WORLD TRADE  
ORGANIZATION  RESTRICTED 
G/TBT/M/55  
9 February 2012 
 (12-0786) 
Committee on Technical Barriers to Trade  
  
 
MINUTES OF THE MEETING OF 10-11 NOVEMBER 2011 
 
Chairperson:  Ms Denise Pereira (Singapore) 
 
Note by the Secretariat1 
 
I.  ADOPTION OF THE AGENDA ............................................................................................. 2  
II.  IMPLEMENTATION AND ADMINISTRA TION OF THE AGREEMENT .................... 2  
A.  STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2 .................................................................. 2  
B.  SPECIFIC TRADE CONCERNS  ......................................................................................................... 2  
1.  Specific Trad e Concerns ....................................................................................................... .... 2 
(a)  New Concerns .................................................................................................................. ........... 2 
(b)  Previously raised concerns .................................................................................................... .... 14 
2.  Follow-up ..................................................................................................................... ............ 60  
3.  Streamlining the Committee's discussion  of specific trade concerns ................................. 60  
C.  EXCHANGE OF EXPERIENCES  ..................................................................................................... 62  
1.  Good Regulatory Practice ......................................................................................................  62 
2.  Standards ..................................................................................................................... ............ 62  
3.  Conformity Assessment ......................................................................................................... . 64 
4.  Transparency .................................................................................................................. ........ 64 
D.  OTHER MATTERS  ...................................................................................................................... 65  
III. TRANSITIONAL REVIEW MANDATED IN PARAGRAPH 18 OF THE 
PROTOCOL OF ACCESSION OF THE PE OPLE'S REPUBLIC OF CHINA .............. 66  
IV.  TECHNICAL COOPERATION ACTIVITIES ................................................................... 73  
V.  UPDATING BY OBSERVERS ............................................................................................. 73  
VI.  REPORT (2011) OF THE COMMITTEE ON TECHNICAL BARRIERS TO 
TRADE ......................................................................................................................... ........... 74  
VII. DATE OF NEXT MEETING ................................................................................................ 75  
 
                                                      
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the positions of Members or to their rights and obligations under the WTO. G/TBT/M/55  
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  I. ADOPTION OF THE AGENDA  
1. The Committee adopted the agenda contained in WTO/AIR/3821. 
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
A. 
STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2    
2. The Chairperson said that the latest list of st atements submitted under Article 15.2 of the TBT 
Agreement is contained in document G/TBT/GEN/1/ Rev.10, issued on 22 February 2011.  She noted 
that, since the last meeting, Zambia (G/TBT/2 /Add.106) and Mozambique (G/TBT/2/Add.107) had 
submitted their statements under Article 15.2 an d Georgia (G/TBT/2/Add.81/Rev.1) and Turkey 
(G/TBT/2/Add.33/Rev.1) had submitted revisions to th eir original statements.  In total, since 1995, 
124 Members had submitted at least one Statemen t on Implementation under Article 15.2.  She 
recalled that this information was available, a nd regularly updated, on the TBT page of the WTO 
website and in the TBT Inform ation Management System ( http://tbtims ).  The latest list of enquiry 
point contact is contained in document G/ TBT/ENQ/38/Rev.1, issued on 8 July 2011. 
B. SPECIFIC TRADE CONCERNS  
1. Specific Trade Concerns  
(a) New Concerns  
(i) Mexico - Draft Decree Amending Provisions for Drinks with Caffeine 
3. The representative of the European Union expressed  concerns regarding draft amendments to 
the Mexican General Health Law reinforcing the la bel provisions (health warnings) applicable to 
drinks with added caffeine.  These warnings incl uded that products should not  be consumed in excess 
of 500 ml per day, that they should not be mixed with alcoholic drinks, that they are not suitable for 
persons under the age of 18, and that they may lead  to intoxication, insomnia and cardiovascular and 
neurologic disorders.  The EU Enquiry point, she said, had requested in October 2011 that this draft measure be notified to the WTO. 
4. The representative of the United States said that his delegation shared Mexico's worries that 
energy drinks combined with alcohol could be ha rmful to young people.  However, it also raised 
concerns that this proposal, if adopted, was going to ba n or restrict the sale of energy drinks in the 
Mexican market, whether or not they were combined  with alcohol.  He urged Mexico not to proceed 
with this proposal until US and Mexican officials had a detailed technical discussion on the matter.  
He hoped that Mexico would discuss the US  questions submitted in this regard. 
5. The representative of Mexico clarified that th is initiative was being discussed by the Mexican 
Congress and it was at an early stage.  For this r eason Mexico still had not notified this amendment to 
the WTO.  On 27 September 2010, the Mexican Economy Ministry received a communication from 
the Mexican Embassy in Austria containing a number of comments concerning this draft amendment.  
These questions had already been tr ansmitted to the competent authorities.  Mexico continued to work 
on a set of technical regulations relating to this issue, namely the Official Mexican Standard PROY-
NOM-218-SSA1-2009 Products and services.  Non-alcoholic flavoured beverages, their frozen 
versions, concentrates to prepare these produc ts and beverages with added caffeine .  He clarified that 
this measure was published on 22 December 2010 and it was duly notified to the WTO for comments.  
The Mexican Health Ministry was still in the pro cess of analysing the comments they received during 
the period of public cons ultations and responses to those comme nts would be duly published in the 
Mexican Official Gazette prior to the publication of the definitive measure.  G/TBT/M/55  
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  (ii) Peru - Draft Supreme Decree Approving th e Regulations Governing the Labelling of 
Genetically Modified Foods  
6. The representative of Mexico voiced his delegati on’s concerns on this measure.  The Mexican 
Government submitted a number of comments on th is draft decree on 4 September 2011, including 
that this measure could potentially lead to discrim ination.  His delegation considered that this 
measure, in particular the requirement to label products containing geneti cally modified organisms 
(GMOs), lacked sufficient scientific basis.  GMOs had been rigorously evaluated and authorized for 
marketing and consumption by more than 59 countri es’ authorities, including Mexico.  Conventional 
products and GMOs were, in princi ple, equivalent in nature becau se there was no difference in their 
composition in terms of proteins, nutr ition or toxicological or allergenic  properties.  In Mexico's view, 
labelling may only be justified where there were s ubstantial significant differences in the nutritional 
makeup of a food, or in the properties that they contained, as opposed to conventional products. 
7. Moreover, modern agricultural biotechnolog y was a process and a production method which 
did not bear any impact on the final characteristi cs of the products.  Thus, in Mexico's view, an 
obligation to label products whic h were substantially equivalent  to conventional products would 
constitute unjustified discrimination.   The representative of Mexico called upon Peru, in line with the 
provisions of Article 2.5 of the TBT Agreement, to explain the technical and scientific justification of 
this measure in light of Article of 2.2 of the Agr eement.  He also requested, wherever possible, that 
Peru reply to these comments, in conformity with Article 2.9.4 of the TBT Agreement, to establish a 
dialogue between Peru, Mexico, and other interested parties, on these issues. 
8. The representative of Brazil echoed Mexico's concerns.  Comments had been submitted and 
they looked forward to receiving Peru's responses.   
9. The representative of Canada said that his de legation appreciated information provided by 
Peru so far, in particular in relation to how the measure was to be applied,  provisions on testing and 
how imports were going to be monitored.  He re quested confirmation on the status of the draft 
regulation, and whether their comme nts would be taken into account. 
10. The representative of Colombia indicated that  his Government supported labelling to provide 
information to the consumer where this informati on was verified, based on technical facts and did not 
induce error.  However, in his view there was no evidence that there was any difference in properties 
between genetically modified foods and conventiona l food products.  Thus, a differentiated label for 
food products containing GMOs would constitute  a technical barrier to trade under the TBT 
Agreement offering no benefits in terms of  additional information to the consumer. 
11. The representative of Chile noted that this propo sal did not set forth a threshold to determine 
whether a product contained genetically modified s ubstances.  Chile wished to learn whether there 
was a list of Peruvian laboratories accredited by Peru's National Institute for the Defence of Competition and the Protection of Intellectual Property (INDECOPI) to carry out the tests mentioned in the draft and whether foreign laboratories could be accredited or recognized for the same purpose.  
Also, Chile did not consider that the 180-day adaptation period for the phasing in of the new 
requirements established by the measure to be sufficiently long.  
12. The representative of Argentina said that his de legation also considered that this draft 
measure discriminated against products derived fro m modern genetically modified food.  This 
measure was not proportional to the risks involved and would only apply to certain types of products 
such as colza, soya, corn, cotton, etc. without pr oviding an explanation about the exclusion of other 
products also containing transgenic substances from the application of this measure.  Argentina was 
concerned that this measure would be followed by other initiatives regulating matters beyond 
labelling requirements which coul d have serious negative effects for the development and G/TBT/M/55  
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  commercialization of certain genetically modified  foods.  According to the Food and Agriculture 
Organization (FAO), world food production need to  increase by 50% to meet global food demands  
and these new technologies would therefore be necessary. 
13. The representative of Peru clarified that Peru was presently evaluating and reviewing the draft 
regulations on the basis of the comments received.  In line with its international obligations, Peru 
would publish comments in due time, before th e final version of the measure was adopted. 
(iii) European Union - Draft Commission Regulation implementing Directive 2009/125/EC of the 
European Parliament and of the Council w ith regard to ecodesign requirements for air 
conditioners and comfort fans G/TBT/N/EEC/362) 
14. The representative of China, while thanking the EU for formally replying to China's 
comments, said there were still two points that had not yet been solved.  First, China suggested the 
adoption of different evaluation methods and energy efficiency requirements for air conditioners with 
inverters and air conditioners without inverters.  Hi s delegation considered that this was a reasonable 
distinction since there were substantial di fferences between the operation principles and 
characteristics of these two types of air conditioners .  Second, he invited the European Union to 
provide the scientific justification for the noise lim its established by this draft regulation according to 
which noise produced by air conditioners with a rated capacity of equal to or less than 12KW would harm humans and the environment.  If there was no sci entific basis for this requirement, it should be 
removed from the draft regulation. 
15. The representative of the European Union expl ained that the Draft Commission Regulation 
implemented the ecodesign Directive 2009/125/EC  and had, as the latter, the objective of 
environmental protection and fighting climate ch ange through reduced energy consumption and 
emissions.  She informed that the Regulation was not yet adopted, but that adoption was imminent.  
As soon as the adopted text was published, it would be sent as an addendum to the WTO notification.  
16. The draft measure established eco-design requi rements for certain air conditioners and 
comfort fans without distinguishing between those with or without inverters.  Inverters allowed the 
appliance to receive information on the varying air te mperature outside/inside of a building in order to 
adjust its performance to these temperatures.  Thus, inverters allowed for savings in energy 
consumption emissions,  but air conditioners with  and without inverters had exactly the same 
function.  Since the objective of the legislation was the reduction of energy consumption in the fight against climate change, the requirements for power consumption could not be set on the basis of a 
given technology or component used in an applian ce.  In her delegation’s view, China was asking for 
less stringent requirements for a generally less efficient technology.  The EU believed that such 
differentiation would jeopardize the fulfil ment of the legislation’s objective. 
17. Moreover, the EU’s regulations  did not prohibit the marketi ng of air-conditioners without 
inverters;  they could be sold in the European Union if the efficiency requirements were met.  
Regarding the proposed noise limits in the draft me asure, noise was one of the environmental aspects 
that had to be assessed in the framework of eco-design requirements and these limits were based on 
the stakeholder consultation and on limits identifie d by the World Health Organization.  Further 
information on this could be found in the impact ass essment that would be available once the measure 
was adopted. The respective website on which the impact assessment would become available had 
already been sent to China.  G/TBT/M/55  
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  (iv) European Union - issue with respect of honey containing pollen from genetically modified 
maize MON810, Ruling from ECJ 
18. The representative of Argentina expressed his G overnment's concerns about the European 
Court of Justice 7 September 2011 ruling that pollen was a natural component and an ingredient of 
honey.  His delegation believed that this decision contradicted the standard for honey established by 
Codex Alimentarius 81/2001.  Thus, this particular court ruling gave rise to legal uncertainty causing 
honey importers in the EU to interrupt virtually all purchases of honey produced in Argentina.  This 
had an impact on the traditional trade flows in th is sector, causing major social consequences, in 
particular, for small-scale producers, family businesses and regional economies in Argentina.  Argentina had more than 30,000 beekeepers with a longstanding tradition of producing honey for over 
50 years and exporting to more than 40 different coun tries.  The EU market was the main destination 
for the export of Argentinian honey, accounting fo r 30 per cent of its total production.  For this 
reason, Argentina called on the EU to promptly ta ke all necessary measures to remove any legal 
uncertainties arising from this ruling and to eliminate the impact that it had on the import of honey into the EU from other Members.  In addition, he requested the EU to comment on the opinion of the 
IPSAS regarding the innocuous natu re of honey containing pollen and to ensure that implementation 
of this ruling did not, in any way, preven t exports of Argentinian honey into the EU. 
19. The representatives of Brazil, El Salvador, Mexi co and Uruguay, shared Argentina's concerns 
regarding the decision of the European Court of Ju stice and respectfully invited the European Union 
to remove what they perceived as legal uncertain ty arising from this court ruling as well as the 
negative trade impacts arising for imports of honey into the European Union.   The representative of 
Canada echoed the concerns regarding uncerta inty and potential for trade disruption. The 
representative of Mexico also mentioned that the sam e concerns had been voiced in a recent meeting 
of the WTO SPS Committee.  This ruling affected developing-country Members in particular, and 
failing to grant special and differential treatment in this case would negate the meaning of the relevant 
provisions in the TBT Agreement.  
20. The representative of the European Union expl ained that, in 2008, a German beekeeper 
challenged the regulations concerning pollen that co ntained traces of genetically modified organisms 
(GMOs) after he detected GM maize MONSANTO  810 pollen in his honey.  The contamination 
originated from GM plants grown for research purpo ses near the beekeeper's hives.  The "GM honey" 
case was brought to the European Court of Justice.  In its 6 September 2011 ruling,  the Court said that GM pollen in honey fell under the scope of th e relevant EU legislation on GM food and feed 
(Regulation 1829/2003).  Therefore, the marketing in  the EU’s territory of honey with traces of GM 
pollen became subject to an authorization.  More over, according to this ruling, honey containing 
authorized GM pollen had to be labelled accord ing to the provisions of Regulation 1829/2003. 
21. This issue had not arisen in the past sin ce pollen was regarded only as a constituent in 
accordance with Directive 
2001/110/EC relating to honey  thus falling out of the scope of the 
corresponding labelling directive and honey containi ng GM pollen was considered to be out of the 
scope of Regulation 1829/2003.  She acknowledged that the ruling’ s effects were numerous and 
related not only to imports, but to honey produc ed within the European Union as well.  The 
development of harmonized methods for the sampli ng and detection of GM pollen had yet to be 
assessed in order to help EU Member States appl y the Court's ruling, in terms of controls and 
labelling at a national level, of bot h imports and of national producti on.  Regarding imports into the 
EU, since some GMOs were authorized in third c ountries but not in the EU, imported honey products 
from these countries containing GMOs that were not authorized for use in pollen in the EU, would not be allowed in the EU market. 
22. The specific case examined by th e European Court of Justice, involved MON810, a GM crop 
that had been authorized in the EU for more than 10 years.  However, it was authorized for food uses G/TBT/M/55  
Page 6  
 
  which did not include pollen, on the basis of an asse ssment prepared by the European Food Safety 
Authority (EFSA) in 2009.  In addition to these food  uses, MON810 was also authorized for feed uses 
and for cultivation.  EFSA prepared an opinion on the safety of MON810 pollen in honey, delivered 
on 20 October 2011, concluding that MON810 in pollen was as safe as non-GM maize pollen.  In the 
meantime, the company in question, Monsanto, in tended to submit an application to cover MON810 
pollen in or as food, according to the authori zation procedure provided by Regulation 1829/2003. 
23. Finally, she added that the EU was actively refl ecting on the best possible approach to ensure 
the proper implementation of the ruling without causing unnecessary disruptions to the supply of 
honey to EU consumers, be it from domestic or im ported production.  To this end, the European 
Commission held several meetings with third c ountries concerned about this issue, including 
Argentina, as well as a stakeholder meeting on 29 September 2011.  The EU's intended to continue 
discussing this issue bilatera lly over the following weeks. 
(v) United States - ENERGYSTAR 6.0 Draft 2 Program  Requirements for Displays-Draft Partner 
Commitments  
24. The representative of Korea expressed concerns re garding the scope and range of this draft 
measure.  Korea was particularly concerned about  the feasibility and measurement of the reduction 
rates of F-Green House Gases, (F-GHGs or F-gas) established by this measure.  The evaluation of carbon emissions should be calculated not only on the basis of the manufacturing process but also taking into account the raw-material-input and waste processes.  Her delegation was worried that the 
adoption of the point-of-use abatement system could prevent the adoption of another, more efficient 
abatement system—for example, the centralized ab atement system that Korean LCD panel-makers 
have developed. The centralized abatement system  prevented F gas emissions at all stages of the 
process, beginning even before the manufacturing stag e with the substitution of raw materials that will 
not emit F gases. Moreover, the CAS was also more cost effective than the POU system. 
25. Her delegation believed that a llowing alternative and more efficient abatement systems was 
very helpful for the LCD industry and could contribu te to the fulfilment of the US Environmental 
Protection Agency's (EPA) objectives.  In order to  provide more detailed information, the Korean 
LCD industry was planning to submit a report to the EPA regarding the CAS as soon as possible.  In addition, Korean industry believed that the gradual target rate and the date for the reduction of 
F-GHGs were highly unfeasible.  In their view, th e 90 per cent reduction rate was impossible to 
achieve by 30 September 2012, because it would re quire the full operation of abatement equipment 
365 days a year without defects or deterioration of its main components.  It would take at least two 
years to install, test and adjust new equipment and verify its efficiency in one factory alone.
 
Therefore, she requested that th e EPA phase in the new requirements over a reasonable period of time 
to allow the industry to adapt, with the aim of ac hieving a 30 per cent reduction-rate by 2015, a 50 per 
cent rate by 2018 and a 60 per cent rate by 2020. 
26. Lastly, her delegation believed that Nitrogen Trifluoride (NF3) should be excluded from the 
EPA's F-GHGs list because neither the 1997 Kyoto Prot ocol nor the Third Conference of the Parties 
(COP) of the United Nations has identified NF3 as one  of the greenhouse gases that must be regulated 
worldwide.   She noted that the Kyoto protocol listed onl y HFCs, PFCs and SF6 as F-gases as subject 
to regulate and COP reports did not cover NF3 as GHGs.  Moreover, according to her delegation's 
own research, no other country other than the US included NF3 as F-GHGs.  Considering that emissions of NF3 were extremely lower than tho se of other F-GHGs, the effort to regulate NF3 
emissions was too premature and economically inefficient. 
27. The representative of the United States said th at it would relay Korea’s comments back to 
capital for review.  He observed that the ENERGY STAR program was voluntary and, therefore, the 
US was under no obligation to notify many of its specifications to the WTO.  Nevertheless, his  G/TBT/M/55  
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  delegation would consider making such notificati ons during the EPA's next draft revision of the 
ENERGYSTAR requirements which would most likely be posted for comments in late November.  
He noted that there had been already two earlier comment periods.  He also encouraged Korea and 
other Members to consider notifying to the WTO the voluntary measures they were developing, in 
those cases where demonstrating compliance with such measures could be an important factor for 
placing products on their markets. The EPA had been accepting comments through its website during 
the development of these and other ENERGYSTAR sp ecifications, and his Government was taking 
them into account.  Some of those comments were made by Korean stakeholders.  Finally, he took 
note of Korea's offer to provide the EPA with a ne w report on the CAS and suggested that this report 
be transmitted as soon as possible. 
(vi) United States - Amendments to Sterility Test Requirements for Biological Products 
(G/TBT/USA/633) 
28. The representative of Korea expressed her dele gation's view that the proposed amendments 
appeared to provide manufacturers of biological prod ucts with greater flexibility and to encourage the 
use of the most appropriate and state-of-art test me thods for assuring the safety of biological products.  
Nevertheless, her Government was interested in learning more about the exact functioning of the 
proposed measure, and how the US Food and Drug Administration intended to verify sterility 
assurance under these amendments.  Korea understood that cell and gene therapy products were 
included in this amendment.  Sh e asked the US to provide background information concerning this 
addition.  Lastly, she requested the US to update  the Committee on the current situation and future 
prospects of this measure. 
29. The representative of the United States said the intention of the amendment to this measure 
was to provide manufacturers of biological products with greater flexibility and to encourage the use 
of the most appropriate state of the art test methods  for ensuring the safety of such products.  This was 
part of the US' continuing efforts to review retr ospectively and, if necessary, update its biologics 
regulations.  According to its own analysis, the ne t effect of these amendments was going to be the 
reduction of manufacturers' costs.  His delegation was not aware of Korea's interest and concerns 
regarding the proposed amendments as this issu e was never raised during the regular bilateral 
meetings; that during the 90-day comment-period,  neither Korea nor any Korean industry group 
presented comments and that his delegation was not aware of any Korean company providing 
licenced biological products to the US market that had been affected by the proposal.  Nevertheless, 
he would send Korea comments to capital for review and further discussion. 
(vii) Argentina - Resolution 453/2010 establishing mechanisms in order to eliminate dangers 
arising from the use of inks with a high lead content in graphic products 
30. The representative of the United States express ed his Government’s support for Argentina's 
objective of protecting its citizens from exposure to potentially hazardous substances.  However, there  
was concern that Argentina could lack sufficient testing capacity domestically to conduct the testing 
required by this measure.  Moreover, Argentina ha d indicated that it could only accept test reports 
from foreign conformity assessment bodies if there w as a mutual recognition agreement in place.  His 
delegation was not aware of the existence of any such  agreement.  Therefore, it appeared that this 
constituted a de facto  requirement that the necessary testing had to be done in Argentina.  There were 
only one or two laboratories recognized in Argentin a to conduct these tests.  Based on the apparent 
lack of domestic testing capacity coupled with th e lack of recognition of foreign laboratories to 
perform testing activities in the country of produc tion, the US anticipated significant delays and 
additional market costs and burdens for th e industries affected by this measure. 
31. His delegation suggested that Argentina recogni ze laboratories that were accredited by the 
signatories of the International Laboratory Accr editation Cooperation Mutual Recognition Agreement G/TBT/M/55  
Page 8  
 
  (ILAC MRA) with expertise in lead testing as more regulators around the world had already done.  
The US considered this option as a more trade-f acilitative alternative that did not compromise the 
fulfilment of Argentina's objectives.  Finally, it appear ed to the US that this resolution applied only to 
foreign producers.  Hence, he requested a cl arification from Argentina as to whether domestic 
producers of graphic products were subject to these, or equivalent requirements. 
32. The representative of the European Union reca lled that her delegati on had exchanged written 
communications with Argentina and had bilateral discussions on this issue.  Nevertheless, her 
delegation sought more information about the reasons  for introducing compulsory certification for the 
lead content in inks, lacquers, varnishes and printed graphic products.  She noted that in the EU lead 
in paints was prohibited but there was no compulsory  certification or testing for those products.  Her 
delegation shared the US concerns on the certificati on procedures and the recognition of tests.  She 
noted that Article 2 of this resolution mentioned the European standard EN 71-3 as well the international standard ISO 8124-3 as the reference against which graphi c products had to be tested 
and certified.  Article 5 indicated that certificates had to be issued by an Argentinean certification 
body and that certificates had to be based on tests carried out in a "recognised laboratory".  The EU 
asked whether tests carried out for compliance with standard EN 71-3 in the EU in internationally 
accredited laboratories would to be accepted by the Argentinian certification body for the purposes of 
issuing the required compliance certificates.  If th is was not the case, she requested an explanation 
why the tests had to be conducted locally.  She also invited Argentina to clarify the criteria for foreign 
laboratories to be formally recognised.  Since only two Argentinian laboratories had been approved to 
conduct the respective certification tests, how did Ar gentina plan to ensure the necessary capacity to 
handle the potentially very high number of requests.   Finally, the resolution seemed to imply that the 
certification body was to take samples from each imported lot;  the EU asked whether all imported lots from the same manufacturer had to be tested. 
33. The representative of Argentina said that his de legation had already had an exchange with the 
US enquiry point on this issue, and had responded to a request for informat ion that led to a joint 
resolution and the identification of the applicable standards.  Thus, a number of concerns regarding 
this measure had already been dealt with.  Further, Argentina's enquiry point had been in contact with 
the EU's enquiry point and his delegation was not aware of any other attempt to submit comments or 
to request consultations on this matter.  However,  he would relay the comments submitted by the US 
and the EU to the competent authorities in  Argentina for a response in due course. 
(viii) China - Specification for Import and Export of  Food Additives Inspection, Quarantine and 
Supervision (2011 No. 52) – Disclosure of formulas for imported food additives 
34. The representative of the United States recalle d that this measure was enacted by China's 
General Administration of Quality Supervision, In spection and Quarantine (A QSIQ) on 18 April 2011 
and it entered into force on 1 July 2011.  He observe d that this measure required the disclosure of 
formulas for imported food additives sold in China.   While his delegation supported China's goal of 
improving food safety and food quality, these objectives could be accomplished without unnecessarily 
impacting trade.   
35. The US had procedural and substantive concerns  regarding this measure.  Procedurally, this 
measure was not published in draft form, thereby preventing interested stakeholders from submitting 
their comments.  The measure claimed to have tw o objectives, namely ensuring food quality (a TBT 
issue) and food safety (an SPS issue).  Nevertheless, the measure was not notified to either the TBT or 
SPS Committee, despite the fact that the measure app eared to have taken effect less than six weeks 
after it was announced by China.   Thus, China did not grant sufficient adaptation time to importers 
before the specification entered into force.  Substa ntively, he recalled that the US and China had a 
productive bilateral discussion on this issue before th e Committee meeting.  During this discussion, it 
was confirmed that Article 6 of this measure re quired suppliers to disclose their formulas on product  G/TBT/M/55  
 Page 9 
 
 
  labels.  Where the product contained at least one a dditive, labels on these products needed to include a 
list of each additive in its percentage of the produ ct by weight in descending order.  The US was 
concerned that this requirement would force supp liers to disclose business confidential information 
(BCI), i.e. the product formulation, against their le gitimate commercial intere sts.  His delegation did 
not believe that regulators needed this kind of in formation in pursuance of a legitimate objective, and 
in compliance with the TBT Agreement.  Rather, th e US worry was that the measure forced suppliers 
to make public what could be considered BCI. 
36. The US was concerned that that the requirement  to disclose these formulas on product labels 
seemed to apply only to imported food additives, as s uggested by the fact that this requirement was 
contained in the food additives import chapter of  the measure.  If this was not the correct 
interpretation, he asked if there was a measure re quiring Chinese suppliers to disclose their formulas 
on product labels as well.  The US also expressed  its interest in learni ng more about the objective 
pursued by the measure, i.e. to provide information for supply chain customers or to ensure that the 
products in question met the relevant regulatory requ irements in China.  If these were indeed the 
objectives pursued by the measure, other altern atives could be explored such as empowering 
customers to request, under confidentiality agre ements, information on additives in manufacturing, 
which was already an accepted practice.  In c onclusion, the US urged China to suspend the 
implementation of this specification, to notify the measure to the WTO, and to receive and consider 
comments from interested stakeholders.  His delega tion intended to engage in future technical 
discussions with Chinese authorities on this matter. 
37. The representative of the European Union echoed the US concerns.  She reiterated the EU’s 
desire for enhanced transparency in China's development, adoption and enforcement of standards and 
technical regulations in the area of food safety.  Moreover, her delegation had been recently informed 
that on 30 September 2011, the Chinese Ministry of  Health published a draft food safety standard on 
the labelling of food additives.  It was the EU ’s understanding that a one-month comment-period was 
established and that such period had expired on 30 October 2011.  Thus, the EU understood that all 
food additives, with the exception of flavours, needed to comply with this measure as of March 2011.  
She asked if China intended to notify this mandato ry standard to the WTO, in order to provide 
Members with an opportunity to submit their commen ts.  Finally, the EU stressed the need for China 
to provide an adequate period of time between the adoption and the implementation of this measure so 
as to allow economic operators to adapt. 
38. The representative of China reported that on 18 April 2011, the AQSIQ issued a Specification 
for Import and Export of Food Additives Inspection,  Quarantine and Supervision which consolidated 
several provisions on food additives contained in the Food Safety Law and its implementing 
regulations, and the Circular on Enhancing the Supervision and Manageme nt of Food Additives, 
issued by nine Chinese Governmental ministries.  The objective of this measure was to ensure the 
quality and safety of imports and exports of food additives and to pr otect consumer health, which in 
China's view was consistent with  the legitimate objectives recognized  by the TBT Agreement.  The 
mandatory disclosure of food additive formulas  was not a new requirement;  it was already 
established in Article 42.2 of the Food Safety La w of China, which had been notified to the WTO 
several years ago.  For this reason, China did not  consider it necessary to make a new notification 
concerning this new specification to either the TBT or the SPS Committees.  The mandatory 
disclosure of food additives formulas applied to both imported and domestic products.  Thus, there 
was no infringement of the national treatment principl e.  He believed that the EU’s concerns referred 
to other measures which he invited the EU to ra ise under "Other Business" during this meeting. G/TBT/M/55  
Page 10  
 
  (ix) China - GB/T xxxx-xxxx, Information Security  Technology -- Office Devices Security and 
YD/T xxxx-xxxx, High spectrum efficiency and high throughput wireless LAN technical 
requirements 
39. The representative of the United States said that  his delegation believed that China intended 
to integrate several draft voluntary standards in the information and communications technology 
sector that it was in the process of finalizing into certification schemes.  This would turn otherwise 
voluntary standards into de facto  mandatory regulations, without notifying the WTO.  The group of 
draft standards included a series of six informati on security voluntary standards released for public 
comment in July 2011 by the China National Info rmation Security Technical Standards Committee 
(TC260 WG5).  The United States wished to refer to two of these draft standards under this specific 
trade concern.  First, on 20 September 2011, a draft voluntary standard related to information security 
requirements for office equipment, including printers , was released for a public comment-period of 30 
days by a standardization institute under China's Ministry of Industry and Information Technology, 
China's Electronic Standardization Institute (CES I), in conjunction with TC260 WG5.  The US 
considered this standard to be  an office equipment information security standard, designed as an 
alternative to the IEEE 2600 internationa l, information security standard.   
40. Second, on 20 September 2011, a second draft vo luntary standard, related to wireless 
broadband, was released for public comment for 15 days by another Ministry of Industry and 
Information Technology (MIIT) sponsored standa rdization institute, the China Communication 
Standards Association (CCSA).  It was US opinion th at this standard appeared to be a local area 
network standard designed as an alternative to the IEEE 80211 standard (the WiFi standard).  Some 
brief ,bilateral discussions on these two standards had taken place between the US and China.  
However, the US wished to learn more about th e purpose of these standards and the reasons for the 
apparent differences between them and the exis ting international standards and other Chinese 
standards.  The United States also hoped that comme nts submitted by the US industry would be taken 
into account and reflected in the final drafts.  Th e US also requested more information on the conduct 
of the respective conformity assessment procedures, and on whether China was planning to maintain 
these standards as voluntary or turn them into manda tory regulations.  The US also requested that 
China notify these standards and receive comments fro m the affected industries, if they became 
requirements for manufactures to obtain type approva l, China Compulsory Certification (CCC) mark 
registration, or other type of approval in order to sell their products in China.  Finally, the US also asked if there was a timetable for the finalization of these two draft standards. 
41. The representative of China reported that the standard Information Security Technology-office 
Devices Security  was voluntary and was still being drafted .  China also explained that the drafters 
were taking into account the relevant international st andards, China's particular  circumstances, and the 
experiences of other Members. 
42. In relation to the standard of High Spectrum efficiency and high throughput wireless LAN 
technical requirements , China reported that it was still under the approval process of MIIT.  In order 
to solicit opinions from all interested parties, China posted the full text of this draft standard on the 
official website of MIIT.  China intended to take  all reasonable comments into consideration.  He 
announced China's disposition to participate in the drafting of the relevant international standard on 
this subject along with all interested parties.  G/TBT/M/55  
 Page 11 
 
