RESTRICTED  WORLD TRADE  
ORGANIZATION  G/TBT/M/47 
5 June 2009 
 (09-2705) 
Committee on Technical Barriers to Trade  
  
 
MINUTES OF THE MEETING OF 18-19 MARCH 2009 
 
Chairperson:  Ms Xueyan GUO (China)
  
 
Note by the Secretariat1 
 
 
I. ADOPTION OF THE AGENDA.............................................................................................3  
II. IMPLEMENTATION AND ADMINISTRA TION OF THE AGREEMENT ....................3  
A. STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2................................................................3  
B. SPECIFIC TRADE CONCERNS .......................................................................................................3  
1. New Concerns................................................................................................................... .........3  
2. Previously raised concerns..................................................................................................... 23 
C. EXCHANGE OF EXPERIENCES ....................................................................................................64  
1. Good Regulatory Practice ......................................................................................................6 4 
2. Conformity Assessment Procedures......................................................................................65  
3. Transparency ................................................................................................................... .......65  
4. Standards...................................................................................................................... ...........66  
D. OTHER MATTERS ......................................................................................................................67  
1. Consideration of Speci fic Trade Concerns ...........................................................................67  
2. Workshop on the Role of International Standards in Economic Development ................70  
3. ISO 26000...................................................................................................................... ...........72  
III. PREPARATION OF THE FIFTH TRIENNIAL REVIEW...............................................73  
1. Mutual Recognition, Regulatory Cooperation and Other Trade Facilitation 
Arrangements................................................................................................................... .......73  
2. Global Relevance of International Standards ......................................................................75  
3. Proposal on Specifi c Trade Concerns ...................................................................................76  
4. Transparency ................................................................................................................... .......77  
IV. FOURTEENTH ANNUAL REVIEW OF:...........................................................................77  
A. THE IMPLEMENTATION AND OPERAT ION OF THE TBT AGREEMENT UNDER 
ARTICLE  15.3.......................................................................................................................... ...77 
                                                      
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/47 
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  B.
 THE CODE OF GOOD PRACTICE ...................................................................................................77  
V. TECHNICAL COOPERATION ACTIVITIES...................................................................78  
VI. UPDATING BY OBSERVERS .............................................................................................78  
VII. OTHER BUSINESS................................................................................................................7 9 
VIII.  DATE OF THE NEXT MEETING .......................................................................................80  
ANNEX 1 ........................................................................................................................ ......................81  
  G/TBT/M/47 
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  I. ADOPTION OF THE AGENDA 
1. The Chairperson announced that, under Agenda  item 8, "Other Business", she would address 
the process initiated, in February 2009, by the Trad e Policy Review Body regarding transparency and 
the monitoring of recent trade developments associat ed with the current globa l financial and economic 
crisis.  She drew the Committee's attention to an exch ange of letters with the Chairman of the General 
Council, Ambassador Mario Matus.   
2. The Committee adopted the agenda contained in WTO/AIR/3322. 
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
A. STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2 
3. The Chairperson  recalled that latest list of statemen ts submitted under Artic le 15.2 of the TBT 
Agreement was contained in document G/TBT/GEN/1/ Rev.8, issued on 2 March 2009.  Since the last 
meeting of the TBT Committee, revisions of their original statements had been submitted by Peru 
(G/TBT/2/Add.29/Rev.2) and Viet Nam (G/TBT/2/A dd.98/Rev.1), while El Salvador had submitted a 
supplement to its original statement (G/TBT/2/Add. 78/Suppl.1).  In total, since 1995, 117 Members 
had submitted at least one Statement on implementa tion under Article 15.2.  It was noted that the 
latest list of enquiry point contacts was contai ned in document G/TBT/ENQ/35/Rev.1, issued on 
11 March 2009.2     
4. The Committee took note  of the information provided. 
B. SPECIFIC TRADE CONCERNS  
1. New Concerns 
(i) India - Mandatory Certification for Steel Products (G/TBT/N/IND/32) 
5. The representative of Japan  raised a concern regarding India's mandatory certification 
measures for iron and steel products which had b een announced by the Indian Government on 
9 September 2008.  Some of the measures, contained in a First Order relating to six items, were put 
into effect three days after their announcement, while  a second set of measures, contained in a Second 
Order covering 11 items, would become effectiv e on 12 February 2009.  The Japanese delegation 
appreciated that the Indian Government decided to postpone the implementation of the Second Order 
for one year after the European Communities, Ko rea and Japan had expressed significant concerns 
regarding these measures.  However, his delegati on was of the view that substantial concerns 
remained in terms of their consistency with the TBT Agreement, in particular with Article 2.2. 
6. The Japanese delegate noted that the two Orders  had not been notified to the WTO, although 
the Indian Government had acknowledge d its obligation to do so.  Furthermore, he pointed to the risk 
of the measures creating unnecessary obstacles to intern ational trade, as they might be more trade-
restrictive than necessary to fulfil a legitimate obj ective.  He called upon the Indian Government to 
make efforts to find constructive solutions, including  taking into consideration the withdrawal of the 
measures. 
7. The representative of Korea  shared the concerns raised by Japan.  His delegation expected 
that Indian authorities would provide the relevant information on certification procedures for 
                                                      
2 Regularly updated information on Members' enquiry points is also available on the WTO TBT 
webpage: http://www.wto.org/english/trat op_e/tbt_e/tbt_enquiry_points_e.htm. G/TBT/M/47 
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  exporters, recognize testing reports issued by Kor ean testing laboratories and facilitate the mutual 
recognition of certificates of conformity.  He also expressed his delegation's appreciation of the decision by the Indian authorities to delay by one year the implementation of the compulsory 
certification for steel products. 
8. The representative of the European Communities
 shared the concerns expressed by Japan and 
Korea.  She pointed out that the Indian regulati ons established new requirements which were different 
from those notified in 2007 under G/TBT/N/IND/32 and also differed from international standards.  
Moreover, the European Communities was concerned about differences in treatment for domestic and 
foreign manufacturers.  The representative of the European Communities requested the Indian 
delegation to clarify whether and when India would notify these new requirements to the WTO. 
9. The representative of India  said that he would check details with the concerned authorities in 
capital.  However, he confirmed that the In dian authorities had decided to postpone the 
implementation of the Order for one year, thus rem oving the scope for any immediate concern.  He 
assured the Committee that the comments of all con cerned trading partners would be taken into 
account before the final implementation of the measure. 
(ii) Indonesia - Mandatory Certification fo r Steel Products (G/TBT/IDN/23-24) 
10. The representative of Japan  raised a concern regarding Indonesia's mandatory certification 
system for steel and steel products.  On 6 January  2009, two ministerial decrees had been published 
that had made compliance with certain Indonesi an National Standards (SNI) mandatory.  These 
covered hot-rolled steel sheets and coils, for which ma ndatory standards would be put into effect on 
6 May 2009, and zinc-aluminium-coated steel plates,  for which mandatory standards would enter into 
force on 6 July 2009.  Japan considered these meas ures as a technical regulat ion which could have a 
significant effect on trade of other Members and therefore requested Indon esia, in accordance with 
Article 2.5 of the TBT Agreement, to explain the justification of these measures in terms of the provisions of Articles 2.2 to 2.4 of the TBT Agreem ent.  He requested Indonesia to make continuous 
efforts to find constructive solutions regarding Jap an's concerns, including considering preferential 
treatment of foreign manufacturers. 
11. The representative of Korea
 welcomed the withdrawal by Indonesia of the implementation of 
mandatory SNI certification for zinc-coated steel sheets, notified under G/TBT/N/IDN/17 last year.  
However, he shared the concerns raised by Japan regarding the new compulsory certification 
measures for certain steel products.  He suggested  that Indonesia grant a grace period which would 
allow trading partners to prepare for the certifi cation, to accept test reports issued by Korean 
laboratories, and to exclude certain products from th e regulation, in particular steel sheets used for 
automobiles.  He also suggested that bilate ral discussions on this issue be intensified. 
12. The representative of the European Communities  noted that Indonesia had notified two 
decrees that rendered certain Indonesian national standards mandatory on 23 February 2009 with the 
reference G/TBT/N/IDN/23 and 24.  She asked if these notifications covered the same issues 
addressed by Japan and Korea.  She also observed that  the notifications did not mention any final date 
for comments nor any explanation as to why such a date could not be mentioned.  She requested 
Indonesia to clarify if the notified measures had al ready been adopted and on which international 
standards the Indonesian standards were based. 
13. The representative of Chinese Taipei  associated her delegation with the comments made by 
Japan, Korea and the European Communities.  She al so stressed that the notification circulated on 
23 February 2009 did not provide any period for comme nts.  She expressed particular concern about 
the early entry into force of the measure and the contradictory requirements in SNI standards.  She 
requested Indonesia to provide a period for comments on the notified regulations of not less than 60  G/TBT/M/47 
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  days and to provide for an interval of not less th an six months between the publication of the measure 
and its entry into force, so that producers would have  sufficient time to adapt to the new requirements, 
as specified in the Ministerial Decision on Implemen tation-related issues and concerns adopted on 14 
November 2001 (WT/MIN(01)/17) with regard to  Article 2.12 of the TBT Agreement.  The 
representative announced that Chinese Taipei would submit comments in writing and urged Indonesia 
not to adopt the notified measures befo re concerns were fully resolved. 
14. The representative of Indonesia  took note of the concerns raised which would be 
communicated to the capital.  He pointed out that In donesia had held constructive bilateral discussions 
with Japan and Korea, during which steps to resolve the issue had been identified.  His delegation was 
open to further discussions with all delegations concerned.   
(iii) Thailand -Mandatory Certific ation for Steel Products 
15. The representative of Japan  expressed concerns about Thaila nd's new criteria for conformity 
assessment with mandatory standards for steel produc ts which had been put into effect by the Thai 
Industrial Standard Institute (TISI) on 26 January 20 09.  It appeared that TISI had abolished these 
criteria as of 4 March 2009 and released different criteria at the same time which would become 
effective on 1 May 2009.  It had also been announ ced that TISI would release detailed guidelines in 
April 2009 after hearing from the relevant private sector stakeholders.  The Japanese representative 
maintained substantial concerns in terms of the ne w criteria's consistency with the TBT Agreement.  
The new criteria would still require importers and foreign producers to bear a heavy burden for 
product certification, as they would be required to provide a number of documents certifying 
conformity with the mandatory standard, allow TI SI to conduct sampling tests for every shipment, 
and undergo annual TISI factory and facility inspections.  He pointed out that the new criteria could 
potentially create unnecessary obstacles to internationa l trade.  He therefore requested Thailand to 
make efforts to find constructive solutions, in cluding considering withdrawing the measure. 
16. The representative of Korea  shared the concerns raised by Japan and also urged Thailand to 
reconsider the measure.  More generally, Korea ex pressed serious concerns regarding some Members' 
tendency to implement their conformity assessment procedures in a trade-restrictive manner, in 
response to the downturn of the world economy.  Su ch actions could create a harmful effect on world 
trade and delay the recovery from the economic cris is further.  The Korean representative therefore 
urged all Members to fully comply with Article 2. 2 of the TBT Agreement, which stipulated that 
"Members shall ensure that technical regulations are not prepared, adopted or applied with a view to 
or with the effect of creating unnecessary obstacles to international trade.  For this purpose, technical 
regulations shall not be more trade-restrictive than necessary to fulfil a legitimate objective." 
17. The representative of Thailand  pointed out that TISl's new criteria for certification, which 
would be effective as of 1 May 2009, were the same  in principle as the previous criteria, and only 
minor changes had been made with the objective of ensuring quality and consumer confidence in 
products.  He highlighted that the new criteria would be applicable to all products of all origins, and 
thus adhered to the principle of equal treatment for importers and local manufacturers.  Nonetheless, 
importers would enjoy special treatment, as they would have an additional choice for demonstrating 
compliance.  Furthermore, he said that the revised  certification criteria observed ISO 9001, as well as 
ISO/IEC Guides 65 and 67.  On 9 March 2009, TISI ha d held consultations with interested parties, 
and over 2000 local and foreign representatives par ticipated.  A revision had been notified to the 
WTO.   
18. With regard to the specific concerns that had b een raised, the Thai representative clarified that 
the requirement to provide documents would essentia lly deal with the quality management system 
ISO 9001.  As this system was usually implemen ted and documented by manufacturers, this should 
not pose any additional burden for those already in co mpliance.  On shipment sampling, he noted that G/TBT/M/47 
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  TISI would only conduct visual and document insp ection.  Product sampling for tests would only be 
necessary when there was an indication of non-confor mity or violation.  Importers would have the 
choice of demonstrating compliance through either site  visits or importer inspection, while in the case 
of local manufacturers, an annual visit of the fact ory was required.  Additionally, he noted that the 
new criteria were still open for review and assured the Committee that Thailand would inform all 
relevant stakeholders should an add itional review become necessary.   
(iv) Malaysia - Conformity Assessment Procedures for Steel Products 
19. The representative of Japan
 raised a concern regarding the procedure for assessing conformity 
of steel products with Malaysian mandatory st andards that was introduced by Malaysia on 
15 November 2008.  He said that these measures effe ctively made it impossible for imports of the 57 
steel products concerned to clear Malaysian customs without an excessively cumbersome conformity 
assessment procedure.  Consequently, these measures created de facto  trade obstacles in terms of 
stagnant freight distribution and additional fees for storage.  As the stated purpose of the new measure 
was to ensure the safety of steel products for c onstruction use, he suggested that they should be 
applied only to steel products for such use.  He called upon Malaysia to ensu re that the new measure 
be fully consistent with Article 5.1.2 and other Ar ticles of the TBT Agreement and to make efforts to 
seek constructive solutions to address Japan's concerns , including the considera tion of withdrawal of 
the measures.   
20. The representative of Malaysia  took note of the concern and would forward it to relevant 
authorities in the capital as soon as possible for consultation and appropr iate action.  In the meantime, 
his delegation would welcome bilateral discussions with Japan on this issue. 
(v) EC -  Seal products (G/TBT/N/EEC/249) 
21. The representative of Norway  raised a concern about the European Communities' notification 
G/TBT/N/EEC/249 concerning trade restrictions fo r seal products.  This measure would heavily 
impact on Norway's trade in seal products, both to  the European Communities and transiting through 
the European Communities to other markets.  She noted that the In ternal Market Committee of the 
European Parliament had recently adopted a versi on of the proposed regulation which was different 
from the Commission proposal notified to the WTO and would further expand the trade ban.  She expressed doubts as to the WTO consistency of both versions.  On the original proposal from the European Commission as notified to the TBT Committ ee, she noted that it contained a ban on imports 
that did not follow product-related criteria.  In stead, exceptions were based on non-product-related 
process and production method requirements (PPMs) .  Trade would only be permitted under this 
proposed regulation if the hunt was performed in a specific way according to criteria determined 
unilaterally by the European Communities and produc ts would be subjected to labelling.  She 
questioned whether this approach was permi ssible under Article 2 and Annex 1 of the TBT 
Agreement.  While the Norwegian representative stre ssed that technical regulations could be based on 
legitimate environmental concerns, she believed that  environmental concerns were not the objective 
as seal populations were not threatened.  Therefor e, she questioned whether governmental regulations 
that distinguish two otherwise like products, based on ethical concerns relating to the way that they 
were produced, could fulfil the requirement s of Article 2.2 of the TBT Agreement. 
22. As far as the proposal from the European Parliament was concerned, the Norwegian 
representative noted that it constituted an out-right  ban on seal products except where the hunt was 
performed by Inuits.  While she agreed that the trad itional lifestyle of a particular coastal indigenous 
group should be safeguarded, she pointed out that the traditional seal hunt of other coastal populations 
should be equally protected.  Banning the trade in products hunted by coastal populations living 
outside the European Communities,  while allowing trade in products hunted by coastal populations 
living within the European Communities could cont ravene the international obligations of the  G/TBT/M/47 
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  European Communities.  She also noted that the ban proposed by the European Parliament would 
have exceptions for "small scale hunting".  She highli ghted the fact that the proposed regulation - in 
both versions - claimed that the ban and exceptions were justified under the "public morals exception" 
in Article XX(a) of the GATT 1994.  However, No rway questioned how a ban with exceptions that 
were based on the persons that hunted and the number  of animals that they hunted, rather than the 
hunting methods, could fulfil the ethical objectives.   
23. The representative of Norway further asked th e European Communities to explain how a ban 
on the transit of products through the European Communities could be justified based on consumer 
perceptions within certain EC member States.  She concluded that, as the Norwegian seal hunt was performed to the highest ethical and animal welfar e standards, a ban on imports of seal products into 
the European Union, and on transit through the Eu ropean Union, could set a dangerous precedent for 
trade in animal products that were harvested in a su stainable and ethical manner.  She also noted that 
seal products competed in the EC market with pr oducts from other animals, such as deer and boar, 
that were hunted within the European Communiti es without being subject to the same strict 
restrictions.  She urged the European Communities to ensure that should any regulation be finally 
adopted, it be fully consistent with the internati onal obligations of the European Communities.  She 
stressed that Norway would have to consider a ppropriate action under the WTO should its harvest of 
its natural resources be impeded by unjustified restrictions.   
24. The representative of Canada
 shared the concerns raised by Norway.  She commented that, if 
the regulation that was notified by the Commis sion was adopted, the European Communities would 
be unilaterally establishing criteria for animal welf are, not only for products entering their territory, 
but also for products being transported through its te rritory.  If, on the other hand, the version of the 
regulation put forward by the Parliamentary Committee was adopted, th e European Communities 
would be prescribing how and for what purposes Inuit communities may use seal products.  Both approaches were unacceptable to Canada.  In eith er form, the regulation would be both unnecessary 
and inconsistent with the WTO TBT Agreement as well as with the EC's own legislation.  She pointed 
to testimonies from Inuit communities as to the damaging effect of the proposed measures and to 
studies undertaken by the EC which had shown seals could be - and were - killed humanely.  She 
therefore urged the European Communities to recons ider the proposed measure and highlighted that 
Canada continued to reserve its ri ght to take any appropriate action to defend its rights and interests 
under the TBT Agreement and other relevant WTO agreements, and would consider all options 
available to it so as to protect the livelihood of coastal and northern Canadians and their families. 
25. The representative of Iceland
 shared the concerns raised by Norway and Canada. 
26. The representative of Brazil  asked that the European Commun ities provide clarifications on 
the ban on the transit of products through the European Communities. 
27. The representative of th e European Communities  explained that the proposal was notified to 
the Committee at the request of Norway and Canada  at the previous Committee meeting.  While the 
European Communities had done so to ensure tran sparency, her delegation did not consider this 
proposal to fall within the scope of the TBT Agr eement and therefore believed that it is was not 
appropriate to discuss it in the TBT Committee.  She underlined that her delegation had been in 
contact with the interested parties on this propo sal early in the drafting process and was willing to 
pursue these bilateral discussions.  She noted that th e regulation was still in the early stages of the 
legislative process, as the European Parliament would still have to adopt its position in a plenary 
session in early April, and the Council likewise.  Th e Commission would only then give its opinion on 
the suggested amendments.  She invited interested  Members to submit their comments by the end of 
the comment period of 11 May 2009. G/TBT/M/47 
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  (vi) China - Quality Assessment System for Imported Cotton (G/TBT/N/CHN/336) 
28. The representative of the United States
 raised concerns regardi ng China's registration and 
quality assessment system for cotton which w as established by Announcement No.  87 on 
"Administration Measures for the Registration of  Overseas Cotton Exporters" of 5 August 2008 and 
the related  "Circular on the Issuing of Administra tive Regulations on Qua lity Credit Assessment of 
Overseas Cotton Exporters" published on 28 Novemb er 2008 by China's Administration of Quality 
Supervision, Inspection and Quarantine (AQSIQ).  He  pointed out that the system appeared to be 
inconsistent with international practice, by establishing a government-run scheme to grade foreign 
exporters of cotton to China, while in other countries cotton quality was not addressed by the government, but by commercial parties through inte rnational contracts and commercial arbitration 
regimes.  Furthermore, the means by which Ch inese Government inspectors would assess the quality 
of imported cotton appeared to diverge from intern ational testing and assessment methods, as well as 
from the testing and assessment methods used for domestic cotton. 
29. The US representative further highlighted that China would assign foreign cotton suppliers a 
downgraded "B" or "C" rating when government insp ectors identified deficiencies in cotton quality or 
weight in light of contract terms that include cott on quality standards.  His delegation was particularly 
concerned about the fact that such lower ratings could be assigned to an exporter based on a single incident and based on a small and likely unrepresenta tive sample.  AQSIQ had not clarified whether it 
would publicize cotton exporter ratings, but doing so would risk to unfairly damage the reputation of 
foreign suppliers.  Moreover, it was noted that, while the quality grading system provided an 
opportunity to appeal a "B" or "C" rating, such an a ppeal could only be made to the same entity that 
had issued the initial grade with no opportunity  for appeal to an independent entity.   
30. Further, the representative of the United States called into question whether registration was 
effectively voluntary, as claimed by China.  He pointed  to the fact that exporters that did not register 
were subject to pre-shipment inspection and were automatically assigned a "C" rating.  He also reported that Chinese cotton mills had been refu sing to do business with US producers that were 
unregistered.  He suggested that registration could therefore be de facto  mandatory.  Additionally, the 
United States was concerned that the registrati on and rating system required the disclosure of 
confidential business information relating to the trad ing volume, value, and history of an exporter's 
business in China, while this information was not sought from domestic cotton producers.  He 
requested that China explain its objec tive in requiring such information. 
31. The representative of the United States also st ressed that AQSIQ's registration and quality 
assessment system seemed to apply only to imported cotton, whereas domestic cotton was not subject 
to a similar registration or quality assessment syst em.  This provided unequal competitive conditions 
for imported cotton compared to domestic cotton.  He expressed concern that Chinese purchasers of 
cotton would view imported cotton from a "B" or "C" rated exporter as inferior to cotton from 
Chinese producers which were not subject to such a rating system.  He noted that no other country 
penalized foreign cotton exporters based on qualit y or contract performance.  He requested 
clarification from China on the issues raised and suggested a six-month suspension of the measures which had already come into effect on 15 March 2009, so as to provide an opportunity to engage in a dialogue on a workable solution to address China' s objectives in a manner consistent with global 
practices.  Furthermore, he requested that China notify the 28 November 2008 "Circular on the Issuing of Administrative Regulations on Quality Cr edit Assessment of Overseas Cotton Exporters" to 
the WTO, in order to give Members the opport unity to present comments in writing and provide 
China an opportunity to make appropriate modificat ions to its proposed regulations reflecting these 
comments. 
32. The representative of Australia
 shared the concerns raised by the United States.  She noted 
that the Announcement No. 87 and the quality assessment circular providing details on the  G/TBT/M/47 
 Page 9 
 
 
  implementation of an import registration system wa s first notified in general terms to the Committee 
in February 2008.  She expressed appreciation of  the constructive approach taken by Chinese 
authorities, in particular AQSIQ, on this issue and her expectation that further work on the issues 
would resolve problems that Australia had identified with this system.  She called on China to provide 
additional time for consultation.  Further, she requested clarification on several aspects of the 
measures.  She noted that China had notified on 20 February 2008 that "no cotton from the supplying 
enterprises shall be permitted to enter into mainland China without such registration".  She requested 
China to clarify whether the measures now put into effect were mandatory or voluntary.  If they were voluntary, she asked for clarification on the imp lications for exporters choosing not to obtain 
registration.  She also pointed to the fact that s uppliers could be placed into "B" and "C" categories for 
periods of three to six months on the basis of non-compliance of only one or two inspected shipments.  
She asked China to provide clarification as to whether these three and six month periods were 
mandatory minimum periods, or whether it would be possible to consider individual suppliers' records 
in order to rectify quality issues in a shorter peri od of time than six months.  She also requested 
additional information on how the views of supp liers would be taken into account in grading 
decisions, and what formal process existed for an i ndependent appeal of any decision.  Furthermore, 
she requested that China demonstrate that domestic suppliers were subject to similar requirements.   
33. The representative of the European Communities
 noted that her delegation had already 
outlined its concerns in comments sen t to China with regard to this  notification.  However, this 
notification had only contained basic information about the planned registration system, while the 
more precise implementing measures had not been notified.  It was the EC's view that quality 
concerns were not a legitimate objective to justify a system that went beyond a simple registration for 
producers, but involved a quality credit evaluation system.  The evaluation of the quality of cotton could be controlled by economic ope rators themselves, in particular  through commercial contracts; 
the interference of state authorities did not seem to be necessary or proportionate.  She also stressed 
that the criteria for the quality evaluation were  unclear.  The European Communities therefore 
requested China to reconsider the introduction of  such a registration and evaluation system and 
suggested further bilateral consultations. 
34. The representative of China
 explained that, as the largest cotton importing country in the 
world, China had faced many serious quality a nd safety problems in imported cotton over the past 
years.  The new registration system was devise d to allow for a better demonstration of the 
qualification of cotton companies and in turn allo w more convenient customs clearance for companies 
with good records while applying stricter administra tion to others.  The measure was therefore a trade 
facilitation measure.  He stressed that China had fu lfilled its transparency obligation by notifying the 
draft measure in February 2008.  While, at that time, comments were solicited from other Members, 
China had not received comments from the United States.   
35. The representative of China also pointed to the f act that China had dealt with more than 120 
foreign cotton companies' applications and had already approved 104 of them, including those of 
eight companies from the United States.  He explained that the registration was free of charge and had not affected trade in cotton.  Cotton exporters that  had not registered before  15 March could still apply 
for registration free of charge.  He assured the Committee that business information would be kept 
strictly within the relevant government authorities a nd not be shared with any third party.  He also 
highlighted that compared to imported cotton, dom estic cotton was subject to stricter market access 
conditions, as defined in a regulation jointly i ssued by the State Development and Reform 
Commission, the State Administration of Industry and Commerce, and AQSIQ in October 2006.  He explained that, if a company wanted to appeal the r esult of the evaluation of the grades, it could do so 
to the relevant Chinese Government body which woul d then re-evaluate the grading based on further 
information provided by the company. G/TBT/M/47 
Page 10  
 
  36. The representative of the United States
 thanked the Chinese delegation for the clarifications 
provided.  Regarding the fact that the United States did not file comments on the measure when it was first notified, he pointed out that the circular which actually contained the quality assessment criteria 
that AQSIQ inspectors would be using had not been  not notified, so there had been no chance to 
officially comment on it.  However, US officials had met Chinese officials to discuss the matter many 
times.  Further, he noted that while several US pr oducers had registered, this should not be interpreted 
as acceptance by US industry of the current system.  The registration was made under duress as it was the only way that products that were already on their way could enter into Chinese territory. 
37. The representative of China
 said that companies with a certificate of registration could get 
more convenient customs clearance treatment, while those which were not registered needed to 
provide some information and were subject to nor mal on-site inspection when their products arrived 
in Chinese ports.  They were, however, not prohib ited from importing.  Hence, the registration was 
voluntary. 
(vii) Colombia - Quality and Identity Requirements  for Distilled Spirits (G/TBT/N/COL/120 and 
121) 
38. The representative of the United States,  with regards to the notification G/TBT/N/COL/121, 
pointed out that the measures had the potential of restricting US exports of distilled spirits to 
Colombia.  Colombia had chosen requirements for various elements of spirit manufacture that were 
different from international practice, such as proposing a maximum alcohol content level.  
Clarification was sought on Colombia's objective in setting a maximum limit, given that no health and 
safety concerns had been identified.  Additionally,  the regulation would also set a minimum alcohol 
content for liqueurs that was higher than internationa l practice, thus restricting certain liqueur exports 
to Colombia.  The regulation would also define di stilled spirits products through the use of minimum 
and maximum limits on naturally occurring constitu ents, which could also restrict exports, for 
example of certain US vodka and gin products becau se of maximum limits on total congeners, or of 
certain US rum products because of minimum limits on total congeners.  Other proposed parameters 
could have similar effects, for example, mandati ng a minimum aging period for whiskey of three 
years and restricting aging methods for brandy.  In addition, the omission of flavored spirits from the 
regulation raised questions as to whether flavored  vodka and rum could be shipped to Colombia.  
Colombia was requested to clarify its reasons for such provisions.   
39. The representative of the United States also noted that draft regulations required that 
shipments of beverage alcohol be accompanied by a "quality certificate issued by the producer in the 
country of origin in order to indicate the product' s suitability for human consumption."  Given that 
Colombia already had established sanitary requireme nts, he expressed his delegation's concern that 
this requirement was redundant and asked for fu rther information on the rationale for additional 
requirements.  Concerning the requirement that th e product and brand "must be clearly, visibly and 
indelibly labelled in Spanish ...  ", he requested Co lombia to clarify whether it was intended that brand 
names be translated into Spanish and if so for wh ich reasons.  Colombia was also asked to confirm 
that it intended to recognize Bourbon and Tennesse e Whisky as distinctive products of the United 
States.  He asked that Colombian authorities take account of oral and written comments and suggested 
that technical discussions be held on these issues. 
40. The representative of the United States, with regards to the notification G/TBT/N/COL/120, 
explained his delegation's understa nding that Colombia would requi re most alcoholic beverages 
entering three special customs zones to be labelled as exclusively for entry and importation in specific 
ports and that this label would be required until December 2009.  He requested Colombia to clarify 
what would happen once this provision expired.  W ould special labels no longer be required, would 
Colombia return to the labelling specifications th at were notified, requiring that most alcoholic 
beverages be labelled with the statement “ Exclusively for import into the Republic of Colombia ”  G/TBT/M/47 
 Page 11 
 
 
  regardless of port of entry, or was Colombia pla nning to uphold the current labelling provisions for 
the three special customs zones?  
41. The representative of th e European Communities  shared the concerns raised by the United 
states with regard to the Colombian notifica tion G/TBT/N/COL/121 and also expressed concerns 
regarding notification G/TBT/N/COL/120, which al so dealt with alcoholic beverages.  She 
highlighted that both draft measures introduced a number of requirements that diverged from 
international practice and appeared to constitute  an unnecessary barrier to trade, for example 
regarding the  definitions of spirit drinks categories or minimum/maximum alcohol content 
requirements.  Furthermore, she noted her delega tion's concerns that the draft regulations would 
impose overly strict labelling obligations, which woul d incur important costs for economic operators.  
The draft resolution notified under G/TBT/N/CO L/120 introduced certain specific requirements 
which appeared to affect only imports and hence would be in breach of Article 2.1 of the TBT 
Agreement.  She therefore requested Colombia to indicate the reasons for diverging from international 
practice, and for setting strict labelling requirements fo r alcoholic drinks.  Colombia was also asked to 
clarify the relationship between the two notifi cations G/TBT/N/COL/120 and 121.  Furthermore, 
Colombian authorities were urged to provide a suffi cient transitional period for producers to adapt to 
the new requirements. 
42. The representative of Colombia  noted that bilateral consulta tions had been held with a 
number of countries, including the United States.  The comments that had been received to date had been analysed and studied by the appropria te authorities and detailed responses would be 
communicated.  Comments on the notification G/TBT/N/COL/120 would also be studied by the 
Colombian Government which had shown in the p ast to respond to concerns by modifying or 
withdrawing measures if necessary.  With regard to the notification G/TBT/N/COL/121, she asked the 
European Communities to submit their comments in writing, so that these could be analyzed and 
appropriately considered by the Colombian Government. 
(viii) Ecuador - Test report and certificate of conformity  for industrial products including tyres, 
steel products and automobile co mponents  (G/TBT/N/ECU/41-43) 
43. The representative of the United States
 raised concerns with respect to the new conformity 
assessment requirements in Resolutions No. 001- 2008, 002-2008 and 003-2008, which implemented 
various articles of the Ecuadorian Quality Contro l System Law (No. 2007-76).  The resolutions 
introduced new requirements on a wide-range of produ cts, including apparel and footwear, rubber and 
tyres, safety glass, transformers, ceramic and porcelain house- and tableware, white goods and 
appliances, auto parts, cement, plastic, steel and al uminium, matches, batteries, and lubricants.  He 
took note of the 180 day delay in enforcement Ec uador announced pending its development of new 
procedures to implement these requirements.  He also  stressed that the initial six-day period between 
adoption of the measure and its publication and effec tive date had been insufficient for exporters to 
respond to the new requirements.  He noted that, as the requirements had become effective on the date 
of publication, and there had been no WTO notifica tion, importers had not been able to comply, and 
many US manufactured goods had been held at the border.  Entry of goods had been delayed until 
either the importer ensured that the new requi rements had been met or provided a substitute 
certification or the specific product shipment receiv ed an exemption from the Ecuadorian authorities. 
44. The United States was concerned about the lack of clarity regarding the details of the new 
requirements with respect to the criteria Ecuador used  in listing products subject to the requirements. 
Clarification was also requested about which certif ication bodies were qualified to certify conformity 
with Ecuadorian requirements.  The US representativ e highlighted that companies had been unable to 
find an accredited certification body for the require d scope of certification for certain products 
because, among other reasons, no country had previously  identified a need for such certification.  He 
explained his delegation's assessment that the health, safety, or other rationale that would require third G/TBT/M/47 
Page 12  
 
  party certification for these products was unclear a nd requested clarification in this regard.  His 
delegation appreciated Ecuador's willingness to accept substitute certificates and to issue exemptions 
as well as the fact that Ecuador had made some equivalency determinati ons between domestic and 
international standards.  However, he stressed that  more time was needed to understand the details of 
the equivalency determinations and their relationship to the new conformity assessment requirements.  
He noted that constructive discussions with Ecuador had taken place and suggested that bilateral talks 
to resolve the issue should continue. 
45. The representatives of Colombia
 and Mexico  supported the concerns raised by the United 
States and called on Ecuador to revise its proposed regulations.  Colombia expressed its interest in 
having bilateral discussions on this issue in the fra mework of its mutual recognition agreement with 
Ecuador.   
46. The representative of Chile  endorsed the comments made by the United States, Colombia and 
Mexico.  She noted that exports of several Chilean  companies had been negatively affected by the 
measure which had been introduced unexpectedly a nd without an adequate transition period.  She 
stressed that the new requirements were complex and contained a number of confusing provisions.  
She also noted that a significant delay had occurred  in the required procedures.  While bilateral 
consultations had already been held, she expressed the need for further clarifications and dialogue.   
47. The representative of Korea  associated his delegation with the concerns raised by the US, 
Colombia, Mexico and Chile.  He expressed his delegation's appreciation of the 180-day grace period 
on compulsory measures granted by Ecuadorian author ities in February 2009.  However, even after 
the postponement of the implementation date, Korean exporters still had concerns that the conformity 
assessment regulation constituted an excessive burden.   He therefore suggested that the regulated 
items be limited in accordance with Article 2.2 of  the TBT Agreement.  Regarding the conformity 
assessment procedure, he suggested that the system  of Suppliers' Declaration of Conformity (SDoC) 
should be maintained. 
48. The representative of the European Communities  noted that several of their economic 
operators had indicated that barriers to trade ha d been encountered because of the new conformity 
assessment procedure.  She also pointed out that th e measures had already ente red into force when the 
notifications G/TBT/N/ECU/41-43 were made, in contravention of Article 2.9.2 of the TBT 
Agreement.  Her delegation was analyzing th e situation and would send written comments to 
Ecuador.   
49. The representative of Ecuador  explained that the new conformity assessment mechanism that 
had been put in place in order to ensure that  domestic as well as impor ted products were only 
marketed in Ecuador if they complied with the quality and safety requirements established by domestic legislation.  The new mechanism had b een established through resolutions of the National 
Quality Council, the updating of the list of goods s ubject to technical regula tions, and the recognition 
of entities emitting conformity assessment certificates.   The Ecuadorian delegation believed that the 
new procedures were both more effective in achieving  their objective and in conformity with the TBT 
Agreement.  However, due to the observations and comments made by several Members, Ecuador 
was re-evaluating these measures in order to estab lish a mechanism taking into account the concerns 
expressed in the Committee.  Ecuadorian author ities were working on a general framework for 
conformity assessment which would reform the notified resolutions.
3   
50. Until this new framework was finalized, impor ted products had to be accompanied by a 
recognition certificate in one of the following forms: a conformity certificate issued at origin by an 
accredited organism recognized by the Ecuadorian Accreditation Organisation (OAE), which certified 
                                                      
