision for a standards 

development process. The draft measure would establish the general principle that mandatory 

national standards should not incorporate patented technologies. However, when they do 

incorporate patented technologies, the draft measure provides for the possibility of a compulsory 

license if a patent holder does not grant a royalty-free license. This differs from the typical 

practice of accredited standards developing organizations in other countries, which require 

disclosure of intellectual property in the standards development process and support “reasonable 

and nondiscriminatory” (RAND) licensing policies with respect to intellectual property that is 

incorporated into a standard. RAND policies require concerned patent right holders to make any 

intellectual property incorporated into the standards that these bodies develop available to all 

interested parties on RAND terms. Within the standards development process, licensing terms 

are typically negotiated between the right holder and parties interested in implementing the 

standards. 

Second, in 2006, the Chinese government’s Electronic Standardization Institute (CESI), a 

Chinese government entity, released draft intellectual property policy rules for standards-setting 

organizations (SSOs). These draft rules envisage Chinese government involvement in standardsetting processes, including a requirement that SSOs obtain government approval for patent 

claims. Such government involvement could be exercised in a way that affects private party 

transactions and could raise concerns under certain circumstances. 

The United States will continue to monitor how China treats intellectual property through its

SSOs, including the development and finalization of CESI’s rules, as well as the development of 

SAC’s revised Provisional Regulations. 

Colombia

Bilateral engagement

The United States discusses TBT matters with Colombia during, and on the margins of, TBT 

Committee meetings. In addition, in January 2010, U.S. and Colombian regulators and trade 

officials held a technical discussion via digital videoconference on Colombia’s proposed quality 

and identity, as well as labeling, requirements for distilled spirits (discussed below), and continue 

to work toward resolution of the remaining issues. 

Distilled spirits - labeling requirements

In an effort to block sales of contraband products, Colombia has proposed two amendments to its 

alcohol labeling requirements over the past two years. In November 2008 and May 2009,

respectively, Colombia’s Ministry of Commerce and its Ministry of Social Welfare proposed

amendments to Title V of Law No. 09 of 1979, which regulates alcoholic beverage production 

facilities, as well as alcohol production, hydration, bottling, distribution, sale, export, and import. 

Colombia notified both proposals to the WTO. 
76

The United States respects Colombia’s right to take measures to reduce imports of contraband 

products. Following discussions with U.S. officials, Colombia modified its labeling proposal so 

that producers will not be required to translate their brand names into Spanish or use quotation 

marks to indicate brand names, and to permit producers to use “ordinary course of business” lot 

numbers. The United States also understands that Colombia plans to consolidate related measures 

to reduce confusion. 

The United States remains concerned about certain labeling provisions that Colombia may 

incorporate into the final measure. U.S. industry would appreciate flexibility to apply labels 

bearing the information unique to Colombia either at the place of production or by applying 

removable overlay “stickers” to their products after they reach Colombia but before they enter 

Colombia’s customs territory. U.S. producers believe that, in some instances, mandating that 

products be labeled with Colombia-specific information at the point of production is less 

effective in preventing fraud than is permitting the application of overlay permanently-affixed 

stickers.

Colombia has indicated that producers will have eighteen months to comply with them. The 

United States will follow up with Colombia to confirm that producers will have 18 months to 

comply with these new labeling requirements. 

Distilled spirits - quality and identity requirements

In November 2008, Colombia notified the WTO that it was proposing to adopt quality and identity 

requirements for distilled spirits. The United States and U.S. industry submitted comments to 

Colombia in March 2009, stating that the proposal would restrict U.S. exports of gin, rum, vodka, 

and whiskey.

 

In response to the U.S. comments, Colombia adjusted several elements of its proposed measure, 

including by clarifying the minimum congener requirement for vodka; indicating that age 

declarations for rum will be voluntary; noting that flavored spirits were included in the definition of 

liqueurs; and indicating that de minimis flavorings could be used as permitted by regulatory 

specifications. These changes represent important steps in addressing U.S. concerns on this issue.

The United States remains concerned, however, about Colombia’s proposal to use analytical 

parameters to govern the sale of spirits in Colombia, particularly the prospect of imposing limits on 

total congeners included in gin, vodka, and rum, and the possibility of imposing minimum and 

maximum alcohol content limits that could bar some U.S. spirits from the Colombian market. The 

standards of identity for all distilled spirits sold in the United States, the European Union, Canada 

and nearly every other major spirits market are based solely on the raw materials and processes 

used to produce them, and are not defined in terms of a product’s chemical composition. 

Naturally occurring constituents produced in the fermentation and distillation process, including 

volatile acids, esters, higher alcohols, aldehydes, and furfural, are integral to the distinctive flavor 

characteristics of the various brands and categories of distilled spirits, and these constituents vary 

from product to product. These naturally occurring components are not regulated, either in 

minimum or maximum levels, by the TTB. Moreover, U.S. regulators are not aware of any 
77

scientific evidence suggesting that these constituents may be harmful to consumers in the 

concentrations found in distilled spirits. 

The United States has also asked Colombia to clarify whether it will permit brandy to be aged in a 

single oak barrel, in addition to using the solera aging method, and if it will permit liqueurs to 

contain certain synthetic colorings and de minimis amounts of other substances, as TTB and other 

regulators do. 

Finally, Colombia has not implemented a ban on the sale in Colombia of spirits labeled as 

Kentucky Bourbon or Tennessee Whiskey but produced outside the United States. Colombia has 

indicated that it will implement such a ban only after the U.S. Congress approves the pending U.S.-

Colombia Trade Promotion Agreement, which includes a provision recognizing Kentucky Bourbon 

and Tennessee Whiskey as distinctive products of the United States.

Ecuador

Bilateral Engagement

The United States discusses TBT matters with Ecuador during, and on the margins of, meetings 

the TBT Committee. 

Various products – conformity assessment

On November 25, 2008, Ecuador’s National Quality Council adopted Resolutions No. 001-2008, 

002-2008 and 003-2008, which implemented various articles of the Ecuadorian Quality Control 

System (Law No. 2007-76). These resolutions became effective upon publication on December 

1, 2008, and required importers of a number of specific products to demonstrate that they 

conform to new Ecuadorian product requirements by providing a certificate of conformity from 

an accredited certification body. Products covered by this certification requirement included 

apparel and footwear, rubber and tires, safety glass, transformers, ceramic and porcelain house 

wares and tableware, white goods and appliances, auto parts, cement, plastic, steel and aluminum 

products, matches, batteries, and lubricants. 

Because Ecuador did not publish these resolutions and notify them to the WTO before adopting 

them, interested parties had no opportunity to submit comments on them, importers were unable 

to comply with the new requirements, and some U.S. manufactured goods subject to the new 

requirements were held at the border. Ecuadorian authorities blocked entry of the U.S. goods 

until importers either (1) demonstrated that the products met the new requirements, (2) provided 

a substitute certification (e.g., from the American Petroleum Institute), or (3) obtained an 

exemption for specific shipments. 

The United States conveyed the concerns of U.S. manufacturers regarding these resolutions in 

meetings with Ecuadorian officials on January 22, 2009, and during the TBT Committee meeting 

in March 2009. Several other WTO Members, including Korea, Chile, and the European Union, 

also raised concerns during the TBT Committee meeting about the certification requirements. 

U.S. officials noted that Ecuador had neither notified the WTO nor provided an opportunity for 
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Members to comment on the resolutions. U.S. officials asked Ecuador to explain its rationale for 

imposing new requirements on such a large group of products and to provide information about 

the evidence Ecuador considered in determining the health, safety, or other risks these products

posed. The United States also outlined the difficulties the new certification requirements had 

caused for many U.S. exporters, in particular that they had found it difficult to identify test 

laboratories accredited to test many of the products subject to Ecuador’s new requirements (e.g., 

socks) because other countries do not require them to be tested. 

Ecuador rescinded the new resolutions in early 2009 and notified the rescission to the WTO. 

 

The European Union

Bilateral engagement

The United States has actively engaged the European Union on TBT-related matters in 

multilateral fora, including the TBT Committee, as well as bilaterally. These are the primary 

mechanisms through which the United States raises specific trade concerns with the EU 

regarding standards-related measures. 

In addition, cooperation between regulators has been a core element of the work of the 

Transatlantic Economic Council (TEC) since its inception in 2007. The Framework for 

Advancing Transatlantic Economic Integration between the United States of America and the 

European Union – the TEC founding document agreed to during the 2007 U.S.-EU Summit –

established “fostering cooperation and reducing regulatory burdens” as a principal objective of 

the TEC. Consistent with this mandate, U.S. and EU regulators have engaged in discussions on a 

number of horizontal and sector-specific issues during and in periods between the four TEC 

meetings held since 2007. At the conclusion of its fourth meeting in October 2009, the TEC 

agreed to renew the mandate of U.S.-EU regulatory cooperation and identified the goal of 

achieving “greater compatibility of effective and economically beneficial regulation...that could 

promote economic integration.” TEC principals also discussed the possibility of identifying 

emerging sectors in which neither side had yet implemented an extensive regulatory regime so 

that the two sides could seek to avoid unnecessarily divergent regulatory approaches. 

U.S. and EU regulators have also exchanged views and deepened cooperation in a range of areas 

under the U.S.-EU High-Level Regulatory Cooperation Forum (HLRCF). On the basis of 

recommendations contained in a joint paper prepared by OMB and the Secretariat General of the 

European Commission, both sides have taken steps to ensure better analysis of and greater 

transparency concerning the effects of proposed regulations on international trade and 

investment. The HLRCF presented a report on strengthening cooperation relating to the safety 

of imported products, which included concrete recommendations for overcoming current 

constraints on effective information sharing. OMB and the Commission presented papers in the 

HLRCF describing the U.S. and EU approaches to the use of voluntary standards in support of 

regulation. A “Transatlantic Risk Dialogue” will develop white papers in three focus areas: (1) 

development of a framework for exposure assessment; (2) uncertainty and terminology; and (3) 

new/rapid approaches to risk assessment. 
79

In addition, the United States and the EU have jointly advocated to trade and regulatory officials 

in key emerging markets such as Brazil, China, and India the importance of maintaining open 

and transparent regulatory and standards development processes. 

Accreditation rules

The United States continues to have serious concerns regarding the EU’s new accreditation 

framework set out in Regulation (EC) No 765/2008. This regulation, which became effective on 

January 1, 2010 and applies to all sectors, requires each Member State to appoint a single 

national accreditation body and prohibits competition among Member States’ national 

accreditation bodies. The regulation further specifies that national accreditation bodies shall 

operate as public, not-for-profit entities. This means that only a single, government entity in 

each Member State shall be permitted to accredit conformity assessment bodies in the EU. 

The United States has raised a number of concerns about the regulation both bilaterally and in 

the TBT Committee. First, the regulation raises serious questions as to whether the EU or its 

Members States will continue to recognize non-EU accreditation bodies that have been 

accredited under the ILAC MRA and the IAF MLA and continue to accept conformity 

assessments performed by ILAC MRA and IAF MLA accredited bodies. Because the regulation 

gives Member States discretion regarding whether to recognize non-European accreditation 

bodies and whether to accept conformity assessments issued by ILAC MRA and IAF MLA 

accredited bodies, it is possible that Member States may refuse to recognize non-European 

accreditation bodies – including ILAC MRA and IAF MLA accredited ones – and refuse to 

accept conformity assessments issued by these bodies. 

Second, the EU’s basis for instituting the new framework remains unclear, including what 

information the EU relied on to determine that (i) its new accreditation system should limit 

accreditation activities to governmental bodies or bodies that act in the exercise of official 

authority, (ii) accreditations should be viewed with a higher degree of confidence when provided 

by a single national accreditation body, and (iii) competition might compromise the quality of 

accreditations and should therefore be limited. 

Finally, the EU has offered no explanation for why the regulation imposes conditions on 

accreditors operating in the EU market that go beyond the relevant ISO/IEC standard used under 

the ILAC MRA and the IAF MLA. 

The United States also expressed concern that, without clear guidance from the Commission, 

Member States may refuse to recognize non-European accreditation bodies and conformity 

assessments issued by non-European testing and certification bodies. The European co-operation 

for Accreditation (EA) acknowledges that attestations of conformity assessment results issued by 

bodies that have been accredited by non-European bodies that are ILAC MRA or IAF MLA 

signatories are equally reliable as those issued by European bodies complying with the new 

accreditation requirements set forth in Regulation 765. Yet, the Commission has indicated that 

the quality and validity of accreditations issued by non-European bodies that have not been 

accredited under Regulation 765, and attestations of conformity issued by conformity assessment 

bodies accredited by such bodies, could be in doubt. This raises market access concerns for 
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products, including many U.S. products, certified by conformity assessment bodies accredited by 

non-European accreditation bodies. Given the EU’s stated intent to spread its accreditation 

approach worldwide, the United States remains concerned that the EU approach will both 

undermine the international accreditation system under the ILAC MRA and the IAF MLA and 

impede U.S. exports to the EU. 