 
  (x) Indonesia - Technical Guidelines for the Impl ementation of the Adoption and Supervision of 
Indonesian National Standards for Obligatory Toy Safety 
43. The representative of the United States informed  the Committee of bilateral discussions with  
Indonesia, including some on the margins of the Asia-Pacific Economic Cooperation (APEC) toy 
safety work.  The US recalled that a toy safety standard, i.e. the underlying standard, was adopted by 
Indonesia's Ministry of Industry in May 2010.  The US concerns were not directed towards this 
standard, but towards the draft conformity assessm ent measure, i.e. the technical guidelines, that 
related to the toy safety standard.  The US understo od that the development of the draft conformity 
assessment measure was at an early stage.  Howeve r, the US asked if Indonesia would confirm that 
that it was going to notify this measure to the WT O, once it was completed.  The US also asked if, 
under this measure, producers were going to able to become certified under ISO 9001, and not only 
under the Indonesian version of this standard.  The US also asked about the definition of a "brand" for 
testing purposes under this draft measure, who woul d be able to conduct the corresponding sampling, 
and whether the mark required on the product needed to be placed on the product itself or on the product packaging.  The US was also concerned about  ensuring equitability in relation to the fees paid 
by domestic and imported products. 
44. He identified the testing issue as his delegation’ s most important concern regarding this draft 
measure.  Indonesia’s National Accreditation Body was a signatory to the ILAC MRA.  The US 
hoped that Indonesia was going to accept test results from laboratories that had been accredited by 
ILAC MRA signatories, even if they were locat ed outside Indonesia, provided that they were 
qualified to perform toy testing.  Recognition of t est results from ILAC accredited laboratories in the 
toy safety area was already a common internationa l practice and his delegation was concerned that 
there could be a lack of laboratories in Indonesia acc redited to conduct toy testing.  The US was also 
concerned that Indonesia might require, in addition to an accreditation under the ILAC MRA, the execution of a Memorandum of Understanding (MoU ) between the governments involved.  The US 
expressed doubts about whether such requirement could add value to the reliability of the 
accreditation or testing processes, and noted that such requirement could cause trade disruptions.  His 
Government's would continue to hold bilateral technical discussions with Indonesia on this issue. 
45. The representative of Indonesia confirmed his G overnment’s intention to  develop regulations 
on toy safety, but that he had no information on any timetable nor indication of a possible date for the 
conclusion of this draft measure.  However, Indonesi a's intended to notify the finalized measure.  His 
delegation welcomed the US intention to c ontinue bilateral discussions on this issue. 
(xi) Korea - National Tax Service Notice 2011-17  (Requirements for Radio-Frequency 
Identification Tags for Imported  Whiskeys) (G/TBT/N/KOR/338) 
46. The representative of the United States pointed  out that the Korean National Tax Service 
published an official notice under the number 2011-17 on 11 July 2011 requiring both, imported and 
domestic whiskey bottles to have a radio frequency identification tag or an RFID.  The US invited 
Korea to notify this measure to the WTO and to  establish a reasonable period of time for comments 
by interested parties.  Additionally, the US wa nted to learn more about the rationale behind the 
requirement, in particular, why whiskey was specif ically targeted, as opposed to other products.  The 
US understood that Korea was implementing this to prevent counterfeiting and to detect illegal 
(untaxed or black market) transactions which was a legitimate objective.  However, the US believed 
that these goals could be met through other less co stly and burdensome methods.  He noted the costs 
associated with installing the RF ID readers in the warehouses where the products in question were 
stored and adding machines or additional labour to ap ply the tags.  He asked if Korea had considered 
achieving these objectives through other means such  as tax stamps, bar codes, or the use of a 
prototype system before the impl ementation date.  If so, what were the reasons why Korea chose the 
RFID option over any of these alternatives. G/TBT/M/55  
Page 12  
 
  47. The US was aware of the industry’s struggles to  design a tag that would be able to fit on 
whiskey bottles of different sizes;  in some cases th is task had proved to be unfeasible.  Moreover, the 
RFID readers sometimes malfunctioned when the bottle cap contained metallic materials.  Therefore, the US requested Korea, if it decided to maintain this measure, to establish a reasonable interval for 
the implementation of this measure, taking into account the technical difficulties described by the US, 
so as to provide stakeholders with suffi cient time to comply with the measure. 
48. The representative of the European Union c onsidered that these requirements contained 
technical regulations and were thereby subject to th e notification obligation contained in Article 2.9.2 
of the TBT Agreement.  Thus, the EU shared the US interest in knowing whether Korea intended to 
notify this measure to the TBT Committee for Memb ers’ comments.  Her delegation had already sent 
questions to the Korean TBT Enquiry Point on 8 November 2011 and it looked forward to receiving 
Korea's response. 
49. The representative of Korea explained that th e purpose of the requirement was to to use 
mobile phone technology to verify the brand authenti city of each bottle of whiskey they purchased , 
and also to be sure how much tax importers and wh iskey dealers are paying.  This requirement was in 
force since 1 November 2011 for domestic whiskies in  six Korean provinces, and would apply to all 
whiskies sold in Korea, including imported whiski es, as of 1 October 2012.  There would be no 
discrimination between domestic and imported products. The tagging RFID requirement on imported 
whiskies was applicable to the importers and not to the exporters.  This was because of  differences in 
radio frequency from nation to nation as well as diffe rences in terms of compatibility between tag 
readers.  Therefore, whisky exporters did not have  to be concerned about increasing costs as a result 
of the application of this measure.  The reason fo r the introduction of RFID tags instead of barcodes 
was that RFID provides information unique to a specific product—for example, a specific bottle of whiskey—not just a group of similar products as a barcode does.  Regarding concerns about potential 
RFID malfunctioning caused by the use of metallic materials and the difficulties of tagging small bottles, Korea expected that these technological diffi culties could be solved in the near future through 
the advancement of the RFID technology.  One al ternative of these problems is to tag the box], as 
specified in the notice.  Korea' s would notify this measure to th e WTO through the Korean National 
Tax Service in November 2011. 
(xii) Mexico -- Refusal of the National Water Co mmission to re-certify HDPE pipe products 
meeting quality/safety standards for pi ping set out in NOM 001 and NMX 
241(G/TBT/N/MEX/206 and G/TBT/N/MEX/206/Add.1) 
50. The representative of the United States expressed  concern that Mexico's National Water 
Commission (NWC) was refusing to allow corruga ted high-density polyethylene (HDPE) pipes, 
mostly produced by US companies, to become cer tified to the mandatory technical standards that 
were codified under Mexican law.  He recalled that these technical standards had granted market 
access to US products for many years.  Accord ing to the US, the NWC changed its policies and 
started requiring compliance with an ISO standard th at only covered Polyvinyl chloride (PVC) pipes, 
which were produced mostly by Mexico-based compan ies.  Thus, this change in policy by the NWC 
effectively precluded the sale of HDPE pipes in the Me xican market.  The standard previously applied 
by the NWC was based on performance characte ristics, thus outlining minimum performance 
requirements to achieve sufficient strength, longevity , and hermeticity.  This standard covered three 
types of pipes for use in Mexico, including HDPE pip es.  By contrast, the ISO standard that Mexican 
authorities were enforcing more recently was based  on design and covered only PVC pipes.  The US 
believed that the effect was to exclude HDPE pi pes from the Mexican market, even though they 
performed the same function than PVC pipes. 
51. The US was also concerned that the NWC d ecided to require compliance with the ISO 
standard, abruptly and without any warning.  The US was unaware of any WTO notification related to  G/TBT/M/55  
 Page 13 
 
 
  this policy change.  Therefore, the US requested Me xico to continue applying the piper standard that 
was on the books in Mexico, that permitted access  of HDPE pipes to the Mexican market, and 
allowed HDPE pipe producers to be certified.  If Mexi co intended to change its policy on this matter, 
the US asked what objective pursued by Mexico w as, and whether Mexico considered the adverse 
impact on US pipe exports arising fro m this change in policy.  Finally, the US intended to follow this 
issue closely and looked forward to receiving the requested information. 
52. The representative of Mexico recalled that the c oncerns raised during bilateral meetings with 
the US on this issue had already been sent to the NWC.  In January 2011, Mexico published in its 
Federal Official Gazette, a draft amendment to the Official Mexican Standard NOM 001 CNA .  This 
standard was applicable since 2009 and dealt with drinking water, sewerage, and domestic collectors 
for sewerage.  The purpose of this amendment was to establish specifications for products that were in 
the drinking water system, sewerage and also househol d collectors, to make sure that these systems 
were water-tight over the long-term so as to avoid leakages, to establish proper operating and 
maintenance conditions, and to guarantee a minimum longevity of these systems. 
53. Information regarding this amendment was transmitted to the WTO and distributed to 
Members on 5 January 2011 in document G/TB T/N/MEX/206 and a 60-day comment-period was 
established.  This draft amendment was also notif ied directly to the US on 6 January through its 
contact point.  Finally, during the public consu ltation period, the US did not submit any comments 
regarding this document.  Mexico thus asked the US to submit its comments directly to Mexico's 
NCW even though the consultation period had elapsed. 
(xiii) El Salvador - Law on hygienic production of m ilk and milk products and the regulation of 
their sale  
54. The representative of Mexico expressed concer ns with regard to the law on hygienic 
production of milk and milk products and the regulati on of their sale in El Salvador.  Article 21 of the 
relevant law prohibited the marketing of milk, cr eam and cheese emerging from the reconstitution and 
recombination of powdered milk, as well as the mark eting and sale of these pr oducts using additives.  
Aspects of milk product production, such as produc ing cheese using milk powder, were acceptable at 
the global level and foreseen in the Codex Alimenta rius.  Thus, there was no problem accepting this 
practice.  In Mexico and in other countries, ther e was neither any hurdle to overcome when marketing 
milk products based on powdered milk, nor any legislation prohibited their sale.     
55. Mexico did not believe that there were any inte rnational precedents indicating that the use of 
milk powder for producing milk pr oducts could have negative conse quences on nutrition.  At present, 
there was no method of proving whether a milk product had been produced on the basis of liquid or 
powdered milk since both products had the same ch emical properties.  Cheese containing vegetable 
fat was now considered to be an additive in El Salvador.  The use of vegetable fat or lard was 
authorized in Mexico, although it had to be  labelled as an imitation on the label.   
56. Mexico's request to export products with these ch aracteristics freely to El Salvador had been 
rejected.  Though Mexico recognized Members' right s to establish necessary measures to ensure the 
quality of products for the protection of health, hum an, animal and plant life, or the environment 
should be respected, it was important to ensure that  the levels of protection were recognized and to 
prevent any unnecessary trade restrictive measures.  Since a number of concerns had been raised 
regarding this provision, it was necessary to ex amine the scientific evidence.  The prohibition 
discriminated against Mexican exports since a numbe r of El Salvador's products did not indicate use 
of these so-called additives, nor bear the word im itation on their labels.  Powdered milk was often 
used in the relevant products in El Salv ador, however not always listed on the label. G/TBT/M/55  
Page 14  
 
  57. The representative of El Salvador took note of the concerns raised and said that he would 
relay these to capital for a reply. 
(b) Previously raised concerns 
(i) European Union – Regulation on the Regist ration, Evaluation and Authorization of 
Chemicals (REACH)2 
58. The representative of India said that many of hi s delegation's concerns had not been addressed 
in EU bilateral discussions.  Specifically, his delega tion was concerned with the criteria and definition 
of small and medium enterprises (SMEs) given the la bour intensive industries in developing countries 
like India.  This could result in unfair treatment  for these enterprises.  His delegation also sought 
clarity on the registration to be made by merchant  exporters which were not manufacturers under this 
legislation.  This created particular problems fo r the trade and industry which operated through such 
merchant exporters.  Hiring of the Only Representa tive had been a burden for many SMEs and added 
to the cost.  His delegation therefore requested th e EU to review the provision for permitting direct 
registration by the exporters.  He also reiterated ear lier concerns about the creation of the Substance 
Information Exchange Fora (SIEFs) and consortia  which were outside the purview of regulatory 
control and had the potential to be dominated by the EU industry.   
59. The representative of Argentina reiterated his de legation's concern with the complexity of the 
regulation which constituted an unnecessary obstacle to  trade without complying with environmental 
and health concerns.  The complexity of REACH was seen in the continual modifications of the 
regulations and the explanatory guides for complianc e.  REACH had been modified 19 times, and the 
24 guides which existed for interpretation were c ontinually changed.  In 2011 alone, the regulatory 
text was modified six times and three explanatory guides were changed.  In 2012, there was to be a 
general revision which might add further modificat ions.  Also, the changes foreseen for 2013 by the 
European Agency for Chemical Substances (ECHA) for classificati on, packaging, and labelling of 
substances and blends were even more discour aging for companies.  ECHA claimed that the 
timeframes for some of the REACH processes ha d to be modified as well as changes in the 
prerequisites to justified alternatives to animal m odel tests and in the evaluation of the security of 
different chemicals. 
60. The situation was worrisome, especially for SM Es, because the continuous changes gave rise 
to confusion and it was difficult for companies to meet their obligations.  Costs accumulated for 
having an Only Representative (OR), a lot of bureaucr atic formalities, as well as for the registration of 
each substance.  In this context, the forthcoming reduction of costs for substances for SMEs would be 
offset by other costs.  Figures provided by ECHA showed some 1500 chemicals which should have 
been registered in 2010, were not.  This accounted  for more than 30 per cent of the total of the 
substances on the registry, for a sector exporting large volumes.  This meant greater cost had to be borne to comply with REACH.  For the above r easons, his delegation asked the EU to make the 
process more transparent, to avoid the huge number of  changes, and to provide greater reductions in 
the registration cost for SMEs.  His delegation un derstood the need to protect the environment and 
human health, but REACH was an obstacle to trad e.  If the various problems were not solved, a 
number of companies, especially SMEs, would not be able to export their chem icals to the European 
market.  This would result in a loss of a large number of jobs in their home countries. 
                                                      
2 G/TBT/N/EEC/52, G/TBT/N/EEC /52/Add.1, G/TBT/N/EEC/52/Add.2, G/TBT/N/EEC/52/Add.3, 
G/TBT/N/EEC/52/Add.4, G/ TBT/N/EEC/52/Add.5, G/ TBT/N/EEC/52/Add.6; G/ TBT/N/52/Add.3/Rev.1; 
G/TBT/N/EEC/295, G/TBT/N/EEC /295/Add.1; G/TBT/N/EEC/297 , G/TBT/N/EEC/297/Rev.1; 
G/TBT/N/EEC/333, G/TBT/N/EEC /333/Add.1, G/TBT/N/EEC/334 , G/TBT/N/EEC/334/Add.1,  
G/TBT/N/EEC/335, G/TBT/N/EEC/335/Add.1, G/TBT/N/EEC/336, G/TB T/N/EEC/336/Add.1.  G/TBT/M/55  
 Page 15 
 
 
  61. The representative of the United States sought clarification as to whether ORs under REACH 
were able to apply for authorization.  If the ORs were unable to apply for an authorization, then each 
importer of a substance would have to apply, whic h would have a significant impact for US and other 
foreign manufacturers who would potentially have to submit multiple authorization requests for the 
same substance, whereas a new producer of the same substance would only have to submit one 
request.  In general, many of the problems enc ountered by ORs and, by extension, their non-EU 
customers which tended to be SMEs since they di dn't have a European presence, stemmed from the 
lack of clarity regarding the role of the OR in Article 8 of REACH.  It could be useful for the Commission to consider writing an official technica l guidance document for ORs, in the context of 
the REACH review, to help remedy some of th ese problems.  The OR organization had already 
submitted its ideas for such a document, including allowing ORs to be used by companies in the 
context of the CLP regulation as well.  This coul d be an important initiative, given the large 
percentage of OR customers that were SMEs.  La stly, his delegation would continue its bilateral 
discussions on other issues related to SIEFs including  data compensation rules with the EU, not just 
on REACH, but on other EU legislation too.   
62. The representative of Australia  had raised his delegation's concerns previously, which were 
still valid.  His delegation maintained its reserva tion on these issues, including those related to the 
data costs on SMEs and the overall burden on trade.   
63. The representative of the Kingdom of Saudi Arabia  reiterated its previously raised concerns 
regarding REACH, and supported those raised by other Members. 
64. The representative of the Philippines echoed th e concerns raised by other Members, 
particularly on the complex and costly procedures of REACH and how they might adversely and 
disproportionately impact the small and medium enterprises.  His delegation believed that this 
regulation could potentially lead to unnecessary disr uptions in trade, and would be grateful for  
answers from the EU on its concerns. 
65. The representative of Cuba reiterated her dele gation's concerns, and s upported statements by 
other Members, in particular regarding the high costs involved in this REACH regulation and the 
modification which had been made.  They led to a great deal of uncertainty for developing country 
businesses.  Furthermore, her delegation was concerne d by the scientific evidence provided by the EU 
regarding nickel being damaging to public health . Her delegation asked the EU to bolster its 
collaboration in line with Article 2 of the TBT Ag reement and to take into account the situation of 
developing countries, particularly concerni ng technical assistance and other such issues. 
66. The representative of the European Union note d that most of the points raised were 
reiterations of previous concerns expressed.  Th e Indian concern on the SME definition had been 
addressed at the last meeting in detail;  as had Arge ntina's concern on the complexity and changes to 
the regulation of the guidelines.   
67. Regarding the functioning of the Substance Information Exchange Fora (SIEF), she had 
already stressed in the Committee that it was up to industry to organize itself and that every individual 
SIEF had to establish its own working practices,  transparency schemes, times schedules, legal 
agreements and the cost sharing mechanisms. She said that the European Commission and the 
European Chemical Agency (ECHA) could not inte rfere in the organisation and agreements between 
SIEF members, but that they continued their proactive approach to help industry, including SMEs.  She informed that there was a new report of 20 September 2011 by the Director's contact group, 
created by the European Commission, to discuss acti ons to solve certain practical problems.  This 
report contained an analysis of the lessons to be learned from the first registration date of December 
2010, and it contained solutions and recommendati ons to certain problems encountered.  It was 
available on the ECHA's website. The ECHA and the Commission were also working on a full update G/TBT/M/55  
Page 16  
 
  of the guidance document on data sharing, so the Commission remained open to improvements in this 
respect and welcomed receiving any informati on including concrete examples of difficulties 
encountered. 
68. Regarding the possibility for the Only Repr esentative to apply for authorisation the 
representative of the European Union informed that  this was still under discussion in Brussels.  She 
could not provide any answers at this meeting but w as aware that an urgent solution was needed.  She 
promised to transmit to the relevant authorities the US proposal that the EC issue a new guidance 
document for the Only Representative related to Article 8.   
(ii) European Union – Directive 2002/95/EC on the Restriction of the Use of certain Hazardous 
Substances in Electrical and Electronic Equipm ent (RoHS) and Directive 2002/96/EC on 
Waste Electrical and Electronic Equipment (WEEE)
3 
69. The representative of Korea said that Korean industry continued to be concerned about the 
revised Directive.  Due to the introduction of CE ma rking, companies needed more transition time to 
comply with the system and to develop substitutes for restricted substances.  She asked the EU to 
explain how it would control spare parts manufactured  before the implementati on date but still on the 
market after the date.   
70. The representative of the European Union expl ained that after the agreement between the 
European Parliament and the Council of Minister s, the new RoHS Directive was published in the 
Official Journal of the European Union on 1 July 20 11. The Directive must be transposed by all EU 
member States into national law within 18 months af ter publication, in other words, by January 2013. 
Until then, the current RoHS Directive continued to a pply.  As Members were aware, the scope of the 
Directive had been extended to all electronic equi pment, cables and spare parts. Exemptions could 
still be granted in cases where no satisfactory alterna tive was available. In view of the significant 
extension of the scope, the new Directive introduced  transition periods of up to 8 years for the new 
products affected by the rules.  The new Directive would continue to ban lead, mercury, cadmium, hexavalent chromium and the flame retardants Po lybrominated biphenyls (PBB) and Polybrominated 
diphenyl ethers (PBDE).  However, the list of ba nned substances would be periodically reviewed.  
71. The first review of the list of banned subs tances was foreseen in July 2014, and WTO 
Members would be notified in due time.  Furthermor e, any review of the list of substances would be 
undertaken in consultation with interested parti es, would be based on scientific evidence and an 
assessment of the socio-economic impacts and would take into account informat ion on the availability 
and reliability of possible substitutes.  His delegati on had discussed this issue bilaterally with Korea 
and hoped that the explanation provided was helpful in alleviating Korean concerns. 
(iii) European Union - Proposed Measures on th e Labeling of Wine (G/TBT/N/EEC/366)  
72. The representative of the United States raised his delegation's concern regarding the restricted 
ability of non EU wine producers to use common descriptive or commercially valuable terms to 
describe their products on the grounds that those terms were traditionally asso ciated with European 
wines.  His delegation's concerns were known in this Committee and negotiations on this issue were 
ongoing.  Some progress had been made and, perh aps in March, his delegation would have new 
information to report.  His delegation would also be interested in any updates.   
                                                      
3 G/TBT/N/EEC/247, G/TBT/N/EEC /247/Add.1, G/TBT/N/EEC/247/Add.2  and G/TBT/Notif.00/310, 
Corr.1.  G/TBT/M/55  
 Page 17 
 
 
  73. The representative of the European Union said that her delegation was currently examining 
the applications filed by the US, and was discussi ng this issue bilaterally with countries concerned 
and would continue to do so. 
(iv) India – Pneumatic tyres and tubes for automotive vehicles4  
74. The representative of Japan expressed his delegati on's concern with regard to the compulsory 
certification system for automobile tyres in India, due to the Indian Government's enforcement of the 
relevant system, although his de legation had requested a postpone ment and improvement of the 
implementation on several occasions.  In addition to the problem of tyre companies not being able to obtain factory certification due to the lack of capaci ty of the certification authority, the acquisition of 
certification by each tyre size had not been complete d.  His delegation requested India to improve and 
speed up the certification process for currently applie d sizes and those that would be applied in the 
future. 
75. In the previous meeting, India had said that a legal modification woul d be made regarding 
clause 6.3 of the template, which prohibited exports of the BIS marked tyres to countries other than 
India.  This modification had not yet been done . Therefore, Japan's relevant companies were 
suspending export from Japan to India, and request ed the immediate deletion of clause 6.3 which was 
nothing but a technical barrier to trade.  
76. The representative of the European Union said th at her delegation shared Japan's concerns on 
the Indian Quality Order on Pneumatic Tyres and Tu bes for automotive vehicles.  India had indicated 
in the last meeting that its Government was looking at the options to change the requirement that the 
ISI marking for tyres could not be used on tyres sold outside India.  This prevented manufacturers 
from producing tyres for various markets and obliged  them to produce tyres for the Indian market 
alone, constituting an unnecessary barrier to trade.  India also promised in the last Committee meeting 
that its Government would look at the issue of th e royalty fees which were calculated on the basis of 
the total number of tyres produced and marked with the ISI marking and not on the basis of the total 
number of ISI marked tyres de facto  imported to India which, toge ther with the aforementioned 
prohibition to use the ISI marking of tyres sold outside India, rendered the export of tyres to India 
extremely costly.  Her delegation would appreciate an  update on the current state of discussions in this 
respect and urged India to find a solution to this trade barrier.  Finally, her delegation remained 
concerned about the delays in the certification pro cess of certain tyre manufacturers and the lack of 
availability of accredited laboratories inside and outside  India to carry out the required tests.  In this 
respect, the EU urged India to accept test reports ca rried out in ILAC accredited laboratories in the 
EU. 
77. The representative of Korea echoed the comments made by Japan and the EU and continued 
to be concerned about the capacity of the certifi cation authority, and the unreasonably long grant 
process.  Currently, one Korean manufacturer was facing severe delays in certification without any 
problem from the company side.  As a result, its ex ports to India had been immensely disrupted.  His 
Government had not received any explanation on this situation from the Indian authorities.  
Additionally, upon request from the Indian delega tion at the June Committee meeting, Korea sent 
concerns to both the BIS and the Indian Mission on 1 July 2011.  However, it had not received any 
reply.  Korea strongly asked India again to accelerate the process and explain the situation. 
78. With regard to the severe delays, Korean ty re manufacturers believed that the one year 
validity was unreasonably short.  Considering the severe delay in certification, manufacturers might 
have to reapply as soon as they got certification.  Also, most countries did not specify the term of 
validity for just one year.  Korea and the European Union granted permanent certification and many 
                                                      
4 G/TBT/N/IND/20 and G/TBT/N/IND/20/Add.1; G/TBT/N/IND/40 and G/ TBT/N/IND/40/Rev.1. G/TBT/M/55  
Page 18  
 
  other countries granted five years.  Korea asked India to expand the term of validity to at least five 
years.  With regard to Article 6.3 of the BIS Agreem ent, Korea invited India to explain the situation of 
the legal amendment and believed that th e requirement created unnecessary burdens. 
79. The representative of India recalled that his de legation notified the original measure in July 
2006.   The last notification in November 2010 stipulated May 2011 for its entry into force.  
Therefore, the time period of five years from the original notification was more than reasonable and 
well beyond those mandated in the TBT Agreemen t and TBT Committee Decisions.  Moreover, on 8 
September, his Government had notified the exempti on of some 316 sizes of types of tyres imported 
by the original equivalent manufacturers for the repl acement market.  He pointed out that most of the 
applications for certifications by tyre companies had been cleared and those still pending were only 
because of incomplete information from companies or  unavailability of test reports.  In a bilateral 
discussion with Japan, his Government was given a list of some specific applications which were 
pending.  However, these were additional size requi rements sought by these co mpanies so they were 
effectively new applications.  His Government ha d given positive consideration to the removal of 
Article 6.3 of the BIS Agreement, which was now only subject to certain approvals.  The marking 
fees were fairly low and reasonable and equitable in  terms of unit costs of tyres for both domestic and 
foreign manufacturers.  Finally, on the capacity of th e Indian labs to carry out certification, he said 
that around 85 licences were granted and there were very few pending Japanese or Korean applications. 
(v) Canada – Compositional requirements for cheese (G/TBT/N/CAN/203 and 
G/TBT/N/CAN/203/Add.1) 
80. The representative of New Zealand registered  her delegation's concern that Canada's 
compositional cheese standards were inconsistent with Codex standards, which did not prescribe 
limitations on the sourcing of milk proteins fo r use in cheese manufacture.  New Zealand had 
accepted Canada's offer at the TBT meeting in J une 2011 to discuss this issue bilaterally.  
Unfortunately, the discussion did not give New Ze aland any confidence that Canada intended to 
provide more clarity on how its cheese compositiona l standards complied with Codex standards or 
addressed NZ's concerns.  Canadian dairy farmer s had lobbied the Canadian Government for a 
yoghurt standard.  Like other WTO Members, Ne w Zealand was concerned that any compositional 
standards for yoghurt would also be inconsistent w ith Codex standards, and encouraged Canada to 
adhere to the Codex standard wh en making decisions on any future federal dairy regul ations/standards 
for yoghurt.  New Zealand said that it would co ntinue to monitor these developments closely. 
81. The representative of Australia also raised concerns about Canada's regulation on the 
compositional standards for cheese and access for milk  proteins.  His delegation supported the 
concerns raised by New Zealand and expressed dis satisfaction with Canada's assertion that it had 
taken international standards into acco unt when developing the measures. 
82. The representative of Canada noted that it was unfortunate that New Z ealand was not satisfied 
in the wake of bilateral discussions.  As previous ly stated, the Committee ha d not seen evidence that 
Canadian regulations have constr ained the overall use of milk ingredients such as milk protein 
concentrates and that all imported cheeses to date had been deemed to be in compliance with 
Canadian standards.  He confirmed that the Ca nadian Government had not initiated any regulatory 
processes for establishing compositional standards for other dairy products. 
(vi) India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33) 
83. The representative of the European Union tha nked the Indian Government for postponing, to 
April 2012, the enforcement of this measure.  Th e EU delegation proceeded to ask whether a revision 
of the notified text was being considered by the In dian health authorities.  In particular, would the  G/TBT/M/55  
 Page 19 
 
 
  validity of the importing licences be increased from three to five years in order to bring it in line with 
the validity of domestic licences.  The EU also inqu ired whether India had considered accepting test 
reports carried out in foreign laboratories, attes ting compliance with international standards, as an 
alternative to local testing.  Finally, would India accept labelli ng to be carried out in bonded 
warehouses as an alternative to la belling in the country of origin? 
84. The representative of the United States said his de legation shared the EU concerns about the 
differential period for the licensing and the test repor t and the supplementary labelling.  He also asked 
how the regulation fee would apply to particular br ands of products, whether the proposal referred to 
the trade name or the product line; and whether the placement of the import registration numbers could only be required on the outer package, rather th an on the inner package as well. In view of the 
delay in implementation, the US hoped to resolve so me of these technical issues bilaterally.  US 
industry was very interested in having a dialogue w ith India.  He asked India to update the Committee 
on any progress made in the establishment of technical level meetings. 
85. The representative of India reiterated earlie r comments on automotive tyres, in which the 
particular rules took approximately 5 years from the initial intention to regulate.  The validity of the 
registration certificate was three years as per the ru les, primarily because of the difference in the 
technicality of the inspections and testing carried out in the two processes.  While there was just a 
one-time inspection of documents at the time of registration for importers, domestic manufacturers 
had to obtain a manufacturing license that was issued  after a comprehensive inspection of premises, 
equipment and capability.  Since the firm could also  be inspected at any time between the grant and 
the renewal of that licence, the validity was kept sep arate. Therefore the validity period of the licence 
and registration were different ta king into account the risks of non fulfilment. India would pass on the 
comments of the EU to the regulatory authorities.  The Indian delegate had already relayed the US 
concerns to the Indian ministry regarding an a ppropriate forum to hold technical discussions on these 
rules. 
(vii) Colombia – Draft Decree Establishing Prov isions to Promote the Use of Biofuels5  
86. The representative of the European Union th anked Colombia for the written reply of 4 
October 2011 on the new version of the draft d ecree notified under G/TBT/N/COL/96/Add.5. The EU 
delegation maintained its opinion that Article 1 of the new version should be clearer in expressing 
that, from 2015 onwards, there would be a parallel  supply of E10 gasoline for conventional cars and 
E25-E85 gasoline for flex-fuel vehicles.  The EU no ted that Colombia had assured that all changes 
concerning the percentage of alcohol in gasoline w ould be subject to technical analysis, internal 
stakeholder consultation and to a notification under th e TBT Agreement.  In case of a change, a time 
period would be provided to permit producers to adapt to new percentages.  The EU also highlighted 
Colombia's assertion that petrol stations had to provide a clear separation and labelling of different 
mixes to help consumers become aware of the ki nd of fuel they purchased.  Given that the new 
version of the decree should replace Decree 1135 requiri ng engines to be capable of running with E85 
gasoline as of 1 January 2012, the EU urged Colombia  to ensure that the new decree entered into 
force before this date and that E10 gasoline continued to be available as of the same date. 
87. The representative of Mexico said that his delegation believed that special marking or 
labelling in petrol stations would be necessary so as to avoid confusion by consumers when filling the 
fuel tank of conventional vehicles, given that E25-E85 were designed exclusively for flex-fuel 
engines.  Furthermore, it considered a detailed an alysis of the impact upon performance, durability of 
fleets, available technology and infrastructure an d distribution equality of biofuels unnecessary.  
                                                      
5 G/TBT/N/COL/96, G/TBT/N/CO L/96/Add.1, G/TBT/N/COL/96/Ad d.2, G/TBT/N/COL/96/Add.3, 
G/TBT/N/COL/96/Add.4 and G/ TBT/N/COL/96/Add.4/Rev.1 , G/TBT/N/COL/96/Add.5, 
G/TBT/N/COL/96/Add.6. G/TBT/M/55  
Page 20  
 
