RESTRICTED  
  
G/TBT/M/69  
 
 
22 September 2016  
(16-5037) Page: 1/72 
Committee on Technical Barriers to Trade    
 
 MINUTES OF THE MEETI NG OF 15-16 JUNE  2016  
CHAIRPERSON: MS ESTHER PEH  
Note by the Secretariat1 
1   ADOPTION OF THE AGEN DA ................................ ................................ ........................  1 
2   ELECTION OF THE CHAI RPERSON  ................................ ................................ ................  1 
3   IMPLEMENTATION AND ADM INISTRATION OF THE A GREEMENT  ................................ . 1 
3.1   Statements from Members under Article 15.2  ................................ ................................ . 1 
3.2   Specific Trade Concerns (STCs)  ................................ ................................ .....................  2 
3.2.1    Withdrawn concern s ................................ ................................ ................................ .. 2 
3.2.2    New concerns  ................................ ................................ ................................ ...........  2 
3.2.3    Previously raised concerns  ................................ ................................ ........................ 12 
3.2.4    Exchange of Experiences  ................................ ................................ .......................... 68 
4   TECHNICAL COOPERATIO N ACTIVITIES  ................................ ................................ .... 71 
5   UPDATING BY OBSERVER S ................................ ................................ ........................  71 
6   DATE OF NEXT MEETING ................................ ................................ ............................  72 
 
1  ADOPTION OF THE AGEN DA  
1.1.  The Committee  adopted the agenda contained in WTO/AIR/TBT/ 5. 
2  ELECTION OF THE CH AIRPERSON  
2.1.  The Committee elected Ms Esther Peh (Singapore) as the Chairperson of the Committee for 
2016.  
3  IMPLEMENTATION AND A DMINISTRATION OF THE  AGREEMENT  
3.1  Statements from Members under Article 15.2  
3.1.  The Chairperson  reminded the Committee of Members' notif ication obligation under 
Article  15.2 of the TBT Agreement and further informed the Committee that the latest list of 
statements on implementation submitted under this provision was contained in document 
G/TBT/GEN/1/Rev.15, issued  on 29 February 2016. She informed the Committee that since the 
last meeting in March 2016 , Ukraine and South Africa had submitted revisions to their original 
statements . She further informed the Committee that since 1995, 132 Members had submitted at 
least one statement of impleme ntation. Information on the list of statements is available at 
http://tbtims.wto.org .  
                                                
1 This document has been prepared under the Secretariat' s own responsibility  and is without prejudice 
to the positions of Members or to their rights and obligations under the WTO.  G/TBT/M/69  
 
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  3.2  Specific Trade Concerns (STCs)  
3.2.1   Withdrawn concerns  
3.2.  The Chairperson  reported that the following STCs had been withdrawn from the agen da at 
the request of the concerned Member:  
a. Chile - Proposed Regulation on antimicrobial products  
b. United States - Energy Conservation Program: Certification and Enforcement – Import 
Data Collection   
c. European Union - Proposal for a Regulation of the Europe an Parliament and of the 
Council setting a framework for energy efficiency labelling and repealing Directive 
2010/30/EU.  
d. Saudi Arabia - Draft for update of the Technical Regulation No. SASO 2857:2014 
"Vehicle Tires Rolling Resistance and Wet Grip Requireme nts" 
3.2.2   New concerns  
3.2.2.1   Russian Federation – Measure affecting import of Ukrainian products  
3.3.  The representative of Ukraine  stated that, as reiterated in the Committee since 2013, the 
Russian Federal Service for Surveillance on Consumer Rights Protection and Human  Wellbeing 
(Rospotrebnadzor) had banned imports into Russia of Ukrainian confectionary, dairy products, 
beer, juice, salt and wallpaper , justifying such actions on sanitary and safety grounds. He said, 
however, that these bans were discriminatory, non -transparent and unjustified, and therefore 
inconsistent with the TBT Agreement, in particular with Articles 2.1, 5.1.1 and 5.1.2, as the above -
mentioned Ukrainian products had been, and continued to be, successfully exported to other 
countries with well -develo ped economies and high -quality national infrastructures. He further 
illustrated this point by referring to two specific Ukrainian products  - wallpaper and beer  - which, 
while banned in Russia, were normally exported to various other countries: Germany, Fra nce, 
Poland, Baltic countries, Romania and Bulgaria (wallpaper) and Germany, Italy, the Czech 
Republic, Baltic countries, Canada and the US (beer).  
3.4.  He also stated that Ukrainian producers had provided the competent Russian authority 
(Rospotrebnadzor) with  all necessary documents and test results carried out in Russian and 
Ukrainian laboratories recognized by the Russian Federation accreditation body in both Ukrainian 
and Russian. Moreover, according to the information provided by the Ukrainian producers to  the 
competent Ukrainian authorities, letters with testing results of Ukrainian products had been 
received and registered in the Rospotrebnadzor. In return, he added, Russia still failed to provide 
the Ukrainian competent authorities and producers with req uired testing results and justification. 
More specifically on this point, he said that the Russian competent bodies (namely, the Ministry of 
Economy, Ministry of Transport, Ministry of Industrial Policy, the Federal Agency on Technical 
Regulating and Metro logy (Rosstandart) and Rospotrebnadzor) had never provided justification for 
the above -mentioned restrictions, despite repeated requests by Ukrainian manufacturers and 
various Ukrainian government bodies (the Ministry of Economic Development and Trade, the  State 
Veterinary and Phytosanitary Service as well as the Sanitary Service). His delegation believed that 
by not responding to such enquiries, Russia had been acting inconsistently with Article 10 of the 
TBT Agreement.  
3.5.  Finally, he noted that as from 2016  all Ukrainian products that had been banned from being 
imported into Russia would also be prohibited from transiting through the Russian territory. He 
said that this concern, which had been raised several times before the TBT and SPS Committees as 
well as  the WTO General Council, still remained unaddressed by Russia.  
3.6.  The representative of the Russian Federation  expressed his delegation's view that the issue of 
transit raised by Ukraine was not covered by the TBT Agreement but that all other actions had 
been taken in full compliance with Russia's WTO obligations, in particular those under Articles 2.1, 
2.2 and 5.1.1 of the TBT Agreement. He explained that the imports of certain Ukrainian goods into G/TBT/M/69  
 