3 A communication was subsequently sent by Ecuador and is contained in G/TBT/W/308.  G/TBT/M/47 
 Page 13 
 
 
  fulfilment of mandatory Ecuadorian technical sta ndards and regulations; a conformity certificate 
issued at origin by an accredited body which cer tified fulfilment of an international standard 
equivalent to the obligatory Ecuadorian standard or regulation; or a declaration of conformity of the 
manufacture according to standard ISO 17050-1, dealing with companies registered with the quality system certification ISO 9001, issued by a body duly accredited and recognized by the OEA.  In 
respect of the latter, testing reports certifying conf ormity with Ecuadorian or  international standards 
also had to be provided.  Furthermore, the conf ormity certificates issued under mutual recognition 
agreements would continue to be accepted within  the terms and conditions of those agreements.  
Modifications to the measures at issue were being prepared would be notifie d to Members as soon as 
possible in accordance with the TBT Agreement.   
(ix) EC - Marketing Standards for Olive Oil (G/TBT/N/EEC/226) 
51. The representative of the United States
 raised concerns regarding the European Communities' 
marketing standards for olive oil.  He clarified that these concerns did not primarily concern the 
notification G/TBT/N/EEC/226, but more generally th e current EC olive oil marketing requirements.  
In the view of the United States these requirements a ppeared to be trade restrictive, as they were 
based on standards elaborated by the Intern ational Olive Council (IOC) which was not an 
internationally recognized standard-setting body.  On  the contrary, the IOC standards were developed 
by predominantly European olive oil producers, as the IOC did not represent all countries that produced olive oil.  The representative of the Unite d States mentioned that the IOC survey on which 
the requirements were based also noted "the poor representivity of the data presented."   
52. He pointed out that the values chosen by th e European Communities for certain parameters, 
based on IOC grading standards, often worked to pr eclude olive oil produced in other regions of the 
world from being labelled as extra virgin olive oil.  He  explained that this was caused by the fact that 
IOC grading standards for fatty acid composition were  based on historical data from Europe and did 
not account for fundamental climatic and geographical  factors that could affect key components of 
fatty acid and sterol composition, such as linolenic acid and campesterol, causing them to vary from 
region to region.  For instance, while the proposed  USDA standard of a 1.5 per cent linolenic acid 
parameter would allow extra virgin olive oils produ ced anywhere in the world to be labelled as such, 
the EC parameter of 1.0 per cent would restrict some extra virgin olive oil produced outside the 
European Communities from bearing that label.  He  also stressed his delegation’s concern that the 
European Communities was currently seeking to export these requirements into Codex.  He urged the 
European Communities to reconsider its requirement s and to refrain from efforts to transform an 
essentially regional standard into a Codex standard.  The EC proposal in Codex raised concerns about 
whether its purpose, or at least its effect, was to  try to unjustly preclude extra-virgin olive oil 
produced outside the Europ ean Communities from bearing the extra virgin label. 
53. The representative of New Zealand
 shared the concerns expressed by the United States and 
stressed that her delegation also considered the o live oil marketing standards to be more restrictive 
than necessary to achieve a legitimat e objective.  She pointed out that not the IOC, but Codex was the 
pre-eminent food standard setting body, while the IOC only set standards for its mostly European 
membership which was much smaller than the member ship of Codex.  She noted that the IOC neither 
enjoyed the status of Codex nor was it referenced  in the SPS and TBT Agreements.  Therefore, she 
expressed her delegation's concern about the system ic implications of the European Communities 
unilaterally adopting a standard de veloped by another organization which would effectively subvert 
the Codex process.  She quoted the European Commi ssioner for Agriculture, Mariann Fischer Boel as 
saying: "Different agricultural traditions and varied  extraction and blending practices mean that the 
taste of olive oils from different countries can be ve ry distinct."  The representative of New Zealand  
pointed out that, in the same way, the levels of el ements such as linolenic aci d in high quality olive oil 
also varied from country to country depending on  geographical and clima tic conditions and that 
labelling regulations should take account of the realities in all olive oil producing countries.  Her G/TBT/M/47 
Page 14  
 
  delegation's main concern was the divergence from in ternationally accepted standards, similar to the 
concern the European Communities had previous ly raised itself regarding Colombia's new 
requirements for distilled spirits. 
54. The representative of the European Communities
 informed the Committee that a reply to the 
comments by the United States had recently been s ubmitted and noted that her delegation had not 
received comments from New Zealand prior to the meeting.  The draft Commission regulation 
amended certain sections of Commission Regulati on 1019/2002 on marketing standards for olive oil, 
mainly by introducing an obligation for the declaration of origin of olive oils destined for retail stage; 
rules on the labelling of the origin of virgin and extra-virgin oils; and provisions on the labelling of 
certain characteristics of these oils following th e last update in the International Olive Council 
standards and methods.   
55. The EC representative noted that the comments made by the United States and New Zealand 
related to the Regulation that was currently in for ce and not to the measure that had been notified.  
She found this surprising as the measure had been in place for many years and this was the first time 
that concerns were being raised..  Regarding linol enic acid and campesterol limits, she pointed out 
that the notified draft measure did not contain any pr ovisions on the characteristics of olive oil, which 
were laid out in different pieces of EC legislati on, including Annex I to Regulation 2568/91.  She also 
noted that this issue related directly to the cu rrent work of the Codex Committee on Fats and Oils 
which was in the process of discussing a proposed draf t amendment to the standard for olive oils and 
olive pomance oils, in particular regarding linolenic  acid. She was of the view that these issues should 
discussed in that context, and not in the TBT Co mmittee, with the objective of finding an agreement 
by all parties.  She invited the United St ates to submit their comments to the Codex. 
(x) France - Unique Requirements for Ride-on Lawnmowers 
56. The representative of the United States  raised a concern regarding France's requirements for 
ride-on lawnmowers which his de legation believed to be unique and non-transparent.  The French 
Ministry of Agriculture had imposed a requirement that ride-on lawnmowers be fitted with a special 
piece of equipment known as a "skirt" for bystande r protection, while both US and EC industry had 
argued that there was no accident data to support th is requirement and that it could actually increase 
the potential for safety problems by increasing the ri sk of fire caused by accumulating debris in the 
vehicle.  He therefore requested France to identif y the safety risks for which it had introduced the new 
requirement and to provide clarification on how the new requirement reduced them, including by 
revealing the safety data that France had accumulated in support of its position.   
57. The US representative further noted that France had not notified the measure to the WTO nor 
published the requirement.  Lawnmower producers had learned of this require ment because retailers 
had informed them of a memorandum that the Ministry sent them forbidding the sale of lawnmowers that did not have a skirt.  Moreover, ride-on la wnmowers without a skirt had been seized by French 
customs and had not been released until a skirt had been attached.  He stressed that, although the 
French Ministry claimed that this demonstrated a cceptance of the requirement, the companies that had 
installed the skirt had done so only out of necessity to secure the release of their goods from customs.   
58. Furthermore, the representative of the Untied St ates pointed out that the European Garden 
Equipment Manufacturers Federation (EGMF) had f iled a petition with the European Commission's 
Directorate General Enterprise challenging the Fr ench requirement and its conformity with the 
Machinery Directive.  This petition was still pending.  Further, he highlighted that France continued 
to insist on a skirt, despite a 2008 vote in CEN
4 Technical Committee 144, in which the French 
                                                      
4 European Committee for Standardization.  G/TBT/M/47 
 Page 15 
 
 
  proposal to amend the CEN ride-on lawnmower standa rd to include a skirt for bystander safety had 
been rejected.   
59. France had originally tried to move the discussion to TC-144 and out of ISO, presumably 
because non-European companies could not participat e in the CEN standards development process.  
But even in CEN, France was unable to make the c ase to its counterparts and European industry that 
the skirt was necessary.  Undeterred by CEN’s rejection, the French Ministry had published another proposal requiring the skirt in January 2009, which ha d been rejected by both US and EC industry.  It 
was noted that since that time, US industry was re porting increased actions directed at them by French 
customs authorities regarding not only ride-on lawn mowers, but also walk-behind lawnmowers.  A 
status update on DG Enterprise's consideration of th e EGMF petition was requested.  In the meantime, 
the United States urged France to publish the measure in an official publication and notify it to the 
WTO for comment, and refrain from enforcing it, including recent customs actions against importers of US lawnmowers, to provide time for consideration of comments. 
60. The representative of the European Communities
 noted that bilateral discussions had taken 
place and that the European Communities was aware of the issue.  He recalled that in June 2004, the 
French authorities had started a ma rket surveillance action relating to ride-on lawnmowers under the 
applicable legislation, the Directive on the safety of  machinery 98/37/EC.  This action had lasted until 
March 2007 and had covered all models of ride-on lawnmowers placed on the French market, not 
only imported ones.  As part of this action, Fren ch customs authorities, acting as market surveillance 
authorities, had identified some non-conformities concerning the protection of bystanders from access 
to the moving transmission parts of the machine in  some models of importe d ride-on lawnmowers.  
Consequently, those products had been held by Fr ench customs, pending the outcome of discussions 
with the economic operators to find technical solutio ns capable of remedying those non-conformities.   
61. The French authorities had consulted the expert  groups set up under the Machinery Directive 
in which both members State experts and stakeholders  were represented, as their interpretation of the 
relevant essential health and safety requirements  of the Machinery Directive relating to access to 
moving parts had been contested by the manufacturers concerned.  At its meeting in March 2007, the 
machinery working group had agreed that "moving tran smission parts of ride-on lawnmowers must be 
made inaccessible to persons, including operators and other exposed persons (bystanders), as far as 
possible, taking into account the state of the art.  Access to these moving parts shall be prevented by 
integrated safety measures."  In parallel, CEN had begun, on its own initiativ e, a revision of the 
relevant European harmonized standard on the saf ety of lawnmowers, EN 836, with a view to 
enhancing the clarity of its provisions relating to  the protection of bystanders and the related 
verification methods.   
62. The representative of the European Communiti es further noted that in September 2007, 
EGMF had filed a complaint with the European Co mmission with respect to the position taken by the 
French authorities.  The complain t had been examined by the Co mmission services according to the 
applicable procedure which required strict confid entiality.  The complainant had been regularly 
informed about the state of play of the investigati on and several meetings had also been held with the 
complainant.  The EC representative pointed out th at the Commission services were close to finalizing 
their assessment and that the complainant would be  notified of the findings as soon as those were 
completed and would be given an opportunity to co mment.  He further explained that no measure had 
been notified under the TBT Agreement, because no fo rmally binding measure restricting placing on 
the market of certain models of ride-on lawnmowe rs had been adopted.  The discussions between the 
French authorities and the respective economic opera tors had taken place in the context of market 
surveillance activities in application of an existing t echnical regulation (the Machinery Directive).  He 
stressed that in the context of such activities, it was normal practice that as soon as national authorities 
had a doubt regarding the compliance of a product w ith the applicable requirements, they started 
discussions with the manufacturers with a view to finding a solution.   G/TBT/M/47 
Page 16  
 
  (xi) Turkey - Inspection of Imported Medical Equipment 
63. The representative of the United States
 raised a concern regarding Turkey's new medical 
device regulation, the Communiqué for Standardiza tion in Foreign Trade Related to Inspection of 
Imported Medical Equipment.  He pointed out that the draft of the measure had not been notified to the WTO and that the final measure had entered into force on 1 January 2009, one day after it had 
been published in the Official Gazette, which did not  leave a reasonable interval for implementation.  
He noted that this had led to serious disruptions in the market over the past months, as customs clearance time had expanded from a few days to several weeks or more.  He noted that during 
bilateral discussions, Turkey had explained that the same measure was regularly published at the 
beginning of every year, so that it could not be seen as a new measure.  However, the US delegation 
stressed that the list of products to which this regul ation applied, contained in its annex, varied from 
year to year, making it effectively a new measure which should be notified.   
64. The representative of the United States also point ed out that the regula tion did not apply to 
domestically-produced medical devices.  Turkey had however indicated that there was another measure applying to domestic products and the US delegation would review it.  He also pointed to the 
fact that the import inspection measure exempted  medical devices manufactured in the European 
Communities.  Further, he noted that the measure neither indicated its objective, nor explained how 
the list of medical devices in the annex covere d by the measure was determined; additional 
clarification on these issues was needed.  He urge d Turkey to notify the measure to the WTO and 
suspend implementation until comment s from interested stakeholders had been taken into account and 
potential discriminatory aspects of the measure had been addressed.   
65. The representative of Turkey
 explained that there were three national regulations on medical 
devices published by the Ministry of Health in 2007.   Their provisions applied to both domestic and 
imported goods.  The Communiqué mentioned by the US delegation aimed at ensuring that necessary safety controls of imported medical devices were performed on a risk basis and according to requirements mentioned in these regulations.  He stressed that this was not a new piece of legislation, 
as all Communiqués on import controls were revised each year, but only for the purpose of reflecting 
some operational issues such as changes in HS C odes of annexed products.  Since there was no 
change in the medical device regulations, the require ments for the products that had to be fulfilled by 
the importers remained the same.  In accordance with the Communiqué, Turkey controlled all devices 
contained in the annex, except those produced in the European Communities due to the customs union 
between the European Communities and Turkey.  Th e list of medical devices contained in the annex 
to the Communiqué was established by Ministry of  Health of Turkey, acco rding to a risk-based 
methodology and based on information gathered from the users of those products, such as hospitals.   
Detailed information on this issue would be provi ded to the delegation of the United States. 
(xii) India - Restriction on Chinese toys (Notific ation No.82 and 91/(RE-2008)/2004-2009 of 
Department of Commerce, Ministry of Commerce and Industry of India) 
66. The representative of China
 raised concerns relating to India's ban and discriminatory 
measures on almost all Chinese toys introduced through Notification No. 82 and No. 91 issued by the 
Department of Commerce of India's Ministry of Commerce and Industry.  He drew the Committee's 
attention to document G/TBT/W/304 which outlined the Chinese position with regard to these Indian 
measures.  He noted that the Notification No. 82 imposed a general ban only on toys from China for at least six months without specifying reasons for th e restriction.  He stressed that the ban was 
discriminatory and thus in breach of fundamental principles such as the general elimination of 
quantitative restrictions, and both MFN and Nati onal Treatment which were established under GATT 
1994 and the TBT Agreement.  He also noted that  the measure had created unnecessary obstacles to 
international trade in toys.  Although the Notifi cation No. 82 had been replaced by Notification No. 
91 which had been issued and implemented on 2 March 2009, the Chinese representative emphasized  G/TBT/M/47 
 Page 17 
 
 
  that the discriminative nature of the restrictions remained.  Notification No. 91 required Chinese toys 
to conform to certain standards and conformity assessment procedures while toys manufactured in India and originating from other Members were not s ubject to the same requirements.  Therefore, his 
delegation believed that Notification No. 91 accorded  unfavourable treatment to Chinese toys and was 
inconsistent with India's obligations under th e GATT 1994 and the TBT Agreement's Articles 2.1 and 
5.1, in particular.  He also noted that India had neither notified its Notification No. 82 nor its 
Notification No. 91 to the WTO and reminded India of its transparency obligations under Articles 2.9, 
2.10, 5.6 and 5.7 of the TBT Agreement.  While Ch ina appreciated the clarifications provided by the 
Indian authorities in bilateral talks, he urged Indi a to stand by its promises to avoid protectionism 
despite the economic crisis and to revoke its  restrictions on Chinese toys immediately. 
67. The representative of India
 pointed out that the Chinese c oncerns regarding a potential 
inconsistency of the Indian Notification No. 82 date d 23 January 2009 had been duly considered by 
the concerned Indian authorities and thereafter an amended Notification No. 91 had been issued on 
2 March 2009.  He took note of the fact that the new notification still did not address the Chinese concerns completely.  He informed the Committee th at a bilateral meeting with China had allowed for 
an in-depth discussion and a better appreciation of the Chinese position.  After the bilateral meeting, 
the Chinese concerns had been conveyed again to the capital.  He also noted that the Chinese deputy 
trade minister was going to hold a high level discussion with the Indian authorities, so that an amicable solution to the issue could be found.   
(xiii) European Communities – Implementing measures of the Directive on eco-design of Energy-
using Products  (G/TBT/N/EEC/ 208, 228, 229, 234, 237) 
68. The representative of China
 raised concerns regarding sever al of the European Communities' 
implementing measures of the Energy-Using Prod ucts Directive (Directive 2005/32/EC), which 
defined eco-design requirements for many products, including electrical and electronic equipments, 
simple set top boxes, external power supplies an d various lamps.  He stressed that China fully 
supported the objective of increasing energy effici ency, but that the European Communities should 
avoid unnecessary obstacles to international trade.  China had submitted detailed written comments on 
these five notifications and had received three re plies to date.  He encouraged the European 
Communities to take into account China's comments a nd make revisions to the draft regulations.   
69. It was pointed out that the measures contained in notifications G/TBT/N/EEC/208 and 228 
required that power consumption of equipment in any off-mode and some stand-by modes should not 
exceed 0.5W.  However, Chinese resea rch showed this requirement had no considerable saving effect, 
as, for example, only 22 kWh per device would be sa ved within five years for microwave ovens and 
electric cookers.  On the other hand, the requi rement would cause add itional consumption of 
resources and energy in the process of design and production.  Additionally, costs would increase by 
about 10 per cent, placing a heavy burden on manufactur ers, particularly SMEs.  He noted that the 
International Energy Agency had proposed a "O ne Watt Plan", seeking to lower stand-by power 
consumption to no more than one watt per electr onic device by 2010, which was supported by many 
WTO Members, including developed country Member s such as the United States and Japan.  He 
therefore urged the European Communities to recons ider the 0.5W requirement in order to avoid 
unnecessary obstacles to international trade.   
70. With regard to notification G/TBT/N/EEC/ 237, the Chinese representative noted that it 
contained three functionality requir ements in terms of life-time for compact fluorescent lamps ("lamp 
survival factor at 6000 hours", "number of switchi ng cycles before failure", "permitted failure rate"), 
whereas the current international standard IEC 60 969:2001 only adopted the parameter of "rated 
average life".  He requested the European Communiti es to adopt a relevant international standard as 
the basis of their technical regulations, in line with Article 2.4 of the TBT.  He also pointed out that 
the measure notified as G/TBT/N/EEC/229 listed diffe rent minimum efficiency values for certain G/TBT/M/47 
Page 18  
 
  single-capped fluorescent lamps with the same nominal wattage.  He considered it unreasonable to set 
minimum efficiency values according to the type of  the lamps and also stressed that the minimum 
efficiency values for lamps that were not listed rema ined unclear.  Therefore, he urged the European 
Communities to set minimum efficiency values in a ccordance with the nomina l wattage rather than 
the types of the lamps.  He also suggested that  the European Communities should take into account 
the special needs of developing country Members and grant more adaptation time. 
71. The representative of the European Communities
 explained that the objective of the Eco-
design of Energy-Using Products Directive was to provide coherent EC-wide rules for eco-design and 
to ensure that differences among member States' regulations did not become obstacles to intra-EC 
trade.  She pointed out that the Directive did not  introduce directly binding requirements for specific 
products . These were laid down by implementing meas ures that had to be adopted by the European 
Commission.  The concern raised by China was about the first set of implementing measures 
proposed by the Commission.  She stressed that all implementing measures were based on technical, 
environmental and economic analyses which had been carried out in full transparency and with the 
participation of stakeholders from around the world, including industry.   
72. The EC representative noted that the Commissi on services had also discussed the measures 
with international partners, includi ng China.  Her delegation believed that the requirements were cost-
effective and lead to significant energy saving.  Sh e highlighted that, in addition to this extensive 
analysis, comprehensive impact assessments, which took into account economic, environmental and 
social impacts, including design/redesign cycles of a ffected products, had also been carried out for all 
the measures.  The timing of the requirements had been fixed on the basis of these impact 
assessments.  She emphasized that a ll measures thus contained transiti on periods sufficient to adapt to 
the requirements.  She concluded by stressing that  the European Communities was of the opinion that 
the measures were justified by  environmental pr otection objectives and in full compliance with the 
TBT Agreement.  She noted that the European Communities had already replied in writing to the 
comments sent by China concerning notifications G/TBT/N/EEC/208, 228 and 234 and would soon 
send replies with regard to G/TBT/N/EEC/229 and 237.   
(xiv) Bahrain - Motor Vehicles – General Requirements (G/TBT/N/BHR/40) 
73. The representative of the European Communities  raised a concern with regard to the 
notification by Bahrain, which laid down technical  regulations for motor vehicles.  The European 
Communities had sent comments on this notification in  May 2008, based on the fact that the draft 
included certain requirements for tyres, windshiel ds and windows of motor vehicles that deviated 
from UNECE Regulations.  Thus, the regulations c ould create barriers to trade for motor vehicles 
being in compliance with UNECE Regulations.  Sh e noted that her delegation had not received any 
reply to its comments and sought clarifications on the state of the proposed regulation and on whether 
comments had been taken into consideration. 
(xv) Chile – Cosmetics (G/TBT/N/CHL/81 and Add.1) 
74. The representative of the European Communities  raised concerns about a proposed Chilean 
measure intended to amend the existing legislati on on the national system for the monitoring of 
cosmetics.  She noted that the draft introduced a registration procedure for low-risk and hygiene 
products which, according to international practice, were only subject to a notification system.  The 
draft also created a new sub-category for cosmet ics called "special cosmetic products" to which 
special obligations apply.  The representative of the European Communities further noted that the 
measure provided for certain labelling obligations whic h appeared to be confusing for consumers, in 
particular those regarding the indication of expiry date and period after opening.  G/TBT/M/47 
 Page 19 
 
 
  75. Furthermore, it was pointed out that the measu re asked for additional local quality controls 
performed by local laboratories for each batch expor ted to Chile, even though the product had already 
been tested by the manufacturer.  In this regard, it was not clear when such additional controls could 
be requested.  The EC representativ e stressed that the above-menti oned requirements seemed to be 
more trade-restrictive than necessary to fulfil the legitimate objective of human health protection and 
safety.  Written comments had been sent to Chile  in February 2009, and her delegation looked 
forward to receive a reply to them. 
76. The representative of Chile  recalled that various bilateral meetings had taken place with the 
European Communities.  While the European Co mmunities had asked to extend the deadline for 
comments, there had already been several comments from various countries during the period of 
public consultations.  She also noted that the period for public consultations had elapsed, and 
amendments to the proposed regulation were cu rrently being considered.  Finally, the Chilean 
representative stressed that all comments would be ta ken into account in the review of the draft.  
(xvi) China – Textiles and Apparel (G/TBT/N/CHN/427 and Suppl.1) 
77. The representative of the European Communities  raised a concern with regard to a Chinese 
measure establishing mandatory requirements for tex tiles and apparel.  While her delegation agreed 
that certain information, like fibre composition or  care instructions, should be shown on the label, 
other information did not seem relevant for the inform ation of consumers.  She referred in particular 
to the indication of product name, effective produ ct standards, safety categories, use and storage 
precautions.  Imposing mandatory labelling of this in formation would be more trade-restrictive than 
necessary.  Moreover, she asked for clarifications  on whether it was sufficient to indicate the name 
and address of manufacturer on the accompanying documents provided with the product.  Her 
delegation looked forward to receive a reply to its comments and information on whether the draft had 
already been adopted.  
78.  The representative of China  recalled that the proposed measure had been notified on 15 July 
2008, and a sixty day period had been provided.  He pointed out that, at the request of the European 
Communities, another fifteen days had been extend ed for comments.  After the comment period, a 
Technical Committee analyzed all comments re ceived from domestic industries and foreign 
stakeholders.  Since some of the comments were considered reasonable, the proposed measure was 
currently under a second review.  Should the reviewed draft contain mandatory requirements substantially different from those in the original version, a new notification would be issued and a 
further period for comments would be granted. 
(xvii)  Colombia – Draft Decree Establishing Provisions to Promote the Use of Biofuels 
(G/TBT/N/COL/96, Adds.1-2) 
79. The representative of the European Communities
 raised concerns about a proposed regulation 
aimed at promoting the use of biofuels in Colomb ia.  She noted that the notified measure provided 
that all gasoline-engine motor vehicles should be flex ible-fuel vehicles,  thus their engines should be 
capable of being operated with either ordinary gasolin e or a blend of up to 85 per cent alcohol fuel.  In 
this regard, a specific timetable was provided:  60 per cent of the annual supply of a brand should 
support E85 fuel as of 1 January 2012; 80 per cen t of the annual supply of vehicles should support 
E85 fuel as of 1 January 2014; 100 per cent of the annual supply should support E85 fuel as of 
1 January 2013 or respectively 2016.  While the EC  delegation understood the objective of promoting 
the use of biofuels, it invited Colombia to e xplain why mandatory technical requirements were 
considered necessary to address this  objective, while a number of other possibilities for measures to 
promote biofuels were available.  Written comment s were being prepared and would be sent to the 
delegation of Colombia. G/TBT/M/47 
Page 20  
 
  80. The representative of Colombia
 explained that the notified measure had been commented on 
by national and foreign producers and that it would a pply both to national and imported vehicles.  She 
pointed out that the measure had been developed on the basis of existing technology and that it was meant to be gradual and carried out over a period of time.  It was also noted that various studies showed the satisfactory results of the use of fl exible-fuel vehicles, and that several Colombian 
companies recognized the benefits of introducing such  technology.  Biofuels were considered a viable 
and less polluting alternative to gasoline, in partic ular in countries like Colombia, with geographical 
and environmental characteristics that required high-powered vehicles.  The representative of 
Colombia encouraged the EC delegation to subm it written comments that, once received, would be 
studied and discussed. 
(xviii)  India - Prevention of Food Adulteration (G/TBT/N/IND/34) 
81. The representative of th e European Communities
 referred to a revision of the Indian rules on 
Prevention of Food Adulteration (PFA), whic h outlined mandatory labelling guidelines for pre-
packaged food.  Written comments had been submit ted to India in Novemb er 2008 and bilateral 
discussions on this matter had been held before the TBT Committee meeting.  Assessing the scope 
and impact of the proposed changes was very difficult,  due to the fact that the original text of the 
regulation had not been made available.  Moreover, the Indian rules on prevention of food adulteration appeared to have been subjected to several further amendments since the above-
mentioned measure was first notified to the WTO.  In particular, the EC delegation referred to an 
amendment notified to the SPS Committee (G/SPS/N/I ND/59) and other amendments notified to the 
TBT Committee (G/TBT/N/IND/38 and G/TBT/N/IND/39).  The representative of the European 
Communities encouraged India to clarify what the relationship was between the different 
notifications, and provide WTO Members with the cons olidated version of the rules being amended.   
82. The representative of the United States
 appreciated the revision of the quantitative ingredient 
declaration requirements in the PFA rules, and asked  the Indian delegation whether the revision would 
be notified to the TBT Committee.  Moreover, he asked for clarification on why the latest notified 
amendment to the PFA rules was notified as an  SPS measure (G/SPS/N/IND/59), and encouraged 
India to clarify which part of the measure was cons idered to fall within the SPS Agreement.  While in 
both cases the requirements for nutritional labelling had been modified and the same objective had 
been stated, it was noted that India's previous amendments to the PFA were notified as a TBT 
measure (G/TBT/N/IND/34).  The Indian delegation was therefore encouraged to explain whether the 
latest amendments would also be  notified to the TBT Committee. 
83. The US representative asked for further clarifica tions with regard to whether the PFA rules  
applied to distilled spirits, in addition to other fo od products.  He noted that in many countries 
distilled spirits were exempted from such labelling requirements as ingredient listings, best before 
dates, expiry dates and dates of manufacture and pack aging.  In this regard, it was his delegation's 
understanding that the above-mentioned requirements we re not applicable to distilled spirits, as they 
had an indefinite shelf life and the ingredients we re not present in the final product after distillation 
and fermentation.  Finally, the US delegation urge d India to consider delaying enforcement of the 
measure notified to the SPS Committee until such ti me as the process of stakeholders' review and 
comment would be completed. 
84. The representative of India  pointed out that the original text of the PFA regulation was 
available on the Ministry of Health and Family Welfar e website.  With regard to the consolidated text 
of the regulation, the issue would be conveyed to the competent authorities for due consideration.  
Regarding the listing of name, weight and volume of  ingredients used at the time of manufacture, 
raised by the European Communities in previous bilateral meetings, the representative of India 
confirmed that India decided to withdraw the require ment.  With regard to the other issues raised, it 
was stressed that they would be conveyed to the capital for due response.  Finally, regarding the US  G/TBT/M/47 
 Page 21 
 
 
  concern on the entry into force of the regulation, the Indian representative recalled that the proposed 
measure was notified in September 2008, giving an adequate six-month comment period.  He further 
stressed that all comments received would be taken into account before finalizing the proposed 
measure. 
(xix) Korea – Beef (G/TBT/N/KOR/202) 
85. The representative of Australia  raised concerns about an amendment to the Ministerial 
Ordinance for the Livestock Products Processing Act.  She pointed out that this amendment entailed a new requirement that for imported beef a Bill of Lading (BOL) number had to accompany products 
sold by domestic retailers of beef.  The notificatio n by Korea indicated that this measure was to be 
implemented on 22 June 2009, bu t did not provide for a reasonable period for Members to make 
comments on the proposed measure and for t hose comments to be taken into account.  
86. The representative of Australia further stated that her delegation was holding constructive 
bilateral discussions with Korea on this matter, but sought greater clarity on both the intent and 
implementation of the measures.  For example, Ko rea had indicated in its notification that the 
objective and rationale of the measure was to pr event deceptive practices.  In other discussions, 
however, there had also been indications that the objectives could also include trace-back, food safety, 
and consumer confidence.  Clarification was s ought on the precise policy objective for the measure, 
and how the use of the BOL number contributed to that objective.  Once the policy objective was clarified, a notification of greater detail on how th e measure would be implem ented in practice would 
also be welcome.  
87. It was Australia's assessment that the require ment to display and record a BOL number for 
imported beef could not contribute to the achieveme nt of such policy objectives and had the potential 
to impose unnecessary costs on trade.  Such le gitimate policy objectives might be met through 
alternative and less costly means.  The Australian re presentative stressed that, in light of the lack of 
clarity of the objective and rationale for the measu re and how it would be im plemented in practice, 
Korea should formally allow a reasonable period fo r comments of Members to  be provided and taken 
into account, and further delay implementing any me asure until such time that more trade facilitative 
alternatives could be identified.  Australia looked forward to working constructively with Korea to 
identify an approach that would address its legitimate policy objectives while not imposing 
unnecessary obstacles on trade.  
88. The representative of Mexico
 shared the concerns expressed by Australia and stressed that 
measures aimed at protecting legitimate objectives should be in conformity with the rules laid down in 
the TBT Agreement.  He noted that Mexico woul d send comments once an analysis of the proposed 
measure, including its trade impact, was concluded.   His delegation hoped that Korea would revise its 
regulation in the light of the TBT Agreement and that it would take into consideration Members' 
concerns. 
89. The representative of the United States  supported some of the remarks made by Australia on 
Korea's new measure requiring the placement of BO L numbers on retail labels or display cards for 
imported beef.  He pointed out that it was unclear  what Korea was trying to achieve with this 
measure.  In his delegation's view, it did not  address food safety concerns, nor did it provide 
information that would be helpful in the event of a recall.  He urged Korea to reconsider the measure 
and discuss with importers and retailers alte rnatives that would address Korea's objectives. 
90. The representative of Canada  shared the concerns expressed regarding the notified Korean 
regulatory amendments requiring that the BOL be disp layed at the retail level for beef products.  In 
particular, Canada was concerned that these amen dments were notified to the WTO without allowing 
for an appropriate comment period.  She sought clarification on the objectives and intent of the G/TBT/M/47 
Page 22  
 