  Mexico also requested further information regard ing the availability of fuel after 2015.  It was 
important for the Colombian Government to introduc e a transitional period that would allow vehicle 
manufacturers to adapt their engines and to avoid an y damage due to levels of ethanol and biodiesel.  
Likewise, Colombia should also take into account th e impact that this legislation would have on the 
vehicles that were already in circulation. Indeed, there could be technical damage to the engines due 
to the presence of ethanol in fuel.  Finally, Mexico  requested more information regarding the date of 
entry into force of Decree 11/35, which demanded that engines of less than 2,000 cc operate on flex-fuel E85.  Originally, the date was set for 1 January 2012.   
88. The representative of Argentina requested Colomb ia to clarify which products were being 
covered by this draft standard.   
89. The representative of Colombia said that, with respect to decrees 2629 of 2007 and 1135 of 
2009, his Government had met all of the various require ments for the preparation of regulations in this 
area.  In relation to the draft decree under TBT/N/ COL/96/Add.4, Colombia notified a new version of 
the draft under G/TBT/N/COL/96/Add.5.  Due to the modifications of content, comments were 
accepted until 30 August 2011.  Colombia received comments from the European Union and Mexico 
and provided answers through the Colombian TBT enquiry point.  Consequently, the Committee on 
biofuels met in September 2011 a nd approved the text, including some of the submitted comments.  
The Colombian delegate predicted that this decree would be sanctioned before 15 December 2011.   
(viii) Thailand – Health warnings for alcoholic beverages (G/TBT/N/THA/332 and 
G/TBT/N/THA/332/Add.1) 
90. The representative of the United States expressed  his delegation's concerns on the proposed 
warning label requirements for alc oholic beverages.  His delegatio n had submitted comments and had 
raised questions about the warning labels including  their scientific basis, the size and the rotational 
requirements as well as other technical issues.  He requested an update on the measure's status. 
91. The representative of the European Union, Chile   and New Zealand supported the concerns 
made by the United States and looked forw ard to receiving updated information.   
92. The representative of Thailand clarified that alcohol labelling was aimed at protecting human 
health.  The Thai Government's campaign sought to  address social problems related to alcohol, by 
prohibiting alcohol consumption during festivals so as to reduce accidents and domestic violence.  
Representatives from the Ministry of Public Health  and from the Industrial Standards Institute had 
come to the TBT Committee meeting to explai n the measure and listen to comments.  These 
comments would be taken into consideration when re viewing the proposed measures.  The Ministry of 
Public Health was in the process of appointing a sub-committee to study the impact of the draft 
regulation.     
(ix) United States – Hazardous Materials: Transportation of Lithium Batteries 
(G/TBT/N/USA/518) 
93. The representative of Japan emphasized the importance of maintaining transportation 
security.  However, his delegation was concerned about the this measure from the perspective of 
consistency with the United Nations Recommendati on on the Transport of Dangerous Goods and the 
technical instructions of the International Ci vil Aviation Organization (ICAO), as well as of the 
impacts on trade.  If the purpose of the regulation w as to ensure safety, its scope did not have to 
extend to goods which were safety assured.  Japan asked not to exem pt lithium ion batteries with low 
SOC (State of Charge) for safety reasons.  Furthermore, the Department of Transportation website 
indicated that it would invite public comments from December 2011 until February 2012 as the stage 
of Supplemental Notice of Proposed Rulemaking.  The Japanese delegation requested that the US  G/TBT/M/55  
 Page 21 
 
 
  commence this.  The website also stated that ther e was a new proposed regulation concerning lithium 
ion batteries. Japan asked for information on this and the TBT notification schedule.   
94. The representative of the European Union requested  an update of the state of play of the 
proposed requirements on the transport of lithium batteries in the Hazardous Materials Regulations.  
She considered that they went beyond the UN Recommendations on the transport of Dangerous 
Goods and the Technical Instructions on the Safe Transport of Dangerous Goods of the ICAO.  The 
EU recalled its previously stated concerns. 
95. The representative of Korea agreed with Japan and the EU, and requested the United States to 
update the Committee on the current status and futu re prospects of this measure.  The Korean 
delegation insisted on the need for including an exem ption for lithium based secondary cells that were 
shipped at no more than 50 per cent SOC, if  the Pipeline and Hazar dous Materials Safety 
Administration (PHMSA) chose not to adopt existing UN and ICAO regulations for the shipment of lithium batteries.   
96. The representative of China supported the previous  statements and urged the US to comply 
with Article 2.4 of the TBT Agreement on the use of  international standards as a basis for domestic 
regulation.  In particular, China drew the US atten tion to the ruling of the Appellate Body in the EC - 
Peru sardines case regarding its interpretation of what  constituted a relevant in ternational standard.  
China called upon the US to make concrete efforts to base this regulation on relevant international 
standards, in this case the UN and ICAO regulations.  
97. The representative of the United States explained that this issue had been discussed with the 
Members who had previously raised this issue.  There had been no changes in the status of the 
measure since the last Committee meeting and it co ntinued to be discussed internally.  The US was 
aware of Members' concerns and ha d been taking their comments into consideration.  In addition to 
the comment period, a public hearing and stakeholde r meetings, had been provided by the Office of 
Management and Budget to which several delegations had attended.   These events brought great 
transparency to this measure and discussions on these particular guidelines continued in ICAO.  The 
US agreed with Japan that the website was sligh tly confusing and agreed to discuss the issue with 
colleagues to make proper adjustments.  He believe d that the proposed measure  remained at the same 
juncture as in the last meeting.  Article 2.4 was not  meant to cut and paste an international standard 
into the measure, but rather to use it as a basi s when relevant, unless it was ineffective or 
inappropriate to fulfil the government's objective.  He reiterated concerns raised in previous 
Committee meetings on the use of the internationa l standard due to the lack of consensus and 
inclusiveness. 
(x) Brazil – Alcoholic Beverages (G/TBT/ N/BRA/348 and G/TBT/N/BRA/348/Suppl.1) 
98. The representative of the European Union recalled that, at the last meeting, Brazil informed 
Members that the draft legislation on alcoholic beverages was still under analysis and that its 
publication was not foreseen in the near future.  The EU recently became aware that a MERCOSUR 
alcoholic beverages labelling proposal which was meant to supersede the Brazilian measure notified 
under G/TBT/N/BRA/348 was under discussion.  She requested an update from Brazil on the state of play of the draft proposal, on the eventual MERCOS UR proposal and an indication of when the new 
draft proposal would be made availabl e and notified to the TBT Committee. 
99. The representative of the United States also asked  whether this measure would go ahead or be 
superseded by a future MERCOSUR regulation.   
100. The representative of Brazil informed the Committee that this measure had not been 
published as a final regulation, and the regulatory process involved had been stopped.  Preliminary G/TBT/M/55  
Page 22  
 
  discussions were developing in the context of MERCOSUR, but it was too early for any kind of 
notification.  If the regulatory process resumed in the future, comments provided during the public consultation phase of the previous text would be taken into account and properly addressed.   
(xi) Turkey – New Conformity Assessment Procedures for Pharmaceuticals (Circular issued by 
the Directorate General of Drugs and Pharmacy of  the Ministry of Health re: "Important 
Announcement regarding GMP Certificates") 
101. The representative of the United States said that  his delegation contin ued to find certain 
aspects of Turkey's GMP decree for pharmaceutical  imports problematic and urged Turkey to take 
immediate steps to restore market access for safe high-quality pharmaceuticals.  The US recalled their 
past opposition to inspection requirements and main tained concerns based on the latest update 
received from the industry. The number of pharmaceuticals waiting market authorization in Turkey 
had reached approximately 550 products.  While the US was pleased with positive discussions on good manufacturing practices over the past year in b ilateral trade meetings, workshops and regulatory 
dialogues, market access was becoming an urgent issue both for US exporters and for patients in 
Turkey.  The US urged Turkey to consider th e following measures to immediately alleviate the 
current blockage of pharmaceutical imports: 1) to  process registration files submitted prior to March 
2010 as filed, so that the GMP requirement would not be applied retroactively without notice; and 2) 
to give priority to innovative drug applications th at provided new medicinal therapies to patients in 
Turkey. The US also noted that the measure had not been published in the official Turkish gazette and 
that it was not notified to the WTO.  Finally, he said members of US Congress had recently sent a letter to Turkey's Ambassador in Washington urging Tu rkey to take immediate steps to restore market 
access for imported pharmaceuticals. 
102. The representative of the European Union shar ed the US’ concerns and urged Turkey to 
continue discussing this issue bilaterally in order to find a suitable solution.  
103. The representative of Turkey explained that good manufacturing practice certificates required 
in licensing applications for pharmaceutical products , ensured that the products were manufactured in 
conformity with the licence requirements and that human health was not at risk due to safety and/or 
quality deficiencies in the production process.  Pharm aceutical products were by nature different from 
other commercial products in that, when entering th e market, they were highly regulated by health 
authorities through licensing schemes.   GMP certificat es were an indispensable part of that licensing 
process.  With the GMP certification, Turkey sought  to ensure that the pharmaceutical market in 
Turkey conformed to GMP rules. The Turkish Mini stry of Health had the necessary capacity to accept 
and process applications for GMP certificates.  All applications were processed immediately provided 
the application files were complete.  For public h ealth concerns, the Ministry of Health used a 
classification system based on therapeutic prio rities of pharmaceuticals which were determined 
according to scientific criteria.  The same pro cess was applied to all countries and all products 
equally, including national products.  GMP inspections conducted by Turkey did not seek to restrict 
trade but to secure public health.  A dialogue with  the European Commission had been held on this 
subject.   
(xii) European Union - Directive 2004/24/EC on Traditional Herbal Medicinal Products 
104. The representative of India said that the primary concern of his delegation was the absence of 
a notification of the 2001 and 2004 directives.  Indi a was also concerned about the requirement of 30 
years of traditional use, including 15 years of traditio nal use in the EU, to estab lish the efficacy of the 
product.  The Indian delegate requested that the EU  consider acceptance of 15 years of traditional use 
even of those medicines to be used as food suppl ements in the EU.  The common technical document 
format, was inappropriate for multicomponent traditiona l medicinal formulations.  Furthermore, India 
requested the EU to recognize the GMP certificates issued in India fo r the purpose of this particular  G/TBT/M/55  
 Page 23 
 
 
  directive.  They also suggested a bilateral inter action with the traditional medicinal experts from the 
European Directorate for the Quality of Medicin es, the European Policy Centre, and the European 
Medicine Agency.  Finally, the delegation announ ced that his Government was working with some 
experts but requested closer interaction in both fields.  
105. The European Union took note of India's concerns regarding Directive 2004/24/EC on 
Traditional Herbal Medicines. The EU reiterated that  this Directive introduced a lighter, simpler and 
less costly registration procedure for traditional herbal medicinal products as compared with 
medicinal products falling under the full market au thorization procedure (Directive 2001/83/EC).  
Extensive technical clarifications were provided in  previous meetings and were in the minutes of 
those meetings. Several bilateral meetings were  organized to discuss the Directive's scope and 
eligibility criteria, and the EU remained open to discu ss remaining issues bilaterally at an expert level. 
(xiii) Colombia – Shelf life for milk powder6  
106. The representative of the European Union conti nued to have concerns with respect to the 
proposed revision of Decree 16/73 of 2010, notified by Colombia in January 2011. This revision 
required imported milk powder to have a minimum shelf life of at least 12 months at import, which 
was six more than previously required. The extensi on of this period could impa ir EU exports of milk 
powder to Colombia. The EU provided written comme nts to Colombia in April 2011, raised these 
concerns at the last Committee meeting; but no reply had been provided. The EU delegate asked 
Colombia to clarify the risk that the authorities s ought to address by extending the required shelf life 
of milk powder, and provide an update on the draft.   
107. The representative of Colombia said the modifi cation of resolution 16/73 of the Ministry of 
Social Protection, was under discussion by the count ry’s national institutions.  Colombia did not yet 
have a specific response for the EU's request but hoped to have a response as soon as possible.   
(xiv) Korea – KS C IEC61646:2007 Standard for Thin-film Solar Panels 
108. The representative of the United States recalled th at solar panels sold in Korea had to be 
certified by the Korean Management and Energy Corporation (KEMCO).  The mandatory Korean 
standard was based on the IEC61646 standard for so lar panels, but was only being applied to one 
particular type of solar panels.  As a result, othe r leading types of film solar panels were essentially 
excluded from the Korean market because they coul d not be tested or certified under the KEMCO.  
The United States was not aware of any scientific or  technical evidence indicating there were risks 
from using thin film solar panels that were not cove red by the Korean version of this standard.  This 
measure not only hurt US companies but kept the most innovative solar panel products out of Korea 
and limited Korean producers from moving into next generation technologies - critical for energy 
conservation.  The US continued to believe that Korea should adopt the IEC61646 standard and not limit its application to only the one type of thin film  solar panel produced by the Korean industry.  His 
delegation had previously discussed Korea's assertio n that it meant to perform additional studies on 
the dangers of cadmium.  Like Korea, the US maintained legal requirements on the safe and effective 
use of cadmium and ensured that the cadmium used  was in the form of a cadmium compound and not 
the more toxic elemental cadmium.  In all the US products currently blocked from obtaining KEMCO 
certification, the total amounts of cadmium in cluded in their modules were well below most 
regulatory levels.  Given the prevalence of these mate rials, and the fact that these solar panels were 
being used in a number of markets around the worl d, the exercise in studying the cadmium issue 
seemed to have needlessly delayed market entry for innovative products that were already in use in 
other markets.  The US continued to question the need for these studies, and urged Korea to complete 
                                                      
6 G/TBT/N/COL/67,G/TBT/N/COL/67/Add.1 G/TB T/N/COL/67/Add.2, G/ TBT/N/COL/67/Add.3, 
G/TBT/N/COL/67/Add.4, G/TBT/N/COL/67/Add.5 G/TBT/M/55  
Page 24  
 
  them as expeditiously as possible.  The US also pr oposed allowing US companies to pre-test the thin 
film solar panels in question according to IEC61646, so  that the data and materials would be ready if 
and when Korea enabled these panels to receive KEMCO certification.   
109. The representative of the European  Union joined the United States in recalling its concerns on 
Korea's standard for thin-film solar panels.  Her delegation requested an update on this issue, in 
particular on the on-going study of the environmen tal impact of thin-film solar panels, and its 
foreseen timeline for completion.  
110. The representative of Korea reiterated that the st andard and its related certification system 
was not mandatory. Currently, non-amorphous silic on types of thin film solar panels, Cadmium 
Telluride (CdTe) and Cooper Indium Gallium Sele nide (CIGS), could enter the Korean market, 
without the KS certification.  Furthermore, the feasi bility study would be comp leted by 30 May 2012.  
Following completion, the Ministry of Knowledge  Economy (MKE) would decide whether those two 
types should be included in KS61646.  The Kor ean Government could only then provide updated 
information. In response to the EU's comment s in the June WTO TBT Committee, noting that 
national authorities had been encouraging invest ment and research and development activities in 
CIGS solar panels, she confirmed that those activities were related to making cadmium-free CIGS 
solar panels.  She would relay the stated concerns to her competent authority.  
(xv) India -  New Telecommunications related Rules ( Department of Telecommunications, No. 842-
725/2005-VAS/Vol.III (3 December 2009); No. 10-15/2009-AS-III/193 (18 March 2010); and Nos. 10-15/2009-AS.III/Vol.II/(Pt.)/(25-29) (28 July 2010); Department of Telecommunications, No. 10-15/2009-AS.III/ Vol.II/(Pt.)/(30) (28 July 2010) and 
accompanying template, "Security and Business Continuity Agreement") 
111. The representative of the United States had a remaining concern with the revised telecom 
security regulations, in particular with the in-country  security assurance testing.  Clause 23.7(a) of the 
amendments state that, as of 1 April 2013, all pr oduct certification of network elements would be 
done in India. The US understood the need to certif y the product to the appropriate standard, but was 
not clear on whether having the product tested domes tically could enhance security.  Another concern 
focused on the facility instructions, which was also  part of the same clause and would require 
vendors, or its designated agencies, to carry out  inspections of the hardware/software design 
development manufacturing facility and supply chain.   This raised numerous concerns, such as the 
proprietary and sensitive issues surrounding the design of products, including the fact that security requests could infringe on intellectual property righ ts and legal obligations and intrude into the 
business operations of vendors.  The US asked that India notify the revisions to the WTO, so as to 
allow comments from industry. 
112. The representative of the European Union iden tified the same concerns as the United States 
with regard to the in-country testing as of 1 April 2013, and asked for some explanation of the 
rationale for this requirement. Since India w as a contracting party to the Common Criteria 
Recognition Agreement (CCRA), ther e was scope for continuing to recognize the certificates issued 
by other Members to that Agreement.  The EU requ ested that the legitimate commercial interests of 
vendors be adequately protected in the framework of  inspections and checks.  The current provisions 
were not precise enough to give full confidence to vendors that they would not have to disclose any 
proprietary information in the context of these inspect ions and checks.  Finally, the EU raised concern 
on the scope for mandatory testing.  The current rules required that only network elements tested 
according to the relevant standards could be used in  telecom networks.  The EU suggested that this 
scope for mandatory testing could be clarified as being limited to those elements that were essential 
for ensuring the security and integrity of the system.  G/TBT/M/55  
 Page 25 
 
 
  113. The representative of Japan supported the US a nd the EU.  Japan was concerned with India's 
regulations on the licensing conditions for teleco m services, which were announced on 31 May.  
Japan thought that this approach might not be in  accordance with the CCR A because the new rules 
(February 2013) dictated that only network elemen ts approved by Indian certification agencies would 
be allowed.  Japan reminded the Committee that India accepted the scheme of CCRA.  Furthermore, 
he asked India to ensure that th eir telecom regulations did not impede market access for foreign 
companies. 
114. The representative of India stated that India's regulations on the licensing conditions for 
telecom services were transparent despite being an issue with security implications.  His Government 
extensively engaged with stakeholders at the high est administrative level and had taken into account 
comments from several Members through joint meetings at the highest level.  The regulation that was 
issued on 31 May 2011 was a consolidation of tho se inputs.  No other Member had such an open, 
transparent process on such a sensitiv e issue as security guidelines for telecom equipment.  Regarding 
the CCRA, India would continue to recognize the process based on performance tests conducted by international laboratories for general guidelines on products that were covered under the CCRA.  
However, these were security testing guidelines of telecom equipment. They called for the application 
of other parameters different from the general guidelines, technical regulations and conformity 
assessment procedures.  India had taken, and wo uld continue to take many of these inputs and 
concerns into account.  He offered to revert to Members on specific issues and to forward these 
concerns to the Department of Telecom for consideration.    
(xvi) Brazil - Instructions for Registration for Labe ls of Imported Products of Animal Origin 
(G/TBT/N/BRA/385, G/TBT/N/BRA/385/Add.1, G/TBT/N/BRA/385/Add.2) 
115. The representative of the United States appr eciated Brazil's willingness to address the US 
concerns including potential for disclosure of conf idential business informatio n and other data points 
that were considered unnecessary.  While the US had already received some useful clarifications from Brazil,  US regulatory agencies were being asked to certify to Brazilian sta ndards and this was beyond 
their scope of authority.  US regulators were willi ng to certify that products with animal content were 
produced in accordance with US requirements, but did not find it appropriate  to certify that those 
products were in accordance with another country's  requirements.  Additionally, the US regulatory 
agencies had already issued a h ealth certification for these products; the need for an additional 
certification was unclear and most likely redundant.   
116. The representative of the European Union mainta ined concerns on the need to register the 
labels of products of animal orig in for approval before being marketed in Brazil.  It must be ensured 
that this requirement did not create unnecessary dela ys and costs for the EU's economic operators.   
117. The representative of Brazil reminded Members that the aim of these measures was to 
facilitate trade of products of animal origin.  Th is measure had simplified requirements related to 
registration of labels of such products, in comparison  to previous Brazilian requirements in this area.  
Brazil had not received any reports on interruption or  disturbances of trade due to these measures.  
These regulations were notified at the end of 2010 and were follo wed by comments from interested 
Members.  Brazil modified the regulations in or der to take those comments into consideration, 
including the requirement mentioned by the Unite d States on the authority of the exporting country 
declaring whether products complied with Brazilian standards.  This was no longer present in the 
regulation.  Brazil had tried to organize a bilateral vi deo conference with the US on this issue, but due 
to technical difficulties, it would have to be resch eduled. Brazil remains available for such bilateral 
talks.  G/TBT/M/55  
Page 26  
 
  (xvii)  Indonesia – Labelling Regulations (Ministry of Trade Regulation 62/2009 and 22/2010)  
(G/TBT/N/IDN/47) 
118. The representative of the European Union clarif ied that while her dele gation did not question 
the obligation to label goods in the Indonesian langua ge, it queried why labelling had to be approved 
by Indonesian authorities before importing products and that labelling had to be done before the goods 
entered Indonesian customs.  Indonesia had said in the previous Committee meeting that these rules 
were for pre-market surveillance purposes and help ed to control imported goods.  However, the EU 
found these measures burdensome for importers and encouraged Indonesia to pursue the option of 
providing at least the possibility of re-labelling produc ts in a specific zone after entering Indonesian 
customs. This would ensure a less burdensome procedure for importers, while still fulfilling the 
objective of control and consumer protection. 
119. The representative of the United States said th at the supplementary labelling for processed 
food products should be allowed to be applied at  the importers' select warehouse and other approved 
locations.  The products could be released to the importers' warehouse where the supplemental labels 
could be applied prior to full customs clearance.  Th e delegation thought that this would be sufficient 
to meet Indonesia's objectives and the Indonesian regul ator, BPAM, would retain the right to inspect 
the importers' selected warehouse and other approved lo cations.  An important trade issue for the US; 
it could affect approximately $250 million US dollars' worth of processed food exports to Indonesia.   
120. The representative of Australia sh ared these concerns and was inte rested in hearing responses 
from Indonesia.  Australia's prefer ence was to allow exporters to u se labelling stickers upon the entry 
of a good into the market.  They encouraged Indo nesia to ensure that any labelling standards be 
consistent with international standards, such as C odex, which provided guidanc e in relation to using a 
secondary label in a country. 
121. The representative of Indonesia informed the Co mmittee that because its territory was spread 
throughout many islands, the Government had to con duct tight market surveillance. Affixing labels in 
Bahasa Indonesia was an instrument of pre-market surveillance which would be done by the relevant 
officers.  The pre-market mechanis m was applied to facilitate officers'  control of goods, particularly 
of imported goods in accordance with the respective regulations.  Implementation of this regulation 
was aimed at giving consumers the right to obtain sufficient, correct, clear and accurate information, 
as stated in the Act No 8/1999 concerning Consumer Prot ection.  It was also a tool of surveillance as 
well as a means to minimize the entrance of illegal goods into the Indonesian market.  Indonesia 
provided the opportunity for importers to use stickers, as stated in annex I, II, III, and IV in the Decree 
of the Ministry of Trade.  However, the importer ha d to comply with the provisions of the regulations, 
which required goods to be labelled before entering the Indonesia market. 
122. Indonesia’s interest in tightening market surv eillance did not specifically target the re-
labelling of goods after entering Indonesian custom s, but to minimize and avoid  the possibility of 
having illegal goods enter the Indonesian market.  Ther efore, the decree regulated that imported goods 
were to be labelled before entering the Indonesia cust om area.  The label would also be used for the 
Government of Indonesia to trace the origin of the mentioned goods. Indonesia acknowledged the 
importance of receiving comments in the reviewing process. 
(xviii)  Turkey – Communiqué  SUT 2010 regarding documen tation requirements for medical devices 
123. The representative of the United States urged Turk ey to take action to eliminate the Social 
Security Institution (SGK) documentation requireme nts in communiqué SUT 2010, so that suppliers 
of medical devices could continue to place their pr oducts on the Turkish market, provided that their 
products met the requirements of the Medical Device Dir ective and by the Ministry of Health.  As this 
measure was not notified to the WTO, interested  stakeholders had no notice or opportunity to  G/TBT/M/55  
 Page 27 
 
 
  comment on the measure in draft form; and the measure went into effect only seven days after 
publication.  Therefore, suppliers did not have a reasonable interval for implementation.  It was 
unclear what purpose it served to require companies to provide these additional documents, given that 
Turkey's Ministry of Health did not require comp anies to prove the safety and efficacy of medical 
devices.  It was also unclear why SGK selected medi cal devices used in three specific areas to provide 
these additional requirements.  Documentation re quirements were problematic also because some 
devices were manufactured in a country where they had not been used, so producers did not have to 
obtain these documents and many medical devi ce regulators did not provide documentation on 
product usage or proof of reimbursement even when devices were used in the country of manufacture.  
The US understood that the SGK was currently re viewing this measure, and looked forward to 
receiving updated information. 
124. The representative of Turkey explained that  both domestically produced and imported 
medical devices had to comply with the applicable national technical regulati ons and the 'CE' marking 
was assumed to be the indicator of that complianc e. While the Ministry of Health regulated the 
entrance of medical devices into the market, it wa s SGK that had to decide which devices would be 
reimbursed.  In this decision-making process, the in stitution's primary consideration was to ensure 
that high-quality products were provided to patients.  Secondly,  the SGK took into account public 
expenditure and budgetary constraints.  As TBT Committee had been previously informed, the SGK 
issued a communiqué in relation to the reimburseme nt of medical devices and this  was still bein 
revised.  The concerns of the US would be taken into account during the revision process. 
(xix) Italy - Law on "Provisions concerning the marke ting of textile, leath er and footwear products 
(G/TBT/N/ITA/16) 
125. The representative of India asked for an update from the EU on the status of implementation 
of Italy's labelling law.  This labelling law covere d a large number of regulations and provisions of 
information at each stage of processing, which created  difficulties for an industry that was premised 
on global and multiple sourcing.  There was also c oncern about certain non-pr oduct-related processes 
and production methods (the nPPMs) which were s ought under the law such as details of employment 
in the sector. India expressed concern and request ed an update on this Italian labelling law. 
126. The representative of the European Uni on announced that there had been no new 
development on this measure.  Italian authorities ha d decided to postpone the application of this law 
as it depended on the adoption of implementing measures which had not yet been adopted and no adoption date was foreseen.    
(xx) Brazil - Draft Resolution No. 112, November 29t h 2010; maximum levels of tar, nicotine and 
carbon monoxide permitted on tobacco products and prohibition of additives 
(G/TBT/N/BRA/407)  
127. The representative of the European Union refe rred to comments made at the previous two 
Committee meetings on this measure.   The proposed measure would imply discontinuation of 
European exports of traditionally blended tobacco pro ducts to Brazil, and would also affect European 
exports of additives that were currently used in tobacco products.  The EU supported Brazil's 
objective of protecting human health, in line w ith the WHO Framework Convention on Tobacco 
Control (FCTC).  It explained that it was itself in the process of revising its Tobacco Products Directive and had identified regulation of ingredie nts as one area of possible change.  She recalled 
questions raised by the European Union at previous  meetings to help fac ilitate understanding of the 
measure; for instance, had Brazil evaluated alternat ive legislative solutions to a ban on all additives 
and why had these alternatives not been considered as effective for achieving the legitimate health 
objective? She requested an update on the status of the proposal, and a reply, prior to adoption of the notified draft, to the EU's written comments. G/TBT/M/55  
Page 28  
 
  128. The representative of Mexico requested information on the implementation of Brazil's draft 
resolution, and a formal response from the Braz ilian Government on Mexico's comments regarding 
the draft resolution presented on 31 March 2011.  
129. The representative of Nigeria said his delegation was concerned with this draft resolution 
because his country had a long tradition of both gr owing and manufacturing tobacco products, and 
because the draft resolution came from Brazil, the worl d's third largest grower of tobacco leaf, behind 
only China and India in both the number of hectares  devoted to tobacco growing and the number of 
tonnes of tobacco leaf harvested each year.  ANVI SA, Brazil's National Health Surveillance Agency 
responsible for the draft resolution, continued to re view its content and to gather public input.  He 
asked for an update on the latest devel opments in the public hearing process. 
130. He further asked Brazil to reasses s the resolution prior to adoption,  so as to ensure coherence 
between the rights and obligations of Nigeria, al ong with the other African, Caribbean and Pacific 
countries (ACP) and African Union (AU) member St ates in the WHO, WTO and other international 
fora, particularly with respect to agricultural a nd rural development objectives.  He expressed concern 
with Brazil's intention to impose a regulation that  would create an unnecessary obstacle to trade for an 
agricultural product of great importance to many developing countries.  He encouraged Brazil to 
modify the proposed resolution to ensu re that it was fully WTO compatible. 
131. The representative of the Philippin es echoed concerns raised.  In particular, the resolution to 
ban the use of various types of additives with no reasonable justification e quated to a total ban of 
traditionally blended tobacco products in the Brazili an market.  Philippines shared the objective of 
protecting young people's health.  However,  this objective could be achieved through less restrictive 
measures;  her delegation encouraged Brazil to base any final decision on this resolution on scientific 
and technical evidence. 
132. The representative of Indonesia informed that her delegation had consu lted with Brazil on the 
follow up of its official letter of 4 April 2011 to the Minister of Development, Industry and Foreign 
Trade.  She asked Brazil to clarify the date of the public hearing on the Draft Resolution No. 112. 
133. The representative of Turkey said her delega tion was closely following this measure. 
134. The representative of Colombia supported the c oncerns raised, and asked Brazil to explain 
any progress made with respect to this resolution.  He was concerned that the draft resolution could be 
confirmed as notified, and believed it ran count er to Article 2.1 of the TBT Agreement. 
135. The representative of Honduras, Zambia and th e Dominican Republic reiterated previously 
raised concerns on the draft resolution and request ed an update from Brazil on the measure. The latter 
asked if Brazil could reassess the resolution in fa vour of a less trade restrictive alternative? 
136. The representative of Zimbabwe joined other delegations in re questing an update from Brazil 
on the status of this draft resolution. His de legation had submitted writte n comments expressing its 
concerns and awaited Brazil's response. 
137. The representative of Chile shared the concerns  raised, in particular that the measure was 
more trade restrictive than necessary.  Her delega tion did not oppose the legitimate objective of the 
measure, but believed there were alternative me asures to achieve the objective in a less trade 
restrictive way.  She asked for an update  on the current status of this measure. 
138. The representative of the Russian Federati on, speaking as an observer shared Brazil's 
objective of protecting human health and of redu cing the incidence of smoking amongst young people 
and the general population.  Neverthe less, he supported concerns raised, in particular that the measure  G/TBT/M/55  
 Page 29 
 