The United States continues to have a number of questions about how the new EU accreditation 

framework will operate in practice. For example, it is unclear under the new EU framework 

whether European national accreditation bodies are permitted to accredit foreign conformity 

assessment bodies and, if so, whether they are required to accredit such bodies on no less 

favorable terms than they accredit European conformity assessment bodies.

U.S. accreditation bodies and other ILAC MRA signatories continue to be concerned that the 

EU’s response to stakeholder concerns is inadequate. The United States will continue to raise 

this issue with the EU bilaterally and in the TBT Committee and hopes to hold technical 

discussions with the EU in early 2010. In the interim, the Unites States urges the Commission to 

issue guidance to Member States indicating that accreditations by ILAC MRA and IAF MLA 

signatories are no less reliable than accreditations by European national bodies, and therefore 

that Member States are free to accept testing and certification from non-EU bodies that have 

been accredited by an ILAC MRA or IAF MLA signatory.

Borates and nickel compounds: classification and labeling requirements

In 2007, the EU notified an amendment (the 30th ATP) to the Dangerous Substances Directive 

(DSD) introducing and modifying EU harmonized classification and labeling requirements for 

896 substances, including borates, nickel carbonates and other nickel compounds. The U.S. 

industry considers that the proposed classification of borates under Category 2 of the DSD is

unnecessarily trade-restrictive, and that the scientific justification for the classification was 

inadequate because it was not based on “normal handling and use” of downstream products 

containing borates. Industry has raised further concerns that by classifying borates in Category 2 

of the DSD, the amendment would lead to restrictions and bans on using borates in certain 

products (e.g., cosmetics, detergents, and fertilizers) under related EU directives. The U.S. 

nickel plating industry – along with the nickel industries of Australia, Canada, Cuba, Brazil, and 

other Members – has raised concerns about how nickel is classified under the DSD, asserting that 

the EU did not properly apply the OECD’s “read-across” methodology.

In December 2008, the EU promulgated the Classification, Labeling and Packaging (CLP) 

regulation to replace the DSD. The classifications of both borates and nickel have since been 

transferred – without any new analysis – to the CLP regulation, whose classification 

methodology and category and labeling schemes are different from those of the DSD. In 

September 2009, the EU published the 1st ATP (Adaptation to Technical Progress) to the CLP 

regulation – a combination of the 30th and 31st ATP to the DSD – which classified certain borate 

compounds as category 1B (that is, the equivalent of Category 2 under the DSD).

The United States has frequently raised questions regarding this issue in the TBT Committee,

and has asked the EU to clarify its procedures for transferring the borates and nickel 

classifications from the DSD to the CLP. Industry has raised concerns that the EU has not 
81

followed the procedures specified in the CLP regulation for harmonizing classifications. The 

United States has also asked the EU to clarify how the borates classification will affect 

cosmetics, since the EU’s risk and impact assessments did not cover cosmetics. Various 

industrial producers have launched cases in the UK courts and in the European Court of First 

Instance seeking to annul the borates classification. 

On a positive note, the EU recently provided additional information on its nickel classification, 

which U.S. officials are reviewing. The EU also recently proposed an amendment 

(G/TBT/N/EEC/297) of REACH Annex XVII to permit the use or placement on the market 

without restriction of borate compounds used in household cleaners, detergents and certain 

photographic mixtures. While this is a welcome development, the EU’s procedures for 

classifying borates and certain nickel compounds continue to raise concerns, specifically 

regarding possible flaws in the EU’s classification methodology, the procedures the EU used in 

transferring these classifications from the DSD to the CLP, and the effect that these 

classifications will have under other EU measures, such as the Cosmetics Directive and the EU’s 

chemicals regulation REACH. The United States will continue to monitor the potential adverse 

trade effects of the EU’s nickel and borates classifications as well as the methodological issues 

mentioned above.

Chemicals 

While supportive of the EU’s objectives of protecting human health and the environment, the 

United States has raised trade-related concerns with respect to the EU’s chemicals regulation, 

REACH, which entered into force June 1, 2007. REACH impacts virtually every industrial 

sector, from automobiles to textiles, because it regulates chemicals as a substance, in 

preparations, and in products. It imposes extensive registration and testing and data requirements 

on tens of thousands of chemicals. The first registration deadline is November 30, 2010 with 

subsequent deadlines on the same day in 2013 and 2018. REACH also will subject certain 

chemicals to an authorization process that would prohibit chemicals from being placed on the EU 

market except as authorized for specific uses by the European Commission. The United States

has raised a number of trade-related concerns regarding REACH.

First, unlike EU manufacturers, non-EU manufacturers lacking an EU presence cannot register 

substances to fulfill REACH’s registration requirements. Only EU legal entities may register. 

To avoid having each of their importers or downstream users in the EU register their substances, 

non-EU manufacturers may have no alternative but to appoint “Only Representatives” (ORs) to 

register chemicals on their behalf. Hiring an OR is an additional cost shouldered only by nonEU manufacturers. In addition, non-EU manufacturers may be required disclose business 

proprietary information to an OR (or importer) in order to have their substances registered. The 

United States has pressed the EU to address the problems that REACH’s OR provisions pose.

Further, REACH requires polymer manufacturers and importers to register reacted monomers in 

many circumstances. Industry has raised concerns about this requirement given that reacted 

monomers no longer exist as individual substances in polymers and would not create exposure 

concerns in the EU. By contrast, EU polymer manufacturers generally can rely on the 

registrations of their monomer suppliers. As a result, the reacted monomer registration 
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requirement provides an incentive for distributors to stop importing polymers and switch to EU 

polymer suppliers, since the reacted monomers in those polymers will already have been 

registered. The United States has pressed the EU to eliminate the requirement to register reacted 

monomers in polymers entering the EU market. 

In addition, all pre-registrants must join a Substance Information Exchange Forum (SIEF) to 

facilitate data sharing between the companies and submit registration dossiers. Many SIEF 

members have indicated that SIEFs do not function effectively, in part because of the large 

number of members in some SIEFs, which may cause many companies to miss the first 

registration deadline. The United States has asked the EU to address these problems. 

Moreover, REACH contains notification and communication obligations with respect to 

substances on the Candidate List, a list of substances that may become subject to authorization. 

Differing interpretations regarding whether these obligations apply if a substance on the 

Candidate List is present in an article in concentrations above 0.1 percent of the article’s entire 

weight or above 0.1 percent of the weight of the article’s components or homogenous parts have 

engendered uncertainty about how to comply with these obligations. The United States has 

asked the EU to ensure consistent interpretation of these obligations. 

Under REACH, certain “phase-in substances” benefit from extended registration deadlines in 

2010, 2013, and 2018. Imported substances not listed in the European InNventory of Existing 

Commercial Chemical Substances (EINECS), did not qualify for pre-registration, and thus 

extended registration deadlines, even though they were lawfully on the EU market. Substances 

in the EINECS are either already considered registered or were eligible for pre-registration, with 

full registration required up to ten years later based on an extended “phase-in” schedule. 

Therefore, EU manufacturers of products containing these substances do not bear the cost and 

burden of registration or have an extended deadline to register. The United States has asked the 

EU to guarantee the same treatment it grants to “phase-in substances” to non-EU manufacturers 

through a transparent and legally certain solution. 

Further, U.S. SMEs are concerned that REACH will put them at a disadvantage with larger 

companies because the registration and testing requirements that REACH imposes, as well as 

participation in SIEFs, will require substantial resources. The United States has asked ECHA to 

provide assistance to SMEs through its help desks that will aid their efforts to continue shipping 

to the EU market. 

In addition, inadequate transparency and delays in providing legal clarification in the REACH 

implementation process make compliance planning difficult and limit opportunities for 

stakeholders to provide input. For example, the United States understands that some REACH 

guidance documents currently being updated will be finalized too late and will not clarify some 

pending issues, to help with the first registration deadline in November 30, 2010. Additionally, 

there has been limited opportunity for stakeholders to provide input into certain guidance 

documents. 

Lastly, EU and U.S. stakeholders are concerned that the substantial data requirements under 

REACH could result in an increase the use of animal testing as implementation of REACH 
83

proceeds. In September 2009, the European Chemicals Agency (ECHA) issued a clarification 

that will help prevent duplicative testing. The United States welcomes other steps to avoid 

unnecessary animal tests.

The United States has raised concerns regarding REACH at every TBT Committee meeting since 

2003, and has been joined by many other delegations, including Argentina, Australia, Brazil, 

Canada, Chile, China, Colombia, Cuba, the Dominican Republic, Ecuador, Egypt, El Salvador, 

Israel, Japan, Korea, Malaysia, Mexico, Qatar, Russia, Singapore, Switzerland, Taiwan, and 

Thailand. The United States also has raised its concerns regarding REACH bilaterally with the 

Commission. In addition, it has worked with the ECHA on specific technical issues. The United 

States will continue to monitor closely REACH implementation in the upcoming year, including 

the first registration deadline on November 30, 2010 and Member State-level implementation 

and enforcement regimes, as well as the REACH review process that the Commission has started 

this year and will be completed by June 1, 2012. 

 

Hazardous substance restrictions

The United States has raised trade-related concerns with the RoHS directive. The RoHS 

directive prohibits placing certain categories of electrical and electronic equipment on the EU 

market that contain certain chemicals such as lead, mercury, cadmium, and hexavalent 

chromium. The RoHS directive includes certain application-specific exemptions from the 

prohibitions. Requests for additional exemptions are considered on an ongoing basis. The EU is 

preparing a major review of all existing exemptions. 

While it supports the EU’s objectives of protecting human health and the environment, the 

United States has raised concerns regarding the transparency and predictability of the process 

and timing for considering exemption requests and the absence of a common approach to 

enforcement in all EU Member States. With the entry into force of REACH, the United States 

also has pressed for clarification of the relationship between REACH and RoHS to help ensure 

transparency and legal certainty regarding how substances will be treated.

The EU currently is revising the RoHS directive. The legislative process is expected to be 

completed in late 2010 or early 2011. The United States is urging the EU to provide an adequate 

opportunity for U.S. stakeholders to provide input into the revision process, and to ensure that 

the revised RoHS directive clarifies the relationship between REACH and RoHS and includes an 

improved exemption process. The United States has also urged the EU to ensure that any 

decision to expand the RoHS directive’s scope of covered products be informed by a thorough 

impact assessment. It also has urged the EU to ensure that any decisions regarding the scope of 

covered products, additional restrictions, and exemptions included in a revised RoHS directive 

are based on science, taking into account intended end-uses and all available scientific and 

technical information. 

Ride-on lawnmowers – unique French requirements

The United States continues to have concerns with respect to the French Ministry of 

Agriculture’s (MoA) “skirt” requirement for ride-on lawnmowers, a measure that France never 
84

published as part of an official law or decree and that was not notified to the WTO. The MoA 

requirement for ride-on lawnmowers already has disrupted U.S. lawnmower exports to France. 

If other Member States were to adopt this requirement, a significant portion of the approximately 

$1 billion in annual U.S. shipments of lawnmowers to Europe could be adversely affected. 

The United States is not aware of any technical basis for requiring ride-on lawnmowers to be 

fitted with an extra piece of equipment (or “skirt”). EU and U.S. lawnmower manufacturers 

assert that the MoA has not presented any accident data supporting the need for the requirement, 

and they allege that the requirement could in fact increase the potential for safety problems by 

increasing the risk of fire caused by accumulating debris in the vehicle. The European Garden 

Machinery Industry Federation has challenged MoA’s requirement on several grounds, including 

France’s allegedly flawed interpretation of CEN standard, disregard of internal market norms, 

and alleged infringement of EU laws. U.S. officials understand that the skirt requirement 

represents a unique French requirement that is neither consistent with requirements in other EU 

Member States, nor based on internationally developed ASTM or ISO ride-on lawnmower 

standards used throughout the world. 

The United States has urged DG Enterprise to re-evaluate its rejection of the European industry 

petition challenging the MoA requirement’s conformity with the Machinery Directive. The 

United States has reiterated a request that the Commission share accident data it believes 

supports the French position that installation of the lawnmower skirt would increase bystander 

safety, and any analysis undertaken by the MoA on the potential fire hazard that installation of 

the skirt could create. If this information does not exist or does not support the necessity of the 

skirt requirement, the United States requested that the Commission recommend that France base 

its ride-on lawnmower requirements on a relevant international standard, and eliminate the skirt 

requirement. 

Wine – labeling requirements

The EU continues to seek exclusive use of so-called “traditional terms” such as tawny, ruby, 

reserve, classic, and chateau on wine labels, although the EU appears to be willing to “license” 

use of such terms to third country producers as long as those third countries regulate the terms in 

their home markets. Under the United States – EU wine agreement, the EU granted a three-year 

derogation for the use of such terms for U.S. wines sold in the EU. The derogation expired in 

March 2009, and the EU indicated that it would not renew the derogation. As part of its effort to 

redesign its Common Market Organization on wine, the EU published its new regulation (EC No 

607/2009) on July 14, 2009, laying down detailed rules for implementation of EC regulation 

479/2008 with regard to protected designations of origin and geographical indication, traditional 

terms, labeling, and presentation of certain wine products. The regulation leaves enforcement to 

EU Member States. It is unclear how Member States will enforce the regulation or how the 

Commission plans to ensure consistency of interpretation across Member States.

