RESTRICTED  WORLD TRADE  
ORGANIZATION  G/TBT/M/52  
10 March 2011 
 (11-1228) 
Committee on Technical Barriers to Trade  
  
MINUTES OF THE MEETING OF 3-4 NOVEMBER 2010 
 
Chairperson:  Mr. Amit Yadav (India)
 
 
Note by the Secretariat1 
 
 
 
I. ADOPTION OF THE AGENDA.............................................................................................2  
II. IMPLEMENTATION AND ADMINISTRA TION OF THE AGREEMENT ....................2  
A. STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2..................................................................2  
B. SPECIFIC TRADE CONCERNS .........................................................................................................2  
C. EXCHANGE OF EXPERIENCES .....................................................................................................62  
D. OTHER MATTERS ......................................................................................................................67  
III. TECHNICAL COOPERATION ACTIVITIES...................................................................68  
IV. UPDATING BY OBSERVERS .............................................................................................69  
A. INFORMATION FROM OBSERVERS .............................................................................................69  
B. APPLICATIONS FOR OBSERVER STATUS IN THE TBT  COMMITTEE ...........................................69  
V. REPORT (2010) OF THE COMMITTEE ON TECHNICAL BARRIERS TO 
TRADE .......................................................................................................................... ..........70  
VI. OTHER BUSINESS................................................................................................................7 0 
VII.  DATE OF THE NEXT MEETING .......................................................................................70  
 
                                                      
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the positions of Members and to their rights and obligations under the WTO. G/TBT/M/52  
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  I. ADOPTION OF THE AGENDA  
1. The Committee adopted the agenda contained in WTO/AIR/3624. 
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
A. 
STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2    
2. The Chairman recalled that the latest list of  statements submitted under Article 15.2 of the 
TBT Agreement is contained in G/TBT/GEN/1/Rev.9,  issued on 5 February 2010.  He noted that 
since the previous meeting of the Committee, Be lize and Cambodia had submitted their statements 
(G/TBT/2/Add.103 and G/TBT/2/Add.104).  Moreove r, Indonesia, Malaysia and Tanzania had 
submitted a revision to their statements (G/T BT/2/Add.9/Rev.2, G/TBT/2/Add.3/Rev.4 and 
G/TBT/2/Add.94/Rev.1).  The Chairman said that in  total, since 1995, 121 Members had submitted at 
least one Statement on implementation under Article 15.2.   He recalled that the latest list of enquiry 
point contacts is contained in document G/TBT/ENQ/37, issued on 15 June 2010. 
B. SPECIFIC TRADE CONCERNS  
1. New Concerns 
(i) Italy - Law on Provisions concerning the marke ting of textile, leather and footwear products 
(G/TBT/N/ITA/16) 
3. The representative of India  expressed concern about Italy's draft law requiring a label to 
indicate compliance at each stage of textile, leather and footwear products processing. In particular, he 
was concerned that these criteria would be difficult to  meet for an industry that relied on global and 
multiple sourcing.  The cost of compliance for exporters from developing countries in particular, 
could make this labelling scheme more trade rest rictive than necessary to fulfil its legitimate 
objectives.  In addition, it was India's view that th e requirement to have deta ils of employment was a 
non-product related process and production method (PPM) which was not covered by the TBT 
Agreement.  Furthermore, he noted that non-prod uct related PPMs also altered the conditions of 
competition to the detriment of the imported goods , which would violate the provisions of the 
GATT 1994.  The representative of India argued th at this information requirement was clearly 
unwarranted as it sought to link labour issues with tr ade.  India was also concerned about compliance 
with environmental regulations, which would co nstitute a trade barrier affecting exports from 
developing countries.  According to the Indian re presentative, linking environment with trade issues 
was questionable.  He queried whether Italy had give n due consideration to other less trade restrictive 
regulatory alternatives to fulfil the intended obj ectives and concluded by requesting the Italian 
Government to take the Indian indus try's concerns into consideration. 
4. The representative of the European Union  noted that the new legislation concerning the 
marketing of textile, leather a nd footwear products required a co mpulsory labelling of finished 
products.  Although the law was supposed to enter in to force on 1 October 2010, the representative of 
the European Union noted that Italian authorities had decided to postpone the application of the law due to on-going internal discussion in the European Union.  In addition, according to interpretative 
guidelines issued by the Italian authorities, the provisions on the labelling of finished and semi-
finished products and on the use of the "Made in It aly" mark in textiles, leather goods and footwear 
industries would be considered effe ctive only once an Inter-ministerial Decree pursuant to Article 2 of 
the law would be adopted.  The representative of the European Union mentioned that the 
implementing measures were also still under internal discussion.   G/TBT/M/52  
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  (ii) Brazil - Instructions for Registration for Labe ls of Imported Products of Animal Origin 
(G/TBT/N/BRA/385) 
5. While the representative of the United States  appreciated that Brazil had postponed the 
implementation of its new labelling requirements fo r products of animal origin from 1 October 2010 
to 1 January 2011, concerns persisted.  It was the US delegation's understanding that according to 
section 2 Field 6.2 of Brazil's Circular Letter, US regulatory authorities would be required to certify to 
Brazilian market requirements.  Although they w ould have the authority to certify that US food 
products were produced in accordance with U.S. re quirements, US regulatory authorities would not be 
able to certify products for compliance with Brazil's private market standards, which were outside the 
scope of US legal authority.  As a consequence, the US representative claimed that these requirements 
would significantly disrupt trade.  In addition, the representative of the United States pointed at 
another concern related to Field 10.1 of the Circular Letter (Field 10 of the Registration: 
"Composition" and "Ingredients"), which would require  suppliers to list all of their ingredients and 
their respective percentage in the product in order to  be registered.  The re presentative of the United 
States was concerned that this requirement could resu lt in the disclosure of confidential information.  
Instead, the US delegate proposed to list ingredie nts in descending order as a less onerous option.   
6. The representative of the European Union  also expressed appreciation for the postponement 
of the entry into force of the measure and the gr anting of a longer comment period.  She asked for 
clarification about the rationale for requesting that al l labels of products of an imal origin be approved 
before they could be marketed in Brazil.  In additi on, she asked for an update on the state of play of 
the notified measure and looked forward to recei ving a written reply to her comments from the 
Brazilian TBT enquiry point.  
7. The representative of Switzerland  echoed the concerns raised by the representatives of the 
United States and the European Union and drew the Co mmittee's attention to three points.  First, since 
product labels already contained an expiry date, she asked if Brazil could provide further clarification 
for the reasoning behind the requirement to include  the date of manufacture.  Second, since Swiss 
companies exporting to Brazil were already subject  to Brazilian approval procedures, she requested 
clarification regarding the separate approval process fo r these labels.  Finally, the Swiss representative 
was pleased to hear that Brazil had extended period for comment. 
8. The representative of Brazil  recalled that his delegation had provided several clarifications on 
the measure at issue during the last meeting of  the Committee on Sanitary and Phytosanitary 
Measures (the "SPS Committee").  He noted that  there had been no indication whatsoever of 
interruptions or difficulties in the flow of export s to Brazil of products covered by the measure. 
Second, the objective of the measure was to facilitate trade by simplifying  the formalities for the 
registration of labels, without a dding or changing any substantive re quirement, thus facilitating the 
process of complying with mandatory registration requirements for products of animal origin.  Finally, the entry into force of the measure ha d been postponed to 1 January 2011 and the comment 
period to 1 November 2010 in order to allow for in terested parties to beco me acquainted with the 
measure and so as to grant an additional transition period.  Regarding the comment of the European 
Union about the date of adoption, the Brazilian re presentative explained that  April 2010 had been the 
date on which the public consultation on the draft re gulation had started.  Therefore, Brazil remained 
open to comments and would respond to them until January 2011, the date of entry into force. G/TBT/M/52  
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  (iii) India - Department of Telecommunications, No . 842-725/2005-VAS/Vol.III (3 December 
2009); No. 10-15/2009-AS-III/193 (18 March 2010); and Nos. 10-15/2009-
AS.III/Vol.II/(Pt.)/(25-29) (28 July 2010 ); Department of Telecommunications, No. 10-
15/2009-AS.III/Vol.II/(Pt.)/(30) (28 July 2010)  and accompanying template, "Security and 
Business Continuity Agreement" 
9. The representative of the United States
 expressed concern about the issuance, by India's 
Department of Telecommunications, of a "template agreement for security and business continuity" in July 2010.  He viewed this "template agreement" as a mandatory part of private commercial contracts 
between telecommunication service providers an d vendors of all telecommunications-related 
equipment, products and services.  It was his unde rstanding that the Indian measures contained a 
series of requirements and conditions as well as bur densome and irrelevant testing and certification 
requirements.  Two particular requirements raised concern: companies had to deposit their source 
codes in escrow and transfer their technology to I ndian companies.  According to the US delegation, 
the fact that companies had to meet all security st andards made this measure a technical regulation, 
while the fact that the "template agreement" contained certification requirements made this legislation 
a conformity assessment procedure.  The represen tative of the United States raised another concern 
regarding the fact that, under the terms of the rules issued by India, the same requirements had to be 
met by all vendors seeking to sell telecom equi pment and products to Indian telecom service 
providers.  This obligation was problematic beca use terms would necessarily vary from contract to 
contract.  The representative of the United States requested an explanation why India had applied 
these requirements only to imported products an d exempted telecom equipment and products 
manufactured in India.  According to letters from global US industry, the issuance of these 
requirements, particularly the "template agreement"  had abruptly halted billio ns of dollars of US 
equipment sales in India, while Indian suppliers had not been similarly affected.  
10. The representative of the United States also ques tioned the lack of transparency involved in 
the adoption process of the measures at issue.  He acknowledged the fact that India had announced its 
willingness to suspend implementation of the "t emplate agreement" and review the security 
requirements given the concerns raised.  However, US exporters would still be hindered by a lack of 
clarity regarding the specific security requirements curre ntly in effect.  Moreover, despite the fact that 
India had indicated that it was going to consult w ith stakeholders, the US delegation was still waiting 
for the announcement of a transparent process of  public consultation which would give all 
stakeholders (including equipment manufacturer s) the opportunity to participate in those 
consultations.  Moreover, in the view of the Unite d States, India had failed to notify any of these 
requirements to the WTO.  In fact, all of the measu res had been issued as final edicts for immediate 
implementation without any guidance as to how the telecom service providers were to operationalize 
these sweeping requirements.  This omission caused serious confusion and distress in the market.  In addition, repeated requests for information by the US Enquiry Point to the Indian enquiry point had 
been ignored.  While the US delegate supported the objective of telecom secur ity, he considered that 
open and transparent rulemaking processes consis tent with TBT obligations would yield the 
information critical to formulating effective secu rity policies.  Soliciting input from potentially 
affected parties could therefore increase the ef fectiveness of the measure and reduce needless and 
unintended impacts on economic activity.  The representative of the United States strongly reminded the Government of India of its obligations under Artic les 2.9, 5.6 and 10.1 of the TBT Agreement.  He 
recommended that, once the review of the suspende d requirements would be done, any new measures 
would have to be notified in draft form in order to give trading partners the opportunity to comment 
on them and take those comments into account.  Fina lly, he urged the Indian delegation to carefully 
consider the discussions in the TBT Committee on  the importance of instituting mechanisms and 
processes of internal coordination, so that its Enqui ry Point would be able to answer all reasonable 
questions formulated by other Members.   G/TBT/M/52  
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  11. The representative of Japan  raised similar concerns about  India's New Telecommunications 
related regulations (Amendment to the Unified Access Service License Agreement for security related concerns for expansion of Telecom Services), publ ished in December 2009, March and July 2010.  
According to the Japanese representa tive, the requirement for transferring of technology (item (viii) of 
the March 2010 document) and the mandated escrow of sensitive information such as source codes 
((vii)(c) of the July 2010 document) were elements  that could have severe effects on the market 
access of foreign products and the establishment of a fair business environment.  It was Japan's view 
that the requirement of transfer of technology to  domestic vendors could be in conflict with the 
national treatment principle.  In addition the manda ted disclosure of sensitive information, which was 
vital to maintain corporate competitiveness, was also  a cause of concern from Japan as well as other 
Members' industries. 
12. Moreover, the representative of Japan highlighted the lack of clarity in the formulation of the 
Indian regulation.  First, it was unclear whethe r the regulation of item (vii)(a) in the July 2010 
document (requiring certain security specificatio ns for telecommunication products) could be 
regarded as a compulsory certification scheme.  Second, it was not clear whether item 13 of the 
"contract agreement" regarding network certifi cation was based on relevant guidelines of an 
international standardizing body.  For these reasons , the Japanese delegate considered the regulation 
and "contract agreement" associated with the licen se conditions for telecommunication operators as a 
measure that substantially affected trade.  He also believed that the notification to WTO Members 
should be conducted based on the TBT Agreement if part of the mandatory regulation consisted of 
compulsory certification.  The Japanese representativ e called upon the Indian Government to review 
the regulations in order to make them consistent with internationa l rules, including WTO rules, and 
appropriately protect intellectual property of industr ial firms.  In addition, he requested that the 
scheme at issue be established fo llowing a transparent and fair process for all stakeholders.  In 
particular, he asked if the Indian delegation could give information on the current situation of the 
review and upcoming schedule since the Prime Minister's office of India had instructed the relevant 
departments to suspend the finalization a nd review of the scheme in August 2010. 
13. The representative of the European Union
 echoed the concerns raised by the United States 
and Japan, particularly regarding the unclear and vague  content of the measures at issue.  It was his 
delegation's view that the measures appeared to  mandate, via the "template agreement" between 
telecom operators and equipment ve ndors, compliance with certain standards and testing procedures.  
The measure further included disclosure of sour ce code which although deposited in escrow would be 
accessible not only to the telecom operators but also to the Department of Telecoms.  The 
representative of the European Union was interested in the rationale behind this approach which was 
not based on the principle of least trade restric tiveness; could India consider less trade restrictive 
alternatives while preserving the legitimate interest  of the industry concerning the confidentiality of 
certain information, like source codes and network design?  The representative of the European Union 
also called for more transparency in the process and an opportunity for stakeholders to provide input.  
Finally, the European Union delegation appreciated th e fact that the measure had been put on hold on 
request from the Prime Minister's Office.  Althou gh the suspension period was – or was going to be 
extended – the representative of the European Un ion recommended that the measure be put on hold 
pending further technical examination and internal coordination within the Indian Government as well 
as dialogue with interested stakeholders , foreign industry and governments.   
14. According to the representative of India , the provisions of the Unified Access Service License 
Agreement for Telecom Services were not covered by the TBT Agreement.  In fact, it was argued that 
the provisions were in line with the security ex ceptions under Article XXI of GATT 1994.  India was 
therefore of the view that the TBT Committee was not the correct forum to discuss the measure.  
Moreover, in the view of India, the measure was in line with the promotion of transfer of technology 
according to the Working Group on Trade and Transfer  of Technology and the mandate in paragraph 
37 of the Doha Ministerial Declaration, and subseque nt affirmation in paragr aph 43 of the Hong Kong G/TBT/M/52  
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  Ministerial Declaration.  Finally, the Indian representative informed th e Committee that India's 
Department of Telecommunications was working on simplifying the procedural aspects of the License 
Agreement. 
(iv) Mexico - Mexican Official Standard PRO Y-NOM-051-SCFI/SSA1-2009:  General 
specifications for the labelling of pre- packaged food and non-alcoholic beverages - 
Commercial and health information (G/TBT/N/MEX/178) 
15. The representative of the United States
 reminded the Committee that his Government was 
supportive of nutritional labelling where information could assist consumers in selecting foods that 
could lead to healthier diets.  He thanked Mexi co for clarifying that the commercial information 
contained in the Mexican Technical Regulation (NOM-051) was not subject to certification.  He also noted and appreciated the fact that the Secretaria t of Economy of Mexico was currently reviewing the 
implementation of conformity asse ssment procedures (pre-registration,  certification and surveillance) 
and would publish additional guidance in acco rdance with NOM-051 requirements with the 
possibility of public comments for at least 60 days .  The US representative inquired when this 
additional guidance would be issued and asked if Mexico had any plans to extend the exemption for 
allergen and nutrition labelli ng to small volume producers. 
16. The representative of Mexico
 said that the modification to the official standard NOM-051-
SCFI/SSA1-2010, regarding general labelling specifications for food and non-alcoholic beverages, 
had been published in the official journal of th e Federation on 15 April 2010.  A resolution, which 
modified various aspects of Mexican official standa rd at issue had been published in the Official 
Journal of the Federation on 26 October 2010; its en try into force was set for 1 January 2011.  This 
modification had been carried out on the basis of  Article 51 of the Federal Law on Metrology and 
Standardization.  According to the Mexican delegate , the general objective of this modification was to 
establish alternative and optional use of various concepts on nutritional values, tolerance levels, 
symbols and abbreviations.  In particular, the m odification allowed substituting the term nutritional 
information with nutritional data as well as the term  calorie and kilocalorie.  In addition, on small 
surfaces, where one could not report this informat ion, a web address had to be included so that 
consumers could access all this information.  It was her delegation's view that these modifications 
were compatible with the provisions established by the Food and Drug Administration and the Code 
of Federal Regulations.  Therefore, the homologation of the applicable regulations to food, both in 
Mexico and the United States, was guaranteed wi thout any reduction in the level or degree of 
protection for the consumer. With regard to the questions raised by the United States, the Mexican 
representative said she would submit them to her capital in order to obtain a detailed reply. 
(v) Turkey – Communiqué SUT 2010 regarding documenta tion requirements for medical devices 
17. The representative of the United States  expressed serious concerns about Turkey's new 
medical device regulation.  He noted that alt hough medical devices were already regulated by 
Turkey's Ministry of Health, a second regulation,  the objective of which was quality assurance, had 
been issued by Turkey's Social Security Institu te (SGK) on 15 June 2010.  It was his understanding 
that all producers of medical devices used in sp inal, orthopaedic, arthroplasty and traumatology 
procedures were required to supply additional docum entation in order to maintain 100 per cent of 
current reimbursement levels.  In particular, prod ucers were required to document that each group of 
products was certified by the regulator in the coun try where the products had been manufactured or 
imported from, as well as used.  The US representative  noted that some devices were manufactured in 
one country and used in another; hence producers woul d not be able to obtain such certification.  In 
addition, many medical device regulators did not provide documentation on product usage or proof of 
reimbursement.  As a result, obtaining such certifi cation or shipping a device through a country where 
the producer had obtained a certificate, would be costly, unnecessary and time-consuming.  According 
to the United States, the consequences of not pr oviding such documents were significant.  The  G/TBT/M/52  
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  reimbursement rate of a device filed after 15 June 2010 dropped to 60 per cent of the current 
level.  Moreover, if a product filing was not made by the end of 2010, SGK would cancel all 
reimbursement for the device.  As a result, the US  representative argued that the regulation restricted 
trade in safe, effective medical devices.  He furthe r noted that the regulation had not been notified to 
the WTO. Consequently, interested stakeholders ha d not been given notice and were deprived of the 
opportunity to comment on the draft measure.  He also criticized the fact that the measure had been 
published on 25 March 2010 and went into effect onl y seven days later on 1 April 2010, with the 
requirements imposed as of 1 May 2010 (later changed to 15 June 2010).  As a consequence, suppliers 
were denied a reasonable period of time for implementation.  
18. The representative of the United States invited Tu rkey to explain the objective of SGK to 
require companies to provide these additional documen ts, given that Turkey's Ministry of Health 
(MoH) already had requirements to prove the safety and efficacy of medical devices.  In particular, the MoH, which was the competent authority in charge of implementing the EU Medical Device 
Directive in Turkey, required a European CE mark for devices to be marketed in Turkey.  He also 
asked Turkey to explain whether the MoH was of the view that the Medical Device Directive was 
insufficiently robust.  If so, the representative of the United States was interested to know the basis to 
impose these additional requirements on medical de vices. He also questioned the reason why SGK 
specifically selected medical devices used in sp inal, orthopaedic, arthroplasty and traumatology 
procedures for these additional requirements.  Th e US delegation urged Turkey to suspend the 
implementation of the SGK measure until it was no tified to the WTO for comment; had met with 
industry stakeholders to hear their concerns and ta ken these into account so as to eliminate or reduce 
any unnecessary documentation requirements.  Ultima tely, suppliers could continue to place their 
products on Turkey's market provided they were satisfied with the requirements of the Medical 
Device Directive.  Finally, the representative of the United States reiterated Turkey's obligation to 
notify to the WTO any new extension of these require ments to other devices so that comments could 
be taken into account and a reasonable interval for compliance be provided. 
19. The representative of Turkey
 explained that medical devices fell under the scope of the 
Customs Union Decision between Turkey and the Eur opean Union. In particular, he informed the 
Committee that Turkey had fully harmonized the rele vant directives of the European Union in its own 
national legislation.  In this context, medical de vices had to bear the CE mark before they were 
introduced to the Turkish market.  According to  the representative from Turkey, the implementation 
did not discriminate between domestic and foreig n products because domestic producers had to 
comply with the same legislation.  He made clear  that customs controls were conducted according to 
the communiqué on standards legislation that indicat ed which medical devices had to be checked and 
how this needed to be done. He highlighted the existence of an exhaustive list attached to the 
communiqué which included only a small number of medi cal devices subject to this legislation.  The 
Turkish representative concluded that, in his view, the current legislation and implementation did not 
create any technical barriers to trade and did not discriminate among third countries.   
(vi) United States - Foreign Manufacturers Legal Accountability Act 
20. The representative of Mexico  expressed concern regarding the HR 4668 law of responsibility 
of foreign manufacturers, introduced in the US H ouse of Representatives in February 2010 and under 
consideration for a possible vote in the House.  It was her delegation's understanding that this 
legislation would request foreign producers or manufacturers to estab lish an authorized representative 
in the United States in order to accept representation a nd notifications on their behalf for any civil and 
regulatory procedure of federal and state courts in the US.  The Mexican delegate noted that the bill 
established that 180 days after the implementa tion of the regulation, foreign producers or 
manufacturers would no longer be able  to import covered products if th ey did not have a registered 
agent in the United States.  Acco rding to the Mexican delegation, this would correspond to a ban. 
While Mexico shared the commitme nt to guarantee product safety and consumer protection, concerns G/TBT/M/52  
Page 8  
 
  remained that the requisite for fo reign manufacturers to appoint a registered agent in the United States 
as a condition for the import of its products would contravene US international commitments.  In 
addition, the Mexican representative st ressed that the application of this act would be very costly; it 
would adversely affect producers, importers and exporters.  She argued that other countries could 
decide to implement similar measures, especially in  sectors in which the product chains were located 
locally.  She therefore urged the US Governme nt not to adopt these measures given its WTO 
commitments.  She also invited the United St ates to further inform the Committee of the 
consequences of this bill in order to comply with  all the technical regulations in effect.  Based on 
Annex 1 of the TBT Agreement, which define d procedures for conformity assessment as any 
procedure used directly or indirectly to determin e that the provisions complied with the relevant 
technical regulation or rules, the Me xican delegate viewed the necessity  to comply with the legislation 
in order to fulfil the technical regulations as a hor izontal provision which was part of the technical 
regulations themselves. 
21. The representative of Australia
 was also concerned about elements of the US Foreign 
Manufacturers Legal Accountability Act.  It was her de legation's view that the draft bill would require 
exporters of certain products to establish a regist ered agent in the United States to accept service of 
processes on their behalf and to consent to the jurisd iction of the state or the federal courts of the 
United States in which their agents would be locat ed.  While the representative of Australia supported 
the objective of enhanced consumer protection, she encouraged the United States to use less 
burdensome and less trade restrictive measures to achie ve this objective.  She believed the draft bill 
would impose an additional and costly regulatory burden on foreign manufacturers exporting to the 
United States.  In particular, additional costs wo uld make foreign inputs less attractive to US 
manufacturers; this could impact on competitiven ess and costs for the manufacturers relying on 
foreign imports.  Ultimately, some manufacturers co uld refrain from exporting to the United States.  
More generally, she highlighted the potential impact  of the bill on the disruption of supply chains in 
the United States, especially the supply of component parts. 
22. The representative of Hong Kong, China  shared the concerns raised.  
23. The representative of the United States  explained that the objective of the bill was to ensure 
that foreign producers, just like domestic ones, co uld be held accountable in US courts if their 
products harmed or injured people or property in th e United States.  He confirmed that the bill was 
still being discussed in Congress but could expire at the end of the congressional session in November 
or December 2010 if it remained pending. In any case, the Office of the United States Trade 
Representative would continue to follow this legisla tion if it was re-introduced in the next Congress.  
According to the US representative, this legislation did not appear to fall within the scope of the TBT 
Agreement's definitions of a technical regula tion or conformity assessment procedure.  Any 
discussions on this legislation should ther efore continue to be held bilaterally. 
(vii) United States – Draft legislation on chemicals – Bill 5820 
24. The representative of the European Union  expressed interest regarding the introduction of a 
draft measure entitled "Toxic Chemicals Safety Act of  2010" in the US House of Representatives.  It 
was her delegation's understanding that this bill w ould amend the existing Toxic Substances Control 
Act by providing a new framework for the management  of chemicals in the United States in order to 
ensure public and environment protection from chemi cal exposure risks.  She noted that the draft 
would give the US Environmental Protection Agency  (EPA) power to lay down further rules but other 
parts of the draft already established important requirements for chemical manufacturers, processors 
or importers.  For instance, the draft would provi de for a precise time-frame according to which 
manufactures and processors would have to submit da ta on chemicals.  The EPA would also be given 
the power to prohibit the production and the placing on the market if the relevant data was not 
submitted. The representative of the European Union referred to the case of new chemical substances  G/TBT/M/52  
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  and mixtures or new uses, which would be subj ect to a prohibition of production and placing on the 
market unless a notice to the EPA was submitted 90  days before the manufacturing or processing.  
This notice would need to attest that the anticipat ed use of the chemical substance or mixture caused 
no risk of injury to health or the environment a nd met the safety standards.  Based on these examples, 
the EU representative concluded that the draft cont ained technical regulations covered by the TBT 
Agreement even if, for some aspects, it still needed to be complemented in order to be fully applicable 
to producers ".  While the EU delegation shared the objectives pursued by the draft bill, she asked 
why it had not been notified to the WTO in order to give third countries the possibility to get 
acquainted with the draft and comment on it.  She also  pointed out the existence of a similar draft bill 
being discussed in the US Senate, which was also supposed to amend the Toxic Substances Control 
Act.  Finally, the representative of  the European Union invited the United States to confirm that, in 
accordance with Article 2.9 of the TBT Agreement,  the draft bill would be notified at an early 
appropriate stage and before its adoption so amendments could still be taken into account 
25. The representative of the United States  explained that in order to properly protect public 
health and the environment, the Toxic Substances Control Act (TSCA) of 1976 (TSCA) had to be 
updated and strengthened. He quoted Lisa Jackson, EPA's Administrator, who had made a statement 
to this effect in September 2009.  The objective wa s to enable EPA to expeditiously target chemicals 
of concern and promptly assess and regulate new and existing chemicals.  Relevant "principles" for updating TSCA were made availabl e on a US Government website.
2  The US representative stressed 
that it was, at this point, premature to discuss the shape of the legislation and its notification because 
the bill was still being discussed and would expi re at the end of the Congressional session in 
November or December 2010, if it remained pending .  In case the bill was re-introduced in the next 
Congress, the issue would continue to be monitored.   In the meantime, the US delegation remained 
available to address bilaterally any questions raised . He informed Members of the publicly available 
website reporting all draft legislation.3 
(viii) Indonesia – Labelling Regulations (Ministry of  Trade Regulations 62 /2009 and 22/2010) 
26. The representative of the European Union  raised concerns about the above-mentioned 
measures.  It was her delegati on's understanding that these regul ations provided for rules on 
mandatory labelling affecting a wide category of go ods.  She pointed out that these regulations had 
not been notified under the TBT notification procedure despite the fact that they contained detailed rules on the labelling of products.  In this regard, sh e drew Indonesia's attention to the fact that this 
was already the third occurrence in a short period  of time that legislation containing important 
requirements affecting a large number of goods had not been notified to the TBT Committee.  The 
representative of the European Union regretted th is omission.  It was the European Union's 
understanding that according to Article 2 of these re gulations, the products had to be labelled in 
Indonesian language at the time when they entered the territory of Indonesia.  The EU representative 
invited Indonesia to clarify whether this provisi on meant that the products had to be labelled in 
Indonesian before  they were shipped to Indonesia.  If this was the case, the delegate of the European 
Union wished to receive a justification from Indonesia on why imported products could not be 
labelled or re-labelled in Indonesia before they we re actually placed on the market.  Second, it was the 
European Union's understanding that according to Artic le 3 of the Regulations, labels which appeared 
on goods had to be approved by the Indonesian authorities before  the goods were imported and 
labelled.  The representative of the European Union noted that a pre-approval of labels for electronics 
goods, certain construction products, vehicle parts, textiles and other consumer products seemed to be 
more trade restrictive than  necessary.  Indonesia was therefore asked to provide the reasons for such a 
pre-approval procedure.  Third, the representative of  the European Union asked for clarification about 
Article 11 of the latest regulation (21 May 2010)  which provided for an exemption procedure for 
                                                     