 
  was more trade-restrictive than necessary and violat ed Article 2.2 of the TBT Agreement.  There was 
insufficient scientific evidence to demonstrate that additives used in blended tobacco made those 
products either more attractive to c onsumers, more harmful to health, or more addictive.  Could Brazil 
provide the evidence upon which the draft resoluti on was based?  His delegation was particularly 
interested in comparative data on the health imp act of blended versus non- blended cigarettes, and on 
the risk to human health of additives used for blended products vers us additives that give 
characteristic flavours. 
139. The representative of Brazil reiterated that the objectives of this measure were to protect 
public health by reducing the attractiveness of certain  tobacco products particularly to children and 
youth.  Tobacco addiction usually began at a young age, when individuals were more vulnerable to 
tobacco products' appeal;  flavourings could in crease their appeal.  A previously cited study 
conducted by the National Institute on Cancer in Br azil showed that 45 per cent of smokers in Brazil 
between 13 and 15 years of age consumed tobacco products with flavour.  In addition, the WHO, 
through its partial guidelines linked to the implem entations of Articles 9 and 10 of the FCTC, had 
recognized that from the perspective of public hea lth there was no justification for permitting the use 
of ingredients such as flavouring agents which help make tobacco products attractive.  With respect to 
the status of this measure, the draft resolution ha d not yet been published as a final regulation.  His 
delegation was consolidating comments received on the draft resolution;  given the large amount 
received, additional time had been required but al l comments would be answered prior to final 
adoption.  Also, a public hearing on the draft re gulation was tentatively scheduled for December 
2011. 
140. Regarding the scientific basis of the measure, Brazil had compiled the scientific references 
that served as a basis for this measure.  These had been shared with Members that expressed concerns 
during the last TBT Committee meeting;  he would o ffer it to other interested delegations.  On the 
question of why Brazil had chosen to prohibit addi tives instead of flavoured products, he reiterated 
that previous attempts in Brazil to prohibit flavoured  products rather than additives proved inefficient, 
given the subjective nature of the assessment re garding the presence of flavours and smells in a 
product.  Moreover, certain additives, such as acet aldehyde, levulinic acid, gamma-valerolactone, and 
ammonia, apart from their flavouring properties, coul d potentiate the addictive effects of nicotine.  
Finally, studies indicated that in addition to in creasing the addictiveness of tobacco products, some 
additives when burned could augment the carcinogenic properties of cigarettes. 
141. Regarding the impact of the draft resolutio n on traditional blended products, the tobacco 
industry had possessed the technology to produce bl ended tobacco products without additives since 
1996; for example, processing burley tobacco without  sugar.  Finally, both domestic and foreign 
producers were required to comply with the requirements of the draft resolution. 
(xxi) China – Requirements for information security pr oducts (including, inter alia, the Office of 
State Commercial Cryptography Administration (OSCCA) 1999 Regulation on commercial 
encryption products and its on-going revision and the Multi- Level Protection Scheme 
(MLPS) 
142. The representative of the European Union reite rated his delegation's concerns about the 
Chinese measures on information security products.  He requested an update on the timeline for the 
revision of the regulation on commercial encr yption products managed by OSCCA, and sought 
assurance that the process would be conducted in a transparent manner, allowing for consultation of 
interested parties, and that the draft revised regul ation would be subjected to TBT notification.  He 
mentioned that China had, in the previous meeting,  confirmed that the revision was on the agenda (for 
2011) of the State Council Legislative Office, and requ ested an update from China.  He also reiterated 
concerns about the Multi Level Protection Scheme  (MLPS) managed by the Ministry of Public 
Security (MPS) and by the Ministry of Industry and Information Technology (MIIT) for G/TBT/M/55  
Page 30  
 
  implementation.  While the stated objective for th e scheme was national security, it had an impact on 
areas not considered sensitive for national secu rity, including commercial sectors of economic 
significance such as banks, financial institutions, pub lic transport, energy, etc.  He requested more 
transparency on the classification cr iteria used to establish the leve l of security sensitivity of IT 
systems, triggering restrictions on the kind of pr oducts and technology which could be deployed in 
such systems .  He noted, further, that European IT industry did not know whether they would be able 
to continue conducting business in China in sectors impacted by MLPS.  
143. The representative of the European Union was al so concerned about standardization practices 
in the area of information security, mainly carried out by the Information Security Standardization 
Technical Committee (TC 260) managed by the China Electronics Standardization Institute (CESI).  
The standardization procedures followed by th is technical committee did not allow foreign 
companies, or even foreign invested companies esta blished in China to participate directly in the 
standardization process.  The European Union str essed the need for more ample opportunity for such 
companies to participate in the standards devel opment process, especially since these standards could 
potentially be applied beyond areas traditionally covered by national security, and beyond areas which 
were covered by government procur ement.  He welcomed the comment period that had been provided 
for the six draft information security standards th at had been developed by the Technical Committee 
in the Summer of 2011, and expressed hope that such  consultation practices could continue and be 
expanded, and allow for more meaningful contributio ns – for instance, in this case, only 30 days had 
been allowed for comments, the documentation ha d been very comprehensive and technical and 
related legislative measures were often not publicly available.  
144. The representative of the European Union also ra ised concerns about the relationship between 
these standards and the regulatory framework bein g discussed i.e. the OSCCA regulation and the 
MLPS.  He said that the standards appeared to  be developed for the purpose of implementing 
requirements embedded in those regulations.  Theref ore, the European Union was concerned that the 
standards would become either de facto or de jure  mandatory once adopted, via a reference to them in 
the OSCCA regulation and the MLPS or related conf ormity assessment procedures.  He requested 
clarification on the subject.  In the event that the European Union observa tion was correct (that the 
standards were likely to become mandatory) he recalled the transparency obligations under the TBT Agreement.  
145. Finally, he also highlighted the need for greater dialogue on the subject.  He noted that the 
complex legal framework put into place by the Chinese authorities prevented the deployment of 
foreign technology in areas which were important  from an economic perspective, but not necessarily 
security sensitive.  With reference to other specifi c concerns, preventing the deployment of foreign 
technology was not necessarily the best means of e nhancing information security.  Moreover, this was 
a field where there were global challenges and coul d not be handled by one country alone – indeed, 
there was a need for greater international engageme nt on this issue. The European Union therefore 
would welcome a platform to discuss these issues with interested trading partners. 
146. The representative of Japan supported the Eur opean Union's position.  He noted that the 
various schemes and regulations in China on inform ation security continued to pose difficulties for 
trade in information security products and prev ented the placement on the market of certain 
technologies; furthermore, the schemes could not be  regarded as being cohe rent with global norms 
and approaches.  He recalled that delegations ha d requested China to be prudent in introducing 
additional measures on information security, whether or not they were related to the OSCCA 
regulation and MLPS.  From the transparency persp ective, it would be desirable for China to provide 
additional information on information security regulations. 
147. The representative of Japan supported the Eur opean Union's position.  He noted that the 
various schemes and regulations within China, co ncerning information security continued to pose  G/TBT/M/55  
 Page 31 
 
 
  difficulties for trade in information security products ; in particular the schemes could not be regarded 
as being coherent with global norms and approaches.   He recalled that delegations had requested 
China to be prudent in introducing additional measu res on information security, whether or not they 
were related to OSCCA and MLPS.  From the tran sparency perspective, it would be desirable for 
China to provide additional informati on on information security regulations.  
148. The representative of China noted first that  the Regulation on Commercial Encryption 
Products had been listed in the legislative agenda of the State Council and that OSCCA was focusing 
on a revision.  OSCCA would full y consider openness and transparency during the process and would 
undertake scientific discussion and public consu ltations, taking into account comments from the 
European Union and other interested parties.  Regarding the State Administrative Measures on 
Classified Protection of Information Security (MLPS) , she noted that Article 9 of the Regulations for 
Safety Protection of Computer Systems specified th at the classified protection of information security 
would be implemented for computer information sy stems and that the classification standard and the 
specific measures for classified protection would be fo rmulated by the Ministry of Public Security, in 
conjunction with other relevant authorities.  In 2007,  the Ministry of Public Security, jointly with 
other competent agencies, had issued the State Administrative Measures on Classified Protection of 
Information Security.  The objective of the system was to protect the basic information network and 
key information system of China, and to safeguard  national security and public interests.  Five 
different levels of protection were envisaged.  The commercial sectors which were not sensitive to 
national security would not be affected by those measures.  
(xxii)  Brazil - Canned Sardines - Ministerial Act Nº 406, 10 August 2010 
149. The representative of Peru referred to the a bove-mentioned documents and noted that Peru 
had engaged constructive b ilateral consultations of technical na ture in Brasilia in September 2011.  
Unfortunately, it had not been possible to find a so lution.  Peru was concerned that Brazil was not 
using relevant international standards as a basis fo r national regulations, in particular: Resolution 1 
was not covered.  Further consultations could not  be ruled out and neither could recourse to the 
dispute settlement mechanism of the WTO.  
150. The representative of the European Union refe rred to the above-mentioned notification which 
set the identity and quality requirements for canned sardines marketed in Brazil.  She was concerned 
over the final Brazilian text measure which still showed a significant divergence from the 
international Codex standard for canned sardines a nd sardine-type products (Codex Stan 94- 1981).   
151. The representative of Brazil reaffirmed Brazil's openness to pursuing the issue bilaterally with 
Peru, aiming to achieve a mutually satisfactory outcome.  
(xxiii)  Indonesia - Draft Decree of Minister of Industry on Mandatory Implementation of Indonesia 
National Standard for electroiysis tin coat ed thin steel sheets (G/TBT/N/IDN/46) 
152. The representative of Korea noted that while th e proposed decree had not yet been adopted, 
she asked the Indonesian authorities to update th e Committee on the measure.  In particular, she 
requested that Indonesia only regulate final products, not intermediate ones.  
153. The representatives of the European Union a nd Japan supported Korea's statement.  In 
addition, Japan expressed serious concern about the possible future expansion of mandatory standards 
to cover steel imported from Japan which was already produced under a strict quality management system at ISO 9001 certified steel mill s.  If the scope of mandatory standards was extended further, it 
would add to the cost required to receive and ma intain certification. This would have serious 
implications on foreign trade, such as increasing dist ribution costs and delaying deliveries for specific 
industries in Indonesia.   Indeed, this might even  make industries in Indonesia less competitive in G/TBT/M/55  
Page 32  
 
  global markets.   The European Union doubted th at mandatory third party certification was necessary 
in this case and asked why acceptan ce of foreign tests was not possible without a mutual recognition 
agreement.  
154. The representative of Indonesia said that the dr aft regulation of Ministry of Industrial 
Mandatory Implementation of Indonesian national st andard for electrolysis tin-coated steel had not 
yet been finalized.   His government was working on technical guidance documents.  
(xxiv)  China - Administration on the Control of Pollution Caused by Electrical and Electronic 
Products  (G/TBT/N/CHN/140,  G/TBT/N/CH N/140/Add.1 and  G/TBT/N/CHN/140/Rev.1) 
155. The representatives of the European Union, Jap an and Korea asked for information on the 
state of play, particularly on the progress of discussions about the product catalogue and certification 
procedure (Management Catalogue of Standard-R eaching for the Control of Pollution caused by 
Electrical and Electronic Products).  The representa tive of the European Union remained concerned 
about mandatory third party certification and request ed further clarification on the voluntary standards 
currently developed for six product categories, and on  how those standards were linked to the notified 
draft.   
156. In addition, the representative of Korea al so asked the Chinese authorities for detailed 
information on the requirements for certificati on bodies and laboratories for State Recommendation 
Voluntary Certification on Electric Informati on Products, which had entered into force on 1 
November 2011.  The representative of Japan re called had his delegation had recommended that 
China facilitate a voluntary suppliers' declaration of  conformity certification (SDoC) on the "National 
certification system for the control of pollution caused by electronic products."  The Chinese 
Government had replied to these comments suggesting th at it would plan to designate a catalogue of 
the target products of the regulation as a positive list, and would notify the TBT Committee upon completion of the catalogue which was an indispensab le part of the conformity assessment procedure 
scheme.   
157. The representative of China said that the revisi on had commenced in 2010 and that China had 
solicited suggestions from relevant  stakeholders and had notified it to the WTO.  China had 
considered and adopted some sugges tions received, but there was no timetable yet for the publication 
of the regulation or the Management Catalogue of  Standard-Reaching for the Control of Pollution 
caused by Electrical and Electronic Products.  Regarding the State Recommendation Voluntary Certification on Electric Information Products, the voluntary certification product catalogue had been 
jointly promulgated by the Ministry of Indus try and Information Technology (MIIT) and the 
Certification and Accreditation Administration (CNC A) in August 2011.  Certification was voluntary 
and the catalogue covered six kinds of products an d accessories.  The relevant documents could be 
found on the official website of the MIIT.  Requi rements for certification laboratories were still under 
discussion.   
(xxv) India – Food Safety and Standards Regul ation - Food labelling requirements 
(G/SPS/N/IND/69) 
158. The representative of the European Union noted th at this measure had not been notified to the 
TBT Committee despite several requests and the f act that the regulation contained several TBT 
components, such as labelling and packaging requirements, which did not fall under the SPS Agreement.  She asked India to confirm that the cu rrent practice of allowing la belling to take place in 
customs bonded warehouses, as an alternative to labelling in the country of origin, would be 
maintained permanently.  For labelling requirements a pplicable to alcoholic beverages, the European 
Union would continue to seek an exemption from the indication of date of manufacture, and the  G/TBT/M/55  
 Page 33 
 
 
  acceptance of the "single ingredient status" for the list  of ingredients.  She reiterated that the Indian 
legislation deviated from Codex Alimentarius on certain aspects.  
159. The representative of the United States said th at his delegation continued to be concerned 
about why India considered that th e data production label needed to a pply to distilled spirits given that 
such products did not have an expiration date.  He noted that identification numbers could provide 
better information should a product recall be nece ssary and therefore urged India to remove the 
labelling requirement for distilled spirits.  He al so expressed continued concern about requirements 
for the listing of ingredients for alcohol, since inte rnational practice did not require an ingredient list 
for non-nutritive products as this provided little  useful information for the consumer.   
160. The representative of India said that many of the specific information requirements had been 
taken from the Prevention of Food Adulteration Act, which was the main act under which the 
particular regulation in question was made; this took into account the specific needs of India. The representative of India would nevertheless conve y the concerns and suggestions mentioned. 
(xxvi)  Korea: PVC flooring material and Wallpaper and paper linoleum, and toys
7  
161. The representative of the United States said that  Korea had informed the United States about a 
study on the release of phthalates in constructi on materials which was the basis for a proposed 
phthalates concentration limit for PVC flooring materi al in paper and paper linoleum.   While the 
United States had requested a copy (letter of 2 June  2011) a response had been received in July about 
a different study of a safety assessment for PVC-fl ooring and wallpaper, one that had been conducted 
between July and October 2010.  He asked that  both studies be made available so as to better 
understand how the results had been obtained and to compare them with other existing studies.  The 
EPA, he said, had published an action plan on phtha lates which outlined a number of actions being 
pursued, or which were under consideration because of  the toxicity of phthalates and pervasive human 
and environmental exposure to the substances.  Th is action plan was available online.  The United 
States was unaware of any scientific or technical data showing the significant release of phthalates from PVC flooring or wallpaper or data showing the impact of these products on human health.    
162. The representative of Japan supported the US stat ement and stressed the need for a scientific 
basis for the regulation as well as the need for Korea to disclose their safety assessments.   
163. The representative of Korea said that the prop osed measure could help protect children's 
health from the three phthalates.  Her delegation had previously explained that all Korean houses used 
a very unique floor-heating system called Ondol whic h had been in use for centuries and as a result 
most houses in Korea used PVC flooring materials a nd wallpaper.  As children tended to play on the 
floor, regulations for PVC flooring materials were necessary, as in the case for toys.   The competent 
authority, KATS, had received comments from stak eholders and was in the process of taking these 
into account.  
(xxvii)  Colombia - Alcoholic Beverages8  
164. The representative of the European Union not ed that on 2 November 2011, Colombia had 
notified an amended text which incorporated some of the comments made by the European Union, 
particularly those on the definitions of brandy , fruit spirits, and rum.  However, she expressed 
continued concerns about the recently notified text (A dd.4) – particularly regarding the definitions of 
                                                      
7 G/TBT/N/KOR/303 and Add.1 and G/TBT/ N/KOR/304 and G/TBT/N/KOR/304/Add.1, 
G/TBT/N/KOR/304/Add.2. 
8 G/TBT/N/COL/121, G/TBT/N/COL/121/Add.1, G/TBT/N/COL/121/Add.2, 
G/TBT/N/COL/121/Add.3, G/TBT/N/COL/121/Add.4. G/TBT/M/55  
Page 34  
 
  alcoholic beverages (e.g., vodka, gin and liqueur) and ask ed for clarification.  Moreover, fixing labels 
of origin could be problematic, particularly for low-volume imports; she suggested that for imported 
products, labeling in warehouses be explicitly accepted as an alternative to labeling at origin.   In 
addition, the draft legislation cont inued to require the presentation of a quality certificate at the time 
of importation  - she asked Colombia to clarify if  the requirement was also applicable to locally 
produced goods.  She also asked what treatment woul d be given to stocks of products legally imported 
into Colombia before the legislation entered into fo rce, and whether they would be subject to the new 
requirements.   
165. The representative of the United States acknow ledged progress in discussions with Colombia 
but wished to highlight a few outstanding con cerns. Colombia continued to use its chemical 
composition limits to define alcoholic beverages rather than the raw materials used for their 
production, which was standard international practice for traded alcoholic beverages.  Also, Colombia 
had decided to maintain the three year minimu m aging requirement for whiskey; this would 
negatively impact trade in blended whiskeys.   Sin ce neutral spirits were almost never aged, if those 
were added to straight whiskies the resulting blen d would not meet the ageing requirement.  Micro 
distillers in the United States that were able to ag e whiskey in less than th ree years (with different 
barrel technology) would also be excluded by this requirement.  Could US whiskies be marketed in 
Colombia even if they did not meet the three year aging requirement given that in April 2011 Colombia had stated in a written communication that  it accepted US sanitary registration on whiskies?  
He understood that Colombia was also considering revising the process to apply a health warning 
label to the bottle, and requiring all bottles to have a blue stripe through the brand label.  If that was 
the case, could Colombia provide more information on the initiative and the basis for the blue stripe 
requirement.   
166. The representative of Colombia said that his c ountry had been transparent in the way the 
measure had been developed and that the modifi cations made to the measure were technical 
justifications based on international practice. 
(xxviii)  Korea – Good Manufacturing Practice requirements for cosmetics ( G/TBT/N/KOR/301) 
167. The representative of the European Uni on reiterated concerns  about Korea's Good 
Manufacturing Practice Requirements for Cosmetics (K CGMP).  It was the EU understanding that the 
Korean Food and Drug Administration (KFDA) was considering how to ex tend the KCGMP regime 
to foreign manufacturers or importers, to allow them  to benefit from the preferential treatment therein 
and, in this regard, she asked for confirmation a nd more information as to how Korea would ensure 
the same treatment to domestic and foreign manufacturers – for instance, whether the KCGMP 
Regulation would be revised in order to allow fore ign manufacturers or importers to apply for GMP 
inspection and, if so, how the Regulation woul d be implemented with respect to foreign 
manufacturers, given current resource constraints on the KFDA's side. 
168.  She also asked for confirmation that KCGMP was fully in line with the international 
cosmetics GMP Standard ISO 22716 with no substantia l deviations; in the past Korea had indicated 
that the KCGMP was meant to be harmonized with ISO 22716., but there was yet no clarity whether the KCGMP was in any way different from the ISO standa rd  In this context, the EU also reiterated its 
query whether the KFDA would accept the assessme nts performed or certificates issued by 
independent third parties proving compliance with the ISO 22716, or even consider self-certification 
by cosmetic manufacturers, as was the case in th e European Union and other major cosmetics 
markets.   
169. In addition, the EU asked Korea to provide more details with regard to the exact scope of the 
preferential treatment provided under the KCGMP Regulation – in the previous Committee meeting, 
Korea had indicated that this would imply an ex emption from the requirement of conducting batch  G/TBT/M/55  
 Page 35 
 
 
  tests and conducting quality management by lot number; however, as the text of the KCGMP 
Regulation was not very specific in this regard, th e EU was concerned that there may be room for 
different interpretations at the implementation stage.  
170. Lastly, the European Union had been informed that Korea was in the process of revising the 
Enforcement Regulation of the Cosmetics Act, in li ght of the revision of the Act adopted in June 
2011.  She expressed concern that the revision might eliminate or restrict the existing waiver of 
quality inspections for imported cosmetics in the terr itory of Korea, provided for by Article 8.2 and 
Article 9 of the current enforcement regulation.  She asked for confirmation that these provisions 
would be maintained in their current form in th e revised Enforcement Regulation, in accordance with 
the bilateral arrangements agreed to in the year 2000.  
171. The representative of the United States shared the concerns raised by  the European Union 
and, similarly, sought clarifica tion on similarities between the Korean standard and ISO 22716.  He 
was particularly interested in the informati on that Korea would recognize GMP certificates from 
foreign manufacturers, so that all manufacturers – foreign as well as domestic – could obtain such certification.  In his view as Korean Pharmaceutical  Traders Association (KPTA) had been in charge 
of certifying compliance to the standard, this appeared  to create a potential conflict of interest.  Since 
the GMP standard seemed to be based on the ISO st andard, one alternative could then be to accept 
certification to that standard from an independent third party, instead of requiring a KPTA review. 
172. Regarding the KPTA in particular: contrary  to assurances provided in 2008, the KPTA 
continued to participate in customs clearance pro cess for imported cosmetics and, in that capacity, 
was responsible for reviewing conformity assessment  related (and other) documentation provided by 
US companies.   While the United States underst ood that KPTA only required the frame formula (not 
the formula including percentages of ingredient s), responses provided to US questions had been 
somewhat ambiguous and inconsistent and this s ituation was not reassuring to the US cosmetic 
industry.  There appeared to a clear conflict of inte rest and the United States requested an explanation.  
He also invited Korea to review Article 5.2.4 wh ich provided that confidentiality of information 
provided in connection with conformity assessment mu st be respected in a manner that ensured that 
legitimate commercial inter ests were protected.   
173. The representative of Korea confirmed that KF DA was at that moment going through reviews 
so that KCGMP certification for foreign manufacturers  could be made possible.  In line with Article 
2.1 of the WTO TBT Agreement, KFDA was proposi ng to give equal treatment to both domestic and 
foreign manufacturers of cosmetics through onsite  inspection when importers applied for KCGMP 
certification.   In this same vein he noted th at domestic manufacturers required an independent KFDA 
certification even if they had third party certif ication from overseas certification bodies, proving 
compliance with the ISO standard – therefore forei gn manufacturers were not being treated differently 
from domestic ones. Regarding import clearance, the submission of a frame formula and sales certificate (which had to be submitted if the product had been imported for the first time) to KPTA via 
EDI system was to confirm minimal requirements in order to access the Korean market.  On the EU's 
last query on the article on existing exemptions, Ko rea indicated that, as already confirmed to the EU 
in their bilateral meeting, Korea was not planning to remove this exemption for  importers from the 
text of the Regulation.     
(xxix)  China - Provisions for the Administrati on of Cosmetics Application Acceptance 
(G/TBT/N/CHN/730 and G/TBT/N/CHN/821) 
174. The representative of the European Union acknow ledged China's efforts in clarifying and 
streamlining the new requirements and dealing with the backlog of product applications.  Regarding 
remaining concerns, the most significant one was a bout the registration of products containing new 
ingredients which had been initially hampered by the lack of guidelines on the definition of a "new" G/TBT/M/55  
Page 36  
 
  ingredient.  On 8 June 2011 China had notified a set  of guidelines on the requirements for application 
and evaluation of new ingredients and the European Union had provided written comments 
(22 September 2011).  The European Union had welcomed the issuance of the guidelines which 
would eliminate existing hurdles in registration and grant impetus to the approval process of 
cosmetics.  However, concerns remained: with regard to the treatment of complex ingredients 
commonly used; the possibility to omit certain re quired information, such as molecular weight 
structure in the case of naturally extracted ingred ients; the acceptance by the China State Food and 
Drug Administration (SFDA) of the internationally us ed mutagenicity tests.   She asked whether the 
guidance document would be applied to pending ingredient and product applications made before the 
entry into force of the guidelines on 1 July 2011.   
175. The representative of Japan supported the EU statem ent.  In addition, he noted that several 
widely-used cosmetic raw materials originating fro m minerals with various surface treatments, as well 
as plant extracts which were mixtures of several subs tances existed.  Based on international practices, 
safety assessments needed to be conducted.  He re quested to review the application of the said 
guidelines. The Article 3 Clause 3 of the guidelines require a summary and flow chart of the 
manufacturing process for new ingredients. Some of  examples requested detail information related 
with manufacturing process including reaction pr ocess and reaction temperature etc., these are 
industrial properties and know-how of  the applicants. He also requ ested to review the scope of 
publication for the newly examined ingredients, not  to disclose information related with industrial 
properties etc. The SFDA made public not only th e name of the two new ingredients of which 
examination had been completed, but probably a pa rt of application document as well.  Japan also 
requested clarification, or feed-back, in terms of applications "exami nation postponed" for new 
ingredients submitted prior to the implementation of the measure at issue. 
176. The representative of China said that the Guidan ce of Application and Evaluation for the New 
Cosmetics Ingredients had been notified to th e TBT Committee in June.  The SFDA had solicited 
public opinion several times on cosmetics manufact urers including those from the European Union 
and Japan, and indeed adopted some of their advice.   After the release of the Guidance, the SFDA had 
carried out fruitful trainings for foreign and dom estic cosmetics manufactures. At the moment, the 
application and evaluation of a new cosmetic ingredient was proceeding smoothly. In respect of Article 2.2 of the TBT Agreement, he stressed that  the objective was to strengthen the regulation for 
cosmetics as consumers around the world were now pa ying more and more attention to the safety of 
cosmetics, especially after the safety problems that emerged with cosmetics in particular with child 
bathroom products and talcum pow der in 2009.  There was no difference in the way the guidelines 
affected domestic and foreign manufacturers.     
(xxx) Ecuador - Certification of Ceramic Tiles (Resolutions 17 and 18 of CONCAL)
9 
177. The representative of the European Union re ferred to the Add.1 which had informed 
Members of significant modifications to the originally notified conformity assessment procedure.  
Changes had been adopted on 17 December 2010 and had entered into force on 19 January 2011; 
there had been no notification at a draft stage even though the changes were significant.  She 
understood that Ecuador no longer accepted suppliers' declarations of conformity (SDoC) from 
enterprises certified according to ISO 9001 as this st andard was not product related and therefore not, 
according to Ecuador, an appropriate tool for certifyi ng requirements for ceramic tiles.  She noted that 
certification according to ISO 9001 had the objective of providing authorities with assurance that the 
manufacturer possessed an appropriate quality manage ment system.  She asked why SDoC had to be 
changed into a system of third party certificati on (in the European Union ceramic tiles were not 
subject to mandatory third party certification, even  though an adequate level of safety was ensured).  
As an alternative, would Ecuador consider ac cepting tests conducted in accordance with the ISO 
                                                      
9 G/TBT/N/ECU/63, G/TBT/N/ECU/63 /Add.1, G/TBT/N/ ECU/63/Add.2.  G/TBT/M/55  
 Page 37 
 
 
  standard 13006?  She enquired if such tests coul d only be recognized if they were conducted by 
certification bodies recognized by the Accreditation Bo dy of Ecuador of whether tests conducted by 
laboratories accredited by ILAC/IAF would be rec ognized?  Ecuador had previously mentioned that it 
had started to increase the number of laboratories and certification bodies – had more such bodies 
been recognized since the prev ious TBT Committee Meeting?  
178. The representative of Ecuador said, regarding th e acceptance of ISO 9001 certification, that 
the ISO and IAF themselves had determined that ISO 9001 accredited certification did not imply that 
the organization was providing a superior product although the product itself was certified as meeting 
the requirements of an ISO standard or specificati on.  This meant that ISO 9001 certification was not 
the most appropriate tool to measure the technical qualities of a specific product , ISO 9001 
certification was needed to ensure the trustworthiness of the management  system of the organization.  
Regarding SDoC, Ecuador had seen cases where complia nce with ISO 9001 had nevertheless resulted 
in several problems with the products at issue.  Tests conducted in line with ISO 13006 by accredited 
laboratories were recognized in Ecuador in line with  Article 26 paragraph 2 of  the Ecuadorian Quality 
System Law.  Certificates of conformity were r ecognized under Article 1 paragraph (a) of Resolution 
018 of Ecuador's National Quality Council, if th e certificate was accredited and recognized by OAS 
and their period of validity was one year and they re lated to imports of products carried out during the 
period of validity and were in line with Article 9 of Resolution 010 of CONCAP.   However, he 
stressed that the certificates of recognition INEN 1 under ISO 9001 were no longer valid since the deadline had lapsed.  In conclusion, the representativ e of Ecuador stressed that the measure was not 
trade restrictive: this was demons trated by the fact that for the period of January to April 2010, 7.6 
million USD worth of imports had been registered , while for the same period in 2011 imports had 
amounted to 15.5 USD, which was a 108 per cent increase in imports.   
(xxxi)  Australia –  Tobacco Plain Packaging Bill 2011 (G/TBT/N/AUS/67, G/TBT/N/AUS/67/Add.1, 
G/TBT/N/AUS/67/Add.2) 
179. The representative of Ukraine reiterated his delegation's concerns about the proposed 
legislation, noting that if enacted into law as drafted, the plain packaging requirements would violate a 
number of Australia's WTO obligations, including under the TBT Agreement.  He noted that the 
Tobacco Plain Packaging Bill 2011 and the accompan ying Trade Mark Amendments Bill 2011 passed 
the House of Representatives of the Australian Pa rliament in August 2011 without any substantive 
amendments, and passed the Senate on 10 Nove mber 2011, again without any substantive 
amendments that would, in his delegation's opinion, render the legislation compatible with Australia's 
obligations under the WTO.  Among the technical amendments was a provision to delay by five 
months the effective date for compliance by fo reign manufacturers until 1 December 2012.  Following 
approval by the Senate, the legisl ation would soon become law in Au stralia.  His delegation regretted 
this development, but hoped that Australia would still be able to ensure conformity between the 
legislation and WTO requirements.   
180. While WTO Members could implement domestic measures they deem appropriate for the 
health and welfare of their citizens, it was also the right of other WTO Members to question whether 
such measures were consistent with the provisi ons of WTO Agreements, and to challenge such 
measures under the WTO's dispute settlement system.  As stated by his delegation at the recent TRIPS 
Council meeting, the Australian plain packaging me asures were highly controversial and of concern 
not only to Ukraine, but to many governments,  intellectual property owners, and business groups, 
both within Australia and around the world.  Ukra ine made a written submission to the Australian 
TBT Enquiry Point and also to the Australian Sena te Legal and Constitutional Affairs Committee.  In 
the latter submission, Ukraine expressed its regret  that the Australian Government had provided no 
substantive responses to Ukraine's questions a nd concerns regarding WTO consistency, or 
effectiveness, of the proposed plain packaging meas ures.  In this submission, his Government urged 
the Australian Senate to amend the law to ensure c onformity with Australia's WTO obligations;  this G/TBT/M/55  
Page 38  
 
  unfortunately appeared not to have been the case.  Ukraine had only received an update on the status 
of the measures without any substantive expl anation or justification for the measures. 
181. He reiterated that the Australian legislation was more trade-restrictive than necessary to fulfil 
its stated objective and, as such, was contrary to Ar ticle 2.2 of the Agreement.  The effect of the 
legislation would be to remove all distinguishi ng designs, logos, colours, and other similar marks 
from the packaging of branded tobacco products.  Th is would commoditize the appearance of tobacco 
product packaging, making it virtually impossible to  identify and recognize sp ecific branded products, 
therefore making it near impossible, for foreign ma nufacturers new to the Australian market, such as 
Ukrainian manufacturers, to enter it.  The potential a dverse impact on trade in tobacco products with 
Australia was significant.  While, his delegation appreci ated Australia's review of its internal process 
regarding this measure, and its willingness to seek public comments, it  deeply regretted that trade-
related committees in the Australian parliament ha d not been given the opportunity to review the 
measure, and that the measure had not been modifi ed to ensure WTO consistency.  Ukraine reserved 
all its WTO rights in this matter. 
182. The representative of the Dominican Republic expressed concerns about Australia's 
measure.10 
183. The representative of the European Union refe rred to previous comments made, and noted her 
delegation's support for Australia's objective of pr otection of human health.  The EU was in the 
process of revising its Tobacco Products Directive,  and plain packaging or other limitations on 
packaging were among the possible future policy op tions being considered in the on-going impact 
assessment.  She thanked Australia for its replies to  the questions raised by her delegation but had 
further questions.  First, when did Australia inte nd to make public all comments received in the TBT 
notification process?  She reiterated her delegation' s request for a written reply to its comments and 
questions on Australia's notification sent in June 2011 , and also requested that Australia include a list 
of research evidence and other relevant background material used in the legislative process.  She 
recalled the importance of an efficient and e ffective handling of comments, which included 
responding to written comments in writing.  Second,  had Australia evaluated other alternative 
legislative solutions to plain packaging, and why th ese solutions had been considered less effective for 
achieving the legitimate health objective pursued.  Finally, she appreciated the information recently 
received from Australia on the state of play of the draft measure and the timeline for its future implementation, and stressed the need for sufficien t time to be provided to economic operators to 
adapt to the new requirements, on ce the final measure was adopted. 
184. The representative of Mexico sought information on the status of its comments submitted on 
31 May 2011 and 22 July 2011; he formally request ed a reply from the Australian Government on 
these comments.  He reiterated his delegation’s re quest for scientific and technical information 
demonstrating that plain packaging would reduce num bers of smokers in Aust ralia, and  explaining 
how obligations under Articles 2.2 and 2.4 of the TB T Agreement were respected in this measure.  
Had an analysis of less trade-restrictive regulator y options that could help to achieve the objective 
pursued by the legislation been conducted.  While  his delegation shared the objectives, he asked 
Australia to explain how it took into account the pa rticular circumstances of Mexico as a developing 
country, and how it would afford special and di fferential treatment under this legislation. 
185. The representative of Nigeria believed that this measure related to branding and its effects on 
both the market and the consumer. She highlighted several elements that were related to ensuring 
effective consumer protection, such as brand identit y, protection against product imitation, confidence 
and trust in a product and finally, product descripti on.  Consequently, alt hough Nigeria appreciated 
                                                      