The United States continues to have serious concerns regarding these measures, which severely 

restrict the ability of non-EU wine producers to use common or descriptive and commercially 

valuable terms to describe their products, on the grounds that those terms are traditionally 

associated with European wines. Some of these terms do not have a common definition across 
85

all EU Member States, and the United States is aware of no effort to monitor or limit the use of 

those terms within the EU. The United States remains concerned about negative trade impacts 

caused by the EU’s March 10, 2009 termination of the three-year derogation for the use of such 

terms on the labels of U.S. wines sold in the EU, as well as the EU’s limitation on the use of 

traditional expressions in trademarks. 

While the EU attempts to justify limitations on the use of traditional terms by indicating that they 

could be used to mislead consumers, the fact that these terms have been used without incident on 

U.S. wines in the EU market for many years suggest that there is no risk to consumers. Adding 

to the U.S. industry concern is the fact that the EU has not indicated how it intends to enforce the 

limitations with respect to imported wines and whether it will take action to block importation of 

U.S. wines bearing a traditional expression. Furthermore, the European Court of Justice has 

expanded the scope of the measures and, contrary to the assurances provided by EU officials, the 

traditional terms are now protected in languages other than the one for which protection was 

identified. 

Each of the issues elaborated on this section of the report are ones that the United States will 

continue to follow closely in 2010 and to raise with the EU with a view to resolving the concerns 

these issues pose for U.S. exporters and producers.

Gulf Cooperation Council 

Bilateral engagement

The Gulf Cooperation Council (GCC) is an economic and political policy-coordinating forum for 

the six Member States (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab 

Emirates (UAE)). The United States engages on standards-related issues with the GCC 

collectively and with individual Member States. The United States has concluded an FTA or 

Trade and Investment Framework Agreement (TIFAs) with each of the Member States. These 

agreements, as well as the WTO, provide context for U.S. engagement on standards-related 

issues arising in GCC Member States. 

In October 2009, officials from the United States, the six GCC Member States and the GCC’s 

standards body – the Gulf Standards Organization (GSO) – held a workshop in Dubai, United 

Arab Emirates to address a variety of standards-related matters. This workshop was co-hosted 

by the U.S. Department of Commerce’s Commercial Law Development Program (CLDP) and 

the Emirati Standards and Metrology Authority (ESMA) and provided a forum for U.S., GCC 

Member State and GSO authorities to exchange information and hold technical discussions with 

a view to better understanding each other’s respective regulatory and standards systems and to 

explore ways to further cooperation between United States and the GCC regarding their 

respective standards and regulatory systems. U.S. speakers included officials from USTR, the 

U.S. Department of Commerce, OMB’s Office of Information and Regulatory Affairs, and the 

Consumer Product Safety Commission, and featured presentations on the TBT Agreement, the 

importance of transparency in facilitating trade, and comparative approaches to product safety, 

especially with respect to toys. The event was also attended by regional representatives of U.S.-

based exporters and conformity assessment bodies, who were able to ask questions and express 
86

their views to officials from the United States, as well as by the GSO and the GCC Member 

States. 

In November 2009, the GSO hosted a conference on standards and conformance to continue 

technical discussions and exchange additional information on the U.S. and GCC standards 

systems. Along with representatives from GSO, representatives from NIST, ANSI, and several 

U.S.-domiciled standards developers participated in the conference. 

After conclusion of this workshop, the Secretary General of the GSO and the Assistant USTR for 

Europe and the Middle East agreed to continue to increase the two sides’ engagement on 

standards-related issues, and officials from the United States and the GSO, with input from the 

Member States, are currently working on an action plan to deepen bilateral engagement over the 

coming years. 

Conformity assessment procedures – lack of transparency

In 2006, the Saudi Ministry of Commerce implemented the Certificate of Conformity (CoC) 

Program. This program requires every shipment of products sold in Saudi Arabia to be 

accompanied by a document certifying that the product conforms to the relevant Saudi Arabian 

technical regulation ("conformity certificate"). With certain exceptions, the CoC program 

requires that all products sold in Saudi Arabia be tested and certified to ensure compliance with 

the relevant Saudi requirements. 

Although at the time of its accession to the WTO Saudi Arabia committed to provide detailed 

public guidance in English on how to comply with the new conformity assessment program, it 

has not yet done so. The lack of publicly available guidance on the requirements has created 

confusion and uncertainty in the marketplace. The company with which Saudi authorities had 

contracted to provide services for the now abolished ICCP appears to be advertising (via the 

Internet at www.iccp.com) that its services are a requirement for access to the Saudi market. 

Because Saudi Arabia has not identified which companies may provide testing and certification 

services under the CoC system and what this company’s role should be under the CoC system, 

use of its services appears to remain a de facto requirement for access to the Saudi market. As a 

consequence, U.S. conformity assessment bodies appear unable to provide testing and 

certification for the Saudi market at least without involving this company in some way.

The United States has raised this issue both bilaterally and in the TBT Committee since 2006, 

including its concern that Saudi Arabia has still not issued guidance in English on how to comply 

with its CoC requirements. The United States has urged Saudi Arabia to publish guidance on 

how to comply with the CoC, in particular the criteria that Saudi Arabia will use to approve 

bodies to test and certify products for the Saudi market, and based on such criteria, a list of 

conformity assessment bodies that are approved to provide testing and certification for the Saudi 

market. 

To this end, the United States has requested that Saudi Arabia dissolve the iccp.com website and 

establish a new central website to provide information on CoC requirements. A central website 

could: (a) list entities that the Ministry of Commerce has approved to test and certify products for 
87

the Saudi market; (b) set out the criteria and procedures that the Ministry of Commerce uses to 

approve bodies to test and certify products for the Saudi market; (c) describe the formal process 

it uses to notify bodies whether they have been approved; (d) set out clear procedures for 

approved bodies to follow when issuing conformity certificates or marks to convey that a product 

complies with the relevant requirements; (e) clarify when testing is required (e.g., for each 

individual shipment or once for each product type); and (f) indicate whether the procedures will

change once Saudi Arabia adopts the GCC conformity assessment scheme and if so the duration 

of any transition period that will ensure suppliers have adequate time to adapt to any such 

changes. 

Saudi and U.S. officials are attempting to resolve this issue on a technical level. The United 

States believes that the issue can be resolved in the near term if Saudi Arabia is willing to devote 

sufficient attention to the matter at senior levels.

The GSO is currently developing a conformity assessment scheme that could be adopted by each 

of the six GCC Member States. (Committee representatives have informed U.S. officials that the 

GCC intends for the scheme to be implemented in successive stages, beginning with toys in 

2010.) Thus, in parallel with efforts to resolve concerns with Saudi Arabia’s CoC program, the 

United States is working to establish a dialogue between U.S. and GCC technical experts to 

discuss the proposed GCC-wide conformity assessment scheme, with the goal of helping to 

ensure that it is developed, adopted, and applied in accordance with WTO rules and that it is 

fully transparent.

India

Bilateral engagement

The United States discusses TBT matters with India during and on the margins of TBT 

Committee meetings. U.S. government officials also discuss such matters with Indian officials 

under the U.S.-India Trade Policy Forum (TPF), the TPF’s Tariff and Nontariff Barriers and 

Agriculture Focus Groups, the U.S.-India Commercial Dialogue and the High-Technology 

Cooperation Group. 

Cosmetics – registration requirements

U.S. industry has raised concerns regarding India’s “Drugs and Cosmetics (Amendment) Rules, 

2007,” which would amend the Drug and Cosmetics Rules, 1945. Industry contends that the 

amendment would create an unreasonably costly and burdensome registration system for 

cosmetics products that would also result in unnecessary delays for cosmetic products being 

brought to market. 

Given that India did not notify this measure to the WTO, the United States requested that India 

notify the measure promptly, delay enforcement to allow a reasonable time for Members to 

comment, and afford suppliers a reasonable period to comply with the new requirements. India 

eventually notified the measure, and the United States submitted comments including concerns 

raised by U.S. stakeholders through India’s TBT Inquiry Point. 
88

In response to these comments, India’s Ministry of Health (MoH) made a number of 

clarifications and modifications to the proposed measure, including that it would: not require

companies to list all countries where marketing authorization of a product exists; accept 

manufacturers’ self-certification of compliance supported by laboratory reports issued by foreign 

laboratories, so long as suppliers provided the required data; provide suppliers with either six 

months or a year to comply and an exemption for products that had already been imported into 

India from the new requirements; not require suppliers to obtain separate registrations for 

individual colors of the same product (e.g., lipstick); and recognize internationally-accepted 

names for ingredients, as set out in the International Nomenclature of Cosmetic Ingredients 

(INCI) dictionary. 

However, the United States remains concerned that MoH intends to treat all cosmetics, whether 

low- or high-risk, the same under the new system.

 

Food and distilled spirits – nutritional labeling

The United States continues to raise concerns regarding MoH’s changes to its nutritional labeling 

requirements. In February 2009, India addressed a major U.S. concern by removing a provision 

that would have required producers of proprietary foods to list the formulation of their products 

on the label. MoH also clarified that producers of distilled spirits would be exempt from the 

requirements to provide nutritional information and the expiration date on labels. The revised 

measure entered into force in June 2009, after India provided a three-month delay in enforcement

at the request of the United States and other stakeholders. 

The United States is still concerned that the measure may require the labels of distilled spirits to 

provide the date of production, which is irrelevant in the case of distilled spirits, since such 

products have an indefinite shelf life. Other outstanding technical questions and concerns that 

India has yet to address include: the labeling of proprietary foods; the declaration and 

calculation of certain nutrient values, especially trans fats; the criteria for labeling a product as 

“trans fat free;” the allowance of stickering on products; and the rules for front of pack flavoring 

declarations using the statement “CONTAINS ADDED FLAVOUR.” 

A recent proposal from the Food Safety and Standards Authority of India (FSSAI) may resolve 

several of the outstanding labeling issues, including the front of pack flavoring declaration rules, 

but the United States is awaiting further clarification from India on these points. The United 

States will continue to press India to resolve the remaining issues, including in forthcoming 

discussions between U.S. and Indian trade and regulatory officials. 

Tires – conformity assessment procedures

Since 2007, the United States has raised concerns, both bilaterally and at the TBT Committee,

about a proposed Bureau of Indian Standards (BIS) measure setting out conformity assessment 

procedures for tires. India published the final version of this measure in November 2009, with 

an effective date of 180 days from date of publication. The measure requires tire suppliers to 
89

apply for approval for each of their tire plants in order to export tires to India. As part of the 

application process, suppliers need to identify tire families and send sample tires for each family 

to India for compliance testing at the Central Institute for Road Transport (CIRT). CIRT is

currently the only laboratory authorized by BIS to conduct the testing; given CIRT’s limited 

capacity, industry believes that this could lead to testing backlogs and disrupt trade in tires to 

India. 

The United States supports India’s goal of promoting vehicle safety, and notes the positive 

bilateral discussions between the United States and India on this issue over the years. However, 

if the BIS procedures are promulgated without BIS authorizing additional laboratories to do the 

testing or providing a sufficient transition period, trade in tires could be disrupted. BIS has 

recently indicated that it may recognize foreign laboratories to test the tires as long as such 

laboratories meet the Indian standard and are accredited by the Indian accreditation agency. The 

United States has advocated that BIS should provide this information and the relevant 

application procedures, on the BIS website so that test laboratories know how to apply for 

recognition and what the BIS criteria are. In response, BIS officials have recently indicated that 

the criteria for accreditation of laboratories may be found on the National Accreditation Board 

for Testing and Calibration Laboratories (NABL) website and that the guidelines for recognition 

of laboratories may be found on the BIS website. 

On November 19, 2009, India published Notification SO2953 relating to these procedures in its 

official journal, setting the implementation date at 180 days from publication. 

While these are helpful steps, U.S. officials will continue to seek clarification of the criteria, as 

well as advocate that India recognize additional test laboratories, such as laboratories that have 

been accredited by ILAC MRA signatories, wherever they may be located. Additionally, U.S. 

officials will monitor the transition period to ensure that it is an appropriate period of time for 

compliance. 

Indonesia 

Bilateral engagement

The United States discusses TBT matters with Indonesia both bilaterally and during meetings of 

the TBT Committee. The United States – Indonesia Trade and Investment Framework 

Agreement (TIFA) Council provides a forum for bilateral discussions on a variety of traderelated issues, including TBT issues. Indonesia participates actively on standards and 

conformance issues in APEC.

