RESTRICTED  
  
G/TBT/M/61  
 
5 February 2014  
(14-0699)  Page: 1/50  
Committee on Technical Barriers to Trade    
 
  MINUTES OF THE MEETING OF 30-31 OCTOBER 2013 
CHAIRPERSON: MR. JINGO KIKUKAWA 
Note by the Secretariat1 
Contents 
 
1   ADOPTION OF  THE AGENDA ........................................................................................ 2  
2   IMPLEMENTATION AND ADMINI STRATION OF THE AGREEMENT ................................. 2  
2.1   Statements from Me mbers under Article 15.2 ................................................................ 2  
2.2   Specific Trade Concerns.............................................................................................. 2  
2.2.1   New Concerns  ........................................................................................................ 2  
2.2.2   Previously Raised Concerns ..................................................................................... 12 
2.3   Exchange of Experiences ........................................................................................... 45 
2.3.1   Special and Differential Treatment an d Technical Assistance (Thematic Session on 
29 October 2013)  ............................................................................................................ 45 
2.3.2   Conformity Assessment Procedures (Thematic Session held on 29 October 2013) ............ 48 
2.3.3   Tran sparen cy ........................................................................................................ 48 
2.3.4   Good Regulatory Pr actice (JOB/TBT /44/Rev.2) ........................................................... 49 
2.3.5   Standards ............................................................................................................. 49 
2.3.6   Other Matters ........................................................................................................ 49 
3   TECHNICAL ASSISTANCE ........................................................................................... 50  
4   UPDATING BY  OBSERVERS ........................................................................................ 50  
5   REPORT (2013) OF THE COMMITTEE ON TECHNICAL BARRIERS TO TRADE ............... 50  
6   DATE OF NE XT MEETING ........................................................................................... 50  
 
                                               
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the positions of Members or to thei r rights and obligations under the WTO. G/TBT/M/61 
 
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1  ADOPTION OF THE AGENDA  
1.1.  The Committee adopted the agenda contained in WTO/AIR/4198. 2  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
2.1  Statements from Members under Article 15.2  
2.1.  The Chairman said that the list of stat ements submitted under Article 15.2 of the TBT 
Agreement was contained in document G/TBT/GEN/1/Rev.12, dated 18 February 2013. He 
stressed that while 126 Members had submitted at least one Statement on Implementation under 
Article 15.2, 23 Members had not yet fulfilled this obligation and he urged them to do so in a timely manner. He recalled that this information was available, and regularly updated, on the TBT 
Information Management System (the "TBT IMS"
2).  
2.2  Specific Trade Concerns 
2.2.1  New Concerns 2.2.1.1  Ecuador - Resolution No. SENAE- DGN-2013-0300-RE relating to post entry 
control of imported alcoholic beverages  
2.2.  The representative of Mexico expressed her delegation's view that the measure was a 
technical regulation and should therefore have been notified to the Committee. Further, the 
measure, the objective of which was unclear, was designed to create unnecessary obstacles to 
trade in discordance with Article 2.2 of the TBT Agreement. Ecuador should therefore consider less 
trade-restrictive alternative measures. Mexico also asked for the opportunity to comment and hold consultations with Ecuador on this matter. 
2.3.  The representative of the European Union associated herself with Mexico's concerns. She 
asked Ecuador to suspend the application of the measure and notify it to the TBT Committee so as 
to provide Members a minimum 60-day comment pe riod, and to duly take any comments into 
account. She asked Ecuador to confirm whether the measure only applied to some types of spirits 
and did not cover domestic products. She observed that Article 3 of the Resolution required some imported spirits to bear a country-specific front label to be applied at origin - rather than within 
customs warehouses in Ecuador - detailing the Ecuadorean importer, and that the use of stickers 
was not permitted. She asked Ecuador for the rationale behind these requirements as they would create significant burden on foreign companies and were against international practice. Finally, the EU expressed its concern with the entry into force of the measure, as it allowed just 30 days 
before beverages shipped to Ecuador would be required to comply with the labelling obligation, 
and just four months until beverages already present in the Ecuadorean market would be prohibited from being sold or displayed unless th ey met the labelling requirements. She therefore 
asked Ecuador to provide an adequate time, not less than 6 months for the entry into force of the 
measure, in line with Articles 2.9 and 2.12 of the TBT Agreement. 
2.4.  The representative of Canada expressed he r delegation's view that by not notifying the 
measure to the WTO and not allowing for a comment period, Ecuador was in violation of Article 
2.9.1 and 2.9.2 of the TBT Agreement. Additional ly, Ecuador had not yet published the measure in 
its official register and was not allowing a suffi cient time-period between its publication and entry 
into force. Canada thus asked Ecuador to notify the measure to the WTO and allow for a comment 
period, as well as to reschedule the entry into force to allow for a full 6-month period after 
notification of the final technical regulation as stipulated in Article 2.12 of the TBT Agreement. 
Canada also expressed concerns with Article 3 of the measure, which required improperly labelled 
liquor to be returned to the country of export. Canada asked Ecuador to explain how the measure, 
in particular its application only to imports, was in compliance with Article 2.1 of the TBT Agreement, as well as how the measure was in co mpliance with Article 2.2 of the TBT Agreement 
by being no more trade restrictive than necessary to accomplish its legitimate objectives. Canada 
concluded by inquiring whether Ecuador had consid ered other less trade restrictive alternatives. 
                                               
2 http://tbtims.wto.org . G/TBT/M/61 
 
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  2.5.  The representative of Ecuador explained that in G/TBT/N/ECU/19 of 30 June 2007 Ecuador 
notified "Technical Regulation of the Ecuadorian Standardization Institute RTE INEN n. 022 on the 
Labelling of Processed and Packaged Food Products"). This regulation established that the labelling of these products must meet the requirements set out in Ecuadorian Technical Standards NTE 
INEN 1334-1, 1334-2 and 2074 and in the "Organic Law on Consumer Protection". Members were 
given 60 days to make comments on this measure. One of these standards, Ecuadorian Technical Standard NTE INEN 1334-1:2011 (third revision), established minimum requirements for the 
labelling of packages or bottling of food prod ucts intended for human consumption, including 
alcoholic beverages. Additionally, Ecuador's Customs Regulation on such products has been applied for years. More specifically, Ministeria l Agreement 428 (13 July 1995) of the National 
Secretariat, provided: (i) Article 1 - imports of alcoholic products, including beer, shall only 
originate from the country of origin and through legally authorized representatives, and be only 
permitted after the granting of the relevant sanitary registration and other legal requirements; (ii) Article 3 - from their place of origin, imported  alcoholic products and beers shall contain a front 
label with the following information: "imported by " (name of agent or representative), the word 
"Ecuador", the sanitary registration number, the volume in cubic centimetres, and the statement "Warning: excessive consumption of alcohol can ca use serious damage to health and can endanger 
your family" (to be located either in the main or secondary label, in line with Decree n. 1828 of 10 
June 1994); and (iii) Article 4 - alcoholic products and beers imported into Ecuador's internal market without complying with Article 3 shall be presumed to have entered the country illegally.  
2.2.1.2  Italy - Testing requirement on  import of steel cutlery products 
2.6.  The representative of India expressed his co untry's concern with Italy's requirements for the 
import of stainless steel utensils (HS code 73.23.93.90) and stainless steel cutlery (HS code 
82.15.99.00). He noted that while other EU Me mbers (such as France, Germany and the UK) 
accepted the import of grade 200 stainless steel, Italy only allowed the import of grades 202 and 
204. This was at odds with the fact that the grade 200 stainless steel met the Italian chromium threshold requirement of 13% and was considered  adequately food-safe. India considered its 
internal BIS N1, N2 and N3 tests as adequately fu lfilling food safety requirements, and argued that 
the testing method prescribed by Italy – including the stipulation that a serving tong of the same product must be kept in acid for at least four days – was more trade restrictive than necessary given that serving tongs hold food for a very short time. India concluded by expressing concern 
over the lack of harmonization among EU Members' standards on this particular aspect. 
2.7.  The representative of the European Union th anked India for its questions, and stated that the 
questions would be referred back to Italy and a reply would be provided at the next Committee 
meeting.  
2.2.1.3  European Union - Draft Commissi on Regulation implementing Directive 
2009/125/EC of the European Parliament and of the Council with regard to ecodesign 
requirements for vacuum cleaners (G/TBT/N/EU/79) 
2.8.  The representative of China noted that Ch ina had submitted four separate comments on the 
draft measure following the EU's notification of the measure at the end of 2012. China stated that 
the EU had accepted two of the four comments at the time of the adoption of Commission 
Implementing Regulation EU 636/2013 in July 2013. While China was glad to see that two of these 
comments were taken into account, the concerns expressed in the other two comments persisted. China still believed that the noise tolerance for cleaners proposed in the regulation, 80 dba, could 
be met by canisters of input power less than 9 00 watts through technological improvement, but 
that upright vacuum cleaners with smaller brush sizes would have difficulties meeting the requirements due to restrictions on shape and structure. China noted that the current noise level 
of upright vacuum cleaners was 85-90 dba, and suggested that the EU revise its noise tolerance 
level to 85 dba. Second, China expressed concern that the regulation required vacuum cleaners to undergo performance testing on metrics such as dpuc, dpuhf and dust emission rate, but the regulation did not stipulate the specific requirem ents of relevant reference systems or the main 
measures necessary for enhancing environmental performance. As a result, vacuum cleaner 
manufacturers in third-party countries could not carry out their own testing and instead had to send samples to the German laboratory that had drafted the European standard for vacuum 
cleaner testing, EN60131. China asked the EU to disclose details regarding testing so as to fulfil its 
WTO non-discrimination and transparency obligations. G/TBT/M/61 
 
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  2.9.  The representative of the European Union thanked China for its interest in the measure. With 
regard to the sound power level requirement, she stated that vacuum cleaner models on the 
market did not demonstrate a correlation between energy consumption and sound power level, and the EU had identified both parameters as sign ificant and displaying room for improvement. In 
response to China's concerns over upright vacuum  cleaners, she explained that setting different 
requirements for products with the same functi onality is not the EU's preferred legislative 
approach. Manufacturers would have sufficient time to adapt upright vacuum cleaner models that 
did not yet comply with sound power level requirements, given that the sound power level 
requirements would start to apply four years after adoption of the regulation.  
2.2.1.4  Indonesia - Regulation number 84/Permentan/PD.140/2013, on halal food 
2.10.  The representative of Brazil asked Indonesi a to clarify its regulations on halal foods as no 
new regulation had been notified to the WTO. Braz il expressed concern regarding lack of clarity in 
the requirements, particularly a previously exis ting requirement for poultry exporters seeking 
access to the Indonesian market to utilize specific slaughterhouses employing halal-compliant 
slaughter practices. Brazil wished to know whether measures in this area were compliant with the 
guidelines of the Codex Alimentarius for the us e of the term "halal", doc. CAC/GL/24 of 1997. 
Specifically, Brazil drew attention to Article 2.2.1, allowing for the preparation, processing, or 
storing of halal food in different sections or lines within the same premises where non-halal foods 
were produced, as well as Article 2.2.2, allowing for the preparation processing, or storing of halal food using facilities which had previously been used for non-halal foods provided that cleaning procedures compliant with Islamic requirements have been observed. Brazil reminded Indonesia 
that if its requirements went beyond international guidelines, Indonesia may be required, upon the 
request of another Member, to explain the justification of the technical regulation in terms of the provisions of paragraphs 2-4 of Article 2.5 of th e TBT Agreement. Brazil also noted that a number 
of Muslim countries had already taken initiatives under the Organization of Islamic Cooperation, of 
which Indonesia was a member, to develop common standards for halal foods so as to remove technical barriers to trade. A specific affiliate body – the Standards and Metrology Institute of 
Islamic Countries – was cited by Brazil as leading work in this area for the OIC and as having 
published two additional guidelines for certification and accreditation in the area of halal food. Brazil inquired as to whether Indonesia's halal food requirements follow these guidelines, and concluded by noting its openness to conducting bilateral discussions with Indonesia for the 
resolution of the matter. 
2.11.  The representative of Indonesia thanke d Brazil for its comments, and noted that the 
concern was also raised in the SPS Committee. Note of Brazil's concerns was taken and the issue 
would be brought to capital for discussions with the Ministry of Agriculture. 
2.2.1.5  Ecuador - Resolution establishi ng the "General conformity assessment 
framework for Ecuador" and the "Handbook of procedures to be observed prior to all 
stages of the customs clearance, marketin g and market surveillance of manufactured, 
imported and marketed goods subject to Ecuadorian technical regulations 
(G/TBT/N/ECU/44, G/TBT/N/ECU/44/ Add.1, G/TBT/N/ECU/44/Add.2, 
G/TBT/N/ECU/44/Add.3) 
2.12.  The representative of Colombia stated3 that the resolution at issue was not notified and that 
no period for comments from Members had been provided. Given that it was not notified as an 
urgent measure, it also omitted the consultation process. Additionally, the resolution did not 
indicate what were the legitimate objectives justifying the measure. Further, the measure did not 
provide for a transitional period before its entry into effect. Given the foregoing, Colombia argued that this measure was not compliant with the main principles of the TBT Agreement, particularly 
those relating to transparency, and requested that  Ecuador suspend its implementation until these 
deficiencies have been addressed. 
2.13.  The representative of Chile supported the concern expressed by Colombia. While Chile 
understood Ecuador's desire to ensure product quality, it stated that the measure at issue was 
more restrictive than necessary, particularly with regard to the recognition of Ecuadorian, bilateral 
or multilateral certification agreements. Chile noted that because Ecuador was not a signatory to 
                                               
3 See also Colombia's communication in G/TBT/W/373. 
 G/TBT/M/61 
 
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  the IAF, certificates obtained through the accreditation organization were not being recognized by 
Ecuador, despite a previous understanding that mutual recognition would indeed take place. 
Recalling the positive economic relationship between the Ecuador and Chile as well as the close ties between standardization institutions in both countries, Chile called for a quick solution to its 
concerns. 
2.14.  The representative of Peru began by aligni ng her delegation with the concerns expressed by 
Colombia and Chile. She recounted the basic structure and functioning of the Ecuadorian general 
conformity assessment framework, including the issuan ce of conformity certificates by certification 
organizations for products whose accreditation was recognized by the Ecuadorean accreditation organization, as designated by the Ecuadorean Ministry for Industry. She also recalled that 
Peruvian exporters with valid certificates of conformity with technical regulations had seen their 
exports restricted after the entry into force of the Ecuadorean measure. This was not because the 
exporters did not comply with the specifications of the standard, but instead because no accredited organizations existed in Ecuador that were both reco gnized by the Ministry of Industry, and thus in 
a position to certify exporters' products as requ ired under the Ecuadorean measure. Peru argued 
that the Ecuadorean measure represented an unnecessary trade barrier in violation of the TBT Agreement's principles, as it established a standard without enacting measures necessary to 
comply with this standard. Peru also noted that the resolution was notified without giving either 90 
days for comments, as required by the Andean  Community, nor six months between publication 
and entry into force, as required by the TBT Agreement. Peru asked Ecuador not to apply the 
measure until the principles of the TB T Agreement had been complied with. 
2.15.  The representative of Ecuador stated that the measure was compliant with the applicable 
non-discrimination provisions of the TBT Agreement, which was published in the official registry 
no. 4 on 30 May 2013.4 In this respect, Ecuador recalled that Article 2 of the measure established 
that the general framework for conformity assessment was applicable to any goods – national or 
imported - subject to Ecuadorean technical regulations for trade, as well as Article 4, establishing the means of demonstrating compliance with th e conformity assessment requirements. Ecuador 
stated that in neither of these provisions was there discrimination in the process of introducing a 
product into Ecuador or commercializing it within the Ecuadorean market. Ecuador added that Chapter 2, Sections 1-2, Articles 9 and 16 of the measure instructed national manufacturers to register the conformity or inspection certificate in  a sub-secretariat of quality in the Ministry of 
Industry and Production. Ecuador said that th ese examples underscored the consistency of the 
measure with applicable non-discrimination provisions of the TBT Agreement as imported products were given no less favourable treatment than locally-manufactured products. A number of 
additional legal provisions of the measure were cited by Ecuador, including the second general 
legal provision in Chapter 3, referencing compliance "without discrimination to imported goods subject to local regulations", as well as text from the third legal provision specifying that civil, 
penal and fiscal responsibility for non-compliance would be found in existing legal provisions and 
would impact manufacturers, importers, and traders alike. Ecuador summarized these various examples as demonstrating that its regulations were  based on the principle of national treatment. 
The Ecuadorean representative added that any om issions made in terms of procedure could be 
attributed to the substantial task of consolidating the entire institutional conformity assessment 
structure. With regard to concerns over mutual recognition agreements (MRAs), Ecuador stated that it had clarified in the March 2013 TBT Committee meeting that with regard to its 5 March 
1997 MRA with Colombia, terms refer to WTO rules and not to those of the Andean Community. 
Ecuador concluded by addressing a Colombian request to hold bilateral consultations in the bi-national "Committee of Standardization, Technical Regulations, Certification, and Metrology", 
and stated that although it felt that the TBT Committee was the proper forum for addressing these 
issues, it was also happy to carry out the work necessary to hold meetings in the bi-national Committee.  
2.2.1.6  Russian Federation – Measure affe cting import of Ukrainian confectionary 
products  
2.16.  The representative of Ukraine expressed concern with the measure's consistency with a 
number of provisions of the TBT Agreement. Ukrain e's full statement is contained in G/TBT/W/377. 
                                               
4 Notified in G/TBT/N/ECU/44/Add.2 of 5 June  2013 and G/TBT/N/ECU/44/Add.3 of 30 August 2013. G/TBT/M/61 
 
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  2.17.  The representative of the Russian Federa tion recalled that the technical regulations in 
question were adopted in 2011 and established obligatory requirements for food products, 
particularly in terms of labelling. He added that  a number of discrepancies were recorded in the 
indication of product categories, which did not corr espond to the definitions laid out in the Russian 
technical regulations. The decision to suspend the import of Ukrainian "Roshen" confectionary 
products did not introduce new requirements and thus WTO notification was not required. The Russian Federation was maintaining bilateral cons ultations with Ukraine, and the Federal Service 
for Supervision of Consumer Rights Protection and Human Welfare (" Rospotrebnadzor ") was 
monitoring agreements reached during a meetin g between competent authorities in August 2013. 
The Russian representative stated that information regarding labelling violations in "Roshen" confectionary products, related bilateral negotiat ions and implementation of the agreements was 
available on the official website of Rospotrebnadzor . He emphasized that there was not a ban of all 
confectionaries from Ukraine, but instead the su spension of imports from a single producer, 
Roshen. He added that the decision reached by Rospotrebnadzor  could be reviewed when full 
compliance of Roshen with the Custom s Union requirements was achieved. 
2.2.1.7  Indonesia - Mandatory Indonesia Nati onal Standard (SNI) for Glazed Ceramics 
(G/TBT/N/IDN/37, G/TBT/N/IDN/37/ Add.1, G/TBT/N/IDN/37/Add.2) 
2.18.  The representative of the European Union expressed concern with the measure, which 
required mandatory third-party certification of compliance with the SNI for all glazed ceramic 
tableware, closets and ceramic tiles imported, di stributed and marketed in the country. The EU 
asked Indonesia to explain why this "mandatory st andard" was necessary for products that already 
complied with relevant ISO standards for glazed ceramic. The EU also reiterated comments sent to 
Indonesia in relation to the original notification of the Decree in G/TBT/N/IDN/37, asking Indonesia to clarify why release limits for lead and cadmium in the SNI 7275:2008 diverged from 
international standards and whether it would consider accepting tests from ILAC-accredited EU 
laboratories. The EU recounted that EU industry had been experiencing difficulties since the decree 
had begun implementation, largely due to excessively burdensome and costly certification 
requirements. Companies were asked to disclose large amounts of detailed information, including 
confidential data on raw materials and products, and were also required to accommodate factory visits by Indonesian inspectors. The EU asked Indonesia to reconsider the need for these requirements and explain how certification costs were calculated. The EU also inquired as to the 
duration of the certification of products using the SNI mark (SSPT-SNI) and the products covered 
by the certificate. It was concerned that SNI markings were required to be put on each product and not the packaging, which it said was not in line with ISO standards and would imply significant 
costs. Recalling Article 5.1.2 of the TBT Agreement, the EU asked Indonesia to consider less 
burdensome conformity assessment procedures. 
2.19.  The representative of Indonesia recalled that notification G/TBT/N/IDN/37 pertained to the 
Ministry of Industry's regulation no. 82/MIND/T ER/2012 on mandatory implementation of the SNI 
for Glazed Ceramic. Indonesia took note of the EU concerns, which would be relayed to the capital for discussion with the related ministry.  
2.2.1.8  Thailand - Draft Thai Industrial Standard for Ceramic Tiles (TIS 2508-2555) 
(G/TBT/N/THA/407) 
2.20.  The representative of the European Union raised a number of concerns regarding the Thai 
measure, recalling that it would enter into force as a "mandatory standard" on 15 January 2014. It 
first asked Thailand why a Thai Industrial Standa rd was needed for products that already complied 
with relevant ISO standards for ceramic tiles such as ISO 13006:2012. It also noted discrepancies with certain ISO 13006:2012 elements, such as water absorption thresholds, and asked Thailand 
to provide further rationale for these discrepan cies. The EU also expressed concern with the 
prescribed conformity assessment procedure for the Thai Industrial Standard, which required product testing and onsite audits by the Thai Industrial Standards Institute (TISI) in order to inspect manufacturers' quality control systems. TISI required "TISI Standard Mark" and "TIS 
2508-2555", along with the manufacturer and registered trademark, to be marked on every tile, 
rather than allowing such marks be placed on the packaging. The EU stated that these marking 
requirements were not consistent with ISO 13006:2012 and would lead to significant costs. 
Additionally, the EU complained that the Thai measure's certification process could only be 
completed within Thailand; was valid per importer and per product line only and was not granted to third-country manufacturers; required the disclosure of confidential information by G/TBT/M/61 
 
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  manufacturers, and subjected manufacturers to on-site factory visits by TISI inspectors. The EU 
said that, overall, the certification process ap peared to be unnecessarily burdensome, redundant 
and costly. Recalling Article 5.1.2 of the TBT Agreem ent, the EU called on Thailand to consider less 
burdensome conformity assessment procedures for ceramic tiles, and invited Thailand to consider 
postponing implementation of the measure so as to  provide industry with more time to apply for 
certification. The EU concluded by asking Thailand whether test results from EU laboratories and certificates from EU conformity assessment bodies would be accepted. 
2.21.  The representative of Thailand informed th e Members that the measure had been notified to 
the WTO under G/TBT/N/THA/407 on 5 October 2012 with a period of 60 days for comments. 
Thailand stated that the standard would enter into force on 15 January 2014, or 180 days after its publication in the government's official gazette. The Thai representative stated that she would 
consult with capital authorities in order to formulate an appropriate response to the concerns 
voiced by the EU. 
2.2.1.9  United Arab Emirates - Control Regu lation for Halal Products - Part I - Halal 
Food (G/TBT/N/ARE/153) 
2.22.  The representative of the European Unio n thanked the UAE for notifying its draft Control 
Regulation for Halal Products on 15 May 2013 and un derlined its support for providing more clarity 
on halal requirements. The EU nevertheless was concerned that the proposed measure introduced 
stringent requirements without providing sufficient guidance on their implementation. It thus asked the UAE to provide appropriate detaile d guidelines on how the measure would be 
implemented as well as how it would supersede the existing regulatory framework. In particular, 
the EU was concerned with the lack of details regarding the requirements for recognition of 
accreditation bodies and for acceptance of co nformity assessment bodies, and noted that the 
standards mentioned in the draft (UAE.S OIC/SMIIC  1, 2 & 3) had not yet been issued. The EU 
also requested more clarity regarding mutual recognition of certificates and halal marks, and 
emphasized the importance of having a well-functioning system of mutual recognition at the time of the measure's entry into force. Citing the potentially significant implications for international 
trade of the draft measure, the EU suggested that  the UAE should further consider the economic 
and practical implications of implementing the regulation.  
2.23.  The representative of New Zealand welcomed  the UAE's notification of the draft regulation. 
Noting its status as a major exporter of high quality halal food products, New Zealand said that it 
was closely following the development of the regu lation and were engaged in direct discussions 
with UAE officials over aspects of the regula tion, and looked forward to receiving further 
information and a notification of the draft regulation at the next appropriate stage. 
2.24.  The representative of the United Arab Emirates was not present at this meeting. The 
Chairman thus asked the Secretariat to convey to the UAE the concerns raised by the EU and 
New Zealand.  
2.2.1.10  Chile - Safety for Printers and Energy Efficiency for Printers 
(G/TBT/N/CHL/213, G/TBT/N/CHL/214) 
2.25.  The representative of the United States raised concerns with two Chilean measures, "Safety 
for Printers" (CHL 213) and "Energy Efficiency for Printers Labelling" (CHL 214), notified in August 
2012. The US also expressed appreciation for its past bilateral engagement with Chile regarding its 
concerns. The US noted Chile's June 2013 announcement changing implementation deadline from April 2014 to 27 December 2013, thus leaving only 6 months until compliance. The US considered 
this period to be insufficient to allow companies to adjust inventories and production. Further, it 
noted that the list of 10 approved testing faciliti es was only released by Chile in late July 2013, 
and that many of these facilities were possibly not located in the same geographical area as 
relevant printer equipment production. The US also expressed dissatisfaction that industry 
comments had not been taken into account when Chile released its final protocols in December 2012, and that extensive engagement by the US had been necessary to raise awareness of the 
issues contained in its comments. The US asked Chile to confirm whether the final measures would 
be liable to revision in the context of Chile' s revision of the overarching framework for the 
measures through Decree 298-2005, as US companies developing compliance plans for the two measures were concerned about future revisions being triggered by changes to the framework. G/TBT/M/61 
 