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  Russia had not been banned as such, rather temporarily suspe nded for the following reasons: (i) 
inconsistency with the requirements under the relevant technical regulations; (ii) prevention of 
deceptive trade practices; and (iii) the need to maintain the appropriate level of human safety and 
health protection. He e xplained that at various times the Russian authorities had informed their 
Ukrainian counterparts, as well as interested enterprises, about the necessary regulatory steps 
that needed to be followed but that up to now in most cases Ukraine had failed to prov ide the 
required documentation. His delegation did, however, welcome the fact that some Ukrainian 
producers had complied with the relevant Russian requirements; in these cases after follow -up 
inspection, the introduced measures had been promptly cancelled.  With respect to the Ukrainian 
concerns over the circulation of test results, he underlined that, in accordance with the Russian 
Law No. 294 -FZ, as from 26 December 2008 this information could no longer be delivered to any 
private person or legal entity ot her than under the inspection, due to the legislative requirements 
to protect their commercial interests. He concluded by expressing his delegation's hope that, by 
working together in a transparent manner and in good faith, Russia and Ukraine would be able  to 
reach a permanent and mutually satisfactory solution to this matter.  
3.2.2.2    Egypt - Manufacturer Registration System (Decree No. 43/2016 and Decree 
No. 992/2015) , G/TBT/N/EGY/114 , G/TBT/N/EGY/115  
3.7.  The representative of Turkey  noted that  Decree No. 43/2016 man dated imports for 
commercial purposes of certain products to only be allowed into Egypt provided they were 
produced by manufacturing plants or imported from companies owning the respective trademarks 
for these products or their distribution centres registe red in the relevant established register in the 
General Organization  for Export and Import Control (GOEIC)  of Egypt . He said that th e measure , 
which  was published in  Egypt's Official Gazette on 16 January 2016, had entered into force on 
16 March 2016, befo re the end of the 60 -day comment period of 1 April 2016.  
3.8.  He also said that the measure covered "r egistration ", which was one  of the types of 
"conformity assessment procedures " (CAP) disciplined  by the TBT Agreement, as defined in 
Annex  1 thereof . He recal led that Article 5.6.2 of the TBT Agreement stated that notifications for 
CAP sh ould take place at an early appropriate stage, when amendments could still be introduced 
and comments taken into account. In addition, Article 5.6.4 required Members, without 
discrimination, to allow reasonable time for other Members to make comments in writing, discuss 
these comments upon request, and take these written comments and the results of these 
discussions into consideration. He noted, in this respect, that Turkey had provided Egypt with 
written comments and had very recently received a written reply from  Egypt, but remained 
disappointed that its comments and concerns had not been fully taken into account . In addition, 
Turkey reminded that Article 5.9 of the TBT Agreeme nt stipulated that Members sh ould allow a 
reasonable interval between the publication of requirements concerning CAP and their entry into 
force in order to allow time for producers in exporting Members, and particularly in developing 
country Members , to ad apt their products or methods of production to the requirements of the 
importing Member . Turkey considered that the measure's registration  requirements constituted  
CAP that imposed further burdens on producers and/or compani es in the export market. Turkey 
believed that Article 5.9 was valid and applicable for Egypt's manufacturer registration system as 
well. However, despite its broad product scope and burdensome new requirements, no meaningful 
transition period ha d been provided to producers to adapt  to the new registration system.  
3.9.  Turkey also considered that the requirements o f Egypt's  new registration system w ere 
burdensome and created unnecessary obstacles to international trade , and thus inconsistent with 
Article 5.1.2 of the TBT Agreement . This TBT pr ovision, recalled Turkey, stated that CAP should  not 
be prepared, adopted or applied with a view to , or with the effect of , creating unnecessary 
obstacles to international trade. This means, inter alia , that CAP should  not be more strict , or be 
applied mor e strictly , than necessary to give the importing Member adequate confidence that 
products conform ed with the applicable technical regulations or standards, taking account of the 
risks non -conformity would create. It was Turkey's  understandi ng that the obje ctive behind 
Egypt's registration system was not well  defined. For instance, under this system: (i) products 
selected for registration purposes neither  share d common characteristics nor belonged to certain 
clusters; (ii) required documentation did not prov ide information or ensure the quality and safety 
of the products ; and (iii) it remained unclear  whether the same documents, including quality 
certificates , were also required internally for the Egyptian companies . Furthermore, he said  that 
the practical pr ocess of application for the registration ha d not been clarified in the decree. The G/TBT/M/69  
 
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  companies ha d been unable to obtain  concrete information on the way to carry out  the application 
process.  
3.10.   Turkey  also noted that the Decree ha d been changed twice before  entry into force. 
Furthermore, there ha d been changes even after the commencem ent of the registration process. 
This situation caused confusion , complication and thus uncertainty for the applicants. This 
uncertainty, said Turkey,  was compounded by the difficulty that applicants encountered in  
access ing the Egyptian authorities  to get exact information.  Moreover, the preparation process of 
the documents required long and various  approval procedures. After providing the documents 
listed in the decree, these  were to be approved first by the Chamber of Commerce, or equivalent 
bodies, followed by the governorships. Certified Arabic translations of all documents were required 
to be submitted along with the original  versions.  Both the local and Arabic versions  of all  
documents were also required to be approved , one by one , by the Egyptian consulates . For 
Turkey, a ll these steps and procedures increased the cost and time for completing the registration 
procedures, in turn damag ing applicants ' competitiveness on the Egy ptian market. Additionally , 
the registration form, along with other required documents, had to be submitted to GOEIC 
registration offices in Egypt by the legal representative (their delegates, agent s, or counterpart s) 
of the factory . This further complicat ed and prolonged the process by putting a significant  burden 
on producers and companies with trademarks. He also noted that  Article 2, paragraph 3 , of the 
measure introduced the question of the validity of the submitted documents. In this respect, 
Turkey a sked Egypt: (i) h ow would a document  be considered as invalid ? (ii) what  kind of 
company or factory inspection would be carried out ? and (iii) what would the process be in case a 
company or producer was  rejected?   
3.11.   Turkey also noted that, i n addition to the formulation of the registration system, its 
implementation also seemed problematic. Turkey recalled that, according to Egypt,  there ha d been 
over a thousand  registration s. However, according to Turkish industry, most of the companies ha d 
faced serious pro blems during this process and as a result had not been able to get register ed. The 
companies which  had already completed the application procedure ha d been waiting for a long 
time and ha d not received  any response on the current situation regarding their a pplication. The 
procedure was n either well -conceived nor well-designed and did not appear to address  the 
objective of safety or quality of the products. Moreover, since the measure's implementation 
process was not transparent, Turkey also had no available information on the data regarding the 
registration system. Turkey therefore requested Egypt to share the list of companies registered 
and the average time required for their registration.   
3.12.   As a result of all the foregoing concerns, Turkey believed that Egy pt's manufacturer 
registration system constituted a genuine hindrance to market access and therefore requested 
Egypt to reconsider its current approach and explore less trade -restrictive alternatives. With the 
aim of overcoming the problem faced by many co mpanies trading with Egypt, Turkey also asked 
Egypt to bring its legislation and implementation in to compliance with the principles and rules of 
the WTO , including the TBT Agreement , by not creating unnecessary obstacles to trade.  
3.13.   The representative of Switzerland  expressed his delegation's concern regarding the two 
measures at issue, notified by Egypt to this Committee on 1 February 2016, namely: (i) Decree 
No. 991/2015, which entered into force on 31 December 2015 and provided for the registration of 
producers and pre -shipment inspections; and (ii) Decree No. 43/2016, which entered into force on 
16 March 2016, and which provided for a second registration procedure relating, inter alia , to 
manufacturing sites and quality control certification. Switzerland a sked Egypt why the latter 
decree, which applied to 25 categories of products, had entered into force before the end of the 
period established by Egypt for the submission of comments pertaining to its notification. He 
recalled, in this respect, that the TBT  Agreement required notifications to take place at an 
appropriate stage, when amendments could still be introduced and comments be taken into 
account. Furthermore, according to Article 2.12 of the Agreement, a reasonable interval should be 
allowed between the publication and entry into force of a TBT measure (except in urgent 
circumstances) in order to allow producers to adapt to the new requirements.  
3.14.   In terms of substance, he expressed his delegation's belief that, by providing for two 
overlapping registr ation procedures, these two decrees were more trade restrictive than necessary 
because they created unnecessary costs and obstacles. Switzerland thus encouraged Egypt to 
consider a less trade -restrictive  approach. He also noted that Decree No. 43/2016 prov ided for the 
registration of foreign factories and trademark owners of products imported into Egypt. It included  G/TBT/M/69  
 
