RESTRICTED  WORLD TRADE  
ORGANIZATION  G/TBT/M/48 
29 September 2009 
 (09-4537) 
Committee on Technical Barriers to Trade  
  
 
MINUTES OF THE MEETING OF 25-26 JUNE 2009 
 
Chairperson:  Mr. Ami Levin (Israel)
 
 
Note by the Secretariat1 
 
   
I.
 ADOPTION OF THE AGENDA.............................................................................................2  
II. ELECTION OF CHAIRPERSON ..........................................................................................2  
III. IMPLEMENTATION AND ADMINISTRA TION OF THE AGREEMENT ....................2  
A. STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2................................................................2  
B. SPECIFIC TRADE CONCERNS .......................................................................................................2  
1. New Concerns................................................................................................................... .........2  
2. Previously raised concerns..................................................................................................... 18 
IV. FIFTH TRIENNIAL REVIEW .............................................................................................56  
1. Good regulatory practice ....................................................................................................... 56 
2. Conformity Assessment Procedures......................................................................................59  
3. Standards...................................................................................................................... ...........63  
4. Transparency ................................................................................................................... .......67  
5. Technical As sistance ........................................................................................................... ....79  
6. Operation of the Committee ..................................................................................................79  
V. TECHNICAL COOPERATION ACTIVITIES...................................................................82  
VI. UPDATING BY OBSERVERS .............................................................................................82  
VII. DATE OF THE NEXT MEETING .......................................................................................84  
 
                                                      
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/48  
Page 2  
 
  I. ADOPTION OF THE AGENDA 
1. The Committee adopted the agenda contained in WTO/AIR/3373. 
II. ELECTION OF CHAIRPERSON 
2. Pursuant to Article 13.1 of the TBT Agreement, the Committee elected Mr. Ami Levin 
(Israel) as the Chairperson of the TBT Committee 
III. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
A. S
TATEMENTS FROM MEMBERS UNDER ARTICLE 15.2 
3. The Chairman  recalled that the latest list of stat ements submitted under Article 15.2 of the 
TBT Agreement was contained in G/TBT/GEN/1/Rev.8,  issued on 2 March 2009.  Since the previous 
meeting of the Committee, Ecuador had submitted its statement under Article 15.2 
(G/TBT/2/Add.101).  In total, since 1995, 118 Me mbers had submitted at least one Statement on 
implementation under Article 15.2.  Additionally,  the latest list of enquiry point contacts was 
contained in document G/TBT/ENQ/35/Rev.2, issued on 13 May 2009. 
4. The Committee took note  of the information provided. 
B. SPECIFIC TRADE CONCERNS  
1. New Concerns 
(i) European Communities – Tariff Rate Quota on Meat and Meat Products 
5. The representative of Australia  raised a concern regarding an agreement signed between the 
EC and US delegations on 13 May 2009 related to  a dispute on Measures concerning Meat and meat 
Products.2  This agreement provided that a tariff ra te quota would be opened by the European 
Communities for beef products produced without gr owth-promoting hormones.  In particular, the 
quota requirements set out specific product characteristics, including dietary requirements and 
evaluation criteria, which mandated a governme nt-approved evaluation method and government-
appointed evaluators.  It was Australia's unde rstanding that these requirements could have a 
significant effect on trade and appeared to be trade restrictive. 
6. The Australian representative noted that di scussions with the European Communities had 
taken place and suggested that bilateral talks to resolve the issue should continue.  However, her 
delegation encouraged the European Communities to clarify what the exact requirements and 
conditions of the tariff rate quota were, and how th ese had been developed.  The EC delegation was 
also invited to clarify whether the product charact eristics or the other quota conditions related to, or 
were intended to, address health and safety con cerns.  Moreover, Australia asked for further 
information on the objective and rationale for including the evaluation criteria mandating a 
government-approved evaluation method and governme nt-appointed evaluators.  The EC delegation 
was finally encouraged to explain how this ta riff rate quota would be implemented in a manner 
consistent with Article 2.1 of the TBT Agreement.  
7. The representative of Uruguay  echoed the concerns expressed by Australia.  His delegation 
requested further clarification on the requirements  and implementation of the tariff rate quota, and on 
its conformity with Articles 2.1 and 2.2 of the TBT Agreement. 
                                                      
2 Dispute No. DS26.  G/TBT/M/48 
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  8. The representative of Paraguay  supported the comments of prev ious delegations and asked for 
further information on the implementation of the tariff rate quota and on its conformity with 
Article 2.1 of the TBT Agreement.  In particular , the EC delegation was encouraged to clarify the 
requirements contained in Article 6 of the EC -US agreement, which seemed to constitute an 
unnecessary barrier to trade within the meani ng of Article 2.2 of the TBT Agreement. 
9. The representative of Argentina  joined the concerns already expressed by other Members. 
10. The representative of the European Communities  explained that the product definition of a 
tariff rate quota did not fall within the scope of the TBT Agreement.  However, she informed the 
concerned delegations that the produc t definition of this tariff rate quota had not yet been finalized by 
the European Commission.  Her delegation assure d Members that the proposed measure would be 
implemented in conformity with Artic les 1 and 13 of the GATT Agreement. 
(ii) Korea – Labelling Standards for Food (G/TBT/N/KOR/192) 
11. The representative of China  raised concerns regarding Kore a's proposed revision of labelling 
standards for food.  Written comments had been sent  to Korea in February 2009 and his delegation 
looked forward to receiving a reply.  While China appreciated Korea's efforts to protect consumers 
and improve public health, concerns remained on the proposed revision of the Korean standards.  In 
particular, China was concerned about requirements related to the compulsory labelling of nutritional 
ingredients of food products and referred to the relevant Codex standard in this regard (Codex 
146/1985).  The Chinese delegate stressed that th e proposed revision of the Korean measure would 
increase manufacturing costs that were not necessary to pursue a legitimate objective.  Therefore, in 
order to avoid unnecessary barriers to trade and to fu lfil the obligations under Articles 2.4 and 2.2 of 
the TBT Agreement, China invited Ko rea to use the relevant international standard as a basis for its 
measure. 
12. The representative of the European Communities  joined the comments expressed by China 
regarding the revision of the Korean labelling sta ndards for foods, which required mandatory labelling 
for foodstuffs.  In particular, she was concerned th at all the goods for which the brand owner and the 
producer were different companies from different c ountries, i.e. the so-called Original Equipment 
Manufacturer (OEM) products, would have to be labelled as "OEM prod ucts".  It was her delegation's 
view that this requirement was unnecessary, overly restrictive and burdensome.  The EC 
representative also noted that increasingly bur densome and constantly  changing labelling 
requirements for foodstuffs had been introduced by Korea.  It was str essed that at least six different 
agencies regulated labelling obligations for foodstu ffs.  For example, imported alcoholic products 
were required to include at least eighteen pieces of information on the label, some of which were only 
required for imported products.  In the EC's view , this contributed to confusion and lack of 
predictability for economic operators, who would have to repeatedly change labels in order to comply 
with Korean requirements. 
13. The representative of Korea  explained that the measure had been adopted for protecting 
consumers from being mislead and confused.  He  noted that the measure had been notified on 
24 October 2008 and had entered into  force on 4 June 2009.  He also stressed that the OEM labelling 
requirement applied only to imported products that were manufactured abroad but were labelled with 
the trademark of the Korean outsourcing company.   This requirement did not apply to products 
labelled with the trademark of the foreign manufac turer or products of fo reign and multinational 
companies.  With regard to the other specifi c concerns, the representative of Korea assured the 
Committee that they would be conveyed to the competent authorities for due consideration. G/TBT/M/48  
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  (iii) United States – Test Procedures for Fluo rescent Lamp Ballasts in stand-by mode 
(G/TBT/N/USA/452) 
14. The representative of China
 raised a concern regarding the US test procedures for fluorescent 
lamp ballasts in stand-by mode.  While the Chinese  delegation appreciated the US efforts to improve 
energy efficiency, it was stressed that, although wr itten comments had been sent to the United States 
on 9 April 2009, no reply had been received.  Since there was no relevant international standard on 
the energy consumption of fluorescent lamp ballasts in stand-by mode, the United States was requested to provide scientific data on which this requirement was based.  Furthermore, the Chinese 
representative referred to Article 3 of part 430 subp art b) Appendix Q of the US regulation, which 
contained a test method for power line camera control signal.  He pointed out that EMC had not been 
taken into account and this could result in divergences of test results for different laboratories.  The 
US delegation was therefore requested to review th e test methods and avoid unnecessary barriers to 
trade.  Finally, the United States was encouraged  to provide the test data and share relevant 
experiences on this matter with other WTO Members. 
15. The representative of the United States
 noted that the proposed regulation had been notified to 
the WTO on 30 January 2009 and that the comment period had expired on 6 April 2009.  He 
reassured Members that the Department of Energy  would review the comments and suggestions 
submitted by China and other interested parties, a nd would take them into account when finalizing the 
regulation. 
(iv) European Communities – Decision on Restrictions of the Marketing and Use of 
Organostannic Compounds (G/TBT/N/EEC/244 and Add.1) 
16. The representative of Japan  thanked the EC delegation for its reply to the comments made in 
March 2009 about the draft decision regarding restrictions of the marketing and use of organostannic compounds.  However, concerns remained that this measure would constitute an unnecessary barrier to 
trade.  In particular, the Japanese delegation belie ved that the ban of Dibutyltin compounds in all 
articles and mixtures and Dioctyltin compounds in specific products was not adequately based on 
scientific grounds. 
17. The representative of the European Communities
 recalled that the draft decision regarding 
restrictions of the marketing and use of organostannic compounds was notified to the WTO in January 2009 and adopted on 28 May 2009.  She explained that the decision was based on a risk assessment which had been peer-reviewed by the European Commission's Independent Scientific 
Committee on Health and Environmental Risks.  The risk assessment set out how organostannic 
compounds used in articles contributed to the expos ure in humans using these articles.  It also 
identified the different risk levels of different organostannic compounds and the different exposure 
scenarios.  Based on this risk ass essment, Dibutylin compounds would be  prohibited in all articles and 
mixtures as of 1 January 2012, except in certain articles and mixtures for which no suitable alternatives would be available until 2012.  For th ese articles and substances a transition period was 
foreseen until 1 January 2015. 
18. The EC representative confirmed that the use of Dioctyltin compounds would also be 
prohibited as of 1 January 2012.  However, th ese compounds would only be prohibited for certain 
specific consumer articles, which had been found to  contribute most to exposure in humans using 
them.  The reason behind a different treatment of these substances was that certain Dibutylin 
compounds had been classified as toxic for reproduction (Category 2), which was not the case of 
Dioctyltin compounds.  Exposure to Dibutyltin compoun ds had to be reduced as far as possible and 
preferably eliminated.  Therefore, the different  treatment was based on scientific grounds and on the 
impact assessment that identified the best measures to reduce risks to human health, also considering  G/TBT/M/48 
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  their effectiveness, practicality and socio-economic im pacts.  Japan was invited to provide solid and 
concrete scientific arguments and discuss th em bilaterally with the EC delegation. 
(v) European Communities – Biocide Dimethy lfumarate (G/TBT/N/EEC/258 and Add.1) 
19. The representative of Japan  drew the attention of the Committee to the EC measure requiring 
EC member States to ensure that products cont aining biocide Dimethylfumarate (DMF) were not 
placed or made available on the market.  He was c oncerned that this measure would have a significant 
impact on international trade.  In addition, since Japan had observed a differential enforcement of this 
decision across the EC member States, the European  Communities was requested to ensure a uniform 
application of its measure across all member States. 
20. The representative of the European Communities  explained that the decision to ban products 
containing DMS from the EC market as of 1 May 2009 was notified under the urgency procedure 
established in Article 2.10 of the TBT Agreem ent on 23 March 2009 (G/TBT/N/EEC/258).  She 
stressed that hundreds of consumers had suffered from serious dermatitis wh en using upholstered 
furniture and footwear containing DMF.  Therefor e, it was necessary to act qu ickly to avoid further 
cases of serious consumer health effects.  The EC delegate emphasized that these risks could not be 
immediately addressed under REACH, but a perman ent measure would be established under REACH 
in the coming years.  In response to the Japanese allegations, she clarified that DMF had never been 
authorized in the European Comm unities and therefore products cont aining this biocide should have 
not been placed on the EC market.  She also added th at her delegation had no indications that products 
imported from Japan contained DMF and therefore no impact on trade was expected.  On the uniform 
implementation of this decision across EC member  States, the European Communities representative 
explained that the provision was simple and clear:  the maximum concentration limit of DMF allowed 
in consumer products was 0.1 mg per kilo. 
(vi) Korea – Conformity Assessment Procedures for Lithium-Ion Batteries (G/TBT/N/KOR/193) 
21. The representative of Japan  raised a concern with regard to Korea's conformity assessment 
procedure for lithium-ion batteries, notified on  31 October 2008 under G/TBT/N/KOR/193.  
Considering that Korea had designated only few testing laboratories for conformity assessment 
procedures so far, the Japanese delegation belie ved that this measure could create unnecessary 
barriers to trade.  Japan requested  Korea to authorize foreign labor atories to perform the requested 
conformity assessment procedures. 
22. The representative of the European Communities  joined the statement made by Japan and 
raised some other specific concerns.  Did the si x month grace period only apply to the stock of 
batteries already on the market or also on new im ports?  Also, could Korea clarify the conditions 
under which foreign test results would be accepted? 
23. The representative of Korea  explained that the regulation on lithium-ion batteries had been 
introduced due to increasing public concerns about the safety of mobile devices using these batteries.  
Considering the current global economic crisis, how ever, Korea had decided to provide a six month 
grace period for the implementation of the labelling re quirements.  On the test reports obtained by 
foreign laboratories, the representative of Korea poi nted out that the Korean Agency for Technology 
and Standards would accept test reports from laboratories that were accredited by a body which was part of the MRA with ILAC.  Finally, the Korean delegate said that the questions on the exact scope 
of the six month grace period and on the conditions for laboratory designation would be conveyed to 
the relevant authorities for due consideration. G/TBT/M/48  
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  (vii) Brazil – Health Products (G/TBT/N/BRA/328) 
24. The representative of the European Communities
 raised concerns about a Brazilian regulation 
concerning Good Manufacturing Practice (GMP) certifi cates for the registration of certain health 
products, which had been notified to the WTO on 18 Ma y 2009.  The EC representative regretted that 
this regulation had been p ublished as an adopted text in the Braz ilian Official Journal only four days 
after the date of notification to the WTO.  She be lieved that Brazil had thereby failed to comply with 
Article 2.9.2 of the TBT Agreement.  This was pa rticularly troubling because some key issues of the 
Brazilian regulation required further important clarif ication.  For example, the regulation did not 
indicate the competent authorities responsible for issu ing the GMP certificate.  In this regard, it was 
the EC delegation's understating that the objective of  the measure was to reinforce the existing audit 
requirements by requiring submission of a GMP certificate at the time of application or re-registration 
of all, domestic and foreign, class III and class IV devices.  The EC representative further inquired 
whether Brazil would continue to accept ISO 1348 5 certification as evidence of compliance with 
these requirements and if this would not be the case, Brazil was invited to give the reasons for such a 
refusal.  Finally, she asked Brazil to clarify whethe r a GMP certificate would also be needed for low 
risk products that were currently excluded from registration. 
25. The representative of the United States  had serious concerns with Brazil's new inspection 
requirement for certain medical devices.  In pa rticular, the United States was concerned that the 
Agência Nacional de Vigilância Sanitária  (ANVISA) could lack sufficient resources to inspect all 
Brazilian and foreign facilities subject to the new requirements by the deadline of 22 May 2010.  As a result, a serious disruption in the trade in medical  devices was to be expected.  Brazil was therefore 
invited to clarify whether ANVISA planned to condu ct all the inspections by May 2010 or would 
extend the deadline.  The US representative further st ressed that failure to clarify these issues would 
lead to serious trade disruptions, and would je opardize the adequate supply of essential medical 
devices to the Brazilian market.  
26. The United States was also concerned about the pr ocedural history of this measure.  While the 
US delegation was grateful that Brazil eventually notified the measure to the WTO, the adoption of 
the measure only four days after its  notification denied foreign stakeholders a meaningful opportunity 
to comment.  In this regard, US industry had submitte d some suggestions that would ensure that trade 
in medical devices not to be disrupted in the event that ANVISA would be unable to complete all the 
inspections by the deadline.  Brazil was request ed to take those comments into account when 
implementing the new inspection requirement.  In addition, the representative of the United States 
noted that, up until now, Brazil had been accepting in spection and quality system certification by US 
Food and Drug Administration (FDA) as a basis for allowing imports of US medical devices without requiring ANVISA inspections.  ANVISA had not iden tified any specific problems with this system 
in terms of safety and effectiveness.  Therefore,  it was the US delegation's opinion that allowing 
imports of US medical devices to continue pending inspections did not compromise safety or efficacy 
concerns.  Finally, the representative of the Unite d States noted that his delegation continued to 
monitor the situation closely and looked forward to further discussion with Brazil on this issue. 
27. The representative of Mexico
 shared the concerns expressed by previous speakers.  In 
particular, he regretted that Brazil did not appear to have fulfilled the obligations under Article 2.9 of 
the TBT Agreement.  Moreover, the Mexican repr esentative sought clarification on the issue of 
inspections and on whether Brazil would con tinue to accept ISO certification as evidence of 
compliance with the new requirements. 
28. The representative of Switzerland  shared the concerns expressed by other WTO Members and 
looked forward to a written reply to her delegati on's comments.  It was Switzerland's understanding 
that, so far, ANVISA had required suppliers of  imported medical devices to be certified in 
conformance with international recognized qualit y standards such as ISO 13485, and that quality  G/TBT/M/48 
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  inspection carried out by conformity assessment bo dies under this standard had been accepted.  The 
representative of Switzerland noted that this relian ce on internationally recognized quality inspections 
represented the same approach followed by the Sw iss government, and asked Brazil to identify the 
part of its new regulation which de viated from relevant international standards.  She also asked Brazil 
to explain why such deviation ha d been considered necessary.  W ith regard to the deadline for 
inspections by ANVISA, the Swiss delegate emphasi zed that there were many plants worldwide 
producing medical devices to be imported in Brazil.   Therefore, her delegation sought confirmation 
that registrations and re-registrations of medical devices for suppliers certified in conformance with 
international standards would still be possible if inspections by ANVISA would not take place within 
the deadline due to time constraints.  Otherwise, the new regulation would create an unnecessary 
barrier to trade thus violating the less trade restri ctive principle contained in Article 2.2 of the TBT 
Agreement. 
29. The representative of Singapore  echoed the comments made by the European Communities, 
the United States and Mexico about the Brazil's new inspection requirement for certain medical devices.  In this regard, she urged Brazil to provide  a sixty-day period for comments on the regulation, 
as recommended by the TBT Committee.  Furtherm ore, her delegation invited Brazil to clarify 
whether ANVISA inspections could be completed by the deadline and whether there were plans to 
extend the deadline if inspections could not be completed. 
30. The representative of Brazil
 pointed out that the adoption of  Resolution 25 had been preceded 
by one month of public consultation during whic h interested parties had had the possibility to 
comment on the draft text of the regulation.  However, since Brazil’s Federal Prosecutors had 
determined that ANVISA should treat equally nati onal and foreign suppliers, it was impossible to 
further delay the adoption of the measure.  In fact , before the adoption of Resolution 25, only national 
producers were required to present a GMP certificate.  The Brazilian representative stressed that this 
situation illustrated how difficult it could be to comply  with more stringent notification obligations, as 
it had been demanded by some delegations during the preparation of the Fifth Triennial Review. 
31. Furthermore, the representative of Brazil drew the attention of the Committee on the 
simplification of registration procedures related to h ealth products, which had been reoriented to focus 
essentially on risk.  He explained that Resolution 25 was aimed at implementing provisions contained in the Brazilian Federal Law 6360 (1976) regulated by Decree 3961 ( 2001), which established that the 
register of products subject to the Brazilian Hea lth Surveillance required the presentation of a GMP 
certificate.  He further clarified that Brazilian health products were categorized in four risk-levels.  
Categories I and II were classified as low risk levels , while Categories III and IV were high risk.  In 
this regard, the Brazilian representative noted that health products under low risk categories were now 
exempted from registration obligations.  No certif ication was required for these products, which had 
simply to be notified through an electronic form  on the ANVISA webpage.  The Brazilian delegate 
stressed that these new provisions were laid down in Resolution 24, which had been published jointly 
with Resolution 25, and significantly simplified a wide range of procedures.   
32. Brazil confirmed that Resolution 25 would ente r into force within one year, and reassured 
WTO Members that ANVISA had the operational capacity  to certify all companies that required to be 
certified.  The Brazilian delegate also noted that  the majority of health product companies that 
supplied the Brazilian market had already requested  certification.  ANVISA had increased the number 
of inspectors responsible for issuing GMP certific ates and was fully prepared to meet demand.  
Moreover, it was emphasized that Resolution 25 was not  a new subject for health product companies.  
Since 2001, Brazilian legislation established that a GMP certificate had to be presented to register 
health products, but such determination was not be ing fully implemented.  Finally, the representative 
of Brazil reaffirmed his delegation's position that  Resolution 25 was not discriminatory and was 
intended to achieve the legitimate objective of prot ecting human health.  His delegation was open to 
further discuss the issue bilaterally with interested delegations. G/TBT/M/48  
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  (viii) Canada – Labelling for Food Allerg ens (G/TBT/N/CAN/248 and Add.1) 
33. The representative of the European Communities
 raised a concern regarding Canada's 
proposed regulations on Enhanced Labelling for Food Allergen and Gluten Sources and Added 
Sulphites, notified to the WTO in G/TBT/N/CAN/ 248.  She stressed that her delegation supported 
Canada's objective to improve cons umer information.  However, the European Communities believed 
that this measure would constitute an unnecessary burden for European foods producers wishing to 
export to Canada.  The EC representative point ed out that the Canadian proposal required a 
mandatory declaration of food allergens on the label of  all pre-packaged products, either in the list of 
ingredients, or in an allergy and intolerance decl aration.  However, unlike legislation currently in 
force in the European Communities and in other majo r trading partners of Ca nada, the draft regulation 
did not foresee any exception from this declaration requirement, for example in cases where the name 
under which the foodstuff was sold clearly referred to the possible allergen ingredient itself.  
Moreover, in the case of sulphites, Canada required a mandatory format of the labelling consisting of 
the statement "Allergy and Intoleranc e Information: contains ...", whic h did not appear to be in line 
with internationally-accepted practices and w ould impose significant labelling costs on economic 
operators, as they would have to specifically adapt thei r labels to the Canadian market only.  This was 
particularly concerning for alcoholic drinks produ cers.  The European Communities therefore asked 
Canada to review its requirement s and to accept the EC label as sufficient for placing products on the 
Canadian market. 
34. The representative of Canada  explained that the proposed alle rgen labelling regulations would 
enable allergic and celiac consumers to identify th e source of allergens and gluten in a systematic 
fashion, using simple and plain language wording in  English and French, with the aim of mitigating 
health risks associated with the unintentional consum ption of allergenic ingredients.  She noted that 
this objective had to be achieved without prej udging the level of popular knowledge on the sourcing 
and manufacturing of foods, or the level of literacy and education of consumers.  For instance, any 
food deriving from milk ingredients like cream, butter, cheese and yogurt, would have to indicate 
their source, that is milk.  This would be the case of any other food allergens, gluten sources or 
sulphites.  
35. The Canadian delegation understood that EC  regulations provided an exemption from 
requirements to label food allergens if the name unde r which the foodstuff was sold clearly referred to 
the ingredient concerned.  However, there was no consideration being given to including a similar 
exemption in the Canadian regulations.  In Canada 's view, it was better to make certain that the 
specific name of the food allergen appeared on the label of the food, either in the ingredient list or in a 
contained statement.  This approach would ensure the consumers had the information they needed to 
make an informed decision on whether to eat a produc t or not.  With respect to the specific issue of 
sulphites, Canada was considering the EC comment s and would continue to consider them when 
finalizing the regulations. 
(ix) China – Green Dam Youth Escort internet filtering software 
36. The representative of the European Communities  drew the Committee's attention on Circular 
2009/226, issued by the Chinese Ministry of In dustry and Informati on Technology (MIIT) on 
22 May 2009.  The EC representative explained that, according to this measure, all computers sold in 
China, whether imported or domestically manufactured , would need to be equipped with the so-called 
Green Dam Youth Escort internet filtering software as of 1 July 2009.  He noted that the Green Dam 
software would be either preinstalled in the comput ers or provided on a DVD included in the package.  
Computer manufacturers would also need to report to the Software Service Department of MIIT on 
the monthly sales volume of computers equipped with this software.    G/TBT/M/48 
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  37. The European Communities fully acknowledge d the legitimate objective of protecting 
children from exposure to pornographic internet cont ent.  However, the EC delegation was seriously 
concerned by the absolute lack of transparency in the procedural history of the above-mentioned 
measure.  In this regard, the EC delegate remark ed that the regulatory process had been characterized 
by opacity and no notice had been issued about the intention to introduce this mandatory requirement, 
as provided in Article 2.9.1 of the TBT Agreement.  The measure had not been notified, thus violating 
Article 2.9.2 of the TBT Agreement.  Moreover, the European Communities was concerned that the 
extremely short implementation period did not fulfil  the obligations established by Article 2.12 of the 
TBT Agreement.  For the above-mentioned reasons, China was strongly urged to suspend the entry 
into force of the measure and to notify the draft to the WTO, in order to allow Members to better 
understand the proposed measure and react accordingl y.  In addition, the representative of the 
European Communities noted that it was not the firs t time that measures issued by MIIT were adopted 
without prior consultation with foreign stakeholders and without  having adequately discussed 
implementation issues.  Therefore, the European Communities urged Chinese authorities to reconsider 
the adequacy of the regulatory process in this fiel d and to take appropriate measures to ensure full 
compliance with the obligations aris ing from the TBT Agreement.   
38. The EC delegate further noted that, based on a preliminary analysis of the requirement and 
the software, technical concerns had been raised by EC industry particularly in respect of system 
reliability and performance.  For example, would th is software be compatible with all operating 
systems?  How would this software interplay with  the manufacturers original software and other 
hardware components?  Concerns had been raised  about networking systems security and integrity.  
Since the software foresaw regular on-line updates,  the computers would become more vulnerable to 
hacking and other forms of malicious attack.  Speci fic concerns had also been expressed with regard 
to product liability in case the software would cause the computers to crash.  For example, who would 
be responsible for the damage suffered by the computer user?  In conclusion, it was the EC 
delegation's hope that a debate could be engaged on less trade restrictive measures available to 
achieve the legitimate objective pur sued by the Chinese authorities. 
39. The representative of the United States  noted his delegation's concern with Circular 2009/226, 
which mandated the installation of the Green Dam intern et filtering software or the inclusion of a disk 
with respect to all personal computers sold in Chin a.  While the United States respected the Chinese 
concerns about the ability of minors to access illicit or inappropriate internet content, the above-
mentioned measure appeared to be an overly drac onian measure in the area of internet filtering 
software, with little evidence that the stated obj ectives would be effectively achieved.  The US 
delegate said that numerous questions about the so ftware had been raised by worldwide media, 
Chinese citizens and global tec hnology companies.  These questions included issues related to 
technical problems with the software, whether the Green Dam software would filter illicit content or 
religious and political content, the security weaknesses in the software  that could enable hackers to 
exploit personal computers, and allegations that th e software infringed on the intellectual property of a 
California-based software company. 
40. The representative of the United States stressed  that the scope of this requirement was 
dramatic.  In this regard, it was the US delegation' s opinion that no other country in the world had or 
would mandate the installation of a largely unkn own and untested piece of software on all personal 
computers with less than six weeks notice.  It was recalled that the TBT notification obligations were 
intended to help facilitate the deve lopment of technical regulations in  an open and transparent manner.  
Indeed, worldwide concern on this issue was in no sma ll part provoked by the lack of transparency in 
the procedural development of the Green Dam soft ware.  Therefore, the US representative requested 
China to revoke the measure; he looked forward to solving this serious trade concern before the 
Strategic Economic Dialogue meeting in July 2009.  He said that the US government and global 
industry would welcome the opportunity to engage wi th China in a meaningful dialogue on the topic 
of internet parental controls where the two countries shared many fundamental goals. G/TBT/M/48  
Page 10  
 
  41. The representative of Japan
 expressed concerns about Circular 2009/226, which had not been 
notified and was still substantially unclear.  Japan asked China to clarify:  when and how this 
requirement had been notified to all computer manu facturers operating in China;  who would bear the 
costs of the software and, who would take responsib ility if software errors occurred.  Finally, Japan 
invited China to provide further clarifications on the measure and ensure a longer implementation 
period. 
42. The representative of China  thanked the delegations which ma de comments and clarified that 
the so-called Green Dam youth escort was an inte rnet filter software with the only function of 
preventing harmful information such as pornographic content.  The software did not revise any internet content and was fully under the control of  the users.  The Chinese representative noted that 
the use of technical means and tools to preven t harmful information was a common international 
practice.  He explained that the Chinese government  purchased the software in form of government 
procurement and confirmed that the software could be freely downloaded from internet or preinstalled 
on computers, in order to avoid extra costs.  Th e Chinese delegate also informed Members of the 
Committee that, in order to ensure adequate tim e for manufacturers to make production plans, pre-
install and test the software, MIIT had held a meeting with main manufacturers in March 2009 and 
related concerns had been fully discussed.  He also  stated that an understanding had been reached in 
that meeting and that consensus had emerged with re gard to the timeline and method to pre-install the 
software.  Comments and questions would be conveyed to capital for due consideration. 
(x) Tunisia – Labelling and Presentation of Pre-packaged Food (G/TBT/N/TUN/20) 
43. The representative of the European Communities
 raised concerns regarding Tunisia's 
proposed measure on labelling and presentation of pre-packaged food, notified to the WTO in 
G/TBT/N/TUN/20.  She informed the Committee that  comments on this measure had been sent to 
Tunisia on 16 October 2008 and that her delegation had not yet received any reply.  Concerns were 
raised on several issues.  With regard to the labe lling of the "Best Before" date, the Tunisian proposal 
foresaw that products having surpassed half of their va lidity period would not be allowed into Tunisia.  
In this regard, the Tunisian authorities were i nvited to indicate the reasons that justified the 
introduction of such a measure, which appeared to be  both arbitrary and discriminatory.  Additionally, 
it was noted that, according to Article 4 of the draf t proposal, alcoholic drinks  labels would have to 
contain the mandatory statement "Products containing alcohol".  The European Communities noted that such a statement was not required either in the EC or in other major markets, and appeared 
redundant in light of the fact that alcoholic products  were already labelled with their alcoholic content 
in percentage of volume.  Furthermore, Article 5 of the draft proposal introduced a prohibition to use 
adhesive stickers in order to convey the informatio n requested by Tunisian authorities on the label.  
The EC delegation invited Tunisia to clarify why it was considered necessary to introduce such a 
prohibition, given that adhesive stickers would represent a less burdensome, but equally effective, 
means to achieve the objective of consumer informa tion than permanent labels.  Finally, Tunisia was 
requested to take these concerns into acc ount and provide a written reply to them. 
(xi) Argentina – Testing Requirements for Impor ted Toys (G/TBT/N/ARG/51, Adds. 1-4 and 
Suppl.1) 
44. The representative of the United States
 expressed concerns about Argentina's testing and 
certification requirements for phthalates contained in Resolution 583/2008, notified under G/TBT/N/ARG/51.  He stressed that the United Stat es strongly supported the objective of protecting 
children from exposure to potentially hazardous substa nces in toys and children's articles, but the 
testing and certification requirements of the above -mentioned measure appeared to apply only to 
imported products.  US industry was also concerned about the need to perform the required testing in 
Argentina.  In this regard, it was the US delega tion's understanding that impor ted toys and children's 
articles needed to be accompanied by a certificate demonstrating compliance with certain  G/TBT/M/48 
 Page 11 
 
 
  requirements, and that such certificate had to be  issued by an official Argentine government 
laboratory of the National Institute for Industrial Technology (INTI).  The US representative regretted 
that certificates from other laboratories, including acc redited laboratories in the country of production, 
would not be accepted.  Considering that INTI sometimes took 130 days to acknowledge and process 
a certification request, US companies were raising complaints that the new requirements would result 
in delays and trade disruption after their entry in to force on 15 August 2009.  Therefore, the United 
States invited Argentina to consider less trade-restri ctive alternatives and ensure that its measure did 
not afford less favourable treatment to imported produc ts.  In particular, Argentina was encouraged to 
recognize test results from ILAC accredited laboratories as equivalent to those issued by INTI.  The US representative noted his understanding that Ar gentina could be consid ering the possibility of 
allowing other laboratories to conduct the testing, and requested that Argentina provide an update on 
that issue.  Finally, the US representative noted  that Argentina and US toy regulators had had a 
constructive meeting in May 2009 a nd reiterated his delegation's desire  to share information and work 
together with toy regulators in Argentina and ot her countries to enhance the safety of children's 
products. 
45. The representative of China
 shared the concerns raised by the United States.  In particular, it 
was his delegation's view that the Argentine regul ation accorded discriminatory treatment to imported 
toys, thus violating the obligations established by Article 5.1 of the TBT Agreement.  China invited 
Argentina to give further clarifications on this measure and amend it according to the obligations 
under the TBT Agreement. 
46. The representative of the European Communities  agreed with the concerns expressed by 
previous delegations and noted that the new tes ting requirements would cause further delays to the 
already extremely long procedure associated w ith Argentina's non-automatic import licence and 
general policy for toys.  He explained that these requirements made it impossible for importers to 
access the Argentine market at the beginning of the season for which the toys were designed.  Argentina was therefore encouraged to clarify wh ether an amendment of the new requirements was 
being considered, in order to make the system more reasonable and less trade restrictive. 
47. The representative of Argentina
 drew to the Committee's attention the fact that his delegation 
had held bilateral consultations w ith the United States on this issue, during which the majority of the 
concerns expressed had been addressed.  He expl ained that Resolution 58 3/2008 would modify the 
scope of previous regulations, extending provisions to all games and children's articles for phthalates 
DEHP DBP and BBP and for children's articles and toys that could be put into children's mouth for 
the phthalates DIMP DIDP and DNOP.  The ban establis hed in this and previo us regulations covered 
without distinction the manufacture, import, export and sale of the products in question.  However, 
since the ban was based on the volume percentage  of phthalates DIMP DIDP and DNOP, it was 
essential to verify the percentage through testing.  He further explained that the responsibility of the 
testing had been assigned to the Centre for Research  and Technological Development for the Plastics 
Industry, which reported to INTI with respect to all products sold on the domestic market or exported.  
In this regard, the Argentinean delegate stressed  that the testing requirements were mandatory for 
products both imported a nd of domestic origin. 
48. It was further reported that the Health Minist ry of Argentina had held consultations with 
affected parties, in order to fu lfil the legitimate objective of protec ting public health.  In particular, 
observations and comments expressed by the chambe rs of commerce, business persons, supermarket 
chains and importers of the products covered by the regulation had been taken into account.  With 
regard to the issue of possible delays in testing,  INTI had reported that an appropriate operating 
procedure had been set up, aimed at ensuring the deli very of reports sixty days after the opening of the 
service request.  The representative of Argentina furt her noted that a network of laboratories, which 
would ensure that testing take place in a timely and appropriate fashion, had been set up.  Finally, the 
Argentinean delegation reassured Members of the Committee that Argentina would continue to G/TBT/M/48  
Page 12  
 
  protect human health in a way compatible w ith the rights of other WTO Members under the 
multilateral trading system. 
(xii) China – WAPI standard requirements 
49. The representative of the United States
 raised a concern regarding the Chinese WAPI 
standard requirements.  The US industry had repo rted that the Chinese Ministry of Industry and 
Information Technology (MIIT) was establishing a process for approving handheld wireless devices 
such as cell phones and smart phones using the gl obally accepted 802.11 Wi-Fi standard, but only 
when also equipped with a chip or software that used the WAPI standard.  The WAPI standard was a 
Chinese domestic wireless standard.  The US represen tative noted that China had agreed to suspend 
its plans to mandate the use of WAPI in computers,  routers and other wireless computer networks in 
April 2004.  He sought confirmation from China that MIIT accepted applications for type approval of 
mobile handsets using the 802.11 Wi-Fi standard fo r wireless computing and permitted use of Wi-Fi 
in mobile handsets.  China was also invited to clar ify whether it would require that the WAPI standard 
be included as a dual mode function in such handsets.   If this was the case, the United States requested 
the delegation of China to explain why the relevant  international standard had been found to be 
ineffective or inappropriate to fulfil China's objective.  Since services and devices based on Wi-Fi 
alone were widely available and le gally sold in China, the Chinese delegation was also requested to 
indicate the justification and legitimate objective of th is requirement, if this was indeed a requirement. 
50. The representative of the European Communities  supported the comments expressed by the 
United States and requested further clarification fro m China.  In particular, he asked the Chinese 
delegation to clarify whether a mandatory type approval process had been introduced enabling the 
marketing in China of mobile phones with internet  connectivity, and whether a condition for such a 
type approval process was that the mobile handsets be WAPI enabled and therefore compliant with 
the Chinese national standard on wireless internet connection in local area networks (LAN).  If this 
requirement existed, China was urged to notify th e measure under the TBT procedures and to explain 
why the existing relevant international standard was considered inappropriate or ineffective. 
51. The representative of China  pointed out that mobile phones were widely used devices and 
concerns existed about potential risk of personal information se curity.  Since WAPI standards 
provided a sound solution to the security concerns of consumers, the Chinese Government decided to 
impose WAPI standards in the type approval pr ocess of mobile phones with WLAN function.  
However, China did not exclude the use of Wi-Fi standards and they could co-exist with WAPI 
standards in mobile phones.  The Chinese repre sentative assured Members th at the comments made 
would be conveyed to capital for due consider ation and encouraged those who had expressed 
concerns to discuss them bilaterally with the Chinese delegation. 
52. The representative of the European Communities  sought formal confirmation that a 
mandatory type approval process for mobile phones with internet connectivity in a WLAN 
environment existed and that these handsets needed to  be WAPI enabled.  If that was the case, why 
had this requirement not been notified?  The EC de legation believed that this was another example of 
the opaque regulatory process concerning measures adopt ed by MIIT and urged China to notify this 
measure. 
53. The representative of China  explained that the WAPI standard had been notified under 
G/TBT/N/CHN/187, 188 and 1189, and discussed ma ny times with concerned WTO Members.    G/TBT/M/48 
 Page 13 
 