Meat and poultry products – halal certification

Indonesia only allows the sale of meat and poultry products that have been certified halal by 

certifiers recognized by Indonesia’s Council of Ulama (“MUI”). Halal certification involves 

certifying that the product has been slaughtered and handled in a manner consistent with Islamic 

law. On March 9, 2009 MUI issued a decree announcing that a new list of MUI recognized halal 

certifiers would become effective October 1, 2009, superseding all previous MUI recognized 
90

halal certifiers. MUI did not make publicly available or notify to the WTO the new procedures 

and criteria for recognition and inclusion of certifiers on the new list. MUI published the new 

list of halal certifiers on October 22, 2009, 21 days after the decree’s effective date, causing a 

twenty-two day disruption in all halal trade to Indonesia. The procedures and criteria for MUI 

recognition remain unclear, preventing U.S. certifiers from effectively petitioning for recognition 

and inclusion on the list of recognized halal certifiers. The new halal certifier list does not 

include any MUI recognized poultry certifiers, which has blocked all U.S. exports of poultry to 

Indonesia. The new list of certifiers also excluded several U.S. processed food halal certifiers 

that MUI has historically recognized. 

In bilateral and TBT Committee discussions with Indonesia on this matter, U.S. officials 

emphasized that the United States respects Indonesia’s right to regulate halal products and that 

Indonesia and the United States share the common goal of ensuring that foods labeled “halal” 

meet Indonesia’s requirements. The United States, however, is concerned with the lack of 

transparency in the development and application of the new halal certifiers list. U.S. officials 

requested clarification on how Indonesia makes regulatory decisions with respect to halal issues, 

including which entities are responsible for composing the list of recognized halal certifiers, and 

for clarification of the scope of Indonesia’s halal regime, including whether halal certification is 

voluntary or mandatory. The United States has also asked Indonesia to clarify an attachment to 

the final certifiers list, which indicates that the certifiers can only certify raw materials. The 

United States has pressed Indonesia to notify all halal procedures and criteria in draft form to the 

WTO for comment. Finally U.S. officials have urged Indonesia to allow U.S. halal certifiers to 

apply for and receive recognition under transparent procedures and criteria and, until that 

happens, to allow previously-recognized halal certifiers to continue to certify halal products for 

the Indonesian market. 

 

Food, supplements, drugs, and cosmetics – distribution license requirements 

On August 31, 2009, Indonesia’s National Agency of Drug and Food Control announced new 

requirements for the distribution of food, food supplements, drugs, and cosmetics. These 

requirements state that no food, food supplements, drugs, or cosmetics may be distributed in 

Indonesia without first obtaining a distribution license. The criteria that must be met to receive a 

license differ by product type and are based on several factors, including whether certain 

ingredients are halal. For instance, in the case of pharmaceutical products, drugs sourced from, 

containing, or manufactured using certain animal substances cannot be awarded a distribution 

license unless there is an “emergency.” 

In emergencies, a Cross Sector Team for Legality and Emergency, comprising officials from the 

Health Ministry, the National Agency of Drug and Food Control, MUI, and relevant expert 

physicians, determines which drug products will receive a license. Once awarded a license, drug 

products sourced from swine must bear a label indicating “Swine Content.” Further, drug 

products manufactured using substances sourced from swine in the production process must bear 

a label indicating that: “The manufacturing process involves a substance that [is] sourced from 

swine and has been purified so that [it is] not detected on final product.” Food sourced from 

swine is subject to a separate set of emergency procedures. Distribution licenses also cannot be 

awarded for products containing alcohol, such as certain pharmaceuticals, cosmetics, and food 

flavorings. Indonesia did not publish the draft measure in advance or notify it to the WTO.
91

The new requirements could disrupt U.S. exports to Indonesia of foods (many flavorings contain 

alcohol, sometimes in de minimis amounts); drugs (many products, such as cough syrups and 

other over-the-counter drugs, contain alcohol and others, such as gelatin capsules and vaccines, 

are sourced from swine); and cosmetics (many products contain alcohol). The United States is 

particularly concerned that the new requirements may disrupt trade in critical medicines, such as 

vaccines, as well as trade in many other products. For example, vaccines developed to address a 

pandemic can be sourced from swine and thus could be banned in Indonesia under the new 

requirements. In addition, because the decree indicates that the use of traditional drug products, 

cosmetics, and food supplements are “in general not emergency,” it appears that Indonesia will 

generally not award a distribution license for products sourced from, containing, or derived from, 

certain animal substances.

While the United States respects Indonesia’s right to regulate halal products, Indonesia should 

have developed and applied its requirements affecting trade in halal products in a transparent 

manner that does not disrupt trade. Because the measure entered into force on the date of 

publication, and Indonesia did not notify it to the WTO in proposed form, stakeholders did not 

have an opportunity to comment on, or a reasonable period to comply with, the new 

requirements. In addition, many of the operational details of the licensing system are unclear. 

U.S. officials have posed several questions to Indonesia to better understand the new 

requirements. In particular, U.S. officials raised questions about the basis for Indonesia’s 

decision to create separate procedures for halal products to receive distribution licenses, as well 

as a number of questions regarding the operation of the new requirements including: the criteria 

and procedures used to determine whether an emergency exists and who makes that 

determination; the procedures to apply for a distribution license; the criteria and procedures the 

Cross Sector Team will use to evaluate whether to grant a distribution license; and any avenues 

for appealing application denials. 

The new requirements raise further concerns. Because there is currently no test for detecting 

porcine (swine) materials in drugs, it may not be feasible for producers to label drugs 

manufactured using porcine (swine) content (and awarded distribution licenses under the 

emergency provision) and thus Indonesia is asking drug manufacturers to certify to something 

that they may not be able to confirm readily.

The United States has raised this issue with Indonesia bilaterally and in the TBT Committee and 

has requested technical talks with Indonesia to try to resolve the matter. The United States has 

requested that Indonesia suspend enforcement of the measure until it notifies it to the WTO and 

takes comments from trading partners into account. The United States believes that additional 

transparency and clarification of Indonesia’s distribution licensing regime is needed, and that 

Indonesia can meet its regulatory objectives while ensuring that trade in food, food supplements, 

cosmetics, and drugs (including critical products such as medicines) is not disrupted. 
92

Israel 

Bilateral engagement

The United States and Israel engage on TBT issues in a variety of venues. The United States 

discusses TBT matters with Israel during, and on the margins of, TBT Committee meetings and 

at Joint Committee meetings of the U.S.-Israel FTA. The United States and Israel also convene 

an annual Working Group on Standards and Technical Regulations to discuss outstanding 

bilateral issues, as well as achieve greater cooperation in the areas of standards and conformance. 

During the most recent Working Group meeting in Jerusalem in March 2009, U.S. officials met 

with numerous officials from Israeli trade and regulatory agencies, including the Standards 

Institute of Israel (SII), to discuss their countries’ respective standards systems and ways that the 

two sides can work together more closely on standards-related issues. U.S. officials have forged 

a constructive relationship with SII, which has generally been responsive to U.S. concerns, 

notifies draft measures to the WTO for comment and takes WTO Member comments into 

account, and engages with U.S. officials to find solutions to bilateral challenges. 

Distilled spirits – quality and identity requirements

On January 12, 2009, Israel notified to the WTO proposed amendments to its alcoholic 

beverages identity requirements that, if implemented, would restrict exports of certain U.S. 

spirits to Israel. The United States submitted comments on March 5, 2009, requesting that Israel: 

(1) clarify that Bourbon and Tennessee whiskey are distinctive U.S. products that may be 

produced only in the United States in accordance with U.S. laws and regulations; (2) eliminate 

the mandatory aging requirement for blended whiskey; and (3) ensure the proper use of the term 

“straight” whiskey. U.S. officials have discussed these concerns with Israel bilaterally including

on the margins of TBT Committee meetings as well as in Working Group and Joint Committee 

meetings. 

In May 2009, the SII Technical Committee – Alcoholic Beverages indicated that it would accept 

requests (1) and (3) above, and these changes were incorporated into the final measure. 

However, the SII Technical Committee denied the U.S. request to eliminate the minimum aging 

requirement for “General kinds of whiskies” (e.g., whiskies whose labeling is not based on the 

geographical site of production). 

The United States continues to have concerns regarding Israel’s decision to maintain the 

mandatory aging requirement for whiskey because that decision will adversely affect exports to 

Israel of certain U.S. whiskey products (though not Bourbon and Tennessee whiskey). The 

problem arises with respect to blended whiskeys, which are defined as mixtures that contain 

straight whiskey or a blend of straight whiskeys at not less than 20 percent on a proof gallon 

basis, together with other whiskeys (i.e., not straight whiskeys) or neutral spirits. Neutral spirits 

are almost never aged and therefore, if neutral spirits are added to straight whiskeys, the resulting 

blended whiskey will not meet any minimum aging requirement.

There is no international standard for “whiskey” including none pertaining to maturation 

requirements for whiskey. Depending on climactic conditions, whiskey does not need to be aged 
93

three years in certain parts of the world (e.g., in some U.S. States) in order for the product to 

obtain the characteristics of whiskey. Given that Israel does not produce whiskey, it is surprising 

that Israel would choose to retain such restrictive requirements for the identity of whiskey that 

will prohibit certain U.S. blended whiskeys from entering the Israeli market. 

U.S. officials have urged Israel to create an exception from the three-year aging requirement for 

“blended whiskeys” that conform to the exporting country’s origin requirements. This would 

allow the importation of U.S. blended whiskey without undermining the three-year aging 

requirements for Scotch whisky and Irish whiskey. SII has indicated that the U.S. proposal has 

been sent to the SII Technical Committee for its consideration. The United States is prepared to 

provide additional information to the SII Technical Committee as it considers the proposal. 

Infant formula – requirements for approval, labeling, and conformity assessment

In March 2007, U.S. industry began raising concerns about the lack of clear, consistent, and 

publicly available information on Israel’s requirements for issuing import approvals or licenses, 

conformity assessment procedures, and labeling requirements for infant formula. 

The United States raised this issue with Israel, both bilaterally and during TBT Committee 

meetings, on several occasions, including in written communications to Israel’s Ministry of 

Health (MoH). In particular, the United States sought to obtain additional information about 

Israel’s requirements for infant formula and requested that Israel notify these requirements to the 

WTO so that other Members could comment on them. 

In December 2009, Israel published a document setting forth its technical requirements 

governing infant formula, which appears to apply equally to domestic and imported formula, for 

instance: how frequently testing must be conducted (every batch); which laboratories are 

authorized to test for particular vitamins, minerals, or other substances; and procedures for 

inspection of domestic facilities. U.S. officials are analyzing this document and in 2010 will 

follow up with Israel on any remaining technical issues. The United States will continue to urge 

Israel to indicate the specific quality and health requirements that infant formula must meet to be 

sold on the Israeli market.

Spare parts – labeling requirement

The United States has serious concerns regarding Israel’s country of origin labeling requirement 

for automotive products and heavy equipment. On December 9, 2008, Israel’s Ministry of 

Transportation (MoT) finalized Regulation 31/08, the “Regulation for Labeling of Imported and 

Locally Produced Automotive Products – Name of Manufacturer and Country of Origin 

Requirements.” The apparent objective of the regulation is to help ensure that suppliers are 

complying with the existing country of origin labeling requirement on spare parts. 

The United States does not object to Israel’s country of origin labeling requirements for these 

products, which have existed for many years. However, the new measure appears to treat U.S. 

products differently from Israeli and third-country products by requiring the label to indicate the 

U.S. State, and possibly the city, in which those products are manufactured, in addition to the 
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country of origin. This requirement has generated significant concern among U.S. manufacturers 

of auto parts and heavy equipment. In particular, sections 8 and 9 of the regulation state that the 

markings such as “Made in Japan,” “Made in India,” and “Made in China,” are acceptable, but 

“Made in the USA” is not. Instead, spare parts from the United States – and the United States 

alone – must also indicate the State of production, and possibly even the city or town (e.g., 

“Made in the USA-Detroit, Michigan”). 

WTO rules generally do not permit a Member to treat another Member’s products less favorably 

with regard to marking requirements than it treats like products of other WTO Members. 

Regulation 31/08 appears to treat certain U.S. products differently from similar products 

manufactured elsewhere. Israel has not provided a plausible justification for such disparate 

treatment. The reasons for this disparate treatment are particularly difficult to discern given that 

U.S. producers must also provide a Certificate of Origin for these goods to Israeli Customs on

importation in order to qualify for duty-free treatment pursuant to the U.S.-Israel FTA, and are 

required to provide a detailed declaration upon request to substantiate any origin claim. Israel 

also failed to notify the measure to the WTO for comment in its proposed form. 

Given that Regulation 31/08 was not developed in a transparent manner and appears to treat U.S. 

automotive products and heavy equipment differently from like products that are manufactured 

in other countries, the United States has urged Israel both bilaterally and in the TBT Committee 

to repeal the regulation’s additional marking requirements for U.S. products so that U.S. spare 

parts receive treatment that is comparable to like products from Israel and other WTO Members. 

In January 2010, Israeli authorities indicated that Israeli Customs would no longer enforce the 

additional marking requirements for U.S. products and that they would pursue a change in the 

applicable regulation within the next few months. 

