WORLD TRADE  
ORGANIZATION  RESTRICTED 
G/TBT/M/57 
18 September 2012 
 (12-5032) 
Committee on Technical Barriers to Trade  
  
 
MINUTES OF THE MEETING OF 13-15 JUNE 2012 
 
Chairperson: Mr. Salim Lahjomri   
 
Note by the Secretariat1 
 
I.  ADOPTION OF THE AGENDA ............................................................................................. 1  
II.  ELECTION OF CHAIRPERSON .......................................................................................... 1  
III. IMPLEMENTATION AND ADMINISTRA TION OF THE AGREEMENT .................... 1  
A.  STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2 ................................................................ 1  
B.  SPECIFIC TRADE CONCERNS  ....................................................................................................... 2  
(a)  New Concerns .................................................................................................................. ........... 2 
(b)  Previously Raised Concerns .................................................................................................... . 18 
C.  EXCHANGE OF EXPERIENCES  .................................................................................................... 54  
1.  Good Regulatory Practice ......................................................................................................  54 
2.  Standards ..................................................................................................................... ............ 56  
3.  Conformity Assessment ......................................................................................................... . 61 
4.  Transparency .................................................................................................................. ........ 62 
D.  OTHER MATTERS  ...................................................................................................................... 69  
IV.  UPDATING BY OBSERVERS ............................................................................................. 70  
V.  DATE OF NEXT MEETING ................................................................................................ 70  
 
 
I. ADOPTION OF THE AGENDA  
1. The Committee adopted the agenda contained in WTO/AIR/3942. 
II. ELECTION OF CHAIRPERSON 
2. The Committee elected Mr. Salim Lahjomri (Morocco) as chairman. 
III. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
A. STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2    
3. The Chairman said that the list of statem ents submitted under Artic le 15.2 of the TBT 
Agreement was contained in document G/TBT/GEN/ 1/Rev.10, dated 22 February 2011.  He noted 
                                                      
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/57 
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  that, since the last meeting of the Committee, Ukraine (G/TBT/2/Add.100/Rev.2) and Malaysia 
(G/TBT/2/Add.9/Rev.31) had submitted revisions to th eir original statements.  In total, since 1995, 
126 Members had submitted at least one Statem ent on Implementation under Article 15.2.  He 
recalled that this information was available, and regularly updated, on the TBT Information 
Management System (hereafter "the TBT IMS"
2).   
B. SPECIFIC TRADE CONCERNS  
(a) New Concerns 
(i) European Union – Draft Implementing Regula tions amending Regulation (EC) No. 607/2009 
laying down detailed rules for the application of Council Regulation (EC) No 479/2008 as 
regards protected designations of origin and geographical indications, traditional terms, 
labelling and presentation of certain wi ne sector products (G/TBT/N/EU/44) 
3. The representative of South Africa had previ ously expressed his delegation's concerns 
regarding the allergen labelling regulations for wine, including by joining the World Wine Trade 
Group.  As Europe was a very important market, South African producers should be informed of the detailed labelling requirements within a reasonable tim eframe to ensure compliance.  Unfortunately, 
no clarity had yet been provided on the language to be used in each EU memb er with regard to the 
allergens concerned, nor was it clear whether pi ctograms were sufficient when accompanied by a 
statement in one language, or whether the pictogram s hould be in black and white or grey scale.  The 
30 June 2012 deadline was problematic for South African producers because the 2012 wine harvest 
had already been completed in the southern he misphere and labelling had already commenced.  
Furthermore, consignments of wi ne could take over a month to ship from South Africa to Europe.  
Without guidance and clarity on the labelling for i ndividual EU member states, it would be difficult 
for exporters to comply with the current deadline.  Once the regulation was clarified, exporters would 
still require between three and six months to source compliant labels .  The fact that the measure 
would be implemented just three days after publicatio n in the Official Journal of the European Union 
was likely to cause significant trade disruption, and all label stock not affixe d by 30 June 2012 would 
have to be destroyed, causing significant financial losses.   Article 2.12 of the Agreement required a 
"reasonable interval" between the publication of tec hnical regulations and their entry into force.  
Furthermore, Ministers decided at the Fourth Ministerial Conference in Doha, that the phrase "reasonable interval" shall be understood to mean nor mally a period not less than 6 months, a decision 
also adopted by the TBT Committee.   
4. He recalled the "special and differential treat ment" provisions in Article 12.3 of the TBT 
Agreement.  South Africa, therefore, requested th e postponement of the implementation date for the 
labelling regulation of at least six months to allow a reasonable chance of compliance by South African exporters. 
5. The representative of New Zealand stated that th e EU had the responsibility to ensure that its 
rules were applied transparently thus allowing for commercial certainty.  Since a prior exemption was 
extended in late 2009, it was known that wines labe lled after 30 June 2012 would be required to bear 
compulsory allergen labels.  Despite multiple a ttempts by both government and industry, no 
information on how these regulations would be impl emented had been obtained until the notification 
to the TBT Committee on 25 June 2012 - only five  weeks prior to implementation.  This was 
significantly less time than the minimum period of six months recommended by the Committee under Article 2.12.  Only now was New Zealand aware that limits of detection were specified.  However, the 
required ELISA testing kits to analyse wines for detectable limits of Casein and Ovalbumin were not 
commercially available in New Zealand and could not be ordered and deliv ered before 30 June. 
                                                      
2 http://tbtims.wto.org .  G/TBT/M/57 
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  Furthermore, the components of these tests have biosec urity implications.  This meant that even wines 
with safe levels would nevertheless have to be labelled as allergenic. 
6. The implementation date of 1 July fell during the normal bottling season for New Zealand and 
other Southern Hemisphere producers.  It would ta ke weeks to redesign labels, which were generally 
ordered 3 months prior to bottling.  Some bottles co uld be labelled before 30 June, but consumers in 
the EU might find it confusing that the same wine could appear on shelves with or without the 
warning labels depending on when they were bo ttled.  The EU's failure to provide adequate 
information in good time would cause significant comme rcial injury to New Zealand's wine industry 
and to other Southern Hemisphere producers who were operating in the EU market in good faith.  
This injury would happen because: (i)  the consid erable expense of having to re-label bottles to 
comply with the new guidelines with only five week s' notice; (ii)  Southern Hemisphere products 
would be the first  on the market with these allergen  labels and would bear the brunt of any adverse 
consumer reaction; (iii)  the relevant ELISA tests were not yet available in the Southern Hemisphere, 
which meant that producers in that part of the wo rld would not be able to demonstrate that their 
products did not contain detectable allergens (where as the tests would likely be widely available for 
EU producers when they  release their 2012 vintag e wines,  creating a source of considerable 
prejudice to Southern Hemisphere producers since th ey would have to label products that their EU 
counterparts would not); and (iv) the EU producer s would still be entitled to an exemption for 
unlabelled products that were "in the market" afte r 30 June 2012, an exemption that effectively 
covered all "stock on hand" (whether or not it was bo ttled or labelled).  Like the tests, the application 
of this exemption would be highly prejudicial si nce Southern Hemisphere producers would not be 
able to take advantage of it except in the very  limited case where bulk wine had landed in the EU 
before 30 June.  Given shipping time, no Southern  Hemisphere producer would be able to take 
advantage of this exemption by shipping bulk wi ne after notice of the new regulation had been 
provided because these products would arrive too late in the EU market. 
7. Thus, the only way to avoid significant prejudice to  non-EU producers would be to exempt all 
wine produced before 30 June 2012 un til stocks were exhausted.  Th is would be no more than an 
application to third country producers of the "stock  on hand" exception that already applied within the 
EU market, in line with the national treatment obl igations.  This prejudice was levelled at New 
Zealand producers despite repeated attempts to co mply in good faith with the regulations.  New 
Zealand urged the EU to push back the implementation date of this regulation to a reasonable interval 
of not less than six months. 
8. The representative of Australia  noted that in 2011 Australia  exported over 363 million litres 
of wine to the EU and had a significant commercial inte rest in this market, so it was vital trade not be 
disrupted.  Australia was therefore interested in the European Commission's proposed labelling 
requirements for allergens in wine.  Australia acknowledged the importance of providing accurate 
information to consumers regarding allergens in wi ne as Article 2 of the TBT Agreement provided for 
measures to help protect human health.  However, Australia was also concerned with the lack of 
transparency surrounding the EU's approach to th ese new requirements for various reasons: (i) the 
30 day comment period was half of what WTO Member s normally provide;  (ii) the proposed date of 
adoption - June 2012 – allowed wine producers in th ird countries almost no time to amend their labels 
before the regulation took effect; (iii) such an a pproach was inconsistent with the decision of the 
TBT Committee in 2002 that Members should normally provide a period of not less than 6 months 
before bringing a technical regulation into force so as to allow time for producers to adapt their 
products or methods of production to the requireme nts; (iii) Article 2.9.2 of the TBT Agreement 
required that notifications take place at an early appropriate stage, when amendments could still be 
introduced and comments taken into account. 
9. Australia was particularly concerned with th e impact this regulation would have on wine 
producers in the Southern Hemisphere, where th e entire 2012 southern hemisphere harvest was G/TBT/M/57 
Page 4  
 
  already completed and labels were already prepared  for wines that were made and not yet bottled.  
The uncertainty of these labelling requirements under the EU measure was likel y to cause a disruption 
to trade for wines from this region.  Australia asked  whether the information the EU was seeking must 
be provided in multiple languages, or whether the indicated pictograms were sufficient when 
accompanied by a statement in one language.  Australia  also noted the uncertainty of the labelling or 
certification requirements for non-vintage wines under the proposed EU regulation and asked for 
clarification. 
10. Australia recalled it had already sought from th e EU information and clarification on the 
requirements in the proposed regulation on numerous occasions, both individually and as a member of the World Wine Trade Group.  However, to date no su ch clarifications had been received, so Australia 
urged the EU to provide them as soon as possible.  Given the significant impact that this regulation 
would have on wine producers in third countries, c oupled with the late notification of the content of 
the regulation, Australia requested that the EU delay its implementation by between three to six 
months. 
11. The representative of Canada associated his dele gation with the previous concerns and asked 
the EU for more clarification as to how precisel y the labels would be presented and the languages 
applied under the measure:  would a producer just use one language or it could use one language 
together with the pictogram. 
12. The representative of Argentina stated that, as a member of the World Wine Trade Group, 
Argentina had asked the European Commission, on diffe rent occasions and with  due anticipation, for 
clarifications on the implementation of the measure.  These questions concerned the form, 
written style and idiom to be included in the bottle 's pictograms and about whether wine bottled prior 
to the entry into force of the measure would be exempt from such requirements.  He explained that such clarifications were necessary so that the Argen tine wine industry would be able to adapt to these 
requirements with sufficient time.  This was part icularly important given the timing of the 2012 
Southern Hemisphere grape harvest and this new EU label had to be ready at least one month before 
the date of entry into force of measure.  However, the lack of response on the part of the EU to these 
clarifications, he said, resulted in a situation under which the regulation to be applied as of 
1 July 2012 would constitute an unnecessary barrier to  imports of Argentinean wine into the European 
market, in violation of Articles 2.9.2, 2.9.3, 2.12 and 11 of the TBT Agreement. 
13. Argentina therefore asked the EU to postpone th e entry into force of the measure establishing 
labelling information requirements for allergens in wines until the European Commission clarified the 
above-indicated clarifications.  Taking into account  that Southern Hemisphere grapes had already 
been harvested this year, Argentin a also asked that wine produced (either totally or partially) with 
those grapes, be exempt from the measure's new labe l requirements so as not to disrupt wine exports 
to Europe. 
14. The representative from the United States said that the draft implementing regulation would 
require statements with respect to allergens to app ear on the label for wine in which sulphites milk or 
milk-based products, and egg or egg- based products were used in the making of the beverage.  The 
measure also allowed the statement to be compleme nted by a pictogram.  She asked the EU in what 
language must the allergens statement be made: could it be done in English on all labels?  Was there a 
minimum size for the pictograms? 
15. The representative of the European Union noted that the obligation to label allergens, when 
the ingredients used during producti on were still present in the final product, was not new:  it existed 
since 2007.  Howeve r, in order to allow producers sufficient time to adapt, a transition period 
to comply with the new labelling requirements wa s provided until 31 May 20 09.  This transitional 
period was extended for wines twice (most recently , in December 2010) and an additional extension  G/TBT/M/57 
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  was provided by Commission Regul ation 1266/2010 for products placed  on the market or labelled 
before 1st July 2012, until stocks were exhausted.  She explained that one of the objectives of 
this latest exemption was to allow the European  Commission and the European Food Safety Authority 
to examine the requests received from the wine indus try for exemptions of certain milk and egg-based 
ingredients from labelling rules.  The European Food  Safety Authority, in its opinions of October 
2011, found that wines containing these ingredient s could trigger adverse effects in persons who 
suffer from an allergy to those ingredients.  As a result of these findings, th e Commission rejected the 
requests for exemptions.  Furthermore, no additiona l transitional period (beyond 30 June 2012) was 
foreseen. 
16. She also explained that the draft implemen ting Regulation, which was notified as document 
G/TBT/N/EU/44, intended to clarify the applicable rules with regard the labelling of allergens in 
wine, in particular by providing: (i) the terms c oncerning sulphites, milk a nd milk-based products and 
eggs and egg-based products, which sh all be used, and; (ii) the pictograms that producers could use if 
one or more of the allergens were still present in th e product sold to the consumers.  The measure also 
clarified which products were covered by these requi rements.  In particular, the draft Regulation 
indicated that only wines produced with grapes harv ested as from 2012 and labe lled after 30 June 2012 
were concerned by the compulsory labelling of milk and egg allergens.  The reason for this short period of time for comments on this notification was because such requirements were not new.  Further, the 
adoption of the Regulation until 30 June 2012, the da te when the exemption from labelling was set to 
expire, was important in order to avoid trade disr uptions for those wines which were not covered by 
this labelling requirement.   
17. She informed the Committee that the European Commission had had numerous bilateral 
exchanges with countries  concerned over the past few mont hs, including with Australia and New 
Zealand, and had taken their concer ns into account when developing the draft Regulation – most notably 
by clarifying that wines from grapes harvested before  or in 2012, which were la belled or placed on the 
EU market before 1 July 2012, would not be concer ned by these requirements.  Finally, the EU invited 
all interested delegations to submit comments to the TBT notification until the deadline of 
24 June 2012. 
(ii) Spain – Ministerial Order of the Government of Spain IET/822/2012, published on 
21 April 2012 and in force as of 22 April 2012 
18. The representative of Argentin a expressed concern with the prohibitive and distorting trade 
impacts of the Spanish measure, which de facto  prohibited imports of biodiesel produced outside the 
EU by allowing the use of biodiesel produced exclusivel y in plants situated in Spain or in any other 
member State of the EU. This prohi bition was established by the Spanish 
measure (Ministerial Order IET/822/2012) by regulating the allocation of biodiesel production volumes in order to comply with the mandatory bi ofuel consumption objectives of the EU. For this 
purpose, the Order established a certification procedure to certify that the biodiesel was totally 
produced in plants located within EU territory. This measure affected  Argentina in particular because 
Argentina was Spain's principal supplier of biodiesel .  It was remarkable that the measure was only 
applied to biodiesel and not to other biofuels, esp ecially given that Directive EC/2009/28 (which dealt 
with the promotion of renewables and was the basi s of the Spanish measure) covered various sources 
of renewable energy, such as biogas and bio-etha nol.  Since Argentina was the Spanish market's 
principal biodiesel supplier, it is clear that the m easure's main objective was to keep Argentina out of 
that market.  This was therefore a measure that  unjustifiably discriminated between biodiesel from 
EU/Spain and from any other origin, in violation of  the most basic principles of the multilateral trade 
system - National Treatment and MFN - which were en shrined in Article 2.1 of the TBT Agreement.  
Additionally, the measure also violated Article 2.2 of the Agreement by creating an unnecessary obstacle to the international trade in biofuels. G/TBT/M/57 
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  19. He recalled that while EU Directive EC/2009/ 28 established certain biofuel sustainability 
criteria, it did not restrict, much less ban, market  access to suppliers of such fuels.  Nor did such 
Directive require that the supply of biofuels be  only made by EU producers.  Thus, the Spanish 
measure was in contradiction with the EU rules.   He also noted that Argentina followed the 
conception and evolution of this European Directiv e and gave the EU sufficient scientific evidence 
showing that Argentina's biodiesel clearly complied w ith the sustainability criteria included therein.  
Therefore, Argentinean biodiesel and biodiesel pro duced in Spain and in other EU members were 
"like product". 
20. He also expressed concern with the fact that Sp ain did not notify this measure given that it 
would have a significant impact on international tr ade. Thus Spain violated Article 2.9 of the 
TBT Agreement. As a result of the lack of notifi cation, Spain did not grant other Members time to 
make comments or begin discussions with its authoriti es.  Further, given that the main suppliers of 
biodiesel to Spain were developing countries, Spain did not comply with the special and differential 
treatment provisions of Article 12 of the TBT Agreem ent, especially Article 12.3.  In this respect, 
Argentina noted that the measure would have the e ffect of stopping developing countries' exports 
from ascending the value chain.  I ndeed, the measure would limit these countries to the role of mere 
raw material providers, thus imposing seri ous obstacles for their industrialization. 
21. He concluded by stating that the measure was a technical barrier to trade the sole objective of 
which was to protect Spanish producers while unj ustifiably discriminating against non-EU biofuel 
producers.  Argentina noted that this measure was adopted, without any scientific justification, based 
on a supposedly environmental objec tive.  However, given that the measure evidently did not pursue 
any such objective, but rather to harm argentine biodiesel exports, Argentina expressed concern with a 
growing tendency of Members enacting protecti onist measures with the pretence of having 
environmental objectives.  Argentina asked Spain to take immediate step s to respond to these 
concerns so as to comply with its WTO obligations  and requested the EU to ensure that its member 
States complied with WTO obligations. 
22. The representative of the European  Union stated that the Spanish Ministerial Order related to 
the allocation of production volumes for calcula ting compliance with the objectives set by the 
Renewable Energy Directive. These allocation procedures fell outside the scope of the TBT Agreement and therefore this Committee was not an appropriate forum for either discussing this 
issue or providing a reply to Argentina's questions. 
(iii) United States – Standards of Identity for Pisco and Cognac (G/TBT/N/USA/697) 
23. The representative of Chile expressed concer n with the proposed amendments to the 
regulation as it would treat Pisco as a type of bran dy, a re-classification which was not in accordance 
with the existing internationa l definition of Pisco.  While brandy and Pisco were both 
alcoholic beverages, they were fundamentally differe nt wine products with respect to their respective 
production process.  The US standards required that br andy be bottled with at least 40 per cent alcohol 
by volume.  Pisco would then have to meet such condition in order to have that specific label.  
However, the measure disregarded the fact the Pi sco could contain from 32 to 40 per cent alcohol by 
volume.  Chile asked the US to consider in their final version of this measure these comments as well 
as those made during the public consultation. 
24. The representative of Peru stated that on 29 May 2012 his delegation submitted some 
comments to the US Alcohol  and Tobacco Tax and Trade Bureau  (TTB) with respect to the this 
proposed measure, which included Pisco as a type of brandy that had to be produced in accordance 
with the laws and regulations of its country of or igin.  In its previous comments to the TTB Peru 
referred to Article 5.22 of the Federal Code (p aragraph K3), which indicated that the existing 
regulation already prohibited the importation and commercialization of products named Pisco unless  G/TBT/M/57 
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  they came from the place of origin of Pisco.  With  respect to the proposed amendment, Peru sought 
confirmation to its understanding that the labelli ng approval certificate (under sections 27CFR.5.51 
and 5.55 of the Federal Regulati on) would be applicable to both imported and domestically 
commercialized products, in conform ity with the TBT Article 2.1. 
25. With respect to the origin of the name of "Pisco", Peru noted that it already sent this 
information to the TTB with the objective of explai ning the pre-Hispanic meaning of this term in 
Quechua.  "Pisco" was a term used by the Incas to identify a valley, a community and the pottery used 
to storage distilled spirits. Information was also given about the use of the term "Pisco" by the 
Spanish as from mid XVI century to designate th e river, people and port in the above-mentioned 
valley.  Further information was also given to th e TTB about the peculiar making process of Peruvian 
Pisco, which included the following  steps: harvest, marinating, pr essing, fermentation, distillation 
and, finally, the cleaning of the final product.  Pe ru also provided information showing that, according 
to Peruvian regulations, there were only eight typ es of grapes that could be used to make Pisco:  
Quebranta , Negra Criolla , Mollar , Uvina , Italia , Moscatel , Albilla  and Torontel .  As a result of all 
this process, Peruvian Pisco had an average alc oholic volume of more than 40 per cent, which was 
consistent with the limit included in the proposed US  standard.  Given the ingredients, the particular 
production method and the unique characteristics of  the final product, Peru suggested the US 
proposed standard be amended so as to make a distinction between Pisco from Peru and other 
brandies made from grapes or wine.  
26. The representative of the United States clarified that the proposed rule was intended to state 
that Pisco could only come from Peru or Chile.  The US explained why including Pisco as a type 
within the class of brandy was the most appropriate  approach.  First, the class for brandy covered 
alcoholic distillates from the fermented juice, mash, or  wine of fruit: Pisco was indeed a distillate of 
grapes.  Therefore, it would not be appropriate to  create a new class from a distilled spirit that was 
derived from an agricultural commodity that was al ready covered by an existing class designation.  
Second, the US regulation had recognized Pisco as a brandy since 1933, as evidenced by its listing in 
27 CFR 5.22(k)(3) as "Pisco brandy".  Third, this a llowed the US to specifically state that Pisco must 
be produced in accordance with the laws and regulati ons of Peru or Chile, the countries of origin.  
This addition of a new type of designation for Pi sco within an already existing class (Brandy) was 
also consistent with the recognition in US regul ations of other distinc tive products of foreign 
countries (e.g., cognac, Scotch whisky, and Irish whisky ).  Finally, this addition would clarify that the 
product may be labelled simply as "Pisco" rather than as "Pisco brandy". 
27. She also noted that the Peruvian and Chilean standards for Pisco production allowed Pisco to 
be bottled at as little as 38 per cent alcohol by volume and 30 per cent alcohol by volume, respectively.  However, to be consistent with th e US standards of identity for distilled spirits, which 
required that any neutral spirits (including vodka, whisky, gin, bran dy, rum and tequila) be bottled at 
not less than 80° proof (or 40 per cent alcohol by vol ume), Pisco bottled below that limit could not be 
labelled with that type designation.  On the other ha nd, the US allowed, and would continue to allow, 
products bottled at less than 80° proof to be labelled with a truthful and adequate statement of 
composition or as "diluted".  The US believed it was a ppropriate to apply this 80° proof standard for 
brandy to products of foreign countries so that th e same standard applied to domestic and foreign 
producers. 
(iv) Korea – A Draft of Regulation for Measurem ent of Energy Efficien cy of Tyres for Motor 
Vehicles, and Its Rating and Identification (G/TBT/N/KOR/319, G/TBT/N/KOR/319/Add.1) 
28. The representative of Japan stat ed the Korean measure provided two methods of conformity 
assessment:  by an authorized testing body or by self-measurement.  Japanese tyre manufacturers 
selected the latter approach.  However, in eith er case an appropriate period was necessary, in 
accordance to Article 5.9 of the TBT Agreement, be tween the publication and entry into force of the G/TBT/M/57 
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  measure, which was 1 December 2012 for passenge r car tyres.  Self-measurement required 
certification for the drum alignment of test fac ilities in addition to the procedure by the accredited 
testing body.  However, according to Japanese tyre  manufacturers, this procedure required several 
months and it was therefore not possible to deal wi th this issue by 1 December 2012.  Japan thus 
requested Korea to postpone the entry into force of  the measure for passenger car tyres by one year, 
i.e. until 1 December 2013, and to set a sufficient period to smoothly proceed with the procedures for 
foreign tyre manufacturers including Japanese tyre manufacturers.  
29. He also said that, according to Article 5.2.3 of  the TBT Agreement, the information required 
for conformity assessment procedure was limited to information necessary to assess the conformity and to determine the fees.  However, accordi ng to Japanese tyre manufacturers, the documents 
required by the Korean Ministry of Knowle dge Economy included conf idential and personal 
information not related to the safety of the prod ucts.  These Japanese manufacturers had indicated to 
the Korean Government that they would provide these data upon the event of a factory audit by the 
Ministry of Knowledge Economy.  In response, the Korean authorities stated that an audit could not 
be conducted unless these documents were submitted, making it therefore impossible to schedule the 
audit.  Consequently, Japan requested Korea to  explain why under the measures confidential and 
personal information was necessary for conformity  assessment.  Japan also requested that an 
appropriate guideline for providing information be prepared.  
30. Finally, he stated that the reason why Kor ean tyre manufacturers had almost concluded  
dealing with the system was because they were able to conduct tests at the accredited testing bodies.  
If this system would be enforced in its current fo rmat, it would possibly constitute a technical barrier 
given the discrimination between domestic and fore ign tyre manufacturers.  Taking the above into 
consideration, the Japanese Government requested th e Korean Government to take rational measures. 
31. The representative of the European Union shar ed Japan's concerns and asked Korea for an 
update on the implementation timeline of the measur e as well as to clarify whether testing values 
would be made public on the website of the relevant Korean authority. 
32. The representative of Korea responded that Korea recognized two kinds of testing bodies:  
"Authorized Testing Bodies" (mentioned in Article 6) and "Independent Testing Bodies" (mentioned 
in Article 8).  As set forth in Article 7, tyre manufacturers, which had their own experts and testing 
facilities, could apply for approval as Independent Testing Bodies.  The Korean government's role 
would then include the reviewing of applications , performing of an on-site inspection, and the 
approval of qualified applicants.   
33. Regarding the request to extend the implemen tation date and matchi ng the implementation 
date with UNECE regulation, Korea explained th at the measure was notified on 12 August 2011 and 
was announced on 14 November 2011 and that it would enter into force in December 2012.  Korea therefore believed it granted sufficient time and th at there was no need to extend the implementation 
date. 
34. With regard to the concerns with the submis sion of confidential and personal information, 
Korea clarified that the Ministry of Knowle dge Economy only required mi nimum information on 
facilities, manpower status and working procedures in  order to review the competence of the testing 
bodies and the reliability of test results.  
35. Finally, with respect to the EU's questi on on the publication of testing values, Korea 
responded that, pursuant to the Energy Efficiency Law, it was planning to publish its grade and testing 
values on KEMCO's website.  This practice was applie d not only to tyres but also other products such 
as refrigerators and motor vehicles.  This was becau se Korea believed that customers had a right to 
information on what they buy.  There was therefor e no reason to exempt tyres from this practice.  G/TBT/M/57 
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  (v) Viet Nam – Regulations relating to liquor production and trading 
36. The representative of Australia expressed her de legation's concern that, if implemented, the 
revised Decree 40 on liquor production and trading c ould negatively affect exports of Australian wine 
to Viet Nam, particularly for small and medium  sized producers. Australia understood the revised 
Decree 40 included a requirement for "import stamps" to be affixed to all packages of alcoholic 
products at the point of production overseas, before  exportation to Viet Nam.  Under the proposed 
new arrangements, a limited number of importers of  alcoholic beverages w ould be given, and be 
responsible for, a registered quantity of import stamps for their import business.  Importers and 
exporters would then need to ensure that the stam ps were affixed to packaging units of alcoholic 
products intended for Viet Nam.  While the decree  had been under development for some time, and 
was now in its 14th draft, it was still not notified to the WTO.   Australia recalled that the notification 
of proposed measures at an early appropriate stage, together with an indication of their objective and 
rationale, was essential so as to allow comments to be taken into account and amendments to be 
introduced, before the proposed measures entered into  force.  Australia therefore urged Vietnam to 
notify Decree 40 to the WTO so that concerns coul d be taken into account when finalizing the final 
version of the measure.  In making this notifica tion, Australia asked Viet Nam to clarify what 
objective Decree 40 was intended to achieve and how the proposed measures would fulfil such objective.  Australia also asked what alternative measures Viet Nam had considered to achieve its 
objective.   
37. Australia also asked Viet Nam to provide an o fficial translation of the proposed Decree 40 in 
order to allow WTO Members to become acquainted w ith this technical regulation.  On the substance 
of Decree 40, Australia asked how the proposed liquor product trading licenses would work and why 
Viet Nam considered it necessary to limit the num ber of available licenses for liquor trading.  
Australia also asked clarification on how the "import stamps" system would operate and whether the import stamp system would differ from the stamps for domestically  produced products.  Australia 
appreciated Viet Nam’s willingness to discuss the issues bilaterally. 
38. The representative of the European Union shared Australia's concerns with regard to the draft 
Decree, in particular its Article 15, which required the affixing of fiscal stamps in the country of 
exportation, or at the production site, starting on 1 Ju ly 2013.  This new requirement of affixing such 
stamps in the country of origin would entail significant costs and logistical difficulties for EU producers.  What were the reasons that prompted this proposed change of the current system, which 
allowed for the affixing of fiscal stamps at the poi nt of import, particularly in bonded warehouses?  
Did Viet Nam consider that the current system po sed any risks?  If so, which were these risks? 
Furthermore, would Viet Nam allow under the propo sed new rules affixing the fiscal stamps at any 
time before importation, including in hub ports?  Could Viet Nam provide an update on the state of play of this revision (which was already modified numerous times), and a timeline for its adoption? 
39. The representative of New Zealand urged Viet Nam to notify its proposed Decree to the 
TBT Committee as soon as possible so as to allow sufficient time for comments and consultations.  
New Zealand was particularly concerned about a dr aft Decree proposal to require foreign alcoholic 
beverage producers to affix import stamps to bottl es at the point of production.  This would place 
significant compliance burdens on foreign exporters given the time and effort needed to obtain and 
affix labels, especially when the final destination of  product may not be clear at point of production.  
New Zealand urged Viet Nam to assess this proposed requirement against Article 2.2 of the 
TBT Agreement, which stipulated that technical regul ations should not be more trade restrictive than 
necessary (given the alternative a pproach of affixing stamps in Viet Nam).  New Zealand also 
requested Viet Nam to provide mo re information about its proposed  approach to the labelling of 
alcoholic beverages for sale in Viet Nam so as to  enable a full assessment against TBT principles. G/TBT/M/57 
Page 10  
 