  proposed measure.  Although not having had time  to fully assess, these amendments appeared 
potentially burdensome to importers and Canada believed that less trade restrictive options could exist 
to meet Korea's objectives.  Furthermore, Canada wa s concerned that this measure, or one similar in 
nature, would extend to commodities other than beef  and would continue to follow the development 
and implementation of these regulatory amendments.  
91. The representative of New Zealand
 associated her delegation with the intervention of 
Australia, United States, Mexico and Canada on the issue of Korea's prolongation of new regulations 
for requirements of labelling of beef for retail sale, particularly the requirement for the inclusion of a 
BOL number at the point of sale for imported beef.  She sought further information on these requirements and on their consistency with the TBT Agreement, in partic ular to ensure that measures 
were not more trade restrictiv e than necessary and to better understand the implications for New 
Zealand trade.  Specifically New Zealand requested clarification on the specific objectives and rationale of the measures and on how the new labelling requirements met that objective.   
92. The representative of New Zealand further pointed out that, based on the information 
provided so far, the new measures appeared to be more trade restrictive than necessary than current 
international standards and Codex guidelines that could be considered in  developing such new 
regulations.  Her delegation had r eceived no indication that Korea had considered these standards and 
guidelines, nor consulted with its trading partners in  developing its new measure.  She stressed that 
her delegation would provide a formal response to  Korea's notification and requested that Korea 
consider New Zealand's comments and those of ot her Members before impl ementing the regulation. 
While Members' concerns were being considered , Korea should delay the implementation of these 
new requirements.  Finally, she pointed out that an update on how Member s concerns were being 
addressed would be sought at the June TBT Committee meeting. 
93. The representative of Korea
 explained that the objective of the BOL number to imported beef 
was to announce beef recall immediately if a hazardous  accident in the market occurred.  He pointed 
out that consumers' distrust was increasing due  to concerns about the mad cow disease and false 
country of origin labelling.  Therefore the reca ll system needed to be reorganized to provide 
consumers with correct information, to prevent deceptive practice and to eliminate the hazardous 
factors resulting from emergency situations. In this  regard, while domestic be ef would be controlled 
by animal identification number, imported beef  would be controlled by the BOL number.   
94. The representative of Korea further stressed that  this system was the result of comments from 
importers and distributors, in particular the rele vant interest groups including representatives of 
retailers, who noted that there was no problem in a pplying this system.  In addition, authorities in 
Korea had taken the relevant Codex standard as the basis for this system.  Therefore, Korea believed 
that the measure was in line with the TBT Agreemen t.  However, his delegation was open to discuss 
with interested Members any alternative options and hoped to intensify its bilateral talks on this issue. 
(xx) European Communities – Green Paper on Agricultural Product Quality Policy 
95. The representative of Mexico  raised an issue with respect to a recent Green Paper by the 
European Commission which would examine variou s certification programmes, labelling schemes, 
geographical indications and regional certification quality measures in use in the European Communities for agricultural products.  He noted th at the green paper cove red issues such as basic 
requirements for production and marketing standa rds, specific quality systems, geographical 
indications, traditional specialities and environmenta l systems for certification of quality.  For his 
delegation, the Green Paper had raised the following issues:  if it became mandatory to indicate the 
place of cultivation of raw materials and if stigmatiza tion of products that did not comply with various 
standards for aesthetic reasons was authorized, how would this affect the system of geographical  G/TBT/M/47 
 Page 23 
 
 
  indications from third countries?  How could it improve the EC single market for agricultural 
products? How would consumers not be  confused with certification?  
96. The representative of Mexico further pointed out that his delegation had sent preliminary 
comments to the European Commun ities about the paper and noted that the draft project contained 
provisions that could be contrary to the principl es of non discrimination, avoidance of unnecessary 
obstacles to trade, adopting the least trade restrictiv e measure to achieve a legitimate objective.  Also, 
the green paper was not in compliance with the pr inciples of transparency with regard to the 
notification of draft technical regulations or c onformity assessment procedures when they had an 
effect on trade of other Members, nor with the obli gation to review technical regulations in force to 
ensure that they could achieve the legitimate objec tives, nor with the obligatio n to use of standards, 
guides and recommendations as a basis for technical regulation.  He asked the European Communities 
to review the norms in the green paper in line with  its WTO obligations, taking into consideration the 
provisions of the TBT Agreement to take into ac count the comments submitted in the formulation of 
the final standard. 
97. The representative of the European Communities  explained that the Green Paper was a 
consultation document on the future of agricultu ral product quality policy, including geographical 
indications.  It was open for consultation from st akeholders, inside and outside the European 
Communities from 15 October until 31 December 2008.  560 responses, including several from third country administrations, had been received.  All contributions had been published and the final 
summary response had also been published on the EC  website.  The summary document contained 
statistics and an introduction on the responses receive d.  She further explained that the responses were 
being used as input in a communication which woul d be adopted in May and which would chart the 
strategic orientations for agricultural products qualit y policy.  However, no legislation was foreseen at 
this stage.  She stressed that, should legislati on be considered, it would be drawn up in compliance 
with WTO rules and in respect of the procedural  requirements laid out in the TBT Agreement. 
2. Previously raised concerns 
(i) EC - Directive 2002/95/EC on the Restriction of  the Use of certain Hazardous Substances in 
Electrical and Electronic Equipment (G/TBT/N/EEC/247 and G/TBT/Notif.00/310, Corr.1) and Sweden - Restrictions on the use of Deca-bromo diphenylether (deca-BDE) 
(G/TBT/N/SWE/59) 
98. The representative of the United States
 raised concerns with regard to the European 
Communities' ongoing review of its Directive c oncerning restrictions on hazardous substances in 
electrical and electronic equipment (RoHS Directive)  and announced that his delegation would submit 
comments in writing on the recently notified propo sed revision.  He expressed concern about the 
potential magnitude of the cost of compliance, in particular for small and medium sized enterprises, 
that could result from an expansion of the directiv e.  He also emphasized the need for the EC to 
ensure a risk- and science-based a pproach to the RoHS review, for instance when evaluating whether 
to add substances to the list, set maximum concen tration levels for specific substances, or grant 
exemptions.  He noted that the Commission's proposal  for a revision of the RoHS directive contained 
a reference to specific articles of the REACH Regul ation, on which a new RoHS substance selection 
and assessment procedure would be based.  It was unc lear to the United States' delegation what this 
reference meant.  He noted that any selection a nd assessment procedure should be based on specific 
scientific criteria and specific recognized risk assess ment processes, and take into account end uses.  
The U.S. representative also urged the EC to clarify how RoHS and REACH would fit together.  He 
pointed to the potential that the relationship between these measures could create problems as all the substances that were selected for priority asse ssment under the proposed RoHS revision were also 
listed on the authorization candidate list for REAC H.  He requested the European Communities to G/TBT/M/47 
Page 24  
 
  clarify which directive would apply in such cases and whether the RoHS Directive would be phased 
out in order to ensure that conflicts would not develop. 
99. The representative of the United States also not ed that the Commission's proposal contained 
provisions for renewable four year exemptions to  RoHs compliance. Requests for extension of an 
exemption would have to be submitted 18 months in advance of its expiration date.  He pointed to 
experience with the current RoHS Directive which s howed that, in some cases, the processing of an 
exemption request could take longer than 18 mont hs.  He requested the European Communities to 
clarify what would happen if a request for extens ion was made within the prescribed time frame, but 
the Commission failed to reach a decision before the e xpiration date.  In genera l, he highlighted that 
the procedure for granting and renewing exemptions had been non-transparent and unpredictable in 
duration and therefore called on the European Co mmunities to ensure that a transparent and 
predictable process be put in place for the treatment  of exemptions, including by ensuring meaningful 
opportunities for comment by all interested stakehol ders.  He also urged the European Communities 
to provide a reasonable period of time for suppliers to implement any changes that were made to the 
directive. 
100. The representative of Japan
 recalled that, regarding the re-examination of the exemption of 
Deca-BDE, the European Communities had mentioned at the last Committee meeting that this would 
be addressed in the RoHS Directive revision process, that the best scenario which would minimize the 
negative impact on trade would be published with th e draft revised text shortly and then, asked for 
their progresses including TBT notification procedure.  Moreover, he also noted that four substances 
(HBCDD, DEHP, BBP, and DBP) were proposed as additional candidate substances of the RoHS 
Directive revision and were at the same time proposed as substances of very high concern (SVHC) 
under the REACH Regulation.  He pointed out that the EC risk assessment regarding DEHP showed 
that "risks are not expected" and "risk reducti on measures already being applied are considered 
sufficient" whereas, under the REACH Regulation, after the substances were defined as SVHC, 
producers and exporters would need authorization to  use them.  The Japanese representative requested 
the European Communities to provide clarifications  on intended relationship between the revision of 
the RoHS Directive and the REACH Regula tion in terms of above-mentioned aspect. 
101. The representative of Israel  shared the concerns raised by  the United States and Japan in 
particular with regard to Deca-BDE.  He recalled that the ban on the use of Deca-BDE had first been  notified to the TBT Committee as a restriction on the use of Deca-BDE by Sweden (G/TBT/N/SWE/59).  Deca-BDE had then been exem pted from the original RoHS directive following 
a risk assessment which concluded that Deca-BDE di d not represent any significant risk to health or 
the environment.  On the grounds of procedural failures, however, a ruling form the European Court 
of Justice had annulled this exemption, which meant that Deca-BDE had been banned from use in 
electrical and electronic equipment in the Europ ean Union as of 1 July 2008.  The most recent 
development in this regard ha d occurred on 3 September 2008 when the European Commission issued 
a proposal for the revision of the RoHS directive in which Deca-BDE was still included in the list of 
banned substances in Annex 4.  However, the repr esentative of Israel stressed that the scientific 
results of the EC risk assessment on Deca-BDE had not been called into qu estion and that potential 
substitutes had not been subject to similar level of scientific scrutiny rega rding environmental and 
health impacts.  He stated that Israel therefore c onsidered the maintenance of the proposed restriction 
on the use of Deca-BDE as running counter to EC  obligations under the TBT Agreement.  In 
particular, Article 2.2 and 2.3 prohibited the Eur opean Communities from instituting or maintaining a 
restriction without necessity.  He therefore ur ged the European Communities to follow its own 
scientific results and avoid the ban of Deca-BDE. 
102. The representative of Jordan
 supported the comments regarding Deca-BDE that been made by 
Japan and Israel.  She stressed that Deca-BDE ha d been exempted based on scientific evidence and 
that the evidence that had supported the exemption in 2005 was even stronger today.  Her delegation  G/TBT/M/47 
 Page 25 
 
 
  therefore considered the ban on Deca-BDE unjustifie d and warned that continuing to apply the 
restriction would undermine the credibility and us efulness of risk assessme nts and in turn the 
scientific foundation of RoHS and similar directives. 
103. The representative of th e European Communities  explained that the RoHs Directive required 
the Commission to review the measures provided for in the Directive, in particular to examine 
whether two additional categories of equipment ha d to be included in its scope, namely medical 
devices and monitoring and control instruments.  It was also required to examine whether the list of 
substances had to be revised, with the objective of  adapting it to technical and scientific progress and 
ensuring coherence with other pieces of Community le gislation, namely REACH.  She noted that the 
main objective of RoHS was to ensure the elimin ation of certain hazardous substances from electrical 
and electronic equipment.  However, where this was not possible, exemptions could be granted.  On 
the basis of the impact assessment that had been  undertaken by the Commission, it had been decided 
that no new substances be included in the scope of RoHS.  The two above-mentioned new categories 
of products would however  be covered by the revised RoHS Directive, after long transitional periods 
ending in 2014 and 2017.   
104. With regard to Deca-BDE, she pointed out th at the Commission had maintained the current 
restriction, based on the existing scientific informa tion, including the revised EU risk assessments.  
These had concluded that uncertainties remained concerning the toxicity of Deca-DBE and its degradation to other banned substa nces and had determined the need  for further information and/or 
testing with respect to the risk of Deca-BDE to workers, to humans exposed via the environment and 
to the aquatic ecosystem.  For this reason, th e Commission had imposed testing and information 
requirements on the importers or manufacturers of  Deca-BDE  for a period of ten years from 2006-
2016.  Hence, the Commission had assigned the resp onsibility for producing the additional evidence 
required.  In line with recital 7 of the current pr oposal, the current restriction of use would be kept 
under review and, if necessary, adjusted to take acco unt of new technical and scientific information.  
The representative of the European Communities also pointed out that user industries could apply for 
temporary exemptions from the ban in accordance with  the criteria of article 5.1.b of the proposal.  
With regard to the four substances Japan had me ntioned, the Commission had concluded that it was 
not necessary to include them in the proposal.  Ho wever, these substances would be monitored, in 
particular with regard to potential problems in waste management.  The European Communities 
invited Members to submit their comments in writi ng before the expiry of the comment period on 10 
May 2009.   
(ii) Brazil - Toys (G/TBT/N/BRA//259 and 313)  
105. The representative of China
 raised a concern about the new Brazilian regulation on toys, 
Decree 384 notified as G/TBT/N/BRA/313.  China had already expressed its concerns about Brazil's Decree 326, notified as G/TBT/N/BRA/259 on 16 Oct ober 2007, that had accorded less favourable 
treatment to imported toys to be implemented for nearly two years despite its alleged emergency and 
temporary nature.  He noted that Brazil had revi sed the emergency regulation and submitted the new 
notification G/TBT/N/BRA/313.  However, he pointed out that the proposed new decree failed to address the many WTO inconsistencies that had been identified in previous meetings.  For example, 
according to the proposed decree, if original tests were performed abroad, supplementary test would 
be required on the products' arrival in Brazil.  This would be inconsistent with Brazil's WTO 
obligations, because it would discriminate agains t imported toys by impos ing an additional and 
redundant test on imported toys alone.  In additi on, the decree required imported toys to have the 
required seal placed on them at the time of clearance, rather than at the time and place of manufacture, 
as was permitted for domestic toys.  This would also constitute a discriminatory requirement and 
impose substantial additional costs for importers.  It would also cause practical difficulties as millions 
of toys imported annually would ha ve to be labelled in bonded wa rehouses in Brazil that had no space 
for this activity.  He informed the Committee th at China had sent written comments to Brazil in G/TBT/M/47 
Page 26  
 
  December 2008 and that Brazil replied that all th e comments sent were being analyzed and could be 
incorporated after the closure of the public hearing in Brazil foreseen for January.  At that point, the 
publication of the final version had been scheduled  for March 2009 and Brazil had also committed to 
the final regulation being notified to the WTO.  Given that it was already mid-March, the Chinese 
representative requested an update on this process. 
106. The representative of the European Communities
 shared the comments ra ised by China.  He 
noted that the European Communities had sent wr itten comments to the Brazilian authorities on 21 
January 2009.  He also stated that the proposed m odifications introduced by the notified text still fell 
short of addressing the concerns previously raised.  He pointed out that the proposed decree would reinstate, with some amendments, the so-called Sy stem 5 procedure for imported toys alongside the 
currently available System 7 procedure, which was welcomed by the European Communities.  
However, the revised version of System 5 as applied to imported toys also gave rise to a number of 
concerns.  System 5 was based on the evaluation of the manufacturer's quality management system 
and type-testing of a number of samples taken from the production line.  Toy suppliers were given the 
possibility of having the tests performed either in  Brazil by an INMETRO-accredited laboratory or 
abroad.  With respect to the test s carried out abroad, the notified te xt provided for the acceptance of 
tests conducted by foreign laboratories accredite d pursuant to IAF (International Accreditation 
Forum) or ILAC (International Laboratory Accredita tion Co-operation) rules.  However, even where 
full tests covering all relevant safety requirements ha d been carried out abroad  in accordance with the 
set conditions, additional tests would be required to be  carried out in Brazil at the time of importation 
by an INMETRO-accredited laboratory on samples taken from each imported batch.  These additional 
tests would cover major aspects such as general, ph ysical and mechanical properties and migration of 
certain chemical elements.   
107. The representative of the European Communiti es emphasized that this would effectively 
establish a double-testing obligation on imported toys leading to significant additional costs and delays, while domestic toy suppliers would be able  to complete the System 5 procedure prior to 
placing their products on the market.  He stressed that  this appeared to be mo re strict than necessary 
and would thus create unnecessary obstacles to interna tional trade within the meaning of Article 5.1.2 
of the TBT Agreement.  Hence, European toy suppl iers would continue to be granted less favourable 
access to the Brazilian market than supp liers of like toys of national or igin, in a comparable situation, 
which was inconsistent with Brazil's obligations  under Article 5.1.1 of the TBT Agreement. 
108. The representative of the European Communities also noted his delegation's concern over the 
requirement for the affixing of the conformity ma rking after importation, as this would require the 
unpacking of goods upon importation, their storage in local warehouses and a number of operations 
relating to the affixing carried out locally, thus enta iling additional costs.  This could be a breach of 
the national treatment principle referred to in Ar ticle 2.1 of the TBT Agreement.  The European 
Communities considered that, in its present form, the draft Decree imposed overly strict marking and 
labelling requirements, considering in particular that the packaging used for most toys was not 
exclusively for the Brazilian market and that b onded warehouses typically had no extra space for this 
activity.  He also pointed out that domestic toy manuf acturers would be able to affix the mark at the 
place of manufacture and to print it on the packag ing.  These requirements would therefore constitute 
an unnecessary barrier to trade within the mean ing of Article 2.2 of the TBT Agreement. 
109. The representative of the European Commun ities thanked INMETRO for its openness and 
willingness to have bilateral discussions with EC re presentatives.  He requested further information 
on the date of the public hearing with inter ested parties which INMETRO had announced.  He 
suggested that alternative ways could be explored with a view to pursuing the legitimate objective of 
protecting children from risks arising from certain im ported toys.  In particular, he suggested that 
Brazilian authorities could consider, rather than strengthening the conformity assessment procedure 
on unequal terms on imports as compared to domes tic production, concentrating on better targeted  G/TBT/M/47 
 Page 27 
 
 
  enforcement activities on imported products, based  on appropriate risk assessment tools, 
considerations relating to the origin of the product,  the track record of the importer or manufacturer, 
the characteristics of the products, the health and safety risks associated with the product, accident 
data, and so on.  As this approach had been su ccessfully applied by the European Communities for 
many years, they would be ready to share their e xperience in this field with the Brazilian authorities. 
110. The representative of Thailand  expressed similar concerns.  Her delegation's assessment also 
came to the conclusion that the newly notified decr ee did not come any closer than its predecessor to 
ensuring conformity with the TBT Agreement.  Despite  Brazil's assurance at the last meeting that its 
revised procedure would accept foreign test reports, th e conditions for the consideration of foreign test 
reports did not favour effective acceptance.  The foreign laboratory would have to pass stringent 
accreditation criteria set by Brazil.  Additionally, the test reports would have to be accompanied by a 
certified translation into Portuguese.  She noted that this was more trade restrictive than necessary, as 
an international language such as English was accepte d worldwide, especially in technical areas.  As 
already noted by other delegations, Brazil also required that, where foreign testing was used, 
supplementary testing had to be performed on the same general, ph ysical, mechanical and chemical 
requirements that had already been tested overseas.  Sh e said that this would have to be interpreted as 
Brazil's non-recognition of foreign testing and intern ational collaboration under ILAC, contrary to the 
Brazilian claim to accept foreign test report.   
111. She further pointed out that the importer had the responsibility to notify the Brazilian 
authority to sample products for tests, but only after arrival at the port.  This implied that the importer 
had to rent bonded warehouses to st ore the products in waiting.  Additio nally, she noted that Article 5 
of the new measure required that the conformity identification seal could only be affixed on imported 
toys after the certification was completed.  She emph asized that this effectively meant that exporters 
would have to hire labour to unload all warehouses, unpack all products, and affix a seal on every 
individual toy item and packages thereof.  They would have to repackage and reload them for 
transportation out from the port.  Substantial additio nal time, work and costs would have to be spent 
by all toy importers into Brazil, in contradiction to Article 2.1 of the TBT Agreement, which states 
that members must be accorded treatment no less favourable than that accorded to like products of 
national origin.  Furthermore, she pointed out that Brazil's new conformity assessment procedure failed to ensure conformity with Article 5.1.1 and 5.1.2 of the TBT Agreement, as it would create 
unnecessary obstacles to international trade, being more stringent than necessary to give Brazil 
adequate confidence that imported toys conformed to  its requirements.  She pointed out that better 
ways existed to safeguard children safety. 
112. The representative of Thailand had noted that her delegation was still awaiting a response to 
the comments submitted on 24 December 2008.  She urged Brazil to consider withdrawing the measure or bringing it into conformity with the TBT Agreement, respecting the principles of Good Regulatory Practice.  She also suggested bilateral talks and asked Brazil to acknowledge receipt of the 
Thai comments and respond to them in writing. 
113. The representative of the United States
 noted his delegation's appreciation of the revisions 
that Brazil had made to its regulations with a view to ensure that all toy producers, whether foreign or 
domestic, could utilize either System 5 or 7 to dem onstrate that their toys conformed with Brazilian 
requirements, and that allowed exporters to use ILAC accredited laboratories outside of Brazil to 
conduct the testing required under either system.  Ho wever, he also shared the systemic concerns 
raised by other delegations that the new decree applied an additional in-country testing requirement 
solely to imported toys.  While the United Stat es understood the importance of devising appropriate 
measures so as to ensure that children were pr otected from potentially unsafe toys, a continued 
dialogue would be important in tackling these comm on challenges confronted by regulators in many 
countries.  He announced that the United States wo uld be willing to facilitate discussions between 
regulators and to share experiences and discuss alternative approaches. G/TBT/M/47 
Page 28  
 
  114. The representative of Brazil
 recalled that the current Brazilia n regulation on toys had been 
adopted in an emergency situation with the aim of addressing a lack of confidence regarding the 
conformity of toys.  Since the end of 2008, Brazil's toys regulation had been unde r revision.  He noted  
that a proposed new regulation had been no tified to the TBT Committee under G/TBT/N/BRA/313 
and Members had had the opportunity to analyse a nd comment on this draft.  He emphasized that 
imported toys would be allowed to use System 5 certification again.  Both imported and domestic 
producers would be subject to a regular testing as a means of ensuring conformity with safety specifications.  He stressed that tests performed by foreign labs accredited by ILAC would be accepted.  He informed the Committee that INM ETRO had been assessing all the comments received 
during the public consultation period and would hol d a public hearing on the draft regulation in the 
coming weeks, to which all interested parties were  invited.  The date of the hearing would be 
confirmed by INMETRO in the near future a nd his delegation remain ed open for bilateral 
consultations on the subject. 
(iii) European Communities – Dangerous Chemical  Substances; Draft Commission Directive 
amending, for the 30th and 31st time, C ouncil Directive 67/548/EEC (G/TBT/N/EEC/151, 
Adds. 1-2 and G/TBT/N/EEC/212, Adds. 1-3) 
115. The representative of Thailand
 raised concerns regarding the EC measures on dangerous 
chemical substances.  Her delegation shared the obj ectives of protecting human health and consumers.  
However, she stressed the importance of having regul ations based on solid scientific justification, 
especially when they could have vast and chai n-like effects on competitiveness of developing and 
least developed countries.  She also noted that the European Communities would incorporate the 30th 
and 31st Adaptation to Technical Progress (ATP) to the Dangerous Substance Directive 67/548/EEC 
(DSD) into a new 1st ATP to the Regulation on Classification, Labelling and Packaging of Substances 
and Mixtures (CLP).  In this regard, Thailand requ ested the European Communities to notify the new 
classification in due time, in order to allow meaningful opportunity for comments from WTO Members.  The representative of Thailand also stre ssed that the industry and trade of her country 
would be significantly affected if the new cla ssification would be applied under REACH.  The 
European Communities was therefore encouraged to  base its regulations on solid scientific finding 
and procedural thoroughness. 
116. The representative of Cuba, speaking on behalf of GRULAC
 regretted that the European 
Communities had adopted the 31st ATP, despite the procedural and substantive concerns expressed by 
GRULAC and other WTO Members at the last TBT Committee Meeting, the letters sent on this 
matter and the bilateral meetings held by several delegations with EC authorities in Brussels.  In 
particular, the European Communities was requested not  to proceed with the reclassification of nickel 
substances under the 30th and 31st ATPs and to allow sufficient time for scientific information 
submitted by industry to be properly considered.   
117. The representative of Cuba recalled that GRULAC had raised both specific and systemic 
concerns about the above-mentioned classifications, which had not been satisfactorily addressed by 
the European Communities.  He pointed out th at some GRULAC Members possessed the world's 
largest reserves of nickel, and the reclassification of  nickel substances would negatively affect their 
trade.  In particular, this was the case of sma ll and vulnerable economies like Cuba and the Dominican 
Republic, where nickel exports represented about 50 per cent of total exports  of goods.  Furthermore, 
contrary to previous EC statements that the 31st ATP only related to labelling and would not result in 
bans or restrictions on the use of chemi cal substances in c onsumer products, the 31st ATP would have 
an immediate legal effect across a wide range of  existing regulations, including requirements relating 
to cosmetics (Directive 76/768/EEC), biocide prod ucts (Directive 98/8/EC) and plant protection 
products (Directive 91/414/EEC).  Again, the repr esentative of Cuba remarked that these adverse 
effects would be particularly severe for devel oping countries which, given their low level of 
development and industrialization, relied on a fe w export products for employment and revenue.  G/TBT/M/47 
 Page 29 
 
 
  118. The Cuban representative also pointed out that the reclassification of nickel substances was 
taking place in the context of an economic crisis which was severely affec ting developing countries, 
and which had led to a global contraction of credit,  trade, investment and demand.  It was also 
recalled that the international price of nick el had decreased from US$50,000 per ton to about 
US$10,000 per ton in less than two years.  In th is context, such reclassification would further 
aggravate conditions in this industry and increase production, transport and insurance costs.  The 
representative of Cuba stressed that the impact of th ese classifications would be felt not only by nickel 
producers, but also by other countries which used nickel compounds in a broad range of industries and chemical processes.  At the same time, the reclassifi cation of nickel in one of the largest and most 
important world nickel markets would affect the access of nickel and nickel products not merely to 
that market, but also to other major markets, as ha d previously been the case with other standards and 
classifications. 
119. The Cuban representative also expressed concer ns regarding the inappropriate level of 
transparency and lack of scientific rigor of the reclassification, which could have implications in future similar classification processes.  In partic ular, it was noted that the read-across methodology 
based solely on water solubility could be used as a precedent for taking regulatory decisions about 
other substances and concentrates produced in devel oping countries, especially in view of the EC’s 
implementation of REACH and the UN Globally Ha rmonised System of classification and labelling 
of chemicals (GHS).  Given the significant co mmercial implications outlined, the European 
Communities was asked to take into considera tion Article 12.3 of the TBT Agreement, which 
provided that "Members shall, in the preparation and application of techni cal regulations, standards 
and conformity assessment procedures, take account of  the special development, financial and trade 
needs of developing country Members, with a view  to ensuring that such technical regulations, 
standards and conformity assessment procedures do not create unnecessary obstacles to exports from 
developing country Members".   
120. While Members of GRULAC recognized the n eed for authorities to regulate the use of 
dangerous substances for protecting human health a nd the environment, it was noted that the read-
across methodology and other non-testing methodol ogies had to be used in a transparent and 
scientifically justified manner.  In this regard, th e delegation of Cuba recalled that the grouping and 
read-across methodology used in the 31
st ATP did not conform to the criteria established by the 
OECD or the criteria of the US Environmental Protection Agency (EPA).  This was due to the fact that the European Communities disregarded three of  the eight essential verification steps established 
by the OECD guidelines, without providing any sci entific explanation as to why those steps were 
omitted.  Furthermore, while the European Communities relied on water solubility as a single data point and primary basis for classifying nickel co mpounds, no data existed on the water solubility for 
most of the nickel compounds that were classified in the 31
st ATP.  For both the OECD and the US 
EPA, establishing categories or groups of chemicals for the purpose of this methodology was a 
complex process involving the review of a number  of elements.  In this regard, the European 
Communities did not appear to have taken such elements into account. 
121. Finally, the representative of Cuba drew the attention of the Committee to the timetable 
established by the European Communities for the adoption of the 31st ATP.  He considered that the 
European Communities did not allo w sufficient time for consultations to be held, as required under 
Article 2.9.4. of the TBT Agreement.  In partic ular, he noted that the Technical Progress Committee 
(TPC) approved the 31st ATP on 19 November 2008, within 24 hours of the end of the notification 
comment period.  His delegation therefore believed that the European Communities did not have time to take into account the comments provided by othe r WTO Members the day before.  Cuba urged the 
European Communities to notify the 1
st ATP to the CLP regulation, as required under Article 2.9 of 
the TBT Agreement. G/TBT/M/47 
Page 30  
 
  122. The representative of Cuba
, speaking on behalf of his own delegation, regretted that the 
European Communities approved the 31st ATP despite the concerns and many requests from WTO 
Members to extend the period for comments.  In th is regard, he recalled that the TPC approved the 
new reclassification within 24 hours of the end of  the notification comment period, thus acting 
inconsistently with the requirements set in Article  2.9.4. of the TBT Agreement.  Concerns were 
expressed about the negative impact that the 31st ATP would have on the demand for nickel especially 
in developing countries, which were  highly dependent on nickel expor ts.  This was the case of Cuba, 
where nickel exports represented, in 2007, more than 50 per cent of the total exports in goods.  
Furthermore, the reclassification was taking place in the context of a global economic crisis. 
123. The representative of Cuba pointed out that the reclassification of nickel substances would 
trigger a contraction in demand and investment in this industry and an increase in labelling, 
packaging, transport, processing, storage and insuran ce costs.  Indeed, the adverse effects of the new 
classifications would also have repercussions on other important markets.  Cuba supported the 
objectives of protecting human health and the enviro nment, however the requirements set by the new 
regulation appeared to be inconsistent w ith Article 2.2 of the TBT Agreement.   
124. The representative of Cuba recalled that water solubility was only one of the many 
physical-chemical properties to be considered when making a comparison, but no data existed on 
these properties for most of the substan ces that were classified in the 31st ATP.  He further stressed 
that there was a different behaviour among the s ubstances of the same class:  nickel oxide, for 
example, was highly soluble in water, whereas green nickel oxide was not. 
125. With regard to the read-across methodology , the Cuban representative recalled that the 
European Communities had disregarded three of th e eight essential verification steps established by 
the OECD guidelines.  He further stressed that th e European Communities did not offer any scientific 
evidence to establish a clear causal link between wate r solubility and toxicity of nickel substances.  
Moreover, the same substance being used as a refe rence, nickel carbonate, was already incorrectly 
reclassified as dangerous, using the sam e method without any scientific support. 
126. The delegation of Cuba believed that the Eur opean Communities did not give a satisfactorly 
clarify the many concerns raised on the 31st ATP, which appeared to be more trade-restrictive than 
necessary and therefore incompatible with Article 2.2 of the TBT Agreement.  Cuba also believed that 
the European Communities did not take into account the special needs of developing countries when 
adopting this regulation, as required by  Article 12.3 of the TBT Agreement. 
127. The representative of Cuba noted that the Eu ropean Communities intended to incorporate the 
30th and 31st ATPs to the 1st ATP to the CLP regulation, which would be submitted for approval to the 
EC member States on 25 March 2009.  In this regard , the representative of Cuba regretted that the 
European Communities would notify the draft 1st ATP for informative purposes only, because it 
covered the same substances covered by the 30th and 31st ATPs to the DSD, which had already been 
notified to the TBT Committee.  He stressed that , since there were no international standards 
regarding the classification of nickel compounds and the regulation would have a significant effect on 
trade of WTO Members, the European Comm unities was obliged to notify the draft 1st ATP, as 
required under Article 2.9 of th e TBT Agreement.  Moreover, the CLP and the DSD regulations 
imposed different standards and obligations.  For ex ample, the CLP regulation had different rules on 
format, methodology and information requirements, which could require a different assessment of the 
substances.  Also, the two regulations had differe nt thresholds for high toxicity and different 
qualitative descriptions, restrictions, rules on packagi ng, labelling and risk warnings.  The European 
Communities was therefore urged to comply with the obligations set by Article 2.9 of the TBT 
Agreement, and notify the draft 1st ATP at an early appropriate stage, allowing reasonable time for 
other Members to make comments, discuss these co mments and take them into account.  Finally, the  G/TBT/M/47 
 Page 31 
 
 
  European Communities was urged to amend the 31st ATP to exclude nickel compounds from the 
scope of its application, sound scientific evidence of their toxicity was available. 
128. The representative of Japan  regretted that a satisfactory clarification to the many concerns had 
not been given by the European Communities at the last TBT Committ ee meeting.  Japan was further 
concerned that, given the technical nature of the issue, the period granted by the European 
Communities to comment on the 31st ATP was too short.  Furthermore, since the CLP regulation 
came into force on 20 January 2009, Japan reque sted the European Communities to provide, in 
advance and extensively, WTO Members with deta iled information on the schedule of the related 
procedures, like the timeline of the 1st ATP to CLP and the timing of its notification to the TBT 
Committee. 
129. The Japanese representative recalled that th e scientific evidence of the read-across 
methodology applied to the 30th and 31st ATPs had been questioned by many WTO Members.  
Accordingly, he urged the European Communiti es to discuss the above-mentioned methodology with 
the countries that raised concerns and take thei r comments into account to take an appropriate 
approach to classification that meets with th e GHS requirements. It was emphasized that an 
inappropriate approach to the classification of nickel compounds would have a significant impact both 
on nickel compounds manufacturers and on their users. 
130. The representative of Canada  supported the objectives of protecting human health and the 
environment.  However, her dele gation regretted that the European Communities did not seem to have 
taken into account the concerns expressed by trading partners with regard to the reclassification of 
nickel substances.  The Canadian representative st ressed that the EC reclassification could have a 
significant impact on the economy of her country, th e economies of the other 21 WTO Members that 
expressed concerns at the last TBT Committee meeting and the economies of some EC member States.  Some other specific concerns on the 31
st ATP were raised by her delegation.  First, Canada 
requested that the European Comm unities explain the consequences of the entry into force of the CLP 
regulation.  In this regard, it w as Canada's understanding that the 30th and 31st ATPs were of no legal 
effect, as they were amendments to the DSD regul ation which was repealed before the amendments 
came into effect, and subsequently replaced by the CLP regulation.  Second, Canada urged the 
European Communities to explain what procedure would be used to add the 30th and 31st ATPs to the 
1st ATP to the CLP, and what the expected timefra me was.  Third, the European Communities was 
requested to outline the risk management measures considered  for the substances in the 30th and 31st 
ATPs.   
131. The representative of Canada further stressed that the European Communities should notify 
the draft 1st ATP to the TBT Committee, and allow sufficien t time for comments.  It was also essential 
to Canada that any classifications of substances be based on transparent, sound science.  Canada 
expected scientific information on nickel substan ces to be supplied by its industry under REACH and 
expected that the European Co mmunities would give serious consideration to such scientific 
information to conduct a further review of the cl assifications.  The Canadian representative stressed 
that her delegation looked for information on pr ocedures regarding the implementation of the 30th and 
31st ATPs, and would monitor the introduction of risk  management measures to ensure they were not 
unnecessarily trade restrictive.  Finally, she urged th e EC delegation to clarify what the regulatory 
response to the adopted classifications of nickel would be.   
132. The representative of Mauritius, speaking on behalf of the ACP Group  thanked the EC 
delegation for its reply to the comments made at  the last TBT Committee meeting regarding the 
decision to classify as hazardous over 100 nickel compounds in the 31st ATP directive.  However, he 
noted that the issues raised had not been satisf actorily addressed by the European Communities and 
introduced a new submission from his delegation containing further comments (G/TBT/W/307).   G/TBT/M/47 
Page 32  
 
