WORLD TRADE  
ORGANIZATION  RESTRICTED 
G/TBT/M/56  
16 May 2012 
 (12-2640) 
Committee on Technical Barriers to Trade  
  
 
MINUTES OF THE MEETING OF 20-21 MARCH 2012 
 
Chairperson:  Ms Denise Pereira (Singapore) 
 
Note by the Secretariat1 
 
I.  ADOPTION OF THE AGENDA ............................................................................................. 2  
II.  IMPLEMENTATION AND ADMINISTRA TION OF THE AGREEMENT .................... 2  
A.  STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2 ................................................................ 2  
B.  SPECIFIC TRADE CONCERNS  ....................................................................................................... 2  
1.  Specific Trad e Concerns ....................................................................................................... .... 2 
2.  Follow-up ..................................................................................................................... ............ 60  
C.  EXCHANGE OF EXPERIENCES  .................................................................................................... 61  
1.  Good Regulatory Practice (GRP) .......................................................................................... 61  
2.  Standards ..................................................................................................................... ............ 63  
3.  Conformity Assessment ......................................................................................................... . 66 
4.  Transparency .................................................................................................................. ........ 68 
D.  OTHER MATTERS  ...................................................................................................................... 69  
1.  Sixth Triennial Review: Reminder of deadlines ................................................................... 69  
III. ANNUAL REVIEW OF THE TBT AGREEMENT (G/TBT/31) ....................................... 69  
IV.  TECHNICAL ASSISTANCE ................................................................................................ 70  
V.  UPDATING BY OBSERVERS ............................................................................................. 70  
VI.  OTHER BUSINESS ................................................................................................................  70 
VII. DATE OF NEXT MEETING ................................................................................................ 70  
 
                                                      
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the positions of Members or to their rights and obligations under the WTO. G/TBT/M/56  
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I. ADOPTION OF THE AGENDA  
1. The Committee adopted the agenda contained in WTO/AIR/3896. 
2. The Chairperson drew delegations' attention to the agreed recommendations made by the 
Committee on Budget, Finance and Administration to  the General Council concerning savings to be 
made in documentation, as well as in meeting organi zation (contained in WT/BFA/128).  In light of 
these, she informed the Committee that, as of 1 Ap ril 2012, TBT notifications would be available 
online only.2 At the same time, the Secretariat would c ontinue to enhance and further develop its 
information management system for TBT notifications  (the TBT IMS), including with respect to the 
on-line submission of TBT notifications.  
II. IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
A. STATEMENTS FROM MEMBERS UNDER ARTICLE 15.2    
3. The Chairperson said that the latest list of st atements submitted under Article 15.2 of the TBT 
Agreement is contained in document G/TBT/GEN/1/ Rev.11, issued on 29 February 2012.  She noted 
that, since the last meeting, Namibia (G/TBT/2 /Add.108) had submitted its  statement under Article 
15.2 and South Africa (G/TBT/2/Add.60/Rev.1) had subm itted a revision to its original statement.  In 
total, since 1995, 125 Members had submitted at l east one Statement on Impl ementation under Article 
15.2.  She recalled that this information was availabl e, and regularly updated, on the TBT page of the 
WTO website and in the TBT Info rmation Management System ( http://tbtims ).   
B. SPECIFIC TRADE CONCERNS  
1. Specific Trade Concerns  
(a) New Concerns 
(i) Russian Federation – Draft on Technical Regulati on of Alcohol Drinks Safety (published on  
24 October)  
4. The representative of Mexico recalled comments sent by her delegation in December 2011 
expressing concern about the compatibility of this me asure with the TBT Agreement.  She appreciated 
the removal of the definitions of tequila and mescal  from the technical regulation, since they were not 
considered generic products.  Nonetheless, she re quested information about how these products would 
be categorized and whether they would be ac knowledged as having undergone a process of protection 
in the context of their denomination of origin regi stration by the Russian Federation.  Her delegation 
considere0d certain requirements of the measure - stat e registration, declaration of conformity, as well 
as of import and circulation licences for alcoholic beverages - to be excessive (in terms of 
notification) and duplicative (of existing regula tions).  She requested that the accreditation of 
laboratories, and the results of laboratory tests c onducted by those laboratories, be acknowledged by 
Russian Federation customs authorities, given that tequila already complied with a complete system of certification and guarantee.  
5. With regard to the commercial information to  be included in labelling, the delegation of 
Mexico believed that the requirements were very br oad, and that the measure was more restrictive 
                                                      
2 Documents related to a specific meeting ca n be downloaded from the WTO website at:  
http://docsonline.wto.org/gen_meetings.asp .  G/TBT/M/56  
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  than necessary to achieve its legitimate objective.  Furthermore, she asked that product specifications 
established by the measure not apply to tequila a nd mescal, since these products bore a denomination 
of origin and complied with the specifications of re levant Mexican rules.  Finally, the representative 
requested further information about the technical regulation from the Russian Federation, as well as a 
formal answer to Mexico's comments.  
6. The representative of the European Union ann ounced that should this draft regulation be 
adopted in its current form, a considerable number of  EU exports of wines, spirits and other alcoholic 
beverages would no longer be allowed on the Russian  market.  In addition, she was concerned about 
the establishment of several new administrative requirements with no added value for health 
protection.  She urged the Russian Federation to  amend the draft regulation and to not impose 
requirements regarding production processes nor trans port of products when circulating outside the 
Customs Union.  The representative stressed that co ntrols carried out by European authorities should 
be deemed sufficient, and asked that EU certific ation be accepted.  She further requested that 
laboratory tests not be carried out on each single c onsignment; this would create serious delays at 
customs given the substantial trade flows of these products. 
7. Additionally, the EU requested the Russian Fede ration to remove the notification procedure, 
which was more stringent than necessary to fight co unterfeit products.  Furt her, labelling provisions 
should be fully aligned with Codex Alimentarius, especially the defin itions and analytical parameters 
of alcohol products.  Also, steps should be taken to duly protect EU geographical indications.  She 
noted that a number of bilateral technical meeti ngs had taken place, and that her delegation had 
submitted detailed technical comments in Decemb er 2011.  Her delegati on hoped these bilateral 
discussions would continue, and that EU comments would be taken into acco unt before the adoption 
of this technical regulation. 
8. The representative of the Russian Federation (O bserver) stated that development of these 
technical regulations was carried out in accord ance with transparency provisions of the TBT 
Agreement, and in accordance with transparency pr ovisions of Working party report on the Russian 
Federation accession to WTO.  He said that all interest ed parties had the opportunity to participate in 
a two month public discussion period (which ended December 2011), and that WTO members had the opportunity to submit comments.  Comments were be ing consolidated, and an improved draft of this 
technical regulation was under preparation, which would be available on the official website of 
Customs Union and Minister of Industry and Trad e of the Russian Federation after completion. 
(ii) Dominican Republic – Draft of the Technica l Regulation "Categorization of Alcoholic 
Beverages" (G/TBT/N/DOM/143 and G/TBT/N/DOM/143/Add.1) 
9. The representative of Mexico noted her delegation's written comments expressing concern 
over the compatibility of this measure with the TBT Agreement, particularly because tequila had not 
been acknowledged as a denomination of origin.  However, she announced that her delegation had 
received a positive response from the Dominican Re public, acknowledging tequila as a denomination 
of origin, and that the definition proposed by Mexico had been included in the draft regulation.  
10. The representative of the European Union reite rated concerns expressed in her delegation's 
written comments.  She raised concerns and requested clarifications regarding the definitions of beer, 
wine, fortified wine, sangria, whisky, vodka, grapa,  pisco, tequila, gin and distilled gin, blended 
spirits, liqueur, sambuca, cream liqueur, and pastis.  With regard to the definition of "tolerance", the 
representative stressed that a negative tolerance be low the minimum alcohol level should be accepted, 
as was the case in EU legislation.   
11. In addition, the EU called for the draft regulati on to be aligned with the Codex Alimentarius.  
At present the draft did not allow the use of pro cessing aids, and it prohibited the use of sweeteners G/TBT/M/56  
Page 4  
 
  for some beverages, both of which were permitted under Codex.  Furthermore, the draft did not allow 
the bottling of beverages outside the factory, which could be problematic for bulk imports.  In terms 
of labelling, the representative stressed that this dr aft regulation created uncertainty for marketing of 
products that did not fit into listed categories. She also expressed concerns with the requirement of a 
preferred "used by" date for wines, which was not in  line with the Codex Alimentarius.  Furthermore, 
the health warning: "Consuming alcohol is harmfu l to health" was too generic and misleading for 
consumers.  
12. The representative of the Dominican Republic clar ified that this draft regulation was based on 
28804, which was a modification of no. 11 94 of the code of the Dominican Republic establishing 
consumption taxes on alcohol, and which included elem ents related to the general characteristics of 
alcoholic beverages and the designation of each cat egory.  He indicated that his delegation had 
responded to Mexico's comments, a nd had taken into account most points therein, particularly those 
that referred to tequila, and those related to Ar ticles 2.11.11, 2.11.7 and 6.1.7.  Finally, the 
representative said his mission had not received the EU's comments, and he presumed that they had been sent directly to capital.  
(iii) 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) 
13. The representative of Brazil referred to Di rective 62, which introduced requirements 
regarding the process of importation of the so-calle d “active substances”, with the aim of preventing 
the introduction of falsified medical products in th e supply chain.   According to these new rules, 
active substances to be imported in the EU had to  comply with two requirements: produced according 
to Good Manufacturing Practices (GMP) equivalent to those of the EU; and, be accompanied by a 
written declaration of the competent authority of the exporting country to this effect.  The second requirement was not applicable to some exporting c ountries indicated in a list contained in Directive 
2001/83/CE, but he noted Brazil had not been included in this list.  He belie ved this regulation was 
not in accordance with international practices rega rding the certification of GMP. If implemented in 
its current form, it could create an unnecessary barrier to the trade of medicinal products in the context of Article 2.2 of the TBT Agreement. 
14. Brazil was not aware of any other WTO Member that required a regulatory authority in an 
exporting country to confirm that a medicinal produc t was in accordance with the requirements of the 
importing country.  He recognized that Members ha d the right to establish necessary requirements to 
attain their legitimate objectives.  However, the ki nd of certification required by the EU had to be 
conducted by the regulatory authority of the EU, or by an accredited body.  This certification would 
be an unjustifiable burden for the regulatory authorities of the exporting country, who could only certify that the products complied with their ow n regulations or with the existing relevant 
international standard: the Technical Report 37/2003 of  the World Health Organization.  This report, 
which was widely acknowledged by Members, provided relevant international reference regarding the 
certification of GMP.  In this context, the representative requested clarification on a series of questions:  
(a) Why the EU has decided to modify its procedures in this area? 
(b) Why was it necessary for the certification to be  issued by the Regulatory Authority of 
the exporting country?  
(c) Does the EU have the intention to certify the products imported in the EU?  G/TBT/M/56  
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  (d) Would the EU be willing to certify that the European medicinal products complied 
with the Brazilian requirements for certification of GMP?  
(e) Does the EU acknowledge that the WHO Technical Report 37/2003 is a valid 
reference for this issue? 
(f) To what extent did the EU requirements deviate from those established by the WHO 
reference?  
(g) What does the EU mean by “confirm that the standards of good manufacturing 
practice applicable to the plant manufactur ing the exported active substance are at 
least equivalent to those laid down by the Union”? 
(h) What kind of document did the EU expect a Regulatory Authority of an exporting 
country to issue? 
(i) Will the EU be responsible for verifying th e equivalence or compatibility between the 
requirements of the exporting coun try and its own requirements? 
(j) What were the criteria for a country to be included in the exception list of Directive 
83, and why had Brazil not been included in that list?  
15. The representative of China raised further con cerns following a previous bilateral meeting 
with the EU.  He noted that Directive 2011/62/EU had been notified on 6 February 2009 
(G/TBT/N/EEC/246), and had mentioned GMP.  However, the concept paper Implementing Act on 
the Requirements for the Assessment of the Regulat ory Framework Applicable to the Manufacturing 
of Active Substances of Medicinal Products for Human Use , dated 7 December 2011, which was the 
final concrete conformity assessment procedure fo r this measure, had not been notified, denying 
Members the opportunity to have their comments in to account.  This was especially important given 
the existence of WHO GMP guidelines, which had not been followed in the measure.   He understood 
that Directive 2011/62/EU had been published to preven t the entry of falsified medicinal products into 
the supply chain.  However, the EU failed to provide evidence of falsified medicinal products 
originating from China.  It also failed to consider other less trade-restrictive measures, such as specific 
measures targeting particular fals ified products, before requiring that  all imported medicinal products 
comply with the Directive.  Therefore, he ar gued it created unnecessary obstacles to international 
trade, as per Article 5.1.2 of the TBT Agreement.  
16. Furthermore, according to Directive 2011/62/EU , EU holders of preparation-manufacturing 
authorization were only required to review GM P equivalence of produci ng and manufacturing of 
Active Pharmaceutical Ingredients (API) procur ed, while API importers had to review GMP 
equivalence and ask the authority of the expo rting Member to provide a written equivalence 
confirmation.  He explained this would subject suppliers of like products originating from other 
Member countries to less favourable conditions.  In addition, the representative of China explained 
that according to Article 46b(2) of Directive 2001/ 83/EC, active substances shall only be imported 
inter alia  if they were accompanied by a written confirmation from the competent authority of the 
exporting country.  In practice, competent author ities regulated enterprises by their respective GMP 
standards.  The obligation to fulfil the GMP re quirement fell upon importers rather than exporting 
Members.  The EU was urged to follow international practice in this regard.  
17. He also noted that the EU failed to follow relevant GMP guidelines of WHO on API.  His 
delegation understood that the EU considered the International Conference on Harmonization of 
Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH GMP) 
requirements as an equivalent.  Yet, the representativ e explained that ICH was a platform that brought G/TBT/M/56  
Page 6  
 
  together the regulatory authorities and the pharma ceutical industries of Europe, Japan and the US 
only, to discuss scientific and technical aspects of drug registration.  It was neither an intergovernmental organization nor an intern ational standardization body according to: Decision Of 
The Committee On Principles For The Developm ent Of International Standards, Guides And 
Recommendations With Relation To Articles 2, 5 And Annex 3 Of The TBT Agreement .   The 
representative said that HS codes did not distin guish between API, intermediate products and 
chemicals.  Indeed, many API HS codes were inte grated codes, thus custom officials could not 
regulate API exports separately.  The fact that Directive 2011/62/EU had neither specified its coverage of API products, nor estab lished concrete measures to identif y API at EU customs, would, 
according to the representative, lead  to increased costs and burden upo n exporters.  He argued this 
Directive was not practicable, and expressed hope th at the European Union would adopt less trade-
restrictive alternatives to achieve its legitimate objective.  
18. He announced that China had been implementing its newly revised GMP for medicine, which 
referred to and were equivalent to WHO, EU a nd US GMP guidelines.  Furthermore, several GMP 
guidelines - of United States Food and Drug Administration, United Kingdom Medicines and 
Healthcare Products Regulatory Agency (MHRA) and WHO - recognized the newly revised Chinese 
GMP guidelines.  To prove equivalence between Chinese API GMP and those of WHO, the State 
Food and Drug Administration (SFDA) was ready to issue written certificates for exporters, or for 
specific products exported, as per the WHO certificate format.  He hoped that the EU would explore the possibility of accepting a WHO format API GMP certificate under its requirements.  Given that 
imported API made up approximately 80 per cent of th e EU market, and that analysis had not been 
finalized on WHO GMP equivalence, he urged the EU  to provide a reasonable interval before entry 
into force, as per Article 5.9.  He also asked that  the written confirmation requirement be suspended to 
maintain supply stability. 
19. The representative of the European Union indicated  that the Directive had been notified to the 
TBT Committee in February 2009 (G/TBT/N/EEC/ 246), and neither Brazil nor China had issued 
written comments at that time.  After agreement be tween the European Parliament and the Council of 
Ministers, the Directive was published in the Official Journal of the European Union on 1 July 2011, and will be applicable as of July 2013.  The Directive addressed inter alia  manufacturing (in the EU) 
and the importation (into the EU) of API for medici nal products for human use.  She explained that 
manufacturing of API in the EU had to comply with GMP, and that Member States were therefore required to ensure that manufacturers of API in their territory followed GMP.  With respect to 
importation, she said API had to be manufactured in accordance with standards of GMP at least 
equivalent to those that applied in the EU.  The Directive established that, in the case of imports, the 
competent authority of the exporting country had to issue a written confirmation stating that the 
standards of GMP applicable to the plant manufacturi ng the API were at least equivalent to those of 
the EU; this written confirmation had to accompany imported API. 
20. In relation to the use of international standard s for GMP of API, she explained that the EU 
GMP rules were fully in line with the Guidelin es of the International Conference on Harmonisation 
(ICH).  Her delegation was assessing whether th e World Health Organisation GMP guidelines for 
API, based on ICH guidelines, were equivalent to th ose of the EU and ICH.  The EU had also been 
exploring the possibility of using a WHO-formatted API GMP certificate.  A draft template for the 
written confirmation was being prepared and would be shared with main trading partners.  She noted 
that the EU had discussed this issue repeatedly, and organised awareness-raising sessions with third 
countries.  Her delegation had also discussed this  issue bilaterally with China and Brazil on the 
margins of the TBT Committee, and remained ope n to discussing any further issue bilaterally.   G/TBT/M/56  
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  (iv) China – Measures for the Administration of Certification Bodies (G/TBT/N/CHN/798 and 
G/TBT/N/CHN/798/Suppl.1) 
21. The representative of the European Union expr essed concerns regarding the measures for the 
administration of certification issued by China's General Administration of Quality Supervision and 
Inspection and Quarantine (AQSIQ), and Certifi cation and Accreditation Administration (CNCA).  
The measures took effect on 1 September 2011 and ai med to implement a Stat e Council regulation on 
certification and accreditation from 2003.  Accordi ng to their scope, the measures applied to the 
activities of both domestic and foreign invested certification bodies within China, regardless of 
whether such activities were related to products d estined for the Chinese domestic market or export 
markets.  The measures laid down rules on the establishment and approval of certification bodies as 
well as on the opening of representative offices of foreign certification bodies. 
22. The representative of the EU reported that his delegation had a written exchange with Chinese 
authorities, and had also held bilateral talks in  the framework of regulatory dialogue between DG 
Enterprise and AQSIQ.  In these talks, the Chinese au thorities had clarified the scope of the measures 
as also covering activities carried out in China throug h temporary presence of natural persons - i.e. in 
the absence of any permanent establishment or representative office by foreign certification bodies 
approved by foreign regulators.  This meant that  measures would apply, extra-territorially, to 
conformity assessment bodies (CABs) located ou tside China when th ese bodies acted in the 
framework of mandatory conformity assessment proc edures set out in foreign regulations.  According 
to this interpretation, if a foreign CAB had r eceived an application from a Chinese manufacturer and 
the relevant conformity assessment procedure appl icable in the importing country of destination 
required some activities to be carried out in Chin a (e.g. factory inspection), the foreign CAB was 
required to either: i) to open a subsidiary in China;  or, ii) to sub-contract the activities in question to 
certification bodies established in China.  The EU was concerned about the impact of these new measures on the ability of the foreign CABs locat ed outside China, and approved by foreign 
regulators, to fulfill their obligations regardi ng the certification of Chinese products intended for 
export.  China's approach was unique, a nd without precedent in any WTO Member. 
23. He stressed that the activities referred to were carried out in accordance with legal 
requirements of the importing country, rather than of China.  He asked the Chinese delegation to 
explain the objectives of this new interpretation and how these could be reconciled with any of the 
objectives identified in Article 5 of the TBT Agreemen t.  Moreover, his delegation had noted that the 
definition of conformity assessment procedures in Annex 1.3 of the TBT Agreement also covered 
approval of CABs.  
24. The representative of the United States reported bilateral engagement with China's CNCA on 
this issue, and had raised several questions.  Despite  this, the intent of the various provisions in the 
measures, including the provisions suggesting extrat erritorial application of the Chinese rules, 
remained unclear.  She encouraged China to engage in further dialogue with interested foreign parties.  
25. 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 1 September 2011.  It was 
based on relevant international standards such as ISO IEC 17021, ISO IEC Guide 65, ISO/IEC 19011, 
as well as China's relevant laws and regulations , including the License Law and Regulations on 
Certification and Accreditation.  In accordance with  Article 9 of the Regulations on Certification and 
Accreditation of China, he noted that domestic a nd foreign certification bodies were not allowed to 
carry out certification activities within Chinese terri tory unless approved by the competent Chinese 
authority.  In this regard, the measure in questio n did not exceed the requirements of the Regulations 
on Certification and Accreditation of China, prom ulgated in September 2003.  Furthermore, the 
measure did not differentiate betw een domestic and foreign certification bodies.  Foreign certification 
bodies could establish wholly owned or joint venture bodies in China.  The representative stated that G/TBT/M/56  
Page 8  
 
  legally established foreign-wholly owned and join t venture certification bodies that obtained approval 
would enjoy the same rights and obligations as domestic certification bodies. 
(v) Kingdom of Saudi Arabia – Motor vehicles
3  
26. The representative of the European Union request ed information on the state of play of 
several notifications from Saudi Arabia.  He r delegation had sent written comments on five 
notifications from Saudi Arabia in April 2010, high lighting differences between the notified texts and 
requirements under different UNECE Regulations.  The EU received a positive reply from Saudi 
Arabia on 8 December 2010 announcing that co mments had been taken into account and 
modifications would be introduced in the final measures.  Since then, the EU TBT Enquiry Point had tried at several instances without avail to obtain information about the notified texts, and on the 
modifications introduced, from the Saudi Arabia Enquiry Point.    During 2011, the EU TBT 
Notification and Enquiry Point were made aware of  two other new measures that were not notified 
under the TBT Agreement, and enquiries had been sent by email to the Saudi Arabia Enquiry Point.  
Several of these enquiries remained unanswered, a nd the representative reminded Saudi Arabia of its 
obligations under Article 10 of th e TBT Agreement, and requested a better flow of information. 
27. The representative of the Kingdom of Saudi Arabia  clarified that three of these notifications
4 
were made in January 2010, and had been approve d as voluntary standards, rather than technical 
regulations.  The other two notifications5 were still in draft form.  The representative noted that his 
delegation had replied to the EU, inviting them to  provide comments on the latter two drafts.   
Additionally, he reported exchanges of emails be tween the Saudi Arabia and Omani Enquiry Points, 
and the EU regarding this subject.  An informal bilateral meeting had take n place, and his delegation 
had clarified questions.  On anothe r matter, regarding a notification on kitchenware, he clarified to the 
EU delegation that it was not a technical regulati on, and that his delegation was not prepared to 
answer questions which it viewed as originating fr om a private certification-related company.   
(vi) Egypt – Two Decrees of the Minister of Industry and Foreign Trade of Egypt (626/2011 and 
660/2011) related to the import requirements for leather, footwear and textile products 
28. The representative of the European Union noted two Egyptian Decrees of the Ministry of 
Industry and Foreign Trade6 that modified the import requirements for leather, footwear and textile 
products.  Both decrees introduced a new certificat ion procedure that mandated certain information 
about imported products, and certifie d that products complied with Egyptian rules.  By introducing 
the new conformity assessment procedure, the Decr ees rendered the Egyptian standards mandatory.  
The representative therefore requested that both D ecrees be notified under Articles 5.6 and 2.9 of the 
TBT Agreement, and further requested that Egyp t postpone implementation until notifications were 
carried out and other WTO Members had the opportunity to comment.  No responses had been received from Egyptian Enquiry Point on why the Decr ees had not been notified. In addition, she 
asked whether the new certification requirements applied only to importe d products or whether 
similar requirements existed for domestic products.  Fi nally, she requested detailed information on the 
specific Egyptian standards that were made manda tory through the new certification procedure. 
29. The representative of Egypt was not present at th is meeting. Through the Chairperson they 
offered to provide a response to the EU promptly. 
                                                      
3 G/TBT/N/SAU/121, G/TBT/N/SAU/122 G/TBT/N/SAU/123, G/TBT/N/SAU/124, 
G/TBT/N/SAU/125. 
4 G/TBT/N/SAU/121, G/TBT/N/ SAU/122, G/TBT/N/SAU/124. 
5 G/TBT/N/SAU/123, G/TBT/N/SAU/125. 
6 Ministerial Decrees: No 626 on textiles, publishe d 17 November 2011; and, No 660 on leather and 
footwear, published 24 November 2011.  G/TBT/M/56  
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  (vii) European Union – Safety evaluation of childcare cosmetic products 
30. The representative of China explained that in April 2010, AFSSAPS ( Agence Française de 
Sécurité Sanitaire des Produits de Santé ) issued advice for safety evaluation of cosmetics for children 
under three years old.  As there was no such EU re gulation, he wondered whether this measure would 
be mandatory within France or within the EU, a nd if it were mandatory he asked why it had not yet 
been notified. 
31. The representative of the European Uni on said that the new Cosmetics Regulation7 was 
adopted in 2009 and will enter into force in July 2 013.  As explained to China bilaterally, work on its 
implementation was on-going, including on guidelin es for product safety management, which were 
scheduled to be ready before the entry into for ce of the Regulation.  With respect to the safety 
evaluation of childcare cosmetic products, the represe ntative stated that there were no harmonized EU 
level specific childcare cosmetics safety management guidelines.  However, EU harmonized guidelines on safety management of cosmetics in general  were being developed, and some sections 
would be dedicated to products for children unde r 3 years old.  These guidelines would be published 
before July 2013.  The representative flagged her delegation's on-going concerns on the registration of 
baby care cosmetics in China, for which there had been a complete standstill in approvals since April 
2010.  The European Commission and SFDA had discussed  this issue bilaterally the previous week, 
and hoped that these bilateral exchanges would he lp solve this longstanding trade concern. 
(viii) European Union – Alt ernatives to animal testing and new cosmetic regulations 
32. The representative of China indicated that the Eur opean Parliament and the Council had, in its 
2009 cosmetics regulations, clarified the possibility of  using Alternatives to Animal Testing (AAT) to 
ensure safety of cosmetics, and had set a deadlin e.  China supported the principles of reduction, 
replacement and refinement, and in this regard, China's State Food and Drug Administration (SFDA) 
on 2 March 2012 notified Test Method of In-Vitro 3T3 NRU Phototoxicity for Chemical Raw 
Materials Used by Cosmetics  (G/TBT/N/CHN/886).  However, at present some AAT were not 
mature, and China had raised concerns about their impracticability in previous meetings.  He urged 
the EU to explain the rationale for its 2009 cosmeti cs regulations, in particular with regard to AAT. 
33. The representative of the European Union explaine d that the regulation provided for a robust, 
internationally recognized regime, which reinfor ced product safety and took into consideration the 
latest technological developments, including the pot ential use of nanomaterials.  The implementation 
of the Regulation was being prepared.  The ban and strict regime aimed at phasing out animal testing 
had not been modified.  In fact, a full testing ba n in the EU had been in place since 2009, as well as a 
marketing ban in relation to some testing "endpoi nts".  In relation to three remaining endpoints 
(repeated-dose toxicity, reproductive toxicity and to xicokinetics), the marketing ban would enter into 
force on 11 March 2013.  Despite intense efforts and considerable research progress on alternative 
methods, validated alternative methods for the thr ee endpoints would not be available by 2013, and 
therefore the EU was analysing the impacts of the marketing ban.  She mentioned that the European 
Commission and SFDA had discussed the Regulation's pr ovisions and the details on animal testing in 
Beijing in March 2012, and her delegation remained  open to discussing this issue bilaterally. 
(ix) European Union - Provisions on limit values for allergenic substances in children's products 
(2009/48/EC) (G/TBT/N/EEC/184 and G/TBT/N/EEC/184/Add.1) 
34. The representative of China shared the EU's objective of protecting children's lives and 
health, such as through Directive 2009/48/EC which regul ated in detail the use of chemical substances 
in toys.  However, he was concerned that the Directive had not established corresponding testing 
                                                      
7 Regulation (EC) No 1223/2009. G/TBT/M/56  
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  methods.  With a view to effectively implementing the regulation, the repres entative suggested that a 
testing method and standard for carcinogenic, mutagenic or reprotoxic (CMR) substances and 
allergenic aromatic substances be  determined.  If no such testing methods were made available, he 
suggested delaying the implementation of the dir ective until such time as they were formulated. 
35. The representative of the European Union provide d an update on standards that had been 
developed to support the new toy safety directive.  Even though it did not specifically concern the 
aspects raised, he referred the Chinese delegation to the most recent publication of standards, 
published in the official journal of the Europ ean Union in October 2011.  As for the Chinese 
delegation's concerns on the testing for CMR substa nces and allergenic fragrances, he recalled that 
Article 18 of the new toy safety directive had fo reseen an explicit obligation for manufacturers to 
carry out a safety assessment for the purposes of c onformity assessment.  Safety assessment consisted 
of an analysis of all the chemical, physical, me chanical, electrical flammability, radioactivity and 
hygiene hazards that a toy may present as well as an  assessment of the potential exposure to them - 
i.e. whether there was risk arising from the use of any prohibited or restricted substance in a toy.  
Therefore, manufacturers were required to assess th e likelihood of the presence of a particular 
prohibited or restricted substance in a toy, and th e scope of any possible testing would have to be 
based on that assessment.  Given the high number of substances involved, it had not been feasible to foresee a testing procedure for each specific substa nce.  On the contrary, he underscored that any 
possible testing should be focused on instances when an actual risk h as been assessed to exist in view 
of the actual exposure to particular substances in a toy. 
36. He referred the Chinese delegation to  a comprehensive guidance document
8 on how to 
perform the safety assessment and any subsequent t esting, which had been prepared by toy safety 
experts.  The EU had discussed this issue with Ch ina in detail and organized training events in 2011 
and 2012 for Chinese manufacturers in China.   He noted that requirements related to CMRs would only apply as of 20 July 2013.  CEN, the relevant  European standardization body, was reviewing 
relevant standards concerning chemical substances.  As new standards became available in 2012, or 
early 2013, useful guidance could be derived fro m certain standards on organic chemical compounds, 
which had been developed under th e old toy safety directive.  A reference to these standards was 
contained in the aforementioned guidance docum ents.  Concerning allergenic fragrances, the 
representative specified that in general the Directiv e permitted traces of a fragrance, provided that its 
presence was technically unavoidable in GMP and di d not exceed 100mg per kg.  In this regard, 
useful guidance could be derived from the relevant European and international standard for GMP, EN 
ISO 22716.  His delegation remained available fo r bilateral discussions and clarifications. 
(x) United States – Test procedures for high density discharge lamps
9  
37. The representative of China appreciated that these technical regulations aimed at energy 
saving, nevertheless, he hoped they would be based on scientific norms and not create unnecessary 
obstacles to bilateral trade.  With regard to th e requirements on testing methods, he explained the 
measure required that HID (high-intensity discharge) lamp efficiency of voltage be controlled within 
0.1 per cent of the related voltage  reference balance.  However, the IEC international standard 
specified that deviation within 0.5 per cent from th e voltage reference balance was acceptable.  He 
requested the US to explain this difference, and asked that the measures follow international 
                                                      