 
  (xiii) European Communities – Accreditation and market su rveillance relating to the marketing of 
products (G/TBT/N/EEC/152) 
54. The representative of the United States  drew the attention of the Committee to EC Regulation 
765/2008, which would enter into force on 1 January  2010.  This regulation established, among other 
things, requirements for accreditation for conf ormity assessment bodies and required each EC 
member State to appoint a single national accreditation body that would operate as a public 
not-for-profit entity, independently of any other conformity assessment body.  The regulation also 
prohibited competition among Member States’ natio nal accreditation bodies.  The United States was 
concerned that the new accreditation framework would undermine the international accreditation 
system under the ILAC MRA and IAF MLA.  Another concern was whether accreditations by non-
EC bodies would continue to be accepted in Europe , and whether products certified by conformity 
assessment bodies accredited by non-EC accreditation bodies would be allowed to be placed on the 
EC market once the regulation became effective. 
55. Given that the US industry and accreditors  remained concerned about how the new 
accreditation system would operate in practice, th e European Communities was invited to provide 
further clarification on the new framework, especially on its implementation.  In  particular, would the 
accreditations issued by non-EC accreditation bodies th at were also signatories of the ILAC MRA and 
IAF MLA be accepted in the Euro pean Union?  Would the Eur opean Communities mandate that 
existing cooperation agreements between accredita tion bodies be renegotiated to include MRAs, the 
terms of which required foreign accreditation bodies to comply with EC accreditation rules?  If such accreditation would no longer be accepted, what were the EC reasons for no longer accepting 
accreditations from ILAC MRA and IAF MLA signato ries?  What information did the European 
Communities rely upon to determine that regula tions by a government non-profit monopoly provided 
a higher degree of confidence than accreditations pr ovided by other accreditation bodies, for example 
ones that were signatories to the ILAC MRA?  Why was the European Communities adopting a new 
accreditation framework rather than relying on the existing international framework for accreditation 
under the ILAC MRA and IAF MLA? 
56. The representative of the European Communities
 explained that, where EC product 
legislation required third party conformity assess ment, accreditation was the preferred method of 
determining that the conformity assessment body me t the applicable require ments to carry out the 
specific conformity assessment activities.  The new accreditation framework was first and foremost a tool in support of the EC internal regulatory po licy to evaluating the technical competence of bodies 
which had to undertake specific tasks under EC produ ct related legislation.  These bodies, which took 
the name of notified bodies, were designated by EC member States and notified to the European 
Commission. The new rules would therefore not a ffect the way accreditation was operated in third 
countries.  He further explained that, under Re gulation 765/2008, the new common framework for 
accreditation would be fully implemented by 1 Jan 2010.  Existing safety product specific legislation 
would be revised in order to make reference to th e new accreditation system, with respect to the tools 
to evaluate the technical competence of conformity assessment bodies.  
57. The EC delegate said that the European co -operation for Accreditation (EA) had been 
recognized as the supporting infrastructure at the EC  level to coordinate the implementation of the 
new accreditation framework.  As part of this pr ocess, general guidelines for the cooperation between 
EA, the European Commission, EFTA and the comp etent national authorities, had been signed on 
1 April 2009.  The documents were ava ilable on the European Commission website.
3  In addition, a 
framework partnership agreement between the Eur opean Commission and EA would be concluded to 
set out the common cooperation objectives and the legal administrative and financial provisions 
                                                      
3 http://ec.europa.eu/index_en.htm  G/TBT/M/48  
Page 14  
 
  relating to the Community financing that could be gr anted to EA.  This document would also be made 
public. 
58. With regard to the implementation at the nati onal level, all EC member States were in the 
process of adapting their national accreditation system s to the new requirements, including the setting 
up of a single national accreditation body.  Th e representative of the European Communities 
confirmed that the new system required the si ngle national accreditation body to operate on a non-
profit basis.  Since the accreditation and support of regulatory policy was seen as the authoritative and 
last level of control of conformity assessment activi ties, the EC legislator had considered that this 
activity should be pursued without undue pressure s arising from commercial interest and competition 
concerns.  Therefore, it was considered that the non-profit requirement and the existence of a single 
accreditation body in each EC member State would act to reinforce the authority and the 
independence of accreditation. 
59. With regard to the practical consequences of the activities that foreign testing organizations 
were able to carry out for the purposes of new legislation, the EC representative reassured WTO 
Members that the new rules were not intended to  affect the way accreditation operated in third 
countries.  He further stressed that there was no in tention to apply these rules outside the European 
Communities.  The new EC accreditation framework was addressed to EC member States and did not 
affect the existing multilateral arra ngements under ILAC and IAF.   
60. Regarding the way conformity assessment bodies established in third countries could 
participate in conformity assessment activities, the representative of the European Communities 
explained that the designated notified bodies c ould subcontract specific tasks connected with 
conformity assessment under private contractual agreements.  This included the possibility of 
subcontracting to third country CAB and testing laboratories.  Under these arrangements, notified 
bodies needed to ensure that the subcontractor  or subsidiary met the technical competence 
requirements relating to notified bodies and retained full responsib ility for the tasks performed by 
subcontractors or subsidiaries.  Third country CABs and testing laboratories holding accreditation 
certificates under IAF or ILAC would generally be presumed to fulfil those technical competence 
requirements, and therefore be able to enter into  subcontracting arrangement s with the EC notified 
bodies.  In addition, where international private sectoral voluntary arrangements for the recognition of test results supported by ILAC/IAF accreditation we re in place, such as the IECEE-CB Scheme on the 
safety of electrical equipment or the IECEx Scheme  on the safety of equipment used in explosive 
atmospheres, such arrangements were already widely used by EC notified bodies, in relation to both 
the voluntary and mandatory third party certification,  and thus provided potential for trade facilitation. 
61. Finally, the EC representative recalled that similar answers to the comments raised by WTO 
Members on the EC new accreditation framework had been given in the context of the Trade Policy 
Review of the European Communities, which had b een carried out in April 2009.  The EC delegation 
remained available for bilateral discussions and, once the new framework woul d be in place, would 
consider making a presentation to the TBT Committee to give a more comprehensive overview of the 
new system, its internal implications for regulator y policy and the existing international arrangements 
in this field. 
(xiv) Korea – Regulation for Food Industry Pr omotion Act (G/TBT/N/KOR/204 and Suppl.1) 
62. The representative of the United States
 raised concerns regarding Korea's Ministerial 
Enforcement Regulation for Food Industry Promo tion Act, notified on 17 February 2009 under 
G/TBT/KOR/204.  He recalled that his dele gation had sent written comments to Korea on 
16 April 2009.  The new measure, which included gu idelines, regulations and certification procedures 
for organic processed foods, had become effectiv e on 28 June 2009 and would enter into force on 
1 January 2010.  As a consequence of its entry into  force, products certified to their national organics  G/TBT/M/48 
 Page 15 
 
 
  programs, and previously recognized as organic in  Korea, would no longer be recognized as such 
unless Korea provided procedures for equivalence or  recognition.  However, Korea's enforcement 
regulations did not contain any procedure for recognizing a foreign government's conformity 
assessment body to accredit certifiers, nor did they contain procedures for determining equivalence.  Korea was therefore encouraged to  extend the grace period for foreign products by eighteen months, 
or until June 2011, in order to provide time for th e Korean Ministry for Food, Agriculture, Forestry 
and Fisheries (MIFAFF) to recognize or accredit foreign organic certification bodies.  The US representative suggested that, during this time peri od, foreign organic products could be temporarily 
allowed entry in Korea without the use of the MIFA FF seal.  He further emphasized that, without such 
an extension, many exports of organics products to Korea would be seriously disrupted in the near 
term, and entirely eliminated by the end of 2009.  Korean organics producers, who often needed to 
source foreign organics products as ingredients,  would also be negatively impacted.   
63. The United States invited Korea to clarify th e procedures that foreign organic certifiers 
needed to follow to be accredite d by MIFAFF, and noted its understanding that MIFAFF had yet to 
accredit any foreign organic certifier.  The United States also asked for an update regarding the 
procedures to request equivalence of organic re gulations from MIFAFF and for an estimate on the 
amount of time required to complete the review .  Furthermore, Korea was urged to provide 
clarification on the testing requirements for orga nic processed products, and explain whether such 
testing was mandatory.  The representative of the Un ited States noted that the Codex Alimentarius 
"Guidelines for the Production, Processing, Labelling and Marketing of Organi cally Produced Foods" 
were intended as production guidelines for process-b ased standards certifying the process of organic 
production, rather than the final product.  In this re gard, he noted that the costs of mandatory testing, 
which did not appear to be necessary in light of the Codex standard's emphasis on process, could be 
sufficiently high to deter both Korean and forei gn producers from participating in Korea's growing 
market for processed organic foods. 
64. Finally, the United States encouraged Korea to  adopt a tolerance threshold for the unintended 
presence of biotech for all processed organic products, in order to be consiste nt with Appendix 3 of 
Article 9 of the Enforcement Regulation of MIFAFF's Sustainable Agriculture Promotion Act.  The US representative recalled that this Act recognized the unintended presence of biotech in organic feed 
grains fed to animals which would produce organi c meat.  The US delegation looked forward to 
continued discussions with Korea on this issue.  
65. The representative of Australia
 was concerned about the proposed changes to the Korean 
Food Industry Promotion Act.  Australia’s assessment indicated that it would be difficult, costly and 
burdensome for Australian organic certifiers to comply with the new requirements.  The Australian delegation had sent written comments to Korea on this matter.  The representative of Australia 
supported the United Stated in seeking a delay for im plementation of the new organic regulations until 
June 2011, in order to ensure minimal trade disrupti ons.  He said that this would provide time for 
MIFAFF to recognize foreign organic certificati on bodies and access equivalence and reciprocal 
submissions. 
66. The representative of the European Communities
 joined the delegations of the United States 
and Australia in expressing concerns regarding Kor ea's Ministerial Enforcement Regulation for Food 
Industry Promotion Act, notified under G/TBT/N/KO R/204.  She noted that her delegation had sent 
written comments to Korea on this measure on 27 April 2009.  In particular, the European 
Communities was concerned that, under the new ru les, imported organic processed products would 
have to meet exactly the same requirements as dom estic products, and that the possibility to accept as 
equivalent the technical regulations applied by other WTO Members was not foreseen.  The European 
Communities was confident that its legal framework for organic products could ensure that products 
placed on the market were safe for consumers and did not mislead them in any way.  Therefore, the 
EC representative invited Korea to accept that produc ts made in conformity with the EC regulations G/TBT/M/48  
Page 16  
 
  on organic products would satisfy the Korean requi rements and could automatically be placed on the 
Korean market.  She noted that the European organi c regulations already provided for this type of 
recognition when a scheme of a third country was deemed equivalent. 
67. Furthermore, the European Communities believed that some of the requirements imposed on 
the certification bodies, in particular with regard  to inspections, were unnecessarily restrictive and 
could generate high compliance costs for economic ope rators.  The obligation to have at least three 
permanent Certification Inspectors as well as the e nvisaged inspection visits of the Korean Review 
Team to the certification bodies appeared to be the most problematic requirements.  The EC 
representative also noted that the draft Korean me asure referred not only to organic products, but 
more generally to "fine foods".  In this regard , she sought confirmation from Korea that the proposal 
was limited in scope to organic products only.  Fi nally, Korea was encouraged to clarify to what 
extent the Codex "Guidelines for the Production, Processing, Labelling and Marketing of Organically 
Produced Foods" had been taken into acc ount in the drafting of this measure. 
68. The representative of Chile
 shared the concerns expressed by other delegations on the 
proposed changes to the Korean Food Industry Pr omotion Act.  In particular, she supported the 
proposal to extend the grace period for foreign produc ts.  She encouraged Korea to take into account 
Chile's comments and looked forward to have a bilateral discussion on this issue. 
69. The representative of New Zealand  associated his delegation with the detailed comments 
made by previous speakers.  In particular, Ne w Zealand sought an assurance from Korea that the 
requirement that all raw materials, ingredients and processed organic foods be certified by MIFAFF, 
would not be more trade restrictive than necessary to  meet Korea's stated legitimate objective.  Based 
on the information provided so far on the accredit ation of certification bodies, New Zealand was 
concerned that only two Korean certifiers and no international or foreign bodies had achieved 
accreditation.  In this regard, the representative of New Zealand encouraged MIFAFF to work with 
international and foreign certification bodies to cl arify the requirements for accreditation, and to 
provide assurances that these requirements would not be prescribed or applied in a way that would 
discriminate against international and foreign bodies seeking accreditation.  He also sought 
confirmation from Korea that, under the new requirements, it would be feasible to process all the applications for international a nd domestic organic products awaiting certification before the deadline 
of January 2010.  In the case that this confirma tion could not be provided, New Zealand requested a 
postponement in the implementation of the regulati ons for a reasonable period, in order to allow 
applications currently under review to be processed .  Finally, since the Korean proposed regulation 
failed to provide for the recogn ition of equivalence, New Zealand urged Korea to consider 
equivalence agreements with the Internati onal Organic Accreditation Service and foreign 
governments. 
70. The representative of Canada
 associated her delegation with the comments made by previous 
speakers and urged Korea to consider a postponement  of the entry into force of this measure.  
71. The representative of Korea  confirmed that the proposed pr ocessed organic food certification 
programme was based on the Food Industry Pr omotion Act and had entered into force on 
26 June 2008.  He explained that the programme  was aimed at improving the quality of organic 
processed food, encouraging its production, and protecti ng the consumers.  He also confirmed that, as 
of 1 January 2010, any product with an organic clai m needed to fulfil the requirements set by the 
processed organic foods certification programme.  Until then, labelling for organic food products 
could be based either on labelling requirements acco rding to the Food Sanitation Act administered by 
the Korean Food and Drug Administration (FDA), or on organic certification guidelines according to the Food Industry Promotion Act administered by MIFAFF.  The Korean representative stressed that 
the programme was applied both to domestic and imported products, and that  imported products had 
to be accredited by either domestic or foreign certifying agents approved by the Korean government.   G/TBT/M/48 
 Page 17 
 
 
  He reassured Members that his delegation was ope n to further discussion with all delegations 
concerned, and that the comments raised woul d be forwarded to relevant authorities. 
(xv) China – Antibacterial and Cleaning Function for Household and Similar Electrical 
Appliances (G/TBT/N/CHN/603-604 and G/TBT/N/CHN/606) 
72. The representative of Korea  noted that the technical specifications contained in China’s 
notifications G/TBT/N/CHN/603-604 and G/TBT/N/ CHN/606 were GB standards, and while GB 
standards were usually associated with relevant mandatory certification, a corresponding reference 
could not be found in the notifications.  However, he  noted that bilateral cons ultations had been held 
with China and many of these issues had been clarified.  Korea looked forward to continue 
cooperation with China on this issue. 
73. The representative of China  welcomed the dialogue with Korea and looked forward to having 
further discussion on this issue. 
(xvi) United States – Food and Drugs Cosmetic Act 
74. The representative of Mexico  raised concerns regarding the Food Safety Enhancement Act of 
2009 which was being discussed by the US Congr ess.  It was Mexico's understanding that this 
regulation contained several measures intended to improve food safety in the global market.  
However, on the basis of a preliminary analysis, Mexico believed that these measures would have a 
knock-on effect on foreign producers by imposing requirements to register and store files and directories.  Mexico was also concerned that this  measure could cause goods to be held at the border, 
and could make distinctions betw een more and less favoured countries with regard to the imposition 
of importation requirements.  Concerns remained also on other specific issues, as for example:  the 
requirements for an annual registration of food processing plants;  the adoption of a food safety plan 
as a prerequisite for operations;  the registration of plants classified as high risk, low risk and very low risk;  the adoption of a system enabling US author ities to determine the traceability of products;  the 
adoption of import certificates for safety of fo od products;  the adoption of fines exceeding 
USD 150,000;  the country of origin system;  the registration of importers;  the possibility of 
inspections on foreign soil.  Finally, the Mexican  representative noted that Mexico was undertaking 
an analysis which would assess the impact of this programme and its compliance with the TBT and SPS Agreements.  He encouraged the United States to take into account the comments which would 
be submitted and review the draft regulati ons in line with its WTO obligations. 
75. The representative of the United States
 noted that bilateral discuss ions with Mexico had taken 
place on this issue, and that the majority of concerns raised by Mexico seemed to relate to food safety.  
Therefore, Mexico was urged to di scuss this issue with the SPS team of the US delegation.  The US 
delegation reassured Mexico that the comments ma de would be analyzed and could be further 
discussed bilaterally. 
(xvii)  EC – Poultry Meat (G/TBT/N/EEC/267) 
76. The representative of Brazil  raised a concern regarding proposed amendments in the EC 
regulation on marketing standards for poultry m eat (Proposal for a Council Regulation amending 
Regulation (EC) No 1234/2007 establishing a common or ganisation of agricultural markets as regards 
the marketing standards for poultry meat).  While Br azil agreed that marketing standards contributed 
to improvements in quality and consumer inform ation, his delegation was concerned that those 
proposed in the EC regulation regarding the processi ng and marketing of poultr y meat could be more 
trade-restrictive than necessary to fulfil the obj ectives pursued by the European Communities. G/TBT/M/48  
Page 18  
 
  77. The proposed amendment altered the current definition of "fresh poultry meat" and included 
new definitions such as "fresh poultry meat prepar ation". As a result, "stiffened poultry meat" and 
frozen poultry meat used in preparations would no longer be marketed as "fresh".  These definitions 
appeared to be more stringent than the definitions of fresh meat contained in international standards 
such as the OIE’s “Terrestrial Animal Health Cod e” and as well as those contained in the European 
Communities' own hygiene regulation.  Brazil asked  that the European Co mmunities to provide the 
rationale and scientific basis behind this.  
78. The representative of Brazil stressed that buy ing thawed poultry meat as fresh poultry meat 
was part of consumer habits and tastes. Therefore,  the proposed definitions were not motivated by 
consumers’ expectations. On the contrary they constituted a regulatory intervention that created 
consumer expectations which might negatively im pact future competitive imports. His delegation 
suggested that by labelling poultry meat and its prep arations marketed as fresh with a phrase such as 
"previously frozen" would allow consumers to unde rstand that the poultry meat characteristics were 
not modified, to know all the processes it has b een submitted to, and to make a better informed 
choices. 
79. As well, the delegation of Brazil also asked fo r clarification regarding the labelling of poultry 
meat preparations which could be  sold either as "fresh", "fro zen" or "quick-frozen" as the proposed 
amendment laid down definitions only for "pou ltry meat preparations" and fresh poultry meat 
preparations".  Given the distance between Brazil and the EU market, all poultry meat had to be 
frozen at temperatures between -2
oC and 4oC to cross the ocean and therefore the restriction to 
marketing thawed poultry meat as fresh poultry meat or using it as a basis for fresh poultry meat 
preparations would be a de facto discrimination in favour of European producers. It would also mean 
that thawed poultry meat, which was a like-product compared to poultry meat that had never been 
frozen, would be banned from the EU marketpla ce without any scientific or other reasonable 
justification.  
80. The representative of the European Communities  said the comments would be analysed and a 
reply sent.   
2. Previously raised concerns 
(i) 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 and G/TBT/N/EEC/264) 
81. The representative of New Zealand  reiterated her delegation's interest in the EC new regime 
for regulation of its wine market, which affected wine trade with the European Communities.  While 
she appreciated the constructive engagement that  had been shown by the European Commission, 
concerns remained about the proposed regulation.  The New Zealand representative further noted that 
her delegation's assumptions remained that the ne w EC wine regulation impl ementing regulations and 
any transitional arrangements included in these, par ticularly those related to  wine labelling, would 
result in rules for the wine trade that fully complied with the provisions of the TBT Agreement, as 
well as other principles and disciplines contained in  other relevant WTO Agreements.  Consequently, 
there would be no adverse affect on market access for non-members of the Eu ropean Communities as 
a result of the implementation of the regulations.  Finally, the representative of New Zealand recalled 
that her delegation had made a submission to the EC TBT Enquiry Point in November 2008 in respect 
of the intended third country provisions for the use of  Geographical Indications (GIs).  She noted that 
a reply from the Commission had been received and a request for further clarification had been 
submitted to the EC TBT Enquiry Point on tradi tional terms, grape variety names, certification 
requirements, certification systems and closures for sparkling wine.  G/TBT/M/48 
 Page 19 
 
 
  82. The representative of the United States  continued to have serious concerns about 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 problematic 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.  Concern was also expressed with rega rd to the negative trade impact resulting from the 
EC's failure to extend the derogation for the use of such terms on US wines sold in the EC market and 
the EC's recognition of so-called tr aditional expressions contained in tr ademarks.  In addition, the US 
representative recalled that various concerns had b een raised at previous TBT Committee meetings 
and could be found in the minutes prepared by th e WTO Secretariat.  Detailed written comments had 
also been sent to the Eu ropean Communities.  In this respect, the EC delegation was encouraged to 
clarify the current status of the measure and how comments received would be taken into account in 
the implementation of the regulation.  The United St ates also expressed interest in having an experts 
meeting to review the comments with the EC delegation. 
83. The representative of Australia  noted that written comments had been submitted to the 
European Communities in April 2009 and thanked the EC delegation for bilate ral discussions held 
before the TBT Committee meeting.  Her delegation raised concerns with regard to the draft EC 
regulation laying down certain detailed rules for the implementation of EC regulation No 479/2008, 
which had been notified to the TBT Committee unde r G/TBT/N/EEC/264.  Australia was concerned 
that the European Communities appeared to claim exclusive rights to use a number of common grape 
variety names listed in Part B of Annex XV, on the basis that these names partially contained a 
Protected Designation of Origin (PDO) or a Protected Geographical Indication (PGI).   
84. In particular, Article 62(4) of the draft regula tion provided that wine grape varieties and their 
synonyms listed in Part B of Annex XV that partia lly contain a PDO or PGI and directly refer to the 
geographical element of the PDO or  PGI in question, may only appear on the label of a product with a 
PDO or PGI or GI of a third country.  For exam ple, the names "cortese", "nebbiolo", "primitivo", 
"sangiovese" and "vermentino" were listed for exclusiv e use by Italy.  Australia did not consider that 
a sound basis for this protection existed, as these grap e varieties were generic and did not include the 
geographic component of the name.  The Austra lian representative explained that in the case of 
"nebbiolo d'Alba", the geographic component wa s the suffix "d’Alba" and the variety name 
"nebbiolo" did not contain any designation of origin or GI.  In this context, she sought confirmation 
from the European Communities that Australia woul d not be prevented from using the generic grape 
variety names listed in Part B of Annex XV in th e presentation and description of wines produced in 
Australia.  She also urged the European Communi ties to provide a reply to the detailed comments 
previously submitted by her delegation. 
85. The representative of the European Communities  explained that the comments had been 
examined and the Commission services were close to  finalizing a response.  She noted that new 
implementing provisions would enter into force on 1 August 2009 and thanked Members for the 
comments provided, which had been taken into account  in the revision of the measure.  She further 
emphasized that various bilatera l meetings had taken place before the TBT Committee meeting; these 
had clarified most of the concerns raised by Members.  To clarify the remaining issues, an expert from the DG Agriculture of the Eur opean Communities informed the Committee of the modifications 
introduced after the revision of the draft regulation.   
86. On protected designations of origin and geographi cal indications, a clarification relating to the 
annual verifications of wines with protected designa tions of origin or geographical indications had 
been introduced with the view to limiting the scope of these checks to EC wines only.  On traditional 
terms, clarifications concerning the "applicant" we re made, in particular when the applicant was a 
"representative professional organization".  Furthermor e, the "generic" character of traditional terms 
was defined, and the relationships  between trademarks and traditiona l terms were clarified to avoid G/TBT/M/48  
Page 20  
 
  any legal gap which could negativel y affect holders of trademarks .  The scope of protection of 
traditional terms was also clarified.  On labelli ng and presentation, further clarifications were 
introduced with regard to some optional particul ars such as the indication of the holding on wine 
labels, or derogations as provided for in Article 59.  On "varietal wines", the annual verification 
foreseen for EC wines did not concern imported wines and the text was therefore modified.  Finally, 
the EC representative clarified that the list of wine grape varieties to be used on wine labels for wines 
bearing, for instance, third countries' geographical indications, listed in Part B of Annex XV of the 
draft regulation, could be modified upon a EC me mber State or third country request.  He assured 
Members that a written reply to their comm ents would be sent in the coming weeks. 
(ii) 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) 
87. 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 were rapidly being forced to shut down.  Concerns were also reiterated with regard to 
the Only Representative (OR) provision, which cr eated severe and insurmountable difficulties for 
SMEs. 
88. The representative of Canada  supported the objectives of protecting human health and the 
environment but reiterated her dele gation's concern about REACH.  With respect to the issue of 
authorization and restriction, Canada asked th e European Communities to clarify whether the 
timelines for future submissions of Annex XV dossiers by EC members States or the European 
Chemical Agency (ECHA) had been determined, and whether substances of these dossiers could be 
grouped.  It was Canada's understanding that work  packages of substances were being developed for 
the June 2009 REACH meeting of Competent Au thorities (CARACAL) and some substances were 
being considered for authorization.  In this rega rd, the European Communities was invited to provide 
further clarifications.  In particular, would EC member States be expected to choose which dossier to 
notify to the Registry of Intentions (RoI) as the firs t step in the authorization process?  Were there any 
nickel-containing substances in these packages?  On the relationship between REACH and the 
Directive concerning Restrictions on Hazardous S ubstances in electrical and electronic equipment 
(RoHS), the Canadian representative urged the EC delegation to clarify how the two measures would 
work together and which one would take precedence  in case of conflict.  Since industry still faced 
many problems with the implemen tation of this regulation, the Canadian delegation hoped that 
REACH Help Desks would be widely prom oted and be responsive to enquiries. 
89. The representative of Japan  continued to have concerns about REACH.  On the Substance 
Information Exchange Forum (SIEF), he noted that big gaps existed in various aspects, pointing out as 
an example the one between the current number of  formally established SIEFs, which were around 
10,000, and the fact that around 55, 000 substances were expected to be  registered before the deadline 
on 30 November 2010.  The European Communities was therefore urged to take practical measures to 
promote the creation of SIEFs.  Concerns were also  expressed with regard to the potential applicants 
of the SIEF Formation Facilitator (SFF), because only a limited number of consultant companies had 
chosen to be responsible SFF for many substances and sometimes this seemed to be an obstacle for 
the potential applicant to be designated as SFF.  On the authorization procedure, Japan encouraged the 
European Communities to specify some decision criteria and give opportunities to stakeholders, 
including from non-EC companies, to comment on the procedure for inclusion of substances in Annex 
XIV of the REACH regulation.  Finally, the Japanese representative noted that ECHA planned to 
release the Chemical Safety Assessment (CSA), an IT tool necessary for registration, by the end of 2009.  Considering that the deadline for registrati on of substances was on 30 November 2010 and that  G/TBT/M/48 
 Page 21 
 
 
  registration through an Only Representative was a lengthy process for non-EC companies, Japan 
requested the European Commun ities to speed up the procedure for releasing the CSA tool. 
90. The representative of the United States  shared the EC concern for protecting human health 
and the environment.  However, the United States c ontinued to consider the breadth, costs, burdens 
and complexity of the REACH regulation in light  of ongoing implementation and remained concerned 
about its potential to disrupt and distort global trad e.  The representative of the United States noted 
that new concerns were continuously raised by indu stry.  In particular, he reiterated his concern with 
regard to the different interpretation of REACH provisions across the EC member States.  The US 
delegate noted that six EC member States expressed disagreement over the 0.1 per cent threshold for the notification and communication obligations with  respect to substances on the candidate list.  
Although the guidance document stated that the 0. 1 percent threshold applied to the article as 
produced or imported, six EC member States had in formed ECHA that, accord ing to their view, the 
0.1 per cent threshold should apply to components or homogenous parts of the articles.  Since this 
disagreement could confuse US industry, the Euro pean Communities was invited to clarify whether 
companies should follow the ECHA guidance or EC member States’ interpretations. 
91. The delegate of the United States also reiterate d his concern regarding the negative impact of 
REACH on Small and Medium sized Enterprises (S MEs), which had to bear a disproportionate 
burden of the costs associated with the registrati on process and participation in SIEFs and pre-SIEFs.  
In this regard, he stressed that many SMEs were being forced to reformulate their products or stop 
supplying certain substances and products to the EC market -- not because the substances had been 
found by ECHA to pose a risk, but rather due to th e expenses associated with the registration process.  
Regarding the issue of cosmetics, the US representa tive recalled that there was no legal certainty yet 
and the problem remained unresolved.  Further concerns  remained with regard to  the issue of the Only 
Representative, including the inability of many importers to secure necessary information for 
registration and the potential compromise of sensitiv e commercial information.  In addition, the 
United States was concerned that foreign supp liers had to bear an unnecessary burden for the 
registration of reacted monomers in polymers.  In  this regard, the US representative noted that a 
recent advisory opinion to the European Court of Justice emphasized that this requirement was aimed 
to protect the competitive position of the EC chem ical industry, in line with REACH objective to 
promote EC industry competitiveness, and not due to  any health or safety reason.  The European 
Communities was invited to clarify whether EC HA would provide guidance on what information 
registrants should provide for reacted monomers in material safety data sheets, given that reacted 
monomers were inextricably bound to the polymers. 
92. The representative of Argentina, speaking on behalf of GRULAC
 pointed out that the 
procedure established by REACH contained sever al inaccuracies and its overall cost remained 
uncertain.  It was GRULAC Members' opinion that the complexity of the REACH regulation, coupled 
with its lack of transparency and proportionality,  constituted a serious concern for industry and an 
unnecessary barrier to trade.  The representative of Argentina stressed that the burdensome costs 
associated with REACH had severe consequen ces on exporters of developing countries and 
constituted a serious impediment to their continued presence in the EC market.  Therefore, Argentina 
requested the European Communities to provide a ppropriate technical assistance to interested 
Members and consider more flexible deadlines for developing countries.  The EC delegation was also 
invited to provide further clarification on the issue of penalties for non-compliance to REACH. 
93. The representative of Argentina  reiterated his delegation's conc ern with regard to REACH.  
The complexity and serious transparency problems of REACH showed that this regulation constituted 
an unnecessary barrier to trade.  In general terms,  the Argentinean represen tative stressed that the 
costs related to REACH were excessive and cons tituted a serious impediment to the continued 
presence of Argentinean companies in  the European market.  This situation was further aggravated by 
looming implementation deadlines.  Serious concerns remained also on specific issues.   G/TBT/M/48  
Page 22  
 