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  The US asked Chile to delay the measure's entry into force until the revision of Decree 298-2005 
had been finalized and notified.  
2.26.  The representative of Chile said that her delegation also appreciated the bilateral dialogue 
both countries have had on this matter. She stated that Chile has been developing the two 
protocols with the aim of establishing a clear process of certification to promote better consumer 
information, prevent falsification, and facilitate control processes. Recalling that the protocol was notified to the WTO in August 2012, Chile stated  that comments submitted by the US during the 
consultation process were responded to in a timely manner by Chilean authorities. Based on 
comments received and consideration of the consequences of the measures, Chile would adopt new measures by means of resolutions of the oversight mechanism. Chile elaborated that the date of entry into force for importing agencies and products manufactured locally by December 2013 
would be changed to 30 April 2014. With regard to testing facilities, Chile stated that new 
laboratories were being considered to facilitate the certification process. Chile also stated that it aimed to ensure that conformity assessment procedures were no more trade restrictive than 
necessary, and that the Ministry of Economy had stipulated that a review of the decree would take 
place. Chile reiterated that both protocols had complied with commitments of transparency and notification, and that Chile had maintained constant dialogue with the US so as to arrive at a 
mutually satisfactory resolution of the issues. 
2.2.1.11  China - Regulations of the China F ood and Drug Administration on Legislative 
Procedures (Exposure Draft)  
2.27.  The representative of the United States said her delegation was encouraged that CFDA 
("China Food and Drug Administration") was proactively working to strengthen its legislative 
procedures through systematic, formalized stakeholder outreach. She also noted its strong support for provisions of the draft regulations that refl ected good regulatory practices discussed in the 
TBT Committee, such as the required solicitation of public opinion on CFDA drafts of laws, 
administrative regulations, and rules listed in its legislative plan, through obligatory posting of such drafts on the State Council Legislative Affairs Office (SLCAO) website for no less than 
30 days. Recalling the TBT Committee's Sixth Triennial Review and discussions on Good Regulatory 
Practices, she urged China to consider establishing a "whole-of-government" approach to transparency and stakeholder input that would be a pplicable to all ministries and agencies involved 
in regulatory development.  
2.28.  With regard to the content of the draft regulations, she noted that drafts were to be 
submitted to the SCLAO website after having b een examined and amended by the CFDA's Law 
Department. She sought clarification on how comments submitted at this late stage would be 
considered by the Law Department. She proposed that the solicitation of public opinion occurring 
under Article 17 of the measure specify that "public  online solicitation" required posting the draft 
on the SCLAO website for a 30 day comment period to ensure that online comments could 
realistically help shape the draft. She also requested that interpretations and opinions as specified 
under Article 36-37 of the measure should be subj ect to the same transparency requirements as 
those affecting draft regulations, and urged th e CFDA to amend Article 36-37 to require draft 
interpretations to be posted on the CFDA's website to solicit public comment for a period of no less 
than 30 days. She expressed appreciation for the CFDA's proposal in Articles 43-44 to solicit public 
opinion on normative documents, but sought clarity on the definition of such documents and requested that all draft normative documents of  a binding nature were posted on the SCLAO 
website for a public comment period of at least 30 days. Recalling China's transparency 
commitments under the TBT Agreement and its WTO Accession Protocol, she recommended that the CFDA specify in the Draft Regulations the proc ess for notifying pertinent measures to the WTO 
and that the CFDA would answer comments and inquiries in a timely manner. She reiterated the 
US' support for the CFDA's work on increasing transparency and public participation in the legislative process, and recommended that, in line with Articles 2.4 and 5.4 of the TBT Agreement, 
the CFDA Law Department's examination under Article 22 specifically include consideration of 
whether draft measures are based on extant or imminent international standards, guides or 
recommendations. She also applauded the CFDA's pl ans to require the evaluation of social and 
economic impacts of its measure and to report and evaluate those impacts, and suggested that the 
US FDA's regulatory impact assessment process pr ovided useful guidance. She also praised the 
CFDA's proposed legislative planning process, along with hopes that it would provide an opportunity for early stakeholder feedback and differe nt perspectives on CFDA legislation. To this 
point, she highlighted the government's Unified Ag enda of Regulatory and Deregulatory Actions as G/TBT/M/61 
 
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  an example for developing criteria for regulatory planning and execution. She concluded by urging 
China to continue its exploration and adoption of relevant international regulatory best practices and to take full consideration of comments submitted by US industry and other interested parties in addition to those presented in the TBT Committee. 
2.29.  The representative of the European Union echoed the concerns of the US and said that while 
her delegation welcomed the CFDA's efforts to impr ove transparency in its legislative process, she 
would still need to ask for clarification on whether the public comment process would take place at 
a sufficiently early stage and afford equal treatment of foreign and domestic stakeholders. She 
also asked whether the same transparency would apply to all categories of normative documents published by the CFDA such as guidelines and ot her implementing rules. She recalled the need for 
TBT notification to take place at a sufficiently early stage without prejudicing internal public 
consultation in China, and also stressed the need for greater reliance on international standards in 
the regulatory process in accordance with China's commitments under the TBT Agreement.  
2.30.  The representative of China noted her delegation's view that the CFDA's measure was an 
internal document that regulated legislative procedures and was not related to any specific product 
or conformity assessment procedures. Accordingly, China argued that the measure was not covered by the TBT Agreement. It welcomed the US to participate in domestic transparency 
procedures through bilateral communications, but felt that the TBT Committee was not a suitable 
forum for such discussions. 
2.2.1.12  European Union – Fuel Quality Directive 2.31.  The representative of the United States, stat ed that it shared the goal of the EU Directive, 
and noted its likely importance to other WTO Members. She understood that this process was 
nearing conclusion in terms of selecting an implementation option from among the alternatives. She articulated transparency concerns with this impact assessment process, in particular the lack 
of detailed public information regarding various implementation options under consideration by the 
Commission, and in light of the potential trade im pacts of some of the options understood to be 
under consideration. In this regard, she noted that public comment on impact assessments was 
considered to be a good regulatory practice. 
2.32.  The representative of Canada shared the concerns raised by the US and added Canada's 
view that the draft Commission proposal for implementation, as written at the time, had the 
potential to create market access barriers for North American petroleum products in the EU. She 
emphasized the need for the Directive's implementing measures to be based on the best available 
science and to encourage transparency. The Canadian representative also stressed the importance of treating all globally-traded petroleum products  in an equivalent, non-discriminatory manner. As 
it seemed that the impact assessment process was nearing finalization, Canada looked forward to 
learning the results of such assessment. Canada urged the EU's impact assessment to be full, open and transparent, include multiple views, and examine effects on consumers and the European 
economy.  
2.33.  The representative of the European Union argued that since the draft Commission proposal 
for the implementation measures had not yet been adopted, it was premature to discuss the issue 
in the TBT Committee. The EU had carried out an impact assessment and a series of stakeholder 
consultations and would ensure that the implementing measures were WTO-compatible. 
2.2.1.13  Mexico - Draft Mexican Official  Standard PROY-NOM-032-ENER-2013: Maximum 
electrical power limits for equipment and a ppliances requiring standby power. Test 
methods and labelling (G/TBT/N/M EX/263, G/TBT/N/MEX/263/Add.1) 
2.34.  The representative of the United States said that while her delegation supported Mexico's 
efforts to promote energy conservation, it nevertheless had a number of concerns over Mexico's 
draft standard as well as the related test me thods (notified in G/TBT/N/MEX/263) and labelling 
requirements (notified in G/TBT/N/MEX/214). First, the US was concerned with what it viewed as duplicative labelling and conformity assessment regimes, and asked how they would result in 
energy efficiency for consumers. It considered that these differing regimes could not be resolved 
through a single label or test, but would instead require two labels and two tests of many of the 
same products. Addressing in-country testing provisions in Articles 11.4.3 and 11.6.1 of the draft G/TBT/M/61 
 
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  standard, the US asked Mexico to confirm whether the Mexican Ministry for Energy (CONUEE) 
planned to allow non-Mexican labs to provide certification and requested a list of labs approved for certification. The US also noted the lack of identified risk in the risk assessment, and inquired as to how the measures would achieve Mexico's goal of energy conservation. Noting that the final 
version of NOM-032 would be published in November 2013, the US asked for details on the date of 
entry into force and whether Mexico planned to take comments into account. It concluded by articulating a belief that further study and analysis could contribute to resolving some of the issues 
raised, and requested that Mexico take such concerns into account prior to setting an 
implementation deadline.  
2.35.  The representative of Mexico recalled that the measure was published on 22 May 2013 in 
Mexico's Official Gazette and was notified to the WTO on the same day, with distribution by the 
WTO on 27 May 2013 as G/TBT/N/MEX/263. Mexico received from comments from three 
businesses in the US, which were sent to the appr opriate regulatory body, the Ministry of Energy. 
Mexico also recalled receiving comments from Canada on 23 July 2013, outside of the consultation 
deadline. Noting that some observ ations made by Canada coincided with observations made by the 
US in their respective comments, Mexico stated that the official responses given to the latter also responded to the former's questions. It added that  the Mexican Ministry of Energy invited the US 
Consumer Electronics Association to meetings of the working group tasked with preparing the draft 
standard. It was at these meetings that multiple amendments were made to the transition articles of the measure in order to minimize the impact  of the measure's implementation. The Mexican 
Government was working to provide responses to various governments' comments as soon as 
possible, and that these would be taken into consideration before the final publication of the draft 
standard. There was not yet a scheduled date for this final publication, but it noted Members' comments and would respond publicly through its official gazette. 
2.2.1.14  Turkey - Draft Communiqué on Wa rning Messages Placed on Containers of 
Principles Concerning Domestic and Foreign Trading of Alcohol and Alcoholic Beverages 
(G/TBT/N/TUR/41, G/TBT/N/TU R/41/Add.1, G/TBT/N/TUR/42, 
G/TBT/N/TUR/42/Add.1) 
2.36.  The representative of Canada voiced her delegation's concern that Turkey's proposed 
measures appeared to violate Articles 2.9.4 and 2.12 of the TBT Agreement. Canada recalled that 
it had already provided comments to Turkey's TBT Enquiry Point on two occasions. Canada cited a 
communication from Turkey to Canada, dated 29 August 2013, explaining that these measures 
were "prepared as secondary legislation to the Law 6487 dated 11 June 2013, which mandated secondary legislation to enter into force within two months after the publication of the Law, that is, 
as of 11 August 2013". Canada asked how such entry into force period complied with Article 2.12 
of the TBT Agreement. Canada also asked wh ether Turkey had conducted any studies to 
demonstrate the efficacy of its proposed labelling in achieving its objectives of educating its 
population on the risks posed by alcohol consumpt ion to those underage, pregnant, or driving, and 
whether it had considered less trade restrictive measures to achieve these objectives. 
2.37.  The representative of Mexico expressed her delegation's concern that the proposed 
measures could be in violation of Article 2.2 of the TBT Agreement as less restrictive measures 
could be used to achieve the same legitimate objectives. Mexico asked Turkey to explain the 
scientific basis for the proposed measures on pack aging, as it believed that the measures be a 
violation of intellectual property rights.  
2.38.  The representative of the European Union noted that although her delegation understood 
the objective of warning consumers about the risks of alcohol, and particularly those for young 
people and pregnant women, it found the content, format, and placement of the obligatory 
warning messages to be affixed on the packagin g of alcoholic beverages to be excessive. In 
particular, she noted that there already existed Turkish legislation forbidding the sale of alcohol to individuals under 18 years of age and on driving under alcoholic influence thus making it unnecessary to require using packaging logos that warned customers about the risks of alcohol. 
She also raised a concern with the obligation to affix on containers of alcoholic beverages the 
message "alcohol is not your friend", arguing that it was excessive consumption – not any consumption – that posed a risk to consumer heal th. The EU thus found the obligatory message to 
be misleading, as it gave the impression that even a moderate amount of alcohol consumption 
would be harmful to consumers. The EU considered that the measure's objective could be better achieved through information campaigns and consumer education initiatives stressing the danger G/TBT/M/61 
 
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  of excessive drinking or putting emphasis on re sponsible consumption of alcoholic beverages. The 
EU also noted concerns on the draft regulation on procedures and principles concerning domestic and foreign trading of alcoholic beverages. In particular, the EU was concerned with Article 4, which stipulated that the brand, identification or distinguishing signs used on alcoholic beverages 
could not be used on non-alcoholic beverages, and vice-versa. This could have the effect of 
prohibiting an EU brewer using a uniform mark for its entire product range from selling alcohol-free beer in Turkey if its variant containing al cohol was already on the Turkish market and vice-
versa.  
2.39.  The representative of the United States supported the concerns of Canada, Mexico and the 
EU relating to Turkey's draft regulation. She thanked Turkey fo r its 30 August 2013 response to 
US comments, and expressed appreciation for the 60-day comment period afforded by Turkey. 
She asked Turkey to explain the science behind the required warning statement "Alcohol is not 
your friend" to be placed  on alcoholic beverages. 
2.40.  The representative of Turkey informed that the proposed measures were prepared as 
secondary legislation to Law n. 6487 of 11 June 2013, which mandated entry into force of the 
secondary legislation within two months after the publication of the Law. He stated that due to the 2-month deadline, after the preparation of the secondary legislation by the relevant Tobacco and 
Alcohol Market Regulatory Authority, the comment period could only be provided until 9 August 
2013. Nevertheless, comments provided until and past this date had been accepted. He also noted that in response to requests, Turkey extended the comment period to 6 October 2013 by means of 
addenda to the original notifications on 29 August 2013, thus allowing Members a total of 60 days 
to comment. Turkey recalled that also on 29 Au gust 2013, it informed the relevant TBT Enquiry 
Points of other Members that although the comm uniqué and regulation had been published in the 
O f f i c i a l  G a z e t t e  o f  T u r k e y  o n  1 1  A u g u s t  2 0 13 in accordance with Article 2.9.4 of the 
TBT Agreement, additional comments would be evaluated and taken into account and that 
secondary legislation would possibly be re-exami ned and amended if considered necessary. With 
respect to Article 2.12 of the TBT Agreement, he st ated that importers, producers and distributors 
were provided a 10-month transitional period so as to allow them to adopt their products or 
methods of production to the new requirements. He clarified that the objective of the relevant measures was to provide better consumer information, as well as the protection of human health and safety, which embodied the protection of es pecially three internationally accepted target 
groups - minors, drivers and pregnant women - from the adverse effects of alcohol consumption. 
Turkey assured the Committee that the measures would not be adopted in a manner that would constitute arbitrary or unjustifiable discrimination or disguised restriction on international trade. 
Turkey stated that it would provide written replies to the comments it had received from several 
Members. 
2.2.1.15  United States — EPA Palm Oil Biofuels Regulatory Program  
2.41.  The representative of Indonesia raised concern over the U.S. Environmental Protection 
Agency's (EPA) Renewable Fuel Standard (RFS) program. He recounted that the U.S. Energy 
Independence and Security Act of 2007 established national mandates for biofuel use and established thresholds of greenhouse gas (GHG) emission savings versus traditional fossil fuels 
that individual biofuels must demonstrate in order to be considered "renewable" and count towards 
these mandates. To this end, EPA had required that biofuels represent a 20% reduction in GHG 
emissions over their entire lifecycle, including the consideration of any land-use change associated 
with the production of the biofuel's feedstock.  In 2011 the EPA published a notice of data 
availability regarding its analysis of the GHG li fecycle emission savings demonstrated by a number 
of biofuels. Biodiesel produced from palm oil, of which Indonesia was a significant producer and 
exporter, did not meet the EPA's threshold and thus did not qualify as a renewable fuel for the 
purposes of the RFS program's mandates. Indonesia argued that both the GHG emission savings threshold and the methodology for calculating a biofuel's lifecycle GHG emission savings were arbitrarily set. Noting that no international stan dard had been developed for renewable biofuel, the 
Indonesian representative reminded Members that the TBT Agreement required members to use 
international standards as the basis for domestic regulation and that such regulation should be as minimally trade-restrictive as possible. He noted that Indonesia was continuing to work with 
US officials to address its concerns. In March 2012,  Indonesia submitted to the EPA the results of 
its own calculations of the lifecycle GHG emission savings associated with biodiesel derived from palm oil. These results indicated lifecycle savings far above the threshold value of 20%, which 
would qualify Indonesian palm oil-derived biodiesel as a renewable fuel in the RFS. Indonesia G/TBT/M/61 
 
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  noted, however, that it did not receive a positive  response from the EPA regarding these submitted 
results. He added that Indonesia had invited EPA officials to come to Indonesia for the purpose of collecting first-hand data. The officials accepted and a visit took place in October 2012. Indonesia also recalled that it had expressed similar concerns during the Trade Policy Review of the US on 
18-20 December 2012, and received a response from the US that the EPA's analysis of palm oil-
derived biofuels was ongoing. The Indonesian repres entative concluded by reiterating its invitation 
to EPA to address its concerns regarding the GHG emission savings values assigned to Indonesian 
biofuels derived from palm oil, including full consideration of the alternative calculation submitted 
by Indonesia. The resolution of Indonesia's concerns, he said, would allow Indonesian palm oil intended for biofuel use to revive its position in the US market.  
2.42.  The representative of Malaysia joined Indonesia in raising concerns over the RFS. 
Specifically, Malaysia argued that the EPA's calculations of GHG emission savings values for palm 
oil-derived biofuels were based on erroneous assumptions and projections, including those pertaining to peatland expansion and the development of biogas plants. It added that the EPA's 
projections failed to take into consideration new policies and regulations that would result in a 
departure from historical trends. Indonesia note d that it had been engaging the EPA on the 
matter, but was still waiting for a response to comments and inputs that it had previously 
submitted.  
2.43.  The representative of the United States no ted that the US had not been informed prior to 
the meeting that this concern would be raised, so there had been no opportunity to receive 
instructions or consult with relevant regulators. The US would thus provide a response at the next 
Committee meeting having consulted with officials in the capital.  
2.2.2  Previously Raised Concerns 2.2.2.1  European Union – Registration, Ev aluation, Authorization and Restriction of 
Chemicals (REACH)
5 
2.44.  The representative of India reiterated concerns made at past meetings on: (i) the high cost 
of compliance for small and medium-sized enterprises (SMEs); (ii) the opaque and arbitrary 
functioning of the Substance Information Exchange Fora (SIEF), including cost associated; (iii) the 
definition of micro, small and medium-sized enterprises; (iv) the discrimination of not allowing traders to directly register; and the cost associated with hiring an Only Representative (OR). With the new threshold date coming into effect in 2014, a number of SMEs would be covered under the 
REACH legislation. As regards Commission Regulation 836/2012, prescribing a threshold 
concentration of 0.05% for the use of lead in jewellery, India asked whether the EU had issued guidance to parents and enquired for the ration ale of exemptions made for vitrose enamels and 
crystal. He requested the sharing of any scientific studies and risk assessment analysis mentioned 
in Regulation 836/2012. 
2.45.  The representative of Indonesia asked for clarification about, and voiced concerns on, a 
number of issues, including: (i) burdensome an d additional cost for Indonesian exporters; 
(ii) compliance by SMEs; (iii) the use of volume threshold for registration; and (iv) extensive and complex constant revision and frequent amendments to the legislation. 
2.46.  The representative of the United States  reiterated concerns on: (i) the treatment of 
nanotechnology; (ii) the precise meaning of the term "article"; and (iii) the overall impact on small 
and medium-sized companies. She also recalled concerns on the rationale of singling out one class of chemicals as regards nanomaterials, or on assessing the potential risk or market barriers for a 
broad range of products. She asked for any updates regarding an EU-wide central registry, and on 
the issuing of guidance on accepted measuremen t methods, implementation, or compliance. She 
further asked for clarifications as regards expect ations on nanomaterials in the REACH Annexes, 
and for further guidance on the differing interpretati on of the term "article". The lack of clarity and 
consistency across EU Member States led to confusion, higher costs of compliance, and the lack of a harmonized approach on the notification of substances of very high concern (SVHCs). She 
                                               
5 G/TBT/N/EEC/52 (+Adds.1-7) G/TBT/N/EEC/52/Add.3/Rev.1, G/TBT/N/EEC/295, 
G/TBT/N/EEC/295/Add.1; G/TBT/N/EEC/297, G/TBT/ N/EEC/297/Rev.1, G/TBT/N/EEC/297/Rev.1/Add.1; 
G/TBT/N/EEC/333, G/TBT/N/EEC/333/Add.1, G/TBT/N/ EEC/334, G/TBT/N/EEC/334/Add.1; G/TBT/N/EEC/335, 
G/TBT/N/EEC/335/Add.1; G/TBT/N/EEC/336,  G/TBT/N/EEC/336/Add.1; G/TBT/W/208 G/TBT/M/61 
 