8 "Guidance document on the application of Directive 2009/48/EC on the safety of Toys", in English: 
"http://ec.europa.eu/enterprise/sector s/toys/files/tsd-guidance/tsd_rev_1-
4_explanatory_guidance_document_en.pdf ; and in Chinese: http://ec.europa.eu/enterprise/sectors/toys/files/tsd-
guidance/tsd_rev_1-3_explanatory_guidance_document_chinese.pdf ".  
9 G/TBT/N/USA/669, G/TBT/N/ USA/669/Add.1 and G/TBT/N/US A/649, G/TBT/N/USA/649/Add.1, 
G/TBT/N/USA/649/Add.2, G/TBT/N/USA/649/Add.3. 
  G/TBT/M/56  
 Page 11 
 
 
  standards.  On the issue of aluminum maintainer s measured at 40per cent and 70per cent of service 
life, he explained that discharge characteristics, frequent switching, as well as  vibration during testing 
would negatively influence measured parameters.  Furthermore, at the end of life, aluminum 
maintainers may speed up malfunction of discharged lamps, so frequent aluminum testing was neither 
recommended nor worthwhile.  Finally, the represen tative of China noted the measure required the 
execution of annual recertification and review at the price of USD5000 - USD8000.  As per Article 
2.2 of the TBT Agreement, he suggested a review or recertification only occur if there was a change 
in product design, structure, raw material, produc tion equipment or process.  Such review and 
recertification would either be related to a specific model, or an expert would determine, through a 
pre-review, that such change had no impact on effi ciency and thus no review or recertification was 
required. 
38. The representative of the United States indicated that the United States Department of Energy 
(DOE) maintained an extens ive program to improve the energy efficiency of a range of products 
under the amended Energy Policy and Conservation Act of 1975.  The program consisted of four 
parts: (i) testing; (ii) labelling; (iii) Federal en ergy conservation standards; and, (iv) certification, 
compliance, and enforcement.  Testing requirements consisted of test procedures that manufacturers 
of covered products would use as the basis for certifying to DOE equipment compliance with 
applicable energy conservation standards under En ergy Policy and Conservation Act (EPCA), and for 
making representations about the efficiency of this equipment.  She noted that these test procedures 
also provided the protocols upon which the Federal Trade Commission based its energy guide label 
for these products.  She further explained that DOE's  review of specific test procedures for lamps was 
part of the requirement to review procedures and standards every seven year s.  With respect to 
G/TBT/N/USA/669, submitted on 11 December 2 011, DOE had issued a notice of proposed 
rulemaking to add new types of lamps - namely HID lamps - to its existing energy efficiency 
program.  The representative noted the comment pe riod on this notification had closed 28 February 
2012.  Under the proposed rule, testing had to be  conducted by a facility accredited by the National 
Voluntary Laboratory Accreditation Program (NVLAP), or by an organization recognized by 
NVLAP.  Additionally, she reported NVLAP was a signatory to the ILAC MRA and had accredited many laboratories in China relevant to this regulation. 
39. She further explained that DOE interpreted the la nguage in this rule as it does with regard to 
all products covered by the NVLAP; allowing testin g by any laboratory accredited to the appropriate 
scope by any accreditation body signatory to the IL AC MRA.  Since China's accreditation body was a 
signatory to the ILAC MRA, test laboratories in  China could seek accreditation through this body.  
She asserted there were likely many laboratories in China and worldwide that met the requirements set out by DOE for NVLAP.  With respect to China's suggestion on conditions under which recertification and review were required, she was unsure whether China referred to the recertification 
of test labs or to manufacturer certification of product.  If it was the latter, she indicated that 
manufacturer certification requirements were specifie d in another regulation (10CFR part 4.29), and 
not in this notification. 
40. The DOE allowed testing by any laboratory accredited by ISO IEC 17025, and accredited to 
the proper scope by an ILAC MRA signatory.  The ru le stated that manufacturers' or importers' own 
laboratory, if accredited, may be used to conduct the applicable testing.  This was consistent with 
DOE's directive to ensure that its standards,  test procedures and other requirements were 
technologically feasible, economically justified a nd resulted in significant energy savings.  She 
assured the Committee that DOE had chosen trade fac ilitative arrangements.  Finally, she noted that 
Members, including China, could recognize confor mity assessment bodies outside of their territories 
and accredited by IAF to meet their regulatory and other program needs.  She welcomed the productive bilateral discussion with China on this matt er, and looked forward to further exchanges.  G/TBT/M/56  
Page 12  
 
  (xi) European Union – Regulation (EC) No.1 222/2009 Labelling of Tyres, Commission 
Regulation (EC) No.228/2011, No.1235/2011
10  
41. The representative of Korea reported a bilatera l meeting with the EU.  His delegation was 
aware that this regulation had already been publis hed after receiving public comments, nevertheless, 
he reiterated concerns that these regulations could act as barriers to the Korean tyre exports to the EU.  
According to Article 2.2(g) Regulation (EC) No. 12 22/2009, he said the regulation did not apply to 
tyres fitted with additional devices to improve traction properties, such as studded tyres.  Korean tyre manufacturers shipped studded tyres with the stud pins detached, as stud pins could easily damage 
tyres during the loading and shippi ng process.  In this regard, he requested the EU to accept C1 and 
C2 studded tyres without pins - the same as studded ty res with pins - and to allow studded tyres with 
stud pins detached temporarily for transportati on purposes to be imported without any labelling 
requirement during customs processes.  He was awar e that detaching pins to  avoid tyre damage was 
common practice during the transportation of studded tyres. 
42. On the subject of Regulation (EC) No. 228/2011 , he understood that the Standard Reference 
Test Tyres (SRTTs) used for the wet grip index were  different from those used for the General Safety 
Regulation (EC/661/2009); the former were 16-inch tyres and the latter were 14-inch tyres.  His 
delegation requested an explanation for this discr epancy, since according to UNECE Regulation No. 
117 there was only one type of SRTTs.  He asked th e EU to unify SRTT size for both regulations, or 
otherwise justify this divergence.  The represen tative recalled that Regulation (EC) No. 1235/2011 
was published on 29 November 2011 and would apply to tyres produced after 1 July 2012.  Since the necessary wet grip tests were carried out at temperatures ranging between 5 and 35 degrees Celsius, it 
was impossible for manufacturers to begin testing un til April.  Thus, manufacturers would not have 
sufficient time to comply with the regulation.  A dditionally, since Michelin was the only manufacturer 
of C3 SRTTs, other manufacturers had to order them from Michelin for the purposes of testing, and would not acquire them on time.  Therefore, he ask ed the EU to provide stakeholders with sufficient 
time to comply with the regulation and to  postpone implementation by six months. 
43. The representative of the European Union info rmed the Committee that studded tyres were 
not within the scope of Regulation (EC) No 1222/20 09; normal tyres intended to be fitted with studs 
are not mentioned.  Her delegation would look in to this issue, and inform Korea under which 
conditions tyres intended to be st udded would be excluded from the scope of the Regulation (EC) No 
1222/2009.  She confirmed that ASTM 16 reference ty re needed to be used in the test method for 
measuring wet grip braking perfo rmance under Regulation (EC) No 1222/2009, and that the methods 
developed were meant to improve upon those laid down in UNECE Regulation No. 117.  The use of 
ASTM 16 reference tyres was necessary to limit th e variability of the testing procedures, and the 
representative clarified the ASTM 16 reference tyre was closer to the current market average rim, 
rather than the ASTM 14 reference tyres pr escribed in the UNECE Regulation No. 117. 
44. She indicated that the transitional period was considered sufficient and provided a level 
playing field for all business actors irrespective of si ze and location.  The Regulation was adopted on 
29 November 2011, and the labelling scheme would be mandatory from 1 November 2012 for all 
tyres for passenger cars, and for tyres for light a nd heavy commercial vehicles produced from 1 July 
2012.  She observed the time between publication of the measure and its applicability was at least 7 
months, which was in compliance with the Commi ttee's recommendations regarding Article 2.12 of 
the TBT Agreement.  Finally, all three Regula tions referenced were  notified under the TBT 
notification procedure, with a comment period of either 60 or 90 days;  no comments from WTO 
members were received.  Since all three Regulations  were adopted, they would be difficult to change. 
                                                      
10 G/TBT/N/EEC/241, G/TBT/N/ EEC/241/Add.1, G/TBT/N/EEC/3 38, G/TBT/N/EEC/338/Add.1, 
G/TBT/N/EEC/374, G/TB T/N/EEC/374/Add.1.  G/TBT/M/56  
 Page 13 
 
 
  (xii) 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) 
45. The representative of Korea reported a bilateral me eting with Colombia to discuss this issue, 
and he reiterated his concerns in hope that his requests would be taken into account.  The Korean 
government respected the efforts of the Colombia n government to improve services for people with 
reduced mobility and/or ability to communicate.  Ho wever, Korean industry was concerned about the 
regulation's possible negative impact on trade.  Korea submitted comments on 16 January 2012, but 
had not received a reply.  According to Article 2.4 of the WTO TBT Agreement, members had to use relevant international standards.  The repre sentative said UNECE Regulation No. 107, which 
excluded vehicles used for school transportation, was c onsidered the relevant international standard in 
this case.  In Colombia, there were schools for child ren with special needs, which also had specially 
equipped buses, and it was therefore unnecessary for all school buses to have these features.  The 
representative requested Colombia to harmonize the scope of the new regulation with UNECE 
Regulation No. 107, and thus exclude vehicles used fo r school transportation.  Additionally, he asked 
Colombian authorities not to enforce these regulations until these updates and modifications were 
reflected, and also asked for inform ation on the current state of play. 
46. The representative of Colombia would send Korea’ s concerns to the competent authority, and 
hoped to be able to provide an official response to Korea promptly. 
(xiii) European Union – Wine and Grape Juice Certification (G/TBT/N/EU/5) 
47. The representative of the United States noted that  this draft regulation was notified in January 
2012.  Her delegation supported its goal of si mplifying the existing regulation and reducing 
administrative burdens for operators by revising cer tification requirements to vine products.  She 
noted that the US had raised this issue with the EU on multiple occasions, including in the EU/US 
bilateral wine meetings in Marc h 2011 and November 2011.  She recalled the requirement for a VI 1 
wine making certificate for grape juice had been in  place in the EU since 1985, yet grape juice from 
non-European countries could not be made or blen ded into wine per Council Regulation (EC) No 
479/2008.  The purpose of the certificate - to ensure the safety of wine products - was not furthered by 
the inclusion of grape juice in this certification requirement.  If the stated objective of this draft 
regulation was to simplify the existing regulatio ns and reduce the administrative burdens for 
operators, she inquired as to rationale for requiring  wine making certificates for grape juice of non-
European origin, if such grape juice was not to be  used for European wine.  In February 2012, her 
delegation sent a letter requesting the removal of the wine making certificate requirement for US 
grape juice, and she asked for informat ion on the status of this request. 
48. The representative of Brazil expressed concern with  some aspects of this measure, including 
insufficient adaptation time provided to traders.  He  believed certain requirements of the measure had 
the potential to create additional difficulties for expor ters, despite the objective of facilitating trade.  
He said this issue would be discussed bilate rally with the EU following the meeting.  
49. The representative of the European Union ann ounced that the draft Commission Regulation 
was intended to modify two pr evious Commission Regulations11, in particular regarding the 
documents accompanying consignments of wine products across the EU (so-called "accompanying 
documents").  The draft Regulation aimed to rati onalize and simplify the requirements applicable 
to such accompanying documents, reducing admi nistrative burden for economic operators.  She 
explained the provisions of this Regulation did not modify the rules currently applicable to trade 
relations between the EU and third countries.  Consequently, wines from the US still fell under the 
                                                      
11 Commission Regulation (EC) No 555/2008; and Commission Regulation (EC) No 436/2009. G/TBT/M/56  
Page 14  
 
  procedures established by the EU-US Wine Agreem ent; namely, wines could enter the EU on the 
basis of a commercial document issued in the US. 
50. The Regulation, it was explained, sought to sp ecify the chain of responsibility and the links 
between the certificates issued by th ird countries or authorized operators (VI 1, simplified VI 1, or 
commercial documents) and the accompanying documen ts required for the movement of products in 
the EU market after importation.  By not requiring new analyses after importation, the EU expected to 
improve traceability and facilitate the free circulation of goods on the internal market.  Specifically, 
the Regulation required that the accompanying doc ument for wine products imported from a third 
country make reference to the certificate drawn up in the country of origin (including, e.g., the number and date of the certificate, and the name and address of the authority of the third country 
which issued the document or authorized its completi on by a producer).  Regarding the issue of grape 
juice raised by the US, she highlig hted that the requirement to present a certificate of analysis had 
previously existed and had not been introduced by the Regulation under discussion.  She took note of the request of the US, and indicated that the EU would examine the possibility of introducing specific 
rules for those products in the context of future m odifications to the scope and procedures applicable 
to the certificate of analysis.  The EU would con tinue to discuss this issue with the US under the 
framework of their bilateral agreement.  Finally, sh e informed the US that a reply to their comments 
was under preparation and w ould be submitted promptly. 
(b) Previously raised concerns 
(i) European Union – Registration, Evaluation, Au thorization and Restriction of Chemicals 
(REACH)
12  
51. The representative of India reiterated his delega tion's concern about the definition of small 
(micro) and medium enterprises (SMEs) in th e Regulation because it did not account for labour 
intensive industries in developing countries like Indi a.  The use of staff head count in addition to 
annual turnover and balance sheet ceiling would classi fy many of India's micro enterprises as large 
under REACH despite meeting the annual turnover or balance sheet ceiling.  This went against the 
spirit of Art. 12.3 of the TBT Agreement as it created unnecessary obstacles to developing country 
exports.  Secondly, the absence of any regulator y mechanism governing the creation of SIEFs and 
consortia which, although non-mandatory, were a de facto reality for exporters and put a high burden 
specifically on SMEs.  Problems associated wi th SIEFs and consortia included the opaque 
functioning, high joining fee, penalties for late jo ining with no clear timelines, yearly maintenance 
fee, consultancy costs and the non-uniform rules fo r consortia, high fees of the lead registrants, the 
refusal of members to take in participants, and the prohibitive cost of the letter of acceptance.  
Thirdly, the EU-based Only Representative (OR) , a reality for compliance with REACH, was 
burdensome for many Indian SMEs and added to the co st.  He asked the EU to review the provision to 
permit direct registration by exporters.  The delega tion of India appreciated the principles in ECHA's 
guidance document specifically on the conditions of co st of sharing data at an early stage.  But 
implementation under REACH remained poor since e xporters were informed about the cost by the 
consortium late which left no option but to pay th e amount requested.  Also, what was the rationale 
for registration of the entire tonnage of a substance in an article if less than 100 per cent was intended 
                                                      
12 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/Rev.1, G/TB T/N/EEC/52/Add.4, G/TB T/N/EEC/52/Add.5, G/ TBT/N/EEC/52/Add.6, 
G/TBT/N/EEC/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/TB T/N/EEC/336/Add.1. 
  G/TBT/M/56  
 Page 15 
 
 
  for release upon use. This increased the tonnage band for registration, therefore putting a greater 
burden on the registrant.  
52. The representatives of Argentina, Australia, Tha iland and China reiterated their previously 
stated concerns in the hope that the EU would pr ovide satisfactory responses.  They referred Members 
to the minutes of previous meetings for details.   
53. The representative of the European Union first responded to a previously raised question on 
whether an OR can apply for authorizations for certain substances under the REACH regulation. This 
question had appeared due to a lack of express provisi ons in the regulation.  She explained that based 
on the text of the REACH regulation and the principle of non-discrimination, the European Commission took the view that the OR should not be denied the right to apply for authorization.  This 
opinion was confirmed on the ECHA website on 25 Jan 2012 in the updated Q&A section, and the 
webforms had been revised to allow the OR to send its  application.  She added that the other concerns 
were answered in detail in previous Committee m eetings.  On India's request to permit direct 
registration by exporters, she explained again th at the REACH registration obligation applied to 
manufacturers and importers in the EU only.  It di d not apply to manufacturers or traders outside the 
EU because enforcement actions, such as inspecti on and fines, could not be carried out. The EU 
importer, not the foreign manufacturer, had the re gistration obligation.  Manufacturers or trading 
companies did not have to, but also could not, in co nsequence, register their substances directly.  In 
cases where the foreign manufacturer did not wish to  reveal the information to the EU importer, 
REACH gave the foreign manufacturer the possibility to  appoint an OR to carry out the registration.  
The appointment of an OR remained an option, not an obligation for the non-EU manufacturer.  
Consequently, under Article 8, traders or merchant exporters were not allowe d to appoint an OR.  
This was in line with the reasons that prompted th e role of the OR, i.e. the protection of confidential 
business information concerning the substances impor ted into the EU which remained with the 
manufacturer of the substance, the formulator of th e preparation, or the producers of the articles, not 
with trading companies that would need to request the information from the manufacturer. 
54. Her delegation had replied to th e concerns about the functioning of the substance information 
action, fora and the consortia previously, and ha d presented the considerable efforts made by the 
European Commission and the ECHA while it was up to  the substance exchange forum participants to 
organize themselves.  She informed that new data  sharing guidelines would be published.  On the 
claim that REACH was too burdens ome, especially for SMEs, and the concerns about the functioning 
of the SIEFs, the Commission continued to assist companies in their activities in the substance 
information exchange forum and in their preparat ion for the next registration deadline in 2013.  
ECHA was offering in this respect a series of s upport activities including workshops in 2012, a series 
of webinars and other training opportunities on the fu nctioning of the SIEFs and data sharing.  ECHA 
had published a preliminary 2011-2013 schedule for the webinars on its website.  These would be 
video recorded and subsequently published on th e ECHA website.  She invited Members to inform 
industry about these upcoming possibilities so that co mpanies, especially SMEs could carry out their 
new registration obligations 
(ii) European Communities – Directive 2002/95/EC on the Restriction of the Use of certain 
Hazardous Substances in Electrical and El ectronic Equipment (RoHS) and Directive 
2002/96/EC on Waste Electrical and Electronic Equipment (WEEE)
13  
55. The representative of Korea said that industry continued to be concerned about the revised 
directive.  For some of the materials listed in Anne x III (to which the restrictions in Article 1 did not 
apply), alternative materials still had not yet been developed.  In other cases, although alternatives 
                                                      
13 G/TBT/N/EEC/247, G/ TBT/N/EEC/247/Add.1, G/ TBT/N/EEC/247/Add 2. 
 G/TBT/M/56  
Page 16  
 
  materials had been developed, their reliability w as uncertain.  For instance, although there was a 
substitute for cadmium in the production of col our-converting II-VI LEDs for solid illumination and 
display systems, manufacturers considered the cadmi um-free product so unreliable that they could not 
apply it in commercial production.  Additionally, hi s delegation had been informed that the technical 
requirements for CE certification had not been publis hed yet.  In the absence of published technical 
requirements, industries would have difficulty comply ing with the regulation.  It was the EU's duty to 
publish them and invite comments from stakeholders .  His delegation requested the EU to allow a 
longer transition period for economic operators to deve lop alternatives to restricted substances and to 
comply with CE certification. 
56. The representative of the European Union said th at the concerns expressed today and in past 
meetings on this agenda item related to the RoHS Di rective; the EU suggested that the reference to 
Directive 2002/96/EC on Waste Electrical and El ectronic Equipment (WEEE) be removed.  As 
mentioned previously, the RoHS Directive had been published in the Official Journal of the European 
Union on July 2011.  However, the current RoHS Directive continued to apply until the new Directive 
was transposed by all EU Member States into natio nal law by January 2013.  As the scope of the 
Directive had been extended, the new Directive in troduced transitional periods for the new products 
of up to 8 years.  It was considered, therefore, that sufficient transitional periods were provided. 
57. The new Directive would continue to restrict 6 substances.  However, as of 2014, the list of 
restricted substances may be periodically review ed.  Any review would be duly notified to the 
Committee and would be based on scientific eviden ce, detailed impact assessment and would take 
into account availability and reliability of possi ble substitutes.  The European Commission was 
preparing a FAQ document that would be available to stakeholders by mid-2012.  She noted that, 
according to Article 5 of the Directive, decisions  on exemptions and on the duration of exemptions 
would take account of the availability of substitut es and the socioeconomic impact of substitution. A 
manufacturer, an authorized representative or any economic operator in the supply chain could apply 
for an exemption or renewal of an existing exem ption. Annex V of the RoHS Directive listed the 
information that needed to be provided in this regard.  On the new requirement of CE marking, 
according to Article 15, the requirements to affix th e CE marking applied only to finished electrical 
and electronic equipment. Spare parts, as defined in Article 3.27 of the Directive, did not need to be 
CE marked. Article 7, 8 and 9 of the Directive detail ed the obligations of manufacturers, of authorized 
representatives and of importers in this respect. 
(iii) European Union – Regulation on Certain Wine Sector Products (G/TBT/N/EEC/264) 
58. The representative of the United States maintain ed its concerns regarding EU measures that 
severely restricted the ability of non-EU wine producer s to use common, descriptive, or commercially 
valuable terms to describe their products, on the gr ounds that those terms are traditionally associated 
with European wine.  Some of these terms did not have a common definition across EU member states nor was her delegation aware of efforts to mon itor or limit the use of those terms within the EU.  
This cast doubt about any uniformity in consumer pe rceptions across the EU on the meaning or use of 
traditional terms.  The EU's approval of the terms by third countries through its bilateral agreements 
further rendered suspect the notion of a general consumer perception regarding terms traditionally 
associated with European wines.   US producers experienced signi ficant losses from the 10 March 
2009 termination of the three-year derogation for use of  such terms on the labels of US wines sold in 
the EU, and from the EU's recognition of so- called traditional expressions in trademarks. 
59. Her delegation was concerned th at applications by wine America submitted on 19 June 2010 
had thus far no response from the EU.  She asked the EU for its meaning of "promptness" in Article 5, 
noting that those US suppliers that used those term s remained unable to ship their products even while 
the EU had granted approval for the use of these te rms through its bilateral agreements with other 
countries.  Her delegation was further disappointed that the European Court of Justice had expanded  G/TBT/M/56  
 Page 17 
 
 
  the scope of these measures; contrary to the assura nces provided by the EU officials, the traditional 
terms were now protected in languages other than the one for which protection was identified.  In 
addition to TBT related aspects of the EU regul ation, her delegation was concerned about the 
provisions of the regulation regarding protection of  trademarks and intellectual property, and sought 
information from the EU on the status of its request.   
60. The representative of the European Union recalle d that it was still examining the applications 
filed by US industry for the use of traditional te rms.  Her delegation was providing information 
regularly to the US on the status of these appli cations, and remained open to continued bilateral 
discussions, notably in the framework of the bilatera l wine Agreement between the EU and the US.   
(iv) India – Pneumatic tyres and tubes for automotive vehicles14  
61. The representative of the European Union recalled India's indication at the last Committee 
meeting that its Government had given positive consid eration to changing the requirement that the ISI 
marking for tyres could not be used on tyres sold outside India and that the change was now only subject to certain approvals.  Since the last  TBT Committee meeting, the EU had not heard 
confirmation of a modification of Article 6.3 of th e BIS Agreement. She asked India to report on new 
developments in this respect.  The EU reiterate d its concern about the royalty fees which were 
calculated on the basis of the total number of tyr es produced and marked with the ISI marking, and 
not on the total number of ISI marked tyres de facto imported into India.  The lack of accredited laboratories both inside and outside India available to carry out the required tests, and the absence of 
recognition of tests also remained a concern for the EU. 
62. The representative of Japan had raised concer ns about Article 6.3 of the BIS Agreement 
which prohibited export of the BIS marked tires to countries other than India.  In the previous 
meeting, India had responded that India had positive consideration to the removal of Article 6.3 which 
was only subject to certain approvals.  However, ac cording to his information, India had not removed 
the Article.  Prohibition of the exportation of BIS-marked tires to countries other than India discouraged Japanese tire manufacturers from making BIS-marked tires and distorted the conditions 
of competition.  This was an unreasonable technica l barrier to trade and his delegation requested 
immediate deletion of Article 6.3. 
63. The representative of Korea continued to have c oncerns about Article 6.3, marking fees, time-
consuming procedures, excessive paperwork, and the term of validity for ISI certification.  Korean 
industry bore an undue cost burden because Article 6. 3 of the BIS Agreement prohibited exports of 
ISI-marked tyres to other countries.  Korea requested  that the Indian authorities repeal Article 6.3 and 
also review the marking fees.  These were unfai rly calculated because they were based, not on the 
total number of ISI-marked tyres imported to India, but on the total number of tyres produced and marked with the ISI symbol.  Compared with simi lar marks issued by other countries which did not 
charge marking fees for tyres, fees were consid erably higher for the ISI.  Furthermore, the 
administrative procedures and excessive paperwor k from application to the issuance of the 
certification took almost one year.  Other countri es could process certification in 45 and 90 days. 
64. Considering the long process time to obtain the certification, Korean tyre manufacturers 
considered the one year validity too short; manufact urers had to renew their certification as soon as 
they had received it.  Since other countries granted 5 years or a permanent term of validity, his delegation requested that India simplify its admini strative procedures and extend the term of validity 
to at least five years or an indefinite term.  A dditionally, his delegation requested India to accept test 
results carried out in in-house laboratories in Ko rea.  It was common global practice in the tyre 
                                                      