  94. On the registration of substances in articles,  the representative of Argentina requested the 
European Communities to clarify the content of Ar ticle 7.1 (b) of the REACH regulation:  "the 
substance is intended to be relea sed under normal or reasonably foreseeable conditions of use ".  The 
Argentinean representative also noted that both th e ECHA and EC authorities had not satisfactorily 
responded to requests for assistance.  Moreover, Arge ntinean companies complain ed 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.  As a result many companies pre-registered substances 
without knowing whether they needed to be register ed.  In this context, a massive number of pre-
registrations had been submitted by a small num ber of companies, which showed that the 
competitiveness of the EC market had been serious ly distorted and that REACH gave rise to a 
situation of monopoly in the EC market.   
95. Several concerns remained with respect to the l ack of transparency of REACH.  In particular, 
the representative of Argentina reiterated his delega tion's request to have a list of companies which 
had already carried out the pre-registration pro cedure.  Argentina also required 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 th rough regular communications.  Further concerns 
remained with regard to the process of inclusi on of substances in the Substances of Very High 
Concern (SVHCs) list, included in Annex XIV of the REACH regulation  (List of Substances Subject to Authorisation).  Finally, the European Communiti es was invited to provide further clarifications on 
the operation of the Substance Information Exchange Forum (SIEF). 
96. The representative of Australia
 supported the concerns raised by previous speakers and 
reiterated her delegation' s concern about the REACH regulation,  which had the potential to disrupt 
and impede global trade in chemicals.  Australia was particularly concerne d that REACH would have 
a disproportionate impact on SMEs and that, as a r esult, many SMEs would be unable to continue 
exporting into the EC market.  The Australian repre sentative also asked for further clarifications on 
the authorization process for Substances of Very High Concern (SVHCs).  She urged the European 
Commission to take into consideration the concerns expressed by Members about REACH. 
97. The representative of Brazil  supported GRULAC's statement and noted that his delegation 
recognized the importance of protecting human hea lth and the environment.  However, concerns 
remained that the REACH regulation was unnecessarily trade-restrictive and could disrupt international trade in chemicals and chemical pr oducts.  In particular, th e Brazilian representative 
highlighted the difficulties related to the pre-SIEF stage of REACH.  The Br azilian chemical industry 
had indicated that around 15,000 pre-registered substances had not organized their pre-SIEF yet.  Brazil was concerned that this delay could preven t the registration of many substances within the 
deadlines, thus causing an inte rruption of trade.  This situation coul d be aggravated by the fact that the 
laboratory tests required by REACH were comple x and needed a long time to be concluded.  
Therefore, the representative of Brazil requested th e European Communities to provide clarifications 
on the outcome of the pre-SIEF stage, and in pa rticular whether it was considered necessary to 
postpone the original REACH registration deadlines.   Finally, the Brazilian representative reiterated 
his delegation's concern with rega rd to the high costs and trade-r estrictiveness associated with the 
REACH regulation.  He regretted that only OECD test methods were accepted for the registration of 
chemical products under REACH.  In this regard, it was his delegation's view that laboratory tests 
performed according to ISO standards, including ISO 17025, could provide the equivalent level of 
assurance for EC authorities and be in accordance with the provisions of the TBT Agreement. 
98. The representative of China
 supported the comments made by previous speakers about 
REACH.  Considering the current global economic  crisis, the European Communities was urged to 
take into consideration the concer ns which had been expressed many times by its trading partners.   G/TBT/M/48 
 Page 23 
 
 
  99. 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 penalties for non-compliance with 
REACH.  It was her delegation's view that the responsibility for the formulation of penalties under 
REACH should not fall under the competences of each EC member States.  The European 
Communities was therefore urged to take these concer ns into account, to clarify what the penalties for 
non-compliance with REACH would be and whether criminal penalties were  being developed.  
Finally, the representative of Chile stressed that no measures had been taken to protect confidential 
business information that non-EC firms were expected to provide.   
100. The representative of Kuwait  shared the concerns raised by other WTO Members about the 
adverse impact that REACH could have on trade in chemical products, including petroleum.  He was 
especially concerned about the lack of transp arency and clarity of the REACH regulation. 
101. The representative of the European Communities  recalled that several concerns about 
REACH had already been raised and discussed at previous meetings of the TBT Committee. She 
referred to the previously provided answers recorded  in the minutes.  On the procedure concerning 
substances that would be subject to authorisation, the EC representative explained that the Substances 
of Very High Concern (SVHCs) would be identif ied and included in Annex XIV of the REACH 
Regulation (List of Substances Subject to Authorisati on) according to the criteria laid down  in Article 
57 of the REACH Regulation.  She emphasized that the procedure for substances subject to authorisation consisted of different stages, was ca rried according to criteria and rules set out in the 
REACH Regulation and that the process was transparen t and open to consultation with all interested 
third parties.  First, a dossier with the substances which could qualify as SVHCs was prepared by 
ECHA or by EC member States (so called Annex XV Dossiers).  General stakeholder consultations 
were carried out on these dossiers.  Second and foll owing this stakeholder consultation, it was decided 
whether to include the identified substances in  the candidate list according to the procedure 
established by Article 59 of the REACH regulation.  Third, ECHA had to identify priority substances 
to be included in Annex XIV according to the crit eria for prioritisation contained in Article 58 of 
REACH.  Extensive stakeholder consultations were held also in this phase.  Third and following these 
consultations, ECHA had to send its  recommendation to the European Commission, which had to take 
the final decision on the inclusion of a substance in Annex XIV.  The decision of the European 
Commission was taken according to the so-called "Comitology Procedure", which involved both the 
European Parliament and EC member States.  On th e same topic, the representative of the European 
Communities explained that in addition to these di fferent steps of the procedure ECHA published a 
Registry of Intentions before the creation of a Annex XV dossier in order to add even more 
transparency and predictability to the all process  This registry showed the intention of a Member 
State or ECHA to start working on an Annex XV Dossier and was available on the ECHA website.
4 
She also clarified that substances of the Annex XV dossiers could be grouped together and that 
REACH did not foresee any specific timeline for the submission of these dossiers.   
102. With regard to the questions on the  current  state of play of the procedure, the EC 
representative recalled that the candidate list contai ned fifteen substances.  She confirmed that on 1 
June 2009, after stakeholder c onsultations, ECHA recommended to the European Commission to 
prioritize seven substances out of the fifteen to be  included in Annex XIV.  The prioritization was 
based on the hazardous properties of these substances , the volume used and the likelihood of exposure 
to humans or the environment.  The European Commission was currently working on the final 
decision. 
103. On the issue of uniform interpretation and im plementation across the European Communities, 
the EC representative recalled that a detailed and co mprehensive explanation of the EC system had 
                                                      
4 http://echa.europa.eu/chem_data/reg_intentions_en.asp  G/TBT/M/48  
Page 24  
 
  been provided at the previous meeting of the TBT Co mmittee.  She stressed that the system contained 
sufficient instruments to ensure a uniform application of REACH. 
104. On the documentation to be provided to custom authorities of different EC member States, the 
representative of the European Communities noted that  enforcement authorities of EC member States 
had the right to check if the obligations of REACH were respected.  She pointed out that there were 
different ways to demonstrate that substances had been pre-registered or registered and that in practice 
no problems had been encountered to date.  Once th e necessary information had been provided to the 
enforcement authorities, all products had been rel eased and could be put on the market.  Regarding 
the concerns about the protection of confiden tial business information, the EC representative 
confirmed that the enforcement authorities were  obliged to keep the information provided 
confidential.  However, the concerns on the di sclosure of the registration number of chemical 
substances had been taken into account and were currently being examined.  
105. On the Substances Information Exchange Forum (SIEF), the EC delegation clarified that all 
substances pre-registered would fa ll under a relevant SIEF, unless the potential registrant deliberately 
decided not to register because it stopped manufacturing or importing to the EC market and that there 
was one SIEF per substance.  The European Communities stressed that ECHA had recently launched 
a campaign intended to raise awareness of the urgent  need for action for companies which wanted to 
meet the 2010 registration deadline.  Presentations of a stakeholder event organized in May 2009, 
where many representatives from third countries were present, and two new web sections on SIEF (called HELP and SIEF) were also available on the ECHA website
5. 
106. On the Chemical Safety Assessment (CSA) and the SIEF Formation Facilitator, the EC 
delegate stressed that the IT tools were not manda tory and that substantial work could already be 
carried out without these tools. 
107. On the relationship between REACH and the Di rective concerning Restrictions on Hazardous 
Substances in electrical and electronic equipment (RoHS), the EC representative explained that the REACH Regulation stated that it was without prejudice to other environmental legislation.  REACH 
had a more horizontal scope and therefore vertical legislation that was better adapted to specificities 
of certain sectors would continue to exist.  Cert ain links existed however be tween the two measures.  
For example, RoHS called for the application of the REACH methodology and REACH provided that chemical substances already restricted under ot her EC legislation could not be subject to 
authorization.  On the issue of monomers in polymers, the representative of the European 
Communities recalled that the case was still pendi ng at the European Court of Justice.
6  O n  t h e  
specific request to have a list of companies wh ich had already carried out the pre-registration 
procedure, the EC delegation clarified that this  was confidential information and could not be 
provided. 
108. Regarding the requests for technical assistance,  the EC representative invited WTO Members 
having specific needs for technical assistance progra mmes to direct their requests to the respective 
delegations of the European Commission in their c ountry.  Finally, she informed the Committee that 
ECHA had recently published two new guidance docu ments called "Guidance in a nutshell", which 
were the first documents in a series of planned simplified guidelines providing an overview of the 
obligations under REACH.7 
                                                      
5 http://echa.europa.eu/home_en.asp  
6 Case C-558/07. 
7 http://guidance.echa.europa.eu/guidance2_en.htm .  G/TBT/M/48 
 Page 25 
 
 
  (iii) European Communities – Directive 2002/95/EC on the Restriction of the Use of certain 
Hazardous Substances in Electrical and El ectronic Equipment (RoHS) and Directive 
2002/96/EC on Waste Electrical and Electroni c Equipment (WEEE) (G/TBT/N/EEC/247 and 
G/TBT/Notif.00/310, Corr.1) 
109. The representative of the United States  drew the Committee's attention to the European 
Communities' ongoing review of the Directive con cerning Restrictions on Hazardous Substances 
(RoHS).  He emphasized that the United States s upported the objectives of protecting human health, 
safety and the environment.  He also noted his de legation's appreciation for the transparency and the 
broad consultations with stakeholders that charact erized the RoHS revision process.  However, the 
United States was still concerned about the magnitude of  the costs of compliance, in particular for the 
disproportionate impact on SMEs.  In this rega rd, the US delegation highlighted the high costs 
associated with re-design, testing, and qualifi cation of components and products, as well as 
information technology, human resources, s upply chain management and compliance costs. 
110. The US representative called on the European Communities to ensure that a transparent 
process be put in place for the implementation and ope ration of the proposed RoHS revision.  He also 
stressed that EC regulators should ensure a risk  and science-based approach to the RoHS review, 
including evaluating whether to add additional su bstances or products to the list, set maximum 
concentration levels for specific substances, or gran t exemptions.  It was emphasized that a failure to 
grant exemptions could lead to certain medical te chnologies no longer being available to patients in 
the European Union.  In addition, the US re presentative announced that his delegation submitted 
comments in writing on the notified proposed revisi on and urged the European Communities to take 
these comments into account.  He stressed the importa nce of providing adequate legal certainty to 
stakeholders regarding how substances would be  treated and emphasized that any selection and 
assessment procedure, under RoHS or REACH, s hould be science- and risk-based and take into 
account intended end uses and all available scientific  and technical information.  Finally, the US 
delegation sought an update on the current status  of the measure, requested the European 
Communities to provide a timetable on the review of the RoHS Directive, and suggested that an 
experts meeting be set up to review the US comments. 
111. The representative of Canada  echoed the US comments on the extension of the scope of 
RoHS to medical device manufactures and raised some specific concerns.  First, Canada requested the 
European Communities to consider delaying the application of RoHS to all medical devices to 
1 January 2014.  Second, Canada encouraged the European Communities to consider delaying the 
applicability of RoHS to in vitro  diagnostic medical devices until 1 January 2016.  Third, the 
European Communities was encouraged to consider  excluding implanting medical devices from the 
scope of RoHS.  The Canadian representative stres sed that industry was concerned about the costs 
associated with RoHS, in particular for SMEs. 
112. The representative of Japan  recalled that the purpose of the RoHS Directive was "to 
contribute to the protection of human health and environmentally sound recovery and disposal of 
waste electrical and electronic equipment".  In th is context, he requested the European Communities 
to provide clarification on the intended relations hip between the revision of RoHS and REACH, 
including the procedure for adding new substances to the RoHS Directive and the criteria used for 
identifying the substances regulated by RoHS.  On  the review of exemptions, Japan requested the 
European Communities to provide an adequate tran sitional period of at least two years when the 
exemption of substances was terminated.  The Euro pean Communities was also encouraged to ensure 
that a transparent process be put in place for the granting and renewing of exemptions, including by 
ensuring opportunities for comments by all interested stakehol ders.  On the same topic, the 
representative of Japan considered that it was neither  economically nor technically reasonable to set a 
maximum period of four years for the exemptions.  It was his delegation's view that this timeframe 
should be set on scientific and technological grounds, al so considering the availability of alternative G/TBT/M/48  
Page 26  
 
  technology and the economic and social impact on th e market.  In this regard, Japan requested to 
change the "exemption expiry period" in a "revision period".   
113. Finally, the attention of the Committee was drawn to four substances (HBCDD, DEHP, BBP, 
and DBP) that had been considered as additional candi date substances of the RoHS Directive revision.  
In this regard, Japan recalled that at the last  TBT Committee meeting the EC delegation recognized 
that it was not necessary to include the above-mentione d substances in the revision of the Directive.  
Therefore, the European Communities was urged to formally remove them from Annex III of the draft 
RoHS Directive. 
114. The representative of Jordan
 shared the concerns expressed by the United States and Japan 
regarding the revision of RoHS and announced th at her delegation had submitted comments in writing 
on the ban of Deca-BDE.  She urged the European  Communities to take th ese comments into account 
and review the status of Deca-BDE. 
115. The representative of China  joined the comments made by previous delegations on the 
revision of RoHS and the ban on the use of Deca- BDE.  Written comments had been sent to the 
European Communities in May 2009 and his delegati on looked forward to receiving a reply.  China 
noted that the draft revision of the RoHS Directive expanded its scope and would create unnecessary 
barriers to trade.  In addition, the CE conformity  assessment requirement could cause an extension of 
the production cycle and increase costs.  The Euro pean Communities was therefore urged to take a 
reasonable and scientific approach in evaluating whethe r to add additional substances to the list.  The 
needs of manufacturers, especially in developing countries, to adjust product design and value-chain had to be taken into special account when setting dead lines.  Finally, China noted that the definition of 
a "manufacturer" contained in the draft of the RoHS review and the definition contained in the 
REACH regulation were different and requested th e European Communities to clarify this point. 
116. The representative of the European Communities
 thanked the delegations which submitted 
comments on the revision of the RoHS Directive.  The European Communities was in the process of 
reviewing them and would reply within the shortest delay.  On the issue of medical devices raised by 
Canada, the EC representative noted that Article 4.4 of the RoHS Directive established that the 
restrictions should not apply to spare parts for the repair or the reuse of am ong others, medical devices 
and monitoring and control instruments as of 1 January 2004 and indivi dual diagnostic medical 
devices as of January 2016.  Implantable medical  devices remained excluded from the scope of 
application of RoHS, subject to a review by 2010.  Moreover, exceptions for the use of banned substances in medical devices were proposed in the new Annex 6. 
117. On the inclusion of new products under the scope of RoHS, the representative of the 
European Communities explained that the decision  had been based on an in-depth study, which 
considered various elements such as reliability of su bstitute materials, characteristics of the equipment 
and impact on users.  This study provided scientif ic and technical information necessary to propose 
the inclusion of these product categories in the scope of RoHS.  On the declaration form that had been 
proposed in Annex 7, the EC representative noted that  the current RoHS Directive did not provide for 
declarations of conformity.  Therefore, there were no existing declaration formats to rely upon.  It was also stressed that the proposed Annex 7 format had been formulated according to the new EU 
legislative framework on marketing of goods. 
118. With regard to the concerns raised on the revi ew of exempted applications, the EC delegate 
clarified that exemptions were temporary derogatio ns from a ban granted to manufacturers to facilitate 
the transition to substance-free products in case s ubstitutes were not available.  The need for a 
transition period could be assessed on a case-by-case basis when exemptions were reviewed.  The representative of the European Communities also cl arified that the four years period could be 
prolonged if stakeholders could prove that the exemption was still justified.  G/TBT/M/48 
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  119. With regard to the four substances Japan  had mentioned, the European Communities 
reiterated that restrictions had not been propo sed.  While the Annex III substances were those 
identified as potentially dangerous for the enviro nment, the European Commission considered the 
data on these substances not sufficient at this stage to  justify restrictions.  However, these substances 
would be monitored and their status reviewed  when new information would be available. 
120. On the definition of a "manufacturer", the EC de legate explained that the definition contained 
in the draft RoHS Directive was in line with simila r definitions of other EC legislation, for example 
Regulation (EC) No 768/2008 setting out the requireme nts for accreditation and market surveillance 
relating to the marketing of products.   
121. With regard to Deca-BDE, the EC representa tive referred to the comments made by her 
delegation at the previous TBT Committee meetings. 
(iv) European Communities – Ban on the Use of Nickel-Cadmium in Batteries (G/TBT/N/EEC/98)  
122. The representative of Japan  raised a concern on the EC Directive on Batteries and sought an 
update on the current status of the measure.  While the Directive would enter into force on 
26 September 2009, the methods for measuring the ba tteries capacity had not been announced yet.  
The Japanese representative emphasized that EC co mpanies could be able to comply with the 
Directive, since they were only required to ship th e batteries before the deadline.  However, in the 
case of electrical and electronic equipment where batteries were enclosed in the product, or in the case of lead storage batteries embedded in automobiles, a certain amount of time was required to measure 
the capacities of the individual batteries, to design  and manufacture the labels, to transport the 
products and clear the distributor inventory.  In other words, it was impossible for non-EC companies 
to respect the proposed deadlines.  The Japanese delegation stressed that this process was contrary to 
the obligations arising from Article 2.1 of th e TBT Agreement.  Therefore, the European 
Communities was requested to delay by one year the implementation of the Directive. 
123. The representative of the European Communities
 clarified that the European Commission, 
together with EC member States, was currently in  the process of drafting rules for the implementation 
of capacity labelling requirements for rechargeable  batteries, automotive batteries and accumulators in 
accordance with Article 21.2 of th e Directive on Batteries.  The purpose of the labelling requirements 
was to harmonize the labelling requirements within the European Union.  With regard to the capacity 
labelling of non-rechargeable batteries, the EC de legate confirmed that further assessments were 
needed.  The EC delegate noted that, due to thei r complexity, the new rules would not be adopted 
before the end of 2009 and stressed that in absence of the implementing rules required by Article 21.2, 
there was no obligation for the EC member States to impose the capacity labelling obligation on 
producers.  In other words, the producers did not ne ed to indicate the capacity of batteries before the 
entry into force of the implementing measures.  The same requirement applied to EC and non-EC 
manufacturing companies, without discrimination.   Finally, the representative of the European 
Communities reassured Members that enough time for preparation would be granted to industry and 
that implementing measures would be notified to the WTO in due time. 
(v) India – Pneumatic tyres and tubes for auto motive vehicles (G/TBT/N/IND/20 and Add.1) 
124. 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 therefore requested India 
to ensure that domestic and foreign based firms could conduct testing and conformity assessment 
procedures within a reasonable period of time, in order to avoid business disruptions.  The Japanese 
delegate also reiterated that there needed to be a longer implementation period, at least two years, in G/TBT/M/48  
Page 28  
 
  order to allow industry to adapt.  He recalled th at concerns had been expressed at the TBT Committee 
meeting in March 2009 and that a reply from India to the Japanese comments made had yet to be received.  A written reply was also pending for the comments submitted to the Indian Enquiry Point.  
125. The representative of the European Communities
 shared the concerns raised by Japan, in 
particular with regard to the new Indian proposal for tyres and tubes for automotive vehicles that was 
notified as an addendum to a previously discussed notification (G/TBT/N/IND/20/Add.1).  In this 
regard, the EC representative stressed her delegati on's appreciation for India's notification of the 
measure and for the exemptions granted for tyres which were originally equipping new vehicles.  
However, serious concerns remained with regard to the rules on replacement of tyres.  First, the EC 
delegate emphasized that the tyres needed to carry a specific mark of  the Bureau of Indian Standards 
(BIS) and that the "E-mark" providing complianc e with UN-ECE regulations was not recognized as 
equivalent.  She also stressed that the labelling ob ligations would imply changes of thousands of tyre 
moulds and could stop production li nes.  In order to avoid unnecessar y costs and disruption of trade, 
India was urged to recognize tyres complyi ng with UN-ECE regulations as equivalent.  
126. In addition, it was the EC delegation's unders tanding that only imported replacement tyres for 
which no domestic equivalent exis ted were exempted from the certif ication and labelling obligations.  
However, once a certain type of tyres was domestica lly produced in India, imported tyres would have 
to comply with the above-mentioned obligations.  Th is provision seemed to have the only objective to 
support local production and did not appear to be  based on a legitimate objective as required by 
Article 2.2. of the TBT Agreement.  With rega rd to tyres which were not exempted from the 
certification and labelling requirements, the EC re presentative asked for further clarifications on 
whether tyres could be certified in other laborator ies than the only accredited laboratory in India and 
on the functioning of the licence procedure, as the notif ied draft contained no details in this regard.  
Were the clarifications given by India at the l ast TBT Committee meeting also valid for the revised 
draft?  Furthermore, the representative of the Eu ropean Communities noted that the revised text 
should come into force 120 days after its publication in the Official Gazette.  120 days appeared to be 
a period too short since the text provided fo r fundamental new requirements and relevant 
implementing guidelines were not known yet.  The EC representative noted that her delegation was in 
the process of finalizing comments that would be sent to India and invited India to take these 
comments into account and to reply to the requests for clarification. 
127. The representative of India  said with respect to tyre testi ng, that India had a well established 
laboratory for testing of tyres.  Test reports from accredited laboratories abroad could also be 
accepted, provided that they complied with ISO IE C 17025 and were accredited by a body which was 
a part of the MRAs with ILAC on a reciprocal basis.  On the same topic, the Indian delegate explained 
that the Indian test standards were different from those contained in UN-ECE regulations because of the different conditions of Indian roads and vehi cle use.  Due to these differences, re-testing and 
approval was still necessary.  With regard to th e comments to be provided by the European 
Communities, the Indian delegation noted that a written reply would be sent in due time. 
(vi) India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33) 
128. The representative of the European Communities
 reiterated her delegation's concerns related 
to the Indian order laying down a registration procedure 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 meeting.   However, concerns still remained on the time 
limits of the registration procedure, the foreseen in spection requirements at the manufacturer's site in 
Europe, the recognition of testing requirements and the conditions for taking samples.  The notified 
draft seemed unclear and excessive in this respect.  The EC representative also stressed that detailed 
comments had been submitted to India in July 2008,  which could be found as usual on the EC's TBT  G/TBT/M/48 
 Page 29 
 
 
  website.8  While India had promised to send additional written information in order to provide further 
clarification, a reply had not been received.  Fina lly, India was urged to foresee reasonable timeframes 
for the registration procedure, recognize certificat es that prove compliance with ISO 22716 on good 
manufacturing practice for cosmetics and specify the rules on sampling and testing, which were currently vague. 
129. The representative of India
 explained that the measure did not discriminate against foreign 
manufacturers and that all comments received in re sponse to the notification were currently being 
considered.  The EC delegation was encouraged to organize a video conference with the Indian 
Ministry of Health to clarify the remaining technical issues.   
(vii) Israel – Infant Formula 
130. The representative of the United States  noted his delegation's conti nued concerns that Israel 
had not published a draft regulation on its measur es related to infant formula for comments, nor 
notified it to the WTO.  He noted that the deta iled comments of the United States could be found in 
the minutes of previous TBT Committee meetings and sought an update on the current status of the 
draft regulation.  The US representative also noted that the United States had had a fruitful bilateral 
meeting with the Israeli Ministry of Health.  It  was his delegation's hope that continued bilateral 
discussions would help to resolve this issue before the end of 2009. 
131. The representative of Israel  thanked the US delegation for the comments provided and 
explained that this highly sensitive issue was current ly being addressed bilatera lly.  The delegation of 
Israel would update the Committee about the progress. 
(viii) Saudi Arabia – International Conformity Certification Programme (ICCP) 
132. The representative of the United States  reiterated his delegati on's concern about Saudi 
Arabia's apparent failure to abid e by its accession commitments to publicize in English its Conformity 
Certificate requirements.  He stressed that Saudi  Arabia had committed to remove the burdensome 
requirements of its former International Conformity  Certificate Program (lCCP) administered by the 
Saudi Arabian Standards Organization (SASO), a nd replace it with a "Conformity Certificate" 
program to be administered by the Ministry of Commerce and Industry.  Saudi Arabia had also 
committed to provide detailed public guidance on how to comply with the new conformity assessment 
requirements post-ICCP.  These commitments did not appear to have been fulfilled.  
133. The representative of the United States stressed th at the lack of publicly available information 
on the requirements had created c onfusion and had allowed the company previously contracted to 
provide services for Saudi Arabia's previous certifica tion program to falsely advertise on the internet 
that its services were a mandatory requirement for access to the Saudi market.  Saudi Arabia should 
take steps to dissolve the "ICCP.com" website.  In March 2009, the United States discussed with 
Saudi Arabia the types of information that should be placed on the Ministry of Commerce website.  
These included:  (i) the current requirements for pr oduct testing and certification;  (ii) the list of 
entities that Saudi Arabia believed were qualified to complete testing and certification work for the 
country;  (iii) the criteria that Saudi Arabia wa s using to recognize approved test laboratories and 
certification bodies to provide services to the Saudi market;  (iv) a formal notification process for 
accrediting or approving such bodies;  (v) clear procedures for approved bodies to follow when issuing conformity certificates or marks to c onvey that a product complies with the relevant 
requirements.  Publication of this information would provide the necessary clarity that companies 
needed to trade their goods in the Saudi market.  The US delegation noted that a list of specific 
                                                     
 
8 http://ec.europa.eu/enterprise/tbt/index.cfm?dspLang=en  G/TBT/M/48  
Page 30  
 
  questions had been submitted to the Saudi Arab ian Ministry of Commerce and a reply was still 
awaited. 
(ix) European Communities – Fire Performance of Construction Products (G/TBT/N/EEC/92 and 
Add.1) 
134. The representative of Japan
 thanked the European Communiti es for the expert meeting about 
the EC's decision on Fire Performance of Constr uction Products organized in December 2008.  He 
also acknowledged receipt of the test data and co mplementary note which served as the basis for the 
EC decision.  However, concerns remained that the EC decision was not based on sufficient scientific 
grounds.  Japan had sent comments on the test data  received and looked forward to receive a reply 
from the European Communities. 
135. The representative of Thailand  supported the statement made by Japan.  
136. The representative of the European Communities  thanked Japan for the fruitful bilateral 
discussions that had taken place in December 2008.  She explained that the Japanese comments were 
currently being examined and a reply would be provided in due time. 
(x) European Communities – Dangerous Chemical  Substances: Draft Commission Directive 
amending, for the 30th time, Council Directive 67/548/EEC (G/TBT/N/EEC/151 and Adds.1-2) 
and European Communities – Dangerous Chemical Substances; Draft Commission Directive 
amending, for the 31st time, Council Directive 67/548/EEC  (G/TBT/N/EEC/212 and Adds.1-3) 
137. The representative of the United States  reiterated his delegation's concerns about both the 30th 
and 31st Adaptation to Technical Progress (ATP) of the EC's classification of borates and certain 
nickel compounds under the Dangerous Substances Dir ective (DSD).  With regard to borates, he 
pointed out that the results of the private ri sk assessment commissioned by the European 
Communities validated the concerns that the United States and other WTO Members had been raising.  
The assessment demonstrated that  there was no appreciable risk of exposure from using the borate-
containing products analyzed (e.g., detergents, glass  and fertilizers).  This called into question why 
certain borate-containing products needed to be labelled.  The replacem ent of the Dangerous 
Substances Directive (DSD) by the Classificati on, Labelling and Packaging (CLP) Regulation 
provided the European Commission with a good opport unity to revise its determination and to take 
into account the results of new studies.  He sought confirmation that the European Communities was open to revising its dete rmination based on new available in formation.  While the European 
Communities had stated that the CLP Regulation cont ained provisions for transferring determinations 
from the Dangerous Substances Directive, the differe nces in the labels, categories and classification 
methodologies between the CLP Regulation and the DSD required clarification in terms of how 
substances would now be treated.  
138. Specifically, the two systems had different cu t-off levels for acute toxicity, different 
qualitative descriptions and evidentiary standards.  Moreover, the product and packaging restrictions 
under the regulatory regimes were different.  For example, the two regulations used different warning 
and risk phrases and labels (the skull and cross bones label would be replaced by an exploding man), 
and it was not clear that the classifications under the CLP Regulation would have the same downstream consequences as the classifications under the DSD.  US industry had concerns about how 
shifting the classifications to the CLP Regulation wo uld work in practice, given all these differences. 
139. The representative of the United States furthe r stressed that, irrespective of whether 
Community law provided for the classification shif t from the DSD to the CLP Regulation, the first 
ATP to the CLP Regulation appeared to be a new proposed measure with respect to the TBT 
Agreement and should therefore be notified.  His delegation would continue to monitor the potential  G/TBT/M/48 
 Page 31 
 
 
  adverse trade impacts of the nickel and borates cl assifications, and analyze the EC's classification 
methodology and analyses that had led to these classifi cations, in the context of REACH and other EC 
measures. 
140. The representative of Japan  reiterated concerns about the ina ppropriate classification of nickel 
compounds following an inadequate read-across met hodology.  This would have an impact not only 
on nickel compound producers, but also on the users.  He recalled that the European Communities had 
announced that the content of the 1st ATP to the CLP Regulation had been transferred from the 30th 
and 31st ATPs to the Dangerous Substances Directive.  However, the 30th and 31st ATPs had resulted 
from a flawed methodology.  He requested that the European Communiti es discuss the methodology 
for the classification and base this on science, c onsidering the important consequences that EC 
decision would have.  Also, the European Communiti es should consult thoroughly with all concerned 
trade partners and stakeholders both within and outside the Communities. 
141. The representative of Canada  was disappointed to learn that, despite repeated expressions of 
concern from Canada and the international nickel industry, the European Communities was proceeding towards the adoption of the 1
st Adaptation to Technical Progress (ATP) to the new 
Classification Labelling and Packaging (CLP) Regulati on.  Her delegation was also disappointed that 
the European Communities had yet to notify the CLP’s 1st ATP, as required by the TBT Agreement 
and stressed that notification of proposed measure s and the provision of reasonable comment periods 
was a cornerstone of the Agreement.  
142. Moreover, now that the CLP - and not the DSD - was to be amended, trading partners should 
have the opportunity to analyze and comment on the amendment’s trade impacts.  Furthermore, 
Canada noted that, despite the EC’s characteriza tion of the nickel classifications as "mere labelling 
requirements", concerns on their downstream impacts we re longstanding and had yet to be allayed.  In 
fact, the classification had already started to have an impact:  for example, recently proposed EC legislation could result in a prohibition on the u se of nickel substances in children’s toys.  
Additionally, nickel metal producers were being asked  to certify that their products did not contain the 
substances classified as carcinogenic under the ATPs.    
143. The representative of Canada further pointed out that, at a recent meeting of the International 
Agency for Research on Cancer, delegates had sugg ested that the EC classifications of nickel 
compounds provided grounds for the classification of ni ckel metal as a carcinogen.  Nickel metal was 
not covered by any of the ATPs in question.  Sh e stressed that, if this proposal proceeded, the odd 
result could be a European ban on the use of stai nless steel.   Given their potential to negatively 
impact nickel producers and exporters, it was essen tial that any classifications of substances be based 
on transparent, sound science, regardless of what legi slation or regulation they were made under.  To 
this end, Canada sought assurances that the Eur opean Communities would give serious consideration 
to the research data that industry was producing as part of the REACH registration process, as well as 
other relevant sound scientific info rmation, and that in light of this information the European 
Communities would review the classifications of nickel in a transparent manner.  
144. With respect to how the harmonization of classifications of chemicals could be proposed and 
updated, the representative of Canada sought confirmation that , once a substance received a 
harmonized classification, only an EC member State competent authority could submit a proposal for an updated harmonized classification.  She noted th at, like all countries, Canada shared the EC 
commitment to the protection of human health and the environment.  This commitment, however, did 
not diminish Canada’s concerns regarding the trade impacts the EC’s classification of nickel could 
have, particularly since the potential trade restrictiveness of the measures flowing from these classifications remained to be seen.  Canada would therefore continue to closely monitor the EC’s 
regulation and risk management of nickel substanc es and urged the European Communities to ensure 
that any measures taken did not create unnecessa ry obstacles to international trade.  G/TBT/M/48  
Page 32  
 