Vehicle headlights – replacement requirement

Section 351A of MoT Regulation 262 requires that all vehicles intended for civilian use 

manufactured in North America that enter the Israeli market be re-fitted with headlights that 

meet the UNECE headlight standard (EEC 756/76). 

U.S. industry is concerned that the additional cost of replacing the headlights on imported U.S. 

vehicles puts them at a competitive disadvantage in the Israeli market. While cars built to U.S. 

Federal Motor Vehicle Safety Standards (FMVSS) specifications may be imported and sold in 

Israel, industry believes that considerably more U.S. vehicles would be shipped to Israel if this 

requirement were eliminated. According to Israeli distributors of certain U.S. vehicles, 

converting a vehicle’s headlights from FMVSS to UNECE adds approximately $1,300 to the 

price of every U.S.-made car sold in Israel, putting such cars at a disadvantage against other 

imported cars. One company states that, if this measure were eliminated, the company would 

import approximately 3,500 additional cars into Israel annually, which would result in an 

additional $70 million in sales. 

The United States supports Israel’s right to regulate in the area of automobile safety, but has 

indicated U.S. interest in learning more from MoT about the scientific and technical basis for its 

headlight requirement. The U.S. government is seeking discussions on this issue with Israeli 
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auto regulators so that the U.S. Department of Transportation’s National Highway Traffic Safety 

Administration can provide additional information on the FMVSS for headlights and better 

understand MoT’s safety concerns.

Japan 

Bilateral engagement 

The United States discusses TBT matters with Japan during, and on the margins of, TBT 

Committee meetings. In addition, the U.S.-Japan Regulatory Reform and Competition Policy 

Initiative (Regulatory Reform Initiative) has served as one important forum for engagement 

between the United States and Japan on market access and business environment issues, 

including some with a potential TBT component. Four working groups and a high-level officials 

group have been addressing issues in areas such as telecommunications, transparency, 

agriculture, medical devices and pharmaceuticals, information technologies, and cosmetics and 

nutritional supplements. The Regulatory Reform Initiative has been led by USTR and Japan’s

Ministry of Foreign Affairs, and has involved a broad array of U.S. and Japanese departments 

and agencies. 

The July 2009 Regulatory Reform Initiative’s Report to the Leaders outlines the steps that Japan 

has either taken, or will take, across a number of areas. In the area of pharmaceuticals and 

medical devices, Japan is setting clearer performance measures for reviewers involved in 

approving new products. For nutritional supplements, Japan will continue efforts to improve 

transparency at its quarantine stations to streamline import procedures. Japan will also continue 

an exchange of views with consumers and industry groups, including from the United States, on 

ways to improve the Foods for Specified Health Uses (FOSHU) system, use of which allows 

health claims to be made about nutritional supplements, and on industry proposals for a system 

allowing ingredient-specific health claims that is science-based and transparent. Japan also 

explained its classification criteria for drugs, foods, and food additives and the process it uses to 

determine whether ingredients qualify as drugs, as well as the process it uses to provide 

opportunities for industry to exchange views and ask questions about the classification criteria 

for new ingredients and the application process for health foods. 

Regarding cosmetics, Japan indicated that it had published a list of active ingredients from 

previously approved medicated cosmetics applications to increase transparency in the approval 

process. Japan reported it will continue to engage in consultations with U.S. industry concerning 

Japan’s “quasi-drug” regulations, the appropriate labeling of cosmetics, and the regulation of 

manufacturer claims on the effectiveness of cosmetics. Moreover, Japan will devise ways of 

streamlining the import process for cosmetics, including publishing additional regulatory 

information and continuing to discuss the issue with industry, including U.S. industry. 

Lastly, Japan will continue to take steps to encourage its ministries and agencies to increase the 

number of public comment periods in administrative rulemaking that are longer than thirty days, 

as well as to take other steps to promote more effective implementation of the public comment 

procedure, including allowing sufficient time for agencies to consider comments where possible, 

and to provide responses as efficiently as possible. The United States has continued to press 
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Japan regarding the importance of taking additional steps to ensure that the private sector has 

sufficient information on regulations and interpretations and commentaries of laws and 

regulations are published and made easily available to the public. 

Organic product requirements

Despite close cooperation between U.S. and Japanese officials, U.S. organic exports to Japan 

continue to be hindered due to several factors.

First, U.S. organics exports to Japan are limited by Japan's ban on alkali extracted humic acid, a 

substance that USDA permits for use on U.S. organic crops. After examining scientific data 

provided by the United States on lignin sulfonate, potassium bicarbonate, and humic acid, 

Japan's Ministry of Agriculture, Forestry and Fisheries (MAFF) announced in October 2008 that

it would permit only (1) potassium bicarbonate and (2) some uses of lignin sulfonate for binding 

and anti-caking. Japan explained what information it needed to re-assess the use of humic acid 

in organic production. The United States subsequently requested that Japan allow the use of 

lignin sulfonate as a floatation device for cleaning fresh fruits in the organic production process, 

but MAFF rejected the request on the grounds that there was a lack of research on the subject. 

However, Japan conveyed its willingness to re-examine the issue if U.S. officials could provide

data supporting the need to use lignin sulfonate for this purpose. 

In addition, Japan's zero tolerance policy for pesticide and herbicide residues on organic products 

is problematic. While such substances may not have been applied to organic crops, they are 

present in the natural environment, so a zero percent residue is rarely achievable. Mandating 

zero tolerance for pesticide and herbicide residues would appear to go beyond the Codex 

Guidelines for the Production, Processing, Labeling and Marketing of Organically Produced 

Foods. The Codex Guidelines apply to the process by which organic foods are produced. They 

do not require organically produced foods to comply with specific safety or quality criteria and 

do not mandate specific maximum residue levels for pesticides and contaminants. In fact, 

paragraph 6 of the “Forward” to the Guidelines notes that organic production practices do not 

ensure products are completely free of residues.

In March 2002, Japan granted equivalence to the U.S. National Organic Program (NOP), 

meaning that products that are certified organic under the NOP can be marketed as organic in 

Japan. In January 2007, Japan requested that USDA recognize the MAFF organic requirements 

as equivalent to the NOP and submitted a side-by-side comparison of MAFF and NOP 

requirements. In May 2008, U.S. officials recognized MAFF to be the competent authority to 

accredit Japanese certifiers to certify domestic organic production to the NOP requirements. 

However, U.S. officials cannot deem the Japanese requirements to be equivalent to the NOP 

unless Japan eliminates its zero tolerance policy on pesticide residues. 

On April 8, 2009, MAFF announced that it would begin the process of revising Japan's 

requirements for organic plants, organic processed foods, organic livestock products and organic 

feeds. It indicated that during the revision process, which is scheduled for completion by 2011, 

MAFF will discuss with stakeholders the question whether to ensure that organic foods are free 

from pesticide residues. 
97

Korea 

Bilateral engagement

Korea and the United States hold regularly scheduled bilateral consultations to address potential 

bilateral trade issues, including technical barriers, as they emerge. These bilateral consultations, 

led by USTR with participation from the full range of relevant U.S. agencies, serve as an 

important forum for discussing and resolving these issues and are augmented by a broad range of 

senior-level policy discussions. In 2009, bilateral trade consultations were held on three 

occasions: in March, July, and December, leading to the resolution of a number of TBT issues. 

A similar slate of meetings will be held in 2010. In addition, USTR and other agency officials 

meet with their counterparts in the Korean government on a regular basis to discuss trade-related 

issues, for example, in the context of the TBT Committee or WTO NAMA negotiations. 

Cell phones – WIPI

Prior to April 2009 Korea required manufacturers to install the Wireless Internet Protocol for 

Interoperability (WIPI) software platform on all cell phones sold in Korea. The WIPI software 

platform is a Korea-unique standard, and is technologically incompatible with the open network 

architecture used on Internet-capable smartphones. (Please refer to the National Trade Estimate 

reports from 2003-2009 for more information on WIPI and U.S. Government efforts to address 

concerns with this requirement.) This requirement expired on April 1, 2009, following years of 

U.S. Government engagement on the issue. Subsequently, a number of smartphone models have 

been launched in the Korea market.

Conformity assessment 

The pending United States – Korea Free Trade Agreement addresses conformity assessment 

issues in several ways, most notably by committing Korea to provide national treatment in its 

recognition of conformity assessment bodies, to recognize conformity assessment bodies on the 

basis of published criteria, and to take steps to implement Phase II of the APEC Telecomm MRA 

with respect to the United States as soon as possible. At the current time, however, Korean laws 

and regulations generally limit the bodies that may test and certify products for compliance with 

Korean electrical safety requirements to “domestic nonprofit organizations equipped with 

suitable testing equipment and qualified testing personnel...” U.S. industry has argued that the 

inability of U.S. testing and certification bodies to test and certify products for the Korean 

market disadvantages U.S. manufacturers on account of the fact that U.S. manufacturers must 

have their products tested and certified in Korea, which can be inconvenient, time consuming,

and costly and cause delays to market. However, there were positive developments on this front 

in 2009 with respect to lithium ion batteries and energy efficiency testing as noted below.

Energy efficiency testing

U.S. appliance manufacturers had raised concerns about Korean measure requiring that their 

products be tested for energy efficiency only in designated Korean laboratories. Following U.S. 

engagement on this issue (together with engagement on related issues regarding energy 
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efficiency testing for refrigerators discussed below), in December 2009 Korea amended its 

certification requirements for refrigerators to allow manufacturers to use laboratories accredited 

by ILAC MRA signatories, including non-Korean laboratories, to test their products for 

compliance with Korea’s energy efficiency requirements. 

 

Lithium ion battery testing

Prior to September 2009, U.S. consumer electronics producers had also expressed concerns 

about new Korean safety regulations for lithium ion batteries, in particular the requirement that 

the batteries used in their products (e.g., laptops and cell phones) destined for the Korean market 

be tested at one of four Korean laboratories, which could lead to bottlenecks and resulting delays 

to market. U.S. officials raised this issue with Korea and, in September 2009, Korea published 

final measures that will allow non-Korean laboratories to test lithium-ion batteries for conformity 

with Korean safety requirements. The measures provide that the Korean Agency for Technology 

and Standards (KATS) will accept test results issued by laboratories that have been accredited by 

an ILAC-MRA signatory and that have been designated by KATS as having the Korean battery 

standard (which is based on IEC 62133) within the scope of their accreditation. This decision 

benefits U.S. consumer electronics producers as it enables them to use batteries in their products 

destined for the Korean market that have been tested outside of Korea (e.g., in the United States).

While welcoming this development, U.S. officials are also urging the Korean government to use 

the decision in this instance to allow foreign laboratories to test products for the Korean market 

as a precedent for other such products for which testing is required. 

Cosmetics – approval of active ingredients and testing requirements

In 2009, the United States raised industry concerns that the Korean Food and Drug 

Administration’s (KFDA) process for adding new active ingredients to its list of “approved 

active ingredients” for functional cosmetics (e.g., facial creams containing sunscreen), and its 

process for providing notice of such additions, lacked transparency. The list of approved active 

ingredients is important, as products that use such ingredients are not required to undergo the full 

testing and approval regimen required of products containing other active ingredients. The lack 

of transparency led to concerns that KFDA may have been informing Korea’s domestic industry 

of new approved ingredients sooner than U.S. industry was able to obtain this information. To 

resolve such concerns, KFDA clarified its process of updating its list of approved active 

ingredients for functional cosmetics, providing a notice and comment period for proposals to add 

new approved active ingredients to the list and publishing the list on its web site. 

U.S. cosmetics manufacturers have also raised concerns about KFDA’s quality control testing 

requirements. Korea allows foreign cosmetics manufacturers to export cosmetics to Korea 

without additional quality control testing in Korea, if their manufacturing plants have been 

certified by KFDA through an audit and inspection process. A lack of clarity regarding whether 

KFDA would certify a plant that uses testing processes different from those used in Korea led 

many manufacturers to not pursue this option. U.S. officials discussed this issue with Korea on 

several occasions in 2008-2009. 
99

In March 2009, KFDA approved the application of a major U.S. cosmetics manufacturer to ship 

non-functional cosmetics to Korea from all of its U.S. facilities without requiring those products 

to undergo quality control testing in Korea. Korea indicated that it would also approve 

applications of U.S. cosmetics manufacturers to ship functional cosmetics without requiring 

them to undergo quality control testing in Korea. However, for functional cosmetics, Korea 

indicated that under its Cosmetics Act it could only certify U.S. manufacturing facilities that 

implement Korean testing requirements – in particular, testing the final product for presence of 

heavy metals. As the more common international practice is to test a product’s ingredients –

rather than the final product – for heavy metals, U.S. companies have been unable to obtain 

certification of their plants with respect to functional cosmetics. The United States will continue 

to work with Korea to increase opportunities for U.S. manufacturers to use this manufacturing 

facility certification process if they choose, including for functional cosmetics. 