14 G/TBT/N/IND/20, G/TBT/N/ IND/20/Add.1; G/TBT/N/IND/ 40, G/TBT/N/IND/40/Rev.1. G/TBT/M/56  
Page 18  
 
  industry that if the test laboratories of companies were verified according to international standards, 
the results from these laboratories should be  accepted by the tyre certification body. 
65. The representative of India reiterated that the BIS and the Ministry of Consumer Affairs were 
seriously considering the removal of Article 6.3 of the BIS Agreement which had created problems 
for some suppliers of automotive tyres and tubes.  The marking fee charged in India was equitable in 
terms of the unit cost of tyres for both domestic and foreign manufacturers and, on a comparative 
basis, India was probably at the lower end vis-a-vis  other countries.  Most of the applications made for 
certification by tyre companies had been cleared , and those pending were because information was 
sought from companies.  The latest information s howed 93 licenses granted to  foreign manufacturers. 
It would transmit Korea's concerns about the cumbersome procedures and the validity of the 
certificate to its regulators. 
(v) Canada – Cheese Compositional Standards (G /TBT/N/CAN/203, G/TBT/N/CAN/203/Add.1) 
66. The representative of New Zealand recalled that this was the 15th TBT meeting to deal with 
this issue.  New Zealand considered that the Canadi an requirement that for certain cheese varieties to 
be labelled as 'cheese' they must be produced with a percentage of proteins to be sourced directly from 
"raw milk" - i.e. from domestic milk suppliers had the effect of limiting the amount of protein that 
could be sourced from powdered (i.e . imported) dairy ingredients. Th ese ingredients, including milk 
protein concentrates, milk protein isolates, whey protein concentrate and skim milk powder, were 
widely used and accepted as cheese ingredients in  many countries.  Further, the compositional 
standards were inconsistent with Codex standards,  which did not prescribe limitations on the sourcing 
of milk proteins for use in cheese manufacture.  Ne w Zealand's bilateral discussions did not give rise 
to confidence that Canada intended to provide more clarity about how its cheese compositional 
standards complied with Codex standards or to ad dress New Zealand's concerns. No further efforts 
had been made by Canada to address these issu es since November 2011.  The Dairy Farmers of 
Canada had lobbied the Canadian Government for a yoghurt standard.  Like other WTO members, 
New Zealand was concerned that any compositional st andards for yoghurt would also be inconsistent 
with Codex standards, and encour aged Canada to adhere to th e Codex standard when making 
decisions on any future federal dairy regulations or standards for yoghurt and other processed dairy 
products.  Her delegation woul d continue to monitor these developments closely. 
67. The representative of Australia shared Ne w Zealand's concerns on this issue. 
68. The representative of Canada reiterated that th ere was no evidence that these regulations had 
constrained the overall usage of milk ingredients such  as milk protein concentrates;  his information to 
date suggested that all imported cheeses in Canada ha d been deemed to be compliant with the revised 
standards and no complaints had been received.  His delegation had also not  initiated any regulatory 
processes to establish similar standards for any other dairy products. 
(vi) India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33) 
69. The representative of the European Union asked if the entry into force of this legislation was 
still April 2012 or was a revision of the notified text under consideration by Indi a.  In particular, was 
India considering increasing the validity of the impor ting licences to bring it in line with the validity 
of domestic licences, i.e. from 3 to 5 years?  Also, was India considering accepting test reports carried out in foreign laboratories as an alternative to local  testing?  Finally, the EU asked if India would 
accept labelling to be carried out in bonded wa rehouses instead of in the country of origin. 
70. The representative of the United States shared the EU's concern on the validity of importing 
licences.  She also asked India to clarify its stat ement at the November Committee meeting suggesting 
that there were differences between the attesta tions required for the certificates and licences for  G/TBT/M/56  
 Page 19 
 
 
  foreign versus domestic producers. Also, she recalle d that at the November meeting India responded 
that enforcement was postponed un til April 2012the difference in te rms between domestic and foreign 
firms (i.e., 3 years versus 5 years) was necessary due to technological changes and the fact that 
domestic manufacturing licences were not imposed on imports.  She asked India to clarify the nature of the technological changes.  She also asked India to provide an update on its consideration of the US 
request to hold a technical level discussion on these i ssues.  Technical level discussions were sought 
quickly to clarify longstanding issues on transition periods for suppliers, registration fees, the question 
of providing stickers or supplem entary labels, and import registra tion numbers.  Her delegation also 
urged India to consider allowing producers to conduc t the required test in the country of origin in 
accordance with internationally recognized methods of testing common throughout the industry.   
71. The representative of India confirmed 1 April 2012 as the date of implementation.   The 
validity of the registration certificate for importers  was three years because importers, unlike domestic 
manufacturers, were not subjected to the comp rehensive inspection of  documents, premises, 
manpower, equipment and capability.  He informed Members that he had word from his capital that 
labelling, specifically the name and address of th e importer and the import license numbers, could be 
carried out in a declared place approved by the licensing authority after import.  
(vii) Colombia –Draft Decree Establishing Provisions to Promote the Use of Biofuels15   
72. The representative of Mexico reiterated her de legation's concern on establishing compulsory 
percentages of blends of ethanol, the increase of these  percentages in the future and the restrictions to 
trade they might generate.  Mexico believed that the percentages should be decided and based on an 
international standard and scientific evidence.  She asked for information on the state of 
implementation of the draft decree and a response to  Mexico's previously submitted questions.  She 
also requested confirmation that if the percenta ges were increased that obligations of the TBT 
Agreement be fulfilled and notification be made to the Committee within a reasonable period of time.  
73. The representative of Colombia confirmed that the measure was currently in force but that 
any future modification made to the percentages of  fuel blends for ethanol and biodiesel would be 
notified to the TBT Committee. 
(viii) India – Mandatory Certification for Steel Products ( G/TBT/N/IND/32) 
74. The representative of the European Union had sent written comments on 6 September 2011 to 
the Indian Enquiry Point concerning the sec ond addendum of 22 July 2011 to notification 
G/TBT/N/IND/32 announcing that certain intermed iate steel products w ould be subject to a 
mandatory third party certification.  It had not r eceived a reply to these comments. India had promised 
at the last meeting to provide a reply at this meeting.  The EU was therefore disappointed to learn that 
India had adopted the proposal on 12 March 2012.  The EU still questioned the necessity of the third 
party certification for intermediate steel products in an area where international standards were 
recognized and used internationally.  India also imposed factory audits and did not seem to recognize 
any test results from foreign laboratories. Moreover,  the EU remained concerned with the difficulties 
and backlogs that companies were encounterin g with the existing certification procedure for 
galvanized steel and urged India to provide for steel  products for a more rapid and efficient procedure. 
75. The representative of Japan expressed support for the EU statement.  It was not necessary to 
impose mandatory standards on intermediate goods, such as steel products because protection of 
                                                      
15 G/TBT/N/COL/96, G/TB T/N/COL/96/Add.1, G/TBT/N/COL/96 /Add.2, G/TBT/N/COL/96/Add.3, 
G/TBT/N/COL/96/Add.4, G/ TBT/N/COL/96/Add.4/Rev.1 , G/TBT/N/COL/96/Add.5, 
G/TBT/N/COL/96/Add.6. 
 G/TBT/M/56  
Page 20  
 
  human health or safety could be attained only through safety regulations on final products, as the 
regulation in Japan.   
76. The representative of India noted surprise with  the EU concern for transparency since the 
final measure was based on deliberations carried out  on the draft regulation notified 5 years ago, on 5 
February 2007.  Five years was more than a re asonable amount of time for industry to adapt to 
mandatory certification on steel products.  His delega tion considered that intermediate products, like 
ingots and bellets, were critical for the safety of  the final building and were covered under the 
mandatory certification procedures and had to co nform to the desired composition and property. 
Moreover, products such as high string deformed st eel bars, wires, hot rolled medium and large size 
string structures, and sheet steel were essential for building safety and other load bearing applications. 
(ix) Thailand – Health warnings for alcoholic beverages (G/TBT/N/THA/332 and 
G/TBT/N/THA/332/Add.1) 
77. The representative of the United States continue d to have concerns and questions on this 
measure and hoped that Thailand would favorably consider the US comments submitted.  Her 
delegation was concerned about the size of the warn ings on the label, relative to the bottle, which may 
detract from the brand name and render the label mo re subject to counterfeiting.  She asked that 
Thailand modify its alcohol warning label to ensu re that implementation would minimally impact 
trade; if Thailand continued to require warning la bels, her delegation asked that they did not cover 
trademarks. 
78. The representatives of Chile, the European Uni on, Mexico and New Zealand joined the US in 
recalling its concerns and asked if any developm ents had taken place since the previous Committee 
meeting. 
79. The representative of Thailand informed the Comm ittee that the regulation still remained a 
draft.  According to the Department of Disease C ontrol of the Ministry of Public Health, a sub-
committee to study the impact of the draft regulati on is to be appointed, bu t he had no additional 
information on the appointment and the enforcement had not been envisaged as yet. 
(x) United States – Hazardous Materials: Transportation of Lithium Batteries 
(G/TBT/N/USA/518 and G/TBT/N/USA/518/Add.1) 
80. The representative of the European  Union asked for an update on this measure.  He recalled 
that the measure went beyond the UN Recommendati ons on the Transport of Dangerous Goods and 
the Technical Instructions on the Safe Transport of Dangerous Goods of the International Civil 
Aviation Organization.  The issue had recently b een discussed in the International Civil Aviation 
Organization, new rules enhancing the control of sh ipments of Lithium Batteries had been agreed, and 
work had started to amend the relevant Annexes to the Chicago Convention.  The EU urged the US to 
align its proposal to the requirements agreed in th e ICAO, and to refrain from a unilateral approach. 
81. The representative of Korea supported the EU's comments.   
82. The representative of Japan understood the importance of maintaining transportation security.  
However, Japan was concerned that this measure was inconsistent with the United Nations (UN) 
Recommendation on the Transport of Dangerous Goods and the International Civil Aviation 
Organization (ICAO) Technical Instructions, and had an the impact on trade.  Japan sought 
consistency with the UN Recommendation and with the ICAO Technical Instructions.  If the purpose 
of a regulation was to ensure safety, its scope s hould not extend to goods for which safety had been 
assured.  Japan reiterated its request that the co mments and concerns expressed by Members and  G/TBT/M/56  
 Page 21 
 
 
  private enterprises be fully taken into account altho ugh the final rule would be set to be released in 
May 2012 according to a website. 
83. The representative of the United States confirmed that a revision of the notified measure   has 
been under review since 5 October 2010.  Since th at time, the Federal Aviation Administration and 
the Pipeline and Hazardous Material Safety Administ ration had participated extensively in several 
multilateral discussions through the dangerous goods panel of the ICAO.  UN member state technical 
representatives and various aviation and battery industry  groups also participated.  ICAO's final draft 
guidance document was under consideration and antic ipated to be finalized soon.  There was a 
proposed implementation date of January 2013.  The proposal would increase the number of battery 
shipments subject to full hazardous materials labelli ng and handling information, but also included an 
exception for some smaller shipments of bare lithiu m batteries.  This was a departure from previous 
ICAO proposals which would have required fu ll hazardous materials labelling and handling 
requirements for all shipments of bare lithium batteri es.  She noted that the current draft of the ICAO 
guidance did not include batteries "packed within e quipment" or consumer electronic goods with an 
installed battery.  She concluded that the US was considering various regulatory alternatives but the 
timeline of finalization of changes to dom estic rules in this area was still uncertain. 
(xi) Turkey – New conformity assessmen t procedures for pharmaceuticals 
84. The representative of the United States conti nued to find aspects of Turkey's decree for 
pharmaceutical imports problematic, a nd urged Turkey to take steps to restore market access for safe, 
high quality pharmaceuticals.  While the US w as not opposed to inspec tion requirements for 
pharmaceutical manufacturing facilities, it was concer ned that the measure was neither published in 
Turkey's official gazette in proposed form nor notified to the WTO.  She noted that other measures on 
medical devices, biotechnology labelling, and in spection procedures for medical devices and IT 
products were also published in fi nal form without any WTO notification or possibility to comment.  
She urged Turkey to re-evaluate its internal pr ocedures for transparency and WTO notification to 
ensure that future measures were properly notified to the WTO  
85. Secondly, Turkey had provided the US with a list of recalled pharmaceutical products which 
it claimed was the impetus for the GMP decree.  Th e US considered product recall as a critical aspect 
of ensuring that concerns regarding the safety of  a pharmaceutical product were addressed promptly 
and effectively.  The fact that some US products ha d been the subject of recalls should be viewed as a 
sign that the current system was working to prot ect consumers.  Her dele gation urged Turkey to 
consider not applying the GMP requirement retro actively, giving priority to innovative drug 
applications that provided new medicinal therapies to  Turkish patents, and allowing the integration of 
GMP inspection into the marketing authorization pro cess.  This would alleviate the current blockage 
of pharmaceutical imports.  While pleased with th e positive bilateral discussions held on GMP, she 
noted that the number of pharmaceuticals that awaite d marketing authorization in Turkey had reached 
over 500 products. This was an urgent market ac cess issue for US companies seeking to export to 
Turkey as well as for, Turkish patients who would be nefit from these products.   Her delegation urged 
Turkey to take steps to restore mark et access for imported pharmaceuticals. 
86. The representative of the European Union shar ed the US concerns and urged continued 
bilateral discussions to find a solution to the cons iderable backlog of registration of medicines in 
Turkey. 
87. The representative of Switzerland echoed the EU and US.  Swiss Medic and the Turkish 
Ministry of Health had a bilateral dialogue in 2011 where common ground was identified.  Her 
delegation looked forward to continui ng this dialogue this year.   G/TBT/M/56  
Page 22  
 
  88. The representative of Turkey said that the GM P certification of pharmaceuticals had been 
explained in detail at the previous Committee meeti ngs.  Turkey discontinued its unilateral acceptance 
of GMP certificates issued by other countries becau se the Turkish Ministry of Health had concerns 
that automatic recognition of GMP certificates of  other countries, without having access to the 
relevant background documentation, posed serious ri sks to human health.  The Ministry of Health 
conducted GMP inspection in accordance with its “G MP Guidelines for Pharmaceutical Products”, 
which were in conformity with the World Health Or ganization guidelines.  In addition, the Ministry 
used a classification system based on therapeutic pr iorities for pharmaceuticals. These priorities were 
determined on scientific criteria and responded to public health c oncerns.  Turkey’s current GMP 
inspection system was implemented on a non-discr iminatory basis and, after two years since 
modification, worked effectively.  
(xii) European Union – Directive 2004/24/EC on Traditio nal Herbal Medicinal Products (THMP) 
89. The representative of India requested the EU to put in place a simplified, specific alternative 
application dossier for registration of traditional pr oducts based exclusively on traditional use with 
references made to the national pharmacopeia for all compliances for specification and quality 
parameters.  India would also request the EU to cons ider applicants with 30 years of traditional use in 
the country of origin instead of 15 years of traditional use in the EU in order to establish the efficacy of the medicinal product.  Also, the common technical document under the directive was inappropriate for multi-component traditional medici ne formulations, given that it was almost an 
impossible task to provide information with respect to such traditional formulations.  India urged the 
EU to look at recognition of GMP certificates fr om developing members such as India in this 
particular directive, and to notif y this regulation to the Committee. 
90. The representative of China supported India' s concerns.  According to the Directive 
2004/24/EC, TCM products that entered the EU market  after 1996 did not have the opportunity to 
prove they were safe medicine products since they could not be sold in the EU for 15 years after the 
Directive formally entered into force from 1 May 201 1.  Meanwhile, registered TCM products needed 
EU GMP certification before they were distribut ed.  Many Traditional Chinese Medicine enterprises 
obtained TGA (Australian Therapeutic Goods Administ ration) certification.  Since both Australia and 
EU were PIC/S members (Pharmaceutical Inspec tion Convention and Pharmaceutical Inspection Co-
operation Scheme) and recognized each other’s result s of conformity assessment procedures, he asked 
why the EU refused to accredit TCM enterprises that  already acquired TGA certificate.  He asked the 
EU to explain what fell into mutual recognition among EU and other PIC/S members. 
91. The representative of the European Union reiterate d that this Directive introduced a lighter, 
simpler and less costly registration procedure for traditional herbal medicinal products as compared 
with medicinal products falling under the full market  authorization procedure (Directive 2001/83/EC). 
Herbal products that did not fulfill the defin ition of medicinal product did not fall under the 
registration scope.  On the specific request for the EU to accredit enterprises that had already acquired 
a GMP certificate from other Pharma ceutical Inspection Convention and Pharmaceutical Inspection 
Co-operation Scheme (PIC/S) members, the EU note d that PIC/s was an organization for cooperation 
on inspections. The GMP certificates issued by PIC/s Members could only be recognized in the EU if 
the Members were EU Member States.  The EU also recognized GMP certificates from countries with 
which the EU had a mutual recognition agreement on GMP for sites on the territory of the country in 
question.  The inspection for GMP compliance was a national competence so China and India should 
contact the Member States where the medicinal products would be placed on the market.  
92. The Common Technical Document (CTD) was an internationally agreed consistent format 
produced to overcome delays in the submission of  applications to the different International 
Conference on Harmonization of Technical Require ments for Registration of Pharmaceuticals for 
Human Use (ICH) regions and it had facilitated th e exchange of information between medicinal  G/TBT/M/56  
 Page 23 
 
 
  products' regulatory authorities.  She advised Me mbers to refer to minutes of previous TBT 
Committee  meetings and to bilate ral meetings with India and China where, among other issues,  the 
directive's scope and the eligibility criteria were  discussed.  Her delegation was happy to continue 
bilateral discussions on other subjects if necessary.   
(xiii) Korea – KS C IEC61646:2007 Standard for Thin-film Solar Panels 
93. The representative of the United States reiterate d its view that Korea should adopt the IEC 
61646 standard in its entirety without  limiting application to only thin filmed solar panels produced by 
Korean industry.  She urged Korea to complete its deliberations internally as expeditiously as possible 
so that companies be allowed to complete all necessa ry pre-testing of thin film solar panels according 
to IEC 61646.  , KEMCO would have all the nece ssary input to provide certification expeditiously 
once this issue had been resolved. 
94. The representative of the European Union joined  the US' concerns and asked for an update 
from Korea on the study on the environmen tal impact of thin-film solar panels. 
95. The representative of Korea reiterated that the related certification system was not mandatory. 
Currently, non-amorphous silicon types of thin film  solar panels - Cadmium Telluride (CdTe) and 
Cooper Indium Gallium Selenide (CIGS) - did not ha ve problems entering the Korean market without 
certification.  The feasibility study was due by the 30 May 2012, following which the competent 
authorities would decide whether these two types should be included in KS  IEC 61646.  Updated 
information would be provided when ready.  She added that if and when Korea enabled panels 
IEC61646 to receive KEMCO certification, Korean authorities could not allow pre-testing because 
factory inspection results were required beforehand.  The other points would be sent to her authorities.   
(xiv) Colombia – Shelf life Requirements for Milk Powder16 
96. The representative of the European Union was c oncerned that the extension of minimum shelf 
life for imported milk powder to at least 12 months  at import, which was already six more months 
than was required previously was not notified when the measure was adopted in 2010 and could impair EU exports of milk powder to Colombia.  Although the proposed revision established a similar 
requirement for milk powder manufactured in Colomb ia, it was discriminatory because it did not take 
into account the time necessary for getting the product in the Colombian market.  It was thus more 
favourable to Colombian manufacturers.  No repl y had been received from Colombia to the EU's 
written comments.  She asked Colombia to clarify the risk its authorities sought to address by extending the required shelf life of milk powder,  and to provide an update on the draft text. 
97. The representative of Colombia hoped to have a technical response as soon as possible which 
it would submit to the EU delegation. 
(xv) India – New Telecommunications related Rul es (Department of Telecommunications, No. 
842-725/2005-VAS/Vol.III (3 December 2009); No. 10-15/2009-AS-III/193 (18 March 2010); 
and Nos. 10-15/2009-AS.III/Vol.II/(Pt.)/( 25-29) (28 July 2010); Department of 
Telecommunications, No. 10-15/2009-AS.III/ Vol.II/(Pt.)/(30) (28 July 2010) and 
accompanying template, "Security and Business Continuity Agreement")  
98. The representative of the European Union had re maining concerns with the revised telecom 
network security regulations and their accompanying  template agreement on "security and business 
continuity" between telecom netw ork operators and equipment supp liers.  With regard to the 
                                                      
16 G/TBT/N/COL/67, G/TBT/N/CO L/67/Add.1, G/TBT/N/COL/67/A dd.2, G/TBT/N/COL/67/Add.3, 
G/TBT/N/COL/67/Add.4, G/TBT/N/COL/67/Add.5. G/TBT/M/56  
Page 24  
 
  requirements for in-country testing of network el ements as of 1 April 2013, the EU failed to 
understand to what extent the obligation to carry out testing domestically could enhance security.  
How could state security justify such drastic disco ntinuation of the acceptance of test results from 
foreign, internationally accredited laboratories?  Th e EU requested India to postpone or, not enforce, 
the requirement for in-country testing and hoped that  bilateral dialogue could lead to a satisfactory 
solution. 
99. The EU welcomed India's statements that it remained fully committed to honouring its 
obligations under the Common Criteria Recognition Agreement (CCRA) for the acceptance of 
certificates issued by other members to that agreem ent.  The EU asked India for assurance that the 
requirements for in-country testing would, in any event, not affect India's current acceptance of 
certificates issued under the CCRA.  He also request ed confirmation that testing and any further 
security evaluation would be made in accordance with the relevant international standards, such as the 
ISO IEC Common Criteria standard and, for mobile  phones, the international standard for third 
generation mobile phones.  Finally, the EU drew atten tion to its earlier request that vendors' legitimate 
commercial interests be adequately protected in  inspections and checks and that, consequently, 
sensitive propriety information need not be disclosed.  In that regard, the EU reiterated its request that 
mandatory testing be limited to those elements that were essential for ensuring the security and 
integrity of the system. 
100. The representative of the United States shared the EU concerns.  While appreciating 
improvements made in the revised telecom networ k security regulations, the US still had remaining 
concerns, in particular why the in-country security  assurance testing was necessary to address India's 
security concern.  Recalling India's signatory stat us to the common criteria recognition arrangement 
(CCRA), she asked India whether the test perfo rmed in labs according to the common criteria 
arrangement would be sufficient for its needs.  The US also encouraged India to reconsider the scope 
of products subject to the in-country testing re quirement.  Although the current license amendment 
appeared to apply to all telecom equipment, furt her examination of India's security concerns may 
reveal that such an onerous requirement coul d only add value to specific subsets of telecom 
equipment that raise those concerns.  The US  understood that India had begun the process of 
establishing some labs in-country that would perform  the necessary testing of telecom equipment, and 
had invited the private sector to work with th e government setting up those labs.  The US expressed 
concern about the role of those private actors in r unning the labs where they were also manufacturers 
of telecom equipment.  This created obvious potential  for conflicts of interest , raising questions about 
the ability of a manufacturer to protect intellectual property and the confidentiality of other business 
proprietary information.  The US noted that  the requirements for running a competent and 
independent laboratory were set out in ISO/IEC 17025, and the assessment of whether labs met the 
terms of that international standard was done through accreditation by p eer-reviewed accreditation 
bodies.  In this respect, the US noted Article 5 of  the TBT Agreement, which contained the obligation 
to use international conformity assessment standards backed by international systems, such as ILAC, 
consistent with Article 9. 
101. The US requested India to postpone the im plementation date of its measure.  The 
establishment of labs would take time, especially ones that were accredited and internationally 
recognized.  India would therefore need to est ablish adequate safeguard s to assure foreign 
manufacturers that their intellectual property would not be jeopardized as a result of requiring testing 
in a test lab done by a competitor.  Additional bilateral discussions were welcome to explore 
commercially viable options in order to m eet India's legitimate security concerns. 
102. The representative of Japan shared concerns ra ised by the EU and the US.  It was still 
concerned with India's regulations on the licensi ng conditions for telecom services, announced on 31 
May 2011.  The representative of Japan stated that Japan would also maintain interested in these 
regulations and their future improvement.  As ment ioned at the previous TBT meeting in November  G/TBT/M/56  
 Page 25 
 
 
  2011, Japan thought that this approach might not  be in accordance with the CCRA because the new 
rules starting in April 2013 dictated that only network elements approved by Indian certification agencies would be allowed.  Japan recalled that  India had accepted the CCRA scheme.  Furthermore, 
he
 asked India to ensure that th eir telecom regulations did not impede market access for foreign 
companies. 
103. The representative of India stated that India w ould continue to recognize the process based on 
performance tests conducted by international labor atories for general guidelines on products covered 
by the CCRA.  India would continue such recognition notwithstanding the fact that it was not a complete member of the CCRA and despite the fact that India's own tests were not recognized by 
other Members.  India also reiterated that these were security testing guidelines of telecom equipment 
and, as such, they called for the application of othe r parameters different from the general guidelines, 
technical regulations and conformity assessment procedures.  At the same time, India wished to make this measure as trade facilitating as possible.  He  understood the concerns expressed and the request 
for extending the measure's timeline, and would communicate them to his authorities. 
(xvi) Brazil – Instructions for Registration for L abels of Imported Products of Animal Origin
17  
104. The representative of the United States appreciat ed bilateral discussions and was pleased with 
Brazil's indication that it would consider a Food Safe ty Inspection Service (FSIS) proposal, to be sent 
by letter as soon as possible, addressing the concerns of both countries. 
105. The representative of Brazil noted that the bila teral videoconference allowed Brazilian experts 
to better explain to their US counterparts the requirements of the Brazilian regulation.  Brazil 
remained open to receiving the US proposal. 
(xvii)  Indonesia – Labelling Regulations (Minist ry of Trade Regulation 62/2009 and 22/2010) 
(G/TBT/N/IDN/47) 
106. The representative of the European Union th anked Indonesia for explaining, at the last 
TBT Committee meeting, that the approval proce dure of labels and the obligatory labelling in 
Indonesian of certain imported goods before entering the Indonesian customs area were necessary for 
consumer information and to carry out pre-market surveillance of imported goods.  However, the EU 
found these measures burdensome for importers and enc ouraged Indonesia to re-consider the need for 
the approval procedure and to provide at least th e possibility of re-labelling products in a specific 
zone after  entering Indonesian customs, a common practice in many WTO Members.  Sufficient 
market surveillance actions could still be ensure d under this option and it would ensure a less 
burdensome and less trade-restrictive procedure fo r importers, while still fulfilling the control and 
consumer protection objectives.  The EU also as ked for clarification on whether Indonesia would 
reconsider the possibility that importers had to use stickers  for the re-labelling.   
107. The representative of the United States requested  that US food products be allowed into 
Indonesia; supplemental labels would be applied in a facility under the importer's control, subject to 
the Indonesian Government's approval.  The re-lab elling of goods would subsequently be subject to 
BPOM's inspection before entry into commerce, as was a common practice for many WTO Members.  
The US requested Indonesia to indefinitely delay any implementation date until the issue was resolved; the US sought resolution to the matter in a way that would meet the two countries' shared 
objectives of informing consumers and continuing their trading relations.  This was an important trade 
issue for the US, affecting approximately $430 million worth of processed food exports to Indonesia.   
                                                      
17 G/TBT/N/BRA/385, G/TBT/N/BRA/3 85/Add.1, G/TBT/N/BRA/385/Add.2, 
G/TBT/N/BRA/385/Add.3, G/SPS/N/BRA/654, G/SPS/N/BRA/654/A dd.1, G/SPS/N/BR A/654/Add.2, 
G/SPS/N/BRA/654/Add.3. G/TBT/M/56  
Page 26  
 
  108. The representative of Australia shared the con cerns expressed.  Australia's preference was to 
allow exporters to use labelling stickers upon the entry of a good into the market.  Australia 
encouraged Indonesia to ensure that any labelling sta ndards be consistent with international standards, 
such as the Codex Alimentarius, which provided gui dance on using a secondary label in a country. 
109. The representative of Indonesia explained to th e EU that the pre-import labelling obligation 
was imposed to protect the consumer by providing clear information, facilitating the implementation 
of monitoring and enforcement of custom in the re ign of custom excise, and minimizing the entry of 
illegal import and circulation of i llegal goods.  Indonesia would revert to the EU for further bilateral 
discussions on this issue.  The US requested that Indonesia allow supplementa ry labels for processed 
food products supplied at an importer-selected wareh ouse, and or in approved locations.  He referred 
to the regulation HK0315121109955 of 2011 of the Indonesian national agency for drug and food 
control intended to process food registration and la belling requirements.  Articles 35 and 36 of this 
regulation require that processed food should comply  with quality, nutrition and labelling criteria.  He 
added that distributed processed food should comply with staff-approved labels at the time of registration into Indonesia.  Article 36.1 requir es that registration be done by an approved 
manufacturer, or other party which had the approval as an importer pur suant to the regulation and had 
authorization from the company.  When the processed food entered Indonesia, the label must fulfil 
these stated requirements. 
(xviii)  Italy – Law on "Provisions concerning the marketing of textile, leather and footwear 
products" (G/TBT/N/ITA/16) 
110. The representative of India asked the EU for an update on the implementation of this law.  It 
covered a large number of regula tions and required provision of information at each stage of 
processing, which created difficulties for industr ies premised on global and multiple sourcing. 
111. The representative of the European Union reitera ted that Italian authorities had decided to 
postpone the application of this law.  It depe nded on the adoption of implementing measures for 
which no adoption date was foreseen.    
(xix) Turkey – Communiqué SUT 2010 regarding documenta tion requirements for medical devices  
112. The representative of the United States urged Tu rkey to eliminate the Social Security 
Institution (SGK) documentation requirements in co mmuniqué SUT 2010 so that suppliers of medical 
devices could continue to place their products on the Turkish market, provided that they met the 
requirements of the Medical Device Directive and th e Ministry of Health.  As this measure was not 
notified to the WTO, interested stakeholders had no notice nor opportunity to comment on the 
measure in draft form.  Since the measure went into  effect only seven days after publication, suppliers 
did not have a reasonable interval for implementa tion.  The purpose of requiring companies, and only 
selected medical devices used in 3 specific areas,  to provide these additional documents was unclear, 
given that Turkey's Ministry of Health, which is the regulatory authority r esponsible for ensuring the 
safety and efficacy of medical devices, does not require companies to provide such documents.  She 
asked if these documentation requirements we re being reviewed since they posed prob lems for 
producers.  She asked for an update on the review by Turkey's reimbursement authority of these 
requirements.  
113. The representative of Turkey explained that medical devices were regulated, as in the EU, 
under three different pieces of legislation in Turkey: (i) the Regulation on Medical Devices; (ii) the 
Regulation on In-Vitro Diagnostic Medical Devices;  and (iii) the Regulation on Active Implantable 
Medical Devices.  A requirement for market entry in to Turkey was that medical devices must comply 
with the applicable technical regulations which were  indicated by the "CE" marking.  Therefore, any 
medical devices, either imported or produced domesti cally, could enter into the Turkish market freely  G/TBT/M/56  
 Page 27 
 
 
  if it bore this marking.  While the Ministry of H ealth regulated the entrance of medical devices into 
the market, SGK decided which devices would be reimbursed.  SGK's primary objective was to serve 
public interest and protect public health by assuri ng that the most efficient medical devices were 
provided to patients; while also keep expenditures within its pre-set budgetary limits.  The SGK did 
not regulate market-access conditions for the Turkis h market; companies could decide to sell their 
products to this institution by accepting its re imbursement policies.  Additionally, SGK's 
documentation requirements were neith er excessive, nor discriminatory. 
(xx) 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) 
114. The representative of the European  Union asked Brazil for an update on this proposal, as the 
EU had learned that a text had been a dopted and published on 16 March 2012 as ANVISA 
Resolution 14/2012.  The EU also asked Brazil to pr ovide an outline of the changes contained in the 
adopted Resolution, compared to the notified draft, and a timeline of implementation of the measure.  
She reiterated her request for Brazil to repl y in writing to the EU's written comments. 
115. The representative of Mexico associated her de legation with the EU's statement regarding 
possible breaches to the TBT Agreement in this dr aft technical resolution.  She asked Brazil for a 
formal response on Mexico's comments on th e draft resolution presented on 31 March 2011. 
116. The representative of Honduras considered th at the Brazilian me asure seemed to be 
incompatible with the TBT Agreement; Article 2.1 of the Agreement required that technical 
regulations not discriminate against domestic and like imported products .  Depending on market 
conditions, the prohibition on the use of component s may be incompatible with this obligation 
because it would be a de facto  prohibition of traditional US-blend  cigarettes, whereas Virginia-type 
cigarettes would not be similarly affected.  Article  2.2 of the TBT Agreement provided that technical 
regulations not be more trade restrictive than necess ary to fulfil a legitimate objective and that they 
must take into account the risks of non-fulfilment.  This provision also stated that in evaluating these 
important elements, the following elements should be  relevant when assessing such risks:  available 
scientific and technical information; related pro cessing technology; and intended end use of products.  
Brazil had been unable to explain how its legislation would fulfil such requirements.  In particular, it 
seemed that the Brazilian measure was not based on scientific evidence or any impact assessment.   
117. Article 2.8 of the TBT Agreement stated that, wherever appropriate, Members shall specify 
technical regulations based on product requirements in terms of performance rather than design or 
descriptive characteristics.  Other WTO Members ha d adopted a standard based on performance that 
only prohibited those cigarettes that truly had a fruity or sweet characteristic flavour.  Brazil was 
seeking to regulate the design of the product and th e components of cigarettes without taking into 
account how such components affected the performance;  in other words the characteristic flavour of 
the product.  The focus based on characteristic flavou r was a lot more specific and targeted than an 
approach prohibiting a list of additives in any amount , regardless of their effect on the end product.  
Article 12.3 of the TBT Agreement required Members to  ensure that their technical regulations would 
not create unnecessary barriers to exports from developing country Members.  By affecting tobacco leaf markets, Brazil's measure may be creating a barrier in violation of this provision. 
118. The representative of Guatemala supported previous comments and expressed concern that 
the measure might have an impact on the trade of US blends cigarettes using burley tobacco.  As the 
Resolution was recently published, Guatemala was still looking at its possible impact on the 
marketing of tobacco products.  Guatemala was concer ned that banning certain kinds of additives that 
were necessary to make the US blend may result in a de facto  ban on the marketing of this kind of 
cigarettes.  Because of the way it was cured, burle y tobacco had to use certain additives in order for 
the cigarette to retain moisture and recover the suga rs that were lost during the curing process.  This G/TBT/M/56  
Page 28  
 