  145. The representative of Cuba
 reiterated that the adoption of the 31st ATP was a matter of 
concern to Cuba, as well as to many other Members, since it affected nickel, one of Cuba's main export products.  As stated previously, Cuba's main concerns were related to the incorrect application 
on the part of the European Communities of the OECD methodology, referred to as "read-across", 
which had failed to take into account  - with no justification - certain important steps, for example the 
absence of water solubility data for nickel compounds , this being the main characteristic which the 
European Communities had used as its basis for the classification.  She pointed out that nickel 
carbonate, nickel sulphite and nickel oxcide were not even soluble in water. 
146. The representative of Cuba also recalled that the 31
st ATP was adopted despite the numerous 
requests for a delay in implementation expressed by de legations.  In addition, several concerns had 
been raised which, in her delegation's view, had not received a satisfactory response.  Moreover, she 
was concerned about the absence of a notification and consultation on the 1st ATP to the CLP 
Regulation, which the European Communities claimed would incorporate the 30th and 31st ATPs.  She 
stressed that new criteria for assessment were incl uded in this regulation, which constituted a new 
regulatory framework.  Therefore, this was not an exact transfer of the 30th and 31st ATPs.  Cuba was 
also concerned that the European Communities ha d failed to supply a satisfactory response to the 
request for clarification with regard to expert opinion s.  Concerns remained also about the effect that 
this measure could have in othe r Member countries, as well as the possibility of other Members 
imitating the EC procedures.  She recalled that the European Communities had claimed that the 31st 
ATP would only have a knock-on effect on health and security for facilities situated within the 
territory of its member States, and that there woul d be no effect on third countries.  However, the 
costs of transportation of highly hazardous substances would increase by approximately 70 per cent, 
let alone the cost of operations of insurance handlin g and storage.  Additionally, the damage inflicted 
on the image and reputation of nickel industry coul d affect its use in numerous industrial processes 
and products, for example stainless steel products worldwide. 
147. The representative of Cuba stressed that th e measure was an unnecessary barrier to trade 
within the meaning of Article 2 of the TBT Agre ement, as it restricted trade beyond necessary levels 
to protect health, safety and the environment.  Sh e called on the European Communities to review the 
30th and 31st ATPs of the DSD as well as the draft 1st ATP of the CLP Regulation in light of the 
comments made by Members, with a view to adop ting a more appropriate classification for nickel 
compounds based on clear scientific evidence.  She also invited the European Communities to notify 
the 1st ATP to the CLP Regulation promptly, as provided for in Article 2.9 of the TBT Agreement at a 
stage where amendments would still be possible and to provide sufficient time for Members to take 
comments and discussions into account.  Additionally,  she reiterated the request to the European 
Communities to take account of the provisions of  Article 12 of the TBT Agreement concerning 
special and differential treatment, in particular para graph 3, with a view to ensuring that there was no 
unnecessary creation of barriers to trade for developing countries. 
148. The representative of Australia  reiterated her delegation's concerns and disappointment 
regarding the EC’s adoption of the 31st ATP, while the concerns of WTO Members and other 
stakeholders remained outstanding.  In particular , her delegation remained concerned that the EC’s 
decision to reclassify 117 nickel compounds under the 31st ATP was based on questionable scientific 
and procedural grounds.  Regulatory decisions of this nature, with potentially far-reaching 
commercial implications, needed to be based on sound, defensible and tr ansparent science, which 
took account of all relevant research as well as m eaningful consultations with stakeholders. 
149. Concerns were also expressed about the fact that  industry had reported that there were moves 
in the European Communities to further restrict the use of nickel carbonate via REACH processes.  
Despite assurances by the European Communities that the only impact on industry from the 
reclassification of nickel would be a requirement  to label products differently, there was some 
evidence of stigmatisation of nickel resulting from the reclassification of various nickel compounds.  G/TBT/M/48 
 Page 33 
 
 
  For example, the 2008 London Olympic Games Sustainabl e Sourcing Code listed nickel, in relation to 
battery applications, as a material to be avoided.   Australia recognized the importance of ensuring a 
high standard of protection for human health and safety and for the environment and supported the 
development of regulatory strategies to insure such  protection.  However, Australia noted that, in 
accordance with Article 2.2 of the TBT Agreement, the EC’s regulatory regime for nickel should not 
create unnecessary obstacles to international trade. 
150. The representative of Australia also supported the US call for the 1st ATP to the CLP 
Regulation to be notified.  The CLP was a different instrument from the 30th and 31st ATPs and, as 
Cuba had also pointed out, would have a greater gl obal effect.  As such, it was likely to be viewed 
differently from the EC’s previous regime, whic h made the necessity for notification ever more 
relevant. 
151. The representative of Indonesia  recalled that at the previous meeting of the Committee her 
delegation had expressed serious c oncerns about the classification of nickel substances in the 31st 
ATP.  Indonesia's nickel industry had the same conc erns as Cuba about the absence of water solubility 
data for nickel compounds proposed for classification,  which was the only classification criteria used 
by the European Communities.  Sh e was also concerned about the lack of consultation with WTO 
Members on the draft of the 1st ATP to the CLP Regulation, on the ground that consultations had 
already taken place on the30th and 31st ATPs.  However, new provisi ons were added in the CLP 
which made it a different regulatory framework. 
152. The representative of Brazil , speaking on behalf of GRULAC , reiterated concerns about the 
EC's decision to reclassify, as ha zardous, nickel substances in the 31st ATP, despite many procedural, 
substantive and commercial concerns expressed by this group and several other Members at TBT 
meetings held in November 2008 and March 2009.  He recalled that  GRULAC's specific commercial 
concerns shared by the whole group had been expr essed, as well as systemic concerns which had not 
been satisfactorily addressed by  the European Communities.  
153. It was stressed that the measure would have a significant market impact for those producers 
and exporters within GRULAC that hosted some of  the world biggest nickel reserves, like Brazil, 
Cuba, Colombia, Dominican Republic and Venezuela and where nickel contributed in some cases to 
about 50 per cent of total exports of goods.  The implementation of the 31st ATP was likely to further 
aggravate conditions in an industry already severely affected by the world economic crisis and a fall 
of world nickel prices, and would cause increased  production, transport and insurance costs.  
154. Furthermore, it was pointed out these new classifications also affected those countries that 
manufactured goods using nickel compounds, in a br oad range of industries and chemical processes, 
affecting their access not only to the EC market but also to other major markets.  GRULAC Members 
also had a systemic concern regardin g the insufficient level of transpar ency and the lack of scientific 
rigor displayed by European Communities which could have implications in future similar 
classification processes.  For example, the absence of  data for the classification of nickel carbonate, 
the flawed application of the OECD read-acro ss methodology, the absence of justification for 
skipping some important read-across steps, the l ack of water solubility data for nickel compounds 
proposed for classification despite it being the only step used by the European Communities and the 
fact that the European Commission had failed to demonstrate that the classification decisions were 
based on any data at all.  
155. GRULAC members understood that the Europ ean Communities intended to reintroduce the 
30th and 31st ATP nickel classifications in the 1st ATP to the CLP Regulation, and that this legislative 
process had already begun.  It was also GRULAC 's understanding that the European Communities 
intended to adopt the 1st ATP to the CLP Regulation at the end of June, without notifying the 
Committee nor providing WTO Members and interested parties an opportunity to comment.  This was G/TBT/M/48  
Page 34  
 
  regrettable, since GRULAC and other Members ha d expressed their expectation that, as required by 
Article 2.9 of the TBT Agreement, the European Communities would notify any such proposal to the 
WTO at an early stage, and would fully engage  with WTO Members to address any concerns.  
156. The lack of consultation of WTO Members on the draft 1
stATP to the CLP Regulation on the 
grounds that consultation had already occurred on 30th and 31stATPs did not have a sound basis 
because the CLP was a different regulatory framewo rk.  GRULAC Members also believed that the 
European Commission had not provided satisfactory an swers to Members' requests for clarification.  
Therefore, Members of GRULAC requested the European Communities to make the appropriate arrangements to take into consideration the concer ns raised, and to consult WTO Members about the 
1
st ATP to the CLP Regulation at an early appr opriate stage when amendments could still be 
introduced and allow reasonable time for other Me mbers to make comments in writing, discuss those 
comments upon request, and take the written comment s and the results of the discussions into 
account.  GRULAC Members also looked forward to a satisfactory response to previous requests for 
clarification regarding the 30th and 31st ATPs.  
157. On behalf of his own delegation, the representative of Brazil  regretted that the addenda to the 
notifications of the 30th and 31st ATPs circulated in March 20099 did not seem to imply that the 
European Communities was willing to take into acc ount the comments and concerns raised by WTO 
Members on these measures.  In Brazil's view, the European Communities had failed to give 
satisfactory answers to some fundamental questions  regarding the proposed classification for nickel 
compounds, such as: (i) why had the European Communities skipped some steps recommended by 
OECD guides on read-across methodology when classifying the nickel compounds; (ii) why was 
water solubility disregarded when classifying nickel carbonates under the 30th ATP, while under the 
31st ATP water solubility was the sole criterion for groupi ng substances;  and, (iii) what exactly would 
be the consequences of nickel compounds being classi fied as Category 1 for carcinogenicity under the 
REACH legislation. 
158. The representative of Brazil said that his delega tion continued to believe that that the 31st 
ATP was not based on sound science and that it would create unjustifiable and unnecessary obstacles 
to trade.  He recalled that several developing count ries had been pointing out the importance of nickel 
to their exports and the possible impacts of the 31st ATP on their economies.  Several developed and 
developing countries had also argued that the 31st ATP could cause disruptions in the global supply 
chain of nickel, thus negatively affecting productio n, job creation and innovation.  In a context of 
global crisis, it was Brazil's recommendation that  the European Communities halt the process of 
classification until there was sufficient data on the actual risks of nickel compounds.  
159. The representative of Turkey  shared the concerns expressed by other Members about the 30th 
and 31st ATPs and the about the transposition of the results of these ATPs into the 1st ATP of the 
Regulation on Classification, Labelling and Packagi ng of substances and mixtures (CLP).  He recalled 
that at previous meetings, the European Communitie s had declared that the classification of borates 
would have no impact for the European market in  terms of production and import of substances and 
preparations containing borates, as long as they comp lied with the concentration limits set out by the 
Directive.  He sought clarification on the type of restriction that would be applied if concentration 
limits exceeded those set by the Directive.  While the situation for biocidals in cosmetics was clear, 
clarification was needed on the issue of the borates in products such as detergents, plant protection 
products, food supplements or medicinal products.  
160. The representative of Turkey further noted that  the CLP Regulation imposed an obligation to 
notify classifications to the Classification and La belling Inventory, which was managed by the 
European Chemicals Agency (ECHA).  This obligati on applied to substances subject to registration in 
                                                      
9 G/TBT/N/EEC/151/Add.2 an d G/TBT/N/EEC/212/Add.3.  G/TBT/M/48 
 Page 35 
 
 
  accordance with REACH and placed on the market, as well as to substances meeting the criteria of 
classification as hazardous and placed on the market, regardless of whether they were subject to harmonized classification or not.  He wondered ho w borates and its derivatives would be treated 
within the system of CLP and REACH without being affected negatively from the classification decision.  He sought clarification on the impact on trade of the classification decision and stressed that 
any measure which created unnecessary obstacles to trade would hardly be TBT consistent. 
161. The representative of China
 shared the concerns expressed  by previous speakers and 
expressed disappointment at the adoption of the 1st ATP of the CLP Regulation.  His delegation 
believed that the classification of more than 100 nickel compounds was not based on sound scientific 
information since the European Communities had not provided specific data of water solubility for the 
nickel compounds proposed for classification.  The OECD read-across methodology was not applied 
completely and no justification for skipping some important steps had been provided.  Furthermore, 
the CLP Regulation was a different regulatory frame work from the Dangerous Substance Directive.  
However, the European Communities had not notified the incorporation of 30th and 31st ATP into the 
CLP.  The representative of China noted that previ ous clarifications and replies from the European 
Communities did not address Members' concerns and requested the European Communities not to 
adopt the 1st ATP to the CLP Regulation until Memb ers' concerns were fully addressed. 
162. The representative of Mauritius, speaking on behalf of the ACP Group , stressed that the 
Group awaited a convincing response from the Eu ropean Communities about the procedural, 
substantive and commercial questions raised by th e Group and other Members at previous meetings 
regarding the reclassification of nickel substan ces.  He reiterated the concerns expressed.  ACP 
countries were also deeply concerned that the European Communities intended to transpose the 30th 
and 31st ATP nickel classifications in the 1st ATP to the EC’s new Classification, Labelling and 
Packaging (CLP) Regulation.  He noted that this measure was to be adopted soon and had not been 
notified, despite Members' requests to allow for c onsultations in accordance with Article 2.9 of the 
TBT Agreement.   He emphasized that the nickel  classification directives would have a significant 
negative economic and commercial impact on all nick el exporting countries.  They would hurt those 
developing countries, including some LDCs, which re lied only on a few basic exports for employment 
and revenue.  For example, Botswa na, Cuba and the Dominican Repub lic were Small and Vulnerable 
Economies (SVEs) which were highly dependent on mine ral exports.  In 2007, in each of them, nickel 
contributed to about 50 per cent of total exports of  goods.  The nickel market was worth about US$ 4 
billion per year for South Africa.  Against the b ackground of the worst world economic crisis which 
was already affecting developing countries, these dire ctives would further aggravate conditions in the 
nickel industry and by-products industries and result in increased production, transportation and 
insurance costs as well as a further reduction in nick el demand, world prices and employment in this 
sector and related ones. 
163. It was also stressed that the EC market alone  accounted for some 40 per cent of world nickel 
use.  Therefore, the classification of nickel com pounds would reduce access to this vital market and to 
other major ones through domino effects of othe r standards and classifications.   The ACP Group 
recognized the need for a high standard of protec tion of human health and the environment which 
required appropriate regulatory polic ies.  However, the European Communities had yet to prove that 
nickel reclassifications were based on a sound or transparent scientific method.  Indeed, the ACP 
Group continued to disagree that the EC’s "grouping" and "read-across" methodology used in the 31st 
ATP for nickel compounds were in conformity with the OECD or the US EPA guidance.  The 
European Communities had skipped, without scientif ic basis, some essentia l steps set out in the 
OECD’s guidance.  
164. Furthermore, the ACP Group believed that the EC ’s continued reliance on a single data point, 
water solubility, as the primary basis for categorizi ng nickel compounds stood to be challenged, since 
there was no water solubility data for most of the ni ckel compounds classified.  Besides, according to G/TBT/M/48  
Page 36  
 
  the OECD and US EPA guidance, the read-acro ss method required reviewing a number of inputs, 
rather than only one, such as water solubility.  In th is respect, a read-across method, based solely on 
water solubility, gave rise to systemic concerns since this could be used as a precedent for taking 
regulatory decisions on other substances. 
165. It was a fact that the nickel classifications involved highly technical and complex scientific 
issues and had important commercial implications .  Yet, the legislative timetable of the 31
st ATP had 
failed to provide sufficient time for meaningful consultations with other WTO Members, as was 
required by Article 2.9 of the TBT Agreement.  It  was the ACP Group's expectation that this would 
not happen with the 1st ATP to the CLP Regulation.  It would be not be correct to assume that there 
was no need for any consultation on the 1st ATP to the CLP on grounds that consultations had already 
taken place on the 30th and 31st ATPs.  The ACP Group considered that the CLP was a different 
regulatory framework, that new endpoints were a dded in the CLP and the transposition of the 30th and 
31st ATP into the CLP was also a new element.  Furthermore, the Europ ean Communities had not 
provided satisfactory answers to previous requests for clarification.  
166. The ACP Group requested the European Communities to notify promptly the 1st ATP to the 
CLP, as required by the TBT Agreement, so as to al low for consultations with Members at an early 
stage, when amendments were still possible.  Such  notification needed to allow reasonable time for 
Members to submit comments and for these comments to be duly considered.   Furthermore, given its significant commercial implications, it was essential that any classification of nickel compounds and 
any other substances produced by many develo ping countries took into account the special 
development, financial and trade n eeds of developing countries, as was required by WTO agreements.   
167. The representative of Botswana
 associated his delegation with the concerns expressed by 
Mauritius on behalf of the ACP group and also shared  the concerns expressed by other Members.  He 
urged the European Communities to notify the 1st ATP to the CLP Regulation in accordance with 
Article 2.9 of the TBT Agreement. 
168. The representative of th e European Communities , referring to the comments made by the 
United States and Turkey on the 30th ATP, recalled that Members had been informed at the previous 
meeting that a study had been carried out to ex amine whether it was necessary to impose, under the 
EC Directive on the marketing and use of dangerous  substances, any restriction on the use of borates 
in consumer products.  This study  had concluded that measures were not necessary as there were no 
products in the market which containe d borates beyond the limits set in the 30th ATP. Yet, it was 
subsequently found that a few products did cont ain a higher concentration of borates, notably 
detergents and photographic applications.  Howeve r, a risk assessment had shown that there was no 
risk of exposure to these products, therefore there woul d be no need to impose restrictions.  Regarding 
the US comments on the difference in the labelling obligations imposed by the 30th ATP and the 
results of this study, she clarified that the former   was based on the hazard profile of the classified 
substance or preparation  and the latter to the  risk derived from exposure to articles which contain 
these substances or preparations. . She stressed onc e again that there was no labelling obligation on 
articles, only on preparations or substances. 
169. Regarding the 31st ATP, the representative of the Eur opean Communities noted that all the 
concerns raised were merely reiterations of c oncerns previously expressed, and to which her 
delegation had already adequately  replied.  Regarding the 1st ATP to the CLP Regulation the EC 
delegation, after careful review, had concluded that it was not a new measure and that therefore there 
was no obligation to notify it.  She explained that the 1st ATP to the CLP Regulation was made to 
mechanically transpose the harmonised classifications contained in the 30th and 31st ATPs to Annex 
VI to the CLP Regulation.  This transfer wa s necessary because, upon its entry into force on 20 
January 2009, the CLP Regulation had deleted Annex I to the Dange rous Substance Directive which 
the 30th and 31st ATPs aimed to amend.  The 1st ATP of the CLP Regulation converted for the already  G/TBT/M/48 
 Page 37 
 
 
  classified substances (over 8000) the corres ponding classification and labelling to the GHS 
classification and labelling codes.  This correlation table was already included in Annex VII of the 
CLP regulation and was notified to the TBT Committ ee. Annex VII to the CLP Regulation contained 
a correlation table, which provided how the classifica tion and labelling codes of the more than 8000 
currently classified substances should be translated under the GHS.   
170. On the methodology, the representative of the European Communities referred to the 
explanations given by her delega tion at previous meetings of th e Committee and added that at the 
meeting of the International Agency for Research  on Cancer (IARC) held on 24 March 2009, the EC 
conclusions on the carcinogenicity of nickel substanc es had been confirmed.  No additional scientific 
evidence had been presented to indi cate that the classifications of the substances concerned would be 
different to those already agreed.  She noted that Canada had raised concer ns regarding the possible 
prohibition on the use of nickel substances in toys and clarified that the new legislation on toys, which 
had been notified to the TBT Committee at the appr opriate time, had only reduced the tolerable limit 
values that could be used.  Furthermore, before the 30th and 31st ATP, several nickel compounds and 
substances were already covered by the classificatio n obligations.  These limit values did not apply to 
toys which due to their accessibility, function, vol ume or mass clearly excluded any hazard due to 
sucking, licking, swallowing or prolonged contact with skin.  The restrictions did not apply to 
stainless steel either.  Also, she noted that nickel metal and its powder form were already classified as 
carcinogenic in Category 3 in the 30th and 31st ATPs, and that delegations had the possibility to 
comment on them at the appropriate time. 
171. The EC representative further explained that, regarding the question on the procedure for the 
update of classified substances, once the substance received a harmonized classification for a specific 
hazard class (e.g., carcinogenicity) only a member State's competent authority could submit a proposal for an updated harmonized classification for th is specific hazard class.  Such proposal could 
be developed by industry, who could then ask a member State to submit the proposal.  Regarding 
comments made by several delegations including Au stralia and Cuba on the stigmatization that the 
proposal could create on nickel, she stressed that sev eral nickel compounds, including the most traded 
nickel compounds in the world, had  been classifi ed in the European Comm unities for several years 
and that there had not been any negative impact on trade.  With respect to comments made by 
Australia on the restriction on use of nickel in batte ries, she noted that several  toy manufacturers had 
started  to phase out nickel cadmium batteries due to  scares in the toy sector.  Finally, she stressed that 
the European Communities would revise its classifi cation as and when new scientific evidence was 
provided. 
172. The representative of Cuba
 regretted that there was not a meaningful dialogue on this issue.  
Her delegation would continue to  raise concerns until comments by  all Members were taken into 
account.  She stressed that there should be a step between raising concerns in the TBT Committee and 
bringing them to the attention of the DSB and reca lled that Costa Rica had made a proposal in this 
regard.  The Committee needed to consider a mechan ism whereby concerns coul d be resolved without 
having to repeat the same comments at each meeting. 
(xi) Norway - Proposed regulation concerning sp ecific hazardous substances in consumer 
products (G/TBT/N/NOR/17)  
173. The representative of Japan  reiterated his delegation's c oncerns regarding Norway’s 
prohibition of 10 hazardous substances in consumer pr oducts and sought an update on the status of the 
measure.  Japan stressed that, when introducing a regulation that was not harmonized with existing 
regulation in other countries, for example the EC RoHS or REACH, from the viewpoint of substances, conditions and threshold, scientific evidence should be provided.  This should be taken into account by Norway.  It was also nece ssary to provide enough time to analyze the measure 
before its enforcement.  Japan also requested Norway that bisphenol A  be exempt from the scope of G/TBT/M/48  
Page 38  
 
  the measures because electric and electronic products did not contain it. In case it was included, an 
announcement of a clear exposure scenario and providing an opportunity for comments was necessary. 
174. The representative of Jordan
 requested an update from Norw ay on the examination of the 
remaining ten substances in the regulation, includi ng HCBDD, and on the timeline for the regulation's 
entry into force. 
175. The representative of the United States  also sought an update on the state of play of the 
measure. 
176. The representative of Norway  pointed out that the proposed regulation had been subject to an 
extensive hearing process, both at the national and international levels including in the European 
Economic Area.  The regulation had not entered into  force on 1 January 2008 as had been originally 
proposed in the draft and eight substances had been removed from the list.  The Norwegian environmental authorities were currently evaluating the proposal and the comments received.  Other modifications, such as limit values or further ex emptions, were still being considered for the 
remaining ten substances and there was neither a set schedule to conclude this work, nor for the 
regulations' entry into force.  He would transmit the questions and comments regarding the need for 
examination of bisphenol A  and on HCBDD to the competent authorities in capital. 
(xii) China - Compulsory Certification (CCC) System (G/TBT/N/CHN/399 and Suppl.1)  
177. The representative of Japan
 noted that the CCC system had not been open to foreign-based 
certification bodies and reiterated his delegation's requ est to China that foreign certification bodies be 
appointed under the system without discrimination,  as per Article 6.4 of the TBT Agreement and 
paragraph 195 of the Working Party Report on the Accession of the People's Republic of China.10  
178. He recalled that, at the previous meeting of the Committee, China had stated that if the 
Government of China and the Government of Japan concluded a Mutual  Recognition Agreement 
(MRA), foreign-based certification bodies coul d be appointed under the CCC system without 
discrimination.  On the other hand, even if  China and Japan concluded an MRA, Japanese 
certification bodies in China could not make use of the MRA.  He sought information on how 
Japanese certification bodies in China could be appointed under the CCC system without 
discrimination.  Additionally, he s ought information about the date of entry into force of the amended 
regulation. 
179. The representative of China  noted that Japan had sent comments about the measure and that a 
detailed reply had been provided.  He also high lighted that a dialogue was on-going with China's 
trading partners, including Japan, and that joint research on conformity assessment procedures had 
been carried out with the Europ ean Communities in order to excha nge experiences and to improve the 
schemes.  The objective of the notified regulation was to streamline the compulsory certification of China and to improve the effectiveness of the CCC system, based on the experience gained.  
Members' questions about the objective, the scope and the substantial changes in the measure had 
been answered.  He pointed out that the draft regulation was still under revi ew and that its final 
version would be published once the intern al approval procedures were concluded.  
180. With regard to Japan's questions about the r ecognition of foreign certification bodies and their 
test results, he recalled that there were two channels under the current regulation for foreign 
certification bodies to be able to perform conformi ty assessment procedure of China.  First, China 
recognized the test results of laboratories under the IECE/CB Scheme and, second, foreign 
                                                     
 
10 WT/ACC/CHN/49 and Corr.1.  G/TBT/M/48 
 Page 39 
 
 
  certification bodies could acquire qualificati on for the CCC system through inter-government 
agreements.  China was open to discuss mutual reco gnition and cooperation with foreign counterparts 
based on the principles laid down in the TBT Agre ement with the view to avoiding duplication of 
certification and minimizing trade barriers. 
(xiii) China - Proposed Regulations on Inform ation Security (G/TBT/N/CHN/278-290)  
181. The representative of Japan  reiterated his delegation's serious concerns with these measures.  
He pointed out that the Chinese Government had hoste d a meeting for foreign stakeholders in which it 
was explained that China would implement compulsory certification system on certain categories of IT security products.  From 1 May 2010 the applicati on of the system would be  limited to government 
procurement, as indicated the public announcement No. 33 of 29 April 2009, which was available on 
the website of the Certification and Accreditation Administration of the People's Republic of China 
(CNCA).
11  While Japan appreciated that the Chinese Gove rnment had been ready to take into account 
the comments from stakeholders, it believed that, al though the scope of the compulsory certification 
had been reduced, it could still pose an unnecessary obst acle to international trade within the meaning 
of Article 2.2 of TBT Agreement.   
182. The representative of Japan further noted that hi s delegation remained concerned about IT IP 
protection, in particular in light of the character istics of IT security products, which included sensitive 
technical information.  He stressed that for IT  security products, there was a voluntary IT security 
certification scheme that was used internationally  and had a mutual recognition framework.  He 
requested China to explain the reason why a manda tory certification scheme was needed instead of 
the existing voluntary one and, more generally, th e rationale behind these regulations.  He further 
asked China to consider a mechan ism which not only achieved improvement of IT security, but also 
ensured IP protection of foreign enterprises.   
183. In addition, the representative of Japan st ressed that, according to announcement No. 33, 
compulsory certification for government procur ement would be conducted based on the Chinese 
Domestic Act.  However, the Japanese delegation w as concerned about the definition of government 
procurement in this Act.  China was therefor e requested to clarify the scope of government 
procurement.  It was also pointed out that impl ementation rules of this regulation had also been 
published, despite Japan's request to hold adequate  consultations with stak eholders before their 
publication.  It was regrettable that the decisi on of the Chinese Government had not been based on 
consultations with other countries.  China was requ ested to continue information exchange between 
governments and industries of interested countries. 
184. The representative of th e European Communities  thanked the CNCA for keeping an open 
channel of communication with the European Co mmunities and European industry regarding the 
concerns raised on these measures.  His delegation welcomed the joint announcement by CNCA, the 
Ministry of Finance and AQSIQ12 of 29 April 2009, further to which the scope of the proposed 
regulations would be limited to the government pr ocurement area, and the entry in force postponed 
until 1 May 2010.  While this was a positive devel opment, the substantive rules had not been 
significantly changed.  Hence, concerns remained  regarding deviations from the existing ISO, IEC 
information security standards and the internati onal mutual recognition framework based on the so-
called Common Criteria (the Common Criteria Recogn ition Agreement).  Concerns also remained 
about the commercially sensitive information requi red of applicant companies in the CCC process, 
such as the disclosure of the source or design cod es or other sensitive proprietary information.   
                                                      
11 www.cnca.gov.cn  
12General Administration of Quality Supervision, Insp ection and Quarantine of People's Republic of 
China.  http://english.aqsiq.gov.cn/  G/TBT/M/48  
Page 40  
 
  185. With respect to the revised version of the scheme, the representative of the European 
Communities sought clarification about the exact scope  of the notion of governme nt procurement.  He 
noted that, in Circular 33/2009, reference was made to Article 2 of China's Law on Government 
Procurement for the precise definition of th e bodies covered by the notion of government 
procurement.  It was the EC's understanding that  this would concern all bodies receiving direct 
funding from the central government.  Hence, this concept could potentially be interpreted in a broad 
sense as including entities that did not belong to the government.  He therefore requested China to 
clarify whether the revised scheme would apply to state-owned enterprises and to suppliers of goods 
and services to governmental bodies.  Even on the assumption that the revised scheme would not apply outside governmental bodies, the scope of th e revised regulations remained much broader 
compared to the practice of other economies, where specific information technology product 
assurance requirements existed only in relation to na tional security critical infrastructure, i.e. well 
defined defence and military applica tions.  He requested China to explain why it provided such broad 
coverage for mandatory certification requirements in this area.   
186. In addition, in the European Communities' vi ew, it was important to discuss the relationship 
between the CNCA's regulations and other aspects of  China's information secu rity policy potentially 
affecting the commercial area.  Specifically, the EC delegation believed it was essential to better 
understand the relationship between the CCC system  on one hand and the encryption regulations 
managed by the Office of State Commercial Cr yptography Administration (OSCCA) on the other, 
including the role of OSCCA in th e CCC process.  It was also important to understand the relationship 
between the CCC and the Multilevel Protection Scheme under the purview of the Ministry of Industry 
and Information Technology and the Ministry of P ublic Security.  This was necessary in order to 
avoid any overlapping requirements and to ensure coordination between all these different schemes.  
Now that a decision had been taken to implement manda tory rules in this field following consultations 
also with other Members, China was invited to co mmunicate the final version of this scheme in the 
text that it planned to implement as of May 2 010 to the TBT Committee for the sake of greater 
transparency.   
187. In concluding, the representative of the Europ ean Communities reiterated his delegation's call 
for a meaningful dialogue, including an exch ange of experiences and best practices on the 
identification and management of the information security risks.  There were common challenges in 
this area and providing global solutions to those challenges was highly preferable than each economy 
introducing its own unique approach.  In this sense,  the European Communities regretted that such 
dialogue could not take place before the revisions  to the CNCAs regulations were announced.  His 
delegation would continue to work with the Chin ese authorities and hoped that the same level of 
openness that CNCA had demonstrated would be shar ed by the other actors in the Chinese regulatory 
landscape. 
188. The representative of the United States
 noted China's announcement related to the 13 
technical regulations on information security that had been notified to the WTO in August 2007.  He 
sought clarification from China on plans to reduce the scope of these measures to products in the 
government procurement area.  Specifically, his de legation would appreciate clarification from China 
regarding whether the measures applied only to produc ts purchased by state-owned enterprises or also 
to products purchased by entities such as public schools and hospitals.  He also asked for an 
explanation of the substantive changes in the r ecently amended implementin g regulations and urged 
China to notify these amended technical regulations to the WTO.  This was important given the long-
standing concerns that had been raised in the Co mmittee on this issue and the serious questions that 
remained about the scope of the application of  these regulations, that could extend beyond 
government procurement into the realm of commerc ial entities.  Despite the concerns, the United 
States noted and appreciated the willingness of o fficials from CNCA and China's Ministry of 
Commerce to maintain an open line of communicati on with government officials and industry groups 
from the United States and other countries on this important issue.  G/TBT/M/48 
 Page 41 
 