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  informed on a survey conducted by the Dutch Ministry of Infrastructure and the Environment 
regarding the potential impact of registration requirements on its SMEs that had found higher costs of implementation and compliance with REACH than previously foreseen, and lower awareness among SMEs than expected. The su rvey confirmed concerns voiced in the 
TBT Committee on insufficient knowledge or available information on compliance with REACH; 
costs of compliance and for participating in SIEFs, including adverse impacts through the imbalance of power among SIEF participants; as well as downstream users experiencing problems 
with drafting, interpreting, translating, distributing and updating of Safety Data Sheets 
(SDSs/eSDSs). She enquired how findings and reco mmendations of this study would be taken into 
account. 
2.47.  The representative of the Philippines reiter ated concerns on the impact of REACH on SMEs, 
specifically with regard to high costs and predictability. 
2.48.  The representative of the European Union recalled that her delegation's support for SMEs 
had been analysed in the REACH review of February 2013. She stressed that the Commission was 
currently working with the European Chemicals Agency (ECHA) on an implementation working 
plan. As an immediate action, through Commissio n Implementing Regulation No. 254/2013 of 20 
March 2013, the Commission had revised ECHA fees with a further increase in reduction for SMEs. 
The Commission had also asked ECHA to nominate an SME ambassador to initiate and coordinate 
ECHA activities, and was considering the need to revise and produce new guidance documents with regard to the operation of SIEF and data sharing. She said that the Commission was launching a technical assistance study to advise Member States on how to assess the impacts of 
proposed restrictions on SMEs. 
2.2.2.2  India - Pneumatic tyres and tubes for automotive vehicles 2.49.  The representative of Japan expressed concern on Article 10.2 of the revised "Agreement 
for the Granting of BIS licence", under which only  foreign tyre manufacturers were required to 
provide a bank guarantee of USD 10,000. Japan re quested India to amend this clause and to 
improve the ISI Marking fee calculation method. The ISI Marking Fee was charged for all tyres 
manufactured in India, as well as those imported into, or exported outside, the Indian Market. 
Japan considered that tyres exported outside Indi a should be exempted from the ISI Marking Fee, 
and asked for clarification on the total payment for the ISI Marking Fee. 
2.50.  The representative of the European Union reiterated longstanding concerns with regard to 
the Order's certification procedure and mandatory marking for tyres. First, the EU requested 
removing the bank guarantee of USD 10,000 for the payment of royalty fees, which only applied to foreign manufacturers. Secondly, of particular concer n were the royalty fees to be paid on the total 
production of tyres produced and marked with ISI marking. She urged India to remove the royalty 
fees or to modify their calculation with a view to limiting them to tyres de facto  exported to India. 
Finally, she requested India to accelerate the rather slow certification process and to consider 
extending the validity of the licences for more than only two years. 
2.51.  The representative of Korea reiterated previous concerns regarding marking fees that 
appeared significantly unjustifiable and unreasonable and were imposed only on tyres imported to 
India. Compared to similar marks issued by other countries, these fees were considerably higher 
for the ISI system. He said that most countries in general did not charge marking fees for tyres. 
Korea urged the Indian authorities to revoke or  amend the requirement and to provide evidence 
that marking fees were comparable or even lower than those by other Members. He also requested 
India to repeal the USD 10,000 performance bank guarantee required for foreign tyre 
manufacturers outside India and to achieve objectives in a non-discriminatory manner. 
2.52.  The representative of India replied that the bank guarantee fee was intended to protect the 
Bureau of Indian Standards (BIS) from breach on  behalf of the licensee during the tenure of the 
licence, and covered a civil liability that might aris e during the period of the licence or thereafter. 
He said that bank guarantees were prevalent in international trade, specifically with regard to performance of contracts. He also explained that  once a tyre was marked with an ISI mark, the 
liability fell on the agency providing the particular mark, while the possibility of the particular tyre 
being re-exported back to India could not be exclud ed. India believed that its overall fee structure 
was comparable to, if not lower than, those a pplied by other Members. On the speed of the G/TBT/M/61 
 
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  certification process, he had been informed that BIS labs were managing their workload 
adequately. 
2.2.2.3  India – Mandatory cert ification for steel products  
2.53.  The representative of the European Union welcomed India's biennial exemption on imports 
of steel and steel products and enquired how this would work in practice. Nevertheless, the EU 
considered third party certification to be inappropriate and too burdensome for intermediate steel products. She noted that European industry continue d to report difficulties during the certification 
procedure, including long delays for issuing certificates, extensive and detailed information to be 
provided, mandatory factory inspections, the la ck of feedback on reasons for refusal of 
applications, and the lack of recognition of test results carried out by foreign laboratories. She asked India to institute a more expeditious proced ure with clear deadlines and the possibility to 
challenge the refusal of the application. 
2.54.  The representative of Japan considered that there was no need to impose mandatory 
standards on intermediate goods such as steel products, as the protection of human health or 
safety could be achieved by safety regulations for final products. He said that the scope of the 
standards would have to be specified clearly, and that mandatory standards should be implemented in a manner that did neither obstruct customs and other importation procedures, nor 
disrupt Japanese supply of high-quality steel products. He also asked for clarification on the rules 
of exemptions with regard to the standard on structural steel (IS2062) that applied to steel used in the construction sector, but not to steel used in the manufacturing sector, such as automobiles. 
2.55.  The representative of India reiterated that, subject to certain conditions, exemptions had 
been provided to projects in infrastructure, petroleum and to manufacturing products involving 
high end technologies, nuclear reactors, defence chemicals and petrochemicals and fertilizer sectors. As regards implementation of notified goals, he said that certain conditions were 
applicable to all projects. India informed that one of the Orders of the Ministry of Steel, issued on 
1 October, had extended the date of application for certain products to 1 April 2014. Hence, he considered that most of the industry concerned in terms of adaptability to this Order had been 
addressed. The regulation applied to all sectors with not specific exemption in place. 
2.2.2.4  Brazil – Health Products Good Manuf acturing Practices (GMP) Requirements for 
Health Products  
2.56.  The representative of the European Union welcomed the bilateral meeting held with Brazil 
on its procedures for the registration of medical devices as well as its efforts to accelerate 
inspections. She requested an update on further step s to be taken, in particular on whether Brazil 
intended to rely on or accept Good Manufacturi ng Practices (GMP) inspections reports issued by 
foreign authorities. 
2.57.  The representative of Brazil reiterated that Decree n. 8077 was published in the Brazilian 
Official Gazette on 14 August 2013, revoking Decree n. 79094 of 1977. With this new Decree, the 
National Health Surveillance Agency (ANVISA) had autonomy to define products that would require 
GMP certification for registration, and those cases in which other health authorities or accredited bodies' inspection reports could be accepted to issu e the GMP certification. He said that Brazil was 
moving towards more flexibility with respect to the requirement to issue GMP certificates. ANVISA 
would soon publish a draft technical regulation defining the requirements to obtain 
GMP certification so as to make the whole process faster and friendlier. He said that the draft text would be notified to the Committee for comments. The new technical regulation revoking 
Resolution n. 25/09 was intended to enter into force at the beginning of 2014. The Brazilian 
delegation recalled the importance of setting up confidentiality agreements between ANVISA and health authorities of other Members to enable data exchange related to inspection reports. G/TBT/M/61 
 
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  2.2.2.5  India - New Telecommunicati ons related Rules (Department of 
Telecommunications, No. 842-725/2005-VA S/Vol.III (3 December 2009); No. 10-
15/2009-AS-III/193 (18 March 2010); and Nos. 10-15/2009-AS.I II/Vol.II/(Pt.)/(25-
29) (28 July 2010); Department of  Telecommunications, No. 10-15/2009-
AS.III/Vol.II/(Pt.)/(30) (28 July 2010) an d accompanying template, "Security and 
Business Continuity Agreement")  
2.58.  The representative of the European Union requested an update on recent developments 
regarding security clearance requirements for equipment to be used in telecommunication 
networks as laid down in the Uniform Access Lice nce Agreement. It posed the following questions: 
Would India continue to accept self-certification by equipment vendors in light of postponement of 
implementation until 1 April 2014? Would a "Telecom Testing and Security Certification Centre" be 
only set up in Bangalore? Would this Centre have the capacity to process all expected applications 
for testing and certification? Could India confirm the possibility for foreign labs to be approved by Indian authorities, and  to supply test reports  which will constitute a sufficient basis for the 
issuance of required certification? India had recently been recognized as "authorising member" 
under the Common Criteria Recognition Arrangement (CCRA) and would thus be able to test electronics and IT products and to issue certificates with respect to information security accepted 
in all other 25 CCRA Members. Could India therefore confirm that it will accept test results of labs 
appointed by CCRA Members for the purposes of the required security clearance assurance? The competence of labs operating under the CCRA is established through a very rigorous process and, hence, they should be allowed to perform any of  the tests required by the Indian authorities. 
Finally, India's Department of Telecommunications had issued final guidelines for the granting of 
Unified Licence on 19 August 2013, which contained a template for the licence agreement laying down in its chapter 6 the required security conditions and prescribing compliance with a number of 
security standards, including the CCRA standards. Could India clarify whether this document is the 
final technical guidelines for the implementation of security clearance requirements, or whether a 
more detailed guideline would still need to be issued. In this regard, the EU stressed the need for 
greater clarity and predictability in the implemen tation of the scheme and the avoidance of market 
disruptions.  
2.59.   The representative of the United States welcomed India's extension for compliance to 
January 2014. She also expressed her delegation's continuing disagreement with India's premise 
that domestic testing was necessary or sufficient to meet its legitimate security concerns. While 
the US welcomed India's acceptance to the CCRA as a certifier, it was concerned with the process of recurring three-month extensions, causing the industry to be continuously preoccupied with the 
imminent implementation of the requirement, and with implications for the broader investment 
climate. Finally, she noted the practical challe nges posed for the implementation of telecom 
requirements, including India's lack of testing capacity and infrastructure. She urged India to 
consider postponing the implementation date with a view to testing requirements and the needs of 
industry to comply with the tests. 
2.60.  The representative of Japan supported the concerns expressed by the EU and the US. Japan 
had an interest in the Unified Access Service Lice nse Agreement and asked India to ensure that its 
telecommunications regulations would not impede market access for foreign companies. 
2.61.  The representative of India clarified that th e relevant notification had specified an extension 
of time for security certification of telecom equipment within the country in respect of licence 
amendment, dated 3 June 2011, for security related concerns for expansion of telecom services in 
various zones of the country. While the specific date for internet service providers was 30 June 
2014, he would enquire for the exact end date on the unified licence agreement certification. Due 
to its upgrading under the CCRA, India's guideline had referenced the Common Criteria Labs as 
being able to certify until 30 June 2014, with certification being conducted by authorised certified agency labs in India from 1 July 2014 onwards. He said that he would revert back on the certification centre in Bangalore. In terms of in-country testing, he clarified that India was 
addressing the problem of spyware and malware attacks on telecom equipment. 
2.2.2.6  Korea – KS C IEC61646:2007 Standard for Thin-film Solar Panel 
2.62.  The representative of the United States continued to have serious concerns regarding 
methodologies and scientific flaws employed in Korea's environmental study, which had led to the 
exclusion of a certain type of solar panel manufactured in the US from its certification programme. G/TBT/M/61 
 
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  The results of this study would hence de facto  determine access to the Korean market, leading to 
market access issues for US producers. 
2.63.  The representative of Korea referred to bilateral meetings and Korea's suggestion of holding 
an expert-level dialogue. He informed that, following last June TBT Committee meeting, 
certification for CIGS modules had started in July 2013 on a pilot basis with the certification 
system scheduled to officially start at the beginni ng of 2014 when preparation for certification of 
the CIGS module, including test criteria and relevant facilities, was completed. Korea would refer 
other points raised to their competent authorities. 
2.2.2.7  China – Requirements for informatio n security products (including, inter alia, 
the OSCCA 1999 Regulation on commercial encryp tion products and its on-going revision 
and the Multi-Level Protection Scheme (MLPS) 
2.64.  The representative of Brazil said that the proliferation of independent standardization 
activities for security products might create uncertainty and unnecessary technical obstacles to 
trade, contrary to Article 2.2 of the TBT Agreem ent. According to best practices, cryptography 
standards for civil goods should be based on multilateral standardization rules in accordance with 
the "Decision of the Committee on Principles for the Development of International Standards, Guides and Recommendations with Relation to Ar ticles 2, 5 and Annex 3 of the TBT Agreement" 
(G/TBT/9, 13 November 2000, para. 20 and Annex 4). In line with Article 2.4 of the TBT 
Agreement, he stressed that ITU standards and recommendations on cryptography to privacy and 
data confidentiality had to aim exclusively at the protection of the transactions performed. 
2.65.  The representative of the European Union supported Brazil's comments and reiterated some 
systemic concerns about the Chinese regulatory landscape on ICT security, including on 
transparency, opportunities for foreign stakeholders to participate in the regulatory and standardisation process, and predictability of the regulatory regime. As framework conditions 
continued to be not very conducive to a predictable business environment, he requested specific 
updates on several issues. First, he enquired on an update on process and substance of the 
revision of the 1999 Regulation on commercial en cryption products by the Office of State 
Commercial Cryptography Administration (OSCCA).  The representative reiterated the need for 
transparency in the process, domestically (i.e. public consultation) and in the WTO (i.e. TBT notification). On substance, he welcomed an indi cation of elements being considered to remove 
current discriminatory aspects, which failed to allow foreign companies to apply for certification. 
Second, on the Multi-Level Protection Scheme (MLPS) , he welcomed the launch of a revision of this 
scheme and requested that a clear distinction be made between IT systems for commercial use and those relevant for national security. He said that more stringent national security 
requirements should be limited to areas where national security was genuinely at stake and 
stressed the lack of a clear definition of "critical infrastructure". The development of such a definition as well as of a catalogue of systems that would fall under this definition were necessary 
to increase predictability in the application of the scheme. He further reiterated the need for all 
interested parties (including non-Chinese companies or nationals) to participate in the standards process and asked China to consider ways to open the process of developing and releasing algorithms to be used in commercial encryption products to all interested parties (consistent with 
international practice providing for peer review of algorithms in global consortia or international 
standard-setting bodies), and to publish the license conditions for acceding to these. Lack of transparency and inclusiveness in the process was potentially detrimental to the reliability of 
algorithms to ensure the level of protection requ ired. As an example, the national standard for 
mobile payments did not define the actual algorithms, but only included a generic reference to an Algorithm E, to be determined at a later stag e by OSCCA. No further details on the algorithm 
development process, and licensing conditions to interested users were available. Finally, he 
requested that standards developed by standardisation organisations under the direct control of central governmental bodies comply with the TBT Agreement's Code of Good Practice. 
2.66.  The representative of the United States an d Japan reiterated support for Brazil and the EU. 
The representative of Japan paid particular attention to the various schemes and regulations within 
China with regard to how these could negatively affect trade of information security products. 
2.67.  The representative of China informed that a revision process had started with regard to the 
MLPS. For further concerns, she referred to minutes of the previous meeting. G/TBT/M/61 
 
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  2.2.2.8  China - Provisions for the Administ ration of Cosmetics Application Acceptance 
Cosmetics Label Instructions Regulation s and Guidance for the Cosmetics Label 
Instructions. 
2.68.  The representative of Japan requested China to accelerate the examination of new 
ingredients as only three new ingredients had be en registered since the implementation of the 
Guidance in May 2011. Japan also considered requirements with regard to safety data on isolated components of plant extracts and fermented solutions as excessive and trade-restrictive. Japan 
requested China to revise the Guidance, taking into account the practices of safety evaluation of 
cosmetic ingredients currently taken in many countries, including Japan, the US and the EU, with a view to cosmetic manufacturers being able to register new ingredients without additional processes. In addition, Japan asked China for an explanation on (i) scientific grounds for 
evaluating a complex ingredient with a single component; and (ii) the assumed risk on the product 
safety. 
2.69.  The representative of the European Union considered that there was still a lack of sufficient 
progress in the approval of new ingredients and of cosmetic products with new ingredients. She 
recalled that since 2010 only four new ingredients (and one product containing a new ingredient) had been approved, although 120 applications had been made and several hundred new 
ingredients introduced safely outside China. Further improvements were therefore needed with 
regard to the burdensome registration process and the speed, efficiency and predictability for this fast-moving and innovative sector. The EU believed that significant further efforts were necessary to ensure that the registration of ingredients and of products with new ingredients increased to 
levels comparable with those prior to the introduction of these requirements. She asked for an 
update from China on the steps taken to solve the situation. The EU was also concerned about China's State Food and Drug Administration's (CFDA) intention to pursue a systematic positive list 
approach for cosmetics ingredients, and the defini tions of "new" and "exist ing" ingredients. Given 
that an important number of ingredients and cosmetics products currently sold in China might be subject to the above-mentioned onerous registra tion procedure, China should reconsider its 
approach. Finally, she recalled previous concerns  on the new cosmetics labelling requirements 
(notified as G/TBT/N/CHN/937) possibly introducing duplication of, or even conflict between with, 
the CFDA and the Administration of Quality Superv ision, Inspection and Quarantine (AQSIQ). She 
asked for an update from China on the state of play of this notification. 
2.70.  The representative of the United States associated herself with points made by previous 
speakers. The reclassification of special function cosmetics in June 2011 had resulted in a virtual 
standstill in approvals for cosmetics containing new ingredients causing a serious impact on 
US cosmetics companies. She asked for an update  on China's efforts to expedite approval and 
expressed concerned about the CFDA's creation of a "positive list" of ingredients, requesting China 
to instead allow companies to demonstrate that ingredients were "existing" by means other than 
appearance on a positive list. She asked for clarification on the CFDA's stated intention to devolve 
responsibility for managing "normal cosmetic" registrations to provincial-level authorities, and inquired whether these would have adequate training and resources. She asked China to provide assurance that provincial-level authorities would be treating imported "normal cosmetics" in the 
same manner as they had treated locally manufactured products. With respect to the notification 
in G/TBT/N/CHN/937, she noted an overlap of requ irements with existing AQSIQ regulations. She 
also requested that the CFDA address existing conc erns on the failure to provide alternative means 
of labelling small packages that lacked enough  surface area to carry all the information as 
required. 
2.71.  The representative of Canada and the representative of Korea shared the concerns raised by 
previous Members. 2.72.  The representative of China said that her delegation had been cooperating closely with their 
trading partners in the implementation of the regulation. China had formed a working group on 
this issue with the EU, Japan and Korea to keep continuous communication and discussion at both 
administrative and technical levels. China believed that the specific technical issues as well as the 
smooth implementation of the regulation could be solved by bilateral open and transparent 
communications between technical experts. She reiterated that the cosmetic label instruction 
regulations and guidance had been notified on 21 December 2012 as G/TBT/N/CHN/937, but that 
an adjustment in the CFDA's legislation plan had taken place that might lead to the possible introduction of new regulations administrating cosmetics labels in the future. G/TBT/M/61 
 
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  2.2.2.9  France - Loi No. 2010-788: The Na tional Commitment for the Environment 
(Grenelle 2 Law) 
2.73.  The representative of India thanked France for the presentation made in the WTO 
Committee on Trade and Environment (CTE) on 16 October, which provided details regarding the 
national commitment for the environment containe d in the Grenelle 2 Law. He said that the 
Grenelle 2 Law used a simplified lifecycle analysis and was currently based on voluntary participation. He also understood that a report of the results of the experimental phase of the 
Grenelle 2 Law had been submitted to the French Parliament for review and that next steps would 
be determined after the review had taken place. He requested an update regarding the status of such assessment report and the next steps, and raised concerns regarding the benchmarking of 
the Grenelle 2 Law against the ISO carbon footprin t standard and the limitations of the lifecycle 
analysis throughout the experiment. 
2.74.  The representative of Brazil thanked the EU for their bilateral discussions. He also raised 
concerns over the lack of transparency of the Gren elle 2 Law, and encouraged the EU to notify the 
relevant measures to the Committee. Additionally, he inquired about the meaning of the word 
"generalisation" employed in Article 2.28 of the Grenelle 2 Law, indicating that "this text will be subjected to the parliament and will evaluate the opportunity for generalisation of this provision". 
Finally, he requested an update regarding the revi ew by the French Parliament, and clarification 
over whether the emissions resulting from the international transport of the products would be included in the computation of the carbon footprints. 
2.75.  The representative of Argentina reiterated previously raised concerns and recalled that at 
the March 2012 Committee meeting the EU said that the results of the experiment would be made 
available at the beginning of 2013. He asked for an update on this aspect and also whether the results had already been submitted to the French Parliament, and how they could be accessed.  
2.76.  The representative of the European Union reiterated that the Grenelle 2 Law did not contain 
technical regulations and provided only for an ex periment concerning environmental labelling. She 
invited Members to refer to minutes of past meetings with respect to the objective and scope of 
the experiment. The results of the experimental phase were evaluated by the French Government 
in autumn 2013, and her delegations was prepared to share information about the results of the 
experiment and future developments as soon as the information became public. 
2.2.2.10  Peru - Draft Supreme Decree Approving the Regulations Governing the 
Labelling of Genetically Modified Foods 
2.77.  The representative of the United States thanked Peru for their bilateral discussions. She 
requested an update on the status of the proposed labelling requirements, and recalled concerns 
raised by several Members about potential impacts on trade. She suggested that mandatory 
labelling requirements for genetically engineered foods that were substantially equivalent to conventional foods could give the false impression that the labelled food or feed was substantively 
different from, or less safe than, the conventional equivalent. She also said that mandatory 
labelling requirements were likely to increase costs to industry, consumers and government authorities. Her delegation believed that voluntary labelling would allow for consumer choice at a lower cost and with less trade disruption. She sought clarification as to how Peru was taking the 
comments of other Members into consideration when  finalizing the measure, and encouraged Peru 
to continue to work with stakeholders so that any final measure would be practical and implementable within standard industry practices.  She also noted that any revision to the draft 
regulations should be notified to the WTO. Sh ould Peru decide to move forward with the 
implementation of the regulation, she requested fu rther clarity on the scope of the requirements 
as well as the implementing mechanism for monitoring, supervision, verification and compliance. 
2.78.  The representative of Peru explained that there had been no progress regarding the draft of 
the regulation since the June 2013 Committee meeting, and that the expected date of publication 
of the technical regulation was not yet established. G/TBT/M/61 
 
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  2.2.2.11  Russian Federation – Draft Techni cal Regulation of the Customs Union on 
Alcoholic Products Safety  
2.79.  The representative of Australia reiterated that Australia and the Russia Federation shared a 
commitment to adopting international standards for alcoholic products as set out by the 
International Organisation of Vine and Wine (OIV), and to avoid the creation of unnecessary 
obstacles to trade in wine. He recalled that his delegation had submitted comments on Russia's notification in February 2013, which focused on  commonly used additives and processing aids, 
identified by the OIV, which did not affect the safety of alcoholic products. Australia noted that 
several Members were concerned about the regulation, and recalled his delegation's suggestion that Russia consider adopting the OIV list of appr oved additives and processing aids, as set out in 
the International Oenological Codex and the International Code of Oenological Practices. He 
continued to seek clarification about the legal status of wines which conformed to the health 
warning statement under the previous legislation, and were in circulation at the time the draft 
regulation entered into force. Once more, he suggested that Russia introduce a six month 
transition period for those products so as to enab le industry sufficient time to implement the new 
labelling requirements. He asked Russia to confirm whether wines labelled with an Australian "geographical indication" (GI) would be considered as a protected GI under the new technical 
regulation, and whether the relevant exemptions from the regulations for protect GIs would apply 
to them. He also requested clarification about re quirements relating to the bottling location of 
wines that include a GI in their description and presentation. He asked whether the Eurasian Customs Union regulations required such wines to be bottled within the boundary of the GI stated 
in the description and presentation of the wine. 
2.80.  In addition, the representative of Australia raised a number of new issues. He expressed 
concerns about the proposed notification process for the declaration of conformity requirements 
contained in Resolution No. 474 "On Submission of  Notifications about the Beginning of Turnover 
(sale) of Alcoholic Products in the Territory of the Russian Federation", which may present an undue administrative burden for wine exporters. The requirement that exporters ensure that all 
information relating to their product on the Federal Register be up to date would require exporters 
to re-notify the Russian authorities of, for example,  a new vintage date on the label of a wine that 
was exported, or a packaging size change, in response to customer requirements. Australia believed a robust regulatory system could be maintained within the Eurasian Customs Union 
without requiring such detailed information from exporters. Finally, Australia sought clarification on 
issues pertaining to the enforcement of the Eu rasian Customs Union requirements. For example, 
further information on the sanctions that would be put in place if an exporter failed to meet the 
notification requirements. 
2.81.  The representative of the European Un ion inquired about the status and timeline for 
adoption of the regulation, and summarized previously raised concerns. Regarding wines, she 
reiterated that enrichment with "concentrated must", "rectified concentrated must" or "sucrose" 
should be allowed under the measure for all types of wines, since these were oenological practices 
widely accepted at internationally level. She said bottling in the country of destination should also be allowed for all types of drinks with protected GI or designation of origin. Regarding beers, the 
limit on sugar content should be eliminated and th e use of fruits and additives should not trigger 
the obligation to label beers containing such components as "beer beverages". She also asked for assurances that EU GIs were duly protected and that some missing definitions of alcoholic drinks 
were added to the regulation. She requested confirmation that the production control procedures 
and conformity assessment procedures would not be applicable to production sites that had been already controlled by EU national authorities. Fi nally, she suggested that Russia reconsider the ban 
on PET packaging and to notify such measures to the Committee. 
2.82.  The representative of Mexico supported the comments of Australia and the European Union 
and expressed her delegation's concerns on the duplication of requirements already found 
elsewhere, and requested a reasonable period of time for the implementation of the regulation. 
She also inquired about the status of the regulation  and its date of entry into force, and requested 
a formal response to their comments. 
2.83.  The representative of the Russian Federati on said the draft technical regulation was being 
developed in order to establish unified requiremen ts for turnover of alcoholic products - both 
imported and domestically produced. A public hearing on the draft technical regulation was 
completed in December 2011, prior to Russia's accession to the WTO. In accordance with the TBT G/TBT/M/61 
 