 
2 http://www.epa.gov/opptintr/existi ngchemicals/pubs/principles.html  
3 http://thomas.loc.gov/  G/TBT/M/52  
Page 10  
 
  producers and importers.  In particular, she invited Indonesia to clarify how this procedure was 
applied and under which c onditions producers and impor ters were exempted fr om the obligation to 
label the product in Indonesian language. 
27. The representative of Australia
 supported the concerns raised about the implementation of 
Regulation 62/2009 and 22/2010. In particular, sh e noted that there was, apparently, conflicting 
information between two Indonesian authorities.   On the one hand, Australia had received 
confirmation from Ministry of Trade officials that  Regulation 69/1999 allowe d for labelling stickers 
to be applied to imported food pr oducts in Indonesia.  On the other hand, the Indonesian Food and 
Drug Agency had advised that Regulations 62/ 2009 and 22/2010 prohibite d the use of labelling 
stickers.   The Australian delegate also noted th at there was confusion as to whether the regulations 
applied to both food and non-food products.  It wa s Australia's preference to allow exporters to use 
labelling stickers which would be the least trade restrictive option to Indonesia's policy objective. 
Indonesia was encouraged to ensure that any labellin g standards adopted were consistent with existing 
international standards, such as t hose of the Codex, which would provi de guidance in relation to using 
a second label.  
28. The representative of the United States  noted that his delegation had been informed by US 
industry that Indonesia might no longer allow for the use of sticker labels with translations to be 
applied on imported products.  While the representativ e of the United States appreciated the need for 
imported food products in Indonesia to bear a label in  Bahasa, he asked why sticker labels would not 
fulfil this need.  The US representative invited Indone sia to clarify whether it had in fact changed its 
requirements.  In this regard, he noted that  Codex' General Guidelines for the Labeling of 
Prepackaged Foods (Article 8.2) encouraged the u se of supplemental labels to comply with national 
language label requirements.  It was his delegati on's view that a supplementary label affixed as a 
sticker could provide all informati on required by the pertinent regulati ons.  In addition, a prohibition 
on applying sticker labels in Bah asa could negatively impact US exports in the form of increased 
costs.  In case this change had indeed been ma de, the US representative asked Indonesia to suspend 
implementation while it notified the measure to the WTO for comment and took these comments into 
account.  He urged Indonesia to reconsider the pr ohibition during the notification process and to 
accept stickers to be affixed as supplemental Ba hasa language labels for imported products as 
Indonesia had previously allowed (and as was al lowed by the United States for exports from 
Indonesia).  He reiterated the European Union's syst emic concern about the lack of notifications by 
Indonesia of TBT measures.  
29. The representative of Indonesia  noted that the discussion concerned the Regulation of 
Minister of Trade RI No.62/M-DAG/PER/12/2009 and No. 22/M-DAG/PER/5/2010 on the obligatory label affixing on any goods – which had entered in to force on 1 September 2010.  He informed the 
Committee that these regulations were going to be notified to the WTO in due time.  He further 
explained that the said regulations stated that ever y producer and importer of goods to be traded in the 
Indonesian market had to affix a label in Indonesia' s language.  The list of a ffected products had been 
included in the attachments of the regulation of the Minister of Trade RI No. 22/M-DAG/PER/5/2010. 
However, the Indonesian representative mentioned that the following goods were exempted from 
these regulations: goods sold in bu lk and packaged directly in front of the consumers as well as goods 
listed in Annexes I-IV of the regulation of Minist er of Trade RI No. 22/M-DAG/PER/5/2010, if they 
were used as raw materials in the production process.  
30. The Indonesian delegate explained that the pr ocedure for getting the approval for the label 
was free of charge and listed in the regulation No .22/M-DAG/PER/5/2010.  In particular, the label 
had to be clear and easy to understand.  Producers and importers had to submit a sample of the label to 
the Director of Domestic Business Development and En terprise Registration, Ministry of Trade.  If all 
requirements had been completed for given goods, the Director of Domestic Business Development 
and Enterprise Registration would issue the certificat e of affixing label in Indonesia language within  G/TBT/M/52  
 Page 11 
 
 
  five days after receiving the sample.  Requirement s on how to put the label as well as information 
contained in the label were stated in the annexes of the Regulation of Minister of Trade No.22/M-DAG/PER/5/2010, whereas sanctions and any other requi rements were included in both regulations.  
In particular, the Indonesian delegate made clear that the certificate would be valid as long as the 
producers and/or importers produced and/or imported the same goods mentioned in the certificate.  If 
the producers and/or importers were to produce a nd/or import goods other than goods mentioned in 
the certificate, the producers and/or importers would have to submit again the sample of the label to 
the Director of Domestic Business Development and En terprise Registration, Ministry of Trade.  With 
regard to goods listed in Annexes I, II, III, and IV  of the Regulation of Minister of Trade No. 22/M-
DAG/PER/5/2010 which were already placed in the market  before the date of entry into force of the 
regulation, the producers and/or importers of the goods had to adjust their label of products to comply 
with the regulation within 28 months after the da te of entry into force of the regulation on 1 
September 2010.  
(ix) China – National Standard of the P.R.C., Direction for Use and Labels for Carpets 
(G/TBT/N/CHN/624) 
31. The representative of the European Union
 requested clarification regarding the National 
Standard of China, Direction for Use and Labels fo r Carpets, which had been notified in April 2009, 
and which had been the subject of an extensive b ilateral exchange of comments.  The representative 
of the European Union thanked the delegation of  China for clarification transmitted through the 
Chinese TBT Enquiry Point, in particular with  regard to which labelling requirements were 
mandatory and which were voluntary; it was now understood that the mandatory labelling 
requirements were based on ISO 6347.  She sought clarification as to whether the information 
presented on labels, including dimensions  of carpets (point 5.3 of the dr aft), fibre conten t (point 5.4 of 
the draft) and product standard number (point 5.8 of the draft), were also to be verified and tested 
according to ISO 6347, or another relevant inte rnational standard.  The representative sought 
clarification whether ISO 6347 had been adopted in its full integrity, without modification, or if 
certain aspects had been modified.  The representativ e of the European Union noted that the notified 
draft provided for the use of international flame resi stance pictograms; there appeared, in this regard, 
to be divergences between Chinese requirements on the test methods of flammability for building 
materials and relevant ISO standards (ISO 11925-2 and ISO 9239-1).  She noted that these pictograms were only permitted for use on products that had been tested in compliance with these ISO standards.  
Thus, the representative inquired as to whether the re levant Chinese standards were identical to the 
relevant ISO standards.  In addition, she asked  whether the notified draft had been adopted, or 
whether it was still under consideration. 
32. The representative of China
 explained that the Chinese National Standard Direction for Use 
and Labels for Carpets had been notified to the WTO on 29 April 2009.  The standard provided basic principles and requirements for the use and labelling of carpets sold in China.  In fact, the European 
Union had commented on the standard on three diffe rent occasions: 31 May 2010, 28 July 2010, and 3 
September 2010.  The comments had cove red a number of different areas, inter alia , scope of 
application, name and address of the manufacturer , product name, dimensions, names and contents of 
the pile fibre, total thickness, total mass per unit area, mass of pile per unit area, product standard 
number, product quality grades, issues related to Chap ter 7, Annex A and Annex D, flame resistance, 
and provision of English versions of  the two national standards.  It was explained that the fifth chapter 
of the standard was mandatory, wh ile the others were voluntary. 
33. The representative noted that China had sought to address EU concerns in four different 
replies.  He reminded the Committee that different levels of technical deve lopment between Members 
led to different technical legislative objectives, a nd that a Member could not be forced to amend 
regulations based on comments from other Members.  Nevertheless, the TBT Agreement stated that 
Members shall "without discrimination, allow othe r members to present their comments in writing, G/TBT/M/52  
Page 12  
 
  discuss these comments upon request, and take th ese written comments and the results of these 
discussions into account". After full consideration, the competent authority in China had adopted, or 
was is in the process of adopting, EU comments about flame resistance, Annex A, Annex D, and mass of pile per unit area.  In their 3 September 2010 comment, the European Union had welcomed the clarification of Chinese standards regarding fire performance which had follo wed relevant EU test 
methods; the European Union also welcomed the clarification that producers could select one of the 
three label forms described in Chapter 7.  The repr esentative hoped that efforts made by China in this 
respect had been understood and recognized by the EU delegation. 
34. With regard to the second and third sets of co mments submitted by the European Union, the 
representative of China expressed concern at repetition of  issues already discussed by the two parties.  
In particular, EU concerns around product size, spec ifications and flame resistance had been repeated, 
including in the fourth set of EU comments – and this after several hours after mutual consultation the 
preceding day.  The representative of China affirm ed that such comments were the right of a WTO 
Member, and could be a useful form of techni cal exchange. However, comments and enquiries on a 
technical regulation submitted in succession over a pe riod of one year and four months, or even 
longer, including after the end of the comment peri od, were not covered by the provisions of the TBT 
Agreement.  The TBT Agreement was implemented to  better facilitate international trade, not to 
influence the regulations of other Members without limitations.  In fact, the representative of China 
noted that when his delegation commented on EU no tifications (or those of another Member) they 
much appreciated receiving careful answers and e xplanations which could be used for technical 
reference.  He hoped that EU comments could displa y the same degree of precision as EU replies, and 
noted that professionals in China put in signi ficant work to respond to EU queries.   
35. The representative of China went on to note that, with respect to the EU request for English 
language versions of GB/T8626  and GB20286, Article 10.5 of TBT Agreement required only 
developed country Members to provide English, Fr ench or Spanish translations if requested from 
other Members, and hence his delegation would be un able to supply the European Union with English 
versions.  Finally, given that most of the points raised by the European Union concerned detailed 
technical exchanges, he suggested that furt her exchanges occur with professionals at the 
Standardization Administration of China. 
(x) Korea - Automobile standards of  the efficiency of average en ergy consumption and allowable 
emission of greenhouse gases (G/TBT/N/KOR/ 296) 
36. The representative of the European Union
 welcomed the objective of the draft Korean 
regulation, notified to the TBT Committee unde r G/TBT/N/KOR/296, to reduce carbon dioxide 
emissions and increase motor vehicle fuel efficiency . She believed that it woul d provide an important 
contribution to the limitation of emissions of greenhouse gases, alongside measures already adopted by the European Union and other countries.  Nevert heless, the representative noted that the draft had 
raised concerns amongst EU car manufacturers present on the Korean market, in particular with 
regard to significant potential impacts on imports.  She explained that the EU was currently discussing 
these issues with Korea bilaterally , and understood that Korean au thorities were consulting widely 
with stakeholders in order to ach ieve a balanced final regulation. 
37. The representative of the European  Union posed a series of questions in order to improve her 
delegation's understanding of the notified draft.  She first asked whether the measures proposed by 
Korea had been subject to a comprehensive impact  assessment.  If such an impact assessment had 
been completed, she asked if it was publicly availabl e.  Secondly, could Korea provide indications, in 
percentage points, as to the emission cuts to wh ich imported car makers would be subject to on 
average, as compared to those required of domestic car makers?  Her delegation estimated that EU carmakers would be subject to em ission cuts more than double tho se applicable to domestic car 
makers. Thirdly, what measures were Korean auth orities considering to take into account for the  G/TBT/M/52  
 Page 13 
 
 
  specific situation facing foreign car makers in Ko rea, so as to avoid negative impacts on imports?  
Also, she requested information about the envisaged  timeline for publication and entry into force of 
the requirements.  In particular, the representative not ed that the proposed date of entry into force was 
1 January 2012, one year after the envisaged a doption of the draft. She asked whether Korea 
considered such a short time period sufficient for car manufacturers to adjust their products and 
production methods to the new requirements.   
38. The representative of the European Union noted that EU legislation on automotive emissions 
had been developed in close consultation with a ll stakeholders, including domestic and foreign car 
makers, with a view to setting achievable emission targets.  European legislation also offered a considerably longer period for the implementati on of the new requirements, and provided for a 
number of derogations to take into account the specific situations of individual car makers. 
39. The representative of the United States
 was also concerned that the regulation, as currently 
drafted, would significantly restrict market acces s for US automobiles.  Although the representative 
recognized positive aspects of the draft regulation aimed at limiting barriers to trade, including 
relating the standard to the weight of the car, using the 'US combined' fuel economy measurement, 
and certain flexibility mechanisms, he stated that the draft regu lation nevertheless could have a 
dramatic impact on US and other manufacturers, especi ally considering the short period (one year) to 
prepare for its implementation.   
40. The representative of the United States explaine d that imported automobiles sold in Korea 
were much heavier on average than the fleets sold by domestic Korean  manufacturers, and, as a result, 
his delegation was concerned that the latest draft regulation could place a serious burden on 
manufacturers producing imports for the Korean market .  In addition, the short transition period was 
insufficient to allow manufacturer s to adapt.  The new US regulation on auto emissions and fuel 
economy had been announced three years before impl ementation, and was being phased in over five 
years, beginning in 2012.  However, Korea wa s allowing only one year between announcement and 
the start of implementation, and was phasing in th e regulation over a period of four years.  The 
representative of the United States asked how the dr aft regulation took into account the fact that 
importers sold a different type of fleet, concen trating on a smaller number of premium models.  
Finally, his delegation asked whether Korea would consider an exemption for small volume exporters, 
and derogation for medium volume exporters. 
41. The representative of Korea  thanked the delegations of the United States and the European 
Union for their comments. He explained that the Ko rean Government had set a target of a 30 per cent 
reduction in greenhouse gas emissions by 2020 under th e national vision of low carbon green growth.  
To this end, the Ministry of the Environment had prepared the regulation at issue and notified it to the TBT Committee (G/TBT/N/KOR/296) on 18 October 2010;  it carried explicit references to EU and 
US legislation.  The measure would be applied to  passenger automobiles and to automobiles carrying 
up to 10 passengers and freight; auto-manufacturer s had to choose to comply with one of these 
standards.  The measure would be phased in fro m 2012 to 2015, progressing from 30 per cent to 100 
per cent coverage and would be applied in a flexible  manner according to the average fleet weight of 
an auto manufacturer. 
42. The representative of Korea highlighted the fact that the draft regulation was less strict than 
either EU or US regulations. For instance, he noted that the draft regulation targeted average 
emissions of automobiles of 170 grams CO
2 per km in 2006, falling to 140 grams CO 2 per km 
between 2012 and 2015.  Under the EU regula tion the 2006 target was set at 150 grams CO 2 per km, 
and aimed for 130 grams CO 2 per km between 2012 and 2015.  Thus, the representative explained that 
auto manufacturers in complian ce with the European measures should have no problem complying 
with the Korean regulation.  The Ministry of En ergy was considering an exemption for small volume 
manufacturers, and would notify the TBT Committee upon a decision.  Moreover, the representative G/TBT/M/52  
Page 14  
 
  of Korea noted that the Ministry of Environmen t had conducted a comprehensive impact assessment 
on the introduction of the draft regulation; further information could be provided at the request of 
Members.  
43. Regarding the alleged discriminatory treatmen t of European and American car manufacturers 
in terms of more stringent emissi on reduction targets, it was noted that the impact assessment showed 
no evidence of discrimination against foreign manuf acturers. The representative of Korea said that 
information about a specific manufacturer's requi red rates of emissions reduction could not be 
provided since this was related to proprietary business information.  On the time-frame for 
implementation, it was recalled that the Korean Government had informed domestic and foreign 
manufacturers, including European and American car makers, of this regulation as early as July 2009. 
Furthermore, European and American car makers w ould be ready to conform to the Korean regulation 
by the end of 2011.  As the comment period w ould expire on 17 December 2010, Members were 
encouraged to submit comments by that date. The Ko rean ministries of Energy and Environment were 
evaluating all comments received and would take them  into account when finalizing this regulation. 
(xi) Canada - Propo sed Amendment to the Energy Efficiency Regulations (G/TBT/N/CAN/ 317 and 
Add.1) 
44. The representative of Korea
 thanked Canada for the recent decision to postpone 
implementation of the proposed regulation (G/T BT/N/CAN/317 and Add.1) until April 2011.  While 
the Republic of Korea supported the objective of protecting the environment, his delegation was 
concerned that costs imposed upon manufacturers would exceed the purported benefits of the 
regulation.  He requested that Natural Resources Ca nada reconsider the introduction of regulation, due 
to issues related to accreditation of foreign certif ication bodies, including Korean bodies. In particular, 
he cited the requirement of active engagement in  national standard-setting and the establishment of 
working relationships with applicable Canadi an regulatory authorities as challenges.  The 
representative invited Canada to explain how the provi sions would be implemented with respect to the 
accreditation procedure of certification bodies.  In add ition, he stated that a longer transition period 
would be helpful for foreign certification bodies.  
45. The representative of Canada  explained that the measure in question had been developed to 
promote efficient and economic use of energy, and the benefits of this activity in relation to the costs 
had been analysed, and that this analysis was publicly available, including in supporting documentation that accompanied the notification to the WTO.  He expressed appreciation for 
comments received on this regulation, not only from Korea, but also as a part of the notification 
process from industry and other stakeholders.  He noted  the changes made by the regulatory authority, 
in particular the suspension of the measure until 1 May 2011.  The representative encouraged 
Members with questions to contact his delegati on bilaterally even though the comment period had 
closed.  The third party conformity assessment sy stem, and the system for accrediting conformity 
assessment bodies, had proven to be efficient, open and transparent.  Documentation related to the 
accreditation of certification bodies in Canada was available on the website.
4 
(xii) China - Provisions on the administration of medical device recalls (G/TBT/N/CHN/729) 
46. The representative of the European Union  expressed concern with regard to China's proposed 
measures for the administration of medical device  recalls. China had replied in July 2010 to 
comments made by the European Union in May 20 10, but its reply had not assuaged EU concerns. 
While the European Union considered the draft re gulation developed by China's State Food and Drug 
Authority as a significant step towards alignment with  international standards, it remained concerned 
in particular about the requirement to stop selling a medical device and/or suspend its use in case of a 
                                                      
4 http://www.scc.ca   G/TBT/M/52  
 Page 15 
 
 
  recall as this was perhaps not the most appropriate  response for many medical devices such as, for 
instance, life supporting devices or implanted devices.  In the absence of e ffective and immediately 
available alternatives, this requirement could create ot her risks to the health of patients. Therefore, the 
European Union urged China to determine the appr opriate corrective actions in a documented risk 
analysis, carried out in cooperation with the medical device manufacturer.  Additionally, she 
remarked that the draft established a multi-layer notification and review structure that could 
potentially generate conflicting requirements that manufacturers might have difficulties in complying 
with.  
47. The representative of China  informed the Committee that its provisions on the recall of 
medical devices had been notified to the WTO on 3 March 2010.  Upon reque st, China had extended 
the comment period by 30 additional days, ending on 15 May 2010.  She noted that the European 
Union had submitted its comments on 20 May 2010 and China had responded in writing on 
20 July 2010.  She also stated th at, currently, the relevant Chinese au thorities were considering further 
comments received from the European Union on 26 October 2010. 
(xiii) United States - California Code of Regul ations: Chapter 53 Safer Consumer Product 
Alternatives (G/TBT/N/USA/579 and Corr.1)  
48. The representative of the European Union  noted that the above-mentioned notified measure 
described the requirements that chemicals, chem ical ingredients and products containing these 
chemicals had to comply with if imported into Ca lifornia.  She also noted that the final date for 
comments on this text was 1 November 2010.  The Eu ropean Union recalled that when it had inquired 
with the US TBT Enquiry Point if there would be  an adequate period for comments, as recommended 
by the TBT Committee, especially considering that the text consisted of 92 pages, the US Enquiry 
Point had announced that the notification would be withdrawn.  Indeed, the United States had indicated by corrigendum (of 29 October 2010) that th e text had been notified in error and that the 
United States wished to withdraw the notification.   The European Union asked what reasons had led 
to the withdrawal of the draft.  
49. The representative of the European Union furthe r noted that the draft laid down a complex 
system for the management of chemicals in relation to consumer pr oducts and manufacturing 
processes and approaches.  It was th e European Union's view that th e draft potentially affected all 
products placed on the market in California, many of which were produced in third countries.  In addition, she noted, the draft provided for an ob ligation to submit data concerning chemical and 
products and laid down rules to set up different lists of  chemicals.  It also set out the precise criteria 
according to which the lists had to be prepared.  It wa s the EU view that the inclusion of a chemical in 
one of these lists could have impor tant consequences.  For instance, the obligation to carry out 
alternative assessments for substances that should l ead to the redesign or the reformulation of a 
consumer product; the obligation to  remove a product from the market; the obligation to set up end-
of-life management programs or the prohibition to se ll a product.  The European Union also noted that 
the draft contained requirements for setting up lists of the chemical substances as well as all the 
details of the procedures that would have to be followed, and all the consequences that resulted from 
the fact that a substance was included in the list.  Hence, the draft appeared to contain technical 
regulations and aspects of conformity assessment procedures. 
50. The European Union's representative stated that her delegation was aware that the 
government of California had carried out a public consultation on this docu ment that had ended on 
1 November 2010.  However, she added, the Europ ean Union did not know the reasons why the draft 
had not been submitted for comments under the TBT Agreement.  The Europ ean Union shared the 
United States' objective of protecting human health and the environment.  However, it expressed its 
desire to have the possibility to  comment on the aforementioned draft, and to share with Californian 
regulators the experience that the European Union ha d gained from the application of the Registration, G/TBT/M/52  
Page 16  
 
  Evaluation, Authorisation and Restriction of Chem ical Substances (REACH) Regulation.  Finally, the 
European Union inquired whether any feasibility  and impact assessments had been conducted by 
California on this matter. 
51. The United States
' representative recalled that during pr evious bilateral conversations his 
delegation had informed the European Union that California's regulators had independently studied 
this measure and determined that it was neither a technical regulation nor a conformity assessment 
procedure.  Based on this and USTR’s assessment, the United States had determined that it was not necessary to notify the measure under the TBT Agreem ent.  Due to an internal miscommunication in 
processing the European Union's request for notifica tion, the measure had been inadvertently notified 
– it had subsequently been withdrawn. 
52. It was the United States' opinion that the European Union's description of the provisions of 
the measure was a mischaracterization.  For instan ce, despite the European Union's assertion that 
companies exporting products to California had to submit data under these regulations, the United 
States indicated that this proposal did not require stakeholders to take any action.  Moreover, the 
United States indicated that the regulations did no t specify particular characteristics or related 
processes or production methods for any product.  Acco rding to the United States, they did not require 
a particular size, shape, design, function or pe rformance for any product.  Nor did they impose any 
specifications on any product or product ingredient.  It was the US view that these regulations simply established a process that allowed the California Department of Toxic Substances Control to 
subsequently request information from stakeholders. 
53. In relation to the European Union's request to  be able to comment on the measure, the United 
States noted that all US regulatory measures were subject to a domestic comment process that allowed 
stakeholders to submit their observations on the pr oposed measures.  This was applicable also to 
measures that were not covered by the TBT Agreemen t.  According to the United States, this proposal 
in particular had been developed through many draf ts over many years and all stakeholders, including 
those of the European Union, would have been able to comment on them through the corresponding 
US domestic process.  The United States considered that if any subsequent measures were proposed in 
connection to these regulations that met the defin ition of a technical regulation or a conformity 
assessment procedure, they would be noti fied to the WTO Secretariat for comment. 
54. The representative of the European Union
 recalled that Annex 1.1 of the TBT Agreement not 
only applied to documents which la id down product characteristics, but also to their related processes 
and production methods, including applicable admi nistrative provisions, with which compliance was 
mandatory.  While she acknowledged the US assertion that the proposed regulations did not require 
any action from the stakeholders at the moment was indeed correct, in her delegation's opinion this was only because the substances which would be incl uded in the list had not yet been identified or 
qualified.  Nevertheless, she noted, this piece of legi slation laid down the criteria to create these lists 
and once the substances had been identified,  immediate consequences would follow for the 
stakeholders.  It was the European Union's opinion that the United States' approach concerning these 
regulations could establish a dangerous precedent.  A ccording to the European Union, by laying down 
a whole framework of technical regulations a nd conformity assessment procedures, without 
identifying the covered products, Members could de lay the entry into force of these regulations 
thereby circumventing their notification obligations under the TBT Agreement. 
55. The representative of the United States
 observed that the definition of technical regulation 
contained in Annex 1.1 of the TBT Agreement was informed by the phrase "with which compliance is 
mandatory", which in the US view meant that the document in question needed to be mandatory in 
order to be considered covered.  The regulations at issue did not establish a conformity assessment 
procedure and did not contain a registration requireme nt either.  In relation to the European Union's 
offer to share its experience with the United Stat es on the application of the REACH Regulation, the  G/TBT/M/52  
 Page 17 
 
 
  representative of the United States suggested that Californian regulators could provide technical 
assistance to the European Union on  their regulation of chemicals. 
56. The representative of the European Union  asked for further clarification on the mater of its 
mandatory application; she noted, in this regard , that once a substance had been identified and 
included in the list the requirements established by the regulations became mandatory for the 
manufacturers of those substances or products containing them. 
(xiv) European Union Proposal for a Council Regul ation on the Indication of the Country of 
Origin of Certain Products Imported from Third Countries (SEC(2005)1657) 
57. The representative of the United States  noted that it was his understanding that the European 
Union's Parliament had recently voted to approve a proposal for a European Parliament and Council 
Regulation on the indication of the country of origin of certain products imported from third 
countries.  According to the United States, this meas ure would require that certain consumer products 
imported from third countries be labelled with thei r country of origin.  In the United States' 
understanding, the specific products that would be re quired to be marked included: leather, travel 
goods, handbags, apparel, textiles and textile articles, ceramics, glassware, jewellery, furniture, 
bedding, lamps and lighting, brooms and brushes, sc rews, nuts and bolts, tools and tyres.  While the 
United States recognized that there could be legi timate reasons for requiring country of origin 
labelling, such requirements should not discriminate based on origin.  According to the United States, 
this measure appeared to only require products imported from third countries to be labelled; products 
of the European Union, as well as of Turkey and members of the EEA Agreement, had been excluded 
from the application of the requirement. 
58. In the US view, any origin labelling requireme nt for consumer goods needed to apply not 
only to imported goods or only to imported goods of some countries.  The US representative clarified that his government was still reviewing the proposal and could have additional views at a later date.  
However, he expressed his interest in hearing any clarification from the European Commission on 
why the new requirements would only apply to importe d products but not to domestic products.  The 
US representative also expressed interest in more information as to why imported products from some 
countries were excluded from the application of this labelling requirement.  Moreover, the US 
representative asked for updated information on the status of this proposal in the European 
Parliament, and on the process by which the Europe an Union would request input from Members and 
other stakeholders.  He also asked for more in formation about when the European Council would 
consider the measure. 
59. The representative of Mexico
 informed the Committee that her delegation was currently 
analysing the proposal; she reserved her delega tion's rights to comment at the next Committee 
meeting. 
60. The representative of the European Union  regretted the fact that her delegation had only been 
informed very late that this issue was going to be  included on the agenda.  Because of this it had not 
been possible to consult with its experts.  Comments would be transmitted to experts. 
(xv) European Union - Directive on eco-design req uirements for household dishwashers 
(G/TBT/N/EEC/321), European Union - Direc tive on eco-design requirement for fans 
(G/TBT/N/EEC/323)  
61. The representative of China  stated that the European Union's Directives on Eco-design 
Requirements for Household Dishwashers, and on Eco-design Requirement for Fans imposed 
technical requirements that deviated from internati onal standards.  As exampl es of these deviations, 
China referred to some indictors that were stri cter than those set out in existing international G/TBT/M/52  
Page 18  
 
  standards, or other European standards, and to some definitions and calculation methods that, in 
China's view, were inconsistent with internationa l standards.  It was China's opinion that these 
deviations from international pa rameters had the effect of significantly increasing production and 
trade costs for manufacturers and created uncertainty as to what the required specifications were.  In 
China's view, this would affect exports to the European Union from developing countries, including 
China.   
62. The representative of China recalled that duri ng the last TBT Committee meeting, China had 
enumerated several examples of EU notifications
5 involving eco-design requirements for products 
such as household, office electrical and electronic equipment, several types of lamps, power supply 
and household refrigeration equipment that were of concern to China.  Other notified measures were 
also of concern.   
63. For instance, China noted that Article 21C of Annex I of the EU Directive on Eco-design 
Requirements for Household Dishwashers (G/TBT /N/EEC/321), stipulated for all household 
dishwashers, that the cleaning efficiency index had to  be greater than 1.12.  This Directive had been 
notified to the WTO Secretariat one year after its pub lication in the Official Journal of the European 
Union.  According to China this cleaning efficien cy index requirement differed from that used by 
other developed countries such as Australia a nd New Zealand, where the stipulated cleaning 
efficiency index had to be greater 0.9.  Chin a encouraged the European Union to harmonize its 
standard with those of other countries, or at least to use these other standards as reference. 
64. In relation to the EU Directive on Eco-desi gn Requirements for Fans (G/TBT/N/EEC/323), 
China considered that the standard  for fans was inconsistent with  the standard ISO 13349: 2010 Fans 
– Vocabulary and Definitions of Categories.  Acco rding to China this created confusion amongst the 
manufacturers.  Moreover, China observed, the calcula tion formula of the target energy efficiency in 
the European Directive was inconsistent with IS O 5801: 2007 Industrial Fans – Performance Testing 
Using Standardized Airways and ISO 5802: 2001 In dustrial fans -- Performance testing in situ. 
65. China noted that the European Committee on Standardisation and the European Committee 
for Electrical Technical Standardisation had establis hed a close cooperation relationship with ISO and 
IEC through the Vienna Agreement on Techni cal Cooperation and the Dresden Agreement, 
respectively.  Therefore, China hoped that the Eu ropean Union would be more proactive in preserving 
the reference-role of international standards.  Ch ina also encouraged the European Union to conduct a 
systematic analysis of the consistency of its recen tly established and revised technical regulations and 
conformity assessment procedures with the relevant in ternational standards, and to produce statistical 
information on the rate this standards were adopted as the basis for European Directives. 
66. The representative of the European Union  observed that the eco-design requirements were set 
in mandatory performance levels and that those leve ls were set in accordance with the framework eco-
design Directive 2009/125/EC of the European Parliament and of the Council, establishing a 
framework for the setting of eco-design requirements for energy-related products.  She also recalled 
that eco-design requirements aimed at reducing the environmental impact of energy-related products 
on the basis on a lifecycle analysis. 
67. With regard to the remarks made by China on the use of relevant ISO standards, and on the 
measurement requirements and test methods, the representative of the European Union stated that the 
eco-design implementing regulations specified that me asurements of the releva nt product parameters 
                                                      