  40. The representative of the United States associat e herself with the interventions of previous 
delegations in urging Viet Nam to notify the revision  to Decree 40.  The US al so asked for a delay in 
the implementation of the measure until after the notification was made, the comment period passed 
and those comments were taken into account in the measure.  The US also shared the view on the 
need to apply stamps in bonded warehouses, rather than  at the country of origin of the product.  The 
US also asked for more information on the measure and its application. 
41. The representative of South Africa shared the sa me concerns voiced by previous delegations.  
He stated that the proposed measure would require import stamps be given in a pre-established 
quantity to importers. The importers should then ensure  that theses stamps be affixed to all packaging 
of alcoholic products at a point where they were pr oduced before being exported to Viet Nam.  South 
Africa urged Viet Nam to notify this draft techni cal regulation as soon as possible so as to allow 
Members to comment on it before its final adoption.  South Africa also requested Viet Nam to give 
Members an update on the status of this draft regulation. 
42. The representatives of Canada and Chile shared  the same concerns and questions expressed 
by the EU.  Canada asked whether alternative ways for affixing stamps, other than in the country of 
production, were available.  Chile asked Viet Nam to notify the regulation so as to allow Members to 
comment on it, and requested an update of the status of this regulation be provided.  
43. The representative of Viet Nam said that all statements and concerns raised by Members 
would be forwarded to capital so an appropriate response could be prepared.  He also asked these 
Members to provide it with more details on their c oncerns in written form.  He informed that the 
revision of the Decree was undergoing a drafti ng process and Viet Nam was in the process of 
notifying it to the TBT Committee. 
(vi) Indonesia – Draft modification to the technical regulation HK.00.05.52.4040 on food 
categories, published on 9 October 2006  
44. The representative of Mexico expressed concern w ith the draft modification of the Indonesian 
technical regulation HK 00.05.52.4040 on alcoholic drinks, published on 9 October 2006.  Mexico 
shared Indonesia's objective of protecting human health  and lives.  However, also concerned with the 
compatibility of this measure with the provisions  of the TBT Agreement, on 22 May 2012 Mexico 
sent the following comment to Indonesia:  that the measure might be more restrictive than necessary 
in order to comply with the stated legitimate obj ective because the proposed definition for Tequila did 
not have the necessary elements that guaranteed the resp ect of that designation of origin's integrity.  In 
particular, the measure did not minimize possible risks of fraud to the consumer and actions of unfair 
competition with respect to Tequila, which shoul d had also been recognized in Indonesia as 
designation of origin and as a distinctive product from Mexico.  Likewise, Mexico pointed out that this regulation might violate Articles 2.2 and 2.9 of  the TBT Agreement and that it might also have a 
negative impact on the productive sector.  According to Mexico, Indonesia did not comply with the 
obligations under Article 2.9 because the measure was not notified to the TBT Committee.  Mexico 
asked Indonesia for information with regard to the stat us of this draft modification and to inform if it 
would provide a formal reply to Mexico to the comments presented on 22 May 2012. 
45. The representative of South Africa also noted that  these draft regulations were not notified to 
the Committee and requested Indonesia for further information on it. 
46. The representative of Indonesia first asked the title  of the STC to be corrected to be on the 
"food category".  He informed that this draft re gulation was currently under a revision process and 
would be duly notified to the WTO.  With respect to the Tequila definition, he explained that 
Indonesia took positive consideration with respect to  the proposed definition by Mexico.  Indonesia 
also recognised the context of the definition part of  the disciplines of the TR IPS Agreement as well as  G/TBT/M/57 
 Page 11 
 
 
  the WIPO IP Conventions.  Indonesia noted the commen ts and was ready to engage in further bilateral 
consultations. 
(vii) European Union – Amended limit values for soluble cadmium in toys (Directive 2012/7/EU) 
47. The representative of China noted that the EU revised the content on toy safety of Part III, 
Annex II of Directive 2009/48/EC so as to modify the limit values for cadmium in toys.  China 
recognized the efforts made by the UN, the WHO a nd other organizations in formulating regulations 
on tolerable cadmium intake for children, and appreci ated the efforts of the EU to protect children 
from cadmium damage.  However, China hoped that before implement this regulation the EU could 
consider the relationship between the "cadmium preci pitation" and "cadmium content" of toys as well 
as the relationship between the daily intake and the source of cadmium.  China conducted periodical 
research on toy safety and could cooperate with th e EU on this issue, including by providing more 
scientific and rational assessment methods.  China also  believed that the expressions "dry", "brittle", 
"power-like" or "pliable and scrapped off" for to ys caused difficulties for the implementation of the 
measure.  China hoped the above expressions could be quantified via peeling strength and impact 
resistance in order to facilitate the enforcemen t of the production and inspection.  While China 
appreciated the details on the measure explained by  the EU during the bilateral meeting, China still 
needed written replies to the questions raised  so they could be sent to its industries. 
48. The representative of the European Union asked  whether China's use of the term cadmium 
"precipitation" was, in fact, a reference to "migra tion".  The EU then recalled that it had been the 
European legislator's choice to establish limit values  for chemical substances expressed in terms of 
"migration".  The use of "migration" instead of "content" was meant to focus on children's real 
exposure to the substance.  "Content" referred to situ ations when "a substance [was] present in a toy".  
However, there were instances in which the substance would not "migrate", for instance if the relevant 
toy parts were not accessible to children when the toy was used as intended or in a foreseeable way 
(taking into account children's behaviour).  In su ch cases, children would not be exposed and, 
consequently, it would not be necessary to establish limits.  Migration limits for cadmium, as well as 
for other 18 elements, had been established in th e new toy safety Directive 2009/48/EC, based on the 
best scientific evidence available at  the time.  This evidence originat ed from a study carried out by the 
Dutch National Institute for Public Health and the Environment (RIVM), details of which were 
provided in the preamble to Directive 2012/7/EC, at i ssue in this meeting.  The Toy Safety Directive 
allowed the European Commission to amend such  limits in order to take into account science 
evolution and assure alignment with the latest scie ntific evidence.  The migration limits were set 
based on the assumption that exposure of children to chemicals in toys may not exceed a certain level, 
which was called "tolerable daily intake" (TDI). In this regard, since children were exposed to 
chemicals also via other sources than toys, only a per centage of the TDI should be allocated to toys.   
49. As a general background leading to the amendm ent of the measure, the EU explained that 
cadmium and other chemical substances were particul arly toxic and should not be intentionally used 
in those parts of toys that were accessible to children. Hence, the recommended allocation did not 
exceed 5 per cent of the TDI in order to ensure that only traces that were compatible with good 
manufacturing practice would be present.  In January  2009, the European Food Safety Authority had 
issued an opinion recommending a lower TDI in view of new developments rela ted to the toxicology 
of cadmium.  As a result, the European Commission  proceeded to an amendment of the limits for 
cadmium allowed under the Toy Safety Directive. 
50. As to the relationship between the TDI and th e source of cadmium, the EU explained that 
consideration was given to the amount of cadmium coming from toys compared to other sources of exposure, such as water and food.  Thus, the legislation took into account the fact that children were more exposed to cadmium via water and food than vi a toys.  On a conservative basis, it was therefore 
established that only 5 per cent of the TDI could come from toys and that 95 per cent of cadmium G/TBT/M/57 
Page 12  
 
  exposure came from other sources.  It was true that the contribution of toys to exposure to cadmium 
was insignificant as compared to the overall exposur e of this substance.  However, it was precisely 
because children were already overexposed via food a nd water that it was necessary to regulate toys 
and reduce exposure from other sources than food.  
51. As to the final question on how to apply the migration limits to the different types of 
materials, the EU referred China to the guidance document on the application of the new Toy Safety 
Directive, which was also available in Ch inese and was publicly accessible on the website.
3  In this 
guidance document, each type of material was descri bed and explained in deta il.  By setting different 
limits for each type of materials, the aim of the le gislator was to show as much as possible the reality 
of the exposure scenarios so as to simplify economic operators' situation.  The strictest limit 
concerned toys containing liquid materials, like finger paints, where exposure was direct and 
immediate (as opposed to toys containing "scraped off" materials, in which the exposure was less 
probable).  In fact, children would have to scratch or bite those "scrap materials" with their fingers or 
teeth for a long time to be exposed to significant risks.  Pages 107 to 114 of the guidance documents 
contained the most relevant inform ation on the matter.  The EU concl uded stating that it was available 
to continue discussions with China in the frame work of their bilateral dialogue on toy safety, 
including exchanging views on relevant scientific evidence. 
(viii) European Union – Air conditioners, liquid chilling packages and heat pumps, with 
electrically driven co mpressors, for space heating and cooling. Testing and rating at part 
load conditions and calculati on of seasonal performance （EN 14825 ） 
52. The representative of the China stated that his delegations had some concerns with the 
European Standard EN 14825:2012, approved by CEN on 14 January 2012.  First, this EU standard 
required measuring "seasonal energy efficien cy ratio" (SEER) and "active mode seasonal 
energy efficiency ratio" (SEERon).  However, for "invariable air-conditioners", it was hardly possible 
to achieve the specified 74 per cent, 47 per cent and 21 per cent of part load ratio conditions though 
on-off mode.  So the maximum uncertainty of 10 pe r cent for the heating and cooling capacity is 
impossible to be met.  This standard was not theref ore applicable to "invariable air conditioners".  As 
most air conditioners that were exported from China to the EU were "invariable air conditioners", the 
EU standard would be greatly problematic for Chinese manufactures and exporters.  China hoped the 
EU would make available the necessary documents to ta ke into account of the situation of "invariable 
air conditioners".  China concluded by asking the EU to explain whether under the standard the 
method of measuring SEER was the "air enthalpy method", the "room-type calorimeter method" or 
both. 
53. The representative of the European Uni on stated that the Commission Regulation 
implementing Directive 2009/125/EC with regard to  ecodesign requirements for air conditioners and 
comfort fans (document G/TBT/N/EEC/362) stipulat ed that measurement of the product parameters 
on energy efficiency and sound power should be meas ured through reliable, ac curate and reproducible 
measurement methods.  These measurement methods t ook into account the recognised state of the art 
including, where available, harmonised standards a dopted by the European standardisation bodies.  
The European Commission mandated on 18 February  2011 the European standardization bodies 
(CEN, CENELEC and ETSI) for standards in the fi eld of air conditioners and comfort fans. The 
standards currently developed unde r this mandate, in particular EN 14825, at issue in the present 
meeting, were intended to beco me harmonised standards for the EU Regulations on ecodesign and 
energy labelling for air conditioners and comfort fans. 
54. Regarding the specific questions raised by Chin a on EN 14825, the EU first clarified that it 
had not yet been accepted by the European Commission as a harmonized standard.  The EU 
                                                      
3 http://ec.europa.eu/enterprise/sectors/toys/documents/guidance/index_en.htm   G/TBT/M/57 
 Page 13 
 
 
  confirmed that EN 14825 applied to both inva riable (on-off, fixed capacity) and variable 
air-conditioners (variable capacity).  Furthermore, with regard to China's question of whether the 
method of measuring the SEER and SEERon was the "air enthalpy method" or the "calorimetric room testing method" or both, the EU noted that this  question was currently under discussion within the 
relevant CEN technical committee.  Measuring Seasonal Energy Efficiency Ratio with the 
air enthalpy methodology showed higher uncertainties and might not meet the tolerance criterion of 
8 per cent to be applied duri ng the verification procedure fo r market surveillance purposes. 
(ix) European Union – Lists of substances prohib ited and restricted in cosmetic products 
(2008/0025 COD and other related regulations) 
55. The representative of China asked the EU to e xplain the scientific rationale for the maximum 
concentration of certain restricted substances in  cosmetic products, especially those that were 
accidentally incorporated due to technical limitations.  Was there a monitoring mechanism for these restricted substances? 
56. The representative of the European Union expl ained that according to the EU Cosmetics 
Directive 76/768/EEC the manufacturer was fully r esponsible for the safety of cosmetic products 
placed on the EU market.  Manufacturers had to carry out the safety assessment of the product in 
conformity with the legal requirements set out in the Directive, and had to prepare a product 
information file (the "safety file").  In this file , information had to be pr ovided on the qualitative and 
quantitative composition of the product, physicochem ical and microbiological specifications of 
ingredients and the product, manufacturing met hods, safety assessment for the whole product and 
undesirable health effects.  In addition to the safety responsibility of the manufacturers, the 
Cosmetics Directive regulated certain ingredients of  high concern.  These ingredients were listed in 
several annexes to the Directive. Annex II (the  "List of Prohibited Substances") contained over 
1350 substances which were banned for use in cosm etics.  Annex III listed over 250 substances that 
were subject to specific restrictions and conditions.  Substances used as colouring agents, preservatives or UV-filters were allowed in cosme tics only if listed in relevant annexes to the 
Directive (i.e. Annexes IV, VI and VII) after a proper safety assessment was carried out by the 
Scientific Committee on Consumer Safety (SCCS). 
57. The EU also said that the existing regulatory  dialogue on cosmetics between the European 
Commission services (DG SANCO) and China's State Food and Drug Administration (SFDA) was a good way to gain a better mutual  understanding of the EU and Chinese cosmetics legislation, in 
particular with regard to safety assessment of cosm etic ingredients.  This dialogue allowed the two 
sides to clarify a number of issues and find solutions to concrete problems.  This dialog helped ensure 
a smooth trade flow in cosmetic products between  the two regions and was also beneficial for 
consumer safety. 
(x) United States – Application of third party t esting requirements; reducing third party testing 
burdens (G/TBT/N/USA/659) 
58. The representative of China still ha d some remaining concerns left  after the bilateral meetings 
his delegation held with the US before this meeti ng.  The measure required that children's products be 
tested by the third-party testing bodies which were  recognized by the US Consumer Product Safety 
Commission (CPSC).  As this could result in dupl icative test and increased burden to enterprises, 
China suggested CPSC accept the testing bodi es accredited according to ISO/IEC 17025 as the 
appropriate third-party testing bodies without imposi ng additional requirements.  Moreover, as certain 
international standards (e.g. ISO 8124 and IEC 62115) and Chinese standards (e.g. China National 
Toy Standard GB 6675-2003) were equivalent to the US toy safety standard in certain items, China 
suggested CPSC to recognize items which were equivalent to US standards. G/TBT/M/57 
Page 14  
 
  59. The representative of the United States explained that in October 2011 the Consumer Product 
Safety Commission (CPSC) completed its rule-making pursuant to implementation of the Consumer 
Product Safety Improvement Act of 2008 (CPSIA) by adopting a final rule that established protocols 
and standards with respect to certification and conti nued testing for children's products.  The final rule 
also established requirements for labelling of cons umer products to show that the product complied 
with the certification requirements under section 14(a)  of the Consumer Product Safety Act (CPSA).  
The final rule implemented several sections of  the CPSA, as amended by section 102(b) of the 
CPSIA .  In November 2011, the CPSC issued a Federa l Register Notice inviting public comments on 
opportunities to reduce the cost of third party testing requirements consistent with assuring 
compliance with any existing CPSC consumer product safety rules, bans, standards, or regulations. 
For CPSC, third party testing requirements apply to most children's products that were subject to a 
children's product safety rule.  The comments period closed on 23 January 2012. 
60. She noted that that CPSC was reviewing all of the comments submitted by China, including a 
suggestion that CPSC take the testing bodies accredited in accordance with ISO/IEC 17025 as the 
applicable third-party testing bodies accepted by C PSC.  With respect to the latter suggestion, she 
explained that the law governing the CPSC 's third-party testing program required the CPSC to either 
adopt or create an accreditation process for labs that test children's products.  The CPSC chose to use 
the existing global ILAC system as the basis for ensu ring fair and transparent accreditations.  With the 
exception of governmental and firewalled laborator ies, which had additional requirements under the 
law, any laboratory with the proper accreditation by an ILAC signatory could join the CPSC's 
program .  However, to be recognized as valid , all testing must be conducted in a lab in the CPSC's 
program.  However, the CPSIA did not permit govern ment laboratories to participate in the CPSC 's 
program if the laboratory was accorded more favourable treatment than other 
conformity assessment bodies in the same nation who was accredited for the programme.  Accordingly, CIQ laboratories would not qualify becau se CIQ test results were required in order to 
obtain export permits for many consumer produc ts and also because CIQ centres were the only 
entities in China authorized to issue product safety and quality export permits.  CPSC officials spoke 
in depth with AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine) 
Chinese counterparts about this bilaterally and ther e appeared to be no misunderstanding about this 
matter.  Although CIQ labs did not qualify under the new law, other Chinese laboratories were well 
represented in the testing programme.  The CPSC lis ted a total of 110 Chinese labs in its programme 
and of those 25 had Chinese Government affiliation.  
61. Finally, she stated that CPSC was consider ing China's request for ideas on how to reduce 
third-party testing burdens.  These alternatives were  being considered bearing in mind the need to 
maintain a high level of safety for children's products. 
(xi) United States – Energy conservation program: en ergy conservation standards for residential 
refrigerators, refrigera tor-freezers, and freezers  (G/TBT/N/USA/583; 
G/TBT/N/USA/583/Add.1; G/TBT/N/USA/583/Add.1/Corr.1) 
62. The representative of China stated that in October 2010 the US notified its "Energy 
Conservation Program Energy Conservation Standard s for Residential Refrigerators, Refrigerator 
Freezers, and Freezers" (G/TBT/N/USA/583).  Acco rding to these standards, the annual energy 
consumption requirements for some refrigerators re mained almost unchanged, while those for other 
refrigerators decreased by 25 per cent or more.  Th is did not occur when standard edition 1993 was 
upgraded to edition 2001.  There was a considerable quantity of refrigerators exported to the US from 
China falling into the categories with great annual en ergy consumption decline.  Therefore, Chinese 
refrigerator manufacturers would have to devel op new products and improve the production process, 
which, in turn, would increase the cost and lower the competitiveness of these products.  Furthermore, 
it would be difficult to meet these require ments in such a short period of time.  G/TBT/M/57 
 Page 15 
 
 
  63. China acknowledged that the introduction of these standards had positive effects on energy 
conservation and environmental protection.  However,  China noted that the US failed to explain the 
reason why the annual decline ratio in the value of energy consumption for different types of 
refrigerators differed so much.  The adjustment co efficient was not changed so greatly as to cause 
such a big difference.  This left open the questi on as to whether there were double standards in energy 
consumption for different types of refrigerators.  China urged the US to clarify these questions, take 
them into consideration and take the necessary m easures to minimize the impact of the revised 
standards on international trade.   
64. The representative of the United States responded that the proposed rule  was notified to the 
WTO in November 2010 and the final rule was notified in September 2011 
(G/TBT/N/USA/583/Add.1).  China provided comments on the proposed rule.  With respect to the 
final rule, the Department of Energy (DOE) amen ded energy conservation standards for residential 
refrigerators, refrigerator-freezers and freezers.  These revised standards in some cases were based on 
updated and more accurate test pro cedures, thus explaining the differences that China referred to in its 
intervention.  The new DOE standards would take effect in September 2014, which was three years 
from the notification of the final rule.  These new standards ranged from 10 per cent to 30 per cent 
more efficient than the current minimum base line depending on the product class.  China was correct 
that DOE adopted amended energy conservation sta ndards for residential refrigerator products that 
were in most cases more stringent than the exis ting standards as well as more stringent than the 
current energy star requirements. 
65. She explained - by way of background and in order to reflect the importance of energy 
efficiency to the US' larger environmental ener gy security and other policy goals - that the US 
maintained two major energy efficiency progra mmes for electrical appliances.  The DOE set 
minimum energy requirements for all appliances sold on the market, while the Environmental Protection Agency (EPA) maintained a voluntary la belling programme to identify for consumers the 
most energy efficient products.  In effect, the DO E programme pushed up the energy efficiency by 
lifting the floor, while the EPA voluntary programme pulled up energy efficiency from the top.  DOE 
set the floor for energy efficiency in appliances through a formula that incorporated factors that 
related to technical feasibility, economic expense,  the impact on competition and other factors that 
were identified in statute.  Although they we re distinct programmes, DOE and EPA closely 
coordinated the revisions to their respective pr ogrammes and, as the floor moved up to reflect 
technological advances, economic feasibility and othe r market factors, the EPA would respond.  The 
current EPA standards for these products dated to  2008 and a process was now underway in EPA to 
revise those standards.  The effective date of DOE  standards was in 2014 and the energy star level 
was expected to be in step with the DOE requirements by that date. 
(xii) Viet Nam – Decree No 38 Detailing the Implementation of Some Articles of Food Safety Law 
(G/SPS/VNM/27) 
66. The representative of the United States noted he r delegation's interest in Viet Nam's decree 
No. 38, which was notified to the SPS Committee as document SPS/VNM/27.  The US requested 
Viet Nam to respond to its most recent set of comme nts that were provided after the signing of decree 
No. 38 into law.  The US also requested Viet  Nam to immediately delay the 11 June 2012 
implementation date of the Decree until these con cerns were addressed.  The US further requested 
that Viet Nam to enter into technical discussions w ith the US and take further action to ensure that 
there would not be trade disruptions as a result of this measure. 
67. The representative of Australia said that while her delegation supported Viet Nam's right to 
implement measures to protect the health of its cons umers, it was also important that such measures 
not be more trade restrictive than necessary to ach ieve their stated objectives.  Australia understood 
that Decree 38 was scheduled to enter into force on 11 July 2012 but there were still some conflicting G/TBT/M/57 
Page 16  
 
  information as to how this measur e would be implemented.  Australia encouraged Viet Nam to delay 
the implementation of Decree 38 until arrangeme nts for such implementation were clearly 
communicated to trading partners and wanted to  work constructively to ensure trade was not 
disrupted. 
68. The representative of the European Union associ ated herself with the US' and Australia's 
concerns and stated that the EU was still waiting fo r responses to the questions it had posed bilaterally 
to Viet Nam.  The EU was concerned with the co mplexity and unnecessary bu rden that this Decree 
would cause, in particular the multitude of declara tions of conformity and related documentation that 
had to be submitted to Vietnamese authorities prio r to importation.  This complexity was compounded 
by the fact that several different Ministries appa rently had competence over various aspects of these 
requirements.  It was also unclear how coordination and timely processing of a dossier between these 
Ministries would be ensured, particularly when a product fell under the responsibility of more than 
one authority.  Furthermore, as Decree 38 lacked clarity in many areas, its implementation would most likely require the issuance of further technical guidance and other implementing measures.  This also contributed to the uncertainty felt by economic operators.   
69. While it was commendable that Viet Nam had notifie d an earlier draft of this decree to the 
SPS Committee, the EU asked why Viet Nam did not notify this measure also to the TBT Committee 
as some of its elements - such as labelling requirements - were covered by the TBT Agreement.  The EU considered that some of these obligations had the potential of being problematic, either because 
they were unclear (such as the ones related to the "best before" date), or were overly prescriptive (for 
instance, the requirement that the font of the name of  the product be at least three times larger than the 
font of the other information on the label).  Th e EU therefore requested Viet Nam to suspend 
application of the Decree pending a TBT notification, in order to enable interested trade partners to 
submit comments.  The EU also noted that the implementation of the Decree already started on 11 June 2012, although its adoption only occurred at the end of April.  In this context, the EU 
reminded Viet Nam of its obligations under WTO rules to provide a sufficient period between 
implementation and entry into force of mandatory requirements.  
70. The representative of New Zealand endorsed the comments made by previous delegations that 
Decree 38 had to be also notified to the TBT Comm ittee.  Given its highly complicated nature, New 
Zealand urged Viet Nam to assess the content of this  Decree against its obligations under Article 5 of 
the TBT Agreement, which obliged Members to ensu re that conformity assessment procedures did not 
create unnecessary obstacles to trade. Given the si gnificant uncertainty surrounding implementation 
of Decree 38 in practice, New Zealand also urged Vi et Nam to establish an extended transition period 
so as to allow exporters and governments to seek cl arification of various aspects of implementation 
without any disruption to trade in the meantime.  Fi nally, New Zealand also requested that Viet Nam 
notify further draft circulars as well as other inst ruments guiding implementation of the Law on Food 
Safety that relate to food imports.  This would allow Members sufficient time for submitting 
comments well before prior to their finalisation and entry into force. 
71. The representative of Canada informed that hi s delegation was interested in any accurate 
information on any transitional or implementation measures enacted by Viet Nam. Canada already 
conveyed such interest directly to Viet Nam thr ough its embassy in Hanoi and wished to continue 
discussing how this measure would be im plemented so as to avoid disruption. 
72. The representative of Chile shared the concerns voiced by previous delegations, in particular 
the lack of clarity of with respect to the implemen tation of Decree 38, in particular given that some 
circulars were already implemented, such as Circulars n.  13 and n. 25.  Chile also considered that this 
measure should had been notified to the TB T Committee and asked for some delay in its 
implementation.  G/TBT/M/57 
 Page 17 
 
 
  73. The representative of Viet Nam responded that b ecause this trade concern was raised for the 
first time at the present TBT meeting it would like to simply take note on the comments and concerns 
made and send them to capital for adequate response.   Viet Nam asked Members to send the details of 
their concerns in written form. 
(xiii) Korea – Windows Energy Efficiency, Ministry of Knowledge Economy (MKE) Notification 
2011-263, December 2011 
74. The representative of the United States expr essed her delegation's interest in this 
Korean measure setting requirements for testing the energy efficiency of windows.  The US asked 
Korea to notify this measure and informed that th e two countries had a constructive bilateral dialogue 
where particular concerns were taken into account.  
75. The representative of Korea explained that this measure was not notified because it was 
harmonized with the relevant international st andards in ISO 8990 and ISO 6613.  Korea would 
however convey to capital the US' notification request. 
(xiv) China – Draft Mobile Smart Terminal Admini strative Measure, Ministry of Industry and 
Information Technology (MIIT), 10 April 2012 
76. The representative of the United States noted  that China's Ministry of Industry and 
Information Technology (MIIT) issued the Mobile Smart Terminal Administrative Measure on 
10 April 2012 ("the Measure").  The Measure estab lished a new regulatory framework for the mobile 
device market.  The US's concerns with the Measure were first raised bilaterally with China in April 
and May 2012.  The US considered that the M easure imposed numerous new obligations, technical 
mandates, and testing requirements on informa tion technology and telecommunications hardware, 
operating systems, applications, app stores, and other related services.  The scope and mandatory 
nature of these requirements were unprecedented am ong the major global markets for mobile smart 
devices.  At the same time, t he US noted that on 1 June 2012, MIIT published a draft of the Measure 
on its website, soliciting public comment for 30 da ys.  The US appreciated this action, and 
acknowledged MIIT's positive response to the US' requ est for transparency on this measure.  The US 
requested that China notify this technical regulation and any accompanying measures to the 
TBT Committee and fully consider the vi ews of Members before finalizing them. 
77. The representative of Japan shared the concerns expressed by the US.  Japan considered that 
the measure imposed new technical requirement s and obligations to conduct inspections on 
manufacturing and distribution of smart mobile term inals.  Japan hoped that the new requirements 
would not constitute an excessive burden to manufactu rers of smart mobile terminals or would not 
require excessive technological disclosures.  The meas ure should take into consideration the fact that 
it would be difficult for terminal manufacturers to control all behaviours of applications.  Japan hoped 
that the sufficient information would be provided through the TBT notification system or by other methods in the future. 
78. The representative of the European Union shar ed the concerns raised by the previous 
delegations and noted that the measure establis hed a rigid regulatory framework with a very 
prescriptive approach which regulated in detail ev ery aspect of mobile smart phones.  It also 
introduced burdensome testing requirements which r esulted in voluntary industry standards becoming 
mandatory through conformity assessment.  These were systemic concerns that the EU had already 
flagged at numerous occasions at the TBT Committee in respect of regulations developed by MIIT.  
On the other hand, the EU welcomed the webs ite posting of the draft measures for public 
consultation, although it regretted that this was li mited to 30 days.  The EU therefore requested a 
longer period be allowed and th at wider opportunities for input into this process be provided to G/TBT/M/57 
Page 18  
 
  foreign industry.  The EU also requested that the measures be notified to the TBT Committee when 
they reached maturity. 
79. The representative of China stated that in or der to protect user information security and 
personal privacy, MIIT drafted a notice on st rengthening network access management on mobile 
smart terminals. The draft of the measure was put on MIIT's website on 1 June 2012 for public 
comment for one month.  China understood the con cerns from the foreign industry and welcomed any 
further comments, which would be taken into acco unt within China's decision making process and in 
accordance to WTO rules. 
(b) Previously Raised Concerns 
(i) European Union – Registration, Evaluation, Au thorization and Restriction of Chemicals  
(REACH)4 
80. The representative of Argentina said that REAC H continued to present serious complexities 
that confirmed what Argentina had been stating si nce its entry into force in 2007: this Regulation 
constituted an unnecessary technical barrier to trade and was not in compliance with the 
environmental and health objectives for which it was,  theoretically, established.  The complexity of 
REACH was manifested by the incessant modificat ions of the Regulation as well as their guiding 
documents and, as a result, in the excessive and unpredictable compliance costs for SMEs exporting 
to the EU market.  There were more than 20 modifications to the regulation and 25 guiding 
documents for its interpretation (that were also c ontinually modified) – and this was only one example 
of the unpredictability and complexity of REACH.   Since 2011, the regulation had already been 
modified eight times, and beginning in 2013, according to ECHA, more changes are foreseen 
including on the deadlines of some proceedings. Moreover, it could be assumed that additional 
modifications would be brought as a consequence of the general review undertaken by the European 
Commission. 
81. In addition, there was cause for concern rega rding the excessive costs (that ECHA appeared 
not to take into account) for SMEs exporting to the EU market generated by:  a) Continual 
modifications to the regulation which forced SM Es to seek external advice, usually given by 
European consultants, to know their obligations; b) The designation of the only representative in the 
European market (a cost not to be faced by a local  producer).  Because this representative had to have 
residence in the EU, this service usually come fro m a European entity – the same as those providing 
consulting services; c) The cost of participati ng in the Substance Information Exchange Forum 
("SIEF") was controlled by the major companies, ma inly European.  As SIEF was not subject to any 
control standards, the large companies that cont rol them established prohibitive requisites and entry 
costs for SMEs; d) Bureaucratic steps required for registration of each substance were excessive because they did not take account of different cost structures between European and non-European SME.  In relation to this last point, it was notew orthy that, in accordance with ECHA, almost 90 per 
cent of the registrations were carried out by ma jor enterprises.  As REACH provided that each 
substance had to be registered, it would be expect ed that, when the SME would comply with this 
proceeding, the SMEs would find out that the substance have alr eady been registered and most 
probably by a large company.  For this reason, SMEs had to face the unpredictable costs imposed 
                                                      