10 See: G/TBT/W/346, 1 December 2011.  G/TBT/M/55  
 Page 39 
 
 
  Australia's efforts towards protecting consumer heal th, the representative stressed the need to avoid 
causing confusion in the market and for consumers. 
186. At the October Meeting of the TRIPS C ouncil, her delegation had described the 
manufacturing facilities in the tobacco sector whic h generated substantial economic activity, tax 
revenue and employment in Nigeria.  Tobacco pr ovided employment and income to many Nigerian 
farmers, and her delegation was ther efore concerned about the systemic implications of the Australian 
measure, and its direct and indirect commercia l consequences for the national economy.  At the 
TRIPS Council, her delega tion had observed that the Bill was incons istent with Australia's obligations 
under the TRIPS Agreement, was more trade restri ctive than necessary to fulfil legitimate health 
objectives, and was contrary to the provisions of Ar ticle 2.2 of the TBT Agreement.  The legislation 
also failed to take into account adverse impacts on de veloping countries as required by Article 2.13 of 
the TBT Agreement.  While the Australian Governme nt had asked the Australian Senate to consider 
certain technical amendments to the legislation regarding entry into force, the latter had not 
considered any substantive amendments.  Her de legation sought information on the status of the 
legislation, and the intentions of the Australian Government given the numerous concerns raised by 
Members. She urged Australia to live up to its WTO obligations. 
187. The representative of Colombia highlighted two documents relevant to this measure11, and 
reiterated previous concerns that the stringency of the measure in question may adversely affect the 
protection of other legitimate objectives recognised by the TBT Agreement, namely the prevention of 
deceptive practices and misleading consumers.  The removal of differentiating criteria would prevent 
consumers from identifying their preferred products. 
188. The representative of Chile shared concerns raised by other Members and said that, while her 
delegation was not against the legitimate public po licy objective pursued by the measure, there was 
concerns that the regulation was more trade-restri ctive than necessary,.  Sh e requested information 
from Australia on when it would reply to comments  received, and whether they were taken into 
account.  She also requested continued ex change of information on this matter. 
189. The representative of Honduras understood that the Australian Senate adopted the Tobacco 
Plain Packaging Bill on 10 November 2011.  Although Honduras recognized that the aim of the 
measure was to protect health, it was of systemic concern to his delegation because it ran contrary to 
WTO Agreements.  Many international undertakings and intellectual property organizations had also 
lodged concerns with the measure, in particular in relation to geographical indications, marks of 
origin, trademarks, designs, and copyrights, am ong others.  Although the Australian measures had an 
obvious health objective, they would create unnecessary  barriers to internatio nal trade because they 
were more trade-restrictive than necessary to atta in the objective pursued, having regard to the risks 
that non-fulfilment would create.  They therefore infringed upon Article 2.2 of the TBT Agreement. He explained that the Australian measures were "technical regulations " because they established 
characteristics of products, such as their packag ing.  However, they constituted a significant 
restriction on trade because they made it difficult, if not impossible, for brand-name products to 
penetrate the Australian market, creating a disin centive to export such products to Australia.  
190. Given that there was a lack of persuasive evid ence that the measures would help in attaining 
the health objectives pursued, they constituted an unn ecessary obstacle to trade.  In fact, the measures 
might have unwanted consequences that undermined achievement of the health objectives, such as, 
the uniformity in goods resulting in an increase in  unlawful trafficking and price suppression, which 
                                                      
11 G/TBT/N/AUS/67/Add.1, notified on 3 October, on the regulation of tobacco product packaging in 
Australia, specifically in relation to proposed new graphic health warnings; the second document is G/TBT/N/AUS/67/Add.2, notified on 4 October, on the plain packaging requirements for non-cigarette tobacco 
products. G/TBT/M/55  
Page 40  
 
  could lead to an increase in smoking.  Moreover, there were equally effective and less trade-restrictive 
measures by which those objectives could be attained.  Finally, he considered that Australia was 
creating obstacles to exports from developing co untries, like Honduras, which was contrary to 
Article 12.3 of the TBT Agreement. 
191. The representative of Norway said that public health in general, and tobacco control 
specifically, were topics very dear to Norway.  No rway was in the process of implementing revisions 
to its tobacco control strategy, and a new five-y ear strategy would be im plemented from 2012-2016.  
Her Government was, thus, interested in following similar processes under way in other jurisdictions.  
Implementation of the WHO Framework Convention on Tobacco Control (FCTC) could make the 
greatest single contribution to preventing non-comm unicable diseases, and implementation of FCTC 
provisions was thus a pressing public health issue.  She noted that most WTO Members, including the 
majority of those who have asked for the floor u nder this agenda item, are parties to the FCTC. 
192. Her delegation did not see any c ontradictions between regulatin g tobacco products and other 
international obligations, including the mutually supportive rights and obligations of the FCTC and 
the WTO.  It was within the rights and obligations  of each WTO Member to regulate to take into 
account the legitimate objectives and health needs of its people.  Tobacco control policies and 
preventive measures, such as that proposed by Australia, pursued the legitimate objective of 
protecting public health by reducing smoking.  In fact, Article 11 of the FCTC and the accompanying 
guidelines for implementation explicitly mentioned pl ain packaging as one of the options to achieve 
the objective of health protection.  Regarding the scientific evidence or basis for these kind of 
measures, she quoted the WHO statement made at the June 2011 TBT Committee meeting: "a strong 
and irrefutable body of evidence had demonstrated that product packaging has traditionally served as 
one of the tobacco industry’s central vehicles in initiating and maintaining addiction to the lethal 
products among consumers".  Norway believed that  the regulation of tobacco product packaging was 
a vital measure for reducing tobacco consumption, and signalled its support for Australia's right to 
introduce plain packaging as a measure designed to fulfil its FCTC obligations to protect public 
health, while at the same time being in line with WTO commitments.  She trusted that the measure 
would be implemented in such a way that it comp lied with all of Australia's international treaty 
obligations.  Finally, he r delegation would continue  to follow this case with interest, and would 
continue to defend the interest of public health while complying with its international obligations. 
193. As an important tobacco producing and exporti ng country, the representative of Turkey 
expressed caution about the Australian Tobacco Plain Packaging Bill.  A full impact assessment of the 
measure, both the intended health benefits and the impact on trade in tobacco, should be conducted 
before further steps were taken.  His delegation w ould follow developments in this measure closely. 
194. The representative of Uruguay reaffirmed its suppor t for Australia's measure.  In this regard, 
he quoted Article XX of the GATT.  Uruguay consider ed it a general principle that the protection of 
public health fell within the sovereign authority of States.  Every country was entitled to legislate in 
its public interest, as had recently been recogni zed in the Punta del Este Declaration on the 
implementation of the WHO FCTC.  Australia made e fforts so as to not infringe upon its international 
obligations while defending its public health inte rests, and Uruguay endorsed the explanations and 
justifications provided by Australia.  The measure  proposed by Australia should raise no objections 
since it was consistent with the provisions of WTO Agreements. 
195. The representative of New Zealand welcomed Australia's decision to implement plain 
packaging for tobacco products.  The negative eff ects of smoking could not be underestimated;  in 
New Zealand, smoking was one of the leading pr eventable causes of early death.  She noted 
Australia's assurance that it had paid close attenti on to its WTO obligations in developing its proposal. 
The TBT Agreement recognised that no country s hould be prevented from taking measures necessary 
to protect human health.  Numerous scientific st udies demonstrated that plain packaging of tobacco  G/TBT/M/55  
 Page 41 
 
 
  products could lead to positive pu blic health outcomes by reducing the attractiveness and desirability 
of smoking, and increasing the prominence of public health warnings. As part of a suite of tobacco control measures, plain packaging could contribute to reducing smoking rates. 
196. The representative of Indonesia had previously submitted her delegation's concerns.  At the 
June 2011 TBT Committee meeting, Australia had clar ified that the main purpose of this measure was 
to improve public health, and had argued that pa ckaging could influence cigarette consumption 
decisions.  For this reason, Australia made the assu mption that the implementation of plain packaging 
could reduce cigarette consumption.  However, her delegation requested that Australia provide further 
information in this respect, and respond in writing to questions raised by Indonesia. 
197. The representative of Zambia echoed concerns  regarding Australia's measure, which had 
implications for Australia's obligations under th e TBT and TRIPS Agreements.  On the TBT side, 
plain packaging of tobacco products , if implemented in the form as contained in this legislation, 
would unjustifiably infringe upon Australia's obligati ons under the TBT Agreement.  Article 2.2 of 
the Agreement provided that technical regulations, su ch as in this legislation, must comply with two 
requirements so as not to constitute unnecessary obstacles  to international trade:  they must pursue a 
legitimate objective, and they must not be more trad e restrictive than necessary to fulfil the objective.  
Mandatory plain packaging was a disproportionate response to the stated health objectives of the 
legislation.  While the TBT Agreement acknowle dged human health as a legitimate objective for 
technical regulations, it also provided guidelines to  ensure that measures were not more trade 
restrictive than necessary.  There was no credible  evidence that tobacco plain packaging, and in 
particular the measures identified in Clause 31 of th e draft bill, would achieve any legitimate health 
related objective or improve public health.  Her delegation considered the research presented by 
Australia in support of the legislation speculative, as it relied on asking individuals what they would 
do in a given hypothetical situation.  The legislati on assumed that changes in packaging would lead to 
changes in tobacco product consumption behaviour.   
198. Zambia believed that there were less trade rest rictive alternatives to achieve the stated public 
objectives.  The stated health objectives of the legi slation would be best achieved through alternative 
regulatory solutions that were consistent with Au stralia obligations under the WTO, including those in 
Article 2.2 of the TBT Agreement.  Packaging was fundamental to consumer choice and brand 
navigation in a competitive market, particularly wher e other channels of inte raction with consumers 
such as advertising and point of sale display were restricted. Indeed, packaging conveyed guarantees 
of origin and quality of a given product.  Austra lia's legislation could expose consumers to more 
harmful tobacco products due to the prolifera tion of counterfeit products whose quality was not 
controlled by any regulatory body.  Due to the l ack of credible evidence that the assumed public 
health objectives would be achieved by plain packaging,  and to the availability of less trade restrictive 
alternatives measures, her delegati on believed that Australia's meas ures had implications for its 
obligations under the TBT Agreement.  Specific trad e concerns relating to tobacco had become more 
frequent, and would continue to be discussed as individual Members adopted measures aimed at 
meeting national objectives whilst fulfilling region al and multilateral obligations.  To promote 
coherence and coordination at th e national level and to ensure the supportiveness of obligations 
undertaken in various regional and multilateral fora , she proposed that the TBT Committee organise a 
joint meeting with WHO FCTC to exchange inform ation; this would address tobacco trade concerns 
in a holistic manner. 
199. The representative of El Salvador shared the concerns expressed by the delegations of 
Ukraine, the Dominican Republic, the European Un ion and Mexico.  El Salvador recognised and 
endorsed the objective of protection of human hea lth, as explained by Australia.  However, his 
delegation maintained the view that Australia's me asure went beyond the parame ters of international 
regulations and guidelines in this area.  He requested  that this measure remain under consideration by G/TBT/M/55  
Page 42  
 
  the TBT Committee to ensure that Australian aut horities give due consideration to any challenges 
posed by the measure. 
200. The representative of Zimbabwe supported con cerns raised by Ukraine, the Dominican 
Republic, Nigeria and Zambia.  His delegation took  note of the announcement by the Minister of 
Health and Aging that plain packaging would remove the last channel of tobacco marketing, as part of 
a government strategy to reduce the toll of 15,000 annual tobacco-related deaths in Australia.  While 
he expressed appreciation for Australia's efforts to pr otect public health as per its sovereign right;  he 
expressed concern that the proposed measure was more  trade restrictive than necessary to achieve the 
stated policy objective.  Although the WHO FCTC pr ovisions encouraged the use of plain packaging 
to control tobacco consumption, the measure was not supported by scientific evidence, and was not 
consistent with the TRIPS and TBT Agreements, in particular, Articles 2.2 and 12.3 of the TBT 
Agreement in view of the trade restrictive nature of  the legislation, and the adverse impact on exports.  
Article 12.3 of the TBT Agreement required Members to ensure that technical regulations did not 
create unnecessary obstacles to exports from developi ng country members, like Zimbabwe, where 
some 200,000 farmers and their families depended on  tobacco production for their livelihood.  Also, if 
passed, the bill would violate the Paris Convention for the Protection of Intellectual Property.  He 
urged Australia to take into cons ideration the views and concerns raised by Members so as to come up 
with alternative measures that provided the right  balance between public health objectives and WTO 
obligations, and to implement measures that were supported by relevant in formation and scientific 
evidence.  Finally, he requested that Australia provi de responses to questions raised by delegations at 
the October 2011 TRIPS council meeting. 
201. The representative of Japan said his delegation would continue to follow this measure's 
progress because the number of different arguments i ndicated that this was an important issue from 
the point of view of compliance with the TBT Agreement.   
202. The representative of Cuba noted that th e Australian Senate approved the Bill under 
consideration on 10 November 2011.  Her de legation had submitted several questions12 to which it 
had not yet received a reply.  On 24 October 2011,  Cuba's TBT enquiry point sent a reminder to 
Australia;  no reply had yet been received.  Her delegation acknowledged the damage that tobacco 
products caused to human health and the responsib ility of governments to protect their citizens' 
health, and Cuba was adopting measures to this end.   However, Australia could have adopted a less 
trade-restrictive measure than plain packaging.  It  would have been possible to apply a measure that 
neither nullified intellectual property rights nor raised  the threat of counterfeit goods being marketed.  
In addition to these general concerns, her delegati on learned on 30 September 2011 that the legislation 
would be applied to prod ucts other than cigarettes, especially cigars and twisted tobacco, sold by 
Cuba on the Australian market.  These products we re not marketed in a single format such as a 
cigarette box.  Instead, there were over 300 different forms of packaging.  Such a variety of packaging 
meant that application of the Australian measure  would hugely increase marketing costs to Cuban 
exporters in the Australian market, threaten ing the continued export of these products. 
203. Cuban concerns on increased counterfeiting had been expressed to Australia, through various 
channels.  Cuban cigars had been the targets of counterfeiting over many years and in many markets, 
forcing the industry to adopt various measures to minimize this risk.  These measures were not 
advertising measures.  Rather, their aim was to indicate origin and prove the authenticity of the 
product.  Plain packaging would defeat those measures; it would no longer be possible to use the 
"Habanos designation of origin" seal , or the "National Guarantee of Origin" seal, used by Cuba on all 
its cigars for almost 100 years.  Nor would it be pe rmissible to use the ring on the upper part of each 
cigar bearing the brand name and place of origin, La Habana, Cuba.  Furthermore, these products 
were aimed at a market segment completely different from that of cigarettes.  Cigars were for the 
                                                      
12 G/TBT/W/338 dated 9 June 2011.  G/TBT/M/55  
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  most part consumed by people over 40 years of age with high purchasing power.  Moreover, they 
were consumed on an occasional basis, and were ofte n purchased for collections and not in order to be 
smoked.  These concerns were lodged with the Au stralian Government, but she was concerned they 
were not taken into account prior to the adoption of the Bill. 
204. It was therefore vital that Australia present scientific evidence demonstrating the link between 
the measure applied and the specific health objectives for cigars and twisted tobacco.  Hitherto only 
studies on cigarettes had been presented, and the results of such studies could not be extrapolated and applied to a hugely different market segment such as  that for cigars.  Austra lia needed to respond to 
questions raised, especially in rela tion to the analysis used to quan tify the impact of the measure on 
trade from developing countries like Cuba, where t obacco products were a significant part of the 
economy and accounted for thousands of families' liv elihoods.  Moreover, was it possible to prevent 
illicit trade in counterfeit products?  In addition, she endorsed Zambia's proposal for a debate on 
achieving better consistency betw een the implementation of the FCTC and WTO provisions.  
According to the Cuban national authority,. ov er 80 measures had been notified to the TBT 
Committee (including at least 23 since 2008) asso ciated with the implementation of various 
provisions of the WHO FCTC, and there was signifi cant variability and differences in the stringency 
of requirements between notifying countries.  Article  2 of the FCTC encouraged Parties to implement 
measures beyond those required by the Convention and its protocols.  As a result, there was a wide variety in the types of measures applied, with so me measures more restrictive than others.  38 
notifications with very dissimilar requirements ha d been presented relating to labelling and health 
warnings, ranging from the minimum requirements laid down in the Convention, namely that 
warnings and messages be rotated and cover no less th an 30 per cent of the principal display areas, to 
the maximum restriction now applied by Aust ralia in the form of plain packaging. 
205. Although this wide range of rules among mark ets was consistent with the legitimate 
objectives of health protection under the FCTC, it was causing serious competition problems for 
traders of these products, especially in developi ng countries which were required to bear high 
adjustment costs to be able to trade on different  markets with different requirements.  Tobacco was 
significant to tobacco growing countries' economies , representing thousands of families' livelihoods.  
She proposed that the Secretariat review notifi cations related to implementation of the FCTC. 
206. The representative of Nicaragua expressed con cerns with Australia’s measure, which would 
contravene provisions of the TBT and TRIPS Agre ements.  These had been expressed in the TRIPS 
Council.  Adoption of this measure would be incomp atible with Article 2.2 of the TBT Agreement, 
which applied because plain packaging was a techni cal regulation.  In the absence of any evidence 
that this type of packaging influenced consumer behaviour, the imposition of this technical regulation 
would unnecessarily restrict trade without attainin g the legitimate objective pursued by Australia, 
namely the protection of its population's health, the validity of which she did not dispute.   Article 12.3 of TBT Agreement provided for Members to ensure that their technical regulations did 
not constitute unnecessary obstacles to exports of developing country Members.  Through this 
measure, Australia would be creating unnecessary obstacles to market access for products from developing countries, and would therefore be breaching its WTO commitments by establishing unjustifiable new measures governing access to its market.  The FCTC guidelines merely 
recommended the use of plain packaging; they did not require Parties to implement it.  As a producer 
of tobacco as a raw material, his delegation was concerned this Bill would damage Nicaragua's 
economic interests, where production in this sector  generated numerous direct jobs and supported 
many families, attracted ongoing investment, and w as a source of foreign exchange revenues.  He 
urged Australia to revise the Bill, so that in exerci sing its right to apply health protection measures, it 
did not prejudice Nicaragua's rights under the TBT and TRIPS Agreements. 
207. The representative of Jordan said his delegation supported Australia's objective of protecting 
public health and deterring minors from smoking.  Howe ver, it believed that this technical regulation G/TBT/M/55  
Page 44  
 
  was in breach of Article 2.2 of the TBT Agre ement.  The TBT Agreement required technical 
regulations to not be more trade restrictive than necessary to pursue a legitimate objective.  Since 
there was no evidence that plain packaging influe nced consumer behaviour, imposing this technical 
regulation would restrict trade without doing anyt hing to achieve a legitimate objective.  Plain 
packaging had not been introduced anywhere in the world;  this meant there was no real evidence to 
demonstrate that it would be eff ective and achieve Australia's stated aims.  His delegation further 
believed that the bill was in breach of Article 12.3 of the TBT Agreement.   In light of the investment 
needed to comply with the bill, his delegation requ ested that Australia reconsider its approach in 
favour of less restrictive alternatives.  Finally he re iterated support to all countries in their efforts to 
adopt regulations to protect health objectives; however, developments in Australia could set a 
damaging precedent that other countries may follow by implementing unsound and ineffective health 
policies that violate international obligations.  If this type of regulation, which undermined the 
legitimate rights of brand owners, were to take  hold in other product categories, the impact on 
international trade would be even greater.  
208. The representative of Hong Kong, China noted a Member’s right to implement measures 
necessary to protect human health.  Australia had given a rather substantive account at the last 
meeting as to how it had developed the legislativ e proposal in question, reflecting the scientific 
evidence it had found over the years.  In light of the trade concerns expressed by a large number of 
Members, his delegation trusted that Australia w ould continue to give due consideration to its 
obligations under the TBT Agreement, with a view to ensuring that the enactment and implementation 
of the proposal would not be more trade restrictive than necessary to fulfill its legitimate objectives.  
Consultations and dialogue with affected Member s would be helpful in easing and minimizing the 
impacts in the course of its implementation.  His de legation would closely monitor this in the WTO.  
209. The representative of the Russian Federation, speaking as an observer, said his delegation 
recognised the health risk associat ed with tobacco product use;  Ru ssian experts participated in 
activities of the appropriate international forum with the aim of formulating the international 
framework regarding trade in these products.  His de legation considered the Australian measure to be 
more trade restrictive than necessary and asked Australia to evaluate alternative measures for 
achieving the public health objective, and to pr ovide additional inform ation regarding the link 
between plain packaging and reduced consumption of tobacco products. 
210. The observer of the World Health Organization reiterated what had been stated concerning 
public health evidence in the context of the pl ain packaging issue at the June 2011 TBT Committee 
meeting.13  He added that economic costs of tobacco use were equally as devastating as the public 
health costs.  Though the tobacco industry routin ely cited the economic contribution of tobacco, in 
reality, tobacco use placed an enormous financial bur den on countries, in addition to the fact that 
tobacco and poverty were inextricably linked at the individual level.  The costs of tobacco use encompassed increased h ealth-care costs, lost productivity due to illness, premature death, and 
widespread environmental damage.  As tobacco  consumption rates and tobacco-related illnesses 
increased in developing countries so did tobacco-rela ted healthcare costs.  Conservative estimates 
suggested that tobacco imposed a US$500 billion drain on the world economy, exceeding total annual health expenditures in low and middle-income c ountries.  Further, the economic burden of NCDs, 
with tobacco representing the largest risk factor, was staggering.  Recent macroeconomic simulations 
suggested that over the next two decades cardiov ascular disease, chronic respiratory disease, cancer, 
and diabetes, would cause a cumulative output loss of more than US$30 trillion, representing 48 per 
cent of global GDP in 2010.  This, in turn, would push millions of people across the planet below the 
poverty line. 
                                                      
13 G/TBT/M/55, paras 33-46.  G/TBT/M/55  
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  211. He informed the Committee that  the impact of tobacco on NCDs on both public health and 
national economies was highlighted at the recen t United Nations General Assembly High Level 
Meeting on the Prevention and Control of NCDs, he ld in September 2011 in New York.  At that 
meeting, Heads of States adopted a political declar ation which recognised the fundamental conflict of 
interest between the tobacco industry and public health, and wherein member states unanimously 
committed to advancing the implementation of multi-sector, cost effective, population-wide 
interventions in order reduce the impact NCD risk factors.  The WHO believed that the 
implementation of tobacco plain packaging, represen ting a legitimate tobacco control measure, would 
have a substantial impact on tob acco consumption, was in the spirit and intent of the UN High Level 
Meeting, and was in accordance with interna tional legal obligations under the WHO FCTC. 
212. Concerning the Framework Convention on Tobacco Control, the observer explained that the 
FCTC, in force since 2005, was negotiated under the auspices of the WHO in response to the 
globalization of the tobacco epidemic.  Its pr ovisions were based on evidence and had been 
specifically designed by the international public h ealth community to effectively address the tobacco 
epidemic. Like other international legal instrume nts, States party to the FCTC undertook certain 
obligations pursuant to its implementation.  Sin ce the June 2011 TBT Committee meeting, the number 
of States that were party to the Convention had risen to 174; only 12 of the 153 WTO Members were not party to the FCTC.  The WHO FCTC contai ned a number of provisions relevant to plain 
packaging of tobacco products.  Article 3 set out the collective objectives of the Parties in establishing 
the FCTC, and Article 5 established gene ral obligations on Parties, including, inter alia , the obligation 
to "develop, implement, periodically update a nd review comprehensive multi-sectoral national 
tobacco control strategies, plans and programmes in accordance with" the FCTC.  Recognition by 
Parties of the importance of comprehensive, multi- sectoral measures in the fight against the global 
tobacco epidemic was a theme that recurred throu ghout the Convention and its obligations, and that 
comprehensive, multi-sectoral approaches ensured that tobacco control measures contained in the 
FCTC were most effective. 
213. With respect to plain packaging for tobacco, Ar ticle 11 of the Convention required Parties to 
adopt and implement effective measures in respect of the packaging and labelling of tobacco products, 
including health warnings and other appropriate me ssages.  According to the most recent reports on 
implementation, which were required pursuant to Ar ticle 21 of the Convention, 65 per cent of Parties 
(88 States) had banned descriptors on packaging a nd labelling that were misleading, deceptive or 
likely to create an erroneous impression of the product.   Furthermore, 82 per cent of Parties (111 
States) had adopted policies requiring tobacco product  packaging to carry hea lth warnings describing 
the harmful effects of tobacco smoke.  Finally, 74 per cent of Parties (100 States) had introduced measures to ensure that health warnings were large,  clear, visible and legible.  After five years of 
implementation, Article 11 attracted one of the hi ghest implementation rates among Parties.  Another 
specific provision of the FCTC was Article 13, wh ich required Parties to undertake a comprehensive 
ban of all tobacco advertising, promotion and spons orship.  The comprehensive ban must be read in 
light of the broad definition of "tobacco advertisi ng and promotion" which, according to Article 1(c) 
meant "any form of commercial communication, r ecommendation or action with the aim, effect or 
likely effect of promoting a tobacco product or tobacco use either directly or indirectly."  
Additionally, the Guidelines for the implementation of  Article 13 adopted by consensus by the Parties 
included "packaging and product design features" on the indicative list of forms of advertising, 
promotion and sponsorship.  The most recent reports indicated that 55 per cent of Parties (74 States) 
had introduced a comprehensiv e ban on tobacco advertising,  promotion and sponsorship. 
214. Finally, information submitted by Parties a llowed for an analysis of the progress in 
implementation of various obligations under the C onvention.  Between one-third and one-half of 
reporting Parties registered progress in introduci ng stronger health warnings and in banning 
advertising, promotion and sponsor ship.  This indicated that Parties were undertaking progressively 
more stringent tobacco control measures in keepi ng with their Article 11 a nd Article 13 obligations.  G/TBT/M/55  
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  The Conference of the Parties (COP) of the FCTC, met for its 4th session in November 2010. At that 
session, the COP adopted the Punta del Este Declaration
14 regarding public health policy, 
international trade and the activities of the tobacco  industry. The declaration reiterated the firm 
commitment of Parties "to prioritize the implementation of health measures designed to control tobacco consumption" and made specific reference to Article XX(b) of the GATT and Article 2.2 of 
the TBT Agreement, including its reference to "pro tection of human health or safety" as a "legitimate 
objective".  Regarding illicit trade in tobacco produc ts, negotiation of the first protocol, the draft 
Protocol to Eliminate Illicit Trade in Tobacco Pr oducts, was in its final stages, and the last session 
was planned for 2012.  Lastly, work was continuing with respect to the identification of economically 
sustainable alternatives to tobacco growing in relation to Articles 17 a nd 18 of the Convention. 
215. The representative of Honduras informed the Committee that Honduras was a member of the 
WHO and a Party to the FCTC.  He understood and respected the principal objective of the FCTC, 
namely to reduce tobacco consumption in order to address health-related matters.  This was embodied 
in its national law.  Moreover, his delegation ha d conducted campaigns, regulated packaging and had 
reduced the number of smokers. However, in th ese processes, Honduras had always complied with its 
WTO commitments.  He asked the WHO if its statem ents were consistent with WTO Agreements and 
with the trade perspective.  Could the WHO indicat e if the studies it referred to on plain packaging 
provided scientific evidence, or a clear scientific conclusion, that plain packaging would stop people 
from smoking cigars and cigarettes.  If such evid ence existed, he requested the WHO to circulate 
these studies, which should be scientifically conclusi ve, and not just provide inconclusive scientific 
evidence.  If such studies did not exist, he asked that it be recorded that the WHO intervention was 
made from the public health perspective, a nd not from the WTO Agreements perspective. 
216. The representative of Mexico said his country w as a Party to the FCTC, and a member of the 
WHO, and he regarded the technical and scientific  information presented by the WHO representative 
useful to the WTO and to the TBT Committee.  Ho wever, he disagreed with the notions that an 
observer body was drawing conclusions as to the comp atibility or otherwise of specific measures with 
WTO law, which was self-contained.  The struct ures capable of ruling whether the measure was 
compatible with a Member's comm itments were WTO panels and the dispute settlement mechanism.  
His delegation was not objecting to the WHO.  Rather he objected to the important precedent that may be set whereby an international organization endorsed, in one direction or anot her, a measure taken by 
a WTO Member and argued its validity on the basis of WTO law.  He hoped that other organizations would not be able to make similar statements to this or other WTO Committees in support of a 
particular measure;  that debate was better suited to other forums. 
217. The representative of the Dominican Republic sh ared the concerns of Honduras and Mexico.  
His national authorities had also imposed strict rest rictions in terms of a dvertising and taxation of 
cigarette consumption.  However, WHO regulati ons were one matter, a nd regulations of other 
multilateral bodies, such as the WTO, were anothe r matter.  His delegation was concerned about a 
precedent whereby the TBT Committee may be discu ssing other items that the WHO viewed as 
dangerous to health.  On that basis, existing re gulatory constraints of an organization such as the 
WTO may be infringed upon by a nother multilateral organization. 
218. The representative of Zimbabwe  reminded the Committee that Zimbabwe was a member of 
both the WHO and the WTO.  He expressed concern that the WHO’s intervention seemed to insinuate 
that what Zimbabwe said at the WTO was inconsiste nt with the Heads of State declaration (of the 
United Nations General Assembly High Level Meeti ng on the Prevention and Control of NCDs).  He 
and his fellow delegates represented those same count ries involved in the declaration.  Discussions in 
this Committee were related to ob ligations under the TBT Agreement.  His delegation agreed with 
                                                      