5 Including: G/TBT/N/EEC/208 , G/TBT/N/EEC/228, G/TBT/N/ EEC/229, G/TBT/N/EEC/234, 
G/TBT/N/EEC/237 and G/TBT/N/EEC/273).  Other notified measures were also of concern: G/TBT/N/EEC/321 (concerning eco-design requirements for household dishwashers) and G/TBT/N/EEC/323 
(concerning eco-design requirements for fans).  G/TBT/M/52  
 Page 19 
 
 
  needed to be performed using reliable, accurate and reproducible measurem ent methods which took 
into account the recognized state-of-the-art m easurement methods, including, where available, 
harmonized standards adopted by the European Sta ndardisation bodies.  She added that in practice, 
this meant that the European Commission always is sued a mandate to the European Standardisation 
bodies (CEN, CENELEC and ETSI) for the developmen t of harmonised measurement methods once a 
new eco-design regulation was adopted.  She clarified that the EN standards al ways used, as a basis, 
the IEC or the ISO standards, whenever they existe d.  The measurement requirements set in European 
standards differed from the IEC and the ISO standa rds when the latter did not allow for a proper 
implementation of the eco-design regulations.  She also recalled that every time China had posed 
questions concerning deviations from the ISO standa rds involving European st andards, the European 
Union had given, in the framework of the TBT Committee, and also in writing, the corresponding 
explanations why it had been necessary to de viate from the IEC and the ISO standards. 
68. In relation to the comments made by Chin a regarding the Directive on Eco-design 
Requirements for Household Dishwashers (G/TBT/N /EEC/321), the representative of the European 
Union recalled that a detailed wr itten response from the European Uni on had been sent to China.  She 
invited China to submit to the EU TBT Enquiry Poin t any further questions China had in relation to 
the answers provided. 
69. With regard to the European Union Dir ective on Eco-design Requirements for Fans 
(G/TBT/N/EEC/323), the representative of the European  Union noted that an answer had not yet been 
provided to China.  However, she announced that this answer was going to be delivered in the 
following days.  With respect to this measure, the related ISO standard had not been followed because 
ISO was developing a new standard in this area.  Th e European legislator had been in close contact 
with ISO on this matter in order to follow the new standard, which was going to be adopted soon 
under the number ISO 12759.  
(xvi) United States - FCC Rules 96-493 on Broadcas t Services; Television Broadcast Stations; TV 
Transmission Standards 
70. The representative of China  noted that the US Federal Communications Commission (FCC) 
had adopted, on 24 December 1996, the FCC 96 – 493 Broadcast Services – Television Broadcast 
Stations and TV Transmission Standards.  These rul es had been published in the Federal Register on 
25 March 1997.  It was China's understanding that the FCC rules had not been notified to the WTO 
Secretariat.  She also noted that the FCC rules inco rporated, by reference, ATSC/52, the Digital Audio 
Compression Standard.  Section 73.682 D of the FCC rules provided that transmission of digital 
broadcast television signals needed to comply with  various standards, including the ATSC Digital 
Audio Compression Standard.  China also noted th at, since 1 March 2007, all digital televisions 
bigger than 30 inches had to comply with this mandatory standard.  Acco rding to China, Chinese 
export of digital TVs to the US market had, as a c onsequence, been substantially impaired.  China was 
particularly concerned about the mandatory audi o compression standard A/52 incorporated in the 
FCC rules.  China questioned the compliance of  the US measure with Article 2 of the TBT 
Agreement; it was China's view that the measure w as creating an unnecessary obstacle to international 
trade.  China reiterated its invitation to the United States to explain the legitimate objectives it pursues 
by making the audio standard for digital TVs mandatory. 
71. The representative of the United States  noted that his delegation had only learned the day 
before that this particular issue was being raised  in this TBT Committee meeting.  Therefore remarks 
were of a preliminary nature.  As China had noted, this was an "old" measure.  He recalled that the 
FCC had started developing this measure in 1987 and that this process had continued for ten years.  In 
fact, the events predated the TBT Agreement's notific ation provisions.  During this time, he stated, US 
regulators had entertained comments from numerous stakeholders.  They had also looked at many 
different types of technologies and did consider allowing for the use of competing standards.   G/TBT/M/52  
Page 20  
 
  72. It was the US opinion that there was no country in the world that did not mandate a single 
standard for terrestrial free-to-air TV, whether digita l or analogue, including China.  He explained that 
that the adoption of the DTV Standard served th e public interests and brought many benefits to 
American consumers by providing certainty to broadcasters, equipment manufacturers and consumers of digital broadcasting.  Moreover, he added, adopt ing a single digital television standard promoted 
increased choices in video programming with dramatica lly better visual and audio resolution and, in 
addition, new and innovative services could be made  available by the data transmission capabilities of 
the digital television standard.  Further, in the Un ited States' view, the digital television standard 
permitted inter-operability with computers and enc ouraged innovation and competition.  The decision 
had allowed US viewers to receive dozens of different channels with one single device.  The prospect 
that viewers would need more than one device to view different channels was an unacceptable 
alternative for consumers. 
73. The representative of the United States invited Ch ina to submit its specific concerns.  It was 
the US impression that China was concerned about a particular technical issue in connection to 
mandatory audio compression standards.   China need ed to be more precise about this so that his 
delegation could discuss these concerns with the FCC upon the return to Washington. 
2. Previously raised concerns 
(i) European Union – Regulation on the Regist ration, Evaluation and Authorization of 
Chemicals (REACH) (G/TBT/N/EEC/52 and Adds.1-5;  Add.3/Rev.1; G/TBT/N/EEC/295 and Add.1; G/TBT/N/EEC/297; G/TBT/N/EEC/333-6) 
74. The representative of Japan
 drew the Committee's attention to a 27 September 2010 European 
Commission press release (ECHA/PR/10/19) offe ring assistance to companies having trouble 
complying with the deadlines for registration of pre -registered chemicals produced or imported at a 
rate exceeding 1000t/year.  He noted that affected  companies which faced exceptional circumstances 
could be given new registration deadlines on a cas e-by-case basis.  The representative of Japan 
expressed concern that certain companies might not have knowledge of this recourse and could face 
difficulties as a result.  Japanese industry was of the view that REACH rules required improvements 
in implementation due to difficulties in comp liance and uncertainties in interpretation.  
75. The representative of Japan suggested that  the European Commission undertake wider 
consultations on the new draft guidance documents , and take into account responses from affected 
parties prior to imposing additional REACH relate d registration deadlines.  He stated that the 
European Commission needed also to consider  fundamental improvements to REACH rules to 
address the issues raised in the aforementioned press release, so as to ensure that REACH achieved 
high-level protection of human health and the environment while upholding free circulation of 
chemicals in Europe. 
76. He recalled that the Government of Japan had previously requested the abolition of 
mandatory registration of monomer substances contained in polymers within REACH, and noted that 
the European Court of Justice had upheld mandatory monomer registration in a July 2009 ruling.  The 
Government of Japan continued to harbour doubts about the necess ity of registration of monomers 
contained in polymers, since i) polymers generate d by polymerization did not negatively affect the 
environment, and ii) mandatory registration was inco nsistent with Article 2.2 TBT Agreement, given 
that this policy was more trade restrictive th an necessary.  The representative reiterated his 
delegation's request that mandatory registration of  monomers contained in polymers be reconsidered, 
and that exemption provisions, such as those bei ng implemented by other countries under the OECD 
system, be established.  G/TBT/M/52  
 Page 21 
 
 
  77. The representative of Canada  inquired as to whether the European Union had taken steps to 
increase application processing capacity in response to  a potential surge in applications leading up to 
the 30 November 2010 deadline.  He wondered wh ether companies which had submitted documents 
prior to the deadline, but faced a delay in processing  due to high numbers of  applications, would be 
treated as non-compliant.  He noted that the EC REACH Committee had proposed changes to Annex 
XIII criteria for the classification of "persistent, bio-accumulative, and toxic (PBT)" substances, and 
"very persistent or very bio-accumulative (vPvB) " substances.  The representative of Canada asked 
about the rationale for these changes and how they might affect the identification of 'Substances of 
Very High Concern', as well as what opportunities ex isted for non-EU interested parties to comment 
on proposed changes. 
78. The representative of Canada also drew the Co mmittee's attention to the publication of Annex 
V guidance by the European Chemical Agency (ECHA), which addressed products of modern bio-
technology.  He questioned how the "fast track guida nce update procedure" worked, in particular with 
respect to impacts on vegetable oils sourced from GM  plants.  He asked about the objective of a 30 
November 2010 review of Annex V guidance by the ECHA, and what progress had been made in this 
respect. 
79. The representative of China  questioned the REACH requirement that monomers contained in 
polymers be registered, and noted that European co mpanies had resorted to court challenges of this 
requirement - although the challenges had been reject ed by the European Court of Justice.  Many 
companies continued to express concern about lack of clarity on this issue, and this uncertainty had 
hindered preparation of company dossiers and use of International Uniform Chemical Information 
Database (IUCLID5).  She proposed that the Euro pean Union and ECHA provide clearer guidance on 
the registration of polymers. 
80. With respect to Substance Information Exch ange Forums (SIEFs), she expressed concern 
about the financial burden imposed  on SMEs, and recommended that co st sharing arrangements be set 
up for SIEFs on the basis of firm size. REACH required registration of the entire tonnage of 
substances, even if less than 100 per cent of the substance was intended for release.  This provision 
had the effect of increasing the tonnage band fo r registration which placed increased burden on the 
registrant. 
81. The representative of China also expressed concern about the prohibition on traders 
registering directly with REACH in light of the financial and human resour ce capacity limitations 
faced by SMEs in developing countries like China, a nd the fact that these SMEs did not trade directly 
with EU importers.  She suggested that the Europe an Union permit traders or associations to appoint 
an 'Only Representative' to register with REACH on behalf of SMEs. 
82. Chinese companies had encountered difficulties while preparing particular dossiers, for 
example, regarding the analytic spectrum of alloys. REACH required that alloys be registered as every one of their metal components, but she explai ned that this would lead to challenges since the 
component analysis of the alloy would not match with  data provided by lead registrants of the metal 
substances.  Lack of clarity on this issue fro m ECHA had prevented Chinese companies from moving 
forward with the registration process.  The represe ntative of China requested an extension of the 
registration deadline, given the delays caused by this lack of guidance. 
83. The representative of Argentina
 reiterated concerns about the lack of transparency around 
REACH. He explained that REACH constituted an  unnecessary barrier to trade, especially for 
Argentinian SME exporters due to difficulties in understanding the rules and the disproportionate and 
needless costs associated w ith compliance.  The representative noted  that the text of the regulation 
was extensive and complex and subject to constant  revision, and that the 52 supplementary guidance G/TBT/M/52  
Page 22  
 
  documents had not improved this situation, since they were often even more extensive and again 
subject to multiple revisions.  
84. The representative of Argentina requested an swers to a number of outstanding questions 
which continued to cause uncertainty, particul arly in light of the upcoming 30 November 2010 
registration deadline.  He inquired as to whether s ubstances contained in exported articles needed to 
be registered for REACH compliance.  Moreover, he asked how the European Union ascertained that 
exported articles containing listed substances did so in  excess of the one tonne registration threshold.  
He also wondered whether companies and importe rs knew about the requirement of registering 
substances contained in articles. 
85. The representative asked what information non-EC  companies needed to provide with respect 
to the registration exemptions for substances presen t in articles in total annual quantities less than one 
tonne, or less than 0.1 per cent of weight, or not to be released under normal or predictable 
circumstances.  In particular, he wondered if th ere was an established means of communicating this 
information, and when, and to which authoriti es this information needed to be presented 
86. On costs, the representative of Argentina em phasized eight different payments associated 
with REACH: registering; requests for confidenti ality of information; stating of timeframes for 
tonnage; other updates; notifications; extensions; revision of authorization; and appeals against 
decisions.  Costly sanctions for errors or non-co mpliance were also noted, as was the possibility of 
ECHA introducing other fees at any time pursuan t to Article 11 of Regulation ECE 340/2010. 
87. In the view of Argentina, the costs associated with REACH we re disproportionate since they 
did not provide sufficient reduction rates for SMEs.  Regulation ECE 340/2008 gave ECHA full 
discretion to determine whether a company qualifie d as an SME, and the representative noted that 
ECHA could apply a surcharge when a company had not  'sufficiently' demonstrated that it was an 
SME, even though there existed no explanatory guide for companies to follow in proving that they were an SME.  Hence, the representative inquire d as to what documentation a company needed to 
provide to sufficiently demonstrate that it was an SME.  In addition, the representative noted that 
extra-community SMEs bore additional costs relative to European SMEs, since they had to hire an 
Only Representative or open an office in Europe . The implementation of REACH still works as an 
unnecessary obstacle to trade and, unless a solution is  brought to the indicated concerns, many 
enterprises will be excluded from the European market.  
88. The representative of India
 shared concerns raised by previous speakers.  He questioned the 
logic of mandatory registration of monomers given that the lifecycle of a monomer ended when it was 
reacted into a polymer, and monomers themselves did not pose separate risks from those of polymers.  
He expressed concern about European industry dominating SIEFs and cons ortia with resultant 
detrimental impacts on SMEs.  High membership fees, penalties for late joining, yearly maintenance fees, non-uniform rules of consortia, high fees for lead registrants, refusal of members to admit participants, and the prohibitive cost of letters of  acceptance were cited as challenges particular to 
SMEs. 
89. The representative of India also questioned the ra tionale for registration of the entire tonnage 
when less than 100 per cent of the substance was intended for release upon usage, which further 
increased the burden on registrants.  The definition of an SME, which consid ered annual turnover and 
number of employees, was flawed and would classify many Indian SMEs as large enterprises, leading to higher registration fees.  He also noted the lack of special and differential treatment with respect to 
the cost of data sharing and the prohibition on new animal testing, rendering associated costs 
prohibitive, again especially for SMEs.  The represen tative of India stressed the high cost of data 
sharing in SIEFs and asked the European Union to consider computer simulation of chemical testing 
as an option.  G/TBT/M/52  
 Page 23 
 
 
  90. The representative of Kuwait , on behalf of the Gulf Coope ration Council (GCC), expressed 
concern about the ambiguity of the REACH programme  and its potential impacts on trade in chemical 
substances, in particular petrochemical substances.  Referring to his delegation's previous request for 
information, he asked the European Union to clar ify details of the programme, including standards 
and criteria adopted for the identification of goods c overed.  REACH was a real and direct threat to 
the economic interests of developing countries and to the rules and principles of the multilateral 
trading system. 
91. The representative of Colombia  noted that her delegation shared concerns raised by previous 
speakers with respect to REACH.  She asked the European Union to  re-examine the scope of the 
measures and provisions contained in REACH in light  of the comments made to the Committee.  She 
highlighted the process of registering substances, part icipation in SIEFs and the lack of legal certainty 
and security with respect to requirements and d eadlines in light of possible changes to guidance 
documents, all of which disadvantage exporters, esp ecially SMEs.  Her dele gation would welcome the 
establishment of a webpage explaining how REACH overlapped with other regulations.  The REACH 
revision process continued to be an obstacle for Colombian industry given that revisions were 
communicated in English only.  The representative requested that progress made in amendments of 
Annex VII of REACH be notified under G/TBT/N/EEC/297. 
92. The representative of the United States  explained that his delegation shared the EU concern of 
protecting human health and the environment, but th at his delegation continue d to have trade-related 
concerns with REACH and its implementation.  He hi ghlighted several concerns, in particular serious 
impediments to industry meeting the first registra tion deadline at the end of November.  Given the 
sheer number of dossiers yet to be submitted ( over 30,000) and numerous lead registrants waiting 
until the last minute to submit registrations, the poten tial for secondary registrants to miss the deadline 
appeared to be high.  He inquired as to what step s the Commission had taken to ensure that it had the 
necessary personnel to handle a surge in applications , and to ensure that trade was not disrupted by 
delays in lead registrations.  In addition, he e xpressed concern that if lead registrants failed their 
completeness check, notification of which might not  occur until 1 March 2011, then all trade from 
secondary registrants transpiring between 30 N ovember 2010 and 1 March 2011 could be rendered 
illegal. Given the length and complexity of lead re gistrations, the representative of the United States 
did not consider this to be a theoretical concern. 
93. The representative of the United States highlighted differences in interpretation of the 0.1 per 
cent threshold for notification and communication obligations between member States and the 
Commission.  He welcomed the draft guidance fro m the ECHA on this subject, which was consistent 
with the Commission's legal position that 0.1 per cent threshold applied to the entire article, but 
expressed concern about the divergent views of six me mber States.  His delegation viewed efforts by 
these six member States, and others, to change the Commission's position on this matter as akin to 
seeking protection from imports.  Companies had not undertaken material analysis on the sub-article 
level, which would be extremel y time-consuming and burdensome, and he noted that the ECHA IT 
tools might be incapable of conducting an inventory at the sub-article level.  He emphasized that 
serious disruption of transatlantic trade would r esult if the Commission reversed its position on this 
point. 
94. On another matter, it was noted that US stak eholders had concerns about the impact of 
REACH on animal testing, as it was not clear from the ECHA press release what measures the 
European Union had taken on the subject.  He conc luded by noting that the United States intended to 
participate in the upcoming review of the REACH regulation, and would submit comments by the 1 December 2010 deadline. 
95. The representative of Ecuador
 supported the statements made by other Members to the effect 
that REACH represented an unnecessary barrier to trade given its complexity and costly nature.  He G/TBT/M/52  
Page 24  
 
  noted that registration would negatively affect deve loping country exporters of chemical substances, 
in particular SMEs.  He sought further informa tion on Resolution 210 102/A/15 and the modifications 
to the REACH regulation published in the dail y bulletin of the EU during August 2010.  
96. The representative of Cuba
 supported previous speakers and st ated that compliance with the 
requirements of REACH represented a real challeng e for developing countries given the complexity 
of the system and the high costs imposed on exports.  Outstanding issues included different 
implementation across member States of the EU base d on different interpretati ons, and that technical 
assistance offered by the European Union to date had been insufficient.  She requested that the 
European Union hold seminars or conferences on REACH.  She confirmed that her delegation 
supported the protection of human health and the en vironment but that the REACH regulations were 
more trade restrictive than necessary.   
97. The representative of the Bolivarian Republic of Venezuela  shared the concerns of other 
Members with respect to technical aspects of REAC H.  He noted that the Bolivarian Republic of 
Venezuela acknowledged the legitimate objective of the European Union to undertake measures to 
promote human health and the environment.  Howe ver, the measures adopted by the European Union 
under REACH contained elements which were obst acles to compliance, in particular since the 
European Union had not presented sufficient informa tion nor had it sufficiently addressed the requests 
and concerns expressed by Members. He calle d on the European Union to provide further 
clarifications through the publication of verifiab le data illustrating classification decisions.  The 
complexity of the regulation would impose signi ficant cost and burden on SMEs in developing 
countries, which had great difficulty complying w ith technical requirements given lower staffing 
levels.  The technical assistance aspects of the TBT Agreement and S&D tr eatment for developing 
countries needed to be taken into consideration.  Th e fact that the regulations were not available in 
Spanish – as well as their sheer size – made them ve ry hard to comprehend in this context.   
98. The representative of Australia , Bolivia , Chile , the Philippines  and Thailand  supported the 
concerns raised by other Members. 
99. The representative of the Russian Fe deration, speaking as an observer , highlighted the 
negative impacts of REACH on the Russian steel indus try.  He explained that in 2008, the European 
Confederation of Steelmakers (EUROFER), with the support of the World Steel Association and 
Russian steelmakers, had proposed to the ECHA a nd the European Commission that semi-finished 
steel products and rolled conversi on products, including slabs, be classified within the 'products' 
category, and not subject to substa nce registration.  This approach had been approved by the ECHA in 
September 2009, confirming that the substances in  these products did not require registration under 
REACH.  Subsequently in March 2010, the German Federal Institute for Safety and Health (BAUA) 
had decided to categorize slabs within the 'mixtu res' category, and thus subject to substance 
registration, given that the September 2009 decisi on of the ECHA on requirements for substances in 
articles (RIP) had no legal force, and member Stat es were allowed to interpret the provisions of 
REACH as they saw fit.  The representative of Ru ssian Federation expressed concern that a precedent 
had been set whereby a member State of the Eur opean Union could diverge from the ECHA position.  
The result of this was uncertainty for the steel i ndustry regarding registration, potential disruption in 
deliveries, related disputes between market partic ipants, and additional costs to the Russian steel 
industry.  The competitiveness of the 12 million tons of Russian steel exported annually to the European Union would be greatly reduced by the n eed to register every input separately in each EU 
country.  The representative concluded that the Russi an steel industry could not comply with REACH 
due to the ambiguity of the methodological guidance on requirements for substances.  
100. The representative of the European Union
 thanked delegations for their comments and noted 
that many of the issues raised ha d been discussed at previous Committee meetings.  Others were more 
specific and linked to the fact that the first re gistration deadline (of 30 November 2010) for certain  G/TBT/M/52  
 Page 25 
 
 
  classified phased-in substances and for substances manufactured or imported in quantities reaching 
1000 tons or more per year was upcoming..  Sh e emphasized the importance of Members reminding 
all companies concerned to submit their dossiers in time and in full.  The Commission and the ECHA were continuing to do all they could to support th e industry in this exercise, including establishing a 
'directors' contact group'.  The group, chaired by the European Commission had found, since its 
establishment, solutions to 28 issues of concern fo r industry or Members which were related to the 
first registration deadline. The solutions had b een published on the ECHA website in September. 
101. The 'directors' contact group' also identified excep tional situations that were likely to prevent 
companies from submitting REACH compliant registrations on time.  In these specific scenarios, ECHA could offer help if it was alerted on time.  She noted that this was the press release Japan had 
referred to and emphasized that assistance was reser ved for exceptional situations only, whereby the 
registrant was unable to submit full registration dossiers by the 30 November 2010 deadline through no fault of their own.  An example of this was the lead registrant going bankr upt two weeks before the 
deadline thus being unable to submit the registration on time.  This flexibility was designed to prevent 
undue exclusions from the market due to unforeseeabl e circumstances, which were not in control of 
companies.  It had, however, not been the aim to postpone the existing deadline of 30 November 
2010.  
102. The representative of the European Union assured Japan, and other concerned Members, that 
the EU undertook every effort to properly prepar e guidance documents.  As already explained 
previously, ECHA had decided not to update ex isting guidance until after the 30 November 2010 
deadline, so as to allow industry to concentrate on the registration process.  The efforts that the EU 
were making in order to help companies, including from third countries, to comply with the REACH 
regulations showed to be fruitful: as of 27 October 2010, 2,839 lead registrants had been registered 
and as of 2 November 2010, 9,515 registrants had been registered, which represented more than a 
doubling of registrants since October 2010. 
103. With respect to the completeness check questions (raised by the United States), the 
representative of the European Union explained that  products would not be illegal during the time that 
ECHA was evaluating a dossier so long as a company had registered on time.  However, ECHA could revert to the company if they found that data was missing.  
104. In response to concerns expressed by the de legations of Japan, China and India, the 
representative confirmed that on 3 July 2009 the ECJ ruled that Art. 6 Para. 3 of the REACH 
regulation providing for the registration of reac tive monomers and polymers was valid, since it 
pursued a legitimate objective of protecting human health and the environment.  In particular, 
registration furthered knowledge of  polymers and addressed certain health and environmental risk 
such as monomer residues. China was referred to detailed guidance on monomers and polymers 
available on the ECHA website and offered to fo llow up with regard to the specific questions 
bilaterally.   
105. It was noted that the position of the European Commission had been provided at the March 
2010 meeting of the Committee to the Canadian qu estion on exclusion of GMOs, as well as in  
bilateral meetings  and that the position of the Eu ropean Commission had not changed. Furthermore, 
the representative of the European Union recalled th at the guidance concerning Annex V would not be 
up-dated until 30 November 2010. 
106. With respect to the changes to Annex XIVand Annex XIII, it was noted that all amendments 
had been notified to the WTO during the summer, and that the EU delegation had not received any 
comments on them.  However, the representative of  the European Union offered to accept comments 
even though the comment period had expired.  The Annexes had not yet been adopted – any eventual adopted text would be notified to the WTO. Concerning Ecuador's request on Resolution 210 G/TBT/M/52  
Page 26  
 