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  Agreement, all interested parties were given opportunity to provide their comments during a 
60-day comment period. At the moment, the draft technical regulation was being modified and the comments of Members were being reviewed. The draft technical regulation had not been approved and Russia was actively engaged in bilateral consulta tions. The draft provisions on the notification 
procedure were excluded from the text. He mentio ned that in accordance with Resolution No. 474, 
as of 5 June 2013, a legal entity would have to provide information on the product to the Federal Service of Alcohol Market Regulation in electronic form on a once off basis. Information provided in 
such notifications would be publicly available at  the website of the Federal Service of Alcohol 
Market Regulation. Given that at all stages of the procedure information would have to be provided by electronic means, his delegation believed th at it would not be burdensome for economic 
operators. The objectives of the notifications procedure were exclusively related to information and 
greater transparency of the market. Regarding th e definitions of various alcoholic products and 
references to OIV, Russia considered the definitions provided by OIV as relevant international standards and there were intentions to review cert ain provisions of the draft accordingly. On the 
issue of GI, the regulation did not contain a list of alcoholic products with protected GI. In addition, 
the ban on the use of PET bottles was eliminated from the text of the draft and the draft did not 
set requirements on the use of additives. Finally,  he expressed Russia's willingness to continue to 
engage in bilateral consultations with interested WTO Members. 
2.2.2.12  Korea— Registration and Ev aluation of Chemical Materials  
2.84.  The representative of the United States thanked Korea for their bilateral discussions and 
highlighted three main concerns: (i) that all new chemicals must be registered, which could have 
far-reaching impacts and particularly seriously disrupt product development for semiconductors, 
phones, LED TVs, and other household and industri al products; (ii) the sharing of proprietary 
information within the supply chain; and (iii) the onerous reporting requirements under the 
measure, which could be expensive. She also requested an update on the status of the 
implementation of the Act, and asked whether products on the market under TCCA must be re-registered under REACH. 
2.85.  The representative of Japan supported the statement of the US. He also requested Korea to 
review the Act taking into account Japanese concerns. The representative of Japan requested an 
exemption for new chemical substances of small volume similar to the exemption provided for by Japan, the US, Canada, Switzerland, Australia and the Philippines, as the policy objective of the 
Act was to protect human health and the environment by managing chemical substances according 
to the results of assessments of the chemicals ha zard and risk, but did not provide an exemption 
for new chemical substances of small volume, making the Act more trade restrictive than 
necessary to achieve its objective. In order to ensure enhanced transparency, he requested Korea 
to provide foreign enterprises with opportunities to  express their opinions on the designations of 
permissible, restricted or banned chemicals as re sults of hazard evaluations and risk assessments. 
Finally, the representative of Japan asked for clarif ication regarding the protection of confidential 
business information and the penalties for its illegal disclosure. 
2.86.  The representative of Switzerland supporte d the remarks made by Japan, especially on the 
issue of the protection of confidential business information. 
2.87.  The representative of Korea informed that  the Presidential Decree and Ministerial Ordinance 
were being drafted, and that the Act would be fi nalised by the end of 2013 and shared in early 
2014. She explained that a consultative group incl uding industry was consulted and that the Act 
would reflect these discussions. She also recalled that the purpose of the Act was to protect 
human health and the environment from the risk of  chemicals, by producing and sharing necessary 
data. Driven by recent chemical accidents, Korea aimed at establishing a precautionary chemicals 
management system: in April 2011, chemicals contained in humidifier disinfectants caused acute 
lung injuries and 111 deaths; and in September 2012, leakage of hydrofluoric gases in Gumi 
caused five fatalities and enormous financial damages. These accidents were mainly attributed to the lack of available information regarding the use and toxicity of chemicals, as well as to the 
inadequate knowledge on handling practices in work places. The Act reflected therefore the need to 
avoid similar accidents.  
2.88.  She then addressed certain concerns raised by the US, Japan and Switzerland based on the 
discussions taking place within the consultative group. Regarding the exemption for new chemical 
substances of small volume, she said that given that the Act intended to reduce risk arising from G/TBT/M/61 
 
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  unknown chemicals, new chemicals were a major target. However, from the perspective of 
effectiveness, she considered that differentiated approaches to new low volume chemicals were appropriate. In this regard, the consultative group was having discussion to seek more reasonable ways to maintain the purpose of the Act, to pr omote its effective implementation, and to reduce 
industry burden. These discussions included measures to simplify and shortened registration 
procedures. Regarding the designation of authorised , restricted or banned chemicals, she said that 
Korea decided to put in place various measures, including public notice of designation and 
collecting opinions from stakeholders such as foreign companies, and consultations between 
relevant ministries and the Chemicals Evaluation Committee. Finally, on the issue of confidential 
business information, she explained that they would be protected at a similar level to other Members like the EU, the US and Japan, and recalle d that the Act stipulated data protection. For 
instance, Article 45 of the Act stated that, if requested, dossiers submitted for reporting, 
registration, hazard review and risk assessment should not be opened to the public. Likewise, on information shared between manufacturers/importe rs and downstream users, the Act excluded 
information directly related to business secrets such as chemical composition and manufacturing 
processes. 
2.2.2.13  European Union - Directive 2009/ 28/EC, Renewable Energy Directive (EU - 
RED)  
2.89.  The representative of Indonesia reques ted information on the calculation method for 
determining sustainability criteria under Articl e 17 of the amendment of Directive 2009/28/EC. He 
also asked whether EU's rapeseed fulfilled the su stainability criteria of 60% of GHG savings and 
inquired on other sources of renewable energy used by the EU. 
2.90.  The representative of Malaysia supported the statement of Indonesia and reiterated his 
delegation's concern over the discriminatory treatm ent of palm based biofuel under the EU – RED. 
Palm-based biofuel was given a lower default greenhouse gas emission saving value compared to 
biodiesel from other competing raw materials, such as rapeseed oil. He explained that this disadvantaged palm-based biodiesel in terms of access to the EU market. Malaysia had conducted 
research on the greenhouse gas emissions saving of palm-based biodiesel, and the results 
indicated high emissions savings compared to the EU assessment under the EU - RED. He urged the EU to consider the technical data Malaysia submitted to the Joint Research Centre of the European Commission and the Europe an Commission. A revision of default values for palm-based 
biodiesel using the data offered by Malaysia would provide further market opportunities for 
Malaysian biodiesel producers. Finally, he said that the EU – RED significantly reduced the market opportunity for Malaysia's farm-based biofuel and that Malaysia continued to monitor the extent of 
the negative impacts of the EU – RED. 
2.91.  The representative of Argentina informed the Committee that a case had been initiated in 
the DSB against the EU "Certain measures on the Importation and Marketing of Biodiesel and 
Measures Supporting the Biodiesel Industry" (DS 459). Consultations with the EU and certain 
Member states had taken place on 26-27 June 2013 regarding directives 2009/28 and 2009/30. 
2.92.  Argentina reiterated concerns previously expressed regarding what it considered to be an 
arbitrary threshold of 35% of GHG reductions for biof uel to be considered sustainable. He said that 
this threshold could not be scientifically justified nor was based on international standards, and 
that it created an unnecessary obstacle to international trade. The challenged Community regulation established a default value of 31% for soybean biodiesel. Therefore soybean biodiesel 
could not comply with the GHG reduction thresh old. This led to an assessment and approval 
procedure that imposed additional costs on Argentine industry. Argentina requested this default value to be corrected in the Annex of these Directives. 
2.93.  Argentina stated that the current European normative framework, its proposed 
modifications and the different investigations driven  by the European industry against biodiesel of 
non-Community origin, aimed to protect the highly oversized local industry.  
2.94.   The representative of the European Union considered that the TBT Committee was not an 
appropriate forum for discussing this issue. She said that the EU remained open to further bilateral 
exchange in this regard. G/TBT/M/61 
 
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  2.2.2.14  Indonesia - Technical Guidelines fo r the Implementation of the Adoption and 
Supervision of Indonesian National Standards for Obligatory Toy Safety - Draft Decree of the Ministry of Industry on Mandatory Impl ementation of Indonesia National Standard 
and Technical Specification for Toys 
2.95.  The representative of the European Union thanked Indonesia for their bilateral discussions. 
He recapitulated the chronology of the measur e: on 12 April 2013, the Indonesia Ministry of 
Industry adopted Decree No. 24, concerning the mandatory application of the Indonesian national 
standard for toys, with an entry into force foreseen for 12 October 2013; then, on 24 September 
2013, technical guidelines supporting the Decree were issued, and on 9 October 2013, the training of customs officers responsible for taking the samples of imported toys for testing purposes started; finally, on 16 October 2013, the Ministry of Industry adopted Regulation No. 52 appointing 
8 Certification Bodies and 7 laboratories responsible for the testing and certification under Decree 
No. 24, with entry into force with immediate effect. The representative of the EU inquired whether his delegation's understanding of the chronology of the measure was correct and highlighted that 
an immediate entry into force was likely to disrupt the importation of toys, as customs officers 
were not yet trained and the laboratories and certification bodies had just been appointed. He therefore requested Indonesia to consider postponing the entry into force of the measure. He then 
recalled the following previously raised concer ns: (i) that conformity assessment procedures 
provided for in Decree No. 24 were more burdensome for imported products (i.e. testing of each shipment as compared with samples taken every six months from the production line for domestic products); (ii) whether Indonesian certification bodies would accept test reports from foreign 
laboratories accredited by signatories to the ILAC MRA, and whether this would be sufficient for 
the acceptance and usability of foreign conformity assessment results; (iii) the need to exempt companies that held an ISO 9001 certificate issued by a certification body accredited by a 
signatory to the IAF MRA from the annual factory audit; and (iv) that restrictions for phthalates, 
azo dyes and formaldehydes were unclear. Finally,  he raised a new concern with respect to the 
requirement for a list of production equipment to  accompany a request for certification, and asked 
what the rationale for that requirement was. 
2.96.  The representative of the United States  supported the statements made by the EU. She 
expressed disappointment at the implementation of  the regulation despite numerous questions and 
concerns, and repeated requests for a delay. She was also concerned about the different product 
testing requirements for domestic and imported pr oducts. Furthermore, she indicated that bilateral 
MoUs appeared to be necessary for the results of conformity assessment procedures, and urged Indonesia to use bodies accredited by ILAC. Finall y, she requested the suspension of the regulation 
until the concerns were addressed. 
2.97.  The representative of Indonesia informed that the Regulation No. 24 entered into force on 
12 October 2013, and that Indonesia could not extend the date of entry into force for reasons of 
safety, health and consumer protection. Regarding technical guidance, she said that they were 
stipulated in Regulation No. 9 of 23 September 2013, which covered standards coverage, the procedure to obtain a certificate of using an SNI mark, testing methods, and marking requirements. In the context of conformity assessment procedures, she explained that the 
certification scheme conducted by Indonesia was based on ISO/IEC Guide 67:2004. On the issue 
of testing, the Ministry of Industry designated  several testing laboratories accredited by the 
National Accreditation Body (KAN) and the designation of conformity assessments bodies was 
stipulated through Regulation No. 52. Finally, regarding chemical substances, the limit of 
phthalates was set at ≤0.1%, and the maximum amount of az o dye was set to "non azo dye" 
while the limit of formaldehyde was set at 20 ppm. 
2.2.2.15  China – Testing and Certification Requirements for Medical Devices 
2.98.  The representative of Brazil reiterated his delegation's concern about the testing and 
certification requirements for medical devices in China. Despite bilateral understandings with the 
Chinese authorities as well as discussion on this matter held in previous Committee meetings, 
Brazil producers were still facing problems in exporting medical devices to China due to the 
uncertainty of the requirements in force. In particular, the lack of transparency about the requirements for the certification was making the whole process unclear. Further, the lack of 
accredited testing facilities and long delays in them being carried out created hindered the 
certification process. He also recalled the obligation to notify all legislative changes at an early and appropriate stage in line with provisions of Articles 2.9 and 5.6 of the TBT Agreement.  G/TBT/M/61 
 
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  2.99.  The representative of the European Union said  that her delegation associated itself with the 
statement of Brazil and recalled its concerns wi th the ongoing revision of China's Order 276 on 
Medical Devices, and more generally the regulatory framework applicable to medical devices imported and sold in China. She also asked China for an update on the state of play of the revision 
of its medical devices legislation, and recalled the need for this revision to address industry 
concerns – not only on the registration procedure as such, but also divergences between China's mandatory standards and international ones, the insufficient acceptance of foreign clinical trial 
data and foreign test results, and the need for appr oval of the products in the country of origin or 
of manufacture prior to their placement on the Ch inese market. She stressed the need for China to 
notify this comprehensive legislation to the TBT Committee, allowing WTO Members a reasonable time to provide comments and taking their comments into account, and provide a sufficient 
implementation period, of at least 1 year, between the publication of the Order and its entry into 
force. 
2.100.  The representative of China said that the State Council of China has been open to public 
consultations online since September 2010. During this period, China has received comments from 
relevant organizations and foreign medical device enterprises. The Legal Affairs Office of the State Council was still revising this regulation while taking into account comments received from 
stakeholders. 
2.2.2.16  European Union – Draft Implementi ng Regulations amending Regulation (EC) 
No. 607/2009 laying down detailed rules for th e application of Council Regulation (EC) 
No 479/2008 as regards protected designations of origin and geographical indications, 
traditional terms, labelling and presentati on of certain wine sector products  
2.101.  The representative of Argentina reiterated his delegation's concern that this legal regime 
was not consistent with the EU's obligations under the TBT Agreement. Nevertheless, with the 
objective of finding a constructive solution to overcome the obstacles of the community 
regulations, and avoid the halting of shipments to the EU, and at the EU's invitation, Argentina submitted in July 2009 its dossier on the terms "Reserva" and "Gran Reserva". Although this 
dossier had been approved by the European Commission's Management Committee for Wine in 
March 2012, it had still not been adopted within the Commission and published in the Official 
Gazette. After more than 19 months of this approv al process within the committee, the EU has still 
not made any progress with regard to finalizing th e last procedure, despite it being purely of an 
administrative nature.  
2.102.  He reminded the Committee that the EU had given the same reply that “formal adoption of 
the draft regulation regarding reserve and gran re serve is still pending” at both the November 
2012 and March 2013 meetings and said that it did not have any further updates on this issue at 
the June 2013 meeting. These were, according to Argentina, merely a description of a situation that had happened 19 months ago. Therefore, the EU's replies were unsatisfactory and dilatory. 
This delay was doubly unjustified as the procedure hadn't concluded within a reasonable time-
frame (the last stages had taken more than four years) with no explanation for the delay, which could constitute a barrier to trade in itself. There did not appear to be any will to resolve this issue as the lack of information on the inclusion of the matter on the agenda of the Commission 
demonstrated. The lack of transparency disadvantaged high quality Argentine wines in the EU 
market, both from a price and a labelling perspective. 
2.103.  This STC, he said, was the second one in terms of frequency and quantity of Members that 
raised the same concern. These facts reflected the pr otection given by the EU to this sector to the 
detriment of wines from other regions. He noted that Argentina believed that this legal regime was not consistent with obligations stemming from the TBT Agreement. These traditional expressions 
only constituted indications of quality that fell within the scope of the TBT Agreement and not the 
TRIPs, thus neither registration nor the granting of exclusive rights over these terms was appropriate. He was concerned about registration  requirement of these terms when there were 
diverging definitions of those complementary quality mentions at the European Community level, 
therefore failing to provide clear, objective and transparent quality parameters for the use of said 
terms. He also expressed concern that the EU had given, through bilateral trade agreements, 
other countries the use of these terms without a registration requirement which amounted to 
discrimination against the rest of countries with whom the EU did not have bilateral agreements. 
Given that this issue remained unresolved, he again requested the EU to eliminate the unjustified G/TBT/M/61 
 
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  restrictions that harmed the Argentine wine industry by including this topic in the agenda of the 
relevant authorities and by publishing the relevant regulatory act in the Official Journal. 
2.104.  The representative of the United States associated herself with Argentina and asked the EU 
to provide an update on the status of the applicat ions that were submitted by the US wine industry 
more than three years ago. She recalled that the US had suppliers that used these traditional 
terms and that were unable now to ship those products to the EU. She expressed concern with the lack of progress on this matter and noted her delegation's discontent with the unilateral 
recognition of these terms. 
2.105.  The representative of the European Union informed that her delegation had no updates on 
this issue. She referred delegations to the minutes of the previous Committee meetings.  2.2.2.17  Israel – Warning Regulations on Alcoholic Beverages 
2.106.  The representative of the European Union said that while her delegation welcomed some 
improvements in the last available draft, it nevertheless regretted that some of its comments had 
not been taken into account. In particular, the EU was still concerned about the establishment by 
this draft regulation of two different types of warnings on alcoholic consumption whose use varied 
depending on the alcohol content of the beverage. In this respect, she stressed that according to scientific studies, it is excessive  consumption of alcohol that was harmful for health, regardless of 
the type of alcoholic beverage. The differentiation between strong intoxicating beverages and 
regular intoxicating beverage as regards the warning message as laid down in the notified draft regulations could mislead consumers who could conclude that some alcoholic beverages were more harmful than others. She therefore invited the Israeli authorities to consider providing only one 
form of warning statement against excessive consumption of alcohol. Regarding the size and 
placement of the warning, she considered that the information to the consumer should be provided with less restrictive requirements, limited to the size and legibility of the message. Strict 
provisions related to the colour of the text or to the inclusion of a black frame did not seem 
justified. She thus requested clarification regarding the usefulness of such requirements as well as to where the warning had to be placed and if the use of stickers would be allowed.  
2.107.  The representatives of the United States and Mexico associated themselves with the EU 
statement. Mexico added that they also considered  that it was the excessive consumption, not the 
type of alcohol that was harmful. This measure was therefore believed to be an unjustified measure, including with respect to its labelling requirements. 
2.108.  The representative of Israel explaine d that the regulations were approved by the 
Economics Committee of the Israeli parliament towards the end of July 2013. During the 
discussions, the parliament committee took into account the comments received from the party 
and certain amendments were introduced consequently. One of them, for example, was to 
eliminate the requirement of putting health warning labels on the front of the bottle. 
2.2.2.18  Brazil – Draft ANVISA Resolution on Used, Refurbished, Rented and Lent 
Medical Devices 
2.109.  The representative of the European Un ion requested an update on the ANVISA draft 
resolution on used, refurbished, rented and lent  medical devices, notably its expected time for 
adoption. In the EU's opinion, reconditioned equipment, independent of its place of first 
installation, should be allowed for importation in Brazil as long as it complied with the health and 
safety performance requirements. The EU would thus welcome a revision of this resolution in this direction. 
2.110.  The representative of Brazil explained th at the rationale for its regulations was to avoid 
having used or refurbished medical equipment be ing exported for Brazil for purposes of final 
disposal and to hold the producers of such goods liable for their appropriate disposal. With respect 
to the status of the new regulation in question, he said that, at the present moment, the Brazilian 
national surveillance agency, ANVISA, was merely considering the possibility  of issuing. In other 
words, there would not be any legal requirement in force which would impact ongoing commercial transactions, or even those to be performed in the near future. Prior to any final decision, the 
Brazilian authorities would undertake new public consultations on the matter. Additionally, there G/TBT/M/61 
 
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  were some critical issues to be settled, especia lly those relating to definitions about refurbished 
goods. A regular time-frame for the conclusion of  the whole process was not yet established, and 
any further developments would be properly communicated to Members in order to receive their timely comments. 
2.2.2.19  European Union – Tobacco products, nicotine containing products and herbal 
products for smoking. Packaging for retail sale  of any of the aforementioned products  
2.111.  The representative of Cuba recalled that in the Committee meetings which took place in 
June Cuba analysed the implications of the application of this directive for many developing 
countries, and specifically for Cuba. On that occasion, Cuba also outlined a series of questions directed to the EU that were later circulated to Members in G/TBT/W/371. These questions were still outstanding. She also noted that on 8 Octo ber 2013 the plenary of the European Parliament in 
Strasbourg had voted on the European Directive for tobacco products, according to which member 
states would have 18 months to adapt to that directive within their national legislation after it enters into effect. 
2.112.  The representative of Malawi expressed he r delegation's concern with the consistency of 
the proposed EU measure with the TBT Agreement. Her full statement is contained in 
G/TBT/W/376. 
2.113.  The representative of the Dominican Repub lic recalled that at the TBT Committee meeting 
of June 2013, her delegation voiced its concerns regarding the draft report presented on 10 April 
2013 by Mrs. Linda McAvan, spokesperson for the Committee on the Environment, Public Health 
and Food Safety of the European Parliament. Subsequently, on 8 October 2013 the European 
Parliament adopted amendments to the notified directive. She asked the EU to provide more 
information about the next steps in this legislative process: would there be a review of this directive? If yes, when? She also expressed her delegation's view that the present text of the 
measure lacked critical scientific basis demonstrating: (i) that it would contribute to, rather than 
undermine, the legitimate objective of health in the EU; and (ii) that it constituted the least trade restrictive measures possible to achieve this objective. For these reasons, the Dominican Republic 
believed that the packaging requirements under the measure were incompatible with the 
TBT Agreement and the GATT 1994.  
2.114.  The representative of Guatemala said that while her delegation shared the policy objective 
of the EU to improve public he alth by discouraging people from  using tobacco products, it was 
nevertheless not clear how the proposed regulations would achieve such legitimate objective. 
Furthermore, according to the preliminary assessm ent of Guatemala these regulations appear to 
be more trade restrictive than necessary to achieve such legitimate objective, so less restrictive 
alternatives should be considered. 
2.115.  The representative of Honduras supported the positions of the preceding Members and said 
that while Honduras understood the need to protect human health, it considered that the measure 
was more trade-restrictive than necessary to attain such objectives. 
2.116.  Recalling the statements of his dele gations at the last Committee meeting, the 
representative of Nicaragua considered that beca use the draft directive was more trade-restrictive 
than necessary and lacked scientific basis, it was not in accordance with Article 2.2 of the 
TBT Agreement. He encouraged the EU to consider less trade-restrictive alternatives. Nicaragua 
also believed that the proposal of introducing plain packaging, in particular, could not be justified under the WHO's Framework Convention on Tobacco Control ("WHO FCTC"), as the proposed 
measure extended beyond the requirements of th is Convention. He explained that Nicaragua had 
about 23 tobacco producers which together generated 35,000 direct jobs and 45,000 indirect jobs. Nicaragua's tobacco exports were valued up to 185 million dollars. He also underlined that the 
tobacco industry helped to stimulate Nicaragua's tourist sector as the tobacco production sites 
attracted many visitors. The EU's proposed dire ctive could therefore cause serious economic and 
social adverse effects to his country.  
2.117.  The representative of Australia reiterated the comments made by his delegation to this 
Committee in March and June 2013 in support of the EU's revised Tobacco Product Directive 
proposal. The significant public health challenge resulting from tobacco use was a global issue G/TBT/M/61 
 