14 FCTC/COP4(5).   G/TBT/M/55  
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  Honduras that scientific evidence should be presented in  an unbiased manner, rather than in a way to 
favour certain positions, which c ould inadvertently influence th e discussion in the Committee.  
219. The representative of Australia updated the Comm ittee on the measure's status.  The Tobacco 
Plain Packaging Bill 2011 and associated Trade Marks Amendment (Tobacco Plain Packaging) Bill 
2011 were introduced into the Australian Parliament on 6 July 2011.  Both Bills passed the House of 
Representatives on 24 August 2011 with no amendmen ts.  However, there was some delay in 
consideration of the Bills by the Australian Senate.  As a result, amendments to  the entry into force of 
the Bills were proposed in order to allow a longer lead time for implementation and to provide an 
additional two weeks for retailers to sell through any product in non-compliant packaging before retail 
offences commenced.  Under the proposed amendmen ts, most of the preliminary provisions that 
would have commenced on 1 Janua ry 2012 would now commence once the Bills had been passed by 
both Houses of Parliament and had been signed by  the Governor-General.  All tobacco products 
manufactured in Australia would be required to be sold in plain packaging by 1 October 2012, 
extended from the previous date of 20 May 2012.  A ll other tobacco products would be required to be 
sold in plain packaging by 1 December 2012, exte nded from the previous date of 1 July 2012. 
220. A further amendment to address a technical implementation issue relating to requirements for 
the inside of cigarette packs was also proposed a nd passed by the Senate on 10 November 2011.  The 
Bills would need to return to the House of Re presentatives for consideration of the amendments, 
which was likely to occur in the sitting week of 21 November 2011.  With respect to the specific 
question of cigars, there was a consultation pr ocess underway regarding Plain Packaging for non –
cigarette tobacco products, including cigars.  He r delegation was considering the submissions 
received, and intended to finalise relevant regulations  by the end of 2011.  Australia had been very 
open and transparent with its trading partners thr oughout the process of introducing this measure.  In 
recent months, her delegation had met or offered to meet with all WTO delegations that raised this 
issue in previous meetings of the various Committees of this organization, in order to explain the purpose and details of the proposed measures and to  provide detailed inform ation in relation to 
questions raised.  In addition, Australia’s over seas posts had conveyed information to Ministries of 
Trade and Health in all WTO Members’ capitals.  Her delegation had provided a significant amount 
of written information in response to Members’ c oncerns, both in hard copy and electronically and 
had made detailed statements in the TBT and othe r WTO Committees that responded to questions and 
issues.  Therefore, it was unreasonable to claim th at Australia had not responded to questions.  
221. The Committee should keep this measure in pe rspective;  while respecting the systemic 
issues, and she noted that Australia was a minor im porter of tobacco products,  and that Australia's 
imports represented a half of one per cent of global tr ade.  Many of the Members that raised concerns 
exported almost no tobacco to Australia, and in some cases none.  In recalling the purpose of the 
measure, namely promoting public health, she noted that 15,000 Australians die every year from smoking, 3 million Australians s till smoke, and smoking cost over A$31.5 billion every year.  Her 
delegation was confident that, as part of a comprehe nsive package of tobacco reforms, this measure 
would make an effective contribution to reducing smoking, and thereby would reduce the health impacts of smoking on Australian individuals and th e community at large.  Tobacco packaging was 
one of the last remaining forms of tobacco a dvertising in Australia, and the plain packaging 
legislation was the next logical step in Australia’s to bacco control efforts.  The effect of the legislation 
would be that tobacco company branding, logos, sy mbols and other images that may have the effect 
of advertising or promoting the use of the tobacco wo uld not be able to appear on tobacco products or 
their packaging.  The brand name and variant name would be allowed on packaging, and she said that information which was required by other legislati on or regulations, such as trade descriptions and 
graphic health warnings, would also be allowed to appear.   
222. Plain packaging was designed to: reduce the attr activeness and appeal of tobacco products to 
consumers, and particularly young people; in crease the noticeability and effectiveness of mandated G/TBT/M/55  
Page 48  
 
  health warnings; reduce the ability of the tobacco  product and its packaging to mislead consumers 
about the harms of smoking; and through the achieveme nt of these aims in the long term, and as part 
of a comprehensive suite of tobacco control measure s, contribute to efforts to reduce smoking rates.  
The proposed legislation was consistent with  recommendations made to the Government by 
Australia’s National Preventative Health Taskforce,  which were based on extensive research and 
evidence that explored the impacts of tobacco p ackaging and tested the reactions of respondents 
exposed to different packaging options under experi mental conditions.  The weight of the evidence 
indicated that a plain packaging requirement, as pa rt of a comprehensive suite of tobacco control 
measures, would help to reduce smoking rates. Guide lines agreed by the Conference of the Parties to 
the WHO FCTC in 2008 for the implementation of Articles 11 and 13 of the FCTC recommended that 
Parties consider the introduction of plain packaging.  
223. With respect to alternative measures, plain pack aging needed to be considered in the context 
of Australia’s overall efforts on tobacco control, which spanned over 30 years.  In this period, 
Australia had implemented a number of measures to reduce smoking rates:  extensive and continuing 
public education campaigns on the dangers of smoking;  age restrictions on tobacco purchase; pricing 
measures through excise and customs duties; compre hensive bans on tobacco advertising, promotion 
and sponsorship; bans on smoking in certain pl aces to reduce the impact of second-hand smoking; 
bans and restrictions on the reta il display of tobacco products; mandato ry graphic health warnings on 
tobacco product packaging; and quit smoking’  support services including free counselling and 
subsidised pharmaceutical products. 
224. She added that Australia had been responsive to comments from trading partners and other 
stakeholders, and was fully committed to its interna tional obligations, including its obligations under 
the TBT Agreement.  Prior to the introduction into Parliament of the Bills, the Australian Government 
consulted widely with trading pa rtners, including tobacco exporting developing countries, through a 
series of outreach meetings to explain the propo sed measures.  The comments received were taken 
into account and led to some changes to the Bill a nd draft regulations, where those changes were in 
line with the policy objectives.  This included r esponding to concerns about the protection of the 
rights of trademark owners, with changes made to ensure their effective operation.  Amendments to 
the Tobacco Plain Packaging Bill had been proposed to ensure trademark owners’ ability to protect 
their trade marks from use by other persons, and to  ensure the ability to register, and maintain 
registration, of a trademark.  Additionally, a parallel Trade Marks Amendment Bill has been introduced to allow the Government to strengthe n those protections should uncertainty arise. 
225. Her delegation had also eliminated import offe nces for non-compliant tobacco products, in 
response to submissions received.  This change w ould allow tobacco products to be imported into 
Australia in non-compliant retail packaging, and then be repackaged for retail sale in Australia.  In 
this respect, the Bill required compliance with plai n packaging requirements from the first point of 
sale (whether wholesale or retail) of imported produc ts in the Australian supply chain.  Regarding 
claims that Australia’s plain packaging proposal would increase illicit trade in tobacco products, her 
delegation disagreed.  Trade in illicit tobacco in Au stralia was low and her delegation did not expect 
this to change with the new measu res.  At present, counterfeiters ha d little trouble replicating branded 
tobacco packages, and, regardl ess, she stressed that smoking of any tobacco product, licit or 
otherwise, was fundamentally harmful to human health.  Nevertheless, given expressed concerns, 
allowances had been made to ensure that protec tive markings could be used for anti-counterfeiting 
purposes.  These included the use of unique alphanumer ic code markings on each pack and cigarette 
stick, and covert markings in comp liance with other aspects of the Bills. 
226. 
She underscored that the proposed plain packaging legislation related only to tobacco 
products and retail packaging of those products.  The Australian Government was not considering 
extending the measure to other products.  Tobacco was a singular product, which caused 
extraordinary harm and required appropriate measur es.  She quoted the World Health Organisation:  G/TBT/M/55  
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  "tobacco is the only legal consumer product that ki lls up to half of those who use it as intended and 
recommended by the manufacturer".  She reiterate d her delegation’s commitment to Australia’s 
international obligations, and assured Members that in framing this measure, Australia had paid full 
regard to obligations under the TBT Agreement and other WTO Agreements .  Her delegation would 
ensure that the new policy was implemented in a ma nner that was consistent with those obligations. 
(xxxii)  Korea - Regulation on Registration and Evaluation of Chemical Material 
(G/TBT/N/KOR/305) 
227. The representative of China requested a clear  timetable on the issuance of the supporting 
regulation in order to facilitate bilateral trade and improve transparency.  He urged Korea to consider 
mutual recognition of test data as well as the classifications of Chinese laboratories, through 
cooperation at multiple levels including government and technical organizations.  He suggested the 
recognition of test results issued under the EU REACH framework and similar frameworks so as to 
avoid repeated registrations, and multiple testing.  In addition, this recognition would provide a faster 
approach for registrants having access to the EU market. 
228. The delegate of the United States noted that the US industry had expressed serious concerns 
about some of the provisions of the proposal which would create significant changes to Korea's 
current chemical regulatory regime – and whic h would affect both producers and importers of 
chemicals in Korea.  It was the US understanding that Korea had taken many of these comments into 
consideration and had made revisions to the pr oposed act.  While acknowledging the considerations 
given to the comments regarding the potential effe cts of the proposal, he asked Korea whether any 
updates could be provided to the Committee on key issues raised by the United States and other 
delegations at the last meeting, in particul ar with respect to the proposed annual reporting 
requirements and the minimum tonnage threshold for pre-registration and registration of 500 mg.    
229. The delegate of Korea confirmed that the Mini stry of Environment was taking into account all 
the comments from various stakeholders and it had not  yet been determined when the new legislation 
would be finalized.  Once it passed in the Nationa l Assembly, a subordinate statute or enforcement 
ordinance would be proposed within a year. Th e Ministry of Environment would notify members 
when it was preparing to draft the subordinate stat ute and would invite comments from stakeholders at 
that time. With regard to the minimum tonnage threshold of half  a tonne and the annual reporting 
requirement, the Ministry of Environment was positively considering whether to amend these 
provisions following consultations with the industri es concerned. With regard to the question of 
which chemical substances would be subject to these regulations, studies were under way to 
determine which ones should take priority. The de tails would be set forth in the enforcement 
ordinance. 
230. In response to some of the comments at the last TBT Committee meeting, she confirmed that 
the Ministry of Environment would publish a document in English explaining the procedures in detail 
so that foreign industries could comply without  undue inconvenience. This legislation was in 
accordance with the provisions of the United Nations Globally Harmonized System of Classification 
and Labelling of Chemicals (GHS), which Korea a dopted for substances on 1 July 2010. Beginning 1 
July 2013, the GHS would also apply to mixtures.  Regarding the submission of data using OECD 
software, she indicated that the Ministry of En vironment would also assess the compatibility of the 
software with the Korean system. Furthermore, certain  chemicals, such as those to be used solely for 
research and development, would be exempted from the new regulations.  The enforcement ordinance 
would specify the list of exempted substances. Finally, she confirmed that according to the Ministry 
of Environment, if test data were reliable and met the standards prescribed in the applicable laws and 
guidelines, data produced abroad would also be a ccepted. When new tests were carried out, however, 
the OECD Good Laboratory Practices must be followed. G/TBT/M/55  
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  (xxxiii)  Viet Nam – Conformity assessment procedu res for alcohol, cosmetics, and mobile phones 
(Notice regarding the import of alcohol, cosm etics and mobile phones, No.: 197/TB-BCT (6 
May 2011) 
231. The representative of the United States recalled that Viet Nam had released a Ministry of 
Finance Document 4629 on the import of spirits and cosmetics and a Ministry of Industry and Trade 
Notice on the import of alcohol, cosmetics and mobile phones (on 7 April 2011 and 6 May 2011, 
respectively).  Both notices, involving new conf ormity assessments procedures, appeared to have 
gone into effect on 1 June 2011.  The United States  was concerned that these measures were legally 
binding or created new requirements; they appear ed to require specific quality control procedures, 
such as the submission of a quality control certificate a nd the designation of specific ports in charge of 
control.  It was unclear how Viet Nam would ensure that domestic Vietnamese manufacturers of these 
products would undertake comparable procedures.  Th e justification and criteria used to select some 
products and not others remained missing.  Details  of the product codes subject to the Notice 197 
were also unavailable.  The representative of the United States emphasized that although Viet Nam claimed that this measure did not create new requirements, US companies were facing compliance 
problems since procedures were not set out in writing.   Details were also lacking on: quality control 
procedures; specificities for the quality conformity certificate; the identity of the body issuing the 
certificate; and, the standards used for the certifica tion.  It was also not clear why the quality control 
procedures had been limited to three ports.  Obtain ing a stamp and paying a fee at the consulate prior 
to shipment would not help ensure products qua lity or prevent counterfe iting, but only added 
unnecessary cost in delays for exporters.   
232. The representatives of Australia, Chile, the Eu ropean Union and New Zealand supported the 
statement made by the United States and noted that the measure would be monitored closely. It was 
also suggested that the measure be suspende d until further clarification was provided. The 
representative of Canada expressed an interest in a ny further information that Viet Nam was able to 
provide with regard to the measure. 
233. The representative of Viet Nam stressed that the measures were aimed at the prevention of 
smuggling and counterfeit of spirits, cosmetics and mobile phones, the protection of consumers' safety 
and health; these measures were in favour of foreig n exports.  He also confirmed that the document 
No. 4629 issued by the Ministry of Finance of Viet Nam was not a legal document; therefore there was no legal enforcement to apply it.   
(xxxiv)  Malaysia -- Draft Protocol for Halal Meat and Poultry Production (G/TBT/N/MYS/23) 
234. While recognizing Malaysia's desire to institute  a reliable halal system for meat and poultry 
products, the representative of the United States noted  that the Department of Islamic Development 
had not addressed his country's main concern that  sufficient processes were in place to avoid any 
commingling of halal and non-ha lal products processed in the same establishment.  Although 
Malaysia explained that the entire supply chain did no t need to be dedicated exclusively to halal, the 
United States remained confused by some of Malays ia's responses, which would require confirmation.   
While Malaysia indicated that separate transport w as not required for halal a nd non-halal products, the 
US sought to confirm a completely separate supply ch ain would in fact be  required for products from 
pigs.  In addition, Malaysia indicated that the meas ure would require all halal meat to be stored in 
freezers in approved halal establishments, which to the US indicated a separate supply chain for halal 
products would, de facto, be needed.  Likewise,  the measure would also forbid any commingling 
between halal carcasses' meat from several establishm ents.  The United States questioned the need for 
a dedicated supply chain if an American compa ny could sufficiently demonstrate a complete 
segregation between halal and non- halal products.  In particular, it was unclear whether a US 
establishment currently certified to export meat and poultry products would be allowed to export 
under the existing rules.  Malaysia also needed  to provide a reasonable interval for those  G/TBT/M/55  
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  establishments to comply before formally scheduling Halal audits.  In this regard, it was the US 
understanding that educational outreach to US-Isla mic centres and other US establishments was 
expected in order to ensure prope r understanding of the new protocol. 
235. The European Union said that exporters con tinued to face numerous difficulties in meeting 
halal related import require ments due to lack of transparency and non-alignment with international 
standards. Given the mandatory nature of these impor t conditions, she urged Malaysia to ensure clear, 
transparent and more easily available halal import requirements and standards.  In particular, she 
reiterated her delegation's request for the measure  to be notified to the SPS Committee, as some 
aspects appeared to be covered by the SPS Agreement. 
236. The European Union further noted that Malays ia required an audit for every foreign meat 
establishment that wanted to export to Malaysia. The EU considered this  requirement to be not only 
unnecessarily burdensome and costly, but also not in line with the international Codex standard on 
audits (CAG/GL26-1997): for instance, the Codex st andard recommended the evaluation of official 
inspection and certification systems rather than the inspection visit of specific commodities or 
establishments. The standard also clearly indicated, inter alia , that all cost should be borne by the 
importing country, that inspection visits should be announced in advance and results should be 
communicated to the applicant.   The European Un ion also requested the measure to fully comply 
with the international Codex standard on halal (C AC/GL 24-1997), which would allow the certificates 
granted by the religious authorities of the exportin g country to be accepted in principle by the 
importing country.  Finally, the representative c oncluded by asking Malays ia to provide some 
information on the state of play of the so-calle d "Trade Description Act" 2011, which also included 
halal labelling requirements. 
237. The representative of Argentina was concerne d because seven establishments, which had 
previously been able to export to Malaysia, had been suspended since November 2010 by the 
Veterinary Services Department.  In Argentina's view  the requirements of the standard did not comply 
with Article 2.2. of the TBT Agreement because they  were more stringent than necessary to achieve 
the objective, i.e. to ensure that food satisfi ed halal conditions thr oughout the production chain 
thereby avoiding fraudulent declaration of halal meat.  Argentina consider ed that the Article 4.2 of the 
protocol, stating the obligation for establishments to  rely exclusively on halal production without any 
possibility of production shift to other types of meat , created an unnecessary barrier to international 
trade.  Since the draft protocol was inconsiste nt with the CODEX Standard for halal products 
(CAC/GL 24 1997), Malaysia should have, according to the TBT Agreement, justified any departure 
from the international standard.  For instance, Article 2.2.1 of the general guidelines of the CODEX 
Standard for halal products referred to the possib ility for the same establishment to have different 
production lines for halal and non-hala l products.  Hence, according to  Article 2.2.2 of this CODEX 
standard, halal meat could also be  transported and stored in areas previously used for non-halal meat, 
as long as these areas were prope rly cleaned following Islamic standards.  Thus the production of 
Halal and non-halal meat in line with Islamic La w was possible on condition that the necessary health 
steps were taken on the premises but without relyi ng on separate lines of production.  So setting up 
different shifts on a weekly basis could be one  way to comply with the established Islamic 
requirements. 
238. The representative of Turkey noted that rec ognizing the globalisation of halal food market 
and the growing needs and expectations of Muslim consumer for halal food standards, several Muslim 
countries had taken the initiative, under the Organi zation of Islamic Coopera tion (OIC), to develop 
standards for halal foods.  After three years of technical work, three guidelines on halal food certification and halal accreditation bodies had been adopt ed (in 2011).  In addition, an affiliate body, 
called the Standard and Metrology and Certificate of  Islamic Countries (SMIC) had been established 
by the OIC to take care of the standardization of halal food.  With currently 13 members, including 
Turkey, the SMIC encouraged new membership.  It was important to address the increasing number G/TBT/M/55  
Page 52  
 
  of regional standards by developing a consolidated , global halal food standard so that divergences 
could be eliminated and inte rnational trade enhanced.   
239. The representatives of Brazil and New Zealand remained concerned about the measure and 
would continue to monitor the issue. 
240. The delegation of Malaysia confirmed that Mala ysia's TBT focal point had already provided 
answers to the written concerns and welcomed furt her bilateral discussion with interested Members. 
(xxxv)  Mexico – Energy Labelling Me asures (G/TBT/N/MEX/214) 
241. While the representative of Japan recognized the purpose of the measure, namely the 
protection of the environment through the provision of  pertinent information so that consumers could 
choose energy efficient products, he was concerne d that manufacturers were facing considerable 
difficulties in complying with some of these provisions.  It was problematic that the TBT notification 
had been issued just before their implementation, undermining the transparency  principle as stated in 
Article 2.9.2 of the TBT Agreement.  As a conse quence, the measures had entered into force while 
several concerns concerning about details of la bel designs and the measuring methods remained 
unresolved.  In the absence of clarifications, th e implementation of these provisions would result in 
confusion for both consumers and producers.  He requ ested to standardize details of label designs and 
measuring methods and ,at the same  time, to conduct market surveys of compliance by a reliable third 
party to ensure fairness. 
242. The representative of the European Union echoed the concerns raised by Japan.  She noted 
that although Mexico had indicated its intention to  take comments into account, none of the questions 
raised at the last meeting of the Committee (and sent in writing to the enquiry point) had been 
answered. 
243. The representative of Korea supported Mexico’s obj ectives with regard to energy efficiency 
and environmental protection, however, furthe r clarification is necessary regarding market 
surveillance, the use of pictograms on product labels, and the placement of those pictograms.  During 
a bilateral meeting in September in Mexico, Kore a had been informed that PROFECO planned to 
begin carrying out market surveillance at the end of November. However, Korean industry 
representatives in Mexico had informed the Korean Government that market surveillance commenced 
in October and this was a source of great concern.  This was because important  details had yet to be 
clarified. For example, no recognized energy effici ency tests existed either in the international 
standards or in Mexico’s NOM for some of the prod ucts subject to labeling.  These included industrial 
electric ovens, as well as both industrial and househol d ovens fuelled by liquefied petroleum gas or 
natural gas.  The scope of some products listed in the cat alogue was also problematic because of its 
breadth.  Therefore, the delegation of Korea urged Mexico to narrow down the product list and 
provide a clear labelling pictogram and information on the placement of the label.  Korea further requested Mexico not to apply the measures on a business-to-business basis and to grant a grace 
period for products for which no recognized tests existed.  She asked Mexico to explain the 
registration process to PROFECO and CONUEE.  Without clear guidelines, manufacturers were 
confused regarding which of these organizations they must submit data to, or if they must go through 
both organizations. 
244. The delegation of the United States supported Me xico's efforts to raise consumer awareness 
of energy consumption and to promote energy effi ciency.  However, concerns remained.  The scope 
of the measure was unnecessarily broad and could c over products with minimum energy use.  The 
testing procedures lacked flexibility and clarificatio n; it was important that producers were allowed to 
select their own test procedures and, moreover, a dditional time was needed for producers to comply 
with the measures.  It was also unclear whether manufacturers or importers could submit the required  G/TBT/M/55  
 Page 53 
 
 
  test report electronically.  The United States request ed Mexico to provide in a publicly available 
document clarification regarding the labelling format  and placement – this document needed to be 
transmitted to Mexican ports.  A transition period was needed to delay the entry-into-force until six 
months after the implementation date, so that pro ducers would have sufficient time to comply.  The 
United States also requested Mexico to confirm that  the measures would not apply to products that 
entered the Mexican market prior to  the entry into force of the meas ures.  He suggested that the US 
and Mexico could collaborate on an agreement on common test procedures for specific products as 
had been discussed in a high level regulator y cooperation council earlier in the week. 
245. The delegate of Mexico explained that in September 2010, the "catalogue of equipment and 
machines" had been published requesting producers,  importers and distributors not to regulate the 
energy consumption of equipment and machines, but to include information on energy consumption 
for consumers.  In March 2011, the Official Gaze tte had published the "forma ts and requirements for 
the submission of information by manufacturers and importers of equipm ent using energy to 
function", which had been mandatory since 11 Se ptember 2011.  These mandatory requirements had 
entered into force a year after the original notif ication in the Official Gazette, providing producers 
reasonable time to come into line with the requi rements.  On the 15 June 2011 the catalogue of 
equipment and machines had been notified to the Committee under G/TBT/N/MEX/214, providing a 
60 days period for comments.  This had allowed the United States, Japan, the European Union and 
stakeholder businesses to send their comments during that period.  Korea had also comments, but after the expiry of the comment period.  The Nationa l Commission for the Efficient Use of Energy 
responded to the questions raised by the United St ates, Japan and the business stakeholders and was 
currently reviewing the comments provided by the EU  and Korea.  The National Commission was not 
currently considering any modification to the catal ogue until further details had been obtained about 
the results of its implementation.   
(xxxvi)  Kenya – Alcohol Labelling: The Alcoholic Dr inks Control (Licensing) Regulations, 2010: 
Legal Notice No. 206: 2010 
246. The representative of Mexico asked for informa tion on the implementation of this regulation 
published on 17 December 2010.  He requested a  formal response to comments presented on 12 May 
2011. 
247. The representative of the United States reiterate d previous questions and concerns on the 
rationale behind the possible inclusion of pictures in the alcohol warning statement,  the size of the 
warning label in proportion to the bottle,  the necessi ty of the warning statement rotation requirement 
to meet the stated objective,  ambiguities in the me asure,  its impact on industry as well as the lack of 
an implementation period.  The US was open to discussing these comments with Kenya on a technical level;  it understood that the implementation of some  sections of the measure had been postponed due 
to domestic litigation.  Could Kenya confirm this understanding, and, if this was the case, clarify 
which sections were postponed as well as the exp ected length of the implementation delay.  
248. The representative of the European Union suppor ted the Mexican and US concerns.  In April 
2011, subsequent to Kenya's notification of th e measure, the EU had provided detailed written 
comments.  Despite the issue being discussed in  the last TBT Committee, no written answers had 
been received.  She asked if Kenya had considered  less burdensome alternatives to modify drinking 
behaviour than mandatory health warning labelling, and if it was reviewing the requirement that 
health warnings make up at least 30 per cent of th e total package.  She sought confirmation whether 
products could be imported with a stic ker with the requested warning information added.           
249. The representative of Kenya noted that the Alc oholic Drinks Control (Licensing) Regulations 
("the Regulations") 2010 had been adopted on 16 December 2010 and published in the Kenya Gazette 
Supplement No 91 of 17 December 2010, pursuant to the Alcoholic Drinks Control Act No. 4 of 2010 G/TBT/M/55  
Page 54  
 
  ("the Act").  The Regulations had been enacted  as emergency measures as a result of popular public 
interest, consideration of the adverse effects of al coholic drinks in Kenya, to safeguard against the 
continued loss of life, and for the protection of publ ic health.  This was a problem for the last few 
years and Kenya had consulted with various stak eholders on possible measures.  Kenya had fully 
complied with the provisions of Article 2.10 of th e TBT Agreement.  In March 2011, it had notified 
the Regulations to the TBT Committee as they had a significant effect on international trade.   
250. Article 32(2) of The Alcoholic Drinks Cont rol Act 2010 provided that "every package 
containing an alcoholic drink shall bear a statement as  to its constituents, and have at least two of the 
health warning messages prescribed in the Second Schedule of the Act".  Such information might 
indeed be provided on extra stickers added to the pr oducts, as laid down in Article 32(6) of the Act.  
At the time of notification, Article 32(3) had provide d that the statement and health warnings referred 
to in Article 32(2) should comprise not less than 30 pe r cent of the total surface  area of the package to 
ensure prominent warnings to inform the public of  the dangers of excessive alcohol consumption.  
The 30 per cent requirement was currently under review .  A bill had been tabled in Parliament seeking 
to amend several provisions of the Act.  With re gard to the concerns raised by the US on rotation 
requirements for the warning statements, this was mean t to ensure that all four health warnings were 
distributed evenly in the Kenyan market.  If an y additional materials were added to the warning 
statements, Kenya would notify the WTO accordingly.        
251. Moreover, as a standard requirement for all p ackaged food and chemical products covered by 
the Food Drugs and Chemical Substances Act, Ca p 254 Laws of Kenya, manufacturers would be 
expected to label all ingredients used in the manufacture of the alcohol.  A list of "harmful 
constituents", as prescribed in Section 68(c) and (d ), would be given in s ubsequent regulations, and 
any two of the four health warnings prescribed in  Section 32(2)(b) of the Act should be labelled.  A 
company might advertise its alcoholic drink in ma gazines as long as it met all the requirements of the 
laws and regulations, especially as provided for in Artic les 45, 46, 47 and 48 of the Act.  Further, the 
sale of alcoholic drinks had been restricted to certain hours of the day, and sales to minors below 18 
were forbidden.  Fines for the violation of these laws had been enhanced to promote responsible 
drinking and deter excessive alcohol consumpti on.  Public education campaigns regarding the 
drinking age and responsible drinking had been on -going to nurture responsible citizenry.  As a 
standard practice, legislation would be regular ly reviewed, and any further changes would be 
communicated to the WTO.  Kenya would notify the WTO accordingly if and when the list of 
"harmful constituents" became available.  Submissi ons were based on currently available information 
and Kenya was open to consultations with any dele gation wishing to engage in further discussions. 
(xxxvii)  India – Toys and Toy Products (Compulsory Registration) Order 
252. The representative of the United States supported efforts to regulate to protect children's 
health and understood that the document was still a wo rking draft.  If it became a formal proposal, he 
asked if India would notify it to the WTO for comment s.  In the last meeting, the United States had 
flagged some issues in the working draft.  One was that the draft appeared to mandate a registration 
procedure that seemed to go beyond such requireme nts in other areas of the world.  The required 
information to be registered pertained to each f actory's management composition, the raw materials 
used, serial numbers for all equipment on the f actory floor, factory layout, production process, 
packaging and storage, details of quality control of staff, and notif ication upon removal of a piece of 
equipment from the factory.  He asked if India would allow recognition of sampling and test reports 
conducted by overseas laboratories provided that they had been accredited by an ILAC MRA 
signatory.  If this became a proposal, two agencies wi th separate regulatory regimes in India, the BIS 
and the Director General for Foreign Trade, would be responsible for the product safety of imported 
toys; while domestic toys and coordi nation would be regulated by BIS.  He asked that these concerns 
be taken into account in developing the draf t, and that India notify a draft proposal.    G/TBT/M/55  
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  253. The representative of the European Union sup ported the US concerns while also supporting 
the objective of enhancing toy safety for the protection of children.  He asked for further clarification 
on the rationale for the envisaged change in c onformity assessment, and for the shift to a more 
stringent regime based on mandatory testing carried out in India without scope for recognition of test 
results from foreign ILAC accredited laboratories.  Moreover, onerous regi stration procedures would 
add burdens to the procedure envisaged.  Due to the potential significant impact on exports of toys to 
India, he requested guaranteed transparency in the process and that India notify a draft at the 
appropriate stage to the TBT Committee so as to allow for comments and dialogue.  
254. The representative of India reported that the Department of Industry Policy and Promotion 
was still in the process of formulating the draft gui delines on the proposed order.  He took note of the 
issues raised by the US, especially  on the existing DGFT import notification and the alignment of the 
guidelines therewith.  He considered it premature to comment, and gave assurances that India would 
decide on notifying a draft once the process was completed. 
(xxxviii)  France – Loi No. 2010-788:  The National Commitment for the Environment 
(Grenelle 2 Law) 
255. The representative of Argentina asked the Europ ean Union to notify th e law to the WTO and 
inquired about its consistency with  relevant EU legislation.  He asked for confirmation that the 
Grenelle Law 2 was still at a pilot stage since July  2011, and what was its status this year.  He 
inquired whether a calculation method for carbon footpr int was defined and whether this would apply 
to agriculture exports from developing or just developed countries, taking into account common but 
differentiated responsibilities.  He further inquire d whether the Law would lead to compulsory 
labelling for carbon footprint during its pilot stage with  regard to developing countries.  He asked for 
a reply to Argentina's questions raised in the prev ious meeting, including whether, and if so, which 
stakeholders had been consulted, particularly in developing but also developed countries.  Moreover, 
Argentina was interested in know ing whether there were any clauses on special treatment for 
developing countries not included in Article 12 of  the TBT Agreement and taking into account the 
development, financial and trade possibilities of th ese countries.  Argentina also asked if technical 
assistance provisions, particularly for small and me dium-sized businesses, in developing countries had 
been included and whether an analysis of the regu latory impact of the standard had taken place.  
Lastly, Argentina asked for additional information on how the carbon footprint would be quantified, 
such as details, variables and assumptions to be used.    
256. The representative of the European Union clarifie d that the Law did not contain any provision 
foreseeing compulsory environmental labelling. the Law had provided for an experimental run for a 
minimum period of one year, starting as of 1 July 2011 ,to inform consumers on the carbon equivalent 
used for product packaging and to look at consum ption of natural resources as well as environmental 
impacts due to products during their life cycle.  This experiment would ha ve to be submitted to 
Parliament which was considering th e general application of this me asure. This trial would apply to 
companies on a voluntary basis to as sess the feasibility of environmental labelling with the purpose of 
creating a pool of ideas.  A high degree of flexibility was left to the implementation of this experiment.  Since 1 July 2011, 168 companies had participated on a voluntary basis, representing a 
great diversity in terms of companies' origin, si ze and production.  Several third-country companies 
had been involved, either directly as was the ca se for individual companies in South and North 
America, or indirectly via projects run by distributors, particularly Asian companies.   
257. The French authorities wanted to contribute to the on-going thinking related to environmental 
labelling that was currently being looked at in  a number of national and international bodies.  
Nevertheless, the adoption of a provision on national labelling had not  finally been decided and no 
provision regarding the types of products concerne d or the implementation of labelling had been 
proposed.  Discussions in this Committee were prem ature and her delegation could not yet respond in G/TBT/M/55  
Page 56  
 