  102/A/15 she stressed that she would need further explanations to understand to what Ecuador was 
referring to. 
107. On enforcement of the registration obligation of substances in articles (the questions raised by 
Argentina), the representative of th e European Union explained that the obligation for registration and 
notification of substances in articles was an oblig ation imposed under certain conditions by Article 7 
of the REACH regulation. So, the obligation lay w ith the importer and there were no authorities that 
would notify the importer as such.  Thus it was the responsibility of the importers to prove that the 
registration had been carried out, if they fell under th e Article 7 criteria, or to demonstrate that they 
did not fall under those criteria, and hence did not  have to register or notify under the REACH 
regulation.  Article suppliers needed to cons ider documenting the results of their compliance 
checking, especially when they believed that they did not fall under the registration or notification 
obligation under REACH.  Further advice on the obl igations and how to prepare such documentation 
could be obtained on page 20 of the guidance on Articles
6. 
108. On discriminatory treatment, in particular in terms of ECHA deciding which companies fell 
under the SME definition or how SMEs were treat ed, the representative of  the European Union 
referred to Commission recommendation 2003/361/EC of 6 May 2003 which provided the official 
definition of an SME, and which was used for the purposes of REACH. Documentation had to be provided according to the criteria laid down in this recommendation. 
109. Regarding the sharing of costs between partic ipants in the SIEF (China's question), she 
explained that the Commission was leaving it up to th e industry to organize such cost arrangements in 
the SIEF.  Although the European Commission and EC HA were making efforts to facilitate the SIEF 
process, the final organization was in the hands of  industry.  Regarding queries from India and China 
on changes to Article 7, it was explained that there were no plans to change the criteria laid out in the 
Article.  Regarding China's suggestion that traders an d associations should be able to appoint an Only 
Representative, she reiterated that the appointment of an Only Representative was not mandatory, but 
a voluntary measure. Also, an Only Representative could represent more than one non-EU 
manufacturer.  With regard to specific questions from China and the Russian Federation on alloys and 
steel products, it was suggested to contact the ECHA helpdesk and in case the issue was not clarified 
to inform the EU delegation bilaterally. 
110. In response to the request from Cuba for c onferences on REACH, the representative of the 
European Union noted that her delegation had notified the Committee on several occasions of 
stakeholder meetings and conferences organized  by ECHA, which could be accessed through the 
internet, including streaming of archived events. 
111. The representative the European Union noted that  the candidate list totalled 38 substances and 
that ECHA had published on 30 August 2010 a proposal to identify 11 chemicals as Substances of Very High Concern and possible candidates for author isation.  A public consultation had been held, 
and comments were possible up to the 14 October 20 10.  The first proposals to include substances in 
Annex XIV of REACH had been notified to the WTO on 30 June 2010 (G/TBT/N/EEC/337); no 
comments had been received to date on this.   
112. Regarding developments on the draft Commi ssion regulation amending Annex XVII, it was 
recalled that this proposal covered, inter alia , borate and nickel substances that had been reclassified 
through the 30
th and 31st Adaptations to Technical Progress (ATP).  This proposal was still under 
discussion and there were no new developments.  She dr ew the attention to the fact that despite the 
invitation to Members having indicated in the Committ ee that they were aware of the availability on 
                                                      
6 http://guidance.echa.europa.eu/docs/guidance_document/articles_en.pdf  
  G/TBT/M/52  
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  the market of substances or mixtures for the use of consumers containing borates or nickel compounds 
above the concentration levels to provide this information to the EU, no such information had been 
received.  
(ii) European Union – Directive 2002/95/EC on the Restriction of the Use of certain Hazardous 
Substances in Electrical and Electronic Equipm ent (RoHS) and Directive 2002/96/EC on 
Waste Electrical and Electronic E quipment (WEEE) (G/TBT/N/EEC/247 and 
G/TBT/Notif.00/310, Corr.1) 
113. The representative of Japan  expressed concern about proposals to regulate nanomaterials 
(especially carbon nanotubes (CNT) and Nanosilver) under EU RoHS rules adopted by the European Parliament on 2 June 2010.  The proposals prohi bited CNT and Nanosilver use, and would require 
enterprises to notify the Commission of the us e of MNOs (Manufactured Nano Objects) and 
PCMNOs (Products Containing Manu factured Nano Objects) in a ddition to related labelling for 
products that could lead to consumer exposure.  S hould the European Union desire to prohibit the use 
of CNT and Nanosilver, scientific evidence needed fi rst be presented, including  data that documented 
danger to human health and the environment. 
114. Japan was also concerned about EU RoHS requirements for nano labelling, which would 
obstruct the development of nanotechnology, and create standardization barriers to innovation and 
dissemination.  He noted that economic operations of products affected by the implementation of 
these regulations were distributed broadly over many industrial fields, a nd huge costs and immense 
work would be required to ensure the conformity  of nanotechnology.  He hoped that the European 
Union would proceed cautiously when imposing restri ctions on nanomaterials within EU RoHS and 
inquired as to the current status of the discussion on these regulations. 
115. The representative of Japan also asked about the relationship between REACH and the RoHS 
Directive in particular with respect to the applica tion of the threshold value which appeared to differ 
between the two regulations. Under REACH, the entir e article was the denominator in the calculation, 
while in the RoHS Directive, the homogeneous ma terial in the article was the denominator.  These 
differences could give rise to confusion.  He reque sted that the threshold value for concentrations 
subject to control be calculated using the sa me standard in both sets of regulations. 
116. The representative of the United States
 expressed support for the RoHS directive's objective 
of protecting health, safety, and the environment. Ho wever, he stated that the Council and Parliament 
proposals for an open scope with certain exclusions would likely have an impact on many producers.  
He noted that US industry was concerned about pr oposals for an open scope and additional substance 
restrictions, and hoped that the European Union wo uld take these concerns into account.  He asked 
about the steps the Commission was taking to defe nd its proposal for a closed scope and limited 
substances restrictions based on a scientific appr oach within the trialogue process (negotiations 
between the Commission, Council and Parliament). 
117. The United States was also concerned about the relationship between RoHS and REACH and 
suggested that the Commission's pr oposal for the RoHS recast coul d benefit from greater clarity.  
Should the same substances be eval uated under two separate measures, and by two separate agencies 
using different criteria, and having different objectiv es, different conclusions seemed likely.  He asked 
for more information from the Commission on: how such conflicts would be handled; and whether 
there would be a transparent exemption process w ith fixed timeframes for decisions, a meaningful 
opportunity for all interested parties to comment and have those comments taken into account, and an 
explanation setting out the basis for decisions that  would improve the operation of the Directive. 
118. The representative of Korea  noted that it was his delegation's understanding that Belgium had 
proposed the abandonment of the Priority List (Annex III) in September 2010.  He invited the G/TBT/M/52  
Page 28  
 
  European Union to explain the Belgian proposal and to clarify the status of the RoHS recast.  Finally, 
he reiterated his delegation's request that a scienti fic risk analysis be undertaken prior to any 
substances being added to the lists. 
119. The representative of the European Union
 explained that the proposal was currently being 
discussed by the European Parliament in the 'first r eading' of the legislative process.  The European 
Parliament Committee on Environment, Public H ealth, and Food Safety (ENVI Committee), which 
was the lead committee on the proposal, had adopted , on 2 June 2010, its report on the Commission's 
proposal.  This report retained 103 amendments out of over 300 amendments that had been tabled in 
several parliamentary committees.  The ENVI comm ittee had proposed extending the scope of RoHS 
to all electrical and electronic equipment, including cables, consumables and accessories as of 1 July 
2014, as well as adding 29 substances to a list of candidates for future  restrictions under Annex III.  
The ban on the use of carbon nanotubes and nanos ilver and the notification requirements for 
nanomaterials had also been proposed by the ENVI  committee – no such proposal had figured in the 
Commission's original proposal. 
120. The European Parliament would vote on th e report of the ENVI committee during the 22 
November 2010 plenary session.  In the meantime, me mber States were considering the Commission's 
draft text and had initiated discussions with the European Parliament to assess the potential of 
reaching a first reading agreement.  Clearly, at th is stage there were broad differences between the 
proposals of the three institutions, in terms of sc ope, substances and restrictions, and that it was 
therefore not possible to determine whether a compro mise might be achieved in the first reading.  
Should an agreement be found between the Europ ean Parliament and the Council, and if the 
Commission agreed to the proposed amendments, th e text and legislation would be finalised.  
However, if a compromise was not reached, the text  would be resubmitted to the European Parliament 
and Council for examination under a 'second reading'. 
121. Given the uncertainty about which amendments  might survive the vote in the Plenary session 
of the European Parliament, an d as to the positions that member States and the Commission would 
take on these amendments, her delegation consider ed that it was premature to express any views on 
the matter.  She assured Members that all of thei r concerns would be conveyed to the European 
Parliament and to the Presidency of the Council of  the European Union.  Should the Commission's 
initial proposal be substantially amended, the new te xt would be notified to TBT Committee.  The EU 
delegation would update Members on developments  in the legislative process at the next TBT 
Committee meeting. 
(iii) European Union – Regulation on Certain Wine Sector Products (G/TBT/N/EEC/15, Corr.1-2, 
G/TBT/N/EEC/57 and G/TBT/N/EEC/252 and Add.1 and Add.2;  G/TBT/N/EEC/264 and Add.1)  
122. The representative of the United States
 noted that despite continued discussions between US 
industry and the Commission, serious concerns rema ined with respect to the above-mentioned notified 
measures.  The United States was of the view that the EU measure would severely restrict the ability 
of non-EU wine producers to use common or descrip tive and commercially valuable terms (many of 
them adjectives) to describe their products on the grounds that those terms were traditionally 
associated with European wines.  In particular, th e European Union was still trying to obtain exclusive 
rights to use terms commonly included on the labels of wines such as chateau, vintage and superior – 
except under certain limited circumstances.  Whil e the European Union attempted to justify 
limitations on the use of traditional terms by indicati ng that consumers could be misled by their use, 
the fact remained that th ese terms had been used without incident  on US wines in the EU market for 
many years.  G/TBT/M/52  
 Page 29 
 
 
  123. In addition, the European Union had not indicat ed how it intended to enforce limitations with 
respect to imported wines.  For example, he asked whether the European Union or its member States 
would take action to block importation of US wi nes bearing a traditional expression. The European 
Court of Justice had expanded the scope of the measures that protected these so-called terms in 
languages other than the one for which protection was id entified.  To illustrate his point, he gave the 
example of the recent case in Cyprus where protecti on was requested for the term "special reserve" in 
English as a traditional term in Cyprus.  He al so expressed on-going concerns with non-TBT related 
aspects of the protection of trademarks and intellectua l property, concerns that had also been raised 
within the European Union in other fora. 
124. The representative of New Zealand  was particularly concerned about the discussion between 
the Commission and Cyprus with r espect to the application for the "special reserve".  She reminded 
the Committee that New Zealand had raised issues on the matter of traditional terms use for some 
time.  Regarding the special reserve application,  New Zealand had been assured by the Commission 
that it expected to resolve the matter in the near future.  She requested an update on the matter. 
125. The representative of the European Union  confirmed bilateral discussions with US authorities 
on the issue of traditional terms in the context of bila teral wine talks.  Furthermore, she informed the 
Committee that in June 2010, two US wine associ ations had filed several  applications to the 
Commission for the use of certain traditional term s.  In October 2010, the objection procedure had 
been launched with the publication of the applicati on forms in the Official Journal of the European 
Union and Commission services would shortly send its first observations to the applicants regarding 
the admissibility of the applications.  The repr esentative explained that Cyprus had made an 
application for the use of the "special reserve"  term, and that the Commission was reviewing the 
application in light of oppos itions received from the United States and several member States. 
(iv) India – Pneumatic tyres and tubes for autom otive vehicles (G/TBT/N/IND/20 and Add.1; 
G/TBT/N/IND/40 and Rev.1) 
126. The representative of Japan  reported that the Government of India had postponed the entry 
into force of this regulatory act for an additional 180 days, now scheduled for 14 November 2010.  
Yet the number of tyres to be certified had increased and additional factories needed to be accredited, in particular since the certification system had be en modified in mid-course.  Thus, he requested 
further postponement of at least one additional year  in order to give companies adequate time to 
prepare.  He explained that 360 days was insufficient time to complete factory accreditation and lab tests.  Regardless of India's claims that this regul ation had been first notifie d in 2006, his delegation 
emphasized that the scope of the regulation ha d in fact been determined in May 2010. 
127. The representative of Japan further noted that Ar ticle 3(1), reported in the Official Gazette in 
November 2009, stipulated that tyres without India Statistical Institute (ISI) certification marks were 
prohibited from being manufactured, imported, stored fo r sale, sold, or distributed in India.  Japan was 
concerned about the time lag between time of manuf acture and the time of sale or distribution, and 
requested that the time of manufacture serve as the poi nt of enforcement, following other international 
regulations for automotive tyres. 
128. While Paragraph 6.3 prohibited foreign manuf actures from exporting tyres bearing the ISI 
certification mark to destinations other than Indi a, the same requirement was not imposed on domestic 
manufacturers – which were able to use the same  mould to manufacture tyres for both domestic and 
export markets.  Foreign manufacturers, on the other hand, were required to use two separate moulds.  
This provision was unreasonable and amounted to an unnecessary restriction on trade since it 
competitively disadvantaged foreign manufactures; he  requested that this provision be deleted. G/TBT/M/52  
Page 30  
 
  129. The representative of Japan also expressed concer n about a series of fees associated with the 
BIS certification mark, pursuant to Paragraph 2 of the agreement for the use of the certification mark.  
This included: a minimum marking fee, renewal application fees; annual license fees; and marking fees. He categorized these fees as unprecedented and un acceptable by any international measure, since 
they were based on tyre unit production – they  needed to be be modified or eliminated. 
130. The representative of Korea
 reported that Korean tyre manufacturers that had applied for BIS 
certification had been faced with delays due to the new certification requirements and had found it 
extremely difficult to obtain the necessary certifi cation by 19 November 2010.  He cited factory 
inspection and sample testing requirements as par ticularly burdensome, and requested that India 
accelerate the process.  Given the delays, his delega tion believed that a longer transition period would 
be beneficial for both foreign manufacturers and Indi an authorities; he requested that the entry into 
force of the new requirements be delayed by an a dditional year. Furthermore, he noted that Korean 
tyre manufacturers were having difficulties crafti ng appropriate moulds and determining appropriate 
production and sales plans due to the lack of detail ed information regarding: sampling, ISI marking, 
and the terms of validity of BIS certification under the new requirements. 
131. The representative of the European Union  reiterated concerns discussed at several past TBT 
Committee meetings, in particular regarding the addi tional marking introduced by the new Order.  In 
the EU view, tyres produced according to United Nations Economic Commission for Europe (UNECE) regulations would in principle not have di fficulties to comply with the Indian requirement, 
but would need to be produced–with different moulds, which increases production costs and creates 
an unnecessary barrier to trade. The European Union regretted that India had decided to move forward 
with entry into force on 14 November 2010, and urge d India to resolve certain  issues in advance of 
this date, or postpone entry into force.  The repr esentative of the European Union notably urged India 
to apply the royalty fees to the tota l value of actual imports to India rather than to total production. 
132. Similar to the point raised by Japan, the Eur opean Union was concerned about the provisions 
of the BIS license agreement that prevented foreign ma nufactures from exporting tyres with the ISI 
Mark to destinations other than India, while ex empting Indian manufacturers from this requirement. 
This requirement appeared to be discriminator y and entailed an unnecessary barrier to trade since 
foreign producers had to produce tyres specifically fo r the Indian market.  She sought clarification as 
to whether the ISI Mark could be dyed or affixe d as a non-permanent label, as had been discussed 
bilaterally, or if it had to be embossed on the tyre .  Furthermore, she asked if the number of the 
standard and the plant specification designation had to  be embossed in addition to the ISI Mark.  The 
representative of the European Union also asked w hy detailed information concerning raw materials, 
manufacturing machinery, the name of the maker,  the number of installed machines, and test 
equipment had to be provided in the certification procedure. 
133. The European Union was also concerned about the lack of laboratories operated by Indian 
authorities, since there appeared to be only two laboratories in India able to conduct the required 
testing.  She invited India to accept tyres tested in  International Laboratory Accreditation Cooperation 
(ILAC) laboratories, or to reduce the varieties of tyres requiring testing in Indian laboratories.  She reported that one application had been rejected by BIS due to lack of in-house testing facilities – she 
asked India to clarify whether in-house testing facilities were a requirement. 
134. The representative of the European Union requ ested that manufactures be allowed additional 
time to comply with the requirements, given the narrowing of the certification procedure exemption 
notified by India in June 2010.  Moreover, producer s needed to be permitted a transition period of at 
least six months following the finalization of the list of tyres covered by the requirements of the Order 
by the local technical Committee. The European Union delegation w as, in addition, still awaiting a 
response to written comments submitted on 11 May 2010 regarding G/TBT/N/IND/40.  G/TBT/M/52  
 Page 31 
 
 
  135. The representative of India  noted that although he appreciated the concerns regarding further 
postponement of implementation, he reminded the Committee that this regulation had been first 
notified in July 2006 and that industry had been made  aware of plans to create a certification system.  
In November 2009, the revised certification schem e had been notified and the 360 day period before 
entry into force was more than reasonable, and beyond the time period mandated by the TBT 
Agreement.  Nonetheless, he assured Members that he would convey the request for postponement to 
relevant regulatory authorities.   
136. In response to points raised, the representative of India noted that the stipulation in the BIS 
agreement that ISI marking could only be used for expor ts to India did not restrict trade, nor did it bar 
exports to other markets.  On fees, in some cases foreign manufacturers could pay less in fees overall 
as compared to domestic producers – hence fees were equitable in terms of unit cost of tyres.  
Regarding the rejection of applications due to lack  of in-house testing facilities, the representative of 
India would confer with authorities and provi de a detailed reply at the next meeting. 
137. The representative of India reminded Members th at India was not a signatory to the 1958 
UNECE Agreement and therefore India was not required to follow UNECE regulations for the 
automotive sector. Nonetheless, BIS had considered UNECE and other standards, such as those of 
ISO, in designing a standard specific to India's ge ographic context and road conditions.  For example, 
the BIS standard included the tyre strength test, the endurance test, and the bead unseating resistance 
test, but had adapted these tests and the standard  to differences in the climatic conditions, 
geographical terrain a nd road conditions.  
(v) European Union – Regulation on Classificati on, Labelling and Packaging of Substances and 
Mixtures (ATPs and CLP) (G/TBT/N/EEC/ 151 and Adds.1-2; G/TBT/N/EEC/212 and Adds.1-
3; G/TBT/N/EEC/163 and Adds.1-2, Add.1/Corr.1) 
138. The representative of Japan  expressed concern about the upcoming notification deadlines 
under the Regulation on Classification, Labelling a nd Packaging of Substances and Mixtures (CLP) 
for hazardous substances (in pure and mixed forms) .  Products on the market prior to 1 December 
2010 were required to be notifie d by 3 January 2010, while products on the market on or after 
1 December 2010 were required to be notified within  one month. He noted obstacles to importers 
gathering information on the constituent component s of mixed substances, due to lengthy supply 
chains, and stated that importers might not be able  to meet the deadline as a result. The delegation of 
Japan requested an extension to the CLP notificatio n deadline for mixed substances, similar to that 
under REACH. 
139. The representative of the United States  reiterated concerns regarding the initial classification 
of certain borate and nickel compounds under the Da ngerous Substances Dire ctive (DSD), and their 
translation to the CLP.  He noted that the most  recent EU commissioned risk assessment had found 
that borates usage in the cases exam ined posed no or negligible risk to the general public.  On the 
basis of this finding, the European Union had propos ed that there should be no restrictions on market 
access and use of borates-containing substances in household cleaners, detergents, and certain 
photographic mixtures.  However, the European Union had not adopted this exemption due to 
disagreements between member States, and had inst ead referred the issue back to the ECHA's Risk 
Assessment Committee, which once again had fou nd that "normal use" of photographic compounds 
was indeed safe.  He requested an update on the status of this exemption. 
140. The United States emphasized that available sci entific and technical information should be 
considered with respect to the decision to pl ace borate compounds on the Substances of Very High 
Concern list.  He reiterated his delegation's concer ns about the 'knock on' effects of the initial borates 
classification under other EU measures, which appeared to have been confirmed by this decision.  It 
was worrying that the Danish compet ent authority appeared not to have completed all of the necessary G/TBT/M/52  
Page 32  
 
  steps of the OECD read-across methodology.  Namely steps 5 through 8 of the methodology had been 
excluded, which raised concerns that not all ava ilable scientific and technical information had been 
taken into account, including with regard to intended end-uses. His delegation had been unable to 
detect any legislative reasons that would prevent the European Union from fully following the read-
across methodology; hence the United States urged the European Union to revisit its analysis so as to 
include the steps omitted in the initial analysis.  The United States would continue to monitor 
potential adverse trade impacts of the nickel and borates classifications, and the on-going litigation on 
these classifications, as well as the potential methodologi cal issues related to this measure and other 
EU measures. 
141. The representative of Canada
 expressed concern about the precedent that the process had set 
for future classification exercises, as well as the downstream effects and possible unintended 
consequences of classification.  For example, he not ed that while the EU Raw Materials initiative had 
identified six platinum group metals  and cobalt as being critical to the EU's economic well-being, the 
EU classification of nickel and nickel substances under CLP could adversely a ffect the provision of 
these critical metals since they arose princi pally as by-products of nickel mining.   
142. The representative of Brazil  shared the concerns of ot her delegations regarding the 
classification of nickel compounds under the 1st Adaptation to Technical Progress (ATP) to the CLP 
Regulation.  This classification was based upo n inadequate use of the OECD read-across 
methodology, and thus potentially more trade re strictive than necessary to achieve health and 
environmental objectives.  Several steps of the me thodology relating to scientific validation tests had 
been omitted by the European Union, and, although this omission had been justified by the European 
Union on the basis of legal obstacles, his delegati on believed that this was not reasonable grounds for 
classification. 
143. In addition, Brazil was concern that water solub ility appeared to be the only criteria taken into 
account by the European Union to classify nickel compounds in the context of the 1st ATP, and that 
consideration of other criteria including biological effects could lead to a more scientifically sound 
classification.  Industry was concerned about wrong assumptions made in the water solubility testing 
of nickel compounds, given that this testing was based on a report that was neither published nor peer 
reviewed.  He asked the European Union to pr ovide a list of nickel compounds for which water 
solubility data was available for the 1st ATP and asked whether the Eu ropean Union had considered 
criteria other than water solubility. 
144. In addition, it was noted that the trade and regulatory impacts of the measure would not be 
limited to labelling, since the EU rules on pr evention of major accidents involving dangerous 
substances would also apply following the chronic toxicant classification under the 1st ATP.  This 
additional regulation implied higher costs related to  transport and storage of nickel compounds, as 
well as costs related to emergency plans and proce dures adopted by companies.  He noted that the 
proposed amendment to the CLP regulation envisag ed a specific label for mixtures containing a 
sensitizer, even when the mixture wa s not a sensitizer.  His delegation considered this requirement to 
be unjustifiable and in need of revision.  In addition, he asked whether the highest sensitization categories would be used as criteria for the determ ination of Substances of Very High Concern under 
REACH. 
145. The representative of the Dominican Republic
 reiterated his delegati on's serious concerns 
regarding the EU decision to adopt the draft of the 30th and 31st modification of Directive 67/548/CEE 
on the reclassification of nickel carbonates and othe r nickel compounds, and the inclusion of those 
substances in the new CLP regulation.  He noted that the 1st ATP had been in force since 26 
September 2009; his delegation maintained that insu fficient scientific evidence had been taken into 
account.  He expressed regret that the European Un ion had not considered comments on this matter, 
including written comments.  In particular, like ot her delegations, the Dominican Republic objected to  G/TBT/M/52  
 Page 33 
 
 
  the way in which the European Union had app lied the OECD read-acr oss methodology; this 
constituted, in the view of the Dominican Republic, a violation of Article 2.2 of the TBT Agreement.   
146. For the Dominican Republic, the labelling require ments for nickel compounds or substances 
would impose very prejudicial effects on producers and exporters of nickel substances.  In particular, 
he cited an increase in the cost of production, tr ansport and insurance for ferrous nickel, which would 
compound the detrimental impacts of the economic cr isis, especially harming developing and small 
vulnerable countries which produced these substances.   He appealed to the European Union to 
reconsider their position on these regulations, and ensu re that they complied with the provisions of the 
TBT Agreement. 
147. The representative of Turkey  noted that this was the 10th TBT Committee meeting at which 
this issue had been on the agenda, and because his delegation's comments had been reflected in the 
minutes of these previous meetings – these points remained valid as there had been no improvement 
to date. 
148. Turkey was particularly concerned that the cl assification of borates did not have a sound legal 
and scientific basis, and that subsequent downstrea m impacts of this classification posed significant 
barriers to trade.  Turkey had in fact notifie d the European Union of recent published scientific 
research undertaken in China, prov iding a different perspective on the issue, to which his delegation 
had yet to receive a response.  In addition, anothe r study, conducted in Turkey, would be shared with 
the European Union following publication.  He hoped th at this scientific research would be seriously 
considered and that a mutually sa tisfactory solution would be reached. 
149. The representative of Cuba  reiterated concerns about the cla ssification of nickel substances 
under CLP, since it was based on inadequate cons ideration of evidence and scientific data, and 
incomplete application of the OECD read-across methodology.  The European Union had arbitrarily 
decided that it was not obliged to notify the 1st ATP of the regulation to the Committee since it related 
to classifications adopted in the 31st ATP of the Directive 67/548, even though the former concerned 
distinctive issues, within a different framework. De spite EU assurances that this regulation affected 
only labelling, and not trade in nickel products, C uba was of the view that the inclusion of these 
classifications within REACH would impose one rous additional registration burdens on these 
products and could lead to the prohibition of these products on European markets. Furthermore, these 
classification decisions could lead to stigmatization of nickel products thereby hindering trade.  The 
delegation of Cuba appealed to the EU to re-evaluate its nickel product classifications. 
150. The representative of Colombia  said that a number of outstanding concerns remained, in 
particular with regard to the accelerated approval process of the regulation, which called into question 
the transparency with which Member's comments we re addressed.  Furthermore, she questioned the 
scientific basis of the regulation, as well the in complete application of the OECD read-across 
methodology, which had led to the reversal of the burden of proof; substances were classified on the 
basis of their water solubility until such a time as proof to the contrary was provided.  Evidence 
supporting the reclassification of nickel compounds , and the associated risk  assessment, suggested 
that this regulation did not conform with good pr actice as established by Members.  In practice, the 
scope of the measure extended we ll beyond labelling, and could in fact lead to the prohibition of 
nickel substances, since they we re classified as Category 1 carcinogens.  Colombia wished to have 
further information regarding progress on th e modification of Annex 17 of REACH, 
G/TBT/N/EEC/297, since this seemed to be a cl ear example of the prohibitive effect of the 
classification of nickel compounds. 
151. The representative of Australia  reiterated concerns about the EU decision to reclassify nickel 
compounds, in particular in terms of the scientific va lidity of the exercise.  She noted that concerns 
raised by her delegation at a number of prev ious TBT Committee meetings remained unaddressed.  G/TBT/M/52  
Page 34  
 