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  which all WTO Members must face. Australia therefore commended the EU and its member states 
for the tobacco control measures it had implemente d to date, and for its revised Tobacco Products 
Directive proposal. He noted that one of the objectives of the EU proposal was the implementation of the WHO FCTC. In addition to a range of measures, including mandating increased graphic 
health warnings, Australia understood that under the proposal, EU member states would be 
allowed to implement plain packaging of tobacco pr oducts as far as compatible with the Directive 
and EU law. In particular, Australia welcomed the decision by Ireland to take the lead by 
developing legislation to mandate plain packaging of tobacco products. Australia was of the firm 
view that Members had the right to implement measures necessary to protect human health, while complying with relevant international treaty obligations, including the TBT Agreement. The proposed EU Directive was a legitimate measure designed to achieve a fundamental objective – 
the protection of human health, in particular, the protection of young people against smoking 
initiation and uptake.  
2.118.  The representative of New Zealand registered his delegation's support for the European 
Union for its move to introduce further controls on the packaging of tobacco products, including by 
allowing individual EU members to take plain packaging measures. The negative effects of smoking could be not be overstated for it constituted th e single largest cause of preventable death and 
disease in New Zealand.  
2.119.  The representative of Canada recalled that Canada was a pioneer in package labelling 
requirements for tobacco products, a core component of the right to regulate in the interest of the 
Canadian public. She noted that the EU proposal could impose labelling requirements for cigarettes 
similar to those already in force in Canada where pictorial health warnings occupied 75% of the 
front and back of packages.  
2.120.  The representative of Norway stressed that  public health and tobacco control were topics 
of particular interest to his delegation and thanked the EU for notifying the proposal at such an 
early stage in the process. In Norway's view, it  was within the rights of each WTO Member to 
adopt measures which were necessary to protect pub lic health as long as they would be consistent 
with WTO obligations. Norway had a long history in tobacco control. In 1933, the Norwegian 
parliament adopted the first tobacco control act ba nning advertising, setting up an age limit for 
sale of tobacco, and mandating health warnings. However, he said, smoking continued to be the single factor with the greatest negative impact  on public health in Norway, with about 5,100 
people dying each year from smoking-related diseas es (13% of all deaths). On average, each of 
them loosing 11 years of their lives. Smoking was also a major cause of social inequality and health. The Norwegian Government therefore strong supported the EU in its effort to combatting 
tobacco epidemic. 
2.121.  The representative of the European Union referred to the statements her delegation made 
at the last Committee meeting and then provided a brief update on the state of play of the 
Directive proposal's draft. The proposal was put forward by the Commission on 
19 December 2012, and was currently going through the EU's legislative process, in which both 
the Council of the European Union and the Parliament had to give their approval in order for it to be adopted. The Council reached a position on the proposal on 21 June 2013. On 8 October 2013, 
the European Parliament also voted on the draft proposal, paving the way for inter-institutional 
negotiations with the Council and the European Commission on the draft. These discussions were 
currently ongoing, with a view to concluding an  agreement on the draft Directive as soon as 
possible and, in any case, no later than the end of the mandate of the current European 
Parliament in May 2014.  
2.2.2.20  Chile - Proposed amendment to th e Food Health Regulations, Supreme Decree 
No. 977/96 
2.122.  The representative of Mexico said that, as stated in the previous sessions of the Committee 
in March and June 2013 and set forth, respectively, in documents G/TBT/W/361 and 
G/TBT/W/372, Mexico considered that Chile had violated basic WTO principles relating to the 
preparation of technical regulations, such as transparency, proportionality, scientific basis and 
conformity with international standards. It also  believed that these measures could constitute 
violations of the TRIPS Agreement. Mexico also as ked Chile: (i) to provide an update on the status 
of this measure; (ii) to consider Mexico's comments in light of Article 2.9 of the TBT Agreement; 
(iii) to comply with the TBT Agreement and its provisions that trade should not be restricted more G/TBT/M/61 
 
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  than was necessary, by promoting public policies that helped the population to obtain accurate 
information on food nutrients, so that they could make food choices based on their particular needs; (iv) to modify its measure so as to base it on relevant international standards (Article 2.4 of the TBT Agreement), such as the Codex Alimen tarius; (v) to consider other public policy 
instruments that could be less trade restrictive, such as launching outreach campaigns to 
encourage the population to eat healthily and promot ing physical activity programmes; (vi) to take 
into account other instruments that could form part of the Chilean regulatory framework for the 
marketing of foods, such as the " Código de Autorregulación y Ética Publicitaria " (Code of Self-
Regulation and Advertisement Ethics). 
2.123.  The representative of Guatemala reiterated her delegation's comments made at the last 
two meetings in March and June 2013, including its concern that the measure could be more trade 
restrictive than necessary to fulfil its legitimate objective and that Chile should therefore consider 
alternative less trade-restrictive measures. 
2.124.  The representative of Argentina said that his delegation continued to be concerned with 
the provisions of the law 20.606 and the draf t regulations - decrees number 12 and 28 - 
elaborated to implement this law. They were considered to be excessive to the legitimate objective they sought to pursue, by not being in accord ance with Article 2.2 of the TBT Agreement. 
Argentina asked Chile to notify the decrees numbe rs 12 and 28 of 2013 before their publication 
and asked for confirmation on whether Argentina's comments had been taken in consideration. 
2.125.  The representative of Brazil expressed hi s delegation's support to any measure taken by 
any Member with the purpose of protecting human health, including those relating to food 
labelling, provided they complied with WTO rules. However, Brazil believed that such objective 
could be addressed in a more effective and less restrictive manner than currently established in the proposed measure, which therefore seemed to conflict with Articles 2.2 and 2.4 of the 
TBT Agreement. Brazil considered that a good departing point to address these shortcomings in 
the measure could be to establish different label ling requirements for different types of food. It 
would thus be important to distinguish between, on one hand, products that contained ingredients 
or substances that might cause allergies or that are related to food decolourants (like gluten and 
lactose) and, on the other hand, products with common ingredients that were not harmful per se (like sugar or salt). In the specific case of the proposed measure at issue, Brazil's concerns related to the grounds for the threshold determining whether or not products were unhealthy. In this 
respect, he noted that the proposed measure was not based on the WHO's dietary guidelines that 
took into account the suggested daily intake of nutrition. He also noted that the new Chilean draft contained an even harsher approach prohibiting the commercialization of products considered 
unhealthy in school shops and requiring all products to observe the regulation irrespectively if they 
had already been registered with the Chilean authorities or not. Finally, the way that Chile's measure pursued its legitimate public heath objective seemed to be incompatible with the list of 
prohibited claims under Section 3 of the Codex General Guidelines on Claims . For example, 
Section 3.5 of these guidelines prohibits "claims which could give rise to doubt about the safety of similar food or which could arouse or exploit fear in the consumer." 
2.126.  The representative of the European Union associated herself with the statements made by 
the preceding delegations and expressed concern that the measure was never notified to the 
Committee. She also recalled the EU's concerns regarding the lack of scientific basis for the definition of the maximum levels for the relevant nutrients, noting the absence of international 
guidelines backing up this measure. The EU was also not convinced about the proportionality and 
effectiveness of the measure. Regarding the labelling technical specifications, the EU asked Chile the following questions: (i) the technical graphical specifications only established that the stamp 
had to cover 7.5% of the total surface of the pack age. Has Chile considered that for small products 
(e.g. candy bars, mints, and candies) the stamp would cover substantially more than 7.5% of the surface, taking into account the requirements on the fonts to be used? Was there any exemption foreseen for these products, considering that it wo uld not be possible to comply with the 7.5% of 
the surface requirement? (ii) the specifications provided examples in which it seemed that the 
stamp shall cover 7.5% of one of the main surfac es of the products. However, the 7.5% of the 
surface requirement was to be calculated based on the entire surface of the package. If this was 
the intention of the legislator, it would entail a significantly larger stamp as compared to a stamp 
covering 7.5% of one of the main surfaces of the products. Could Chile clarify this point?; (iii) the 
specifications did not require that the stamp be placed on the front of the package. Could Chile 
clarify that indeed the stamp can be placed on th e back of the package? (iv) all pictures in the G/TBT/M/61 
 
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  technical specifications showed the stamp on the lo w left corner of the package, but there was no 
explicit indication that this placing was a formal requirement. Could Chile clarify if the stamp could be placed anywhere on the package or on a specif ic location of one of the main surfaces of the 
package? and (v) could Chile also clarify why the label must refer to "high in fat" when the 
regulation actually referred to "saturated fats"? 
2.127.  Finally, after noting that the measure's implementation deadlines for labelling obligations 
would now be at least 6 months from the final da te of publication, she expressed the EU's view 
that this period was too short for economic operators to be able to comply with such 
comprehensive legislation. In this context, she noted that the EU's own legislation on nutritional labelling was adopted in 2011 but would only come into force in 2014. Given that adaptation to new labelling requirements required significant investment for manufacturers and a redesign of the 
packaging and given the uncertainties previously  exposed, the EU asked Chile to consider 
providing an even longer deadline. 
2.128.  The representative of the United States a ssociated herself with the previous speakers on 
Chile's regulation, including their view that Chile's proposed regulation could impose unnecessary 
barriers to trade. She also noted the existence of alternate approaches, grounded in international standards, which could provide similar information to consumers in a less trade restrictive manner. 
Chile's regulation was not based on science and its labelling requirements could be misleading and 
stigmatize foods that could be part of a healthy diet. Under the measure, imported foods would need to be labelled specifically for the Chilean market, raising their costs for Chilean consumers and making them less attractive than similar domestically produced goods. In this respect, she 
recalled that on 4 October 2013 the Chilean Minist ry of Health's proposed regulation, currently 
under consideration by Contraloría General de la República , only marginally altered the 
requirements under the original proposal, ignoring alternative voluntary approaches and thus did 
not address WTO Members' underlying trade concerns. For instance, the regulation still required: 
(i) the use of "STOP sign" shaped icons that would account for a significant portion of the package (7.5%); (ii) nutrient limits by food category that lacked a clear explanation of the scientific basis; 
(iii) category nutrient thresholds that required many "healthy" imported foods to bears icons while 
Chile's traditional foods that were "higher in fat, sugar and sodium" were exempted; (iv) front of pack icons that could mislead consumers or create fear about consuming food, even in moderation, as part of a healthy diet; and (v) insufficient time for implementation. The US asked 
Chile to delay finalisation of its regulation until these concerns were addressed. 
2.129.  The representative of Canada said that her delegation associated itself with the previous 
speakers. While Canada supported Chile's policy objectives, it however remained concerned that 
the updated draft regulations deviated from international standards, was not based on science, 
and were likely to be more trade restrictive than necessary. Canada had raised this issue with Chile in several fora including the WTO TBT Committee and on the margins of APEC in Indonesia, 
as well as bilaterally via the Canadian Embassy in  Chile. Canada has been assured that Chile was 
reconsidering its regulations with a view to making them WTO compliant. 
2.130.  The representative of Costa Rica said that his delegation shared the same concerns voiced 
by previous delegations. 
2.131.  The representative of Chile stated that obesity was becoming epidemic in Chile, 
particularly among those aged under 14. This law was one of the first measures which Chile has 
adopted to address this problem and was based on the understanding that the public needed to be 
able to make informed decisions about their food consumption and avoid excessive consumption of 
substances which lead to obesity. Regarding the decree at issue, he explained that the on 3 July 2012 the President of the Republic finalized the proposal, taking into consideration the comments 
received. Two days later, the final proposed decree was then submitted to the general controller's 
office, one of the final steps in Chile's internal legislative procedure. On the 27 September 2013, the controller issued an opinion making a series of comments that should be included into the Ministry of Health's proposal. These were incorporated into the decree and would be submitted 
back to the controller. Once the controller issued a new decision the decree would be published in 
the official journal. Regarding the content of the decree, Chile informed that the final version signed by the President contained the following: (i) a timeframe for entering into force at least 6 
months from the final date of publication; (ii) the fact that only a small number of products would 
be affected (24% of products); (iii) the warning label would no longer take the form of an octagonal "STOP sign" but rather a coloured hexagon and its size would be established in relation G/TBT/M/61 
 
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  into the size of total area of the products (7.5%) ; and (iv) that it would provide for the possibility 
of using stickers for the warning label.  
2.2.2.21  India - Electronics and Informat ion Technology Goods (Requirements for 
Compulsory Registrati on) Order, 2012 
2.132.  The representative of Japan requested Indi a to re-postpone the date of full enforcement of 
the Order until 3 April 2014. According to "Burea u of Indian Standards Rules, 1987" (hereafter 
"the BIS rules") 16B (3), test reports issued by the testing laboratories designated by BIS were 
required for equipment registration. However, as of September 2013, only 11 testing laboratories 
in India had been designated for testing informat ion technology equipment, although thousands of 
applications from companies inside and outside In dia have been submitted. According to a survey 
of Japanese industry, some applicants have been waiting for over 6 months to finish the testing 
and it often took over 200 days to issue test repo rts. Therefore, Japan would like to request India 
to give additional 3 months for transition period  and re-postpone the date of full enforcement until 
3 April 2014. Also, in order to shorten lead-time of testing, Japan requested that India, as one of 
IECEE members, utilizes CB certificates and CB test reports issued by National Certificate Body in 
the other member countries. Japan also requested India to set adequate transitional period for new product categories. On 11 July 2013, India announced that "projectors" were within the scope 
of new product category. However, according to th e Japanese industry, they estimated that more 
9 months were needed as a sufficient transitional period to comply with the current registration procedures, including testing, registration, labelling and transport from factories to India. In light of this practical difficulty, Japan needed to requ est India to set sufficient transitional period of 
more than 9 months for new product categories  when some product categories become newly 
subject to the Order. Japan further requested Indi a to simplify registration procedures. Since May 
2013, many kinds of notifications have been issued to specify various registration forms in addition 
to Form VI and VII specified by BIS rules, which caused confusion among applicants. Applicants 
must prepare large number of application document s and BIS also spent a long time checking the 
documents. Japan therefore requested India to si mplify the registration documents in order to 
shorten the time spent for the registration procedures.  
2.133.  Japan further requested India to simplify conformity marking requirements. According to 
the Order, a product or a package must bear conformity mark with a self-declaration of 
conformity, the technical standard applied and its edition (year) as well as the registration 
number. However, under this new requirement, a sp ecific size of font was required to be used, 
which caused a longer preparation time for the industry to adapt to the new conformity making requirement. Japan asked India to simplify the contents of the conformity marking requirement 
and to provide a sufficient transitional period to inform applicants of all marking requirements 
broadly and beforehand. Lastly, Japan requested India to set a transitional period for revision of technical standards. According to the BIS rules 16L, when Indian standards (IS) were withdrawn 
or abolished, any registration granted in respect thereof were deemed to have been cancelled from 
the date of withdrawal of the standard. If ther e were no transitional periods, importers and 
manufacturers must stop supply of products for a ce rtain period of time until they get prepared for 
re-registration based on the new standards and replace the conformity mark on the products. In 
this regard, an adequate transitional period woul d enable smooth re-registration. For example, the 
EU gave suppliers almost three years as a transitional period when a new European standard replaced an old one. For this reason, Japan reques ted India to set transitional period of 24 months 
or longer during which both of old and new standards would be applicable, in order to enable 
importers and manufacturers to prepare for smooth transition to the new standards. 
2.134.  The representative of the European Union sa id that his delegation associated itself with 
Japan's concerns. He sought confirmation of the current situation of the measure in legal terms. In 
this respect, he noted the postponement of the entry into force of the new legislation until 3 January 2014 pursuant to a notification by the Ministry of Communications and Information Technology (MoCIT), dated 30 September 2013. He understood that the lack of testing 
infrastructure to ensure timely processing of all testing applications was the decisive factor in 
ordering this postponement. He therefore asked India to confirm that, pending the entry into force of the new regime, a supplier's declaration of conformity would be considered sufficient to place 
products on the market. On a more general point, as observed by Japan, he also noted with some 
concern the fact that successive amendments, clarifications, interpretations have been issued on a regular basis, and that the recent notification  from India in G/TBT/N/IND/44/Add.2 provided a 
compendium of all these successive amendments, interpretations via Orders, Circulars, Notices G/TBT/M/61 
 
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  etc. He considered this to be detrimental to the predictability of the regulatory framework as it 
caused confusion and prevented sound business planning. He thus asked the Indian authorities to consider a more structured process when regulating and that all important elements be consolidated in one single text to put out for stakeholder comments and notified to other WTO 
Members.  
2.135.  Besides the specific points made by Japan, he said that the EU had three main general 
points. First, the EU continued to view this schem e as excessively burdensome in view of the low 
safety risk associated with the 15 categories of electronics products concerned. These were office 
equipment, printers, scanners, laptops, answering machines, not really equipment with a serious safety risk. Therefore, the EU continued to have concerns on the overall necessity and 
proportionality of the scheme. Second, the EU took note of the assurance given at the last meeting 
by India that, pursuant to a Circular by the Department of Electronics and IT issued on 29 May 
2013, safety critical components would be accepted if certified or tested by a certification body that was a signatory to the IECEE CB scheme or accredited to the relevant international standard 
ISO 17025 by an accreditation body that was a signatory to the ILAC MRA. Despite the EU's 
general concerns about the scheme in general being too heavy-handed in relation to the product risks involved, the acceptance of foreign testing wo uld alleviate the burden for exporters. Finally, 
on the mandatory testing frequency of every two years, the EU considered this as excessively 
burdensome as the testing that should only be re peated if a product was substantially changed in 
such a way that its safety properties were affected. The EU expressed hope that there would be the possibility to further discuss bilaterally with India these concerns and that workable solutions 
could be found before the entry into force of the scheme. Like Japan, the EU recommended that 
consideration be given to further postponement of the measures until all these aspects had been discussed and addressed satisfactorily. 
2.136.  The representative of the United States associated herself with the comments made by 
Japan and the EU. While acknowledging the granti ng of extension until 24 January 2014, the US 
continued to be at a loss on understanding why in-country testing in the security context was 
necessary. She stressed that the criterion and systems to assure the competence and 
independence of testing laboratories were well established in international standards and in the international systems of conformity assessment. Competence and independence of labs was not 
determined by place of domicile. She then ad dressed some practical challenges posed with 
implementing the ICT Product Safe ty requirements, as they are currently constituted. First, the 
issuance of test reports by BIS approved labs  added an unnecessary stage in the compulsory 
registration process. Manufacturers already tested their IT products to the international standard 
(IEC 60950). They must then retest them to an id entical Indian standard. While BIS approved labs 
continued to work through the backlog, there woul d likely be an on-going  bottleneck beyond the 
January 2014 implementation, as manufacturers su bmit new products for testing. In addition, 
under the current registration process, test reports would expire ninety days after issuance. This 
was an unnecessary burden on the manufacturer th at, given the existing backlog of testing and 
approvals, could result in further delays in getti ng products on the market, if the manufacturer did 
not meet the ninety day window for registration application. Second, there were conflicting 
labelling requirements being issued by BIS and the Department of Electronics and Information 
Technology (DeitY). BIS stated that products and packages must be labelled with location 
requirements and font size to be at least ¾ of brand name font or 12 points, whichever was larger. 
DeitY states that it was preferable for products  to be labelled, but packaging may instead be 
labelled due to limited product size or other restrictions. Unlike BIS, DeitY did not indicate any location for labelling nor did it require a specific font size. Third, there were issues with Highly 
Specialized Equipment (HSE) Circular No. 2, which stated that DeitY "may" issue Exemption Orders 
for exempted HSE to clear India customs. As a result, manufacturers were forced to react to BIS, DeitY or Customs' interpretation of this policy on a case-by-case basis. Manufacturers were left in need of a routine process that yielded predictable outcomes.  
2.137.  Another issue of concern to the US related to "Import of Prototypes" under Circular No. 1 
of 2013, according to which DeitY would allow for import of up to 5 units of prototype or test samples (devices for demonstration/development/testing) without penalty. This limitation was far 
too low to support product development in India and it would have an immediate impact on the 
ability of industry to introduce new products globally. If this limit was not changed or if these prototypes/samples were required to be tested or registered before sample units were shipped to 
India, manufacturers may be forced to move ha rdware and software development out of India. 
Given the foregoing, the US urged India to postpone the implementation date so as to allow for G/TBT/M/61 
 
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  proper notification and comment, and welcomed the opportunity to further discuss this issue with 
India on a bilateral basis so as to better explore more commercially viable options that would fully meet India's electrical safety needs. 
2.138.  The representative of Canada said that her delegation was concerned with the excessively 
burdensome nature of India's Order. Canada belie ved that India's in-country testing requirements 
were not needed given the nature of the products in question. Canada asked India to reconsider its 
Order as it currently stood and to respond to Members' concerns, as had already been enumerated 
by Japan, the EU and the US.  
2.139.  The representative of India started by giving Members an update on the status of the 
measure. He said that as per the notification dated 30 September 2013, the Order had come into 
effect as from the 3 July 2013 but some manufacturing units with specific conditions have been 
provided an additional period until the 3 January 2014. The test labs are actually hosted both on 
the DeitY as well as the BIS websites. There were 11 labs, including of foreign labs, which have been recognized for testing as of the 3 October 20 13. In terms of the notifications, he explained 
that G/TBT/N/IND/44, Addenda 1 and 2 provide clarification on the scope and other aspects. These 
addenda have emanated from many of the questions that Members have asked in this particular forum as well as bilaterally. Regarding Japan's ques tions about the delay in the report, he said that 
India had put up lists of the workload being hand led by the 11 laboratories, and it seemed that 
they were well on track and were adequately addressing demand of testing under this particular order. This fact would also dispel the concern that the procedures were cumbersome. On the question of the time period for amendment or withdrawal, he said that under this particular 
regulation there had been no amendments or withdrawal at this point of time. He said that 
nevertheless he would forward this input to BIS because this was a larger generic issue rather than a specific issue to the DeitY Order. Concerning EU points, he expressed surprise about the 
confusion of the Addenda. The EU, like some of the other delegations, has been an advocate of 
transparency. He recalled that the EU has made a statement whereby they very categorically said 
that they wanted transparency database containing  all the notifications in one place. The addenda 
were issued exactly to address this request. The a ddenda were an output of the clarifications that 
have been sought out by Members or by the stakeholders on specific issues they came across when this particular Order was issued by DeitY. On the specific issue raised by the US on the 
prototypes, he said that India had forwarded those questions to both to BIS and DeitY.  
2.140.  Finally, he addressed two other issues that have been raised in the last meeting as well as 
in the current meeting. One was about the terminology of further Orders, which was used in a circular dated 29 May 2013. DeitY had confirmed that this terminology had primarily being used to 
expressed that safety critical components would be accepted if there were either certified or tested 
by certification body that was a signatory to IECEE CB Scheme or accredited according to the relevant international Standardized IEC 17025 by an  accreditation body that was a signatory to 
ILAC MRA until the circular got amended or modifi ed further. On the US question on the testing 
labs, he explained that DeitY has clearly said it wo uld be unfair to claim that Indian labs were ill-
equipped as most of the labs recognized by the BIS had already been testing under the International Safety Certification programmed for decades. In fact three of the recognized labs 
were of US origin (e.g. UL India Private Limited, in Bangalore and Inter Tech Private Limited, in 
New Delhi). 
2.141.  The representative of the European Unio n thanked India for the information provided and 
made a clarification with respect to the EU's posi tion on the Addenda. He said the EU welcomed 
the submission of the notifications of the two addend a. This has been very useful to recap the long 
history of successive interpretations, clarifications and amendments to the original measures. 
Addendum 2 listed not less than seven of such ci rculars, adopted in the period from 29 May until 
11 September 2013. So, in the time span of just three and a half months, seven times the measures were subject to amendments and interpre tations, extensions and so on. It was this way 
of adjusting the original measures and introducing essential implementing elements that, in his 
view, created problems. It was not the use of addenda per se. Indeed in this particular case, 
without the addendum it would have been very difficult for the EU to establish a clear chronology of events during the last months. Thus, while the EU would encourage the use of addenda, it 
would also prefer if these measures would be introduced perhaps in a fewer texts and that these 
texts would be notified for comments. G/TBT/M/61 
 