4 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.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/EEC/52/Add.7;  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/297/Rev.1/Add.1; G/TBT/N/EEC/333, G/TB T/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/TBT/N/EEC /336/Add.1; G/TBT/W/208. 
  G/TBT/M/57 
 Page 19 
 
 
  arbitrarily by major companies in the corresponding "SIEF" because of lack of regulation.  In this 
context, the supposed flexibilities provided by RE ACH for the SMEs in the EC regulation 340/2008 
become irrelevant.  The registration process of REACH seemed to only favour big companies eliminating SMEs competition.  SMEs could not comp ete when they had to comp ly with the last stage 
of registration in 2018 as they would find difficult to meet the direct registration costs or, most likely, 
the very high and arbitrary cost s imposed by the major companies that had already registered the 
substances.  His delegation urged the EU to make the process more transparent by avoiding continuous modifications to the re gulation and by providing greater reduction to the registration costs 
for SMEs outside the EU, while establishing contro l mechanisms for the major companies which had 
already registered substances, so as to avoid prohib itive costs for SMEs.  Without a solutions to these 
difficulties, he said, the majority of SMEs ex porting chemical substances to the EU would 
progressively be displaced from the Europ ean market, resulting in job losses.    
82. The representative of India shared Argentina' s concerns.  He reiterated his delegation's 
concern about the trade barriers for Indian SMEs.  The definition of micro, small and medium sized 
enterprises (MSMEs) in the EU for the purposes of lower registration costs did not account for labour 
intensive industries in developing Members like I ndia.  The use of criteria like annual turnover, 
balance sheet ceiling and staff headcount rendered ma ny of India’s micro enterprises large enterprises 
for REACH, despite meeting the first criteria.  This  resulted in their unfair treatment and was against 
the spirit of Article 12.3 of the TBT Agreement as it created unnecessary obstacles to exports from 
developing country Members.   
83. The only representative (OR) is a burdensome pr oposition for many of our SMEs and adds on 
to their cost.  Despite having raised this issue in  earlier meetings, the problems associated with SIEFs 
and consortia persisted, including th eir opaque functioning, high joining fee, penalties for late joining 
with no clear timelines for joining, yearly maintena nce fee, consultancy costs, non-uniform rules for 
every consortia.  Data sharing under REACH rema ined a problem for Indian companies due to the 
prohibitive cost of data purchase.  Most data sharing was commanded by the big companies.  In 
addition, there was no provision for merchant expor ters to undertake the registration process directly; 
his delegation had requested such a provision in the REACH legislation.  The rationale for registration 
of the entire tonnage of the substance in an article , even if less than 100 per cent of the substance was 
intended for release in using the article, was not clear.  
84. The representative of China supported Argentina and India. He had two questions for the EU 
from Chinese exporters. First, he asked the EU to check if there were sufficient human resources to 
deal with the complexity involved in complying with the REACH regulation.  Understaffing would 
lead to different interpretations of the rules whic h would lead to inefficiency.  Most customers of 
members did not supervise imports in line with RE ACH, and registration did not lead to different 
trade treatment.  China hoped the EU could check  these claims. Secondly, for some substances, 
registration involved millions of RMB, which often went beyond the capacity of exporters, especially 
for SMEs. The EU was asked to explain whet her mechanisms existed to control costs. 
85. The representative of Australia registered his delegation's on-going concern with REACH, 
referring to previous minutes of meetings. Th e representative of the Philippines supported the 
concerns raised by Argentina, India and China, particularly regarding the unpredictable costs for 
SMEs.   The representative of Thailand shared the concerns raised by previous Members. 
86. The representative of the European Union said that replies to most of these questions had 
been provided in previous meetings of the Comm ittee and referred members to the minutes of those 
meetings. Attention should focus on the new regist ration deadline in 2013.  ECHA and the European 
Commission had made huge efforts to inform comp anies about the REACH obligations and to take 
their concerns into account.  To assist companies in  their SIEF activities and in the preparation of the 
next registration deadline in 2013, ECHA was offering a series of support activities including G/TBT/M/57 
Page 20  
 
  workshops in 2012, a series of webinars and other training opportunities, including a workshop on the 
functioning of SIEF and notably its data sharing.  
87. To answer China's first question, the EU's position and interpretation on REACH had always 
been clear. Moreover, in order to enhance the e fficiency of the system , the competent customs 
authorities of the member states meet regularly in th e forum of the enforcement competent authorities   
of the EU member states to foster good practice and highlight any issues at the EU level.  Regarding 
registration costs for some substances, the EU reiterate that the level of the fees and charges had been set taking into account the workload involved for each of the relevant processes managed by ECHA. 
The fees and charges applied equally to manufacturer s and importers established inside the EU and to 
only representatives of non-EU manufacturers. Moreover th e costs of testing were also included in the 
registration costs, and several approaches to avoid animal testing were described in Annex 11 of the 
REACH regulation. Finally, important reductions, of  up to 90 per cent, applied to micro, small and 
medium enterprises. 
(ii) European Union – Regulation on Certain Wine Sector Products (G/TBT/N/EEC/264) 
88. The representative of the United States noted ongoing bilateral US and EU dialogue on wine 
trade. However, she asked again about current EU me asures restricting U.S. wine exports to the EU.  
At the last meeting, the EU noted that it was s till examining applications for recognition of certain 
terms submitted by the U.S. wine industry on 19 Ju ne 2010.  U.S. suppliers using those terms were 
unable to export their products.  The EU had gran ted approval to use the terms through its bilateral 
agreements with other countries, these terms did not have a common definition across all EU Member 
States, and there had been no effort to monitor or  limit the use of these terms within the EU.  She 
therefore asked how these measures could be pr eserving a general consumer perception regarding 
"terms traditionally associated with European win es".  In addition to TBT-related aspects of the 
regulation, the US had concerns about the regula tion regarding the protection of trademarks and 
intellectual property. 
89. The representative of the European Union sai d that his delegation was still examining 
applications filed by the US industry for the use of  traditional terms, and was providing information to 
the US on the status of these applications on a regul ar basis.  He informed the Committee that a vote 
on the draft regulation recognizing the traditional te rm 'Classic' would take place at an upcoming 
Single Common Agricultural Market Management Committee; if the vote was positive, the 
Commission would proceed to formally adopt this regulation.  Her delegati on was open to continued 
discussion of this issue with the US, with a view to make progress on the US requests 
(iii) India – Pneumatic tyres and tubes for automotive vehicles (G/TBT/N/IND/20, 
G/TBT/N/IND/20/Add.1, G/TBT/N/IND/40/Rev.1) 
90. The representative of Japan recalled that India had stated on two occasions that it would 
positively consider deletion of Clause 6.3, whic h prohibited export of the BIS marked tyres to 
countries other than India.  However, this modification had not been carried out by the relevant 
companies.  Presently, Japanese tyre manufacturers could not export BIS-marked tyres to countries 
other than India. This was an unreasonable restric tion on trade.  His delegation requested immediate 
deletion of Clause 6.3.  Also, according to Japanese tyre manufacturers, India conducted certified factory audits every six months.  Japan saw no ot her cases that required such frequent audits which 
were an unnecessary burden for tyre manufacturers.   Japan requested a drastic reduction in the 
frequency of the audits. 
91. The representative of Korea said his delegation c ontinued to have concerns about Article 6.3, 
marking fees, time-consuming procedures, excessive  paperwork, and the term of validity for ISI 
certification.  Because Article 6.3 of the BIS Agreement prohibited exports of ISI-marked tyres to  G/TBT/M/57 
 Page 21 
 
 
  other countries, the Korean industry had an undue co st burden. Korea also requested the repeal of 
Article 6.3.  If India repealed Article 6.3, marki ng fees would also need to be reviewed. They were 
unfairly calculated (not on the basis of the total nu mber of ISI-marked tyres imported to India, but on 
the basis of the total number of tyres produced and marked with the ISI symbol).  Compared with 
similar marks issued by other countries, most of which did not charge marking fees, ISI fees were 
considerably higher. 
92. Additionally, the process, from the application to  the issuance of the certification, was rife 
with time-consuming administrative procedures and excessive paperwork which took almost one year.  
Other countries could process certification within 45 and 90 days.  Considering the long time to obtain certification, Korean tyre manufacturers believed that one year validity was unreasonably short; 
manufacturers would have to apply to renew their certification as soon as they received it.  Other 
countries granted 5 years or permanent terms of validity. Korea requested that India simplify its administrative procedures and extend the term of valid ity to at least five years, or indefinite.   
93. Additionally, Korea asked India to accept t est results carried out in in-house Korean 
laboratories, consistent with gl obally accepted practices.  Common global common practice in the tyre 
industry was that, if the test laboratories of co mpanies were verified according to international 
standards, the test results from th ese laboratories should be accepted by the tyre certification body.  
Lastly, Korea asked India to allow foreign laboratori es located outside of India to be approved as test 
labs for the ISI mark. 
94. The representative of the European Union recalle d India's confirmation at the last Committee 
meeting that Article 6.3 of the BIS Agreement, which prevented ISI marked tyres from being sold 
outside India, would be removed. The EU would lik e to know whether further steps had been taken in 
this regard and when the modification of the BIS Agreement would be finally published.  
Furthermore, the EU remained concerned by the ro yalty fees to be paid on the total production of 
tyres produced and marked with ISI marking, not only on those which were actually imported to India. The EU urged India to remove the royalt y fees, which were extremely burdensome and more 
restrictive than necessary, or at least to modify thei r calculation so that they would be limited to tyres 
which were de facto exported to India.  Finally, the EU inquired whether tests, carried out by EU-accredited laboratories and showing compliance with  the Indian requirements, could be accepted. 
95. The representative of India said that his Govern ment had decided to remove clause 6.3, and 
the revised agreement was being finalized.  The ma rking fee charged and the overall fee was equitable 
in terms of unit cost of tyres for both domestic a nd foreign manufacturers.  Moreover, the overall fee 
charged by India was comparable to those charged by other Members.  He considered that it might 
actually be lower in India than in many countries ch arging an overall fee for these tyres.  He added 
that the foreign lab recognition scheme of the BIS ex isted.  He did not understand why this question 
was repeatedly asked when  the scheme existed and none of the foreign labs from any of the three 
delegations that spoke had actually a pplied for recognition from the BIS.  
96. Regarding the Korean question about the validity of the license being for one year, the 
internal Indian guideline was one year because th at was what Indian authorities were comfortable 
with as a term of license both to domestic as well as to foreign manufacturers.  There was also a provision for the renewal of the license for one or two years with payment of a requisite fee.  Finally, 
he said that the norm for issuing the license was six months for normal applications, not one year. 
(iv) Canada – Compositional requirements for Cheese (G/TBT/N/CAN/203, 
G/TBT/N/CAN/203/Add.1) 
97. The representative of New Zealand referred to the minutes of the previous 16 Committee 
meetings where her delegation explained its con tinued concerns.  The representative of Australia G/TBT/M/57 
Page 22  
 
  supported New Zealand's intervention as his delegati on continued to have c oncerns about Canada's 
regulation on compositional standards for cheese and the access for milk proteins. The representative 
of Canada took note of th e two delegations' comments. 
(v) India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33) 
98. The representative of the United States conti nued to have concerns with India's proposed 
registration certificates and import licenses for foreign pr oducers, particularly that they last for three 
years, while the certificates and licenses for domestic producers last for five years.  She asked for an 
explanation regarding the difference.  Fo llowing up on the November 2011 and March 2012 
exchanges in the Committee, she also asked for clar ification regarding the information required in the 
certificates and licenses for foreign and domestic producers.  India had suggested at the November 
2011 meeting that there were differences between tho se requirements.  She also asked for an update 
on the state of play of the measure as India ha d said, at the March 2012 Committee meeting, that 
enforcement was postponed until April 2012.  
99. The US industry also remained concerned with  some details associated with implementation 
of the proposed regulation. In January 2011 they had asked to receive additional clarification from 
India on whether there would be an adequate tran sition period for suppliers to comply with the 
measure once it entered into force;  whether the pr oposed registration fee of  $250 "for each brand of 
cosmetic" referred to the trade name or the pr oduct line - and whether the latter could require 
additional filings for changes in manufacturing locati on, for example, which would result in increased 
expense as well as delays in registration approvals ; and whether import regi stration numbers would 
only be required on the outer package, wh ere they were visible to the consumer .  Her delegation was 
pleased that India delayed implementation of the ru les until October 1, 2012, and would like use the 
extra time to work through the remaining technical issues. Industry continued its dialogue with the 
relevant Indian authorities so that companies coul d understand how to comply with the regulation.  
100. The representative of the European Union welcom ed the postponement of the entry into force 
of India's registration procedure until October 2012, and the information provided at the last 
Committee meeting that labelling, specifically the name of the importer and import licence numbers, 
could be provided in an authorized place, su ch as a bonded warehouse, after import. The EU still 
wanted to know if the validity of import licences w ould be increased from 3 to 5 years, and if India 
was developing an arrangement for accepting reports  of tests carried out in foreign laboratories 
attesting compliance with international standards or In dian standards, as an alternative to local testing. 
101. The representative of India confirmed that the measure would come into force on 1 October 
2012.  He explained that the different time pe riod was primarily because of the voluminous 
inspections of factories and even manufacturing practices carried out for domestic manufacturers 
compared to foreign suppliers.  Thus, there was no intention at present to increase the period from 3 to 
5 years. However, his Government was looking at temporary labelling requirement in customs 
designated warehouses. Permission for affixing self-adh esive/stickers or over printing of or stamping 
each pack of the imported  cosmetics with registration number a nd the name of the importer at 
authorized places may be considered.  His delegatio n would examine the technical questions posed by 
the US specifically on the labels on cosmetics.  Finall y, in terms of foreign la b recognition, there were 
currently no test reports required for inspection of cosmetics.  If and when a regulation would come 
into force, his delegation would look at specifi c labs that would be recognized for testing. 
(vi) India – Mandatory Certification fo r Steel Products (G/TBT/N/IND/32) 
102. The representative of the European Union s till had concerns, as mentioned at the last 
Committee meeting and in written comments of 6 September 2011, with India's mandatory 
certification for steel products. He inquired about implementation of the third party certification,  G/TBT/M/57 
 Page 23 
 
 
  which it considered inappropriate fo r intermediate steel products and too burdensome.  He asked India 
to inform the Committee of the date of entry into fo rce of the Steel and Steel Quality Products Order.  
Secondly, EU industry continued to report significant backlogs in the existing certification for galvanized steel. He asked how India would ensure that the plant verifications would be carried out 
for all products covered by the second addendum to G/ TBT/N/IND/32 before it entered into force. In 
this context, the EU also invited India to recognize test results from foreign laboratories.  Finally, the 
EU urged India to provide a more rapid procedure for the steel products that would now be submitted 
to third party certification, so as to ensure an e qual treatment for domestic a nd foreign manufacturers.  
103. The representative of Japan shared the EU view  that India should postpone implementation of 
this order until the equal treatment principle of domestic and foreign manufac turers for obtaining IS 
certification was ensured, and that unnecessary barriers to trade were resolved.  His delegation did not 
believe there was any functional purpose for impos ing mandatory standards on intermediate goods, 
such as steel products. The protection of human heal th or safety could be attained only through safety 
regulations on final products, such as the Japanese regulations. 
104. The representative of India informed the Comm ittee that 9 steel products would be under 
mandatory BIS certification from 12 September 2012.  Indian analysis carried out by technical 
authorities showed the significance of standards on intermediate products because they formed the 
bulwark for the performance of the finished product.  For example, unless the steel plates that go into 
pressure vessels like boilers conformed to specific st andards, there was a danger of explosion or other 
accidents in the plant.  Similarly, electrical steel  sheets (CRNO and CRGO) used in the production of 
transformers and power generation equipment were  critical to the performance of both these end 
products, as were ingots/billets for the safety of the fi nal building.  As stated previously, the BIS had a 
scheme for recognition of third party labs, but neither  the EU nor Japan had applied for recognition of 
their labs. 
(vii) United States – Hazardous Materials: Transportation of Lithium Batteries 
(G/TBT/N/USA/518) 
105. The representative of Korea asked  the US to update the Committee on the current status and 
future prospects of the measure. 
106. The representative of the European Union r ecalled the first addendum of G/TBT/N/USA/518 
in which the US announced that it was consideri ng whether to harmonise with the new Technical 
Instructions on the Safe Transport of Dangero us Goods of the International Civil Aviation 
Organization (ICAO).  The EU asked for an up-date on the proposed requirements for the transport of 
lithium batteries.  He asked the US to confirm th at it would refrain from a unilateral approach and 
would bring its rules into alignment with the new Technical Instructions of the ICAO.     
107. The representative of Japan supported Korea and the EU.  While Japan shared the objective of 
ensuring air transportation safety, Japan had expresse d concern about the negative impact on trade of 
the proposed US regulation on the transportation of lithium batteries which was inconsistent with the 
UN Recommendation on the Transport of Dangerous Goods and the ICAO Technical Instructions.  In 
February 2012, the ICAO agreed to  amend its Technical Instructions , effective January 2013.  Though 
the US had not yet published a final regulation, Japan was looking at whether the final regulations 
were consistent with or more stringent than the ICAO Technical Instructions.  He requested that the 
US provide an opportunity for comments on the final rules to the stakeholders. 
108. The representative of the United States, in its  recent notification, G/TBT/USA/N/518/Add.l, 
informed its trading partners that the Department of Transportation (DOT) would be requesting public 
comments on the impact of changes to the require ments for the air transport of lithium cells and 
batteries that had been adopted in the 2013-2014 IC AO Technical Instructions on the Transport of G/TBT/M/57 
Page 24  
 
  Dangerous Goods by Air.  Experts from Korea, Japan , several EU States and the US participated in 
the ICAO Dangerous Goods Panel for the developm ent of the ICAO Technical Instructions. The 
revised ICAO standards had the support of the entir e Panel.  In its request for comments, DOT said 
that it was considering whether to harmonise with these requirements.  During the comment period, 
DOT received several comments similar to the concerns raised by members here.  DOT was 
reviewing the comments and considering how to pr oceed.  All comments could be read online.  
Regarding the timeline, she replied that DOT was aware of the January 2013 effective date. 
(viii) Turkey – New conformity assessmen t procedures for pharmaceuticals  
109. The representative of the United States continued to find certain aspects of Turkey's decree on 
conformity assessment procedures for pharmaceutical imports problematic, and urged Turkey to take 
steps to restore market access for safe, high qu ality pharmaceuticals. While the US was not opposed, 
in principle, to inspection requirements for pha rmaceutical manufacturing facilities, it remained 
concerned about several aspects of Turkey's require ments which were neither published in the official 
gazette nor notified to the WTO.  She urged th e Turkish Government to consider processing 
registration forms submitted prior to March 2010 as filed; to not apply retro-actively the GMP 
requirement;  and to give priority to innovative dr ug applications that provide new medicinal therapies 
to Turkish patients, all to alleviate the current blockage of pharmaceutical imports.  She understood 
that Turkey was considering allowing the integr ation of the GMP inspection into the marketing 
authorization process.  She requested an update on this as it would be a positive step.  Finally, her 
delegation was pleased with the positive discussions he ld on GMP over the year including in bilateral 
trade talks and during regulators' dialogues in workshops.  However, the number of pharmaceuticals 
awaiting marketing authorization was still high.  This was an urgent ma rket access issue for US 
exporters and Turkish patients and he r delegation urged Turkey to take steps to restore market access. 
110. The representative of Turkey explained that the GMP certificate was a document required for 
the licensing of pharmaceutical products.  The aim of the regulation was the protection of human 
health and life by providing that pharmaceutical pr oducts meet the required effectiveness and safety 
conditions.  The Turkish Ministry of Health had been conducting GMP inspections since 1995 in 
accordance with “GMP Guid elines for Pharmaceutical Products”, which were in compliance with the 
relevant guidelines of the World Health Organizati on (WHO).  Prior to March 2010, GMP certificates 
of other countries along with those provided by the Ministry of Health were accepted when applying 
for licensing.  However, the Ministry of Health  was concerned that automatic recognition of GMP 
certificates of other countries without having access to the relevant background documentation, posed 
serious risks to human health. Therefore, the Minist ry exercised its legitima te right to conduct GMP 
inspections for the protection of public health and human life. 
111. To further improve enforcement, the Ministry developed its capacity to accept and process 
applications for GMP certificates.  All applicati ons were immediately processed as long as the related 
application files were complete.  Turkey reiterate d that the GMP was applied to all countries and all 
products equally, as well as to national products.  Hen ce, GMP inspections aimed not to restrict trade 
but to secure public health.  Furthermore, in line wi th public health concerns, the Ministry of Health 
applied a classification system based on the therap eutic priorities of pharmaceuticals.  Turkey 
informed members that there would not be any policy change regarding the GMP implementations, 
such as unilateral acceptance of GMP certificates.  Lastly, he re-emphasized Turkey's willingness to 
communicate and work constructively with interested members upon their request. 
(ix) Brazil - Health Products (G/TBT/BRA/328) 
112. The representative of the European Union reite rated concerns about the timelines for the 
registration of medical devices in Brazil. As of May 2010, a Good Manufacturing Practices (GMP) 
certificate had to be presented with  the application for registration of health products in Brazil. A  G/TBT/M/57 
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  GMP certificate was issued only after ANVISA had inspected the manufacturing premises.  The EU 
was aware that Brazil was taking some steps to accelerate GMP inspections. However, there was still a number of manufacturing sites for which an inspection request had been submitted but no inspection had taken place, and 20 months appeared to be the average waiting time.  The EU asked for an update 
on the current situation. 
113. The EU stressed that ANVISA n eeded to carry out inspections to foreign manufactures within 
3 months after the request had been filed.  In case reasonable inspection deadlines could not be met, 
the EU invited ANVISA to rely on and take in to account Quality Management System audits 
conducted by accredited auditing bodies such as EU Notified Bodies, which guaranteed that the 
products were safe, and c onsider accepting, on the Brazilian market , products authorized in the EU or 
in other major markets, pending the completion of ANVISA inspections. As an alternative, ANVISA 
was invited to consider subcontracting overseas insp ections to accredited auditing bodies such as the 
EU Notified Bodies that would inspect EU facilities on behalf of ANVISA. This procedure would allow for a reduction of the current backlog. 
114. The representative of Brazil recalled a bilateral meeting with the EU on this issue and that 
Brazilian authorities were aware of the current situa tion.  ANVISA continued to work to improve the 
efficiency of the GMP inspections. His delegation ha d provided considerable detail at the last meeting 
about the measures adopted or are under considerati on by ANVISA;  he invited Members to refer to 
the minutes of that meeting.  He highlighted some of the main actions envisaged by ANVISA to better organize the international GMP inspections:  ANVI SA was considering new criteria to prioritize 
inspections taking into account, for example, the pr oximity between companies in the same region or 
the risk of lack of supply of certain products in the Brazilian market;  ANVISA had sought to make 
the best use of its human resources to avoid capacity  deficiencies in inspection teams;  and Brazil was 
considering  changes in its legislation so that experts from other federal or local bodies could be 
incorporated in the inspection teams. He info rmed the Committee that up to May 2012, ANVISA 
conducted 104 inspections which pointed to an incr ease in the pace of inspections.  Brazil reiterated 
its interest in pursuing bilateral arrangements with  Members like the EU in health surveillance, and 
that some arrangements such as confidentiality agre ements, for example, could speed up the process 
of GMP certification since they would allow inform ation exchange between the authorities of both 
parties. Finally, Brazil joined the Internationa l Medical Device Regulators Forum (IMDRF) and was 
committed to the objectives of regulatory convergence in this area. 
(x) European Union – Directive 2004/24/EC on Traditio nal Herbal Medicinal Products (THMP) 
115. The representative of India noted that the EU  Directive 2001/83/EC relating to medicinal 
products for human use and the subsequent Direc tive 2004/24/EC on traditional herbal medicinal 
products were not notified to the WTO.  His dele gation was concerned that there was no simplified, 
specific alternative application dossier for regist ration of traditional Ayurveda products.  The EU 
should therefore consider Ayurvedic Pharmacopoeia  as India’s specifications and quality parameters 
for registration of traditional Ayurvedic Medicines.  The definition of herbal , medicinal products in 
the EU directive did not include products that ha d minerals and other non-herbal substances which 
provided a  synergistic effect to the herbs in the formulation.  India requested the EU to consider 
expanding the definition of herbal medicinal pr oducts to include non-herbal biological and non-
biological ingredients.  He concluded that th e Common Technical Document (‘CTD’) format under 
the THMP Directive was inappropriate for multi- component, traditional, medicinal formulations 
given that it was almost impossible to provid e information with respect to multi-component, 
traditional medicinal formulations.   
116. The representative of China supported India's con cerns. It hoped that the EU would review 
this directive because it was causing problems for the traditional herb al medicine users in the EU. G/TBT/M/57 
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  117. The representative of the European Union recalled that extensive technical clarifications had 
already been provided in previous meetings of the Committee.  The EU reitera ted that the 2004/24/EC 
Directive introduced a simpler and less costly regi stration procedure for traditional herbal medicinal 
products as compared with medicinal products falli ng under the full market authorization procedure 
foreseen by Directive 2001/83/EC.  In addition, herb al products that did not fulfill the definition of 
medicinal product do not fall under the scope of the re gistration.  On India's request for the EU to 
accept Indian Pharmacopeia as sufficient proof of qua lity parameters of herbal medicinal products, the 
EU highlighted that qualit y, together with safety and efficacy, was one of the essential pillars of the 
EU code for medicinal products for human use that guaranteed that products were adequate for human 
health. Therefore, the quality requirements defined under Directive 2001/83/EC had to be fully met.   
118. The EU noted that the eligibility criterion of 15 years of use in the EU allowed sufficient 
monitoring of the side effects and increased confiden ce in the safety of the products in the absence of 
tests and clinical trials.  For medicinal products for which 15 years use in the EU could not be demonstrated but were otherwise eligible for th e simplified procedure, the Directive 2004/24/EC 
allowed manufacturers to prove the safety of the product by other means, which were to be assessed 
by the Committee for Herbal Medicinal Products of  the European Medicines Agency.  Finally, the 
Common Technical Document (CTD) was an interna tionally agreed consistent format, widely known 
by market operators. Specific guidelines for multi- ingredient components were also available. 
(xi) Korea – KS C IEC61646:2007 Standard for Thin-film Solar Panels  
119. The representative of the United States said th at her delegation had continued to seek a 
solution for these issues raised since June 2010.  She requested an update on when Korea's study on 
the environmental impact of thin film solar panels  would be released.  She expected this study to 
show that other types of solar panels did not have  an adverse impact on the environment, and that, 
therefore, they would be expeditiously incorporat ed into Korean standards and certification programs 
to enable equal access to the Korean markets to domestic and fo reign producers.  She also requested 
that Korea give stakeholders the opportunity to co mment and seek clarification on the results of this 
study. 
120. The representative of the European Union supporte d the US concerns and recalled that, in the 
past, Korea expressed its intention to complete a feasibility study on the in clusion of non-amorphous 
silicon types of thin film solar panels - Cadm ium Telluride (CdTe) and Copper Indium Gallium 
Selenide (CIGS) in standard KS IEC 61646 by 30 Ma y 2012.  She asked Korea to provide an update 
on this study and share its conclusions with the Committee. She also asked  what the next steps 
envisaged by the Korean Ministry of Environment were, in particular whether the Korean standard 
would be amended as requested by the EU and the US. 
121. The representative of Korea indicated that under the current standard KS IEC 61646, all types 
of thin film solar panels could enter the Korean market without certification.  Thus, certification of 
solar panels was not mandatory in Korea.  In May 2012, his Government had completed a two-year 
comprehensive feasibility study to evaluate the envi ronmental risks involved in the use and end-of-life 
disposal of cadmium telluride and CIGS photovo ltaic modules.  The purpose was to determine the 
convenience of introducing certification systems for th ese products in Korea.  To ensure the highest 
degree of reliability, the study involved Korean  test methods for domestic waste as well as US 
Environmental Protection Agency (EPA) method 1311 and the EU EN 12457 method.  
122. The study found that when cadmium telluride modules were damaged or discarded, a 
significant amount of cadmium was leached into th e surrounding environment.  The concentration of 
cadmium leached from these modules was much higher th an the allowable levels specified in various 
national environmental standards.  When Korean test methods for domestic waste were used, the 
average concentration of cadmium was 1.65 milligra ms per liter.  The average concentration was  G/TBT/M/57 
 Page 27 
 