  Her delegation had welcomed assurances that the decision to reclassify nickel substances would result 
only in additional labelling requirements, yet she believed that the measure extended beyond such 
requirements, to the point that there was likely to be a significant impact on trade in nickel 
compounds. 
152. The representatives of China
, Ecuador , the Philippines , Thailand  and Venezuela  shared the 
concerns raised by other Members. 
153. The representative of the European Union  noted the concerns raised by Members about the 
classification of borates and several nickel compounds in the 30th and 31st APT. She regretted that concerns remained, despite the expl anations provided at previous meetings. Indeed, she cited lengthy 
replies on all issues, both written and oral, provided over a number of TBT Committee meetings, 
including a 20 page reply circulated to address a ll Member comments.  Furthermore, two experts had 
provided over two hours' worth of extensive and detailed replies to questions raised by WTO 
delegates.  For this reason, her delegation faile d to see what additional information could now be 
provided in reply to these same issues.   
154. The representative of the European Union strongl y urged delegations to review previous TBT 
Committee meeting minutes which summarize th ese exchanges.  Any new information that 
challenged the Commission's conclusion on classifica tion and labelling of nickel compounds could be 
submitted by industry to a member State, which c ould then be submitted in a dossier to ECHA for 
review of the classification and labelling decision as listed in the 1st ATP of the CLP Regulation.  
With respect to industry comments that the cl assification had been based on wrong assumptions, 
raised by Brazil, she requested that further detaile d information be provided.  In response to the US 
question about the impact assessment for borates, and the question posed by Colombia on Annex 17 
of REACH, these issues had been addressed earli er in the meeting under the REACH discussion. 
155. It was suggested that the issue of the revi sion of CLP regulation, noted by Brazil, be 
addressed bilaterally – as it was not clear which revi sion had been referred to.  Regarding the study 
conducted in China (mentioned by Turkey), the re presentative of the European Union would confer 
with European experts and convey any information to Turkey bilaterally.   
(vi) Canada – Compositional requirements for cheese (G/TBT/N/CAN/203 and Add.1) 
156. The representative of New Zealand
 remained concerned with Canada's compositional cheese 
standards that limited the protein sourced from dairy ingredients, even though such ingredients were 
widely used and accepted in cheese production worl dwide.  Canada's standards appeared to be 
inconsistent with the relevant  international standards as the Codex standards did not prescribe 
limitations on the sourcing of milk proteins.  Th erefore, New Zealand questioned the compliance of 
Canada's regulation with the TBT Agreement. She as ked for an update on deve lopments regarding the 
appeal process following the initial court ruling on the cheese standards and also asked whether the 
standards were being enforced pending the outcome of the appeal.  She also requested information 
about whether Canada's dairy producers were activ ely lobbying the government to introduce similar 
standards for other dairy products such as yoghurt, and what had been the g overnment's response to 
such proposals. 
157. The representatives of Australia  and the European Union  supported New Zealand's concerns 
and asked for an update. 
158. The representative of Canada  confirmed that its federal cour t decision had been appealed.  
However, no date for a ruling had been scheduled yet, so his delegation was unable to provide an 
update to the Committee.  The Government of Canada was not currently working on regulatory 
processes for any other dairy products and, to date , all imported cheeses had been deemed to be in  G/TBT/M/52  
 Page 35 
 
 
  compliance with the revised standards by the regulat ory agency responsible.  Therefore, no shipments 
had to be returned due to non-compliance a nd no complaints had been received to date.  
(vii) India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33)   
159. The representative of the European Union  reiterated concerns regarding the Indian notified 
order laying down a registration procedure for imported cosmetics products.  She noted that 
subsequently India had published a new order in its official Gazette on 19 May 2010 and new 
requirements would enter into force on 1 April 2011.  The European Union asked India to notify the 
new order to the TBT Committee to allow WTO Me mbers to provide comments.  When the initial 
order for cosmetics was notified to the WTO in  2008, the European Union provided extensive 
comments and had suggested India implement a notification system rather than a registration system, 
as registration did not provide improvement in consumer safety.  
160. The representative of the European Union obser ved that the notification system used in 
Europe since 1976 was one used in most internationa l markets.  The system had proved sufficient to 
provide European Union national authorities with necessary information while at the same time 
allowing manufacturers to launch products withou t unnecessary or costly delays.  The European 
Union invited India to replace its registration system  for cosmetic products with a notification system. 
161. If, nevertheless, registration requirements c ontinued to be imposed, the European Union 
urged Indian authorities to postpone implementation until January 2012 and to take steps to ensure 
that economic operators, in particular foreign ma nufacturers, were not faced with overly burdensome 
requirements.  The representative proposed, for instance, that the registration certificate and import license validity period be raised from three to five years, similar to local manufacturing licenses;  that 
the registration certificate should be provided with in a maximum period of two months and be given 
for a product line and not for single products within th e same line;  that tests conducted in the country 
of origin attesting compliance with international cosmetic standards should be accepted;  and that 
labelling and packaging should be allowed to be ca rried out in India by importers or local agents. 
162. The representative of India
 reminded the Committee that the draft rules pertaining to the 
registration of cosmetics had been circulated to  the TBT Committee for comments in February 2007 
and a system of registration of imports of drugs had already been in practice since 2003.  The amendment to the drugs and cosmetic rules for in troducing a system of registration of imports of 
cosmetics into the country had been published on 19 May 2010 with a subsequent amendment dated 
19 July 2010.  The rules would come into effect  on 1 April 2011 and thus met the TBT Agreement 
stipulation of providing a reasonable interval between publication and entry into force.  The 
representative explained that the measure was based pur ely on public health con cerns of consumers.  
The provisions of the amendment did not discrim inate between exporters to India and similar 
provisions were already in existence for domestic manufacturers.  Concerns of the European Union 
and other WTO Members had been taken into consid eration before finalisi ng the amendment, which 
led to the deletion of an objected clause relating to  inspections and visits to manufacturer premises by 
the licensing authority of India.  India therefore felt concerns already had been taken onboard.  
Nevertheless, new suggestions w ould be forwarded to India's regulators for consideration. 
(viii) China – Proposed Regulations on Informa tion Security (G/TBT/N/CHN/278-290)   
163. The representative of the European Union
 raised concerns about the revision of the 1999 
regulation on commercial encryption by the Office of State Commercial Cryptography Administration 
(OSCCA) and implementation of the Multi-Layer Prot ection Scheme (MLPS) under the leadership of 
the Ministry of Public Security.  Regarding the OSCCA regulation, the representative asked China for 
an update and expected timeline on the revision pr ocess carried out by the State Council Legislative 
Affairs Office as well as confirmation that a public consultation would be held  and the draft measure G/TBT/M/52  
Page 36  
 
  would be notified to the TBT Committee at the earli est appropriate stage, when amendments could 
still be introduced so that comments could be take n into account in accordance with Article 2.9.2 of 
the TBT Agreement.  
164. Regarding the MLPS, the representative of the European Union noted that the measure had 
been developed in the absence of a process allowing stakeholders to provide input.  Furthermore, no 
clear implementation guidelines were given, thus creating an uncertain and unpredictable environment 
for foreign manufacturers of ICT equipment operati ng in the Chinese market.  He recalled that the 
MLPS mandated classification of IT systems into five  different levels depending on the importance of 
the information handled in relation to national secu rity.  If a system was classified as "critical 
infrastructure" (level 3 or above), only products incorporating indigenous core technology and key 
components and having obtained certificati on under the OSCCA regulation and under the 
Compulsory Certification for Information Security  (CC-IS) scheme as applied to information security 
products would be allowed to be used in such a system.  Thus, these product requirements effectively 
barred foreign products from entering the Chinese mark et, firstly by mandating the use of indigenous 
technology, and secondly because the OSCCA proce dures were not open to foreign or foreign 
invested companies.  Therefore, even if a foreign company were to incorporate Chinese technologies 
into its product, it would still not be allowed to obt ain the required OSCCA certification.  Also, while 
the OSCCA regulation currently applied only to pro ducts with encryption as a core function, it was 
not clear whether, for the purposes of the MLPS, pro ducts with encryption but without such facility as 
a core function would be require d to be approved by the OSCCA.  Additionally, the representative 
noted that product requirements for critical infrast ructure would mandate a backdoor application of 
the CC-IS in the sense that the current CC-IS w as limited to government procurement but the MLPS 
extended into the commercial area.  
165. The representative of Japan
 supported the concerns of the European Union.  The 
representative said China's regulations were not in conformity with global norms and approaches and 
thus could negatively affect the trade of info rmation security products.  Japan hoped China would 
exercise prudence in introducing additional meas ures and would engage in a dialogue with 
stakeholders should such be deemed necessary. 
166. The representative said the European Un ion was increasingly worried about MLPS 
implementation in sectors such as banking, energy transportation, and education where large state-
owned enterprises with no obvious relevance to na tional security were active.  This concern was 
especially relevant given that the latest calls fo r tenders only solicited offe rs from vendors who could 
demonstrate compliance with the product requirement s set by the MLPS for critical infrastructure.  
Thus, de facto implementation of the MLPS prevented foreign and foreign-invested ICT 
manufacturers from accessing significant sectors of the Chinese economy.  The European Union 
proposed to explore whether alternative but equally effective approaches could assist in achieving the 
legitimate goals of national security protection th at the Chinese authorities were pursuing.  They 
requested an update on the implementation timeline of the MLPS. 
167. The representative of the United States  noted that an expansion of the scope of China’s core 
function test to more information technology products  could create trade disr uptions similar to those 
that had occurred in 1999, when China introduced the first version of its encryption regulations.  The 
United States reiterated its request that China notif y any draft revisions of these measures to the WTO 
so interested parties may comment. 
168. The representative of China  said that, as could be seen from the title of this specific trade 
concern, China's proposed regulations on in formation security involving 13 Chinese TBT 
notifications were limited to gove rnment procurement.  Therefore it was not appropriate to continue 
discussion in the TBT Committee on the issue.  G/TBT/M/52  
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  169. The representative of the European Union  said his delegation would re-formulate the title of 
the specific trade concern to ensure it explicitly refl ected the scope of the European Union's concerns. 
170. The representative of China  said regardless of the title of the specific trade concern, her 
delegation remained to be convinced that the OS CCA and MLPS issues fe ll under the governance of 
the TBT Agreement.  
(ix) India – Mandatory Certification for Steel  Products (G/TBT/N/IND/32 and Add.1) 
171. The representative of the European Union  enquired whether India's envisaged deletion of 
certain steel items in its list of products needi ng to be certified was intended to be permanent or 
whether the deletion was limited to a period of 6 mont hs.  The European Union sought justification as 
to why galvanized steel was not deleted from the list. 
172. The representative of Japan  supported the comments of the Eur opean Union.  In Japan's view, 
finished products, not intermediate materials, were  entirely responsible for ensuring human health and 
safety.  Consequently, safety regulations should be restricted to finished products;  there was no need to impose mandatory standards on intermediate mate rials such as steel products.  Japan understood 
that the Government of India had taken into acc ount this position and India would not establish any 
further mandatory standards for intermediate pr oducts.  The representative sought an update on the 
development of India's draft measure since the last TBT Committee meeting. 
173. The representative of India
 said its regulating authority, BIS , considered intermediate 
products such as ingots and billets to be critical fo r the safety of final buildings, which was why it was 
important to have standards to ensure these produc ts conformed to specific composition and property 
design requirements relating to the safety of the final building per se.  The representative noted that 
following a review carried out by the BIS, some it ems had been deleted from the list.  However, the 
standard IS 277 for Galvanized Steel Sheets had been  retained keeping in view the objective of safety 
specifically of consumers in rural areas who did no t have access to very high quality housing.  Also, 
concerning items deleted from the list, India had not  entirely dropped the development of standards 
for such items.  Instead, the standards for delete d items were under review, while products remaining 
on the list had been prioritized and notified in term s of in terms of mandatory certification.  In 
general, Indian standards for steel were reviewed every five years and at each review a comparison was drawn to international standards.  Wherever ap propriate, elements of international standards were 
adopted, in line with specific needs and requirements of India.  
(x) European Union – Seal products (G/TBT/N/ EEC/249 and Adds.1-2;G/TBT/N/EEC/325)  
174. The representative of Norway
 noted that both the European Union regulation on trade in seal 
products 1007/2009/EC (notified as G/TBT/N/EEC /249), and the related implementing regulation 
737/2010/EU (notified as G/TBT/N/EEC/325), had entere d into force since the last meeting.  The 
implementing regulation raised new questions particul arly with regard to the conformity assessment 
of the attestation bodies required for the documenta tion of seal products conforming to the exceptions 
of the seal regulation.  Norway had asked for s upplementary consultations with the EU under the 
Dispute Settlement Understanding.  It was No rway's view that the seal regulation and its 
implementing regulation were inconsistent with both the TBT Agreement and GATT 1994. 
175. The representative of Canada  supported Norway's concerns. 
176. The representative of the European Union  referred to ongoing WTO consultations on the 
basic regulation.  The representative said the adopted  regulation did not fall within the scope of the 
TBT Agreement and it was not appropriate to discu ss the matter further in the TBT Committee.   G/TBT/M/52  
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  (xi) Colombia – Draft Decree Establishing Provisions to Promote the Use of Biofuels 
(G/TBT/N/COL/96 and Adds.1-3)   
177. The representative of the European Union
 welcomed Columbia's intention to make 
requirements relating to the ability of vehicles to run on biofuel more flexible and observed that 
Colombia currently was undertaking studies on this .  The European Union also welcomed the 
launching of a public consultation on a new draft measu re providing for a lower percentage of ethanol 
in the fuel mixture and implementation in a gra dual manner.  The representative sought an update on 
the consultation procedure and indication of when  a new draft text would be notified to WTO 
Members. 
178. The representative of Colombia  said that on 29 July 2010, the Ministry of Mines and Energy 
had published proposed changes to its decree 1135 of 2009, inviting comments from the general 
public.  Proposed modifications included remova l of a minimum market share of flex-fuel-
automobiles and establishment of prescribed mixtur es between regular gasoline and bio-ethanol.  It 
was further proposed to allow the Ministry for Mine s and Energy to adjust proportions of prescribed 
mixtures with a view to improving the performance of vehicles that would use the new fuels.  
Comments received continued to be analyzed.  Once the process had progressed further, a document 
would be made available to the WTO and a tim eframe set for comments on the amended measure. 
(xii) France – Unique Requirements for Ride-on Lawn Mowers  
179. The representative of the United States  reiterated concerns on the French Ministry of 
Agriculture's "skirt" requirement to cover transm ission moving parts for ride-on lawnmowers.  This 
had disrupted U.S. lawnmower exports to France.  The representative noted that in the preceding 
week, the CEN TC144 WG7 Working Group had discussed the Ministry of Agriculture's proposal.  
After hearing arguments for and against the propo sal, the CEN consultant who is advising TC144 on 
the revision of EN 836 as it relates to the Mach inery Directive mandatory requirements compliance 
review process had concluded that the total enclosure of all transmission moving parts was unnecessary.  This was a direct rejection of the Mini stry of Agriculture's position on total coverage.  
The consultant had further confirmed that the risk of fire from total enclosure was significant, as had 
been noted previously by both European and U.S. producers.  The consultant had suggested shifting 
attention in the revision process to pinch points onl y, instead of concentrating on all transmission 
moving parts.  The United States believed this  was a compromise position industry could accept. 
180. The representative of the United States obser ved that WG7 accordingly would advise  CEN 
TC144 to request the Ministry of Agriculture to with draw its appeal against the original proposal and 
ask WG7 to address the issues of hazards to bystanders during the revision process of EN 836 and 
ISO 5395.  The scope of the bystander access issue,  however, as it related to the revision process 
would be limited to pinch points onl y under the WG7 recommendation.    
181. Despite the outcome of the working group, the Fr ench Ministry of Agriculture had not altered 
its position regarding total coverage and as a result all companies were now being forced to comply or 
face recalls, despite TC144's repeated rejections of the French proposal.  The United States was of the 
view that the issue of bystander access to transmi ssion moving parts of ride-on lawnmowers needed to 
be addressed as part of the CEN/ISO revision process.  Therefore France should refrain from unilaterally enforcing its total coverage position.  Instead, the European Commission should direct 
France to allow the standards revision process to pr oceed.  The representative said the United States 
was especially concerned that France may again seek  to delay the revision process by filing another 
appeal on the latest WG7 recommendation.  United States companies were interested in reaching a 
compromise solution; the United States urged the Ministry of Agriculture to stop blocking the 
standards revision process through c ontinued appeals within the CEN.  G/TBT/M/52  
 Page 39 
 
 
  182. The representative noted that even though the Technical Committees of the European 
Commission issued de facto mandatory requirements for the European Union, these were not notified 
to the WTO for comments.  Non-European Union member States could not vote in these committees 
and observers were small in number and at the di scretion of the respective chairs.  Additionally, 
France had neither published nor notified its skirt measure that deviates from the CEN standard and 
which it has continued to enforce. 
183. The representative of the European Union  thanked the United States for the update, but 
indicated that it could not comment on the substance of the United States' intervention related to the 
standardization process, as the European Commissi on was not directly involved. While sharing the 
objective to achieve the best technical solution fo r all stakeholders, the European Commission's role 
was limited to assessing the adequacy of the harm onised standard against the relevant essential 
requirements of EU legislation (in this case, th e Machinery Directive) when the standards would 
transmitted to it with a request for publication of its references in the Official Journal of the European 
Union. The meeting of the Working Group set up u nder the Machinery Direc tive in December 2010 
would be a good opportunity to take stock of the s ituation and ask CEN for an update. Finally, the EU 
recalled that US manufacturers were providing exte nsive input in the standardization process through 
their European subsidiaries, and also to the para llel ISO standard being developed under CEN lead in 
accordance with the ISO-CEN Vienna Agreement.  
(xiii) Korea – Regulation for Food Industry Prom otion Act (G/TBT/N/KOR/204 and Suppl.1)  
184. The representative of the European Union  thanked Korea for further postponing the entry into 
force of new requirements for organic products until 31 December 2012.  The European Union hoped 
the upcoming revision of the Korean legislation w ould introduce an equivalence mechanism in its 
regulatory framework as foreseen in the Codex guidelines on organic products. 
185.  The representatives of New Zealand , Canada , Australia , Chile , Switzerland , United States , 
and Mexico  supported the European Union and requested introduction of a mechanism to provide the 
requisite legal authority to negotia te equivalence arrangements into Korea's legislation in view of 
avoiding unnecessary barriers to trade.  The representatives of Canada  and Switzerland  suggested 
Korea re-notify its draft measure upon completion of the revision process. 
186. The representative of Korea  informed that the MIFAFF had decided to unify two previously 
separate certification systems for pr ocessed organic food and raw organic food ingredients under the 
Environmentally Friendly Agriculture and Forestry  Act.  In the combined system, accreditation 
procedures for primary products and processed produc ts would be identical, which would help in 
preparing provisions for equivalence agreements.  The proposed regulations were expected to be 
adopted by the National Assembly in the first half of 2011, after having received comments from 
stakeholders and worked through the necessary ad ministrative procedures within government.  
MIFAFF intended to notify the amendment to the WTO as well. 
187. The representative of Korea sai d current labelling requirements under the Food Sanitary Act 
would stay in place until 31 December 2012.  With regard to the accreditation procedure, it had 
previously been required that no fewer than two in spectors conduct on-site assessments.  However, as 
of 17 June 2010, the amended Designation and Opera tion of Food Quality Certification Authorities 
for Organic Processed Food did not specify a numbe r of inspectors for on-site assessments.  The 
representative noted that starting from 1 January 20 13, organic producers and operators who wanted 
to export organic food to Korea should be certified by certification bodies based in Korea or bodies 
outside Korea accredited to Korean standards.  Otherwise, equivale nce agreements should be reached 
between Korea and the country concerned.  Give n the considerable amount of time required for 
equivalence agreements to be concluded, Korea encouraged certification bodies to obtain recognition 
as a qualified certification body in accordance with Korean regulations. G/TBT/M/52  
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  (xiv) Brazil – Health products registration (G/TBT/N/BRA/328) 
188. The representative of the United States
 reiterated concerns on Resolution 25 requiring Good 
Manufacturing Practice (GMP) inspections of me dical devices before re-registration and new 
registration of medical devices.  Concerning re-re gistration of medical devices, the representative 
welcomed reports from United States industry that ANVISA was demonstrating flexibility to enable 
products to remain on the market pending inspectio n.  However, United States industry was also 
reporting lengthy delays for registration of new me dical devices and was conc erned it could take two 
years to clear the current backlog.  The delays fo r United States medical devices exports to Brazil had 
resulted in patients being denied access to innova tive medical technologies.  The United States was 
disappointed by this development given assurances from Brazil at the last TBT Committee meeting of 
not intending to disrupt the entry of medical devi ces into Brazil due to their essential nature.  The 
United States requested Brazil to provide sufficien t resources for both its inspection and registration 
programs in order that new applications could be pr ocessed as efficiently as po ssible so as to ensure 
trade in these new medical device products coul d resume.  The United States would continue to 
monitor the situation closely.     
189. The representative of the European Union  noted that at the previous TBT Committee meeting 
Brazil had provided assurances that there would be no  disruption of imports of medical devices into 
Brazil.  However, according to the Technical Note 1/2010 of ANVISA of 5 October 2010, any 
company wishing to register a new medical device would have to present a GMP certificate as part of the application process for registration.  If the GMP certification had been requested after the deadline 
of 21 May 2010, a receipt of the request for a GMP inspection would not be accepted.  The European 
Union's understanding was that in the case of applica tions for renewals of registration and in the 
absence of a new GMP certificate, companies would be  able to submit the receipt of the request for a 
GMP inspection in order to advance the applica tion process.  If this understanding was correct, the 
European Union expressed concerns that this might potentially lead to restrictions of new medical 
devices not previously registered into the Brazilian market, with a possible negative effect not only on 
trade, but also on access of Brazilian consumers to the best and most advanced medical care.   
190. The representative of Switzerland
 said Switzerland supported the intention behind ANVISA 
resolution number 25/09 which aimed at guaranteeing the quality of medical devices sold in Brazil in 
order to protect human health.  However, Swit zerland remained concerned about the change in 
Brazil's regulation regarding market access for me dical devices classified in Brazil under risk 
categories 3 and 4.  He reiterated particular concern that Brazil no longer recognized quality 
inspection results based on the International Sta ndard ISO 13485 for medical devices.  At the last 
TBT Committee meeting, Brazil had informed Members that inspections necessary for granting certificates of good manufacturing practices had been carried out in a timely and orderly manner by ANVISA.  In addition, Brazil had stressed that the sanitary authorities of Brazil had not received any 
complaints related to the importation or commerciali zation of medical devices.  In this regard, the 
representative informed Brazil that the Swiss medi cal device industry continued sharing with the 
Swiss Government difficulties related to the Br azilian inspection regime, which Switzerland would 
like to discuss with Brazil on a bilateral basis.  
191. The representative of Brazil
 said that since Resolution RDC 25 of ANVISA had entered into 
force in May 2010, there had not been any reports of  trade disruptions related to the implementation 
of the measure.  Imports of health products into  Brazil had not been affected and companies had 
managed to comply with requirements of the resolution.  The representative added that ANVISA had 
been able to respond to all requests of inspection in a timely and orderly manner.  
192. Regarding the United States' comment of an alle ged backlog of two years for inspections to 
be concluded on new registrations, the representa tive of Brazil said Brazil would talk to the 
United States bilaterally in order to find out what  data the United States had used, given that the  G/TBT/M/52  
 Page 41 
 
 
  regulation was in force for only around six months .  The representative shared with Members some 
statistics regarding the pace of inspections that  had been conducted by ANVISA.  He said ANVISA 
had performed 171 inspections so fa r and 50 more inspections were to  be concluded by the end of 
2010.  Moreover, 397 inspections were expected to be performed in 2011, of which 40 were already 
scheduled. 
193. Regarding Switzerland's comment on non-acceptance of ISO 13485 certifications, the 
representative said Brazil had already provided extens ive explanations on this issue and he invited 
Switzerland to consult the minutes of the last TB T Committee meeting.  He emphasized that it was 
essential that companies revalidate their existing registration and request the necessary inspection 
from ANVISA well in advance.  This request should be submitted six months before the expiration of 
the existing registration.  The representative recalle d that Resolution 66 of 2007 of ANVISA ensured 
that if a company requested a GMP inspection at le ast 120 days before the expiration of its existing 
certificate, the latter could remain valid if no pr oblem had occurred with the current certification. 
(xv) European Union – Accreditation and market su rveillance relating to the marketing of 
products (G/TBT/N/EEC/152) 
194. The representative of the United States  reiterated concerns regarding the European Union's 
new accreditation framework set out in Regulatio n 765/2008.  Recalling concerns raised in the 
previous TBT Committee meeting, the representa tive said the United States was particularly 
concerned at the potential impact on recogniti on of non-EU accreditation bodies under the ILAC 
MRA and the IAF MLA and acceptance of conform ity assessments performed by bodies that were 
accredited under those two agreements.  
195. The representative of the United States recalle d that at a previous TBT Committee meeting, 
the European Commission had indicated a lack of scientific and technical basis for the Regulation 765 requirements which was confirmed by the fact that the Regulation did not prevent competition 
between member State accreditors in other markets.   Given this acknowledged lack of scientific and 
technical basis, the United States continued to ha ve concerns with the European Union's stated 
intention to promote EU accreditation policy, including in the recent Framework Partnership 
Agreement with EA (European Co-operation for Accreditation), and wondere d how that would be 
consistent with the IAF/ILAC requirements. 
196. The United States requested clarification as to how implementation of Regulation 765/2008 
would be consistent with two requirements under IL AC/IAF:  first, that a Regional Group needed to 
make its services concerning its Arrangements acces sible to all accreditation bodies whose activities 
fell within its declared field of operation and ge ographic area;  and second, that the Regional Group 
needed to confine its requirements, evaluations and decisions on accreditors wishing to join its 
Arrangement to those set out in ISO/IEC 17011, ot her normative documents relevant to the function 
performed and supplementary requirements and gui dance where appropriate.  The representative said 
the United States was aware of ongoing discussions between EA and ILAC concerning these issues.  
He requested the European Union provide backgr ound on the Framework Partnership Agreement and 
whether it had considered issuing further written clarification regarding how EA would cooperate 
with non-EU accreditation bodies through ILAC and IA F, as the European Union had noted it would 
do at the last TBT Committee meeting.   
197. The representative of Australia
 said Australia was also concerned that Regulation 765/2008 
could potentially impede the recognition of c onformity assessment results from bodies accredited by 
non-EU accreditation bodies that were members of IL AC and IAF.  Australia provided detail at the 
last TBT Committee meeting which could be seen in the Committee minutes.   
198. The representative of Thailand  shared the concerns raised by the United States and Australia.   G/TBT/M/52  
Page 42  
 
  199. The representative of the European Union
 referred to previous explanations by the European 
Union on the fact that the new accreditation fra mework did not change the way both accreditation 
certificates issued by non-EU accreditation bodies a nd conformity assessment results from conformity 
assessment bodies in a non-EU country would be accepted in the European Union. Concerning the 
issue of non-competition between the national a ccreditation bodies in the European Union, the 
representative said the European Union never stated that there had been a lack of scientific and 
technical basis.  The European Union had stated that it was a pol icy choice which was based on the 
conviction that an activity which was performed as a public interest activity should be performed in 
an environment which was immune from commercial pressures and commercial interests. 
200. On the relationship between EA and ILAC, the representative of the European Union recalled 
that the EA had replied in early 2010 to a very elaborate set of questions raised by ILAC Members 
with respect to the EA framework.  In the reply, the EA had explained to all ILAC Members how the 
EA framework met all ILAC requirements.  It w as the understanding of the European Union that all 
issues had been addressed in a satisfactory way a nd it was not necessary to duplicate in the TBT 
Committee a discussion which had already taken place at ILAC and IAF level. 
201. On the Framework Partnership Agreement,  the representative said the agreement was 
necessary to formalize the role of the EA as the body responsible for overseeing the European 
Accreditation Framework and providi ng the required support infrastructure and also for enabling the 
necessary financing operations for the European Uni on.  In light of discussions in TBT Committee, 
the European Union agreed that communication of policies could always be improved.  The European 
Union was convinced that the EA, rather than the Co mmission, was best placed to explain to its peer 
accreditors in other countries the meaning and facts of its external policy.   
202. The representative of the United States  recalled that in reply to the question posed by the US 
at the March 2010 TBT Committee meeting, on whethe r there was a scientific and technical basis 
behind the requirements, the representative of the Eu ropean Union stated that there was none and that 
it had been a political decision. 
(xvi) Canada – Bill C-32 amendment to Tobacco Act  
203. The representative of Mexico  said her delegation shared Canada's commitment to protect 
human health and recognized the impact of smoking in this regard.  Mexico was making efforts to 
discourage smoking among its population. The represen tative said Mexico was concerned at Canada's 
non-compliance with Articles 2.2, 2.9 and 2.9.4 of the TBT Agreement.  Specifically, Canada had not 
notified Bill C-32 to the Committee and therefore had not provided WTO Members opportunity to 
make comments.  The representative recalled that Me xico's concerns were shared by many other 
Members. 
204. The representative of Mexico reiterated that the measure was unnecessarily restrictive as there 
existed other ways to meet the objective without prohibiting the use of taste enhancers.  In other countries where additives to tobacco had been regulat ed, only the quantity had been limited.  Mexico 
noted Canada's commitment to reduce tobacco c onsumption among its population, especially among 
youth, but claimed the measure was restrictive and contrary to Canada's obligations under the TBT 
Agreement.  Mexico requested information on the st atus of the Bill and asked if Canada intended a 
revision to take into account comments made by Mexico and others.  
205. The representative of the European Union
 requested further clarification from Canada on the 
scientific rationale behind Bill C-32, in partic ular given the European Union's own work in 
investigating the link between additives and addictiv eness and attractiveness of tobacco products.  At 
the June 2010 TBT Committee meeting, Canada had made available a room document with selected 
references that had been considered in the devel opment of the amendment of Canada's Tobacco Act -  G/TBT/M/52  
 Page 43 
 
 
  some 170 publications and other information providi ng "evidence that additiv es are used to make 
tobacco products more appealing to youth and no vice users".  However, the selected references 
offered no details with regard to the content of th e studies therein, or their conclusions.  In this 
context, the European Union asked Canada to pr ovide information as to which studies from the list 
specifically dealt with the impact of additives on ad dictiveness and/or attractiveness, in particular in 
children and youngsters, and also provide the TBT Committee with a short summary of their 
conclusions. 
206. The representative of the European Union noted th at the Schedule of the Bill provided for an 
exemption of certain additives including benzoic acid, citric acid, guar gum and menthol from the 
prohibition.  The European Union asked Canada to pr ovide more details as to the scientific rationale 
for the exemptions since, in particular in the case of menthol, several scientific studies had postulated 
that menthol could act as an indirect enhancer of nicotine addictiveness and could also help boost tobacco products' attractiveness, by providing t obacco with a more pleasant, cooling taste.  
207. The representative noted that the 2008 Report to Health Canada on Tobacco Product 
Attractiveness as a Contributor to Tobacco Addiction and Disease  by Ferris Wayne G. & 
Henningfield J. E., had been included in Canada's  room document as an important source of scientific 
reference, used in the analysis for Bill C-32.  The representative invited Canada to make this report 
available to the TBT Committee so WTO Members could become familiar with the scientific 
information therein.  The European Union enquired  whether an impact assessment had been carried 
out prior to the introduction of the Bill, and if yes,  whether this impact assessment or, alternatively, a 
summary of its conclusions, could be shared with the Committee. 
208. The representative informed the Committee that, as part of its own work on attractiveness and 
addictiveness of tobacco additives, the Europ ean Union had asked the Scientific Committee on 
Emerging and Newly Identified Health Risks (SCENI HR) to provide an opinion on this issue.  The 
preliminary opinion of the Committee was published on 12 July 2010 and was available on the website of the Directorate General for Health a nd Consumers Products of the European Commission.
7 
209. The representative of Turkey  reiterated his country's concer n with Canada's Cracking Down 
on Tobacco Marketing Aimed at Youth Act.  Turk ey supported Canada's obj ective of deterring youth 
from tobacco use, but was seriously concerned at th e way Canada sought to achieve this objective.  
The representative reiterated concerns that the Cana dian measure was more trade restrictive than 
necessary as it prohibited the production, sale and distribution of tobacco products containing additives that not only provided a characterising flavour  to the product, but that were also used during 
the blending process of burley and oriental tobacco.  He noted that some of these additives were vital 
and indispensable components for blending Burley an d Oriental tobacco (American blend), that these 
additives did not give a characterising flavour to th e end product that could result in attraction, and 
there was no scientific evidence confirming that Burley  and Oriental blends were more appealing than 
non-blended tobacco.  The representative said blende d and non-blended tobacco  products were like 
products and were substitutes; an y measures resulting in the prohibition of one would favour the 
other.  Turkey asked Canada to reconsider th e Act based on its TBT Agreement commitments and 
requested further information on the exclusion of traditional flavours such as menthol from the 
coverage of the Act.  
210. The representative of Chile
 stated her delegation's support fo r the initiative of Canada towards 
preventing consumption of tobacco products which ma y be attractive to young people.  She reiterated 
concern that the coverage of the measure was broad since it imposed a de facto prohibition on the 
import, manufacturing and marketing of American blended tobacco in cigarettes.  Chile supported 
concerns raised by other Members in this regard , reiterating that the measure prohibited additives and 
                                                      