  measure would therefore have an impact on the grow ing of burley tobacco and would seriously affect 
small countries like Guatemala where the produc tion of this type of tobacco accounted for 
approximately 98per cent of its domestic tobacco pr oduction, generating 1,000 direct jobs and some 
4,000 related jobs.  Guatemala's tobacco exports  in 2011 reached $54 million US.  While Guatemala 
recognized Members' right to adopt standards for th e protection of human health and safety, in so 
doing the criteria established in Article 2.2 of the TBT Agreement, in particular the obligation that 
technical regulations shall not be more trade r estrictive than necessary in order to fulfil their 
legitimate objectives, must be respected.  She requested Brazil to explain how it took into account 
Members' concerns raised in this Committee and to indicate whether Brazil felt that its resolution 
would allow for production and consumption of American blend tobacco.  In particular, how would 
each of the ingredients of American blend be covered by Article 7 of the Resolution? 
119. The representative of Dominican Republic suppor ted the concerns raised by other Members 
and reiterated its previously stated concerns.   
120. The representative of Indonesia reiterated its requ est that Brazil reply in writing to the letters 
from the Indonesian Minister of Trade, sent in March and April 2011, related to this draft resolution. 
121. The representative of Nigeria associated hersel f with the previous speakers and asked for an 
update on the public health consu ltation process.  Given that the resolution would ban the use of 
additives with no reasonable justification, Nigeria en couraged Brazil to ensure that any final decision 
be based on scientific and technical evidence. 
122. The representative of Zimbabwe stated that hi s delegation was still waiting for Brazil's written 
responses to the written comments it had sen t before the November TBT meeting. 
123. The representative of Australia welcomed Braz il's decision to implement tobacco control 
policies and preventive measures aimed at reducin g the attractiveness of certain tobacco products, 
particularly to children and youth.  Each Member  had the right to implement necessary measures to 
protect public health.  Australia would follow Brazi l's implementation of these measures with interest 
and was prepared to continue to defend the right of  members to protect public health while complying 
with relevant international treaty obligations. 
124. The representative of Chile asked about the resolu tion's status.  At the last meeting, Brazil 
said that it was reviewing all comments received and would respond to these before the resolutions' 
adoption.  Chile sought these responses as the re solution would affect developing countries which 
export tobacco products.  
125. The representative of Colombia reiterated prev ious concerns that this measure would be 
contrary to the TBT Agreement and would have an impact on Colombian tobacco products by 
restricting the American blend marketing based on oriental and burley tobacco.  Recently Brazil published a new version of the resolution, similar to  the previous one, restricting the import and sale 
of tobacco products containing ingredients that we re indispensable for the American blend.  The 
exclusion of sugar in the most recent version of the resolution would not substantially change the 
situation for American blend cigare ttes.  Other banned ingredients were  required for this blend, and it 
was likely that sugar would be banned in the futu re.  Colombia was concerned that the resolution 
would infringe Article 1.2 of the TBT Agreem ent, establishing less favourable treatment of 
international products by banning cured tobacco and sugar, of which Brazil was the main producer.  
He asked for the date of the new resolution, whether it  had been notified, and if not, when it would be.   
126. The representative of Zambia asked Brazil to c onfirm that it had enacted a final resolution on 
tobacco additives and, if so, whether it intended to notify it to the TBT Committee.  Did Brazil intend 
to take into account the special development, fina ncial and trade needs of developing countries in the  G/TBT/M/56  
 Page 29 
 
 
  application of this technical regulation, as provide d for in Article 12.3 of the TBT Agreement?  Brazil 
had not provided peer reviewed scientific eviden ce that the banning of additives would address its 
stated health objectives and the imposition of such  measures could create trade barriers, more so 
because the legislation would ban additives on a sel ective basis.  This measure would have far 
reaching implications for countries like Zambia as its implementation would make it impossible to 
blend tobacco, especially the type produced in Afri ca.  Zambia considered that there were more 
balanced approaches to meeting Brazil's policy objectiv es than the current measure.  The regulation of 
ingredients should not be deemed an effective measure to reduce the th reat posed by tobacco.  
Because it was naturally addictive with or without ingredients.  Efforts should focus therefore on 
measures that had proven effec tive on the consumers' behaviour. 
127. The representative of Turkey supported the c oncerns expressed.  While committed to the 
protection of human health consistent with th e WHO Framework Convention on Tobacco Control and 
respectful of the measures taken by Members based on that Convention, Turkey was concerned that 
some Members could use areas of this Convention fo r commercial interests.  The Brazilian regulation 
containing a list of additives to be prohibited in a ll tobacco-related products in Brazil, was an issue for 
Turkey, one of the major Oriental tobacco producers.   Some of the prohibited additives were essential 
components of the blended type of cigarettes, in wh ich both Oriental and Burley tobacco were used.  
The TBT Agreement prohibited discrimination betw een "like products".  The Brazilian Resolution 
would ban the production and sales of blended cigarett es, leaving the market to the Virginia type 
products.  He noted that Brazil was one of the main  producers of the Virginia  type tobacco.  Additives 
did not give any characterizing flavour to tob acco products and this decision was made without 
considering the effects on final products.  Turkey asked Brazil to indicate scientific evidence proving 
that the prohibited additi ves would pose increased risk to human health.  There was no difference with 
respect to the "end use" between blended and the Virginia types, and Brazil had not provided a 
satisfactory explanation for discrimination between  these two types.  Turkey requested Brazil to 
respond to its comments and to amend the Reso lution in accordance with the TBT Agreement. 
128. The representative of Norway informed Member s that Norway had implemented measures to 
combat smoking and would continue to follow th e Brazilian tobacco regulation closely.  Norway 
believed that it was within a Member's right to implement necessary measures in order to protect public health and that this was not in cont radiction with a Member's trade obligations. 
129. The representative of Brazil informed Members that on 16 March 2012, ANVISA, the 
Brazilian Health Surveillance Agency, published th e final regulation on maxi mum levels of tar, 
nicotine and carbon monoxide for cigarettes and on the restriction of additives in tobacco products.  
The measure would be notified to the TBT Committ ee.  A draft regulation had been notified and a 
four-month period for comments was provided.  Furt her, ANVISA promoted several rounds of public 
debate all along the process.  In December 2011, Br azil held a public hearing on the issue and in 
February and March 2012, the board of Director s of ANVISA discussed the draft measure in open 
meetings, with the participation of industry, governments, civil society, academia, etc.  Comments 
received were carefully examined by the Brazilia n authorities who were working on a consolidated 
answer for all Members.   Companies now had 18 months to  adapt their products to the new 
requirements; those that did not comply could be  sold for 24 months only.  The main difference 
between the draft and the final measure was that sugar  had been removed from the list of prohibited 
additives in tobacco products.  The use of sugar as an additive would only be  allowed to restore the 
sugar lost during the drying process of certain tobacco leaves.  Arguments about a possible 
discrimination against traditional blends produced with burley tobacco did not stand since sugar 
would be allowed for this process. 
130. In Brazil, 200,000 people died every year due to diseases caused by tobacco consumption.  
The objective of the measure was to protect public health by reducing tobacco products' 
attractiveness, especially on children and the youth.   Studies showed that the risks of tobacco G/TBT/M/56  
Page 30  
 
  addiction were significantly higher when people st art smoking as children or teenagers; the Brazilian 
regulation was therefore intended to reduce the ince ntive for first experimentation since flavoured 
products had evident appeal to the youth.  A recent study conducted by the Os waldo Cruz Institute in 
Brazil, surveyed more than 17,000 thousand students in several Brazilian cities.  It found that more 
than 50per cent of young smokers preferred fla voured cigarettes.  The Brazilian regulation also 
prohibited the use of additives used  to reduce the harshness of tobacco smoke and to potentiate the 
effect of nicotine which reduced the natural rejecti on to tobacco products and increased their addictive 
characteristics.  Brazilian authorities had taken in to account the FCTC "partial guidelines" to the 
implementation of Articles 9 and 10 as a basis for th e regulation.  Brazilian authorities had also taken 
into account the extensive scientific literature on th e properties and effects of additives in tobacco 
products and had produced a compilation of the scien tific references on this subject, which had been 
shared with several Member.  Brazil is willing to con tinue to share it with other interested Members.  
Moreover, in defining the fla vouring additives covered by the re gulation, Brazil had taken into 
account the work of the Joint FAO/WHO Expert  Committee on Food Additives and of the Flavour 
and Extract Manufacturers Association.  Finally, the measure did not differentiate between national or 
foreign producers.  
(xxi) 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)  
131. The representative of the European Union reitera ted his delegation's c oncerns and requested 
an update on the timeline for the revision of the regulation on commercial encryption products 
managed by OSCCA. He sought assurance that the process would be transparent and allow for 
consultation by interested parties.  In this regard , the EU considered that the publication of the final 
text by the State Council Legislative Office before pr omulgation of the regulation would be too late in 
the domestic regulatory process and would not allo w stakeholders a meaningful opportunity to 
comment.  The EU sought assurance that the draft would be notified to the TBT Committee at an 
early draft stage, when amendments could still be introduced and comments taken into account, as 
required by Article 2.2 of the TBT Agreement.   
132. The EU also recalled that the Multi-Level Protection Scheme (MLPS) had an impact on 
commercial sectors of economic significance such as  banks, financial instituti ons, public transport and 
energy.  He requested more transparency and pred ictability on the classification criteria used to 
establish the level of security sensitivity of IT system s, and that the concept of critical infrastructure 
be construed so as to only include IT systems th at were essential to national security.  The concept 
should not be subject to an extensive interpretati on that could encompass systems involving activities 
that should normally not be covered by the national security exception.   
133. The EU was also concerned with standardizati on practices in the area of information security 
(detailed in the EU's submission G/TBT/W/344 in Ch ina's last Transitional Review Mechanism), in 
particular those carried out by the Information Security Standardization Technical Committee (TC 
260) managed by the China Electronics Standardiza tion Institute (CESI). The procedures of this 
Committee did not allow foreign companies, or even foreign invested companies established in China, 
to participate directly in the standardization pr ocess.  As these standards could impact commercial 
products and applications, the EU requested more  opportunity for the participation of non-domestic 
companies in this process.  He requested an upda te on the six draft information security standards 
issued for consultation by TC 260 in July 2011, on which comments had been made by the EU and 
European industry.   
134. Another concern in the field of standardizati on was a new draft standard issued for public 
consultation by Standards Committee 17 of China National Information Technology Standardization 
(NITS) on 19 January 2011.  This standard con cerned radio frequency based mobile payments - on- G/TBT/M/56  
 Page 31 
 
 
  line payments made by mobile phones.  Recently, European industry had submitted concerns via the 
European Chamber of Commerce in China.  A gene ral concern was the process which did not allow 
foreign invested enterprises to participate, and di d not allow foreign technology to be included in the 
patent pool from which the Standards Committee could draw upon when deciding the encryption technology and the algorithm to be used.  Specific c oncerns regarding this standard included the fact 
that the draft standard referred to an algorith m ("Algorithm E") which was to be used, without 
providing any additional information about its conten t.  The EU requested clarification about the 
accessibility of the algorithm and, in particular, whether the content of the algorithm would be 
publicly released and made accessible on fair terms to  all market players, including foreign invested 
enterprises.  The EU recommended that the implementa tion of this standard be delayed to allow that 
all players not only be given access to all required information, but also benefit from an adequate 
period for product development and in teroperability testing.  In additi on, regarding this draft standard, 
some important divergences had been observed with r espect to the relevant international standard in 
this field, i.e. ISO IEC 14443 Type A, as regards the data frame, coding and security aspects.  Unlike 
China's draft standard, the ISO IEC standard  clearly defined the algorithm to be used. 
135. Mobile payments were another example of a purely commercial application not related to 
state security.  The production of mobile paymen t applications and products incorporating these 
applications should therefore be open to all ente rprises, domestic and foreign invested ones.  This 
could only happen if the algorithm needed to apply th e standard was made available to all.  The EU 
requested that European industry comments be take n into account.  On the relationship between these 
standards and the regulatory framework being discussed, i.e. the OSCCA regulation and the MLPS, 
the EU requested clarification as to the way the stan dards were going to be used and referenced for 
the purposes of implementing the OSCCA regulations and the MLPS.  Greater dialogue among all market players was in the mutual interest of all parties concerned. 
136. The representative of the United States supporte d the EU statement.  Her delegation had 
raised these concerns both in this Committee and bilaterally, includin g on transparency and 
information security testing practices, such as re quirements for the use of Chinese-only intellectual 
property in the core components of IT security pr oducts.  She urged China to ensure that future 
implementation of the MLPS regime take a least trad e restrictive approach to regulating information 
technology products.  
137. The representative of Japan supported the EU and US statements.  Various schemes and 
regulations within China regarding information secur ity continued to pose difficulties for the future of 
trade in information security products, as these sche mes could not be regarded as being in line with 
global norms and approaches.  Japan would closely monitor this issue. 
138. The representative of China noted the bilateral meetings with the US and the EU on this 
measure and that China was studying the concerns  expressed by them and by Japan on the draft 
Commercial Cryptography Administrative Regulation by the State Commercial Cryptography 
Administration.  Concerning the Regulation on Cl assified Protection of Information Security, he 
referred to China's responses contained in the prev ious Committee minutes.  China invited Japan to 
explain the global norm in information security.  China's electronic standardization institute had 
received comments from the EU delegation to Chin a and Mongolia and from the European Chamber 
of Commerce in China.  The institute had contacted  the European Chamber of Commerce twice, most 
recently in February, however, due to scheduling c onflicts, they did not meet. On the procedures of 
standards relevancy, the institute would collect an d record the comments from relevant stakeholders 
before making its final decision.  As China did not  receive the comment about the drafting standard 
on radio frequency mobile payments earlier, he ask ed for it in writing to forward to his capital. G/TBT/M/56  
Page 32  
 
  (xxii)  China – Administration on the Control of Pollution Caused by Electrical and Electronic 
Products
18  
139. The representative of the European Union, asked  for information on the state-of-play of the 
measures, particularly on the progress of discussions on the certification procedure.  The EU remained 
concerned about mandatory third party certification.   
140. The representative of Korea also asked for an update on the measures and for detailed 
information on the requirements for certificati on bodies and laboratories for State Recommendation 
Voluntary Certification on Electric Information Products, which had entered into force on 1 November 2011.   
141. The representative of Japan, while also asking for the state-of-play, recalled previous 
discussions and the TBT notification indicating that the Administration itself was mandatory, while 
the Management Catalogue was volunt ary.  However, it was not clear if the Administration referred to 
the Management Catalogue and thus  made listed products subject to mandatory certification, like in 
the previous Administration.  If the combined regulation of the revised Administration and Management Catalogue became both a mandatory and a voluntary certification system, Japan asked 
China to stipulate SDoC in "nationally recomme nded voluntary certificate system".  This would 
contribute to reducing the burden of manufact urers in China and in other Members. 
142. The representative of China said that the Admini stration on the Control of Pollution Caused 
by Electrical and Electronic Products was still being finalized, and after its publication, the 
Management Catalogue  and the correspondent conformity assessment procedure would be 
determined.  The state-recommended Voluntary cer tification under Administration on the Control of 
Pollution Caused by Electronic Information Products  was to be launched and enterprises would be 
free to choose qualified certification bodies. 
(xxiii)  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)  
143. The representative of Korea asked Indonesia to update the Committee on the status of this 
draft measure.  He requested that Indonesia onl y regulate final products, not intermediate ones. 
144. The representative of Japan supported Korea's statem ent, stated that finished products rather 
than intermediate materials woul d be responsible for protecting human health and safety.  Japan 
expressed concern about the possible further expa nsion of mandatory standards to cover steel 
imported from Japan which was already produced under a strict quality management system at ISO 9001 certified steel mills.  If the scope of mandatory  standards was extended further, it would add to 
the time and cost required to receive and maintain cer tification.  This would have serious implications 
on foreign trade, such as increasing distribution costs and delaying deliveries for specific industries in 
Indonesia.  It might even make industries in Indonesia less competitive in global markets. 
145. The representative of Indonesia said that Indonesi a was currently in the preparation stage of 
revising the national standard SNI for electrolysis tin  coated steel sheets.  When ready, it would be 
notified and Indonesia would then provide more info rmation.  Regarding Japan's question on the ISO 
9001 standard, the product certification was not simila r to the management system of certification.  
Therefore, manufacturers certified with ISO 9001 must comply with the product certification or SPPP SNI.  Indonesia welcomed continued bilateral discu ssion on the issues raised by Japan and Korea. 
                                                      
18 G/TBT/N/CHN/140, G/TB T/N/CHN/140/Add.1, G/TBT/N/CHN/140/Rev.1.  G/TBT/M/56  
 Page 33 
 
 
  (xxiv)  Korea – PVC flooring material and Wallpaper and paper linoleum, and toys19  
146. The representative of the United States referred to  previous discussions on this matter.  In a 
bilateral meeting in May 2011, Korea informed th e US of a study on the release of phthalates in 
construction materials.  The US asked Korea for a copy  of this study in a letter of June.  The response 
from Korea in July stated that the results of  the safety assessment study for PVC flooring and 
wallpaper had been conducted from July to October 2010.  She asked for an actual copy of the study 
so that her delegation could better understand how the results were obtained and compare them to 
other studies.  This information had again been requested in September 2011.  In exchanges with 
Korea, Korea had asked the US to share studies w ith respect to phthalates regulations.  The US 
Environmental Protection Agency (EPA) had pub lished an action plan on phthalates given a 
generalized concern on this material.  However, there were no EPA studies or surveys and the EPA 
was not contemplating taking any action with resp ect to PVC flooring and wallpaper.  The US was 
unaware of any other scientific or technical data  supporting the Korean hypothesis that children would 
be exposed to phthalates in PVC flooring and wallpaper. 
147. The representative of Japan supported the US co mments and asked about the status regarding 
Korea taking into account of comments received from st akeholders in the previous TBT committee.   
148. The representative of Korea said that the prop osed measure could help protect children's 
health from the three phthalates.  Most Korean houses used PVC flooring materials and wallpaper.  
As toddlers and children play on the floor and agai nst the walls, they tend to suck and rub against 
these parts of the house, necessitating regulation of PV C flooring materials, as in the case for toys.  
KATS, the competent authority, had changed the to tal amount of contents in PVC flooring material, 
taking into account other countries' comments.  In PVC flooring material for Ondol (a Korean floor 
heating system), the total amount of DEHP, DBP a nd BBP contents of upper part would now be no 
more than 1.5 per cent and that of lower parts no more than 5 per cent.  In PVC flooring material for non-Ondol, the total amount of their contents of upper  part would be no more than 3 per cent and that 
of lower part no more than 10 per cent.  The revised regulation had been notified under 
G/TBT/N/KOR/303/Rev.1.  Korea would send the ot her points or requests made to its competent 
authority. 
(xxv) Colombia – Alcoholic beverages
20 
149. The representative of the European  Union thanked Colombia for its  January 2012 reply to its 
comments and its efforts to address them.  The EU continued to have concer ns on the notified text 
which were not resolved with the amendments pr oposed in Colombia's reply.  He outlined these 
concerns, which would be sent to Colombia in writi ng.  First, the EU still had some problems with the 
definition of "Gin", in particular, the definition of "London Gin".  Secondly, the EU stressed that 
fixing labels at the origin could be  problematic, in particular for im ports of low volume.  For imported 
products, labelling in warehouses was explicitly accepted as an alternative to labelling at the origin.  
This would guarantee that consum ers were properly informed.  Thirdly, the EU asked if the 
requirement for the issuing of a sanitary insp ection certification, based upon the presentation of a 
quality certificate issued by the manufacturer and co mplemented by physical sanitary checks would 
be also applicable to locally produced goods.  If not, the EU requested that for imported alcoholic 
beverages this requirement be substituted by the presentation of a quality certificate supplemented by 
random physical sanitary checks when deemed necessary. 
                                                      
19 G/TBT/N/KOR/303, G/ TBT/N/KOR/303/Add.1; G/TBT/N/KO R/304, G/TBT/N/KOR/304/Add.1. 
20 G/TBT/N/COL/121/Add.1, G/TBT/N/COL/121/Add.2, G/TBT/N/COL/121/Add.3, 
G/TBT/N/COL/121/Add.4. G/TBT/M/56  
Page 34  
 
  150. The representative of Colombia said previ ous comments were based on a questionnaire 
regarding this measure.  Given that Colombia was hearing new comments for the first time during this 
meeting, he would relay them to the comp etent authorities for the appropriate answer. 
(xxvi)  China – Provisions for the Administrati on of Cosmetics Application Acceptance 
(G/TBT/N/CHN/730, G/TBT/N/CHN/730/Suppl.1 and G/TBT/N/CHN/821) 
151. The representative of the European Union r ecalled previous concerns on China's new 
requirements for the approval of cosmetics products, which had been posing difficulties to EU 
manufacturers for the past two years.  The EU sh ared China's legitimate obj ective of providing for 
consumer protection.  However, in its current form , the registration procedure was considerably more 
burdensome than necessary to achieve this objective,  particularly for smaller companies.  The EU 
considered that further efforts were necessary to streamline and hasten the registration process.  In 
particular, the registration of products with new i ngredients was in a complete standstill.  The EU 
noted that since April 2010 there had not been a single new product accepted by China that contained 
a new ingredient.  During the same time period, th ousands of new products had been safely marketed 
in the EU and exported elsewhere, including to all re gions that required pre-market registration.  The 
EU considered this trade interruption extremely disconcerting for a fast moving product sector that 
was driven by constant innovation and asked the Chinese State Food and Drug Administration (SFDA) to provide more information on the step s being taken to solve this problem.  The EU 
reiterated its commitment to further enhance its bila teral cooperation with Chin a to effectively address 
these issues and appreciated the constructive attitude of the SFDA in the regulatory expert dialogue 
with the European Commission's Directorate General for Health and Consumers, most recently in 
March in Beijing.  The EU also thanked China for the recent reply provided to its comments to 
notification CHN/821. 
152. The representative of Japan welcom ed China's intention to ensure  the safety of cosmetics.  
However, it was still concerned with aspects of the measure.  Article 3.(2), 2, (2) of the national 
guidelines for application and evaluation of new ingr edients for cosmetic products required the safety 
evaluation of single substances.  It stipulated that "[t]he safety evaluation of a new ingredient should 
be carried out with single substances, solven ts, stabilizers and carried substances which are 
technically unavoidable and irremovable are exclude d from this scope. Natural ingredients should be 
single substances, and information on the parts used  for extraction should also be submitted."  The 
scope of exclusion of solvents in these guidelin es was not clear.  Plant extracts were generally 
compounds of chemical substances which could not be isolated.  Even if isolation was possible, the 
isolated substance would be different from the one  contained in the original extract due to the 
chemical reaction in the isolation process.  Theref ore, the evaluation of isolated substance was not 
appropriate.  Japan requested China to revise the guideline so that a single substance in a natural 
ingredient was excluded from the test, and also to cl arify the scope of this requirement at the earliest 
opportunity.   
153. Japan also reiterated its concern that Article  3.3 of the guidelines required a summary and 
flow chart of the manufacturing process of new ingr edients.  Japan requested China to review the 
implementation of the guidelines because accordi ng to Japanese industry, in implementing this 
provision based on the opinion of the Examina tion Committee in August 2011, Chinese authorities 
sometimes required the disclosure of informati on not necessary for the test, such as trade secrets 
related to the manufacturing process, including reac tion processes and reaction temperatures.  In June 
2011, SFDA published new ingredients on its webs ite, which were thought to be approved 
ingredients.  According to industry, SFDA disclosed  the related trade secret such as the name of the 
original ingredients, including the name of the ra w materials, and also part of these applications.  
Because trade secrets were very important in ma rketing, Japan requested improved methods of 
publication to avoid disclosing trade secrets.  Japan w as also concerned with delays in the review of 
applications.  In some cases applications for ne w ingredients which were duly submitted waited more  G/TBT/M/56  
 Page 35 
 