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  a list of documents, such as a list of products manufactured by a given factory and, in particular, a 
certificate establishing that the quality  control system ha d been reviewed by a third party. In this 
respect, he asked Egypt to explain why it had decided that 25 very diverse product sectors should 
be subj ect to third -party assessment. He said that, while Switzerland shared  Egypt's  objectives of  
protecting public health and  the environment , it was nonetheless unclear how Decree No. 43/2016 
would contribute  to these ob jectives. In Switzerland, third -party quality assurance was required for 
certain products presenting risks, and was  linked to essen tial requirements ba sed on public 
interests that were  identified by legislators and dealt with in international standards. The extent to 
which third -party certification had been generalized  on the basis of vague requirements continued  
to be a source of con cern for his delegation . Switzerland,  therefore , asked Egypt for how long had 
third-party assessment of quality control system s been in place at na tional level and verified by 
the authorities , and if  any benefits had been observed.  In this respect, he note d that i n most 
markets, including in Switzerland, several of the products covered  by the measures at issue, which 
posed few risks to consumers, were  not subject to third-party quality control . The absence of 
third-party production certification d id not mea n that a product was unsafe. It was  difficult for 
enterprises that ha d not implemented a quality management program me or ha d chosen to ensure 
quality management independently, to adapt quickly to , and to understand , the requirements 
established by Egypt.  A pragmatic approach in implementation would help manage current 
obstacle s that hinder ed trade.  
3.15.   The representative of the European Union  expressed the same concerns made by 
Switzerland with respect to the earlier -than-expected entry into force of the two decrees and 
asked Egypt to suspend their implementation and re -notify them . The EU also asked the Egyptian 
authorities to consider withdrawing the measures and review ing them in light of the principles and 
obligations  laid down in WTO law. In addition, the E U was also concerned by the possible 
duplication of procedures and the lack of clarity of the requirements to be fulfilled by European 
economic operators. The applic ation of the Egyptian decrees was  already creating unnecessary 
obstacles to trade.  
3.16.   The rep resentative of the United States  remain ed concerned over Egypt' s level of 
transparency during the adoption and enforcement of these  measure s. For exa mple, Egypt had yet 
to inform Members  why it had not allow ed an adequate period of time to consider stakeho lders' 
comments submitted in response to its WTO notification s. The date of implementation was  
16 March  2016, yet the comment per iod ended two weeks later. Under normal circumstances, 
Egypt would have notified the firs t draft of the measure for a 60 -day co mment period.  At the end 
of the comment period, Egypt would have reflected on the comments received and made any 
necessary changes to the draft to acc ount for stakeholder comments. Upon publication of the final 
draft, Egypt would have allowed an adequate t ime for stakeholders to become accustomed to the 
new requirements , normally at least six months af ter publication. However, noted the US, Egypt 
had not do ne so, and yet the WTO notifications did not indicate that Egypt was responding to any 
circumstances t hat required it to deviate from the normal course. Since t hese were measure s 
specifically targeting imports, the US asked Egypt how it ha d ensured that they were consistent 
with its  national treatment commitments. US industry feedback from the measures' im mediate 
implementation indicated that these  companies m ight have to give up on t he Egyptian market 
altogether. Others indicate d great confusion about the specific ity of what documen ts and which 
certifications would  be accepted to demonstrate compliance. Th erefore, the US made the following 
priority requests: (i)  that Egypt suspend implementation of the measures until all stakeholder 
comments had been taken into account and were  given a real chance of being r eflected in the final 
measure;  (ii) that a n adequa te implementation period be provided once the measure s were again 
implemented: 6 months  from the date of publication was  normally considered sufficient, although 
this amount of time m ight not necessarily be adequate for all industries; (iii) t hat Egypt cha nge its 
approach from a horizontal one  - imposing  the same requirements across all industries  - to one 
taking  into account the various global norms, risk factors, and practices across different industries.  
3.17.   Regarding the requirement for a Quality Managemen t System certification, the US asked  
that Egypt recognize the quality control requirements relied on by other Member countries th at 
met the objectives of Egypt' s requirements. In this respect, she asked whether Egypt could 
confirm that ISO  9000 certificati on was  deemed sufficient to demonstrate compliance with the 
Quality Management Sys tem certificate requirement. With respect to  the requirement that imports 
should be accompanied by the product' s trademark and product licence, she asked Egypt to clarify 
who bore responsibility when a trademark had been leased. She also asked Egypt to confirm that 
it would  accept documents that companies already possess on trademarks.  G/TBT/M/69  
 
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  3.18.   The representative of South Africa  said that her delegation shared similar concerns as 
expressed by the delegations of Turkey, Switzerland, the EU and the US . South Africa thanked 
Egypt for the bilateral exchanges between them  and for the comments Egypt had already sent to 
some of its questions, which were  currently under consi deration by her au thorities . 
3.19.   The representative of Australia  share d the concerns raised by other M embers about the 
trade impact of the measures. Australia n businesses were already feeling the effects of the 
regulations and ha d raised concerns to the Australian Government th at the new registration and 
certification requirements create d unnecessary barriers to trade. The registration and certification 
requirements d id not appear to be in line with international best practices. Australia encourage d 
Egypt to take  a risk -based ap proach to certification and conformity assessment requirements.  
3.20.   The representative of Canada  echoe d the concerns raised by  other Members and said that 
his government would contact  Egypt's Enquiry Point shortly to convey concerns in writing 
regarding GOEIC .  
3.21.   The representative of China  said that her delegation was  also interested in this Egyptian 
registration system and would  continue monitoring its development.  
3.22.   The representative of Norway  supported the statements of other delegations and said that 
Norway was interested in following this discussion for systemic reasons . 
3.23.   The representative of Ukraine  joined  the concerns raised by other delegations. Ukraine dr ew 
Members' attention to some inconsistencies of the measures at issue with the TBT Agreement, 
includ ing the obligations under  Articles 2.12 and 5.1 . Given the short period of time (in the case of 
Decree  No. 43/2016) , and the complete absence of time (in the case of Decree No. 991/2015) , 
between the dates of adoption and entry into  force of these measures , Ukrainian companies 
exporting relevant products to Egypt had not been given the opportunity to adapt  themselves to 
the application of requirements of the above -mentioned regulations. This, as a result,  led to the 
creation of certain barriers to trade bet ween Ukraine and Egypt. Article 5.1 of the TBT Agreement 
was not respected becaus e Resolution No. 991/2015 stipulated  that customs processing of supplies 
of certa in types of imported products was  made under certain conditions, including, for instance : 
(i) registration before GOEIC ; and (ii) inspection and verification of certificate' s conform ity with 
Egyptian standards . In any case, he said, customs pr ocessing was  subject to random checks by 
GOEIC . Ukraine  thus consider ed that these provisions put domestic and foreign suppliers in 
unequal conditions.  
3.24.   The representative of Chile said that his delegation  joined  the conce rns raised by preceding 
delegations  with respect to the registration system for manufacturer s established by the measures 
at issue .  
3.25.   The repr esentative of Egypt  explained that the two decrees at issue were mutually  
independent. He explained that Decree No. 991/2015  dealt with pre -shipment inspection to ensure 
conformity of the products with relevant accredited Egyptian standards , which  had alre ady been 
notified to the TBT C ommi ttee over the past years. Decree No.  43/2016 , on the other hand, only 
concerned  the registration of the manufacturing plants and companies owning trademarks qualified 
to export their products to Egypt. The latter measure, therefore, did not deal with  product 
compliance related with specific technical regulations.  
3.26.   He remarked that Decree No.  992/2015 had in fact never entered into force. This measure 
had been cancelled and replaced before its entry into force by Decree No. 4 3/2016.  Decree 
No. 43/2016 , issued by the Minist ry of Trade and Industry, amend ed the rules governing the 
registration of the factori es eligible for export to Egypt. This measure's objective was to ensur e 
that entities exporting to Egypt maintain ed a quali ty control system. Given its administrative  
nature, this  decree did not impose further burdens on producers or companies in the exporting 
markets. He further said that, despite the fact  that the imports of products listed in the said decree 
presented only a minimal share of the  total Egyptian imports, in the last few years the Egyptian 
market had witnessed a  sharp increase of imports of such products  as a result of illegal 
manufacturing practices. Such increase of illegal products had, in turn, a negative i mpact on 
consumer' s health and safety. All required information regarding the registration process and 
samples of the required documents and applications ha d been made available at the following G/TBT/M/69  
 