 
  189. The representative of Korea  welcomed the Chinese Government's announcement that it would 
postpone the implementation of the regulations on information security.   His delegation believed that 
the announcement was the result of the Chinese G overnment's pro-active position shown to other 
countries on several occasions, including at TBT Comm ittee meetings.  He pointed out that two days 
after the announcement, the Chinese Government had also announced that the implementation decrees 
had been revised.  His delegation, after analyzing th e revised decree, had noticed that the scope of the 
covered products had been modified for two prod uct categories and all the related products with 
embedded information security functions would be  covered by the new regulations.  He sought 
clarification from China about what exactly woul d be the products falling within the scope of the 
measure.  He echoed the comments made by the EC delegation regarding government procurement 
and was not clear whether government procurem ent would be the only area covered in the 
implementation of the new regulations. 
190. The representative of China  recalled that, upon notification of the measures in 2007, several 
comments had been received from WTO Members.  Moreover, bilateral communication with interested trading partners, including the United States, the European Communities and Japan had 
been maintained.  As a result, the Chinese government had decided to  postpone the adoption date of 
the proposed regulations for about two years, to  leave sufficient time for further technical 
communication and discussion and to ensure the re gulations were reasonabl e and in line with 
international obligations.  He further noted that , after soliciting comments from a wide range of 
stakeholders, China had revised the draft regulati on and published a joint announcement of the final 
regulation on 27 April 2009.  CNCA  had subsequently held a news release conference for foreign 
stakeholders to introduce the final regulation,  where representatives from the European Communities 
and Japan had also been invited.  He stressed that China had greatly reduced the scope of the original 
regulation to government procurement.  This cha nge was made in light of the comments made by 
Members, including at Committee meetings.  In additi on, in order to leave more time for industry to 
adapt and as requested by Members, a one year transitional period was given.  Therefore, the 
regulation would be implemented on 1 May 2010.  Du e to the substantial amendment made to this 
requirement and according to Article  1.4 of the TBT Agreement, China believed that these measures 
were no longer covered by the TBT Agreement should therefore not be raised in the TBT Committee. 
(xiv) Brazil –Toys (G/TBT/N/BRA/259 and 313) 
191. The representative of Thailand
 thanked Brazil for holding a public consultation on its toy 
import measures in April 2009 in Sao Paulo.  She reca lled that the "temporary" measure had first been 
enforced in October 2007, subjecting imported toys to  be retested in Brazil, incurring unpredictably 
long waits and additional costs for imports.  In response to comments from WTO Members, Brazil 
had modified the measure in June 2008 with even  more stringent effects.  The modified measure 
included provisions on cons ideration of foreign test reports, but not on acceptance.  It further required 
that foreign test reports had to be  translated into Portuguese.  Add itionally, all imported toys had to 
undergo additional tests in Brazil.  Only after co mpletion of the repeated testing and certification 
process, could importers affix the conformity mark on each toy item, one by one.   
192. The representative of Thailand further recalled th at these concerns had been raised at the 
public consultation in Sao Paulo.   About a month later, Brazil had responded in writing, in 
Portuguese.  According to the translation, Brazil insi sted on requiring translation of test report into 
Portuguese.  The official reply mentioned that pr oduct sampling for supplement test had to be done 
after the arrival at the port, but that additional t ests were removed from the toy safety certification in 
light of the comments received.  She noted that  Brazil had also mentioned a new certification 
procedure and greater transparency for the revision of its toy safety measure without providing other specific details.  While the removal of additional tests from the toy safety certification procedure was 
a positive development, clarification was still n eeded about whether or not imports still required 
sampling.  Moreover, it was Thailand's understandi ng that Brazil would consider a review of the G/TBT/M/48  
Page 42  
 
  measure for greater flexibility shortly after the consu ltation.  To date, no update had been received.   
In concluding, the representative of Thailand request ed that: (i) Thailand’s concerns be taken into 
account; (ii) Brazil ensure flexibility for exporters; a nd (iii) any new burdens to undermine fair trading 
be avoided.  Brazil needed also to ensure that th e review bring the measure into conformity with the 
TBT Agreement.    
193. The representative of China
 shared the concerns expressed by Thailand.  In particular, China 
remained concerned about the discriminatory tr eatment imposed on imported toys in terms of 
additional tests and other burdensome conformity assessment procedures.  He recalled that, in the 
public hearing held in April, Brazil had made it clear that additional test requirements on imported 
toys would be eliminated and that the final test w ould be available in June.  However, no information 
had been received on the final regulation.  He info rmed the Committee that, in a bilateral meeting,  
Brazil had confirmed that additional testing require ments would be eliminated.  His delegation was 
also informed that a new draft text would be notified to the WTO and that another public consultation would be held at the end of July, after which a new public hearing would be  heard in August.  The 
final regulation would then be published within 30 days.  He invited Brazil to confirm that this was 
the case and, if so, he encouraged Brazil to take  WTO Member comments' into account and to ensure 
that the final regulation was fully in line with the TBT Agreement.  He further pointed out that the 
current toy regulation, which had been notified on an emergency basis, had been implemented for 
almost two years and that Chinese toy exports had been seriously affected.   
194. The representative of the European Communities
 thanked the Brazilian authorities and 
INMETRO for organizing the public hearing in Sa o Paolo and for the transparency with which 
INMETRO officials had discussed the issue and handled the comments received from his delegation.  
He invited the Brazilian authorities to confirm that  the modifications announced during that meeting 
would be implemented in the revised version of the Decree.  In particular, he pointed out that the 
modifications concerned the elimination of the re quirements for duplicative local testing and the 
acceptance of testing performed by foreign, IL AC-accredited laboratories.  He also sought 
confirmation that companies holding ISO 9001 (2008 ve rsion) certificates would be exempted from 
the factory audit on their quality assurance system in th e context of the so-called System 5 procedure.   
195. With regard to the requirement to provide a full official translation into Portuguese of foreign 
test reports, the representative of the European Co mmunities requested INMETRO to consider in the 
framework of implementation that a translation re quirement should only apply to those parts of the 
test reports that were necessary to establish the conformity of the product with the applicable 
Brazilian requirements. Finally, he sought an up date on the state of play of the measure. 
196. The representative of the United States  welcomed the fact that Brazil would no longer impose 
additional in-country testing requirements on imported toys.  He sought an update on the status of the 
measure and would review the new draft when published.  He looked forward to continuing to work 
with regulators from Brazil and other Members on devising appropriate measures to ensure that 
children's safety was protected from potentially unsafe toys. 
197. The representative of Brazil  informed the Committee that the regulation on toys was still 
under revision.  He recalled that, on 14 April 2009,  INMETRO had held a public hearing about the 
draft regulation, which had been attended by re presentatives from national and foreign producers, as 
well as government officials from several countries which had had the opportunity to express their views on the draft text directly to INMETRO's re gulators.  During the public hearing, INMETRO had 
received significant contributions from interested parties.  In view of that, INMETRO was working on 
a final version of the draft regulation that incor porated some of the comments received.  Once 
concluded, the final version would be submitted to a brief period of public consultation and public 
hearing and then it would be publishe d as a new regulation.  He furthe r informed Members that, in the 
new draft text, the requirement that complementary tests be made only in Brazil had been removed.   G/TBT/M/48 
 Page 43 
 
 
  Foreign products would be allowed to be certified under System 5, as long as the tests are performed 
by laboratories accredited by ILAC.  Moreover, INMETRO would require that conformity assessment bodies collected samples in the mark etplace for performing toxicological tests, so that controls on the 
borders could be simplified, whilst enhancing ma rket surveillance and other non-trade restrictive 
control methods.   
198. With respect to the requirement that foreign tests reports be translated to Portuguese, the 
representative of Brazil pointed out that this coul d not be removed from the revised text.  Brazil's 
Constitution established that Portuguese was the official language of Brazil: therefore, only 
documents in Portuguese had official status in Br azil's public administration.  He confirmed China's 
understanding about the timeline for implementation, a lthough slight variations could occur.  Finally, 
he stressed that the process of revision of the Brazilian regulation on toys had been conducted with 
impartiality and transparency and had been open to all interested parties.  The new draft regulation 
would strike a balance between the need to avoid trade restrictions and the objective of protecting the 
health of consumers. 
(xv) China – Wines (G/TBT/N/CHN/197) 
199. The representative of th e European Communities
 reiterated her delegation's serious concerns 
regarding overly strict specifications related to maxi mum levels of sulphur dioxide in Chinese wines.  
She recalled that the European Communities had re peatedly raised this issue at TBT Committee 
meetings, highlighting the concerns of several EU  member States, among them Germany, France and 
Hungary.   At the most recent TBT Committee meet ing, in March 2009, China had indicated that the 
process of reviewing this standard had been co mpleted and that the maximum allowed level of 
sulphur dioxide in wines would be set at 250 millig rams per litre in line with the Chinese food 
additives standard.  The European Communities noted,  however, that this fell short of the levels 
stipulated in international standards such as th e Codex, where the levels ranged from 350 milligrams 
per litre sulphur dioxide content to 400 milligrams pe r litre, in the case of special white wines.  The 
European Communities urged China to align its specifi cations to international standards or to provide 
the TBT Committee with the reasons for which it consid ered the international standards inappropriate.  
China was also asked when the revision would be notified to the WTO TBT Committee.   
200. The representative of China  said that limits for sulphur dioxide in wine had been notified 
together with a package of standards for wine under TBT notification G/TBT/N/CHN/197.  He noted, 
however, that concerns about these limits were SPS-rela ted.  The level of sulphur dioxide in wine had 
been revised as per notification published by the Ministry of Health on 11 December 2008.  
According to this notice, the limit had been incr eased to 250 milligrams per litre which was consistent 
with the Chinese hygienic standard for food additiv es.  Hence, taking Chinese drinking habits into 
consideration, and with a view to reducing risks of  contaminants caused by food additives, if wine 
producers would actually increase the limited of su lphur dioxide used in wine, it was possible for 
them to apply for review of these limits;  to date , however, no such applications had been received. 
(xvi) United States - Consumer Product Safety Improvement Act (G/TBT/N/USA/421) 
201. The representative of China  reiterated concerns with respect  to the US Consumer Products 
Safety Improvement Act – the CPSIA.  It was noted that in previous interventions, China had clearly 
identified key concerns with regard to transparen cy, associated conformity assessment procedures  
and some related technical problems.  However, only minor progress had been made.  First, the CPSIA fully met the criteria of a technical regulations  and needed therefore to be notified to the WTO 
before adoption so that Members could provide comment.  The notification of the subsequent 
implementing measures could not replace the notification of the Act itself since it already contained technical requirements that had trade effects.   G/TBT/M/48  
Page 44  
 
  202. Second, with regard to third party laboratories,  the United States had made clear that third 
party laboratories included governmental laboratori es.  However, the additional requirements for 
governmental laboratories were too stringent.  Based on China's experience, it was difficult for governmental laboratories of other Members, in cluding China, to be assessed and accredited under 
these requirements.  Developing country Members ha d invested a lot on governmental laboratories as 
an important part of their conformity assessment in frastructure in ensuring the safety and quality of 
import and export commodities so as to protect human life and health.  These governmental laboratories accredited by ILAC and which used ISO and IEC 17025 as their basis, were fully competent to carry out relevant testing activities and there was no reason to discriminate against them.  China therefore urged the United States to provide no  less favourable treatment to such laboratories 
and to initiate the accreditation work of governme nt laboratories expeditiously.  An update on this 
work was requested.  China looked forward to writte n replies to all questions provided to the United 
States. 
203. The representative of the United States
 noted, with respect to transparency, that at least eight 
CPSC implementing regulations ha d been notified to date: he directed China, as well as other 
interested Members, to the Consumer Product Safe ty Commission website which had a special section 
on toy safety that provided key guidance documents on the test procedures, test accreditation, list of 
accredited laboratories, general counsel advisory opinions and specific guidance for small businesses.  
The representative of the United States  agreed with China that the definition of a technical regulation 
did not distinguish between laws a nd regulations.  In this connection, the United States asked China to 
provide information on legislative measures that it had notified to the TBT Committee as the United 
States was not aware of any such measures.  For ex ample, China had not notified the WTO of its draft 
food safety legislation which contained detailed provisions on ensuring the quality and wholesomeness of foods.  Did this mean that China made a distinction between  laws and regulations 
in its notification practice?  Was China planning to notify this bill as well as other pieces of legislation 
that contained technical requirements to the WTO?   
204. Regarding China's concerns with respect to laboratory accreditation, the representative of the 
United States noted that Chinese laboratories were not being singled out in any way.  Based on criteria mentioned at the last meeting of the Committe e, there were 34 laboratories based in China that 
had been accepted by the Consumer Product Safety Co mmission.  It was also not accurate to state that 
the CPSC had not accepted any Chinese Government laboratories.  In fact, the CPSC had approved seven Chinese Government joint venture laborator ies.  Chinese CIQ laboratories had not been 
accepted because they did not meet the relevant  conditions.  The United States asked why China 
continued to raise the issue of laboratory accreditati on.  The United States had opted for a highly trade 
facilitative approach in its testing regime for child ren's articles – one that was based on international 
standards and acceptance of test results from ILAC  accredited labs outside the United States.  The 
United States asked when China would be recognizi ng test results from ILAC accredited laboratories 
with respect to the CCC System, as well as SFDA's medical device registration system.  China had 
refused to recognize any United States laboratory th at was ILAC accredited under those schemes – its 
position with respect to CPSIA seemed, therefore, inconsistent. 
205. The representative of China
 wished to offer some clarificati on.  First, with respect to the 
Chinese notification procedure, the representative of  China assured the United States that it fulfilled 
its notification obligations under the TBT Agreement.   For example, it was known to all Members that 
there was no need to notify standards under the TB T Agreement – nevertheless, China had notified it's 
mandatory national standards to the WTO as technica l regulations since these were found to meet the 
criteria of a technical regulation.  The same princi ples would be followed with respect to laws.  For 
example, the regulation on Import and Export Commodity Inspection enacted by China's State Council, typical Chinese legislation, had been notified to the WTO (G/TBT/N/CHN/182).  With 
respect to the accreditation of US laboratories in Chin a, as had been explained previously in response 
to Japan's concern on China's CCC System – there were  two channels provided for by current laws for  G/TBT/M/48 
 Page 45 
 
 
  foreign laboratories to be accredited.  China re mained open to discuss th e mutual recognition 
cooperation with its foreign counte rparts based on the principles laid down in the TBT Agreement. 
(xvii)  Indonesia - Mandatory Certification for Steel Pr oducts (G/TBT/N/IDN/23, Rev.1 and Suppl.1, 
and G/TBT/N/IDN/24, Rev.1) 
206. The representative of Japan  noted that the Government of Indonesia had announced that it 
would introduce mandatory standards (referred to as  the Indonesian National Standards (SNI)) with 
respect to the above-mentioned measure.  At the last TBT Committee meeting, Japan had expressed 
serious concerns with respect to these measures and requested Indonesia to explain how they were 
consistent with Article 2.2 of the TBT Agreem ent. However, Indonesia’ s response had not been 
sufficient to resolve the concerns.   In Indonesia's notifications of 23 and 24 February 2009, Indonesia 
had indicated the following objectives: (i) to protect  consumers from safety aspects; (ii) to increase 
the product quality; and (iii) to establish fair trade and competition.  Japan asked Indonesia to explain 
how the second and third objectives were consistent w ith Article 2.2 of the TBT Agreement in terms 
of the legitimate objective. 
207. The representative of Japan further noted that desp ite the fact that Article  10 of the Decree of 
the Minister of Industry on hot rolled steel coils pr ovided that the Director of Industry Development 
would stipulate technical guidance, Indonesia ha d implemented the Decree from 6 May without 
establishing such guidance. Japan was concerned that  this delay could harm the transparency and 
credibility of the measures at issue.   In these uncertain circumstances, even if importers tried to go 
through the procedure for obtaining SNI certification, they would have difficulties in making progress. Therefore, Japan requested  Indonesia to enact and release the technical guidance as soon as 
possible. Moreover, since this was also relevant to the Decree on zinc-aluminium-coated steel plates, 
which would enter into force on 6 July, Japan asked  Indonesia to clarify the schedule for issuing the 
technical guidance also with respect to these products. 
208. It was noted that during the second round of b ilateral talks, held on 1 April, Japan had 
understood that the Ministry of Industry of Indonesi a had explained that the scope of these Decrees 
was steel products for construction use only and the scope was not expect to affect steel products for 
manufacturing use (e.g., automobiles, electronics) in the mandatory certification system.  Hence, 
Japan requested Indonesia to reconsider the scope of the measures and to enforce these measures as 
flexibly as possible, giving adequate c onsideration to actual business transactions. 
209. The representative of Chinese Taipei
 echoed the concerns expressed by Japan and noted that 
formal comments had been submitted on 20 March and 11 May 2009, resp ectively.  However, to date, 
no response had been received and, in the meantime , the measures continued to create serious trade 
barriers for industry. 
210. The representative of Indonesia  noted with respect to the "legitimate objective" that the 
measure was intended to increase pr oduct quality and to establish fair trade competition.  The measure 
had been adopted and notified under emergency circ umstances because a lot of steel products on the 
Indonesian market were of low quality, particularly  steel products which were intended for building 
construction – which was very much related to c onsumer safety.  Therefore, the Government of 
Indonesia had decided to enforce the two regulations  so that only steel products which complied with 
SMI requirements would be available in the market.  By implementing this regulation, product quality 
as well as competition would be improved; this woul d enhance consumer protection.  The regulation 
was to be implemented four months after its date of  stipulation because it also applied to all hot rolled 
sheet and coiled steel products which had already b een regulated through another regulation (notified 
in G/TBT/N/IDN/19, Add.1 and Add.2).  This re gulation was based on the Indonesian Government 
policy to convert energy consumption from kerosene to LPG.   G/TBT/M/48  
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  211. Regarding Japan's question about the exclusion of automobiles and electronics, the Ministry 
of Industry had stipulated that the new regulati on on the mandatory implementation of SMI for hot 
rolled sheet and coiled steel had excluded hot ro lled sheet and coiled steel with particular 
specifications (with a thickness below 1.8 mm intende d for specific technical specifications such as 
automotive and electronics).  The notification for this  regulation has been sent to the WTO Secretariat 
for circulation to the Members (see the Rev.1/Add.1 referred to in title, above). 
212. On the concern about product certification, ra ised by Chinese Taipei , the representative of 
Indonesia said that this was not a burden for exporte rs to Indonesia because the product certificate 
was provided based on a third party certification m echanism.  Once the manufacturer obtained a 
license from the product certification body to use the SMI mark on its product, the license was valid 
for three years.  The Ministry of Industry was currently assessing more certification bodies for 
approval.  On the procedure for applying SMI mark  (by the manufacturer), the exporter had to apply 
for certification to the product certification body.  The certification body would then check through 
data on the management system applied by th e manufacturer to ensure product quality and 
compliance with the SMI.  This was done through sampling and testing in laboratories accredited by 
the National Accreditation Body of Indonesia.   It  was noted that the testing laboratories could be 
located outside Indonesia as long as they had b een accredited by a respected national accreditation 
body which had signed an MRA with the National Accreditation Body of Indonesia.  The Ministry of Industry had for some time being developing the final draft of the technical guidance for the 
regulation at issue; once adopted it would be sent to those Member countries that had requested it. 
(xviii)  European Communities – Seal Produc ts (G/TBT/N/EEC/249 and Add.1) 
213. The representative of Canada
 expressed deep concern about the adoption in the European 
Parliament on 5 May 2009 of the European Comm ission's proposed regulation banning trade in seal 
products, which had not – at the time of the meeting – been notified to the TBT Committee.  The stated objective and rationale was "to regulate th e internal market and to address EU citizens' 
concerns on the welfare of seals during commercial hunts".  The version adopted by Parliament 
included a ban on the trade in seal products with some exemptions, but offered no possibility for 
derogation for products derived fro m humanely killed seals.  Canada w as concerned that the European 
Communities was unilaterally condemning sealing practic es without adequate evidence.  International 
standards for animal welfare in sealing had yet to be developed and Canada had repeatedly suggested 
the need for the development of such standards and would, moreov er, welcome the cooperation of the 
European Community in doing so.  
214. The representative of Canada stressed that her c ountry had gone to great length to ensure that 
the seal hunt was humane, well-regulated and sustainable. As the European Union's own studies had shown, seals could be - and were - killed humanely.  There was no justification for a trade ban on seal 
products.  Despite testimony from Inuit communities as to the damaging effects of this proposed measure, the European Communities had not consulte d with them to ensure that they were not 
adversely affected by this regulation.  Canada st rongly urged the European Communities to reject the 
trade ban and engage with sealing countries to set international standards for animal welfare in 
sealing.  She stressed that should the EU Council of Ministers adopt the regulation as currently drafted, Canada would take acti on to defend its WTO rights and interests under the TBT Agreement, 
and other relevant WTO agreements. 
215. The representative of Norway
 recalled his delegation's previous  statement on the relevant EC 
notification (G/TBT/N/EEC/249).   Since the last me eting of the Committee, the European Parliament 
had adopted a regulation concerning trade in seal pr oducts that was different from the draft regulation 
that the European Commission had submitted to the TBT Committee and which had already been 
discussed.  It was Norway's understanding that the d ecision by the European Parliament would have 
to be adopted by the Council of the European Union sometime in the Autumn of 2009, before the final  G/TBT/M/48 
 Page 47 
 
 
  regulation entered into force.  It was also Norw ay's understanding that the Council of the European 
Union, based on internal procedures, would adopt th e final regulation with identical content (except 
for possible technical corrections and typographical errors) as the text adopted by the European Parliament.  Although the adopted text was differe nt from the text transmitted to WTO Members by 
the European Commission, Norway's preliminary anal ysis of the new text confirmed the observations 
Norway had made previously.   
216. Norway had posed a number of questions to the European Commission to gain a better 
understanding of the rationale and justification fo r the proposed ban on trade in seal products.  These 
remained relevant and it was not necessary to repeat  them – Norway continued to believe that trade 
restrictions adopted by the European Parliament were inconsistent with the WTO agreements.  In 
particular, the representative of Norway noted that  his delegation had repeat edly urged the European 
Communities to ensure that any regulation adopted include amendments that ensured full consistency 
with international obligations.  The regulation as adopt ed by the European Parliament fell short in this 
regard.  Norway was thus confronted with a regula tion that unjustifiably restricted trade in one of 
Norway’s natural resources, which was harvested in  a sustainable and ethical manner.  Should there 
be no changes that addressed Norway's concerns be fore the final adoption by the Council of the 
European Union, then Norway would have no option but to seek dispute settlement consultations with 
the European Communities. 
217. The representative of the European Communities
 informed delegations that the proposal for a 
Regulation of the European Parliament and of the Council concerning trade in seal products had been 
amended in the first reading of the EC legislative pr ocedure.  This text would be notified to the WTO 
TBT Committee for information as an addenda to the original notification and the text was expected 
to be adopted in the Autumn of 2009.  The compromise that had been reached between the 
Parliament, Council and the Commission would allo w the marketing of seal products from the hunting 
practised by the Inuit and other indigenous commun ities which contributed to their subsistence. It 
would also allow for the placing on the market of  products resulting from hunting for the purpose of 
controlling seal populations, especially to maintain the balance with available fish stocks. The placing 
on the market would only be possible under strict conditions which would be specified in implementing rules. The transit of seal products throug h EC territory would not be affected.  Thus, the 
proposed legislation, as agreed by Parliament a nd Council, harmonized disparate rules currently in 
force in some of the EC member States while address ing both the EU citizens' concerns with regard to 
animal welfare and interests of other groups th at could be affected by the new legislation. 
218. The representative of the Europ ean Communities noted that th e Commission had been asked 
to adopt, in close consultation with the member States and under Parliamentary scrutiny, implementing provisions.  During this process, th e Commission intended to consult stakeholders and 
interested WTO Members.  It was noted that bot h the Norwegian and Canadi an representatives had  
indicated that they would defend their rights an d interests in the WTO.  While the European 
Communities recognized the rights of both countri es under the WTO, the European Communities 
hoped that the differences would not lead to litigation, in particular given the fact that Canada had not 
disputed legislation that was maintained in a nu mber of other countries around the world which had a 
similar effect as the EU measures. 
(xix) India – Mandatory Certification for Steel  Products (G/TBT/N/IND/32 and Add.1) 
219. The representative of Japan
 welcomed India's decision to postpone implementation of the 
mandatory certification system by one year as had been stated at the Committee's previous meeting.  
He recalled that, at that time, Japan had requ ested India to explain how these measures were 
consistent with Article 2.2 of the TBT Agreement.  It was regrettable that India’s response had not 
been sufficient to dispel Japan's concerns. As fa r as Japan understood, Indi a had not notified the WTO 
Secretariat of the said measures, in spite of the f act that more than four months had passed since G/TBT/M/48  
Page 48  
 
  postponing the implementation of the measures.  Re ferring to the notification for 2007 (contained in 
document G/TBT/N/IND/32), India had reported that the main objective of introducing the mandatory 
certification system was "consumer health and safet y." Japan wished to ask how India deemed that 
there was any possibility that high-value-added Japanese steel products, mainly distributed to 
manufacturers in India, could threaten the health and/or safety of Indian people. 
220. There were also other outstanding problems.  For instance, the requirement that foreign 
companies set up liaison offices in India, and diff erences in the structure of the certification fee 
between domestic and foreign companies. With re gard to the liaison offices, there were some 
Japanese steel mills which did not have any bran ch offices in India.  In these cases, Japan was 
concerned about the consistency of the measure with the Article 2.2 of the TBT Agreement; the 
establishment of such offices would be a tim e-consuming and costly process for foreign 
manufacturers to undertake only so as to obtain mandatory certification of BIS. Although India had already postponed entry into force, Japan requested India to reconsid er the necessity of implementing 
this measure, taking into considera tion potential adverse affects on trade. In addition, Japan was of the 
view that India needed to implement the mandatory  certification system in a way that prevented it 
from being more trade restrictive than necessary, reflecting G20 commitments, as well as giving 
adequate consideration to actual business transactions. 
221. The representatives of Mexico
 and China  supported Japan's position.   
222. The representative of India  noted that the measure had been postponed by one year and there 
were no other substantive changes.  With respect to the objective of the regulation, it was clearly 
mentioned in the regulation that the issue was in  many cases about: minimizing power loss, structural 
safety, the safety when steel was being used in high temperatures, including boilers etc.  On the issue 
of the liaison office, the requirement to set up an office in India should not apply if the Bureau of India Standards enters into an MoU w ith the respective foreign government. 
(xx) Thailand – Mandatory Certification for Steel Products 
223. The representative of Japan
 noted that the Thai Industrial Standard Institute (TISI) had 
announced that it would introduce new criteria for pr oduct certification on 26 January 2009. Although 
the new criteria had subsequently been put into eff ect, TISI had abruptly abolished the said criteria as 
of 4 March 2009 and released different criteria, to be  put into effect from 1 May 2009.  At the last 
TBT Committee meeting, the delegation of Japan ha d asked Thailand to explain how the new criteria 
released on 4 March were consiste nt with Article 5.1.2 and other relevant provisions of the TBT 
Agreement, because there was a possibility that th e new criteria would create unnecessary obstacles to 
international trade. Japan had also expressed its ser ious concern that the new criteria would have a 
major adverse effect not only on foreign producer s’ businesses, but also on manufacturers’ businesses 
in Thailand, as well as impacting on the ove rall industrial competitiveness of Thailand. 
224. The representative of Japan noted that the new criteria required importers and foreign 
producers to: (i) provide a number of documents to certify conformity with the mandatory standard, 
(ii) allow TISI to conduct sampling tests for ev ery single shipment, and (iii) undergo annual TISI 
factory and facility inspections. Japan was convinc ed that these requirements would impose a heavy 
burden on importers and foreign manufacturers, even  though the stated objective of the measures was 
"consumer protection".  For instance, shipment sa mpling should be carried out in accordance with 
Article 5.2.6 of the TBT Agreement, which provided that "…the selection of samples are not such as 
to cause unnecessary inconvenie nce to applicants or their agents." Furthermore, since this requirement 
did not match actual business transactions, if it was en forced strictly, there was a possibility that it 
would cause the cessation of supply of high-grade steel  products from Japanese st eel mills to the Thai 
automotive and electronics industries.  G/TBT/M/48 
 Page 49 
 
 
  225. It was Japan's understanding that detailed guidelines , which were going to be issued in April, 
had not yet been released. In order to ensure the transparency and credibility of the Thai conformity 
assessment procedure, and to eliminate uncertain factors for importers and foreign manufacturers to the extent possible, Japan requested Thailand to en act and issue the sectoral guideline promptly. In 
Japan's view, Thailand needed to acknowledge business realities in order to make the guideline more 
beneficial.  Japan requested Thailand to reconsider  the necessity of implementing the new criteria, 
taking into account any possible adverse impact on their economy and trade. In addition, Japan strongly believe that the new criteria for product certif ication should not be more strict – or applied 
more strictly – than necessary. 
226. The representative of Thailand
 noted that TISI’s new criteria for certification, which had been 
effective from 1 May 2009, were in principle the sa me as the previous criteria.  The objective was to 
ensure quality in line with ISO 9001, as well as ISO/ IEC Guides 65 and 67.   The difference was that 
they were now applied strictly to importers as  well as to local manufacturers for the purpose of 
consumer confidence and safety – which was, she noted, a legitimate objective under the TBT 
Agreement. While early on in the enforcement of  the measure some difficulties had arisen, these had 
mostly related to quality control requirements in re lation to ISO 9001.  Thailand was of the view that 
importers already in compliance with the measures w ould not have any additional burden; in fact, the 
provision of adequate proof of compliance would facilitate the process for importers to their own 
benefit.  The representative of Thailand reiterated that the criteria were applicable not only to the steel 
products of Japan but to all products of all orig ins equally.  Transitional issues were worked out 
gradually and conti nually with importers.  Indeed, if Japan  were presently to check with its own 
importers they would find that the situation had im proved.  With respect to the strictness of the 
measure, the representative of Thailand assured Japan that the measure was applied equally to local 
Thai manufacturers. 
(xxi) Colombia - Quality and identity requirements  for distilled spirits (G/TBT/N/COL/121 and 
Add.1) 
227. The representative of the European Communities  referred to the above-mentioned notification 
on alcoholic beverages.  She recalled that her de legation had sent written comments to Colombia on 
19 March 2009 and had also raised the issue at  the previous TBT Committee meeting. In its 
comments, the European Communities highlighted various requirements in the Colombian draft 
measure that could pose significant problems to EC  alcoholic drinks exporters – for instance the 
setting of maximum alcohol content levels, the obligati on to translate the brand name into Spanish, or 
the requirement to have certain warnings on the labels  of alcoholic drinks.  As  a more general remark, 
the European Communities highlighted serious con cerns with regard to the increasingly complex, 
numerous, and often duplicative requirements that exporte rs of alcoholic drinks to Colombia faced. In 
the last eight months alone, Colombia had notifie d three draft measures on alcoholic drinks to the 
TBT Committee:  G/TBT/N/COL/120, COL/121 and COL/130 (the first of which had since been 
withdrawn), all containing mandatory and potentially duplicative specifications for the labelling of 
alcoholic drinks.  The European Communities asked Colombia to clarify the relationship between the 
different notified measures and urged Colombia to provide a written reply to its comments. 
228. The representative of the United States  noted that his delegation was currently reviewing 
written responses received and would revert to Colombian officials if there were outstanding 
concerns. 
229. The representative of Colombia  noted that the measure at issue was currently being reviewed 
and revised.  Nevertheless, the Colombian governme nt had taken up one part  of the measure which 
had not been subject to objections and had proceeded  on an urgent basis to publish this (the Add.1 
notification). G/TBT/M/48  
Page 50  
 
  (xxii)  India – Prevention of Food Adulteration (G/TBT/N/IND/34) 
230. The representative of the European Communities
 once again expressed her delegation's 
concern with the above-mentioned measure to wh ich comments had been submitted since November 
2008; concerns had also been raised at the last  TBT Committee meeting.  In its comments, the 
European Communities had highlighted the difficult y to assess the scope of the changes envisaged by 
India to the Rules on the Prevention of Food Adultera tion due to the fact that these had been subjected 
to several seemingly unrelated revisions.  The European Communities requested detailed 
clarifications on the measure from the Indian authoriti es, in particular with regard to the requirements 
on the labelling of alcoholic drinks: for instance, the classification of alcoholic drinks as "non-nutritive products", the obligation to indicate the list of ingredients, and the requirement to include the 
date of manufacturing and the date of packaging on  the label of alcoholic drinks.  The European 
Communities once again urged India to provide an an swer to these comments and to make available a 
consolidated version of the Rules on the Preven tion of Food Adulteration, taking into account all 
revisions to these rules that had recently been no tified to both the SPS and TBT Committees. This was 
all the more urgent in light of the fact that the Revision notified under G/TBT/N/IND/34 had 
apparently entered into for ce on 19 May 2009, and the initial 3-month grace period provided for 
producers to adapt to the new requirements would soon expire.   
231. The representative of the United States
 appreciated India's delay in enforcement of its revised 
labelling provisions and the response it had provide d to the United States on the applicability of 
certain sections of the requirements to distilled spirits.  A few questions and concerns remained, 
however.  The United States was unsure whether India w ould allow the use of stickers to comply with 
the labelling requirements.  The United States still had concerns as to why India considered that date 
of production should apply to distille d spirits which had an indefinite shelf-life when, in the US view, 
lot identification numbers could better provide th e identification needed if a product recall was 
necessary.  The United States also had other outstanding concerns on other technical issues which had been discussed bilaterally with India and on which clarification had been requested, possibly through 
a video conference. 
232. The representative of India
 noted that the original text of the regulation at issue was available 
from the Ministry of Health of India (contai ned in GSR66-64, dated 19 September 2008 and a 
corrigendum issued GSR135, issued on 27 February  2009).  India had no formal mechanism for 
consolidating the various texts and producing a cons olidated copy, however, if there were technical 
issues which were still of concern to United Stat es and the European Communities, these delegations 
could either request a bilateral in New Delhi, or, alternatively, a video conference.  Regarding the 
issues raised by the United States on stickers and the shelf-life for distilled spirits, these would be 
passed on to relevant authorities and a repl y would be provided as early as possible. 
(xxiii)  Malaysia - Conformity Assessment Procedures for Steel Products 
233. The representative of Japan  noted that since the introduction of the measure, imports of 57 
steel products had become impossible to clear through Malaysian customs without excessively 
cumbersome conformity assessment procedures.  Consequently, these measures had created a de facto trade obstacle.  Moreover, distribution was sta gnating and additional fees had become necessary to 
pay for storage.  At the last TBT Committee meeting,  Malaysia had explained that the objective of the 
measures was to ensure the safety of steel products  for construction use.  Also, Japan had recently 
learned from the Ministry of International Trade a nd Industry (MITI) of Malaysia that it planned to 
expand the scope of the mandatory certification from th e current 57 items to all kinds of steel products 
(627 items) because several accidents had happened w ith buildings collapsing in Malaysia over a few 
weeks. Japan was seriously concerned that the me asures that the Malaysian government intended to 
introduce would not be consistent with Article 2.2 of the TBT Agreement which stipulated that  G/TBT/M/48 
 Page 51 
 