 
  17.75 milligrams per liter with the EPA Method 1311,  and 0.84 milligrams per liter with the EN 
12457 test.  The maximum allowable concentration of cadmium in Korean drinking water was 0.005 
milligrams per liter.  For bodies of water, the maximum was 0.01 milligrams per liter.  And for 
industrial wastewater, it ranged between 0.02 and 0.1 milligrams per liter.  In addition, it found that 
higher concentrations of cadmium were leached in to the environment when cadmium telluride was 
exposed to acid.  Thus, there was great potential ha rm to the environment from just a tiny amount of 
powder from a damaged module, if the powder came into  contact with acid rain.  An agency in Japan 
(SIMAZU), reached the same conclusions.  Therefor e, Korea concluded that the social and economic 
costs of allowing cadmium telluride modules on the Korean market would outweigh the benefits.  The competent authorities would provide Members with the results of this feasibility study upon request.  
Since CIGS modules contained little cadmium, Korea was considering setting up a certification 
system for this type of module.  This process would take approximately two years. 
(xii) India – New Telecommunications related Rules  
123. The representative of the European Union reitera ted its concern regarding the revised telecom 
network security regulations and their accompanyi ng template agreement on security and business 
continuity between telecom network operators a nd equipment suppliers.  He believed that the 
regulations adopted on 31 May 2011 constituted the final version.  Considering that 1 April 2013 was 
the deadline for the implementation of the requirement  for in-country testing of network elements, he 
requested the Indian authorities to reconsider discontinuing the acceptance of foreign test results of 
network elements as of 1 April 2013, and moving to a system based solely on in-country testing.  He 
inquired whether the certificates issued under th e Common Criteria Recogn ition Agreement (CCRA) 
would be accepted as before, and whether such certifi cates would be sufficient to meet all the security 
testing requirements under the new rules.  He request ed that only those elements that were essential 
for ensuring the security and integr ity of the telecom network system be covered by the test, in order 
to avoid the disclosure of sensitive propriety information. 
124. In addition, he mentioned that the Indian au thorities had held a public consultation process 
from 18 April to 18 May 2012 on draft guidelines for certification of telecom equipment.  He 
requested clarification on the relationship be tween these new draft guidelines and the revised 
telecommunication network security regulations.  In his view, the scopes of these two documents 
partly overlapped, and the EU was concerned that  these draft guidelines could establish an additional 
layer of testing and certification for telecom equipm ent.  According to the draft guidelines, suppliers 
could choose from among three different approval  schemes. The Telecommunication Engineering 
Center based in New Delhi, along with its regiona l offices, were in any event the only laboratories 
entitled to carry out the corresponding testing.  It was not clear to the EU whether foreign testing 
outside India by internationally accredited laborator ies would be accepted.  He welcomed the public 
consultation process and expected the Indian author ities to properly take th e comments submitted into 
consideration, and to eventually notify these measures in accordance with the TBT Agreement. 
125. The representative of the United States s upported the EU comments.  Her delegation 
appreciated India's reassurance th at it remained committed to complying with the CCRA.  However, 
the US did not understand the reasons for requi ring in-country testing for telecommunication 
networks, and requested clarification on the rela tionship between this requirement and India's 
assurance that it would continue to accept CCRA certif ications.  India had not explained the security 
reasons for requiring all telecommunication equipment to be tested in-country, especially considering 
that the testing could be conducted by foreign telecom firms as well.  Thus, she requested an 
explanation of the concerns underlining the in-c ountry testing requirement, and the reasons why 
testing in common criteria labs c ould not address India's concerns. 
126. The representative of Japan echoed the EU and US  concerns.  Japan was concerned about the 
compatibility between the new regulations and the C CRA.  Japan believed that, as it mentioned at the G/TBT/M/57 
Page 28  
 
  previous TBT meeting, according to the new rule s, only network elements approved by Indian 
certification agencies would be allowed.  He s ought reassurance that India’s telecom regulations 
would not impede market access for foreign companies. 
127. The representative of India restated India's in tention to continue to recognize the process-
based conformity tests conducted by internationa l labs for general IT products covered under the 
CCRA.  However, for national security considerations, India had issued regulations for the testing of 
telecom equipment against security standards.  For such security testing, India intended to establish 
test standards, procedures, tools and accreditation of test labs in India.  Addressing the US concern for the protection of property rights under the new regi me, he stressed that the new regulations contained 
adequate safeguards for protecting intellectual prope rty rights.  He would revert to the comments on 
the relationship between the new testing guidelines a nd the security guidelines; and requested that the 
three delegations provide their informed comments to India's regulatory agency concerning the draft 
guidelines for certification of telecom equipment. 
(xiii) Italy – Law on "Provisions concerning the marketing of textile, leather and footwear 
products" (G/TBT/N/ITA/16) 
128. The representative of India requested an update on the status of these provisions which could 
severely impact India's exports of textiles and clot hing to Italy. The representative of the European 
Union reiterated that Italian aut horities had postponed application of this law until the adoption of the 
implementing measures.  Adoption was not foreseen at present. 
(xiv) Brazil – Draft Resolution No. 112, 29 Nov 2010; maximum levels of tar, nicotine and carbon 
monoxide permitted on tobacco products and pr ohibition of additives (G/TBT/N/BRA/407) 
129. The representative of Mexico said that, despite  answers provided by Brazil, her delegation 
remained concerned that some aspects of the draft resolution could be inconsistent with Articles 2.2 
and 2.8 of the TBT Agreement, and requested furthe r information on the resolution's implementation.  
130. The representative of Guatemala reiterated her de legation's concern that this draft resolution 
could have negative impacts on the marketing of ci garette products of American tobacco mixture 
because it prohibited the use of certain types of add itives necessary for its preparation.  She requested 
Brazil to clarify how each of the ingredients of th e American mix would be covered by Article 7 of 
the draft resolution, and whether the American mix could be marketed in Brazil. 
131. The representative of the Dominican Republic s upported Mexico and Guatemala.  He asked 
that Brazil take proper account of these observati ons and provide information on this measure. 
132. The representative of Colombia recalled previous  concerns expressed re garding this measure, 
and noted that no response had yet been provide d by Brazil to their comments and questions. 
133. The representative of Chile, while appreciative of the recent notification of the addendum, 
restated her delegation's concerns and requested more information on the measure's implementation. 
134. The representative of Turkey expressed regret that  the draft resolution entered into force on 
15 March 2012 without taking Turkey's and other co untries' comments into consideration.  Banning 
additives in tobacco products should be based on sci entific evidence that pr oved that the additives 
posed increased risk to human health.  A ban on  all additives constituted, in Turkey's view, a 
disproportionate measure.  As a result of comment s, however, Brazil had removed sugar from the list 
of banned additives.  However, this modifica tion was insufficient to address their concerns.  G/TBT/M/57 
 Page 29 
 
 
  135. He reiterated that some of the prohibited additives were essential components of blended 
cigarettes, in which both Oriental and Burley toba ccos were used.  Since blended and non-blended 
tobacco products were "like pr oducts", a measure resulting in a prohibition of blended tobacco 
products would be discriminatory.  Further, these additives did not give characterizing flavor to 
tobacco products.  Thus, Brazil failed to consider th e effects of such ingredients on final products, and 
Turkey expected it to reconsider adoption of this resolution and to amend it to avoid discrimination. 
136. The representative of Australia welcomed Braz il's decision to implement tobacco control 
policies and preventative measures aimed at reducing the attractiveness, in particular to children and 
youth, of certain tobacco products.  Each Member had the right to implement measures necessary to 
protect public health, while complying with releva nt international treaty obligations.  Australia 
remained prepared to continue to defend this right. 
137. The representative of Brazil recalled bilateral discussions with Mexico where some concerns 
were addressed.  He informed Me mbers that the definitive regulation on the control of additives in 
tobacco products was published as Resolution RDC14 2012 from ANVISA in March 2012; and 
notified to the TBT Committee in April 2012.  Brazil had also prepared a compilation of the answers 
to comments submitted during the consultation pe riod; they were willing to transmit them to 
interested Members.  In relation to the concern re garding the American blend of tobacco products in 
Brazil, the production of tobacco products known as "American blend" was not affected by this 
regulation, since the use of sugar - a key ingred ient for this product - as an additive in tobacco 
products was permitted under the Brazilian measure. 
138. He invited Members to consult the minutes of the previous meeting, where they could find 
extensive answers and explanations on some of the points raised.  He recalled that two hundred 
thousand people died every year in Brazil due to tobacco consumption-related diseases.  This measure 
was intended to protect public health by reducing the attractiveness of tobacco products, especially 
among children and young people.  He assured Member s that this resolution would not discriminate 
between domestic and foreign producers.  Finall y, Brazilian authorities had circulated a compilation 
of the international and scientific refere nces used as the basis for this measure. 
(xv) China – Requirements for information security products, 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)  
139. The representative of the European Union re iterated concerns on these measures and asked 
for an update on the status of the revision of the 1999 Regulation on commercial encryption products 
managed by the Office of State Commercial Cryptography Administration.  The EU requested 
confirmation that this revision was still formally on the agenda of the State Council Legislative Office 
for 2012, and that the draft regulation was going to  be published before its promulgation and notified 
to the TBT Committee in due time, to allow adequa te opportunity for comments from all interested 
parties. 
140. Secondly, he restated the EU's concern about  the "Multi-Level Protection Scheme (MLPS)", 
which required the classification of IT systems acco rding to their importance for national security.  
The EU requested that the classification of IT sy stems be carried out in a more transparent and 
predictable manner.  He inquired as to how ma ny IT systems had been assessed according to the 
MLPS criteria, in what sectors, and how many had been considered as critical infrastructure.  The 
EU's concern was that sectors such as banking, insurance, transport and energy, which were not, 
strictly speaking, sensitive for national security, would be classified as critical infrastructure, 
significantly affecting the ability of products incorp orating foreign technology to be used in those 
sectors. G/TBT/M/57 
Page 30  
 
  141. Thirdly, the EU also requested an update on th e six information security standards that had 
been submitted for consultation in July 2011 by th e Information Security Standardization Technical 
Committee (TC 260) managed by the China Electronics Standardization Institute (CESI).  He asked to what extent the comments received had been taken into account in the final drafts, and whether these 
drafts had been published. 
142. Fourthly, the EU recalled that, in the previous  TBT Committee meeting, it had also mentioned 
a new concern, on radio-frequency based mobile payments, i.e. payments that could be made with a 
mobile phone. In May 2012, European industry  had held meetings with the China National 
Information Technology Standardization (NITS) on the new standard on radio frequency-based 
mobile payments, where it had been confirmed that  the new standard required users to implement n 
algorithm which would not be defined in the sta ndard itself (and thus generically referred as 
"Algorithm E"), but one of the existing national algorithms whose intellectual property rights belonged to Chinese holders.  In the absence of clear information in the standard about the content of 
the algorithm and the conditions under which the al gorithm could be accessed, the EU had serious 
concerns about the workability of the standard in pr actice. He therefore requested that the algorithm, 
its content, its use, and its accessibility be clearly defined in the standard itself.   
143. Finally, considering the global nature of the re levant market, the EU strongly believed that it 
would be beneficial to all participants -includi ng Chinese manufacturers - to develop these standards 
in the most inclusive way, allowing the particip ation of all interested actors, including foreign 
stakeholders, from the start. 
144. The representative of the United States supported the EU comments which they had raised in 
bilateral meetings with China.  The US was c oncerned about the requirement to use only Chinese 
intellectual property in the core components of IT security products, and urged China to implement 
the MLPS regime in the least trade restrictive po ssible way.  Regarding China's 1999 Regulation, the 
US requested China to notify any revisions of this  measure to the TBT Comm ittee to allow interested 
parties to comments on them.  Any expansion of th e scope of the 1999 Regulation to cover more IT 
products would create trade disruptions across a broader swath of the global IT sector, similar to those 
created when China issued the first version of th ese regulations, before their scope was limited to 
products whose core function was encryption.  Such  an expansion could call into question whether 
this measure was the least trade restrictiv e means to assure China's objective.   
145. The representative of Japan supported the EU and US comments, adding that China's 
regulations on information security were not in li ne with global norms and approaches and, thus, 
posed difficulties for the future of international trade on information security products.  Japan was 
closely monitoring the potentially negative eff ects of these measures on international trade. 
146. The representative of China recalled bilateral talks with the EU and the US.  The 1999 
Regulation was still being redrafted, therefore, he had no update to provide on it.  As to the MLPS, 
China encouraged the EU, US and Japan to explain how  their products were affected by this measure.  
He asked Japan to explain why it did not consider  that this measure conformed to global norms on 
information security.  He added that it had been made  clear during bilateral talks with the EU that the 
six information security standards submitted for consultation by the TC 260 managed by the CESI, 
were voluntary.   
147. Five new standards on radio frequency-based mobile payments, issued by China National 
Information Technology Standardization (NITS), ha d been open for public comment from January 19 
to March 2, 2012.  The European Chamber of  Commerce had submitted comments which were 
discussed with the Chinese authorities on 13 April 2012.  He explained that these standards did not set 
up a patent pool and, thus, did not prevent the u se of foreign technology in radio frequency-based  G/TBT/M/57 
 Page 31 
 
 
  mobile payments.  However, the use of any pate nted technology in radio frequency-based mobile 
payments would require the authorization of the patent holder. 
148. He clarified that the reference to "Algorithm E"  in the standard served simply as a symbol for 
text description; it did not specify any particular algorithm.   
(xvi) China – Administration on the Control of Pollution Caused by Electrical and Electronic 
Products (G/TBT/N/CHN/140, G/TBT/N/CHN/140/Add.1, G/TBT/N/CHN/140/Rev.1) 
149. The representative of Korea reiterated her delega tion's request for China to indicate the date 
on which these revised regulations were scheduled to enter into force; to pr ovide detailed information 
on the management catalogue of standards; and to reduce the number of items in this catalogue.  She 
also inquired if the certification procedures establis hed in these regulations were mandatory; whether 
the Chinese authorities had identified certain certific ation bodies and laboratories eligible for State 
Recommendation Voluntary Certification on Elect ric Information Products; and whether China 
provided any incentives, such as tax relief, in exchan ge for complying with certification requirements.  
Korea believed that the use of such incentives could in practice, turn a voluntary standard into a 
mandatory measure.  Lastly, she requested China to  include in its State Recommendation Voluntary 
Certification System, the possibility of submitting c onditional suppliers' declar ations of conformity 
(SDoCs).  For example, China could allow compan ies with good quality records or with no problems 
detected at market surveillance to do SDoCs for a certain period of time. 
150. The representative of the European Union su pported Korea's comments and requested an 
update on the measure notified in G/TBT/N/CHN/14 0 Rev. 1 and on the discussions on the type of 
conformity assessment to determine compliance with the requirements of this measure.  The EU also 
recalled its previously raised concerns on the use of  mandatory third-party certification in this field. 
151. The representative of China recalled the 2010 revisi on of this measure, and its notification of 
21 October 2010 in G/TBT/N/CHN/140 Rev.1.  The measure was under revision and the Management 
Catalogue and corresponding conf ormity assessment procedure would be determined after the 
measure was promulgated.  In April 2012, the Certification and Accreditation Administration 
(CNCA) and China's Ministry of Industry and Information Technology (MIIT) jointly launched the 
Confirmation on Certification Bodies and Labor atories Engaged in the State-Recommended 
Voluntary Certification on Electronic Information Products.  The corresponding certification procedures would be launched soon, with the aim of allowing enterprises to choose freely qualified 
certification bodies. 
(xvii)  Indonesia – Draft Decree of Minister of Industry on Mandatory Implementation of Indonesia 
National Standard for electrolysis tin coat ed thin steel sheets (G/TBT/N/IDN/46) 
152. The representative of Korea request ed an update on the status of this un-adopted draft decree.  
He restated Korea's view that Indonesia should regulate final, and not intermediate, products. 
153. The representative of Japan supported Korea, addi ng that finished products, not intermediate 
materials, were relevant for the protection of hum an health or safety.  Japan was concerned that 
further expansion of mandatory standards for st eel imports from Japan, which were produced under 
strict quality management systems at steel mills, would increase the time and resources required to 
receive and maintain certifications, thereby incr easing distribution costs and delaying deliveries in 
specific Indonesian industries.  These negative imp acts could even make Indonesian industries less 
competitive in global markets. 
154. The representative of Indonesia said that the nati onal standard SNI for electrolysis tin coated 
steel sheets was still under revision.  On the ISO 9001 standard, product certif ication was not similar G/TBT/M/57 
Page 32  
 
  to the management system of certification.  Therefore, manufacturers certified under ISO 9001 had to 
comply with product certification or SPPP SNI.  I ndonesia welcomed continued bilateral discussions. 
(xviii)  China – Provisions for the Administrati on of Cosmetics Application Acceptance 
(G/TBT/N/CHN/821) 
155. The representative of Japan recognized Chin a's efforts to address Members' concerns 
regarding these provisions, noting that China's Stat e Food and Drug Administration (SFDA) preferred 
bilateral technical exchanges be tween competent authorities which were responsible for safety 
examinations.  Japan recognized the importance of such dialogues.  Howeve r, Japan was concerned 
that most Japanese applications of new plant extract s and ferments were rejected because the safety 
evaluation was not carried out as a single substance, but as a mixture or complex. These new 
ingredients, having passed safety evaluations, were used in finished products already on the Japanese 
market and had not caused any consumer safety proble ms.  Only 2 applications in the two years after 
the publication of these provisions have been approved  for new ingredients.  Thus, exports of many 
cosmetics containing other new ingredients were blocked.   
156. Japan believed that this was a trade-restrictiv e requirement unnecessary to ensure the safety of 
cosmetics containing new ingredients.  It consider ed that the best way to evaluate the safety of 
cosmetic ingredients was to conduct tests with th e same substance that was used in the finished 
product, as accepted by international safety manage ment practices and other countries such as Japan, 
the EU and the US.  Japan requested China to a pprove applications of plant extracts from a single 
substance or of plant ferments without requiring th e exclusion of solvents or other substances.  
Alternatively, Japan invited China to provide sci entific grounds for the exclusion of solvents from 
other substances or risks that were derived from the evaluation without exclusion of solvents by 
taking specific examples supporting China's claims.  He recalled China's announcement during the last Committee meeting that solvents from plant ex tracts would be handled on a case-by-case basis.  
To ensure fairness, he asked for clear guid ance on the kind of solvents to be isolated. 
157. The representative of the Europ ean Union restated EU concerns about the significant trade 
disruptions from these requirements since April 2010 .  The approval of products with new ingredients 
continued to be blocked, despite the 2011 publicat ion of the Guidelines for the registration of new 
ingredients.  She requested an update on China's measures to address this problem.  She hoped that 
further dialogue at the expert level between th e SFDA and the European Commission's Directorate 
General for Health and Consumers woul d lead to a satisfactory solution. 
158. The representative of the United States supported the EU and Japanese comments.  It was her 
understanding that the SFDA's reclassification pr oposal would impact more than 70 per cent of 
cosmetic products being marketed in China.  US  industry reported that registration of ordinary 
cosmetics could typically take many months.  Moreover, the additional requirements imposed on 
"new ingredients" in April 2010 resulted in a virtua l standstill in approvals fo r cosmetics containing 
new ingredients, evidenced by the fact that only two new ingredients had been approved for use in 
China, despite their acceptance in  the US and European markets.  The US was concerned that the 
criteria used by SFDA to create a new category of "special function" cosmetics was not transparent 
and appeared to differ significantly from those a pplied in other countries;  this created unnecessary 
delays and significantl y disrupted trade. 
159. She welcomed a recent SFDA call for comment s on non-special use cosmetics category 
management, recalling that, on 1 May 2012, the US submitted comments through its Enquiry Point.  
She urged China to continue dialogue with all inter ested parties regarding these measures and to take 
into account the comments received.  China should also  consider alternative measures that were more 
commensurate with the risks involved, such as post-market surveillance and reliance on  G/TBT/M/57 
 Page 33 
 
 
  internationally-recognized good manufacturing practices (GMPs).  These alternatives would meet 
China's legitimate regulatory objectives with l ess disruptive effects on international trade. 
160. The representative of China recalled bilateral ta lks with Japan the day before where they 
learned of Japan's comments submitted through its Enquiry Point on 6 June 2012.  The SFDA would 
reply to these comments in written form.  Alt hough China had already provided sufficient 
information, it remained open to future bilateral, t echnical exchanges, and hoped to be able to provide 
more detailed answers to Japan's questions at the next TBT Committee meeting.  Concerning the 
classification and management of non-special cosm etics, the SFDA requested comments on-line from 
the public from February to March 2012.  On 28 March 2012, China notified the corresponding 
revision in G/TBT/N/CHN/887.  Moreover, the SFDA called again for public comments on-line from 
29 May to 15 June 2012.  He welcomed all the comments and concerns from interested parties. 
(xix) Colombia – Alcoholic beverages (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) 
161. The representative of the European Union recogni zed Colombia's efforts to address some EU 
concerns.  However, on 23 March 2012, the EU subm itted a new set of comments to which Colombia 
had not yet responded.  The EU was still concerned about the definition of Gin, particularly the 
definition of London Gin, and considered that the re quirement to fix labels at the origin could be 
problematic, particularly for imports of low vo lume.  Labeling in warehouses should be accepted for 
imported products since the information to consumer s would be provided anyway.  She also asked if 
the requirement that issuance of a sanitary insp ection certification be based upon the presentation of a 
quality certificate issued by the manufacturer and co mplemented by physical sanitary checks was also 
applicable to locally produced goods.  For imported alcoholic beverages, this requirement could be 
substituted by the quality certificate and random physi cal sanitary checks, when deemed necessary.   
162. The representative of Colombia said that the measure  would enter into force in July 2012.  All 
comments had been taken into account, including th e EU's concerns on labeling products at origin. 
(xx) Korea – Good Manufacturing Practice requi rements for cosmetics (G/TBT/N/KOR/301) 
163. The representative of the Eur opean Union asked for an update on Korea's indication in the 
previous Committee meeting that the Cosmetic s Act would be amended to allow foreign 
manufacturers to apply for KCGMP certification.  She also reiterated the EU's request for the Korean 
Food and Drug Administration (KFDA) to accept certif icates issued by independent third parties 
proving compliance with ISO 22716, or self- certification by cosm etic manufacturers. 
164. The representative of Korea announced that the Cosmetics Act would be amended to revoke 
the Cosmetics Standards and Test Methods.  The En forcement Regulations of the Cosmetics Act had 
also been amended to allow manufacturers to sel f-select testing items during quality inspection of 
final products.  Furthermore, the KCGMP would be  amended, and re-notif ied during the second half 
of 2012.  However, in compliance with Article 2. 1 of the TBT Agreement, equal treatment under the 
KCGMP meant that both domestic and foreign manufacturers must receive an independent KFDA 
certification even if they had third party certifi cation from an overseas certification body attesting 
compliance with international standard ISO 22716. G/TBT/M/57 
Page 34  
 
  (xxi) 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) and Ministry of Finance No.: 4629/BTC-TCHQ on the importation of spirits and cosmetics (7 April 2011)  
165. The representative of the United States said th at both notices, the Ministry of Finance 
Document Number 4629 on the import of spirits and cosmetics and the Ministry of Industry and 
Trade Notice Number 197 on the import of alcohol, co smetics and mobile phones, appeared to be 
legally binding as of June 2011, and involved new conformity assessments  procedures.  In addition, 
they seemed to require specific quality control proc edures, such as the submission of quality control 
certificates and the designation of specific ports in ch arge of control.  Answers provided by Viet Nam 
to comments raised were not satisfactory.  For in stance, Viet Nam denied that the measures were 
legally binding or created any new requirements, while acknowledging the US interpretation.  She 
urged Viet Nam to notify these measures to the TBT Committee, to suspend their implementation 
until comments were received and ta ken into account, to modify the measure as appropriate, and to 
provide a reasonable period of time for suppliers to comply. 
166. The representative of New Zealand continued to  monitor these measures and requested an 
update as to whether Viet Nam intended to establis h a new certificate of quality achievement process 
for alcoholic beverages and cosmetics as proposed  in the MOF Official Letter 4629/BTC-TCHQ of 7 
April to MOIT.  If yes, did Viet Nam inte nd to notify this new process to the WTO? 
167. The representative of the European Union supported the US and New Zealand comments.  
She appreciated the additional information provided by Viet Nam.  However, she sought further 
clarification as to whether quality checks applied to all consignments of  alcoholic beverages, 
cosmetics and mobile phones; whether a Quality  Control Certificate should accompany these 
consignments; if so, what entity was in charge of issuing it; and what the timeline for issuing was.  
She also requested further details about this certificat e.  For instance, was there a template to be used; 
what quality standards were to be certified; a nd what other information should accompany this 
certificate? 
168. The EU also inquired as to whether these measu res had resulted in reducing counterfeiting or 
smuggling of these products.  Finally, she requested a clarification on whether these measures were intended to be temporary, and, if so, how long would they last. 
169. The representative of Australia supported the US, New Zealand and EU concerns, adding that 
his delegation was concerned with the conformity  assessment procedures in Ministry of Finance 
Document Number 4629 and  the measures' consistenc y with the TBT Agreement.  The Ministry of 
Industry and Trade Notice Number 197 was an administrative burden on exports, especially for small and medium enterprises, thereby having unintended negative trade consequences. 
170. The representative of Viet Nam confirmed that  responses to questions raised by some 
Members had been sent by email to the respective TBT enquiry points.  He also offered hard copies of 
those answers to interested Members.  He took note of the additional comments and questions made 
during this session which would be sent to the Capital for analysis and future responses. 
(xxii)  Malaysia – Draft Protocol for Halal Meat  and Poultry Production (G/TBT/N/MYS/23) 
171. The representative of the United States inform ed the Committee about productive bilateral 
discussions in February 2012.  The US still had concerns, including on the requirement that 
production facilities be dedicated exclusively to ha lal production, which raised consistency issues 
with the Codex guidelines.  She asked for continue d discussions for a mutually acceptable resolution.  G/TBT/M/57 
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  172. The representative of Brazil shared the US con cerns on the halal facilities.  He encouraged 
Malaysia to align with the relevant  international standard as required by Article 2.4 of the Agreement. 
173. The representative of the European Union shar ed the concerns of the US and Brazil, and 
requested full transparency of Malaysia's import conditions.  Clear and comprehensive guidelines for 
importers were necessary prior to the implemen tation of such measures, including the public 
availability of draft requirements at an early stag e, sufficient opportunities for economic operators to 
comment on drafts, and a sufficient interval between  publication and entry into force.  The EU was 
concerned that Malaysia's import c onditions were not aligned to the relevant international standard, 
and urged Malaysian efforts to alleviate the im pact of its requirements on foreign producers. 
174. The representative of Argentina reiterated con cerns on the guidelines of the Draft Protocol 
which provided, inter alia , that the facilities to which a country could export be exclusively devoted 
to halal production.  This created unnecessary barrier s to trade and was more trade-restrictive than 
necessary to reach the legitimate objective of guara nteeing that halal meat complied with relevant 
prerequisites and was genuinely halal.  The Code x relied on general guidelines for use of the term 
halal in labelling products. The Malaysia's Protoc ol did not take the Codex guidelines into due 
account.  Seven Argentinian facilities that were author ized to export to Malaysia had been suspended 
by the Malaysian Department of Veterinary Services (DVS) since November 2010 without any 
official communication or warning.   
175. The representative of Turkey said that the Ma laysian Draft Protocol envisaged special 
requirements for production facilities, the handling of products, as well as li mitations on conformity 
assessment bodies.  The Protocol was inconsistent with international rules and practices of Muslim 
countries.  The "Standards and Metrology Institute  of Islamic Countries" (SMIIC), established under 
the Organization of Islamic Cooperation (OIC), had adopted guidelines for standardization, 
certification, and accreditation of halal food.  While it fully supported attempts towards setting 
common halal standards and conformity assessment pr ocedures, such rules and procedures should be 
determined collectively and in close cooperation with other Muslim countries.  Turkey invited 
Malaysia to participate in the development of  common standards, conformity assessment, and 
accreditation procedures on halal food, and to reconsider the Draft Protocol. 
176. The representative of Malaysia indicated that b ilateral discussions were on-going;  Malaysia 
would continue working with its trade part ners to find a mutually acceptable solution. 
(xxiii)  Korea – Regulation on Registration and Evaluation of Chemical Material   
177. The representative of the United States said the US Government and industry appreciated the 
objective of safeguarding public health and the en vironment, and hoped that consultations would 
continue to develop a regulation able to achieve th ese goals with minimum adverse effects on US and 
Korean firms.  Korea's proposed "Act on Registrati on, Evaluation, Authorization and Restriction of 
Chemical Substances" (Public Notice 2011-74) had br oad implications not only for US industry, but 
for producers and importers of chemicals in Ko rea as it created significant changes to Korea's 
chemical regulatory regime.  US industry had expressed concerns with the proposed regulation, 
submitting comments directly to the Ministry of Environment and meeting with the Ministry of Knowledge Economy.  She asked Korea to update the Committee on key issues previously raised 
regarding the proposed annual reporting requirem ent and the 0.5 minimum ton threshold for 
preregistration and registration.  She requested c onfirmation on whether this would increase to 1 ton. 
178. The representative of Korea explained that the Ministry of Environment taking into account 
all Members' comments and no date had been determined  for the finalization of the legislation.  If it 
passed in the National Assembly, subordinate regulati ons would be proposed that would take effect 
one to two years after the proclamation date.  Th e Ministry would notify WTO Members and invite G/TBT/M/57 
Page 36  
 