7 http://ec.europa.eu/health/scientific_co mmittees/emerging/docs/scenihr_o_029.pdf  G/TBT/M/52  
Page 44  
 
  taste enhancers in specific tobacco products such  as cigarettes and cigars, and as a consequence the 
measure would inhibit traditional tobacco products.  Chile was of the opinion that the measure would 
close the Canadian market to these products but not to other types of tobacco which did not use these 
types of ingredients, creating discrimination.  Th e representative cited examples of alternative 
regulations seeking the same objective in the United  States and France.  She reiterated that the 
Canadian measure had not been notified to the WTO and was more trade restrictive than necessary to 
achieve its objective.  Article 2.8 of the TBT Agreement stated that Members should base their 
technical regulations on the use of products instead of their descriptive characteris tics.  In this regard, 
Canada could adopt an approach based on performance.   
211. The representative of Zambia
 reiterated its concerns that the Canadian measure created an 
unnecessary obstacle to trade and Canada had failed to notify it to the TBT Committee.  Article 2.9 of 
the TBT Agreement required Members to publish, at an early, appropriate stage, the proposed 
technical regulation, whenever such technical re gulation was not in accordance with the technical 
content of relevant international st andards, and if it had a significant effect on trade.  Notification was 
to enable interested Members to become acqua inted with the regulation and submit comments in 
writing, and for the notifying Member to take into a ccount the results of such consultation.  Zambia 
was concerned that Canada had introduced its me asure without due regard to its notification 
obligations.   
212. The representative of Zambia said that for many sub-Saharan African countries tobacco 
production and trade accounted for a large proportion of rural income.  The measure introduced by 
Canada would have a direct impact on the lives of these rural communities whose livelihood revolved 
around tobacco production.  The tobacco industry a ccounted for 20 per cent of Zambia agricultural 
exports.  In the light of the trade impact of th e measure, Zambia urged Canada to reconsider its 
position and take into account concerns raised.  
213. The representative of Ecuador  repeated his country's concerns with respect to the Canadian 
law.  In the view of his delegation, the measure would result in a de facto prohibition against the 
importing and marketing of American  blend cigarettes, which Ecuador  exported.  While Ecuador did 
not object to the legitimate policy objective behind Ca nada's measure, they did question the process 
and measures Canada adopted; these had established standards which did not comply with Articles 
2.2, 2.8 and 2.9 of the TBT Agreement.  The representative observed that any measure seeking to 
promote a legitimate policy objective, such as protection of human health, should be reasonable and proportionate of the objective and should not create unnecessary technical barriers to trade.  Also, the 
Canadian measure did not give due considerati on of the TBT Agreement provision that technical 
requirements be based on performance rather than the product's design or descriptive characteristics.  
214. The representative of Jordan
 reiterated his delegation's support for the objective of Bill C-32 
amending the Tobacco Act.  However, in the view of his delegation, the measure was more trade restrictive than necessary. 
215. The representative of the Dominican Republic
 explained that, in her delegation's view, the 
Canadian law to discourage tobacco marketing di rected at youth would effectively prohibit the 
manufacture and sale of traditional blended tobacco.  Canada should have pr ovided notification, as 
required by Article 2.9 of the TBT Agreement, so  WTO Members could have debated and commented 
on the law.  The representative recalled her country' s previous statements that the law could have 
important effects on the market for cigars and cigarett es, especially with respec t to the Burley tobacco 
market.  As a result, the Bill could have serious adverse effects on tobacco production and the national 
economy in the Dominican Republic, resulting in social problems due to job losses amongst tobacco harvesters.  G/TBT/M/52  
 Page 45 
 
 
  216. The representative of the Dominican Republic ob served that the law was aimed at prohibiting 
the manufacture and sale of tobacco products, includi ng cigars and cigarettes, with characteristic 
flavours such as sweeteners or fruit.  While the Do minican Republic shared the objective of protecting 
human health, the way the Canadian law was drafted was too broad and disproportionate. 
217. The representative of the Philippines  reiterated that Bill C-32 appeared to be more trade 
restrictive than necessary as it banned many additives regardless of whether or not they imparted a 
characterizing flavour to the finished tobacco product.  
218. The representative of Uganda  said his delegation was still awa iting a response from Canada to 
questions raised by Uganda at the June 2010 meeting of the TBT Committee concerning Bill-32 
amending the Tobacco Act.  
219. The representative of Kenya  said her delegation shared concerns raised by other Members.  
The regulation appeared to be more trade restric tive than necessary to fulf ill a legitimate objective, 
contrary to Article 2.2 of the TBT Agreement.  Nor had the measure been notified to the TBT 
Committee as required by Article 2.9 of the TBT Ag reement.  Pursuant to Article 12.3 of the TBT 
Agreement, which required WTO Members to ensu re their technical regulations did not create 
unnecessary obstacles to exports from developing count ry Members, and given Kenya's developing 
country status and heavy dependence on tobacco gr owing, manufacture and export, the representative 
requested Canada consider adopting a less trade restrictive approach.  
220. The representative of Croatia  supported the purpose of the Cana dian law, but reiterated his 
delegation's concern that the law was too restrictive.  
221. The representative of Cuba  supported the objective of protec ting human health, particularly 
the health of young people.  As a country producing and exporting cigarettes and tobacco, Cuba was 
concerned at how the measure would prevent the marke ting of certain tobacco products and cigarettes.  
She asked Canada to provide more information on this Law.  
222. The representative of Canada  recalled that the TBT Agreement required that regulations be 
notified if they may have a significant trade impa ct.  Consideration was given to the commercial 
impact of the Canadian measure as it was being deve loped and analysis of the market for consumption 
of tobacco products in Canada showed that less than  one per cent of the market consumed the type of 
tobacco product that Members had characterized as be ing American style or American blend.  As a 
result, less than one per cent of the total Canadian market for cigarettes was expected to be impacted.  
Given the interest in the measure expressed at past TBT Committee meetings, Canada had been 
carefully following the impact of the measure.  To date, Canada was not aware of any American style 
brands which had been withdrawn from the Canadian market since the measure had come into force. 
223. The representative of Canada said the measure became law on 9 October 2009 and that the 
final additive prohibition came into force on 5 July 2010.  Since then, there had been no impact on the 
cigarette market in Canada.  Canada was of the vi ew that because less than one per cent of the market 
was affected and because there had been no initial impact after introduction of the measure, it did not 
appear the measure was likely to have a large im pact.  Canada understood the interest of tobacco 
exporting Members in the impact of this type of me asure if implemented in various markets.  But its 
implementation in the Canadian market did not look like it would have a significant impact.  
224. The representative noted from trade figures that ma ny delegations that had intervened in the 
present or past TBT Committee meetings had either no trade or no recent trade with Canada.  This 
meant WTO Members were looking at the measure as  a systematic concern.  The representative said 
Canada was willing to engage with Members bilate rally.  He suggested as well that in some cases G/TBT/M/52  
Page 46  
 
  Members' concerns were not of a TBT nature but were more of a general policy nature.  Canada 
would pay close attention to the concerns of Me mbers and was taking note of their interventions.  
225. The representative spoke to the context in whic h the measure was developed and its health 
policy objective.  He noted that each year 37,000 premature deaths occurred in Canada as a result of the consumption of tobacco products.  Tobacco use was estimated to be responsible for nearly four 
and a half billion dollars in direct healthcare cost s in Canada.  This represented a very serious 
situation.  The Canadian approach had been deemed  to be the best fit to address the public health 
problem Canada was facing.  The representative re minded the Committee that more information on 
this subject had been provided by Canada at  the March 2010 session of the TBT Committee.   
226. The representative commented on studies and scientific documentation that had been 
examined in the development of the Canadian measure , noting that Canada was of the view that there 
was sound evidence that certain additives, includi ng flavours, increased product attractiveness of 
tobacco products.  The references included documen tation from the tobacco industry itself, which had 
become available as a result of various litigation exer cises, showing that the use of additives help to 
make tobacco products more appea ling to young people.  The representative noted that Canada had 
previously made reference documents  available.  By showing a sample of some of the documents that 
had been looked at, Canada hoped to raise awaren ess of the information available on the topic.  
Canada was open to further bilateral di scussions on concerns in this area.  
227. Regarding concerns that the measure established a de facto ban of certain types of tobacco 
products, including reference made to cigarettes th at contain Oriental and Burley tobaccos, the 
representative said analysis  carried out prior to th e implementation of the measure showed the market 
in Canada was already next to non-existent for th is product.  Over a long period of time, consumer 
taste had not flavoured that particular product.   
228. The representative emphasised that the measure ha d been developed for the Canadian context, 
where consumers had particular t astes and habits, and that Canada was not suggesting other Members 
adopt precisely the same model should they choos e to address the same public health objective. 
Canada did not believe all of the concerns raised by Members actually played out when the trade data 
was looked at.  Should Members have further ques tions or seek further information, Canada was 
ready to discuss bilaterally 
(xvii)  Indonesia – Regulation of BPOM No. HK.00.05.1.23.3516 relating to distribution license 
requirements for certain drug products, cosmetics, food supplements, and food 
229. The representative of the European Union
 welcomed Indonesia's revised regulation on 
distribution license requirements which had replaced a previous prohibition on the use of substances 
deemed not "halal" with a labelling requirement.  She noted that the regulation had come into force on 
5 July 2010 and sought clarification on what woul d happen to products for which registration had 
been requested under the old regime, but which we re still awaiting approval at the time of the 
revision.  She also asked Indonesia to notify the revised regulation to the TBT Committee.  
230. The representative of Indonesia  informed the Committee that Regulation of BPOM No. 3516 
had been withdrawn and replaced with Declaration BPOM No. 5166 covering the inclusion of information on certain sources, alcohol contained and expiry dates on the marking or labelling of 
drugs, traditional medicines, food supplements and food.  The representative was of the view that, 
because the previous Regulation had been revoked, th e issue of the halal distribution license was no 
longer valid.  Notification would be made in due time.   G/TBT/M/52  
 Page 47 
 
 
  (xviii)  Indonesia – Decree No. Kep-99/MUI/III/2009 relating to Halal certification  
231. The representative of the United States  said the United States respected Indonesia's right to 
regulate trade in halal products.  But he reiterated concerns that the regulations should have been 
developed in a transparent manner.  Basic concerns of the United States were:  (i) the lack of notice 
that a new list of certifiers would be posted and (ii) uncertainty over the criteria for becoming 
accredited by Indonesia.  The representative said this left United States certifiers with many questions 
as well as uncertainties, including whether the relevant authority, MUI, would need to approve US production facilities or the certifiers of the production facilities.   
232. The representative said the United States was of the understanding that va rious halal certifiers 
in the United States had contacted Majelis Ulama Indonesia (MUI) regarding inspection visits.  The 
United States would appreciate being notified by MUI of any trips it might make to the United States 
to inspect halal certifiers, requesting transparency in the inspection process to ensure that no halal 
certifiers would be excluded from an inspection visit.   The representative noted that it was not too late 
for Indonesia to notify to the WTO the draft criteria for accrediting certifiers.  
233. The representative of Indonesia
 noted that the Indonesia Council MUI had had bilateral 
discussions with the United States in April 2010 in  Jakarta.  At that time, the United States had 
encouraged Indonesia to recognise not only halal cer tifiers and agencies for cattle slaughtering, but 
also for poultry and lamb.  MUI had informed that  Indonesia could not recognize halal certification 
agencies for poultry and lamb slaughtering because th e slaughtering had been done by machines.  
However, MUI would conduct a visit to the US certification agencies to see how poultry and lamb slaughtering was done.  MUI had communicated to th e US council the criteria and requirements for 
halal certification agencies in foreign countries, as c ontained in the attachment 2 of the Decree of the 
Indonesia Council of Ulama No. D410 number 2009. 
(xix) Thailand – Health Warnings for Alcoholic Beverages 
234. The representative of New Zealand
 thanked Thailand for hosting a plurilateral meeting which 
allowed Members an opportunity to ask questions  regarding Thailand's labelling requirements for 
alcoholic beverages, including the basis on which th ey had been developed.  New Zealand understood 
Thailand was reviewing the measure, taking into account concerns raised by Members.   
235. The representative said New Zealand supported the right of Thailand to regulate to prevent 
alcohol-related harm, but there were less trade r estricted means of pursuing the objective.  
New Zealand was concerned about significant a dditional costs the measure would impose on 
exporters and how much of that cost would ar ise from differences in Thailand's requirements vis-à-vis  
requirements in the rest of the world.  The repr esentative noted that the World Health Assembly's 
"Strategy on the Harmful Use of Alcohol" provided guidance, indicating that there should be a proper balance between policy goals in relation to the harmful use of alcohol and other policy goals. 
236. The representative of the United States
 reiterated his delegation's concerns with Thailand's 
proposed warning label requirements for alcoholic beverages.  He hoped Th ailand would favourably 
consider the United States' comments submitted with  respect to the notification and the supporting 
study.  While the United States appreciated Thaila nd's efforts to substantia te its proposed alcohol 
regulation with the technical report provided in June  2010, it still had many unanswered questions.     
237. The representative of the United States raised con cerns regarding the size of the warning label 
in proportion to the bottle, and its potential to in terfere with legitimate trademarks on the bottle and 
the ability to display useful information on pr oduct labels, such as information necessary to 
distinguish one product from another.  The represent ative repeated a previous ly raised concern that 
the requirement that warning statements be rota ted every 1,000 bottles would present a very onerous G/TBT/M/52  
Page 48  
 
  problem for industry.  He requested that the impl ementation period be extended to allow for the major 
modifications proposed.  
238. The representative also noted that in October 20 08, Thailand notified changes to its alcoholic 
beverage warning statement requireme nts, which indicated that the Ministry of Public Health would 
issue a proposal to modify the warning statements on alcoholic beverage cont ainers to reflect the 
change in the legal drinking age in Thailand from 18 to 20 years of age.  He asked for clarification as 
to whether requirements to change the drinking ag e would be incorporated into the new labelling 
requirements.  
239. The representative of the European Union
 appreciated Thailand's transparency on this issue, 
and its willingness to discuss with trade partners. Th e EU invited Thailand to provide an update on the 
foreseen revision of the requirement which had been announced by the Thai delegation in the previous 
weeks.  The European Union recalled its concerns that had been expressed in previous meetings, and 
indicated that it would continue to follow this matter with interest. 
240. The representative of Chile  thanked Thailand for meeting with her delegation and was 
appreciative that the Thai authorities were taking their comments into account.  Chile supported the 
objective Thailand was seeking to achieve with the measure but, according to Chilean experts, it was 
not the consumption of alcohol per se , but rather excessive consump tion which could trigger the 
effects mentioned in point 6 of the document delivered by Thailand. 
241.  The representative of Chile said regular a nd moderate consumpti on of wine could be 
beneficial for consumers and she suggested a label on alcoholic beverages refl ecting this could be a 
very useful measure.  Similarly, a whole range of food products could be dangerous for health if 
consumed excessively.  The representative noted th at the measures proposed by Thailand would be 
very costly for many Members.  
242. The representative of Canada  reiterated Canada's concerns that the proposed measure had 
been constructed in a way that could be more co stly than necessary to ach ieve the objective, noting 
also that Canada did not have difficulty with the objective itself.  
243. The representative of Australia  welcomed information that  Thailand was undertaking a 
review of the measure.  The representative request ed an update on the review process, timeframes, 
and whether the updated measure would be made av ailable to WTO Members for consideration.  
244. The representative of Mexico  sought an update from Thailand on progress of the revision and 
its implications.  
245. The representative of Thailand  informed the Committee that concerns raised by Members 
would be taken into account by the Department of Disease Control during the review of the proposed 
measure.  She explained that alcohol is a non-ordi nary commodity in Thailand, where drinking is not 
part of the culture.  The two religions practiced  by 99 per cent of Thais discouraged alcohol 
consumption among followers.  Although increasing signi ficantly, only 30 per cent of Thai adults 
could be classified as current drinkers.  However, the average consumption volume per Thai drinker 
was double the figure from Western countries.  Alcohol consumption had directly and indirectly led to 
extensive impacts on Thai society in addition to public  health impacts.  As a result, at the aggregate 
level, the cost of alcohol consumption that soci ety had to bear was much higher than its public 
benefits.  As such, comprehensive measures, including  the pictorial warning label were of the greatest 
need to control the impacts of alcohol consumption.   
246. The representative of Thailand said protection of human health, safety and life, and not trade 
obstruction, had been the sole objective of the meas ure.  She stressed that because drinking patterns  G/TBT/M/52  
 Page 49 
 
 
  and drinking mentality differed from country to c ountry, tackling the proble m required adjustment.  
While all countries faced alcohol advertising, Th ai drinkers had been bombarded with subtle 
marketing strategies.  Marketing, including adve rtising through beverage packaging, had been the 
most important vector for the alcohol epidemic in  Thailand.  The representative said miseries of life, 
disabilities and death, all depicted on the pictorial wa rnings, were not exaggerating the real impacts of 
alcohol consumption in Thai society.  The freque ncy of which these impacts made front page news 
meant that the government could not ignore these incidences.  
247. The representative said the pictorial warning la bel was expected to have three levels of 
impact.  First, it would provide correct inform ation and understanding concerning health risks and 
potential dangers at the time of purchase.  Second, it would increase knowledge, attention and 
awareness.  Third, the pictorial warning labe l was expected to spe ll out the non-ordinary 
characteristics of alcohol and caution people not to underestimate its impacts.  Thailand was of the 
view that even though the pictorial warning label of alcohol packages had not been a popular initiative, research evidence from tobacco control experiences had proved the success of pictorial 
warning labels.  
248. The representative reminded th e Committee that alcohol drinking had been a national 
problem in Thailand, and tackling it required compre hensive and consistent act ion.  Thailand planned 
to adopt and continue informativ e and educative measures and campai gns in parallel to the labelling 
requirement.  The representative reconfirmed that all concerns raised by Members would be taken into 
account, and the outcome of the review would be notified to Members as soon as it became available.  
(xx) United States – Hazardous Materials: Transportation of Lithium Batteries 
(G/TBT/N/USA/518) 
249. The representative of Japan
 said the United States' proposed restrictions on the transportation 
of lithium batteries were inconsistent with the UN Recommendation on the Transport of Dangerous 
Goods and the International Civil Aviation Organi zation (ICAO) Technical Instructions and would 
negatively impact trade.  He noted that on 8 October 2010 the Federal Aviation Administration had 
issued a Safety Alert for Operators (SAFO) that ad vised air carriers to pay special attention to the 
handling of Class 9 hazardous materials, including lithium batteries, in view of complying with 
existing regulations.  The representative said Japanese industry was concerned that this SAFO may be 
an indicative step towards a strict final rule.  Japan requested that the United States regulation be 
made consistent with the UN Recommendations a nd the ICAO Instructions.  Additionally, Japan 
asked the United States to exempt lithium batteries w ith less than 50 per cent "state of charge", since 
in the draft measure itself, the United States had ma de reference to studies indicating that such low-
charged batteries could be considered to fulf il existing air transportation safety standards. 
250. The representative of Korea  proposed that the United States ensure harmonization and 
compliance with the UN and ICAO requirements.  Despite the non-alignment of the procedures of 
these bodies with the TBT Committee's 2000 decision me ntioned by the United States, in particular 
the failure to follow openness and consensus prin ciples during the standards development process, 
Korea believed these requirements were an effective way to secure safer transportation of Li-Ion batteries. 
251. The representative of Korea said if the Pipeline and Hazardous Materials Safety 
Administration (PHMSA) chose not to adopt the existing UN and ICAO regulations, Korea urged the United States to include an exemption for lith ium based secondary cells (lithium-ion, lithium-
polymer, etc.) that were shipped at no more than 50 per cent of charge.  According to reports referred 
to in the United States' draft m easure, the severity of the hazard aris ing from an internal short circuit 
was strongly affected by the state of charge.  Fire s had been shown to have a minimal effect on bulk 
packaged lithium ion cells with less than 50 per cent state of charge. G/TBT/M/52  
Page 50  
 
  252. The representative of the European Union
 said the draft measure of the United States would 
lead to unnecessary burdens for producers with re gard to the production and packaging of a wide 
range of products, and would require costly changes within the logistic chain.  She noted that the 
United States' claimed that the respective UN r ecommendations and ICAO technical instructions 
could not be considered as an international standa rd in the sense of the TBT Agreement and that the 
respective bodies were dominated by EU Member States.  But this did not explain why the United 
States was opting for a unilateral approach while issu es of relevance to the draft measure were being 
discussed within the framework of these specialized international organizations.  The representative 
pointed out that in its draft measure, the United St ates had maintained that its proposal was meant to 
be largely consistent with the existing UN and IC AO regulations, which the European Union believed 
was not the case.  Should the United States opt fo r a unilateral approach, the European Union 
requested the implementation peri od be extended to 18 months. 
253. The representative of China  said her delegation submitted comments to the United States in 
May 2010 and continued to await a written reply.   The United States' draft measure would impose 
stricter restrictions on the handling of lithium cells and batteries which would significantly impact 
international trade.  China requested scientific jus tification for the elimination of the currently existing 
exceptions to handling certain types of lithium batte ries.  The representative further commented that 
the envisaged implementation period of 75 days would cause difficulties for manufacturers especially of developing country Members to adapt th eir production to the new requirements of the 
United States.  China asked the Unite d States to extend the transitional period to at least six months.  
254. The representative of the United States
 reiterated that the safe transportation of lithium 
batteries aboard aircraft was a serious issue for its regulators, who wished to minimize the risk of 
catastrophic accidents.  Currently, United States regul ators were reviewing a ll comments received and 
were taking them into account as a final measure was developed.  The draft measure was subject to a 
formal review process of the US Office of Inform ation and Regulatory Affair s (OIRA) pursuant to 
Executive Order 12866, under which any interested st akeholder was entitled to request a meeting with 
the OIRA, which would also be attended by US re gulators and USTR.  Several of these meetings had 
been held over past weeks with various stak eholder groups including battery manufacturers, 
transportation companies and retailers.  A list of all meetings, including the names of participants and 
the materials provided, could be found in the Un ited States' online electronic docket.  Regarding 
written replies to submissions, as requested by China,  the representative noted that the United States 
was legally required to publish a detailed reply to all significant comments alongside the final 
regulation, which would explain whether the United  States' regulator agreed or disagreed with 
comments made, and indicate any changes that had been  made to the final regulation as result of these 
comments.  As the United States was still in the process of considering comments, no answers could 
be provided at the moment, yet potentially the EO 12866 meetings could serve as a forum to solicit additional comments. 
255. The representative of the United States confirmed that US regulators were actively 
participating in the work of the ICAO and UNECE  and sought to use their documentation wherever 
possible.  However, in this case, they had expressed  concerns that their views were not actually being 
taken into account, in part also because Europe an Union member States had a majority in the 
Committees and formed set positions prior to meetings .  Furthermore, these bodies were not open in a 
non-discriminatory fashion to all WTO Members.  The United States believed that these procedural 
issues had systemically led to a situation where exis ting standards did not cove r certain batteries that 
did pose serious safety concerns according to the United States' regulatory authorities who had 
analysed them.  The United States expressed hope that  the ICAO and UNECE would take steps to try 
to resolve these procedural issues.  G/TBT/M/52  
 Page 51 
 
 
  (xxi) Brazil – Alcoholic Beverages (G/TBT/N/BRA/348)  
256. The representative of the United States  noted that Brazil had issued a proposed revision to this 
regulation in September and several matters the Un ited States had earlier raised had been addressed.  
However, a number of issues remained unresolved.  The representative noted the proposed revision 
omitted a previously included requirement prohibitin g the use of abbreviations for common terms. He 
requested confirmation from Brazil as to whether abbr eviations for common terms would be allowed.   
257. The representative said the United States agreed  with the intent behind Brazil's plan to 
prohibit illustrations on labels which could mislea d consumers.  He referre d to Article 8 of the 
measure stating that labels that displayed a drawi ng, figure or illustration of any ingredient used to 
prepare the beverage must indicate all of the ingr edients of animal or plant origin, regardless of 
quantity.  The representative requested clarifica tion as to whether the proposed revision to the 
regulation retained the prohibition against illustrations  or statements on the label of ingredients that 
were not present in the composition. 
258. The representative further sought confirmation that the provision concerning illustrations 
would not apply to fanciful drawings and illustra tions which were well-es tablished elements of 
trademarks and which did not purport to represent ingredients.  Examples included the Grey Goose 
logo which pictured flying geese, the "striding figure" portrayed in the Johnnie Walker logo, and the Bacardi bats, which represented the fruit bats that in habited the distillery where the rum had been first 
produced. 
259. The representative sought explanation of the requi rement that cans bear the statement "This 
container must be washed prior to consumption".  Specifically, did this requirement address a health 
or safety concern?  Also, the re presentative expressed concern that th e requirement in Article 13(II) of 
the draft proposal would effectively bar the use of the trademarks of certain internationally-traded 
spirits brands, including spirits prod uced in the United States.  Even  where such terms had not been 
incorporated expressly into a registered trademark, some of them have been used for years without 
incident on the labels of internationally-traded dis tilled spirits.  The representative requested Brazil to 
explain the rationale for its decision to restrict the use of such terms. 
260. The representatives of Mexico
 and the European Union  requested an update from Brazil on 
the revision of the proposal. 
261. The representative of Brazil  informed the Committee that Brazilian authorities were still 
examining comments received on the draft regula tion on beverage labelling.  Members comments 
would be taken into account before  publication of the final measure.  The representative said although 
the deadline for submitting comments on the draf t proposal had expired, Brazilian authorities 
remained available for questions concerning the pro posal's content.  Authorities in the Ministry of 
Agriculture had received visits from representatives of other countries and remained open to dialogue. 
262. The representative of Brazil said the draft measure had the legitimate objective of 
guaranteeing an adequate level of  protection and information to consumers, without creating an 
unnecessary obstacle to the regular flow of beverage exports to Brazil.  Requirements in the draft 
regulation would apply equally to domes tic and imported alcoholic beverages. 
263. The representative explained that because comments from Members were still being 
processed, it was not possible to provide definitive answers on most topics.  However, he provided 
some preliminary remarks.  On the abbreviations  provision, the objective was to avoid consumers 
being misled.  On illustrations, the objective was to  avoid illustrations leading to confusion among 
consumers.  The representative assured the Unite d States there was no intention to prohibit well-
established pictures associated with trademarks, such as the striding Johnnie Walker figure.  G/TBT/M/52  
Page 52  
 