 
  "technical regulations shall not be more trade- restrictive than necessary to fulfil a legitimate 
objective."  
234. In light of the above, the representative of Japan  requested Malaysia to prevent any further 
expansion of the scope of the mandatory certification.   If the objective of the measures was to ensure 
the safety of buildings, Malaysia needed to begi n by establishing building standards (building codes). 
It was inappropriate to introduce mandatory certif ication for materials (steel products) before 
establishing building standards.  Nevertheless, if Malaysia insisted that the scope of mandatory 
certification system cover materials (steel products ), Japan believed that the scope of the measures 
had to be limited to steel produc ts for construction use.  Furthermore, Japan stressed that all steel 
products exported from Japan to Ma laysia were of high quality and high-value-added, and many of 
them were not produced by Malaysian steel makers .  Japan had never heard of any serious safety-
related problems caused by steel products in Mala ysia in the past.  There was therefore no valid 
rationale to subject these products to mandatory certif ication.  In addition, Japan recognized that the 
scope of the measures did include the steel produc ts which were not covered by MS (Malaysian 
Standards). Therefore, Japan had serious concerns  about the effectiveness the measures at issue. 
235. The representative of Japan noted that MITI ha d recently released a "Policy Review for Iron 
and Steel Industry" and planned to introduce manda tory standards not only for imported long steel 
products but also for flat steel products on 1 August 2009 .  In regard to this press release, Japan asked 
for clarification about the objectives and scope. Although this policy review included some trade liberalization (such as a tariff reduction of steel products from 50 per cent to 25 per cent), Japan was 
concerned that expanding the scope of the mandatory  certification system could lead to more trade-
restrictive technical regulations with an adverse effect not only on Japanese steel makers’ business, 
but also on the manufacturers operating in Malays ia.  It would also affect the international 
competitiveness of the Malaysian industry.  Base d on the above, Japan requested that Malaysia 
reconsider the introduction of the said measu res, including the withdrawal thereof. 
236. The representative of Malaysia
 said that the measure would be  implemented consistent with 
Articles 2.2 and 5.1.1 of the TBT Agreement and wa s intended to protect safety and health as well as 
to prevent deceptive practices.  Malaysia was cons idering to review the measures and would take 
appropriate steps to enhance the effectiveness of their implementation. 
(xxiv)  France – Unique Requirements for Ride-on Lawnmowers 
237. The representative of the United States  raised serious concerns with respect to the French 
Ministry of Agriculture's non-transparent "skirt" re quirement for ride-on lawnmowers - a measure that 
was never published in any official law or decree in  France. The Ministry of Agriculture requirement 
for ride-on lawn mowers had already disrupted US  lawnmower exports to France.  If other EC 
member States were to adopt this requireme nt, a significant portion of the approximately 
USD 800 million in annual US shipments of lawnmowe rs to Europe could be adversely affected.  
238. The representative of the United States stressed  that his delegation did not understand the 
basis for the French Ministry of Agriculture's (M oA) requirement that ride-on lawnmowers be fitted 
with a "skirt" for bystander protection.  Both Eu ropean and American industry claimed that the MoA 
had not presented any accident data supporting the n eed for the requirement, and alleged that the 
requirement could actually increase the potential for safety problems by increasing the risk of fire caused by accumulating debris in the vehicle.  The MoA had not responded to these points.  Moreover, it was the US understanding that the skirt requirement represented a unique French 
requirement that was neither consistent with other EC member States' requirements, nor based on 
internationally developed ASTM or ISO ride-on la wnmower standards.  The United States also noted 
that, in September 2007, the CEN Technical Committ ee 144 had voted to reject the French proposal 
to add the skirt requirement to the existing CEN standard.  G/TBT/M/48  
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  239. The United States reiterated its request to DG Ente rprise to re-evaluate its initial rejection of 
the industry petition challenging the MoA requirement's  conformity with the Machinery Directive, 
and urged France to notify the skirt requireme nt to the WTO and cease enforcement of the 
requirement until it received and took into account comments from stakeholders and other Members, 
and provided a reasonable period for industry to adju st to the new requirement, if in fact such a 
requirement was necessary.  In this regard, the re presentative of the United States asked the European 
Commission to share any accident data it believed s upported the French position – that installation of 
the lawnmower skirt would increase bystander safety – as well as any analysis undertaken by the MoA on the potential fire hazard that installation of th e skirt could create.  If this information did not 
exist or did not support the necessity of the skir t requirement, the United States asked the Commission 
to recommend that France base its ride-on la wnmower requirements on a relevant international 
standard and thereby eliminate the skirt requirement.  
240. The representative of the European Communities
 referred to the detailed statement made at 
the previous Committee meeting where it had been mentioned that this matter was subject to a 
complaint procedure, since the US industry had f iled a complaint with DG Enterprise and Industry.  
The preliminary findings on this complaint had b een communicated to the complainant in March 2009 
following which the complainant had challenged some of the findings and submitted additional 
evidence which was currently under examina tion by the Commission services.  Given the 
confidentiality of the procedure, the European Co mmission was not in a position to comment further 
on the substance of the matter.  On the process,  the Commission services aimed at finalizing the 
assessment of the alleged new ev idence submitted by the complainant in September 2009, at which 
time a decision on whether to pursue the procedure and start an infringement proceeding against 
France, or whether to close the case, would be taken.   
241. In respect of the eventual need for a WTO no tification, the European Communities was of the 
view that it was inappropriate to refer to the French measure as introducing a new requirement. The 
requirement to prevent access to moving transmission pa rts of machinery, both for operators and other 
exposed persons such as bystanders and childre n, had been a requirement under the European 
Machinery Directive for 20 years; therefore, the re quirement was not new.  The issue, instead, was 
how the requirement was to be translated into a technical solution capable of achieving the safety 
objective.  The original technical regulation had, in  fact, been duly notified to the TBT Committee.  
But it was not necessary to notify what was, in pract ice, a market surveillance or enforcement action 
aiming at ensuring the effective application of an existing requirement. 
242. The representative of the United States  noted, with respect to the alleged US petition, that it 
was in fact the European  industry that had filed the petition challenging this requirement.  This 
showed clearly that both the US and European indust ry were in agreement that this requirement was 
problematic.  On the notification obligation, while  the United States agreed that a prior directive 
existed, the mandate that emerged from the French Mi nistry of Agriculture was very specific: not only 
did there need to be bystander protection but there n eeded to be a specific piece of equipment attached 
to all ride-on lawnmowers.  The United States did not know when this decision had been taken but 
had simply faced the fact that lawnmowers had been seized by French customs for not having the said equipment installed.  A memo had been issued fro m the MoA to retailers with instructions not to 
stock ride-on lawnmowers unless they had this partic ular piece of equipment installed.  This seemed 
to fit the definition of a technical regulation, i.e ., mandating a particular pr oduct characteristic.  It 
therefore needed to be notified. 
(xxv) India - Restriction on Chinese toys 
243. The representative of China
 drew the Committee's attention to his delegation's submission 
contained in G/TBT/W/304, dated 12 March 2009, which stated China's position with regard to India's 
restriction on Chinese toys.  He recalled that the Indian Ministry of Commerce and Industry, on  G/TBT/M/48 
 Page 53 
 
 
  23 January 2009, had issued and implemented a regu lation imposing a general ban on toys from China 
for at least six months, without specifying a reason.  The Indian Government had not notified it to the WTO.  Subsequently, bilateral consultations betw een China and India had been held several times 
with a view to resolving China's serious concerns a bout the regulation.  On 2 March, India's Ministry 
of Commerce and Industry had issued a second Minist erial Notification, No. 91, to replace the first 
one. However, the discriminative nature  of the second measure had remained.  
244. The representative of China further pointed ou t that the Ministerial Notification No. 91 
required Chinese toys to conform to the related standards and conformity assessment procedures, 
while toys manufactured in India and originating from other Members were not subject to the same 
requirements.  Toys produced in India and in othe r countries, regardless of their conformance to the 
applicable standards, were not covered by the regula tion.  China's view was that the regulation No. 91 
accorded unfavourable treatment to Chinese toys and was inconsistent with India's obligations of 
national treatment and MFN under GATT 1994 and the TB T Agreement, in particular Article 2.1 and 
5.1.  Also, lack of transparency in the second regulation remained.  
245. At the last TBT meeting, China had raised serious concerns about India's ban and 
discriminatory measures on almost all Chinese toys and had asked India to immediately withdraw the 
WTO-inconsistent measures.  At that meeting,  India had recognized that the second ministerial 
notification did not address China's concerns a nd had hoped to find a solution through bilateral 
channels.  At a bilateral meeti ng, India had provided China with a revised regulation, Ministerial 
Notification 113, which had been issued and im plemented on 16 June 2009.  Again, the third 
regulation had not been notified and neither comment  nor transitional period was provided.  After a 
preliminary reading, China had found that the onl y substantive change made was substituting "Import 
of toys from China" with "Import of toys".  Th e new regulation required th at imported toys should 
comply with certain standards, such as ASTM F963, ISO 8124 (Parts I-III), ISO 9873(Parts I-IV) or 
EN 71, and be accompanied by a certificate of conformance from the manufacturer that the representative sample of the toys being imported had been tested by an independent laboratory which 
was accredited under ILAC.  
246. The representative of China requested India to clarify the following points:  (i) Were toys 
manufactured domestically in India required to meet  the requirement of the standards and conformity 
assessment procedure prescribed in the new regulation? (ii) If so, which standard should Indian toys 
conform to?  He also sought further information about related laws or regulations, due to the fact that 
the requirement of compliance of Indian toys w ith the four above mentioned standards was not 
provided in the new regulation.  If Indian toys we re not required to conform with the standards and 
conformity assessment procedures, concerns would ag ain arise about the inconsistency of the measure 
with the WTO national treatment obligation.  
247. It was also noted that the technical specifications of the four standards might differ from each 
other.  Were imported toys require d to comply with all four standards? If so, how could compliance of 
imported toys with all these four different standards, given that  they had different technical 
specifications and might conflict with each other, be ensured?  Were imported toys subject to multiple 
testing?  India was asked to indicate whether it could accept the Chinese standard for toys as 
equivalent, since it was based on the relevant ISO standard. 
248. The representative of India
 pointed out that a bilateral mee ting had been held with China, 
where concerns raised had been discussed.  Chin a's concern regarding the MFN implication of the 
standard had already been addressed and the measure now applied equally to all countries.  The Indian 
toy industry, which was the major competitor of  Chinese imported products, was already complying 
with these standards.  His delegation recognized th at there were some problems regarding small, 
unorganized players in the Indian market and this issue was under examination with a view to 
ensuring that these also complied with the standard s and related conformity assessment procedures.  G/TBT/M/48  
Page 54  
 
  With respect to the comment period, the representa tive of India pointed out that the measure was 
based on international standard, therefore no comme nt period had to be provided.  Finally, the 
representative of India pointed out that Chinese authorities could discuss the matter related to 
equivalence with Indian authorities. 
(xxvi)  Chile - Cosmetics (G/TBT/N/CHL/81 and Add.1) 
249. The European Communities
 reiterated its concerns with regard to the above-mentioned 
measure and referred to its statement at the last  meeting of the Committee.  It was the EC's 
understanding that comments were still under review by  Chile.  Her delegation expected to receive a 
written reply from Chile shortly and requested that Chile did not proceed with the adoption in the 
meantime.   
250. The representative of Chile  stressed that although several comments had been received, the 
Ministry of Health had had to deal with a number of  other urgent matters that had arisen which were 
of national priority and public health.  Therefor e, the process of replying to the comments received 
had been delayed.  She stressed that, in Chile, all comments received had to be replied to in writing; 
moreover, the reply would state whether the comments had been taken into account or not, and if not 
the reasons why.  
(xxvii)  Colombia - Draft Decree establishing provis ions to promote the use of biofuels 
(G/TBT/N/COL/96, Adds 1-3) 
251. The representative of the European Communities  reverted to above-mentioned Decree that 
provided that all gasoline-engine motor vehicles need ed to be flexible-fuel vehicles in the future.  
Even though it had taken note of the explanations pr ovided by Colombia at the previous meeting, the 
European Communities had not yet received an expl anation why Colombia considered it necessary to 
address this aim by laying down mandatory technical requirements while there were a number of voluntary measures available for promoting biofuels, which could be more effective with regard to 
environmental protection. Indeed environmental pr otection would benefit more from the development 
of a number of different and new technologies contribu ting to fuel efficiency, ra ther than from the use 
of a single, compulsory fuel standard that could ha ve the long-term effect of stifling innovation.  The 
technical requirement at issue would not only have  a negative impact on the imports of many car 
models currently sold in Colombia, it would also prevent the placing on the Colombian market of new 
cars which were more fuel efficient. In addition,  the requirements would not only prevent the placing 
on the Colombian market of cars running only on petr ol, but also of those which ran on petrol in 
combination with other alternative fuels, other than the E85 bio-ethanol.  
252. Moreover, the representative of the Europ ean Communities noted that the timing was a 
serious concern, since the lead-time to bring new car models to the market was substantial. The 
periods allowed by the Decree would entail serious  consequences because even where manufacturers 
show a continued interest in the Colombian market, they would not be able to adapt their vehicles in 
order to provide Colombian consumers with a va ried range of products.  It was the European 
Communities’ understanding that Co lombia had adopted the text and published it on 31 March 2009.  
She expressed disappointed that Colombia had adopted  the text shortly after the last TBT Committee 
at which time Colombia had encouraged the Eu ropean Communities to send written comments and 
promised that those comments would be studied a nd discussed.  Colombia was requested to provide a 
reply to the written comments. 
253. The representative of Mexico
 associated his delegation with the concerns expressed by the 
European Communities.  G/TBT/M/48 
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  254. The representative of Colombia  noted that the draft Decree applied to both national and 
foreign vehicles.  She noted that evaluations made  were based on existing technology and there were 
scientific studies that showed that bio diesel w as a viable fuel and less polluting than traditional 
gasoline, particularly in a country like Colomb ia where requirements on vehicles were different 
because of environmental conditions. Colombia rema ined open to bilateral discussions with both the 
European Communities and Mexico. 
(xxviii)  European Communities - Green Paper on Agricultural Product Quality Policy 
255. The representative of Mexico  referred to the concerns his delegation had expressed on this 
issue at the last meeting of the Committee.  Written comments had been sent to the European 
Communities and at the last meeting of the Committe e and, in this regard, the European Communities 
had said that the Green Paper and the comment s regarding the second quarter of 2008 would be 
published in a report in May 2009 dealing with th eir agricultural product quality policy.  Mexico 
asked about notifications and about any particular measure that was envisaged for adoption; he asked 
for a continued dialogue on the topic. 
256. The representative of the United States  noted that some of the potential approaches outlined 
in the Green Paper and the subsequent communica tion could be implemented in ways that might 
create trade concerns for US agriculture and f ood processing entities.  His delegation was reviewing 
the issue closely.  He hoped that  the European Communities would allow ample time for stakeholder 
review and consideration of comments on any resulti ng guidelines or regulations due to the potential 
serious trade impact. 
257. The representative of the European Communities  noted that the above-mentioned 
communication on food quality had been adopted in May 2009.  It set out policy orientations but did 
not contain any legislative proposals.  It was drafted in light of comments from stakeholders and third countries to the Green Paper on agriculture prod uct quality; the process had been open for public 
consultation and received many contributions, in cluding from those countries that were expressing 
concern at the current meeting.  Future analys is would consider: the possible simplification of 
marketing standards to rely more on voluntary meas ures, like those developed by UNECE or Codex; 
the possibility of examining the need for mandato ry “place of farming labelling”; in the area of 
geographical indications there were suggestions to clarify and simplify the legislation and procedures; 
and there was the possibility of replacing the schem e of traditional specialities which was nevertheless 
not used by third countries.  There were also policy orientations on private certification schemes 
which had experienced an important increase in number over recent years.   
258. She noted that it was in the European Commun ities' interest to ensure that operators 
developing these schemes reduce the burden on farmer s, especially duplicative audits, and ensured 
that consumers were not being misled.  The Eur opean Communities proposed, in the Communication, 
to approach this issue through guidelines as it had been deemed unnecessary to adopt legislation, at 
least for the time being.  Any initiatives would of  course be notified to the TBT Committee and period 
for comments given for comment, but no legislation was envisaged until, at the earliest, in 2010. 
(xxix)  Canada - Compositional requirements for cheese (G/TBT/N/CAN/203 and Add.1) 
259. The representative of the European Communities
 reiterated her delega tion's concern about 
Canada's measure on compositional standards for ch eese. She asked that the Canadian delegation 
confirm that there were no further plans to exte nd the scope of the measure to cover other dairy 
products.  
260. The representative of New Zealand  requested that Canada provide an update on the federal 
court challenge to these regulations that was currently taking place.  G/TBT/M/48  
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  261. The representative of Australia
 supported the comments made by the European Communities 
and New Zealand. 
262. The representative of Canada  assured the European Communities that no regulatory process 
had been established for compositional standards fo r other dairy products.  Regarding New Zealand's 
request for an update on the judicial review, she informed the Committee that this had taken place on 
31 March and 1 April 2009. The judge had reserved hi s decision, but as there was no time limit for 
federal court judges to render their decisions, it was not possible to say when the outcome would 
become known. The representative confirmed that she would provide an update at the November 
meeting of the Committee. 
(xxx) Argentina – Measures affecting ma rket access for pharmaceutical products 
263. The representative of Colombia  recalled that this concern had been raised in previous 
meetings of the Committee.  She informed the delegations that despite dialogue between the 
Argentinean and Colombian authorities, the necessary authorization to allow Colombian companies to 
export medical products into the Argent inean market had not been given. 
264. The representative of Argentina  informed the Committee that intensive consultations had 
taken place between the different federal government  agencies, including the National Administration 
of Drugs, Food and Medical Technology, on how to address this issue.  Following these consultations, 
it was agreed that necessary admini strative procedures would be initia ted so as to address this concern 
appropriately. 
IV. FIFTH TRIENNIAL REVIEW 
265. The Chairperson  recalled that the Committee was schedul ed to conclude the Fifth Triennial 
Review of the Operation and Implementation of the TBT Agreement at its meeting on 5-6 
November 2009, in line with the mandate in  Article 15.4 of the TBT Agreement.   
1. Good regulatory practice 
266. The representative of Jordan  introduced her delegation’s pr oposal on good regulatory practice 
(G/TBT/W/311, paras. 9-11).  She emphasized that in  order to ensure that Members develop technical 
regulations and conformity assessment procedures c onsistent with their obligations under the TBT 
Agreement, Jordan proposed that the Committee prepare guidelines for good regulatory practice to address, inter alia, the principles of public consultati on, use of tools for regulatory impact assessment, 
performance based regulations, use of standards in t echnical regulations.  Jordan also proposed that 
the Secretariat updates a list of relevant mechan isms and methodologies related to good regulatory 
practice used by other Members of the WTO. 
267. The representative of Mexico
 noted that a significant problem that Members faced in 
accessing markets for their products was the lack of  regular compliance with substantive obligations 
in the TBT Agreement.  Therefore, Mexico propo sed that the Committee discuss the development of a 
guide for good regulatory practice that would enable Members to verify compliance with the 
obligations provided for in the TBT Agreement before  completing the definitive version of a technical 
regulation.  In the view of Mexico, it was necessary that such a guide include recommended 
procedures to facilitate compliance with the s ubstantive obligations under the Agreement and 
examples of mechanisms that could be used to co mply with these.  The guide would have to be 
applicable to any type of technical regulation.  
268. The representative of the United States  said that good regulatory practice was key to avoiding 
unnecessary barriers to trade and strongly supported the Committee's work to promote greater  G/TBT/M/48 
 Page 57 
 
 
  understanding and implementation of the princi ples of good regulatory practice as well as the 
successful implementation of these principles.  It was recalled that in 1997 the Committee had agreed 
that coordination between regulatory authorities, trade officials and national standards bodies was 
essential to ensure that Members effectively impl ement the Agreement.  The US proposals for the 
Fifth Triennial review sought to help focus the Committee's attention on exchanges of experiences 
related to particular aspects of that coordinatio n.  It was important to focus on the institutional 
mechanisms for internal coordination, particularly  with respect to opportunity for intervention and 
consultation.  It was the US belief that the di scussion of specific trade concerns in the Committee 
would benefit from a better understanding of how comments can be taken into account by other 
Members.  The US submission (G/TBT/W/315) provide d an overview of the institutional mechanisms 
and processes of the United States and described  the US reliance on strong central government 
management of its regulatory regime, an effec tive interagency trade policy mechanism and robust 
public consultation in implementing the TBT Agreement.   
269. In addition, the United States supported Jord an's proposal (G/TBT/W/311) to exchange 
national experiences on good regulatory practice mech anisms and methodologies, and to include good 
regulatory practice in technical assistance plans. Al so, the United States was sympathetic with Jordan 
and Mexico's goal of having Committee guidelines on good regulatory practice but noted that a considerable body of work on good regulatory practi ce had been produced by other organizations in 
the past 20 years, including APEC, OECD and othe rs.  These documents and principles had endured 
the test of time and had been recognized at high level by many Members of the TBT Committee.  Thus, the United States was of the view that an y effort by the Committee at developing guidance 
needed to make the most effective use of its own area of expertise and not duplicate work, or 
contradict established principles. The United States  would support, for example, the collection and 
preparation of existing work on good regulatory pr actice work with Members indicating which of 
these had been useful in helping them implemen t the TBT Agreement as part of the process of 
exchanging national experiences.  
270. The United States further thanked Canada and Me xico for their leadership in developing the 
joint paper on regulatory cooperation (G/TBT/W/317).  The representative of the United States was of 
the view that this cooperation was an essential elemen t in the trilateral effort to minimize the negative 
impact on trade in the integrated North Americ an market of unnecessary divergences in technical 
requirements.  The paper demonstrated that the NAFTA Parties had been much progress in that regard, but there were still technical barriers in North America that needed to be addressed.  The 
United States welcomed further exchanges of national and regional experiences on regulatory 
cooperation in the Committee, including through a workshop on this topic.  
271. The representative of Israel
 supported the proposal submitted by the United States 
(G/TBT/W/315) and that of Canada, Mexico and the United States (G/TBT/W/317) on the issue of good regulatory practices.  Israel was of the view  that regulatory cooperation and policy coordination 
both at the international and domestic levels serve d to reduce the negative impact that technical 
regulatory frameworks may have on international trade. He expressed particular support for the 
workshop proposal to hold a workshop on the topic (G/TBT/W/317, para. 24). 
272. The representative of New Zealand
 joined others is stressing that good regulatory practice 
was the key to reducing technical barriers to trade.  In her delegation’s view, the proposal that some 
from of compilation of good regulatory practice guide lines be put together seemed useful; this was a 
way of building on what had been said at previous triennial reviews.  It was important, however, that 
existing guidelines be used as a basis for any work in the TBT Committee.  On the issue of domestic 
coordination, New Zealand emphasized the importan ce of coordination in a federal system where 
multiple agencies, national and sub-national governme nts all developed different regulations.  The 
representative of New Zealand referred to her countr y’s experience, which had been presented to the 
Committee at a previous meeting of the Committee (G/TBT/W/294) – she welcomed further input in G/TBT/M/48  
Page 58  
 
  this regard. As others had said, regulatory coope ration was an important pa rt of understanding other 
Members’ regulatory regimes and New Zealand, lik e others, supported the proposal for a workshop 
on this subject. 
273. The representative of Korea
 welcomed the proposals on good regulatory practice particularly 
in the area of regulatory cooperation. By was of ex ample he noted that a lack of proper international 
standards was evident in the area of energy efficien cy in electrical and electronic equipment – which 
had been a key issue at a joint workshop by IEA, ISO and IEC that had been held in Paris on 15 March 2009. 
274. The representative of Australia
 noted that information sharing between regulatory authorities 
in Members was helpful; in general, Australia w as supportive of the proposals on the table.  Like 
others, Australia was of the view that developing a guide to good regulator y practice was something 
that should supplement existing efforts, including work in the context of APEC. 
275. The representative of Chile  joined others in underscoring the importance of good regulatory 
practice and supported, generally, the proposals on the table.  In particular, she noted that guidelines 
would be very valuable especially for Members th at did not necessarily have the appropriate technical 
infrastructure in place for the implementation of th e TBT Agreement.  She also referred to work done 
by other organizations and the need to avoid duplication.  
276. The representative of Argentina  expressed support for the proposal tabled by Mexico in 
relation to good regulatory practice (Section IV or G/TBT/W/313). 
277. The representative of the European Communities  noted that the Committee had accomplished 
useful work on good regulatory practice in the pas t; at this point Members agreed, in general, that 
good regulatory practice was about more effective im plementation of the TBT Agreement.  Based on 
what the Committee had done, there was now a need to  link guidance to the specific provisions of the 
TBT Agreement.  A sufficient body of information was available for consolidation that could be 
distilled into basic principles on good regulatory practice that could form part of a Committee 
guidance document.  The European Communities agr eed that the Committee would need to draw on 
work from other institutions although any guidance deve loped had to be tailored to the specific needs 
arising from the TBT Agreement:  Whatever work  the Committee did needed to be linked to 
compliance with the relevant provisions of the Agre ement.  On regulatory coordination, the European 
Communities supported the proposals made and reca lled the relevance of proper mechanisms for 
tracking all measures that should be notified for the fulfilment of the transparency obligations arising 
from the TBT Agreement.  This aspect had been  highlighted in the European Communities' 
submission in transparency.  Also on regulator y cooperation, the representative of the European 
Communities highlighted the importance of deepening th e information exchange in this regard.  This 
was also relevant to the discussion on trade f acilitation arrangements discussed under conformity 
assessment.  He supported the proposal to focus on good regulatory practice in technical assistance 
projects – new technical assistance projects already foresaw a component in this area. 
278. The representative of Canada  supported the proposals regarding the Committee’s work on 
some form of annotated compendium of good regulatory practices based on what Members had 
worked on and developed.  
279. The representative of Pakistan  strongly supported the proposals on good regulatory practice 
and the related area of good regulatory cooperation.  She also noted the usefulness for developing 
countries of conducting workshops held back-to-ba ck with the Committee m eetings where several 
countries shared experiences.  G/TBT/M/48 
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  280. The Chairman  concluded by noting that during the di scussion delegations had echoed the fact 
that the principles of good regulatory practice remain ed important for the work of the Committee.  
These were an effective means of avoiding, to th e extent possible, unnecessary barriers to trade.  
Members had also emphasized the fact that the Committee needed to build  on experiences already 
gained in order to avoid duplication and to take in to account the work of other institutions working on 
similar issues.  Many delegations expressed th eir support for the compilation of guidelines on good 
regulatory practice in this regard.  Members also voiced their overall willingness to continue to share 
experiences on regulatory cooperation and coordination and in this re gard, several delegations voiced 
their desire to have a workshop on the topic. More over, delegations seemed to agree, generally, on the 
importance of technical assistance in respect to good regulatory practice. 
2. Conformity Assessment Procedures 
281. The representative of New Zealand  referred to her delegation’s proposals on the subject of 
conformity assessment (G/TBT/W/295 and 306).  In particular, she emphasized the importance that 
New Zealand attributed to exchanges of info rmation on different types of trade facilitation 
arrangements, ranging from regulatory cooperation arrangements, mutual recognition arrangements 
(MRAs) through to equivalence agreements.  In th is respect, the New Zealand proposal was broader 
than just conformity assessment procedures given that mutual recognition agreements were often 
broader in scope.  In New Zealand’s view, practical guidance on when  the use of particular 
instruments was most appropriate in a particular situation  would be useful – and the Committee could 
consider pursing such work on guidelines, includi ng through the establishment of working groups.  
282. The representative of Singapore  introduced his delegation’s proposal on conformity 
assessment (G/TBT/W/312).  Singapore supported New Zealand’s proposal to exchange information 
on MRAs and regulatory cooperation agreement.  In Singapore’s view, the pursuit of MRAs was 
based on industrial interest: they brought benefits in  the form of market access certainty and reduced 
cost for business due to elimination of duplicative testing and certification and hence faster time to 
market which was crucial due to the shorter lifecycl e of consumer products today. MRAs served as a 
confidence building exercise for the WTO Members a nd their domestic regulatory agencies. In other 
words, it had been Singapore’s experience that a be tter understanding of different regulatory regime 
and a closer regulatory cooperation gained th rough an MRA had helped promote regulatory 
convergence and harmonization in ASEAN.  The MRA had also provided a useful platform for  relevant regulators to come together, also cont ributing to greater confidence building.  Singapore 
proposed that the Committee draw up a template – or  a voluntary guide similar to the Code of Good 
Practice – that would give the Members a head star t in the MRA negotiations and help them address 
some of the challenges involved. 
283. The representative of Singapore also lent his delegation’s support to New Zealand’s proposal 
to revisit the TBT Committee’s indicative list of different approaches to facilitate acceptance of 
results of conformity assessment, adopted duri ng the Committee’s Second Triennial Review (Annex 
A of G/TBT/1/Rev.9).  He underscored, in this  regard, the need to take into account the quality  of the 
conformity assessment procedures rather than the origin  of the product. In other words, the basis to 
recognize and accept other Members’ conformity  assessment bodies needed to focus on the 
competence of the body rather than on the origin of the product.  The origin of the product was 
irrelevant when assessing whether or not a partic ular product met the requirements set out in a 
technical regulation. 
284. The representative of Mexico
 supported New Zealand’s propo sal and the statement made by 
Singapore as a useful way for the Committee to make  headway in the area of conformity assessment.  
He referred to his delegation’s proposal in th is regard (G/TBT/W/313) and stressed that TBT 
Agreement recognizes the possibility there could be  various viewpoints on conformity assessment; in 
fact, Members’ regulatory bodies had the possibility of having various types  of conformity assessment G/TBT/M/48  
Page 60  
 
  procedures.  New Zealand’s proposal was appropriate in this regard because it showed the usefulness 
of an exchange of information on various forms of  cooperation in respect of conformity assessment.  
Mexico also stressed the importance of technical assistance in the area of conformity assessment:  
such assistance was fundamental to allowing Member s the capacity to select and implement the most 
appropriate conformity assessment a particular situ ation.  Moreover, Mexico supported the idea that 
practical guidelines on the way of handling effectiv e and efficient trade facilitation agreements be 
developed. 
285. The representative of India
 noted that while his delegation also believed that MRAs and 
equivalence agreements were impor tant tools available to the Members, currently there were only a 
few MRAs that existed between deve loped and developing countries.  Therefore, India suggested that 
the Secretariat conduct a factual study of MRAs a nd equivalence agreements and evaluate their 
success in terms of enhanced trade flows.  Such  a study could highlight the features of successful 
MRAs and equivalence agreement and provide usef ul lessons for other developing countries to 
follow.  India also proposed that that a Code of Good Practice could be developed for the development of conformity assessment procedures for testing of certification requirements and that 
applied to non-governmental sta ndardizing bodies.  This was important because non-tariff barriers 
that developing countries often grappled with were in the form of testing and certification 
requirements.  Hence there was a need to frame a comprehensive guide to good practices for the 
application of non-governmental conformity assessme nt requirements.  The representative of India 
referred to the guidelines on conformity assessment  produced in ISO and IEC as useful background. 
286. The representative of Chinese Taipei
 supported the proposal from Singapore and noted that 
discussions on the possible elements of MRAs coul d also lead to more regulatory cooperation. 
287. The representative of Pakistan  supported the proposals made regarding MRAs and noted that 
this was one area where better cooperation between developing country Members, as well as between 
developing and developed country Members, could improve trade flows and would be beneficial.  An 
effort to provide guidelines for developing countr y Members as a means of improving effectiveness 
was welcomed by Pakistan. 
288. The representative of Indonesia  supported the proposals presented by delegations, in 
particular with respect to the exchange of info rmation on MRAs so as to build a better understanding 
of the issues that need to be cons idered.  Indonesia also echoed calls for the development of practical 
guidelines on MRAs and the importance of capacity building in the area of conformity assessment. 
289. The representative of the United States  expressed support for the recommendations from New 
Zealand and Singapore to continue to exchange information on MRAs and other arrangements for 
regulatory cooperation, and to examine how to design trade facilitative ar rangements within the 
context of risk management approaches to yield the needed level of assured compliance.  He noted 
that Singapore had specifically mentioned the ASEAN framework agreement as an example of 
guidance – or "template" on MRAs – and the Unite d States invited Singapore to further elaborate on 
its experience on this subject so that the Comm ittee could better understand their recommendation.  
The representative of the United States was also interested in receiving more information on 
Singapore's view with respect to the relationship be tween its proposal to develop voluntary guidelines 
specifically on MRAs and New Zealand’s more ge neral proposal to develop practical guidance on 
trade facilitating  risk management arrangements.   
290. In addition, the United States expressed inter est in the Mexican recommendation to prepare a 
guide for quality infrastructure development. However,  as this was a highly technical area, the United 
States was not sure that the Committee had the approp riate depth of experience to produce a definitive 
guide on this important topic.  The United States looked forward to a bilateral discussion on the  G/TBT/M/48 
 Page 61 
 
 
  subject with Mexico and welcomed more inform ation exchange among Members regarding resources, 
case studies and practices in this regard.   
291. With respect to the recommendations that th e Secretariat or the Committee undertake broad 
studies on the types of issues discussed above , the United States expressed reservations and 
questioned whether this was the most efficient use of  delegates’ and the Committee’s expertise.  In the 
view of the United States, there was a considerable body of work in other international organizations 
on many issues related to good practices in confor mity assessment.  The Unit ed States was of the 
view that the way forward on MRAs proposed by Singapore and New Zealand was useful and did not 
see the value added of a study by the Secretariat on this topic. 
292. The representative of Chile  supported New Zealand’s proposal with respect to MRAs but 
underlined the need to better understand the benefits  of MRAs, for instance:  had they resulted in 
significant reductions of costs and an increase of trade? Chile also supported the Singapore’s 
proposal. 
293. The representative of Australia  expressed broad support for New Zealand’s and Singapore’s 
contributions.  In respect of the development of voluntary guidelines (Singapore’s proposal), he asked 
for more information about the ASEAN experience.   
294. The representative of Argentina  supported, in particular, the proposal from Mexico with 
respect to the importance of technical assistance in the area of conformity assessment and the need to 
develop a guide to facilitate Members’ infrastru cture (as set out in para. 15 of G/TBT/W/313). 
295. The representative of Singapore  indicated his delegation’s intention to provide more 
information on the ASEAN MRA.  
296. The representative of India  clarified, in response to US co mments, that, currently very few 
MRAs and equivalency agreements  existed between developed and developing countries; hence the 
suggestion was that the Secretariat conduct a factual  study of such MRAs and equivalence agreements 
to evaluate their success in terms of actual trade flows. Members – not the Secretariat – could then 
draw useful lessons from this information. If time cons traint was an issue for the Secretariat, the data 
collection work could be outsourced. 
297. The representative of the European Communities  noted that conformity assessment was at the 
core of many specific trade concerns raised in th e TBT Committee.  On a general note, he said that 
while in much of the discussion emphasis had been  put on trade facilitation arrangements and MRAs, 
and while the European Communities agreed that these were relevant topics worth discussing, he 
nevertheless wished to stress that the problem  needed to be tackled at its roots: the criteria  to be 
applied for choosing the most appropriate and least trade restrictive conformity assessment 
procedures.  For instance, many problems could be addressed if conformity assessment procedures were closely linked to, for instance, the level of ri sk to be managed. Thus, the European Communities 
suggested that the Committee should also deepen its  exchange of experiences on the use of the most 
appropriate conformity assessment procedures in a give n situation.  He noted that, in the past, this 
issue had been discussed in detail with respect to SDoC. There was, however, a full range of 
intermediate conformity assessment procedures in be tween the extremes of third party certification 
and SDoC capable of meeting the requirements a nd legitimate objectives of Members that could be 
explored.   
298. With respect to the proposals on the table, th e representative of the European Communities 
noted that the success of regulatory cooperation arrangements very much depended on the objective 
being sought and the level of economic development of the part ner countries.  He was willing, 
together with other Members, to work towards the establishment of an inventory of existing practices G/TBT/M/48  
Page 62  
 
  and develop a document that could perhaps serve to update the existing list of trade facilitation 
arrangements.
13 
299. With respect Singapore’s recommendations on MRAs , and as had been noted before:  MRAs 
that were not based on a prior approximation of legi slation and that were between countries that had 
very different levels of developm ent and different regulatory envir onments, in practice did not work.  
In fact, in these cases, the benefits were very sm all, sometimes not even matching the administrative 
costs linked to the operation of the MRAs.  As Singapore had suggested, MRAs needed to be seen as a potential instrument to foster regulatory harm onization.  MRAs based on equivalence or full 
harmonization and that led to closer economic inte gration between countries or regions perhaps had 
some potential and were worth being explored . However, the European Communities cautioned 
against putting too much emphasis on MRAs as a trad e facilitation arrangement; indeed, the fact that 
few MRAs between developed and developing count ries had been concluded was perhaps because the 
preconditions for success did not exist.  What was needed was to look precisely at the preconditions 
for successful MRAs, this needed to be done befo re making any study of the economic effects of 
MRAs. 
300. With respect to the proposal from Mexico on technical assistance, the European Communities 
agreed with the United States: developing a guide in the TBT Committee might be too far reaching and complex a project for the Committee.  Perhaps the Committee could focus on the criteria for the 
choice of the most appropriate conformity assessmen t procedure, this would work toward the same 
objective as the Mexican proposal.  Moreover, t echnical assistance in the area of conformity 
assessment needed to be seen within a wider contex t of promoting a culture of better regulation, good 
regulatory practice, simplification of the regulatory environment, and building an infrastructure in the 
field of conformity assessment so that devel oping countries could reap  the full benefits of 
international trade.  
301. With respect to the Indian proposal to develop guidelines on non-governmental conformity 
assessment requirements, the European Communities saw this as linked to India's proposal on private 
standards.  This appeared to be about conform ity assessment requirements which would be developed 
in the private sector and would have no link to  any governmental measure, to any mandatory 
conformity assessment requirements.  The Eur opean Communities questioned whether the TBT 
Committee was the appropriate forum to examine this issue and whether the measure would be 
covered by the scope of the TBT Agreement. 
302. The European Communities noted that technical  assistance in the conformity assessment area 
needed to also deal with the appropriate enforc ement activities or market surveillance activities that 
should accompany the application of conformity asse ssment procedures.  In other words, building 
capacity in the area of conformity assessment should not be limited to building laboratory capacity, or 
capacity in the field of metrology.  The enforcem ent side was essential. Experience had shown that 
even the most stringent systems of verification n eeded appropriate market surveillance mechanisms. 
303. The representative of Mexico
 offered a point of clarification.  There was a need to consider 
different types of conformity assessment procedures.  For instance, if a system of SDoC was adopted 
because if was considered the simplest way of assessing conformity of a product with a standard, 
there could be consequences: sometime other types of conformity assessment procedures were required, such as third party certification – despite encouragements from trading partners to use SDoC 
in the first place.  It was important that countries had an infrastructure that enabled Member countries 
to monitor or apply any of the systems in a wa y that was compatible with their obligations.  
                                                     