Motor vehicles – proposed fuel efficiency and emissions requirements 

In 2009, Korea proposed to strengthen its fuel efficiency requirements and introduce carbon 

dioxide emissions limits for automobiles. (See the Korea section of the 2010 National Trade 

Estimate report for a discussion of this issue.) 

Organic products – requirements and conformity assessment issues

In June 2008, Korea published its new Processed Organic Foods Regulation, with an original 

implementation date of January 1, 2010, which would require all products claiming to be organic 

to be certified as organic by a certification body accredited by Korea’s Ministry of Food, 

Agriculture, Forestry and Fisheries (MIFAFF). Many U.S. producers and certifiers have been 

reluctant to attempt to seek certification and accreditation under the new regulation, in part 

because no provisions exist in Korean regulations that allow for negotiating agreements for 

equivalence or mutual recognition, and in part due to Korea’s zero-tolerance policy on 

biotechnology presence in organic products. As a result, the regulation could significantly 

impede, or even stop, U.S. organics exports to Korea. In response to several requests by the 

United States and other exporting countries, in December 2009 MIFAFF agreed to allow foreign 

organic products to be sold in Korea until January 1, 2011 without having to be certified by a 

MIFAFF-accredited certifier. 

While Korea’s decision to extend the implementation date of the regulation to January 1, 2011 is 

a positive development, longer-term solutions will be necessary. The U.S. Government intends 

to address all outstanding its concerns by seeking Korea’s recognition of USDA as the U.S. 

organic accreditation body – so that USDA-accredited certifiers can certify products to both U.S. 

and Korean requirements – and eventual equivalence between the two countries’ organic 

systems. The United States will also continue to urge Korea to re-consider its zero-tolerance 

policy on biotechnology presence in organics. 

Processed food products – mandatory biotechnology labeling 

In October 2008, KFDA proposed expanding its mandatory biotechnology labeling for food 

products containing bioengineered ingredients to include processed products such as vegetable 

oils and distilled spirits. Under this proposal, certain processed products with ingredients 
100

derived from biotechnology commodities, such as corn and soybeans, would require a label

indicating that they are derived from biotechnology products. A decision from the Korean 

government on whether to adopt the proposed requirements remains pending.

As noted in the Trends section, the United States has concerns with the negative effect on trade 

that results from the mandatory labeling of food products containing or derived from 

biotechnology. By expanding the scope of products covered by its mandatory labeling regime, 

Korea’s proposal would result in an even greater disruption of trade in food products. U.S. 

officials have continued to urge Korea to reconsider the need for expanding the regime. 

Refrigerators – energy efficiency requirements

Building on agreements reached in 2007 and 2008, U.S. officials continued in 2009 to address 

remaining issues related to Korea’s energy efficiency regulations, particularly with respect to 

refrigerators. To address U.S. industry concerns that the previous standard resulted in 

underreporting of actual energy consumption that provided unfair advantages to Korean 

domestic manufacturers, Korea expedited adoption of ISO 15502 (Household refrigerating 

appliances – Characteristics and test methods). Adoption of ISO 15502 in April 2008 reduced

the ability of Korean companies to circumvent Korean energy efficiency requirements. Korea

also agreed to require that manufacturers attach energy efficiency rating labels based on the new 

test standard. This requirement applied to new models and existing models whose energy 

efficiency label may have been flawed on account of the previous test method. (See the 2008 

and 2009 National Trade Estimate reports for more details on the history of this issue.) 

However, when the final amended energy efficiency regulation went into effect on April 30, 

2008, a key industry request – inclusion of a complaint mechanism – was not granted. U.S. 

officials continue to press the issue of including a challenge mechanism in the amended energy 

efficiency regulation. In February 2009, Ministry of Knowledge Economy amended relevant 

regulations to include provisions allowing a manufacturer to challenge a competitor’s the test 

results, and to clarify that a subsequent finding of non-compliance with the energy efficiency 

regulation would result in penalties. Nevertheless, concerns remained with the challenge 

procedure as initially implemented, and U.S. officials worked closely with their Korean 

counterparts in 2009 to enhance the effectiveness of the challenge mechanism and stakeholders’ 

confidence in Korea’s enforcement system. 

As a result of ongoing discussions, Korea is moving forward with additional amendments to the 

challenge mechanism to ensure that a case is assessed within a specific period. Korea is also 

positively considering a mechanism that would allow manufacturers to provide test results from 

foreign laboratories as a reference point for Korean authorities to use in initiating their own 

investigations and enforcement actions. U.S. officials have indicated that the United States and 

U.S. industry would like to engage in further discussions with Korea regarding amendments to 

the challenge mechanism to ensure that it is an effective tool that fully accomplishes its 

objectives. Among other things, the United States has stressed that Korea should ensure that

penalties for fraudulent claims (and labels) that a product has a higher energy efficiency ranking 

than actual performance would merit are equivalent to penalties for fraudulent claims that a 

product meets Korea’s minimum energy efficiency requirements.
101

Solar panels – design requirements

U.S. officials raised concerns in 2009 that certain types of thin-film solar panels (TFSP) 

manufactured by U.S. industry cannot be placed on the Korean market. Since July 2008, Korea 

has required solar panels to be certified by the Korea Management Energy Corporation 

(KEMCO) in order to be sold in Korea. In 2007, Korea issued a mandatory Korean standard 

(KS) for TFSP (KS61646:2007 Thin film terrestrial photovoltaic (PV) modules-Design

qualification and type approval). The Korean standard is based on IEC 61646 (thin-film 

terrestrial photovoltaic (PV) modules – design qualification and type approval), except that the 

Korean standard applies only to amorphous silicon (A-Si) type thin film solar panels. Korea has 

not adopted a standard for other types of TFSP. 

As a result, other leading types of panels, including Cadmium Telluride (CdTe) and Copper 

Indium (di) Selenide (CIS), cannot be tested or certified under the Korean standard and 

accordingly cannot gain the necessary certification to be placed on the Korean market. The lack 

of an applicable standard will also affect other types of thin film panels, such as Gallium 

arsenide (GaAs), which are emerging as commercially proven technologies. According to U.S.

industry, Korea is the only country in the world that specifically restricts application of the IEC 

standard to only one of the three leading types of thin film panels. 

U.S. officials have raised this issue with Korea throughout 2009, and will continue to do so, in 

order to press Korea to allow the use of IEC 61646 for thin film panels other than A-Si TFSP.

Malaysia 

Bilateral engagement

The United States discusses TBT matters with Malaysia during, and on the margins of, TBT 

Committee meetings. Malaysia also participated actively in the APEC Toy Safety Initiative.

Toys and children’s articles – conformity assessment procedures

On November 6, 2008, Malaysia notified a proposed toy safety measure to the WTO. Originally 

scheduled to take effect on January 30, 2010, the “Consumer Protection (Certificate of Approval 

and Conformity Mark of Safety Standards) Regulations 2009” would establish new conformity 

assessment procedures for toys and children’s articles sold in Malaysia. The proposed

procedures set out several requirements, including review and approval of test reports (involving

possibly redundant testing), and submission of toy samples to determine placement of a new 

Malaysian mark of conformity. 

Under the proposal, in order for a toy to qualify for the Malaysian mark of conformity, its 

manufacturer would be required to have the product tested for compliance with Malaysian toy 

safety standards by an accredited laboratory and obtain a “Conformity Assessment Report” 

(CAR) and a “Certificate of Approval” (COA) from the Malaysian government. To obtain a 

CAR, the manufacture would need to file an application with SIRIM QAS International Sdn. 
102

Bhd – a subsidiary of SIRIM Berhad, which is a wholly-owned company of the Malaysian 

Government under the Ministry of Finance. A separate application would need to be filed for 

each “set” of products that are similar in function and material. If, based on its assessment, 

SIRIM determines that the products comply with applicable Malaysian safety requirements, 

SIRIM will issue a CAR. 

To secure a COA, the measure would require the manufacturer to submit application showing

that the manufacturer complies with the requirements established by the Companies Commission 

of Malaysia as well as submit extensive documentation on the company itself. Once the 

manufacturer obtained the COA, the company would be permitted affix the new Malaysian 

conformity assessment mark on the “set” of toys covered by the application. The manufacturer 

would also have to obtain approval from SIRIM regarding the position of the mark on the 

product. 

Malaysia proposed to begin enforcement of these requirements on January 30, 2010. As of that 

date, toys that had not received a CAR and COA and marked in accordance with the procedures 

could not be introduced into commerce, and any products on store shelves or in inventory that 

had not been tested, certified, and marked would have to be withdrawn from commerce. 

U.S. industry raised three primary concerns with the proposed measure. First, it was concerned 

that Malaysia appeared to be imposing a government certification system for toys and expressed 

its preference that Malaysia adopt a system similar to the one used in the United States – a selfcertification system based on third party testing. Second, many of the details of the procedures 

were unclear. Third, the proposed measure would apply retroactively to all toys in the supply 

chain, with enforcement set to begin after a very short period. 

The United States discussed the issue with Malaysia bilaterally on the margins of the TBT 

Committee. The United States noted its strong support for Malaysia’s objective to protect 

children from exposure to potentially dangerous toys and children’s articles. The United States 

also sought clarification on several aspects of the proposed regime to gain a better understanding 

of how the system would work. In addition, U.S. officials noted the importance of Malaysia’s 

engagement in the regulator-to-regulator discussions as part of the ongoing APEC Toy Safety 

Initiative. Malaysian officials participated actively in the APEC Toy Safety Initiative Regulator 

Dialogue in August 2009 in Singapore. Subsequently, a Malaysian regulatory official also 

participated as a speaker at the “Open Dialogue for All Stakeholders on Toy Safety” in Hong 

Kong in January 2010. In Hong Kong, Malaysia indicated in its presentation that it would not 

implement the system it had notified to the WTO in November 2008 and would switch to a 

system based on suppliers’ declaration of conformity. 

Under the system announced in Hong Kong, manufacturers and importers will need to provide a 

Certificate of Conformity with every shipment and provide a test report to Malaysian authorities 

upon request. Further, Malaysia reported more streamlined requirements for the placement of its 

mark of conformity. Lastly, Malaysia extended the implementation date from January 30, 2010 

to July 1, 2010. U.S. industry has not raised any concerns with the new Malaysian measure. The 

United States appreciates the efforts of Malaysia and looks to Malaysia to notify these changes to 

the WTO. U.S. officials plan to review that notification.
103

Mexico 

Bilateral engagement

The United States discusses TBT matters with Mexico during and on the margins of TBT

Committee meetings. The United States also discusses specific trade concerns and systemic 

issues with Mexico together with Canada in the NAFTA CSRM and subordinate TWGs 

established to address particular standards-related issues. For example, the NAFTA TWG 

established to address food labeling and packaging led to enhanced cooperation among the three 

NAFTA parties regarding food laboratories and nutritional labeling. The NAFTA parties also 

address standards-related measures in the context of the NAFTA RCF. For details on these fora 

and other trilateral cooperation regarding standards-related measures between the NAFTA 

parties, see SectionVIII.

Conformity assessment body recognition

Under Article 908.2 of the NAFTA, Mexico is required to accredit, approve, license, or 

otherwise recognize conformity assessment bodies (e.g., certification bodies or testing 

laboratories) in the United States on terms no less favorable than those applied to conformity 

assessment bodies in Mexico.

Applications by two U.S. conformity assessment bodies for accreditation by the Entidad 

Mexicana de Acreditacíon (EMA), the body responsible for accrediting conformity assessment 

bodies to test products for compliance with Mexican Official Standards (NOMs), were delayed

for years because of resistance from Mexican conformity assessment bodies. However, in 2006 

Mexico announced that it would create a “trust fund” into which accredited bodies would 

contribute 10 percent of the revenue from conformity certificates issued for standards 

development in Mexico. The two U.S. conformity assessment bodies signed an accord agreeing 

to contribute to the trust fund. Mexico accredited one U.S. body in December 2007 and another 

in January 2008 to perform conformity assessments for certain electrical and electronics 

products. These two accreditations could significantly increase U.S. exports to Mexico of 

electrical and electronics goods because U.S. producers will no longer need to re-certify their 

products in Mexico, acquire multiple certifications, and experience certification delays. 

The United States hopes to see Mexico clarify its conformity assessment process and to ensure 

non-discriminatory treatment for all conformity assessment bodies. In this regard, the United 

States asked Mexico to clarify its accreditation procedures. In particular, the United States has 

urged Mexico to clarify whether an application for a new accreditation or an expansion of an 

existing accreditation can be submitted at any time or only in response to a specific call to 

certifiers. The United States also urged Mexico to set a reasonable period for evaluating 

accreditation requests. The United States has asked Mexico to clarify these issues so that U.S. 

conformity assessment bodies can avoid long delays in the accreditation process. In addition, the 

United States believes Mexico should fulfill its commitment to modify its accreditation rules to 

incorporate the required contributions to Mexican standards development as part of a formal 

accreditation fee in order to provide the necessary transparency for this process. 
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Food products – nutritional labeling

In 2009, Mexico proposed to amend its nutrition labeling rules, notifying to the WTO for 

comment the “Draft Mexican Official Standard PROY-NOM-051-SCFI/SSA1-2009: General 

Specifications for the Labeling of Pre-packaged Food and Non-alcoholic Beverages -

Commercial and Health Information.” The United States submitted comments to Mexico on the 

proposal in which it posed technical questions and expressed concerns about the possible trade 

implications of the proposed rules. 