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  2.2.2.22  Ireland - Proposal to introduce standardised/plain packaging of tobacco 
products in Ireland. 
2.142.  The representatives of the Dominican Re public and Malawi expressed concern with the 
consistency of the proposed Irish measure with the TRIPS Agreement and/or the TBT Agreement. 
Their full statements are contained, respectively, in G/TBT/W/374 and G/TBT/W/375. 
2.143.  The representative of Honduras expressed concern with the fact that the proposed Irish 
tobacco plain packaging measure was similar to that of Australia, which was currently under five 
dispute settlement proceedings in the WTO - including one initiated by Honduras - and whose 
consistency with WTO rules has been challenged in this Committee by a large number of WTO Members. Honduras urged Ireland to reconsider its decision to start the adoption of plain packaging with respect to tobacco products and to, prior to taking such a decision, at least wait for 
the conclusion of the disputes lodged against Australia. 
2.144.  The representative of Nicaragua associated his delegation with the statements made by 
the previous delegations and expressed concern as to whether the measures proposed by the 
Government of Ireland would achieve the desired result. While not questioning Ireland's sovereign 
right to introduce measures to protect public he alth, Nicaragua believed that the Irish measure at 
issue would not achieve this objective. Like prev ious speakers, Nicaragua asked Ireland to either 
reconsider this measure or at least suspend its adoption until the disputes against Australia have 
resolved. 
2.145.  The representative of Guatemala stated th at while her delegation shared Ireland's policy 
objectives related to public health and tobacco control, it was nevertheless concerned with the 
proposed legislation and encouraged Ireland to consider less trade restrictive alternative measures 
that would effectively achieve its own legitimate objectives. 
2.146.  The representative of Zimbabwe said that her delegation shared the concerns raised by the 
previous delegations regarding Ireland's proposal  to introduce standardized plain packaging of 
tobacco products. While Zimbabwe appreciated efforts to protect the health of consumers, the proposed measure would be inconsistent with the TBT Agreement (Articles 2.2 and 2.4) and 
TRIPS Agreement (Article 20) inter alia  because there was no scientific evidence that it would 
meet the intended objectives. Developing countries, such as Zimbabwe, relied on tobacco farming. The proposed measure would therefore negatively  affect their employment creation efforts. 
Tobacco was Zimbabwe's largest single exporting item in the agricultural sector, with over 1,000 
tobacco growers. Over 80% of growers were small scale farmers. Zimbabwe therefore urged 
Ireland to reconsider its measure.  
2.147.  The representative of Cuba expressed do ubts as to whether the Irish plain packaging 
measure would attain its intended legitimate public health objectives. None of the countries 
proposing or implementing such a measure had been  able to prove its effectiveness, nor did they 
have scientific evidence on which it could be based. On the contrary, serious doubts existed as to 
whether plain packaging was appropriate, partly due to its undesirable effects, which did not result 
in the reduction in the consumption of tobacco products. A measure such as this was therefore more trade restrictive than necessary under the rules of the TBT Agreement, and also undermined 
the provisions of international legislation on geographical indications, including the TRIPS 
Agreement. 
2.148.  The representative of Australia reiterated comments made in previous Committee 
meetings in support of Ireland's decision to le gislate for mandatory plain packaging of tobacco 
products. Tobacco plain packaging was a legitimate measure, designed to achieve a fundamental 
objective - the protection of human health. Australia looked forward to supporting Ireland as it underwent the development of its own measure. The tobacco plain packaging measure was 
endorsed by leading public health experts as well as the World Health Organization (WHO) and 
was supported by extensive research reports and studies. Tobacco plain packaging was recommended in the guidelines for the implementation of Articles 11 and 13 of the WHO Framework Convention on Tobacco Control, to which Australia and the EU were both Parties. 
Australia was of the firm view that Members ha d the right to implement measures necessary to 
protect public health, while complying with relevant international treaty obligations including the TBT Agreement. G/TBT/M/61 
 
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  2.149.  The representative of New Zealand stated that his delegation supported Ireland's move to 
consider introducing controls on the packaging of tobacco products. There was an extensive and 
compelling body of international research and scientific studies that established that plain packaging, as part of a comprehensive tobacco control programme, would contribute to the 
objective of improving public health. WTO rules, including those in the TBT Agreement, contained 
appropriate flexibilities to enable WTO Members to  regulate for health and other public policy 
purposes. New Zealand was therefore confident that Ireland would be able to introduce a Plain 
Packaging regime in a manner consistent with it s obligations both under the WTO and WHO FCTC. 
2.150.  The representative of Norway recalled his delegation's usual stance that it was within the 
rights of each WTO Member to adopt measures necessary to protect public health as long as they 
were consistent with WTO Agreements. Norway th erefore supported Ireland's intent to introduce 
this kind of measure. 
2.151.  The representative of Canada recognized how challenging it was to introduce tobacco 
control measures that had never been implemented before. Canada was in a similar situation a 
decade ago when it introduced pictorial health warnings on tobacco packages. Canada took these 
regulatory and other steps because tobacco use was a significant problem, both in Canada and around the world. In Canada alone, 37,000 people died annually from tobacco use – Canada's 
leading cause of preventable death and disease. To bacco products were also the only goods that 
were the subject of a legally-binding health tr eaty, the WHO FCTC. As Members move forward in 
their discussions on this topic, they may want to consider the complete economic picture regarding tobacco control, including whether tobacco may actually be a net economic drain for many 
countries. 
2.152.  The representative of Uruguay expressed hi s delegation's conviction that the Irish plain 
packaging measure was compatible with WTO rule s. In implementing such a measure, Ireland 
would be simply exercising its sovereign right to protect public health by giving effect to the 
obligations assumed as a party to the WHO FCTC, in particular its Article 11 and relevant implementing guidelines. 
2.153.  The representative of the European Union again informed that on 28 May 2013 the Irish 
government decided to begin the process of develo ping legislation introducing plain packaging for 
tobacco products sold in Ireland. It was therefor e premature to discuss this issue in the context of 
the TBT Committee at this stage.  
2.2.2.23  Peru - Act to Promote Healthy Eating Among Children and Adolescents. 
2.154.  The representative of Mexico expressed her delegation's concern with the fact that this 
law, which would have an impact on international trade, had not been notified to the WTO. Mexico 
considered that this measure was not the least trade restrictive alternative available to Peru to 
address its public health objective. In this regard , Mexico referred to other alternative ways, such 
as public campaigns promoting healthy eating and physical activities. Mexico also noted that the 
measure did not mention the technical parameters that were used to select the "foods adequate 
for each age". Nor did it provide for the scientific basis justifying the list of restricted foods or the prohibition to sell such products in schools or the use of expressions to inform consumers a product was "high in" a given nutrient. Finally, given the existence of relevant international 
standards in this area, like the Codex, this measure could be also inconsistent with Article 2.4 of 
the TBT Agreement.  
2.155.  The representative of Argentina recalled its concern that the law 30.021 was not in 
accordance with the obligation of Article 2.2 of the TBT Agreement, as this law contained measures 
that were more trade restrictive than necessary to  achieve the legitimate objective. Argentina was 
also aware that in late May 2013 the Ministry of  Health of Peru created a Sectoral Commission 
(Ministerial Resolution n. 301-2013-MINSA) char ged with the drafting of the implementing 
regulation of Law n. 30.021. In June 2013, the presidency of the Council of Ministry created a parallel Multisectoral Commission for the same  purpose (Supreme Resolution n. 210-2013-PCM). 
Argentina therefore requested Peru to notify any dr afts and reports elaborated by the Ministry of 
Health to the PCM and by the Multisectoral Commission. G/TBT/M/61 
 
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  2.156.  The representative of the European Union associated her delegation with the statements 
made by Mexico and Argentina. The EU regretted that the law had not been notified and WTO 
Members have therefore not had the opportunity to  comment on it. While sharing Peru's public 
health concerns, the EU also doubted if the approach taken in the notified draft was the best way 
to achieve these objectives and whether it was proportional to the aim pursued, which was to 
empower consumers to make an informed choice in order to foster effective competition and consumer welfare. In this respect, and in relation to the warning labels and implementing 
provisions which would establish limits for certain nutrients as foreseen in the transitional 
provisions, the EU recalled the Codex's Guidelines on Nutrition Labelling (CAC/GL 2-1985 CODEX) which stated that the information contained in the nutrient declaration "should not lead consumers to believe that there is exact quantitative knowledge of what individuals should eat in order to 
maintain health, but rather to convey an understan ding of the quantity of nutrients contained in 
the product". The EU noted that no nutrient thresholds have been established by CODEX for the nutrients targeted by the Peruvian legislation. The EU recognised that for certain nutrients there 
was evidence of a positive association between its intake and the risk of developing a disease or 
disorder but there was no scientific evidence sugge sting an identifiable threshold above which the 
risk existed. The risk increased rather continuo usly when the nutrient intake increased above the 
levels recommended by the nutritionists. The EU also asked Peru to provide information on the 
foreseen deadlines for the entry into force of this legislation. The EU noted that according to the second transitional disposition, some of its provisions would come into force 120 days after the publication of the implementing regulation. The EU highlighted that adaptation to the new labelling 
requirements would require significant investment for manufacturers and a redesign of the 
packaging for some categories of products whic h were not defined yet. The EU therefore asked 
Peru to postpone the entry into force of the measure and provide a reasonable implementation 
period in accordance with Article 2.12 of the TBT Agreement. In this respect, the EU noted its own 
legislation on nutritional labelling, adopted in 2011 but would only come into force in 2014. 
2.157.  The representative of the United States stated that her delegation shared Peru's concerns 
regarding poor nutrition and its link to obesity and other non-communicable disease. The US has 
been a key supporter of work to implement the recommendations of the 2004 WHO Global 
Strategy on Diet, Physical Activity and Health  through new Codex guidance on nutrition and 
labelling. The US however still remained concerned that some front-of-pack labelling provided 
under the measure could stigmatize certain food s as "bad" when any food could be eaten in 
moderation as part of an overall healthy diet. Al ternative approaches could instead provide similar 
information to consumers, without the cost of mandatory product relabeling. Codex, for example, 
recommended mandatory nutritional labelling of products and recently expanded the list of 
nutrients for declaration to include saturated fat, sodium, sugars (and trans fatty acids in countries where this nutrient was a public health concern). The Codex Committee on Nutrition and Foods for 
Special Dietary Uses had also proposed Nutrient Reference Values for labelling purposes for 
sodium and saturated fat, which provided another means for consumers to identify foods "low" and 
"high" in nutrients. In addition, Codex had defined voluntary "low" claims, "no added sugars" claims, and conditions for health claims. The US no ted in this regard that Peru had not yet adopted 
a daily allowance for saturated fats and required this information as part of the Nutrition Facts 
panel as recommend by Codex. Product labelling was only one element of a larger effort needed to 
change consumer behaviour in a way that fostered healthier eating. Robust consumer information 
programs were therefore key to changing patterns in consumer behaviour. Finally, as Peru 
continued to consider its regulatory approach, the US reiterated the need for an extended period 
for compliance with the measure. By way of exam ple, she recalled that when the US issued its 
Final Rule requiring mandatory nutritional labelling in 1993, it allowed for an 18-month period for 
compliance to reduce the costs associated with re labeling of products. An even longer period, of 
three years, was allotted for trans-fat labelling when it was adopted in 2003. 
2.158.  The representative of Canada said that while her delegation supported Peru's objective of 
reducing obesity and other non-communicable diseases, it was nevertheless concerned that this 
measure may be more trade restrictive than necess ary to achieve this objective. Canada wondered 
whether Peru had considered less trade restrictive alternatives to pursue its objective. For 
instance, the Codex Committee on Nutrition for Foods for Special Dietary Uses had also proposed 
Nutrient Reference Values for labelling purposes for sodium and saturated fat, which provided another means for consumers to identify foods "low" and "high" in nutrients. In addition, Codex 
had defined voluntary "low" claims, "no added suga rs" claims, and conditions for health claims. 
Canada also shared other WTO Members' concerns that this measure was not properly notified to the WTO for comment and thus recommended that Peru notify this measure, along with a copy of G/TBT/M/61 
 
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  the full text of the proposed regulation, so as to allow for comments. Canada also understood that 
some internal review had taken place in Peru with a view to potentially adjusting the proposed regulation. Canada encouraged Peru to provide Members with an update on the scope, purpose 
and timing of the proposed regulations includin g proposed dates of notification, deadline for 
comments, and entry into force. With respect to entry into force, Canada also encouraged Peru to 
adhere to Article 2.12 of the TBT Agreement, noting that Members shall allow a reasonable interval between the publication of technical regulations and their entry into force. 
2.159.  The representative of Guatemala stated th at her delegation shared the view that healthy 
eating should be promoted in order to preven t diseases among the population. Nevertheless, 
Guatemala was concerned that the Peruvian measure might be more trade restrictive than necessary to achieve the stated legitimate objective of reducing obesity in order to fight 
non-communicable diseases. In this context, it was absolutely essential to know the scientific basis 
of the measure. 
2.160.  The representative of Peru informed that the Multisectorial Commission that was drafting 
the implementing technical regulation of Law n.  30.021 was ready to publish such a draft with 
respect to the parameters to be used to establish the content in sodium, sugar and saturated fat. This draft would be notified to the WTO with a 90-day period for comments. 
2.2.2.24  Indonesia – Ministry of Health Re gulation 30/2013 on the inclusion of sugar, 
salt and fat content information, as well as  health messages on the label of processed 
foods (G/TBT/N/IDN/84). 
2.161.  The representative of the European Union recalled that this Regulation required mandatory 
nutrition labelling for salt, sugar and fat content of processed foods. Such nutrition declarations 
must be based on tests carried out by accredited labs. Furthermore, a mandatory health warning message would have to be included on the label of all processed food products. Firstly, with regard 
to procedure, the EU requested Indonesia to no tify the regulation to the TBT Committee in 
accordance with its obligations under the WTO. It also requested that the application of the Regulation be suspended until such notification has been submitted. In this context, the EU also 
noted that Indonesia had indicated in the last TBT Committee meeting that an implementing 
Decree for this Regulation would be issued. The EU  therefore requested that this Decree be also 
notified to the TBT Committee while still in draft form, and Members be provided sufficient time to comment. While supporting Indonesia's goals of providing nutritional information to consumers so 
as to prevent diet-related chronic diseases, the EU wondered whether these objectives could not 
be achieved with less trade restrictive means, su ch as, for example, promoting healthy lifestyle 
and eating habits, rather than through a warning message applicable to all pre-packaged products. 
The EU was also concerned with the lack of clarity as to how these requirements would apply. For 
instance, it was not clear where on the label the nutritional information and related health warning should be placed; what methods would be used fo r the tests verifying the nutrition declarations, 
and whether tests performed by foreign laboratories, or in-house laboratories of companies would 
be accepted. It was also unclear how the gradual implementation of the Regulation would take place, in particular how the risk of the products with respect to non-communicable diseases would be assessed. Finally, the EU enquired whethe r Indonesia would allow stickers placed after 
importation, and before being placed on the market in Indonesia (for instance, in customs 
warehouses) as a means to show compliance  with the Regulation. 
2.162.  The representative of the United States associated herself with the comments made by the 
EU including with respect to notifications and delaying the implementation of the measure. She 
noted that Indonesia had finalized MOH Regulation 30/2013 and that it would enter into force three years from the date of adoption. The US also  sought clarification with respect to the testing 
provisions set forth in Article 6 of MOH Regulati on 30/2013, which seemed to establish a strict 
testing procedure that would not allow minimum normal variations between batches and would possibly include unnecessary shipment by shipment inspections.  
2.163.  The representative of Indonesia informed  that the regulation had been issued by the 
Minister of Health, dated on 16 April 2013 and would enter into force three years after 
promulgation, thus giving an appropriate time for industry and other sectors to comply with it. Within three years, the coverage products obliged to use the label and health messages would be 
implemented gradually by considering the level of  risk of non-communicable diseases. Basically, 
the inclusion of sugar, salt and fat content as well  as health messages for processed food aimed to G/TBT/M/61 
 
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  protect consumers from certain non-communicable disease such as hypertension, stroke, and 
diabetes and heart attack (cardiovascular). In addition, the Regulation was also to educate consumers. He further informed that the Ministry of Health would later develop a Technical Guidance to be used as reference of the implementa tion of this Regulation. Further, the Ministry of 
Health had conducted certain surveys on public consumption patterns and diet to determine the 
type of products which would be obliged to use the label and health message. The inclusion of labels and health messages was not intended to prohibit consumer to consume additional nutrition 
(sugar, salt and fat). Rather, the purpose was to better inform consumers on nutrition in order to 
prevent certain non-communicable disease. In addition, the inclusion of label and health message was part broader policy in favour of a healthy diet.  
2.164.  Regarding the affixing of a sticker prior to entering the Indonesia custom area, he clarified 
that this would be determined by the Ministry of Health and would be discussed with relevant 
Ministries involved. Regarding alternatives ways to  address the health objectives of the measure, 
Indonesia had conducted several activities to supp ort nutrition awareness, including through video 
campaign, advertising and video profile. He said th at Indonesia appreciated information on the on 
the Codex's Special Dietary Uses on nutrition claims. In this regard, this Regulation had adopted requirements on nutrition labelling throug h regulation HK. 03.1.23.11.11. 09909 Year 2011 
concerning Claim on label and processed food advertisement, stipulated by NAFDC (BPOM). The 
said Regulation of NAFDC was based on international references. With regard to testing, as provided in Article 6 of the regulation, he info rmed that this matter would be discussed further 
with the competent authority, in particular the NAFDC (BPOM). Finally, with respect to 
notifications, he said that Indonesia was still in the process of notifying the regulation of Ministry 
of Health No. 30 Year 2013, which would be sent to the WTO Secretariat at the soon as possible. 
2.2.2.25  European Union - Proposal for a Re gulation on Fluorinated Greenhouse Gases  
2.165.  The representative of Japan raised three co ncerns with the current version of the Proposal. 
First, he said that although in its written reply the EU responded that "the ban on the placing on 
the market of pre-charged equipment applies with out discrimination to equipment produced within 
or outside the EU", there was a lack of clarity in the Proposal as to how Hydrofluorocarbons (HFCs) 
quota foreseen under Article 14 would be allocated to imported equipment pre-charged outside the EU. A way to allocate this quota in a fair manner, irrespective of whether the equipment was produced within or outside the EU, could be for Article 14 or Annex 5 to specify that the amount of 
HFCs in pre-charged equipment imported into the EU be included in the reference value of quota 
allocation specified in Article 14. Another way could be to provide for the Proposal to lay down a concrete method for quota allocation, either in Article 14 or Annex 6. According to the 
Commission's impact assessment, the amount of HFCs imported in pre-charged equipment to the 
EU was estimated to be 11% of the total amount of HFCs placed on the EU market. He noted that if the amount of HFCs imported in pre-charged eq uipment was not included in the reference value, 
or if included, importers of pre-charged equipment were not allocated quotas for administrative 
reasons, the importers would be treated as "new en trants". In this situation, he stated that the 
importers would be allocated a maximum 5% of th e reference value, which was the amount to be 
allocated to new entrants. His delegation believed that this situation unfairly modified conditions of 
competition between EU and foreign products. The second concern involved Article 12. In this 
respect, Japan requested that the European Union withdraw the prohibition of pre-charging, which 
his delegation believed was a trade restrictive measure. As noted at the June 2013 Committee 
meeting, this requirement lacked technical validity and rationale, because it would lead to 
increased HFCs emissions through leakage. He said that therefore the EU would not be able to achieve the stated policy objectives of the Proposal. Under the third and last concern, with respect 
to the "Ban on HFC use", he requested the EU co ntinue to allow the use of HFCs after 2020. He 
reported that the Environment Committee of the European Parliament had adopted in the Proposal a ban on the use of HFCs in stationary refrigeration and air-conditioners after 2020. He noted the technical difficulties of phasing out HFCs by 2020, since no alternative refrigerants had been 
developed to date which were both sufficiently safe and had low global warming potential (GWP). 
Furthermore, he argued that the ban lacked rationale in light of the policy objective of combating global warming; given that over their lifecycle, HFCs refrigerants had a very limited impact on 
global warming. Until alternative refrigerants were developed, his delegation requested that the EU 
allow the use of HFCs after 2020. 
2.166.  The representative of Korea noted with appreciation the fruitful bilateral meeting held with 
the EU delegation, and that his delegation respected the efforts of the EU to protect the G/TBT/M/61 
 
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  environment. His delegation understood that Article 12 of this regulation specified that HFCs gas 
should not be charged into refrigeration, air-co nditioning, and heat pump equipment before the 
equipment was placed on the market or before it was made available to end-users for final installation. The EU had explained that the ban on pre-charging was aimed at reducing the risk of 
accidental release of HFCs during installation, and at reducing the use of HFCs in products 
manufactured and charged outside the EU and im ported into the EU. Regarding Article 14 on 
"Quota Allocation", he noted that according to the EU delegation this provision covered both 
manufacturers and importers of equipment using HFCs . His delegation appreciated this clarification 
and requested that the EU send an official interpre tation of this provision. Nevertheless, he said 
concerns remained as to how the EU would allocate the quota and whether manufacturers or importers of equipment would still need to charge HFCs after installation within the EU. 
Furthermore, he emphasized the need to reco nsider the prohibition on pre-charging. His 
delegation believed that during installation and charging, accidental releases were more likely when using bulk HFCs, even if the equipment was installed and filled with HFCs by certified 
persons. He noted that the amount of released gases in this case could be significant. He recalled 
that at the last Committee meeting his delegation had stressed that the precise level of refrigerant was a critical factor for the performance and energy efficiency of air-conditioners, and that 
manufacturers had to test the performance of products filled with refrigerants prior to placing 
them on the market in order to comply with Di rective 2009/125/EC (on eco-design requirements). 
However, to then comply with the proposed regulation under discussion, manufacturers would have to remove refrigerants after testing, which could affect the performance of the products in 
the process. He stressed that this would make it difficult for manufactures to guarantee the 
performance of products which were charged with HFCs after installation. 
2.167.  The representative of the United States ex pressed support for global efforts to phase-down 
the consumption and production of climate-damaging HFCs, but nevertheless raised procedural 
and participation concerns regarding this proposal. She first requested that the foreseen entry into force deadline of 2015 for refrigerators and freezers be pushed back, so that industry would have 
time to comply. The representative next noted a pressing concern regarding the exemptions 
required by both the EU and US semiconductor industries to continue semiconductor production. She noted that semiconductor manufacturers had al ready eliminated non-critical usage of HFCs, 
but no alternative existed for certain production processes. As opposed to other sectors, there 
were no substitutes available for the fluorinated gases used in semiconductor production. She 
further emphasized that the fluorine atom's stability was critical for precise manufacturing, and had specific chemical properties and functionalities which were critical to the production process 
for semiconductors. Moreover, she noted that the semiconductor industry was an insignificant 
contributor to absolute emissions of fluorinated gas, emitting less than 0.05% of total EU HFC emissions in recent years. She finally sought clarification of her delegation's understanding that 
the EU member states and the Council had agreed to text that would exclude semiconductor 
processes from the HFCs phase-down, but that the European Parliament was currently debating the issue, and she asked for an update on this aspect. 
2.168.  The representative of China said that while his delegation supported the environmental 
protection efforts of the EU, China, as a major exporter of refrigerators and air conditioners, was 
still concerned that this measure was more trade restrictive than necessary, and that it would have a significant impact on Chinese manufacturers, es pecially small and medium sized enterprises.  
2.169.  The representative of the European Union said the proposal was currently under discussion 
between the Council and the European Parliament. Her delegation was aware of the trading 
partners' concerns about the ban on the placing on the market of equipment pre-charged with 
HFCs, and those concerns were being taken into account in ongoing discussions in the 
EU legislative process. Turning to the US concerns on the availability of HFCs for the manufacturers of semiconductors, she stated that the needs of this industry had been fully taken into account in the drafting of the proposed meas ure. She noted that only one of the fluorinated 
compounds used by the semiconductor industry, HFC-23, which had a very high Global Warming 
Potential (GWP), would be subject to the phase-down, while PFCs, SF6, NF3 and other fluorinated compounds used by this industry were not. The representative explained the proposed 
phase-down would provide the necessary gas quotas to cover all critical uses up to 2030, of which 
semiconductors was one. Moreover, since the amounts needed for the semiconductor industry were very small, a shortage of gas was extremely unlikely. With respect to the concerns raised by 
Japan and Korea on the allocation of quotas for importers of pre-charged equipment, she noted G/TBT/M/61 
 