 
13 Indicative List of Approaches to Facilitate A cceptance of the Results of  Conformity Assessment 
contained in document G/TBT/1/Rev.9, Part I, Section II (pp. 6-7) and Annex B (on pp. 35-36).  G/TBT/M/48 
 Page 63 
 
 
  304. The representative of the India  noted, with respect to the EC point on the scope of the TBT 
Agreement vis-à-vis private standards, that TBT Agreement stated that Members "shall take such 
reasonable measures as may be available to th em to ensure that local government and non-
governmental standardizing bodies within their terri tories, ... accept and comply with this Code of 
Good Practice" (Article 4.1 of the TBT Agreement) .  Also: "Members shall not take measures which 
have the effect of, directly or indirectly, requiring or encouraging such standardizing bodies to act in a 
manner inconsistent with the Code of Good Practice. "  He also noted that obligations of Members 
with respect to compliance of standardizing bodies with the provisions of the Code of Good Practice 
applied irrespective of whether or not a standa rdizing body had accepted the Code of Good Practice 
305. The Chairman  concluded by noting that conformity assessment clearly was essential to 
building confidence between trading partners and facilitating regulatory convergence, and the 
Committee attached importance to the continued exchange of informati on in this area.  The point was 
made that it was important to examine not only how  to design conformity assessment procedures but 
also the criteria used in order to decide the most  appropriate conformity assessment approach in a 
given situation in order to  facilitate trade and reduce costs, also taking into account previous work that 
had been done by the Committee.  It was also point ed out that technical assistance remained important 
in respect to building capacity (supply side) for conformity assessment but, again, awareness needed 
to be raised about the choice of approach.  Issu es related to enforcement and product reliability were 
also mentioned as important to consider in the area  of technical assistance.  Experiences with respect 
to the use of MRAs were also recalled and, in this regard, the question of their effectiveness was 
raised, particularly with respect to de veloped-developing country partnerships. 
3. Standards 
306. The representative of Japan  informed the Committee that it had withdrawn its proposal 
regarding the global relevance of in ternational standards (JOB(09)/25). 
307. The representative of India   noted that the multiplicity of standards, guides, recommendations 
posed a serious barrier to international trade – a nd one that had a particularly negative impact on 
developing country exports.  To fully understand th e impact of this diversity and multiplicity of 
standards on developing country exports, India propo sed that the Secretariat undertake a factual study 
to ascertain the impact on trade flows of such standards in selected sectors of developing country export interest.  The study could estimate the additiona l cost borne by developing country exporters in 
complying with these requirements. Members could th ereafter consider the fi ndings and de velop ways 
to resolve the problems so identified. 
308. With respect to private standards, the delegati on of India reiterated its point about Article 4.1 
of the TBT Agreement (see paragr aph 304, above). It was noted that private sector commercial bodies 
were bringing in a range of private standards that  negatively affected access of developing countries 
to certain markets in developed countries. There w as therefore a need for th e TBT Committee to come 
up with guidelines on what "reasonable measures" as re ferred to in Article 4.1 of the TBT Agreement 
meant.  These guidelines could address possible ways in which enforcement of Code of Good Practice 
could be strengthened in respect of private standard setting bodies.   
309. The representative of Mexico
 supported the statement from India.  He noted that the SPS 
Committee had discussed this issue at length and su ggested that the TBT Committee, when discussing 
the matter, enhance its coordination with othe r Committees in respect of this issue.   
310. The representatives of Kenya  and Uganda  supported the proposal by India noting that private 
standards had affected their exports.  Even thou gh these standards were not developed by central 
government, they de facto had the effect of a tec hnical barrier to trade.  Both Kenya and Uganda 
therefore supported the call from India for the TBT Committee to intervene. G/TBT/M/48  
Page 64  
 
  311. The representative of Egypt
 supported the points made by India and Mexico and stressed that 
the TBT Committee needed to give more attention to the subject of private standards given their 
effects on developing country exports.  It would also  be important to invite input other international 
organizations such as the Codex and the ISO; th e Codex had apparently pr oduced an informative 
study on the matter.14   
312. The representative of Cuba  supported calls from more discussion of private standards in the 
TBT Committee – there was indeed a need for more  analysis, particularly in the TBT Committee. 
Coordination was also necessary with the SPS Committ ee.  The representative of Cuba suggested that 
a first step for the TBT Committee could be to id entify the problem, as had been done in the SPS 
context, and, thereafter the Committee could begin to consider specific suggestions on further action.   
313. The representative of Tanzania  stressed the problems his country faced in complying with 
requirements on the international markets that were based on standards.  Technical assistance needed 
to become a priority in this area .  Bother actual infrastructure (e.g. laboratories) and awareness of the 
importance of conformity with standards needed to  be raised.  Without such assistance LDCs in 
particular would not be able to benefit from the multilateral trading system. 
314. The representative of China  supported India's proposal and noted that this was an important 
issue in both the TBT and SPS context.   
315. The representative of Pakistan  noted that the issue of private standards was very complex; it 
required an informed debate.  A dialogue needed to be initiated and intern ational standard-setting 
bodies involved, as had been done in the SPS Committee.  
316. The representative of Argentina  agreed with delegations' views in respect of the importance of 
discussing private standards and stressed that the consequences of these measures did not just affect 
developing country Members but also developed countries. 
317. The representative of the European Communities  referred to his delegation's previous 
statements in respect of private standards.  He  noted that his delegation did not challenge the 
relevance of the concerns raised, rather, the European Communities questioned whether the TBT 
Committee was the appropriate forum for discussi on.  In his view, the problem had not been 
sufficiently defined: the proponents of the discussion on private standards needed to better qualify their concerns and make a clear distinction betw een standards for the purposes of the TBT Agreement 
and what they referred to as "private standards".  In the view of the European Communities, standards 
for the purposes of the TBT Agreement were only those standards developed by "recognized bodies" 
(Annex 1, para 2 of the TBT Agreement).  It was likel y that most of the "private standards" referred to 
by delegations were not developed by "recognized  bodies" for the purposes of the TBT Agreement.  
Delegations were also encouraged to consider pa ragraph 8 of Annex 1 of the TBT Agreement which 
clearly defined the concept of "non-governmental  body".  Any measure falling outside the above-
mentioned definitions did not fall within the scope of the TBT Agreement.  Any eventual discussion 
on the subject needed to be undertaken without prej udice to the TBT Agreement and the role of the 
Committee. 
318. The representative of the United States
 made some preliminary remarks on proposals 
regarding standards.  With respect to Mexico's  observation that greater understanding of how 
standards were used and how regulators and market participants determined which standard was most 
relevant and effective in meeting their objectives, th e United States was of the view that this could be 
                                                      
14 See Codex document: ALINORM 09/32/9D-Part II (The Impacts of Private Food Safety Standards 
on the Food Chain and on the Public Standards – Setting Process, Paper prepared for FAO/WHO by Spencer 
Henson and John Humphrey).  G/TBT/M/48 
 Page 65 
 
 
  useful.  He noted that the Standards Workshop held in March 200915 had been a good start to the 
discussion and suggested that more work was need ed before any further Committee recommendations 
would be appropriate. The United States also supported Mexico's recommendation to look at 
documented successes.  Again, Me mbers' presentations at the March Workshop had given a clear 
picture of the challenges as well as the economic and social benefits of participating in the 
development and use of international standards;  the exchanges had offered important practical 
information on the relationship between standards and trade.   
319. The representative of the United States also t ook note of India's proposal to require Members 
to explain deviations from international standards and specifically the provisions of its proposal to 
exempt developing countries.  However, the Unite d States could not understand the manner in which 
the use of – or deviation from – international standa rds was necessarily related to risk.  International 
standards were used for many purposes, including w ith respect to addressing risk.  The United States 
was interested in learning more from India about the elements of India's regulatory framework and 
decision-making process, including how Indian regul ators made a general linkage between risk and 
international standards.  With respect to India' s proposal that internati onal organizations should 
modify international standards that were not globa lly relevant to become relevant within a fixed 
period of time, the United States recalled the relevant Committee Decision of 200016 which called on 
international standardizing bodies to put in place proc edures to identify and review standards that had 
become obsolete as well as to put in place proce dures to communicate this with the WTO. Perhaps 
rather than request a fixed period of time, the Committee could request updates from international 
standardizing bodies on their procedures to review  standards and identify ones that may need 
updating.   
320. With respect to private standards, the United Stat es shared some of the concerns raised by the 
European Communities. It was not clear what the te rm "private standard" meant and it was not clear 
that the Committee had done enough work to include it in the Fifth Triennial Review.  The United States questioned the need for the Committee to cl arify the term: it was not a term used in the 
Agreement and, in addition, it was not obviou s how clarification could benefit Members' 
implementation of the Agreement. In the view of the United States, standards driven by the private 
sector ensured market relevant and efficient techni cal solutions.  The Committee had, moreover, been 
discussing standards developed in private sector bodies for many years, including at the March 
Workshop. 
321. The United States drew the Committee's attention to a new OECD study on the Use of 
International Standards in Technical Regulation whic h was, at the time of the meeting, work in  
progress and expected to become available in October 2009.
17  The representative of the United States 
noted that the study laid out both the definitional and analytical challenges involved in identifying whether and how international standards were actually  being used in regulation in any systemic way. 
Despite these difficulties however, one of the OECD study's primary findings was that Canada, the 
European Communities, Japan, Korea, Mexico and th e United States had all taken steps to meet their 
TBT obligations in using relevant international standards as the basis of technical regulations where 
possible.  The United States supported efforts by th e TBT Committee to continue its engagement and 
exchange of experiences between TBT and standards experts, including by inviting Members to share 
national experiences on public-private collaboration,  particularly with respect to case studies on 
stakeholder outreach and engagement in the de velopment of national technical committees and 
                                                     
 
15 A Summary Report of the WTO TBT Workshop on Good Regulatory Practice is contained in 
document G/TBT/W/287.  
16 Paragraph 4 of the Decision on Principles for the Development of International Standards, Guides 
and Recommendations with Relation to Articles 2, 5 and Annex 3 of the TBT Agreement, contained in document G/TBT/1/Rev.9, Part I, Section III (pp. 10-12) and Annex B (on pp. 37-39). 
17 TAD/TC/WP(2009)12, OECD, 27 May 2009. G/TBT/M/48  
Page 66  
 
  technical infrastructure as the examples from the March Workshop from Peru, Kenya, Pakistan and 
others made clear. These types of efforts could yield important benefits to trade.   
322. The representative of India
 noted, in reference to the US statement, that while the term 
"private standards" had not been used in the TBT Agreement, standards framed by non-governmental 
bodies had been used.  Regarding the EC point on the definitions contained in the TBT Agreement, 
the definition of non governmental body was an incl usive definition which also included NGOs that 
had legal power to enforce technical regulations.  He clarified, on a general note, that India's 
suggestion regarding private standards was for the prep aration of a format similar to the one that had 
been circulated by the SPS Committee aimed at  collecting information from Members who were 
interested in providing the information.18 
323. The representative of Japan  noted, in respect of private standards, that his delegation shared 
the views of the European Communities and th e United States: the TBT Committee needed to 
distinguish between a standard under TBT Agreement and a "private standard". 
324. The representative of Egypt  noted that the Committee was at an early stage of understanding 
what the relevance of the TBT Agreement was to th e private standards;  no actions or decision could 
be taken in the Committee before an informative discussion had taken.  What was needed was an 
exchange of opinions and ideas, not a legal discu ssion on definitions and sc ope.  Moreover, the TBT 
Committee should not fall behind other Committees that were already discussing the issue.  
325. The representative of Cuba  agreed with India that the definition of a standard in Annex 1 of 
the TBT Agreement was sufficiently broad to be ab le to allow for a relevant discussion within the 
TBT Committee.  Because the issue had not been adequately analyzed and time was short Cuba 
suggested that delegations continue to analyze this topic and that the Members recommend that 
discussion be perused in the Committee as part of its future work.    
326. The Chairman  concluded by noting that during the di scussion delegations had focused mainly 
on the issue of private standards – although other pr oposals on the table also dealt with other aspects 
of standards.  He noted that it was clear from th e interventions that there were concerns from a 
significant number of developing country Members about the negative impacts on market access of 
private standards.  In general, it was possible to  say that the TBT Committee's discussion of private 
standards was at the early stage and several delega tions were seeking conti nued debate and dialogue.  
Some delegations had also stressed the need for the TBT Committee to consider the work of other 
committees in this area, particularly the SPS Committee, as well as the work of other organizations.  It 
had also been pointed out that any discussion of private standards needed to take place without 
prejudging any legal aspects, including the scope of the TBT Agreement.   
327. The Chairman also pointed out that, more gene rally, the importance of technical assistance in 
the area of standards was stressed:  it remained impo rtant to build the capacity to participate in the 
work of international standardization bodies and to reinforce or build capacity to comply and show 
conformity with such standards.  Members also e xpressed a wish to continue to exchange information 
about the benefits of the use of internationa l standards and a few studies and work of other 
organizations had been mentioned. 
                                                      
18 See G/SPS/W/232 and G/SPS/GEN/932.  G/TBT/M/48 
 Page 67 
 
 
  4. Transparency 
(a) Notifications 
(i) Technical regulations and conf ormity assessment procedures 
328. The representative of the European Communities  introduced his delegation's paper on 
transparency (G/TBT/W/309).  He pointed out th at the EC paper reviewed the existing body of 
recommendations in the field of transparency an d that, in his delegation's view, some of these 
recommendations were not fully applied by Members.   The paper also described the EC experience on 
the adjustments, which had been made in the EC internal practice to comply with those 
recommendations.  In some cases the paper propo sed suggestions on how to further enhance the 
implementation of the transparency provis ions contained in the TBT Agreement. 
329. With respect to the proposed recommendations on notifications, the representative of the 
European Communities stressed th at there were cases where measu res which should have been 
notified were not notified.  This could be due to the lack of internal regulatory coordination 
mechanisms.  In some cases, however, it could also  be a deliberate choice of Members not to notify 
certain measures which were considered as framew ork legislation requiring further implementing 
measures.  His delegation believed that this de prived Members from the opportunity to address 
potential concerns at a sufficiently ear ly stage.  There could also be cases in which it could be difficult 
to determine the appropriate timing of notification,  in particular when measures were developed by 
national parliaments where procedures might be mo re complex, involving in some cases different 
drafts being simultaneously discussed.  His delegation was interested in other Members' views on these issues.   
330. The representative of the United States
 agreed with the European  Communities that in some 
instances technical regulations and conformity assessment procedures were not being notified as 
required under the TBT Agreement, or, that they were  only being notified after they had been adopted 
and agreed.  The implementation of the notificatio n obligation could be improved.  However, his 
delegation disagreed that the Committee should in terpret the scope of that obligation.  The 
Committee's efforts would be better focused on ways to improve Members' notification practice, for 
example by continuing discussions on ways to promot e better internal coordination and application of 
good regulatory practices.  In this regard, the United States emphasized the importance of Members 
having mechanisms in place for effective internal coordination and drew the Committee's attention to 
the US proposal in this regard (G/TBT/W/315).  
• Submission of notifications (Format and Guidelines) 
331. The representative of Singapore  introduced the proposal contained in G/TBT/W/312.19  She 
explained that the proposal was about the refinement of the TBT notification format in order to create 
a tracking mechanism on the use of international standards.  Article 2.4 of the TBT Agreement 
encouraged the use of internationa l standards where technical regulations were necessary.  In light of 
the importance of the relationship between intern ational standards and t echnical regulations, her 
delegation believed it would be bene ficial to monitor the use of international standards in the 
elaboration of technical regulations.  One suggested refinement was to include an additional section in 
the existing TBT notification format, describing whether the technical regulation was based on a relevant international standard that existed.   
332. The representative of Singapore further noted th at in the SPS notification format, Members 
were required to state if the SPS measure was based on any relevant existing in ternational standards.  
                                                     
 
19 See also JOB(09)/16/Rev.2, para.14. G/TBT/M/48  
Page 68  
 
  If the SPS measure deviated from international sta ndards, Members were required to set out the 
reasons for this.  She pointed out that the Comm ittee could consider adopting the SPS notification 
format and include a similar section to the existi ng TBT notification template.  Based on the revised 
template, the Committee could then consider a mon itoring mechanism on the extent to which the new 
technical regulations notified were  based on relevant existing intern ational standards.  This could 
enable Members to see where regulatory convergence was higher and where it was low.  It would also 
help Members understand and possibl y mitigate regulatory divergences. 
333. The representative of Switzerland
 welcomed the proposal from Singapore.  However, she 
stressed that pursuant to Article 2.9 of the TB T Agreement, Members were only obliged to notify 
draft technical regulations when no relevant interna tional standard existed or the technical content of 
the proposed technical regulation was not accordance with the technical content of relevant 
international standards.  Therefore, statistics on the extent to which notified t echnical regulations were 
aligned with international standards would not be very useful.  Moreover, in the context of trade 
policy reviews, Members had to inform the Secretar iat to what extent national standards were based 
on international standards.  In he r delegation's view, it would be be tter to extract information on the 
Member's alignment with international sta ndards from the trade policy review reports.  
334. The representative of Israel  supported Singapore's proposal.  His delegation remained 
confident about the benefits derived from greater tr ansparency.  In this respect, Members should take 
into consideration and, to the extent possible, ha rmonize their local regulatory framework to existing 
international standards so as to minimize a negativ e effect associated with regulatory divergences. 
• Notifications of Proposed Technical Regulations  and Conformity Assessment Procedures of 
local Governments at the level directly below that of the Central Government 
335. The representative of the European Communities  introduced his delegation's proposal on the 
topic (G/TBT/W/309, para. 10).20  He noted that this issue was about effective regulatory 
coordination, in particular between the central level and the local level.   This was particularly relevant 
to those Members with a federal or a regional stru cture which delegated subs tantial regulatory powers 
to the local level.  Notifications of measures take n at a level below the central government level had 
increased in recent years, but were still below the ac tual level of regulatory activity at some federal 
sub-state levels.  His delegation encouraged the Co mmittee to continue to discuss ways to improve the 
coordination between central and local state level.   He invited those Members with experiences on 
this issue to share these so that other Members c ould learn from those good practices.  He also invited 
the Secretariat to continue to provide statistical information on this matter. 
336. The representative of the United States  supported the proposal by the European Communities.  
He noted that in the United States the notification of  sub-federal regulations posed some challenges.  
Despite this, the United States had been able to increase the number of notifications: for example, 
over the last two years, about 120 sub-federal me asures had been notified. Unfortunately the United 
States appeared to be the only Member that was doi ng this consistently.  He stressed the importance 
of other Members putting procedures in place to  ensure that this obligation was met.  
• Length of time allowed for comments 
337. The representative of Jordan  introduced her delegation's proposal  contained in paragraph 4 of 
G/TBT/W/311.21  She recalled the recommendation adopted by the TBT Committee that encouraged 
all Members to provide more than 60 days for co mments.  Jordan proposed that a 75-day comment 
period be provided by all Members, especially si nce many notified documents were not provided in 
                                                      
20 See also JOB(09)/16/Rev.2, para. 15. 
21 See also JOB(09)/16/Rev.2, para. 16.  G/TBT/M/48 
 Page 69 
 
 
  WTO official languages, and some of the comment pe riod was consumed in translating the document.  
The representative of Jordan also  noted that some Members esta blished a specific deadline for a 
submission of comments on the notification format.  However in some cases, administrative procedures could delay the circulation of the notifica tion.  Therefore, Jordan proposed that a period of 
75 days be provided, starting from the date  of circulation of the notification. 
338. While the representative of Canada
 understood the need to translate notified measures and the 
fact that one could not always rely on immediate circulation of notificati ons, there were domestic 
processes which needed to be taken into account an d which relied on having a fixed closing date for 
the comments.  It could be difficult for domestic  processes to be held up by any administrative 
problem which could occur with the circulation of the notification.  Therefore, Canada was of the 
view that the practice of calculating the 60 days  from the date of notification be continued. 
339. The representative of Costa Rica  presented his delegation's proposal on the subject, contained 
in G/TBT/W/319, paras. 8-11. In particular, he stre ssed that notification procedures should provide an 
effective opportunity for Members to become acqua inted with draft regulations and conformity 
assessment procedures as early as possible.  This would help them react quickly to any new 
requirements which might affect market access.  If notifications were to achieve this objective, the 
obligation to make notifications at an early stage,  and not when the measure was at a late stage of 
development or were already in force, should be fu rther stressed.  Making notifications at an early 
stage provided interested Members with the opport unity to ensure that their comments were duly 
taken into account.  
340. The representative of Brazil  echoed Canada's comments on Jordan's proposal.  For example, 
he explained that in Mercosur Members had the obligation to provide a 60 day comment period for 
common regulations. 
341. The representative of the European Communities  fully agreed with the proposal by Costa 
Rica on the need to notify at a su fficiently early stage and to communicate the final version of the 
adopted text.  Concerning the proposal from Jo rdan, he stressed that in the EC submission 
(G/TBT/W/309, para. 24(b)) his delegation had suggest ed that a period of 90 days should be provided 
when the notification was not in one of the three WTO official languages.  His delegation's preference was to keep this aspect of flexibility in the length of time allowed for comments and believed that 60 
days was is principle an adequate period of time wh en the notified text was available in one of the 
WTO official languages.  A longer period of 75 days  in all cases, as suggested  by Jordan, could be 
difficult to comply with due to internal domestic c onstraints and applicable domestic procedures.  On 
the other hand, his delegation agreed with Jordan that a comment period of 60 to 90 days was better 
than a specific date indicated on the notification fo rm and that his delegation also saw the advantage 
of certainty if the period of time for comments w ould start from the date of circulation of the 
notification rather than from the date of notification.   
342. The representative of Kuwait
 supported the proposal by Jordan to allow 75 days for 
comments starting from the date of circulation of the notification. 
343. The representative of Japan  shared the views expressed by Brazil and Canada and believed 
that 60 days for comments was an adequate period. 
344. The representative of China  supported the point that the comment period should be calculated 
from the date of circulation of the notification.  Indeed, China always pr ovided a comment period of 
60 days starting from the date of circulation of the notification.   
345. The representative of Chile  agreed with Jordan's proposal that the comment period should be 
calculated from the date of circulation of the no tification.  However, the proposed 75 days for G/TBT/M/48  
Page 70  
 
  comments might pose difficulties.  For example, in Chile, there was a Decree on Good Regulatory 
Practice which required institutions  dealing with technical regulations or conformity assessment 
procedures to leave a period of at least 60 days for comments.  This could be longer than 60 days, but 
could not be definitely set to 75.  The comment  period could be extended when requested.  She 
stressed the importance of Members leaving an appr opriate comment period on  the notified measures.  
Indeed, sometimes difficulties arose when Members did not provide any comment period at all.  
346. The representative of Argentina
 also agreed that the comment period should be calculated 
from the date of circulation of the notification.  He supported the comments made by the European 
Communities on this point.  
347. The representative of Egypt  supported the proposal to calculate the comment period from the 
date of circulation of the notification.  He also  agreed with a proposal by the European Communities 
to extend to 90 days the comment period when th e measure notified was not in one of the WTO 
official languages.  
348. The representative of Cuba  supported the proposal from Jordan and agreed that the time for 
comments should be calculated from the date of circula tion of the notification.  She also supported the 
proposal by Costa Rica in this respect.  Additiona lly, she suggested that the Committee should take 
note of the way Members took into account the comments made on notified measures. 
349. The representative of Ecuador  supported the proposal from Jordan .  In respect of the length of 
time for comments, his delegation's preference was 90 days. 
350. The representative of Mexico  stressed that the debate on transparency should focus on how to 
comply with the existing set of obligations and recommendations.  He pointed out that very few 
Members were complying with the recommended peri od of 60 days.  In some cases, notifications 
were made and measures entered into force immedi ately.  In other cases, short comment periods of 
15-20 days were granted.  Therefore, he believe d that Members should at least comply with the 
recommended comment period of 60 days, starting from the date of circulation of the notification.  Furthermore, in many cases, comment periods were established by domestic legislation.  In the case 
of Mexico, for example, public consultation be gan from the moment of the publication of the 
regulation in the official gazette.  If a different length of time for comments from WTO Members was granted, this would have consequences on the time for comments granted domestically.  
351. The representative of the United States
 supported the points made by Mexico.   
• Handling of comments 
352. The representative of th e European Communities  presented his delegation's proposal on the 
issue (G/TBT/W/309, para. 24).  He stressed that  proper handling of comments was key to enabling 
an effective exchange between Members on notifie d drafts.  Although the provisions of the TBT 
Agreement did not provide any obligation to respond in writing to comments made, the TBT Committee had recognized that a written response to  comments received was the most effective way 
to enable a real dialogue and effective exchange between the notifying and the respondent party. He pointed out that in some cases Members did not or rarely provided writte n answers to comments 
received.  This could be due to a lack of operati onal capacity of the notification and enquiry points.  
When this was the case, technical assistance projec ts could be used to build capacity, especially in 
developing and least developed countri es.  However, in other cases, it was a deliberate choice of some 
Members not to provide a written reply before th e adoption of the notified text.  His delegation 
believed that such an approach was not fully consistent with the aim of Article 2.9.4 and 5.6.4 of the 
TBT Agreement.  He pointed out that the Co mmittee should reaffirm the importance of the 
recommendation to provide written replies to comments made.  His delegation was also interested in  G/TBT/M/48 
 Page 71 
 
 
  continuing to explore ways to further improve eff ective implementation of the provisions of the TBT 
Agreement on the handling of comments.  
353. The representative of Jordan  introduced her delegation's proposal on the topic 
(G/TBT/W/311, para. 2).  She pointed out that the Secretariat could provide a platform for notifying authorities to post comments received from other Memb ers and responses.  She also recalled that in 
the Fourth Triennial Review the Secretariat had b een invited to prepare a list of national websites 
based on information provided by Members.
22  
354. The representative of Mexico  was in favour of the creation of a website where comments sent 
and replies received could be posted.  He stresse d the importance of providing written replies to 
comments.  
355. The representative of Argentina  supported the proposal made by the European Communities.  
356. The representative of the United States  pointed out that his delegation had no difficulty in 
reaffirming previous Committee's recommendations.  However, his delegation did not support re-
writing or re-casting those recommendations as the EC proposal appeared to do.  He emphasized that 
"encouraging" and "voluntarily" were key elemen ts in the existing Committee's recommendations on 
this issue and these terms should remain prominent in  any new text.  More fundamentally, the aim of 
Article 2.9 of the TBT Agreement was to ensure  that Members took comme nts and the results of 
discussions into account.  He noted that the US recommendation in its submission on Good Regulatory Practice
23 which encouraged Members to share experiences in this regard sought to 
address this issue from a performance perspective.  The EC proposal sought to address the obligation 
to take the comments into account from a design perspective, using Members' filing of written 
responses to comments prior to finalizing the m easure as a proxy for taking comments into account. 
He pointed out that this proxy would not necessarily  indicate whether the Member took the comments 
received into account in finalizing the measure, for ex ample if the response was simply dismissive of 
the concerns raised.  His delegation encouraged those Members who chose to provide meaningful 
written responses to comments prior to finalizing meas ures to continue to do  so, as these responses 
could contain useful information and noted that th e United States included, al ong with the publication 
of its final measures, an explanation of how it took into account the comments received, whether oral or written.  
357. With respect to the proposal from Mexico a nd Jordan to create a platform to collect 
comments, the representative of the United States we lcomed these expressions of interest in sharing 
comments and agreed that greater transparency  in the exchange of comments could improve 
understanding in the Committee, particularly by tho se delegations that did not actively participate in 
the discussions on specific trade concerns.  However,  he recognized that these types of websites took 
resources to create and maintain and would be interest ed in the Secretariat's views as to whether there 
were sufficient and appropriate resources at its disp osal for such a task.  He also wondered whether 
there were other options available.  For example, the United States maintained a single website for all 
regulatory activities
24 and noted that other Members had similar websites.  He further noted the 2006 
Committee recommendation to request the Secretariat to  prepare a list of these websites and sought an 
update of that information.25 
358. The representative of India supported the proposal by Jordan and Mexico. 
                                                      
22 G/TBT/1/Rev.9, page 19. 
23 G/TBT/W/315. 
24 www.regulation.gov  
25 Information on websites is contained in document G/TBT/GEN/39, Rev.3. G/TBT/M/48  
Page 72  
 
  359. The representative of China
 supported the proposal that written replies of comments should 
be provided, in particular to comments made by de veloping Members.  If a reply to comments was not 
received, Members might lose the chance of follow- up consultations to furt her express positions and 
make contributions to the final texts of the notif ied measure.  Also, if no information was provided 
about the development of the notified text, a Me mber would not be able to pass on relevant 
information to domestic industry at an early st age.  This could undermine the objectives of the 
transparency obligations.  
360. The representative of Switzerland  welcomed the EC proposal to share information on 
comments received and replies thereto.  Her delega tion also welcomed the suggestion by Jordan and 
Mexico that the Secretariat provide a central pl atform where all comments and written replies could 
be posted.  She also suggested that the Secretar iat could monitor the number of comments and replies 
issued by the Members and could publish statistics in this respect.  
361. The representative of Canada  pointed out that in some cases not providing written replies to 
comments was not a matter of principle, but a matte r of law.  In Canada, any regulation was cabinet 
confidence until it was published.  While Canada trie d to reply in writing to all comments received, it 
was sometimes limited in how much detail could be provided as a result of its domestic laws.  
However, even if the written replies were not as complete as other Member might like, comments 
were taken into account.  The representative of Cana da also pointed out that in her country comments 
were not published.  Therefore, her delegation would not support the proposal by Jordan and Mexico 
to create a platform where all co mments and replies thereto could be  published.  She also wondered 
whether the Secretariat would have the resources to carry out this task. 
362. The representative of Cuba  stated that the various proposals on the handling of comments 
constituted a good basis for the Committee's work.  However, she was concerned about the cost 
implications of some of the proposals, for example the creation of websites.  She also suggested that 
experiences in other Committee should be considered. 
363. The representative of the European Communities  pointed out that the purpose of his 
delegation's proposal to provide written replies to  comments was not to force unnecessary changes in 
the laws of some Members.  At the same time, he noted that, especially for developing country 
Members, follow-up would be difficult without a written reply to their comments,.  Developed 
countries had more resources and other means to pursue a dialogue bilaterally with the Members concerned.  A reply pointing out what the state of play of the notified draft was and giving a contact point for further information coul d at least be one step forward.  The fact that no response was 
provided and feedback was only given together with  the adopted text was not, in his delegation's 
opinion, a satisfactory response to the legitimate requ est to have a meaningful dialogue with notifying 
parties.  If there were constraints due to intern al laws, Members could reconsider whether those 
constraints, for instance on the confidentiality, were always fully justified, or whether the necessity of 
fully complying with the transparency oblig ation in the TBT Agreement would recommend a 
revisiting of provisions in internal laws.   
364. The representative of Canada
 noted that her delegation could certainly provide a reply 
acknowledging receipt of comments as well as providing a contact point.  
365. The Chairman  noted that discussions had taken place regarding the importance of handling of 
comments.  There were existing recommendations of  the Committee in this regard that could be 
reaffirmed.  He pointed out that the Committee would continue to discuss ways to improve the 
handling of comments.  G/TBT/M/48 
 Page 73 
 