 
  than one year for an "examination postponed" no tice, without any additional feedback.  Japan 
requested China to notify the applicants of the cu rrent status of such examinations.  Japan had 
submitted comments to the Chinese notification G/TBT/N/CHN/821 on 2 August 2011 and expressed its concerns in the November 2011 Committee.  Si nce then, Japan had not received any response and 
it urged China to reply to its comments and concerns   
154. The representative of China stated that Chin a had replied to the EU comments of 22 
September 2011 to the EU Enquiry Point on 16 Marc h 2012.  Although the Guidance for Application 
and Evaluation of New Cosmetic Ingredients did not provide 60 days for comments, both EU and 
Japan had learned about it and were able to ha ve effective exchanges with SFDA.  The EU had 
reached consensus with SFDA at the Third Meeting of the Sino EU Cosmetic Working Group in June 
2011.  In July 2011, the SFDA organized training activities, to which L’Oreal, Unilever and Nivea 
from the EU, Amore from South Korea and Pola from Ja pan participated.  At the EU-China technical 
exchanges, held in November 2011 and March 2012,  experts from the EU and China discussed more 
details about the Guidance.  Currently, application and evaluation of new cosmetic ingredients were 
being carried out smoothly.  He added that Japane se companies could also exchange their technical 
concerns with SFDA, but questions as to whether pl ant extracts were solvents, stabilizers, or carriers 
due to inevitable technical constraints; or any technical problems on natura l ingredients and formula 
ingredients, were questions that had to be r esolved on case-by case basis.  The SFDA encouraged 
these issues to be discussed through bilateral technical exchanges.  Natural extracts, like plant 
extracts, should be applied with relevant information on ingredient s (information on active ingredients 
with known structure in plant extracts, for example)  in the applications.  For plants whose whole 
bodies were approved for use as cosmetic ingredients,  the concentration limit of the whole plant was 
not applicable to extracts from certain parts of that plant.  For ingredients accepted and being evaluated, the Guidance for Application and Evaluati on of New Cosmetic Ingredients should apply.  
Applicants who provided materials involved with  confidential intellectual property information 
should make this point clear in the application.  According to SFDA regulations, applicants could log 
onto the following website to check the status of  the evaluation of applied new ingredients via 
usernames and passwords:  http://123.127.80.6/enterprise/index.jsp .   
(xxvii)  Korea – Good Manufacturing Practice requi rements for cosmetics (G/TBT/N/KOR/301) 
155. The representative of the European Union reiterate d previously raised concerns.  In the last 
meeting, Korea confirmed that the Korean Food and Drug Administration (KFDA) was reviewing 
whether KCGMP certification for foreign manufactur ers could be made possible to provide equal 
treatment to domestic and foreign manufacturers of cosmetics in accordance with Article 2.1 of the 
TBT Agreement.  The EU asked for an update on this, particularly since this issue was not covered by 
the new Enforcement Regulation to the Cosmetics Act,  adopted in February 2012.  The EU also asked 
for confirmation that the KCGMP did not substantia lly deviate from the international cosmetics GMP 
standard ISO 22716, and whether KFDA would acc ept assessments performed or certificates issued 
by independent third parties proving compliance with ISO 22716, or self-certification by cosmetic 
manufacturers, as was the case in the EU and other major cosmetic markets. 
156. The representative of the United States supported the remarks of the EU on the issues of ISO 
22716 and certification.  The US was concerned with  the Korean cosmetic trade association's (KPTA) 
participation in the customs clearance process for imported cosmetics.  In that capacity, KPTA was 
responsible for reviewing conformity assessme nt and other documentation provided by foreign 
competitors.  The US asked for clarification on KP TA's role in this review process because it was 
concerned that there could be a serious conflict of interest. 
157. The representative of Korea explained that the Cosmetic Act would be amended to revoke the 
"Cosmetics Standards and Test Methods".  This would mean that foreign manufacturers could receive 
equal benefits to manufacturers  with KCGMP certification.  The Enforcement Regulations of G/TBT/M/56  
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  Cosmetic Act was amended to allow manufacturers to self-select testing items during quality 
inspection of final products.  U nder Article 2.1 of the TBT Agre ement, both domestic and foreign 
manufacturers must receive an independent KFDA certification even if they had third party 
certification from an overseas certification body.  For import clearance, the submission of a frame formula and sales certificate (submitted if the produ ct was imported for the first time) to KPTA via 
EDI system was the minimal requirements to access the Korean market.  Furthermore, the 
Enforcement Regulations provided an exemption if th ere was an import history, and the submission of 
an ingredient list to manufacturers that received an import declaration through the EDI system.   
158. The representative of the United States supported the remarks of the EU on the issues of ISO 
22716 and certification.  The US was concerned with  the Korean cosmetic trade association's (KPTA) 
participation in the customs clearance process for imported cosmetics.  In that capacity, KPTA was 
responsible for reviewing conformity assessme nt and other documentation provided by foreign 
competitors.  The US asked for clarification on KP TA's role in this review process because it was 
concerned that there could be a serious conflict of interest. 
159. The representative of Korea explained that the Cosmetic Act would be amended to revoke the 
"Cosmetics Standards and Test Methods".  This would mean that foreign manufacturers could receive 
equal benefits to manufacturers  with KCGMP certification.  The Enforcement Regulations of 
Cosmetic Act was amended to allow manufacturers to self-select testing items during quality inspection of final products.  U nder Article 2.1 of the TBT Agre ement, both domestic and foreign 
manufacturers must receive an independent KFDA certification even if they had third party 
certification from an overseas certification body.  For import clearance, the submission of a frame 
formula and sales certificate (submitted if the produ ct was imported for the first time) to KPTA via 
EDI system was the minimal requirements to access the Korean market.  Furthermore, the Enforcement Regulations provided an exemption if th ere was an import history, and the submission of 
an ingredient list to manufacturers that received an import declaration through the EDI system.   
(xxviii)  Australia – Tobacco Plain Packaging Bill (G/TBT/N/AUS/67, G/TBT/N/AUS/67/Add.1, 
G/TBT/N/AUS/67/Add.2) 
160. The representative of Mexico requested an update  and an official response to its comments 
sent on 22 July, 31 May and 22 July 2011. 
161. The representative of Dominican Republic reite rated her delegation's concerns expressed in 
this Committee and in the TRIPS Council.  Aust ralia had only provided concerned Members with 
partial preliminary responses that showed a lack of  scientific basis for such a radical measure.  The 
measure would affect the competitive advantages of t obacco products, in general, and cigarettes, in 
particular.  It would result in negative effects to developing countries, such as the Dominican 
Republic, which had invested heavily in the deve lopment of high quality tobacco products.  Her 
delegation believed that the measure was not in conformity with several WTO disciplines.  By prohibiting the use of special designs and by requi ring tobacco products to be sold in essentially 
identical packages, the measure would eliminate a ll means of differentiation between products.  This, 
in turn, would prevent consumers from having access to essential information about tobacco products, 
creating confusion in the market.  As a conseque nce, the competitiveness of these products would be 
affected as would their intellectual property rights  be violated.  The measure would not attain the 
legitimate stated objective of protecting public hea lth;  on the contrary, it could result in unintended 
negative effects.  For example, eliminating diffe rentiation between tobacco products could result in 
lowering tobacco product prices, which, would lead to an increase in their consumption.  Australia 
had not explained how this conseque nce would contribute to attaining th e measure's stated objectives.   
162. Australia considered the measure to be a t echnical regulation under the TBT Agreement and 
thus accepted that it had to be compatible wi th Article 2.2 of the TBT Agreement and its  G/TBT/M/56  
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  jurisprudence.  This meant that Australia accepted th at the measure could not be more trade restrictive 
than necessary to attain its policy objective, a nd that it could only be maintained if less trade 
restrictive alternatives were not available.  The measure, however, did not respect these conditions for 
several reasons.  Firstly, Australia contended th at the measure was justified by public health 
objectives, referring to a number of studies.  Ho wever, the scientific evidence underpinning the 
measure had been challenged in  public documents submitted to the Australian Government, and 
Australia had not yet fully explained the scientific basi s of its measure.  Secondly, Australia had at its 
disposal other measures that would be more effectiv e to attaining the stated objective without being 
detrimental to the competitive opportunities of imported  tobacco products.  In this respect, Australia 
had never satisfactorily explained why such alte rnative measures had never been contemplated.  
Finally, her delegation urged Australia to recons ider its position and honour its WTO obligations.   
163. The representative of El Salvador stated that  while her delegation endorsed the measure's 
objective of protecting human health, it had doubts as to its compatibility with the TBT Agreement.  
For instance, how would the measure comply with Artic le 2.2 of the TBT Agreement, in particular the 
requirement that the measure not be more trade r estrictive than necessary to  attain its objective and 
that it should not constitute an unnecessary obstacle to trade.  El Salvador would continue to monitor 
the development of this discussion both in  this Committee and the TRIPS Council.  
164. The Representative of Honduras noted that her country was also a party to the Framework 
Convention on Tobacco Control (FCTC).  While Honduras understood the public health objectives of 
the measure, it still harboured concerns.  Article 2. 2 of the TBT Agreement required that technical 
regulations not constitute unnecessary obstacles to trade and be as least trade restrictive as possible to 
attain a certain stated objective.  Given the lack  of evidence that plain packaging would influence 
consumer behaviour, the measure would burden producers and exporters  and restrict trade without 
attaining its stated legitimate objective of reduc ing tobacco consumption among youth.  It would 
result in disproportionally high negative financ ial and competitive consequences to tobacco 
producers, including making their brands less valuab le.  Brands were important to differentiate 
various tobacco products and a brand's reputation w as only gained after many years in the market. 
165. The plain packaging provision of the FCTC was not mandatory and its implementation should 
be in conformity with the WTO disciplines.  The FCTC  itself required that when parties went beyond  
minimum obligations, like with plain packaging, th ey should do so in accordance with "international 
law", which clearly included the WTO Agreements and the Paris Convention.  Finally, the Australian measure, in contravention with Article 12.3 of the TBT Agreement, would create unnecessary barriers 
to the exports from developing countries, like Hondu ras, which depended on tobacco cultivation.   
166. The representative of Nigeria stated that her de legation recognized Australia's right to take 
appropriate measures to protect its citizens' health and welfare.  Ho wever, Nigeria was concerned with 
the compatibility of the measure with WTO disciplines, in particular, the TBT Agreement.  The measure would remove all distinguishing designs, logos, colours and other similar marks from the 
packaging of branded tobacco making it virtually im possible to identify any specific branded product.  
This would make it difficult for foreign manufacturer s to enter the Australian market.  She requested 
scientific and technical information demonstrating that plain packaging would reduce the number of 
smokers in Australia and how the measure would comply with Articles 2.2 and 2.4 of the TBT 
Agreement.  She urged Australia to  take into account Members' views and concerns and to produce an 
alternative measure that would ensure comp liance with Australia's WTO obligations.   
167. The representative of Colombia shared the con cerns expressed.  It reiterated its concerns 
expressed at the June 2011 meeting and was still waiting for Australia's official responses.   
168. The representative of Hong Kong, China noted  the number of substantive concerns on the 
consistency of the legislation with the TBT Agreemen t, despite a wide recognition of Australia's right G/TBT/M/56  
Page 38  
 
  to adopt measures to protect public health.  He also noted that a tobacco manufacture company with 
its Asian headquarters in Hong Kong, China was ma king a claim against the Australian Government 
under an agreement on the promotion and protectio n of investments concluded between these two 
economies.  Discussions and mediations were being a rranged on this claim.  He trusted that Australia 
had taken its international obligatio ns seriously and hoped that the parties to that dispute would find 
an amicable and satisfactory solution, so that the impact of the measure on trade would be minimized. 
169. The representative of Chile stated that while  his delegation shared Australia's goal of 
protecting public health, it also shared the view  expressed that measures should not be more trade 
restrictive than necessary.  He asked when Australia would reply to comments received. 
170. The representative of Cuba supported the points raised.  While acknowledging the transparent 
consultation process held by Australian public health  authorities, in which Cuba participated, she 
regretted the lack of Australian responses to Cuba 's questions raised in document G/TBT/W/338 of 
June 2011; made via the TBT enquiry  point;  and posed to the Australian Ministry of Health.  
Previously, Cuba had emphasized the additional barri ers that plain packaging would create for cigars; 
Australian law established that the "ring" on top of  each cigar should have the same plain packaging 
characteristics.  In other words, the "ring" should be olive green without any distinctive sign of the 
brand.  In order to comply with this requirement , an additional process woul d be performed by hand, 
which, in turn, would produce an adverse impact  on cigar producers because the outside packaging 
was fragile and the "ring" was part of the cigar.  Cuba asked Australia to s how the scientific basis for 
this additional requirement and to explain its contribution to the measure's policy objectives. 
171. She was also concerned that the measure woul d stimulate illegal trafficking of tobacco 
products; under the plain packaging measure false products would be more easily produced because 
identical packaging would make it more difficult to  distinguish between illic it and legal products.  
Unlike in Cuba, there would not be any official stam ps, denomination of origin stamps or other marks 
affixed on imported tobacco products .  In addition to intellectual pr operty rights, the measure would 
have an impact on Article 2.2 obligations of th e TBT Agreement which required measures to not be 
more trade restrictive than necessary to achieve a legitimate public health aspiration.  While the 
measure would reduce the attractiveness of tobacco products, it would also make the continued sale of 
many cigars impossible in the Australian market.  This would not only produce adverse consequences 
to Australian consumers, but also to the small deve loping countries which produce and export cigars.  
Cuba asked Australia to take these concerns into consideration and to provide a satisfactory reply. 
172. The representative of Nicaragua noted that his delegation had expressed concerns at the TBT 
Committee and the TRIPS Council, as well as to the Australian Government by an open letter.  
However, it never received a response from the latt er.  His delegation did not question Australia's 
right to regulate the sale of tobacco and efforts to  protect health, it was concerned that the measure 
would infringe Australia's WTO commitments, particularly those under the TRIPS and TBT 
Agreements.  As a tobacco producing and exporting country, Nicaragua considered that there had to 
be a balance between health objectives and the rights of other WTO Members.  Nicaragua asked 
Australia to provide more scientific evidence on th e measure and to reply to the note it sent to 
Australia's focal point and posted by Australia on its official website. 
173. The representative of Canada said that Canada ha d been a pioneer in regulating packaging of 
tobacco products and would follow with interest these discussions.  It understood the challenge of 
introducing never before implemente d tobacco control measures as it had been in a similar situation a 
decade ago when it introduced pictorial health warn ings on tobacco packages.  Canada put in place 
this measure after extensive research suggesting its effectiveness in increasing public awareness of the 
products' health effects and hazards.  Canada unde rstood that Australia had also conducted serious 
research to support introduction of its new measure,  and considered that information and discussions 
on the measure would help Members' understanding of this complex matter.  G/TBT/M/56  
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  174. The representative of Norway said that public hea lth and tobacco control, in particular, were 
dear to Norway and it did not see an inherent cont radiction between regulating tobacco products and 
other international obligations.  Each Member was within its right to regulate these products so as to 
take into account the legitimate concern of its people' s health needs.  Norway believed firmly that the 
FCTC and the WTO rights and obligations were mutua lly supportive, and that regulating packaging of 
tobacco was in line with both sets of binding oblig ations.  Tobacco control policies and preventive 
measures, such as those proposed by Australia, had the legitimate objective of protecting public health 
by reducing smoking.  Article 11 of the FCTC , and the accompanying guidelines, explicitly 
mentioned plain packaging as one of the options for achieving this objective.  On the question of the 
scientific basis for this measure, the WHO had previo usly stated that a strong and irrefutable body of 
evidence had demonstrated that product packagi ng had traditionally served as one of the tobacco 
industry's central vehicles in initiating and mainta ining addiction to their lethal products among 
consumers.  Norway believed that regulation of product packaging was vital to reduce tobacco 
consumption and supported Australia's right to intr oduce measures necessary to  fulfil its obligations 
under the FCTC to protect public health.  Norway  trusted that implementation of Australia's 
legislation would be done in compliance with all international treaty obligations.  Norway would 
follow this matter with interest and was prepared to  continue to defend the interests of public health. 
175. The representative of Zimbabwe shared previous  delegations' concerns that the measure was 
not consistent with WTO disciplines and did not accord  effective protection to trademarks as provided 
under the TRIPS Agreement.  The measure would burd en consumers who would no longer be able to 
readily identify their favourite brand of tobacco pr oducts, risking their health as they experiment from 
one cigarette pack to the next in the absence of fu ll information.  This c ould have possible adverse 
consequences to the national health budget.  Th e measure constituted an unnecessary obstacle to trade 
and was more trade restrictive than necessary to  achieve Australia's health objective; thereby 
inconsistent with Article 2.2 of the TBT Agre ement.  Zimbabwe urged Australia to look for 
alternative ways to meet its health objective while respecting its WTO commitments. 
176. The representative of New Zealand welcomed Australia's plain packaging legislation for 
tobacco products.  The negative effects of smoking could not be overstated;  in New Zealand smoking 
was the leading preventable cause of early death.  Australia had given past assurances that it had paid 
close attention to and respected its WTO obligations in developing its plain packaging proposal.  The 
TBT Agreement recognized that no country should  be prevented from taki ng measures necessary to 
protect human health.  Furthermore, numerous scientific studies had demonstrated that plain 
packaging could lead to positive public hea lth outcomes by reducing the attractiveness and 
desirability of smoking and increasing prominence of public health warnings.  In a comprehensive 
suite of tobacco control measures, plain packaging could contribute to efforts to reduce smoking rates. 
177. The representative of Turkey said his delega tion would comment on the measure later.  
178. The representative of Brazil thanked the Aust ralian delegation for clarifications provided 
previously.  Brazil supported the legitimate objectiv es pursued by the legislation and fully recognized 
the right of Members, in accordance with the TBT and the TRIPS Agreements, to regulate the tobacco 
sector to protect public health.  Brazil would follo w the international developments and Members' 
regulatory experiences in this area. 
179. The representative of Ukraine sh ared the concerns expressed on this measure.  His delegation 
believed that the measure clearly violated the pr ovisions of the TBT Agreement, and its position was 
detailed in the minutes of the last TBT meeting. 
180. The representative of Guatemala expressed system ic interest in the discussions of this 
measure.  While the measure sought to give legal af fect to certain FCTC obligations, it was not clear 
how it could be reconciled with Australia's oblig ations under the TBT and TRIPS Agreements.  The G/TBT/M/56  
Page 40  
 
  WHO and WTO rules contained mandatory interna tional obligations.  For international legal 
coherence, the rules of one system could not be adhered to the detriment of those of the other. Implementation of international health obligations to fight smoking within the WHO must be 
compatible with WTO obligations, particularly  those in the TBT Agreement which recognized 
Members' rights to ensure the quality of products, protection of the health and safety of humans and 
animals, preservation of the environment and prevention of deceptive practices at levels they 
considered appropriate.  To fulfill these objectives, Members needed to ensure that in drafting, 
adopting or implementing technical regulations di d not create unnecessary barriers to international 
trade.  Article 2.2 of the TBT Agreement provided th at technical regulations should not be more trade 
restrictive than necessary to full the objective, ta king into account the risks of non-fulfillment. 
181. In Guatemala's view, the FCTC Guidelines w ould not justify non-compliance with TBT or 
TRIPS obligations.  Many of those Guidelines were not even mandatory.  In particular, paragraph 46 
of the Guidelines referring to plain packaging, stated that the parties should consider the possibility  of 
adopting measures to restrict or prohibit the use of logos, colors, trademark images or promotional 
material other than the brand na me or the name of the product in ordinary lettering and font, i.e. plain 
packaging.  Any WTO Member considering adoption of such measures should consider their 
international obligations, incl uding those under the WTO Agreements.  Moreover, according to 
paragraph 46 of the Guidelines, plain packaging "enables greater noticeability and effectiveness of 
health warnings and messages preventing the pack age from distracting attention from these messages 
and prevents the use of industrial packaging designs  that would suggest that some products are not as 
harmful as others".  Guatemala interpreted th is provision as behind the Guideline's legitimate 
objective.  In seeking to fulfill this legitimate objective, WTO Members must take into account that 
they could not adopt measures more trade restrictiv e than necessary to fulfill that legitimate objective. 
182. The representative of China expressed her delegati on's continued interest in this topic which  
involved both the TBT and the TRIPS Agreement. 
183. The representative of the European Union recalled its previous comments and continued 
interest in this matter, particularly in light of the on-going revision of its own tobacco legislation. 
184. The representative of Indonesia recalled a comm unication send on 8 June  2011 on the impact 
of Australia's draft regulation (G/TBT/W/336) in wh ich it raised five questions related to the bill's 
justification.  Responses were still outstanding. 
185. The representative of Australia informed Me mbers that the Tobacco Plain Packaging Act 
2011 and the Trade Marks Amendment (Tobacco Plain Packaging) Act 2011 had been passed by the 
Australian Parliament and they received Royal A ssent on 1 December 2011.  The former, which had 
been passed on 21 November 2011, included amendmen ts to:  (i) extend implementation timeframes 
and provided an additional two weeks for retailers  to sell through ("flush-through") any product in 
non-compliant packaging before the retail offe nces commence;  and (ii) address a technical 
implementation issue identified by tobacco compan ies to permit rounded corners to be used on the 
inside lip of cigarette packs.  The associated Trade Marks Amendment (Tobacco Plain Packaging) 
Bill 2011 passed the Parliament on 10 November 2011.  All tobacco products manufactured or 
packaged in Australia would be required to be in plain packaging by 1 October 2012 (previously 20 
May 2012).  Moreover, all tobacco products would be required to be sold in plain packaging by 1 
December 2012 (previously 1 July 2012).  The fina l regulations related to cigarette products, were 
revised in response to comments from industry, and approved on 7 December 2011.  
186. The representative informed the Committee that the fina l Tobacco Plain Packaging 
Amendment Regulation 2012, which incorporated  the specifications for non-cigarette tobacco  G/TBT/M/56  
 Page 41 
 
 
  products, was published on 2 March 2012.21  The Amendment Regulation was approved in the same 
form by the Executive Council on 8 March 2012.  She said the Australian Government had undertaken two consultation processes in relation to  the Amendment Regulation and that submissions 
made as part of those processes had been take n into account.  She also emphasized the open and 
transparent manner her Government had adopted with  its trading partners throughout the process of 
introducing the measure. Australia had met or offered to meet with all WTO Members that had raised 
this issue in the TBT Committee and TRIPS Counc il to explain the purpose and details of the 
proposed measures and to provide detailed answers to the questions raised. Australia had conveyed 
information to Members' Ministries of Trade and Health; including substantial information on the 
evidence underpinning the measures; and had pr ovided substantial written information both 
electronically and in paper form on the concerns ra ised. Australia had made detailed statements in 
various WTO committees.  The representative therefor e considered that claims that her Government 
had not responded to questions and requests for fu rther information to be unreasonable and that 
Australia had indeed met its obligations under Article 10 of the TBT Agreement. Furthermore, 
Australia had been responsive to comments from trad ing partners and other st akeholders, including by 
taking their comments into account, which in turn led to changes to the law wh ere those changes were 
in line with the Government’s policy objectives.  
187. The effect of the above-mentioned legislati on was that tobacco company branding, logos, 
symbols and other images that may have the effect of advertising or promoting the use of the tobacco product would not be able to appear on tobacco produ cts or their packaging.  On the other hand, the 
brand name and variant name woul d be allowed on packaging.  Info rmation which would be required 
by other legislation or regulations, such as trade d escriptions and graphic health warnings, would also 
be allowed to appear.  Australia w as implementing this legislation in the interest of promoting public 
health.  Tobacco products caused extraordinary harm  and required appropriate  measures.  According 
to the WHO, tobacco was "the only legal consumer pr oduct that kills up to half of those who use it as 
intended and recommended by the manufacturer".  15 ,000 Australians died each year as a result of 
smoking, with some 3 million Australians conti nuing to smoke, costing Australia's society and 
economy over A$31.5 billion per annum .  Smoking rates were particul arly high among disadvantaged 
groups such as teenage mothers, aboriginal and To rres Strait Islanders, people with mental illness and 
the unemployed.  Tobacco packaging was one of the last remaining forms of tobacco advertising in 
Australia and this legislation was the next logical st ep in Australia's tobacco control efforts.  It was 
confident that, as part of a comprehensive package of tobacco reforms, it would make an effective 
contribution to reducing smoking, and thereby reduc ing the health impacts of smoking on Australian 
individuals and the community at large.  Plain packaging of tobacco products was designed to: (i) 
reduce the attractiveness and appeal of tobacco product s to consumers, particularly young people; (ii) 
increase the noticeability and effectiveness of mandated health warnings; (iii) reduce the ability of the 
tobacco product and its packaging to mislead c onsumers about the harms of smoking; and (iii) 
through the achievement of these aims in the long term, as part of a comprehensive suite of tobacco 
control measures, contribute to efforts to reduce smoking rates.   
188. The measure was part of a balanced packag e of measures designed to contribute to the 
Government's target of reducing the adult daily sm oking rate in Australia to 10 per cent by 2018.  
Other measures introduced by the Government include d: (i) the 25 per cent tobacco excise increase in 
April 2010; (ii) over A$ 85 million investment in  anti-smoking social marketing campaigns; (iii) 
legislation to restrict internet advertising of tob acco products in Australia; (iv) the extended listing of 
nicotine replacement therapies and other smoking cessation supports on the Pharmaceutical Benefit 
Scheme (PBS); and (v) record investments (about A$100 million) in support for indigenous 
communities to reduce smoking rates.  This came on top of a comprehensive suite of tobacco control 
measures already in place in Australia, including: (i ) minimum age restrictions on purchase of tobacco 
products; (ii) comprehensive adve rtising bans under the Tobacco Advertising Prohibition Act 1992; 
                                                      
21 http://www.yourhealth.gov.au  G/TBT/M/56  
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  (iii) retail display bans; (iv) bans on smoking in offices, bars, restaurants and other indoor public 
spaces, and increasingly outdoor places where childre n may be exposed to environmental tobacco 
smoke; (v) extensive and continuing public educa tion campaigns on the dangers of smoking;  (vi) 
PBS subsidies for smoking cessation supports; a nd (vii) quitlines and other smoking cessation support 
services in each State and Territory to help people quit.  The plain packaging legislation related only 
to tobacco products and retail packaging of tho se products;  the Australian Government was not 
considering extending the measure to other products.  Australia w as, and continued to be, fully 
committed to its international obligations.  In fra ming its policy on plain packaging, Australia had 
paid full regard to its obligations under the TB T Agreement and would ensure that the new policy 
would be implemented in a manner c onsistent with that agreement. 
189. The representative of the World Health Organiza tion recalled that its previous interventions 
providing information on the FCTC, in particularly  Articles 11 and 13 of the Convention, as well as 
the relevant Guidelines.  She referred Members to  minutes of those meetings.  She highlighted the 
substantial number of States that were both Party to the FCTC and Members of the WTO;  of the 174 Parties to the FCTC, 137 of them were also WTO Members.  These States were thus subject to 
obligations under both legal regimes.  On 15 and 16  March 2012, the Secretariat of the FCTC hosted a 
workshop at WHO Headquarters to promote the sharing of knowledge and information among country trade and health representatives on trade -related aspects of tobacco-control measures taken 
pursuant to the WHO FCTC and its guidelines for impl ementation.  The workshop was held further to 
a decision of the fourth session of the Conference of  the Parties (the supreme governing body of the 
FCTC) relating to "Cooperation between the Convention Secretariat and the World Trade 
Organization" (FCTC/COP4(18)) which, inter alia, requested the Convention Secretariat to cooperate 
with the WTO Secretariat with the aim of info rmation sharing on trade-related tobacco control 
measures.  Representatives from the trade and health  sectors of over 65 countries participated in the 
workshop, including several who travelled from cap itals to participate.  The FCTC Secretariat 
intended to continue its efforts to cooperate and to share information.  She informed that the 
negotiation of the draft Protocol to Eliminate I llicit Trade in Tobacco Products was expected to 
conclude from 29 March to 4 April 201 2, and the draft protocol was exp ected to contain provisions on 
the tracking and tracing of tobacco products. 
(xxix)  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)  
190. The representative of the United States noted that  Ministry of Finance Document 4629 on the 
import of spirits and cosmetics and Ministry of  Industry and Trade Notice 197 on the import of 
alcohol, cosmetics and mobile phones involved ne w conformity assessments procedures.  They 
appeared to have gone into effect in June 2011, to  be legally binding and to create new requirements 
on specific quality control procedures such as s ubmission of a quality control certificate and the 
designation of specific ports and charge of contro l.  While the US appreciated Viet Nam's written 
responses to its concerns and willingness to engage in this issue, Viet Nam's view that the measures 
were not legally binding was creating confusion for US  exporters.  For example, Viet Nam stated that 
the measures were not legally binding and did no t create any new requirements.  How Vietnam did 
not explain why it chose these partic ular products to be subject to such procedures and not others, and 
what its criteria were.  Further, Vietnam said th at it would provide detailed HS codes that were 
“subject to” Notice 197, while continuing to argue th at the measure is not a normative legal document 
and does not create new trade measures. Viet Nam al so clarified that some component products had 
been excluded from the scope of the measure, but th e responses did not provid e any details of quality 
control entailed for each of these products, nor wh at the quality conformity certificate mentioned in 
document 4629 was and who was responsible for i ssuing it.  The US would continue to seek 
clarification from Viet Nam on these issues and on why consularization was necessary.  G/TBT/M/56  
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  191. The representative of Australia shared the US concerns, in particular on the conformity 
assessment procedures set out in document 46 29, including its compatibility with the TBT 
Agreement.  Australia was also concerned that  notice 197 was administratively burdensome and 
having unintended ne gative trade consequences, particularly on small to medium enterprises 
exporting small quantities. 
192. The representative of the European Union shar ed the US concerns and asked Vietnam to 
provide further clarification on the status of th ese measures.  Since Notice 197 was presented as a 
temporary measure soon to be repealed, the EU wond ered whether it was still in place.  As for Notice 
4629, Viet Nam stated in the last TBT meeting that  this was not a legally enforceable document.  
Thus, the EU asked Viet Nam to clarify what this meant.  For instance, were  quality checks meant to 
be applied to all consignments of alcoholic be verages, cosmetics and mobile phones?  Should a 
Quality Control Certificate accompany these consignm ents and, if so, what entity was in charge of 
issuing it and what was the timeline for it?  Was a template used for issuing the certificate and what 
quality standards were supposed to be certified by th is document?  What other information should this 
Certificate cover?  Finally, why was quality contro l limited to only three sea ports?  The EU recalled 
that previously, Viet Nam indicated that these me asures were meant to prevent counterfeiting and 
smuggling.  Had these measures met their stated pur pose?  Was a drop in counterfeiting or smuggling 
recorded?.  The EU urged Viet Nam to  notify these measures to the WTO.   
193. The representative of New Zealand thanked Viet  Nam for its responses.  It continued to 
monitor these measures from a TBT perspective.  New Zealand requested an update as to whether 
Viet Nam had established, or intended to establish,  a new "certificate of quality achievement" process 
for alcoholic beverages and cosmetics as propo sed in MOF Official Letter 4629/BTC-TCHQ of 7 
April to MOIT.   She asked if Viet Nam intend to notify this process. 
194. The representative of Viet Nam recalled its prev iously provided answers to the concerned 
delegations.  Regarding document 4629, Viet Nam confirmed that this document did not create any 
new conformity assessment procedures because it was not a legal document and had no legally 
binding force.  Moreover, the Ministry of Finance was not the authority responsible for goods quality 
control.  Regarding Notice 197, although its purpose was anti-counterfeiting and anti-smuggling and 
the protection of consumer health and safety, the measure was not a conformity assessment procedure specified by particular standards and technical re gulations.  In recent years, its market had been 
seriously suffering from smuggling and counterfeiting,  especially in cosmetics, alcohol and mobile 
phones.  In 2010, about 12,000 cases of counterfeit produc ts were found, and in the first half of 2011 
about 15,000 cases were found;  cosmetics, alcohol and mobile phones were the largest categories of 
counterfeit illegal imports in Viet Nam.  As justifi cation for standard and consumer protection, 52 per 
cent of consumers did not know that the products they  had purchased were count erfeited, in particular 
when the products were foreign brand cosmetics, alcohol and mobile phones.  The requirements in 
Notice 197 supported agencies in their more effect ive control of smuggling and counterfeiting in 
alcohol, cosmetics and mobile phone , thus benefiting both consumers and foreign exports.  Viet Nam 
noted Members' comments and welcomed bilate ral discussions with interested Members. 
(xxx) Malaysia – Draft Protocol for Halal Meat  and Poultry Production  (G/TBT/N/MYS/23) 
195. The representative of the United States appreciated  visits from Malaysian officials to the US 
to discuss the halal requirements with US industr y and Government.  The US still had concerns, 
including the requirements that production facilities be dedicated exclusively to halal production.  
This raised issues of consistency with the C odex halal guidelines and ha d implications for US 
industry.  She asked for continued bilateral discussi ons to find a mutually acceptable resolution.    
196. The representative of the European Union s upported the US concerns, stressing that 
transparency of import conditions was a key prere quisite for ensuring that trade flows were not G/TBT/M/56  
Page 44  
 
  unnecessarily impeded.  There had been progress, in particular with the TBT notification in December 
2011 of Malaysia's new Trade Description Orde rs (as notification G/TBT/MYS/27).  However, 
Malaysia' halal related measures were still not aligne d to international standards such as Codex, in 
particular in the way audits were carried out.  Th eir application lacked cl arity, transparency and 
predictability and, as a result, EU exporters faced  difficulties meeting these conditions. The EU urged 
Malaysia to make more efforts to alleviate the impact of its requirement s on foreign establishments. 
197. The representative of Brazil thanked Malaysia for its written answers but his delegation still 
had concerns about this measure, especially the re quirement that halal production should take place in 
a facility dedicated exclusively to that kind of pr oduction.  This contradi cted the relevant Codex 
standard on this issue.  Brazil expressed its con tinued interest in discussi ng this issue bilaterally. 
198. The representative of Turkey said that the use of different standards and conformity 
assessment procedures in the halal food industry lead  to technical barriers to trade, including among 
Muslim countries.  A number of Muslim countries took initiatives under the Organization of Islamic 
Cooperation (OIC) to develop standards for halal fo od so as to remove technical barriers to trade 
through common rules and procedures.  To this end, an affiliate body, namely "Standards and 
Metrology Institute of Islamic Countries" (SMIIC) was established by OIC.  SMIIC not only prepared 
guidelines for halal food standardization, but also published two additional guidelines for certification 
and accreditation in the area of halal food.  Malays ia's Draft Protocol for Halal Meat and Poultry 
Production envisaged employing additional requirement s on halal-related imports without considering 
common rules and traditions.  Conformity assessment bodies would be further limited by the Malaysian Government.  Turkey emphasized the im portance of the initiative taken by 14 Members of 
SMIIC.  In order to prevent technical barriers on ha lal products and to promote international trade, 
common standards should be established with the support of especially Muslim countries.  Additionally, mutual recognition of conformity  assessment and of accreditation bodies should be 
maintained.  Therefore, Turkey exp ected Malaysia to reconsider the Dr aft Protocol in conformity with 
its WTO commitments and invited Malaysia to beco me a member of SMIIC and participate in the 
development of common standards, conformity  assessment and accreditation among countries. 
199. The representative of Malaysia took note of the comments and indicated its willingness to 
continue bilateral discussions with interested  Members in order to resolve this issue. 
(xxxi)  Korea – Regulation on Registration and Evaluation of Chemical Material 
(G/TBT/N/KOR/305) 
200. The representative of the United States indicat ed that the US government and industry 
appreciated the objectives of Korea's "Act on Regist ration, Evaluation, Authorization and Restriction 
of Chemical Substances" (Public Notice 2011-74) to safeguard public health and the environment and 
hoped that consultations would con tinue on developing regulation able to achieve these goals with 
minimum adverse effects on US and Korean trade inter ests.  It was the US view that the proposed Act 
had broad implication not only for US industry, but also for producers and importers of chemicals in 
Korea, by creating significant changes to Korean's current chemical regulatory regime.  She noted that 
the US industry had expressed various concerns with the proposed regulation and that multiple 
entities including, among other, the American Ch emistry Council (ACC), Society of Chemical 
Manufacturers and Affiliates (SOCMA), the US Council on International Business had submitted 
comments directly to the Ministry of Energy in Korea.  She appreciated the responses provided by 
Korea to most of these groups, which were still evalua ting the replies.  She asked Korea to update the 
Committee on key issues raised at previous meet ings regarding the pr oposed annual reporting 
requirements and the 0.5 minimum ton thresholds for preregistration and regist ration.  In particular, 
she wanted confirmation whether it was planned to increase the 0.5 ton threshold to 1 ton.  G/TBT/M/56  
 Page 45 
 