Specifically, the United States requested that Mexico: clarify certain definitions and regulatory 

objectives, as well as requirements for irradiated foods, compound ingredients, and quantitative 

ingredient disclosure; provide information on the scientific basis for its Recommended Daily 

Allowance (RDA) values, including how Mexico took Codex RDA values into account; explain 

its energy calculations, including how soluble fiber is accounted for; clarify its policy on the use 

of voluntary claims (e.g., “natural”, “pure”, “fresh”, “homemade”, “kosher”, “halal”, “organic”, 

and “biological”); set out clear guidance for companies to make claims on labels regarding 

nutrient content and health benefits; and establish an adequate period for compliance.

The United States seeks to arrange a technical discussion between U.S. and Mexican regulators 

in 2010 to discuss the proposed measure and share experiences and best practices for dealing 

with common regulatory issues involving nutritional labeling.

Medical devices – re-registration requirement

In 2005, the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) issued a 

decree requiring medical device manufacturers to re-register by February 24, 2010, any medical 

device or medical equipment (regardless of class) that COFEPRIS had approved prior to 2005. 

Where re-registration was necessary, companies were initially required to re-submit complete 

product dossiers and clinical evidence in order for their products to remain on the market. U.S. 

industry estimates that this re-registration requirement covers 30,000 products. 

COFEPRIS was unable to process applications before the deadline for all of the 30,000 products 

covered by re-registration requirement by the February deadline. Shortly before the deadline, 

COFEPRIS issued a clarification in writing to Mexican Customs authorities indicating that if a 

foreign company establishes a “re-registration plan” with COFEPRIS, or if it has already submitted 

its re-registration applications, it can continue to send its products for placement on the Mexican 

market after the deadline. U.S. industry contended that, because of insufficient staff and resources 

at COFEPRIS, trade in medical devices with a prior COFEPRIS registration could have been 

interrupted if COFESPRIS had not issued the clarification. Trade in medical devices with a prior 

COFEPRIS registration appears to be continuing without interruption. 

However, industry is reporting that the backlog of re-registration requests has led to substantial 

delays in processing registration requests for new medical devices. 
105

Nutritional supplements – local plant requirement

Prior to August 2008, Mexico maintained a “local plant requirement” for foreign companies that 

sought to sell pharmaceutical and dietary supplements in Mexico. Specifically, Mexican Health 

Ministry regulations required the inspection and approval of an applicant’s manufacturing 

facility as a prerequisite for obtaining a sanitary license to sell these products, yet Mexican 

authorities refused to inspect U.S.-based supplement and pharmaceutical manufacturing 

facilities. As a result, companies seeking to sell these products in Mexico could not receive the 

required licenses unless they established production facilities in Mexico or contracted with a 

Mexican competitor. The United States and other trading partners repeatedly protested this plant 

requirement in a variety of fora. 

In August 2008, Mexico issued a decree reforming its regulations and lifting the local plant 

requirement in phases over a two-year period. 

As follow-up, U.S. officials have urged Mexico to clarify the decree’s documentation 

requirements. With respect to pharmaceutical products, Mexican officials clarified that Mexican 

regulations allow suppliers to provide COFEPRIS with a Certificate of Free Sale, or its 

equivalent, and a Certificate of Good Manufacturing Practices (GMP) issued by the ministry or 

competent authority in the country of origin. Reportedly, Mexican health authorities have been 

accepting such documents, which U.S. pharmaceutical suppliers have obtained from the U.S. 

FDA and submitted as part of their applications to obtain a sanitary registration in Mexico. 

U.S. officials are now requesting Mexico clarify its compliance requirements for vitamin 

products and other products marketed as dietary supplements in the United States. Because the 

FDA does not issue export certificates to confirm compliance with GMPs for vitamin products, 

the United States has asked whether COFEPRIS would accept either a manufacturer’s selfstatement of GMP compliance or a GMP certificate issued by a third-party certifier.

Telecommunications equipment – acceptance of U.S. test results

Under Article 1304.6 of the NAFTA, Mexico committed to adopt, as part of its conformity 

assessment procedures for telecommunications equipment, provisions necessary to accept test

results from test laboratories in the United States. Mexico could meet this commitment by 

implementing the CITEL Telecom MRA or the APEC Telecom MRA with respect to the United 

States. These MRAs contain procedures for each party to recognize laboratories located in the 

other party’s territory as competent to test or certify equipment for compliance with the party’s 

technical requirements. If Mexico implemented the CITEL or APEC Telecom MRA with the 

United States with respect to testing of telecommunications equipment, U.S. laboratories could 

test telecommunications equipment for the Mexican market, saving U.S. producers the expense 

and burden of having to send their products to Mexico for testing. 

The United States has raised this issue with Mexico on a number of occasions. In particular, in 

their June 2009 meeting, Ambassador Kirk urged Mexican Secretary of Economy Ruiz Mateos 

to move quickly to implement the CITEL MRA with respect to testing of telecommunications 

equipment. Secretary Ruiz Mateos subsequently reported in a June 11, 2009, letter that he had
106

asked COFETEL, the Mexican telecom regulator, to work quickly to resolve the issue. At the 

July 2009 meeting of the NAFTA CSRM, U.S. officials made clear that U.S. experts were ready 

to meet with their Mexican counterparts to move forward on implementing the CITEL MRA. 

Since then technical discussions between U.S. and Mexican regulators have intensified, 

including a trilateral meeting of experts from the United States, Canada, and Mexico to discuss 

technical issues in February 2010. In addition, during his February 2010 trip to Mexico,

Ambassador Kirk again urged Secretary Ruiz Mateos to encourage Mexico’s 

telecommunications authorities to work expeditiously with U.S. authorities to implement the 

CITEL MRA.

Russia 

Bilateral engagement

The United States engages with Russia regarding its technical regulations, standards, and 

conformity assessment procedures both on a bilateral basis as well as in the context of 

negotiations over Russia’s accession to the WTO. (Once Russia joints the WTO it will be 

required to adhere to the TBT Agreement.) In addition, the Working Group on Business 

Development and Economic Relations established under the U.S.-Russia Bilateral Presidential 

Commission provides a forum for the United States and Russia to discuss among other matters 

standards-related regulatory cooperation. 

Alcoholic beverages – labeling requirement

Russia’s United Federal Automated Information System requires importers and domestic 

manufacturers of alcoholic beverages to print Universal Product Code data on small paper excise 

stamps attached to each bottle.

Importers are required to report individual sequentially-numbered stamps, whereas domestic 

producers may report stamps by batches of products. U.S. producers also contend that this

requirement is costly and burdensome. 

The Government of Russia has indicated its intention to impose the requirements, which

currently applicable only to importers, on domestic producers as well, but that regulatory step 

has not yet been taken. In addition, the government announced its plan to allow product data to 

be filed electronically with Customs, which may reduce the burden on importers. However, the 

system for e-reporting has not yet been developed. 

The United States will ask Russia to clarify this issue in 2010.

Encryption technology – testing requirements

Russia requires that any product containing encryption technology be imported under an import 

license; those encryption products that are subject to non-automatic licenses must be tested and 

approved by Russia’s Federal Security Service before they can be imported into Russia. The 

United States is continuing to work with Russia to address concerns leading U.S. technology 
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companies have raised with respect to these requirements. For further discussion of this issue 

see the 2010 National Trade Estimate. 

Taiwan

Bilateral engagement

The United States discusses TBT matters with Taiwan during, and on the margins of TBT 

Committee meetings. In addition, in September 2009 the United States and Taiwan held a 

successful Total Economic Engagement (TEE) event in Taiwan under the auspices of the U.S.-

Taiwan Competitiveness Forum. The “Leveraging the WTO TBT Agreement and Standards” 

workshop, co-hosted by the U.S. Departments of Commerce and State through the American 

Institute in Taiwan (AIT), provided a forum for information exchange and technical discussions 

between U.S. and Taiwan authorities to initiate greater cooperation on respective regulatory and 

standards systems. The event also brought together U.S. and Taiwan industry experts and 

officials to discuss the TBT Agreement, its role in facilitating trade in safe, high quality products, 

and the implementation of standards and conformity assessment regimes in both economies.

TBT issues are also discussed in the bilateral Trade and Investment Framework Agreement 

(TIFA) process.

Ceiling panels – requirements for incombustibility testing methods

U.S. companies that manufacture finished interior building materials, such as ceiling panels and 

wood paneling, have raised concerns regarding the test method that Taiwan mandates for 

determining whether those materials meet applicable incombustibility requirements. Industry 

asserts that Taiwan’s test method, which appears to be derived from ISO 5660‐1, is unsuitable 

for products such as ceiling tiles since it does not provide a consistent and accurate measure of 

the extent to which these materials are incombustible. As a result, ceiling tiles manufactured in 

the United States are given a lower incombustibility rating than is otherwise warranted and, in 

some instances, fail the test altogether, which makes it more difficult for U.S. producers to sell 

their ceiling tiles in Taiwan’s market. 

Industry has urged Taiwan to lift its requirements for producers to use Taiwan’s version of ISO 

5660-1 as their test method and allow them to use other test methods until a new ISO standard, 

ISO 5660-3, has been completed. In the interim, industry has suggested Taiwan accept an 

alternative testing method, such as that contained in ASTM-E84, which is an international 

standard, or rely on type testing and Underwriters Laboratories (UL) plant certifications instead 

of batch testing. (Currently, producers can only use type testing if their plants are ISO 9001 

certified.) 

At a September 2009 meeting at the Bureau of Standards, Metrology, and Inspection (BSMI) in 

Taiwan, BSMI confirmed that it would consider adopting ISO 5660-3 when it is released in 

twelve to eighteen months. In the interim, BSMI indicated that it was open to accepting, as an 

alternative to ISO 9001 certification, UL certification of ceiling tile manufacturing plants if the 

United States provides additional information on the UL certification process and BSMI can visit 

the U.S. plants in question. U.S. and industry officials are working to provide this information to 

BSMI.
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Chemical substances – management system

In September 2009, Taiwan’s Council on Labor Affairs (CLA) confirmed plans to establish a 

national registration and management system for chemical substances that includes a voluntary

Existing Chemical Substance Nomination (ECN) program and a mandatory New Chemical 

Substance Notification (NCN) program. The CLA began the voluntary program on October 31, 

2009 and it will run through December 2010. Reportedly, chemical manufacturers may continue 

their existing chemical exports to Taiwan during this time period. However, despite the fact that 

the ECN program is ostensibly voluntary, chemical exporters that fail to register under the ECN, 

during this period will be required to register those chemicals under the NCN, when it takes 

effect and pay the associated registration fee. Taiwan has confirmed that it intends to include the 

NCN regulation in its Labor Safety and Health Act in 2010, and to implement the new system in 

June 2011. 

The United States supports a robust science-based chemical management system and has 

indicated to Taiwan that U.S. officials would like to gain a better understanding of Taiwan’s

chemical registration process, including through an opportunity to review proposed measures and 

provide comments through the WTO notification process. To this end, in a bilateral meeting on 

the margins of the November 2009 TBT Committee meeting, the United States provided a list of 

technical questions to Taiwan officials regarding the operation of the ECN and NCN programs. 

U.S. officials have also urged CLA and the Safety and Health Technology Center (SAHTECH)

officials to organize a workshop with industry representatives to explain the details of the ECN 

program, including the application process, data requirements, and the treatment of confidential 

business information. Taiwan and the United States have indicated a mutual interest in setting 

up a dialogue to discuss their respective chemicals management regimes. 

Product multipacks – labeling requirements

The U.S. retail industry has reported that Taiwan’s Ministry of Economic Affairs MOEA has reinterpreted its Commodity Inspection Act and Commodity Labeling Act to require all units 

included in a retail multipack to be labeled, even if the retailer will not divide up the multipack 

for sale as single units. For example, the new rules will require a country of origin label for each 

pair of socks included within a sock multipack, even when the socks are sold as a six-pack. U.S. 

suppliers assert that this imposes unnecessary additional costs as they will be forced to add 

additional labels on their products to continue exporting to Taiwan. 

Commodity goods – labeling requirements

In 2009, U.S. industry also raised concerns that Taiwan is requiring all “commodity goods” to be 

labeled with the manufacturer’s or producer’s name, telephone number, and address. Industry 

notes that some commodity goods may be produced by several different manufacturers, and 

product labels may not be large enough to contain each name, address, and phone number. U.S. 

industry also contends that inspectors in Taiwan visit their warehouses and require expiration 

dates to be placed on non-food items, such as furniture and electronic goods. U.S. industry 

would like to see a more definitive list for goods – in place of the ambiguous “commodity 
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goods” designation – that require an expiration date label, as well as the rationale behind the new 

requirement. The United States will seek additional clarification from Taiwan on these issues in 

2010. 