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  website of the General Authority for Export and Import Contro l (GOEIC) .2 Egypt strongly believe d 
that the registration requirements under Decree No. 43/2016 were not more trade  restrictive than 
necessary . Nonetheless, with a view to  facilitat ing the process, Egypt had adopted a number of 
measures aimed at ensuring  that registration requirements would not impose excessive burdens 
on producers or compan ies in the exporting markets.  
3.27.   In reference to the quality control system certificate, he explained that there was  no specific 
standard against which the certificate need ed to be issued. It was intentional not to require any 
specific certificate in order to ensure that the requirement would not create any unnecessary 
burden on credible manufacturing plants and trademark owning companies that already 
maintain ed a quality co ntrol system. The onl y requirement was  that this certificate stat e that the 
producer or the t rademark owner company maintained  a quality control system , to be  issued by 
entities accredited by national or regional accreditation bodies such as  the Internatio nal Laboratory 
Accreditation Cooperation (ILAC) , or the International Accreditation Forum (IAF) , or an Egyptian or 
foreign governmental entity approved by the Ministr y of Trade  and Industry . A copy of the 
certificates stating that the producer  or the trade mark owner company maintain ed a quality 
control system would thus be  accepted , provided that it was  available on the electronic data base 
of the accredited certification service providers and that GOEIC would be able to  verify it online. 
The r egistration of  the manufacturing plants, or the company owning the trademark, allow ed any 
intermediary or trading house to import the relevant products to Egypt. The r egistered companies 
in GOEIC, according to Article 94 of the  Ministerial Decree No. 770 /2005, and its a mendments 
issuing the Executive Regulation to Imple ment the Import and Export Law "WHITE LIST" , were 
considered in compliance with the requirements of the Ministerial Decree No.  43/2016 until they 
had completed their registration process. The following wer e excluded: products that had been 
shipped or had arrived before the entry into force of the decree;  shipments for which credit was 
opened before the entry into force of the decree; contracts concluded, legalized and accredited 
from Egyptian consulates abr oad in case of transfer of at least 10% of its value before the date of 
entry into force of the decree, provided they were implemented in a time period of no longer than 
a year; and m anufacturing plants and companies owning trademarks that had completed an d 
submitted the required documents and administrative service fees to GOEIC and pending the 
issuance of the Ministerial Decree concerning their registration. This facilitating measure had been 
made available for shipments that had arrived at Egyptian ports  prior to 30 May 2016.   
3.28.   He concluded by drawing Members' attention to that fact that Egypt had  conducted a 
number of bilateral meetings with interested delegations, during which  they had the opportunity to 
receive  all clarifications needed with respect to their comments. The d etailed replies had also been 
provided both through Egypt's Enquiry P oint, and directly to missions in Geneva. Egypt 
nonetheless took note of all points raised at the present meeting, which would be conveyed to 
capital for consideratio n and response in due course . Egypt, he said, respected its commitments 
under the TBT Agreement and was  in full compliance with its articles . 
3.2.2.3    Colombia - Draft Resolution of the Ministry of Health and Social Welfare and the 
Ministry of the Environment and Sustainable Development "adopting the Technical 
Regulation establishing the maximum levels of phosphorus and the biodegradability of 
surfactants in detergents and soaps, and introducing other provisions" , 
G/TBT/N/COL/214 , G/TBT/N/COL/214/Add.1  
3.29.   The represen tative of Mexico  said that her delegation was concerned with certain aspects of 
the Colombian measure. She noted that both Articles 8 and 10 of the draft resolution required the 
submission of a first -party conformity declaration before importing detergents  and soaps. In this 
regard, unlike the Colombian measure, the corresponding Mexican regulation – the draft Mexican 
regulation on the biodegradability of domestic detergents: specifications and test methods – which 
had been awaiting publication in the Offic ial Journal of the Federation, did not require certification 
to verify the biodegradability of this type of product. Therefore, the party subject to the 
regulations must ensure the certification of these products in order to import them into Colombia, 
resulting in procedures which, in Mexico's view, were more costly and lengthy than necessary, and 
which restricted trade. She also noted that Article 7 of the measure required the laboratory testing 
of surfactants contained in detergents and soaps, which could  only be carried out in laboratories 
accredited by Colombia, or by those recognized through a  mutual recognition agreement  (MRA). 
Mexico considered that these tests were not designed to be conducted on finished products, as 
                                                
2 www.goeic.gov.eg  G/TBT/M/69  
 
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  they may produce a biased result  indicating that the product was biodegradable. As surfactant 
agents were the main component of detergents, in addition to an organic compound, this implied 
that the surfactants were also biodegradable substances and therefore the tests would indicate 
failure to fulfil the conditions of the conformity assessment. In comparison, the Mexican regulation 
on surfactants only provided a non -exhaustive list of surfactants that had already undergone such 
tests therefore no conformity certificate was required by Mex ico. This contrast supported Mexico's 
view that the Colombian regulation may create an unnecessarily burdensome obligation for the 
party subject to the regulations, and thus may be inconsistent with Article 2.2 of the TBT 
Agreement.  
3.30.   Given the foregoing re asons, Mexico requested that Colombia reconsider the relevance of 
performing laboratory tests on soaps and detergents to determine the permitted biodegradability 
limits of surfactants, or allow for the recognition of tests that had been performed in other 
countries. Mexico also suggested that the regulation could contain an annex listing the surfactants 
that had already undergone such tests and therefore met the standards required, which would be 
sufficient to fulfil the legitimate objective pursued by the measure. As a result, it would no longer 
be necessary to submit conformity certificates for each shipment imported into Colombia.  
3.31.   The representative of Colombia  clarified that its government did not require certification 
with regard to this technical regul ation, rather a third -party declaration of conformity in line with  
ISO/IEC 17050, Part 2. Therefore, he said, the Mexican arguments with regard to the costs of 
certification were not valid as they related to a declaration of conformity submitted by Colombi an 
manufacturers or importers relating to this technical regulation. With regard to testing that would 
be carried out on detergents with the support of a declaration of conformity, he said that it could 
be carried out in laboratories accredited by Colombia 's national body or laboratories with prior 
evaluat ion by manufacturers and importers. With regard to the requirement on certification, he 
said that this was a procedure that was applied in Colombia in the same manner as other WTO 
Members with regard to ce rtification of technical regulations and the verification of conformity with 
requirements. In fact, he said, here Colombia had been even more open in its domestic legislation 
by establishing the possibility of accepting third -party certification by foreign ers in Colombia 
wherever there was an agreement between the parties (e.g. with Canada and Mexico).  
3.2.2.4   China - Draft Standardization Law  
3.32.   The representative of the Republic of Korea  expressed his delegation's concern with the fact 
that, while the Chinese govern ment gathered comments within the country with respect to this 
Draft Standardization Law, WTO Members could not submit comments at an appropriate stage 
since the regulation had not been notified to the Committee as per Article 2.9.2 of TBT Agreement, 
and u rged China to notify the draft accordingly. He also noted that Article 24 of the draft measure 
required enterprises to unveil their corporate standards, such as functional criteria, performance 
criteria, and testing methods of product services. Korea was c oncerned that this may cause 
damage to those enterprises by revealing confidential information and may infringe on intellectual 
property rights, which would not be in accordance with Article 5.2.4 of the TBT Agreement. Korea 
therefore requested China to wi thdraw this specific provision from the draft measure.  
3.33.   The representative of China  informed that his capital was analysing the comments received 
from Members and would take reasonable comments into consideration when finalizing the 
standardization law. Wit h regard to the transparency request from Korea, she said that China 
would make an evaluation of whether, consistent with the TBT Agreement, a notification to the 
WTO would indeed be necessary.  
3.2.2.5    China - Chinese Standards of Exhaust Emissions (China 6, BEIJ ING VI)  
3.34.   The representative of the Republic of Korea  said that his delegation had been informed that 
domestic processes were under way to adopt the China 6 and BEIJING VI standards, which would 
be enforced on 1 December 2017 and 1 January 2020, respectively . However, as these standards 
had not been notified to WTO Members, Korea requested China to do so, as per their obligation 
under Article 2.9.2 of the TBT Agreement. He went on to express concern that, even with the 
same objective, these two standards took  a different approach with regard to test cycles, 
standardization methods, etc. These standards were deemed to be burdensome because 
manufacturers would have to develop two vehicle models in order to meet the two standards. G/TBT/M/69  
 