 
  201. The representative of Korea explained that the announcement for public opinion on the 
legislation was made in April 2011 and the promul gation of the Act was expected to take place in 
2012.  The Ministry of Environment of Korea w as at the moment taking into account all the 
comments from Member countries.  He further menti oned that no date had been determined for the 
new legislation to be finalized.  In general, Acts and subordinate regulations were enforced two years 
after the day of their promulgation.  Enforcement ha d been postponed to provide a certain preparation 
time to the industry.  In the case of registration, maximum 8 years of grace period were granted depending on the substance. 
202. With regard to the minimum tonnage thr eshold of 0.5 ton and the annual reporting 
requirement, he explained that the Ministry of E nvironment was considering whether to amend these 
provisions following consultations with the concerne d industries.  With respect to which chemical 
substances would be subject to these regulations, stud ies were under way to determine this and details 
would be set forth in the enforcement decree.  Th e legislation was in accordance with the provisions 
of the United Nations Globally Harmonized System  of Classification and Labeling of Chemicals 
(GHS), which Korea had adopted for substances on 1 July 2010 and would also apply to mixtures 
beginning 1 July 2013.  He further explained th at the Korean ministry would assess the compatibility 
of the OECD software with the Korean system  for data submission.  The enforcement decree 
specified the list of exempted substances, such as  certain chemicals used solely for research and 
development.  He also confirmed that reliabilit y was essential for submitting physiochemical data, but 
the data did not have to be produced under GLP.  The remaining points raised in the Committee were 
conveyed to the competent authority. 
(xxxii)  Mexico – Energy Labelling Measures (Law for Sustainable Use of Energy, 28 Nov 2008; 
Regulation of the Law for Sustainable Use of Energy, 11 September 2009; National Program for Sustainable Use of Energy 2009-2012, 27 Nov 2009; and Catalogue of equipment and appliances used by manufacturers, import ers, distributors and marketers that require 
mandatory inclusion of energy consumption information, 10 September 2010)  
(G/TBT/N/MEX/214) 
203. The representative of the United States suppor ted Mexico's effort to raise consumer 
awareness in the area of energy consumption th rough a testing and labelling system and noted that 
similar programs were maintained in the US.  She thanked Mexico for notifying the Catalogue in June 
in response to requests from trading partners and noted the comments that had been provided, including from the US.  Her delegation welcomed the idea proposed by Secretary of Energy for 
Mexico, Jordy Herrera, during a recent meeting w ith the US Ambassador, Anthony Wayne, for the 
US-Mexico Working group to start a review proces s of the products catalogue  and consider narrowing 
products categories.  Nevertheless, she was c oncerned that the current regulation was overly 
burdensome and not transparent.  She noted US indu stry willingness to comply with the Mexican law 
and regulations  and  hoped that the working gro up could identify product categories that could be 
removed from the catalogue based on the de minimis  energy consumption criterion and could also 
work towards US-Mexico greater alignment in th e area of energy consumption and labelling and 
energy efficiency, including leveraging the existing US Energy Guide, US or international standards 
for testing and convergence. 
204. The representative of Japan appreciated the purpo se of the measures in question but remained 
concerned that some of the provisions of the Me xican measures introduced considerable difficulties 
with respect to, among other things, compliance for product manufacturers.  In particular, the measure 
regulated products contributing little to their objec tives, and the specific procedures and methods of 
measurement were not clear.  It was Japan's view that an inappropriate measuring method could allow 
low energy efficiency products to claim “high energy  efficiency” resulting in confusion for consumers 
as well as manufacturers.  He concluded by re questing the Mexican government to clarify the G/TBT/M/56  
Page 46  
 
  measurement method and notify it to the WTO when stipulated in order to provide opportunities for 
comments by Members. 
205. The representative of Mexico pointed out that the new catalogue of equipment and appliances 
had been notified as document G/TBT/N/MEX/214, on 15 June 2011 and a 60 days comment period 
had been provided in compliance with the comm itments established under Article 2 of the TBT 
Agreement.  The US, Japan, the EU and interest ed companies that had submitted comments had 
received a reply from the National Committee for effici ent energy use.  The comments made by Korea 
after the expiration of the public consultation period had also been  responded to.  The delegate of 
Mexico stressed that on 11 November 2011, the period for submission for formats and requirements 
for delivery of information from manufacturers and importers of equi pment and appliances 
consuming energy had expired.  Since then, the Federal Office for Consum er Protection (PROFECO) 
and Energy Saving Committee had begun the analysis and review of the information referring to test 
methods used to measure energy.  
(xxxiii)  Kenya – Alcohol Labelling: The Alcoholic Dr inks Control (Licensing) Regulations, 2010: 
Legal Notice No. 206: 2010  
206. The representative of Mexico asked Kenya to provide information with respect to the 
implementation of the regulation published on 17 December 2010.  She further requested a formal 
reply from the Government of Kenya to the comments submitted on 12 May 2011.  
207. The representative of the United States made sever al enquiries during her intervention.  First, 
it was unclear why Kenya had notified the regulatio n under Article 2.10.1 of the TBT Agreement (as 
an urgent measure).  She noted that both dates of notification and adopti on were the same, 1 March 
2011, and asked Kenya to provide a time period for interested parties to submit comments and take 
them into account in revising the measure.  It was also the US understanding that implementation of 
some sections of this measure had been postponed due to a pending lawsuit in Kenya.  She requested 
Kenya to notify, pending the outcome of the case,  any changes to the labelling section of this 
regulation to the WTO.  The US delegation, like Mexico, was still waiting to receive a reply to the 
comments submitted on 7 April 2011; she urged Kenya to allow for time to consider changes.  
Finally, although her delegation appreciated the objectives of Kenya's alcohol labelling, she was 
interested on the rationale behind the inclusion of pictures in the alcohol warning statements – and 
how this would ensure that the warning labe ls would not unnecessarily impact on trade. 
208. The representative of the European Union sup ported the concerns expressed by Mexico and 
the US.  Her delegation was still waiting for a written answer from Kenya to the detailed written 
comments sent in April 2011.  She also asked if Kenya had considered less burdensome alternatives 
other than mandatory health warnings labelling to  modify drinking behavior.  She also requested 
confirmation if the requirement for health warnings to comprise at least 30 per cent of the total area of the package had been amended, as stated during the previous TBT Committee meeting. 
209. While the delegate of Kenya took note of all th e comments made, he explained that in regards 
to the on-going lawsuit he was not able to pr ovide a comprehensive response.  Appropriate 
information would be reported to the Committee when  available.  He confirmed that comprehensive 
responses to the written comments would be pr ovided at the next Committee meeting. 
(xxxiv)  Korea – Proposed Cosmetics Labelling an d Advertisement Guidelines: KFDA draft 
Guidelines for Management of Nanomaterials in Cosmetics (G/TBT/N/KOR/308) 
210. The representative of the European Union reitera ted her delegation's call for the Korean Food 
and Drug Administration (KFDA) to apply the ab ove-mentioned Guidelines in a transparent and 
participatory manner, and to regularly discuss thei r implementation with concerned industries.  Her  G/TBT/M/56  
 Page 47 
 
 
  delegation remained concerned that the Guidelines co uld pose problems with respect to the control of 
claims in languages other than Korean, including names of globally marketed products (for instance 
brand names) if they were to fall within the scope of the Guidelines. 
211. The representative of the United States explained that she had previously raised concerns in 
conjunction with Korea's labelling measures for cosmetics and advertising guidelines as well as 
KFDA draft guidelines for management of Nano materi als in cosmetics.  She thanked Korea for their 
engagement, accepting the comments submitted by th e US industry and for amending the guidelines 
to provide a one-year grace period for new products en tering the market to enab le adjustments to the 
new labelling guidelines.  However, it was unclear whether the transition time was also allowed for 
products already available on the market, including those already in the manufacturing and shipment 
process.  She informed the Committ ee that the US Embassy in Seoul had raised this issue with both 
MOFAT and KFDA in early February 2012 and had re quested, once again, the date of manufacture 
for the importer and not the one of import to be the enforcement date, b ecause factors, such as 
shipping times and in transit goods, could impact the ability of importer to comply. She further 
requested an update as to how the Ministry was a ddressing concerns raised about the Hangul language 
requirement on both the primary and secondary packaging. 
212. The representative of Korea explained that specific standards for Cosmetic 
Advertising/Labelling scheme came into effect on 5 February 2012 following the Amendment in 
Cosmetic Act.  Details for methods and procedures w ould be notified in June 2012 after receipt of all 
public comments and completing the harmonization pro cess with international standards.  He further 
confirmed that KFDA could not approve exem pting foreign languages from the labelling items 
requiring regulations. The amended co smetic act was intended to regul ate the concerns with a product 
name written in a foreign language on imported cosme tics that could deceive or mislead consumers to 
consider this product as pharmaceutical product.  The guideline specified the methods allowing 
importers to modify, correct, delete and over-label the advertisements or labels written in foreign 
languages in order to comply with the guidelines.  Finally, he explained that the guideline for 
cosmetics containing nanomaterial was currently  going through internal review and would be 
uploaded on the KFDA website once finalized. 
(xxxv)  Colombia – Draft of the modification of the Resolution 910 / 2008 an d Resolution 2604/2009, 
concerning the emission of contaminant sou rces for heavy vehicles with a diesel motor. 
213. While the representative of Mexico shared Co lombia's objective to improve the quality of 
fuels and contribute to a reduction in air pollution, she expressed some concerns with respect to the 
draft amendment to the resolutions 910 of 2008 and 2604 of 2009 regarding the establishment of 
stricter emission limits for heavy vehicles using a diesel motor.  It was Mexico's view that the 
measures could be incompatible with the TBT Agreem ent by allowing vehicles with a specific diesel 
engine technology to circulate but prohibiting tho se with a different technology.  In addition, the 
measure could be a potential unnecessary restriction to  trade regarding its potential negative effects on 
Mexico's manufacturing sector and exports to Colomb ia.  She further noted that the measure had not 
been notified and her delegation was still waiting for a reply to a request sent on 5 December 2011 
followed by a reminder sent on 31 January 2012.   
214. The representative of the United States thanked Colombia for the  regulator-to-regulator 
dialogue held recently on this matter and noted that  the US is; waiting for a reply to its technical 
questions following that dialogue, which were sent on 9 February 2012.  She estated that the  trade 
impediment issue noted at the last TBT Committee meeting if Colombia would make available 15 
ppm sulphur fuel not be an issue, which would allow EPA 2007 and EURO V standards to be used, 
and enable Colombia to achieve  greater environmenta l and health benefits. , and.  She noted that may 
countries, including in Latin America, had made th is transition or were in the process of doing so. G/TBT/M/56  
Page 48  
 
  215. The representative of Colombia explained that this measure had not been notified to the 
Committee, because the draft resolution had yet to be  finalized.  Preliminary tests were currently 
drawn up with the participation of all interested parties, including importing firms from Mexico and 
the US.  He confirmed that the final version of th e draft would be notified as soon as it was available. 
(xxxvi)  South Africa – Liquor Products Act of 1989  
216. The representative of the United States recalled the difficulties faced by US industry to import 
liquor since 2009 because of the South African identity standard for liquors requiring a minimum 
alcohol content of 24 per cent and preventing the US industry to import products with a 17 per cent 
alcohol content.  She noted that this product had been classified as liquor in a number of countries 
including the United Stated, and a number of countries defined liquor based on raw materials and 
production processes rather that the chemical compositi on such as alcohol content.  She invited South 
Africa to provide a status update on the labelling a nd ingredient documentation application submitted 
by the US industry as suggested by South Africa in  two Committee meetings and to also explain the 
reason for the delay in responding.  She conclude d by highlighting the importance of considering 
revising its standard of identity to provide a cat egory for products such as "Hpnotiq" - product of 
interest to the US - in order to enable more trade facilitative approach or considering granting a 
waiver or exemption. 
217. The representative of South Africa recalled that  two categories under the Liquor Products Act 
No. 60 of 1989, namely liqueur and spirit cocktail, were relevant to "Hpnotiq", the product the US 
wished to export.  It was South Africa's view th at the technical regulations for both products under 
this Act were based on product requirements, incl uding raw materials, production process and alcohol 
limits, and therefore fully compliant with the TBT Ag reement.  The South African delegate noted that 
alcohol content limits were also referred to in th e USA Federal Alcohol Administration Act to define 
products such as Brandy with more than 40 per cent of alcohol content by volume.   
218. According to South African Liquor Products Act, liqueur, whose minimum alcohol limit by 
volume could not be less than 24 per cent, had to be  produced by macerating fresh or dried fruit, or 
peels thereof, or aromatic plants, or leaves, herbs,  roots or seeds in a spirit; by adding flavourants of 
vegetable origin or extracts thereof, or herbs or na tural extracts of herbs, to a spirit; or by redistilling 
the product obtained in terms of maceration or fla vor addition, and thereafter adding thereto a syrup 
containing honey or sugar derived from cane or grain, a nd, if applicable, colourant.  In contrast, spirit 
cocktail, whose minimum alcohol limit could not be  less than 24 per cent alcohol by volume, had to 
be produced by the addition of herbs, natural extracts of herbs, other flavourants of vegetable origin or 
nature-identical, egg or milk flavourants, and sugar derived from cane or grain to a spirit in order to 
create a distinctive taste and aroma different from that of wine or a class of wine.  He further explained that both technical regulations did not differentiate between locally produced or imported 
liqueurs or spirit cocktails given that both importer and local producers had to comply with the same 
requirements on production processes, raw material a nd minimum alcohol.  Finally, he reiterated that 
the products "Hpnotiq" could not be compared with  Amarula, because both products specifications, 
raw materials and production pr ocesses were totally different. 
(xxxvii)  Peru – Draft Supreme Decree approving the regulations governing the labelling of 
genetically modified foods.  
219. The representative of Mexico expressed concerns about Peru's intention to potentially label 
differently foods containing genetically modified i ngredients.  Following the notification of the draft 
measure under G/TBT/N/PER/37 on 27 June 2011,  these concerns, submitted as comments on 14 
September 2011, were still pending on an official reply by the government of Peru.  As had been 
mentioned in previous Meetings, it was Mexico's view that this proposal could be more trade 
restrictive than necessary to achie ve the legitimate objective.  In this respect, she recalled that,  G/TBT/M/56  
 Page 49 
 
 
  pursuant to Article 2.5 of the TBT Agreement, her delegation had request ed Peru to provide a 
technical scientific justification of the draft technical  regulation.  She further invited Peru to share the 
latest update on the status of implementation of th e draft decree approving the regulation on labelling 
genetically modified foods and requested an  official reply to the comments submitted. 
220. Similarly, the representative of Chile requested an update on the status of the draft technical 
regulation and a reply to the comments submitted la st November.  He reiterated the importance of 
considering extending the timeframe beyond the pr oposed 180 days to provide sufficient time to 
enable the Chilean industry to adapt to the new requirements. 
221. The representative of Colombia supported the con cerns expressed by Mexico with respect to 
the requirements of different labelling for food de riving from genetically modified organisms and 
requested an update of the status of the draft measu re as well as a reply to the concerns expressed in 
the Committee.  
222. The representative of Peru explained that this  draft was still under review as the Peruvian 
authorities were still reviewing and compiling all the comments received.  In particular, no date of 
publication of the final technical regulation had been specified by the multi-sectoral working group in 
charge of drafting this regulation.  Therefore, fu rther information on any particular changes to the 
draft would be provided in due time and in complia nce with international obligation.  According to 
the Peruvian delegation, the draft regulation did not put into question the safety of genetically 
modified organisms or genetically modified foods.  He explained that the rationale of the technical 
regulation was to provide consumer with clear and sufficient informati on on various products and 
services to avoid any type of potentially misleading practices, as promoted by the Mexican Federal 
Law on Consumer Protection and the Per uvian Code for Consumer Protection. 
(xxxviii)  Mexico – Draft Decree Amending Provisions for Drinks with Caffeine  
223. The representative of the European Union expr essed some concerns about the draft decree 
amending the General Mexican Health Law and foreseei ng a restriction to sell drinks with caffeine to 
persons of less than 18 years old.  She explained th at, according to the latest scientific information, 
moderate consumption of caffeine was unlikely to  present any health risk for most consumers, 
although moderation of caffeine inta ke was advisable for certain consumers such as pregnant women 
and children of less than 12 years.  It was the EU view that health warnings included in labels of 
drinks with caffeine constituted a sufficient means to achieve the legitimate objective of protecting 
human health.  The EU delegate requested Mexico to  provide the scientific information justifying the 
sale prohibition of drinks with ca ffeine to individuals of less than 18 years old and to update the 
Committee on the state of play of this draft decree and its TBT notification timeline. 
224. The representative of Mexico explained that the Mexican Secretary of Economy had received, 
on 27 September 2011, a communication from the Ambassa dor of Austria about the concerns that the 
draft decree relating to warning labels and the establishment of caffeine levels w ould be approved 
without discussion and review of available scientific information.  She informed delegations that the 
related official Mexican standard (NOM- 218-SSA1-2011) on non-alcohol aromatized drinks, 
including concentrated products used to prepare th em, had been published in the Official Journal on 
10 February 2012 and specified sanitary requirements as well as testing methods including technical requirements, warning legends and labe lling of drinks with added caffeine.  It was Mexico's view that 
the elaboration of this standard complied with Artic le 2 of the TBT, including the notification of the 
draft under G/TBT/N/MEX/207 on 19 January 2011. 
225. She confirmed that on 31 January 2012 the Federal Commission for the Protection against 
Sanitary Risks (COFEPRIS) provided the Austrian Em bassy in Mexico, the interested firm and the 
EU focal point with the scientific evidence used to justify the requi rements included in the official G/TBT/M/56  
Page 50  
 
  Mexican standard and the draft decree.  With respect to the draft decree amending the General 
Mexican Health Law, she confirmed that the Committees of Health and Legislative Studies of the Chamber of Senators had presented the "Opinion of  the Joint Committee on Health and Legislative 
Studies on the Draft Minutes of the draft decree amending and adding vari ous provisions of the 
General Health Law, in terms of  drinks with added caffeine." 
(xxxix)  Korea – National Tax Service Notice 2011-17 (Requirements for Radio-Frequency 
Identification Tags for Imported Whiskeys) (
G/TBT/N/KOR/338)  
226. The representative of the United States considered  that there were less costly or less 
burdensome methods to achieve Korea's objectiv es of ensuring brand authenticity, preventing 
counterfeiting and providing information to the aut horities on tax payments.  She asked if Korea was 
considering working with a prototype system befo re the implementation date.  Was Korea concerned 
that this measure could send a precedent and was it considering applying RF ID tracking to other 
products in the future?  Since counterfeit whisky did not pose a significant risk to safety and human 
health, she requested clarification on the rationale of applying these new requirements, as opposed to 
other requirements, to whisky.  Finally, she requested more information on the testing fees. 
227. The representative of the European Union recalled that her delegation had submitted 
comments to Korea on this notification on 29 February 2012 and was waiting for Korea's reply.  
While the EU supported appropriate  counterfeiting measures, it wonde red whether RFID tagging was 
the most appropriate and cost-effective method.  Pr oducts were invariably marked with the producer's 
lot code; in the event of any query, the lot or batc h from which the whisky came could be traced back 
to the producer.  Therefore, prohibiting the import of products without the producer's lot code would 
be an important step towards counterfeiting preven tion.  Korean authorities could also require all 
shipments of whisky to be accompanied by the Certif icate of Age or Origin issued by the authorities 
in the country of origin as proof of their authenticity.  
228. This measure could bring financial and logi stical burdens to small European whisky 
producers that exported to Korea, or that sought to enter the Korean market.  In addition to set-up and 
unit costs, there were other practical difficulties.  The EU suggested that Korea consider making RFID 
tagging voluntary for imported bottled-at-origin whiski es, or that companies exporting below a certain 
threshold, for instance under 5 per cent of the Korean  whisky market, be exempted.  Furthermore, the 
tags should be allowed to be  affixed either at the exporter's choi ce.  For bottles sold in cartons, the tag 
should be allowed to be placed on the carton.  Fi nally, the EU asked why whiskey, a product which 
was almost entirely imported in Korea, was subject  to treatment different from other spirit drinks. 
229. The representative of Korea recalled that his G overnment had notified the regulation on 28 
November 2011.  Its purpose was to enable Kor ean consumers to use mobile phone technology to 
verify the brand authenticity of each bottle of wh iskey being purchased, as well as to prohibit tax 
evasion related to whisky transactions.  It came into effect on 1 October 2011, and presently applied 
only to domestic whiskey in six areas of Korea, in cluding Seoul, Gyeonggi Province and Jeju Island.  
As of 1 October 2012, it would apply to all importe d and domestic whiskey across the country.  The 
reason for introducing RFID tags instead of barcod es was that RFID provided unique information for 
a specific bottle of whisky rather than a group of similar products.  Regarding cost increase concerns, 
Korea said that it would provide tax reduction as compensation.  The Korean authority had also 
provided scanning equipment to manufacturers, importe rs and distributors, and considered providing 
it to foreign manufacturers as well.  As for techni cal issues such as the possibility of malfunction or 
the difficulty of tagging very small bottles, the Kore an authority would allow the exemption of tags 
with prior-approval from competent authorities.    G/TBT/M/56  
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  (xl) Argentina – Resolution 453/2010 establishing m echanisms in order to eliminate dangers 
arising from the use of inks with a hi gh lead content in graphic products  
230. The representative of the United States had prev iously expressed concern that this regulation 
appeared to apply to foreign producers only, and th at Argentina's testing capacity was insufficient to 
perform all the required testing.  This, coupled with  the inability to test these products in the country 
of production, would lead to significant delays, co st and burdens for industry.  She asked whether 
Argentina would accept certification by internationa lly accredited laboratories outside of Argentina 
and requested that Argentina consider postponing implementation or not enforcing temporarily the 
requirements in the regulation.  Her delegation would submit comments on the regulation and sought 
discussion on the regulation.  Her delegation request ed postponing implementation so that Argentina 
could take discussions into account when reformulating the measure. 
231. The representative of the European Union supported the US concerns, noting that 
"Disposición N° 26/2012", issued on 5 March 2012, implemented Resolution 453 and had not been 
notified to WTO members.  The EU understood that only 2 Argentinean laboratories had been approved for carrying out the tests for the required ce rtification for printed graphic products.  The EU 
requested information on how Argentina would en sure the necessary capacity to handle the high 
number of potential requests.  She asked if test reports, carried out in European internationally 
accredited laboratories, would be accepted by the Argentinean certification body for the purposes of 
issuing compliance certificates.  If not, she asked for ju stification as to why tests needed to be carried 
out locally. 
232. The representative of Argentina informed the Committee that Argentina had notified a 7th 
addendum to this notification on 14 March 2012.   Resolution N° 453/2010 gave the National 
Direction for Internal Commerce the power to di ctate the pertinent measures for interpreting, 
clarifying and implementing the Resolution.  Ther efore, the National Direction has initiated the 
issuance of regulations for an effective and effici ent implementation and appl ication of the regime 
established in the Resolution.  The 7th addendum  established a transition period in which the 
Argentinian Government would accept a sworn declar ation made by the producer or importer that 
ensured that the product, or group of similar pr oducts, complied with the applicable norm, ASTM 
(ASTM D 3335-85a).  The National Direction for Internal Commerce continued to work on the pending issues that required implementation, inte rpretation or clarification in the Resolution. 
(xli) China – Specification for Import and Export of Food Additives Inspection, Quarantine and 
Supervision (2011 No. 52) - Disclosure of formulas for imported food additives  
233. The representative of the United States had had constructive bilateral discussions with China 
and she provided an update.  The three Chinese measures related to labelling are:  the 2009 Food 
Safety Law, the 2010 Chinese Standard for th e Labeling and Prepackaged Foods, and the 
2011(AQSIQ) Specification No 52 that addressed specifically Food Additives and required the 
disclosure of formulas which was inconsistent with  CODEX guidance in this area and is a serious 
concern for the US.  The Food Safety Law included a provision for prepackaged foods to list the 
ingredients in a table.  In bilateral discussions, Ch ina noted an agreement with the US that the Food 
Safety Law did not require a formula disclosure.  This interpretation was consistent with the Chinese 
Food Safety Law and the 2010 Standard for the Labeling of Prepackaged Foods, the latter being 
consistent with Codex Standard  for the Labeling of Prepackaged Foods, i.e. how to provide 
information on ingredients on labels. 
234. Her delegation was concerned that (AQSIQ) sp ecification No 52 for Food Additives appeared 
to go beyond the requirement for ingredient lis ting contained in China's 2010 Standard for the 
Labeling of Prepackaged Foods .  US authorities ha d received repeated reports that US industry had 
been asked to declare the amount of food additiv es in a manner that was equivalent to formula G/TBT/M/56  
Page 52  
 
  disclosure.  Chinese authorities had requested percen tages in the content and dosages of additives in 
contrast to a simple listing of ingredients.  This  went beyond the ingredients table approach contained 
in the Codex Standards as well the approach cont ained in the Chinese 2010 Standard for Prepackaged 
Foods and the interpretation of the 2009 Foods Safety Law provided by China in bilateral discussion.   
235. Her delegation accepted China's invitation to e ngage on these technical issues and had started 
by identifying the specific discr epancies across the measures as we ll as their application.  She 
suggested issuing interpretation guidance documents  on these measures to provide certainty to US 
exporters that formulas would not be requested for disclosure. 
236. The representative of the China said that the US' concerns had already been addressed in 
previous bilateral and TBT Committee meetings.  China reiterated that this "Specification" was 
mainly a consolidation of China's previous provisi ons on food additives specified in the relevant laws 
and regulations, which were being currently implem ented.  The requirements on mandatory listing of 
ingredients or components were not new; they had already been specified in Article 42 of China's Food Safety Law, which had been notified to the WT O years ago.  The US concerns raised at this 
meeting could be a misunderstanding of the Chin ese measures.  China would welcome information 
from the US on any possible inconsis tencies across the Chinese measures. 
(xlii) 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 
237. The representative of the United States had hi ghlighted concerns at the last Committee 
meeting over this draft voluntary standard.  She unde rstood that the draft had been released for public 
comments for a period of 30 days by a standardizati on institute under China's Ministry of Industry and 
Information Technology (MIIT), and the China Elect ronics Standardization Institute, in conjunction 
with another standardization body, the China Na tional Information Security Technical Standards 
Committee (TC260, Working Group 5).  Since the l ast meeting, US indus try had noted several 
positive improvements in the recent revisions, such  as removing consumables from the product scope 
and the narrowing of applicable encryption re quirements to exclude non-sensitive data.   
238. Her delegation, encouraged China to use the rele vant international standards with a view to 
harmonizing conformity assessment procedures on as wide a basis as possible and, where appropriate, play a full part in the preparation of guid es and recommendations for assessment procedures by 
international standardizing bodies. She was concer ned about China's plans to implement a national 
voluntary standard for wireless Local Area Network (L AN) devices, which appeared to diverge from 
an existing international standard, IEEE 802.11n.  On 13 February 2012, China's Ministry of Industry 
and Information Technology announced on its website the finalization of the standard.  The US was 
concerned that the standard may be incorporated into type approval, CCC mark registration or other 
certification processes.  She encourag ed China to include all interested  parties in the development of 
these central government standard and conformity assessments procedures, and urged China to notify 
the draft of the new conformity assessment procedures, when available, so all WTO members could 
comment and their comments be taken into account. 
239. 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 international practice.  He 
hoped that the comments submitted by foreign industri es would be reflected in the final drafts, and 
requested China to provide more information on the implementation of recent drafts, including the 
office device standards, which applied to each Member’s demands. 
240. The representative of the European Union supported the US and Japanese statements.  G/TBT/M/56  
 Page 53 
 