  detail to the questions raised by Argentina.  The EU was willing to provide information on the 
experiment's results that would probably be  made known at the beginning of 2013.  
(xxxix)  Korea – KFDA draft "Guideline for Cosmetics Labeling and Advertising" 
(G/TBT/N/KOR/308) 
258. The representative of the United States had raised  two concerns. First, since the current Fair 
Trade Commission Regulation and Product Liability  Law already covered personal care products, 
how would the new Guideline interact with tho se measures to ensure that these would not be 
redundant and confusing for companies.  Second, regarding transparency, if a company wanted to make a claim that was not found on either of the lists  set out in the Guidelines, the relevant procedure 
and whether companies would have to file a petition on a claim by claim basis with KFDA was 
unclear.  Additional clarification was needed in cas es where the wording was different than indicated 
on the negative list.  As an example, if a compan y could not state that a product could reduce a scar, 
he questioned whether it could argue that the pr oduct would reduce its appearance.  Moreover, he 
asked whether claims could be made if they were not mentioned in either of the positive or negative 
list.  He asked about the Korean rational for a br oad negative list which included claims that were 
normally accepted in other jurisdictions since it could have a negative impact on trade.   
259. Regarding the use of foreign la nguages on labels, the US was c oncerned about the problem of 
companies translating product names on labels.  Si nce some U.S. products were known to Korean 
consumers under the English names, this require ment could negatively impact sales and provoke a 
lack of understanding for consumers on claims being made.  He asked if these translations would need 
to be placed on the packaging or on a separate document accompanying the product.  Given the 
confusion caused by the Guideline for both domestic and foreign industry, the US urged Korea to 
revisit this after discussions with relevant stakehol ders, and to provide clarity on questions in order 
not to disrupt legitimate trade.  He asked Ko rea to update the Committee on these discussions.    
260. The representative of the European Union s upported the US concerns.  Her delegation had 
sent written comments on 22 June 2011, and received a reply from Korea on 28 July 2011.  While the 
EU was grateful for Korea's reply, it continued to have a number of concerns, that had been submitted 
to the Korean Enquiry Point on 7 November 2011.  Th e EU continued to consider that some elements 
of the Guidelines were still not sufficiently clear or  specific, and contributed to a significant level of 
uncertainty for foreign cosmetics companies operati ng on the Korean market.  She reiterated the EU's 
request that KFDA provide more specific indi cations on how these Guidelines would apply, 
particularly in conjunction with Article 14 of the new Cosmetics Act passed by the Korean National 
Assembly on 29 June.  Secondly, the Cosmetics Act w ould have to be complemented with lower level 
legislation to make the new legal framework fo r cosmetics fully operational.  These implementing 
Decrees would also cover claims substantiation.  It  was not clear how the notified Guidelines would 
fit into the new legal framework or whether they would have to be modified once the implementing 
rules were adopted.  Thus, she asked Korea to de lay the implementation of the Guidelines until the 
legal framework was fully established so as to avoid confusion and lack of pr edictability for economic 
operators.  The EU stressed the need for these me asures to be developed in a transparent and 
participatory manner, involving cons ultation with industry.  Third, the new Guidelines might also 
prove problematic with the control of claims in  languages other than Korean.  Since the list of 
prohibited and permitted claims in the Guidelines w as provided in Korean only, there was a lack of 
clarity on how claims in foreign languages woul d be treated.  Her delegation asked if KFDA also 
interpreted names of globally marketed products su ch as brand names as within the Guidelines' scope. 
261. The representative of Korea said that KFDA could not exempt items written in foreign 
language from labelling.  If the concern was that th e labelled product name of  an imported cosmetic 
would lead to consumer deception or cause the item to be considered a pharmaceutical product, this 
was to be regulated not only by the amended Co smetics Act, but also by the current one.  The  G/TBT/M/55  
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  Guideline specified methods, such as correction, de letion, over-labelling for a dvertisements or foreign 
language labels, for importers  to modify them to conform with the Guideline.  She clarified that some 
standards were currently going through internal review to establish more specific standards for 
regulations related to cosmetic  labelling and advertising under the Cosmetic Act, including, inter alia , 
the preparation of details for the substantive target , scope and requirements fo r substantiation data or 
method of submission.  Once finalized, Korea would notify the amended regulations to WTO 
Members.  KFDA would refer to the relevant sta ndards of other countries such as Canada, Australia 
and Japan to apply international standards as much as possible.  Even though the Guideline was not 
legislation, it had been notified to the WTO for comments as requested by the EU. 
(xl) Colombia – Commercial Truck Diesel Emissions  Regulation (Resolution 2604, 24 December 
2009)   
262. The representative of the United States noted that  Resolution 2604 had been withdrawn, that 
the Ministry of Environment had published a draft Regulation in Colombia's Official Journal entitled 
"Modification of Resolution 2604" in July 2011, a nd that the industry had been invited to submit 
comments which it did on 27 July 2011.  In a ddition, an inter-agency process was on-going in 
Colombia to discuss mandatory emission limits from commercial diesel trucks.  He asked if this was 
the correct status of the measure and, if not, coul d Colombia explain.  The US supported Colombia's 
objective to lower emissions from commercial diesel  trucks for health, safety and environmental 
reasons.  He was concerned that the diesel fuel curre ntly available in Colombia, and required for U.S. 
trucks as of 2013, was not compatible with th e US Environmental Protection Agency's (USCPA) 
2010 emission standards.  Engines built to meet th is specification required ultra-low sulphur diesel 
fuel that would not be available in Colombia un til 2019.  This requirement barred US diesel trucks 
from the Colombian market.  He suggested requiring diesel trucks sold in Colombia to meet EPA 
2004 rules that would help reduce emissions in Colomb ia and keep trade flowing.  The US welcomed 
further bilateral discussions at a technical level. 
263. The representative of Colombia clarified th at Resolution 2604 of December 2009 was 
currently being reviewed.  It would set maximum em ission levels for those vehicles that transported 
people as well as trucks.  Consequently, this would affect hybrid transport as well as transportation of 
goods and people.  Colombia was also looking at Resolution 9/10 that focused on the number of contaminants allowed in motor vehicles. Colombia would review standards of diesel vehicles in the 
course of these various reforms to improve air qua lity, the environment and people's health with a 
particular focus on children.  Standards based on in ternational standards, as well as possible problems 
of conformity with regard to health protection of  Colombia's population in the short, medium and 
long-term had to be borne in mind.  Inter-depar tmental agencies, such as the Environment Mine 
Energy, Trade, and Tourism, that had raised these issues could together decide on a standard.  Once 
set, the standard would be notified to the TBT Committee for third country comments.   
(xli) Korea – Amendment to Radio Waves Act 1/2011 (RRA) G/TBT/N/KOR/334, 
G/TBT/N/KOR/339, G/TBT/N/KOR/343 
264. The representative of Japan appreciated Kor ean Government to extend the dead line for 
comments on TBT notification. However, the Korean Government announced revised EMC 
regulation on 21 January and had already enforced it on 1st July 2011 without TBT notification. By 
reflecting this movement, Japanese industries quickly tried to collect information in order to follow 
the revised EMC regulation. However lack of uniform  explanation by RRA officials caused confusion 
which imposed unnecessary burden on Japanese industries. 
265. The representative of the United States said that  US industry had been working closely with 
Korean Regulators on the implementation of th ese regulations.  The US appreciated the close 
cooperation with the Korean Government to ease th e transition to the new labelling regime.  On 29 G/TBT/M/55  
Page 58  
 
  August 2011, a joint US-Japan industry letter had been sent to the RRA outlining a number of specific 
technical concerns and questions with respect to  the electro-magnetic compatibility element of the 
regulation.  He reiterated the US request that Kor ea respond to the letter and work on the issues raised 
by the industry.  Industry still had questions and c oncerns on the electrical safety certification portion 
of the measures.  First, the US  requested Korea to use the second edition of the IEC 60950 that was 
more widely used internationally.  Second, he appreciated clarification from Korea on the scope of 
products covered under the safety and certification requirements, and in particular whether non-
consumer products, such as business to business pr oducts, could be excluded.  Third, industry 
requested that the KATS, which was implementing the electrical safety portion of the measure, utilise 
the IECEE CB scheme as part of its safety certification programme, as well as a one year 
implementation period to comply with the new re quirements.  He asked Korea to confirm whether 
KATS was planning to postpone im plementation until 2013 as well as pr ovide any other updates on 
the specific issues raised in its intervention.  
266. The representative of Korea informed that it ha d held bilateral meetings with the US and 
Japan, and its newly introduced certification syst em for EMC and electric safety regulations was 
better understood.  With regard to overlaps between the Radio Waves Act  and the Electrical 
Appliances Safety Control Act , the responsible authorities (the Korea Communications Commission 
(KCC) and the Korean Agency for Technology and Standards(KATS)) agreed to split responsibility 
for certification not along product lines but according to the kinds of tests that must be carried out. The KCC was responsible for ensuring EMC, wh ereas KATS was responsible for ensuring that 
electrical appliance manufacturers comply with safety regulations]
 from January 2012 onwards. With 
regard to the acceptance of EMC certification,  the KCC recognized test results from testing 
laboratories located outside of Korea if they were members of the IECEE CB Scheme or if they signed MoUs with Korean CBs. Test results for EMC issued by 76 CBs in the US were currently 
accepted. 
 
267. In response to the US comments on the refere nce standard for new safety requirements, 
although currently the first edition of IEC 60950-1 w as used, the second edition would also soon be 
introduced.  With regard to Japan's comment s on the Conformity Assessment System for 
Broadcasting and Communications Equipment, not ed in G/TBT/N/KOR/334, RRA had notified the 
amendments on 11 October 2011 and had extended the deadline for comments until December 2011.  
She encouraged Members to submit  comments to be taken into acc ount by the RRA while amending 
the regulation.  She would deliver the points raised by the US and Japan to the competent authorities.   
(xlii) South Africa – Liquor Products Act of 1989 
268. The representative of the United States referred to  the June Committee meeting, in which he  
had explained that a US company that had not been able to export one of its  products to South Africa 
due to a gap in South African definitions for al coholic beverages.  While  "liqueurs" required a 
minimum alcoholic content of 24 per cent, "spir it coolers" could only contain a maximum alcohol 
content of up to 15 per cent by volume.  Thus, ther e was a gap in the rules between 15 and 24 per cent 
of alcohol content since the product in question had an  alcohol content of 17 per cent.  Due to this, the 
product had been excluded from the South African mark et, although it had been classified as a liqueur 
in a number of countries including the US and had been  sold in several countries.  Like many other 
countries, the US defined liqueurs based on raw ma terials and production processes, rather than 
factors such as alcohol content.  The US was not aware of any health or safety reasons why alcoholic 
beverages could not contain between 15 and 24 per cent of alcohol by volume.  South Africa had 
made an exception for a domestic product, Amarula,  which contained an alcohol content of 17 per 
cent.  Thus, a domestic alcoholic be verage with 17 per cent alcohol content could be sold in South 
Africa, while a beverage of foreign origin containi ng the same alcohol content and sold all over the 
world was excluded from sale on the South African market.    G/TBT/M/55  
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  269. South Africa had not provided any justification for this disparate treatment between foreign 
and domestic producers of alcoholic beverages.  Th e issue had been discussed bilaterally and the US 
company had provided the requested labelling and i ngredient documentation to the South African 
regulator.  Although the process had been on-going since 2009, the company had neither received approval in marketing its products, nor an explanation for the lack of reply.  The US asked South 
Africa to provide a status update on the app lication, and an explanation for the delay 
270. The representative of South Africa referred to the South African Liqueur Products Act of 
1989 and the comprehensive response provided at th e June Committee meeting.  South Africa drew 
the attention to on-going bilateral efforts within the confines of the South Africa - U.S. Trade and 
Investment Framework Agreement (TIFA) that aime d to find a mutually acceptable solution to the 
US' concern.  The matter had also received atte ntion at a 21 September 2011 meeting between senior 
trade officials and representatives of both the US and South Africa in Pretoria.  As for the progress of the application, South Africa informed that comment s and questions would be relayed to the relevant 
competent authority.    
(xliii)  India – Mandatory Certification for Steel Products ( G/TBT/N/IND/32, G/TBT/N/IND/32/Add.1, 
G/TBT/N/IND/32/Add.2)  
271. The representative of the European Union referred to India's mandatory certification 
requirements for steel discussed at the meeting in J une 2011.  At that time, India had abolished third 
party certification for several steel products.  By means of an addendum to notification G/TBT/N/IND/32 of 22 July 2011, India announced that the products were now again subject to mandatory third party certification without providi ng for a period for comments by WTO Members.  
The EU had sent detailed written comments on 6 Se ptember 2011, but had not received any reply. 
272. She asked why India considered  a mandatory third party certification necessary for the 
products in question.  Steel produc ts were intermediary goods that  could be used for different 
purposes, and it would be more appropriate to verify  conformity with regard to the specific final 
product.  Moreover, international standards existed that were rec ognized and used world-wide.  The 
EU had also been informed that the third party certification procedure, which already existed for 
galvanized steel products, was applied in an ex tremely burdensome, costly, and time-consuming 
manner and that importers were still waiting for the necessary certification after more than one year.  
Could India provide clarifications on (i) the fees impor ters would have to pay;  (ii) if these fees were 
equal to fees due by domestic producers;  (iii) tests that could be recognized in the certification procedure;  and (iv) how a timely conformity asse ssment procedure would be ensured.  Since Article 
5.1.2 of the TBT Agreement prohibited conformity assessments more strict than necessary or from 
being applied more strictly than necessary, the EU urged India to reconsider  the introduction of third 
party certification for the steel products in question and to postpone its entry into force until all concerns were solved. 
273. The representative of Japan supported the EU .  It was pointless to impose mandatory 
certification regulations on intermediate products  such as iron and steel to secure human safety 
because protection of consumer health or safety depe nded on final, not intermediate, products.  This 
objective could be achieved by safety regulations ta rgeted at final products, as implemented by Japan. 
274. The representative of India said this measure had originally been announced through a draft 
regulation in 2007 in notification G/TBT/N/IND/32.  After more than four years, addendum 2 was 
introduced to finalize steel and steel products.  I ndia did not understand why this was a surprise to 
some Members as the amendment ac tually reduced the initial 2007 list to only nine products for 
certification.  Since intermediate products constituted the bulk work of the structural safety issue with 
regard to steel and steel products, they were necess ary to regulate.  Even for electrical products, steel G/TBT/M/55  
Page 60  
 
  sheets for the use of transformers and other electrica l products were the critical components in need of 
standards.  India would revert to the EU qu estions on costs at the next Committee meeting. 
2. Follow-up 
(i) Chile – Resolution 1114 on Emission Standards 
275. The representative of the United States updated th e Committee on the status of one particular 
trade concern.  This was with respect to a draft measure that had been proposed by Chile regarding 
emission standards applicable to heavy duty mo tor vehicles (Resolution 1114 from 15 September 
2011).  The United States thanked Chile for having issued a revision to its diesel truck emissions requirements. The previous version of the requi rements, which had mandated compliance with EPA 
2007 emission standards for US diesel trucks, would ha ve blocked export of US diesel trucks to Chile 
because outside of the Santiago metropolitan area, th e low sulphur fuel that was needed by diesel 
trucks engineered to these standards was not curren tly available.  The proposed change in the draft 
revision to the EPA 2004 emission standards, which would be in effect until such time as the 
appropriate low sulphur fuel was available through out Chile, alleviated this potential market access 
barrier while still lowering emissions and provid ing enhanced public heal th and environmental 
protection in Chile. 
3. Streamlining the Committee's discussion of specific trade concerns 
276. The Chairperson reported that the Committe e had held an informal meeting on 
6 October 2011 to discuss a proposed mechanism (JOB/T BT/14) to make more efficient and effective 
the Committee's discussion of STCs, while, at th e same time, giving each Member adequate 
opportunity to address STCs they considered importa nt.  She recalled that while Members generally 
agreed that more information about the status of the various STCs was useful, there had been some 
debate at the informal meeting on the categories for the classification of STCs.  In light of the 
discussion, the Secretariat revised the document wh ich was before Members at the current meeting 
(JOB/TBT/14/Rev.1).   
277. The representative of Japan was of the view that the revised note (JOB/TBT/14/Rev.1) 
reflected his delegation's earlier comments and t ook into account the discussion at the informal 
meeting.  For Japan it was important that Footnote  6 of the document clarified the meaning of the 
status of STC (to the effect that classifications we re intended solely for the purpose of facilitating the 
WTO TBT Committee's review of specific trade concer ns and had no legal implication).   However, 
Japan was of the view that more precision could be useful with respect to the category "progress 
reported".   For more accuracy, this category coul d be usefully divided into two categories: (i) 
progress reported and still active  and, (ii) progress reported and inactive .   
278. The representative of India noted that hi s delegation had come across instances where 
Members were raising concerns about measures where a draft of the measure itself had not even been 
finalized.  It was India's view that such concerns were premature for the Committee.  Therefore, there 
needed to be a category that would capture these  "premature" STCs.  He also queried on the 
difference between "active" and "progress" report.   
279. The representative of the European Union stressed  the need to keep the administrative  
burden, for both the Secretariat and the Members, to  a minimum.  So while further sub-categorization 
might better capture specific cases, the Europ ean Union warned against an overly detailed 
categorization of measures.  His delegation suppor ted the initiative on the understanding that there 
would be only a few basic categories:  the active and inactive categories (as set out in the revised 
draft) needed to be the default categories.  Any "p rogress report" needed to be  voluntary – and entirely 
up to Members to provide.  In this regard he said that it was important to consider who should be the  G/TBT/M/55  
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  source of information about status (under "progress reported"). It was the EU understanding that this 
would be the Member raising  the concern.   
280. The representative of the United States said that  it was important for the Committee to have 
better data on how specific trade concerns were being addressed , including resolved, in its work.  This 
information could streamline the agenda for Comm ittee meetings and could contribute to reducing the 
length of the discussions under the STC agenda item.  The United States agreed with other delegations 
that the "inactive category" needed to be the de fault category; most of the items would probably 
automatically fall under this category.  However, th e United States was of the view that there needed 
to be a fifth category of "unresolved" STCs – and that  this needed to be separate from "inactive".  If 
there were no category for "unresolved" measures, the risk was that Members would continue to raise 
STCs over and over again just to be able to show to their stakeholders that the matter was being 
pursued even after the measure had been adopted and implemented.  A category for "unresolved" measures would enable delegations to  show (their constituents back ho me) that even if the issue had 
not been raised at the meeting it remained unresolved.  It was suggested that there could be a trigger 
mechanism whereby the Secretariat could list all the STCs that had not been raised for the past six 
consecutive meetings, and those could be moved to inactive.  Unless a Member remarked otherwise, 
these STCs would, thus, at that point be "automatically" classified as "inactive".  This would also be an opportunity for a Member to offer informati on about whether the measure could be classified as 
"partially resolved", "resolved", or "unresolved".  In terms of what ki nds of issue that could be raised 
and at what point in time – the lesson learned from the Workshop on Regulatory Cooperation was: the 
earlier the better.  Moreover, in his delegation's view  there was no reason to circumscribe what type of 
measure Members could raise in the Committee. 
281. The representative of Canada stressed the importa nce of finding ways for Members to express 
concern about a measure without necessarily raising it in the Committee, particularly considering that 
the STC-part of the agenda was taking up increasingly more of the Committee's time.  In this sense, Canada supported the US statement to  the effect that delegations n eeded to be able to convey to 
stakeholders at home that they had signalled concern.  It was thus necessary to avoid moving a 
concern to the "inactive status" if the underlying concern was still there and, at the same time, the 
Committee needed to find a way to avoid a series of  interventions simply to maintain the "active 
status".   An alternative to adding more categori es was to consider the category "progress reported" as 
a form of status report – for instance, it could be reported that the matter was being "pursued 
bilaterally".    
282. The representatives of Switzerland, Norway and Pakistan supported the approach taken in the 
revised document and emphasized the importance of simplicity.   
283. The Chairperson noted the importance all Members a ttributed to simplicity and, in general, to 
finding ways of providing more information on the status of specific trade concerns discussed in the 
TBT Committee.  She recalled that the existing TBT IMS contained a slot for information on "status" 
of STCs which was, currently, by default set to "Not Reported" for all STC raised since 1995.15  She 
noted that while in the discussion a number of categories had been raised, the clearest were: 
"resolved" and "unresolved".  Members could initially , and on a voluntary basis, provide information 
in respect of these two categories.  Hence if Member s were aware of an STC that had been resolved, 
this information could be communicated and fed in to the IMS.  Indeed, the category "unresolved" 
could be particularly useful considering the pur pose of this streamlining exercise (to make the 
Committee's discussion of STCs more efficient) – as it would enable Members to flag an issue as 
"unresolved" without necessarily raising it (again) for discussion under the agenda item "previously 
raised STCs".  
                                                      
15 Also reflected in the G/TBT/ GEN/74/-series of documents. G/TBT/M/55  
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  C. 
EXCHANGE OF EXPERIENCES  
1. Good Regulatory Practice 
284. A Workshop on Regulatory Cooperation between Members was held on 
9-10 November 2011.  The Chairperson provided an oral summary of this workshop.  The oral 
summary statement, as well as a summary report, is contained in document G/TBT/W/348.16 
2. Standards 
285. The representative of India introduced his dele gation's submission on in ternational standards 
(G/TBT/W/345) and stressed that the paper was prelim inary, to be considered as a basis for further 
work.  The paper considered the Decision on Principles for the Development of International 
Standards, Guides and Recommendations with Relati on to Articles 2, 5 and Annex 3 of the TBT 
Agreement  from 2000 (hereafter the "Committee Decision").17  It was India's view that 11 years down 
the road there was perhaps a need to review th ese principles and consider the potential need for 
additional principles. 
286. The representative went on to stress some sugges tions contained in the paper, for instance: an 
increased reference to electronic working tools and procedures (under transparency), and using 
principles and elements from the Code of Good Pr actice to increase transpar ency in the standards 
area.  In the area of openness, the representative of India stressed the importance of considering 
resource constraints and finding means of actua lly operationalizing this principle.  On the 
Development Dimension, which India considered to  be the most important principle, two specific 
areas were highlighted: standard setting bodies needed  to have a specific action plan for developing 
country Members; and there was a need to operationa lize the TBT Agreement in respect of the special 
development, financial and trade needs of deve loping countries.  Other proposals on the existing 
principles are reflected in detail in the paper.  The representative of India also suggested three 
additional principles dealing with (i) institutional m echanisms for standard setting; (ii) stakeholder 
consultations; and (iii) guidelines for transposition to national standards.  
287. The representative of Mexico said that his delega tion agreed with India that problems arose 
from the lack of a definition of international sta ndards.  Indeed, the lack of clear concepts and 
concrete definitions had created a number of cha llenges in implementing the TBT Agreement.  While 
it would probably be difficult for Members to agr ee on a definition for international standards, the 
Committee could consider building on the princi ples contained in the Committee Decision, as had 
been suggested by India.  On tr ansparency, Mexico agreed that th ere was a need to ensure that 
international standard setting orga nizations, or at least the bodies that were observers in the TBT 
Committee, better define their work plan.  In par ticular, these bodies could become better at spreading 
information, including to developing countries.  With respect to openness, Mexico stressed the 
importance of technical assistance mechanisms to bolster the participation of LDCs.  Another important point was the decision – to be take n by each Member - of which committees required 
involvement; it was not efficient (or even necessary) fo r all countries to be involved in all committees.    
288. On the issue of impartiality and consensus, a nd the reference to different geographical and 
climatic conditions, Mexico did not see the appropriateness of the proposal given that the TBT Agreement already contained language to  this effect.  Also with respect to the "90 per cent" criteria on 
consensus, Mexico expressed concern and said that the subject needed further discussion.  On the 
Development Dimension, the representative of Mexico said that there was a need to foster the use of 
                                                      
16 More information on the Workshop is available at: 
http://www.wto.org/english/tr atop_e/tbt_e/wkshop_nov11_e.htm . 
17 The full text of this Decision is contained in Annex B of G/TBT/1/Rev.10, dated 9 June 2011.  G/TBT/M/55  
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  other languages, in particular Spanish.  While Span ish was an official language in many international 
organizations this was not generally the case in the standard-setting context, and this was a significant 
hurdle for Mexico.  He also noted that the institu tional mechanism by which standards were set might 
need some form of appeals procedure. 
289. The representative of Hong Kong, China agreed with India on the usefulness of revisiting, 
and even clarifying, the six principles contained in the Committee Decision and to explore new ones, 
if necessary. He recalled that in the discussion that  had taken place in the context of the NTB-related 
negotiations in the Group on Non-Agricultural Ma rket Access (hereafter "NAMA Group") there had 
been consensus on the importance of upholding the si x principles.  The Committee therefore needed 
to consider how to leverage these discussions in the course of the Sixth Triennial Review.  
290. The representative of the European Union recalle d that the Committee Decision had been the 
outcome of complex and lengthy discussions.  Theref ore, Members needed to reflect on whether they 
wanted to revisit the Decision in the context of the Sixth Triennial Review knowing that it would not 
be an easy task, and that it would risk monopoliz ing the work of the Comm ittee while the prospects 
for progress were perhaps better in other areas.  On the issue of defining an international standard, the 
European Union recommended – based on its e xperience – that the Co mmittee focus on the process  
through which a standard was developed, rather than attempting a definition  of an international 
standard per se .   On the issue of geographical and clim atic variations, the representative of the 
European Union agreed with Mexico: it was not rea listic to envisage that an international standard 
could capture all possible geographical, climatic and technological variations that might exist across 
different regions and Members.  The TBT Agreement,  and in particular Article 2.4 thereof, already 
provided clear criteria under which variations from in ternational standards were acceptable; there was 
no need for such variations to be exhaustively ensh rined in the international standard itself..  On 
consensus, the representative of th e European Union recalled that the ISO IEC Guide 2, 2004 version, 
(referred to in Annex I to the TBT Agreement), contai ned a definition of consensus.  It was important 
to consider in this regard that consensus was not linked to voting: it was a process through which 
different views were accommodated.  Indeed, this process sought "to reconcile any conflicting 
arguments" with a view to ensuring "the absence of sustained opposition to substantial issues by any 
important part of the concerned interests" in the draft standard; it took into account the views of all 
parties and reconciled any conflictin g arguments.  Therefore, the European Union did not consider 
that it was appropriate for Members to atte mpt to define a minimum benchmark on voting 
requirements to define consensus. 
291. Finally, the representative of the Europ ean Union recalled that the recommendations 
contained in paragraphs 25(b) and (c) in the Fift h Triennial Review were relevant to the current 
discussion.  These recommendations referred to the im portance of ensuring the effective application 
of the Code of Good Practice, as well as the importance of applying the six principles in the 
Committee Decision – and the sharing of experiences with  respect to their use.  It was suggested that 
the Committee could elicit contributions from Memb ers and from their standardization bodies on how 
the Code of Good Practice was being effectively a pplied.  In addition, with respect to the six 
principles, observers could be asked to offer their e xperiences in this regard.  Indeed, in the European 
Union, the European Commission had requested Eur opean standardization bodies and their national 
members to integrate the six principles into their wo rk because these were, in effect, an expression of 
good practice in standards development and their ap plication should therefore not only limited to the 
development of international standa rds but could also be promoted, mutatis mutandis , at national or 
regional level. 
292. The representative of Canada referred to the negotiations that had taken place in the NAMA 
Group and said that it would be important to elic it input from standards experts.  On the Committee 
Decision, he noted that it was a reflection of a very careful balance that had been struck in previous 
work of the Committee; revisiting them was a tall order.  G/TBT/M/55  
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  293. The representative of the United States agreed w ith the points made by the European Union.  
In addition, he said that the Committee might wish  to consider what Members could do to enable 
meaningful participation in international standard s development (not just attendance). Much useful 
information on this had been discussed at the Committee's March 2009 Workshop on the Role of 
International Standards in Economic Development.18  For instance, several delegations had talked 
about their experiences (e.g., Colombia, Peru and Pa kistan) including on the subjects of asparagus, 
coffee, building codes and textiles in organizing thei r domestic stakeholders to successfully influence 
international standards development, thereby incr easing exports.  On consensus, the United States 
agreed that it would be very difficult to come up with a number; getting the right procedures in place was perhaps more important. 
294. The representatives of Australia, Brazil, Chile , Cuba and the Philippines said that their 
delegations would carefully consider the Indian  proposal and would provide feedback.   The 
representative of Cuba expressed particular interest in the subjects of transparency, impartiality and 
development and emphasized the importance of par ticipation in the standard-setting process.  The 
representative of Australia also recalled that many of the issues raised in India's paper had been 
debated in the NAMA Group and would benef it from the wider input from the Committee. 
295. The representatives of the ISO and OIML supported a discussion of the six principles by the 
Committee and noted that these principles were embodied in their work.   
3. Conformity Assessment 
296. The representative of New Zealand recalled the recommendation contained in paragraph 19 of 
G/TBT/26, particularly in relation to developi ng practical guidelines on how to choose and design 
efficient and effective trade facilitation mechanisms .  She also recalled her delegation's submission 
contained in document JOB/TBT/5 (September 2010) which contained a possible structure for the guidelines.  She recalled that the objective of the guidelines was to develop a practical resource that 
Members could choose to use to guide their deci sions on the choice and design of trade facilitation 
mechanisms.  These would be based on concrete ex amples studies and experiences. For instance, the 
joint ILAC/IAF presentation at the TBT Committee (June  2011) had been a useful contribution in this 
regard, as well as the various contri butions on Regulatory Cooperati on in the context of the recently 
held Workshop (November 2011).  These presentations provided rich material to draw on in further 
developing the guidelines.  In considering what to do in the context of the Sixth Triennial Review, the 
Committee needed to take stock of what was already on its “to do” list (from the Fifth Triennial Review) and take the necessary steps to progress that work, before taking on too many new initiatives.  
4. Transparency 
297. The representative of India referred to the on- going work in the NAMA Group negotiations 
which was aimed at modifying the TBT notification formats; this work, he said, was primarily aimed 
at encapsulating all information pertaining to various  stages of the development process of technical 
regulations or conformity assessment procedures.  In  this regard, India intended to make a proposal 
where, essentially, the idea would be to amend the TBT notification format to facilitate the provision 
– on a voluntary basis – of pertinent additional in formation about the various stages of technical 
regulation. For example, India had notified a final regulation on steel standards19 (discussed under 
STCs) although there was no obligation to do so under the TBT Agreement.  This type of information 
                                                      
18 A summary report by the Secretariat is containe d in G/TBT/W/310. The full presentations made by 
speakers are available on the WTO TBT Website (http://www.wto.org/english/news_e /news09_e/tbt_16mar09_e.htm). 
19 G/TBT/N/IND/32/Add.2 dated 22 July 2011  G/TBT/M/55  
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  was an important means of populating the TBT-IMS database20, and could be particularly useful 
source of information for SMEs.  
298. The representative of the European Union note d, on the issue of transparency, that the 
communication of adopted texts and/or unofficial translations was the subject of existing 
recommendations in the Fifth Triennial Review, and that the European Union regularly availed itself 
of these procedures (see, in particular, paras 49 and 52 of G/TBT/26). She indicated that a lot of 
information was already communicated to the Secr etariat and was available for WTO Members, but 
that she had observed that much of that informa tion was actually not accessed by all WTO Members.  
The European Union drew the Committee's attenti on to its own website where all the information 
about a particular measure was collected on one page and recommended that the WTO IMS take a 
similar approach for all notifications. 21  The representative of the European Union also pointed out 
that it was important for improved transparency th at the notifications were published quickly after 
their sending to the Secretariat. The European Union would be very much in favour of a system that 
would allow the direct online notification by members, while avoiding, however, that information needed to be copied in the notification from by th e notification authority, as it is the case in the SPS 
management system. The representative of the Eur opean Union also stressed that many Members, 
including the EU, did not indicate the HS codes,  which made it difficult to process notifications 
automatically and instead required processing them manually and individually.  To develop common 
classification categories could perhaps be an area th at the Committee could work on.  Further ideas 
and more detail would be transmitte d through an upcoming EU contribution on transparency for the 
Sixth Triennial Review. 
D. O
THER MATTERS  
(i) Preparation of the Sixth Triennial Review 
299. The Chairperson noted that in light of the mandate in Article 15.422, the Committee was 
scheduled to complete its Sixth Triennial Review  of the Operation and Implementation of the TBT 
Agreement at its last meeting in 2012.  The Sixt h Triennial Review would follow a similar approach 
to previous Reviews:  it needed to be based on substantive proposals from Members.  Based on a 
proposal contained in JOB/TBT/13 (dated 6 September 2011), the Committee agreed on the timeline 
for the preparation of the Sixth Triennial Review as follows: 
(a) 10-11 November 2011 :  TBT Committee meeting (discussion on approach and any 
substantive proposals submitted) 
(b) end-February 2012: circulation by Secret ariat of background document compiling 
information available relevant to the review 
(c) 20 – 22 March 2012 : TBT Committee meeting: discussion of substantive proposals. 
(d) 1 June 2012:  deadline for the submission of substantive proposals by Members.  
                                                      