  comments from stakeholders once a draft of the s ubordinate regulations was published.  On the 
minimum tonnage threshold of 0.5 ton and the annual reporting requirement, the Ministry of 
Environment was considering whether to amend these provisions followin g consultations with 
industry.  It would increase the threshold to 1 ton and extend the mandatory reporting period to every 
two years.  The points raised in the Committee would be conveyed to the competent authorities. 
(xxiv)  Kenya – Alcohol Labelling: The Alcoholic Dr inks Control (Licensing) Regulations, 2010: 
Legal Notice No. 206: 2010 (G/TBT/N/KEN/282) 
179. The representative of the European Union sai d the EU had provided written comments to 
Kenya in April 2011.  This measure had not been  notified to the TBT Committee, and her delegation 
was still waiting for a written response from Ke nya.  Had Kenya considered less burdensome 
alternatives than mandatory health warning labe lling to modify drinking behaviour?  She also 
requested confirmation on whether the requirement that health warnings comprise at least 30 per cent of the total area of the package had been amended to  30 per cent of the label surface, as stated at the 
November 2011 TBT Committee meeting. 
180. The representative of Mexico said her delegati on had asked Kenya to provide information on 
the implementation of the regula tion published on 17 December 2010.  Her delegation was concerned 
that this bill was in violation of Articles 2.1, 2.2 and 2.9 of the Agreement.  She requested information 
on the implementation of this legislation and a formal reply from the Government of Kenya to observations made on 12 May 2011.  
181. The representative of Kenya took note of the concerns raised.  Written responses would be 
provided to interested delegations. The regula tion notified as document G/TBT/N/KEN/282 had been 
adopted as an emergency measure in response to public concern and adverse effects of alcohol 
consumption, as well as to safeguard against continue d loss of life and to protect public health.  Kenya 
took note of the views expressed by the EU regardi ng public education on re sponsible drinking and 
behaviour change.  Public campai gns to nurture responsible citizen ry had been on-going long before 
the legislation was drafted, and had yet to show ef fect.  The bill was unlikely to make meaningful 
progress anytime soon.  Most of the current court cases came from manufacturers of PET bottles that 
were challenging the requirement that alcohol drinks  being bottled only in glass bottles.  Most of these 
cases had been dismissed; and no conservatory orders  or injunctions had been issued on any of the 
Act's provisions.  The regulation remained in force and Kenya remained open to further consultations. 
(xxv) France – Loi No. 2010-788:  The National Co mmitment for the Environment (Grenelle 2 
Law)  
182. The representative of Argentina reiterated his delegation's concerns about the lack of 
transparency and predictability of the Grenelle 2 Law. In particular, there was concern about any 
labelling requirement, either mandatory or volu ntary, which implied unnecessary or disproportionate 
costs and certification burdens - because these prev ent small and medium enterprises (SMEs) and as 
well as larger companies in developing countries from getting market access to developed countries.  
To begin with, there was a lack of transparency as the law was never notified to the WTO.  For that 
reason, Members had never been able to put questio ns and requests for clarifications and express their 
opinions.  In addition, no information had been provi ded by the EU regarding the consistency of this 
law with the EU regulations.  Moreover, scarce and confusing information had resulted in the absence 
of predictability.  The law had been implemented as a pilot project from July 2011 to July 2012 but its 
status after this period was unclear.   
183. The representative of Argentina stressed that  the law would be an unnecessary obstacle to 
trade due to its formulation, eventual implem entation and impact, particularly on developing 
countries.  The law implied unfair treatment of lik e imported products, particul arly from developing  G/TBT/M/57 
 Page 37 
 
 
  countries, as: (i) discrimination was based on processe s and production methods not directly related to 
the products themselves, like their environmental impact or the emissions from production of a good; 
(ii) the accounting of carbon emissions, as a result of distribution and transport, would be negligible 
for EU goods compared to geographically distant co untries and (iii) the costs of certifying products 
would be more significant for a company from a deve loping country than from a developed one.   
184. The representative of India supported Argentina's statement.  He urged the EU to notify the 
measure, and requested clarifications on the methodology and period used to compute the carbon 
footprint of products, i.e. whether it was computed over the entire product lifecycle or were there any 
assumptions made in the computation; and whether regulatory impact assessments had been carried out by the EU, specifically with regard to effect s on developing country Members.  Had consultations 
been carried out with WTO Members, and were the special and differential treatment provisions in 
line with Article 12 of the Agreement?  Did the measures cover both agricultural and NAMA 
products; was it based on the relevant international st andard?  Lastly, he asked for a clarification of 
the standards on which was based the provision in th e law, requiring members to provide a certificate 
that fish and fish products on sale in the French ma rket had been raised in a sustainable manner.   
185. The representative of South Africa shared Arge ntina's and India's concerns and requested 
further information.  The regulation would partic ularly impact exports from developing countries to 
the EU, particularly because of the geographical di stance of developing countries, and historic trade 
links as former colonies of EU Member States.   
186. The representative of Uruguay expressed his dele gation's concerns on possible adverse effects 
of carbon footprint labelling on SMEs in developing countries. 
187. The representative of Cuba recalled previous discussions, as well as the Spanish legislation on 
biofuels discussed during the morning session.  Cuba shared concerns and doubts on the extent to 
which the legislation would mitigate adverse eff ects on climate change.  The measure would have 
adverse effects on developing country companies, and th e lack of a scientific basis for the legislation 
was discriminatory towards developing countries.   Cuba requested clarification and additional 
information and asked whether the effect on de veloping countries had been taken into account. 
188. The representative of the European Union recalled that the provision of the Grenelle 2 Law on 
carbon labelling was an experiment without long-t erm measures. He referred to the minutes of 
previous meetings for information on the objective and scope of this legislation.  The pilot project was 
under way until the end of 2012.  For transparency  and cooperation, and to ensure that trading 
partners fully understood, the EU could share the re sults of this French experiment once these were 
known. 
(xxvi)  Korea – Proposed Cosmetics Labelling an d Advertisement Guidelines: KFDA draft 
Guidelines for Management of Nanomateri als in Cosmetics (G/TBT/N/KOR/308, 
G/TBT/N/KOR/362) 
189. The representative of the European Union reiterate d her delegation's concerns, particularly on 
those related to the control of claims in foreign la nguages.  The EU also asked for clarification on the 
link between these Guidelines, notified under G/ TBT/N/KOR/308, and the draft Notice on the 
Substantiation of Cosmetics Labelling and Adve rtisement notified under G/TBT/N/KOR/362.  Did 
Korea intend to revise the Guidelines to bring them in line with the new Notice and, if so, would 
Korea notify the revised Guidelines?  Finally, she thanked Korea for its openness to discuss these 
issues bilaterally. 
190. The representative of the United States clarif ied that her delegation was commenting on 
G/TBT/N/KOR/308.  She appreciated Korea's accepti ng the comments of US industry on the timeline G/TBT/M/57 
Page 38  
 
  for implementation, and requested Korea to consider  additional changes.  The requirement to list the 
address of a manufacturer and marketing authoriz ation holder, a manufacturer's name, and the 
location of imported cosmetics on the primary or secondary packaging was difficult and could 
confuse the consumer.  She suggested only requiring th e marketing authorization holder on the label.  
191. US industry had expressed concern that the pos itive and negative claims list in KFDA's 
"Guideline for Cosmetics Labelling and Advertising" applied to claims printed in Hangul as well as 
English.  This would restrict companies' ability  to market English-marked products in multiple 
markets.  The US understood Korea's possible con cerns regarding consumer deception through false 
labelling, but considered that the objective woul d be better addressed through consumer protection 
laws.  She requested an exemption for claims printed in English to enable all industry participants to 
market the same product in multiple countries.     
192. The representative of Korea explained th at specific standards for the Cosmetic 
Advertising/Labelling scheme came into effect on 5 February 2012 following the Amendment in the 
Cosmetic Act.  KFDA had specified the standards under the Cosmetic Act and had notified the draft 
'Regulation on Substantiation of Cosmetics Labellin g and Advertisement' in April 2012.  Overlaps 
with regard to specifications on the substantiation of the cosmetics labelling and advertisement in the 
two laws would be deleted after the latter's fina l notification.  KFDA could not exempt foreign 
languages from labelling items that required regulation.  Product name s, written in foreign languages 
on imported cosmetics which could deceive consumers,  were to be regulated under the revised as well 
as the previous Cosmetic Act.  The Guidelines sp ecified the methods of modification for importers 
with regard to correction, deletion and over-labelli ng for advertisements or labels written in foreign 
languages.  The draft Guideline for cosmetics c ontaining nanomaterial was provided in December 
2011 as uploaded on KFDA's website.  This guide line contained information on labelling safety 
document verification in the submission of cosmetics containing nanomaterials. 
(xxvii)  Colombia – Commercial Truck Diesel Emissions Regulation  
193. The representative of Mexico appreciated the meetings held between the Mexican private 
sector and Colombian ministries.  She asked for in formation on the status of the planned amendment 
and a formal reply to Mexico's communication of 5 September 2011, 30 January and 11 April 2012.  
194. The representative of the United States a ppreciated the regulator dialogues between 
environmental experts in Colombia and the US.  Th e trade impediment cited at the Committee's last 
meeting would not be an issue if Colombia was to make 15 parts per million sulphur fuel available.  
This would permit Colombia to achieve highe r emission reductions, while yielding greater 
environmental and health benefits.  Many count ries had made or were making this transition, 
including in Latin America.  The US would mon itor developments and looked forward to working 
with Colombia on this issue.  
195. The representative of Colombia clarified that the texts were preliminary, and not yet official 
drafts.  As soon as the content was defined, they  would be notified for comments, and Colombia 
would provide formal replies to questions raised. 
(xxviii)  Peru – Draft Supreme Decree approving the regulat ions governing the labeling of genetically 
modified foods (G/TBT/N/PER/37)  
196. The representative of Mexico said that, on 14 September 2011, his delegation had presented 
comments on the draft notified under G/TBT/N/PER/37 of  27 June 2011.  It requested a formal reply 
to its questions regarding the status of implementation of the draft decree.     G/TBT/M/57 
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  197. The representative of Canada hoped that his delegation's previously sent comments were 
reflected in subsequent changes to the regulation,  and asked for information on the status of the 
measures and their application.    
198. The representative of Chile requested an update on the status of Peru's Draft Supreme Decree 
on which Chile had presented comments at past Co mmittee meetings.  She hoped Peru would take 
into account her delegation's suggestion to extend the timeframe beyond 180 days so that industry 
would have sufficient time to adapt to the new obligations.   
199. The representative of Colombia had expressed his delegation's concerns at the past two 
Committee meetings and asked for a reply and an update on the status of the draft measures. 
200. The representative of Peru said that the preparation and adoption of the Draft Supreme Decree 
was under way; Peruvian authorities were assessing comments received.  The multi-sectoral working 
group in charge of this draft regulation would con tinue its work and did not specify a publication date 
for the final regulation.  Peru would announce the changes to the draft before final adoption.  The 
draft regulation never put into question the safety of genetically modified foods as some comments 
suggested; it sought to guarantee clear and precise in formation for consumers on various products, to 
avoid any type of potentially misleading practi ces and to ensure the security of consumers. 
(xxix)  India – Toys and Toy Products (Compulsory Registration) Order 
201. The representative of the United States reiterate d concerns about India's measure developed 
by the Ministry of Consumer Affairs Bureau of Indian Standards (BSI) that would impose additional 
conformity assessment on foreign toy manufacturers.  Appreciative of information provided by India at the last meeting, her delegation considered th at early engagement with stakeholders on draft 
measures meant gathering of information from a wide  range of perspectives, to assist regulators in 
crafting measures that achieved legitimate goals in  the most efficient and effective manner.  The 
notification and comment provisions of the TBT Agreement were aimed at enabling regulatory 
officials to find trade facilitative solutions and a void unnecessary obstacles to trade.  In light of the 
extensive trade concerns, the US urged India to wo rk with the BIS, the Mi nistry of Commerce and 
Industry's Director General of Foreign Trade (DGF T) to ensure transparency, adherence to WTO 
obligations, and trade -facilitative solutions.  
202. The representative of the European Union sup ported the US statement.  Associating all 
interested parties, including foreign stakeholders , in the development of new conformity assessment 
procedures was important if significant changes to the current regime, reflecting the intention of 
moving towards a system of mandatory testing by domestic laboratories coupled with onerous 
registration procedures, were being contemplated.  The EU also requested an update on the timeline 
and a transparent and open process leading to  eventual notification of the measure. 
203. The representative of India recalled that the issu e had germinated from informal consultations 
held by the Department of Industrial Policy and Promotion (DIPP) on specific guidelines for 
registration of toys.  He assumed that the US, EU  and other Members' industry were aware that the 
Government was having preliminary discussions on fo rmulating a registration order.  The DIPP had 
not produced a draft guideline yet.  If it did, India would notify it to the WTO and provide a draft on the website.  G/TBT/M/57 
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  (xxx) 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. 
204. The representative of the United States had highl ighted concerns at Committee meetings in 
November 2011 and March 2012 over this draft volunta ry standard.  It inquired about the purpose of 
the new national voluntary standard, an office equipm ent information security standard designed as an 
alternative to IEEE 2600, which was an internationa l information security standard.  Her delegation 
understood that the draft had been released for pu blic comment for 30 days by a standardization 
institute under China's Ministry of Industry and Information Technology (MIIT), the China 
Electronics Standardization Institute (CESI), and th e China National Information Security Technical 
(NITS) Standards Committee (TC260, Working Group 5).       
205. In the interim, US industry had noted several  improvements and positive developments in the 
most recent revisions, such as the removal of consumables from the product scope and the narrowing 
of applicable encryption requirements to exclude  non-sensitive data.  The US understood that China 
might be developing conformity assessment procedur es related to this standard.  With a view to 
harmonising conformity assessment procedures on as wide a basis as possible, her delegation 
encouraged China to base these on relevant guides and recommendations of international 
standardizing bodies, and, where appropriate, to play  a full part in their preparation of guides and 
recommendations for conformity assessment procedur es.  The US remained concerned about China's 
plan to implement a national voluntary standard for wireless Local Area Network (LAN) devices, 
which seemed to diverge from an existing international standard, IEEE 802.11n.   
206. On 13 February 2012, China's MIIT had announ ced the finalization of the standard on its 
website.  The US was concerned that the standard might be incorporated into type approval, CCC 
mark registration or other certification processes.  She encouraged China to include all relevant and 
interested parties in the development of th ese central government standards and conformity 
assessment procedures, and to notify drafts of the new conformity assessment procedures, when 
available, so that all Members could comment and have their comments taken into account.       
207. The representative of Japan supported the US co mments.  His delegation believed that this 
standard was being finalized and requested that it  be harmonized with inte rnational standards to 
alleviate trade concerns in security-related products .  Japan appreciated the admission of foreign, 
including Japanese, manufacturers in the drafting process, and hoped that their comments would be 
reflected in the final drafts.  He asked China to provide information on implementation of recent 
drafts, including on the office device standards,  which applied to each Member's demands.  
208. The representative of the European Union sup ported the US and Japanese statements.  The 
development of standards would have benefited from greater involvement of foreign stakeholders and 
all interested parties.  His delegation welcomed  the publication of draft standards by the TC260 
Working Group 5 for consultation, but would have appreciated greater transparency throughout the 
process.  He hoped that comments from foreign stakehol ders would be reflected in the final draft and 
recommended transparency and involvement of af fected parties in case any conformity assessment 
procedures were developed in relation to these sta ndards, and that any standards made mandatory 
through conformity assessmen t procedures be notified. 
209. The representative of China inform ed that the standard was voluntary, currently in the process 
of approval, with no plan for certification consider ed yet.  Regarding high spectrum efficiency and 
high throughput WLAN technical requirements, he referred to the minutes of the last Committee 
meeting.  China would continue to monitor developmen t of the relevant international standards in this 
regard.  G/TBT/M/57 
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  (xxxi)  Indonesia – Technical Guidelines for the Impl ementation of the Adoption and Supervision of 
Indonesian National Standards for Obligatory Toy Safety 
210. The representative of the European Union re quested an update on the timeline for the 
finalization of the draft conformity assessment pr ocedures, supporting the application of Indonesia's 
mandatory toy safety standard that had been adopted by the Indonesian Minister of Industry in May 
2010.  He requested that the process be conducted in a transparent and open manner, allowing all 
stakeholders to provide input, and to finalize measu res only after all parties had had an opportunity to 
comment.  He sought reassurance that the measure w ould be notified in due time to the Committee.  
211. European industry had concerns on the latest draft of the conformity assessment procedures 
which appeared quite burdensome and were based on mandatory product testing.  This implied, on the 
one hand, mandatory testing of every shipment of toys imported into Indonesia (compared to every 
six months for domestic products), and on the othe r hand, certification of the product management 
system of the manufacturer through on-site ve rification of production facilities and process and 
quality control of production.  His delegation understood that the appr oach was to reserve testing for 
domestic laboratories appointed by the Minister of  Industry or accredited by the Indonesian national 
accreditation body (KAN).  Foreign labs would be allo wed to perform this testing provided they were 
covered by a mutual recognition agreement (MRA ) to which KAN or the Indonesian Government 
were a party.  Since KAN was a signatory to ILAC, th e EU sought confirmation that the test results of 
laboratories accredited by signatories of the ILAC MRA would be accepted under the new rules.  
Likewise, the EU considered that the certification of the quality management system of the manufacturer should rest on a certification of compliance with the ISO 9001 standard.  He requested 
that certificates of compliance with ISO 9001, issu ed by bodies accredited by signatories of the IAF 
MLA, also be accepted under the new rules.  The EU confirmed the EU toy industry's desire to co-
operate with Indonesian authorities on this issue and welcomed further dialogue.  
212. The representative of the United States supported th e EU's comments and asked for an update.  
The US had raised concerns over these conformity  assessment procedures at November 2011 and the 
2012 meetings.  She encouraged Indonesia to enga ge in bilateral discussions on these issues, 
including with regard to the acceptance of testi ng done by bodies accredited by ILAC and IAF MLAs.   
213. The representative of Indonesia informed that th is measure was currently being notified to the 
WTO and said his delegation welcomed furthe r bilateral discussions with both countries. 
(xxxii)  Korea – National Tax Service Notice 2011-17 (Requirements for Radio-Frequency 
Identification Tags for Import ed Whiskeys (G/TBT/N/KOR/338) 
214. The representative of the United States asked fo r a reply to comments sent on 27 February 
2012.  She requested more details on Korea's indi cation at the March 2012 Committee meeting that it 
would make available tax reductions to domestic  and foreign manufacturers to help with costs 
associated with the equipment nece ssary for radio frequency id tags .  The US understood that Korea 
was implementing the Notice to enable consumers to ensure brand authenticity and to provide 
information to authorities on tax payments.  Her dele gation supported the legitimate goals associated 
with preventing counterfeiting and co llecting tax payment information, but considered that this could 
be met through less burdensome methods.  She requ ested an extension to 1 October 2012 of the 
implementation date to provide compan ies with sufficient time to prepare. 
215. The representative of the European Union expr essed some concerns that the measure could 
cause financial and logistical burdens to small Eur opean whisky producers that exported to, or that 
sought to enter the Korean market.  She asked for more details, including on th e application procedure 
for the tax reductions granted to companies that had to comply with these requirements that Korea had mentioned at the March 2012 meeting.  Korea had in formed that the National Tax Service that it G/TBT/M/57 
Page 42  
 
  would allow exemptions subject to prior approval in individual cases, such as those that malfunction 
or where there is difficulty tagging small bottles.  The EU asked for more information on granting 
these exemptions, for instance whether they would be provided on a case by case basis upon request by the economic operator concerned.  Furthermore,  what were the conditions economic operators had 
to comply with and how could they apply to bene fit from these exemptions? Finally, the EU enquired 
whether Korean authorities were considering issu ing additional technical guidelines to clarify 
questions related to the implementation of Notice 201 1-17.  She asked for a reply to the EU's follow-
up questions.   
216. The representative of Korea noted that the competent authority, NTS, had replied to the US 
and the EU this week.  An RFID tag included a ll information on importers and wholesalers so that 
producers could be protected from counterfeits by trac ing transactions of each whiskey.  This measure 
enabled consumers to drink whiskey with greater  safety, and might benefit whiskey exporters by 
curbing trade in counterfeit whiskeys.  Att aching an RFID tag was necessary to prevent 
counterfeiting;  it was impossible to determine wh ether an individual prod uct was counterfeited by 
just scanning the bar code.  An RFID  tag proved the product's authenticity, and enabled a user to track 
all previous transactions involving that product.  The tag was designed to break when a bottle was 
opened to prevent an individual from acquiring an empty or refilled bottle  of whisky.  For this reason, 
the lot code, as requested by the EU, could not be  considered as a less expensive alternative.   
217. She hoped that producers would use certificates of origin in conjunction with RFID tagging.  
However, according to Article 236 of the Cust oms Law Enforcement Ordinance and to avoid 
unnecessary costs for importers, a certificate of origin  issued by the competent authorities in the 
country of origin was currently only required for the first shipment of whiskey from each importer.  If 
Korea was to require a certificate of origin for every individual product, costs would inevitably 
increase.  She considered that such a requirement was not sufficient to deter counterfeiting.  Since 
2008, the Korean Government had invested a signi ficant portion of the national budget in the RFID 
business and was making every effort to minimize in conveniences to whisky importers by subsidizing 
the purchase of RFID scanners.  As the RFID t echnology was gradually de veloping, the NTS was 
consulting with experts to find solutions that would allow data to be readable if the RFID chip was 
placed in the cap seal or in the packaging.  As for issues such as malfunction or the difficulty of 
tagging a very small bottle, the Korean authority wo uld allow attaching the tags to individual cases or 
cartons with prior approval.  If such an exem ption was granted, producers and importers were 
responsible for any issues that could arise as a result of  the distribution of counterfeit whiskey.        
218. Her delegation considered that there had been  plenty of time since the measures had been 
announced in July 2011 and the October implemen tation was expected to proceed smoothly.   
Importers were currently preparing to adopt the RFID tag system.  Since a civic organization had 
recently complained that the system constitute d unfair discrimination against Korean domestic 
whiskey manufacturers, an extension of the im plementation date could strengthen their case.  
However, she stressed that RFID tags would not have  to be attached to whiskey bottles sold to liquor 
retailers before 1 October 2012.  Regarding the EU's request for an  exemption for companies that 
exported small amounts of whiskey (i.e. less than 5 per cent of the whiskey market), Korea explained 
that domestic whiskey manufacturers accounted fo r only around 1 per cent of Korea's whiskey 
market, but were required to attach RFID tags to their products since 2010.  Thus, such an exemption 
could not be granted.  The other points raised would be conveyed to the competent authority. 
(xxxiii)  Argentina – Resolution 453/2010 establishing m echanisms in order to eliminate dangers 
arising from the use of inks with a high lead content in graphic products (G/TBT/N/ARG/166/Add.7) 
219. The representative of the European Union thanke d Argentina for information on this measure 
and for its reply to the EU's comments.  However, they did not address the EU's concerns.  First, the  G/TBT/M/57 
 Page 43 
 