  Regarding expressions such as "hand-crafted", "coloni al" or "home-made", the draft regulation aimed 
to prevent their indiscriminate use.  Such expressions could sometimes mislead and confuse consumers, giving the wrong idea of superior product quality. 
264. The representative reiterated that comments recei ved would be taken into account and Brazil 
would try not to make the provision restrictive of trade.  As soon as the revised proposal was 
published, it would be notified to the Committee.  
(xxii)  
Turkey – New Conformity Assessment Procedures for Pharmaceuticals   
265. The representative of the United States  said his delegation continued to find problematic 
certain aspects of Turkey's decree regarding c onformity assessment procedures for pharmaceuticals.  
He urged Turkey to take immediate steps to restore market access for safe, high quality 
pharmaceuticals.   
266. The representative of the United States noted that the current measure had never been 
published in Turkey's Official Gazette and had not been notified to the WTO.  Other recent measures 
relating to medical devices, biotechnology labelling,  and inspection procedures for IT products had 
also been published in final form without WTO notification and without opportunity given for 
Members to comment.  The United States was concerned at the trend and hoped Turkey would take steps to rethink its notification procedures.  
267. The representative informed the Committee that Turkey had provided the United States with a 
list of recalled pharmaceutical products which it clai med had been the impetus for the decree on good 
manufacturing practices.  The United States was still ex amining the list.  However, the United States 
was of the view that product recalls were a critical aspect of ensuring prompt  and effective responses 
to concerns raised over the safety of a pharmaceutical  product.  The fact some US products had been 
the subject of recalls should be viewed as a sign that the system to safeguard public health was 
working.   
268. The representative said the US Food and Drug Administration could be alerted to problems 
with particular products in several ways, for example:  a company could discover a problem and contact FDA as required by law; an FDA inspecti on of a manufacturing facility may determine if 
there was a problem that may warrant a recall; or  FDA could receive reports of health problems 
through various reporting systems and from foreign counterparts. 
269. The representative urged Turkey to consider th e following measures to alleviate the current 
blockage of pharmaceutical exports:  first, process registration applications (as filed) that were 
submitted prior to March 2010 and not apply the GMP d ecree retroactively;  and second, give priority 
in the inspection and registration process to innova tive drug applications that  provide new medicinal 
therapies to patients in Turkey.  The representative further proposed to hold technical discussions with 
Turkey to discuss and quick ly resolve these issues.  
270. The representative of the European Union
 reiterated his delegation's concern with Turkey's 
Good Manufacturing Practices requirements for phar maceuticals which came into force on 1 March 
2010.  European GMP certificates for medicines fo r human use had been accepted by Turkey for 
many years.  However, EU manufacturers were  now requested to submit extensive additional 
documentation related to manufacturing sites and also  had been subject of on-site inspections by 
Turkish Authorities.   
271. The representative of the European Union e xplained that, in order to obtain EU GMP 
certificates, EU manufacturers had to be inspected by  the competent authorities in EU member States.  
Turkey had not provided any indication as to whet her any problems were encountered with EU GMP- G/TBT/M/52  
 Page 53 
 
 
  certified products on its market.  This caused the European Union to question the need for a second 
on-site inspection and need for the extensive docum entation to be submitted before an inspection.  
The European Union was of the opinion that tho se additional administrative requirements would not 
provide any further protection of public health in Turkey and could delay the placing on the market of 
pharmaceutical products potentially important  for the health of Turkish patients. 
272. The representative urged Turkey to revert to  its previous practice and recognize EU GMP 
standards and certificates without additional ad ministrative requirements.  The representative 
explained that, according to information received fro m EU economic operators, the introduction of the 
present measure on such short notice had already led to significant delays in the registration of new pharmaceutical products in Turkey, in particular sinc e the Turkish authorities did not appear to have 
the necessary capacity to carry out all the neces sary inspections and de liver the required GMP 
certificates in a reasonable time. 
273. The representative said if Turkey continued to  impose the requirements, the European Union 
would urge Turkey to take steps to ensure econom ic operators were not faced with overly burdensome 
requirements.  In particular, the European Union encouraged Turkey to:  align the requested GMP 
inspection and documentation requirements with in ternational practices; improve GMP inspection 
capacity; provide market authorizations within a de fined and shorter timeframe; and give priority to 
innovative drugs in the GMP inspection process. 
274. The representative expressed disappointment th at the measure was not notified to the 
Committee despite being a technical regulation.  Furthermore, the three month period between 
publication and entry into force had been too short fo r economic operators to be able to comply with 
the requirements. 
275. The representative of Switzerland
 reiterating previously raised concerns.  He requested 
Turkey inform Members on the outcome of the surv ey, announced by Turkey in previous Committee 
meetings, supporting the new policy.  In partic ular, Switzerland sought information on quality 
problems with pharmaceuticals manufactured acco rding to international principles.  The 
representative said in general the competent Swiss authorities accepted GMP-certificates from 
Members of the Pharmaceutical Inspection Cooper ation Scheme as proof of GMP-conformity.  
Switzerland encouraged Turkey to adopt a similar solution.  
276. The representative of Turkey  said the relevant regulation had been introduced with the aim of 
protecting public health and human life by en suring the effectiveness, safety and quality of 
pharmaceutical products.  The announcement by the Mini stry of Health had been made well before 
entry into force of the implementation change, to provide sufficient time for interested parties to 
adjust to the new situation.  Furthermore, on 31 December 2009, the Ministry of Health clarified 
through a notification in its official website th at GMP certificates accepted by the Ministry would 
either be ones provided by the Ministry through its  own inspections, or those provided by the Health 
Authorities of other countries with which a Mu tual Recognition Agreement existed.  The 
representative said all countries were treated equa lly, with the GMP inspection requirement being 
applied to all pharmaceutical plants, whether domestic  or foreign.  The representative added that the 
Turkish Ministry of Health had sufficient capac ity and personnel to conduct GMP inspections.  As 
encouraged by the TBT Agreement, the Ministry of  Health was open to conclude Mutual Recognition 
Agreements with interested parties.  
(xxiii)  Italy – Dairy products (G/TBT/N/ITA/13)  
277. The representative of New Zealand  reiterated her dele gation's concern with the proposed 
Italian law on dairy products notified to the Committee in February 2010, including provisions 
providing for a ban on the use of protein in cheese making and the proposal to introduce mandatory G/TBT/M/52  
Page 54  
 
  country of origin labelling for milk and dairy ingr edients.  The proposal was not consistent with 
relevant international standards,  including the CODEX General Standard for cheese.  Nor would the 
proposal be the least trade-restrictiv e means to achieve its stated obj ective, including fraud prevention.  
The representative understood the draft law remained  subject of discussions between the Commission 
and Italy and she encouraged the Commission's conti nued engagement on the issue.  She requested an 
update from the European Commission and asked that  ongoing deliberations take Members' concerns 
into account.   
278. The representative of Australia
 supported the concerns raised by New Zealand and requested 
an update.  
279. The representative of the European Union  said the Commission and Italian authorities were 
discussing the measure within the framework of internal notification procedures.  Since the 
discussions were still underway, she could not provide  further information on the measure.  The 
European Union would be available to provide clar ification once the internal consultation process was 
concluded.  
(xxiv)  Viet Nam – Alcoholic Beverages (G/TBT/N/VNM/10)  
280. The representative of the European Union  raised the issue of Viet Nam's new proposal on the 
National Technical Regulation on Food Safety for Alc oholic Beverages.  Viet Nam had sent a detailed 
reply to comments submitted by the European Unio n in June 2010, indicating Viet Nam's willingness 
to take into account most of the European Union' s concerns, notably to e liminate the maximum limit 
for aldehydes in distilled and mixed spirits. The Eu ropean Union was grateful for the constructive 
stance of the Vietnamese authorities. In addition, th e representative requested an update on the state of 
play of the draft Regulation and asked when a re vised text would be made available to the TBT 
Committee. 
281. The representative of the European Union also  sought clarification on the administrative 
requirements in the draft Regulation. For exam ple, what would the "compliance announcement" 
entail?  How would certification be obtained?  Wh ich products would require certification stamps?  
What test would be used to attest complia nce? The representative said these questions were 
particularly relevant for the European Union si nce, upon entering Viet Nam some shipments of 
European wines had been required to present an an alysis certificate on allowable heavy metal limits, 
the legal basis of which was unclear.  
282. The representative of Australia  confirmed Australia's interest in Viet Nam's proposed 
regulation on food safety for alcoholic beverages.  Australia welcomed the response received from 
Viet Nam in June 2010 in which Viet Nam undertook to reconsider areas of concern in the draft regulation in order to bring them in line with in ternational standards.  The representative requested 
information on the redrafting of the proposed regula tion and asked whether it would be notified to the 
TBT Committee for comment. 
283. The representative of Chile
 stressed the importance of Viet Nam's conformity with 
international requirements and regulations.  Chile re quested information on the current state of play 
and asked when the final version of the regulati on would be ready and if comments would be taken 
into account. 
284. The representative of Viet Nam  said his country was in the process of examining comments 
from Members and incorporating them into a new draft.  Viet Nam would update the Committee on 
further developments in due course.  No specific deadline had been set.  G/TBT/M/52  
 Page 55 
 
 
  (xxv) European Union – Directive 2004/24/EC on Tr aditional Herbal Medicinal Products 
285. The representative of India  reiterated concerns on the European Union's 2001 and 2004 
amended Directives on Traditional Herbal Medicina l Products.  The European Union's failure to 
notify either of the Directives to the WTO was a systemic concern.  
286. The representative of India said his delegation was concerned over a provision in the 
Directives concerning extensive documentary evidence to be provided on physico-chemical, 
biological, micro-biological and pharmacological t ests as well as onerous data requirements on quality 
and safety for the purposes of obtaining marketing author ization or registration.  India considered the 
provision constituted an unnecessary obstacle to trad e and may not have been based on scientific 
principles.  Moreover, the Directive requirement  was excessive and not limited to what was 
reasonable and necessary.   In effect, it denied market access to India's ayurvedic products.  
287. The representative informed the Committee th at a proposal was being debated in the 
European Union for an inspection regime on traditi onal herbal medicinal products.  Such a regime 
would create an obstacle to exports of active pharmaceutical ingredients (APIs) and may affect their availability in the European market. 
288. A further concern raised by the representative of  India was that suppliers were required to 
show 30 years of traditional use, including 15 years of  traditional use in the European Union, in order 
to establish the efficacy of the medicinal product.  Such requirements were difficult to fulfil and could 
result in a de facto  ban on imports of Traditiona l Herbal Medicinal Products. 
289. The representative said the Common Technical Document (CTD) format under the Directive 
appeared to be acceptable for single herbs, but ma y not be appropriate for multi-component traditional 
medicinal formulations.  It would be almost impo ssible to provide information with respect to multi-
component traditional medicinal formulations in th e CTD format, even if the products had otherwise 
been eligible as a traditional herbal medicinal product.   
290. The representative said a large number of supp liers of traditional herbal medicinal products 
were small and medium sized enterprises (SMEs), for whom the cost of registration under the 
Directive had been prohibitively high and would ha ve created market access barriers.  If registration-
related costs were broken down into the variou s components such as analytical development, 
galenical development, stability testing, dossier compilation and dossier submission, it was estimated 
they would amount to more than €150,000 for a single ingredient product.  
291. The representative observed that the Directive ha d not recognised ayurvedic products that 
complied with provisions of the Ayurveda Pharmaco epia of India and which had been certified by 
bodies accredited by Members of ILAC/IAF mutual recognition agreements or arrangements.  The 
scope of the Directive had been limited to purely he rbal products and many of the Ayurveda, Siddha 
and Unani products, or "ASU" products , which contained a combination of ingredients which were of 
mineral and animal origin, were denied  registration under the Directive.  
292. The representative said India was of the view  that quality and stability guidelines for herbs 
under the Directive were inappropriate for multi-com ponent traditional herbal products.  Insistence on 
quantitative determination, or Bio Assays, in poly herbal compounds was technically not feasible for 
any poly herbal formulations having more than three to four ingredients. 
293. The representative said Article 16c(4) of the 2004 Directive prescribed an  alternate process, 
of a Committee referral, for seeking registration of traditional herbal medicinal products when the product has been in use in the European Union fo r less than 15 years.  However, the guidelines and 
parameters on how the Committee would assess the pr oduct had not been detailed.  In India's view, G/TBT/M/52  
Page 56  
 
  the derogation from the requirement of showing 15 y ears prior use in the European Union to establish 
efficacy of a product indicated that the 15 years prior use requirement was itself not sacrosanct and 
may not have been based on sufficient scientific ev idence.  The representative asked if the European 
Union had considered any alternate methods or pr ocedures for ascertaining the safety, quality and 
efficacy of traditional medicinal products when fo rmulating procedures under the Directive.  Noting 
that the 2004 Directive provided for registrati on of over-the-counter products, the representative 
sought clarity on the status of other herbal medi cinal products which may fall under the category of 
prescription products. 
294. The representative of China
 reiterated concerns on the European Union's Directive on 
Traditional Herbal Medicinal Products.  China was concerned at the short transitional period and 
requested an extension of the transitional period for simplified registration to the year 2019, to give 
Chinese companies adequate time to fulfil registra tion requirements.  Only one Chinese enterprise had 
so far registered its products through the simplified procedure; this illustrated the complexity of the 
requirements. 
295. The representative recalled that in previous me etings, the European Un ion had informed the 
Committee that once the transitional period finished  in March 2011, no unauthorized herbal medicines 
could be sold on the European market as medicinal products, though they could continue to be sold as 
standard products.  Chinese enterprises had learned from authorities of some European member States 
that most Chinese traditional medicine products we re not in the list of standard products like 
foodstuffs.  Therefore, they would have to appl y as new resource foodstuff and would have to go 
through a complex procedure, taking quite some ti me.  To avoid interruption of normal trade, China 
requested the European Union reconsider China's request to extend the transitional period to 2019 and 
also provide detailed guidance for Chinese enterprises to follow.  
296. The representative of Ecuador  noted that his country exported traditional herbal medicinal 
products.  He encouraged the European Union to pr ovide more information about the Directive and its 
scope.  Ecuador was particularly interested in ru les and/or restrictions which the measure would 
impose on importation or commercialisation of trad itional herbal medicinal products.  Ecuador was 
also interested in the list of medicines to be cove red by the measure.  In Ecuador's view, the measure 
appeared to be in contravention of Articles 2.1,  2.9.1 and 2.9.2 of the TBT Agreement, and thus 
potentially was an unnecessary barrier to trade. 
297. The representative of the European Union  said bilateral discussions with India and China had 
helped the European Union bette r understand Members' concerns. 
298. The representative of the European Union provided background on Directive 2004/24/EC 
amending the standard authorisation procedure (as regards traditional herbal medicinal products) first 
laid out in 2001 for medical products.  The Direc tive provided a simplified registration procedure for 
traditional herbal medicinal products where the manufacturer was exempted from providing a number 
of tests and clinical trials which had been require d under the standard authorisation procedure.   
299. The representative said Article 16 set out criteria that products had to fulfil in order to be 
eligible for the simplified procedure.  This included, inter alia , evidence that the product had been in 
use throughout a period of at least 30 years, including at least 15 years within the Community.  If the 15 year requirement was not met but the product ha d otherwise been eligible for the simplified 
registration, the product would be referred to th e Committee for Herbal Medicinal Products.  The 
Committee would then verify if the other eligibilit y criteria had been fulfilled and in that case, it 
would establish a Community Herbal Monograph to be  taken into account by the member States when 
evaluating requests for registration.  The Directive al so foresaw the establishment of a list of herbal 
medicinal products by the Commission, on the basis of a recommendation of the Committee for 
Herbal Medicinal Products (HMPC).  This list, in practice, meant the manufacturer would not have to  G/TBT/M/52  
 Page 57 
 
 
  justify the 15 years use requirement anymore, nor would it have to submit safety data.  It would only 
have to demonstrate the quality aspects of the product.   The European Union was of the view that the 
15 year requirement did not constitute an obstacle for manufacturers to benefit from the simplified procedure. 
300. The representative recalled that the 2004 Directiv e gave manufacturers seven years to submit 
to the relevant authorities a registration request for their products.  As of March 2011, herbal 
medicines which had not yet been authorised or registered would no longer be sold as medicinal products in the European Union.  Products not fu lfilling the definition of me dicinal products, and not 
containing medical claims, could be marketed as standard products. 
301. The representative said the European Commi ssion in 2008 started an internal reflection 
process on the registration of traditional herbal medicin es; this concluded with the drafting of a report.  
In the report, the Commission stated that it was prepared to consider extending the simplified 
registration procedure to products containing substances other than he rbal substances and that more 
experience with the requirement for at least 15 year s use in the Community would be gathered with a 
view to assessing its necessity.  Any changes would require legislative action.   
302. Regarding non-notification of the Directive, the representative explained that the proposal had 
escaped their radar screen and had not been notified to the Committee.  Nevertheless, both India and 
China had learnt about the Directive through other channels which had enable d both parties to have 
exchanges with EU authorities for several years already.  The European Union said lack of 
notification of the measure did not amount to a systemic problem.  
(xxvi)  
China – Textiles (G/TBT/N/CHN/20 Rev.1)  
303. The representative of the European Union  reiterated her delegation's concerns with China's 
new national General Safety Technical Code for Te xtile Products.  The draft laid down a limit PH 
value as well as a level for colourfastness and require d that textiles could not have a peculiar odour.  
In the view of the European Un ion, the mandatory requirements, which did not impact consumer's 
health or safety, were more trade restrictive than necessary.  
304. The representative of the European  Union informed the Committee that, in a written reply of 
29 September, China claimed that PH values of textiles differing from the one in the draft would 
make the skin more susceptible to suffering from pathogens, that bad colourfastness would permit the 
entering of carcinogenic and allergenous dyestuffs in to the body, and that the odour requirement was 
necessary to avoid excessive chemical residues or risk of mildew.  While appreciative of the 
explanations provided by the Chinese authorities, the European Union's view was that the stated risks 
should be confirmed by scientific evidence.  Th e representative invited China to provide supporting 
scientific evidence.  She further sought informati on on whether the measure already been adopted or 
was still under discussion.  
305. The representative of China  recalled that China notified its National General Safety Technical 
Code for Textile Products to the WTO in February  2010 and provided a 60 day comment period in 
line with TBT Agreement transparency requirements.   China also replied to comments submitted by 
the European Union.  As well, the European Union had raised qu estions as a specific trade concern 
during the June 2010 TBT Committee m eeting and had talked extensively with China on this issue in 
bilateral discussions.  China was of the view that  it had already provided clear, scientific-based 
answers to the European Union on concerns ra ised over PH value, colourfastness, odour, and 
prohibition of carcinogenic enzymes.  For example,  regarding aromatic enzymes, China's reply of 
29 June cited animal test results from interna tional cancer research institutes to demonstrate a 
scientific basis for such prohibition.   China understood the concerns of  the European Union related to G/TBT/M/52  
Page 58  
 
  technical issues; the representative suggested such issues be left to professionals and departments in 
charge.  
306. The representative of the European Union
 clarified that she had not asked for scientific 
evidence on the aromatic enzymes question but had in stead focused her intervention on the PH value, 
odour and the colourfastness.  The European Union would appreciate receiving the scientific evidence 
China mentioned.  
(xxvii)  United States - Conditions and Criteria for Rec ognition of Certification Bodies for the Energy 
Star Program  
307. The representative of Korea  expressed appreciation that many of Korea's comments and 
suggestions on the Conditions and Criteria for Recogn ition of Certification Bodies for the Energy Star 
Program were taken into account by the United States .  He welcomed removal of the requirement that 
certification bodies have a substantial North Amer ican presence.  However, Korean certification 
bodies were still concerned that the requirement relati ng to availability of personnel to the agency and 
provision of information would still necessitate th at certification bodies or personnel have a presence 
in North America.  The representative invited th e United States to clarify the requirement.  
308. The representative of the European Union  said her delegation was following up on this issue 
bilaterally with the United States.  She expressed disappointment that the United States had moved 
away from a self-declaration system to third party certification. 
309. The representative of the United States  noted bilateral discussions with Korea and said many 
changes had been made to the accreditation and ot her conformity assessment procedures in response 
to Korea's comments and requests.  He requested Ko rea be specific as to their additional concerns.  
The United States was of the view that the requi rement to have personnel available to answer 
questions was a reasonable one.  He confirmed that  the provision for a North American presence had 
been deleted from the proposal.  
310. In response to comments from th e European Union, the represen tative of the United States 
noted that the system was voluntary.  Producers coul d still test outside the United States, whether in 
their own facilities or in third party laboratories, in accordance with the procedures, and goods could 
continue to be shipped to the United States rega rdless of whether they had met the Energy Star 
criteria.   
311. To illustrate, the representative noted that th e United States had had several investigations 
that identified vulnerabilities and potential for fraud in  the current qualification process of the Energy 
Star Program.  As well, there had been numerous consent decrees that US regulators had signed with 
producers who had been found to be selling products in the market with an Energy Star label that did 
not meet the criteria.  Under the terms of th e consent decrees, which could be found online, 
companies had agreed voluntarily to stop using the labels. 
312. The representative said based on what had happened in the market place and the potential for 
fraud, US regulators were of the view that they  had little choice but to add these new procedures to 
ensure products being purchased by consumers actually met the criteria.  It was important to uphold the value of the Energy Star brand in the United States, which had been very successful and showed 
that voluntary approaches could be taken to achie ve legitimate objectives - sometimes even better 
than through the use of mandatory measures.    G/TBT/M/52  
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  (xxviii)  Colombia – Shelf life Requirements for Milk Powder  
313. The representative of the European Union  reiterated concerns expressed in previous meetings 
relating to a Colombian Decree, dated 13 May 2 010, requiring imported milk powder to have a 
minimum shelf-life of 12 months.  This was a six month increase over the previous requirement.  The representative observed that the decree had already en tered into force, without being notified to the 
TBT Committee. 
314. The representative said the European Union was c oncerned that the extension of the shelf-life 
period could impair European exports of milk pow der to Colombia.  According to the European 
Union, the normal shelf-life of whole milk pow der was 12 months from the date of production.  
Quarantine time and shipping period usually took up to  two months.  This meant that if the length of 
the shelf-life started from the date of commercialis ation, as established in the Colombian decree, it 
would become impossible to export the product without  incurring additional costs to extend the shelf-
life of the milk powder through specific and costly treatments. 
315. The representative recalled that at the previ ous TBT Committee meeting her delegation asked 
Colombia to clarify several aspects of the decree.  The European Union also submitted a request to the 
Colombian TBT Enquiry Point seeking an update.  Co lombian authorities were still to respond.  The 
representative asked Colombia to id entify the legitimate objective be ing pursued through the measure 
and to clarify if domestically produced milk powder was also subject to the minimum shelf-life 
requirement. 
316. The representative of Colombia
 informed the Committee that the Colombian Ministry of 
Social Welfare was working on a draft resolution in which a number of measures would be adopted.  As soon as the relevant decision was taken, Members would be advised. 
317. The representative said Colombia had not adopted  any decree related to powdered milk.  The 
draft notified for comments (G/SPS/N/COL/126/Add.6 and G/TBT/N/COL/83/Add.6) was a draft 
resolution to modify Resolution 2997 of 2007.  The representative said Resolution 2997 establishes 
technical requirements for powdered dairy products as foodstuffs for human consumption.  The draft 
resolution was notified through the Colombian TBT Enquiry Point on 11 June 2010 and a deadline for comments was fixed on 10 September 2010. 
(xxix)  
China: Regulations of the PRC on Certification and Accreditation (promulgated by Decree No. 390 of 
the State Council of the PRC on September 3, 2003)   
318. The representative of the United States  reiterated a longstanding concern that China was not 
permitting US suppliers to use competent conf ormity assessment bodies, for example, testing 
laboratories or product certifiers located outside th e territory of China, to demonstrate that US 
products comply with Chinese technical regulations , including the China Compulsory Certification 
(CCC) scheme.  According to US estimations, at l east 20 per cent of US exports to China must obtain 
the CCC mark prior to entering the Chinese market.  However, there is typically only one designated 
certification body in China authorized to perform te sting, inspection and certification activities for any 
given product within the scope of the CCC system.  Article 32 of Decree No. 390 required at least two 
certification bodies designated for each field of pr oducts listed in the CCC catalogue.  However, in 
reality there was only one certification body per field of products.  This had led to additional costs, 
burdens and delays for US exporters and was esp ecially prejudicial to small and medium-sized 
enterprises. 
319. The representative of the United States noted  that since Chinese conformity assessment 
bodies did not generally have a presence outside Ch ina, US companies exporting to China had to 
arrange and fund the trip of a Chinese agent to the manufacturer's location for pre-market inspections.  G/TBT/M/52  
Page 60  
 
  Moreover, after receiving the CCC mark, US exporters also needed to comply with the requirement of 
subsequent annual inspections and pay for the certif ication and testing of their products for a second 
time in China.  The representative referred also to  US industry complaints that Chinese certification 
bodies often introduce or change implementing requ irements without advanced notice and without 
providing opportunity for others to comment on su ch requirements. This occurred even after US 
products had obtained market access.  As well, accord ing to US industry, there were inconsistent post-
market surveillance requirements implemented by provincial authorities due to differing 
interpretations of CCC labelling requirements. 
320. The representative recalled that only one US c onformity assessment body had entered into an 
MOU with China.  This allowed the body to cond uct follow-up factory inspections (but not primary 
inspections) of manufacturing facilities that make pr oducts for export to China and which require the 
CCC mark.  However, the representative understood China was not willing to grant rights to other 
US-based conformity assessment bodies, under the argument that the Chinese Government entered 
into only one MOU per country.  The United States  urged China to take positive, trade-facilitating 
steps, whether through the reinterpretation or the modification of Decree No. 390 or through the use 
of some other legal instrument, to liberalize its  approach to recognizing competent conformity 
assessment bodies - regardless of their location.  One step in this direction would be the use of ILAC 
and IAF accreditation as the basis for recognition of facilities. 
321. The representative acknowledged positive bilateral di scussions in which China had invited the 
United States to request a technical discussion with the Certification and Accreditation Administration of China (CNCA).  The United States intended to submit such a request. 
322. The representative of China
 observed that this was a recurrent issue.  China had on previous 
occasions explained its views to the United States in cluding in bilateral discussions and in the TBT 
Committee.  The representative re -emphasized a number of points.  First, in China's view the 
Regulation of the PRC on Certification and Accr editation was consistent with principles of the 
TBT Agreement.  Second, China had concluded a to tal of forty bilateral and multilateral cooperative 
documents with twenty three countries.  Moreove r, China had identified ILAC and MRA as a key 
technical base for mutual recognition between Chin a and other countries.  The representative said his 
government recognised 168 conformity assessment bodi es, including foreign certification bodies.  In 
addition, in recent years the Chinese Government ha d taken a series of measures to simplify the CCC 
certification process and had reduced applicable fees.   These actions were taken to promote China's 
trade with WTO partners. 
(xxx) Korea –  KS C IEC61646:2007 Standard for Thin-film Solar Panels  
323. The representative of the United States  recalled that in the previous TBT Committee meeting, 
the US delegation raised issues concerning Korea's re quirements for the certification of solar panels.  
Since July 2008, Korea had required that solar panels  to be sold in Korea be certified by the Korea 
Management Energy Corporation (KEMCO).  Korea' s standard KS 61646 for the design qualification 
and type approval of thin-film solar panels appeared  to draw from international standard IEC 61646.  
However, the United States was concerned that Korea m odified the standard so that it only applied to 
a certain type of thin-film solar panels, i.e. am orphous silicon (A-Si) solar panels, and not to other 
types of thin-film solar panels.  There were many ot her types of thin-film solar panels currently being 
traded globally as well as others under developmen t.  Since the KS 61646 standard applied only to 
one type of solar panel, other types of solar panels were not allowed to be tested or certified.  As a 
result, these other types of solar panels could not gain the necessary certification to be placed on the 
Korean market.  The United States was not aware of  any other country that applied the IEC standard 
in such a narrow way.  G/TBT/M/52  
 Page 61 
 