- 9 - 
 
  Korea asked China to unify the m ethodology of the two standards, like the current China V and 
BEIJING 5, in accordance with Articles 2.2 and 2.3 of the TBT Agreement.   
3.35.   The representative of China  explained that the Chinese Standards of Exhaust Emissions 
(China 6, BEIJING VI) were drafted  in order to ease the severe air pollution in China, especially in 
Beijing. China committed to conveying all comments back to its capital, since Korea's detailed 
concerns on this issue had only been brought to her delegation's attention during the bilatera l 
meeting.  
3.2.2.6    National Standards on Limits of Volatile Organic Compounds for furniture, 
G/TBT/N/CHN/1094, G/TBT/N/CHN/1095, G/TBT/N/CHN/1096  
3.36.   The representative of the European Union  first thanked China for having notified the three 
standards at issue which, intended to become mandatory, were therefore akin to technical 
regulations. The EU considered, however, that these proposed mandatory measures included 
unnecessary deviations from relevant international standards. In case such standards would 
become mandat ory, products which were currently assessed on the basis of well -known  
international ISO standards would have to be assessed for the Chinese market on the basis of 
specific tests. Some of these specific tests required a complex and costly assessment (e.g. 
requiring multiple test chambers for "volume factor loading" in accordance with 
G/TBT/N/CHN/1094 for wood -based furniture, and a rare mattress test chamber for mattresses). 
In addition, due to the novelty of the proposed test methods, and lack of experienc e thereof, there 
were significant doubts among industry about the relevance of the tests with regard to the 
presence of harmful elements to be measured ("Total Volatile Organic Compound" – TVOC   
measured a sum of harmful and harmless substances) as well as  about the replicability of the 
tests. He therefore underscored the potential of those deviations not only to make trade more 
costly, but also to disrupt trade in a non -negligible manner.  
3.37.   He also said that the EU understood that China was modifying the not ified standards, and in 
particular that the TVOC requirements would be applied on a voluntary rather than mandatory 
basis. The EU thus asked China to confirm this understanding and requested further clarification of 
which parts of the standard would remain  voluntary and which would be mandatory. In particular, 
the EU asked China to inform whether either the TVOC limits set out in the standards, or the 
testing method set out in the standards and their annexes, would be considered as voluntary; or, 
instead, w hether both aspects would be considered as voluntary. The EU also asked whether this 
differentiation would apply to all three notified draft standards. Similarly, the EU asked China to 
provide information regarding the intended status - voluntary or mandat ory - of the other limits 
and requirements included in the notified drafts (e.g. formaldehyde emissions). In this respect, the 
EU encouraged the Chinese authorities to accept equivalent international standards, in particular 
ISO standards, for the product categories covered by the notified drafts. He said that, should 
China consider that the relevant ISO standards could be improved, the EU would invite China to 
bring its proposals for discussion to the ISO. This would enable improvements to be considered 
without creating differences between Chinese and international standards, thus avoiding 
unnecessary barriers to trade. Finally, the EU asked China to indicate the timeline foreseen for the 
adoption of the notified drafts.  
3.38.   The representative of China  noted th at the EU's concerns, such as testing methods, were 
mainly of a technical nature. She said that China's experts had prepared technical details on the 
process for the determination of the testing methods. During the recent bilateral meeting, China 
had provi ded the expert report to the EU delegation. She clarified that the Chinese standards 
adopted testing methods mainly based on international standards. While several aspects thereof 
differed from international standards, they were all designed to simulate re alistic usage conditions 
to ensure that the test results would be more scientific.  
3.2.2.7    Kenya – East African Community (EAC) alcoholic beverage standards   
3.39.   The representative of the European Union , whilst expressing his delegation's support for 
efforts to fight  the consumption of adulterated alcoholic beverages, asked Kenya, and other 
Members of the East African Community (EAC), to notify this and any other applicable technical 
regulations so as to give Members the opportunity to provide comments in order to fin d a solution 
that properly addressed their concerns without creating unnecessary barriers to trade. In the G/TBT/M/69  
 