  133. The ACP Group was concerned that the 31
st ATP would have immediate legal effect across a 
wide range of existing European laws.  This contra dicted previous EC statements, in which the EC 
delegation pointed out that the 31st ATP only related to labelling a nd would not result in bans or 
restrictions on the use of substances in cons umer products.  The ACP Group believed that the 
reclassification of nickel substances would have  a significant negative economic and commercial 
impact on all nickel producing and exporting countries.   These adverse effects would be particularly 
severe for developing countries which, given their low levels of development and industrialization, 
tended to rely on a few basic exports for employment  and revenue.  For example, this was the case of 
many ACP countries including Botswana, Cuba and the Dominican Republic, which were small and 
vulnerable economies highly dependent on mineral exports.  Also, the 31st ATP would seriously affect 
future investments in the South African mining sector. 
134. The representative of Mauritius recalled that th e reclassification of nickel compounds took 
place in the context of a global economic crisis that  was severely affecting developing countries.  The 
31st ATP was likely to further aggravate conditions in this industry, and cause increased production, 
transport and insurance costs.  Given the significan t commercial implications, it was essential that any 
classification of nickel compounds took into account the special development, financial and trade 
needs of developing countries, as required under the TBT Agreement.    
135. While the ACP Group recognized the importance of ensuring a high standard of protection for 
human health and the environment and supported the development of regulatory strategies to achieve 
such protection, the European Communities had not  proved the nickel classifications in the 31st ATP 
was based on a sound and transparent scientific met hod.  In particular, the ACP Group continued to 
disagree that the grouping and read-across methodology were in conformity with the OECD criteria or 
the US EPA guidelines.  Furthermore, the Europ ean Communities' reliance on a single data point, 
water solubility, as the initial and primary basis for categorizing nickel compounds was not supported 
by scientific facts, and was contrary to the OECD and US EPA guidelines.  It was recalled that the 
European Communities had not showed the scientific  basis for its assertion that water solubility was 
an "approximation" of the "systemic bioavailability of the nickel ion". 
136. The representative of Mauritius stressed that th e scientific and commercial issues raised by 
the nickel classifications in the 31st ATP were highly technical and complex.  Yet, the legislative 
timetable of the 31st ATP failed to provide sufficient time for meaningful consultation with other 
WTO Members, as required under Article 2.9 of the TBT Agreement.  Finally, the European Communities was encouraged to notify the draft 1
st ATP to the CLP regulation at an early stage. 
137. The representative of the Dominican Republic  supported the comments made by Cuba on 
behalf of GRULAC and Mauritius on behalf of ACP, and reiterated concerns on the reclassification of 
nickel carbonates and other components of nickel, wh ich her delegation considered to lack sufficient 
scientific evidence.  She also not ed that the comments expressed by various delegations at the TBT 
Committee meetings of March, July and November  2008 had not been taken into account in the 
amendment of the 30th and 31st ATPs.  The representative of the Dominican Republic stressed that 
written comments regarding the 31st ATP had been sent to the EC delegation on 18 November 2008, 
and were subsequently circulated to all WTO Members under document G/TBT/W/302.  She 
regretted that her delegation did not receive any response from the European Communities.  She also 
regretted that the TPC approved the 31st ATP on 19 November 2008, within only 24 hours of the end 
of the notification comment period.  It was her de legation's view that, having been adopted in these 
circumstances, the 31st ATP did not satisfy the requirements set by Article 2.9 of the TBT Agreement.   
138. The Dominican Republic objected to the manner in which the European Communities applied 
the read-across methodology, which inaccurately tr ansposed the toxic effects of one group of 
compounds to a broader group of nickel substances.  In this regard, the representative of Dominican 
Republic believed that the European Communities vi olated Article 2.2 of the TBT Agreement.  She  G/TBT/M/47 
 Page 33 
 
 
  recalled that nickel exports represented, in 2007, more than 50 per cent of the total exports of the 
Dominican Republic, with a total value of US$1,153 million, and that the 31st ATP would have 
serious harmful effects for both producers and exporters  of nickel substances.  Considering the serious 
drop in nickel prices that had already occurred in 200 8, the EC measure would have a negative effect 
on industry and the economy of the country as a whole.   As an example, it was pointed out that, in 
November 2008, a nickel company of the Dominican Republic was obliged to dismiss more than nine 
hundred workers.  Finally, the European Communities was encouraged to comply with the obligations 
set by Article 2.9 of the TBT Agreement, and notify the draft 1st ATP at an early appropriate stage, 
allowing reasonable time for other Members to comment. 
139. The representative of China  echoed the concerns already e xpressed about the adoption of the 
31st ATP by various delegations, particularly those of Cuba.  While China appreciated the European 
Communities' reply to China's comments received on 22 December 2008, concerns with regard to the 
31st ATP still remained.  In particular, the Ch inese representative noted that the European 
Communities did not provide any specific data on the water solubility of most nickel compounds.  Therefore, China believed that the classifica tion of over one hundred nickel compounds was not 
scientifically correct. 
140. Furthermore, the representative of China inv ited the European Communities to clarify the 
procedures, timetables and legal conse quences of the incorporation of the 30
th and 31st ATPs into the 
CLP system.  China was particularly interested in  the legal consequences of such incorporation on 
downstream industries and consume r-end products.  Finally, China asked the European Communities 
whether the 30th and the 31st ATPs would be directly incorporated into the CLP system, or whether 
more evaluations would be conducted.  The Euro pean Communities was encouraged to notify the 
draft CLP at an early appropriate stage, allo wing reasonable time for other Members to make 
comments. 
141. The representative of Brazil  shared the concerns raised by other WTO Members and 
supported, in particular, the comments made by Cu ba on behalf of GRULAC.  While he thanked the 
European Communities for the bilateral consu ltations held with his delegation on the 30th and 31st 
ATPs, Brazil regretted that the 31st ATP had been adopted despite the many concerns raised about the 
inadequate use of the read-across methodology.  In  view of the future incorporation of the 30th and 
31st ATPs to the new CLP regulation, Brazil request ed the European Communities to notify the draft 
1st ATP to the TBT Committee, so that Member s would have sufficient time to analyze the 
relationship between the ATPs and the new CLP regulation.  In th is regard, the representative of 
Brazil highlighted the differences between the new C LP regulation and the previous DSD.  He noted, 
for example, that the CLP and DSD had different thr esholds for acute toxicity of chemicals, and used 
different definitions.  For instance, while Category 1A of the CLP referred to substances known to be 
carcinogenic, largely based on human evidence, Cate gory 1 of the DSD referred to substances known 
to be carcinogenic, based on sufficient evidence to establish a caso association .  Finally, Brazil 
recalled that new studies on the toxicity of nickel compounds were expected to be published in the 
coming months, and asked the European Communities to  take them into account before enforcing the 
30th and the 31st ATPs. 
142. The representative of Colombia  associated her delegation with comments made by the 
delegation of Cuba on behalf of GRULAC.  She reiterated her delegation' s concerns about the 30th and 
31st ATPs and recalled the overwhelming effect s such measures would have for Colombia. 
143. The representative of Botswana  joined the statement made by Mauritius on behalf of the ACP 
group, and raised further concerns about the 31st ATP.  He regretted that the European Communities 
had adopted the 31st ATP, despite the concerns expressed by nickel producers and exporting countries.  
Concerns were expressed that the reclassificati on of nickel compounds as  dangerous substances 
would have far reaching implications for the mining i ndustry in his country.  It was also recalled that G/TBT/M/47 
Page 34  
 
  Botswana was highly dependent on mineral exports, including diamonds, copper, nickel, coal, salt, 
gold and potash.  The mining sector contributed to approximately 40 per cent of Botswana's GDP and about 90 per cent of all merchandise exports.  In 2007, nickel contributed substantially to the country's 
exports and accounted for approximately 48 per cent of  all employment in the country's mining sector.  
The representative of Botswana also noted that c opper and nickel mining sectors had benefited from 
the SYSMIN programme, a system created by the European Communities to stabilize export earnings 
from mineral products.  However, this system would be undermined by the above-mentioned 
measure. 
144. Botswana remained concerned that the recl assification of over 100 nickel compounds as 
dangerous substances would have an overwhelmi ng impact not only on the mining sector, but would 
also affect the very livelihood of communities depe nding on such revenue.  In particular, concerns 
remained about the adoption of the read-across methodology in the 31
st ATP, which Botswana did not 
believe to be based on solid scientific arguments .  While Botswana recognized the importance of 
ensuring a high standard of protection for human health and environment,  the scientific grounds 
sustaining the adoption of the read-across met hodology remained unclear.  In conclusion, the 
representative of Botswana encouraged the European  Communities to delay the implementation of the 
31st ATP until WTO Members' concerns were fully addressed. 
145. The representative of Australia  reiterated her delegation' s concerns regarding the 
reclassification of nickel compounds under the 31st ATP, and shared concerns raised by other 
Members.  While regulatory decisions with far-r eaching commercial implications should be based on 
sound, defensible and transparent science, Australia n authorities remained concerned that the decision 
to reclassify 117 nickel compounds under ATP 31st was based on questionable scientific and 
procedural grounds.  The European Communities was ther efore requested to clarify the legal status of 
the ATP 31st and the 117 reclassified nickel compounds listed in it.  Furthermore, the Australian 
representative remained concerned that the adoption of the 30th and 31st ATPs could set an 
unwarranted precedent for the manner in which ot her groups of chemical substances would be 
classified in future, including under REACH.  In particular, it was her dele gation's understanding that 
the new CLP Regulation provided for harmonized classifications, including those coming from 
REACH, via an ATP procedure.  This would cr eate a precedent, and her delegation was concerned 
about the scientific and procedural grounds of this precedent. 
146. The representative of Australia stressed that the reclassification of nickel compounds under 
the 30th and 31st ATPs could have a significant economic im pact on all nickel producing and exporting 
countries, including developing countries.  She also highlighted the fact that the nickel compounds 
listed in the 31st ATP were used in a large range of pro cesses.  For instance, the nickel compounds 
listed in the 31st ATP were used as catalysts in applications such as petroleum refining, hydro-
cracking, hydro-processing, steam reforming, food  processing, transportation and carbon capture; in 
electroplating and surface treatment applications and technologies; and, finally, in a large number of 
applications and technologies such as lithiu m ion technologies, nanotechnologies, fuel cells, 
electroforming, semiconductor technology and specialized coating. 
147. While Australia appreciated the explanati on given by the European Communities that 
REACH provided for the "possibility of exemptions", concerns remain ed that:  nickel substances and 
preparations containing such substances would need to be labelled with danger symbols, including the 
"skull and crossbones", which would potentially contri bute to the stigmatisation of nickel and nickel-
containing material and could reduce research and i nvestment in important nickel-based technologies 
and materials; the reclassification of nickel  compounds as Category 1 and 2 carcinogenic and 
mutagenic compounds would trigger a series of dow nstream regulatory requirements that would 
impose addition restrictions and prohibition on th e substances; the reclassified Category 1 or 2 
carcinogenic and mutagenic substanc es would be deemed "substances of very high concern" (SVHC) 
under REACH and could result in additional restric tion, prohibition, or substitution of nickel; the  G/TBT/M/47 
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  planned classification would reduce supply of nickel  substances to downstream users and damage the 
competitiveness of manufactures in critical sectors that rely on nickel substances. 
148. Given the significant commercial implications of the proposed reclassification of nickel 
compounds under the 31st ATP, it was essential that any restriction imposed by the European 
Communities on nickel compounds be based on sound a nd transparent science which did not put in 
place unnecessary obstacles to international trade.  Australia recognised the importance of ensuring a 
high standard of protection for human health and the environment, and supported the development of 
regulatory strategies to achieve such protection.  However, in accordance with Article 2.2 of the TBT 
Agreement, these regulations should not create unnecessary obstacles to international trade. 
149. The representative of Zimbabwe  associated herself with th e comments made by Mauritius on 
behalf of the ACP group.  Zimbabwe urged the Eu ropean Communities to address the concerns of all 
nickel producing and exporting countries, also taki ng into account the special development, financial 
and trade needs of developing country Members.   
150. The representative of Indonesia  noted that his country's nickel exports to the European 
Communities would be significantly affected by the entry into force of the 31st ATP.  Considering the 
adoption of the CLP regulation and the preparation of the 1st ATP to the CLP, Indonesia urged the 
European Communities to fulfil its obligations set in  Article 2.9 of the TBT Agreement and notify the 
draft 1st ATP at an early appropriate stage, allowing reasonable time for other Members to make 
comments. 
151. The representative of Argentina  joined the concerns expressed by previous speakers about the 
reclassification of nickel compounds.  He recalled that measures aimed at protecting human health 
and the environment should be based on sound science and not represent an unnecessary barrier to 
trade. 
152. The representative of South Africa  thanked the European Communities for the replies 
received in November 2008.  However, he s upported the concerns already expressed about the 
adoption of the 31st ATP by various delegations, particularly  those of Mauritius on behalf of the ACP 
group, Botswana and Zimbabwe. 
153. The representative of the United States  reiterated his delegation's concerns regarding the 30th 
and 31st ATPs, and regretted that the classification of borates and nickel under the DSD regulation had 
been finalized.  In particular, concerns remained on the legal status of the DSD and CLP regulation, 
and on how they interacted.  The European Communiti es was therefore requested to clarify the status 
of the classifications under the 30th and 31st ATPs.  Were those classifica tions currently binding, did 
they only become enforceable once a dded to the CLP regulation by the 1st ATP or were they 
enforceable on some other date?  What was the pr ocess for adding such classifications to the CLP 
regulation?  Would the European Communities notify the 1st ATP to the CLP regulation to the TBT 
Committee, allow for due comments and reconsider th e classifications in light of new information? 
154. The representative of the United States noted th at the European Communities did not appear 
to have taken into account the normal handling a nd use of borates-containing and nickel-containing 
products when proposing its classification of subs tances, and emphasized that the EC delegation 
acknowledged that its classification was entirely hazar d-based.  In addition, the representative of the 
United States reiterated his delegation's concer n regarding the "skull-and-crossbones" labelling 
requirements for certain borates-containing pro ducts, and the "knock-on" effects under other EC 
legislation, including REACH. 
155. Furthermore, the US representative recalled that, at the last TBT Committee meeting, the 
European Communities claimed that a risk and im pact assessment of downstream uses of borates G/TBT/M/47 
Page 36  
 
  under the Marketing and Use Directive would be conduc ted.  In this regard, it was his delegation's 
understanding that a consultant, Risk and Policy Anal ysts (RPA), completed such a risk and impact 
assessment with respect to borates-containing products in November 2008.  With regard to the use of 
borates in fertilizer, the RPA Report found that th e risks associated with boron fertilizers were 
unlikely to be of serious concern and there was a po ssibility that any potential restrictions on the use 
of borates as a fertilizer would result in costs to  the industry and provide consumers with no or 
minimal benefit in terms of risk avoided.  With re gard to the use of borates in soaps and detergents, 
the RPA Report found that consumer exposures were  negligible.  Concerning the use of borates in 
certain other chemical products, the RPA Report found that the risks to consumers were negligible 
with the restrictions imposing high costs on produ cers.  Lastly, according to the RPA Report the use 
of borates in glass would be unlikely to result in any significant exposure of borates to consumers and 
there were no viable alternatives. 
156. The United States requested the European Commu nities to clarify the effect of the above-
mentioned Report on the EC determination with respect  to restrictions on the use of borates under the 
Marketing and Use Directive.  In particular, the European Communities was asked to confirm that, as 
a result of the RPA Report, there would be no restrictions on the uses of borates under that Directive.  
Given RPA’s finding, the EC delegation was invited to  explain what the basis for requiring skull and 
crossbones labelling on certain borate-containing pro ducts was.  Finally, it was emphasized that the 
United States continued to study the risk and im pact assessment for borates, monitor the potential 
adverse trade impacts both of nickel and borates classifications, and analyze the classification methodology that had led to these classifications in  the context of REACH and other EC measures. 
157. The representative of Turkey
 emphasized that the comments of his delegation were valid for 
both the 30th and 31st ATPs.  While Turkey recognized the importance of ensuring a high standard of 
protection of human health and safety, concerns re mained that the EC classification would not fulfil 
such objectives and would create unnecessary barriers to  trade.  The representative of Turkey recalled 
that his country's authorities had started a study on boron mines, the results of which would be shared 
with interested Members.  He also regretted th at the European Communities disregarded the above-
mentioned epidemiological study.  The results de rived from animal tests could not lead to the 
conclusion that borates caused reproductive toxicity in  humans, and this was also demonstrated by the 
RPA Report mentioned by the US delegation.   
158. In particular, the RPA Report indicated that, in  an array of exposure scenarios from the lowest 
level to the highest, the utilization of borates in e nd-products did not require restrictions due to the 
negligible level of risks associated with their use.  In this regard, concerns remained on the reasoning 
behind the EC decision to approve the 30th and 31st ATPs despite the evidence provided by the report 
and the concerns raised by many WTO Members.  The representative of Turkey encouraged the 
European Communities to recognize the RPA Report as  a basis for future steps regarding borates.  
Furthermore, he reiterated that the classification decisions in both the 30th and 31st ATP did not have a 
legitimate objective and had the effect of  creating unnecessary obstacles to trade. 
159. The representative of Turkey  also noted that the 30th and 31st ATPs required EC member 
States to "bring into force the laws, regulations and administrative provisions necessary to comply 
with this Directive" by 1 June 2009.  In this cont ext, he recalled that the classification and labelling 
system provided under the DSD was currently bein g replaced by the CLP regulation, which entered 
into force on 20 January 2009 and would complete ly replace the DSD on 1 December 2010.  The new 
CLP regulation deleted Annex I of th e DSD regulation and incorporated it into Annex VI of the CLP.  
However, Annex VI of the CLP regulation onl y incorporated Annex I as amended by the 29th ATP.  
The European Communities was theref ore encouraged to clarify the process which would be followed 
for the incorporation of the 30th and 31st ATPs into the CLP regulation.   Considering the differences 
between the new CLP regulation and the previous DS D, the European Communities was urged to take  G/TBT/M/47 
 Page 37 
 
 
  into account the concerns raised by WTO Members with regard to the 30th and 31st ATPs, and 
consider the findings of the above-mentioned RPA report.  
160. The representative of the Philippines  joined the concerns raised by other Members on the 
reclassification of nickel, and encouraged the Eu ropean Communities to take those concerns into 
account. 
161. The representative of the Russian Fe deration, speaking as an observer , supported the 
comments of previous delegations with regard to the nickel classification, and regretted that the 
European Communities adopted the 31st ATP without taking into account the concerns raised by 
WTO Members.  In this context, attention was dr awn to the consequences of the EC decision on the 
nickel industry.  Furthermore, the representative of the Russian Federation recalled that the EC 
regulation lacked scientific consistency and could create unnecessary barriers to trade.  She therefore 
urged the European Communities to remove all ni ckel classification proposals in the draft 1st ATP, 
and take any decisions regarding classification on the basis of scientific evidence provided by industry.   
162. The representative of the European Communities
 confirmed that the 31st ATP had been 
adopted by the European Commission on 15 January  2009, after the Committee of member States 
representatives had given its favourable opinion on 19 N ovember 2008.  She also noted that all the 
comments received from WTO Members had been carefully analyzed by EC authorities and EC member States.  In full knowledge of these comments,  the EC member States voted in favour of the 
proposal, with no vote against it. 
163. With regard to the scientific basis of the me thodology used to classify the nickel compounds, 
the EC delegation recalled that, at the last TB T Committee meeting and at the information session 
held on 4 November 2008, two experts explained in  detail how the read-across methodology had been 
applied and how existing scientific data had been used.  Those explanations could be found in the 
Minutes prepared by the WTO Secretariat.
5  Additional clarifications could also be found in the 
extensive reply submitted by the EC delegation to the comments of WTO Members.  As indicated in 
the adopted regulation, new arguments or scien tific evidence submitted by WTO Members with 
regard to this classification would be examined by the European Communities.  However, the EC 
representative stressed that new data had not been  received yet, neither from industry nor from third 
countries.  It was also emphasized that the Eu ropean Communities had not received evidence from 
downstream users as to the impact this classi fication could have on their activities.  
164. On the issue of the CLP regulation and its link with the 30th and 31st ATPs, it was noted, first, 
that the CLP was aimed at implementing the Glob ally Harmonised System (GHS) of classification 
and labelling of chemicals.  It was also clarified that Annex I of the DSD, which contained the compounds classified under the 30
th and 31st ATPs, had been repealed by Article 55(11) of the CLP 
regulation as of its entry into force in 20 January 2009.  The recently adopted harmonized 
classifications contained in the 30th and 31st ATPs were not in force yet but would be introduced as 
new entries in the CLP regulation via a draft 1st ATP proposal.  This draft 1st ATP had been already 
notified to the TBT Committee as an addendum  to G/TBT/N/EEC/151, G/TBT/N/EEC/163 and 
G/TBT/N/EEC/212.  While several delegations asked  the European Commission to notify the above-
mentioned measure as a new notification, the EC representative noted that only draft proposals which imposed new requirements had to be notified to th e TBT Committee.  This "direct" translation, or 
direct transfer was foreseen in Annex VII of the CLP Regulation and had been  likewise applied to all 
the substances classified under the previous A TPs and covered over 8000 substances  Therefore, 
Annex VII of the CLP regulation contained the classi fication of dangerous substances that had been 
                                                     
 
5 See G/TBT/M/46 pp. 21-25. G/TBT/M/47 
Page 38  
 
  done on the basis of the GHS criteria, and include d the classifications adopted under the previous 
DSD regulation. 
165. With regard to the comments th at had been made in reference to the different criteria and 
safety phrases, the representative of the European  Communities noted that these phrases had been 
harmonized in accordance with the GHS.  In particular, Category 1 CMR under the DSD became 
Category 1 under GHS, Category 2 CMR under th e DSD became Category 1(b) under GHS, and 
Category 3 CMR under the DSD was Category 2 under GHS.  The adoption of the 1
st ATP was 
expected to take place in July 2009, and industry w as expected to implement the obligations in terms 
of classification and labelling by December 2010. 
166. Finally, the representative of the European Communities confirmed that a study had been 
carried out by an external consultant, the purpose of which was to assist the European Commission in 
examining whether it was necessary to impose any restrictions on the placing on the market of 
borates-containing products.  This study was finaliz ed in November 2008 and could be found on the 
website of the European Commission's DG Enterprise and Industry.6  The study demonstrated that 
there were no substances or preparations contai ning borates above the specific concentration limits 
which were sold in the EU market.  Therefore,  the European Communities concluded that such 
classification of borates would have no new impact in terms of production and import of substances 
and preparations containing borates. In this rega rd, it was also noted that the use of borates in 
cosmetic products was already restricted in the Eu ropean Union.  The representative of the European 
Communities also emphasized that the RPA Report had not yet been concluded yet concerning some minor uses and investigations were ongoing as well re garding the risks related to the use of sodium 
tetraborate in detergents.  New informat ion would be provided when available.  
(iv) European Communities – Regulation on the Regi stration, Evaluation and Authorization of 
Chemicals (REACH) (G/TBT/N/EEC/52, Adds 1-5 and Add.3/Rev.1) 
167. The representative of Thailand
 referred to her delegation's previously expressed position on 
REACH.  While Thailand supported the objectives of the protection of human health and the 
environment, the complexity of REACH was be yond the capacity of many developing and least 
developed countries to understand a nd comply with.  Such difficulties were particularly evident for 
SMEs, which represented the majority of Thailand's industry.  Concerns were  also expressed with 
regard to the Only Representative (OR) provision , which created unnecessary and unaffordable costs 
for SMEs.   
168. The representative of Japan  thanked the European Commun ities for the response to the 
comments previously raised on REACH.  Howeve r, some specific concerns about the REACH 
regulation remained.  First, the Japanese representa tive urged the European Communities to issue the 
guidance documents which had been delayed beyond the expected date.  Furthermore, it was noted 
that six EC member States expressed disagreement over the 0.1 weight per cent denominator 
mentioned in the guidance on "requirements for substa nces in articles".  Since this disagreement could 
undermine the compliance with REACH and confu se the Japanese industry, he encouraged the 
European Communities to ensure a unified im plementation of REACH across the European 
Communities and according to the guidelines est ablished under the European Commission and 
ECHA.  The representative of Japan also noted  that some EC member States required a pre-
registration number for the import of chemicals, wh ere other member States did not, despite the fact 
that REACH did not clearly stipulate this.  In th is regard, he emphasized that the operations and 
regulations for imports by EC member States were  different, and there we re inconsistencies among 
different member States.  The EC delegation was ther efore requested to give further clarification and 
                                                      
6 http://ec.europa.eu/enterprise/index_en.htm   G/TBT/M/47 
 Page 39 
 
 
  unification on the operation of pre-registration such as treatment of pre-registration number 
information in customs clearance when EC member States import. 
169. The representative of Japan noted that, accord ing to REACH, downstream manufacturers and 
importers of certain types of substances, such as "monomers contained in polymers", "substances 
which are intended to be released from articl es", "re-imported substances" and "recovered 
substances", were exempted from the registration if th e substances were registered by an actor higher 
up in the supply chain.  However, it was noted that the European Chemic als Agency (ECHA) had 
encouraged downstream companies to pre-register  the above-mentioned substances if they were not 
sure that the substances concerned would be registered by an upstream manufacturer or importer within the pre-registration deadline.  Since compan ies outside the European Union had difficulties to 
identify whether the substances were registered by  an actor higher up the supply chain, the ECHA's 
recommendation caused the submission of multiple pre -registrations by different companies through 
the same supply chain. 
170. On the Substance Information Exchange Fo rum (SIEF), the Japanese representative stressed 
that submitting pre-registration imposed a burden on companies, such as cost s involved in joining a 
voluntary consortium relevant to the SIEF, consu ltant fees, and securing other human resources to 
prepare for data-sharing.  Concerns remained also  on the cost of appointing an Only Representative 
(OR) and on the impossibility to withdraw from the SIEF without a particular reason.  Therefore, 
Japan requested the European Co mmunities to provide some guidelines on the exemptions from the 
unnecessary cost-sharing generated by double pre-regi strations, on the fees for companies to join a 
industry voluntary consortium relevant to the SI EF, and on the withdrawal from the SIEF after the 
conclusion of the upstream registration. 
171. The representative of Mexico
 referred to his delegation's previously expressed position on 
REACH, and noted that concerns remained with rega rd to two issues.  First, Mexico recalled that 
there were less trade-restrictive alternatives to  the OR requirement, such as extra-territorial 
inspections that would enable exporters to regist er chemical substances themselves.  Second, the 
Mexican representative expressed concern on the lack of uniform implementation of REACH among 
EC member States.  In this regard, he brought to the attention of the Committee a recently approved 
French law, which established criminal and moneta ry sanctions for non-compliance with REACH.  It 
was his delegation's understanding that  sanctions were far too high and were not consis tent with WTO 
provisions.  Finally, the Mexican representative urged the European Communities and EC member 
States to take into account the concerns of WT O Members about REACH and its implementation. 
172. The representative of the United States  shared the EC concern for protecting human health 
and the environment.  However, the REACH regula tion appeared to be overl y broad and to adopt a 
costly and burdensome approach that could unne cessarily disrupt and distort global trade.  In 
particular, the representative of the United States noted  that the number of concerns raised by industry 
was growing exponentially since the pre-registration period had ended.  Since all of those concerns 
involved the lack of transparency of REACH a nd its implementation, he had found it disappointing 
that the European Communities had not responded to repeated requests for bilateral technical talks 
made by the United States.  It was noted that the failure of the European Co mmunities to clarify such 
issues would lead to serious trade disruptions, an d that some US companies would have to stop 
shipping into the EC market.  It was also noted that , due to the lack of clarity and transparency of 
REACH, many companies had decided to pre-regist er every chemical substance to the European 
Chemicals Agency (ECHA).  As a result, there were approximately three million pre-registrants of 
over 140,000 substances, which was much larger than what ECHA forecasted.  The US industry 
believed that these large numbers of pre-registrant s would make the SIEFs unworkable and extremely 
expensive, especially for SMEs in both developed and developing countries who in many cases would 
have to pick and choose which substances they w ould continue to produce and use since they would 
not be able to participate in all of the SIEFs. G/TBT/M/47 
Page 40  
 