 
  • Follow-up to notifications 
366. The representative of the European Communities  introduced his delegation's proposal 
(G/TBT/W/309, paras 28 and 19), which was in line with the overall goal of achieving the highest degree of transparency throughout the regulatory process, also at the stage after the adoption of a 
measure.  First, his delegation recommended th at Members should systematically communicate the 
adopted text, specifying the date of publication and entry into force by means of addenda to the 
original notification.  Second, when an existi ng technical regulation or  conformity assessment 
procedure was amended this should be notified as a new notification.  His delegation believed that it 
would be clearer if this notification had a diffe rent number from the notification of the original 
measure.  Some cases had been found where revi sions had been notified as addenda and this was 
rather confusing as it was not immediately clear wh ether the notified text was a new notification. 
However, he noted that other Members found it useful  to have a link to the original notification and 
that they would rather favour the notification by means of an addendum or a revision.  He believed that a common understanding on how to go about the no tification of amendments to existing text was 
needed and that it could be helpful to clarify wh en an addendum, a revision or a new notification 
should be made.  The Committee could agree on some basic principles to be followed in those cases 
and to recommend a practice to be followed by all Members.  
367. The representative of Jordan
 introduced her delegation's proposal (G/TBT/W/311, para. 6) 
which suggested that the notification of the availabi lity of the final text be made directly upon the 
adoption of the technical regulation or conformity  assessment procedure, with emphasis on the actual 
date of entry into force. 
368. The representative of Costa Rica  pointed out that his delegation's submission (G/TBT/W/319, 
para. 11) was similar to the EC and Jordian proposal s.  Costa Rica also considered it important that 
Members notify the final version of technical re gulations and conformity assessment procedures 
which were adopted thus providing certainty to  exporters.  The TBT Committee should therefore 
establish appropriate procedures in this respect. 
369. The representative of Israel  supported the proposal by the European Communities and 
stressed that Israel was already in practice comply ing with its terms.  He encouraged Members to 
provide details and updated inform ation related to the implementati on and modification of domestic 
regulations.  Greater transparency and enhanced  communication among Members would help prevent 
negative effects on trade flows. 
370. The representative of Argentina  stressed that, while the procedure to follow up and monitor 
by means of addenda had been useful, sometimes substantive modifications to notified texts had 
remained hidden in the addenda.  Therefore, he s upported the proposal by the European Communities. 
371. The representative of Cuba  supported the proposal by the European Communities and Costa 
Rica.  Any planned changes to notified regulations should be notified as soon as possible to allow the 
possibility to provide comments and to initiate discuss ions on their content.  Appropriate mechanisms 
for this purpose needed to be developed.  She also stressed that the Committee should be more 
specific about the meaning of "taking comments into  account".  She noted that often notifications 
were made and although Members expressed concer ns, the regulation was adopted, in many cases 
without taking into account the concerns expressed.  She believed that this was an essential aspect for 
the smooth operation of the Committee. 
372. The representative of Egypt  sought some clarification on the EC proposal of notifying the 
adoption of the final text by means of addenda.  He  noted that in the notification form Members were 
required to specify the proposed date of adoption and of entry into force of the notified measures.  He 
was not sure that Members needed to notify ag ain by means of addenda when the measure was G/TBT/M/48  
Page 74  
 
  adopted, as this could be burdensom e for notification authorities, in particular when no change on the 
date of adoption had occurred.  If th e date of adoption of the measure or  its content changed, then this 
should be notified to the WTO.   
373. The representative of the European Communities
 pointed out that it was a rare occurrence that 
the date of adoption and the date of entry into fo rce as indicated in the original notification was the 
actual date of adoption and entry into force.  His delegation believed that for the sake of transparency, 
legal certainty and to give adequa te information to economic operators  it was important that the final 
adopted text accompanied by the final date of a doption and entry into force be communicated.  He 
agreed that this was an additional burden on the enqui ry point, but believed that the advantages of this 
practice outweighed the costs.  He believed that the TBT notification system was the most effective 
one because it was the only tool that reached WTO Members in real time.   
374. The representative of Egypt  suggested that the EC proposal could be modified to specify that 
an addendum to the original notification providing information on the date of adoption and entry into 
force of the notified measure should be provided in  case there was a change in the date of adoption 
and entry into force as announced in the original notification form. 
375. The representative of the European Communities  added that often the original notification did 
not provide a date of adoption or entry into force, because this was known only after the notification 
had been made.  He agreed that if dates set out in the notified text was correct, then no new 
notification needed to take place.  However, this would be rare. 
376. The Chairman  pointed out that the Committee could discuss a harmonized practice on how to 
notify modifications in the notified texts and the adop tion and entry into force of the final text of the 
notified measures.   
(b) Dissemination of Information 
(i) Publication 
377. The representative of Mexico  introduced his delegation's proposal that the Committee 
establish procedures to ensure the fulfilment and implementation of the obligation under Article 2.9.1 
of the TBT Agreement (G/TBT/W/313, para. 7).  He  stressed that his delegation had brought this 
issue to the attention of the Committee for a long ti me, since the Third Triennial Review of the TBT 
Agreement.  However, not much progress had been  made on the implementation of this provision, 
which entailed the publication of a notice at an ear ly stage that work was underway on a technical 
regulation or conformity assessment procedure.  There were not many examples of Members 
following an appropriate practice in this regard.  Mexico always notified the national standardization 
programme which was published at the beginning of th e year.  In that programme, Mexico included 
the list of all issues that would be subject to regula tion in the forthcoming year as well as those subject 
to the preparation of voluntary standards.  His de legation believed that this was a practice which could 
be useful for other Members as well.  It would provide useful information for all actors involved, enabling them to be prepared when the publicati on took place or when public consultation occurred.  
He suggested that the Committee reiterate the importa nce of Members sharing this kind of experience. 
378. The representative of Costa Rica
 supported the proposal by Mexico.   
(ii) Texts of Notified Technical Regulations and Conformity Assessment Procedures 
379. The representative of the European Communities  introduced his delegation's proposal 
(G/TBT/W/309, paras. 12-13) for the Committee to reiterate its earlier reco mmendation that Members 
provide direct access to the text of the notified draf t by indicating in the notification form the link to  G/TBT/M/48 
 Page 75 
 
 
  the webpage where the full text could be found or ot herwise provide an electronic version of the text 
to the WTO Secretariat which would then circulate the link to Members.  This practice was already 
applied by the European Communities and did not  pose an additional burden on the TBT enquiry 
point; it had resulted in a great value added for othe r Members who had been given access to the full 
text of EC notified drafts.  He encouraged othe r Members, especially developed Members, to follow 
this practice consistently. 
380. The representative of Argentina  supported the proposal by the European Communities and 
stressed that the proposal also invited Members who did not yet give access to the text of their measure to consider ways of doing so and to provide  information as to why they had not been able to 
do so. 
381. The representative of Egypt
 recalled that the Secretariat had put in place a facility whereby 
Members could send the text of the measure together with the notification and this text would then be 
stored on a server and a hyperlink created in the notification form. 
382. The representative of China  agreed with the proposal of the European Communities.  He 
believed that a hyperlink in the notification form  would save considerable time to make comments 
within limited time period.   
383. The Chairman  concluded that the Committee was ready to reaffirm its earlier 
recommendation to indicate a website in the notif ication form where the draft text could be 
downloaded from.  Members could also consider us ing the facility provided by the WTO Secretariat – 
which the Committee had already agreed upon – where by texts could be sent to the Secretariat in pdf 
form and a hyperlink in the notification form would be created by the Secretariat.26 
(iii) Provision of Translations 
384. The representative of th e European Communities  introduced his delegation's proposals on the 
provision of translations (G/TBT/W/309, paras. 14-17 ) and stressed that the proposals were made with 
the aim of making the comment period as effective as po ssible, in particular when notified texts were 
not in one of the WTO official languages and needed therefore to be translated.  He recalled that the 
TBT Committee had recommended that Members who translated these drafts could share these 
unofficial translations with other Members, either  by posting them on their website or providing those 
translations to the WTO Secretariat for further dissemi nation.  His delegation was of the view that this 
was a very useful, especially for developing countri es which would have faster access to texts in a 
language which would be understandable for them.  He noted that that the European Communities 
was the only Member which was applying this recommendation and wondered why other Members 
who were also translating measures were not shari ng unofficial translations with the WTO.  He 
invited those Members to explain why this recomme ndation had not been followed and if there was 
any impediment in their system to share such  unofficial translations with other Members. 
385. The second part of the EC proposal dealt with  the comment period in cases when a notified 
text was not in one of the WTO official languages.   His delegation believed it would be desirable to 
provide, in such cases, an extended period for comment s of 90 days in principle.  In these cases it was 
also of paramount importance that the description of the content of the notified draft be more detailed 
in order to give a sufficiently comprehensive overv iew of the content of the notified measure on the 
basis of which Members could already start undertaking a preliminary analysis pending the availability of a language version in one of the official languages of the WTO. 
                                                     
 
26 G/TBT/1/Rev.9, page 24. G/TBT/M/48  
Page 76  
 
  386. The representative of Jordan
 introduced her delegation's proposal (G/TBT/W/311, para. 8) 
which suggested that notifying Members review unoffi cial translations of their notified measures and 
publish them as official, and inform the Secretariat of  the availability of such official translations. 
387. The representative of Mexico  also introduced his delegation's submission on the subject 
(G/TBT/W/313, paras. 11(a) and 11(c)) and stre ssed that, like the Euro pean Communities, his 
delegation also believed that unofficial translati ons could considerably improve transparency and 
allowed for a better understanding of notified documents, in particularly for developing countries that 
did not have the financial and hu man resources to carry out the translations themselves.  Sharing 
translations was a way of saving resources and promoted the sharing of information between 
Members.  He reiterated the importance that Me mbers, particularly developed country Members 
shared unofficial translations they had.  With r espect to the EC proposal of extending the deadline for 
comments when a text was not in a WTO official  language, he believed th at emphasis should be 
placed on the fact that it be for developed countries. 
388. The representative of India  illustrated his delegation's proposal with respect to the provision 
of translation (G/TBT/W/314, para. 2).  He pointed  out that the non-availability of a full text in 
English and other WTO languages was a major obstacl e in the examination of TBT notifications by 
developing countries and in the provision of effective comments.  This in turn affected their ability to 
export once the measure was adopted.  Even if Eng lish translations were la ter made available by 
Members such as the European Communities, this in volved some delays and the effective period for 
providing comments was reduced in the process.  He stressed that the WTO Secretariat, with the help 
of developed country Members, should work out a form al mechanism to make translations of full text 
in English and other WTO languages to available Members.  Also, to make up for the lost time in 
translation process, the comment period should be at  least 90 days.  While his delegation agreed that 
the description of the content of the notified draft should be comprehensive a nd give a more detailed 
overview of the envisaged technical regulation or conformity assessment procedure, the WTO Secretariat needed to work out an appropriate format on the basis of su ggestions provided by 
Members. 
389. The representative of Brazil
 recognized the importance of enhanced transparency but 
considered that the EC proposal on provision of translations could pose a significant burden on Members, especially developing Members, in partic ular those that did not have a WTO language as its 
official language.  Developing countries would encounter difficulties finding the resources needed to translate every new regulation since there were othe r priorities in their regulatory activities.  Brazil 
also believed that the proposed comment period of 90 days for notified regulations that were not in 
one of the WTO languages would affect several de veloping countries that already had operational 
difficulties to provide the current 60 day comment peri od.  Moreover, there would also be legislative 
difficulties to implement this proposed co mment period in countries like Brazil. 
390. The representative of the European Communities
 explained that the goal in promoting the 
sharing of unofficial translation was to assist  developing countries, precisely because they had more 
difficulties in translating documents.  The r ecommendation was mainly addressed to developed 
country Members so that they shared translated documents.  Developing countries were the beneficiaries of this recommendation.  On the comm ent period, he stressed that 60 and 90 days were 
already in the existing recommendations, so his de legation was just referring to current practice. 
391. The representative of Kenya
 noted that Members who made unofficial translations, like the 
European Communities, might do so only for texts of interest to them, which might not necessarily 
apply for developing countries.   The issue of fu ll texts that were only made available in languages 
other than WTO official language had been a problem  especially for developing and least developed 
countries.  Therefore her delegation supported the pr oposal by India that the Secretariat could look 
into ways of coming up with a centralized formal  mechanism to make translations of full text  G/TBT/M/48 
 Page 77 
 
 
  available in English and other official languages.   This would make it possible for Members to 
evaluate the implication of such regulations on their exports. 
392. The representative of Korea  agreed that it was important to make translations available to 
provide more information to WTO members.  Howe ver, he pointed out that technical regulations 
were, by their very nature, different documents from ordinary legal texts and that sometimes referred 
to standards which were very long, and whose cont ent was difficult to translate.  Therefore, he 
expressed reservations about the EC proposals on this issue.   
393. The representative of Singapore  supported the proposals made by the European Communities, 
Jordan, Mexico and India.  Even if unofficial, the translated text would promote transparency which 
was the key area of the Committee's work.  Not only would this facilitate a more effective comment 
procedure, it would also help Members to better understand and comply with the technical regulation 
and to minimize disruption to trade flows. 
394. The representative of Argentina  believed that the issue of translations was important for 
developing countries due to the lack of resources to  make the necessary translation of notified texts 
which were in languages other than WTO official languages.  He also emphasized that there was no 
mandatory requirement for developing countries to provide translations in official WTO languages. 
He noted that often work was carried out to tran slate notified texts and when the translation was 
finally received the comment period had already elapsed.  He believed there should be some 
flexibility from Members to extend the comment pe riod to 90 days.  He further supported India's 
proposal for an appropriate format to ensure that the description of the content of the notified draft 
was comprehensive and provided a more detailed overview of the e nvisaged technical regulations. 
395. The representative of Chile  agreed with the proposal by the European Communities to 
encourage developed country Members to provide uno fficial translations.  On the proposal of Jordan 
for the notifying Member to analyze unofficial transl ations, her delegation belie ved that this posed an 
excessive burden on notifying Members.   
396. The representative of Colombia  expressed support for the proposals by the European 
Communities.   
397. The representative of China  supported the EC proposal that Members should be encouraged 
to share unofficial translations on documents referred to in the notification.  He appreciated the work 
done by the European Communities in this respect.  However, with regard to the EC proposal that 
Members whose notified texts were not in an official WTO language provide a 90-day comment 
period, his delegation shared the same concerns  expressed by Brazil.  In addition, it was his 
delegation's view that Members whose language was not an official WTO language faced even bigger 
challenge in terms of burden of translation work.  Most of these Members were developing country 
Members, which made this challenge severe.  He  drew Members' attention to the recommendation 
adopted by the Committee at the Third Triennial  Review (G/TBT/13, para 26) in which the 
Committee agreed to recognize that, to improve the ability of developing countries Members to 
comment on notifications, and consistent with th e principle of special and differential treatment, 
developed country Members were encouraged to provide more than a 60 day comment period.  His delegation wished to reiterate this recommendati on that developed country Members should provide 
more than 60 days period for developing country Members to have sufficient time to present their 
comments, while developing country Members and LDCs were encouraged to provide a 60 day 
comment period. 
398. The representative of the United States
 agreed with the point made by Brazil, Korea and 
China with respect to translations.  His dele gation did not support differential obligations and 
procedures based on the mother tongue of WTO Memb ers.  With respect to Jordan's proposal on G/TBT/M/48  
Page 78  
 
  translations, it was his delegation's view that unofficial  translations should remain unofficial.  Official 
translations were more costly, more time consuming and carried le gal liabilities.  If all unofficial 
translations were forced to be official, it was likely that many Members would be unwilling to provide 
translations, thus reducing the availability of translations rather than improving it. 
399. The representative of Mexico
 emphasized that his delegation supported the proposal to 
encourage sharing of translations, but did not support that more days should be provided for 
comments by those countries whose notified measures we re not in a WTO official language.  He also 
shared Chile's views with respect to the pro posal from Jordan on the revision of unofficial 
translations.    
400. The Chairman  noted that from the discussions it was clear the provision of translation was 
particularly important for Members.  He recalle d that a mechanism for the notification of the 
existence of unofficial translations had been put in place in December 2007.27  Since then, 170 
supplements to notifications of the existence of  unofficial translations had been received and 
circulated.  From the number of proposals on this issue, it was clear that Members continued to be 
interested in how to improve access to and sharing of tr anslations of notified text.  In light of this, the 
Committee could possibly reaffirm the earlier recommendation for Members to share unofficial 
translations by posting them on websites or providing such translations to the Secretariat to the established mechanism for further dissemination.  The Committee could consider ways to further 
improve transparency when notified text were not in one of the WTO official languages including, for 
example, a more detailed description of the measure in the notification.   In order to strengthen 
understanding of the issue the Secretariat could be to provide statistical information on unofficial 
translations. 
(c) Enquiry Points 
401. The representative of the European Communities
 introduced his delegation's proposal 
(G/TBT/W/309, paras. 7-8).  He stressed that a well functioning enquiry poi nt with good operational 
capacity allowed better compliance with the transpar ency obligation and more effective participation 
of Members in the mechanisms that the TBT Agre ement provided in relation to the notification of 
draft texts.  He highlighted that the EC submission discussed potential causes for lack of operational capacity in enquiry points and also pointed at tec hnical assistance as one of the means to enhance such 
capacity in developing countries.  He explained that the European Communities had been involved in several such successful projects and also regularly welcomed TBT experts from developing countries on study visits.  Sharing experiences on how the EC TBT Enquiry Point had been set up had 
contributed to creating better operational capacity.  It was important to explore how technical 
assistance could be used in order to overcome difficu lties developing countries in particular faced in 
this area. 
402. The representative of Mexico
 pointed out that in his delegation's submission there was a 
section on technical assistance (G/TBT/W/311, para. 31), which also related to enquiry points.  
403. The representative of Korea  sought more information on the type of technical assistance that 
the European Communities provided to enquiry points and on how to make a request in this respect. 
404. The representative of the European Communities  explained that EC technical assistance 
projects were normally four or five years long and, whenever there was a TBT component, building the operational capacity of enquiry points was one of  the typical activities that was undertaken in the 
framework of such projects.  Potential beneficiary c ountries were encouraged to flag their interest in 
receiving assistance in this area through the EC delegations in these countries. 
                                                     
 
27 See G/TBT/GEN/66.  G/TBT/M/48 
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  5. Technical Assistance 
405. The representative of Jordan  proposed that the Secretaria t circulate the format for the 
voluntary notification of specific technical assi stance needs and responses (developed by the 
Committee in 2005) at the end of every year (G/TBT/W/311).28  Also, Jordan proposed that the 
Secretariat provide feedback to countries requesting technical assistance on the status of their request, 
as well as feed-back to the provider of technical ass istance.  Finally, Jordan also proposed that the 
Secretariat include GRP in its technical assistance and training plan in the form of a specialized 
workshop. 
406. The representative of Mexico  drew the Committee's attention to the well-known problem of 
high turn-over among officials dealing with sta ndards and conformity assessment in developing 
countries.   Frequently, in Mexico, officials that ha d been trained were attracted by the private sector 
and when they left this resource was lost to the government.  To counter this, Mexico was proposing 
to set up a certified quality assurance system based on international standards.  More detail is set out 
in Mexico's proposal (G/TBT/W/313, paras. 26.34) .  Such a system would be superior to the 
traditional technical assistance activities (workshops , seminars, etc.), for instance because it 
strengthened institutions – a perm anent benefit for the government. 
407. The representative of Jordan  wished to emphasized the need  to enhance the capacity of 
enquiry points.  It was noted that a more target ed type of assistance directed at the operation of 
enquiry points would be beneficial, for instance through targeted e-training courses.  The representative of Jordan also brought up the impor tance of interaction between Members' enquiry 
points and pointed at mentoring systems as a possibl e option to be explored.  Both these ideas could 
enhance efficiency of technical assistance in the TBT area. 
408. The Chairman
 concluded by recalling that the Committe e's work and decisions in the area of 
technical assistance were captured on pages 29-33 of document G/TBT/1/Rev.9.  He noted that 
Members had, on a regular basis, exchanged experiences and information on technical assistance in order to enhance the implementation of Article 11 of the TBT Agreement. In fact, technical assistance 
had been considered an area of priority work for the Committee si nce its establishment:  it figured on 
the agenda of the Committee on a permanent basi s. The Chairman suggested that the Committee 
could reaffirm the importance and priority attribut ed to technical assistance and further emphasize the 
weight of technical assistance in the areas of GRP a nd transparency in particular.  In the area of 
transparency, one example of targeted technical as sistance could be activities aimed at enhancing the 
operation of enquiry points, for instance through e-training or mentoring mechanisms. The Committee 
could also stress the importance of supply side capacity building in the area of conformity assessment 
for the development of appropriate quality infrastru cture and efficiency using national and all regional 
expertise to this effect. 
6. Operation of the Committee 
(a) Consideration of Specific Trade Concerns (STCs) 
409. The representative of Canada
 introduced her delegation's proposal on specific trade concerns 
and noted that the version currently being discussed (JOB(09)/50) was the result of a discussion with several delegations. 
410. The representative of India
 supported the Canadian proposal and drew the Committee's 
attention to some minor suggestions provided in their submission (G/TBT/W/314).  In particular, 
India proposed that developing countries should have 20 days (instead of 10 days) to respond 
                                                      
28 G/TBT/16, dated 8 November 2005. G/TBT/M/48  
Page 80  
 
  appropriately to the STCs raised against them a nd that these (those STCs raised against developing 
countries) should be communicated to the at least one month in advance. 
411. The representative of Costa Rica
 noted that his delegation attached particular importance to 
the discussion of STCs and that it was important fo r the Committee to ensure that discussions were 
effective. Costa Rica suggested that the Committee should evalua te the effectiveness of these 
discussions – this could be done through an analysis , including information on concerns that had been 
dealt with (solved) and those that had not been d ealt with (still pending).  It would also be important 
to know the time it had taken to deal with STCs,  whether they remained on the agenda of the 
Committee and which Members had been involved.  Mu ch of this information was, in fact, already 
included in the Secretariat's document G/TBT/GEN/74/-series.   
412. The representative of Switzerland  expressed appreciation for the Secretariat's more detailed 
draft annotated agenda containing information about the STCs to be raised.  In her delegation's view, 
the deadlines proposed by Canada were appropriate; it would not be feasible to announce STCs more 
than 12 days before the meeting.  She stressed th at it was important that Members maintained the 
right and opportunity to support other Members ra ising a STC (even if they had not flagged an 
intention to raised it themselves).  
413. In response to the point made by Switzerland, the representative of Canada  clarified that the 
intention was to ensure that Memb er countries be made aware in a dvance that a particular concern 
would be raised – whether this would be raised by  one or more Members was a different matter.   
414. The representative of Japan  supported Canada's proposal. In his view it would contribute to a 
more organized and efficient discussion of STCs in the TBT Committee.  Japan agreed that ten days 
was sufficient time to prepare for the responses to  STCs raised and set out in the annotated draft 
agenda. 
415. The representative of Argentina  supported the proposal made by Canada and agreed with 
India that a period of 20 days should be given to  developing countries. This period of time would be 
particularly important for developing countries.  
416. The representative of Brazil  was of the view that Canada's proposal would enhance 
transparency and predictability in the Committe e's procedures while maintaining a degree of 
flexibility for all Members.  Brazil suggested that th e provisions contained in item (c) of the proposal 
(in JOB(09)/50) also be valid for STCs that were included after the deadline had passed.   
417. The representative of New Zealand  questioned whether the two-day interval between deadline 
for submission of STCs and circulation of the annotated draft agenda was enough time for the 
Secretariat.  In terms of the timeframes provide d, it was New Zealand's understanding that the STCs 
would already have been raised bilaterally betw een the Members concerned before the matter had 
escalated to the TBT Committee.  Therefore, the concerns raised would not normally come as a 
surprise.  The timeframes in Canada's proposal we re thus adequate.  Neve rtheless, flexibility was 
important and this was also recognized in the propo sal.   In New Zealand's view, there were other 
practical ways to improve efficiency of TBT Committee meetings (which did not necessarily require a 
recommendation from the Committee).  For instan ce, Members could associate themselves with 
previous statements or statements from other Memb ers rather than individually reading out what was 
already on the record or what ha d been said by another delegation at the same meeting.  Similarly, 
Members could prepare joint statements where concerns were similar.   
418. The representatives of the United States  and European Communities  supported the proposal 
from Canada to improve the operation of the Comm ittee and agreed with the time periods in the 
Canadian proposal.  In addition, the re presentative of the European Communities  supported the  G/TBT/M/48 
 Page 81 
 
 
  above-mentioned points made by New Zealand and suggested that longer, prepared statements could 
be submitted for the record in writing and only briefly summarized orally. 
419. The representatives of China , Hong Kong, China  and Mexico  expressed general support for 
Canada's proposal.  It was also noted that the Commi ttee was, in fact, already going in this direction 
as demonstrated by the more detailed annotated dr aft agenda and the G/TBT/GEN/74 document series 
prepared by the Secretariat. 
420. The Chairman  concluded by noting that there appeared to be general agreement on the need to 
increase the efficiency of the Committee's discuss ion of STCs and that the Canadian proposal was a 
good step in that direction as it would enhance both transparency and predictability in the discussion.  The Committee would seek to recommend procedures along the lines of the Canadian proposal that 
would be flexible and give appropr iate timeframes.  Some Members had also highlighted the need for 
delegations' to avoid repeating ar guments that had been previously made and/or that had been 
recorded in previous minutes. 
(b) Work Programme on Technical Regulations 
421. The representative of Korea
 introduced his delegation's proposal that the Committee establish 
a work programme to evaluate the trade restric tive and trade distorting effects caused by technical 
regulations, in accordance with Articles 13.2 and 15.4 of the TBT Agreement  (G/TBT/W/316, para. 6).   
422. The representative of Mexico
 noted that his delegation had, during the Trade Policy Review 
Process, expressed concern about the increase in unnecess ary obstacles to trade. However, it was not 
clear to Mexico whether the WTO Secretariat c ould undertake the study Korea was suggesting. The 
Committee could consider consulting with other in ternational organizations and bodies who possibly 
might have a study on the matter: for instance the World Bank or the OECD.  Although this was an important issue to discuss – and the Committee could c ontinue doing so at its regular meetings – it did 
not necessarily have to be part of the triennial review process.  
423. The representative of Israel
 welcomed the Korean proposal – it was useful to consider and 
analyze the impact that technical regulations coul d have on trade by sharin g knowledge and expertise 
among Members. 
424. The representative of the United States  agreed with the concerns raised by Mexico.  While the 
United States shared Korea's concer ns about the need to ensure that technical regulations were not 
inconsistent with the TBT Agreemen t, it was important to note that more  regulation did not 
necessarily mean more  unnecessary trade restrictions.  In fact, the growing number of notifications 
and STCs discussed in the Committee could reflect a better implementation of the Agreement itself.  
The United States emphasized, in particular, the difficu lty of estimating the aggregate trade impact of 
regulatory measures and noted that many of the issues the Committee had discussed under good 
regulatory practice and regulatory cooperation were , in effect, ways for the Committee to promote 
practices to reduce unnecessarily restrictive regulatory outcomes.  
425. The representative of Korea  said that it was, in his delegation's view, time for the WTO 
Secretariat to take over the responsibility to take stock of the issues raised in the Korean proposal, 
particularly in light of the worsening economic situ ation.  For instance, a review of research on the 
topic could be undertaken.   
426. The representative of the European Communities  echoed the positions of the United States 
and Mexico:  while the points made by Korea were in teresting, the complexity of the analysis that 
Korea proposed to undertaken went beyond the scope of the Committee's work and the WTO G/TBT/M/48  
Page 82  
 
  Secretariat's resources to undertake.  It was also noted that TPRB was already engaged in a relevant 
exercise that also covered TBT and SPS measures and that it was important to avoid duplication.
29  
427. The Chairman  concluded the discussion of the various proposals on the table by giving 
delegations the opportunity to provide further comments, in writing, on the proposals discussed at the meeting until Friday, 17 July 2009.
30 
V. TECHNICAL COOPERATION ACTIVITIES 
428. The Chairperson  drew the Committee's attention to a document containing the Secretariat's 
technical assistance activities (G/TBT/GEN/86). 
429. The representative of the Republic of Korea  drew the Committee's attention to their technical 
assistance activities undertaken during the first semester of 2009 (G/TBT/W/322). 
VI. UPDATING BY OBSERVERS 
430. The Representative of ISO  shared information on relevant work in ISO.  On conformity 
assessment, he informed the Committe e that ISO/IEC international sta ndards were widely used in the 
market place and provided a common basis for mutual recognition of conformity assessment results.  He highlighted the ISO/IEC Guide 68:2002, "Arra ngements for the recognition and acceptance of 
conformity assessment results" which gave guida nce on the content of multilateral recognition 
arrangements and recommended this guide for WTO Members putting in place government-to-government mutual recognition agreements. He em phasized the importance that the ISO Committee 
on Conformity Assessment (CASCO) placed on market  surveillance in the conformity assessment 
process and the need for guidance in this matte r.  He said progress was being made in the 
development of an information document compiling b est practices in the field of market surveillance. 
He informed the Committee of a joint ISO/UNIDO guidance document on conformity assessment 
entitled “Building trust” which would be publishe d in September 2009 and recommended this manual 
as a reference tool for those involved in conformi ty assessment and trade.  He also informed the 
Committee of regional awareness workshops on co nformity assessment which had taken place since 
2004. 
431. With regard to private standards, the repr esentative of ISO expressed appreciation for the 
suggestions made by some Members that interna tional standardizing bodies such as ISO should be 
invited to contribute to work that the TBT Co mmittee might undertake on this issue. Should the 
Committee decide to proceed in this way, ISO would be pleased to be involved.   
432. On good regulatory practice, the representative highlighted the publication “Using and 
referencing ISO and IEC standards for technical re gulations” which had been published in September 
2007.  The first three-day course based on this publi cation would take place from 30 June – 2 July for 
ISO members in Central and Eastern Europe and Ce ntral Asia.  This publica tion could be downloaded 
from the ISO and IEC websites.
31 
433. The representative of ISO also brought the Comm ittee's attention to a recent workshop jointly 
held with the International Energy Agency and the IEC on energy efficiency standards.  This 
workshop brought together 290 experts from the pub lic and private sector.  The IEA, ISO and IEC 
established high-level committees to assess gaps in curre nt energy efficiency standards portfolios.  
                                                      
29 WT/TPR/OV/W/2, dated 15 July 2009. 
30 A fax communication to this effect was sent by  the Chairman to all Me mbers on 26 June 2009. 
31  http://www.iso.org/iso/standards_for_technical_regulations.pdf  and 
http://www.iec.ch/news_centre/onlinepubs/about_pubs.htm   G/TBT/M/48 
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  Commitments were made to accelerate the rate of  standards development in this field.  An 
International Standard on energy management (IS O 50001) was currently be ing developed and was 
due to be published in 2010. 
434. The representative of the IEC  provided the Committee with an update on its activities during 
the first half of 2009 (G/TBT/GEN/88). Some of  the activities highlighted were: the increase in IEC 
membership and participation in the Affiliate C ountry programme from 155 to 159 countries; the IEC 
new technical committee on Ultra High Voltage; implementation of the IEC recommendations on electrical energy efficiency; progress of the "Smart Grid"; and the IEC Affiliate Country Programme in the field of electrical safety. The IEC also developed guidelines encouraging stakeholders in developing countries to use the free IEC standards fo r national adoption so as to enable IEC Affiliates 
to take an active part in the preparation of IE C International Standards, as recommended by the TBT 
Committee.  In addition, she informed the Comm ittee about an upcoming workshop for industrializing 
countries on safe use of electrical energy in mining and in the chemical, oil and gas industries to be held during the IEC General Meeting on 18-22 October in Tel Aviv, Israel.  
435. The representative of the ITC
 updated the Committee on activities in the International Trade 
Centre (G/TBT/GEN/89).  He highlighted the publi cation of the "World Directory of Information 
Sources on Standards, Conformity Assessment, A ccreditation, Metrology, Technical Regulations, 
Sanitary and Phytosanitary Measures".32  In addition, he informed the Committee that the ITC would 
publish the second edition of "Export Quality Ma nagement – An Answer Book for Small and 
Medium-Sized Exporters" in 2010.  The represen tative of the ITC also updated the Committee on 
TBT related projects in Bangladesh, Benin and Chad. 
436. The representative of the UNECE  informed the Committee that the 19th session of the 
Working Party on Regulatory Cooperation and Sta ndardization Policies would take place on 25-27 
November 2009.  Given the interest expressed by a number of delegations in the use of risk 
assessment and management methodologies as a pa rt of good regulatory practice, MRAs and 
conformity assessment, she informed the Committ ee that a conference on risk assessment and 
management would take place back to back with th e Working Party.  This conference would review 
the following: risk assessment and management me thodologies be used as a basis for the choice of 
technical regulation objectives and in the decision of  whether a regulation is at all needed;  risk 
assessment in the choice of conformity assessment op tions: suppliers' declaration of conformity vs 
third party assessment;  and, mitigating risks on th e markets for consumer products: risk assessment 
options and market surveillance authorities. The re presentative invited all Members with expertise in 
these areas to contact the UNECE secretariat should th ey be willing to contribute to the Conference.  
A provisional programme would be circulated mid July. 
437. Regarding the Working Party, the represen tative updated the Committee on two initiatives 
undertaken.  The first was on the establishment of practical mechanisms to  facilitate trade at a 
plurilateral level among interested countries in sp ecific industrial sectors.  Giving the example of 
earthmoving machinery, she explained that an adeq uate assessment of such complex machinery often 
only existed in the producing companies themselves.  A number of countries therefore relied on Suppliers Declaration of Conformity (SDoC) but many others used third party certification.  
Following the Working Party's in itiative, third party certification would take place on the basis of 
some agreed principles so as to avoid replication of  tests and to make best use of expertise.  The 
second initiative concerned the on-going work in the area of market surve illance where there was a 
first draft of "Common Terminology for Mark et Surveillance" and a guidance document for 
authorities. 
                                                     
 
32 http://www.intracen.org/eqm  G/TBT/M/48  
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  VII. DATE OF THE NEXT MEETING 
438. The next regular meeting of the TBT Co mmittee will take place on 5-6 November 2009
.   
 
 
__________