 
  measure had been adopted and published at the time of notification, and it had not been notified in 
draft stage.  Second, the EU welcomed that a sw orn declaration would be allowed for a transition 
period for inks, lacquers and varnishes.  However,  her delegation understood that this was only a 
transitional provision until the entry into force of the administrative act establishing the definitive conformity assessment regime. For graphic products , the EU noted that mandatory third party 
certification would apply progressive ly and only above certain amounts of production.  In light of 
Article 5.1.2 of the TBT Agreement, and in view of  the future administrative act, while the EU shared 
the objective of protecting health and environmen t through maximum levels for lead, a mandatory 
third party certification did not seem proportionate to the risk involved.  The EU asked Argentina to 
consider removing the certification procedures or to simplify them by accepting a permanent sworn 
declaration for all products covered by the order.  If Argentina insisted on a compulsory third party 
certification procedure, could tests carried out in internationally accredited laboratories within the EU 
be accepted for certification?  If not, what were the reasons for obliging operators to test in 
Argentina?        
220. The representative of Argentina pointed out that the EU's concern about the possibility to 
submit a foreign sworn declaration of conformity was already contemplated in the provision of the 
national trade office 26/2012 for all products included  in Article 1 of Resolution N° 453/2010 (i.e. 
inks, lacquers, and varnishes used in the graphic i ndustry).  As to products in Article 2 of this 
Resolution (i.e. printed graphic products), the same provision 26/2012 established a chronogram of deferred dates for the entry into force of the mandatory certification requirement for 
commercialization, as well as a quantity of cases they  would be able to sell through presentation of a 
sworn declaration.  Argentina considered that the EU and the US comments had been taken account of 
through the regime's flexibility and exte nsion of the deadlines for adaptation.  
(xxxiv)  China – Specification for Import and Export of Food Additives Inspection, Quarantine and 
Supervision (2011 No. 52) - Disclosure of formulas for imported food additives ( 
221. The representative of the United States reitera ted its concerns, in particular with the 
specification requiring the disclosure of formulas for imported food additives sold in China, which 
entered into force on 1 July 2011.  The transp arency issues raised during previous Committee 
meetings had still not been addressed.  In a letter to China of 31 May 2012, the US detailed their 
questions and concerns regarding the serious im pact on legitimate commercial interests from the 
required disclosure of formulas on labels; the reaso ns for China's labelling measures diverging from 
those of the Codex; and from these requirements a ppearing not to apply equally to imported and 
domestic products.  She asked for written responses a nd for a technical dialogue, and urged China to 
suspend implementation until a solution, satisfact ory to the US and China, could be found. 
222. The representative of China reiterated that the obj ective of the specification was to ensure the 
quality and safety of both importe d and exported food additives to  protect human health. The 
mandatory labelling applied equally to both importe d and domestically produced food additives, and 
his delegation did not agree with the US that there were substantive inconsiste ncies with this measure 
and other food additive labelling measures in China, or  that it was inconsistent with Codex standards. 
The law did not require the exact percentages of ingredients to be specified on the label. The labelling provisions in the specification and in the Food Safe ty Law were based on the relevant international 
standard, the Codex Standard for the Labelling of  Food Additives When Sold as Such - Codex STAN 
107-1981 (GSLFA).  Both Article 4 "Mandatory Labe lling of Prepackaged Food Additives Sold by 
Retail" and Article 5 "Mandatory  Labelling of Prepackaged Food Additives Sold by Other Than 
Retail" set out requirements for the labelling of "net  contents" of food additives and provided general 
recommendations for food additive labelling.  Finally, he explained that the standard referred to by the 
United States - Codex STAN 1-1985 (GSLPF) - set out labelling requirements for pre-packaged foods 
in language very similar to that used in Codex STAN 107-1981 (GSLFA). G/TBT/M/57 
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  (xxxv)  Mexico – Refusal of the National Water Commission to re-certify HDPE pipe products 
meeting quality/safety standards for pipi ng set out in NOM 001 and NMX 241 
(G/TBT/N/MEX/206; G/TBT/N/MEX/206/Add.1) 
223. The representative of the United States said th at, despite efforts, Mexico's National Water 
Commission (CONAQUA) was still not certifying pip es from US companies consistent with Mexican 
law and with international trade agreements.  E fforts by the Mexican Department of Economy to 
convey the concerns to the relevant agencies were  appreciated.  The US Government and industry 
would continue to use appropriate formal processes to obtain certification to ensure equal competition 
in the Mexican market.  She looked forward to  continued coordination with Mexico on this. 
224. The representative of Mexico said that the US c oncerns were being followed closely.  The 
CONAQUA authorities had never refused to certify HDPE but Mexico did insist on the application of 
ISO 21138, in conformity with the TBT Agreement.  A number of options had been proposed so that 
products could meet ISO 21138, such as the US st andard ASTM F894, or the standard ASTM F2762 
and F2764. As notified to the Committee in G/TBT/N/MEX/206/Add.2, paragraph 5 of NOM-001-CONAGUA-2011 established that, in  order to meet specifications enshrined in Mexican and 
international standards, for product certification a nd the construction of portable water systems, 
domestic consumption and sanitary sy stems, and in keeping with tho se free trade agreements to which 
Mexico was a party, specific standards could be a pplied if they met the requirements for safety and 
quality, as laid out in Mexican and International st andards.  Mexico was willing to consider US and 
other trading partners' standards as long as they me t with what was set out above.  Those that met 
quality requirements and the relevant standards in the country of origin  would be allowed to enter the 
Mexican market;  Mexico was awaiting formal requests from interested parties. 
(xxxvi)  Russia – Draft on Technical Regulation of Alcohol Drinks Safety published last October 24th 
by the Russian Federation 
225. The representative of Mexico requested an offi cial reply from Russia to concerns submitted 
on 14 December 2011.  In the proposed definitions of tequila and mescal, there was no guarantee of 
denomination of origin which could lead to decep tive practices and misleading consumers. She also 
raised concern with respect to the maximum levels in beer. 
226. The representative of New Zealand raised con cerns on the definition that excluded wine 
produced with Concentrated Must (CM) or Rectif ied Concentrated Must (RCM) to be labelled as 
wine.  There was no relevant international standa rd which distinguished wine produced from CM or 
RCM from wine produced without CM or RCM as these were considered 'like products'.  This 
distinction served no purpose from a consumer prot ection or safety point of view.  Labelling wine 
produced with CM or RCM as a 'wine drink' would render it to be considered of lesser quality and 
value by consumers, and was therefore an unneces sary obstacle to trade under Article 2.2 of the 
Agreement. 
227. The representative of the Russian Federation (O bserver) informed the Committee that the 
Customs Union members had completed internal ne gotiations on the draft and an updated version  
would be published,  with comments and replies received during the public discussion period, on the 
official website of the Customs Union when the of ficial internal procedure of final confirmation 
began. The recognition of conformity assessment results  was not part of this technical regulation and 
therefore each case would be examined in accordan ce with Article 6 of the TBT Agreement.  G/TBT/M/57 
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  (xxxvii)  European Union – Directive 2011/62/EU of th e European Parliament and of the Council 
amending Directive 2001/83/EC on the Community code relating to medicinal products for 
human use, as regards the prevention of the entr y into the legal supply chain of falsified 
medicinal products (G/TBT/N/ EEC/246, G/TBT/N/EEC/246/Add.1) 
228. The representative of India asked that the implemen ting act of the directive also be notified.  
Many Members, including India, could not certify compliance with EU Good Manufacturing 
Practices and this was clearly in breach of Article 12.3 of the Agreement.  India considered that the 
ICH GMP guidelines were not based on the relevant  international standard - WHO GMP guidelines 
on Active Pharmaceutical Ingredients (API), whereby equivalence must be accepted for exports from 
other countries.  He asked for clarification of the de finition of a "falsified medicinal product" as he did 
not see how "history" and "source" were related to  "falsified medicinal products", while quality, 
safety and efficacy were not included in the definition.  Did EU producers of APIs also have to submit 
certificates of compliance with EU GMP guidelines?  Finally he requested that the EU provide a sufficient time period before mandatory enfo rcement to allow industry time to adjust.  
229. The representative of China shared India's c oncerns. While appreciative of the open and 
cooperative way the EU was addressing this issue, he  urged a response to the questions raised at the 
last Committee meeting and to the issues raised sin ce.  The eradication of falsified medicines was 
being undertaken globally, and while China we lcomed EU GMP inspections on Chinese API 
exporters, they were concerned that authentic products  regulated by China could suffer.  He urged the 
EU to use means other than HS codes to distingu ish API products at EU customs.  He also was 
concerned that under the directive, EU holders of manufacturing authorizations of medicinal products 
could verify GMP equivalence of API producers onl y by conducting audits, wh ile imported APIs had 
to also provide a written confirmation to guarantee the GMP equivalence of the exported APIs with 
the EU standards. This had national treatment issues in violation of Article 5.1.1 of the Agreement.  
Also, in the new directive, active substances could only be imported if, inter alia , they were 
accompanied by a written confirmation from the competent authority of the exporting third country.  
This did not match the common international prac tice whereby competent authorities, including the 
EU, only regulated domestic enterprises by their re spective GMP standards. The obligation to fulfill 
GMP requirements fell upon importers rather than  competent authorities of the exporting third 
countries.  China believed that both China and th e EU should assume equal responsibility whereby the 
EU would issue written confirmation according to Chinese standards and report any non-compliance. 
230. Despite EU assurance that the draft template for public consultation released on 16 April 
2012 was based on, and in conformity with, the WH O Model Certificate of GMP, Chinese authorities 
did not find this to be the case.  He urged th e EU to either follow the WHO model certificate 
completely or accept the Chinese GMP certificate as equi valent.  He also urged the EU to provide a 
transitional period so as to guarantee a stable supply into the EU, given that imported APIs accounted 
for 80 per cent of the EU market share; and th at for EU/GMP-certified companies and for Chinese 
companies certified by "white list countries", the wr itten confirmation requirement could be waived as 
for EU MRA partner countries or PIC/S members. 
231. The representative of Brazil associated his delega tion with the Chinese and Indian concerns.  
While appreciative of the bilateral discussions, c oncerns remained on the requirement that the 
exporting countries' regulatory authority should conf irm that the APIs exported to the EU comply 
with GMP standards at least equivalent to those of  the EU.  Brazil's regulatory authorities faced legal 
and administrative obstacles to issue such a confir mation.  He asked that the questions posed during 
the previous Committee meeting on this be addressed .  In particular, would EU authorities be willing 
to certify that the European medicinal products  complied with Brazilian requirements for GMP 
certification?  Finally, he asked for further clarification on comments sent during the public consultation held in March on the criteria to assess the equivalence between GMP requirements 
related to APIs. The EU reply did not address some  technical issues.  Also, there seemed to be a G/TBT/M/57 
Page 46  
 
  misunderstanding as the EU replies wrongly assume d that the Brazilian comments addressed final 
products instead of GMP requirements on APIs. 
232. The representative of the European Union info rmed the Committee that Directive 2011/62/EU 
had been notified to the Committee in 2009 (G/TBT /N/EEC/246) and would be applicable from July 
2013.  It meant that manufacturers of active subs tances in the EU had to comply with good 
manufacturing practices.  Therefore, imported activ e substances also had to be manufactured in 
accordance with standards of good manufacturing practic e 'at least equivalent' to those applied in the 
EU.  The Directive provided that competent aut horities of the exporting countries issue a written 
confirmation establishing that the standards of good  manufacturing practice applicable to the plant 
manufacturing the active substance are at least e quivalent to those in the EU ; this written 
confirmation had to accompany API consignments  imported into the EU.  This confirmation 
constituted a simple system built on trust between co mpetent authorities worldwide. In response to a 
question raised at the previous TBT Committee mee ting, the EU confirmed that EU/ICH guidelines 
for active substances were considered equivalent to World Health Organization GMP guidelines for 
active substances.  Concerning implementation rules,  a draft template for the written confirmation, 
fully in line with the WHO-formatted API GMP cer tificate, had been shared with main trading 
partners.  The EU had discussed this issue repeated ly, organised awareness-raising sessions with third 
countries and remained open to discussing any further issue bilaterally. 
(xxxviii)  China – Measures for the Administration of Certification Bodies 
(G/TBT/N/CHN/798; G/TBT/N/CHN/798/Suppl.1) 
233. The representative of the European Union reitera ted concerns raised previously on measures 
for the administration of certification bodies issued  by China's General Administration of Quality 
Supervision and Inspection and Quarantine ( AQSIQ), and Certification and Accreditation 
Administration (CNCA).  These measures took effect on 1 September 2011. The EU concerns centered on the extra-territorial application of the new requirements which forced foreign conformity 
assessment bodies acting in the framework of mandato ry conformity assessment procedures set out in 
foreign regulations to either open a subsidiary in China or to subcontract their activities to Conformity 
Assessment Bodies (CABs) in China to carry out their tasks.  This approach could impact the ability 
of foreign CABs who were already approved by foreign regulators to fulfill their obligations 
regarding certification of Chinese products intende d for export. China's approach was unique, and 
without precedent in any WTO Member.  He asked China to explain why it considered necessary to 
regulate the activities of CABs performing activities required by the regulations of another country 
and already approved by the competent authorities of  that country. He sought China's assurances that 
activities of foreign conformity assessment bodies,  when acting in the framework of foreign 
regulations and not established in China, would not be covered by the new rules.  Finally, he invited 
China to consider that the requirements set out in the measures at issue could potentially diverge from 
those in force in third countries. If foreign CABs were required to comply with the requirements laid 
down in the Chinese measures as well, that might cause problems with the continued acceptance by 
foreign regulators of certificates issued by such  CABs. He looked forward to continued bilateral 
discussions. 
234. The representative of the United States shared the concerns of the EU and appreciated the 
bilateral discussions.  Work was on-going to gain a full understanding of the measure and its relation 
to the provisions of the Agreement and internationa l standards, as well as to laws and norms of other 
WTO Members.  She asked for clarification on the re levance of the international standard cited by 
China at the March meeting (ISO IEC 17021, ISO IEC Guide 65, ISO 19011) as it dealt with guidelines for auditing management and not product certif ication.  The application of this measure to 
certification bodies providing certification of products for export to the laws or requirements of the destination country meant that the CABs had to comp ly with two, potentially conflicting, sets of legal 
requirements in the certification procedures for a pa rticular product.  Her delegation believed that  G/TBT/M/57 
 Page 47 
 
 
  there was no CASCO standard that pr ovided for the measure to be a pplied in such a manner and that, 
therefore, China was going beyond acceptable practice.    CASCO standards in general did not deal 
with or contravene national laws. She requested China to continue to engage in dialogue with 
interested foreign parties on the implementation of this measure. 
235. The representative of China said this measure was notified on 21 March 2011 
(G/TBT/N/CHN/798), published on 20 July 2011, and entered into force on 1 September 2011. 
Comments had been received from the EU and China had duly replied. The US had submitted 
comments on 5 August 2011, over two months after the comment deadline. Replies to those comments were provided in November 2011. Articl e 9 of the Regulations on Certification and 
Accreditation of China provided fo r the control and approval of certification activities within China. 
As far as provisions on the legality of certificati on bodies and certification activities are concerned, 
the measure under discussion imposed no new requireme nts. Besides, it applied equally to domestic 
and foreign certification bodies. It was based on re levant international standards and was fully WTO 
compliant. He assured the Committee that China was willing to continue technical discussions on the 
measure in all appropriate arenas. 
(xxxix)  Egypt – Two Decrees of the Minister of I ndustry and Foreign Trade (626/2011 and 660/2011) 
Related to the Import Requirements for Leather, Footwear and Textile Products 
(G/TBT/N/EGY/29; G/TBT/N/EGY/30) 
236. The representative of the European Union welcom ed the notification and postponement of the 
implementation of two decrees of the Minister of Industry and Foreign Trade of Egypt related to the 
import requirements for leather, footwear and textile  products.  She asked that the Egyptian standards 
mentioned in the notification form, which containe d the requirements the products have to comply 
with, be made available to WTO Members so as to allow for analysis and comment.  With regard to 
the requirement for an inspection certificate fro m an authorized authority, the EU felt that a 
conformity assessment procedure was inappropriat e and too burdensome for textile, clothing and 
footwear products. Within the EU these were c onsidered low risk products, and therefore no 
conformity assessment procedure was required.  Rather than a compulsory certificate of compliance, 
protecting human health and safety could be met by  other means such as random inspection.  She 
inquired whether domestic products were also subject  to the same certification procedure. She urged 
Egypt to consider allowing the import of textile, cl othing and footwear products without systemic 
compliance certificate and test reports.  
237. The representative of Turkey expressed thanks for the postponement and said that, while his 
delegation accepted the legitimate objective pursued  by the measures, further clarification was 
necessary.  He asked if the Egyptian standards, as specified in the notification, were in conformity 
with international standards, and if so, why did th e Egyptian authorities not refer to the international 
standard.  He also asked for information on how th ese decrees affected domestic products.  As Turkey 
had significant investment in the Egyptian textile a nd clothing market, he urged Egypt to reconsider 
implementation of these decrees to avoid discrimin ation between imported a nd domestic products. 
238. The representative of Egypt confirmed the postp onement of implementation of both decrees. 
The new certification requirement applied to bot h domestic and imported products on the Egyptian 
market.  He requested the EU and Turkey to provide their concerns in writing for a prompt reply. 
(xl) European Union – Safety evaluation of chil dcare cosmetic products (G/TBT/N/EEC/246, 
G/TBT/N/EEC/246/Add.1) 
239. The representative of China asked the EU to  provide information on the "Guidelines on 
Safety Management of Cosmetics" to be published by July 2013. In particular, he asked in what 
context, and when would these guidelines be published,  and about their relationship with those issued G/TBT/M/57 
Page 48  
 
  by the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) and related 
regulations already published and to  be published at the EU level. 
240. The representative of the European Union conf irmed that the regulation on safety evaluation 
of childcare cosmetic products would enter into force in July 2013.  Work on the guidelines on 
product safety management was still on-going and would be ready in advance of that date. 
Concerning the safety evaluation of childcare cosm etic products, there were no harmonized specific 
childcare cosmetics safety management guidelines at the EU level. The guidelines on safety management on cosmetics, which were also under de velopment, would have some parts dedicated to 
products for children under three years old.  These guidelines would be published before July 2013. 
She flagged the EU's on-going concern that no approv als on the registration of baby care cosmetics in 
China had been granted to EU products since Apr il 2010.  Her delegation hoped that the bilateral 
exchanges that had taken place between the Eu ropean Commission (DG SANCO) and SFDA in 
March would help solve this  longstanding trade concern. 
(xli) European Union – Alternatives to animal testing and new cosmetic regulations 
(G/TBT/N/EEC/246, G/TBT/N/EEC/246/Add.1) 
241. The representative of China, referring to in formation provided by the EU at the last 
Committee meeting, asked the EU if a solution ha d been found on the marketing ban which would 
come into force on 11 March 2013, given that validated alternative methods for the three endpoints would not be available by 2013. He asked for confirmation that the regulation on alternatives to animal testing and new cosmetics applied only to EU member states. 
242. The representative of the European Union confir med that this regulation provided a robust 
internationally recognized regime, reinforcing product safety while taking into account latest 
technological developments, including the use of nanom aterials.  With regard to the marketing ban 
which would come into force on 11 March 2013, th e European Commission was looking at three 
options, including letting the 2013 deadline come into effect, postponing the deadline or, a case-by-case derogation mechanism.  She confirmed that th e marketing ban applied to  all cosmetic products 
placed on the EU market, both within the EU and t hose imported from third countries.  The European 
Commission was aware of the need to clarify the practi cal effects of the marketing ban in more detail.  
The new cosmetic regulation had been discussed  at length between the European Commission, 
China's State Food and Drug Administration (SFDA) and the China's Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) in Beijing in March 2012.  
(xlii) Colombia – Draft Resolution of the Ministry of Transport Issuing the Technical Regulation 
for public transport (G/TBT/N/COL/164, G/TBT/N/COL/164/Add.1) 
243. The representative of Korea respected Colombia's  efforts to improve services for people with 
reduced mobility and communication difficulties. Ho wever, the measure should be harmonized with 
the relevant international standard, in this cas e UNECE regulation No.107 which excluded vehicles 
used for school transportation pur poses.  By applying the interna tional standard, Colombia ensured 
compliance with its obligations under Article 2.4 of the Agreement.  He asked Colombia to modify 
the regulation prior to adoption and to provide an u pdate on the current situation. He also asked that 
Colombia provide an official reply to Korean comments submitted on 15 January 2012. 
244. The representative of Colombia informed the Co mmittee that the Ministry of Transport was 
reviewing the content of the regulation.  An offici al reply to Korea would be provided once the final 
draft was ready.  G/TBT/M/57 
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  (xliii)  European Union – issue with respect of honey containing pollen from genetically modified 
maize MON810, Ruling from ECJ 
245. The representative of Argentina reiterated the concern expressed before this Committee on 
November 2011 as well as in other WTO fora regarding the ruling of the European Court of Justice of 
6 September 2011 (Case C-442/09) on honey contai ning pollen with traces of DNA from genetically 
modified maize MON 810.  According to the ruling, the honey containing pollen derived from 
Genetically Modified Organisms (GMOs) authorized by the EU was a food product produced from GMO, and therefore came under Article 3, para graph 1C of the Regulation (EC) 1829/2003.  
246. This ruling adopted a new interpretation regard ing the scope of Regulation 1829/2003 without 
appropiate scientific justification.  At the same  time, the ruling interpreted that pollen was an 
ingredient of honey, not a natural component, conf licting with the standard for honey in Codex and 
the European Regulations (Annex II of Directive 2001/110/CE and Article 6,  paragraph 2C of the 
Directive 2000/13). According to said EU Regulations , honey was legally declared in its label as a 
single ingredient in and of itself; and therefor e there was no need to specify pollen as a separate 
ingredient in the label of that product. The legal unc ertainty arising from the ECJ ruling, together with 
the fact that the implementation of said ruling at EU level was still pending, affected the exportation 
of argentine honey to the EU, having an impact on regional economies and sm all producers.  Given 
that more than 9 months had passed since the ECJ ru ling, Argentina reiterated its request for the EU to 
promptly dispel all uncertainties raised by the ru ling as well as to eliminate their impact on honey 
exports to the EU from third countries.  Argentina al so requested that the implementation of the ruling 
not result in export restrictions.   
247. The representative of Brazil supported Argen tina noting the trade disruptions from the 
uncertainty surrounding implementation of the ECJ ru ling.  His delegation sought clarification on the 
measures taken to implement the ECJ decision, re questing that such measures not create unnecessary 
obstacles to trade in the sense of Article 2.2 and 5.1.2 of the TBT Agreement. 
248. The representative of Mexico supported the Argentinian and Brazilian statements and 
requests.   
249. The representative of the United States supported the other speakers.  Her delegation believed 
this ruling was a barrier to trade, and encouraged the EU to take expeditious action to resolve this 
trade disruption.  She asked what progress the EU had made on addressing the impact of this ruling on imports. 
250. The representative of Uruguay said that honey was an important commodity in Uruguay, and 
a significant proportion was exported.  Until 2011, th e EU was Uruguay's main market;  it exported 
more than 85 per cent to the EU.  Following the ECJ ruling, it had been difficult  to export to the EU;  
less than 3 per cent of honey exports went to the EU.  This had affected the more than 2000 workers.  
Her delegation asked the EU to consider  these adverse effects of the ruling. 
251. The representative of the European Union r ecalled that a detailed explanation on the 
background and implications of this ruling ha d been provided at the November 2011 Committee 
meeting.  According to the European Court of Justi ce ruling, genetically modified pollen in honey fell 
under the scope of the relevant EU legislation on genetically modified food and feed (Regulation 
1829/2003).  Therefore, GM pollen in honey must be subject to an authorization for such honey to be placed on the EU market, and honey containing aut horized GM pollen would have to be labelled 
according to the provisions of the same Regulation (1829/2003). 
252. In this case, MON810 was a GM crop that had been  authorized in the EU for more than 10 
years, but not uses in pollen.  In October 2011, th e EU's risk assessment body, the European Food G/TBT/M/57 
Page 50  
 
  Safety Authority (EFSA) had delivered the opini on that MON810 in pollen was as safe as non GM 
maize pollen.  Meanwhile, in March 2012, the co mpany in question, Monsanto, had submitted an 
authorization application to cove r MON810 pollen in or as food, as required in procedure provided by 
Regulation 1829/2003.  The EU was actively worki ng 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 imported production.  Harmonized methods are under development by the Joint Research 
Centre of the Commission on sampling and detectio n methods of GM pollen in honey to help EU 
Member States apply the Court's ruling.  In pa rallel, the Commission is shaping its position on the 
need to clarify Directive 2001/110/EC relating to honey. 
(xliv)  European Union – Directive 2009/28/CE, Renewable Energy Directive (EU - RED) 
(G/TBT/N/EEC/200; G/TBT/N/EEC/200/Add.1) 
253. The representative of Argentina noted that the Directive was an unnecess ary obstacle to trade 
due to its unjustified restrictions on imports of biofue ls, in particular to the main suppliers of the EU, 
like Argentina.  This directive restricted biofuel imports by requiring, on one side, the compliance and 
certification of sustainability criteria and, on th e other side, the fulfilment of emissions reduction 
requirements. Regarding the sustainability crite ria, they were unnecessarily excessive, cumbersome, 
arbitrary and unjustified, without any scientific evidence, demanding as well the certification of said criteria as an access requirement to the EU market .  Moreover, the directive specified that the 
reduction of GHG emissions, derived from the use of  biofuel had to be a minimum of 35 per cent. 
This Directive assigned to each biofuel a determined level of GHG reduction. If th is level is under the 
minimum required, as in the case of soya biodi esel, the EU compelled the demonstration the 
accomplishment of the minimum level of reduction.  In this regard, Argentina considered that the 
minimum level of reductions, and the values assigned to each biofuel had been arbitrarily established 
without any scientific basis. It is remarkable that  soya-derived biodiesel, being the type of biofuel 
exported by Argentina -as a main supplier- to the EU, was one of the few to which was assigned an 
emission reduction level under the mi nimum required of 35 per cent.  Due to the sustainability 
criteria, exports from outside the EU faced probl ems, including adverse effects on soya derived 
biodiesel. This Directive indirectly obliged the Europ ean user to avoid the soya biodiesel and to opt 
for biofuels that supposedly comply with the sustai nability criteria. Argentina asked the EU to ensure 
the transparency of this Directive and that its re quirements had a clear, scientific basis and did not 
adversely affect suppliers of biofuels to the EU. 
254. Argentina further requested the EU to ensure th at exporters did not have to meet high costs 
and cumbersome procedures as a result of certifica tion, which would unfairly exclude them from the 
European market.  The EU had set a GHG reduction for Argentinian biodiesel of 31 per cent, while 
the National Institute of Agricultural Technology (INTA) had provided documentation demonstrating 
that the biodiesel produced in Argentina, through direct seeding, represented more than a 75 per cent 
saving in GHG.  This saving value, owing to th e production of soya with the most advanced 
technology of direct seeding, had manifest ad vantages for the environment with regard to 
sustainability, facilitating carbon sequestration in th e soil, saving water supplies as well as a sound 
management of pesticides and less use of fuel.  As  the EU had not approved the certification system 
of the Argentinian private sector since December  2010, Argentinian exporters faced difficulties.  
Since the EU sustainability requirements of biofue l production had to be certif ied, in December 2010 
the argentine private sector grouped around the Bi ofuel Argentine Chamber (CARBIO) had provided 
to the EU authorities a voluntary certification scheme.   This procedure was st ill under consideration, 
even though seven different voluntary certificati on schemes had been approved, including one for 
wheat based bioethanol.  Argentina asked for informa tion about the current status of the certification 
procedure submitted by CARBIO.  
255. The representative of the United States supported the EU's objective of promoting sustainable 
sources of renewable energy, but expressed conc ern that the RED was creating considerable  G/TBT/M/57 
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  uncertainty in global biofuel and biofuel feedstoc k markets and trade.  Implementation had already 
negatively affected imports of US soybeans into the EU.  Exports of US soybeans had decreased by 
70 per cent from September 2011 to February 2012, compared to the same period the year before 
when the RED had not been implemented yet.  Implementation of sustainability measures with 
significant economic impact, such as the RED, had to be done in a flexible manner to avoid 
unintended consequences.  The US, in its bilate ral dialogue with the EU, had presented creative, 
flexible proposals that would enable sustainably pr oduced US soybean exports to be recognized as 
equivalent to the sustainability criteria in the RED.  The US had laws and policies to produce 
soybeans sustainably under the RED criteria, as we ll as considerable empirical evidence supporting 
their success.  Her delegation requested a response to  the US proposals tabled during bilateral talks, 
and recognition of the sustainability of US so ybean exports.  The US believed that the TBT 
Committee was the proper forum for discussing the RED and disagreed with the EU's contention that 
it fell outside the scope of the TBT Agreement.  The US urged the EU to put the issue in the larger 
economic context, to ensure that sustainability goals were met in a manner that did not present 
unnecessary barriers to trade or reduce the potential for growth and jobs in a "green" industry.    
256. The representative of the European Union info rmed that the EU had notified the draft 
Renewable Energy Directive to the Committee in July 2008 (G/TBT/N/EEC/200 ) due to the TBT 
elements in the original proposal's Articles 18(2) a nd 18(3).  These, however, were not retained in the 
final Directive.  Concerns expressed by Argentina a nd the US related to the sustainability criteria for 
biofuels outlined in the Directive that fell outside the scope of the TBT Agreement, and, therefore,  
her delegation considered that the TBT Committee w as not the appropriate forum for discussing this 
issue or providing replies to queries.  The EU remained open to further bilateral exchange. 
(xlv) European Union – Producti on and Labelling of Organic Products (G/TBT/N/EEC/101; 
G/TBT/N/EEC/101/Add.1) 
257. The representative of Argentina said that the requirements for organic product labelling in 
Regulation (EC) 834/07 went beyond the objectives est ablished in the text and did not have any basis 
in relevant international agreements. For these r easons, this Regulation 834/2007 was an unnecessary 
obstacle to trade.  Since the Regulation's object ive was to promote fair competition, consumer 
confidence, and a market for organic products, the re quirement set out in Article 24 by which labels 
had to indicate whether raw materials or final produc ts were obtained in the EU was irrelevant.  The 
TBT Agreement clearly established that technical re gulations were not to restrict trade more than 
necessary to meet a legitimate objective.  The impos ition of an indication as to the origin of the raw 
materials on the label did not determine the orga nic nature of the product and could confuse the 
consumer, as a product's organic character was the resu lt of its processing rather than of the material's 
origin.  He asked the EU whether similar requireme nts for organic products had been in place before 
the introduction of this labelling requirement, and if so, whether there was an obligation to indicate 
the origin of raw materials.  If not, it requested that the EU explain the reason of the changes and 
clarify on which international convention or stan dard were based since the Codex Alimentarius 
guidelines related to production, processing, labelli ng and marketing of organic products did not 
contain any obligation to indicate the origin of ra w materials on the labelling of an organic product.  
In addition, and as a result of higher certifications  costs, the system was unfavourable to exporters 
from developing countries. Argentina requested the EU to eliminate this unnecessary requirement that 
distorted the objectives of Regulation (EC) 834/07 by  restricting the importation of organic products 
from non EU Members.   
258. The representative of the European Union recalle d that the issues mentioned by Argentina had 
already been discussed in the Committee several time s, most recently in 2009.  There was no evidence 
that the new labelling rules would negatively impact sales of Argentinian products or those from other 
countries.  A new logo had been introduced by Regulation (EC) 271/2010, following Article 24 of 
Council Regulation (EC) 834/2007 since 1 July 2010.  Its use would be compulsory on all European G/TBT/M/57 
Page 52  
 
  originating pre-packaged goods from 1 July 2012 onwards but optional on organic products 
originating in third countries and marketed in the EU.  If the logo was used, the obligation to indicate 
the place of farming under Article 24 would apply. 
(xlvi)  Australia – Tobacco Plain Packaging Bill (G/TBT/N/AUS/67; G/TBT/N/AUS/67/Add.1; 
G/TBT/N/AUS/67/Add.2) 
259. The representative of the Dominican Republic  recalled that, as from 1 December 2012, 
Australia would require that all tobacco products (such as cigars and cigarettes) presented for retail 
sale be in plain packaging.  Other restrictions and requirements regarding the appearance of these 
products would also apply.  These requi rements would be mandated through the Tobacco Plain 
Packaging Act 20115 and its implementing regul ations, which were the Tobacco Plain Packaging 
Regulations 2011 , as amended by the Tobacco Plain Packaging Amendment Regulation 2012  
(No. 1).6  The Dominican Republic and other Members had repeatedly expressed concerns with these 
measures, both in the TBT Committee and the Council for TRIPS.7  Two Members, Ukraine and 
Honduras, formally requested consultations  with Australia regarding the measures.8  The Dominican 
Republic considered that these plain packaging meas ures restricted international trade in a manner 
that was inconsistent with Australia's obliga tions under the TBT Agreement.  The measures ran 
counter to the protection of intellectual property rights, including trademarks and geographical indications, as provided by the TRIPS Agreement and the Paris Convention 
(as incorporated into the TRIPS Agreement).  Austra lia failed to identify credible evidence that its 
measures would achieve their objective of reducing t obacco prevalence.  In fact, the measures would 
undermine Australia's objective because they would trigger price competition as a result of the 
"commoditization" of tobacco products, also leading to increased levels of illicit trade.  In view of 
these concerns, the Dominican Republic informed th e Committee that it was compelled to request, in 
the coming days, formal consultations with Austra lia regarding these measures, pursuant to Article 4 
of the DSU and Article 14 of the TBT Agreement. 
260. The representative of Nicaragua supporte d the Dominican Republic and voiced her 
delegation's concerns with respect  to Australia's measures;  they  would have adverse economic and 
social consequences for Nicaragua.  As the measu re would prevent the use of trademarks on any 
tobacco product (only allowing the name of the brand in standard print on a plain package), Nicaragua 
claimed violations of both the TBT and TRIPS Agre ements.  In particular, the measure violated 
Articles 2.2 and 11.3 of the TBT Agreement as it created unnecessary restrictions to trade without 
meeting the Australian Government's goals of limiti ng adverse health effects.  The measure would 
also make it difficult for foreign firms to export to Australia, thus creating unnecessary barriers to 
imports.  Nicaragua urged Australia to review its measure so that domestic health protection would 
not adversely affect other countries' ri ghts under the TBT and TRIPS Agreements. 
261. The representative of Guatemala said her de legation was still unclear how Australia's 
plain packaging measure would be compatib le with its obligations under the TBT and 
TRIPS Agreements.  She cautioned that internati onal, WHO measures on tobacco and health must be 
implemented in a way that would not result in violation of these two WTO Agreements. 
                                                      