- 10 - 
 
  meantime, the EU asked Kenya and other EAC members to suspend the application of these 
measures. The EU believed that widely accepted international s tandards and practices correctly 
addressed this type of health concern and would therefore welcome discussions with EAC members 
in order to analyse how their technical regulations could be better aligned with them.  
3.40.   The representative of the United States  said that her delegation strongly supported the 
EAC's desire to protect its citizens and reduce the consumption of adulterated alcoholic beverages. 
She also noted that many of the notifications submitted by Uganda and Rwanda over the past few 
years on alcoh olic beverage labelling and analytical production limits deviated from widely 
accepted international standards and practices. It was unclear why such deviations were necessary 
in fulfilling the objectives of the measure. The US would welcome discussions wi th EAC members 
to find a solution that would not unnecessarily restrict trade, such as greater alignment with 
standard international practices. She added that if Tanzania, Kenya, and Burundi indeed intended 
to adopt EAC standards on alcoholic beverages, th e US would then request an opportunity to 
provide comments. She recalled that the US ha d previously submitted comments to Uganda and 
Rwanda expressing concern with the implementation of the standard.  
3.41.   The representative of Chile said that his delegation sup ported the US request that Kenya 
notify the measure, which would enable them to make comments.  
3.42.   The representative of South Africa  said that his delegation was also very interested in the 
EAC alcoholic beverage regulations. South Africa fully supported the regulation of alcoholic 
beverages for health protection, the prevention of deceptive practices , as well as for reasons of 
quality. However, in South Africa's view, the pursuance of such objectives should be done in a 
transparent manner, taking into conside ration international standards and best practices. The 
South African wine industry was particularly concerned with the measure's 14% alcohol 
percentage with no actual alcohol percentage tolerance allowed from what was printed on the 
label. This tolerance e xclusion and the 14% limit would in practice exclude many of South African 
red wines from the Kenyan Market. It should be noted that for exporting to other countries, a label 
alcohol tolerance from 0.5% up to 1.5% was normally permitted, allowing for diffe rences in 
analyses between laboratories and different sets of samples. As no tolerance was allowed under 
the Kenyan measure, this meant that if the actual alcohol percentage on the clearance 
documentation and the labelled alcohol percentage of the wine con cerned were not exactly the 
same, the wine would not be granted entry into Kenya. Therefore, this exclusion of a label 
tolerance was not in line with international best practice. South Africa thus asked Kenya to 
consider that a label and actual alcohol tol erance of between 0.5 and 1.0% be allowed for the 
importation of wine.  
3.43.   The representative of Kenya  said that his country, together with other EAC Partner States, 
had been working on the harmonization of standards to facilitate both regional and internation al 
trade. The EAC alcoholic beverage standards were among others to have been harmonized in this 
process. Kenya was committed to the principle of transparency and would therefore ensure that 
the concerns raised by the EU and shared by the US, Chile and Sou th Africa would be addressed as 
soon as possible.   
3.2.2.8   Chinese Taipei - Draft of the Organic Agriculture Act , G/TBT/N/TPKM/225, 
G/TBT/N/TPKM/225/Add.1 , G/TBT/N/TPKM/225/ Add.2   
3.44.   The representative of the European Union  considered that clarity was needed on the s cope 
of the proposed measure with respect to both its product coverage (such as food, feed, processed 
products and plant reproductive material) and process stage coverage (such as primary, 
processing, distribution and retail). The EU also considered that t he draft measure needed to 
include production and control rules on organic farming, which would help to understand possible 
differences in legislative frameworks that could adversely impact operators trading in organic 
products on Chinese Taipei's market. The EU representative also said that, in the EU's view, the 
most critical element of the proposed measure was Article 37, which stated that countries that ha d 
been recognized as having equivalence regarding organic imports before the notified draft was 
implemented would have to re -apply for recognition and that a new bilateral protocol or agreement 
would then have to be signed within one year of the implementation of the notified draft. If the 
one-year timeframe for signature was not respected, then the bil ateral protocol or agreement with 
the third country concerned would be revoked by Chinese Taipei. The EU thus considered that the 
implementation period of one year did not allow trading partners sufficient time to re -apply for G/TBT/M/69  
 
- 11 - 
 
  recognition and to conclude t he required ratification process of the new bilateral protocol or 
agreement. In addition, the EU considered that the penalty imposed for exceeding the one -year 
timeframe was too strict. Such a draft measure, if implemented, would be more trade restrictive 
than necessary. The EU therefore requested Chinese Taipei to consider the possibility of a 
reasonable extension of the timeframe to re -apply for equivalence. For reference, the EU 
representative said, in similar circumstances the EU granted a period of fiv e years.  
3.45.   The representative of Chinese Taipei  said that since the draft measure was still undergoing 
its legislative process, the EU's suggestions regarding the scope of application and extension of the 
grace period for unilateral recognitions would be th oughtfully considered. Comments from 
Australia, India, and the US would also serve as guidance for this legislation.  
3.2.2.9   European Union – Quality Schemes for Agricultural Products and Foodstuffs , 
G/TBT/ N/EU/139 , G/TBT/ N/EU/139/Add.1  
3.46.   The representative of the United States  said that on 12 February 2012 and 23 January 
2014, respectively, the EU had published two applications from Denmark for the registration of the 
terms "danbo" and "havarti" as protected geographic indications for cheese. The US noted that the 
EU had published these two GI applications  made by Denmark under Regulation 1151/2012 of the 
European Parliament and of the Council on the quality schemes for agricultural products and 
foodstuffs, notified to this Committee in 2013 - although the Codex Alim entarius had adopted 
production standards for these two cheeses years ago: 50 years ago, in the case of "danbo" and 
30 in the case of "havarti". These Codex standards had been adopted in order to ensure the 
quality and uniformity of these cheeses in the va rious countries producing them.  
3.47.   While both applications were still pending, the US explained that it had decided to raise th e 
concern at this juncture because it ha d been informed by its producers of "some movement" on 
these applications. The US said that , if granted, these GI registrations would result in the 
prohibition within the EU of the two names for any cheese produced outside of Denmark. She 
therefore posed a series of questions to the EU. First, if the pending EU -level applications by 
Denmark to s eek restricting the use of these Codex -standardized, common name terms solely to 
Danish producers were approved, would the EU prohibit imported cheeses from using the Codex -
standardized terms on the products' labels, even if those cheeses conform ed to thei r respective 
Codex standards? Second, if the applications related to these two names were approved within the 
EU, would the EU seek to use international treaties to prohibit cheeses being sold in other markets 
from using the Codex -standardized terms on the  products' labels, even if those cheeses conform ed 
to their respective Codex standards? Third, ha d the EU considered less trade -restrictive means of 
implementing regulations pertaining to "danbo" and "havarti"? For instance, ha d the US envisaged 
an alterna tive that would instead require the applications to be amended so as to cover only 
"Danish danbo" or "Danish havarti", and that would also allow accompanying clear statements so 
that products produced and labelled in accordance with the Codex standards for  "danbo" and 
"havarti" would be able to continue to be sold in the EU market?  
3.48.   The representative of Uruguay  said that, as one of the world's main producers of "danbo", 
Uruguay followed global developments on these products with close interest. He said tha t, like the 
US, his delegation would like the EU to provide Members with an update on the GI applications 
referred above.  
3.49.   The representative of the European Union  said that the original measure had been notified 
under G/TBT/N/EU/139 and G/TBT/N/EU/139/Add .1. The EU was not in a position to provide a 
detailed reply with regard to an update on the pending applications, due to the short notice of the 
request. The EU remained open to discuss this issue bilaterally.  
3.2.2.10    European Union – Directive  2014/40/EU on the  approximation of the laws, 
regulations and administrative provisions of the member States concerning the 
manufacture, presentation and sale of tobacco and related products and repealing 
Directive 2001/37/EC  
3.50.   The representative of Indonesia , supported by Guatemala , noted that EU member States 
were required to implement the EU Tobacco Directive into their local laws by 20 May 2016, 
Article  7(1) of which prohibited member States from placing tobacco products with a G/TBT/M/69  
 