  173. Regarding the issue of cosmetics, the represen tative of the United States recalled that the 
European Communities had already recognized th at REACH could discriminate against foreign 
cosmetics producers, as many substances in important cosmetics would not have an EINICS number.  The US representative regretted that, despite repeat ed discussions and the urgency of the issue, the 
problem remained unresolved.   
174. On the Only Representative provision, the repr esentative of the United States regretted that 
fundamental structural problems remained.  In  fact, because foreign manufacturers could not 
themselves register as EC manufacturers could, and instead would need to appoint an OR unless they 
had an EU presence, the OR provision raised ser ious concerns for non-EC supply chains, and 
sensitive commercial information could be comp romised depending on who in the supply chain 
appointed the OR and how the supply chain was set up.  It was highlighted that this problem was 
leading several companies to consider as part of th eir sourcing policies whether they needed to start 
purchasing more of their inputs from companies locate d in the European Union.  Foreign chemical 
distributors were being particularly impacted since th ey were not permitted to appoint an OR.  In this 
regard, it was recalled that, in hi s delegation's view, one of the primary objectives of REACH was to 
increase the competitiveness of the European chemical industry. 
175. The representative of the United Stated also reitera ted his concern with regard to the different 
interpretation of REACH provisions across the EC me mber States.  For example, the ECHA guidance 
on "notification obligations for substances in articl es" noted that producers n eeded to check with each 
member State regarding how it would interpret the notification obligations.  It was noted that the 
United States had pointed out the dissenting opinio ns of several member States on substances in 
articles on previous occasions, but those concerns had not been addressed.   
176. Similarly, differential enforcement of REACH across the EC member States had been 
observed by the United States.  In this regard, the attention of the Committee was brought to the 
criminal penalties for non-compliance with REACH being developed by France and United Kingdom.  
Reference was also made to the evidence of pre -registration for imports s ought by Belgium and the 
Netherlands, even though this was not required und er REACH.  In this regard, the United States 
believed that actions seeking evidence of pre-regist ration were potentially problematic for at least two 
reasons.  First, given that REACH allowed six mont hs from the date of import or first manufacture for 
companies to submit late pre-registrations or fo r ORs to add new downstream users, these actions 
could block legitimate trade.  Second, pre-regi stration numbers supplied for purposes of customs 
clearance could be transmitted to downstream user s, who could use them to decipher information 
about product formulations.  Both of these potentia l problems would only affect imports.  Therefore, 
the US delegation asked the European Communities to clarify what actions were being taken to 
prevent differential enforcement and interpretation of REACH provisions, so that producers shipping 
products to the EC market could ha ve legal certainty and be sure th at their proprietary formulas were 
protected.  In concluding, the US representative urged the European Communities to take into 
consideration the concerns which had been expressed by trading partners and other interested parties, 
and to ensure a meaningful opportunity to reflect the views of other governments and stakeholders in 
the process. 
177. The representative of Korea
 pointed out that the Korean industry was still facing many 
difficulties in complying with REACH.  He shared  the concerns expressed by Japan  and the United 
States, in particular about the differential im plementation of REACH among EC member States and 
the supply chain issue.  He stres sed that potential exporters were no  longer shipping to the EC market 
because of the complexity of REACH. 
178. The representative of Argentina  reiterated his delegation's conc ern with regard to REACH.  
The complexity and extensive scope of REACH, coupled with the burdensome costs associated, the 
lack of transparency and appropriate technical assistance, was injuring Argentinean exporters and  G/TBT/M/47 
 Page 41 
 
 
  constituted a serious impediment to their continue d presence in the EC market.  It was noted that 
during the period of pre-registration, which ende d on 1 December 2008, both the ECHA and the EC 
authorities had not satisfactorily responded to the questions that had been raised on technical assistance.  Argentinean companies also complained that the lack of uniformity in the information 
provided by the Enquiry Points of each EC member State had led to different answers to the same 
questions.  In this context, a massive number of  pre-registrations had been submitted by a small 
number of companies, which showed that the comp etitiveness of the EC market had been seriously 
distorted.  The representative of Argentina reitera ted his delegation's request  to have the list of 
companies which had already carried out the pre-registration procedure.   
179. In addition, concerns remained on the Substances of Very High Concern (SVHCs) included in 
Annex XIV of the REACH Regulation.  In partic ular, the Argentinean delegation referred to the 
candidate list of SVHCs updated on 16 February 20 09, which listed 17 chemical substances.  While 
on 14 January 2009 a Press Release of the Commi ssion defined seven of the above-mentioned 
substances as "priorities" and therefore subjected to  public consultation, nothing had been said with 
respect to the other ten substances.  Given the sens itive nature of this topic, Argentina requested the 
European Communities that all information and requir ements discussed in the future be focused in 
one single Enquiry Point established at the ECHA.  On the same topic, Argentina urged the European 
Communities to clarify whether stakeholders ne eded to follow up on the news related to the 
implementation of REACH on the ECHA webpage, or whether the ECHA would directly inform the 
relevant authorities of the EC member States  through regular communications.  Finally, the 
Argentinean delegation held that REACH constituted an unnecessary barrier to trade, as it distorted 
the competitiveness of the EC market in chemical products and substances. 
180. The representative of Canada
 supported the objectives of protecting health and the 
environment, but reiterated her dele gation's concern about REACH.  With respect to the issue of the 
Only Representative, Canada remained concerned th at REACH could have a disproportionate impact 
on SMEs, and that the OR requirement was biased  against non-EU based companies because of the 
extra costs it entailed.  In this regard, Canada believed that a company wishing to comply with 
REACH had to either hire an OR, open an office in the European Union, attempt to navigate the 
complexity of REACH on its own, or choose to  abandon the EC market.  The representative of 
Canada also asked the European Communities to explain what measures were being taken to protect 
confidential business information that non-EC fi rms were expected to provide to their OR. 
181. On the subject of test methods regulations, the representative of Canada noted that the 
European Communities would adopt the OECD test  standards.  She re quested the European 
Communities to clarify what the timeline for adopti on of the test methods and what the practical 
consequences would be.  It was also noted that  the European Communities had declared that the 
OECD test standards would be used except in ex ceptional circumstances.  Canada requested the 
European Communities to clarify what these excep tional circumstances could be and whether they 
would be published.  The European Commission was further requested to postpone the adoption of 
any unique or alternative test methods until their review and acceptance by the OECD.   
182. On the subject of data submitted by industry, Canada believed that i ndustry would be required 
to generate a great amount of scientific  data to demonstrate the safety of  their products.  In this regard, 
the European Communities was encour aged to treat data submitted by industry fairly and objectively 
and clarify how such objectivity would be safeguard ed.  For example, what transparency, oversight 
and peer review measures would be put in place? 
183. On the Substance Information Exchange Foru m (SIEF), the representative of Canada noted 
that Canadian companies needed to provide data to  ORs which, in turn, could be required to report 
this data to the SIEF.  Since only EC-based companie s were able to join the SIEF, this could cause an 
unfair, potentially prejudicial one-way flow of information that could disadvantage Canadian G/TBT/M/47 
Page 42  
 
  companies.  In this regard, the Canadian delegati on stressed that foreign companies should be allowed 
to join the SIEF and benefit from the information sh aring.  Canada requested the EC delegation to 
clarify how it considered the relationship between  mandatory SIEFs, voluntary, pre-existing industry 
consortia and how the two could fit into the RE ACH framework.  Furthermore, the European 
Communities was asked to clarify whether data sh aring requirements under SIEF applied to non EC-
based companies represented by an Only Representative, and provide details on the cost and data 
sharing rules applicable to SIEF.  Since industry still faced many problems with the implementation 
of this regulation, the Canadian delegation hoped that REACH Help Desks would be widely promoted 
and be responsive to enquiries. 
184. The representative of Chile
 reiterated her delegation's concerns  with regard to REACH.  In 
particular, she recalled that there was still lack of clarity on the product coverage of the REACH 
regulation.  Although her delegation had raised this issue previously , the response of the European 
Commission had not been satisfactory.  Chile furt her encouraged the EC delegation to clarify the 
penalties for non-compliance with REACH, which appeared  to be different in each EC member State.  
Moreover, Chile asked the Commission to publish so me guidelines for the interpretation of Annexes 
IV and V of the REACH regulation, and to clarify the issue of cosmetics. 
185. Concerns also remained on the treatment of  copper and molybdenum under REACH.  In 
addition, Chile expressed concern with regard to the last four digits of the registration number of 
chemical substances, which identified the producer  and the consumer.  The representative of Chile 
stressed that, with such a system, the compe titors would gather sensitive information on the 
consumers, while not resulting in a safer manageme nt of chemical substanc es, which was the main 
objective of REACH.  The European Communities were  therefore encouraged to take these concerns 
into account and modify the legislation accordingly. 
186. The representative of Brazil  noted that his delegation recognized the importance of protecting 
human health and the environment.  However, c oncerns remained that the REACH regulation was 
more trade-restrictive than necessary to fulfil tho se legitimate objectives.  The Brazilian representative 
highlighted the difficulties and the costs imposed by the registration procedure, testing, and the OR 
requirement, especially in for SMEs of developing c ountries.  Therefore, he requested the European 
Communities to provide clarifications on the outcome of the pre-registration phase, and in particular 
whether it was considered necessary to change the original timeframe of REACH, given the 
unexpectedly high number of pr e-registrations submitted. 
187. The representative of China  shared the concerns raised by  previous speakers about REACH. 
China was particularly concerned that the particip ation in the Substance Information Exchange Forum 
created complex legal consequences with regard to competition and IP law.  Considering the current 
progress of SIEF and the approximation of deadlin es, the European Communities was urged to 
monitor and evaluate the process and consider  the possibility of extending the deadlines. 
188. The representative of Australia  reiterated her delegation's c oncern about REACH and noted 
its potential to disrupt and impede global trade in chemicals.  While Australia recognized the 
importance of ensuring a high standard of protec tion for human health and the environment, the 
complexity of such a policy and the enormous challenges faced by non-EC  companies remained a 
concern.  Australia was particularly concerned th at REACH would have a disproportionate impact on 
SMEs and that the OR provision could discriminat e against non-EC companies, placing higher costs 
on non-EC producers and manufacturers.  In partic ular, Australian SMEs indicated that the costs 
associated with appointing an OR to pre-register their chemical substances were prohibitive; as a 
result, many SMEs were unable to continue exportin g into the EC market.  It was also stressed that 
non-EC companies continued to require further as sistance from EC experts to ensure a correct 
implementation of REACH.  In this regard, the re presentative of Australia welcomed the development 
of the REACH guidance documents by the Euro pean Communities but no ted that these were  G/TBT/M/47 
 Page 43 
 
 
  continuously subject to change.  Australia urged the European Commission to take into consideration 
the concerns expressed by Members about REACH. 
189. The representative of Cuba  joined other delegations in concerns expressed about REACH.  In 
particular, she was concerned about the complexity and lack of transparency of the REACH regulation, its information requirements, the OR provision, the differential enforcement of REACH 
across EC member States, and the overall difficulties faced by SMEs of developing countries in its 
implementation.  Furthermore, she urged the Eu ropean Communities to pr ovide technical assistance 
and take into account the special needs of developing  country Members.  Finally, Cuba suggested that 
the TBT Committee consider other means of addr essing the REACH issue if no progress was made 
during the regular Committee meetings, for instance through the good offices of the Chairperson.  
190. The representative of Chinese Taipei
 shared the concerns expressed by other Members.  
Furthermore, she noted that according to Article 14( 9) of the REACH regulation, ecotoxicological and 
toxicological test and analysis were required to be  carried out in compliance with the principles of 
good regulatory practice contained in Directive 2004/ 10/EC or with other international standards 
recognized as equivalent by the Commission or the ECHA.  Since the OECD GLP accredited 
laboratories were not the only option available, th e European Communities was asked to clarify what 
alternatives to accreditation systems were available fo r laboratories.  In particular, the EC delegation 
was requested to provide examples of accredited la boratories which were not accredited by the OECD 
GLP but were acceptable to the Commission. 
191. The representative of Kuwait  shared the concerns raised by other WTO Members and 
supported, in particular, the comments made by the United States.  He was es pecially concerned about 
the lack of transparency and clarity of the REACH regulation. 
192. The representative of Egypt  stressed that her delegation had several concerns related to the 
costs, complexity and burdensome requirements of REACH for both manufacturers and exporters of chemical products.  She also reiterated that  technical assistance on the interpretation and 
implementation of REACH was even required by large companies of EC member States. 
193. The representative of the Russian Federation, speaking as an observer
, joined other 
delegations in concerns expressed about REACH.   While the Russian Federation welcomed the 
development of the REACH guidance documents by  the European Commission, several concerns 
remained unresolved.  In particular, the represen tative of the Russian Federation recalled that, 
following the ECHA recommendations, non-EC based co mpanies decided to pre-register nearly all 
the substances exported to the EC market.  As a result, companies pre-registered many more 
substances than necessary.  It was also stressed that co mpanies still had doubts about the status of 
some substances, and they would be forced to su bmit enormous data files for the registration phase, 
bearing burdensome costs for data generation, shari ng and registration.  The estimated costs reached 
over US$300,000 per chemical substance.  The Eur opean Communities was ther efore encouraged to 
reconsider the REACH regulation, which appeared  to be excessively complex, non-transparent and 
burdensome, particularly in the cont ext of the global financial crisis. 
194. Furthermore, the representative of the Russi an Federation expressed concerns about the 
possible discrimination between EC and non-EC base d companies in the registration process, which 
resulted in an additional burden for non-EC comp anies.  Moreover, non-EC companies could not 
participate in SIEF and consortia.  With regard to SIEF, the Russian Federation noted that high 
volume producers had to submit their registration dossi ers to ECHA by the end of 2010, while smaller 
producers could submit their registration dossiers un til 2018.  As a result, big producers were allowed 
to share data and classify substances by the en d of 2010, without consultations with smaller 
producers.  The Russian Federation believed that  this could discriminate against SMEs.  In 
conclusion, the Russian Federation encouraged the European Communities to ta ke into consideration G/TBT/M/47 
Page 44  
 
  the concerns which had been expressed by its trad ing partners, and to reconsider some unnecessary 
procedures under REACH. 
195. The representative of the European Communities
 recalled that at the previous meeting of the 
TBT Committee, two experts from DG Environmen t and DG Enterprise had provided detailed and 
comprehensive answers to the concerns raised by WTO Members on REACH.7  It was also recalled 
that EC authorities had taken note of the comments expressed and would take them into account in the 
implementation of REACH, as far as was possible and appropriate.  With regard  to new developments 
related to REACH, the representative of the Eur opean Communities noted that the pre-registration 
period under REACH ended on 1 December 2008, and th at the ECHA received about 2,7 million pre-
registrations for about 150,000 chemical substances.  She pointed out that a list of the pre-registered 
substances had been published on 19 December 2008,  and it was available on the ECHA website.8  It 
was her delegation's opinion that the high number of pre-registrations proved the effectiveness of the 
EC's awareness campaign.   
196. On the issue of verification and proof of pre -registration numbers, the representative of the 
European Communities recognized that the REAC H Regulation did not regulate on whether pre-
registration numbers had to be provided to custom  authorities.  However, it was emphasized that 
REACH was providing for the obligation to pre-regi ster and that enforcement authorities of EC 
member States had therefore the right to control if  the obligations of REACH were respected. It was 
noted that it was up to the enforcement authorities to decide when and how they carry out these 
checks and companies should be prepared to provide  for a possibility to show that the obligations 
have been respected. It was also  stressed that once the necessary information was provided to the 
authorities, products were released and could be put on the market.  
197. On the Substances Information Exchange Forum, the EC delegation clarified that it was made 
mandatory in order to avoid unnecessary animal testing,  but also to  reduce testing costs, especially 
for SMEs.  It was further noted that the REACH re gulation did not oblige SMEs that had no specific 
data to take the role of lead regi strant or take an active role in the discussion of the SIEF.  In many 
cases,  it would be less costly for SMEs participa ting in the SIEF rather than conducting their own 
studies.  With regard to the question of Canada on the organization of the SIEF, the EC representative 
referred to the guidance document on "data sharing", which was available on the ECHA website. 
198. On the specific issue of the missing guida nce documents raised by Japan, the EC 
representative confirmed that guidan ce on "preparation of an applica tion for authorization" and the 
guidance on "socio-economic analysis authorization"  were still in preparat ion.  However, it was 
stressed that the above-mentioned guidance documen ts were related to au thorization under REACH, 
and there were no substances subjected to authorization yet.   
199. With regard to the questions on the candidate list, the EC representative clarified that the 
Substances of Very High Concern (SVHCs) would be  identified and included in the candidate list 
according to the procedure established by Article 59 of the REACH regulation.  It was emphasized 
that this process consisted of different stages and th at at every stage of th e process interested third 
parties were allowed to comment the procedure. It  was a very transparent process which allowed to 
follow which substances would be included in the ca ndidate list. The representative of the European 
Communities recalled that a first version of the candidate list had been published on 28 October 2008 
and contained fifteen substances.  Two other substa nces, tris(2-chloroethyl) phosphate and arsenic and 
its salts, were not on the candidate lis t yet but had been added in the regi stry of intentions available on 
the ECHA website.  The representative of the Europ ean Communities confirmed that on 14 January 
2009 the ECHA had recommended to prioritise seven substances out of the fifteen, in order to 
                                                      
7 See G/TBT/M/46, paras. 179-191. 
8 See http://echa.europa.eu/   G/TBT/M/47 
 Page 45 
 
 
  determine which substances would be subject to aut horization.  Interested parties were invited to 
submit comments by 14 April 2009.  
200. On the issue of uniform interpretation across the European Communities, the EC 
representative recalled that the legal instrument adopted for REACH was a regulation, which was 
directly applicable in all member States and applied uniformly throughout the European 
Communities.  This point was not affected by the dissenting views of some EC member States or by 
the fact that there had been certain advices for pr actical reasons to check how certain EC authorities 
enforced REACH.  It was further noted that only the text of REACH was legally binding and only the European Court of Justice would have the competen ce to provide a definitive interpretation of its 
provisions.  Therefore, in case enforcement aut horities interpreted REACH in different ways, 
operators concerned could start an action at nationa l courts for  seeking the views of the European 
Court of Justice, who would establish which interp retations should prevail throughout the European 
Union. Therefore, the system contained sufficient instruments to ensure a uniform application of 
REACH. 
201. On the issue of penalties for non-compliance to REACH, the EC representative clarified that 
sanctions, as usual for EC legislation and as a result of the structure of the EC, fell under the 
competence of EC member States and information on sanctions would be publ ished in their national 
official journals according to each member State's legislative system.  Member States were currently 
laying down the provisions on penalties and the Co mmission was closely monitoring this process. In 
this regard, she noted that REACH provided that pe nalties be effective, proportionate and dissuasive 
and that in consequence, penal sanctions could in principle and certain cases be envisaged.   
202. On the specific question about substances that  were lawfully on the EC market before 
1 June 2008, but which did not have phase-in status under REACH (e.g. cosmetics), the EC 
representative stressed that REACH was not discrimi natory with regard to these substances.  In 
particular, Article 26 of the REACH regulation prov ided that for non-phase in substances an enquiry 
to the ECHA had to be carried out prior to the registration.  On 12 December 2008 the European 
Commission had explained in a communication that cer tain problems existed in practice, since it was 
impossible to register these substances at the same  time as the enquiry.  Therefore, the affected 
operators had been invited to submit the enquiry to the ECHA in order to avoid any disruption of 
trade.  It was stressed that th e ECHA was waiting for these enquiries. 
203. Regarding the requests for technical assistance , the EC representative noted that technical 
assistance on REACH either had been already carried out under certain programmes, or there was the 
possibility to incorporate it in ongoing EC trad e-related assistance programs.  She invited WTO 
Members having specific needs for technical assistan ce programmes, to direct their requests to the 
respective delegations of the European Commission in their country.  Finally, the EC delegation 
informed the Committee that th e European Commission was organizing a conference on the EC 
Regulation on Classification, Labelling and Packaging of Substances and Mixtures (CLP) based on 
the UN Globally Harmonised System (GHS), to be held in Brussels on 17 June 2009.  The event 
would be web streamed and would also  be available afterwards on the web
9. 
(v) Norway – Hazardous substances (G/TBT/N/NOR/17) 
204. The representative of Japan  recalled that, at the last TBT Committee meeting, the delegation 
of Norway clarified that, as a result of a second review of the proposed regulation, eight substances had been removed from the list of the regulation wh ile modifications were being considered for the 
remaining ten substances.  In this regard, he s ought an update on the current status of the ten 
substances under review.  
                                                     
 
9 Further information on http://ec.europa.eu/enterprise/reach/information/events/index_en.htm G/TBT/M/47 
Page 46  
 
  205. The representative of Jordan
 requested an update from Norway on the restrictions to the use 
of hexabromocyclododecane (HBCDD). 
206. The representative of the United States  noted that the proposed measure and the information 
provided on the risk assessments were being review ed.  However, he reiterated that his delegation 
continued to have systemic concerns with th e proposed regulation because the measure was hazard-
based and did not appear to consider whether its  benefits would outwei gh any risks identified. 
207. The representative of Norway  made reference to the detailed report given by his delegation at 
the last Committee meeting.  Moreover, he recalled that the proposed regulation had been subject to 
an extensive hearing process at the national and intern ational level.  This process had triggered several 
comments on the proposal from WTO Members, EU industry and other stakeholders.  As a follow-up, 
a second review of the proposed regulation w as conducted by the Norwegian Pollution Control 
Authority.  The regulation had not entered into fo rce on 1 January 2008, as previously proposed in the 
draft regulation. 
208. As a result of the second review, eight substa nces had been removed from the list of the 
regulation.  The original list of eighteen substa nces had been thus reduced to include only ten 
substances.  Furthermore, other modifications were being considered for the remaining ten substances, 
such as limit values or further exemptions.  It was also noted that there was no schedule for the 
conclusion of such work and for th e entry into force of the regulati on.  Finally, the representative of 
Norway mentioned that further technical informa tion on the substances considered by the regulation 
were available on request.  He took note of the con cerns expressed, which would be transmitted to the 
responsible environmental authorities. 
(vi) China – Compulsory Certification (CCC System) (G/TBT/N/CHN/399 and Suppl.1) 
209. The representative of Japan  pointed out that the CCC system had not yet been opened to 
foreign-based certification bodies and that his delegation had requested China that foreign 
certification bodies in China or overseas could be a ppointed without discrimination, as per Article 6.2 
of the TBT Agreement and the Report of the Work ing Party on the Accession of China, paragraph 
195.  He sought clarification on the following point s: first, he expressed his understanding that, 
though China had introduced the IECEE/CB scheme as one of the solution in the previous meeting of the Committee, , under the IECEE/CB scheme, China accepted only testing report related to "Safety". 
He asked whether China planned to accept the t esting report of EMC (Electromagnetic Compatibility) 
and the CoC (Certificate of Conformity) in addition to the acceptance of the testing report of "Safety". 
210. Second, the representative of Japan also noted th at China had stated that "if the Government 
of China and the Government of Japan conclude  a Mutual Recognition Agreement, foreign based 
certification bodies can be appointed under the CCC system without discrimination" whereas, according to Article 13 of the Regulations of People's Republic of China on Certification and 
Accreditation, it was stated that "foreign certification bodies shall not be engaged in certification activities".  He asked whether, if Japan had an MRA with China, Japanese certification bodies were 
excluded from this provision and  if not, what  Jap an needed to do in orde r for China to accept the 
CoC (Certificate of Conformity) of foreign certification bodies. 
211. Third, the representative of Japan stressed that  even if China and Japan concluded a MRA, 
Japanese certification bodies in China could not make use of it.  Therefore, he sought clarification on the way forward for Japanese certification bodies in  China to be appointed under the CCC system 
without discrimination. 
212. The representative of the European Communities
 welcomed the reply by China to the 
comments his delegation had submitted.  The reply c ontained useful clarifications, for instance with  G/TBT/M/47 
 Page 47 
 
 
  respect to the indication that flexibility in impl ementing the CCC certification based on classification 
management of products and factories would be allowed, the scope of factory inspections for 
companies holding ISO-9001 certificates and the conditions for exemptions of spare parts from CCC certification.  The EC hoped that the final versi on of the revised CCC regulations would accurately 
reflect those clarifications. He also welcomed the st atement that the Chinese legislation would strictly 
follow the national treatment principles embodied in  the WTO Agreements on the protection of legal 
rights and interests of foreign-owned certification and testing organizations.  He recalled that his 
delegation had requested China to consider a llowing foreign-owned certification bodies legally 
established in China to be designated for the purpo ses of the CCC and trusted this statement meant 
that the Chinese authorities were giving positive considerations to this request.   
213. The representative of the European Communities reiterated the call for China to undertake a 
structural review of the CCC system, on the basi s of a risk-based approach to conformity assessment 
and with a view to reducing the number of products within the scope  of the scheme and to ensuring 
that conformity assessment requirements were modulated according to the level of risk associated with the products.  His delegation remained open to  bilateral discussions with the Chinese authorities 
within the framework of the existing bilateral re gulatory dialogue.  In particular, he suggested 
continuing to share experiences on product risk  assessment and management of conformity 
assessment systems based on lighter conformity  assessment procedures and effective market 
surveillance.  A joint case study on product risk assessment and impact assessment of the proposed 
CCC implementing regulations could usefully serve to come to a common understanding of risk 
assessment methodologies and evaluation of the economic impact of conformity assessment 
procedures. 
214. The representative of Switzerland
 shared the concerns expressed and noted that industry had 
reported that the CCC system was too complex, cost ly and time consuming.  Switzerland encouraged 
China to apply a more risk-based approach, in orde r to reduce the number of products covered by the 
CCC system.  For example, for low risk products, suppliers declarations of conformity (SDoC) would 
be sufficient. 
215. The representative of China  highlighted that the objective of the modified regulation was to 
streamline the currently prevailing compulsory certif ication in China, based on the experience with 
the CCC system accumulated in the past 6 years.  The proposed substantial changes included: first, 
expanding the single sample collection model for the sa mple of type test to three collection models to 
improve the representativeness of the sample; s econd, establishing a monitoring and supervision 
system to ensure consistency of the performance;  and third, establishing an effective product recall 
system.  With respect to the recognition of foreign certification bodies and their testing results, China recognised the IEC CB scheme.  Ho wever, since China was not a member of the EMC scheme, it 
could not accept results and certification of EMC of foreign conformity assessment bodies. 
216. The representative of China further explained that  according to the regulations on certification 
and accreditation, foreign certification bodies qualification for CCC certification bodies could only be 
acquired through inter-government ag reements, agreements recognised by the Chinese Government or 
agreement with competent authorities within the Chinese Government.  With respect to SDoC, he 
stressed that, as the TBT Committee had discussed in the Second Triennial Review of the TBT 
Agreement, to ensure the SDoC was being implem ented effectively, an appropriate legislative 
framework, including safeguards against non-complia nce of dangerous products such as market 
surveillance and product liability laws and admini strative control, needed to be established in 
advance.  As a developing country Member, China ha d difficulty in this regard and therefore had not 
yet established SDoC as an applicable conformity assessment procedure.  He noted that the draft regulation was under review and that Members' comme nts had been taken into due consideration, and 
some revisions had already been introduced.  The final version of the regul ation would be published 
after internal approval pr ocedures were concluded. G/TBT/M/47 
Page 48  
 
  (vii) China – Proposed Regulations on Information Security (G/TBT/N/CHN/278-290) 
217. The representative of Japan
 welcomed the fact that China had delayed the publication of the 
final implementation rules.  However, as it was e xpressed in the previous meetings, Japan still had 
serious concerns on this planned regulation on IT  security products, which covered a wide range of 
products for civil use and which would have a signifi cant effect on trade; concerns remain about IPR 
protection as well.  He sought an update about the new time schedule for these regulations.  In 
particular, he sought clarification on: (i) whether the implementation of the regulation, originally 
planned for 1 May 2009, would be delayed follow ing the delay of the publication of the final 
implementation rule; (ii) whether consultations coul d be held before the publication of the final 
implementation rules; and, (iii) whether a one year  period between the publication of the final rules 
and the implementation of the regula tions would still be granted.   
218. The representative of the United States  reiterated his delegation's position that these 
regulations went substantially beyond global norms by mandating testing and certification of 
information security in commercial information technology products, not only in products for 
sensitive government use or those used in national security applications.  His delegation appreciated 
the willingness of officials from China's Certifica tion and Accreditation Administration (CNCA) and 
China's Ministry of Commerce to maintain an ope n line of communication with government officials 
and industry groups from the United States and ot her countries.  He also welcomed China's 
commitment to delay publication of final techni cal regulations while Chinese and foreign experts 
continued to discuss possible approaches to the regul ation of information security.  He understood that 
China was working on the proposed revisions to th e thirteen regulations and sought information on 
the substance of potential amendments, including th e possible timeframe for adoption.  Finally, he 
urged China to continue to delay publication of  final measures and not implement them on 1 May 
2009, so that technical discussions between experts could continue.  
219. The representative of Korea also welcomed the postponement of the publication of the final 
rules and stressed that certification should not be  applicable to commercial information security 
products, since important security information coul d be leaked on account of disclosing the source 
code.  This could result in an obstacle to international trade. 
220. The representative of the European Communities  shared the positions expressed by the other 
delegations, recalled the concerns expressed by hi s delegation at the previous meeting of the 
Committee and sought confirmation that the adoption and publication of the final implementation rule 
would be delayed.  His delegation appreciated th e open channel of communication on this issue and 
China's willingness to start an expert dialogue in or der to share experiences with foreign industry and 
governments about current practices in managing risk s arising from information security.  He sought 
information on the proposed revisions which were currently under considerations and on the expected 
timeline and invited China, in case the final deci sion was to implement nonetheless mandatory rules, 
to notify any substantial amendment to the proposed  scheme  to the TBT Committee in order to give 
interested Members an opportunity to comment. 
221. The representative of Canada  echoed the comments made by previous speakers and looked 
forward to the on-going discussion on the subject. 
222. The representative of China  noted that his country had been open and transparent in the 
process of developing information security products compulsory certification scheme, by notifying the proposed regulations and soliciting comments from  stakeholders, both domestically and abroad.  
Bilateral communications between China and other in terested trading partners, including the United 
States, the European Communities and Japan had ta ken place and China was committed to being open 
and transparent in the remaining process, so as to ensure that the final sch eme was science-based and 
reasonable.  He stressed that the objective of th e proposed information security products compulsory  G/TBT/M/47 
 Page 49 
 
 
  certification scheme was in compliance with the le gitimate objectives in the TBT Agreement.   In 
particular, information security was closely related to consumer interests as well as to the country's 
security and certification schemes for information s ecurity products had been established in many 
countries.   
223. The representative of China further stressed that  his delegation attached great importance to 
other trading partners' concerns with the proposed regulations and, in this respect, the decision had 
been made to postpone the adoption date of the pr oposed regulations, so as to leave more time for 
further technical communication and discussion among th e regulators and experts.  He noted that a 
joint introductory meeting about the proposed sch eme was being arranged with the US information 
technology organization and invited a ll interested parties to participate in that meeting to obtain more 
information and share their views about the matter. 
(viii) China – Draft standards for lithium batteries for mobile phones 
224. The representative of Japan  appreciated the fact that the Chinese Electronics Standardization 
Institute (CESI) had created a working group where experts, including from Japan, had met to discuss 
the draft standards for lithium batteries.  He point ed out that the draft standards under consideration 
also dealt with types of material and the methods of manufacturing, despite the fact that they were 
characterized as safety standards.  Therefore, his delegation continued to ha ve concerns with these 
measures, in particular with respect to their c onsistency with internati onal standards and to the 
protection of intellectual property rights, and believe d that the draft standards should be limited to 
safety.  He requested China to ensure a coope rative relationship with foreign manufactures and 
harmonization with international standards in the dr afting process.  He also sought information on the 
current status of these standards on mobile phones and laptops. 
225. The representative of the European Communities  joined Japan in requesting an update on the 
state of play of the standards and urged the Chin ese responsible standardization bodies to limit this 
standard to safety aspects only.  
226. The representative of China  pointed out that this issue went beyond the competencies of the 
TBT Committee.  The standards setting process was taking place at national level, and openness and 
transparency in the process had already been guarant eed.  He also noted that , as mentioned by Japan, 
experts, including from Japan, had participated sever al times in related working group meetings where 
all technical issues were discussed.  He stressed that the formal draf t text of the st andards was still 
under development and suggested that interested Members participate in the already established 
national procedure rather than raising the issue in the TBT Committee.   
(ix) China – Energy efficiency and energy ef ficiency grades for copy machines 
(G/TBT/N/CHN/331/Rev.1 and Suppl.1) 
227. The representative of Japan  reiterated his delegation's concerns on the Chinese measure on 
energy efficiency grades for copy machines.  In particular, he believed that the measure would make it difficult to measure energy efficiency accurately, si nce in the proposed standard energy efficiency 
was measured by copy mode, even if copy-based m achines had the function of printer.  This was 
despite the fact that the regulation was based on the international Energy Star Program which 
stipulated that energy efficiency in machines equipped with the function of a printer should be 
measured by printer mode.  He re called that at previous meetings of the Committee his delegation had 
pointed out that it was difficult to decide whether machines were to be considered as copy machines 
or printers, and that China had responded that th is would have to be decided on the basis of 
fundamental function of the machine, and that it in tended to publish guidelines for the application of 
the measure.  He enquired about the progress of the announced guidelines.   G/TBT/M/47 
Page 50  
 
  228. The representative of Japan further noted that, in  the Chinese measure, there were three levels 
of energy efficiency and that, at the beginning, on ly the lowest one would be mandatory.  However, 
three years after the entry into force of the measu re, the second one would become mandatory as well 
despite that China explained that the second level threshold was based on the international Energy 
Star Program, which was a voluntary scheme.  Chin a was requested not to include this voluntary 
standard in its mandatory regulation.  Additiona lly, he enquired about the progress, including with 
respect to TBT notifications, of the standard on pr inters and fax machines, which China had expressed 
its intention to develop.  He stressed that th ese standards should be harmonized with international 
standards. 
229. The representative of China
 stressed that the objective of this measure was to save energy and 
protect the environment, which was fully in line w ith the legitimate objectives of the TBT Agreement.  
The measure was applicable to c opy machines as well as to multifunc tional machines with copying as 
a fundamental function.  If the machine was a prin ter with copy as a secondary function, the standard 
would not be applicable.  The criteria for such distin ction were specified in the standard itself.  He 
further explained that the measure stipulated three grades of energy efficiency, with the lowest grade 
(grade 3) being the compulsory requirement.  Grad e 2, which was based on the Energy Star Program, 
would become mandatory after three years, thereby giving an adequate time to industry to adapt.  Therefore, the standard would not create an unnecessar y obstacle to international trade.  With respect 
to similar standards for printer and fax mach ines mentioned by Japan, they were still under 
preparation and some Japanese companies were also  involved in the technical consultations.  Once a 
draft was ready, this would be notified to the TBT Committee and an opportunity to make comments 
would be provided. 
(x) India – Pneumatic tyres and tubes for automotive vehicles (G/TBT/N/IND/20) 
230. The representative of Japan
 was concerned about India's mandatory certification for 
pneumatic tyres.  His delegation believed that the regulation caused unfair excessive testing and 
certification costs as well as time constraints for fore ign-based firms.  Furthermore, the testing and 
certification capacity within India was insufficient to meet the needs.  Japan also believed that there 
should be a longer implementation period in  order to allow industry to adapt. 
231. The representative of the European Communities  appreciated India's clarifications at the 
previous TBT Committee meeting, as well as in bilatera l talks, and especially the information that the 
measure had not yet been adopted.  She stressed, however, that her delegation had still not received 
clarifications on whether the license fee for tyres was calculated in a different way for tyres produced 
in India and for imported tyres.  Clarifications we re also still outstanding on whether tyres could be 
certified in other laboratories than the only accredited laboratory in India (notably the Central Institute 
for Road Transport), and  if tyres complying with UN-ECE Regulations would be recognized.  She also sought clarification about the entry into force of the measure, in particular whether the measure 
had been adopted or if it was under revision.  
232. The representative of India
 recalled that the proposed mandatory requirements for imported 
tyres were notified on 17 July 2006 and that the objective of these requirements was to ensure quality 
and safety.  He stressed that the mandatory certification was in the public interest and was not intended to treat imported tyres any less favourably than domestic tyres as the same would also be 
applicable to Indian tyre manufactures.  With r espect to the fee structure or costs for imported 
manufacturers and domestic manufactures, he pointed out that the marking fee structure was common 
for all items under BIS certification pertaining to Foreign Manufactures Certification Scheme.  Some 
additional costs for manufactures of imported goo ds were due to extra expenses borne by the 
certification agency for administering the scheme.  Also, conformity assessment procedures were the 
same for domestic as well as foreign manufactures.   G/TBT/M/47 
 Page 51 
 