Thailand 

Bilateral engagement

The United States discusses TBT matters with Thailand during, and on the margins of, meetings 

of the TBT Committee as well as in bilateral dialogues such as the Thailand TIFA Council and 

the Bilateral Consultative Mechanism. Thailand participates actively in APEC on standards and 

conformity assessment issues, particularly those related to food.

Alcoholic beverages – labeling requirements

Thailand has proposed to modify its warning label requirements for alcoholic beverages to 

require manufacturers to include images of the potential adverse effects of drinking alcohol. No 

international consensus exists on the use of warning labels on alcoholic beverages. Fifteen 

countries, including the United States and Thailand, have implemented some form of warning 

statement for alcoholic beverages. However, U.S. industry has sent several letters of concern to 

the Thai government opposing the size of the warning statements and their graphic nature, and 

questioning the scientific research supporting the need for such statements. 

The United States requested information from the Thai government in late 2009 about the status 

of the proposal, including whether Thailand intended to notify the proposal to the WTO so that

WTO Members and stakeholders would have an opportunity to comment. The United States

also proposed that the two governments’ regulatory agencies engage in a technical discussion to 

share relevant experiences. Thailand notified the proposed measure to the WTO in January 

2010, and the United States is in the process of reviewing it. 

“Snack Food” – labeling requirement 

In October 2006, Thailand proposed to adopt a labeling requirement that would have instituted 

"traffic light" labeling (i.e., red, yellow, and green lights) on five categories of foods: potato 

chips, corn chips, extruded snack foods, biscuits/crackers, and assorted wafers. While Thai and 

U.S. regulators share the goal of reducing childhood obesity, the United States and other 

countries raised concerns about the Thai proposal because it deviated from the prevailing 

scientific and technical information on health and nutrition (e.g., by not focusing on total diet and 

portion size) and had the potential to tarnish in the minds of Thai consumers the reputation of all 

products within certain food groups (even variations with lower salt, fat, and sugar) and to distort 

trade in these products. 

In August 2007, the Thai Ministry of Public Health withdrew the proposal. The Thai 

government then proposed a new requirement that snack foods be labeled with a message stating:

“Should consume small amounts, and exercise for a better health.” For new products, suppliers 

would have to comply within 90 days of the measure’s effective date, but suppliers were given 
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one year to modify the labels for products already on the marketplace. While this warning label 

requirement is a significant improvement over the original “traffic light” proposal, the new 

measure nonetheless raises some of the same concerns. 

In March 2009, U.S. and Thai regulators discussed the labeling issue, including U.S. concerns 

about targeting specific food groups for special labeling treatment and current best practices in 

nutritional labeling, including front of pack labeling. U.S. officials also discussed ongoing work 

in Codex Food Labeling subcommittees and invited Thailand to participate in those fora. 

Subsequently, Thailand conducted a public survey on its labeling requirements. U.S. officials 

have asked Thailand to provide information on the survey’s design and findings. The United 

States will continue to discuss this requirement and other food labeling regulations with Thai 

authorities with a view toward ensuring that Thai requirements are based on relevant scientific 

and technical information on diet and nutrition and adopt an approach that encourages better 

health and avoids creating unnecessary obstacles to trade. 

Turkey 

Bilateral engagement

The United States discusses TBT matters with Turkey during, and on the margins of, the TBT 

Committee meetings and in meetings of the Council established under the U.S.-Turkey TIFA. 

Food and feed products – mandatory biotech labeling

On October 26, 2009, Turkey’s Ministry of Agriculture published a regulation governing 

biotechnology in food and feed that did not have to be approved by the Parliament. The measure 

was neither made public nor notified to the WTO in advance, and contained no phase-in period. 

Turkey published an amended regulation on January 20, 2010. This amended regulation is 

nearly identical to the original regulation and likewise contained no phase-in period (i.e., it 

became effective on the date of publication. Turkey has not notified this amended regulation to 

the WTO.

Among other things, the regulation mandates the labeling of bio-engineered ingredients in all 

food and feed, provided the content is greater than 0.9 percent. As noted in the Trends section, 

the United States has concerns with the negative effect on trade that results from the mandatory 

labeling of food products containing or derived from biotechnology. 

Moreover, Turkey’s regulation goes beyond mandatory method-of-production labeling by 

requiring that “GMO” labels on food should contain health warnings if the biotechnology food 

differs from the non-biotechnology food. This labeling provisions raises additional concerns 

because it appears to presume that food containing biotechnology products that is different from 

its non-biotechnology food counterpart raises a health risk beyond that of its non-biotechnology 

counterpart. In fact, however, the biotechnology food might be different from nonbiotechnology food in ways that do not convey health risks; consequently, such health warnings 

would unnecessarily cause public alarm while providing no additional public health protection. 

For example, changes in oil composition could lead to health benefits, and the oil could still be 
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as safe for consumption as similar oils. Thus, the use of health warnings in the absence of a 

legitimate health concern could misinform the public about the safety of the food. 

The total value of U.S. biotech crop exports to Turkey was over $1 billion in 2008. The United 

States has raised concerns about this measure to Turkey in the TBT Committee and with the 

appropriate officials of the Turkish government, and will continue to do so in 2010. 

Conformity assessment requirements

Starting on December 31, 2008 Turkey has published a series of communiqués in its Official 

Gazette, requiring that prior to entry specific classes of products to obtain certificates of 

conformity and undergo product safety inspections conducted by the Foreign Trade 

Undersecretariat. The list of products subject to the requirement is revised each year. The 

communiqués now in force, issued on December 31, 2009, include No. 2010/8 – radios and 

telecommunications equipment; 2010/10 – toys; 2010/11 – personal protective equipment; 

2010/14 – building materials; 2010/15 – batteries; and 2010/16 – medical equipment. A similar 

communiqué, 2010/9, covers a broad range of “high risk products” to be inspected by the 

Turkish Standards Institute. None of these measures was notified to the WTO; all took effect the 

day after publication. 

The measures, which do not apply to domestically-manufactured products or products 

originating in the European Union, do not explain their rationale or the applicable requirements 

against which the products are being inspected, nor do they explain how the lists of products to 

which the measures apply (and which are set out in Annexes to the measures) were compiled. 

U.S. industry has reported that the measures are affecting numerous U.S. exporters, contending 

that customs clearance time has increased from a few days to several weeks or longer once the 

new measures were implemented. 

The United States has raised this issue with Turkey both bilaterally and in the TBT Committee. 

While the customs clearance time for U.S. origin products included under the above measures 

has reportedly dropped from 30 days or more to between 8-12 days – a vast improvement – this 

is still a longer period than prior to the original implementation of these measures. U.S. officials 

will continue to press Turkey on what steps it intends to take to reduce the clearance time, and to 

ensure that in the future it notifies any related measures to the WTO and provides an opportunity 

for comment and a reasonable time period for implementation. U.S. suppliers also contend that 

the paperwork requirements are redundant, costly, and burdensome – for example, Turkish 

Customs has reportedly applied different inspection regimes to the same product from the same 

manufacturer, and is requiring importer information to be marked on the product rather than 

supplied in the shipping documentation, which companies find to be unduly burdensome. The 

United States will continue to explore these concerns with Turkey in 2010. 

Notification of proposed measures to the WTO

Turkey has a poor track record of notifying WTO Members of its proposed technical regulations 

and conformity assessment procedures, having notified just three such measures to the WTO 

since its accession in 1995. Among the measures that Turkey has failed to notify are registration 
112

requirements for cotton and textile imports, restrictions on products containing bio-engineered 

ingredients, inspection requirements for medical equipment, and a stamp requirement for 

alcoholic beverages. In 2007, Turkey and the United States resolved the stamp issue when 

Turkey agreed to charge foreign and domestic bottlers the same price for a stamp and allowed 

foreign bottlers to apply the stamp at their warehouses in Turkey, rather than requiring them to 

send their products to one of two designated facilities in Turkey, which would have imposed 

unnecessary costs and delays on imported alcoholic beverages. However, this problem, like 

many of the problems suppliers encountered regarding Turkish measures, could have been 

resolved prior to implementation if Turkey had notified the draft measure and allowed 

stakeholders to comment. 

In addition, most changes in Turkey’s measures become effective immediately upon publication, 

with little or no notice to the public. Coupled with Turkey’s need to improve its notification of 

its measures to the WTO, this has resulted in significant trade disruption in several instances that 

might have been avoided.

Vietnam 

Bilateral engagement

The United States discusses TBT matters with Vietnam at the WTO as well as through the 

bilateral TIFA Council, which meets regularly and serves as a forum for raising and resolving 

trade and investment issues and for promoting increased technical cooperation activities. The 

United States has also partnered with Vietnam in advancing standards and conformity 

assessment issues in APEC.

Biotechnology – mandatory labeling

Vietnam is in the process of developing a legal and regulatory framework for foods derived from 

agricultural biotechnology. The United States and Vietnam have worked closely on these issues, 

and the United States remains encouraged by many aspects of the proposed regime. However, 

the Vietnamese proposals include mandatory biotechnology labeling provisions. As noted in 

Section IX (Trends), the United States has concerns with the negative effect on trade that results 

from the mandatory labeling of food products containing or derived from biotechnology. 

The United States has provided extensive comments to Vietnam on its draft proposals both 

directly and in the WTO SPS Committee. The United States has urged Vietnam to notify its 

proposed biotechnology measures to the TBT Committee. 

Telecommunications – conformity assessment procedures

U.S. industry has raised concerns with conformity assessment procedures for certain information 

and communication technology products that are administered by the Vietnamese Ministry of 

Communications (MIC). Specifically, companies have asked MIC to give them greater 

flexibility in fulfilling the requirement to submit test reports demonstrating that their products 

conform with Vietnam’s requirements for electromagnetic compatibility (EMC), and to 
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recognize foreign laboratories that conduct the testing. In 2009, USTR and the Department of 

State held technical discussions with MIC in Hanoi, as did U.S. industry representatives. 

Subsequent to those discussions, MIC indicated that it would allow a foreign manufacturer to 

submit one test report on behalf of all of its importers of the same product, rather than requiring 

each importer to submit an original, notarized test report for the same product. This 

accommodated a key industry concern. MIC has also begun recognizing test reports issued by 

foreign laboratories, pursuant to its commitments under the APEC Telecom MRA. Lastly, MIC 

has indicated that it will review its regulations in 2010 and is receptive to receiving additional 

stakeholder input during the review process. 

 

VIII. Appendices

Appendix A

List of Commenters

Public comments received from:

1. AgBiotech Planning Committee 

2. American National Standards Institute

3. American Potato Trade Alliance

4. California Table Grape Commission

5. Council for Responsible Nutrition

6. Distilled Spirits Council of the United States

7. Grocery Manufacturers Association

8. Herbalife International of America, Inc.

9. Information Technology Industry Council

10. National Confectioners Association

11. National Electrical Manufacturers Association

12. National Milk Producers Federation, U.S. Dairy Export Council

13. Novartis Corporation

14. Outdoor Power Equipment Institute, Inc.

15. Pharmaceutical Research and Manufacturers of America

16. Public Citizen Global Trade Watch

17. Ranchers-Cattlemen Action Legal Fund―United Stockgrowers of America

18. Society of the Plastics Industry, Inc.

19. Telecommunications Industry Association

20. Tobacco Industry

21. Toy Industry Association, Inc.

22. U.S. Wheat Associates 

23. USA Poultry & Egg Export Council

24. Wine Institute, WineAmerica, California Association of Winegrape Growers

25. Yum! Restaurants International 
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Appendix B 

List of Frequently Used Abbreviations and Acronyms

APEC .............................................................................. Asia Pacific Economic Cooperation

CITEL............................................................................. Inter-American Telecommunication Commission 

EU ................................................................................... European Union

IAF ................................................................................. International Accreditation Forum

FTA ................................................................................ Free Trade Agreement 

ILAC ............................................................................. International Laboratory Accreditation 

Cooperation 

ISO ................................................................................. International Organization for 

Standardization

MRA ............................................................................... Mutual Recognition Agreement

NAFTA ........................................................................... North American Free Trade Agreement

OECD.............................................................................. Organization for Economic Cooperation and 

Development

OMB .............................................................................. Office of Management and Budget 

SME ................................................................................ Small and Medium Size Enterprise

SPS.................................................................................. Sanitary and Phytosanitary Measures

TBT................................................................................. Technical Barriers to Trade

TIFA ............................................................................... Trade and Investment Framework Agreement

TPSC............................................................................... Trade Policy Staff Committee 

URAA ............................................................................. Uruguay Round Agreements Act

TTB ................................................................................ U.S. Alcohol and Tobacco Tax and Trade 

Bureau 

USDA.............................................................................. U.S. Department of Agriculture 

USITC............................................................................. U.S. International Trade Commission 

USTR .............................................................................. Office of the United States Trade Representative 

WTO ............................................................................... World Trade Organization