 
  241. The representative of China informed the Committe e that this was a voluntary standard that 
had not yet been issued.  It had been set to ensu re the security of user information stored on office 
devices.  During drafting, China had taken into acc ount relevant internationa l standards as well as 
China’s national conditions.  A dditionally, discussions on some tec hnical concerns with the United 
States Information Technology Office (USITO) and other stakeholders took place.  UHT and EUHT 
(Ultra High Throughput and Extra Ultra High Throughput) were put online from 10 - 25 August 2011 
to solicit comments from Members and observers of China Communications Standards Association.  
Nokia, VimpelCom, Motorola, Intel, Cisco, Sony Er icsson, Sony and other companies participated.  
They were again posted online from 20 September to  4 October 2011 to solicit public opinions.  On 
13 February 2012, UHT and EUHT were formally is sued.  From 20 September 2011 to 13 February 
2012, MIIT had been open to comments from USITO, the European Chamber of Commerce in China, 
Nokia, Intel, CIAJ22, JEITA23, the Korean Chamber of Commerce in China and Euro Digital; 33 
comments had been received and taken into account.  UHT and EUHT made a complete WLAN system with a physical layer, security protocol, internet management and other technical contents, which enabled UHT and EUHT to support WLAN by itself.  UHT and EUHT could be developed 
together with other WLAN technologies like WIFI .  They were implemented as a non-mandatory 
standard to promote innovative technology a nd the WLAN industry, and to better satisfy 
telecommunications demand from the general public.  He added that ISO/IEC standard 802.1/b/g had 
also been adopted, and 802.11ac was in the draf ting phase.  China would monitor development of 
these processes. 
(xliii)  Indonesia – Technical Guidelines for the Impl ementation of the Adoption and Supervision of 
Indonesian National Standards for Obligatory Toy Safety  
242. The representative of the United States had prev iously raised her delegations concerns with 
the May 2010 adoption of the toy safety standard  based on the SNI 8124, in particular over the 
conformity assessment procedures for the toy safety standards.  She urged Indonesia to notify any 
draft conformity assessment measures to the WTO,  and to enable the receipt of comments from 
interested parties.  It was important to accept t est results from qualified bodies accredited by the ILAC 
MRA as a trade facilitative measure in implemen ting any conformity assessment procedures.  She 
asked for an update on this measure. 
243. The representative of the European Union requ ested an update of the expected timeline for 
the finalization of the draft conformity assessment procedures.  He hoped that the process leading to 
the finalization of this measure would be conducte d in a transparent and open way allowing for a 
meaningful opportunity for stakeholders to provide input.  There was some concern regarding the 
introduction of mandatory testing.  In light of a perceived insufficient laboratory capacity in Indonesia, the EU requested that test results fro m foreign laboratories accredited by signatories of 
ILAC MRA be accepted as a trade facilitative measure. 
244. The representative of Indonesia informed the US and the EU that the regulation was still in a 
developing stage and that both countries' issues woul d be taken into consideration in the finalization 
of the regulation.  Subsequently, Indonesia would notify the regulation to the WTO.  He welcomed 
further bilateral discussions on this with both countries.   
                                                      
22 Communications and Information Network Association of Japan. 
23 Japan Electronics and Information Technology Industries Association. G/TBT/M/56  
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  (xliv)  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 and G/TBT/N/MEX/206/Add.2) 
245. The representative of the United States said that  she would convey to her capital technical 
information received in a bilateral meeting w ith Mexico's National Water Commission.   
246. The representative of Mexico confirmed, throug h the National Commission of Water, that it 
had never denied the certification of polietileno pipes of high density and structured walls.  Mexico 
had insisted on the application of ISO 21138 in co nformity with the TBT Agreement.  Mexico had 
informed the US, in bilateral meeting the previous  day, about the following options for accepting such 
products:  a) products had to comply with ISO 21138 ; b) products had to comply with the US norm 
ASTM F 894; or, c) products had to comply w ith norms ASTM F2762 and F2764 once the relevant 
US authorities accepted them for building sanitary dr aining.  Her delegation was open to analysing 
other Member's standards.  Likewise, th e Official National Norm NOM-001-CONAGUA-2011, 
"Sistemas de agua potable, toma domicilia ria y alcantarillado sanitario-Hermeticidad-
Especificaciones y métodos de prueba", had been published in the official national newspaper on 17 
February 2012; this norm integrated relevant elements of the ISO sta ndards.  This draft regulation was 
submitted to the Committee on 18 January 2011 (G/TBT/N/MEX/206) for comments from other Members, and was officially published on 17  February 2012 (G/TBT/N/MEX/206/Add.2).  
247. In conformity with Article 2.7 of the TBT Agreement, the present regulation contained a 
paragraph in Article 5 establishing that imported products used for building potable water systems, 
domestic consumption and sanitary draining coming in  from free trading partners, were allowed to 
apply relevant specifications contained in the norms  of the country of origin, provided they were 
aligned and complied with the objectives of qualit y and security of these products, as defined in 
Mexican norms and in the previously mentioned inte rnational norms.  Therefore, as an alternative to 
NOM-001-CONAGUA-2011, the National Water Commission accepted foreign norms from the US and other trading partners that so requested, as e quivalent standards as long as they complied with the 
performance and quality conditions required for sanita ry draining.  The Commission was elaborating 
a procedure on how to fill in corr esponding petitions and how to satisfy the requirements.  In order to 
ease the situation, Mexico may limit the requireme nts to the following conditions: a) products of 
importation should have a pplied the relevant norms of the country of origin, and shown a 
corresponding laboratory report, b) products should have been used and authorized by competent 
authorities, and c) products should come with a system of quality assurance.  
(xlv) El Salvador – Law on hygienic production of m ilk and milk products and the regulation of 
their sale 
248. The representative of Mexico shared its concerns with this law with El Salvador, in particular 
Article 21, on the commercialization of milk, crea m and cheese for the reconstitution and re-mixing of 
milk powder.  This Article banned the trading of milk, cream and cheese with additives.  Mexico had 
asked El Salvador to allow for the exportation of  products elaborated with milk powder and/or 
vegetable fat or starch, but had received a negative re sponse.  Mexican authorities considered that this 
ban acted as discriminatory and that it may have vi olated the TBT Agreement.  Mexico requested a 
formal response from El Salvador with scientific evid ence on the need for implementing this measure.    
249. The representative of El Salvador reported th at since the November 2011 meeting, Mexico 
and El Salvador had been in bilateral contact.  Th is law was meant to ensure human health and was 
based on a number of relevant inte rnational Codex standards.  The pr ovisions of this law did not make 
any distinction between the national and foreign ma rketing of milk, cream and cheese resulting from 
the combination of powdered milk or the use of additives.  Thus, it was not discriminatory and was  G/TBT/M/56  
 Page 55 
 
 
  consistent with Article 2.1 of the TBT Agreemen t.  His Government would continue bilateral 
discussions with Mexico so as to dispel any remaining concerns.   
(xlvi)  European Union – Draft Commission Regulation implementing Directive 2009/125/EC of the 
European Parliament and of the Council w ith regard to ecodesign requirements for air 
conditioners and comfort fans ( G/TBT/N/EEC/362)  
250. The representative of China noted that the EU  regulation No 206/2012 had been issued in the 
EU Official Journal EU on 10 March 2012 and w ould enter into force on 30 March.  Efficiency 
requirements in phase one  would be implemented on 1 January  2013.  However, the related EU 
testing standard for judging compliance with the regulation had not yet been formulated, and the 
relevant ISO Standard was still under formulation.  Therefore, it was a great challenge and burden for 
enterprises to adapt products to the regulation within only nine months as specified in the regulation.  
Moreover there was no criterion to judge such comp liance.  The delayed issuance of the testing 
standard caused much inconvenien ce to enterprises in conformity assessment and created additional 
trade barriers.  China hoped that the EU would provide the timeline for the formulation of the 
standard of testing method of air conditioner.  In addition, China encouraged the EU to follow other 
Members' practice (e.g. the US and Australia) by issuing regulations on energy efficiency and testing 
standards at the same time, when preparing eco-desi gn regulations for energy using products.  China 
would welcome the EU to issue  testing methods prio r to the development of energy efficiency index. 
251. The representative of the European Union stressed  that she was aware of the importance of 
the existence of test and calculation methods for the ecodesign requirements. The EU system required 
that the European Commission request one of the European Standardization bodies (CEN, 
CENELEC, ETSI) to develop standards specifyin g the relevant measurement and calculation 
methods. She informed that a mandate to that effect  had been issued to the European Standardization 
bodies, CEN, CENELEC and ETSI on 18 February  2011. Pending the elaboration of those 
measurements and calculation procedures, the Eu ropean Commission was also in the process of 
publishing a communication on transitory measurement  methods, developed with stakeholders. It was 
therefore ensured that the necessar y measurement methods would be available when the Regulation in 
question would be applicable. 
(xlvii)  Norway – Proposed regulation concerning sp ecific hazardous substances in consumer 
products ( G/TBT/N/NOR/17/Rev.1)  
252. The representative of Japan examined the Norweg ian draft and had some concerns expressed 
in its comment submitted.  Because it was difficult to  distinguish between natural lead, which is not 
derived from manufacturing process and hence unavoi dably included,and that from manufacturing 
processes, the Maximum Concentration Value (MCV) should be set at levels that would be technically possible to protect human health and the environment.  Risk assessments consisted of 
three key items: hazard identification, dose-respon se assessment and exposure assessment.  In Chapter 
2.4, some hazard identification data and hazard cl assification results under EU CLP regulation were 
mentioned.  However, there were no dose-respon se assessment and exposure assessment data.  The 
lack of analysis of two key items showed that  the risk assessment on lead in Chapter 2.4 was 
incomplete. It should have included the following items :  a) the nature of the most significant hazard 
(primary hazard); b) the level of exposure that w as foreseeable from the envisaged sources, and c) 
whether the envisaged exposure was acceptable or manageable. 
253. The representative of Norway recalled that the original Norwegian notification from 2007 
was related to the regulation of 18 hazardous subs tances in consumer products .  This regulation had 
not entered into force on 1 January 2008 as proposed .  The draft regulation had undergone a process 
of review, and as recounted at earlier TBT-meetings , 8 of the substances were removed from the list 
as a result.  It was then concluded in 2010 that four of the remaining ten substances were to be G/TBT/M/56  
Page 56  
 
  prioritized for regulation at this point in time.   Having taken into account the comments received, 
revised proposals for regulation and impact assessment s were made for the four substances that Japan 
had referred to in its comments: pentachlorophenol (PCP), lead, medium-chain chlorinated paraffin 
(MCCPs) and perfluorooctanoic acid (PFOA).  As provi ded for in Article 2.2. of the TBT Agreement, 
a risk assessment had been pe rformed for the 4 products which was publically available on the 
website of the Climate and Pollution Agency ( http://www.klif.no ).  She would forward it to Members.  
The revised proposals had been notified to the EFTA Surveillance Authority in December 2010 and 
sent for public consultation in the EEA area.  They  were the subject of a national public hearing 
(February 2011) and an additional notification in December 2011 (G/TBT/N/NOR/17).  Norwegian 
environmental authorities were in the process of reviewing the proposals in light of the comments 
received.  In the revised notification, 1 July 2012 w as proposed as date of entry into force.  However, 
this date would likely not be met.  The reviewi ng process was complicated and resource-consuming; it 
was unclear when the regulation would be adopted  and brought into force.  Comments from Japan, 
received on 8 February were res ponded to on 22 February 2011. Additionally, a useful bilateral 
meeting was held and authorities had taken careful note of Japan's comments.  
(xlviii)  India – Toys and Toy Products (Compulsory Registration) Order  
254. The representative of the United States understood that the Ministry of Consumer Affairs' 
Bureau of Indian Standards (BIS) was to issue a new Toys and Toy Products (Compulsory 
Registration) Order.  The US supported the protection of human health, in particular, children's health 
in relation to toys and toy products.  However, sh e reiterated her delegation' s previous concerns.  
Though India considered it premature to comment on this unreleased order, the US believed that early 
identification of potential issues supported the developm ent of quality regulations that could facilitate 
trade, as stipulated by the TBT Agreement.  She ur ged India to notify the proposed regulation so that 
Members could provide comments, and she requ ested an update on the measure's timeline. 
255. The representative of the European Union recalle d previous concerns raised regarding the 
potential new measure that would introduce mandatory  testing carried out domestically, coupled with 
registration procedures that would imply the disclos ure of extensive information by the applicant 
manufacturers.  He requested an updated timeline for the proposed measure and information on the 
handling of the procedure by the Indian authority.  He supported the US request for a transparent and open process for Members to provide input at an early  stage in order to address the potential concerns.  
256. The representative of India ensured both delegati ons that the ASTM and the EU standards for 
import of toy products were taken in to consideration.  Extensive cons ultations had been held by the 
Department of Industrial Policy and Promotion in which the issue had been raised by both 
delegations.  When the draft guideline was finali zed, it would be notified to the TBT Committee.  
(xlix)  France – Loi No. 2010-788:  The National Co mmitment for the Environment (Grenelle 2 
Law)  
257. The representative of Argentina reiterated his de legation's concerns with the Grenelle 2 Law 
regarding transparency, discrimination, lack of pr edictability, exclusion of third party opinions, and 
subsequently, inconsistency with WTO rules.  The representative highlighted th ree aspects of the lack 
of transparency:  i) the draft law was not notified to  the WTO;  ii) the lack of notification removed the 
possibility for Members to submit comments and have th em considered prior to the issuance of this 
law; and  iii) answers were not provided to his delegation's questions of June and November 2011.  
An eventual implementation of this  law would generate discriminator y treatment that would alter the 
conditions of competition between similar products. But similar produc ts should not be differentiated 
on the basis of unrelated processes and production methods, as it was indicated by this law.   G/TBT/M/56  
 Page 57 
 
 
  258. According to the EU, addressing these issues  in the TBT Committee was premature.  
Nonetheless, Argentina considered that the fact this  law was in a testing phase, should not impede the 
following clarifications:  a) did France have consu ltations with interested and potentially affected 
parties, particularly from developing and least -developed countries;  b) would this law cover 
industrial and agricultural products;  c) which me thodology of greenhouse gas quantification would be 
employed by the law; and,  d) had special and differential treatment clauses been envisaged, as 
stipulated in Article 12 of the TBT Agreement (e .g. measures to address the development, financial 
and commercial needs of developing countries and to avoid negative impacts upon their exports)?  
From the EU's answers provided in June and Nove mber 2011, Argentina inferred that there would be 
no mandatory labelling on carbon footpr ints of products and their packaging, on the consumption of 
natural resources nor on their impact on the enviro nment attributable to these products during their 
lifecycle.  Likewise, from the EU's lack of answ ers to the following topi cs, it was inferred that 
developing and least-developed countries were not c onsulted; that the law would not apply to their 
agricultural  and industrial produc ts; and, consequently. the law would not require a mandatory nor 
voluntary labelling on carbon footprints during the pilot phase nor at the end; and that the calculation 
methodology of carbon content of products was not defined. Neither was de fined to which products 
from developing countries this law would eventually appl y.  He reiterated the need to clarify whether 
a regulatory impact analysis (RIA) had been perform ed, and he stressed the need to notify this law, 
bearing in mind that the fact of having been in  a testing period did not exclude France from its 
obligation of notification.. 
259. The representative of the European Union highlight ed that she had explained at the last two 
meetings that the Grenelle 2 law did not require  mandatory environmental labelling.  It foresaw 
carrying out only a trial phase. This provision ha d therefore not to be notified under the TBT 
Agreement, contrary to what Argentina seemed to  imply. The trial phase aimed at contributing to 
discussions on environmental labelling that reflected  the concerns and issues expressed in numerous 
national and international bodies, in relation to th e need and means to inform consumers about the 
environmental impacts of their choices.  The French authorities wished to  play a leading role in the 
thinking about environmental labelling mechanisms and hoped to participate meaningfully in the 
compilation of advanced techniques and me thodologies using scientific data underlying 
implementation of such provisions. They also pa rticipated actively in the development of an 
international standard for the carbon footprint of products (ISO 14067).  
260. Given the need to test the calculation me thods and implementati on of environmental 
labelling, France had decided to pursue this tria l to assess the feasibility of such measures with 
volunteer companies.  168 companies from different countries had participated in this trial voluntarily and it was therefore not correct, as stated by Argentin a, that no consultation had been taking place.  
The EU was ready to provide inform ation about the trial as necessary, however, the results of the trial 
would not be known until the beginning of 2013.  
(l) United States – California Code of Re gulations: Chapter 53 Safer Consumer Product 
Alternatives (
G/TBT/N/USA/579 and G/TBT/N/USA/579/Corr.1)  
261. The representative of the European Union said that the proposed legislation laid down a 
complex system of chemical management that w ould encourage the redesign of consumer products 
and manufacturing processes.  The proposal seemed to be on hold since November 2010.  However, 
on 31 October 2011 the California Department of Toxic Substance Control published the draft 
regulations for Safer Consumer Pr oducts on its website for informal comments.  Main parts of this 
draft remained similar to the text that had been proposed in 2010.  The informal comments received 
were published on the same website on 20 January 2012.  She asked what further steps would be 
taken with regard to this draft and if a formal  public consultation would be carried out.  The EU 
believed that the draft contained technical re gulations and should be  notified under the TBT 
Agreement.  It laid down rules to set up different  lists of chemicals and set out the precise criteria G/TBT/M/56  
Page 58  
 
  according to which the lists had to be prepared.  In  case a chemical was on one of these lists, the draft 
foresaw important consequences for economic ope rators, such as the obligation to carry out 
alternative assessments that would lead to a red esign or a reformulation of a consumer product, a 
removal of a product, an obligation to set up end-o f-life management programs or even product sales 
prohibitions.  While the EU clearly shared the obj ective of the protection of human health and the 
environment, it wanted the possibility to comment  on the draft and to share with California the 
experience that the EU had gained from the applica tion of the REACH Regulation.  Finally, she asked 
if any feasibility and impact assessments had been carried out by California. 
262. The representative of the United States considered  this regulation to be neither a technical 
regulation nor a conformity assessment procedure un der the meaning of the TBT Agreement.  There 
was no draft regulation that specified a particular  characteristic or related processes or production 
method for any products; nor did the regulation call for a particular size, shape, design, function or performance for any product.  The legislation calle d on California's Department of Toxic Substances 
Control (DTSC) to establish a process by which they  could request information from stakeholders on 
particular substances.  Regulators frequently calle d for data and other ty pes of information but 
stakeholders were not automatically subjected to  notification requirements.  She understood that 
DTSC would likely publish proposed measures in the late spring or early summer and provide a comment period.  The EU, like all stakeholders, w ould provide input through the process of domestic 
comments.  If any subsequent measure fell under the TBT requirements, they would be notified.   
(li) Brazil – Health Products (
G/TBT/N/BRA/328)  
263. The representative of the European Union reite rated concerns regarding 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.  A GMP certificate would be issued after the Brazilian Health Surveillan ce Agency (ANVISA) inspected the manufacturing 
premises.  In the June 2010 TBT Committee meeting, Brazil indicated that inspections were being 
carried out in a timely manner with no trade disrup tions.  However, according to information available 
to the EU, a significant number of manufacturing sites had submitted an inspection request with no 
inspection taking place.  It appeared that the el apsed period between the request and the inspection 
was on average 20 months.  She asked Brazil to update the Committee on the number of facilities for 
which ANVISA had completed audits and issued GMP certificates, and those for which audits had 
been requested but not yet completed.   
264. She urged ANVISA to take effective measures to reduce current backlog and guarantee that 
inspections to foreign manufactures would be carried out within a period of three months, particularly 
due to the relatively short life span of medical de vices.  If it was difficult to comply with reasonable 
inspection deadlines, ANVISA could take into acc ount Quality Management System audits conducted 
by accredited auditing bodies (e.g. EU Notified Bodies).  Also, Brazil could consider accepting 
products that had been authorized in the EU or in other major markets, pending the completion of 
ANVISA inspections, or consider subcontracting overseas inspections to accredited auditing bodies 
such as the EU Notified Bodies.  Finally, to incr ease transparency and predictability, ANVISA could 
regularly inform operators waiting of the expected timing for completion of their registration dossier. 
265. The representative of Brazil said Brazilian authorities were aware of the situation and 
ANVISA had been working to increase the number of  GMP inspections.  Several measures had been 
adopted or were under considerati on to review procedures and use resources more efficiently.  The 
representative announced that in 2009, when the syst ematic inspections for medical devices began, 
ANVISA conducted 39 inspections.  In 2011, 226 insp ections were conducted, an increase of 579 per 
cent.  Some of the measures adopted by ANVISA to  improve its inspection capacity included opening 
a public consultation number 62/2011, notified as TBT/N/BRA/454, to define criteria for improving 
the efficiency of international inspections.  Another was the establishment of new procedures for  G/TBT/M/56  
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  prioritizing inspections, such as enabling inspection t eams sent to a certain region to conduct all of the 
inspections requested by companies of that region.  It also hoped to establish a list of priority products 
for inspection, considering the risk  of lack of supply in the Brazilian market, and ANVISA sought to 
make the best use of its human resources by reallo cating experts and forming new teams of inspectors.  
Another measure considered was enabling local  Brazilian governmental experts to work as 
international inspectors.   
266. Brazil remained open to the possibility of prom oting mutual recognition agreements in this 
area, or other arrangements that could expedite the certification process such as confidentiality 
agreements between ANVISA and the competent author ities of other Members.  Finally, Brazil joined 
the International Medical Device Regulator’s Fo rum (IMDRF), with Australia, Canada, the USA, 
Japan, the EU and the WHO among others, to work on regulatory convergence with the participating 
regulatory authorities in the Forum so as to impr ove its regulatory framework on medical devices. 
(lii) India – Prevention of Food Adulteration (G/TBT/N/IND/34) 
267. The representative of the United States had concerns about the Prevention of Food 
Adulteration Act (PFA) and the status of its require ments, particularly those in the 2011 Food Safety 
and Standards Regulations (FSSR).  Did these require ments replace those of the PFA Act?  She asked 
for the expected date of enforcement of complianc e with the labelling provisions in the FSSR.  Both 
measures appeared to be in force which created c onfusion in how to handle their differences.  She 
noted that the US' comments on the FSSR had not b een taken into account in the final measure and 
she was particularly concerned about the lack of consistency with in ternational standards. 
268. In November 2011, India indicated that the final regulation had taken into account India's 
specific needs.  The US was interested in explor ing what those needs were with respect to Codex 
recommendations and guidelines, for example:  a) why did India require both a date of manufacture 
and production, along with additional certification of shelf life for certain perishable products, when 
Codex recommended only the date of minimum durabilit y;  b) why did India require for irradiated 
foods a date, license number of the irradiation un it, and the purpose of the treatment, when Codex 
only stipulated a statement or use of a symbol to alert consumers;  and, c) why did India require a 
special declaration of colors and flavors when Code x required declaration in an ingredients list.  The 
US questioned India's requirement to add the da te of production to distilled spirits when lot 
identification numbers already provided the informat ion needed if product recall was necessary.  She 
urged India to remove this labelling requirement  for distilled spirits as well as the listing of 
requirements for alcohol.  The US de legate was unsure as to  why India continued to require the listing 
of ingredients for alcohol as international practice did not require an ingredient list for non-nutritive 
products as it provided little useful information to  the consumer.  Lastly, she noted that India's 
responses had not provided additional, reliable info rmation on how the elements of this measure 
improved safety, efficacy, and product quality, or how they met the specific needs of India.   
269. The representative of the European Union w as concerned that procedurally, since the 
regulation contained several TBT-related aspects such as labelling and packaging requirements, it 
should be notified to the TBT Committee.  Substan tively, she asked whether India would maintain the 
current temporary practice of allowing labelling to  take place in customs bonded warehouses, as an 
alternative to labelling in the country of origin .  This procedure allowed for duly informing the 
consumer and was more convenient for market ope rators.  In the case of labelling requirements 
applicable to alcoholic beverages, the EU continue d to seek an exemption from indicating the date of 
manufacture, and the acceptance of "single ingredient st atus" for the list of ingredients.  The EU also 
suggested that India align its legislation to Code x Alimentarius standards, such as those on food 
labelling, on cheese and on natural mineral water and bo ttled water.  Finally, the EU had learned that 
India was drafting a new technical regulation dedicate d to alcoholic drinks and she invited India to 
inform the Committee of the state of play of th is draft and the timeline for a TBT notification. G/TBT/M/56  
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  270. The representative of India explained that the new Food Safety and Standards Packaging and 
labelling regulations of 2011 replaces the old 2008 rules, many of which had been incorporated into 
the new regulation.  India had notified this to th e SPS Committee so that Members were aware of the 
specific regulation in place.  India was not aware of  the specific questions raised by the US because it 
did not have a bilateral discussion with the US.  He would communicate their concerns to his 
authorities for a response and would likely have some technical discussions with the US on this issue. 
271. In response to the EU's questions, labelling in capital letters had been established for better 
visual recognition.  While not aligned with Codex, this input was provided by Indian regulators.  He 
confirmed that these regulations applied to alcoholic  beverages under Rule 2.2. 2 of the regulation and 
flexibility in the regulations allowed for single ingred ient status to be acceptable.  However, a list of 
other ingredients shall be declared on the label fo llowing the relevant provision.  Finally, he was not 
aware of the new regulation on alcoholic beverag es mentioned by the EU but he would consult and 
revert to the EU on this.   
2. Follow-up 
272. The Chairperson referred to a Room Document (RD/TBT/3/Rev.1) containing a complete 
listing of all previously raised specific trade c oncerns in the TBT Committee.  She asked if any 
delegation wished to report on the status of previous ly raised concerns, includi ng with respect to the 
resolution of any such concerns.   
273. The representative of Brazil noted that his dele gation understood that this item of the agenda 
was there on a trial basis, and that his delegation was still reflecting on the utility of it.  In particular, 
Brazil had some doubts about the possible implication and value in classifying previously raised STCs 
as "resolved" or "unresolved".  Nevertheless, Brazil could support the idea that this agenda item could 
be used to provide Members with the opportuni ty to report on progress and other developments 
concerning such previously raised STCs. 
274. The representative of the United States was still reflecting on discussions that had taken place 
on this matter.  
275. The representative of the European Union noted that keeping track of the status of STCs was 
important.  Nevertheless, the EU considered that pr oviding a progress report that gave an exact picture 
of the status of an STC was, in most cases, a very  difficult exercise in the TBT area.  In virtually all 
cases that had been raised by the EU, he would not be able to provide a report that gave a clear 
reflection of the current status of the STCs.  Ne vertheless, the EU was not against the approach 
initially put forward by the Secretariat where some  categories would operate by default and other 
based on voluntary reporting by Members – but ther e needed to be only very few and clearly 
identified categories (active, inactive, etc.).  Also, it had to be the Member raising  the concern that did 
the reporting – and this would inev itably be a subjective assessment. 
276. The representative of Canada said that providi ng updates on previously raised STCs could be 
a way of flagging continued "concern" while not  necessarily re-raising the issue for discussion (if 
there was nothing new to add), thereby promoting effi ciency.  There were also situations, Canada had 
noted, where a Member might raise a concern simply to  seek more information or clarification, and, in 
these cases, there might not actually be a problem to "resolve".  It was therefore perhaps not necessary 
to seek to capture the status of every  STC, but rather the Committee might consider a mechanism that 
would provide the Membership option to provide updates on status where relevant. 
277. The Chairperson noted that Members needed more time to reflect on this matter.  G/TBT/M/56  
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  C. EXCHANGE OF EXPERIENCES  
1. Good Regulatory Practice (GRP) 
278. The Chairperson recalled the recommendations  on good regulatory practice (GRP) contained 
in the Fifth Triennial Review (paras. 11 and 16 of G/TBT/26) as well as the recent discussions at the 
Workshop on Regulatory Cooperation between Me mbers (summarized in G/TBT/W/348).    
279. The representative of the United States introdu ced her delegation’s submission (a submission 
on GRP made on behalf of Member Economies24 of the APEC Subcommittee on Standards and 
Conformance (SCSC), contained in G/TBT/W/350).  She recalled that there had been significant support in the Fifth Triennial Review, for impr oving the implementation of GRP as a means to 
improve the ability of Members to meet their regulat ory objectives in a manner that facilitated and 
enabled greater trade and investment in their economies.  Many Members, across a wide spectrum of 
economic development and institu tional capacity, had expressed in terest in gaining a better 
understanding of:  (i) the body of practices and pr ocedures that were known to improve regulatory 
quality; (ii) how other Members had instituted these practices, including ho w practices could be 
adapted in diverse conditions; and, (iii) how  precisely GRP contributed to improving the 
implementation of the TBT Agreement. 
280. On the first point, the US was of the view  that the Secretariat’s compilation was a good 
starting point.
25  This needed to be a living document, revi sed periodically to incorporate experiences 
from WTO Members as well as from multilateral and re gional organizations, and other authoritative 
sources.  The compilation, as well as the above-m entioned summary report of the WTO Workshop 
also addressed the second point:  how Members had instituted GRP.  On the third point, the 
representative of the US recalled that during the Fifth Triennial Review, Mexico had expressly 
indicated an interest in the preparation of a guidance document on good regulatory practices that 
would include:  “(i) recommended procedures that will ensure effective comp liance with each of the 
substantive obligations laid down in the TBT Agreem ent, and (ii) examples of mechanisms for the 
fulfilment of such obligations.”26   
281. The idea put forward by Mexico had been discu ssed in the APEC Subcommittee on Standards 
and Conformance (SCSC) for some time.  In 1997,  the SCSC issued a short document "Guidelines for 
the preparation, adoption and review of technical regulations" which attempted to do this at a high-
level of generality.  At its 6th Conference on GRP in March 2011 co -sponsored by Japan, Malaysia, 
New Zealand, Peru and Singapore, SCSC members agreed to go further.  Thus a new study was conducted: "Supporting the TBT Agreement with GRP:  Implementation Options for Members".  This 
study was authored by a leading authority on regulatory reform, Mr. Scott Jacobs of Jacobs & 
Associates, in consultation and collaboration wi th SCSC members.  It benefited from the 
contributions of several Members, including Chile , Malaysia and New Zealand. Chile and Malaysia, 
for example, had stressed the importance of a ddressing the issue of how countries that do not 
currently have institutions or procedures in pl ace that support GRP can understand and evaluate the 
options for developing and implementing practices and procedures from the array of GRPs.  The 
study not only showed the relationship between various practices and procedures with creating a 
regulatory environment that facilitated trade and in vestment, but also pointed out the options that 
could be implemented both at low cost and yield si gnificant improvements in regulatory quality.  She 
                                                      