 
  324. The representative of the United States said his delegation was also concerned that the one 
type of thin-film solar panel to which standard KS 61646 applied wa s the type of solar panel that 
Korean producers make.  He added that his govern ment was not aware of any scientific or technical 
evidence indicating that there were risks associated with the use of th e other types of solar panels.  
The United States was of the view that Korea s hould adopt the IEC standard without limiting its 
application to only the type of solar panels produced  by its own industry.  This would be more trade-
facilitating than the current system and would also  allow Korean producers and consumers to benefit 
from emerging technologies in the area of energy conservation. 
325. The representative noted bilateral discussions  with Korea in which Korea had expressed 
concern that some of the other solar panels contain certain types of cadmium.  The United States 
shared Korea's concerns on potential environmenta l dangers linked to cadmi um and had established 
legal requirements on its safe and effective use.  Ho wever, according to US solar panel producers, the 
residual level of cadmium in solar panels was ex tremely low since the use of cadmium constituted a 
minor step in the production process and the cadmium  remaining in the panels was minimal.  The 
representative referred to a specific instance of a company producing cadmium telluride panels with 
residual cadmium content of only 2 per cent of a gram per watt basis.  Another example was the case 
of a company producing 200W panels where the amount of cadmium contained in the final product was only 1/8
th of the amount of cadmium found in a si ngle NiCad AA battery.  Another US firm 
whose products were not allowed to be tested and ce rtified for the Korean market produced eight foot 
telluride thin-film solar panels containing, per unit, less cadmium than one size-C NiCd flashlight 
battery.  Since the amounts of residual cadmium we re well below most regulatory levels, the United 
States considered there was no sufficient basis for excluding these products from the application 
scope of standard KS 61646. 
326. The representative recalled Korea's stated inten tion not to allow testing and certification of 
other types of solar panels and to conduct a feasibility  study on the use of such panels.  This decision 
raised two issues:  first, if Ko rea needed to conduct a feasibility study before allowing testing and 
certification of these products, it would confirm that  compliance with the standard was mandatory.  
This would contradict Korea's position that the stan dard is voluntary.  Second, the feasibility study 
could take several years, which w ould substantially delay market entr y for non-Korean solar panels.  
In the view of the United States, the appropriate wa y to address this issue would be to allow foreign 
producers of solar panels to test and certify their products, following which Korea could analyse the evidence produced (instead of conducting a feasi bility study which could take much longer). 
327. The representative recalled Korea's stated inten tion not to allow testing and certification of 
other types of solar panels and to conduct a feasibility  study on the use of such panels.  This decision 
raised two issues:  first, if Ko rea needed to conduct a feasibility study before allowing testing and 
certification of these products, it would confirm th at the standard was mandatory.  This would 
contradict Korea's initial position that the standard is voluntary.  Second, the feasibility study could 
take several years which would substantially delay market entry for non-Korean solar panels.  In the 
view of the United States, the appropriate way to  address this issue would be to allow foreign 
producers of solar panels to test and certify thei r products, following which Korea could analyze the 
evidence produced (instead of conducting a feasi bility study which could take much longer). 
328. The representative of Korea
 noted bilateral discussions had been held with the United States 
on several occasions.  Neither Korean standards a pplicable to solar panels nor their related 
certification were mandatory.  Even without KS 61646 certification, companies can sell their solar 
panels in Korea.  Moreover, Korea's standard fo r thin-film solar panels and thin-film terrestrial 
photovoltaic modules design qualification and t ype approval was largely based on IEC 61646. 
329. The representative of Korea noted that Korea' s standard departed from the international 
standard in matters involving use of cadmium telluri de and copper indium selenide.  He said there G/TBT/M/52  
Page 62  
 
  were valid scientific and environmen tal justifications for this departure, relating to the use of toxic 
substances like cadmium in the manufacturing process of  certain solar panels or in the solar panels 
themselves. 
330. The representative said that in June 2010, KE MCO commenced a feasibility study aimed at 
reviewing technologies other than the amorphous sili con (A-Si) solar panels.  The study is due by 
June 2012.  Korea invited the United States to provi de KEMCO with all information the United States 
deemed relevant during the conduct of the study.  Following completion of the study, KEMCO will be 
able to decide on inclusion of other types of solar panels within the scope of application of standard 
KS 61646.  The representative undertook to deliver to KEMCO all concerns raised by the United 
States in the meeting. 
C. 
EXCHANGE OF EXPERIENCES   
1. Good Regulatory Practice   
(i) Workshop on Regulatory Cooperation between Members 
331. The Chairman  drew the Committee's attention to the draft outline of the Programme for the 
Committee's Workshop on Regulatory Cooperation, circulated on 19 October 2010 as JOB/TBT/7. 
332. The representative of Mexico  reiterated her delegation's interest  to give a presentation during 
the workshop.  Sharing experiences can help iden tify areas for useful cooperation around regulatory 
measures and methods.  Her de legation viewed regulatory cooperation as a catalyst for further 
integration into markets. 
333. The Chairman  thanked Mexico for the offer of a pr esentation and invited the delegation to 
forward details of the presentation at the earliest convenience. 
334. The representative of New Zealand  observed that several of the presentations were being 
organized as joint presentations which underlined  the message of cooperation.  She appreciated 
Mexico's offer of a presentation as it would shed  light on regulatory cooperation in the NAFTA 
region.  The representative observed that developi ng countries and certain regions, for example the 
Caribbean Community, Southern African Development Community and Gulf Cooperation 
Community, were underrepresented in the workshop  presentations and she wondered if Members 
from these groups could volunteer to present their experiences and challenges with respect to 
regulatory cooperation.  Hopefully, Members w ould present both positive and negative experiences.  
New Zealand was enthusiastic about the workshop and the guidance it may provide for choice and design of trade facilitating mechanisms. 
335. The Chairman
 encouraged developing country Members to volunteer to give presentations at 
the workshop. 
336. The representative of Chile  enquired whether they could make their presentation on the APEC 
Agreement on Electronic Products on a joint basis w ith other Members party to the agreement, for 
example Singapore.  She also encouraged pr esentations from Central American Members. 
337. The representative of South Africa  said colleagues in the Southern African Development 
Community intended to make a presentation at the wo rkshop, but had yet to decide who would give 
the presentation. 
338. The representative of the European Union  expressed appreciation for the updates on the 
program. He highlighted the importance of other regional groups (in Africa and the Middle East)  G/TBT/M/52  
 Page 63 
 
 
  making presentations on regulatory coop eration initiatives, and in partic ular developing countries. He 
requested that Members make the links between re gulatory harmonization efforts and more ambitious 
regional economic integration efforts. 
339. He suggested that experiences in international organisations, such as OECD and the UNECE 
be included in the programme, to the extent that their work is relevant for fostering regulatory 
cooperation.  The representative proposed that th e Chairman or the Secretariat contact these 
organisations to explore their availability and inte rest in making presentations.  Bilateral exchanges 
between his delegation and those or ganizations indicated that was such an interest, and he asked 
observers present from those organisations to provide initial feedback on potential topics of presentation.  Finally, he supported the idea, already reflected in the revised programme, of a closing 
Session in the form of a Panel and suggested allo wing sufficient time for discussions among panellists 
and with participants on the lessons learned.  
340. The representative of the United States
 thanked the Secretariat for the draft programme, and 
explained that it strongly supports work to adva nce regulatory cooperation. He stated that the 
Workshop would be a timely and re levant contribution in the context of discussions in the TBT 
Committee, which could strengthen regulatory outc omes and reduce unnecessary barriers to trade.  He 
hoped that Part D of the Workshop could help re gulators overcome impedi ments to international 
engagement, such as resource constraints and narrow mandates. The representative noted that 
outcomes of regulatory cooperation to date have b een uneven, and that his delegation would welcome 
Member suggestions on how to identify successful outcomes, and the factors that produce such 
outcomes. The point made by Brazil that internal  coordination enhances relationships with other 
countries was highlighted, and Brazil's call for incr easing developing country participation in the 
Workshop was echoed. In response to New Zealand's comment about his delegation's participation in 
a NAFTA presentation, he stated that he would disc uss with NAFTA partners, but that his delegation 
was already making two presentations at the Workshop.  
341. The representative of the OECD  welcomed the suggestion of OECD participation in the 
workshop.  She would share the draft programme with colleagues to determine how OECD might 
contribute, and then contact the WTO Secretariat. 
342. The representative of UNECE  suggested UNECE might present on ongoing regulatory 
cooperation initiatives under the Working Party on  Regulatory Cooperation and Standardization 
Policies, regarding development of common re gulatory systems and common regulations, and 
common methods of assessing conformity with regula tions.  She indicated she would consult with 
colleagues on potential areas for presentation, such as on regulatory cooperation in the automotive 
sector, and provide details to the WTO Secretariat. 
343. The Chairman  encouraged Members to finalize their plans and submit information including 
details of their participation to the Secretaria t by 30 November 2010.  He noted the Committee's 
interest in broadening the programme to include  presentations from deve loping countries, regional 
organizations, and other organizations. 
2. Conformity Assessment Procedures 
344. The representative of New Zealand  drew attention to a document circulated by her delegation 
on 17 September 2010 entitled "Trade Facilitation Mechanisms: Guidelines on Choice and Design" (JOB/TBT/5).  The document reflected her delega tion's ongoing interest in developing guidance on 
the choice and design of mechanisms to facilitate tr ade.  It compiled a non-exhaustive list of existing 
materials on trade facilitation mechanisms, which could be augmented with further papers and 
information from Members. G/TBT/M/52  
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  345. The representative of New Zealand said that based on materials available, her delegation had 
prepared a draft outline of guidelines covering context, purpose, typology overview, and key 
considerations.  She hoped the draft could be a starting point for discussion and invited feedback from Members so the document might be further refined.  Questions listed on the fi rst page regarding order 
of the discussion and possible need for additiona l sections may help the feedback process.  The 
representative invited Members to contribute case studies from which lessons might be drawn as well 
as any other inputs to help flesh out the paper.  She observed that the Workshop on Regulatory Cooperation would be a valuable source of information. 
346. The representative observed that the present meeting marked one year since the Fifth 
Triennial Review was held.  Few Member experien ces had been shared and coverage of all regions 
and mechanisms was lacking.  In the view of he r delegation, it would be beneficial to ensure 
implementation of the Fifth Triennial Review r ecommendations before the next Triennial Review, 
leaving only three more TBT meetings to advan ce the matter.  She suggested an initial comment 
period of ninety days for Members to offer input and views, which would be valuable as a first step. 
347. Various delegations expressed appreciation to New Zealand for its document and initiative in 
follow up the Fifth Triennial Review including Hong Kong China
, Egypt , Mexico , Chinese Taipei , 
United States , European Union , China  and Singapore . 
348. The representative of Hong Kong China  said the New Zealand document could be the basis 
for further discussion.  His delegation broadly agr eed with the document and with the fundamental 
principle that the guidelines should not advocate particular mechanisms.  
349. The representative of Egypt  agreed the New Zealand document could be the basis for future 
discussion.  Section C could menti on interregional undertakings.  Ther e could be an additional section 
addressing regional or multilateral undertakings. 
350. The representative of Mexico  said her delegation generally supported the New Zealand 
document and would be pleased to provide more spec ific comments on the proposal.  Mexico attached 
importance to guidelines on conformity assessment, which should cover inter alia  technical assistance 
in this area.  Guidelines could help Members devel op infrastructure and properly engage in different 
conformity assessment schemes. 
351. The representative of Chinese Taipei  said New Zealand's proposal provided a good basis for 
further discussion in follow up to Paragraph 19( c) of the Fifth Triennial Review.  Choices on 
conformity assessment reflect Member's risk manage ment frameworks and therefore the inclusion of 
guiding principles for risk management framework  establishment and operation would be valuable.  
Language reflecting S&D provisions in Article 12 of  the TBT Agreement should be included in the 
introduction or elsewhere in the draft guidelines.  Concerning the typology overview section, the 
representative noted that the document had captured most of the common practices employed by Members for facilitating conformity assessment.  However, multilateral and regional cooperation 
efforts, such as those under APEC, and accredita tion regimes under the International Laboratory 
Accreditation Cooperation (ILAC) and International Accreditation Forum (IAF), could usefully be 
included into the document. 
352. The representative of the United States
 thanked New Zealand for the document, which 
provided useful background for Members to inform and stimulate exchange of information as per the 
recommendation of the Fifth Triennial Review. He co mmented that the document correctly noted that 
domestic regulations will differ around the world accord ing to risk profiles. He noted that Supplier's 
Declaration of Conformity is recognized as the most trade facilitative conformity assessment 
procedure, but it may be inappropria te in particular contexts. The representative offered to share US 
experiences with selecting conformity assessment procedures.  G/TBT/M/52  
 Page 65 
 
 
  353. He inquired as to whethe r some of the options listed for trad e facilitation were more advanced 
than others, in the sense that Members would need  to undertake certain options prior to moving onto 
other more advanced options. Given his delegation's experience he belie ved that this was the case. For 
example, while the TBT Agreement does call for acc epting other technical regulations as equivalent, 
he explained this may not be possible due to di fferences in physical infrastructure and the long time 
frames required for developing relati onships between regulatory agencies in different countries. Once 
a relationship is established, the agencies may begin to share non-public information, with the confidence that it will not be disclosed. His dele gation viewed these preliminary steps as necessary 
prior to moving onto more advanced options, such as mutual recognition and equivalency 
arrangements. He cited experience in developing  a six sector mutual recognition agreement (MRA) 
between the United States and the European Union, which was very challenging and complex, bearing 
a heavy resource burden, and stretched over several year s, even for two jurisdictions at similar stages 
of development, and has not been fully implemente d. Hence the representative suggested that it could 
be instructive for Members to share experiences about the building blocks for enabling greater 
regulatory cooperation between Members. 
354. The representative also questioned the value of Members focusing on MRAs and more 
advanced forms of cooperation in every context. He noted that in certain contexts, MRAs may not be 
appropriate, and may in fact create additional barrier s to trade. An MRA may not be possible if one 
Member does not regulate the sector of interest, if two Members have different ways of regulating the 
same product, and additionally, an MRA may not be co st effective when the volume of trade is low, 
or if trade flows are unidirectional. Should a Memb er insist on an MRA, it could become a barrier to 
trade if there were other more effective ways of achieving the same result, for example, conformity 
assessment through the use of inte rnational accreditation regimes.  
355. The representative hoped Members would take a co mmon sense approach to trade facilitation, 
applying appropriate approaches in different contex ts.  He emphasized that small steps were better 
than no steps.  Also, putting in place necessary building blocks between regulators takes time.  
Advanced forms of cooperation shoul d be used only when necessary, feasible and appropriate.  The 
representative suggested Members focus on the goal of  facilitating trade, rather than emphasizing the 
mechanisms for doing so. 
356. The representative of the European Union
 thanked New Zealand for taking leadership on 
implementing the recommendations of the Fifth Tr iennial Review, and Members for their useful 
comments. He brought to the Committee's attentio n his delegation's proposal to add two additional 
sections to the extensive outline of  issues already provided by New Zealand. First, under "Unilateral 
trade facilitation" in Section III of the New Zealan d paper, the EU was interested to address the 
question of granting trade facilita tion unilaterally, through least restrictive conformity assessment 
procedures, and to share experiences on the criteria informing the choice of conformity assessment procedures in a given regulatory context. These pr ocedures should be based on the relevant risk 
management framework, and he noted that this could help implement the recommendations of 
Paragraph 19B of the Fifth Triennial Review. The representative offered to share EU experience with 
good regulatory practice tools, and in particular im pact assessments for c onformity assessment. He 
reminded that Supplier's Declaration of Conformity was indeed one of the mechanisms listed in the 
Illustrative List of Approaches to Facilitate the Ac ceptance of the Results of Conformity Assessment 
as adopted by the TBT Committee at the end of the Third Triennial Review 
357. Second, the EU representative suggested cons idering relevant initiatives at regional or 
international level aimed at facilitating the accepta nce conformity assessment results by establishing 
or referring to common principles for regulation. He highlighted initiatives within APEC (e.g. MRA 
for telecom equipment), the UNECE Conventions on motor vehicles, OECD (test guidelines and principles for good laboratory practice), as well as  international accreditation schemes under ILAC 
and IAF. In addition, he cited international voluntary cooperation arrangements between conformity G/TBT/M/52  
Page 66  
 
  assessment bodies, such as the International El ectrotechnical Commission System for Conformity 
Testing and Certification of Electrical Equipm ent (IECEE CB Scheme), and the International 
Electrotechnical Commission System for Certification to Standards Relating to Equipment for Use in Explosive Atmospheres (IECEx System). 
358. He agreed with the point made by the Unite d States regarding the need to determine 
prerequisites for different forms of regulatory co operation. The representative noted that the use of 
certain mechanisms depends, inter alia , on the policy context, the regulatory context, the level of 
economic development of partners, existence of sufficient confidence between regulators, 
comparability of regulatory frameworks and infrast ructure for conformity assessment. When placed 
within this context, certain instruments like MRAs may in the long term appear to reduce incentives 
for further convergence, and remove an incentive for approximation. The US-EU MRA, which has 
largely not been implemented, has been an impor tant lesson for his delegation and for the United 
States about the challenges of these approaches, a nd he hoped other Members could learn from this 
experience. 
359. The representative of China
 emphasized the importance of considering a range of factors 
when discussing conformity assessment procedures including diversity of conformity assessment 
measures, differing levels of deve lopment between Members, and diffe rences between Member's rules 
and regulations for conformity assessment.  With r espect to MRAs, important preconditions for such 
agreements may include a sufficiently high tr ade volume, well-suited trade structures, and 
compatibility of the conformity assessment regulati ons.  The representative noted that considerable 
human resources and financial support were requi red for an MRA negotiation.  She emphasized 
practicality of guidelines for conformity assessment, as mentioned in the Fifth Triennial Review, in 
order to pursue the target of efficient and effective trade facilitation mechanisms. 
360. The representative of Singapore  welcomed the New Zealand document as a good basis for 
discussion.  She concurred with New Zealand's sugg estion for further experi ence-sharing which could 
help identify ways to facilitate conformity assessment and assist w ith the development of practical 
guidelines. 
361. The Chairman  noted the lead taken by New Zealand and recalled that one year had already 
passed since the Fifth Triennial Review.  He welc omed the constructive suggestions of Members and 
the experiences shared, in particular with respect  to MRAs.  The Chairman invited Members to 
prepare their papers and help flesh out the skeleton prepared by New Zealand. 
3. Standards 
362. The representative of the OECD  referred to an OECD study entitled "The Use of International 
Standards in Technical Regulations".8  The study assessed technical regulations in three sectors of 
several OECD countries and the extent to which they  follow international standards.  The study took a 
pragmatic approach in defining an internationa l standard as any non-national standard.  The 
representative reported that in all cases countries  under analysis implemented TBT Agreement 
provisions on the use of international standards a nd followed a broad range of non-national standards, 
many of which were not produced by typi cal international standard-setting bodies. 
363. The representative of the OECD noted a lack of  transparency with regard to which non-
national standards were being followed in any par ticular regulation.  This lack of transparency 
severely impeded analysis of whether standards were the basis of technical regulations.  For example, 
                                                      
8 Fliess, B. et al. (2010), "The Use of International Standards in Technical Regulation", OECD Trade 
Policy Working Papers , No. 102, OECD Publishing - http://www.oecd-ilibrary.o rg/trade/the-use-of-
international-standards-in-technical-regulation_5kmbjgkz1tzp-en .  G/TBT/M/52  
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  in some cases different regulatory bodies within a country employed standards in different ways: 
standards might be included as a reference; standa rds might be directly included into a text; or 
standards might be included as references to other standards.  There were difficulties in tracing the 
exact origin of standards in this context. 
364. Furthermore, in some cases non-national sta ndards were incorporated into technical 
regulations without acknowledgement.  While there ex isted national databases of standards linked to 
national technical regulations, often these were not  comprehensive and did not specify regulatory 
objectives.  The representative expressed concern about the lack of publicly available information in 
this context and explained that serious research an d direct contact with regulators were typically 
required to ascertain whether and how n on-national standards were being used. 
365. The representative said the lack of transparen cy was significant because it impeded analysis 
of the use and uptake of standards over time, or anal ysis of the impact of standards on international 
trade, such as in the case of technical regulations following international standards.  She noted that 
interested stakeholders would likely have diffi culty identifying when and where international 
standards were being followed. 
366. The Chairman  noted the importance of the points raised in the OECD study and invited 
Members, observer organizations  and relevant bodies to share experiences and cases studies in 
forthcoming meetings. 
4. Transparency 
367. The representative of the European Union  recalled the importance of the TBT Information 
Management System and its development to Member s. She explained that her delegation would very 
much like to work with Members to further de velop the existing TBT Information Management 
System to become a common WTO website for no tifications, which could help further enhance 
transparency. Reiterating previous comments, sh e explained that a common website could even 
enable Members to carry out notifications direc tly.  This would increase the time available for 
comments. The representative inquired as to the development of a similar initiative in the SPS 
Committee, and wondered whether there had yet b een pilot programs implemented. She asked if 
Members would support the development of such a system, and whether the Secretariat was working 
towards this end. 
368. She explained that the EU had recently completed an internal database for EU Member State 
notifications, with a direct notification function,  which had demonstrated the feasibility of her 
delegation's proposal. Finally, she offered to share th e IT expertise used in the development of this 
website with any Member or the Secretariat. 
369. The Chairman  noted the proposal could be valuable and that he believed there was some work 
occurring to this end in the SPS Committee. He asked  the Secretariat to look into these developments 
and report back to the Committee in the next meeting. 
D. OTHER MATTERS  
370. The Chairman  noted that the particular trade concern on REACH had been raised at 24 TBT 
Committee meetings, including the current meeti ng – the first discussion had taken place on 
20 March 2003.  Over 35 Members ha d engaged in the discussion at vari ous points in time.  Given the 
extent of the discussion, and given that the European  Union had stated that they had replied to many 
questions at previous meetings and did not wish to repeat what had already been said, the Chair 
suggested that the Secretariat compile the questions and answers raised on REACH since 2003, for G/TBT/M/52  
Page 68  
 
  guidance purposes only – and for the sake of making discussions more efficient. The Chair invited 
comments and views from Members on this proposal. 
371. The representative of Argentina
 said that the Chairman's idea was interesting.  Given the 
importance of the issue to Argentina, and given th at his delegation had enga ged extensively on this 
issue in the TBT Committee and bilaterally, he cons idered it to be a positive initiative.  However, 
structuring such a paper was a challenge not to be  underestimated.  He suggested that the European 
Union could perhaps contribute to the process by to  ensuring that information contained therein was 
as accurate and useful as possible. 
372. The representative of India  supported the suggestion of developing such a paper and 
highlighted the importance of clear categorization of  issues.  He believed that such a paper would 
represent value-added for his delegation's capital-based regulators and negotiators. 
373. The representative of Cuba  gave her delegation's support to the Chairman's idea of compiling 
questions and answers on REACH, and stat ed that it should emphasize EU responses. 
374. The representative of the European Union  agreed with Argentina that aspects of the proposal 
would need to be clarified, but that it was an interesting suggestion. With respect to the EU 
contribution, she explained that she would have to consult with experts in Brussels on the extent of 
potential contributions.  She emphasized that her dele gation had taken a very transparent approach on 
this issue and had tried to answer all questions, even  when questions fell outside of the purview of the 
TBT Agreement. 
375. The Chairman  invited the Secretariat to look into the feasibility of the proposal.  
III. TECHNICAL COOPERATION ACTIVITIES  
376. The representative of Thailand  updated the Committee on various technical cooperation 
activities.  In August 2010, the Thai Industrial St andards Institute provided training to the National 
Agency of Science and Technology of Lao People's Democratic Republic on the TBT Agreement.  In 
2009, the TBT Enquiry Point and notification authority welcomed study tours from a Bangladeshi standards organization and the Tunisian National Ins titute for Standardization and Industrial Property.  
In 2008, Bhutan's Standard and Quality Control Authority (SQCA) visited the Thai Industrial 
Standards Institute.  
377. The representative of El Salvador
 thanked the WTO Secretariat for organizing a National 
Workshop on the TBT Agreement and SPS measures, tw o topics which were of great importance to 
El Salvador.  This event would take place on 25-26 November.  
378. The representative of the International Trade Centre  updated the Committee on its technical 
cooperation activities.9  
379. The Chairman  drew the Committee's attention to a document containing the Secretariat's 
technical assistance activities.10  
                                                      
9 G/TBT/GEN/106. 
10 G/TBT/GEN/102.  G/TBT/M/52  
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  IV. UPDATING BY OBSERVERS 
A. INFORMATION FROM OBSERVERS  
380. The representative from the International Telecommunications Union  (ITU) thanked the 
Committee for granting the ITU ad hoc observership status and made a presentation on the ITU and 
Standards.11  
381. The representative of Codex  provided the Committee with an update on its recent events and 
on-going work related to the TBT Agreement.12  
382. The representative of UNECE  informed the Committee that the 20th session of the Working 
Party on Regulatory Cooperati on and Standardization Policies had taken place in November.13  At the 
session, a new group of experts on risk management and regulatory systems was established.  The 
group would develop best practices and recommendati ons on how risk management tools could be 
used to mitigate risks that might hamper econo mic development within the UNECE's mandate of 
technical regulation and standardization policies.   The representative updated the Committee on other 
aspects of work at the 20th session including conformity assessment and on-going secretariat 
initiatives in sectors such as telecoms  and earth moving equipment.  She highlighted the development 
of a skeleton database of market surveillance aut horities and invited delegations to visit the UNECE 
website14 for further information. 
383. The representative of the IEC  provided the Committee with an update on its recent activities 
in developing countries.15 
B. APPLICATIONS FOR OBSERVER STATUS IN THE TBT  COMMITTEE  
384. The Chairman  brought the Committee's attention to the document G/TBT/GEN/2/Rev.2 
containing the list of bodies applying for observer status in the Committee.   
385. The delegate from South Africa  supported the Southern African Development Community's 
(SADC) request for observer status in the TBT Committee.  SADC was comprised of 15 countries, of which 14 were WTO Members.  Facilitation of in ter-regional trade and development of regional 
standards were goals of SADC and the Community had an extensive programme on standardisation, 
quality assurance accreditation and methodology (S ADC–SQAAM) within the Southern African 
region.  Observership status in the Committee woul d complement this programme and contribute to 
integration efforts in the region.  It would also assist the region's wider integration into the global 
family of trading nations and woul d assist implementation of the WTO TBT Agreement in the region.   
386. The delegations of Zambia
 and Namibia  supported the request for observer status by SADC 
and associated themselves with the statement of South Africa. 
387. The Committee agreed  to grant ad hoc observership status to the Southern Africa 
Development Community (SADC).   
                                                      
11 G/TBT/GEN/109. 
12 G/TBT/GEN/107. 
13 Presentations from this meeting are available on 
http://www.un ece.org/trade/wp6/document s/2010/2010_DocsList.html . 
14 http://www.unece.org /trade/wp6/AreasOfWork/Marke tSurveillance/Contacts.html . 
15 G/TBT/GEN/110. G/TBT/M/52  
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  V. REPORT (2010) OF THE COMMITTEE ON  TECHNICAL BARRIERS TO TRADE 
388. The Committee adopted
 its 2010 Report to the Council for Trade in Goods (G/L/940). 
VI. OTHER BUSINESS 
389. The Chairman brought the Committee's attenti on to a letter from the Chairman of the 
Working Group on Trade and Transfer of Technology and his reply to that letter. 
VII. DATE OF THE NEXT MEETING  
390. The next regular meeting of the TBT Committee will take place on 24-25 March 2011 .  
  
__________