 
  233. With respect to the laboratories from which test reports could be accepted, he highlighted that 
India had a well established laboratory for testing of the tyres.  Test reports from accredited laboratories abroad could also be accepted, provide d that these were carried out per the test methods 
prescribed in the relevant Indian standard and that accreditation was based on ISO IEC 17025, by a 
body which was a part of the MRAs with ILAC APLAC on a reciprocal basis.  He pointed out that the 
measure was not yet in force.  With respect to  the request by Japan for a longer implementation 
period, he recalled that the notification was sent to the WTO in July 2006, and that it provided 60 days for comments.  Three years later the measure was not ye t in force, and this could not be considered as 
a short implementation period.  Comments would be conveyed to capital for due consideration before 
the measure entered into force.    
(xi) Brazil – Regulation on Identificati on and Quality Standards of Et hyl Alcohol and other Spirits 
(G/TBT/N/BRA/276-278 and Suppl.1) 
234. The representative of Mexico
 pointed out that the regulation set forth a definition for tequila 
with specifications which were below what was allo wed for under Mexican legislation.  In addition, 
the measure limited the types of tequila which could be  marketed in Brazil, at the same time laying 
down specifications which would allow for the mark eting of a product of inferior quality to the 
product produced in Mexico under the name "tequila".  He stressed that Mexico believed that this ran 
counter to several provisions of the WTO incl uding GATT 1994, the TBT Agreement and the TRIPS 
Agreement.  He recalled that, at the TBT Committe e's meeting held in July 2008, his delegation had 
expressed concerns about the measure in question.   Industry involved and the Mexican Government 
had jointly presented their comments and expresse d their opposition to the measure both to the 
Brazilian Enquiry Point as well as to the Ministry of Agriculture Farming and Supply of Brazil.  He 
recalled that concerns had also been reiterated at  the Committee's meeting in November 2008 and that 
a reply from Brazil to the comments made was still awaited.  
235. The representative of Brazil  informed the Committee that the proposed regulation on spirits 
was in the process of being updated.  He stressed  that public consultations had been held and 
additional time for comments had been granted to in terested parties.  All comments received would be 
analysed before the final regulation was published.  Specifically, on  the issue of tequila, he pointed 
out that, in Brazil, "tequila" was considered a generic name since 1973, when decree 73/267 had set 
quality and identity standard for this kind of spir it.  Therefore, Brazil disagreed with Mexico's 
allegation that Brazil's proposed regulation on tequila  violated TRIPS provisions.  Considering tequila 
as a generic name in Brazil was fully in compliance with Article 4.4 of the TRIPS Agreement, which 
allowed Members to use geographical indications of another Member if it had been doing so for at 
least ten years preceding 15 April 1994.  He reassu red Members that the proposed regulations would 
not affect market access conditions for exports , nor limit the sale of tequila in Brazil. 
(xii) United States – Country of origin labelling (G/TBT/N/USA/25, G/TBT/N/USA/83 and Corr.1, 
G/TBT/N/USA/281, Add.1, Add.2 and Add.3) 
236. The representative of Mexico  recalled that his delegation had expressed concerns that COOL 
imposed a technical barrier to trade and was not comp atible with the TBT Agreement.  In particular, 
his delegation believed that the system did not  aim at protecting consumers, but, rather, 
manufacturers.  Furthermore, the regulation was not based on the CODEX standard on pre-packaged 
products and foods.  He also reca lled that, on 17 December 2008, Mexi co had requested consultations 
on the regulation in the framework of WTO Disput e Settlement Understanding.   Consultations had 
been held on 27 December, in which Mexico's con cern about the negative effect of the measure on 
bilateral trade had been discussed.   
237. The representative of Mexico further noted that  the United States had recently published the 
final regulations.  However, confusion remained with respect to the entry into force of the measures.  G/TBT/M/47 
Page 52  
 
  Additionally, a letter by the Secretary of Agricultu re, Mr. Thomas Vilsack to processors and packers 
of meat which required voluntary labelling that was more restrictive than the Final Rule had also 
generated uncertainty.  He stressed that the legitim ate objective of this measure was still not clear and 
that his delegation believed that trade among WTO Members should be ca rried out in conformity with 
the provisions of the WTO Agreements.  Mexico ha d sent several questions to the United States on 
the status of the requirement of the measure and was awaiting a response. 
238. The representative of Canada
 was concerned with the appare nt contradiction regarding the 
implementation of the country of origin labelling me asure.  In particular, the Final Rule notified in 
G/TBT/N/USA/281/Add.3 was in contradiction with th e Secretary of Agriculture's letter to industry 
of 20 February 2009, which called for the voluntary a doption of stricter labelling practices than what 
was required in the COOL statutory provisions and the Final Rule referenced above.  Her delegation 
believed that it was unusual for industry to be encour aged to follow stricter requirements than those 
set out under the formal rule-making process in th e United States: particularly so when that 
encouragement was accompanied by a threat that if industry did not do so, the final rule could be modified.  She stressed that this had created uncer tainty in the market, particularly among the covered 
commodity producers and processors, as well as at the retail level.   
239. The representative of Canada further pointed ou t that her delegation's concerns were not 
limited to questions of legal uncertainty.  Canada believed that COOL - especi ally as laid out by the 
U.S. Secretary of Agriculture in his letter to industry – would increase production costs all along the beef and pork value chains, with no obvious benefi ts, and would unravel years of progress made in 
creating an efficient, integrated and competitive market.  This was not helpful for industries, 
especially in difficult economic times.  Canada  further viewed COOL as imposing unnecessary 
obstacles to trade and establishing less favourable treatment for imported commodities: Canadian industry had incurred negative economic impacts foll owing the entry into force of COOL under the 
Interim Final Rule on 30 September 2008 (G/TBT/N /USA/281 Add.1).  She stressed that Canada 
continued to believe that COOL was fundamentally  flawed and should be repealed for all products, 
and requested the United States to clarify the requirements of COOL, including how it would be 
administered and implemented.  She asked the Un ited States to also clarify the objectives of the 
measure:  was it, as stated in the WTO notifications , a measure for consumer information, or, as more 
recently stated by Secretary Vilsack and by USTR, a food safety measure?  
240. The representative of the United States
 informed the Committee that  the amendments to the 
COOL program consequent to the 2008 Farm Bill we re now law, and that the Final Rule had been 
published in the U.S. Federal Register on 15 Janua ry 2009 and had taken effect on 16 March 2009.  
He noted that Secretary ViIsack was aware of those concerns raised by Canada and Mexico.  He also 
pointed out that the objective of the rule wa s unchanged and that the United States remained 
committed to implementing COOL in a fair and balanced  manner.  Finally, he clarified that the Final 
Rule was what was legally operative under U.S. law.  The letter was voluntary, and USDA would 
allow industry to use the voluntary guidance in the letter as it deemed appropriate. 
(xiii) United States – Requirements to combat ille gal logging (G/TBT/N/USA/424, Corr.1 and 
Add.1) 
241. The representative of Mexico  recalled that the above-mentioned measure was notified to the 
TBT Committee in November 2008, with the objective of protecting the environment.  In February 
2009, further amendments to the measure were made and a new period for comment was provided 
until 6 April 2009.  He noted that, under this meas ure, it was considered illegal to import, export, 
transport, sell, receive, acquire or purchase certain plants and plant products, both within the United 
States and between the United States and third countries, with limited exceptions.  The measure required the presentation of a declaration of import,  which should include information relating to the 
scientific number, the value of the import, the quant ity and the name of the country from which the  G/TBT/M/47 
 Page 53 
 
 
  plant was harvested.  Implementation would be ca rried out in three phases, through a electronic 
register. 
242. The representative of Mexico further stress ed that, while his delegation supported the 
objective of protecting the environment and had al so undertaken specific actions to combat illegal 
logging, the requirements of the Lacey Act were excessive and would have a negative impact on 
bilateral trade.  Furthermore, his delegation did not believe that the measure was the least trade 
restrictive option, in accordance with the provisions of the TBT Agreement.  For example, there was a 
significant number of industries, including paper industry, which used recycled wood in the production of products for fibreboard  whose identification was not possible under the Lacey Act.  He 
requested the United States to look at the possib ility of excluding industries which used recycled 
materials from the application of the measure.  He was also concerned about the treatment that would 
be provided to wood packaging and noted that to da te the United States had not defined what it meant 
by "common crops".  He asked the United States to  provide answers to the concerns raised.   
243. The representative of Japan
 pointed out that, although it agreed that preventing illegal logging 
was important, the measure should not be more rest rictive than necessary as stipulated in the TBT 
Agreement.  His delegation would follow up the progress on this issue. 
244. The representative of the United States  pointed out that the Lacey Act, as amended, was an 
important tool to support the efforts of other countri es, as well as the U.S. States, in the conservation 
of protected plant and wildlife resources, includi ng ongoing efforts to combat illegal logging.  
Through a variety of activities the United States ha d also continued efforts to assist countries to 
improve forest law enforcement and governance, in order to combat illegal logging at its source.  
Examples of these efforts to assist countries in  combating illegal logging included bilateral 
development assistance, cooperation in the context of bilateral and regiona l trade agreements, and 
capacity building through organizations such as the International Tropical Timber Organization 
(ITTO).  He highlighted that most countries had joined high level statements or commitments to 
cooperate to combat illegal logging.  
245. The representative of the United States furthe r noted that the declaration mentioned by 
Mexico, while it required the scientific name of the plant, quantity and value of importation and name 
of the country where the timber had been harvest ed, did not require information on legality, nor 
require certification of any kind.  The declaration was made by the importer and was not issued by a government agency.  He recalled that at the previ ous meeting of the Committee concerns were raised 
that there was not a positive list of products, that mo re time to comply was required, and about the 
scope of the measure.  These comments had been ta ken into account by the United States.   He 
explained that the revised plan for phased-in enfor cement of the plant import declaration requirement 
had been published in the US Federal Register on 3 February 2009.  This contained a positive list of 
products and phase-in would take place over six month intervals.  
246. It was also noted that Animal and Plant Health Inspection Service (APHIS) and other 
agencies involved in enforcing the provisions of th e Act were working together on the phase-in and 
enforcement, and that an electronic system to co llect the information would be available on 1 April 
2009 or soon thereafter.  In particular, the enforcem ent of the plant import declaration required for the 
import of goods would focus, for the next two year s, on timber and wood products.  A copy of the 
declaration was available on the APHIS website
10 and most importers were expected to use the 
electronic system to file the declaration.  The pr ocess of consultations with trading partners on all 
aspects of implementation of the Lacey Act would continue, and pr ohibitions applied to domestic 
commerce as well as trade.   
                                                      
10 http://www.aphis.usda.gov G/TBT/M/47 
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  247. Finally, the representative of the United States noted that the revised regulation had been 
notified as an addendum to the original notification
11 and this had been done in an effort to be fully 
transparent, even though it was his delegation's view  that the plant import declaration was neither a 
technical regulation nor a conformity assessment proce dure.  With respect to Mexico's concern about 
recycled inputs, these would be transmitted to cap ital and discussed with the relevant regulators. 
(xiv) China – Excessive Packaging (G/TBT/N/CHN/321 and G/TBT/N/CHN/447 and Suppl.1) 
248. The representative of the United States  supported China's stated objective of environmental 
protection and economization of resources.  Indeed , Members such as Korea, Japan, Chinese Taipei, 
Canada, Australia, and New Zealand, as well as some US states, had chosen to reduce the effect of 
waste on the environment by linking packaging costs to specific targets for recyclable content and 
reuse materials.  However, his delegation remain ed concerned about the efficacy of restricting 
packaging in relation to product cost, as China had done, to meet its objective. The cost of environmentally friendly packaging (i.e., packaging wh ich had the highest recyclable content or reuse 
percentage) often far exceeded that of traditional p ackaging.  Thus, if China limited the total cost of 
packaging, the result could be that industry would be forced to package more products in cheaper 
materials that could not be recycled or reused.  Less expensive packaging could also contain higher 
levels of heavy metal contaminan ts and other potentially hazardous materials.  Further, packaging 
designed to protect safety, such as child safety seals, increased packaging costs.  
249. The representative of the United States further st ressed that industry remained concerned that, 
if China was to go forward with the proposed meas ure, limiting total packaging costs to a certain 
percentage of the ex-factory price of the product wo uld have an adverse effect on the ability of the 
food industry to properly deliver a safe and well-pa ckaged product to consumers.  Lastly, concerns 
also remained about the fact that the required re porting of ex-factory price and packaging costs would 
force companies to divulge confidential business information.  What procedures did the Chinese 
Government have in place to assure the confidenti ality of such information?  The United States 
delegation requested that China re-evaluate its approach  to this technical issue or revert to its earlier 
position that compliance with the percentage limit w as voluntary.  China was encouraged to consider 
some of the methods employed by other WTO Members to meet its environmental goals, and the US delegation offered to discuss this issue with China.  
250. The representative of the European Communities
 shared the concerns expressed by the United 
States with regard to the mandatory cost require ments of the Chinese measure, which had also been 
expressed at previous Committee meetings.  Her de legation was of the opinion that such cost 
requirements did not effectively contribute to th e legitimate objective of the reduction of waste and 
the protection of the environment.  Instead, the measu re could have the contrary effect and prevent the 
use of more expensive, but more environmentally friendly packaging.  She also stressed that the 
required data would be difficult to provide for impor ters, since foreign contracts would need to be 
provided. Additionally, prices were often calcula ted in foreign currencies, which had changing 
exchange rates.  Therefore, it would be difficult to respect and to control the cost requirements.  She 
invited China to make the cost requirement voluntar y.  Her delegation was ope n to continue to discuss 
alternatives and less trade restrictive solutions bilaterally with China.  
251. The representative of China  noted that the objectives of the measure were to restrict waste 
costs by excessive packaging, to  save resource and encourage reasonable consumption.  These served 
the need to protect the environment which w as one of the legitimate objectives in the TBT 
Agreement.  He recalled that China had notified the measure in its draft stage and had solicited 
comments from other Members.  After the meeting of the Committee held in November 2008, China 
had replied individually to comments sent by the Di stilled Spirits Council and th e National Institute of 
                                                      
11 G/TBT/N/USA/424/Add.1  G/TBT/M/47 
 Page 55 
 
 
  Standards and Technology of the United States, and al so to those sent by the European Communities.  
Comments had been taken into due consideration and the original requirement of 15 per cent had been 
increased to 20 per cent.   
252. The representative of China further stressed that  the draft standards would apply equally to 
both domestic and imported products.  In fact, China was more concerned about the excessive 
packaging of domestic products rather than importe d products.  China would also take into account 
the request of an interim period for the products al ready put on the market and a reasonable adaptation 
period would be accorded after the adoption of the standard.  His delegation remained open to any 
constructive suggestions from China's trading partne rs and to discussing how to better fulfil China's 
legitimate objectives. 
(xv) European Communities – Regulation on Certai n 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) 
253. The representative of the United States  continued to have serious concerns about the EC 
measures that restricted the ability of non-EC wine  to use common or descriptive and commercially 
valuable terms, on the grounds that those terms were traditional to European wines.  This was 
particularly concerning when some of these term s did not have a common definition across all EC 
member States and there was no effort to monitor or  limit the use of those te rms within the European 
Communities.  He pointed out that the European Communities was trying to claim exclusive rights to 
use terms commonly included on wine labels, such  as "chateau", "vintage " and "superior", except 
under certain limited circumstance s where the exporting country regulated use of the terms to the 
satisfaction of the European Communities.  The ur gency of the issue had increased, given the negative 
trade impact that would result from the EC's failure to extend the derogation for the use of such terms 
on US wines sold in the EC market, which expired on 10 March 2009.  
254. The US representative also str essed that concerns were further heightened due to a EC 
communication in December 2008 to one particular  US wine producer that owned a trademark 
containing the word "chateau" in the United States th at was also registered as a trademark in certain 
European member States.  Specifically, in this comm unication it was noted that only those trademarks 
containing European traditional terms that were registered or had obtained "use-based" rights prior to 4 May 2002 could continue to be used on the Eu ropean market after the expiration of the US 
derogation.  The implications of this letter seemed to be that a ny trademark containing a traditional 
term that had been accepted and validly registered  by various EC member States' national trademark 
offices prior to 4 May 2002 would continue to be protected, but only in those member States where 
they were registered, and not in the rest of th e European Communities and that any such trademark 
registered after 4 May 2002 would be invalid under  the terms of the regulation.  He urged the 
European Communities to clarif y whether that was the case. 
255. Furthermore, the representative of the United States pointed out that, while the European 
Communities attempted to justify limitations on th e use of traditional terms by indicating that 
consumers could be misled by their use, these term s had been used on the EC market on US wines for 
many years with no problems.  Adding to the US industry concern was the fact that the European 
Communities had not indicated how it intended to en force the limitations with respect to imported 
wines.  For example, would the European Commun ities or its member States take action to block 
importation of US wines bearing a traditional expression?  
256. It was further noted that the European Cour t of Justice had expanded the scope of the 
measures and, contrary to previous assurances, th e traditional terms were now protected in languages 
other than the one for which protection had been iden tified.  Additionally, it was pointed out that the 
European Communities claimed that it was working on a proposal to resolve the matter.  However, a 
proposed regulation which would have to be notifie d for comment to the WTO would not be in place G/TBT/M/47 
Page 56  
 
  in time to mitigate the trade impact of the expiration of the derogation.  It was stressed that if the 
European Communities wanted to work constructiv ely towards a resolution, it should continue to 
extend the derogation as provided for under the bila teral wine agreement while discussions on the 
matter continued. 
257. The representative of Argentina
 reiterated his delegation's c oncerns as outlined in document 
G/TBT/W/290 and also expressed in previous meetings of the Committee with respect to the 
implementation of regulation 753/02 of the Eur opean Communities and its amending regulation 
316/2004, in relation to the exclusive use of a series of traditional expressions used by various 
member States of the European Communities in each of their resp ective languages.  His delegation 
also shared the concerns expressed by other memb ers in this respect, and the United States in 
particular.  He stressed that the regulations c ontinued to pose obstacles to products that included 
labels with additional quality comments on Argentin ean wine.  As his delegation had previously 
pointed out, these additional quality comment s referred to production methods or quality 
characteristics that were not under protection of intellectual property rights in the framework of the TRIPS Agreement.  Their use was theref ore governed by the TBT Agreement.   
258. The Argentinean representative further highlighted  that the restriction on the use of traditional 
expressions was not compatible with Article 2 of th e TBT Agreement and requested that the European 
Communities review the regulation to put it into conf ormity with the Agreement.  His delegation had 
taken note of previous statements made by the Eu ropean Communities in the previous meeting of the 
Committee, according to which implementing measur es for the new regulation were being developed 
which were also being examined by working groups in the European Council by EC member States.  
It was Argentina's hope that the new provisions w ould consider the concerns expressed by Members. 
259. The representative of New Zealand
 stressed that her delegation had taken a close interest in 
the EC new regime for regulation of its wine mark et, which affected wine trade with the European 
Communities.  Her delegation was waiting with interest for the notification of the full set of draft implementation regulations and looked forward to  discussing them with the European Communities 
when consultations with third countries started a nd sough an update in terms of the timing of these 
consultations.  She recalled that New Zealand had previously noted with concern some elements of 
the wine regulation itself and had made a submi ssion to the European Commission in April 2008 
accordingly.  A reply from the Commission had been received in July 2008 and further clarification 
was sought from the EC TBT Enquiry Point in Nove mber 2008, in respect of the intended third 
country provisions for the use of Geographical Indica tions (GIs).  A formal response to this question 
had not yet been received and it was New Zealand's hope that this response could be expedited now 
that some progress has been made with regard to notifying the implemented regulation, particularly 
given the fact that the implementation date of the new regulations was approaching.   
260. The New Zealand representative further noted that her delegation's assumptions remained in 
light of informal indications received from the Commission's officials that the new EC wine 
regulations implementing regulations and any transi tional arrangements included in these, particularly 
those related to wine labelling, would result in rul es for the wine trade that fully complied with the 
provisions of the TBT Agreement, as well as othe r principles and disciplines contained in other 
relevant WTO Agreements.  Consequently, there would be no adverse affect on market access for non-members of the European Communities as a result of the implementation of the regulations.  She 
sough formal confirmation of this point.  
261. The representative of Canada
 was also concerned about the st atus of traditional terms in the 
marketing of wine in the European Communities.  Her delegation believed that existing consumer 
protection legislation was capable and better suited to address the possibility that consumers could be 
misled by the use of certain labelling terms on wine products.  Canada was in the process of 
examining Draft Commission Regulation 479/2008 more closely.  G/TBT/M/47 
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  262. The representative of th e European Communities  recalled that the Council Regulation on 
wine common market organisation contained new rul es for the labelling of wines and established that 
these would be further developed by implementing ru les.  She noted that her delegation had recently 
notified the implementing rules on oenological practices.12 Under the new rules, imported wines had 
to comply with the OIV recommendations or with the EC rules on oenological practices, giving third 
countries more flexibility.  She invited delegations wishing to submit their comments to do so within 
the set deadline.  
263. The EC representative further pointed out that a draft proposal laying down detailed rules for 
the protection of geographical indications, traditiona l terms, labelling and presentation of certain wine 
products had been finalised and woul d soon be notified to the Committee13. She explained that he 
provisions on labelling had been simplified and clarif ied and that they would apply to both categories 
of wine, with or without a Geographic Indication (GI).  With regard to the use of traditional terms, the 
draft regulation established that their use on thir d countries' products was allowed, provided they 
fulfilled the same or equivalent conditions to tho se required from member States in order to ensure 
that consumers were not misled.  Her delegation was willing to discu ss this draft proposal and provide 
additional information at the next Committee meeting.   She invited interested delegations to submit 
comments in writing within the deadline.  
264. With regards to the comment ra ised by New Zealand, a reply would be sent shortly to the 
New Zealand Enquiry Point. Finally, on the comme nts from the US regarding the suspension of the 
derogation on the use of the traditional terms, she highlighted that it was unfortunate that the US had not agreed to continue the discussi ons of the bilateral agreement. 
(xvi) Israel – Infant formula 
265. The representative of the United States
 noted that his delegation's continued concerns that 
Israel had not published a draft re gulation on its measures related to infant formula for comments, nor 
notified it to the WTO.  Industry in the United St ates continued to have concerns that Israel's 
unpublished requirements for infant formula discrim inated against imports and were unduly costly, 
burdensome and unpredictable.  He stressed that while  Israel denied these allegations, it had failed to 
publish the measures.  The issue could not be resolv ed until at least Israel published draft measures 
governing infant formula for comment.  
266. The US representative further stressed that th e lack of published requirements governing the 
quality and safety of infant formula, as well as re lated conformity assessment procedures and labelling 
provisions, was particularly concerning given the 2003 Remedia incident.  It was a difficult position 
to maintain that infant health in Israel was more protected by keeping the Ministry of Health infant 
formula requirements secret, rather than by publis hing them for the public to review and comment, 
which was the most basic of all TBT and good regulat ory practice principles.  It was his delegation's 
hope that upcoming bilateral discussions with the Minist ry of Health in Israel would help to resolve 
this issue in the near future.  
267. The representative of Israel  recalled the highly sensitive nature of the issue in his country.  He 
appreciated the willingness of the United States to discuss the issue bilaterally with Israel's health 
authorities and was hopeful that this bilateral proces s would facilitate the prompt resolution of this 
matter. 
                                                      
12 G/TBT/N/EEC/252 and Add.1. 
13 G/TBT/N/EEC/264, notified on 1 April 2009. G/TBT/M/47 
Page 58  
 
  (xvii)  European Communities – Production and Labelli ng of Organic Products: Regulation N° 
834/2007 (G/TBT/N/EEC/101 and Add.1) 
268. The representative of Argentina
 reiterated his delegation's con cerns about the EC Regulation 
834/07 on the production and labelling of organic products and recalled th e two documents submitted 
by his delegation in this respect (G/TBT/W/284 and G/TBT/W/291).  He stressed that the assertion by 
the European Communities that Article 24 of the re gulation would not enter into force until 2010 was 
not enough to address the concerns.  He recalled that  the regulation established that the label of an 
organic product had to contain an indication of orig in of the raw materials and that it would take one 
of the following forms: "EU Agriculture", where the agricultural raw material had been farmed in the 
EU; "non-EU Agriculture", where the agricultural raw material had been farmed in third countries;   
"EU/non-EU Agriculture", where part of the agri cultural raw material had been farmed in the 
Community and a part of it has been farmed in a third country.  The country from which raw materials 
had been obtained could also be mentioned. 
269. The representative of Argentina pointed out that this compulsory identification of the origin 
of products processed in the territory of the Eu ropean Communities was not necessary to ensure that 
there was no confusion among European consumers about the properties in an organic product.  To be 
considered as an organic product, the quality of the raw materials was already guaranteed through 
compliance with the EC requirements.  This legisl ation generated uncertainty  about the nature and 
qualities of the products on offer that was unjustified.   Finally, it was his delegation's view that 
regulation was not in compliance with WTO Agreements and that it was not based on Codex standards. 
270. The representative of Ecuador
 supported the concerns expressed by Argentina.  The proposal 
of differentiating about the label of origin of the raw materials between the European Union and third 
countries could generate confusi on among consumers.  His delegati on was of the view that this 
requirement was not in line with the TBT Agreement,  in particular with Article 2.2.  He urged the 
European Communities to take concerns into account  and to re-evaluate the implementation of the 
regulation under the current parameters. 
271. The representative of Cuba  agreed with Argentina that postp oning the entry into force of the 
regulation to 2010 was not enough to address the c oncerns expressed.  Her delegation believed that 
the regulation was not in line with the TBT Agreement.  
272. The representative of th e European Communities stated that the regulation on the labelling of 
organic products had gone into effect on 1 Janua ry 2009 and clarified that it was a voluntary scheme 
and that its provisions only needed to be fulfilled if a producer wanted to sell its products labelled as 
"organic" in the European Communities and at least 95 percent of the ingredients of the product were 
organic. Non-organic products w ould be entitled to indicate on the label that they contained some 
organic ingredients.   
273. The EC representative noted that the comments ra ised by Argentina referred to the labelling 
of origin for organic products produced in the European Communities containing raw materials from 
third countries.  She pointed out that, as of July  2010, pre packaged food products that used the 
Community organic logo and contained raw material s from non-EU countries would have to carry the 
"EU/non-EU agriculture" statement on the label.  While some countries feared that this could 
influence the choice of consumers, the European  Communities had analysed the concerns and had 
concluded that there was no evidence to support the argument that the labelling requirements could 
negatively affect the sales of third countries in th e European Communities.  Her delegation remained 
available to discuss this matter further with interested delegations.  G/TBT/M/47 
 Page 59 
 
 
  (xviii)  Canada – Compositional requirements for cheese (G/TBT/N/CAN/203) 
274. The representative of the European Communities  informed the Committee that, in bilateral 
discussions, her delegation had received assurances from the Canadian authorities regarding Canada's 
flexibility on the implementing rules of these standard s.  Her delegation conti nued to have concerns 
regarding the overall nature of the measure and w ould monitor its implementation closely, to make 
sure that the negative impact on the cheese expor ts was minimized.  She appreciated Canada's 
willingness to discuss the issue and hoped to continue this bilateral dialogue. 
275. The representative of the United States  recalled his delegation's concerns expressed in 
previous meetings regarding the market access impact and potential cost burden of Canada's 
compositional requirements for cheese.  He stressed th at, as these issues were of great concern to US 
industry, the United States would continue to re view developments closely, including the new 
litigation in Canadian domestic court and the im plementation of the import licensing scheme, and 
would be monitoring the measure's impact on trade flows.  
276. The representative of New Zealand  recalled that concerns about the restrictive nature of these 
requirements had been raised both bilaterally and at previous TBT Committee meetings.  Her 
delegation continued to hold the view that the new regulations were overly restrictive in nature, both 
in terms of their allowance for the use of various ingredients and their impact on trade.  The regulations limited the use of proteins sourced from da iry ingredients at a time when such ingredients 
were widely used and accepted in many coun tries and where the Codex Alimentarius Commission 
had not prescribed any limitations on their use.  She noted that Canadian cheese processors had filed a 
joint application in the Federal Court challe nging the new cheese regulation, and understood the 
hearing would be held in late March or early Ap ril.  She requested that Canada reported on the 
outcome of the Court challenge at th e next TBT Committee meeting in June. 
277. The representative of Australia
 continued to share the concerns expressed by other 
delegations on Canada's requirements concerning the compositional standards for cheese.  Australia 
would continue to monitor the implementation of Canada's measures to ensure there was no negative 
impact on trade. 
278. The representative of Switzerland  recalled the concerns expressed by her delegation at 
previous meetings of the TBT Committee.  
279. The representative of Canada  recalled that discussions on this issue had been held before and 
stressed that her delegation was of the view that th e revised regulations were consistent with Canada's 
obligations.  She noted that the on-going bilatera l dialogue with the European Communities had been 
helpful to EC technical experts and stressed that  any other delegation wishing to have a similar 
dialogue would be welcomed.  She also pointed ou t that her delegation was willing to explain the 
implementation rules in more detail and looked forw ard to reporting on the Federal Court case at the 
next meeting of the Committee.   
(xix) Peru – Labelling of footwear (G/TBT/N/PER/19) 
280. The representative of the European Communities  recalled that, at the last Committee meeting, 
her delegation had expressed concerns with rega rd to the above mentioned notification, which 
maintained the existing requirement to indicate on the label of footwear the fiscal number of the 
importer.  The required information about the fiscal number was considered irrelevant to consumers, 
and it would be more appropriate to require this indication on th e accompanying documents, and not 
on the permanent footwear label, which was very costly for producers and exporters.  G/TBT/M/47 
Page 60  
 
  281. The EC representative further stressed that concer ns remained in particular about the special 
testing requirements for footwear manufactured abro ad which were laid down in Article 6 of the 
regulation.  It was not clear if these testing requi rements were compulsory and if European testing 
methods, using ISO standards, would be accepted.   She recalled that, at the last TBT Committee 
meeting, Peru delegate had said that the comments would be transmitted to capital and that a reply 
would soon be given.  However, her delegation had not received an y reply and she urged Peru to 
inform the European Communities whether the re gulation had been adopted and whether the EC 
comments had been taken into consideration.  
282. The representative of the United States
 shared some of the concerns raised by the European 
Communities with respect to Peru's regulation on f ootwear. Of particular concern was the special 
testing requirements set out in Article 6 of the regula tion, which appeared to apply only to imports.  It 
was his delegation's view that there could be a less trade restrictive procedure for ensuring that 
footwear labels matched the material content of fo otwear than requiring a chemical analysis report on 
each part of the footwear - the upper, lining, inso le, and sole - and requiring that analysis to be 
conducted by a single laboratory in Peru.  Peru's appr oach could cause delays to market for imports.  
He was not aware of other countries requiring this type of procedure and sought clarification from 
Peru as to what led to the imposition of these requirements.  
283. The representative of Peru  explained that, regarding Article 4 of the draft technical regulation 
which set forth that the label should include the fiscal number of the importer, the aim was the prevention of practices that could mislead consumers.   Her delegation believed that consumers had the 
right to receive all the necessary information to take appropriate purchase decisions.  Also, in cases 
when information provided was not correct, it w as important to be able to identify who was 
responsible.  The Peruvian authorities therefore t hought that it was important to include in the 
technical regulation the fiscal number in order to identify the product.  This was in line with the objectives of the technical regulation.  In add ition, information on the fiscal number could also 
identify labels which could be put on the product by the importer.   
284. With respect to Article 6 of the technical regul ation, which related to material content, the 
representative of Peru pointed out that the EC comments had been taken into account in the new 
version of the regulation.  With respect to Article  7 which determined material content of footwear, 
she noted that the draft technical regulation refe rred to the testing procedures.  The European 
Communities could provide information on their testing procedures to see whether they were acceptable to the Peruvian authorities. 
(xx) China – Wines (G/TBT/N/CHN/197)  
285. The representative of the European Communities
 reverted to a previously raised concern 
about the maximum levels of sulphur dioxide in wines established in the above-mentioned Chinese 
measure.  Her delegation had raised this issue in the past three Committee meetings and various 
European operators continued to complain about th e difficulties they were facing in exporting to the 
Chinese market due to the overly strict specificati ons.  The European Communities had been informed 
by the Chinese authorities that the standard was bei ng reviewed and that the relevant international 
standards would be taken into account in the revised version.  However , in a bilateral meeting, the 
Chinese authorities had confirmed that the maximum a llowed level of sulphur dioxide considered in 
this revision would be set at 250mg per litre. She sought confirmation that this was indeed the case 
and stressed that, if so, the limit of 250mg per litre would fall considerably short of the maximum 
allowed limits outlined in the relevant Codex inte rnational standards. .  Lastly, she sought an 
indication from China about when the process would be completed and when the revised measures 
would be notified to the TBT Committee.  G/TBT/M/47 
 Page 61 
 