20 http://tbtims.wto.org / 
21 http://ec.europa.eu/enterprise/tbt/index.cf m?fuseaction=WhatNew. viewLast&dspLang=en  
22 Article 15.4 of the TBT Agreement provides:  "Not la ter than the end of the third year from the date 
of entry into force of the WTO Agr eement and at the end of each three-y ear period thereafter, the Committee 
shall review the operation and implementation of th is Agreement, including the provisions relating to 
transparency, with a view to  recommending an adjustment of the righ ts and obligations of the Agreement where 
necessary to ensure mutual economic advantage and balance of rights and obligations, without prejudice to the 
provisions of Article 12.  Having regard, inter alia,  to the experience gained in the implementation of the 
Agreement, the Committ ee shall, where appropriate, submit proposals for amendments to the text of this 
Agreement to the Council for Trade in Goods". G/TBT/M/55  
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  (e) 13 – 15 June 2012 :  TBT Committee meeting: discussion of substantive proposals. 
(f) July 2012: circulation by Secretariat of first draft report of the Review.  
(g) end-August 2012: submission of written comme nts from Members on the first draft.  
(h) end-September 2012:  circulation of sec ond draft report of the Sixth Triennial 
Review. 
(i) 6-8 November 2012 :  TBT Committee meeting: adoption of the Review Report. 
III. TRANSITIONAL REVIEW MANDATED IN PARAGRAPH 18 OF THE PROTOCOL 
OF ACCESSION OF THE PEOPLE'S REPUBLIC OF CHINA 
300. The Chairperson recalled that, in accordance with Paragraph 18 of the Protocol of Accession 
of the People's Republic of China (WT/L/432), the TBT Committee would undertake an annual 
review after ten years of the implementation by China of the TBT Agreement.   
301. The representative of Japan said that his delegation appreciated past dialogues with the 
Chinese Government, at regional and bilateral leve ls and through this Committee.  These efforts 
contributed to more transparent introductions of TBT measures.  His delegation observed that China 
had made progress but still did not appear to notify al l new or revised standards, technical regulations 
and conformity assessment procedures as required by WTO rules. 
302. He highlighted some points from document G/TBT/ W/342.  First, China appeared to continue 
to pursue the development of unique Chinese natio nal standards as a means of protecting domestic 
companies from competing foreign technologies and st andards.  In addition, his delegation understood 
that, in China, there were not only national st andards, but also sector/professional standards 
established by each department of standardization administration under the State Council or the local 
government, and local standards of the local government.  These also had a huge impact on 
international trade.  Japan would like to know how the central government had fulfilled its obligations 
under Article 3.1 of the TBT Agreement. 
303. Secondly, Japan had asked about conformity  assessment measures several times under this 
agenda item.  It was not clear that China could directly accept Certification of Conformity of the 
China Compulsory Certification (CCC) system, issu ed by foreign based certification bodies, if the 
Chinese Government concluded an MRA with a fore ign government.  In addition, Japan understood 
that China did not accept EMC (Electro-Magnetic Co mpatibility) test results conducted by foreign 
based laboratories under international frameworks, such as IECEE/CB Scheme.  His delegation would 
appreciate China's view on this question. 
304. Thirdly, Japan observed that China, despite modifications regarding the certification scheme 
of information security products, still seemed to be pursuing policies that hindered the use of foreign 
information security products in China.  As Ja pan and other concerned countries had continually 
expressed, it was expected of China to exercise pr udence in such policies and to conform to global 
practices.  This issue was also important because of the intellectual property protection aspect and his delegation was looking carefully at any progress in this area.  
305. He noted finally that, according to China's "Re gulations of the People's Republic of China on 
Certification and Accreditation" and "Measures fo r the Administration of Certification Bodies", 
certification bodies must receive approval of each scope of certification practices from the CNCA in order to carry out certification practices in China.  However, his delegation understood that there were 
some certification practice fields where certif ication rules were not provided by CNCA. His  G/TBT/M/55  
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  delegation asked whether certification bodies in China could conduct a certification practice by 
registering their own certification rules with the CNCA under the "Measures for the Administration of 
Certification Bodies" in cases where the CNCA had not  yet formulated the certification rules.  He 
reiterated the importance of dialogue with the Chinese Government here and in other relevant fora in 
order to facilitate legitimate international trade.   
306. The representative of the European Union, noted that since joining the WTO, China's 
economic transformation and its leading role in inte rnational trade was spectacular.  China was now a 
global economic power whose domestic policies and measures increasingly affected international 
trade.  With power went responsibility and his delegation believed it essential that China take full 
ownership of its international trade and seek to in tegrate global regulatory practices in a systematic 
way in this regulatory process. 
307. His delegation's paper focused on four areas of sy stematic concern.  Each was illustrated with 
some examples taken from the specific trade concerns  currently on the agenda of the TBT Committee 
meeting.  The first area was good regulatory practi ces and transparency.  His delegation welcomed the 
improvements in transparency in China's regulat ory process and, in part icular, welcomed the 
increasing number of public calls for comments. Howeve r, it considered that these practices were still 
not uniform and the application very much depended  on the regulatory body in charge. In addition, 
old systems in certain areas remained which were detrimental to the predictability business needed to 
operate.  His delegation, therefore, requested China to consistently call for public consultation on all 
new, draft laws and administrative measures that migh t have a significant effect on trade, and to allow 
for a reasonable period for comments on these drafts.  His delegation also encouraged China to 
expand its use of regulatory impact assessment analys is in order to ensure that technical legislation 
was not more burdensome than necessary to achieve a legitimate objective.  His delegation's paper 
provided some illustrative examples.  He ment ioned the ICT sector, information security, and 
cosmetics, which offered food for thought on what  kind of measures could be taken to enhance good 
regulatory practice in China.  
308. The second area of focus in his delegation's pape r was about the level of regulation.  His 
delegation noted with concern that China's regulat ory framework in the TBT area was characterised 
by the systematic use of mandatory standards that were almost always combined with a third party 
conformity assessment.  The best illustration was the CCC system which remained a major obstacle 
for foreign companies, in particular for SMEs. Th e CCC was complex, costly and lengthy.  Since its 
implementation in 2003, its scope had steadily gr own and now CCC extended well beyond its original 
objective of protecting consumer safety to new areas such as environmental protection or information 
security. The EU appreciated China's efforts to alle viate some of the administrative burdens of the 
CCC.  However, his delegation stressed the need for China to consider a comprehensive review of the 
system to abandon the approach of "one size fits a ll" and to embrace one that took account of products 
having different levels of risk and safety, by appl ying a risk based approach to conformity assessment, 
and by considering  lighter approaches such as Suppliers' Declaration of Conformity for products 
which posed a very low level of risk like office equipment, most electrical equipment, and ICT 
equipment. The potential introduction of mandatory th ird party conformity assessment in relation to 
the management of legislation on the restriction of hazardous substances was also a concern which 
had been covered in detail under the specific trad e concerns.  His delegation also recommended that 
regulation be focused on what was necessary to ensure  health and safety, and not extend into issues 
like qualitative aspects of products that should be left to the market to decide.  
309. The third area of focus in the paper was regulat ory coordination. In some areas, his delegation 
observed that several ministries or agencies exer cised concurrent regulatory powers over the same 
products and for the same objectives like safety.  This  led to situations where the products which had 
been tested and certified by one regulatory body needed approval from another regulatory body. This 
led to duplicative procedures and added to the burd en for companies.  His delegation, therefore, G/TBT/M/55  
Page 68  
 
  underlined the need for improved coordination to eliminate this overlap in requirements.  His 
delegation's paper provided illustrative examples in IT  security, medical devices, and motor vehicles. 
For the latter, the situation was particularly revea ling with no less than four entities having regulatory 
competence over almost the same regulatory aspects.  
310. The fourth and final area of focus was standardisa tion.  With regard to participation of foreign 
stakeholders in the domestic standardisation process , his delegation noted that in some sectors, like 
ICT, participation of foreign companies, although they were established and incorporated in China 
under Chinese law, was still constrained to observer status.  In other sectors, more involvement of foreign companies was allowed.  As some of th e standards underpinned mandatory certification 
schemes such as the CCC system, fore ign companies were, in effect, deprived of providing input in 
the regulatory process.  His delegation, therefore, called for more transparency, more inclusiveness of 
the standard setting process, and sufficient time fo r public enquiries which would allow stakeholders 
to react to draft standards.  Concerning the implem entation of international standards, his delegation 
noted with appreciation China's achievement concer ning the adoption of international standards and 
the commitment in the 12th five year-plan to the continued alignment of domestic technical 
regulations and standards with in ternational standards. One area of concern however was deviations 
from international standards without such deviati ons being justified on the ground that international 
standards were inadequate or ine ffective for the objective pursued.  
311. Another aspect his delegation asked China to consider was the timely adoption of 
international standards or the latest versions thereo f.  Outdated versions of standards would obviously 
cause trouble to manufacturers, especially foreign ma nufacturers, who were already used to working 
with the latest version of the standard.  His de legation continued to encourage China's increased 
participation in international st andard setting bodies, particularly in areas where issues were global 
and there was common interest in developing comm on global solutions instead of divergent national 
ones.  Such areas included green technology, inform ation security, smart grids, etc.  One additional 
area of remaining concern in the IT sector was the emergence of home-grown standards that featured 
unique Chinese technologies.  This resulted in blackli sting certain features of products by preventing 
innovative products that did not incorporate the technology embedded in the standard from being 
placed on the Chinese market.  
312. Finally, in some areas, his delegation ob served a tendency to make voluntary standards 
mandatory through conformity assessm ent procedures without any prior warning about this change in 
the status of the standard.  When this occurred,  the obligation to notify under the TBT Agreement 
should be triggered.  In conclusi on, his delegation welcomed China's efforts to anchor its system in 
the WTO Agreements.  Again it stressed that the e ffects of China's regulatory process were no longer 
limited to Chinese territory but had prolific effects on global trade.  In this regard, his delegation 
insisted on good regulatory principles to be systema tically followed in the Chinese regulatory process.  
His delegation would continue to use all bilate ral opportunities for regulatory cooperation to work 
with China towards achieving this goal. 
313. The representative of the United States  said that his delegation would like to share its 
observations on the first ten years of China's WTO me mbership within the TBT context.  He recalled 
that the TRM was created largely because China was admitted to the WTO before it had rendered all 
of its trade related laws and regulations WTO co mpatible;  China was able to accept certain WTO 
obligations because of the variet y of transition periods it was gi ven.  The annual TRM meetings, 
therefore, provided Members with opportunities to re view with China, in a multilateral setting, the 
efforts China was making so as to implement sp ecific commitments made in its Protocol of 
Accession.  In the area of TBT, the Protocol was straight forward in requiring the key commitment of transparency, followed by the other obligati ons that all WTO Members had to meet.    G/TBT/M/55  
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  314. His delegation agreed with many of the points raised by the EU both orally and in its 
submission.  He wished to focus on two areas in part icular:  the continued lack of transparency in the 
development of China's technical regulations, st andards and conformity assessment procedures, and 
China's policies on conformity assessment.  In the area of transparency, China had made progress but 
had not yet implemented all of the commitments that it had made upon accession.  Transparency was 
perhaps the most important TBT discipline in that  it enabled regulators to have better access to the 
information they needed to make evidence-based de terminations that would achieve the desired policy 
objective in the least trade restrictive way possible.   It increased the accountability of the regulator to 
the public, and enhanced the legitimacy of the final results and the rule of law. 
315. Early notice of impending proposals also enable d regulatory cooperation activities;  regulator-
to-regulator discussions could minimize unnecessary divergences between regulatory approaches and 
facilitate harmonization of techni cal regulations.  Serious concerns remained about China's 
compliance with the WTO transparen cy obligations even after ten years of WTO membership.  In 
several TRM discussions in different WTO Committees,  his delegation had described concerns about 
China's efforts to comply with th e cross-cutting commitments made in its Protocol that were designed 
to ensure that trade with China w ould be predictable and transparent. 
316. First, with regard to China's commitment to pu blish laws, regulations and other measures, his 
delegation noted that, while China complied with the commitment in many respects, it did not appear 
that China published measures that provided "interna l guidance".  Second, with regard to China's 
commitment to publish measures for comments before implementing them, his delegation noted that China had made improvements over the years, but still did not institutionalise a notice-and-comment 
mechanism for all Chinese agencies.  Third with rega rd to China's commitments to make available all 
laws and regulations and other measures pertaini ng to or affecting trade in one or more WTO 
language, it appeared that China had only made limited progress implementing this commitment.  
With respect to TBT, China had made considerab le progress towards fulfilling its WTO notifications 
obligations.  He acknowledged that  China had notified over 800 measures to the TBT Committee and 
the number of annual notifications continued to rise.  In particular, China's national "GB" standards, 
issued by the Standardisation Administration of China (SAC) under the jurisdiction of the General 
Administration of Quality Supervision, Inspection a nd Control (AQSIQ), had been consolidated into a 
centralised database and appeared to be regularly notified to the WTO. 
317. He considered it regrettable, though, that Ch ina had not put in place such a database for 
proposed technical regulations, standards, and c onformity assessment procedures issued by other 
Chinese government agencies. Perhaps not coincide ntally, China rarely notified such proposals, 
(including mandatory industrial standards) and conformity assessment procedures issued by Chinese 
government agencies other than AQSIQ and it sub-mi nistries such as SAC.  For example, the United 
States was able to identify 25 measures proposed by  the State Food and Drug Administration (SFDA) 
in 2010 that could have been but were not notifie d to the WTO.  The US also discovered five 
measures developed by the Ministry of Industry and Information Technology (MIIT) in 2009-2010, as 
well as numerous measures developed by China's As sociation of Automobile Manufactures that were 
not notified.  It appeared that China also fa iled to notify thousands of mandatory industrial 
professionals' standards to the WTO for comment. Su ch standards, which were frequently developed 
by Chinese agencies when GB standa rds did not exist, covered at least 58 industry sectors from oil 
and gas to textiles, automobiles and for environmen tal protection.  Through its research, the US had 
identified unofficial listings for 15 of these sector s which set out over 20,000 industrial standards of 
which over 20 per cent (approximately 4000) were mandatory.  For instance, the Ministry of 
Environmental Protection (MEP) developed 123 industrial standards from 2008 -2010 and none of 
them appeared to be notified to the WTO. 
318. Lack of WTO notification for mandatory indust rial standards was particularly problematic 
because in most cases they must be purchased through authorized resellers in China. The cost was G/TBT/M/55  
Page 70  
 
  nominal but such resellers generally did not accept in ternational credit cards and required the use of a 
Chinese bank account.  In practice, this requirement had made it impossible for even the largest US 
companies and trade associations to obtain copies of  the Standards if they did not maintain a presence 
in China.  His delegation strongly urged China to ta ke immediate steps to remedy this situation and 
allow persons located outside Chin a to purchase these documents wit hout requiring them to maintain 
a Chinese presence.   
319. In addition, the US had compiled a list of over 50 conformity assessment procedures 
developed by CNCA covering wires and cables, mo tors, electrical products, power tools, welding 
equipment, audio-visual equipment, information technology products, lighting fixtures, and motor-
vehicles and parts, telecommunications, toys and othe r products that were never notified to the WTO. 
The US had provided this non-exhaustive list of exampl es to China for its consideration.  This list did 
not include, for example, the MIIT requirement th at mobile handsets be dua l-enabled with China's 
WAPI wireless standard.  The US had raised th is measure in the Committee on numerous occasions 
without resolution. That particular measure had not been published nor notified to the WTO.  This list 
demonstrated what the US believed to be systema tic flaws in China's notification system.  Perhaps 
China's enquiry point lacked the necessary authority to  notify measures either in whole or in part that 
were developed in or by other Chinese agencies. There could be insufficient internal coordination 
between AQSIQ and the relevant agencies deve loping technical regulations and conformity 
assessment procedures that resulted in a lack of notifications of measures developed by certain 
agencies. Alternatively, non-transparent developm ent of technical regulations and conformity 
assessments procedures by specific Chinese agencies could mean that AQSIQ was unaware of these 
measures because the agencies did not publicize them until they had already been finalised.  Whatever 
the cause, the US urged China to  resolve the issue so that Ch ina notified proposed technical 
regulations and conformity assessment procedures to the WTO irrespective of the agency that 
developed them. 
320. He added that China's development of a centr alised database for GB standards had been 
extremely helpful for enhancing a number of WTO notifications for such measures. Perhaps that 
would be a useful model for China to follow for othe r agencies or, better still, on a global basis.  In 
the US, maintaining a daily official journal of most central government measures, as well a separate 
official journal for each US state, had greatly f acilitated regulatory transparency as well notifications 
to this Committee.  Since most measures needed to be published in draft form in these journals, US 
enquiry point officials could access them directly each day without having to search for them on 
separate agency websites, call agency  officials to ask them what th ey were working on, or request 
permission to notify them.  His delegation woul d be happy to provide assistance based on its 
experience.  If China opted instead for maintaining a number of journals on its website rather than 
having a centralised source, it must take steps to  ensure that proposed technical regulations and 
conformity assessment procedures were made available at an early, appropriate stage so that Chinese 
enquiry point officials could access them and notify th em to the WTO automatically.  To the extent 
that the enquiry point lacked authority to notify certain types of proposed measures developed by certain agencies, his delegation urged China to clar ify internally through appropriate means that it 
must notify these measures to comply with its WTO obligations and that AQSIQ had the authority to 
notify them. 
321. The second area of serious concern for the US wa s conformity assessments.  He cited Article 
6.4 of the TBT Agreement while noting that Chin a did not permit US suppliers to use competent 
conformity assessment bodies (CABs) (e.g. testing laboratories, product certifiers, and inspection 
bodies) located outside China's territory to demons trate that their products complied with China's 
compulsory certification (CCC) and other technical requirements. This policy was highly disruptive to 
supply chains and competitiveness in the interdepe ndent US and Chinese economies.  This was an 
issue that his delegation had raised as a specific trade concern in many Committee meetings, and  G/TBT/M/55  
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  would probably continue to raise in the future.  He  stressed that the issue was China's failure to 
recognise conformity assessment bodies in the ab sence of mutual recognition arrangements. 
322. China claimed that MRAs could be used to recognise CABs located in the US.  But his 
delegation did not see any willingness by China to actu ally negotiate such arrangements, which were 
often unnecessary in any case given that Article 6.3 of  the Agreement did not require MRAs for such 
recognition to be provided pursuant in Art. 6.4.  China had also previously noted that US regulators 
regularly recognised conformity assessments bodies located in China to perform tests and services, 
and MRAs were not even required.  While nego tiation of MRAs in certain contexts may be 
appropriate, his delegation's experien ce found that the insistence of an MRA in other contexts was a 
policy that had less to do with ensuring regulator  confidence and conformity assessment results, but 
more to do with protecting domestic suppliers of  conformity assessment services and the fees that 
they could charge. This increased costs, burden and delays for foreign producers and much of the 
resulting costs were passed on to Chinese consumer s. Government-to-government MRAs could also 
be infeasible in situations where one Member regulated and the other Member did not maintain a comparable scheme.  As noted in previous Committ ee meetings, the US believed, bearing in mind its 
obligations under Articles 5.4 and 9.1 of the TBT Agreement, that the best way for China to liberalize 
its approach to recognising conformity assessmen t bodies as competent was either to use accreditation 
by ILAC MRA or IAF MLA signatories or rele vant international standards, guides or 
recommendations as a basis for direct recognition of foreign CABs.  US product safety regulators had 
employed both methods where relevant, effective, and appropriate. As a result, many CABs from 
outside the US enjoyed such recognition, and the abi lity of US regulators to protect public health, the 
environment, consumer safety and other objectives had not been compromised.  The US urged China 
to take a similar approach.  He noted that earlie r in the meeting, China urged Korea to recognise 
conformity assessment procedures in China, showing that China recognised the importance of having 
its conformity assessment bodies recognized  by foreign regulatory schemes.  
323. The US also noted that China's national accreditation service for conformity assessment 
(CNAS) was a signatory to both ILAC MRA and th e IAF MLA and, had a responsibility under the 
rules of those systems to promote their use in China.  The complementary responsibility to WTO 
obligations in Article 9.1 of the Agreement was to  adopt wherever practicable international systems 
for conformity assessment in instances where pos itive assurances of conformity with technical 
regulations of standards was required.  The US would be interested in learning what programmes 
China and CNAS in particular had in place to promote the ILAC MRA, IAF MLA in China, and if 
China could report on any success that it had achieve d in persuading Chinese agencies to adopt such 
schemes as a basis for their conformity assessment procedures. 
324. Going forward, the US urged China to take step s to improve transparency in the development 
of technical regulations, standards, and confor mity assessment procedures.  This would include 
ensuring that proposed mandatory industrial sta ndards and proposals developed by agencies outside 
AQSIQ such as SFDA, MIIT, and MEP were notified to the WTO.  Improving internal coordination, 
centralizing publication and dissemination and ensuri ng that the enquiry point had the authority it 
needed to perform its functions was critical in this regard.  Secondly, the US urged China to revise its 
policy on recognition of foreign CABs in light of its WTO commitments and begin to allow non-Chinese CABs to be recognised to perform conf ormity assessments servic es within the Chinese 
market just as other WTO Members allow such bodi es located in China to perform such services for 
export.  This could best be done through relian ce on relevant international standards guides, 
recommendations and international systems for c onformity assessments.  His delegation proposed, 
with respect to CCC, that China en sure that no rules, regulations or other legal measures prevented 
non-Chinese organisations from being designated by  CNCA to conduct product testing, initial 
inspection, follow-up audits and certification fo r each CCC product category;  that China publish the 
process by which organizations could be designate d by CNCA to conduct product testing, initial 
inspection, follow-up audits and certification under the CCC system on the CNCA website;  and that G/TBT/M/55  
Page 72  
 
  non-Chinese organisations be allowed to conduct su ch conformity assessment activities for the CCC 
by using the same equivalent procedures and criteri a that CNCA applied for other designated Chinese 
organizations.  The US would cont inue to engage China both here at the WTO bilaterally until these 
outstanding issues were satisfactorily resolved. 
325. The representative of Mexico congratulated China for this ninth transitional review at the 
tenth anniversary of China's implementation of th e Agreement.  His delegation thanked the Chinese 
authorities for all the efforts made to notify the Members of both new and existing technical 
regulations, and the efforts towards conformity in  line with the commitments they had made. His 
delegation added that there were instances, howev er, where it did not seem that China was complying 
with its transparency commitments.  A number of companies had experienced related problems.  His 
delegation invited China to strengthen efforts to make its relevant legislation available in the official 
WTO languages, and to strengthen the notificati on activities as previous delegations had stated. 
326. The representative of China said that during the past decade, China had spared no efforts to 
fulfil most comprehensively and seriously its tremendous commitments made upon accession to the 
WTO.  China had eliminated all non-tariff measure s and reduced its average tariff on goods from 15.3 
per cent at its accession to 9.8 per cent today.  China had overhauled 2300 laws, regulations and 
departmental rules at the central level and 190,0 00 trade-related regulations, policies and measures at 
the local level.  The above-mentioned, hard-won achievements not only contributed to China's full 
compliance with WTO rules, including the rules stipul ated in the TBT Agreement, but also had a very 
positive effect on trade promotion and facilitation at the multilateral level. 
327. As a developing country, China had tried its best  to overcome great capacity constraints in 
order to fully honour the principle of transparency  of the multilateral trading system during the past 
decade. Up to now, China had notified 842 TBT measures, and responded to more than 3000 
enquiries on China's TBT measures mainly through the China WTO Notification and Enquiry Center, in particular, through China's WTO TBT Enquiry Point.  China had also dedicated huge human and financial resources to publish in a timely manner its TBT measures, including through the official 
website of the China TBT/SPS National Enquiry Point.  Furthermore, China had made its best 
endeavour to provide a sufficient comment period for new TBT measures, and to translate as many 
TBT measures as possible into at least one WTO working language in order to achieve greater 
transparency.  In the same open and cooperative spirit, China had submitted to this Committee in 
document G/TBT/W/343 the information requested by Annex 1A in China's Protocol of Accession. 
China was committed to conducting effective and co nstructive discussions with other Members both 
under this final TRM and in the regular Committee in the future.  
328. The Chinese delegation noted the questions recei ved from Japan under this agenda item prior 
to this meeting.  He also noted that the Chinese Mission received an informal email from the EU with 
a 5-page draft attachment of questions two days prior to the meeting, which left Beijing just two 
working days to translate and respond.  He apologized to the EU because his delegation was willing 
but unable to cover all of the EU's concerns at su ch short notice.  For the concerns expressed by the 
US delegate, he considered that some of the pr oblems could have resulted from misunderstanding and 
confusion and warranted further clarification fro m China and further dialogue between the two 
countries. 
329. Regarding standards in China,  the Chinese Government had taken a series of measures to 
ensure the fulfilment of its obligations under the TBT Agreement.  First, while formulating and 
revising technical standards, including industrial  and local standards, China implemented strict 
requirements for adopting international standards as s tipulated in the Administrative Measures for the 
Adoption of International Standards (AQSIQ's No. 10 Order in 2001).   Secondly, pursuant to the 
Standardization Law of China, China's industrial and local standards, once formulated, shall be 
reported to the competent governmental authority fo r the record.  Third, in 2009, in order to  G/TBT/M/55  
 Page 73 
 
 
  strengthen the administration over mandatory standa rds in accordance with the requirements of the 
TBT Agreement, China started overhauling its industrial standards a nd launched a national 
standardization programme. 
330. With respect to conformity assessment measures in China, there had been no change with the 
policies and guidelines governing the mutual reco gnition of the China Compulsory Certification 
system (the CCC system) since the last review. The mutual recognition of CCC was based on the 
mutual recognition agreements signed between th e Chinese Government and foreign governments.  
Based on the bilateral agreements, the designated ce rtification bodies could entrust foreign bodies to 
conduct follow-up checking.  Under the Memorandum signed between China and Japan in 2007, such 
a mutual recognition mechanism had be en put in place.  He also clar ified that China's membership in 
the IECEE/CB Scheme did not cover EMC product cate gory.  According to the rules of IECEE/CB 
Scheme, China did not recognize or accept IECEE EMC Test Results (and Certificates). 
331. As to questions on the restriction of hazardous substances (RoHS), China's Ministry of 
Industry and Information Technology had published on its official website the Catalogue for Products 
subject to Voluntary Certification under RoHS in Augu st 2011.   In the meantime, he confirmed that, 
as suggested by the EU, a "lighter" approach similar to the system of Supplier's Declaration of 
Conformity had been integrated into the Cer tification process under China's RoHS legislation 
regulation. 
332. Regarding internal regulatory coordination, Ch ina had made great progress in enhancing the 
clarity, transparency and predictability of its TBT re gulatory framework during the last ten years.  He 
mentioned medical devices, as an example.  In  2008, the AQSIQ and the SFDA of China jointly 
published the Announcement on the Market Access Related Questions regarding some of the 
Imported Medical Devices (No. 94, in 2008), which fully addressed the problem of duplicative conformity assessment practices by streamlining the re gulatory work to carry out one time inspection, 
one time on-site test of quality system of the pr oduct concerned, and one ti me collection of fees by 
only one of the competent agencies in charge.   Finally, regarding regulation for information 
security, since this question had been fully addr essed earlier under Specific Trade Concerns, he did 
not wish to repeat China's remarks.  He belie ved he had covered everyt hing and reassured Members 
that his Government was ready and w illing to continue its discussions in a ll appropriate fora in future.   
333. The Committee adopted its report of the Nint h Annual Transitional Review (G/TBT/30). 
IV. TECHNICAL COOPERATION ACTIVITIES 
334. The Chairperson drew the Committee's attention to a document containing the Secretariat's 
technical assistance activities (G/TBT/GEN/128). 
V. UPDATING BY OBSERVERS 
335. The representative of the IEC drew the Committ ee's attention to the IEC report to the TBT 
Committee. 23  She highlighted the participation of developing countries in the 75th General Meeting 
which had taken place in Melbourne in October 2011 . Other highlights included the participation of 
Affiliate Leader  Phuntsho Wa ngdi and the marking of the 10th anniversary of the IEC Affiliate 
Country Programme. The report also cover the IEC' s participation in an event organized by the 
African Electrotechnical Standardization Commission held in Nairobi in September 2011, where five 
AFSEC mirror committees of the IEC were launche d. On conformity assessment, she drew attention 
to the IECEE- UNIDO collaboration establishing an electrical laboratory in Bhutan. The IEC, she said, looked forward to continued close coopera tion with UNIDO through publishing joint manuals 
                                                      
23 G/TBT/GEN/126. G/TBT/M/55  
Page 74  
 
  and participating in common capacity building ev ents for developing countries. Finally, the 
representative announced the launch of the IE C-IEEE 2012 Challenge, whereby academics were 
invited to submit a paper on how electro-technolog y can impact economic, social and environmental 
development.  
336. The representative of the UNECE updated the Committee on the 21
st Annual Session of the 
Working Party on Regulatory Cooperation and St andardization. Three recommendations had been 
adopted during the session - two in the area of risk  management in regulatory system and one in 
market surveillance. One publication on "A  Glossary of Market Surveillance Terms"24 was launched, 
and another on "Risk Management in Regulatory Syst ems" was presented in draft form. Other events 
that took place during the session were the launch of a database containing international practice in 
market surveillance legislation25, and a workshop on traceability as a tool for management of risks.  
337. The representative of the ITU updated the Committee on recent developments in 
standardization. These included a new standard on future networks which would cater for multiple 
virtual networks and would also provide superior energy saving ca pabilities. Another new standard 
was for a protocol for secure transfer of biometric information for E-health. The third development 
the representative explained was an internationa l agreement on green ICT methodology which was 
approved in September 2011. This, he said, would help towards assessing the impact of ICTs on 
greenhouse gas emissions and energy consumption.  Also concerning ICT products, the representative 
informed the Committee that the ITU was studying th e benefits and the advantages of standardization 
of batteries for mobile terminals a nd other ICT devices.  This, he said,  would lead to a reduction of 
harmful materials used in batteries and an incr eased lifespan of ICT products. During 2011 the ITU 
had also established a Standards Question and Answer Forum26, and held three regional workshops on 
bridging standardization gaps. These t ook place in Fiji, Algeria and Moldova.27 
338. Concerning capacity building, the representative informed the Committee that a regional joint 
UNIDO/ITU seminar on conformance assessment a nd interoperability testing had taken place in 
Ghana in July 2011. A similar event was held in November in  Moscow for the CIS and Europe 
regions. The ITU was also in the process of setting up a conformance and interoperability portal - a 
unique access point worldwide to all aspects of conf ormity and interoperability from standards to 
testing to certification to recognition agreements. 
339. Finally, the representative gave details on a ma jor project on conformity and inter-operability. 
This project consisted of four main pillars:  se tting up a conformity database; organizing ITU inter-
operability events; organizing capac ity building on conformity assessmen t and testing in developing 
countries and lastly, the establishment of test facilities in developing countries. 
340. The representatives of the OIML, Codex, and the ITC28 provided updates to the Committee on 
their on-going activities in developing countries a nd other work relevant to the TBT Committee. 
VI. REPORT (2011) OF THE COMMITTEE ON TECHNICAL BARRIERS TO TRADE  
341. The Committee adopted its 2011 Report to the Co uncil for Trade in Goods (G/L/962/Rev.1). 
                                                      
24http://www.unece. org/tradewelcome/publications/wp6/2 011/glossary-of-ma rket-surveillance-
terms.html. 
25 http://apps.unece.org/wp6/ 
26 http://groups.itu.int/itu-t/StandardsQA/tabid/ 1750/afv/topicsview/a ff/323/Default.aspx  
27 http://www.itu.int/ITU-T/worksem/bsg/201110/  
28 G/TBT/GEN/124, G/TBT/ GEN/125, G/TBT/GEN/127.  G/TBT/M/55  
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  VII. DATE OF NEXT MEETING 
342. The next regular meeting of the Committee is scheduled for 20-22 March 2012. 
 
 
__________