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  that the proposal did not require quotas to be held for gases in imported equipment. Finally, on 
Japan's last query, she said that the proposal did not contain a total ban on HFCs after 2020. 
2.2.2.26  European Union - Revised Proposal  for the Categorization of Compounds as 
Endocrine Disruptors of 19 February 2013 by DG Environment  
2.170.  The representative of the United States recalled that her delegation provided background 
on the issue of endocrine disruptors at the last meeting, and reiterated concerns over the EU's 
proposal for the categorization of compounds as endocrine disruptors. She noted both procedural 
and substantive concerns with the work underway in the EU, including uncertainty about timing 
and the process ahead, which could entail significant potential impacts on trade. She welcomed the decision to conduct an impact assessment on the plant and biological side, and mentioned independent impact assessments that suggested significant trade impact from a horizontal 
approach. However, she highlighted systemic issues on stakeholder participation and 
transparency, and asked the EU to clarify if this impact assessment would be based on the most recent proposal for categorization, or whether there would be other options considered as well. 
She sought further clarification as to the relationship between this impact assessment and other 
legislation and directives, including with regard  to the plant biological side, chemicals and 
cosmetics. She said that US industry was uncerta in as to the timing of the process ahead, and 
opportunities for stakeholder participation and transparency, and requested that the EU clarify 
those elements. 
2.171.  The representative of South Africa enquired whether this regulation would be notified and 
said that his delegation was concerned about impacts on specific products and related regulations. 
2.172.  The representative of the European Union reiterated that several pieces of EU legislation 
contain specific provisions regarding endocrine disruptors. However, she explained that scientific 
criteria for the identification of endocrine disruptor substances at a horizontal level were not yet 
available. To this end the EU planned to propose ho rizontal scientific criteria to identify endocrine 
disruptors in 2013, which were to be implemented in a second phase in sectorial EU legislation, notably by updating the Biocidal Product Regulati on and the Plant Protection Products Regulation, 
which had put in place provisional criteria. The EU decided to carry out a comprehensive impact 
assessment analysing different options for defining  criteria for the identification of endocrine 
disruptors, and their corresponding health and socio-economic effects once incorporated in different pieces of EU legislation. She noted th at this impact assessment would include a public 
consultation, most likely to be launched at the beginning of 2014 and lasting for 3 months. At this 
stage, WTO Members would have the opportunity to provide comments. She emphasized that only after the impact assessment was concluded, would the European Commission present proposals 
for introducing criteria to identify endocrine disruptors in different pieces of EU legislation, which 
was expected to occur in the second half of 2014. With respect to the questions of the US, she said it was premature to discuss the outline of  the impact assessment, its structure and the 
options that would be assessed, and reported th at the Commission would soon publish a roadmap 
containing this information. The impact assessment would nevertheless follow the European Commission's guidelines for preparing impact assessments, which were publicly available on its website. Finally she specified that the impact assessment would take into account, as a scientific 
basis, existing studies and reports on this matter such as the recent opinion of the European Food 
Safety Authority, the report of the EU Joint Research Centre, the reports of the World Health Organisation and the OECD review paper. 
2.2.2.27  Indonesia - Ministry of Trade Re gulation 82/M-DAG/PER/12/2012 on imported 
cell phones, handheld and tablet  computers (G/TBT/N/IDN/78). 
2.173.  The representative of the European Union expressed regret that this regulation was not 
notified according to the TBT Agreement in a draft stage, denying other WTO Members the 
possibility to comment on it. EU industry reported that following the entry into force of the regulation, considerably more time was needed to place the products concerned on the Indonesian market. Of particular concern was the burdensome requirement for pre-shipment inspections for 
every import taking place at the port of loading by appointed representatives of the Indonesian 
Government. In addition, her delegation was concerned that the type label (SKPLBI) and type approval number label (POSTEL) had to be availa ble at the pre-shipment inspection stage, while 
the usual practice was for these to be available after custom clearance. She requested that G/TBT/M/61 
 
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  Indonesia consider less time-consuming and burdensome procedures for imports of cell phones, 
handheld and tablet computers. 
2.174.  The representative of the United States enquired as to the legitimate objective of the 
measure, and also noted the importance of In donesia respecting TBT Agreement transparency 
obligations. After recalling previous interventions, she noted additional concerns with the 
Information Technology Postel Notification 5 of 2013. In particular, the 60-day comment period was provided only when the measure was alread y in force. She further noted concerns with 
amendments to Ministry of Trade Regulation 82 of 2012 as contained in Ministry of Trade 
Regulation 38, issued in August 2013, and asked for further information from Indonesia regarding 
those changes. Finally, her delegation was awar e that an amendment to Ministry of Industry 
Regulation 108 of 2012 was being considered, an d she requested additional information on the 
changes being considered, and urged Indonesia to notify these measures to the TBT Committee. 
2.175.  The representative of Canada expre ssed the view that these regulations created 
unnecessary administrative barriers to trade, echoin g the US statement. Her delegation's principal 
concern was the need for companies to comply with excessive labelling requirements in order to 
receive importer licenses to sell their products in Indonesia, resulting in significant delays in time to market. In addition, she was concerned that new certification requirements had not been 
notified and requested Indonesia to do so. Lastly, her delegation recommended that Indonesia 
delay the implementation of the wireless certification requirements guidance. 
2.176.  The representative of Indonesia reported that the Indonesian Ministry of Communication 
and Information Technology had conducted bilateral meetings with the US delegation in Jakarta in 
September 2013. At this meeting, the US received a comprehensive explanation from Indonesia on 
the issues of imported cell phones, handheld and tablet computers. Regarding transparency, his delegation had notified the Regulation of th e Minister of Communication and Information 
Technology n. 5 of 2013 concerning Classification of Telecommunication Equipment as 
G/TBT/N/IDN/78. The regulation had three main objectives: ensuring interconnectivity, interoperability, and security for networking and information; facilitating CAB to determine 
appropriate technical regulations; and, facilitating completion of the application form with the 
appropriate HS code. Turning to the certification procedure, he reported that the Ministry of 
Communication and Information Technology had developed a new Regulation concerning Certification of Telecommunication Equipment, which was a revision of the previous 
Regulation n. 29 of 2008 (notified in G/TBT/N/IDN/81). He noted that this revision included certain 
procedural requirements for certification, submission of application, testing requirements and certification license. His delegation was of the view that the requirement for inclusion of 
International Mobile Equipment Number (IMEI) labels was in line with Article 2.2 of TBT 
Agreement. The representative explained that the rationale for this IMEI labelling was national security requirements, as well as to protect consumers from stolen and lost phones, and also for 
prevention of the deceptive practices. The IMEI number could be used by network providers to 
identify valid devices, and could also be used to prevent certain devices from accessing the network. He explained that if a mobile phone was stolen, the owner could request that his or her network provider "ban" the phone using its IMEI  number. In addition, he argued that the 
requirement for Bahasa Indonesia labels did not create unnecessary obstacle to trade, rather this 
provision was aimed at conducting surveillance or monitoring of every product to be marketed in Indonesia in order to prevent deceptive practices. Regarding the technical guidelines on registering 
products for cellular phones, computer and handheld tablets, the representative informed the 
Committee that the Indonesian Ministry of Industry had issued Guideline 5/IUBTP/PER/1/2013 which regulated the implementation of the Decree of Ministry of Industry 108/MIND/PER/11/2012. 
The decree was notified under document G/LIC/N/2/IDN/13. He asked delegations to refer to 
document G/LIC/Q/IDN/27 circulated on 7 October 2013, for answers to other technical questions, in which Indonesian provided written replies to questions from the EU and the US on this aspect, which was. Nevertheless, Indonesia continued to welcome bilateral discussion on these issues with 
concerned Members. 
2.2.2.28  Russia – Safety of light industry products 2.177.  The representative of the European Union said that while her delegation shared the 
legitimate objectives of protection of human life and health, these objectives could be achieved by 
means less restrictive than the mandatory requirements laid down in the technical regulation. The technical regulation subjected many textile and clothing, footwear and leather products to detailed G/TBT/M/61 
 
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  compulsory third party conformity certification, and given that these products were considered as 
relatively low risk, this created unnecessary barriers to trade. She suggested that Russia's legitimate objectives of consumer health protection  be achieved by less strict means, for example, 
random inspections. The representative recalled Russia's clarification in the last TBT Committee 
meeting that mandatory third party certification was limited to products that entered into direct 
contact with human skin, as enumerated in Arti cle 11, paragraph 2 of the technical regulation. 
However, she said this provision covered a wide range of textile products and footwear, and her 
delegation believed that a self-declaration of the manufacturer should be sufficient for all products 
covered by the technical regulation. Furthermore, she contended that the parameters to be tested 
were in many cases not based on scientific and objective criteria. She asked Russia to clarify the relevant standards for the conformity certification. She further noted that the technical regulation 
provided for extensive labelling and marking requirements, some of which were of limited use for 
the customer. In the view of her delegation, mandat ory labelling requirements should be limited to 
essential elements, leaving the remaining information at the discretion of the producer or 
distributor. At the last TBT Committee meeting,  Russia had said that the EU written comments 
were under consideration by the competent Russian authorities, and she requested information as to the outcome of this consideration, and also to receive a written reply to her delegation's 
comments. 
2.178.  The representative of the Russian Federation explained that this technical regulation, 
developed in accordance with Article 2.2 of th e TBT Agreement, was introduced on 3 December 
2011 and entered into force in July 2012, prior to the Russian Federation's accession to the WTO. 
This technical regulation of the Customs Union actually replaced the national legislation and 
substantially facilitated regulation in this field,  in the markets of all the member states of the 
Customs Union. Under Article 11, paragraph 4 of this measure, mandatory certification was only 
required for three kinds of textile products that came into direct contact with the skin, for 
example, underwear, bed linen and socks. His delegation did not share the opinion of the EU that the scope of products subject to mandatory certification was too broad. He noted that other textile 
products were subject to self-declaration of conformity. Moreover, new draft amendments were 
notified in document G/TBT/N/RUS/14, which further facilitated the technical regulation. Specifically, he explained that the amendments repealed excessive regulation of raw materials 
used in manufacturing of final products, by excluding them from the need to undergo conformity 
assessment procedures. He stated that only final products were subject to conformity assessment 
procedures. The representative said that EU comm ents submitted in May 2013 were well received 
during the public hearing, and would be included in the roster of comments of interested parties. 
According to the procedures of the Eurasian Economic Commission, all comments included in the 
roster concerning draft amendments to the technical regulation shall be replied to, and his delegation expected that the roster would be ready in the near future, at which time it would be 
made publicly available on the website of the Eu rasian Economic Commission. The representative 
expressed his delegation's willingness to continue to engage in bilateral consultations on this matter. 
2.2.2.29  China – China Food and Drug Admi nistration (CFDA) EMC Enforcement Notice 
for medical devices of 19 December 2012. 
2.179.  The representative of the European Union said that electro-magnetic compatibility (EMC) 
test for Classes II and III medical devices was mandated in the context of China's registration 
procedure for such devices, and was carried out in order to ascertain compliance with Chinese 
mandatory standard YY0505:2012, which appeared to be equivalent to IEC standard 60601-1-2 (2
nd edition, 2004). The EU was grateful that the China Food and Drug Administration (CFDA) had 
constructively engaged with European industry on this issue and other regulatory issues pertaining 
to medical devices, and also appreciated that the Chinese standard appeared similar to the international IEC standard. In this context, she reiterated her delegation's request that the CFDA accept test reports from foreign laboratories accredited by accreditation bodies who are members 
of ILAC, as an alternative to in-country testing by a Chinese laboratory. This would avoid 
unnecessary duplication of testing, as medical devi ces imported into China were already tested in 
accordance with the IEC standard. She also stated that it would ensure that there was no 
disruption in the importation of medical devices into China from 1 January 2014 due to a lack of 
necessary infrastructure to perform the EMC testing. She noted that the number of laboratories accredited by the CFDA to perform the required EMC testing continued to be quite low, and was 
insufficient to comply with the likely heavy increase in activity resulting from the enforcement of 
the CFDA notice. This would likely lead to longer registration timelines and higher compliance costs G/TBT/M/61 
 
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  for industry, and she therefore asked China to pr ovide information as to steps taken to address 
this problem, and, in particular, if it would allow foreign test reports proving compliance with the relevant IEC standard as an alternative to in-country testing in China. 
2.180.  The representative of the United States said that the new requirement to conduct EMC 
testing in CFDA-approved facilities in China would require medical devices that have already been 
tested and certified outside of China to be re-tested within China, which would significantly impact trade by increasing both the cost and time-to-market for products exported to China. She 
mentioned that China previously accepted EMC test  reports generated outside of China by qualified 
international laboratories, including those recognized under the IECEE CB Scheme. Her delegation requested that China reconsider accepting EMC test  reports generated by laboratories outside of 
China that have been internationally accredited under the ILAC or IECEE CB Scheme. If these test 
reports were not accepted, she requested an explanation why they were considered inappropriate 
in this case. As noted in past interventions, her delegation believed that the confidence and independence of laboratories should not be de termined by place of domicile. Further, the 
representative noted that the new requirements referenced GB standards that were based on an 
outdated version of the IEC standard, and she sought clarification from China that it intended to accept the current version of this standard as equivalent. If this was not the case, she asked for an 
explanation of why the current relevant international standards would be ineffective in meeting 
China's objective. Finally, she recalled that the US submitted an enquiry on these requirements via China's national enquiry point on 17 October 2013, but to date, her delegation had not received a response. She again requested that China notify this requirement to the WTO Secretariat and allow 
a reasonable time for Members to comment. 
2.181.  The representative of China stated that standard YY0505:2012 ("Medical Electrical 
Equipment Part 1-2: General Requirements for Safety, EMC Standard Requirements and Test 
Standards for Medical Devices Industry") was an identical transposition of the IEC international 
medical electrical equipment electromagnetic compatibility test standard IEC 60601-1-2. She said the standard was set to ensure a safe environment for medical devices so as to protect public 
health. As IEC 60601-1-2 was a recognized international standard in this area and was widely used 
by WTO Members, it was her delegation's view that the promulgation of YY0505:2012 would not 
have a significant impact on international trade. 
2.2.2.30  European Union - Transformation  of still wine into sparkling wine (EC 
Regulation 479/2008 of 29 April 2008). 
2.182.  The representative of Australia expresse d ongoing concerns with EC Regulation 479/2008 
of 29 April 2008 which did not allow bulk still wine produced outside the EU to be transformed into 
sparkling wine in the EU. At the same time, the EU permitted still wine from one EU member state 
to be transformed into sparkling wine in another EU member state. The regulation appeared to be inconsistent with the national treatment principle under Article 2.1 of the TBT Agreement. His 
delegation understood that the EU only permitted sparkling wine to be made from still wine in 
limited circumstances and subject to specific cond itions and labelling requirements; however, wine 
sourced from outside the EU was excluded from this possibility under EC Regulation 479/2008. 
Australian wine exporters were seeking access to the same conditions and regulations applicable to 
bulk EU wine being transformed into sparkling wine  in the EU. His delegation encouraged the EU to 
amend the regulation as a matter of priority. 
2.183.  The representative of the European Union re iterated that the transformation of wine from 
still into sparkling in the EU was subject to strict regulations, regardless the origin of the still wine. 
As a result, most sparkling wine sold in the EU could not be produced from still wine from another country, regardless of whether this was a third country or a European one. In the exceptional 
cases where this was allowed by EU legislation, specific labelling rules were in place in order to 
avoid consumer deception. She explained that her delegation was discussing this issue with Australia bilaterally in the framework of the EU-Australia Agreement on trade in wine. 
2.2.2.31  European Union – Implementing Re gulation (EU) No 481/2012 of 7 June 2012 
laying down rules for the management of a tariff quota for high-quality beef. 
2.184.  The representative of Argentina said that despite four years of bilateral negotiations, and 
having met all the requirements and providing all the information required by the EU, Argentina G/TBT/M/61 
 
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  was not yet authorized to export high quality meat to Europe under the tariff quota established in 
August 2009 by Regulation (EC) No. 617/2009. He re called that the latest version of Control and 
Certification Protocol was submitted by Argent ina in February 2012, , more than 20 months 
previously, but had not yet received any response. A number of follow-up requests had been made 
bilaterally, as well as in the TBT Committee context,  and on each occasion the EU replied had been 
vague and dilatory. At the June 2013 meeting, the EU had only said that this request was still 
under consideration. Given the time elapsed, and the clarifications and supplementary information 
provided by Argentina in response to EU requests, he stressed that the time had come for a 
response. As previously stated, this unwarranted  postponement was an unnecessary obstacle to 
trade, and was therefore incompatible with the TB T Agreement. He underscored that the fact that 
Argentina had not received authorization to export meat under the tariff rate quota was 
incompatible with the most favoured nation principle, since other countries in a similar position to 
Argentina, whose production and control systems were similar or equivalent to those of Argentina, had already been authorized to access this quot a, sometimes for a period of several years. He 
therefore once again requested the EU to clarify th e reason for the lack of progress since February 
2012. He also urged it to promptly take a favourab le decision on Argentina's application, publish 
this decision without delay in the official bulletin of the EU with the name of the Argentine body 
issuing the certification of authenticity, as es tablished in Article 5 of Regulation 481/2012 
concerning the management of the tariff rate quota, so that Argentina could participate on equal terms with other Members. 
2.185.  The representative of the European Union reiterated her delegation's doubts that this 
issue, which related to the management of a tariff rate quota, fell under the scope of the 
TBT Agreement. Nonetheless, her delegation was providing Argentina with regular updates on its 
application bilaterally, and would continue to do so. 
2.2.2.32  Peru — Implementing Regulation s of 14 November 2012 for Moratorium on 
Planting Genetically Engineered Crops  
2.186.  The representative of the United States appreciated the productive engagement with Peru 
on this issue during our bilateral discussion in the context of their Trade Promotion Agreement. 
Her delegation nevertheless remained concerned about the lack of notification to the TBT Committee of the implementing regulations for the moratorium on GE crops. 
2.187.  The representative of Peru reiterated that the ten year old moratorium was not a technical 
regulation within the meaning of the TBT Agreemen t, and therefore did not need to be notified. 
She stated that that this was an environmental measure related to the protection of biodiversity. She took note of the comments and pledged to relay them to her capital for due consideration. 
2.2.2.33  New Zealand – Proposal to introduc e plain packaging of tobacco products in 
New Zealand  
2.188.  The representative of Cuba expressed than ks for the bilateral meeting with New Zealand, 
but reiterated that her delegation had not yet received replies in writing to their questions of 
28 November 2012. She also noted a meeting had taken place on the margins of the March 2013 Committee meeting with experts from capital, who had requested additional time to participate in New Zealand's public consultation on this measure. Her delegation remained concerned with this 
measure, and considered it to be incompatible with WTO rules. The representative again asked for 
updated information on New Zealand's domestic legislative process on this aspect. 
2.189.  The representative of Dominican Republic said that her delegation shared New Zealand's 
interest in protecting human health, but the prop osed plain packaging measures were nevertheless 
a source of serious concern. She recalled concerns express at past TBT Committee meetings, as well as in the TRIPS Council meeting of 5 March 2013. Her delegation was concerned that this 
proposed measure ran counter to WTO obligations under WTO Agreements, including the TBT and 
TRIPS Agreements. She further stated that the proposed requirements were unnecessarily trade 
restrictive to meet New Zealand's legitimate objective. She urged WTO Members to postpone any implementation of plain packaging requirements  until the DSB had dealt with the complaints 
brought by five WTO Members, including the Dominican Republic, against Australia's plain 
packaging legislation.  G/TBT/M/61 
 
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  2.190.  The representative of Honduras echoed concerns of Cuba and the Dominican Republic. 
While his delegation fully endorsed New Zealand's public health objective, he reiterated concerns 
that the measures in question were not in line with New Zealand's obligations under the TBT and TRIPS Agreements. He recalled that the TBT Agreem ent mandated that technical regulations be no 
more trade restrictive than necessary to fulfil le gitimate objectives. Moreover, Article 12.3 of the 
Agreement stipulated that Members must ensure that technical regulation do not create unnecessary obstacles to exports from developing country Members. Given the complaints 
currently before the DSB, his delegation hoped that there would not be a proliferation of similar 
legislation in other Members, which risked und ermining the multilateral trading system. He 
therefore urged the New Zealand Government to reconsider its decision to introduce plain packaging for tobacco products while awaiting the results of the complaints lodged by Ukraine, 
Honduras, Dominican Republic, Cuba and Indonesia. 
2.191.  The representatives of Nicaragua and Ma lawi endorsed the preceding interventions. 
2.192.  The representative of Zimbabwe appreciated the efforts of New Zealand in protecting 
public health, but nonetheless shared the concerns expressed by other delegations with the 
proposed plain packaging measures. She reiterated her delegation's position that these measures ran counter to the TBT and TRIPS Agreements . She encouraged New Zealand to await the 
outcome of the Australia case before the DSB, and reconsider its decision to implement these 
measures, which were unnecessarily trade restrictive, would not achieved their legitimate objectives, and were not based on scientific evidence. 
2.193.  The representative of Australia reiterated his delegation's previous interventions in support 
of New Zealand's decision to legislate for mandatory plain packaging of tobacco products. He said 
tobacco plain packaging was a legitimate measure,  designed to achieve a fundamental objective – 
the protection of human health. His delegation looked forward to supporting New Zealand as it 
underwent the development of its own measure, an d appreciated New Zealand's consistent strong 
support for Australia's measure, including in meet ings of this Committee. Tobacco plain packaging 
was endorsed by leading public health experts as well as the World Health Organization (WHO), 
and was supported by extensive research reports and studies. He noted that tobacco plain 
packaging was recommended in the guidelines for the implementation of Articles 11 and 13 of the 
WHO Framework Convention on Tobacco Control, to which Australia and New Zealand were both Parties. Australia was of the firm view that Members had the right to implement measures 
necessary to protect public health, while complying with relevant international treaty obligations, 
including the TBT Agreement. 
2.194.  The representative of Canada said that  international developments in tobacco product 
packaging remained of interest to Canada. She no ted that Canada had been a pioneer in package 
labelling requirements for tobacco products, and considered these sorts of requirements a core component of the right to regulate in the interests of the public. In her delegation's view, it was 
important to recall Article 2.2 of the TBT Agreemen t, which allowed for the legitimate objective of 
protection of human health. Her delegation looked forward to further views from other Members on the appropriate balance amongst regulati on, international trade and public health. 
2.195.  The representative of Norway expressed continued support for New Zealand in this regard. 
2.196.  The representative of Uruguay reiterated his delegation's conviction as to the legitimacy of 
plain packaging under WTO rules, and support for the proposal of New Zealand. He noted that 
New Zealand was acting in line with its commitments in the WHO context, which were shared by 
176 states, and stated that this plain packaging measure was not more trade restrictive than 
necessary to protect public health. The objective of protecting public health was within the sovereign right of states, and he said therefore that each state could legislate in the interest of 
public health as recognised in the WHO FC TC. New Zealand had committed not to undermine 
international standards in implementation of this public health measure, and Uruguay held this justification. 
2.197.  The representative of New Zealand welcomed interest in his government's decision to work 
towards the introduction of a plain packaging regime for tobacco products, and efforts to 
continually reduce the burden of preventable de ath and disease caused by tobacco consumption. 
He recalled that this decision, which was announced in February 2013, was taken to advance G/TBT/M/61 
 