 
  286. The representative of China  pointed out that the TBT Committee was not the appropriate 
forum to discuss the concern about the levels of su lphur dioxide in wine.  Useful bilateral discussions 
had been taking place on the margin of the SPS Committ ee meeting the previous month.  He stressed 
that the limit of sulphur dioxide had already been revised through a notice published by China's 
Ministry of Health on 11 December 2008.  Accord ing to the notice, sulphur dioxide had been 
increased to 250mg per litre, which was consistent wi th Hygiene Standards for Food Additives.  In the 
meanwhile, with a view of reducing risk of contam inants caused by food additives, an approach of 
reviewing applications established by Administra tive Rules on Food Additives had been taken in 
China.  According to this approach, if wine produ cers wished to increase the limit of sulphur dioxide 
used in wine, they could still make an application to  Ministry of Health for review.  Decision could be 
foreseen within a reasonable time period.   
(xxi) India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33) 
287. The representative of the European Communities  reiterated her delegation's concerns related 
to the Indian Order laying down a registration pr ocedure for imported cosmetics products.  She 
appreciated India's explanation concerning the n ecessity of the measure due to quality and safety 
concerns provided at the last TBT Committee meeti ng and in bilateral meetin gs.  She also recalled 
that India had promised to send additional written info rmation in order to provide further clarification, 
which had not been received. The EC representative  sought an update of the state of play of the 
measure and stressed that her delegation would s till appreciate receiving a written reply to its detailed 
comments submitted to India in July 2008. 
288. The representative of India  explained that the manufacture, import and distribution of drugs 
and cosmetics in India were governed by the Dr ugs and Cosmetics Act and the rules made there 
under.  At present, a large quantity of cosmetics we re being imported into the country without any 
appropriate control on quality and safety.  Therefor e, the proposed import registration was to ensure 
quality and safety aspects.  The system of registration of imports of drugs was already in place while that for cosmetics was being introduced and was base d on public health concerns.  He further stressed 
that the measure did not discriminate against foreign manufacturers, as similar provisions existed 
already for domestic manufacturers.  The proposed re gistration would only bring in harmonization of 
imported cosmetics. He reiterated India's commitmen t to comply with the transparency obligations 
under the TBT Agreement.  The draft measure had not yet been finalized and all comments received 
in response to the notification would be taken into consideration. 
(xxii)  European Communities – Novel foods (G/TBT/N/EEC/188) 
289. The representative of Peru
 reverted to a previously raised concern on the EC measure on 
novel foods and the draft amendment which was being reviewed.  Peru had taken note that there had 
been an exclusion of special treatment of traditiona l foods for which a specific request had been made.  
This was a backward step which would have a negative effect on market access to Europe for 
traditional products from Peru which had a high level of consumption.  He referred to the special 
procedure for traditional products and stressed that Pe ru's comments in this respect should be taken on 
board.  Like Colombia had expressed at the previo us meeting of the Committee, his delegation also 
believed that the reply by the European Communitie s was general and did not address the particular 
comments made by each country.  Therefore, he  asked the European Communities to provide a 
specific reply to Peru's comments.  
290. The representative of Ecuador  supported Peru's statement and said that concerns were also 
raised by his delegation in the SPS Committee.  
291. The representative of Bolivia  believed that the EC regulation on novel food presented an 
obstacle to the export of traditional safe foods from various countries, which was very important for G/TBT/M/47 
Page 62  
 
  developing economies.  She requested the Eu ropean Communities to include the proposed 
modifications in the final version of the regula tion, so as to facilitate market access for these 
traditional products. 
292. The representative of Cuba
 was also concerned about the EC measure on novel foods, in 
particular with the exclusion of traditional foods, which posed a market access problem for 
developing countries.  Like Peru, she believed that  the European Communities should provide replies 
to the comments made and pointed out that this was pa rticularly important in light of the possibility of 
requesting technical assistance and also to guarantee diversity of products. 
293. The representative of Colombia  joined the concerns expressed by Peru and the other 
delegations and stressed that this issue was very im portant for Andean countries.  She pointed out that 
the relevant representatives in Brussels were fo rmally presenting to the European Parliament a 
proposed amendment, providing for a simplified pro cedure which would facilitate the entry of fruits 
and vegetables which had a safe tradition of consump tion in various countries and would allow for the 
marketing of these products.  She urged the Eur opean Communities to consider this request 
positively.  
294. The representative of Brazil  shared the concerns expressed.  His delegation woul d continue to 
monitor the trade impacts of this measure. 
295. The representative of the Bolivarian Republic of Venezuela  joined the concerns raised by 
Peru and other delegations and requested the Euro pean Communities to provide specific replies in 
order to resolve the issue and to clarify the economic impact of the measure. 
296. The representative of the European Communities  recalled that at the last meeting of the 
Committee Members had been info rmed that the proposal was under discussion in the European 
Parliament and Council.  An agreement in first re ading had not been found and therefore the proposal 
was now under second reading.  Several of the issu es mentioned by these delegations were currently 
under discussion.  However, given that there was yet not agreement on them, she was not in a position to provide further details. A number of other issues would be developed through implementing 
provisions once the regulation was adopted.  She i nvited delegations to submit their comments in 
writing so that these could be examined and taken in to account in the next steps of the legislative 
procedure. 
(xxiii)  United States – Consumer Products Safety Improvement Act 
297. The representative of China
 again raised concerns on th e US Consumer Product Safety 
Improvement Act (CPISA).  China agreed with  the objective of protecting human health and 
appreciated the cooperative attitude of the US Gove rnment to discuss this issue.  However, his 
delegation remained concerned with  WTO inconsistencies in this Ac t and its impact on international 
trade.  He recalled that, at the previous meeti ng of the Committee, the United States had explained 
that this Act had been signed into law and that it had no obligation to notify it to the WTO.  He also 
stressed that the Act should be notified to the TBT Committee.  In fact, the definition of a technical 
regulation contained in Annex I of the TBT Agreem ent stipulated that a technical regulation was a 
"document which lays down product characteristics and production methods including the applicable 
administrative provisions with which compliance is mandatory". Additionally, the Appellate Body in 
the EC-Asbestos14 and the EC-Sardines15 cases had set forth three criteria to identify a technical 
regulation: (i) the document had to apply to an iden tifiable product or group of products;  (ii) the 
product had to lay down one or more characteristics of the product; (iii) compliance with the product 
                                                      
14 WT/DS/135/AB/R 
15 WT/DS/231/AB/R  G/TBT/M/47 
 Page 63 
 
 
  characteristics had to be mandatory.  He pointed out that the US CPSIA applied to a number of 
consumer products, including child ren's product and health care pr oducts, it laid down a number of 
technical requirements for those product with wh ich compliance was mandatory.  Therefore, CPSIA 
met the criteria of a technical regulation and shoul d be notified to the WTO, providing other Members 
an opportunity to submit comments.  
298. The representative of China further pointed out that the total limit of lead established in 
CPSIA was not based on science.  It was known that total lead content included both soluble lead and 
insoluble lead.  Insoluble lead was impossible to be  absorbed and therefore was not harmful to human 
health.  Reducing the total lead content and reducing it from 600 ppm to 100 ppm would create 
significant unnecessary obstacles to international tr ade, thus violating the less trade restrictive 
principle contained in Article 2.2 of the TBT Agreemen t.  Moreover, he recalled that the United States 
had indicated that third party laboratories included governmental laboratories, and that it stood ready 
to engage with any governmental laboratory to wo rk through issues related to additional criteria. 
However, the method for evaluating governmental laboratories in CPSIA did not include accreditation, as also indicated in notification G/TB T/N/USA/421.  With regard to requirements for 
accreditation of third party conformity assessment bodies under CPSIA, the evaluation method for 
governmental laboratories was neither transpar ent nor operable.  Moreover, the additional 
requirements for governmental laboratories were ve ry stringent and it was difficult for governmental 
laboratories of other Members, including China, which were accredited under ILAC and used ISO 
17025 as their basis to be assessed and accredited.  He urged the United States to accord equal 
favourable treatments to governmental laboratorie s and to provide a practical method for their 
evaluation and accreditation.   
299. The representative of the United States
 pointed out that eight implementing regulations of the 
Consumer Product Safety Improveme nt Act had already been notified (G/TBT/N/USA/421, 436, 439, 
444, 447, 448, 449 and 450).  The Consumer  Product Safety Commission (CPSC) website16 contained 
a special section on toy safety setting out num erous documents, including test procedures, 
accreditation requirements, a list of accredited laborat ories, general counsel advisory opinions, and 
additional guidance for small businesses.  
300. With respect to the issue of lead concentration limits, the US representative noted there were 
provisions and procedures to exempt many pr oducts from the limits based on inaccessibility and 
technological feasibility and to review the limits as a whole based on a transparent notice and comment process, where available evidence and peer reviewed scientific and technical information 
were considered.  Regarding China's concerns with  respect to government laboratories, he stressed 
that Chinese Government laboratories were not be ing singled out in any way.  CPSC had not 
accredited any government laboratory worldwide b ecause CPSC had not yet established the process 
regarding the evaluation of a government laborator y according to statutory criteria.  In any case, 
thirty-two laboratories based in Ch ina had been accredited by CPSC.  He also pointed out that CPSC 
staff recommendations with respect to govern ment laboratories were under review by the 
commissioners of CPSC.  
301. Additionally, it was stressed that the United States had opted for a highly trade facilitative 
approach, which was based on international sta ndards, including ISO 17025, and acceptance of test 
results from ILAC accredited laboratories outside th e United States.  Under this approach CPSC had 
already accredited 32 laboratories based in China.  It was also  noted that there were only 32 
laboratories accredited by CPSC for this purpose in the United States, and this could be a model for 
other countries, including China, that required third party testing.  Given the US recognition of Chinese laboratories, China was invited to provide information on when it would be recognizing test 
results from US laboratories under the CCC system.  
                                                     
 
16 http://www.cpsc.gov/  G/TBT/M/47 
Page 64  
 
  302. With respect to timeframes, the US representa tive noted that CPSC was still willing to accept 
comments and that his delegation was open to arrangi ng additional discussion.  Finally, he pointed out 
that on 30 January 2009, CPSC had agreed to stay en forcement of most of the testing and certification 
requirements regarding the lead limits on ch ildren’s products until 10 February 2010, which 
represents a 12-month delay in enforcement. 
(xxiv)  Argentina – Measures affecting ma rket access for pharmaceutical products 
303. The representative of Colombia
 recalled the concerns expressed by her delegation at previous 
meetings of the Committee, outlined in document G/TBT/W/280 of 29 October 2007.  She noted that 
the Argentinean Decree of 1993 established a procedur e for the evaluation of conformity for countries 
that were classified in Annex 1 and 2.  Howeve r, other countries, including Colombia, were excluded 
from these annexes, which made it difficult for Co lombian products to have access the Argentinean 
market.  The concern expressed had not received a po sitive response from Argentina.   She reiterated 
the request for technical studies related to country's  risk and the studies to establish the fees and the 
classification of countries within this same area.  These had been requested on several occasions.  The 
main request from Colombia to Argentina remained that a review of the Decree be carried out to 
include Colombia in the Annexes 1 or 2 and to estab lish a fee for laboratory visits in accordance with 
article 5.2.2 of the TBT Agreement.  It was Colo mbia's hope that there would be a prompt response 
from Argentina, so as to avoid going to the Dispute Settlement Body. 
304. The representative of Argentina took note of the comments made, which would be transmitted 
to the authorities in capital.  He also noted that  on going bilateral negotiations  with trading partners, 
including Colombia, were being held.  His dele gation hoped that these consultations would ensure 
that the concerns expressed be given a  prompt and satisfactory response. 
C. EXCHANGE OF EXPERIENCES  
305. The Chairperson  drew the Committee's attention to document G/TBT/1/Rev.9, which 
contained all the Decisions and Recommendations that the TBT Committee had made to date and 
covers all the areas of work of the Committee so  far, namely: (i) Good Regulatory Practice; (ii) 
Conformity Assessment;  (iii) Standards;  (iv) Tr ansparency;  (v) Technical Assistance; and, (vi) 
Special and Differential Treatment.  This document could be a useful reference for delegations.   
1. Good Regulatory Practice 
306. The Chairperson recalled that, on good regulator y practice, the Committee had heard, at its 
previous meeting, about New Zealand's experien ce with the establishment of a new model for 
regulatory coordination: the Regulatory Forum.  A submission by New Zealand on this topic was 
contained in document G/TBT/W/294.  Also, the United States had informed the Committee about 
new developments with respect to good regulatory practice.   
307. The representative of the European Communities  updated the Committee on some recent 
developments in the field of good regulatory prac tice. Specifically, he explained that the European 
Communities had finalized at the end of January 2009  its third strategic review of Better Regulation 
in the European Union.  A package of doc uments, namely three communications from the 
Commission to the European Council and the Parlia ment as well as a revised guideline on impact 
assessment, were available on the website of the Secretariat-General and of DG for Enterprise and 
Industry of the European Commission.   
308. The representative of the European Communities stressed that his delegation believed that 
good regulatory practice had to remain an essential pa rt of the response to the current economic and 
financial crisis.  Governments had to regulate only where there was a need to do so, and in a manner  G/TBT/M/47 
 Page 65 
 
 
  which was as straightforward as possible, based  on dialogue with stakeholders.  The burden on 
businesses and citizens should therefore be kept to the minimum necessary. With respect to impact 
assessment, revised guidelines had been adopted on 15  January 2009.  These guidelines integrated the 
recommendations made in the joint paper produced in 2008 by the European Commission and the US Office of Management and Budget, in the fra mework of the EU/US regulatory cooperation. 
309. The objective of the joint paper was to comp are the EC and US respective systems for 
assessing impact on trade and investment of proposed regulations.  As a result, the revised guideline aimed at re-enforcing analysis of proposed regul ations on international trade by considering, for 
example, how the regulatory options considered we re likely to affect trade or investment flows 
between the European Communities and third countri es, or how international obligations, including 
under the WTO, would be affected.  Also, the guide line suggested that consideration should be given 
to international standards or whether common regul atory approaches existed in areas where regulatory 
action was needed, and to what extent the proposed rules were likely to affect developing countries at 
different stages of development. 
310. It was also explained that consideration had b een given to how to ensure that substantive 
amendments to the legislative proposals agreed by  the European Parliament and Council were subject 
to impact assessment as well, and the three institutions of the European Communities were committed 
to completing a joint review of their common appr oach to impact assessment by the end of 2009.  
Other areas which were being analysed were me asures taken to reduce administrative burdens for 
businesses in connection with compliance with new legislation and Member States implementing legislation.  These measures would be part of  a broader programme of simplification of the EC 
regulatory environment.  As well, initiatives to enhance stakeholder consultation in view of 
developing new legislation, for instance on comp lex or sensitive proposals, were also being 
considered.  
311. Finally, the EC representative drew the Committ ee's attention to a Communication that the 
European Commission had adopted on 16 Decembe r 2008 on the "External Dimension of the Legal 
Strategy for Growth and Jobs", reporting on ma rket access and setting the framework for more 
effective international regulatory cooperation.  The Communication discussed the various tools which 
were being implemented in EC trade policy, wi th a view to keeping effective market access 
opportunities in third countries and also within the European Communities, ranging from free trade 
agreements, mutual recognition agreements to bilateral cooperation dialogues seeking regulatory 
convergence, and more ambitious fo rms of economic integration like the agreements on conformity 
assessment and acceptance of industrial products wh ich were being negotiated with Mediterranean 
and Eastern European countries.  He announced  that his delegation would report about these 
developments in writing, also in light of the Fifth Triennial Review of the TBT Agreement. 
2. Conformity Assessment Procedures 
312. The Chairperson
 recalled that a useful exchange of information had taken place in the 
previous meeting of the Committee based on the submission by New Zealand entitled "A Menu of 
Options: New Zealand's Approach to Mutual Recognition Arrangements (MRAs) and Regulatory 
Cooperation Arrangements", containe d in document G/TBT/W/295.  This document also contained a 
proposal relevant to the work of the Committee in  the context of the Fifth Triennial Review.  
3. Transparency 
313. The Chairperson  stressed that transparen cy was an area where many  practical decisions and 
recommendations had been made by the Committee over the years. She noted that, at the previous 
meeting of the Committee, some delegations had stressed the importance of looking at how the 
existing body of recommendations on transparency is being applied by Members, and had stressed the G/TBT/M/47 
Page 66  
 
  importance of the Committee focusing on achievi ng a correct and complete implementation of 
existing provisions and recommendations, while remaining open to possible improvements.   
4. Standards
17 
314. The representative of the United States  introduced her delegation's paper on "Decision of the 
Committee on Principles for the Development of International Standards, Guides and 
Recommendations with Relation to Article 2, 5 and Annex 3 of the Agreement: the experience of the 
United States" (G/TBT/W/305).  She explained that  the paper discussed developments relating to 
international standards with respect to prom oting harmonization and innovation as well as the 
"qualified heaven" provided by Article 2.5 of the TBT Agreement.  The paper also discussed 
cooperative efforts to build technical infrastructure in developing countries.   
315. While standards had many purposes, the TBT Agreemen t referred in particular to their role in 
facilitating trade, increasing productive efficiency a nd transferring technology.  The first section of 
the paper analyzed how these concepts related to efforts to promote harmonization and innovation.  
Harmonization could facilitate trade and, as the global economy had become increasingly integrated, standards could also facilitate trade by conveyi ng information throughout the value chain, which 
extended across countries with varying regulatory stru ctures and technical infrastructure development.  
Standards had to adapt rapidly to technical innova tions and scientific advances, and international 
standardization activities had to respond to these needs.   
316. The US representative stressed that the six principles of the TBT Committee's Decision – 
openness, transparency, impartiality and consensu s, relevance and effectiveness, coherence and 
development dimension – provided a model for sta ndards developing organization to follow in order 
to be globally relevant.  Her dele gation would welcome greater attention to these principles, including 
by the trading partners which maintained various policies which restricted participation or use of 
standards.  In particular, she noted that recent studies indicated that harmonizing to regional standards or regulations carried adverse implications for TBT principles. 
317. The paper also reviewed recent trends in intern ational standardizing or ganizations in relation 
to the effective implementation of the TBT Agreement, pa rticularly with respect to Article 2.5.  In this 
regard, the representative of the United States noted th e current efforts in international standardizing 
bodies to embed broad regulatory and public policies and principles in st andards.  She drew Members' 
attention to the work on the ISO 26000 standard and stressed that her delegation was interested in 
other Members' views on the potential misuse of such standards, including with respect to Article 2.5 
and 2.9
18.  She also asked for delegations' views as to whether international standardizing 
organizations were suitably structured to properly we igh disparate social claims or interpret treaties. 
318. Additionally, the paper called attention to clai ms made by certain standardizing bodies that 
the use of their standards carried automatic TBT c onsistency.  While the US delegation welcomed and 
encouraged standardizing bodies' efforts to provi de accurate and informative capacity building 
materials, it was concerned when the nature of TBT obligations were mischaracterized in such 
documents.  Concerns had been conveyed to the ISO/IEC about their Guide to Using Standards in 
Technical Regulations.    
319. The last section of the paper related to the c ooperative efforts in the development of technical 
or quality infrastructure.  To have a lasting im pact, such assistance needed to be demand-driven, 
formulated with the context of sector-specific national priorities and compatible with the level of 
                                                      
17 For details of the discussion on the Workshop on the Role of International Standards in Economic 
Development see section II(D)(2). 
18 See also section II(D)(3).  G/TBT/M/47 
 Page 67 
 
 
  technical infrastructure development.  The paper emphasized the importance of the OECD Paris 
Declaration on Aid Effectiveness in the area of t echnical infrastructure development assistance and 
the importance of cooperative professional fora that offered developing count ries stakeholders access 
to a variety of viewpoints and in dependent technical assessments.   
320. The representative of Canada  welcomed the US paper, which her delegation would analyze 
more in detail.  She believed that  the workshop held on 16-17 March wa s particularly relevant to the 
topics addressed in the US submission. 
321. The representative of the European Communities  believed that the US and the Secretariat 
documents taken together provided a lot of information and his delegati on could come back to them at 
the next meeting with additional comments.  Some points seemed, from his delegation's perspective, 
to be of great relevance to the discussion on sta ndards.  The first was how standards could support 
legislation.  In this respect, he highlighted that a joint effort was underway with the United States in 
the framework of the bilateral cooperation to co mpare the methods of referencing standards in 
legislation.  A joint study was currently being prepared.  
322. Another issue that had been highlighted at the workshop was the fragmentation in the 
standard-setting process in some sectors.  This w as particularly evident in the IT sector.  In the 
European Communities a reflection had started on how to address this issue and on what kind of 
relationship could be established between the consortia, private-set ting bodies, which involved only a 
small number of players, and the traditional st andard-setting bodies.  The representative of the 
European Communities further informed the Commit tee that the European Commission had issued in 
2007 a communication on the contribution of standard s to innovation, addressing specifically the role 
of standards in promoting innovation and the diffi culties that the standard setting bodies faced in 
adapting to the changing needs of certain industria l sectors which needed fast standards in order to 
cope with the fast pace of technological innovation.   Another challenge was how the standardization 
system adapted and responded to i nnovation and how the necessary resour ces to adapt could be found.  
In the European Communities, a more general refl ection on the European standardization policy and 
standardization bodies had also started, and an expe rt panel had been set up with the mandate to come 
forward with proposals and recommendations by the end of the year.  His delegation would keep the Committee informed on the outcome of those reflections. 
323. The representative of Japan 
appreciated the US document and agreed that securing that the six 
principles in the Committee's Decision were followed was of great importance in terms of developing 
globally relevant international standards.   
324. The representative of the OIML  pointed out that the OIML tried to ensure that the procedures 
for adoption of standards complied with those wh ich were specified in the Annex 3 to the TBT 
Agreement, although international standard setting organizations were  not obliged follow it.  The 
OIML publications were recommendations, although they  were interpreted as international standards 
from the point of view of the TBT Committee. Thes e recommendations were, in fact, intended to be 
model technical regulations to be implemented by the member states of the organization.   
D. OTHER MATTERS  
1. Consideration of Specific Trade Concerns 
325. The representative of Cuba  invited Members to reflect on the consideration of specific trade 
concerns in the TBT Committee.  She noted th at Members had announced they would raise 
approximately fifty-four specific trade concerns, of  which at least twenty-five had previously been 
raised (Job(09)/19).  In 2008, the total number of sp ecific trade concerns raised had been, according to 
document G/TBT/GEN/74/Rev.1, fifty-nine.  She found that the increasing number of specific trade G/TBT/M/47 
Page 68  
 
  concerns raised in a single meeting called for re flection.  In particular, she mentioned that the 
European Communities was the Me mber whose measures had been raised for discussion most 
frequently.  In her view, this perhaps because concer ns may have not been properly addressed.  On the 
other hand, the case of the tyres regulation by India
19 showed that the measure had not been enforced 
for three years while comments were considered and taken into account, in compliance with WTO 
rules. 
326. The Cuban representative further noted that in  other cases, often involving the European 
Communities, although concerns a bout consistency with the TBT Agreement and had been repeatedly 
raised by delegations, these had not properly been responded to.  She stressed that in times of 
economic downturn, it was particularly important  that all Members abide by WTO rules.  
Consolidation of the multilateral trading system de pended on Members' respecting the rules that had 
been established.  In light of this, it was particular  important to give proper consideration to comments 
expressed and concerns raised, and to provide replies to them. 
327. The representative of Cuba further suggested that document G/TBT/GEN/74/Rev.1 could 
usefully include, in future revisions, a descripti on of the trade concerns expressed, including their 
outcome.  For instance, if bilateral consultations were underway as a result of a specific trade concern 
raised in the Committee, this could also be mentione d in that document.  Additionally, she referred to 
Article 13 of the TBT Agreement, which included the possibility of establishing working groups.  She 
also pointed out that some of the concerns liste d in G/TBT/GEN/74/Rev.1, such as "Korea – Fish 
Heads" or "European Communities – REACH" had b een on the Committee's agenda for several years, 
and that a solution had not been found.  A mech anism to solve these long-standing specific trade 
concerns should be found, to avoid concerns beco ming disputes under the DSB.  She believed that the 
Committee should analyze this possibility in a detailed manner.  The representative of Cuba 
concluded by noting that, if concerns were not properly addressed, as had been the case for REACH, they would be likely to be raised again at  the following meeting of the Committee.   
328. The representative of th e European Communities
 stated that the intervention made by Cuba 
highlighted some fundamental points.  First, what  was the role of the TBT Committee in discussing 
STCs, and, in particular, how far discussions on STC s could go after a notified text had been adopted 
and where several rounds of discussions had already been held?  Second, he stressed that the TBT 
Agreement required Members to give an adequa te opportunity for comments, to discuss these 
comments upon request with interested Members and to take those comments into account.  However, 
there was no obligation to modify a notified text if  the comments received were considered not to be 
relevant or sufficiently substantiated to justify a substantial modification.  In the same way as Cuba, 
his delegation could also call into question the useful ness of the approach that certain delegations had 
been taking in discussing repeatedly so me issues in the TBT Committee.   
329. With respect to the allegations made by Cuba that his delegation had not been willing to enter 
into a dialogue or that it had not properly addr essed the concerns raised, the representative of the 
European Communities stressed that  the European Communities was one of the most transparent 
WTO Members.  The fact that there were many spec ific trade concerns raised on EC measures had to 
do with the transparent way in which the European  Communities worked.  All technical regulations 
were notified in due time and ample opportunity fo r WTO Members to become  aware of any draft 
legislation which was in the pipeline was given.  Moreover, the EC lawmaking process had been 
considerably improved in the last few years, th rough the implementation of  the so-called "Better 
Regulation".  In this framework, all legislativ e proposals were based on extensive stakeholder 
consultations, impact assessment which analyzed in  a balanced way the economic, environmental and 
social impact of the proposed measures and, in th is context, extensive c onsultations with foreign 
                                                      
19 See paragraphs 230-233.  G/TBT/M/47 
 Page 69 
 
 
  stakeholders and foreign governments were also he ld.  This preceded any notification to the TBT 
Committee.   
330. With respect to REACH and to the 31st ATP Directive, the representative of the European 
Communities stressed that his delegation had brought,  on several occasions, technical experts to the 
TBT Committee to reply to specific questions.  An in formation session had also been organized by his 
delegation ahead of the November 2008 meeting of the TBT Committee, where participation and the 
questions and comments raised had been disappointing.  Therefore, he rejected any allegation that the 
European Communities had been unwilling to enter into  fruitful discussions.  Additionally, he stressed 
that every time scientific evidence substantiating concerns had been requested, this evidence had 
never been forthcoming.  He reaffirmed the right of any WTO Member to confirm its initial 
regulatory choice if the evidence submitted by th ose Members raising concerns was not enough to 
make regulators change opinion.   
331. On REACH, the representative of the European  Communities believed that it remained an 
important topic of discussion because it was a complex framework legislation which needed implementation over the years.  However, for the purpo se of an efficient use of time and also in order 
to respect the role of the Committee, he suggest ed that the discussion should focus mainly on new 
issues and not on old issues which had been discussed several times and where the EC legislation had been adopted.   
332. The EC representative noted that the European  Communities was often at the forefront in 
promoting regulatory solutions that set ambitious le gitimate policy objectives, for example in the field 
of environmental protection, in the field of ener gy, in the field of risks arising from chemical 
substances from industrial products.  He  stressed  that the TBT Agreement allowed Members to set 
the appropriate level of protection in order to pursue a legitimate policy objective.  While the 
European Communities was often a frontrunner in promoting ambitious regulatory solutions, these 
were then often followed by other Members.  This  posed a challenge, but the challenge was not in 
terms of TBT consistency, but in terms of wh at measures could be put in place to facilitate 
implementation.  With respect to the challenges faced  by developing countries, there were instruments 
that could facilitate compliance with the rules enact ed by developed countries.  For example, the 
European Communities had committed to providing tec hnical assistance in order to build capacity in 
developing countries.  In concluding, he invited Members to refl ect on what the role of the Committee 
was in discussing specific trade concerns.  His dele gation believed that once a text had been adopted 
and issues had been discussed, the TBT Committee was no longer the proper forum for addressing 
those issues.  Bilateral dialogue was the proper pl atform for pursuing these discussions.  This did not 
mean that Members would refrain from having furthe r discussions with other Members but that those 
discussions should take place in a different framework. 
333. The representative of Cuba
 appreciated the detailed explanation by the European 
Communities.  She agreed that when discussions we re exhausted in the TBT Committee they could be 
moved to another body, not necessarily the DSB.  Sh e invited Member to reflect on Article 13.2 of the 
TBT Agreement on the creating of working groups as a possible solution.  She believed that the fact 
that there had only been one dispute related to TB T did not necessarily mean that the mechanism of 
discussing specific trade concerns was working effectively.  Rath er, it was a sign of Members' good 
faith, while questions and comments were repeated ly raised if not answered or addressed.  She 
suggested that comments and questions on specific tr ade concerns should be sent in advance to the 
Member concerned as well as to all WTO Members, so as to be better prepared at the meetings of the 
Committee and to save time.  Finally, the representa tive of Cuba agreed that the TBT Committee was 
a forum for exchange of information and to solve tr ade concerns in an amicable way.  This space 
should be maintained in the Committee and no Memb er should be prevented from presenting specific 
trade concerns.  At the same ti me, comments should be taken into account.  Her delegation was open 
to discuss with other Members about solutions to improve the efficiency of TBT Committee's work.  G/TBT/M/47 
Page 70  
 
  334. The Chairperson
 noted that discussions of specific trade concerns in the TBT Committee 
provided Members a good opportunity to exchange vi ews and information on the concerns they had 
with respect to their trading partners' measures.  At the same time, several bilateral or plurilateral 
meetings were taking place at the margins of TB T Committee meetings, showing that Members were 
constructively working towards resolutions of trade concerns.  Although she believed that the 
mechanism was working effectively,  she agreed that discussions could be held in the Committee more 
efficiently.  In this respect, she invited delegations not to repeat each time the statements which were 
already contained in the minutes of the previous m eetings.  She also believed that fruitful bilateral 
discussions could help reducing the list of trade concer ns raised at the meeting.  She agreed with the 
suggestion that delegations should provide comment s and answers in advance of the meeting, and 
noted that some delegations had already started doi ng so.  She suggested that the issue should again 
be discussed at the June meeting of the Committee. 
2. Workshop on the Role of Internationa l Standards in Economic Development 
335. The Chairperson  reported on the Workshop on the Role  of International Standards in 
Economic Development (Annex 1). It was noted that  the Secretariat had prepared two background 
notes for the Workshop on International Standards and Economic Development held on 16-17 March.   
One provided an overview of standards and the TB T Agreement (Job(09)/15), the other focused on 
the economic rationale for standardization (Job( 09)/17).  A Summary Report of the Workshop is 
contained in document G/TBT/W/310. 
336. The representative of the United States  believed the workshop was an important step for the 
TBT Committee to further the discussion of how the challenges and opportunities related to the 
development and use of international standards affe cted the implementation of the TBT Agreement.  
Her delegation appreciated the wealth of informa tion provided in terms of approaches to improving 
trade through standards and the rich range of topics and the variety of concerns presented, as well as 
the numerous possible paths to increasing partic ipation of developing countries in standards 
development.  As indicated in the Chairpers on's summary, the workshop had also identified many 
ideas that should be given further consideration and reflection.  She noted that abilities to identify, 
participate in, implement and use international sta ndards, including in technical regulations, varies 
considerably among WTO Members.  However,  the willingness of all Members to work 
collaboratively to advance standardization as a tool  for economic development indicated that there 
was much to gain from diversity.   The TBT Committ ee could play an important role in this work, 
although other key actors, such as the domestic stak eholders in the private sector, the national 
standards bodies and standards developing organizati ons, had a lead in addressing challenges and in 
enabling opportunities in international standardi zation and conformity assessment activities.  She 
encouraged TBT Committee Members to focus on prac tical and effective ways to deepen coordination 
with these actors.  In order to take the valu able information from the workshop forward, her 
delegation offered some suggestions fo r consideration by other Members. 
337. First, the Committee could identify ways to enab le WTO Members to be aware of information 
on trade-related studies on effective outreach and en gagement, particularly with small and medium 
sized enterprises in standards development, and on analytical tools to assess the economic value of 
standards at the firm level.  The TBT Committee could also identify best practices and guides for 
effective implementation, including in relation to  incentives provided by national governments to 
increase SMEs' activity in standardization and thei r ability to implement standards.  The Committee 
could also encourage further efforts on technical cooperation.   Twinning had been identified in 
previous triennial reviews as important in th is regard, and continued work towards greater 
effectiveness in twinning, as well as the broader con cept of partnering, should be encouraged.  The 
Committee could also welcome efforts by standards developing organizations to explore ways to 
strengthen on-line collaborative tools, to encourage m eetings to be held in de veloping countries and to  G/TBT/M/47 
 Page 71 
 
 
  promote greater access to expertise, recognizing that to be truly effective, these had to be matched by 
developing country stakeholders to  be active participants and to ta ke ownership of achieving results. 
338. Furthermore, the US representative suggested that the TBT Committee could underscore the 
critically important contribution of cooperative effo rts in technical organizations, both regional and 
international, including by encouraging Members to pr ovide reports of those groups that could be of 
interest to the broader Committee membership.  In addition, the Committee could consider 
transmitting the report of the workshop to th e Committee on Trade and Development (CTD) for 
consideration at its 2 April meeting on Aid for Trad e and encourage stakeholders in the Aid for Trade 
process to take account of the value of sta ndards activities in building productive capacity. 
339. Another suggestion made was that the Committe e could request the World Bank to transmit 
its analysis on the return to investment in sta ndards work to the CTD session on Aid for Trade as well 
and include information on the importance of inco rporating work on quality infrastructure into 
national development plans.  Finally, the Committee could reaffirm its decision on the six principles on the development of international standards a ke y driver for standards that have positive economic 
value.  
340. The representative of Cuba
 found the workshop useful and appreciated the opportunity of 
having had a participant from capital funded through the Global Trust Fund to participate at this 
event.  She stressed that it was important to exch ange experiences as it had been done at the workshop 
and that it was even more important to put lessons  learned into practice.  Therefore, the workshop 
should serve as a basis for future work.  She also believed that discussions on the challenges identified 
in the Chairperson's report should continue at followi ng meetings of the Committee.  In particular, she 
recalled that many participants at the workshop had expressed concerns with the proliferation of 
private standards.  A more in-depth discussi on on this issue should be conducted in the TBT 
Committee, so that specific actions could be undertaken.    
341. The representative of Korea  appreciated the workshop and ag reed with the Chairperson's 
report that, in times of economic crisis, standard s and regulations should not be implemented in a 
manner that restricted trade. 
342. The representative of Antigua and Barbuda  found the workshop very useful and was 
particularly interested in how to improve use of information technology to enhance participation of 
developing countries in internati onal standardizing activities and to exchange information.  Since 
participation of developing countries in interna tional meetings was often depending of available 
funding, IT tools could usefully serve as substitutes to meetings and alleviat e dependency on external 
funding. 
343. The representative of Canada  believed that the workshop had highlighted the importance of 
continuing to explore the value of  standardization and had provided very interesting case studies on 
how particular standards were be ing implemented in several countri es.  Her delegation recognised the 
challenges faced by developing countries in th e implementation of international standards and 
participation in their development.  The presenta tions delivered by developing countries at the 
workshop had been particularly valuable in this regard.   
344. Looking forward, the representative of Canada  suggested that the Committee should continue 
to examine ways for developing countries to improve  their participation in international standards 
development, by taking advantage of the techni cal assistance available through many international 
organizations and thereby leverage the demonstrated benefits that such participation entailed, such as 
increased international trade.  Canada remained co mmitted to assisting developing countries in that 
regard.  She also suggested that the TBT Committe e should take stock of the success stories presented 
at workshop:  this would help the Committee achieve  the goals set out in the Third Triennial Review G/TBT/M/47 
Page 72  
 