24 The APEC members are Australia, Brunei Darussa lam, Canada, Chile, China, Hong Kong China, 
Indonesia, Japan, Korea, Malaysia , Mexico, New Zealand, Papua New Gu inea, Peru, the Philippines, Russia, 
Singapore, Chinese Taipei, Thailand , Vietnam, and the United States. 
25 G/TBT/W/341, 13 September 2011. 
26 G/TBT/W/313, 9 June 2009, para 18. G/TBT/M/56  
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  said said that SCSC members believed that this stud y, referenced in G/TBT/W/350, was an excellent 
start in helping policy makers better understa nd the relationship between TBT and GRP.   
282. The representative of Mexico supported the idea of  developing a guide on GRP as a means of 
helping Members comply with the substantive pr ovisions contained in the TBT Agreement.  The 
guide could include recommended procedures for ea ch substantive requirement, as well as examples 
of mechanisms for compliance.  Mexico was of the view that it was particularly important to provide 
examples of such mechanisms and referred to, as an  example, the use of impact assessments to 
balance benefits against costs when considering th e need for government intervention. This could 
facilitate the work of developing countries, in particular the LDCs as well as recently acceded 
Members.  Mexico intended to make a submission on this subject shortly. 
283. The representative of Mexico also expressed her delegation's appreciation for the organization 
and conduct of the Workshop on Regulatory Co-ope ration, held in November 2011 (G/TBT/W/348).  
In her view, it was of important that the Committee continue to exchange experiences on this topic as 
this was key to increasing the competitiveness of Me mbers, and eliminate unnecessary costs.  Mexico 
suggested that the Committee develop a document c overing the results of the seminar and prepare a 
compilation on the various existing mechanisms in te rms of regulatory co-operation, such as in terms 
of exchange of information, MRAs, technical assistance agreements etc. 
284. The representative of the European Union expr essed support for the proposal to develop 
guidance on GRP.  He recalled that the Fifth Tr iennial Review had given the Committee a two-fold 
mandate: to identify  principles that were relevant for GRP and, to find examples of practices .  In the 
view of the EU there was now a substantial am ount of information on the table stemming from: 
individual papers submitted by Members, the outpu ts from the Workshops (summary reports) and the 
Secretariat’s compilation of sources of existing gu idelines of other international organizations.  
Hence, there was a need for the Co mmittee to shift its focus to effort s to extract those principles that 
were most relevant for the implementation on the TBT Agreement.  The EU intended to work from 
this material to try to identify, from its point of  view based on its own regulatory policy, the most 
relevant principles for GRP – this work was underway and a contribution was forthcoming.  
285. The representative of India noted that his de legation too was looking at making a specific 
submission on GRP, primarily by identifying the key elements of GRP – also considering the output 
from the recent Workshop on Regulatory Coopera tion between Members (G/TBT/W/348). This, he 
said, could be a good background in terms of guide lines for Members.  He cautioned, nevertheless, 
that whatever was being developed by the Committee needed to be fra med in terms of best endeavour 
language. 
286. The representative of Cuba also expressed he r delegation’s appreciation for the Workshop 
mentioned by India.  The exchanges during the Wo rkshop had had demonstrated the wide range of 
mechanisms that existed for co-operation in the area  of regulation. In addition, the exchange during 
the workshop, also reflected the importance and th e need to put together guidelines for GRP also 
specifically with respect to regulatory co-operation between countries. 
287. The representatives of New Zealand and Australia expressed support for the US proposal, 
noting that they too had been closely involved in GRP work within APEC and said that the 
Committee’s Sixth Triennial Review presented a good opportunity to bring in this body of work.  
288. The Chairperson said there was a general willi ngness to bring the Committee’s work forward 
on GRP in the context of the Committee’s Sixth Tr iennial Review, including by developing guidance 
in this area.    G/TBT/M/56  
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  2. Standards 
289. The Chairperson recalled previous work by th e Committee in the area of standards and in 
particular the recommendations contained in paragraphs 25-27 of G/TBT/26.  
290. The representative of India recalled that he had introduced his delegation’s submission 
(G/TBT/W/345) on international standard s at the last meeting of the Committee.27  He reiterated that 
the document considered the Committee’s 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")28, as well as the TBT 
Agreement’s Code of Good Practice.  The submis sion itself had been developed on the basis of 
discussions India had held with international standa rd-setting bodies in Geneva, as well with certain 
Members and regulators in India.  The paper was in tended to stimulate discussions in an area that was 
critical to the TBT Agreement.  In particular, standards-setting bodies had a different notion of the 
principle of consensus as compared to the WTO.  The definition of international standards is an important 
aspect and the only guidance available is the panel repor t on the EC-Sardines case wherein the Codex standard 
was stated to the relevant international standard since Codex figures in the SPS Agreement and participation is 
open to all Members of the WTO.  Also the issues of openness, eff ectiveness, impact assessments and 
coherence were very important.  In the area of development, he noted that many standard-setting 
bodies had action plans for developing countries and that was critical for participation of maximum 
number of developing countries in such bodies.  He  also drew Members’ attention to the proposed 
additional principles contained in the paper. The re presentative of India noted the concerns expressed 
by the ISO and IEC (as contained in a room document29) and asked them to explain how participation 
in the technical committees actually worked.  He also asked for clarification about the concern on 
“independent verification” (para 2 of the room document).   
291. The representative of Colombia introduced his delegation’s submission (G/TBT/W/351).  In 
this submission, Colombia encouraged Members to a ddress the issue of a definition of an international 
standard in the Sixth Triennial Review.  This woul d help overcome the ambiguity that existed in the 
TBT Agreement and that had been addressed by India.   Indeed, Colombia was of the view that the 
lack of clarity over whether a standard was “inter national” or not limited the use of international 
standards. The explicit designation of relevant bodi es – as had been achieved in the SPS Agreement – 
would facilitate the participa tion of developing countries and LDCs in the development of 
international standards. 
292. The representative of Mexico concurred that the lack of a definition on international standard 
generated problems in the interpretation of th e TBT Agreement, and therefore also in its 
implementation.  Mexico suggested that a defin ition be drafted based on the Committee Decision as 
suggested by India and that the Committee re view the principles contained therein.  
293. The representative of the United States said that the papers presented a number of important 
questions.  To begin with, it was important to un derstand just how national standards bodies operated, 
how they facilitated participation in technical co mmittees at the international level, how they 
performed outreach to stakeholders and how they inter acted with regulators.  Participation in technical 
committees (TCs) was critical and, in the US view, it could be important to further explore Members’ 
experiences in this regard.  In one sense, nati onal standards bodies were essentially libraries of 
standards: they were a resource for regulators – a nd this was relevant to the issue of how regulators 
knew what the “relevant” standards were.  She noted,  in this respect, that there was a broad diversity 
among Members on how national standards bodies wo rked.  In fact, for many Members national 
                                                      
27 G/TBT/M/55, dated 9 February 2012, paras. 285 and 286. 
28 The full text of this Decision is contained in Annex B of G/TBT/1/Rev.10, dated 9 June 2011. 
29 Subsequently circulated as G/TBT/GEN/129, dated 2 April 2012. G/TBT/M/56  
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  standards bodies were not governmental  bodies; hence there was a challenge of being an 
intergovernmental institution interacting with  essentially private sector bodies. The Committee 
Decision recognized this very clearly in that it did not tell international standards bodies  to be open, 
to be transparent, to be relevant,etc..  Instead it told WTO Members, in their capacity as participants  
in international standards bodies to  work towards these objectives.  Th is was an important distinction 
that the Committee needed to maintain.  
294. The US was, however, of the view that given the differences among Members, it would not be 
productive for the Committee to reopen the Committee Decision, or to try to readjust it.  The 
Committee Decision, as it stood, had led to signi ficant and robust reflection among an array of 
standardizing bodies as to what it meant to be “g lobally relevant” and to produce standards that 
facilitated international trade.  She stressed that it was not the US government that participated in 
these bodies, but industry players and private sector entities – the economic operators and stakeholders that had an abiding interest in the technical issues discussed.  While the US understood 
that the diversity of bodies could be source of confusion, the key issue was to focus on how to enable national standardizing bodies to fa cilitate this exchange among stake holders.  Again, GRP was key: 
how did regulators become aware of what tools (sta ndards) were available to meet their needs?  An 
important element was the promulgation of draft re gulations, public comment and feedback from the 
industry players and other affected stakeholders. 
295. The representative of the European Union stressed the need to be realistic and to stay focused 
on what could he achieved.  He recalled that at the last meeting his delegation had made a detailed 
statement in this regard.30 Like the US, his delegation had expressed some caution on whether the 
Committee could usefully spend time again on the Committee Decision and the definition of 
"international standard" – this wa s probably not going to be a fruitful discussion given the different 
views that existed.  On the other hand, there was a prospect for a useful discussion following 
paragraph 25 of the Fifth Triennial Review31 in focusing on the application  of the existing principles.  
There were two sets of principles.  First, tho se specifically targeting national and regional bodies 
(contained in the TBT Agreement's Code of Good Practice) and, second, those contained in the 
Committee Decision which focused on the development of international standards – and which were, 
in fact, an expression of good practice in standards development.   
296. The EU believed, and following the recommendations set out in the Fifth Triennial Review, it 
would be useful to have a discussion on the effectiv e application of the Code of Good Practice, and in 
particular the transparency aspects th ereto.  For instance, this could include giving full effect to the 
public enquiry stage in standards development, wh ich was a unique opportunity for those stakeholders 
who were not involved directly in standards develo pment to provide their input on draft standards and 
to have access to the full text of a draft standard before  adoption.  This was particularly important in 
those WTO Members where the regulatory system relied on standards as a basis for regulations, and when standards were almost invariably transformed into technical regulations.  Likewise, a discussion 
on the application of the six principles in the Committee Decision could also be useful.  Some 
standardizing bodies had made a genui ne effort to integrate these pr inciples as an expression of good 
practice in standards development in their own operating procedures – this debate was necessary 
before discussing whether or not the principles needed  amendment or revisiting.  In sum, the EU was 
of the view that too little was known about how these principles and the Code of Good Practice were applied and while the EU was willing to embark on  a discussion in this area, his delegation was not 
willing to contribute to a discussion on the definition of an international standard. 
297. The representative of India supported Colombia ’s submission and Mexico’s statement but 
said he remained perplexed at the last two in terventions. The whole discussion on international 
                                                      
30 G/TBT/M/55, dated 9 February 2012, paras. 290-291. 
31 Paragraph 25 of G/TBT/26.  G/TBT/M/56  
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  standards was so mired in complexity that it w as likely that every organization out there – even 
India’s own national standards bod y – probably thought they were se tting international standards.  
Clearly more clarity was needed.  The principles themselves were not very clear.  If this could not be addressed, what would the value addition be from pe nding triennial review process?  This was the 
backdrop of the NAMA negotiations where actually na ming international standards had been the most 
controversial issue, and why working around the six pr inciples was a useful alternative approach.  But 
now it seemed that some Members were not even w illing to consider revisiting the principles?  The 
representative of India stressed the need to consider  what the Committee wanted  to achieve with the 
Sixth Triennial Review exercise as a whole. 
298. The representative of the IEC noted that, with r espect to participation, it was neither ISO nor 
the IEC that decided on the level of participa tion from each country in the work of technical 
committees – it was the country itself.  And this depended on capacity and th e importance attributed 
to standards in its economy. Both organizations we re endeavouring to involve stakeholders in the 
elaboration of standards.  Similarly, the representative of Codex stressed that all its committees and 
commissions were open to all its 184 Members.   
299. The representative of India noted that there were  different levels of participation in the IEC 
and ISO.  He asked if this meant that a particul ar category of Members decided who participated in 
the standard setting process, and, in that case – wh at was the exact procedure?  Was this done by 
voting, for instance with r espect to participation in the technical  committees?  In other words, was a 
vote held to decide whether or not to allow certain  member to participate or not in the technical 
committees? 
300. The representative of the IEC responded that for the IEC any country that was a member of 
the IEC had the choice to participate in any tec hnical committee. A full member of the IEC could 
participate in any technical committee either as an observer or as a participating member.  Of course, 
even for very big countries, it was not feasibl e (or at all necessary) to participate in all the technical 
committees. The country had to select according to its interests and its capacity. As an associate 
member, the country could participate as an observer and could be a participant member in four 
technical fields. She reiterated that the level of participation was the choice of the country, not the 
IEC.  
301. The representative of the United States expanded on the point made by the IEC, noting that 
countries participated in ISO and the IEC in different  ways.  In fact, it was not necessarily correct to 
say “countries” it was rather “national member bodies”.  And a national member body for some WTO 
Members was a governmental standardizing body or a central governmental body, for others – 
including the US – it was a private sector entit y that actually represented the country. Hence the 
importance of understanding how na tional standard bodies worked, meaning how they assured that 
domestic industry had ample opportunities to participate in standard setting.  This was one of the key 
issues for many developing countries, and in fact an important issue for the US. 
302. The representative of Australia referred to  the “elephant in the room” as the NAMA 
negotiations.  While this, he said, was readily appare nt to those delegations that covered both the TBT 
Committee and the NAMA Group it was perhaps less obvious  to others.  In his view, there was a need 
for some transparency on this matter.  He recalle d that there had been a discussion that the Chair of 
the NAMA negotiations had led which had been about the adequate forum to discuss a number of the 
TBT-related NTB issues: NAMA or the TBT Co mmittee – and this included the debate on 
international standards.  From the point of view  of Australia, it was useful to use the technical 
expertise that existed in the TBT Committee to help inform some of NAMA negotiations as these 
sometimes occurred in the abstract without the technical expertise required.  G/TBT/M/56  
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  303. The Chairperson said that in view of the di scussion it would be difficult to bring forward 
some elements due to the different views among Memb ers.  But at the same time, some Members had 
indicated a willingness to explore ideas that could be  brought forward and in this light the Committee 
needed to further reflect on the matter.  In the meantime, the Committee would await any further 
proposals in this area. 
3. Conformity Assessment 
304. The representative of the United States again st ressed the ambitious nature of the Fifth 
Triennial Review Report (G/TBT/26, paras 17-19) and th e need to build on this work.  In this respect 
she noted that an important part of the Committ ee’s recommendations to date aimed at promoting 
information exchange on the various aspects of conf ormity assessment procedures, including on: (i) 
approaches to conformity assessment; (ii) the use of relevant international standards, guides or 
recommendations, or the relevant parts of them, as a basis for their conformity assessment procedures; and (iii) facilitating the recognition of conformity assessment results.  
305. She said that conformity assessment was a frequent feature of the Committee's discussion on 
specific trade concerns. The Committee's work on trade facilitative approaches to conformity 
assessment was therefore a natural outgrowth of its work to prevent and reduce unnecessary obstacles 
to trade.  Promoting greater understanding of the choices associated with different approaches to 
conformity assessment also served WTO Members’ goals of developing and ensuring that their standards and conformance infrastructure supported th e effective achievement of the larger economic 
and social goals of their countries.  This infrast ructure enabled the achievement of the regulatory 
needs of governments, but importantly, it also s upported the needs of local producers and suppliers 
seeking to improve in a reliable and systematic wa y the quality and safety of their products. This, in 
turn, supported greater exports and could contri bute to improved and safer choices for domestic 
consumers.  With respect to laborat ory testing, a recent World Bank study
32 concluded: "Given the 
high cost involved in most laboratory development projects, inappropriate investment decisions often 
cause a huge waste of resources." And further, "Many investments in public laboratories for food and 
agriculture are not sustainable, at least from a financial standpoint, and sometimes technically as 
well.".  Hence, while the TBT Committee consider ed conformity assessment from a trade facilitation 
perspective, many of these same issues had si gnificant implications as countries sought to support 
their economic and social goals through the deve lopment of their standards and conformance 
infrastructure. 
306. The US submission (G/TBT/W/349) needed to be seen in this light.  It showed examples of 
how the use of elements of the international system of conformity assessment, namely the ILAC 
MRA and IAF MLA, was helping US regulatory agen cies achieve a diversity of goals, and how the 
US government was working to increase awareness across other agencies that these important tools 
were available to them.  She stressed that the technical infrastructure underpinning US economy was 
among the most sophisticated in world, so it was part icularly instructive that the US regulatory bodies 
discussed in this paper have chosen to utili ze the ILAC MRA and IAF MLA for these programs, 
rather than mandate the use of national labs or certification bodies. 
307. She noted that the regulatory agencies them selves had helped write these cases studies 
contained in G/TBT/W/349; these ranged across a wide  variety of programs - from consumer product 
safety, to marine and fire safety equipment to am bulances to conserving energy and water usage.  
Regulators had cited their rationale for using ILAC a nd IAF – and this could be relevant to agencies 
in other countries:  the need to leverage limited resources; improving trust in, and credibility of, test 
results; reducing delays and duplicative testing; improving technical competence; enabling links to 
                                                      
32  "Guide for Assessing Investment Needs in Labo ratory Capacities for Managing Food Safety, Plant 
Health, and Animal Health" can be downloaded from the World Bank website:  http://www-wds.worldbank.org .  G/TBT/M/56  
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  global supply chains and ensuring that results are r ecognized beyond national borders.  In sum, the US 
submission gave many good reasons for using the IL AC and IAF, some of which were, in the US 
view, particularly compelling for economies with li mited resources and institutional capacities.  Her 
delegation encouraged Members of the Committee to consider how this might be used in the Sixth 
Triennial Review to strengthen implementation of Articles 5.4 and 9 of the TBT Agreement.  
308. The representative of New Zealand supported th e US statement on the value international 
systems of accreditation could add to regulatory processes.  She recalled that New Zealand had 
submitted a paper in September 2010 (JOB/TBT/5),  which had put forward a draft outline for 
Guidelines on Choice and Design of Trade Facilitati on Mechanisms.  The paper had been developed 
in response to the Committee’s decisi on in the Fifth Triennial Review to initiate work on developing 
practical guidelines on how to choose and design effi cient and effective trade facilitation mechanism 
(G/TBT/26 para 19(c)).  In New Zealand’s view, more work was needed, and it was timely to proceed on this work in the context of the Sixth Triennial Review, so she urged delegations to revisit this 
paper and she also urged Members offer case studies and examples, as the US had just done.  This was necessary to ensure that the guidelin es were rooted in real life experience. 
309. The representative of the European Union expressed  his delegation’s interest in considering 
the link between GRP and conformity assessment.  He intended to provide the Committee with a 
contribution showing how the application of GRP to  conformity assessment could minimize burdens 
on economic operators arising from conformity as sessment procedures.  The focus would be on 
sharing the EU experience in systemizing relevant  criteria for the choice of appropriate conformity 
assessment procedure in a given risk management cont ext.  This was an important strand of work for 
the Committee.  Indeed, it was very similar to th e work in the GRP context, which was also about 
identifying mechanisms that could facilitate the acceptance of conformity assessment results without 
WTO Members privileging one approach over another.  For instance, the EU intended to show that by 
applying GRP in its system it had progressively expanded the areas covered by Supplier’s Declaration 
of Conformity (SDoC), which by definition elimin ated any need for establishing formal mechanisms 
for the acceptance of results (e.g., government to government). 
310. The representative of Mexico noted that Article s 5, 7, 8 and 10 of the Agreement established 
obligations of a both substantive na ture and procedural (transparency) .  Mexico was of the view that 
the Committee needed to continue its  exchange of experiences as this would then serve as a basis to 
draft guidelines that would contain the requirements that conformity assessment procedures needed to 
fulfil to comply with the provisions established in the Agreement.  Mexico was of the view that the 
Sixth Triennial Review should produce an outcome that would give preference to technical assistance 
provided to Members in the area of conformity assessment. 
311. The representative of India agreed that the IL AC MRA and the IAF MLA were indeed very 
useful international systems for conformity assess ment, especially in the light of the presentation 
made by both agencies at an earlier TBT Committee meeting.  India nevertheless stressed the 
importance of focusing on the development dime nsion.  Many existing conformity assessment 
schemes (laboratory certification agencies and inspec tion agencies) were, in India’s understanding, 
primarily centered around developed Members.  Moreover, the developing country Members who 
were endeavouring to develop this capacity was faced with a complex choice.  Either they needed to 
join the multilateral recognition arrangement or th ey had to actually develop their own laboratory 
infrastructure.  Hence, Mexico had touched upon a very important point: the need for technical 
assistance in order to develop this infrastructure. 
312. The representative of Colombia supported Mexico’s position, and that of India, on the need to 
promote the conformance infrastructure in developing countries.   G/TBT/M/56  
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  313. The Chairperson said that there was certainly scope  to bring work forward in this area and she 
encouraged Members to come forwar d with more experiences and ideas.  
4. Transparency 
314. The representative of Japan noted that his delegation was preparing a proposal on 
transparency.  He wished to highlight some of the points in the forthcoming submission.  He stressed 
that the foremost objective of the submission would be to promote an improvement and strengthening 
of the implementation of the TBT Agreement’s tr ansparency provisions.   He noted that Japan 
sometimes received no responses to inquiries or comments regarding TBT notifications.  Members had already shared the importance of responding to  comments in the past triennial reviews.  One 
example was paragraph 42(a) of the Fifth Trie nnial Review (G/TBT/26), where the Committee 
recommended (on a voluntary basis) that Members r espond to comments in writi ng.  Japan wished to 
reaffirm this recommendation and urge Members to  put this recommendation into practice.  In 
addition, in order to enhance tr ansparency, answering all reasona ble enquiries in a timely manner 
needed to be encouraged – and there might be be nefit to setting a standard period from receipt of 
comments to response.  In addition, there had b een several cases where Members had not answered 
reasonable enquiries from Japan. From the point of improving transparency, the Committee could 
recommend that the replies to such enquiries be required. 
315. In the area of languages, Japan had experienced  situations where their own written comments 
(in English) had not been accepted because the responding country would only accept comments in 
Spanish.  In such cases, Japan had difficulty in providing a translated co mment within the allotted 
period of time. Based on this expe rience, it could be beneficial to recommend that if a comment was 
provided in one of the three WTO official languag es and it reached the Enquiry Points within the 
allotted period for comment, Members would have to accept the translated version of the comment 
even after the end of the standard period.   
316. In respect of the Code of Good Practice and in particular paragraph annex 3-L, which stated: 
“Before adopting a standard, the standardizing body shall allow a period of at least 60 days for the 
submission of comments on the draft standard by inte rested parties within the territory of a Member 
of the WTO.”  With a view to enhancing transparency in standards development , it would be useful, 
Japan argued, to share experiences and best prac tices on the implementation of this provision by 
Members’ standardizing bodies. For instance, th e Japanese Industrial Standards Committee (JISC) 
had the practice of receiving public comments for at  least 60 days via a website when planning new 
standards.  When considered these points, it wo uld be a possible recommendation that, through the 
TBT committee’s future work, Members could share and review experiences of implementation of 
public comment procedures by standardising bodies of Member states. 
317. The representative of Mexico emphasized the im portance of transparency, and proposed that 
the Sixth Triennial Review should issue recommenda tions for the strict compliance with obligations 
in terms of transparency and an improvement of re levant notifications procedures. In particular, the 
Committee could consider: improving access to unofficial  translations; the creation of a website for 
comments and answers on notifications; making it an obligation for the responding Member to provide its response in writing within a period of tim e.  A proposal with more detail from Mexico was 
forthcoming.  
318. The representative of the United States also st ressed the critical importance of considering 
transparency in the context of the Sixth Triennial Review and supported ideas that had been put on the 
table.  The US was particularly interested in  how governments had put in place mechanisms for 
consultation that had enabled coordination with other ministries on the process of enquiries and 
notifications;  a good example of this was South A frica’s revision of its 15.2 Statement (contained in 
document (G/TBT/2/Add.60/Rev.1, dated 14 March 2012).  This was important not only because  G/TBT/M/56  
 Page 69 
 
 
  there were obligations on transp arency but because transparency was a core element in providing 
predictability and certainty to economic actors in th e market place, and enabling the understanding of 
the requirements in a given Member or market and thereby facilitating trade and economic growth 
itself.   
319. The representative of the European Union recalle d that there was already a substantial body 
of decisions and recommendations in the area of transparency.  Nevertheless, there were still 
problems in implementation. The EU shared Japan's and Mexico practical experiences and referred, in 
this regard, to its submission for the Fifth Triennial Review33. The EU supported Japan’s statement on 
the absence of written replies from certain Enquiry Po ints and the refusal to  accept comments written 
in English. It also supported the points made by  Mexico and noted that with respect to access to 
unofficial translations, indeed there were exis ting recommendations that could be reaffirmed.  
320. The EU believed that improvements could be made to the WTO TBT IMS.34  Transparency 
and the implementation of existing recommendations c ould be improved if more effort was put in to 
this system.  Such improvements could, for instan ce, help avoid certain previous discussions about 
when  the 60 day period for comments should start:  when the text had been sent to the Secretariat or 
when it was published and accessible to all Members (on the WTO website)?  There had been no 
agreement on this point in the framework of the Fifth Triennial Review, but the question would be 
solved in practice if the time be tween transmission to the Secretariat and the publication on the WTO 
website would be further reduced.  The EU was of the view that it was within the realm of IT possibility to enable Members to notify electronically  and the Secretariat to publish a notification at 
the latest the day after submission.  The EU was also  keen to find ways to facilitate the work of the 
enquiry points considering the high number of notif ications received. Improvements to the WTO TBT 
IMS could perhaps be make the process more automatic; avoid having one person checking each 
notification to identify what products were covere d by the notification, or to open every single 
addendum to see if it covered a new notification that w ould then have to be circulated to interested 
stakeholders.  Agreeing on a common classification of  product categories could enable the IT system 
to send notifications directly to interested author ities or stakeholders without necessitating any work 
from the enquiry point.  The EU was work ing on ideas and would submit a paper soon. 
D. O
THER MATTERS  
1. Sixth Triennial Review: Reminder of deadlines 
321. The Chairperson, in concluding the discussion on the exchange of experiences, reminded 
delegations of the agreed timeline for the prepara tion of the Sixth Triennial Review (contained in 
G/TBT/M/55, para. 299).  In this respect, she st ressed that the deadline for the submission of 
substantive proposals in the Sixth Triennial Review was 1 June 2012. 
III. ANNUAL REVIEW OF THE TBT AGREEMENT (G/TBT/31) 
322. The Committee adopted the Seventeenth A nnual Review of the Implementation and 
Operation of the TBT Agreement, as contained in document G/TBT/31.  
323. The Chairperson drew the Committee's attention to two lists prepared by the Secretariat to 
facilitate consideration of matters  relating to the operation of the Code of Good Practice for the 
Preparation, Adoption and Application of Standards in  Annex 3 of the TBT Agreement.  The first list, 
contained in document G/TBT/CS/1/Add.16, compiles the standardizing bodies that have accepted the 
Code in the period under review.  The second lis t, contained in document G/TBT/CS/2/Rev.18 
                                                      
33 G/TBT/W/309. 
34 http://tbtims.wto.org/ . G/TBT/M/56  
Page 70  
 
  compiles all the standardizing bodies that have accepted the Code since 1 January 1995.  Since 
1 January 1995, 162 standardizing bodies from 122 Members have accepted the Code of Good 
Practice.  In addition, the Chairman noted that the ISO/IEC Information Centre had prepared the 
Seventeenth Edition of the WTO TBT Standards Code Directory
35, which contains information 
received according to paragraphs C and J of the C ode of Good Practice for the Preparation, Adoption 
and Application of Standards in Annex 3 of the Agreement.   
IV. TECHNICAL ASSISTANCE 
324. The representative of South Africa provided the Committee with information on Technical 
assistance activities undertaken.36 
V. UPDATING BY OBSERVERS 
325. The representatives of the UNECE, Codex and IEC updated the Committee on their on-going 
activities in developing countries and work related to TBT.37  
VI. OTHER BUSINESS 
326. The representative of the European Union in formed the Committee of the change in the 
nomenclature of its notifications.  From 1 November  2011, EU notifications were identified with the 
symbol G/TBT/N/EU/xxx.  
VII. DATE OF NEXT MEETING 
327. The next regular meeting of the Committee is scheduled for 13-15 June 2012. 
 
__________  
                                                      
35 Available at the ISO IEC Information Centre http://www.standardsinf o.net/info/inttrade.html . 
36 G/TBT/GEN/130. 
37 G/TBT/GEN/131, G/TBT/GEN/132, 
http://www.iec.ch/about/g lobalreach/partners/internationa l/pdf_wto/iec_wto_2012_03_en.pdf .