- 12 - 
 
  "characterizing flavour" on the market. In r elation to this specific obligation, the European 
Commission Implementing Decision 2016/786 of 18 May 2016 (the "Implementing Decision") had 
been adopted to lay down the procedure for the establishment and operation of an independent 
advisory panel tasked with assisting EU member States and the European Commission in 
determining whether tobacco products have a "characterizing flavour". Indonesia said that some 
EU member States had already prohibited the importation into their territories of "Kretek " (a 
tobacco product containing clove) on the basis that it was a tobacco product with a "characterizing 
flavour", as a result of which, as of May 2016 all importation of Kretek  to the EU had ceased. While 
Indonesia appreciated and respected the intention of the EU  to pursue a public health policy to 
protect its people from the negative effects of consuming tobacco products, Indonesia nonetheless 
drew Members' attention to the following facts related to this product:  Kretek  was a traditional 
tobacco product original ly created in Indonesia and an important export product for this country; 
the approximate export value of Indonesian Kretek  was US$600 million; and the cultural 
importance of Kretek  to Indonesians all over the world, including EU citizens of Indonesian 
descent, was significant.  
3.51.   Indonesia also noted that the "advisory panel" mentioned by the Implementing Decision had 
not yet been established. The Indonesian government therefore requested the EU to explain the 
basis for the import prohibition of Kretek  that had already been implemented by EU member 
States. Indonesia also noted that Article 7(14) of the EU Tobacco Directive stipulated that tobacco 
products with a characterizing flavour whose EU -wide sales volumes represented 3% or more in a 
particular product category would only be subject to application of the Article 7(1) prohibition as 
from 20 May 2020. Indonesia's interpretation was that, if menthol cigarettes consumed in the EU 
(the vast majority of which were also produced within the EU) were determined t o have a 
"characterizing flavour", they should also be prohibited under Article 7(1). Instead, however, these 
products benefit from the delay in prohibition pursuant to Article 7(14). Indonesia thus believed 
that Article 7(14) of the Tobacco Directive was inconsistent with Article 2.1 of the TBT Agreement 
because, in practice, it accorded to imported Kretek  a treatment less favourable than that 
accorded to domestic menthol cigarettes. Similarly, Indonesia believed that Article 9 of the 
Implementing Decision  was also inconsistent with Article 2.1 of the TBT Agreement. Indonesia said 
that this Article 9 imposed a specific methodology to determine "characterizing flavour", which was 
to be based on a comparison of the smelling properties of the test product with  those of reference 
products. Indonesia considered that by restricting the methodology to smelling properties , and by, 
as a result, excluding tasting methodology properties , this provision inherently discriminated 
against Kretek , which used distinctive Indonesia -grown tobacco leaf. Conversely, cigarettes 
manufactured in the EU were largely made using one or both of the two internationally most 
commonly used tobacco leaves.  
3.52.   The representative of the European Union  informed Members that the Tobacco Products 
Directive was applicable as of 20 May 2016. This measure was a result of thorough consultations 
with all stakeholders involved and an in -depth analysis. It provided for measures that were non - 
discriminatory and proportionate to the legitimate health object ives pursued. During the 
preparation of the measure, the European Commission had carefully balanced the need to put in 
place a comprehensive tobacco control policy, including, on the one hand, the implementation of 
the WHO Framework Convention on Tobacco C ontrol (FCTC) commitments with, on the other 
hand, various economic and trade considerations. The EU was fully convinced that the Directive 
was consistent with the EU's international commitments, including its obligations under the TBT 
Agreement. With rega rd to Indonesia's specific question concerning Kretek , the EU said that it was 
available for bilateral contacts.   
3.2.3   Previously raised concerns  
3.2.3.1   India - Pneumatic tyres and tubes for automotive vehicles, G/TBT/N/IND/20, 
G/TBT/N/IND/20/Add.1, G/TBT/N/IND/40, G/ TBT/N/IND/40/Rev.1 (IMS ID 133)   
3.53.    The representative of Japan  expressed continued concern with respect to five points: (i) the 
ISI marking fee requirement; (ii) the cost of the marking fee ; (iii) certification ; (iv) the bank 
guarantee fee (only for tyre fa ctories outside India) ; and (v) the increase of the test frequency. 
Regarding the marking fee, Japan had repeatedly demonstrated to India calculated evidence that 
the ISI marking fee was expensive compared to other countries. India was requested to reduce 
the fee to the same level as other Members. Regarding the increase in Conformity of Production 
(COP) test frequency, noting other Members' test requirements, Japan considered it possible to G/TBT/M/69  
 
- 13 - 
 
  ensure sufficient safety of tyres by implementing the COP test onc e a year. If the test was 
implemented based on production volume of tyres, it would impose excessive test frequency on 
companies, depending on their firm size. Therefore, Japan requested India to delete the production 
volume -based requirement, to set the f requency only per period and to implement the COP test at 
most on an annual basis.  
3.54.   The representative of the European Union  reiterated his delegation 's concerns with the 
Indian measure at issue which introduced a certification procedure with a mandatory m arking for 
tyres. The EU referred back to its previous statement at recent Committee meetings concerning  
the ISI marking fee and the US$ 10,000 bank guarantee.  India was requested to align its 
procedures to international practices and remove the obligation to pay a marking fee per marked 
tyre and to eliminate the discriminatory bank guarantee requirement. The EU had asked India to 
provide information about the new Schedule of Testing Inspections (STI) 15633/5 of November 
2015. The new measure introduced the concept of "control unit ", meaning 5,000 tyres of the same 
family. It required testing of every tenth control unit for load and speed performance, endurance 
test, bead unseating resistance test and tyre strength test. The EU considered that these testing 
requirements were extremely burdensome and costly and asked what specific safety -related 
objectives India was pursuing. During the last meeting of the Committee, India had said that the 
new measure might be further amended following the comments received; t he EU asked for an 
update on state  of play in this regard  and asked India  to notify the measure.  
3.55.   The representative of India said that concerns relating to the bank guarantee requirements 
were not new and had been responded to several times at previous me etings of the Committee. 
This was similarly the case for the marking fee. Therefore, the interested delegations were 
requested to refer to the statement made by India on these matters at previous meetings, 
particularly in the minutes of the meeting held in  March 2015.   
3.56.   Regarding the comparative data analysis presented by the delegation of Japan, the matter 
had been discussed bilaterally and it had been pointed out that the calculation sheet contained 
some errors. The cost projected in the calculation was di sproportionately high as the volume of 
production shown was significantly more than the actual figures. As per the records of Indian 
authorities, most of the Japanese manufacturers did not exceed 100,000 pieces per year, whereas 
the calculation sheet assum ed an annual production of about 800,000 pieces. As the marking fee 
was linked to the volume of production, the calculation had grossly overstated the actual cost. In 
the records of the Bureau of Indian Standards ( BIS), almost all manufacturers in Japan ha d 
actually paid only the minimum marking fee of approximately US$3,617 (approx.) for the year 
2014-15, as against US$ 20,475 shown in calculations. Regarding a request made by some 
Members for further simplification of documents, these were in fact being si mplified. On the testing 
frequency, the STI for pneumatic Tyres for Passengers Car Vehicles had been revised as 
STI/15633/5 November 2015. In the earlier STIs, the frequency of tests was not linked to the 
production volume. However, in this revised STI, fr equency of test had been linked to the 
production volume. For example, the earlier STI required that Load Speed Performance test to be 
carried out on one sample of a family of tyres, every three months, irrespective of whether the 
manufacturer had produced  100 pieces or 100,000 pieces of the variety in three months. Now, it 
had been proposed that the above test had to be carried out on one sample of a family of tyres for 
every 10 control units. One control unit had been defined as 5,000 tyres of the same fa mily 
manufactured by similar process under similar conditions with similar material composition. Thus, 
this test would be required to be carried out once for every 50,000 tyres, and not every three 
months. If the volume of production was up to 100,000 in a  year, the testing frequency would not 
exceed twice a year.  
3.2.3.2   China - Provisions for the Administration of Cosmetics Application Acceptance, 
G/TBT/N/CHN/82 1, G/TBT/N/CHN/937 (IMS ID 296)   
3.57.   The representative of Japan  asked China to clarify how the "Guidance for Application and 
Evaluation of New Cosmetic Ingredients" would be updated (in particular with respect to the 
contents and schedule) in accordance with the revision of the "Regulations concerning Hygiene 
Supervision over Cosmetics". Regarding the current  version of the "Guidance", she reiterated 
Japan's concerns regarding the three following issues: the speed of examination, the safety 
evaluation requirement, and the information disclosure. She requested that those concerns should 
be resolved in the revis ion of the "Regulations concerning Hygiene Supervision over Cosmetics ". G/TBT/M/69  
 