  to use Members' experiences of technical assistance  received and provided to develop elements of 
good practice in the development of technical assistance in the TBT field.   
345. The representative of Mexico
 also appreciated the workshop and the report by the 
Chairperson.  He referred to the issue of private standards and to the many concerns voiced at the 
workshop with respect to their proliferation and effect on trade.  He noted that the SPS Committee 
had been discussing this issue for some time, a nd believed that discussions should take place in the 
TBT Committee as well.  The work of both Commit tees could merge and come to some conclusion as 
to the applicability of WTO rules to private standards.   
346. The representative of Pakistan  was thankful that the works hop had provided her delegation an 
opportunity to bring a representative from capital to participate in the activity and learn from other 
countries.  Organizing these types workshops was a ve ry useful exercise and was in itself capacity 
building, because for developing countries it was not easy to bring officials from their capitals to 
attend technical meetings.  The very fact that  one person from capital had participated in the 
workshop and TBT Committee meeting and had learnt  about the various experiences of different 
countries was very encouraging. 
347. The representative of Pakistan agreed with the proposals made by the United States.  These 
suggestions could feed into Aid for Trade, by en couraging increased participation of developing 
countries in standards-setting process, so that they could have greater owners hip and could be in a 
better position for implementing standards.  
348. The representative of th e European Communities  thanked the United States for taking the 
initiative to set the process in motion and pointed out  that the Chairperson's report and the suggestions 
made by the United States captured his delegation' s view about the outcome of the workshop.  He 
joined Canada in stressing the importance of shar ing information on success stories in the field of 
technical assistance, as regards raising experti se in developing countries, assisting experts from 
developing countries to participate effectively in the international standard setting process and 
building capacity in developing countries.  Without building capacity in terms of infrastructure, 
developing countries would not be able to reap the full benefits of the international standard-setting 
process in which they had participated, and woul d not be able to support their exporters.   
349. The representative of the European Communities encouraged Members to share information 
how their technical assistance activities were pursu ing those objectives.  The Committee should also 
try to identify some best practices from the ongoing e fforts of the international organizations who are 
active in this field, such as UNIDO, the World Ba nk, the various programmes in the ISO and the IEC 
and the Aid for Trade initiative.  On private standa rds, the EC representative believed that this topic 
fell outside the scope of the TBT Agreement and that the TBT Committee was not the appropriate 
forum to hold discussions on this issue.  He referred  to the detailed statement made by his delegation 
in that regard at the Workshop. 
3. ISO 26000 
350. The representative of Mexico  raised concerns with respect to the draft ISO standard 26000 on 
social responsibility and noted that ISO had circulat ed the draft text for comments with a view to 
approving it as a draft international standard (DTIS).  He stressed that there was confusion in this 
document about concepts of responsibility in gove rnment and private sector.  The document covered, 
among other matters, issues such as culture, human resources, environment and this had brought about 
confusion over its implementation and application.  Furthermore, it went beyond ISO's mandate. He 
warned other countries of the risk that this standard  could pose to international trade if it was adopted 
as an international standard and looked forward to an  exchange of information with other Members in 
this respect.  G/TBT/M/47 
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  351. The representative of the United States  agreed with Mexico on the potential misuse of the 
document, given its wide coverage of issues.  Sh e referred to the paper submitted by her delegation 
titled "Decision of the Committee on Principles for th e Development of International Standards, 
Guides and Recommendations with Relation to Ar ticles 2, 5 and Annex 3 of the Agreement 
(G/TBT/1/Rev.9 Annex B): The Experience of the United States" (G/TBT/W/305) in which systemic 
issues with this type of standards activity were ra ised.  She looked forward to hearing other Members' 
views on this issue.  
352. The representative of the ISO,  in relation to on going work in ISO on social responsibility 
(ISO 26000), pointed out that the decision to prepare work on this standard was the result of a strong 
wish on the part of developing countries to have such a document agreed upon through the consensus-
based process of international standardization.  He explained that, since the process had started, there 
had been a significant increase in the involveme nt of developing countries: from twenty-one 
developing countries involved in 2005, the number ha d increased to forty-eight in 2008.  ISO, through 
donor funding, had supported developing country e xperts from six stakeholder categories, including 
the private sector and governments, to participate in  the standardization process.  In 2008, the number 
of experts involved in the working group from de veloped and developing countries was 143 and 210 
respectively, which illustrated the high number of  experts overall involved in the drafting process. 
353. The representative of the ISO further pointed out that the issue of misuse of the standard had 
been a constant concern among experts, and that sev eral clauses had been included in the text to 
provide guidance as to its final use.  Thus, the fu ture standard would be a guidance document and not 
intended to be used for certification.  Besides, at  the last plenary meeting of the working group in 
September 2008, a specific clause was agreed upon to indicate that the standard was not intended to 
create a non-tariff barrier to trade.  The standard  was not meant to suggest policy guidelines to 
governments, although governmental bodies could use rele vant sections in their institutions if deemed 
appropriate.  He concluded by informing the Committ ee that the next plenary meeting of the working 
group would be held in Canada on 18-22 May 20 09.  Voting by participating national standards 
bodies on the committee draft had been completed and s howed that more than two-thirds of the votes 
were in favour of moving the document to the DIS (draft international standard) phase.  He pointed 
out that the efforts deployed by all parties to ensure the widest representation possible had been 
successful.  
III. PREPARATION OF THE FIFTH TRIENNIAL REVIEW 
354. The Chairperson  recalled that the Committee was schedul ed to conclude the Fifth Triennial 
Review of the Operation and Implementation of th e TBT Agreement at its meeting on 5-6 November 
2009, in line with the mandate in Article 15.4 of th e TBT Agreement.  The Chairperson also recalled 
that, at November 2008 meeting, the Committee ha d agreed on a timeline for the Fifth Triennial 
Review, which was contained in the report of th e Committee's meeting, G/TBT/M/46, page 69, which 
would guide the Committee to the adoption of the Tr iennial Review Report in November.  She drew 
the Committee's attention to a background note circul ated by the Secretariat, containing two proposals 
received to date from New Zealand and Canada.  Th e document was contained in Job(09)/16.  More 
recent submissions had also been received by New Zealand on "Mutual Recognition, Regulatory 
Cooperation and other Trade Fac ilitation Arrangements" (G/TBT/W/ 306) and Japan on the "Global 
Relevance of International Standards" (JOB(09)/25). 
1. Mutual Recognition, Regulatory Cooperation and Other Trade Facilitation 
Arrangements 
355. The representative of New Zealand  introduced her delegation's paper on "Mutual 
Recognition, Regulatory Cooperation and other Tr ade Facilitation Arrangements" (G/TBT/W/306) G/TBT/M/47 
Page 74  
 
  and recalled the previous submission on "A Menu of Options: New Zealand's Approach to Mutual 
Recognition Agreements (MRAs) and Regulator y Cooperation Arrangements" (G/TBT/W/295). 
356. The representative of Chile
 welcomed New Zealand's contributions.  She believed that the 
tools identified would facilitate trade and reduce transaction costs.  Chile did not have much 
experience with respect to these t ools, therefore sharing of experience with other countries which had 
had good results was particularly important.  In Chile, th e possibility of starting to use this type of tool 
was currently being assessed, also in light of th e numerous existing trade agreements.  She supported 
New Zealand's second proposal to develop practical guidelines on how to design efficient and effective trade facilitation arrangements within the cont ext of risk management approaches.  This type 
of guideline would be particularly beneficial in th e design of these types of arrangements, especially 
to developing countries. 
357. The representative of Mexico
 supported New Zealand's proposals and stressed that it would 
be beneficial to discuss these matters in more detail w ith a view to facilitating trade.  He thought that 
it was a mandate provided for in the TBT Agreem ent, in particular Articles 2.7 and 5 which 
encouraged Members to recognize each other's techni cal regulations as equivalent or to enter into 
negotiations for the mutual recognition of conform ity assessment results.  He explained that Mexico 
was initiating a process of regulatory cooperation with its trading partners and to identify how greater 
interaction in the interpretation of technical stan dards could be achieved.  In this respect, the 
experience of other Members would be useful and hi s delegation looked forward to contributing to the 
discussions. 
358. The representative of Japan  agreed that MRAs were important and about the necessity to 
exchange information in this regard.  However, his delegation believed that  MRAs were often not 
utilized efficiently, and that it was very costly to  conclude such agreements.  Therefore, a right 
balance should be struck between  costs and benefits of MRAs. 
359. The representative of Singapore  found New Zealand's list of approaches to facilitating 
acceptance of the results of conformity assessment procedures to be very useful.  In particular, New 
Zealand proposal for the Committee to continue to  exchange information on MRAs was especially 
interesting.  Singapore's experience with MRAs in sector's such as electrical and electronic products 
had been largely positive.  Companies had repor ted strong utilization of these MRAs and had 
benefited from reduction in business costs due to saving from unnecessary testing and certification.  
Her delegation would be happy to share the suc cess stories of such companies and exchange 
experiences on MRAs with interested Members. 
360. The representative of Chinese Taipei  welcomed New Zealand's proposals and supported the 
view that engagements between regulators delivered considerable benefits to international trade.  
361. The representative of the United States  welcomed New Zealand's submission and pointed out 
that, in the United States, success with MRAs had been mixed.  The United States was experiencing 
similar situation as New Zealand, as its busin ess community was strained by compliance and 
transaction costs and was calling for practical solutions.  Therefore, it was important for Members to 
continue to share ideas and experiences to find wa y to address real trade concerns.  This was 
particularly relevant with respect to the engage ment between developed and developing economies.  
The suggestion for the need to develop a more flexible  approach to deal with the reality of the global 
trading system was an area where the greatest challenges lied.  Building trust and confidence among regulators was critical, as it was bringing new pers pectives into the over arching risk management 
framework and its interface with the trade facilita tion framework.  She also agreed on the need to 
build mechanisms for long term cooperative relati onships among regulators: sharing experiences and 
successes in this regard would be useful.   G/TBT/M/47 
 Page 75 
 
 
  362. The representative of Cuba  agreed that continuing to ex change information on mutual 
recognition arrangement, regulatory cooperation arra ngements and other arrangements that aimed at 
facilitating trade was important.  She stressed that th e second part of the proposal, the development of 
practical guidelines on how to design efficient and effective trade facilitation arrangements within a 
context of risk management approaches, was particularly important. 
363. The representative of the European Communities  agreed that the topic was interesting and 
referred to his previous statement about the prelim inary critical assessment of existing tools for trade 
facilitation which was being conduc ted in the European Communities.   His delegation's assessment 
showed that there was not a single approach that could be useful in all cases.  It depended on the 
objectives that were being sought, and also the le vel of development of the countries which were 
building cooperative relations. For instance, if th e objective was regulatory convergence, regulatory 
cooperation could be a very good to ol.  However, if the objective was to harmonize legislation and 
link specific sectors and different economies in specif ic areas, then a long period would be necessary 
and a formal agreement would have to be conclude d based on the alignment on the related legislations 
of the partners.  This could be considered as a new generation of mutual recognition agreements, 
based on equivalence or alignment of legislation.  In the EC view, traditional MRAs had not worked 
too well, because they had provided a disincentive of  the approximation of the regulatory environment 
of partner countries. Where differences in regulat ory approaches were significant the agreements  
were prevented from functioning because the necess ary confidence for those agreements to operate 
was never achieved.   Therefore,  he believed that the range of trade facilitation arrangements was 
quite diverse and depending on the objectives be ing sought and the situations of regulatory 
environment and economic developm ent of the countries involved. 
2. Global Relevance of International Standards 
364. The representative of Japan  introduced his delegation's proposal on "Global Relevance of 
International Standards" contained in document J ob(09)/25.  He noted that, since the TBT Committee 
had adopted its Decision on the six principles for the development of international standards20 the ISO 
and IEC had been discussing the issue of the global re levance of international standards.  He believed 
that the Triennial Review was the appropriate time for the Committee to look into this issue and that 
the TBT Committee should consider the global rele vance of internationa l standards from the 
viewpoint of how much the "International Standard s" were being used and implemented in markets 
around the world. 
365. Essentially, if "International Standards" were used and implemented as broadly as possible by 
affected industries and other stakeholders in mark ets around the world, the following results could be 
expected, which would improve the efficiency of pr oduction and facilitate the conduct of international 
trade, thereby achieving the obj ectives of the TBT Agreement: (i) "International Standards" which 
were used globally should be define d as international standards so that it would be easier to encourage 
Members to align their national standards and re gulations with international standards; (ii) 
"International Standards" which had no global re levance should be abolished; (iii) developing 
countries' participation in developing international standards should be promot ed; and, (iv) developing 
countries' circumstances should be taken into acc ount when international standard bodies develop 
international standards. 
366. The representative of Korea  supported the proposal from Japan, in  particular that international 
standards which had no global rele vance should be abolished.   
                                                      
20 "Decision of the Committee on Principles for the Development of International Standards, Guides 
and Recommendations with Relations to Articles 2, 5 and Annex 3 of the Agreement", G/TBT/1/Rev.9, page 37. G/TBT/M/47 
Page 76  
 
  367. The representative of the United States
 welcomed the proposal from Japan and noted that 
some of the broad themes put forward were also echoed in the US paper on "Decision of the Committee on Principles for the Development of International Standards, Guides and 
Recommendations with Relation to Article 2, 5 and Annex 3 of the Agreement: the experience of the 
United States" (G/TBT/W/305).  The Committee' s decision was an example of how the TBT 
Committee could encourage the various interna tional standards developing organizations to 
strengthen and clarify their rules, to promote better implementation of the Agreement.  She noted that 
the concept of market relevance had been at the h eart of the US standards strategy, which promoted a 
bottom-up, private sector-led approach to standards development.  This allowed standards to embody 
technical excellence and embrace technological in novation in responses to market and regulatory 
needs.  Her delegation looked forwar d to working with Japan, in particular to refine and clarify the 
Committee's considerations of global  relevance and the related impli cations and effects on the concept 
of international standards. 
3. Proposal on Specific Trade Concerns 
368. The representative of Canada
 recalled that her delegation had put forward a proposal 
contained in a room document on the Committee's c onsideration of specific trade concerns.  She 
invited Members to submit comments, so that a final proposal could be submitted. 
369. The representative of Brazil  supported the proposal by Canada, which would enhance 
transparency and predictability in the Committee's work.   
370. The representative of Cuba  recalled her statement under Agenda Item 2(D)(1) on the 
consideration of specific trade concerns and noted th at her delegation had appr oached Canada to make 
comments on its proposal.  
371. The representative of Ecuador  agreed that specific trade concer ns to be raised at a meeting 
should be indicated in writing.  He believed that the timeframe of seven days suggested by Canada 
should be fifteen days instead. 
372. The representative of Japan,  Chinese Taipei  and Australia  supported the proposal from 
Canada.  Japan noted that it would contribute to  a more constructive discussion of specific trade 
concerns in the Committee.  Chin ese Taipei stressed that delegations would be better prepared to 
provide responses when specific trade concerns were raised. 
373. The representative of the United States  noted that the proposal from Canada suggested that 
the Annotated Agenda of the Committee should be i ssued five days prior the meeting, and stressed 
that the practice in other Committees was to issue it ten days in advance.  This timeframe would be 
better in ensuring consistency and also to ensure sufficient time to properly vet the specific trade 
concerns internally and to facilita te discussion in the Committee.  She also recalled that part of the 
suggestion was that there would be a brief outline of  the concern.  However, this was not necessary in 
all cases.  For instance, if the measures had been notified, reference to the notification number would 
be sufficient.   In a case when the measure had not been notified, the title of the measure and the 
reference to the document number would suffice.  If there was no title a brief explanation could be 
provided.  She also suggested that Members wishing to  raise a specific trade concerns after the agenda 
was closed should still be able to raise them under the agenda item on specific trade concerns, after all 
the concerns on the agenda had been discussed.  Ther e could be situations where an urgent concern 
could arise shortly before the Committee meeting,  and this should not be relegated to "other 
business".  G/TBT/M/47 
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  4. Transparency 
374. The representative of the European Communities  recalled that, at the last meeting of the 
Committee, his delegation had flagged the intent ion of submitting a paper on transparency and 
announced that this would be done shortly.21  The paper would share the EC experience on how 
internal practices had been modified where necessa ry, in order to give effect to the Committee's 
recommendations in the field of transparency.  The paper would also submit concrete proposals on 
possible improvements to the implementation of the transparency provisions and the Committee's 
recommendations in some areas.  The topics whic h had been taken into consideration were the 
functioning of notification and enquiry points; the level of compliance with the obligation to notify 
draft technical regulations and conformity assessmen t procedures; various issues in relation to the 
access to the notified text, including translations, th e availability of the original language version of 
the text; and amendments to original notifications.   The obligation to notify text at sub-state level, 
various issues related to the handling of comment s and the publicity given to the comments received 
and made on the notified text were also assessed. 
375. The representative of Cuba  recalled that at the previous meeting of the Committee the 
European Communities had suggested  that the Committee could "consider developing a questionnaire 
for Members as a way of gathering information a bout the practical application of the Committee’s 
recommendations".22 She sought clarification from the European Communities regarding the scope 
and status of this questionnaire. 
376. The representative of the European Communities  noted that it was his delegation's sense that 
the proposal of developing a questionnaire would not receive support from Members. He believed that 
statistical information produced by the Secretariat was and would continue to be helpful in gathering 
information about implementation of Committee's recommendations.  He encouraged Members to 
submit comments to the forthcoming EC paper. 
IV. FOURTEENTH ANNUAL REVIEW OF: 
A. THE IMPLEMENTATION AND OPERATION OF THE TBT AGREEMENT UNDER ARTICLE 15.3 
377. The Committee adopted the Fourteen Annual Review of th e Implementation and Operation of 
the TBT Agreement, as contained in document G/TBT/25.  
B. THE CODE OF GOOD PRACTICE  
378. The Committee's attention was drawn to two lists prepared by the Secretariat to facilitate 
consideration of matters relating to the operation of the Code of Good Practice.  The first list, 
contained in document G/TBT/CS/1/Add.13, compiled  the standardizing bodies that had accepted the 
Code in the period under review.  In the repor ted period, four standardizing bodies from four 
Members had accepted the Code of Good Practice23 and three standardizing body had withdrawn from 
the Code.24   The second list, contained in document G/TBT/CS/2/Rev.15 compiled all the 
standardizing bodies that had accepted the Code si nce 1 January 1995.  Since 1 January 1995, 159 
standardizing bodies from 119 Members had accepted the Code of Good Practice. 
                                                      
21 Subsequently submitted as G/TBT/W/309, dated 11 May 2009. 
22 G/TBT/M/46, para. 357. 
23 G/TBT/CS/N/173, G/TBT/CS/N/174, G/TBT/CS/N /175. Viet Nam notifie d its acceptance of the 
Code of Good Practice in January 2009 (G/TBT/CS/N/176).   
24 G/TBT/CS/N/107/Corr.1, G/TBT/ CS/N/14/Corr.1, G/TBT/CS/N/121 /Corr.1. In addition, two 
standardizing bodies notified the ISO/IEC Information Centre of their withdrawal from the Code– Pro Telecom, 
Association Suisse des Télécommunications (Switzer land) and the Australia Gas Association (AGA). G/TBT/M/47 
Page 78  
 
  379. Additionally, the ISO/IEC Information Centre had prepared the Fourteenth Edition of the 
WTO TBT Standards Code Directory, which containe d information received according to paragraphs 
C and J of the Code of Good Practice for the Preparation, Adoption and Application of Standards in Annex 3 of the Agreement.   
380. The Committee took note
 of these documents.   
V. TECHNICAL COOPERATION ACTIVITIES 
381. The representative of Uganda  requested the Secretariat to provide an update on the voluntary 
notification of technical assistance needs and re sponses and to share with Members the list of 
Members that had submitted such notifications and benefited from this initiative.  He wondered if 
there were evolutions with r espect to this mechanism.  
382. The representative from the Secretariat recalled that the format for the voluntary notification 
of technical assistance needs and responses was cont ained in document G/TBT/16.  Five countries had 
submitted such notification (Jamaica, Armenia, Costa Rica, Uganda and Dominican Republic)25.  
Although in discussions held in the Committee ther e was a general feeling that many technical 
assistance initiatives were taking place already at bila teral level, Members were welcome to continue 
using the voluntary notification.   
383. The representative from the Codex pointed out that, as regards pa rticipation in standardization 
activities, the Codex trust fund wa s in operation.  It had been initiated in 2004 and it facilitated  
participation of developing countries in the sta ndard setting activities of the Codex Alimentarius 
Commission.  A complete report would be provided at the next meeting of the TBT Committee.  She 
drew the Committee's attention to regional Codex coordinating committee for Africa which had been 
held in Ghana in February 2009 to a workshop orga nized by FAO and WTO on the issues of interest 
to the region.  In conjunction with coordinating committees, the C odex often organized workshops on 
various topics.  An e-learning tool was also av ailable in several languages on the FAO website. 
384. The representative of the ISO  presented his organization's ac tions in support of developing 
countries (G/TBT/GEN/83). 
385. The Chairperson  expressed appreciation that several of the participants at the First 
Specialized Course on the TBT Agreement organized by the WTO Secretariat which had taken place in October-November 2008 had attended the Workshop on  International Standards and participated in 
the meeting of the Committee.  She also welc omed the Swedish Mentorship Programme, which 
supported seven East African countries and aime d at enhancing the implementation of the TBT 
Agreement.  The programme allowed, among other th ings, capital-based officials from the beneficiary 
countries to attend the meetings of the TBT Committee.  
VI. UPDATING BY OBSERVERS 
386. The representative of the IEC
 welcomed the Workshop on the Ro le of International Standards 
in Economic Development which had been followed w ith great interest by her organization.  She 
acknowledged the need for international standard-se tting organizations to continue their efforts to 
enhance the participation of developing countries in  standard setting activities.  She encouraged all 
developing countries to use the IEC Affiliate Country  Programme to its full extent as was highlighted 
in the presentations made by Ms Odour from Kenya and Mr. Rodriguez from Costa Rica during the 
                                                      
25 G/TBT/TA-1/JAM, G/TBT/TA-2 /ARM, G/TBT/TA-3/CRI, G/TB T/TA-4/UGA and G/TBT/TA-
5/DOM.  G/TBT/M/47 
 Page 79 
 
 
  Workshop. She informed the Committee that, to da te, the IEC had distributed 7500 standards to 60 
developing countries, of which 3000 have been adopted.   
387. The representative of the IEC further noted that a new version of the guidelines on IEC 
Conformity Assessment for developing count ries was available in English and French.26  She also 
highlighted an article on the success of Affiliate countries using IEC standards in Botswana, Gambia 
and Zambia which was published in the March edition of the IEC Newsletter.  Further information on 
all IEC activities was available on the IEC website.27  She stressed that the IEC was ready to 
participate in WTO workshops if there w as a request by Members in this regard. 
388. The representative of UNECE  updated the Committee on the activities of the UNECE 
Working party on Regulatory Cooperation and Standa rdization Policies (WP6), including the recent 
brochure on sectoral initiatives aimed at eliminating technical barriers to trade.28  The Committee was 
also informed on UNECE's work in market surve illance and counterfeit goods and the development of 
a general market surveillance procedure which will serve as a guide for market surveillance 
authorities.  Delegations interested in the prepar ation of the guide were invited to contact the 
Secretariat.   Delegations were also invited to participate at the next session of the Working Party 
which would take place on 24-26 November 2009 and would be followed by a conference on Risk 
Assessment and Management.29   
389. The representative of Codex drew the Committee's attention to document 
G/TBT/GEN/81containing an update of relevant C odex's work.  In addition, she updated the 
Committee on the state-of-play of the standards for o live oil, which were revised and adopted by the 
Codex Commission in 2003 and were entirely harmoni zed with the International Olive Oil Council, 
apart from the provision related to Linolenic acid which was still under discussion.  This would be 
raised again at the next Committee on Fats and Oils in February 2011. 
390. The representative of Codex also updated the Committee on the Codex Committee on 
Methods of Analysis and Sampling where, after ma ny years, important guidelines were finalized on 
the settlement of disputes arising from methodology  analysis results.  This Committee had also 
finalized a glossary on analytical terminology an d was continuing its discussion on how to interpret 
measurement and sampling uncertainty in relation to standards, and also in relation to food control 
and inspection for imports and exports. 
391. The Chairperson drew the Committee's attenti on to the document on relevant on-going work 
in the OIML30. 
VII. OTHER BUSINESS 
392. The Chairperson informed the Committee of a letter from the Chairman of the General 
Council, Ambassador Mario Matus, about a process in itiated at the informal meeting of the Trade 
Policy Review Body on 9 February 2009 on the mon itoring of recent trade developments associated 
with the current global financial and economic cris is.  Ambassador Matus was seeking input from the 
TBT Committee in respect of notifications and information flows.31   
                                                      
26 http://www.iec.ch/affiliates/acp_conformity-e.htm 
27 http://www.iec.ch 
28 http://www.unece.org/ highlights/what_ECE_does/2009/ 18_what_regulations_WP6.pdf 
29 Further details are available on the UNECE website: 
http://www.unece. org/trade/wp6/documents/2 009/2009_Confer enceRisk.htm 
30 G/TBT/GEN/84. 
31 A copy of the letter and of the reply were made available as room documents. G/TBT/M/47 
Page 80  
 
  393. In the reply, which was communicated to Am bassador Matus under the Chairperson's own 
responsibility, the continuous work the TBT Commi ttee was undertaking in the area of transparency 
had been emphasized – both with respect to the transparency procedures and recommendations, which 
were regularly being refined, as well as the Comm ittee's discussions of specific trade concerns.   
VIII.  DATE OF THE NEXT MEETING 
394. The next regular meeting of the TBT Committee will take place on 25-26 June 2009
.   
 
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  G/TBT/M/47 
 Page 81 
 
 
  ANNEX 1 
 
REPORT BY THE CHAIRPERSON ON THE WORKSHOP ON THE ROLE OF 
INTERNATIONAL STANDARDS IN ECONOMIC DEVELOPMENT 
 
Report by the Chairperson (Ms Xueyan GUO) at the  
Regular Meeting of the TBT Committee of 18-19 March 20091 
   The TBT Committee held a Workshop on the Role  of International Standards in Economic 
Development on 16 and 17 March 2009.  Participation was high.   Some 70 developing country 
capital-based officials were sponsored by the WT O through the DDA Global Trust Fund.  In total, 
over 200 TBT experts attended.  The Workshop provided opportunity for delegations to share 
experiences on the development and use of international standards. 
 
 Mr. Harsha V. Singh , Deputy-Director General of the WTO, opened the Workshop.  In his 
opening remarks, Mr. Singh provided an overview of i ssues related to standards,  trade and the WTO.  
He stressed the economic benefits of standardiz ation and highlighted some of the costs; he 
underscored the importance of the disciplines in th e TBT Agreement as they apply to standardizing 
bodies and to Member governments and he also drew  our attention to the increasing importance of 
addressing non-tariff barriers to trade in the WT O, including in the negotiating context.   
 
 The workshop focused first on the economics of standards .  A synopsis of current work on 
the topic of standards, trade and economic growth was provided.  In particular, based on studies undertaken in Germany, the United Kingdom, Canada , Australia and China, we heard expert views 
from both academia and governments on the benefits  and costs of standardization activities – and 
efforts to quantify these. The gist of the findings of  various studies presented showed that standards, 
as a pool for technological know-how, can contribute positively to economic growth.  It was pointed out that standards promote innovation and technical  progress and are an important instrument to 
facilitate competition in markets and transfer of te chnology.  But these benefits remain difficult to 
quantify and need to be better understood, both in  qualitative and quantitative terms – more research 
is therefore needed, also with respect to aligni ng methodologies and assessment tools.  Of course, 
there are also costs associated with the use of  standards, these are somewhat more tangible.  
Participants were urged to circulate widely any case studies on the impacts of standards, regardless of 
methodologies used.    Several participants reflected on the relevance of  standards to the crisis that is affecting the 
global economy today.  It was pointed out that in ti mes of crisis it is ever more important to ensure 
that standards are not used for protectionist pur poses.  Instead, standards should be seen as an 
opportunity.   For instance, well crafted standards as the basis for regulatory measures may increase confidence in markets and serve to boost trade.  As well, it was pointed out that standards are an 
important link between research, innovation and markets; in effect, an efficient tool for the transfer of 
technology. For companies in particular, participa tion in standardization processes could potentially 
compensate for a downturn in R&D spe nding.  This is be particularly  important today in the areas of 
sustainability and environmental technology.     It was also pointed out that standards need to be  maintained to stay relevant:  they have to be 
up to date with current technology and science – th ey should not lag behind technology.  Science does 
not stay still.  So timing is therefore important. Standards that arrive too late can lock in old 
technology and be counter-productiv e in terms of innovation.   
                                                     
 
1 A Summary Report of the Workshop on the Role of International Standards in Economic 
Development is contained in document G/TBT/W/310. G/TBT/M/47 
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   A number of practical case studies  that illustrate how the use of standards has contributed to 
economic and social development, in particular  in developing countries, were presented and 
discussed. For instance, in the agri cultural sector, we learned how international standards have been 
used to increase exports of asparagus and coffee from Peru.  Egypt illustrated how the adoption and 
use of international standards in general had fac ilitated trade, leading to increases in both imports and 
exports.  We were given the example of how th e Pakistani textile sector had increased exports 
subsequent to the use of inte rnational quality standards. 
  We also heard how standards can have other benefits.  The case of the US-Brazil cooperation 
to develop testing and measurement methods on biofue ls, and the application of Chilean standards on 
energy efficiency showed how the standards can contribute to address global environmental 
challenges.  Standards can also su ccessfully address public safety issu es, as illustrated by Colombia in 
the presentation on building codes and construction.  Kenya’s experience showed how the adoption of 
international standards in the electro technology fi eld had contributed to improvement in the quality 
and safety of imported  products.   
 
 A common element in several of the cases presented was the importance attributed to collaborative work between the public and private sectors; government support for standardization 
activities was considered important, particularly in developing countries.  It was also important to 
have the absorptive capacity to implement standards (not only participate in their development), and, 
sometimes, to tailor them to local or regional circumstances.   
 
 Participants considered effort s to address developing country capacity constraints  in respect 
of the use of international standards. Clearly, par ticipation in international standards-setting activities 
is considered essential and remains a constraint.  In this respect, several initiatives by international 
standardizing bodies, regional bodies, bilateral donor s and other international bodies such as UNIDO 
to increase participation were mentioned.  Kenya suggested that developing countries should to a 
greater extent be hosting working groups and techni cal committees developing standards.  However, it 
was also pointed out that participation in and of itself serves no purpose:  it has to be effective. 
Building expertise  in developing countries and filling informa tion gaps has to be done in ways that 
reflect the needs of each individual country.  
 Several participants expressed concern about th e proliferation of private standards that could 
result in unnecessary barriers to trade that created conf usion in the market place.  It was pointed out 
that initiatives existed and were underway in other organizations, such as UNIDO, to help countries 
comply with such schemes, and that the issu e was being addressed in the WTO SPS Committee. 
 
 The importance to identify best practices fo r technical cooperation in the standards-setting 
field was stressed.  Aid effectiveness  meant that Aid for Trade in the standards setting world has to be 
driven by needs, be sector-specific and include the e ffective participation of a ll stakeholders.  As an 
example of Aid for Trade applied to standards, the relevant work of the Standards and Trade 
Development Facility (STDF) in the SPS area was presented.   
 Many key challenges  remain with respect to standardiz ing activities.  At the end of the 
workshop, in my capacity as Chair, I pointed at a fe w challenges that have arisen in the discussion; 
among these, I would stress the following:  - Quantifying the benefits of standards : The studies and experiences shared at the outset of 
the workshop show the significant positive role  standards can play in promoting innovation 
and technical progress.  The use of standards makes production more efficient.  Yet measuring and expressing the benefits of st andards remains a key challenge.  I would 
encourage Members, through this Committee,  to share case studies that consider the 
economic benefits of the use of standards.   G/TBT/M/47 
 Page 83 
 
 
  - Involving all stakeholders : Creating awareness among all re levant stakeholders, including 
SMEs, of the importance of being involved in standard-setting activities is crucial.  Broad 
stakeholder involvement ensures an open and tran sparent process, in line with the disciplines 
on standardizing bodies contained in the TBT Agreement. On various occasions during the 
workshop, speakers and participants pointed out  that government support and involvement in 
standardization is important, pa rticularly in developing countries – where standardization may 
not always be given priority, and the strate gic importance of standards is not always 
appreciated.  It is important to find incentives to increase support and promotion of standardizing activities in developing countries.  
 
- Participation in international standard-setting activities:   Actual participation in 
standards-setting activities by developing count ries remains a challenge, both financially and 
technically. Only a small proportion of developing countries are responsible for the management of working groups and technical  committees, where the nuts and bolts of 
international standardization work takes plac e.  Although we heard of various initiatives, 
finding effective  ways of increasing such participation remains a challenge.  It was pointed out 
that an essential component of making participa tion effective at the country level is a two-
way exercise.  On the one hand – at the nationa l level – it is important to raise levels of 
expertise in selected areas of importance to th e participating developing country.  And, on the 
other hand – and at the internati onal level – it is important to e ngage that local knowledge and 
expertise in the international standard-setting community.  
 
- Building up standards-related infrastructure . Standards development is part of a bigger 
whole – part of a quality infrastructure that includes: metrology, standards development and conformity assessment activities, including accreditation.  It is not obvious that all components of this infrastructure is needed ev erywhere; for instance, it was pointed out that 
in the Caribbean efforts are underway to build quality infrastructure at the regional level.  
Therefore, it is important that countries prioritize and are selective about where efforts to build capacity should be concentrated.  The Committee may consider developing good 
practices for setting up quality infrastructure.  Expertise could be drawn from both Members 
and international organizations working in this area. 
 
 I would finish by stressing a point that several speakers and participants reverted to in the 
course of the workshop.  In this time of economic crisis
, we, in the TBT Committee need to guard 
cases where standards are used as a basis for non- tariff barriers that are unnecessary.  Continued 
effective use of our transparency provisions is crucia l in the respect.  We also need to reinforce and 
boost the beneficial, confidence-building aspects of st andards.  The use of international standards 
should serve the purpose of facilitating international tr ade, as envisaged in the WTO TBT Agreement.   
  
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