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  public health objectives and followed a comprehensive public consultation process, which was 
notified to the TBT Committee. New Zealand had previously reported to the Committee on numerous occasions the outcome of the consultation process, and had repeatedly responded to the points raised by concerned Members at this meeting. He said that since the February decision, 
officials had commenced the process of preparing draft legislation that would provide for a plain 
packaging regime, and it was his government's intention to introduce this legislation before the end of 2013. Detailed regulations to implement the regime would be developed subsequently. The 
representative stated that prior to the plain packaging legislation being introduced to the New 
Zealand Parliament, his government would allow sufficient time for the public to make submissions on the legislation and for the Parliamentary Select Committee to review the legislation and consider the submissions received. His delegation would also notify the legislation to this 
Committee, to allow Members the opportunity to comment. In announcing the decision to 
introduce plain packaging, New Zealand acknowledged the WTO legal challenges to Australia's plain packaging laws. His government noted, if necessary, that enactment of final entry into force 
of New Zealand's legislation or regulation could be  delayed pending conclusion of Australian cases 
before the DSB. He emphasized New Zealand's willingness to continue to meet bilaterally with concerned Members, including the distinguished delegation of Cuba, to further discuss the 
proposed measure. Finally, he thanked those Members which expressed supported for New 
Zealand's introduction of plain packaging. 
2.2.2.34  Kenya – Alcohol Labelling: The Alcoholic Drinks Control (Licensing) 
Regulations, 2010: Legal Notice No. 206: 2010 (G/TBT/N/KEN/282) 
2.198.  The representative of the European Union thanked Kenya for its written reply to 
EU comments on G/TBT/N/KEN/282. While her delegation welcomed the clarifications therein, 
concerns remained that under current Kenyan requ irements the health warning must comprise not 
less than 30% of the total surface area of the package, an extremely burdensome requirement. 
Her delegation sought further clarifications about these requirements, and urged Kenya to proceed with the proposed amendments regarding the size of the warning, as established by the Alcoholic 
Drinks Control Amendment of 2012, in order to provide legal certainty to economic operators. 
Furthermore, she expressed concern about the ro tation requirement for warning labels, which 
established that: "all the warning labels specified in the Second Schedule shall be randomly displayed in each twelve month period on a rotational basis and in as equal a number of times as 
is possible, on every successive fifty packages of each brand of the alcoholic drink and shall be 
randomly distributed in all areas within the Republic ". In this context she recalled Article 2.2 of the 
TBT Agreement, and requested further clarifications on how this requirement would be enforced. 
2.199.  The representative Kenya took note of the concerns raised, and referred to previous 
responses provided on this trade concern. Nevertheless, her delegation would consult with capital 
and regulatory authorities in order to provide an appropriate response. 
2.2.2.35  Mexico - Refusal of the National Water Commission to re-certify HDPE pipe 
products meeting quality/safety standards for piping set out in NOM 001 and NMX 241 
2.200.  The representative of the United States reiterated concerns over Mexico's restrictions on 
sanitation pipes, detailed in the minutes of the previous Committee meeting. Her delegation 
appreciated Mexico's continuous engagement on th is difficult issue, and understood that there had 
been significant movement. In particular, she confirmed that Mexico intended to grant a three-year certificate, and she awaited written approval to this effect. Her delegation would continue to 
monitor the situation, and she looked forward to a final resolution of this issue. 
2.201.  The representative of Mexico said that her delegation had done everything possible to 
address the concerns of the US on this issue, which had been before the Committee for some time. 
The Government of Mexico was pleased that this ma tter could be effectively dealt with as an STC. 
She said that her government would need to take care of matters officially before a written confirmation could be provided to the companies concerned. Her delegation was happy to deal with these matters, and would continue as necessary to engage in bilateral meetings, as well as in 
other meetings or fora. G/TBT/M/61 
 
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  2.2.2.36  India – Food Safety and Standard s Regulation - Food labelling requirements 
(G/TBT/N/IND/46) 
2.202.  The representative of the European Union voiced concerns regarding the implementation of 
this regulation which was published in the Indian Gazette in August 2011. Her delegation regretted 
that this text and its subsequent amendments had never been notified to the TBT Committee, 
despite several requests from the EU Enquiry Poin t and despite the fact that it contained several 
aspects which fell under TBT Agreement provisions, such as labelling and packaging requirements. 
She reminded India that a publication of the Food  Safety and Standards Regulation on the Food 
Safety and Standards Authority of India (FSSAI) we bsite did not constitute a notification to WTO 
Members in the sense of Article 2.9.2 of the TBT Agreement. She reported that several food containers originating in the EU had been blocked at certain Indian ports allegedly on the grounds 
that compulsory labelling information was missing and/or compulsory labelling information was 
provided by means of a sticker instead of being printed on the package. Her delegation was still 
collecting information on the nature of the problem, and asked India to inform the Committee of 
the current procedures for the control of food imports as regards labelling provisions. She 
encouraged Indian food authorities to adopt the least trade restrictive means to achieve their legitimate objectives, which was, in this particular case, consumer information. Further, the Indian 
regulation of August 2011 defined a food label, and laid out the type of information the food label 
must contain, further specifying that the label shall be applied in such a manner that it would not become separated from the container. She recalled that in October 2011 India issued ad hoc guidelines specifying that certain information, which was India-specific, such as the 
vegetarian/non-vegetarian logos and the name an d address of the importer, were considered 
"rectifiable" information and could be affixed by the importer in customs warehouses. The guidelines also detailed that a number of labelling elements were "not rectifiable". 
2.203.  She said that the EU was of the view that the October 2011 Guidelines, while initially 
intending to provide some trade facilitation to market operators, were in fact, if implemented sensu stricto , not in compliance with Article 2.2 of th e TBT Agreement. She therefore requested 
that India allow all types of food labelling informat ion, and not only India-specific information, to 
be affixed by the importer by means of a sticker in customs warehouses, if needed. This was a sound alternative to labelling in the country of origin which still attained the objective of duly informing the consumer, while being more convenie nt for market operators, in particular for 
products exported to India in small quantities. Fi nally, her delegation was aware that a new Indian 
draft technical regulation dedicated to alcoholic dr inks was being drafted, and she invited India to 
inform the Committee of its state of play and the timeline for notification to the Committee. 
2.204.  The representative of India informed the Committee that his delegation had notified the 
Draft Food Safety and Standards (Packaging an d Labelling) Amendment Regulation, 2013 on 24 
October 2013 in G/TBT/N/IND/46. He noted a fruitful bilateral meeting with the EU, and said that 
all the specific requests raised were sent to his capital, and he was awaiting replies. Regarding the 
draft technical regulation on alcoholic beverages, he said that it would be notified to the Committee as soon as there was a semblance of a draft regulation. 
2.3  Exchange of Experiences  
2.205.  The Secretariat drew Members' attention to the revision of the Committee's compilation of 
decisions and recommendations contained in document JOB/TBT/67. It was noted that this 
document would be open for comments from Members until 29 November 2013 and would 
thereafter be issued as G/TBT/1/Rev.11.6 
2.3.1  Special and Differential Treatment and Technical Assistance (Thematic Session on 
29 October 2013)7 
2.206.  The Chairman reported on the thematic session held on 29 October 2014 on both special 
and differential treatment (SDT) and technical assistance (TA). The full report, provided on the 
Chairman's own responsibility and with comments from Members taken into account, is contained in G/TBT/GEN/156.  
                                               
6 G/TBT/1/Rev.11 was issued on 16 December 2013. 
7 A background document by the Secr etariat is contained in JOB/TBT/65. G/TBT/M/61 
 
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  2.207.  The representative of China appreciated the Chairman's report. He said that China had 
offered, on a preliminary basis, some ideas on possible guidelines for special and differential 
treatment. He stressed that the proposal for the gu idelines was not as such preliminary – this was 
a proposal that China and other Members were making. China made reference to an earlier 
submission from Ecuador (JOB/TBT/49). The Chin ese delegation reiterated the need for more 
effective implementation of the SDT provisions of  the TBT Agreement. In addition, he proposed 
that the Committee establish an e-working to bring this work forwards. He congratulated the EU 
delegation on the pioneering exchange of experi ence specifically on the subject of SDT – and 
hoped that other delegations would follow suit using the EU presentation as a role model.  
2.208.  The representative of El Salvador thanked the Chairman for an accurate and concise 
report. In general, El Salvador was pleased with the work that was being undertaken in thematic 
mode – it had enabled a rich exchange of experiences, SDT and TA. 
2.209.  The representative of Ecuador stressed the importance of moving towards a fully 
operational Article 12 of the TBT Agreement. He drew the Committee's attention to a working 
paper contained in JOB/TBT/71 on general guidelines for Article 12 of the TBT Agreement.  
2.210.  The representative of Cuba thanked the Chairman for an excellent report. She expressed 
support for the statements from China and Ecuador. It was important to look specifically at 
measures implemented by developed countries that  were harmful to developing countries. The use 
of plain packaging for tobacco products was an example of a measure that had serious consequences on small subsistence farmers and their families whose livelihood depended on exporting tobacco products. The EU's REACH regu lation was another example of a measure that 
was more trade-restrictive than necessary. 
2.211.  The representative of India thanked the Chai rman for his exhaustive report. In his view the 
thematic discussions on TA and SDT were particul arly important because they had been the least 
discussed areas in the TBT Committee. The session had been a good start. He supported China's 
suggestion to frame guidelines on the implementa tion of both articles and to establish an 
electronic group to do so. He referred to the SP S Committee as an example in terms of how to do 
this. 
2.212.  The representative of the Dominican Re public thanked the Chairman for his excellent 
report. Like others, she said that the thematic sessions were a concrete outcome of the sixth 
triennial review that was extremely helpful. She expressed interest in the proposals from China 
and Ecuador and said that her delegation would consider how best to move forward.  
2.213.  The representative of Brazil joined others  in appreciating the usefulness of the Chairman's 
report and noted, in particular, the need for a mo re effective implementation of SDT provisions in 
the TBT Agreement. 
2.214.  The representative of Argentina called for more focus on SDT rather than technical 
assistance, and in particular on how developed countries were complying with Article 12. He noted 
that with the exception of the presentation fr om the EU, most presentations had focused on 
technical assistance.  
2.215.  The representative of the European Union thanked the Chairman for an accurate report. He 
was of the view that the exchange of information was both necessary and useful and needed to be 
continued. He recalled that both the sixth and fifth triennial reviews provided a built-in agenda on 
how to discuss the development dimension under each of the main cross-cutting topics of the Committee's work, whether under GRP, conformity  assessment, international standards, or 
transparency. There were, therefore, a number of entry points to deepen the debate on how the 
development dimension was taken into account in  the implementation of the TBT Agreement, 
without necessarily opening a completely new platform on developing new guidelines.  
2.216.  In terms of methodology, the EU said it might be worth recalling what had been done in 
other areas before considering guidelines: in th e areas of GRP and conformity assessment, for 
example, there had first been many substantive papers from Members and an in-depth debate. 
Specific areas had been identified and it was only after a consensus on the main areas had 
emerged that the Committee could usefully conc entrate its work. This was followed by an G/TBT/M/61 
 
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  agreement to move to a different level of ambition: to develop guidelines, or a set of principles. So 
the EU was of the view that this level of maturity  had not yet been attained with respect to SDT. 
The Committee still needed to go through the logical and necessary incremental steps using the methodology that had worked in other areas.  
2.217.  With regard to the obligation in Article 12.3 of the TBT Agreement – this was an obligation 
to take into account the special needs of developing countries, but it was not as such a derogation from the core obligations in the TBT Agreement; the final benchmark was the test of necessity and 
proportionality under Articles 2.2 and 5.1.2 of the TBT Agreement with a view to achieving a 
legitimate objective. One could, for example, consider a mechanism to allow these interests to be "taken into account", expressed or conveyed. It was also necessary to keep in mind the business 
reality. Providing a two-tier structure that allo wed products to fulfil different requirements 
depending on the origin (developed or developing) might not actually be in the interest of 
developing countries. Indeed, within the EU there had been a similar debate with regard to the treatment of SMEs, whether it would be justifiable to provide lower requirements for small 
enterprises. An analysis of the market had revealed  that this would not work: if there were certain 
consumer preferences or perceptions of risk, products that did not comply with certain requirements would simply not have a market. 
2.218.  The EU considered technical assistance a powerful tool to build capacity that enhanced the 
ability to comply. By improving quality, and improving the capacity to certify against foreign requirements, new market opportunities were created. It was therefore not constructive to diminish the importance of technical assistance – it could indeed contribute significantly by 
creating capacity that allowed compliance with technical regulations of developed countries. The 
EU had mentioned a number of examples, REACH being one of them.  
2.219.  The representative of the United States appreciated Members' engagement and said that 
her delegation would look in particular at the id eas put forward by China with a full understanding 
of the importance of this issue as had been ex pressed by other Members. As had been noted by 
the Chairman in his summary, the US was also of the view that the initial exchange of information 
and experience on SDT and TA had been rich with  information; the US would continue to bring 
their own experiences to the table when possible. The US appreciated the interest in creating an 
electronic working group and would consider this, including in light of the SPS experience.  
2.220.  The representative of Egypt joined othe r delegations in thanking the Chairman for his 
concise report. Regarding the implementation of Article 12, Egypt supported working forward on 
guidelines as had been proposed by China and Ecuador. 
2.221.  The representative of Argentina wished to respond to the EU. He noted that his delegation 
did not deny the significance of technical assistance. However, it was important not to confuse TA 
with SDT. In the view of Argentina, TA could help a country to deal with a problem whereas SDT helped to avoid it in the first place.  
2.222.  The representative of South Africa thanked the Chairman for an accurate report and stated 
his delegation's interest in participating in clarifying the provisions of Article 12. 
2.223.  The representative of China emphasized the importance of more work and a concrete 
outcome on SDT in the TBT Committee. He echoed the statements from both the EU and the US 
on the benefit of continued information exchange and encouraged other Members to share 
information and experience on SDT in both detail and depth.  
2.224.  The Chairman noted the strong appetite among Members for swift and concrete progress. 
He also recalled that the Committee was facing several issues on which progress needed to be 
made. There was a need to achieve a good balance between them. He therefore stated his intention to hold an informal meeting in early 2014 to discuss the way forward.
8  
                                               
8 This informal meeting has been preliminarily scheduled for 6 February 2014. G/TBT/M/61 
 
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  2.3.2  Conformity Assessment Procedures (T hematic Session held on 29 October 2013) 
2.225.  The Chairman reported on the thematic session held on 29 October 2014 on conformity 
assessment procedures. The full report, provided on  the Chairman's own responsibility and with 
comments from Members taken into account, is contained in G/TBT/GEN/155.9 
2.226.  The representative of the United States  thanked the Chairman for his excellent summary 
of the discussions. She stressed the difficulties , as had been explained by South Africa, of 
negotiating and implementing MRAs – indeed these were often a drain on resources. With respect 
to the ISO and ILAC IAF presentations, the US emphasized the importance of understanding the 
role of international standards in conformity assessment – this was, in her view, an important element of the Committee's work. Indeed, both  the US' and the EU's presentations had 
emphasized the importance of risk in evaluating  the choice of conformity assessment procedures. 
This was an enduring idea that had recurred ofte n in the Committee's work and could be an area 
for more in-depth work: how exactly to apply risk-based tools with respect to conformity assessment and their direct effect on the efficien cy and effectiveness of the conformity assessment 
procedure itself. The presentation by the representa tive of Chinese Taipei had been valuable in the 
sense that it had provided useful numbers that gave a sense of the significance that the Committee's work had on facilitating trade and reducing unnecessary burdens on producers and 
manufacturers. 
2.227.  The representative of Brazil suggested that the Committee raise the issue of mutual 
recognition in a thematic session in 2014. He recalled that the representative of ILAC and IAF had 
reiterated the importance of multilateral systems for conformity assessment as a means of 
overcoming technical barriers to trade – but this only related to accreditation, largely outside of 
the regulatory system of governments. Brazil st ressed the importance of mutual recognition and 
suggested that the Committee exchange informat ion in this area. Brazil would provide a 
submission on this for the next meeting of the Committee. 
2.228.  The representative of El Salvador noted that all Members had worked very hard on this 
issue; she recalled the substantive mandate before  the Committee for further work and the need 
to start considering possible concrete outputs for the Seventh Triennial Review in the area of 
conformity assessment procedures.  
2.3.3  Transparency  2.229.  Two separate matters were discussed by the Committee under transparency: notification 
formats and the formal launch of the on-line Notification Submission System (TBT NSS). 
2.3.3.1  Coherent use of Noti fication Formats (JOB/TBT/68) 
2.230.  The Chairman recalled that the European Union had circulated a paper at the June 
Committee meeting entitled "A Coherent approach to notification formats". The paper was 
contained in document JOB/TBT/48. At that meeting the Committee had also heard from the SPS Secretariat on their working practices. Since the last meeting, the Committee had received six 
submissions pertaining to this issue, from: South Africa (JOB/TBT/51); Indonesia (JOB/TBT/59); 
Uganda (JOB/TBT/60); Ukraine (JOB/TBT/61); In dia (JOB/TBT/63) and the US (JOB/TBT/64). 
These submissions had been discussed the Committee's informal meeting on 23 September.  
2.231.  Building on Members' submissions and comments as well as relevant previous decisions by 
the Committee and the relevant SPS Committee recommendations, the Secretariat had prepared a 
draft recommendation for delegations' consideration (JOB/TBT/68). During the informal meeting held back-to-back with the ongoing regular TBT Committee meeting, a number of useful points 
had been made. In general, the Chairman note d that there was agreement that JOB/TBT/68 
provided a good basis for further work. He thus  asked Members to prov ide any further comments 
in writing before 31 December 2013.
10  
                                               
9 A background document by the Secr etariat is contained in JOB/TBT/69. 
10 Submissions were received from Japan (JOB /TBT/74) and Canada (JOB/TBT/75/Rev.1). G/TBT/M/61 
 
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  2.3.3.2  Formal Launch of the TBT on-line Notification Submission System (TBT NSS). 
2.232.  The Secretariat announced the launch of the TBT NSS – a system that allows Members to 
submit notifications to the Secretariat through an on-line application. Seven Members were 
currently using the system (Brazil, Canada, Japan, South Africa, Uganda, Unites States and the 
European Union), representing about a third of all incoming notifications. Members wishing to use 
the system could send an e-mail to Tbtnss@wto.org for further instructions.  
2.233.  The representatives of Brazil, Canada, the European Union and South Africa expressed 
their appreciation for the Secretariat's commitment and responsiveness to address challenges 
identified during the testing phase; they were pleased with the reliable final product that had 
emerged and encouraged other Members to use the system as well. 
2.3.4  Good Regulatory Practice (JOB/TBT/44/Rev.2) 
2.234.  The Chairman noted that the Committee had held significant discussions on GRP. For more 
background, he referred to the minutes of the last TBT Committee meeting (G/TBT/M/60) as the 
factual reports of the first and second thematic sessions on GRP, held on 5 March 2013 and 
17 June 2013 (contained in documents G/TBT/GEN/143 and Add.1). At the informal meeting held on 23 September, the Committee had further addressed the topic. Indeed, significant input had been received on the revision of the Non-Exhaus tive List of Voluntary Mechanisms and Related 
Principles of Good Regulatory Practice, contai ned in document JOB/TBT/44/Rev.1. Submissions 
had been received from: Uganda (JOB/TBT/53) , Indonesia (JOB/TBT/54); Japan (JOB/TBT/55); 
Cuba (JOB/TBT/56); India (JOB/TBT/57); and Canada (JOB/TBT/58).  
2.235.  The Chairman recalled that based on this input, and as agreed at the 23 September 
informal, the Secretariat had prepared a revision of the Non-Exhaustive in an effort to consolidate 
the comments received to date. The new revision is contained in JOB/TBT/44/Rev.2. Considering the recent distribution of the document, the Ch airman proposed that Members consider this 
revision and provide comments in writing by 31 December 2013.
11 An informal meeting would be 
organized ahead of the March formal meeting brin g work forward on this. He stressed that the 
current basis for further comments on GRP was JOB/TBT/44/Rev.2.  
2.3.5  Standards  
2.236.  The Chairman recalled that at the fi rst meeting of 2013, the Committee had held a 
thematic session on standards. The Session had considered the topics of (i) the Code of Good 
Practice; (ii) the use of the "Six Principles"; and (iii) transparency in standard-setting. The 
moderator's summary of the session was contained in G/TBT/GEN/144.12 He recalled that there 
had been a high level of engagement and interest  by Members at the session. There had also been 
a sense that the information exchange on standa rds had not been fully exhausted – and that the 
Committee needed to reflect on how to bring this work forward in a more specific and detailed 
manner. At the end of the session it had been su ggested that future work in the Committee might 
focus on some specific elements of the standardization process, in order to deepen Members' 
exchanges.  
2.3.6  Other Matters 2.3.6.1  A new regulatory framework fo r federal food inspection in Canada 
2.237.  The representative of Canada presented a new regulatory framework for federal food 
inspection. A full description is contained in document G/TBT/GEN/154.13 
                                               
11 Submissions were received fro m South Africa (JOB/TBT/72), Japan (JOB/TBT/73),  Canada 
(JOB/TBT/76) and Cuba (JOB/TBT/77). 
12 A background document by the Secretaria t is contained in JOB/TBT/42 and Corr.1. 
13 More detail is also available at: http://www.inspection.gc.ca/food/action-plan/food-safety-regulatory-
forum/presentations/discussion-document/eng/1370029593829/1370029641557 . G/TBT/M/61 
 
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  2.3.6.2  Topics for discussion at the Commi ttee's next thematic se ssion (18 March 2014) 
2.238.  The Chairman noted that the Committee had come full circle. Three thematic sessions had 
been held, covering GRP, standards, transparency, technical assistance and special and differential 
treatment, and conformity assessment procedures . Clearly, and in view of Members remarks, 
dedicating one day to discuss cross-cutting topics, as mandated in the sixth triennial review, had 
been a meaningful exercise and a useful decision  by the Committee. The Chairman proposed that, 
in March 2014, the Committee revert to the topics of GRP and Standards while leaving a window 
open to also address any other issues, depending submissions provided by Members. It was so agreed.  
3  TECHNICAL ASSISTANCE  
3.1.  The Secretariat provided a document containing information on its technical assistance 
activities.14 
4  UPDATING BY OBSERVERS 4.1.  The representative from BIPM reminded the committee that BIPM was the intergovernmental 
body operating the international system of uni ts ensuring comparability of measurements 
worldwide. Recent activities included Colombia becoming a Member State, and Mongolia becoming an associate Member, bringing the BIPM membership to 55 Member States and 37 Associate 
States. Both also signed the CIPM MRA.
15 This MRA had been running for 14 years, and would be 
subject to a major review over the next two years. The representative also informed the 
Committee of a workshop in Lusaka, Zambia, organized in conjunction with AFRIMETS - the Regional Metrology Organization for Africa, so as to increase understanding of the MRA in that 
region.  
4.2.  The representative from UNECE informed the Committee that the 23
rd annual session of the 
Working Party on Regulatory Cooperation and Standardization Policies (WP6) would take place 
from 18-20 November16, and would include an international conference on standards and 
regulatory frameworks.17 She also informed the Committee that the Working Party had been 
developing best practices in the use of risk ma nagement tools in regulatory frameworks and a 
publication was available on Risk Management Regulatory Framework. 
4.3.  The representatives from OIML; IEC and Codex updated the Committee on their activities 
relevant to the TBT Committee.18 
5  REPORT (2013) OF THE COMMITTEE ON TECHNICAL BARRIERS TO TRADE 
5.1.  The Committee adopted its 2013 Report to the Council for Trade in Goods (G/L/1052). 
6  DATE OF NEXT MEETING 
6.1.  The next regular meeting of the Committee is scheduled for 19-20 March 2014. It will be 
preceded by thematic sessions on 18 March 2014. 
 
__________  
                                               
14 G/TBT/GEN/161. 
15 http://www.bipm.org/en/cipm-mra/ . 
16 http://www.unece.org/trade/wp6/welcome.html  
17 http://www.unece.org/fileadmin/DAM/trade/wp6/documents/2013/ReportOfTheConference.pdf  
18 G/TBT/GEN/158, G/TBT/GEN/159 and G/TBT/GEN/160.