5 Tobacco Plain Packaging Act 2011, No. 148, 2011, An Act to discourage the use of tobacco products, 
and for related purposes (date of assent: 1 December 2011). 
6 Tobacco Plain Packaging Regulations 2011, Select Legislative Instrument 2011, No. 263 , as amended 
by the Tobacco Plain Packaging Amendment Regulation 2012 (No. 1), Select Legislative Instrument 2012 No. 
29.    
7 G/TBT/W/339; G/TBT/W/346; IP/C/W/565; IP/C/M/66. 
8 Ukraine filed a consultations request on 13 March 2012 (WT/DS434/1; circulated 15 March 2012) 
and Honduras filed a consultations request on 4 April 2012 (WT/DS435/1, circulated 10 April 2012).     G/TBT/M/57 
 Page 53 
 
 
  262. The representative of Uruguay said that Members were entitled to protect lives and health of 
their citizens, including by implementing the WHO FCTC.  This was, thus, a matter of national 
sovereignty.  On the other hand, Members must not take measures that adversely affect their 
obligations under the TBT Agreement.  Australia had properly justified its tobacco plain packaging 
measure as it was in keeping with its WHO obligations. 
263. The representative of Norway supported Australia 's policies on tobacco control, including its 
plain packaging measures.  Public health in genera l - and tobacco control regulation in particular - 
were of particular interest to Norway.  It was w ithin the right, indeed within the obligation, of each 
WTO Member to adopt measures necessary to protect  public health.  Clearly tobacco control policies 
and preventative measures, such as those implemente d by Australia, had the legitimate objective of 
protecting public health by reducing the use of t obacco products.  Norway trusted that Australia's 
legislation would be implemented in compliance wi th Australia's international treaty obligations. 
264. The representative of New Zealand welcomed Au stralia's decision to legislate for the plain 
packaging of tobacco products.  The negative eff ects of smoking could not be overstated;  in New 
Zealand, smoking was the leading preventable cause of  early death.  Past discussions made clear that 
Australia respected its WTO obligations in develo ping its plain packaging proposal.  On 19 April 
2012, New Zealand's Associate Minister of Health  announced that its Government had agreed, in 
principle, to introduce plain packaging of tob acco products, subject to the outcome of a public 
consultation process.  Final decisions on whether to  introduce such legislation would be made only 
after the results of the public consultation process had been taken into account.  This process was a 
transparent way to review the evidence and test th e case for plain packaging, while giving the public, 
the health sector and business interests a chance to  have their say.  New Zealand would notify the 
details of this consultation to the TBT Committee la ter this year to allow  all interested trading 
partners to have their say. 
265. The representative of Canada said that his delegation continued to  follow the on-going 
international developments on plain packagi ng of tobacco products, in particular the 
Australian measure, and how they might interact with  international trade and public health.  Canada 
understood that Australia conducted serious research  to support the introduction of its measure. 
266. The representative of the Philippines said he r delegation was following these discussions both 
in the TBT Committee and in the TRIPS Council.  It  had a substantial trade interest, having initiated 
cigarette exports to Australia in 2010 and experien cing significant export growth in 2011.  As a 
relatively new entrant in the Australian market, the Philippines was keen to further understand the 
potential impact of the plain packaging law on Phili ppine cigarette exports.  On the other hand, the 
Philippines was also a party to the FCTC and, as  such, was interested in knowing more about the 
relevance of the measure to the effectiv e implementation of this WHO convention. 
267. The representative of Brazil said his delegati on supported the legitimate objectives of public 
health protection that the Australian measure sought to  achieve.  It recognized the right of Members to 
regulate the tobacco sector in conformity with th e WTO Agreements to protect public health. Brazil 
would continue to follow the international devel opments and Members' experiences in this area. 
268. The representative of Australia was disappoint ed by Dominican Republic's announcement to 
this Committee of its intention to request dispute se ttlement consultations with regard to Australia's 
plain packaging measures.  His delegation had not ye t received any official request for consultations 
from the Dominican Republic. It was, therefore, su rprising that the Dominican Republic chose to 
announce its intention in this manner, especially gi ven the bilateral nature of dispute settlement 
consultations.  As explained in previous meeti ngs, Australia was implementing the measures in the 
interest of promoting public health. Australia was confident that, as part of a comprehensive package 
of tobacco reforms, the measures would make an effective contribution to efforts to reduce smoking G/TBT/M/57 
Page 54  
 
  rates, thereby reducing the health impacts of sm oking on Australian individuals and the community at 
large.  Australia had consiste ntly engaged with WTO Members on these measures, including those 
Members that had raised concerns in this Committee. Australia expected any requests for consultations to be made in accordance with Ar ticle 4 of the DSU and would vigorously defend any 
challenge that might result from any such consultations. 
269. Australia also acknowledged the support it recei ved for the important measures.  Australia 
said that there was no significant change in the stat us of the measure since the last meeting.  The 
Tobacco Plain Packaging Act 2011  and the Trademarks Amendment Tobacco Plain Packaging Act 
2011  were passed by the Australian parliament in November 2011 and received royal assent on 
1 December 2011.  The final Tobacco Plain Packag ing Regulations relating to cigarette products, 
which contained additional, specific detail on ho w the plain packaging requirements had to be 
implemented, were approved on 7 December 2011. The final Tobacco Plain Packaging Amendment 
Regulation 2012, which incorporated the specificati ons of non-cigarette tobacco products into the 
regulations, was approved by the Executive Counc il on 8 March 2012.  The Government undertook 
two consultation processes on the approach to pl ain packaging of non-cigarette products and the 
details of the Amendment Regulation.  Submissions  made in those processes were taken into account. 
All retail tobacco products manufactured or packag ed in Australia for domestic consumption would 
be required to be in plain packaging by 1 October 20 12. All tobacco products sold in Australia would 
be required to be in plain packaging by 1 D ecember 2012. Australia received two requests for 
formal consultations under the DSU from Ukrain e (on 13 March 2012) and Honduras (on 4 April 
2012).  These Members claimed that Australia's plai n packaging measures were inconsistent with 
certain WTO obligations.  Australia held consu ltations with Ukraine and Honduras on 12 April and 
1 May 2012, respectively. Australia had been res ponsive to comments from trading partners and other 
stakeholders and these comments were taken into a ccount and led to changes in the Bill and draft 
regulations where the changes were in line with  the Government's policy objectives.  Australia 
recalled that the objectives of the measures were: (i) to reduce the attractiveness and appeal of tobacco 
products to consumers, particular ly young people; (ii) to increase th e noticeability and effectiveness 
of mandated health warnings; (iii) to reduce the ability of retail packaging of tobacco products to 
mislead consumers about the harms of smoking; and (iv) through the achievement of the above aims  
in the longer term (and as part of a comprehensiv e suite of tobacco control measures) contribute to 
efforts to reduce smoking rates. 
270. The Committee took note of the statements made under this agenda item. 
C. EXCHANGE OF EXPERIENCES  
1. Good Regulatory Practice 
271. The Chairman recalled previous recommendati ons made under the Fifth Triennial Review.9 
The following submissions had been made: New Zealand (JOB/TBT/5) and the United States, on 
behalf of APEC member economies (G/TBT/W/350). 
272. The representative of New Zealand recalled he r delegation's submission (JOB/TBT/5) which 
proposed a draft outline of Guidelines on Choice a nd Design of Trade Facilitation Mechanisms, and 
which was developed in response to one of the Fifth Triennial Review decisions.10  She said that work 
remained to implement this Fifth Triennial Revi ew decision.  She therefore suggested that the 
Secretariat could begin the drafting process outlined  in her delegation's submission, populating the 
framework with examples that have been shar ed in Committee context, including: the joint 
International Laboratory Accredita tion Cooperation (ILAC)/ Interna tional Accreditation Forum (IAF) 
                                                      
9 G/TBT/26, paras. 11 and 16. 
10 G/TBT/26, para. 19.  G/TBT/M/57 
 Page 55 
 
 
  presentation delivered during the June 2011 Committee meeting11; the presentations and discussions 
at the November 2011 Regulatory Cooperation Workshop12; and, the submission from the United 
States on the use of the ILAC MRA and IAF MLA by central government bodies.13  
273. The representative of Mexico found New Zealand' s submission to be useful, and said that her 
delegation was willing to share information with Memb ers as proposed therein.  She expected to make 
further comments on the submission afte r analysis by responsible agencies. 
274. The representative of Australia expressed w illingness to further explore the ideas in New 
Zealand's submission in the context of the Sixth Triennial Review.  
275. The representative of the European Union obser ved that the work on the guidelines for GRP 
and on the illustrative list of good implementation practices would necessarily extend beyond the time 
horizon of the Sixth Triennial Review since it was a comprehensive exercise requiring significant 
work, also on finding a suitable balance among va rious Members' positions. He believed that the 
Committee had already made good progress towards fulfilling the recommendations of the Fifth Triennial Review in respect of Good Regulatory Practice (GRP)
14 through useful dialogue in the 
Committee, the Workshop on Regulatory Cooperati on, and contributions from the Secretariat.15  He 
said the Committee should now consider how to fu rther advance work on GRP in those areas that 
were most relevant for the implementation of th e TBT Agreement, in the context of the Sixth 
Triennial Review, and beyond.   
276. While this process should in the first rely on s ubmissions from Members, he suggested that it 
may be better facilitated through discussions in an ad  hoc Working Group, or in some other informal 
context, organized on specific themes of GRP and held back to back with regular Committee 
meetings.  He explained that this  would provide opportunity for interested Members to make progress 
on GRP in a less formal setting, without the need to  record the discussion in Committee minutes.  The 
outcome of such work could subsequently be shared  with the Committee.  He suggested, as a realistic 
deliverable on GRP for the Sixth Triennial Review Report, that the Report could identify areas where 
Members believed there was potential for undertaking this  kind of analytical and in-depth work.   This 
need not include an agreed list of list of illustra tive principles and practices of GRP, but rather it 
would identify the broad headings upon which work would be undertaken towards formulating such a 
list. 
277. The representative of the United States said her de legation had expressed interest in furthering 
work on GRP in the TBT Committee, including in r espect of development of an illustrative list of 
practices and ideas.  While she believed that this  work should be driven by submissions from 
Members, her delegation was open, subject to view s of other Members, to the EU suggestion of a 
Working Group or other informal setting to advanc e work.  From the United States' perspective, 
simply discussing the importance of the relationship between trade and GRP was valuable for Members.  She specified that any work in this re gard should be explicitly non-binding.  With respect 
to the New Zealand submission, she was of the unde rstanding that it related to conformity assessment. 
278. The representative of the Secretariat recalled the substantial information exchange on GRP 
that had been undertaken by the Committee, including at workshops on Regulatory Cooperation 
between Members and on Good Regulatory Practice, he  also noted the Secretariat background papers.  
He said that more work could be done based on Members' suggestions and input.  
                                                      
11 G/TBT/GEN/17. 
12 G/TBT/W/348. 
13 G/TBT/W/349. 
14 G/TBT/26, paras. 11 and 16. 
15 G/TBT/W/340. G/TBT/M/57 
Page 56  
 
  279. In concluding, the Chairman stressed the importance of GRP to the effective implementation 
of the TBT Agreement.  With regard to the de liverables in the Sixth Triennial Review on GRP, 
Members contributions would be important for continued progress on GRP, and for setting a good 
course for future work.  He noted suggestions from Members about the process for advancing this 
work after the Review, including  in a Working Group format. 
2. Standards 
280. The Chairman recalled previous recommendations  made under the Fifth Triennial Review and 
drew the Committee's attention to the following relevant submissions: Colombia (G/TBT/W/351), 
India (G/TBT/W/345) and Korea (G/TBT/W/353).    
281. The representative of Korea introduced his delegation's submission (G/TBT/W/353), 
stressing, in particular, the importance of devel oping country participation in the development of 
international standards.  
282. The representative of India, recalling earlier discussions, noted that some Members appeared 
to be striving for a less ambitious approach on inte rnational standards.  He sensed that since the 
existing Decision on Principles for the Development  of International Standards, Guides and 
Recommendations with Relation to Articles 2, 5 and Annex 3 of the TBT Agreement  from 2000 
(hereafter the "Committee Decision")16 offered a certain amount of flexibility (to regulate) that 
Members were comfortable with, there was hesitati on to tamper with the existing text. Thus the 
Committee, India proposed, could consider a work programme on standards – one that encapsulated 
all Members' participation and considered specific ar eas or themes, such as: best practices by standard 
setting bodies; definitions of international standa rds (as suggested in the Colombian paper and 
supported by Mexico); and, practical aspects of the implementation of the Committee Decision's six 
principles on standard setting by international standardizing bodies including exploring any new 
principles.  Another topic could be to explore speci fic provisions on transparency related to standards 
(as opposed to technical regulations and conform ity assessment procedures), such as comment periods 
on draft standards, access to full text of the st andard, providing on a voluntary basis the impact 
assessments along with the notification format.  Other possible points for discussion could be 
electronic working methods and reasonable fee for access to standards.  As some standard setting 
bodies had an Action Plan for developing country Members, this could be tailored to ensure 
participation of developi ng country Members.  
283. The representative of Cuba stressed the importance of the effective participation of 
developing countries in standard-setting activities.  She also agreed with the points India had made on 
transparency in standard-setting and proposed a cl oser co-operation between the WTO and different 
international standards bodies. 
284. The representative of China proposed that a speci al mechanism be established to ensure that 
more developing country Members could participate in  international standardization. With respect to 
the development of international standards, China suggested that mechanisms or remedies should be 
established to enable any Member to appeal unreas onable decisions made by technical standardizing 
committees. For technical regulations based on inte rnational standards, China supported the proposal 
that standardizing bodies involved should allow Memb ers who adopt those technical regulations to 
publish those technical regulations for free. 
285. The representative of Malaysia said, with respect to the Indian submission, that the principles 
for international standards were adequately cap tured in the existing TBT Committee Decision and 
posed no difficulties for competent bodies to co mply with. She emphasized that standards 
                                                      
16 The full text of this Decision is contained in Annex B of G/TBT/1/Rev.10, dated 9 June 2011.  G/TBT/M/57 
 Page 57 
 
 
  development was a diverse activity and an overly pr escriptive or limited set of principles could be 
counterproductive.  In particular, she argued, in a world of fast changing and new emerging 
technologies, it would be futile to limit international standards to any particular organization.  Clear 
principles to guide the development of internati onal standards were needed, not restrictions on which  
organizations could develop them.   With respect  to India's paper, paragraph 3 (in G/TBT/W/345) 
seemed to imply that regulators  developed international standards.  This was not the case:  as was set 
out in Annex 1 of the TBT Agreement, standard s were defined as documents prepared by the 
standardization community, not regulators.   
286. With respect to India's specific proposals (in paragraph 4) Malaysia had a number of 
comments.  On openness, Malaysia asked for clarif ication on the operationalization of the mechanism 
and action plan for the participation of LDCs in the development of international standards. On 
impartiality and consensus, Malaysia was of the view that the consequence of the procedures as 
proposed would slow down the development process and result in fewer standards. On the issue of 
coherence, Malaysia did not see the need to creat e a database of existing standards; instead, the 
existing system for the sharing of information on re levant international bodies needed to be improved 
through better coordination.  With respect to the additional principles as proposed by India (paragraph 
5) Malaysia noted that there existed appeals me chanisms in the ISO context (ISO IEC Guide 59).  
Finally, on guidelines for transposition to natio nal standards, Malaysia sought some further 
clarifications India.  The representative of Mala ysia also acknowledged the proposal from Korea and 
said that her delegation might have comments at the following meeting. 
287. The representative of Colombia expressed suppor t for the programme of work suggested by 
India: this could indeed lead to an in-depth discussion which would engage developing countries on 
the subject of international standards, and help address some of the underlying uncertainties.  There 
was a need for a clear definition of internationa l standards that would enable the Committee to 
address the ambiguity in the TBT Agreement.  For Colombia, such clarification would mean that 
Members would be able to make better use of intern ational standards.  Currently it was difficult to 
know whether a standard was or was not internationa l, unlike, for instance, in the SPS context.   
288. The representative of Mexico supported the Kor ean proposal, particularly on the importance 
of harmonization.   
289. The representative of Canada asked for some cl arification on Korea's proposal in particular 
with respect to the reference to the "pace of harmonization".   
290. The representative of Brazil noted that Indi a's proposal regarding a work programme on 
international standards seemed to be a useful a pproach to addressing some of the most important 
aspects in the area of international standards befo re the Committee.  Regarding possible topics for the 
agenda, the Committee could consider: "best practices"  in international standardizing activities; the 
definition of relevant international standards; a nd, the principles of the TBT Committee Decision.  
291. The representative of Japan recalled the reco mmendation contained in the Committee's Fifth 
Triennial Review to share experiences on the application and use of the Committee Decision.17  He 
also recalled that the OECD had shared a publicatio n entitled "The Use of International Standards in 
Technical Regulations," which had examined to what  extent technical regulation had been introduced 
in line with international standards by Members.  Th is type of input was important in considering the 
nature of international standards. It was better, in the view of Japan, to continue to share these 
experiences rather than to rush to th e development of new principles.   
                                                      
17 G/TBT/26, para. 25(c).  G/TBT/M/57 
Page 58  
 
  292. The representative of the United States suppor ted the proposal to share experiences on the 
application of the Committee Decision's principles.   However, the United States did not agree that 
defining particular international standards w ould help the Committee promote harmonization of 
product requirements across export markets.  This could instead pose a risk to the wide range of standardizing activities undertaken in the private sect or that were essential to supporting global trade.  
As had been said by the delegation of Malaysia, th e United States stressed that standards development 
occurred in many different contexts and bodies; achi eving the objectives of a ll of these activities was 
essential to underpinning the modern global economy.   These objectives ranged across a wide array of 
areas, including: quality and efficiency of domestic  production; consolidating internal markets and 
enabling access to foreign markets; supporting the operation of complex supply chains; creating new 
markets through interoperability, which was criti cal in the modern economy; and, supporting 
regulatory quality and coherence in addition to pr oviding commercial platforms that enabled all to 
benefit from innovation.  The work of the Committee needed to promote prin ciples and practices that 
embodied the validity of all of these objectives, even if they were weighed differently by different 
Members.  In this regards, a good balance ha d been struck in the Committee Decision.   
293. Regarding the issue of the impact of "private st andards" raised in Colombia's submission, the 
representative of the United States recalled that th e Committee had had an informative exchange at 
the Committee's workshop on inte rnational standards in 2009.
18  Valuable insights had been provided 
by several Members on the on the role of collaboration among producer groups, industry associations, exporters and national standards bodies in developing strategies and building technical conformance 
infrastructure to enable local producers to meet tho se challenges.  There had also been a constructive 
exchange of views on this topic in the Fifth Trienni al Review, including with respect to the lack of 
applicability of provisions of the TBT Agreement to what were essentially the terms of private 
contracts between buyers and sellers.  She recalled that  the Report of the Fifth Triennial Review fairly 
represented the balance between Members' views in the Committee on this issue.  The United States 
would have concerns with proposals that  move beyond the consensus reached.
19  
294. Regarding the programme of work suggested by India, the United States recalled the 
ambitious mandate set out in the last triennial  review, including on standards.  The Committee 
needed, in practical terms, to now consider next steps.  The work of the Committee could perhaps be 
usefully focused, under the agenda item on standards – by agreeing ahead of time on particular themes 
for individual Committee meetings.  This would help the membership to be better prepared and could 
facilitate progress on existing recommendations.  
295. Finally, the representative of the United States wish ed to stress one particular point that India 
had raised and on which they were in complete  agreement: the need for transparency in the 
development of standards by national standards bodies,  and in particular central governmental bodies.  
She noted that in TBT Code of Good Practice there was reference to a mechan ism for transparency on 
standards – the ISO NET.  Yet this had, accordin g to the US understanding, ceased to exist many 
years ago. This only accentuated th e challenge before the Committee. 
296. The representative of Chinese Taipei recalled th ree of the principles set out in the TBT 
Committee Decision:  (i) transparency , (ii) openness and (iii) impartiality  and consensus.  In her view, 
these principles underscored the importance of participation by – and inclusiveness of – all WTO Members in  international standardizing bodies.  In term s of inclusiveness there were a number of 
important questions to pose: would an intern ational standardizing body invite comments from 
specified stakeholders, or, rather, from the general public?  If only from specified stakeholders, what 
would the criteria be for selection of such stak eholders?  If from the general public, how would 
consultations be conducted?  Moreover, would an  international standard  setting body consider 
                                                      
18 G/TBT/W/310. 
19 G/TBT/26, para 26.  G/TBT/M/57 
 Page 59 
 
 
  stakeholder comments from unsolicited sources?  Would,  for instance, an international standardizing 
body consult entities of a WTO Member that was not a member of the standardizing body, 
particularly if and when the entit y of such (a WTO Member) was a l eader or otherwise highly relevant 
in the field?  In terms of impartiality and consensu s, the representative of Chinese Taipei preferred to 
retain the WTO definition of con sensus.  Chinese Taipei emphasized that her delegation stood ready 
to engage in discussions about how to implemen t the principles on the basis of all Members' 
meaningful and effective participation in  international standardizing activities. 
297. The representative of Switzerland referred to  the alleged "ambiguity" of the term 
"international standard" in the TBT Agreement.  He noted that, as mentioned in the Colombian 
proposal, the Committee Decision could serve as a firs t checklist in order to frame the development of 
international standards.  He did not see any urgenc y to re-open the Committee Decision.  While it was 
not necessarily possible to define what an "interna tional standard" was, the Committee could perhaps 
usefully clarify the phrase. The representative of Sw itzerland also considered the idea of setting up a 
database of standards as worthy of exploring.   
298. The representative of the European Union re ferred to Korea's paper and expressed his 
delegation's support for work aimed at enhancing the participation of developing countries in 
international standard-setting activities. On India' s proposal for a work program on standards, which 
the EU understood as applying to "standards" in genera l, whether national or international in nature, 
the EU would look with interest at any proposal subm itted in time to be cons idered in the framework 
of the Sixth Triennial Review.  In general, however, he stressed the need to focus on topics that were 
realistically feasible.  The European Union wished to focus, as a matter of priority, on exchanging 
experiences and collecting information on the applica tion of existing principles for standard setting as 
they were currently embodied in the Code of Good Practice (Annex 3) of the TBT Agreement, and in 
the 2000 Committee Decision (the six principles).  He also stressed the importance of focusing on the 
transparency aspects of standard-setting, in partic ular with respect to how  the public enquiry stage 
was handled at a national and regional standard-se tting level, as well as how stakeholder input and the 
principles of inclusiveness were implemented in in ternational standard-setting.  He supported the 
Colombian point that when standards were made mandatory through technical regulations or through 
references in conformity assessment procedures; th ey needed not only to be notified to the TBT 
Committee, but associated texts also needed to be made fully availabl e.  Regarding the definition of 
an "international standards", the European Union referred to previous comments.    
299. The European Union supported the idea that the Committee could hold dedicated thematic 
sessions to allow Members to delve deeper into certa in topics - without necessarily dealing with all of 
them in one and the same meeting.  This approach would allow delegations to better prepare, and, if 
necessary, bring relevant experts to address specific topics.  This approach could be developed for 
much of the Committee's work as a means of having a more fruitful exchange of views in several of 
its areas of work (i.e., not limited to standards).   
300. The representative of Japan referred to the point s made by Colombia on private standards.  
Japan was of the view that it was not clear whet her Colombia, in its submission, was referring to 
standards developed by a standardization body or a private entity.  Japan echoed the position of the 
United States on private standards.  In the context of Article 4.1 of the TBT Agreement, the Committee had discussed standards developed by no n-governmental standardization bodies for years 
in connection with Members' obligation to take reasonable measures  to ensure that non-governmental 
standardization bodies adopted and applied the Code of Good Practice. Thus, if Colombia's proposal 
was relevant to such bodies, the Committee could discu ss them in that context (Article 4.1). However, 
if Colombia was referring to sta ndards developed by other private entities, this was outside of the 
scope of the TBT Agreement. G/TBT/M/57 
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  301. The representative of the ISO wished to follow-up on the Committee's March discussion on 
standards.  In general, the ISO fully supported th e idea that international standardizing bodies who 
claimed to observe the Committee Decision's six prin ciples needed to be able to demonstrate that 
claim; nevertheless, there would be difficulties associated with an independent verification of 
compliance with the six principles.  On participa tion in ISO technical committees, the representative 
of ISO stressed that all WTO Members could become Members of ISO and participate in technical 
committees dealing with standards development.  Ev en ISO Members not participating in technical 
committees had a voice, since they could vote on draft standards.   
302. The representative of the OIML said that his organization mainly developed model technical 
regulations in the field of legal metrology. He  stressed that the OIML, as an international 
standardizing body, supported the principles of good practice as set out in the TBT Agreement.  He 
agreed with the concerns expressed by the ISO repr esentative, as well as the United States, concerning 
the appropriateness or need to restrict the list of in ternational standard setting organizations or attempt 
to define it any further.  He informed Members that the OIML was in the process of finalizing a 
revision of its working procedures for its techni cal work; these procedures were intended to embody 
the principles of the TBT Agreement as far as possible,  and to ensure that the work of the OIML was 
conducted in compliance with those principles, wher e possible. On the issue of consensus, although 
the OIML tried in its work to ensure that the vi ews and needs of as many of its members as possible 
were taken into account, it was constrained by certa in voting requirements which were enshrined in 
the OIML treaty.  Nevertheless, all information on the OIML technical work – from the very initial 
drafts through to final publications – was publically available and free of charge through its website.  
This process provided adequate opportunity for all interested stakeholders to participate and to 
provide comments.   
303. The representative of India said that his delega tion did not envisage verifying the principles 
that the OIML or the ISO followed, rather his delegation was proposing an exchange of information 
(among WTO Members) on how exactly standards were  set. For example, with respect to the ISO 
process, although all ISO members participated, for those that were not part of the technical 
committee, it was only the negative vote that counted , not the positive vote. The positive vote could 
only be made by the members of that technical committee.  These nuances were difficult to follow 
and could benefit from a closer look in the contex t of a Committee work programme.  There was no 
intention of harmonizing the practices across differe nt bodies but rather to ha ve a better understanding 
of how the organizations worked.   
304. The representative of India further noted that Malaysia had addressed the issue of how to 
ensure that LDCs participated in standard-setting. In this regards, his delegation's paper had suggested 
that standardizing bodies look at having an action plan for developing countries (this already existed 
in some organizations), whereby a single representati ve of an LDC group – or  some other developing 
country group – could participate in, for example, the ISO process representing a larger group.  While 
perhaps not the best solution, it w ould be a step in the right direc tion.  On the voting process, India 
understood that this was contentious: methods va ried from body to body.  Again, India was not 
proposing to change this; nevertheless, there needed  to be some way to ensure that there was a 
sufficiently large number of positive vot es before a standard was adopted.   
305. The representative of India thanked both Braz il and Colombia for support on the idea of a 
work programme and agreed with the United States  on the importance of transparency in standard-
setting.  On the modalities, in India's view the best  forum for this work w as the Committee itself with 
an agreed agenda item for each Committee meeting.   
306. The representative of the United States referred to the point made by India on "action plans" 
for financing the participation of developing countri es in standardizing activities.  She stressed that 
most standardizing bodies were private sector bodi es – not public sector bodies.   Therefore, as WTO  G/TBT/M/57 
 Page 61 
 
 
  Members, governments only exerted influenced th rough their participation in these bodies or their 
technical committees.  A number of the (private) bodies were doing considerable work trying to 
enlarge participation by developing countries – ho wever, she noted, participation in technical 
committees was done largely by volunteers – and this was in large part driven by an interest in using 
the outcome, which was essential for the quality of th e standards thereby developed. She noted that 
voting processes varied widely across bodies, depending on the type of standard in the pipeline; this 
process was also closely linked to what the members and participants of the particular body felt was 
appropriate for the standard in order to deve lop it in a timely and effective manner.   
307. In concluding the Chairman stressed the im portance that the Membership had given to 
participation in international sta ndardizing activities – in this regard  he stressed the principles of 
transparency, inclusiveness and consensus.  He also noted that the proposal to develop a work 
programme, or otherwise find ways and means of focusing the Committee's work, appeared to have 
gained traction.  
3. Conformity Assessment 
308. The representative of the United States reitera ted that conformity assessment was key to 
regulators' ability to assure confidence that requireme nts set out in technical regulations were being 
met.  Moreover, conformity assessment was increasingly being used in voluntary programmes, including voluntary standards.  She recalled that  the United States had presented its paper on ILAC 
and IAF at the previous meeting of the Committee.
20  In this regard, she said that the United States 
saw the work of regional networks of accred itation bodies as essential in building competence, 
proficiency and avoiding conf licts of interest.  In addition to strengthening ideas on the 
implementation of Aarticle 9 of the TBT Agreement,  the United States was interested in finding ways 
to improve the implementation of Article 5 of the TBT Agreement, and in particular Article 5.4 – 
which, she recalled, required central governme nt bodies to base their conformity assessment 
procedures on international standards, except where they would be inappropriate in meeting their 
objective.  It was particularly important to ensu re the competence and independence of conformity 
assessment bodies; a closer inspection by the Cco mmittee of the provisions of Article 5 could yield 
important returns in terms of stre ngthening implementation.  In terms of the themes for discussion in a 
dedicated work programme, the United States proposed  that the Committee could have an information 
session where, for instance, ISO CASCO experts and other experts from conformity assessment bodies or accreditation bodies would prov ide information in this respect. 
309. On New Zealand's submission on trade facilitation
21, the United States supported efforts by 
Members to provide information and perspectiv es to the Ccommittee to promoted shared 
understandings - particularly regarding complex i ssues such as the choice of conformity assessment 
procedure in different situations.  The United St ates was somewhat concerned that the suggested 
content was too detailed for a Ccommittee document and that the level of analys is and complexity in 
the paper was perhaps greater than what was ppr acticable in terms of gaining agreement on the 
language.  The United States would support a more simp lified and flexible approach; for instance, the 
Committee could discuss or compile a set of options for reference for Member s to inform internal 
decision making with respect to trade facilitativ e mechanisms on conformity assessment.  Such 
options would need to include a reference to the use of international standards and international 
systems of conformity assessment. 
310. The Secretariat recalled that some of the recommendations contained in the 6th Triennial 
Review Report were specific in nature.   
                                                      
20 G/TBT/W/349, dated 13 March 2012. 
21 JOB/TBT/5, dated 17 September 2010. G/TBT/M/57 
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  311. The representative of the United States noted th at, in her delegation's view, conformity 
assessment was a particularly complex area and that therefore continued information exchange on the 
implementation of Articles 5.2 and 5.4 of the TBT Ag reement would be useful.  This need was further 
underlined by the many trade concerns discussed in the Committee that were fundamentally about 
conformity assessment procedures.  She reiterated th at there was existing guidance in international 
standards that could be shared and discussed.  It coul d be useful to begin by considering existing work 
on this subject, and the meaning of various guides and recommendations put out by different bodies.  
It was also important to consider these along-side efforts to increase transparency in standard-setting 
as more and more Members regulated on the basis of voluntary standards which addressed critical, societal, public health and/or environmental objectives.  
312. The representative of the European Union not ed that the Committee had progressed less on 
conformity assessment as compared to GRP.  Nevertheless, he noted that the recommendations from 
the Fifth Triennial Review still held and provided a roadmap to follow.  Ind eed, Members were aware 
during the last Review that the work to be done would not be accomplished in the timeframe of one 
triennial review.  Hence, the exchange of informat ion needed to continue.  This would enable the 
Committee to extract some principles, guidelines or  illustrative examples to base its work on. And 
while on GRP the exchange of information has progressed well, and the Committee had gathered 
enough of a critical mass of information from which to extract principles, on conformity assessment there was clearly still scope for more exchange of in formation before going a step further.  It made 
sense, in the view of the European Union, to id entify areas where there was sufficient interest to 
continue work through thematic sessions.  For instan ce, one issue that had not been explored in the 
TBT Committee was the issue of risk assessment vs . risk management in the TBT area. While all 
Members very much supported a risk based approach  to conformity assessment, views differed widely 
on the notion of risk assessment and how to mana ge risks through conformity assessment.  These 
discussions could usefully be explored in further dept h.  Indeed, this was also relevant to GRP:  to 
date, GRP had mainly been looked at with regard  to technical regulations but discussions on GRP 
were equally relevant to conformity assessment. 
313. The Chairman concluded that the emphasis in the area of conformity assessment appeared to 
continue to be on information exchange.  
314. On a separate matter, the representative of Canada  drew the Committee’s attention to the fact 
that the governments of Canada and Mexico had agreed on an MRA on conformity assessment for 
telecommunications equipment.  The agreemen t was subsequently notified to the Committee.22 The 
MRA was aimed at streamlining conformity  assessment for a wide range of products. 
4. Transparency 
315. The Chairman recalled previous recommendati ons made under the Fifth Triennial Review23 
and drew the Committee's attention to the fo llowing recent submissions: Japan (G/TBT/W/352), 
Korea (G/TBT/W/353) and European Union (G/TBT/W/354). 
316. In introducing his delegation's submission, the representative of Japan stressed the importance 
of improving and strengthening th e implementation of the transparency provisions of the TBT 
Agreement.  With regard to the first element of  the submission – response to inquiries and comments 
on TBT notifications – he said that responses to all reasonable inquiries should be provided in a 
timely manner, and that a standard time period coul d be set from receipt of comments to response in 
the context of the Sixth Triennial Review.  Allowing Members to share experiences regarding 
difficulties in responding to comments could be beneficial in this regard. 
                                                      
22 G/TBT/10.7/N/110, dated 12 June 2012. 
23 G/TBT/26, paras. 29-54.  G/TBT/M/57 
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  317. On the second element – ensuring opportuniti es for comments to TBT notifications – the 
representative noted cases when Japan's written co mments in English were not accepted by the 
notifying country, because only wr itten comments in Spanish were accepted.  In this context, his 
delegation faced difficulties in providing translat ed comments within the comment period.  In 
response to such situations, he suggested the Co mmittee recommend that if a comment were written 
in one of three WTO official languages and reached  a notifying country within the comment period, 
Members should accept a translated version of th e comment (if that Member only accepted comments 
in one language) even after the end of the comment period, provided that the translated comments are 
delivered within a reasonable period of time. 
318. Regarding the third element of the submission – reply to enquiries through the TBT enquiry 
point – he suggested that the Committee include in  the Sixth Triennial Review a recommendation to 
encourage Members to reply to enquiries, and fo r Members to share experiences about cases where it 
was difficult to respond to enquiries. 
319. With respect to the fourth element – Code of Good Practice – he recalled that Paragraph L of 
Annex 3 of the TBT Agreement states "Before adopti ng a standard, the standardizing body shall allow 
a period of at least 60 days for the submission of comments on the draft standard by interested parties 
within the territory of a Member of the WTO."  He proposed the Committee consider initiating in the 
Sixth Triennial Review a sharing of Members' e xperiences and best practices on implementation of 
this paragraph. 
320. The representative of Korea noted three issues fro m her delegation's submission.  First, she 
highlighted the ambiguity of the criteria used to de termine "significant" trade effects in Articles 2.9 
and 5.6 of the TBT Agreement, and that notificati ons ultimately relied on the subjective judgement of 
the competent authorities concerned.  Her delegation believed that the abstract criteria to assess the 
significance of a regulation’s effects on trade were partly to blame for the failure of some Members to notify important technical regulations, and she stressed  that more precise criteria in this regard were 
necessary. As a first step, she suggested the WTO S ecretariat investigate specific trade concerns that 
had not been the subject of TBT Committee notifica tions, and analyse the rationale behind the failure 
to notify. 
321. Second, she proposed that Members submit, when ever possible and on a voluntary basis, an 
electronic version of the regulatory impact assessm ent in the Members' national language along with 
notifications to the WTO Secretariat.  The regul atory impact assessment could be made available 
through a hyperlink on the Members website, marked  on the notification.  The representative said the 
new procedures could be phased in gradually; Memb ers could initially share impact assessments for 
Acts, and later for subordina te statues and regulations. 
322. Third, her delegation suggested that in the c ontext of the Sixth Triennial Review, Members 
reaffirm the importance of mechanisms to ensure  intra-governmental coordination under Articles 3.2 
and 7.2 of the TBT Agreement, including encourag ement that Members notif y the TBT Committee of 
local government regulations. She said that Committee was still not being notified of many such local 
government regulations, and that  her delegation had noticed disharmony between technical 
regulations proposed by central and local governme nts. She suggested the Sixth Triennial Review 
encourage Members to share experience  and difficulties regarding these issues. 
323. The representative emphasized the importance of progress in this respect to build Members’ 
confidence in the implementation of the TBT Agreemen t.  Her delegation intended to further develop 
this submission, and was open to any comments or guidance from other Members.  
324. The representative of the European Union explained their submission addressed existing 
obligations under the TBT Agreement and recommen dations developed over time by the Committee G/TBT/M/57 
Page 64  
 
  on transparency, as well as proposals to improve the TBT Information Management System (TBT 
IMS).  He noted Section 2 of the submission cove red similar themes as Japan's submission, namely 
that there remained some serious short comings in  Members complying with certain basic obligations 
in the field of transparency, such as a lack of notif ications or lack of response from the enquiry points, 
as well as Members not following Committee recommendations.
24  The representative stressed the 
need to reaffirm the importance of Members fully complying with their transparency obligations, and 
implementing the recommendations of the Committee. 
325. He expressed concerns about uncertainty as to the actual duration of the comment period, and 
the actual deadline for comments.  More specifically , he said there was a margin of ambiguity as to 
whether the 60 day period began from the moment of sending a notification to the Secretariat, or if it 
began from the moment of circulation of the notification by the Secretariat.  Given that there was no 
uniform time period between sending a notification to the Secretariat and its circulation, this increased 
uncertainty about the comment period, and often re duced the effective length of the comment period 
to significantly less than 60 days. 
326. The representative said his delegation, despite be ing a large Member with significant capacity 
in principle, had faced challenges in managing th e growing number of TBT notifications over recent 
years, which raised the question about ways to he lp facilitate Members efforts to access and manage 
this substantial flow of information.  He said this was important for maximizing the chances that 
Members take full advantage of their opportunities and rights under the notification procedure, in 
other words: becoming aware of notifications; reacting to those that are of interest; and, keeping track 
of regulatory developments in other members. 
327. He believed one way to address this informati on management challenge was improvements to 
the existing TBT IMS.  Given that the Secretariat was engaged in on-going work to enhance the TBT 
IMS, he believed this was an opportune time to e ngage in such a discussion in the Committee.  His 
delegation's submission covered three broad objectives in this respect: promoting efficiency; keeping 
track of information relating to a single notification; and awareness raising. 
328. In terms of making the system more effici ent to promote time savings, his delegation 
proposed that the forthcoming online TBT notificati on submission system enable direct uploading of 
TBT notifications.  He insisted on direct uploadi ng to avoid repetitive copy and paste steps by TBT 
enquiry points, as was the case with the new online SPS notification submission system (NSS).  This was technically feasible; his delegation successfully implemented a similar database for managing internal notifications of draft technical regulati ons by EU member states, and was willing to share 
experience in this regard.  A further advantage of direct uploading would be to minimize the need for 
processing by the Secretariat, reducing uncertainty  about the length of the comment period.  The 
comment period could begin immediately from the uploa ding of the document to the database, or in 
any event, would provide for a standard time pe riod between the uploading of the document and it 
being made available to WTO members.  He noted that online submission should remain voluntary, 
and that Members could continue to use other mean s of notification if they found them more suitable 
for their needs.  However, in th is case, he suggested that the starting date for the comment period be 
the date of the circulation of the notification by the Secretariat. 
329. Further on efficiency, with respect to definitio n of the scope of draft measures, he said that 
reliance on the Harmonized System (HS) codes or International Classification of Standards (ICS) was cumbersome and did not reflect the reality in which technical regulations and conformity assessment 
procedures were developed.  He explained the di fficulty of capturing in an exhaustive way all the 
products that are covered by a technical regulati on or conformity assessment procedure under an HS 
codes.  As a user it was very challenging to search for technical regulations that apply to particular 
                                                      
24 See: G/TBT/1/Rev.10   G/TBT/M/57 
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  products, if one was not very well versed in a partic ular product sector, and wa s familiar with the HS 
customs nomenclature.  Therefore, his delegation proposed a new categorization of products, defining 
by a number of product categories which correspond to the main industry product sectors subject to 
TBT notifications.  When uploading a notification, he explained the notifying authority would choose 
from those predefined categories the one which best  matches the scope of the notifying text.  His 
delegation was open to ideas about th e length of the list of categories and their description.  This 
approach would create a repository of technical re gulations and conformity assessment procedures 
that apply to a given product sector in all Member s, since a user could search by product sector and 
have immediately have access to all notifications from all Members pertaining to that sector.  
330. With respect to keeping track of information rela ting to a single notification, he suggested that 
all information concerning a notification be acce ssible on one single page.  In other words, the 
original notification, the final adopted texts, and any amendment thereto, any corrigendum, and any 
revision should all be accessible on one and the same pa ge.  He noted that this was implemented in 
the European Union database, to the appreciation of  by users who were thereafter better equipped to 
follow developments related to a given measure.  Along these lines, the repres entative proposed that 
the Committee agree to a uniform coding system for the use of addenda and revisions, since there was 
currently some irregularity in the use of addenda  and revisions by Members which caused confusion 
and complicated following developments on a measure. 
331. Lastly, on awareness raising, he said that IT tools helped build and raise awareness about 
TBT notifications, the content of technical regula tions, regulatory developments, and about the TBT 
Agreement in general.  In this re gard, he proposed that a facility be created so that Members could, on 
a voluntary basis, upload comments received from other members and also responses given to 
comments.  He explained that this would allow Memb ers to become aware of concerns raised by each 
other, and since specific trade concerns were largel y a repetition of concerns already communicated in 
written comments, he said this shouldn't create confidentiality issues.  However, he submitted 
Members should be entitled to bring confidentiality issues to the attention of the Secretariat, and 
therefore refrain from posting comments in that case.  Nevertheless, his delegation believed there was 
great potential for learning from one another, si nce the written exchange that takes places in the 
framework of the TBT notification was a powerful learning tool. 
332. The representative noted a second aspect concerning aw areness raising: the use of IT tools to 
develop an email alert system whereby subscribers c ould choose to be informed about notifications in 
one or more product sectors.  In this regard, he pr oposed that synergies be explored with existing 
national or regional databases for TBT notifications, w ith a view towards an interactive system that 
could link with existing or future national or  regional databases, facilitating dissemination of 
information to national authorities as well as stakeholders. 
333. His delegation recognized this was an ambiti ous proposal, and welcomed any comments from 
Members.  He suggested that the next Special Meetings on Procedures for Information Exchange 
consider these issues in greater detail, and noted that timing was linked to the on-going work of the 
Secretariat towards upgrading the TBT IMS. 
334. The representative of Ukraine highlighted key elem ents in respect of transparency, including, 
Members providing for opportunities for comment , responding to comments, and ensuring well-
functioning TBT Enquiry Points.  She noted th e Ukrainian TBT Enquiry Point rarely received 
responses to its enquiries.  Yet, it received many enquiries and comments from other Members and, in 
this context, there were challenges in providing pr ompt and clear responses.  Her delegation supported 
Japan's submission, in particular regarding enc ouragement of written responses to comments and 
Members replying to enquiries.  Her delegation w as willing to share national experiences concerning 
difficulties in responding to comments. G/TBT/M/57 
Page 66  
 
  335. The representative of Malaysia supported the submission of Japan, and agreed that better 
implementation of the transparency provision of the TBT Agreement could result from sharing of 
experiences amongst stakeholders and Members.  She made a number of specific comments on the 
submission.  Regarding responses to enquiries and comments to TBT notifications elaborated in 
paragraph 6, her delegation sup ported the proposal for a standard time period for response to 
comments, so as to encourage timely responses a nd establish an understanding on what constitutes a 
timely response. 
336. The representative welcomed the proposals ou tlined in paragraphs 7 and 9, on ensuring 
opportunities for comments on TBT notifications in any of the official languages of the WTO, and on 
ensuring a 60 day comment period under the Code of  Good Practice.  She said the proposal in 
paragraph 4 for sharing Members' experiences on implementation of Paragraph L of the Code of 
Good Practice was worthy of further consideration, and she requested clarification from Japan on the 
precise nature of this experience sharing. 
337. The representative of Cuba expressed support fo r Japan's submission, in particular on the 
need for enquiry points to reply in writing to request s, in good time and within a standard time period. 
338. The representative of India agreed with Japan 's submission on the need for standardizing 
bodies to provide for a 60 day comment period on draf t standards.  However, he was cautious about 
setting a standard time period for responses by enqu iry points, since this could pose difficulties for 
developing countries; in this rega rd, he favoured sharing of Member s' experience on the response time 
periods. 
339. Turning to Korea's proposal, he submitted that sharing of regulatory impact assessments in 
the context of notification could be useful, provided it was on a purely voluntary basis.  On the 
proposal for the Secretariat to review specific tr ade concerns that were not related to notified 
measures, he said this would be burdensome for the Secretariat and may create controversy, citing 
experience in the Trade Policy Review Mechanism context. 
340. The representative shared the objective of th e European Union proposal to improve TBT 
information technology systems.  From his perspec tive, the future TBT online notification submission 
system could follow the model of the SPS NSS, prov ided that some mechanism was included to allow 
the Secretariat to continue to work with Members to correct discrepancies in their notifications.  He 
was however concerned that development of ne w product categorization approach would be a 
disincentive for Members to provide HS codes on not ifications; regulators may stop sharing data on 
product coverage which they already have on hand, or may not take the time to assess affected 
products.  After all, HS codes remained at the essence  of trade and tariffs da ta, and he cited related 
problems that had arisen in the context of the Information Technology Agreement. 
341. The representative of Hong Kong, China suppor ted the proposals outlined in Japan's 
submission, regarding timely responses from enquiry points on receipt of comments on TBT 
notifications or other enquiries, and experience sharing on this aspect. 
342. The representative of the United States said her delegation shared the general concerns 
identified in the three submissions regarding the lack  of notifications and the inability of some enquiry 
points to respond to basic requests for informati on.  She believed that helping Members to meet 
existing obligations on transparency was an importa nt goal for the Committee.  She noted that many 
Members faced significant institutional, legal,  resource, and other governmental coordination 
challenges in establishing an enquiry point and no tification processes, and any support the Committee 
could provide, including experience sharing, was valuable.  On strengthening notification processes 
and enquiry point operations, she noted that Me mbers had established various mechanisms – for 
example, the United States notification process was supported by a strong inter-agency committee  G/TBT/M/57 
 Page 67 
 
 
  structure as well as a single official journal – and she suggested that Members share best practice for 
these mechanisms.  
343. Regarding Korea's submission, she supported pu blication of regulatory impact assessment on 
a voluntary basis, and echoed the importance of notification of sub central government measures.  On Korea's suggestion that the Committee develop mo re detailed criteria for "significant effects on 
trade", she noted the challenging analytical a nd methodological issues in assessing impacts of 
regulations on trade.  In order to minimize the reasons and opportunities for Members to avoid 
notifying important measures, her delegation believed that Members should adopt a liberal 
interpretation of significant effects,  with a bias towards notification. 
344. With respect to Japan's submission, she repor ted that the United States provided responses to 
comments once the final rule was published by regul ators, and she viewed the TBT Committee and 
the interaction amongst trade officials as an impor tant means to provide interim feedback and 
clarifications.  Her delegati on would continue to take time to inte ract with Members in order to clarify 
concerns on proposed technical regulations.  Fina lly, her delegation supported the intent of the 
European Union proposal of promoting efficiency in information technology systems and expanding 
the uptake of good practices on notification. 
345. The representative of Brazil agreed with the obj ective of the European Union submission of 
using technology as a tool to improve transparency practices.  He noted useful ideas, including the 
direct upload of notifications.  However, in te rms of initiating the 60 day comment period from the 
upload of a notification, he said there were oc casions when it was not possible for Members to 
provide this amount of time for comments.  Nevert heless, he did recognize that Members should do 
their utmost to fulfil this recommendation of the Committee.  Lastly, on the proposal for storing 
comments and responses given during public consulta tion processes, he said this should be done on a 
voluntary basis. 
346. The representative of New Zealand was supportive of increasing the efficiency and 
effectiveness of national enquiry points, and maki ng further improvements to transparency practices 
among Members. Her delegation belie ved there was value in further encouraging Members to take 
practical steps to improve their current practices. 
347. Turning to Japan's submission, she noted that th e role of national enquiry points in receipt of 
and response to comments and enquires was often that of a conduit; regulators were usually 
responsible for considering and responding to comme nts and enquiries.  In order to address Japan's 
concerns, she first suggested th e Committee encourage national enquiry points to acknowledge the 
receipt of a query and to provide a contact point in the organization or ministry responsible for the 
measure, to facilitate direct and fruitful dial ogue between parties.  Second, she suggested 
incorporating a discussion on this topic in next Special Meeting on Information Exchange, with a 
view to identifying practical ways to address these challenges. 
348. Her delegation was supportive of  Japan’s suggestion of shar ing information among Members 
on how the transparency provisions of the Code of  Good Practice were currently being implemented, 
and any challenges encountered.  However, she que stioned whether this should be a focus of the 
Committee’s work; should Members wish to discuss issues around the operation of national standards 
bodies, including transparency issues,  a separate forum could be created such as an ad hoc meeting or 
a dedicated workshop.  
349. With regard to the transparency aspects of Korea's submission on "significant effects on 
trade", she suggested that as a starting point Me mbers exchange information as to how they are 
currently applying Articles 2.9 and 5.6 of the TBT Agreement and the TBT Committee recommendations on this point.  Further, her delegation supported Members supplying more G/TBT/M/57 
Page 68  
 
  information to the WTO as part of the overall notification process, including regulatory impact 
assessments, so long as it remained voluntary and flexib le enough to be appropria te for all Members.  
Finally, she expressed support for promoting intra governmental coordination mechanisms as a means 
to enhancing implementation of th e TBT Agreement.  She noted that her delegation would further 
consider the European Union submission, but was generally supportive of issues raised therein. 
350. The representative of Switzerland said that the Fifth Triennial Review recommendation on 
responding to comments in writing should be reaffirmed  and made more precise in the Sixth Review.  
Responses should be encouraged for comments made in  any official language of the WTO, within an 
indicative deadline.  If for some reason this dead line cannot be respected, he said enquiry points 
should be encouraged to at least acknowledge receipt  of the comment.  Regarding the role of enquiry 
points, he suggested the Committee come up with gu idance that would better enable them to respond 
to comments.  
351. The representative welcomed any efficient and user-friendly information technology solutions 
that reduced the burden on the WTO Secretariat, re duced the delay between receipt of notifications 
and circulation, and facilitated access to notifications for interested stakeholders (such as regulators or 
companies).  His delegation favored an automatized system, which was lean, simple, and available in 
the near future. 
352. In terms of the European Union submission, he welcomed the proposal on general 
categorization of goods subject to measures.  Howe ver, he questioned the feasibility of publishing 
comments online, and said that discussions in the TBT Committee currently provided information in 
this regard. 
353. He expressed interest in Korea's submission with  regard to "significant effects on trade", and 
supported the United States' remarks re lated to that matter.  The exis tence of specific trade concerns 
on measures that had not been notified suggested a ne ed to clarify this ambiguous wording.  He asked 
Members to share the criteria they used to deci de whether legislation projects were notified. 
354. Speaking of Korea's submission, the representativ e of Canada noted that challenges arose in 
providing guidance to Canadian authorities devel oping regulatory measures on the meaning of 
"significant effects on trade".  His delegation be lieved it was best to understand the phrase from the 
point of view of any other Member which may percei ve the measure to be significant, and therefore it 
was best to err on the side of caution and notif y measures when in doubt.  The representative 
suggested the Committee develop some guidance on th is point, which Members could provide to their 
regulatory authorities. 
355. He stressed the importance of using informati on management tools and technology to provide 
information more quickly and efficiently to Members,  and noted the interesting concepts contained in 
the European Union submission.  The representa tive called for simplified access to notification 
information, and support to stakeholders in identifyi ng only those measures that are important to them 
(e.g. measures in key export markets), particularly  given the year on year growth in the number of 
notifications. 
356. On the European Union proposal for developi ng a new categorization for measures, he 
observed that although identifying HS codes for a measure was valuable, it was often very challenging or even impossible.  He explained that regulators did not develop measures with 
particular HS codes in mind, rather measures app lied to an open scope of products relevant to the 
policy objective of the measure.  Being precise in identifying HS codes could undermine the 
objectives of a regulation, for example, if certain pr oducts were missed which were relevant, or if new 
products were developed.  The representative saw some value in providing information to 
stakeholders in terms of broad categories, and would consider the EU proposal further.  G/TBT/M/57 
 Page 69 
 
 
  357. He noted there were few significant delays in circ ulation of notifications by the Secretariat.  
Nonetheless, there remained a risk of certain dela ys (e.g. time for translation, human error) reducing 
the 60 day comment period, and he said improved t echnology should be used to avoid this risk. 
358. The representative of Japan said his delegati on was open to comments and discussion on the 
proposed standard time period from receipt of commen ts to response.  He noted that, on average, 
Japan replied within 60 days of receipt of comment s.  The representative stressed the importance of 
Members acknowledging comments received on TBT no tifications, and welcomed the suggestion of 
New Zealand on this matter. 
359. The representatives of the Secretariat presented recent enhancements to the TBT Information 
Management System (TBT IMS)25, including new layout and search  functions, and the forthcoming 
WTO Integrated Trade Intelligence Portal (I-TIP)26, which provided a birds-eye view of trade policy 
information notified by WTO Members, including TBT information. 
360. The representative of India asked a number of questions about I-TIP: how information 
displayed in I-TIP for measures which lacked HS  codes was being managed; were measures that 
lacked an entry into force date as sumed to enter into force 8 months after date of circulation (i.e. 60 
days for comment period and 6 month "reasonable inte rval"); and, how this database interfaced with 
UNCTAD, World Bank and ITC databases? 
361. The representative of the European Union asked whether a more user friendly approach to 
product categorization of measures had been consid ered.  Finally, he asked about the timeline for 
development of the TBT on-line notification submis sion system, and whether it would be constrained 
to follow the SPS NSS model. 
362. The representative of the Secretariat said that  the focus was on improving the TBT IMS and 
access to its data.  The TBT IMS was directed to of ficials and stakeholders working directly on TBT 
issues, while I-TIP was directed to a broader group of users.  He explained that I-TIP drew on the data 
contained in the TBT IMS, and relied on the comp leteness and accuracy of the TBT IMS data.  He 
noted that the recent enhancements to the TBT IMS addressed some of the issues mentioned in the 
European Union submission, although work remained  to be done.  For example, there was a time lag 
between the receipt of notifications and circulation of between three and five days.  This time lag was 
due to the Secretariat performing quality checks on notifications, and the need to follow WTO formatting and documentation rules.  He noted that  the forthcoming on-line notification submission 
system for the TBT IMS would improve this situati on.  On the question from the European Union, he 
explained that HS codes were one of the comm on features that linked the different databases and 
types of measures (e.g. TBT IMS, SPS IMS, anti-dumpi ng) integrated by I-TIP.  The intention was to 
make the on-line notification system operational dur ing 2013.  The system would be based on the SPS 
NSS as the initial prototype, but would be cust omized for TBT and any required functionalities. 
D. O
THER MATTERS  
363. The Chairman informed the Committee that a room document27 was made available with 
provisional dates for Informal meetings. These dat es were 4 October, 6 November and 26 November. 
                                                      
25 http://tbtims.wto.org/   
26 A prototype of the I-TIP system can be accessed by WTO Members at: https://I-TIP.wto.org  
(username: tntanyuser and password: RWUs3r@10 ). Comments should be directed to: I-TIP@wto.org . 
27 RD/TBT/9 G/TBT/M/57 
Page 70  
 
  IV. UPDATING BY OBSERVERS 
364. The representatives of the ITC and IEC updated the Committee on their on-going activities in 
developing countries and work related to TBT.28  
365. The representative of the UNECE informed the Committee that WP6 (Working Party on 
Regulatory Co-operation and Standa rdization Policies) was now focu sing on education in standards-
related issues.  A revision of a recommendati on from 1970 was necessary as there was a lack of 
awareness by students of the basic standards relate d issues.  This revised recommendation, which it 
was hoped would be adopted at the November meeti ng, would then lead to a model programme on 
standardization which would be included in the UNEC E university programme.  The first draft of this 
programme included contributions from European and CIS universities and from intergovernmental 
organizations.  She invited Members to share any experiences they had in educational programmes in 
this field.  A workshop would be held on 8 N ovember 2012 on this subject and all Members were 
warmly invited to attend. 
366. The representative of the OIML informed the Committee that the Organization had undergone 
a complete revision of its working procedures for all technical work.  A room document would be 
provided at the November meeting of the Committee  explaining in detail the voting procedures in the 
OIML. 
V. DATE OF NEXT MEETING 
367. The next regular meeting of the Committee is scheduled for 27-29 November 2012. 
 
__________  
                                                      
28 G/TBT/GEN/133, G/TBT/GEN/134.