- 14 - 
 
  3.58.   The representative of the European Union  welcomed the plans of China to set up a 
differentiated approach between priority ingredients, which were of higher risk, requiring a pre -
market  registration, and ordinary ingredients, which would only need to be notified to the 
competent Chinese authorities. In this respect, he asked China to indicate the state of play and the 
planned timeframe for the adoption of this change. He also asked China  to explain the current 
state of play of the new Chinese draft on Cosmetics Supervision and Administration Regulation.  
3.59.   The representative of China  informed that there had been no further updates to the 
measure at issue and invited interested Members to ref er to the minutes of the last meeting.3  
3.2.3.3   India – New Telecommunications -related Rules (Department of 
Telecommunications, No. 842 -725/2005 -VAS/Vol.III (3 December 2009); No. 10 -
15/2009 -AS-III/193 (18 March 2010); and Nos. 10 -15/2009 -AS.III/Vol.II/(Pt.)/(25 -
29) (28 July 2010); Department of Telecommunications, No. 10 -15/2009 -
AS.III/Vol.II/(Pt.)/(30) (28 July 2010) and accompanying template, "Security and 
Business Continuity Agreement" (IMS ID 274)  
3.60.   The representative of the European Union  asked India to confir m the postponement of the 
entry into force of its security testing requirements until April 2017 and also that until that time 
the status quo - meaning continued acceptance of foreign test results and suppliers being allowed 
to self -certify their products - would continue to apply. On the issue of applicable testing 
requirements, European industry needed greater clarity. As raised previously, the proposed batch 
testing seemed to be disproportionate and excessively burdensome, creating a bottleneck and 
disruption of the supply chain. The EU suggested that India consider a product -type testing based 
on a prototype of the product being placed on the market. Concerning the applicable standards for 
testing purposes, he reiterated his delegation's past recommendat ion that India relies on relevant 
international standards, namely the Common Criteria and Third Generation Partnership Project 
(3GPP) for EGBB standards on telecom network equipment. His delegation was of the view that 
India should refrain from developing home -grown specific standards, which added costs without 
increasing value in terms of in -house security; the same applied to the requirement for in -country 
testing for which there was no evidence that this would result in enhanced security due also to the 
lack of adequate laboratory capacity in India. He reiterated the EU's request that even after the 
entry into force of the new requirements, an adequate notice and transition period should be 
provided. Foreign test results should continue to be accepted and  flexibility should be provided for 
companies with a proven track record and who have consistently demonstrated over time the 
ability to self -certify products through adequately accredited and competent in -house laboratories. 
Finally he asked India to conf irm that there would be no change to the continued acceptance of 
results of certificates issued under assessments conducted under the Common Criteria Recognition 
Agreements (CCRAs) and related certificates. He concluded by flagging his delegation's upcomin g 
bilateral meeting with India.  
3.61.   The representative of the United States , whilst recalling the numerous times this issue had 
been raised, asked India to confirm that stakeholders would be informed of the new in -country 
testing effective date via a public no tice and that a notification would be made to the Committee.  
She also urged India to allow adequate time between the announcement of the entry -into-force 
date and the actual effective date for producers to comply. Whilst the delayed enforcement of the 
requirement was helpful to the US in the short -term, the long -term remained uncertain for India 's 
trading partners, inhibiting trade and investment.  Once implemented, this in -country testing 
requirement could create an onerous and unnecessary trade barrier on US companies, particularly 
small and medium -sized enterprises. The US respected India's desire to protect its critical 
telecommunications infrastructure from spyware and malware attacks but required specific 
answers on why this could not be addressed by cu rrently available testing schemes, like the CCRA.  
India had only identified security concerns and circumstances that exist in most countries, those 
that did not require in -country testing or an MRA.  She reiterated her delegation's concern that the 
private  sector was already securing networks with innovations that were constantly evolving in 
anticipation of new and more sophisticated types of network attacks.  For example, anti -spyware, 
anti-malware, security specialists, and private and international standa rds were provided by 
globally known, innovative, and reputable companies.  What were the specific and unique 
circumstances in India that rendered such innovations inadequate?  What specific incidences could 
be looked to in order to see India's justification for this regulatory approach?  One of the US's 
                                                
3 G/TBT/M/68, para . 2.66.  G/TBT/M/69  
 
- 15 - 
 
  concerns was that in applying inappropriate domestic requirements, India would discourage 
innovation and competitive technology development. The US asked whether India had prepared a 
more specific response than  the one given in March as to what valid security risks were addressed 
by this measure that were not being addressed through internationally accepted standards and 
testing practices in conjunction with other private sector initiatives.  
3.62.   The US further requ ested a response to a pending query as to whether India had considered 
options for allowing testing to be conducted in the country of export and , if so, what options had 
been considered. Another pending request related to India sharing its analysis on whic h the in -
country testing requirement was based. As stated in previous interventions, security testing that 
would potentially compromise companies' proprietary information such as source code and other 
intellectual property would potentially discourage comp anies from exporting high -quality 
telecommunications equipment to the Indian market, hurting India's trading partners 
unnecessarily and limiting Indian service providers from having access to the broadest possible 
range of network products and components. India was additionally urged to honour its 
commitment in the Common Criteria Recognition Arrangement to accept the results of Common 
Criteria ( CC) tests conducted internationally and to accept international testing standards and 
schemes regardless of wheth er the tests were performed in India or at accredited labs outside of 
India.  
3.63.   The representative of Canada  reiterated his delegation's concerns with respect to India's in -
country test requirements for telecoms products, considering they would hinder or poss ibly shut 
Canadian exporters out of the Indian market. Canada disagreed with India's blanket approach to 
testing in the telecoms sector, questioning why CC testing was not appropriate for India's telecoms 
framework, given that it was internationally accept ed. Allowing accredited foreign conformity 
assessment bodies to test and certify to India's regulatory requirements would reduce testing 
costs and expedite foreign products entering the Indian market. He requested an update from 
India on the status of the entry-into-force date, which, at the previous meeting, India had 
announced would be extended beyond 1 April 2016.  
3.64.   The representative of Japan  expressed her delegation's support for the positions of EU, US 
and Canada. Japan still had interests in the new Un ified Access Service License Agreement, and 
sought assurance that India's telecom regulations would not impede market access for foreign 
industries. In addition, with regard to the statement by India at the last meeting that "the 
requirement of in -country security testing of telecom equipment within India would be extended", 
Japan requested India to clarify the specific implementation date of this requirement.  
3.65.   The representative of India reiterated that in -country security testing of telecoms equipment 
had been mandated for "national security reasons" due to its vulnerability to spyware and malware 
attacks in recent times. He explained that telecom networks were a part of the critical 
infrastructure on which other important infrastructures (e.g. power, tran sportation, defence) 
depend. Accordingly, licences for the provision of telecoms services had been amended on 31 May 
2011 and 3 June 2011 in consideration of national security, requiring security certification of 
network elements before induction into the network. Based on the amended provisions, the 
processes of security testing and certification by authorized and certified agencies/laboratories 
within the country were under development and yet to be finalized. Furthermore, at present the 
authorities were neither considering the suggestion of allowing accredited bodies outside India or 
MRAs to perform security testing and grant certification, nor that of allowing security testing to be 
conducted in the country of export. It was India's belief that the Commo n Criteria was insufficient 
for the purpose of security testing of telecoms equipment, as it is process based and used for 
certifying only the security features, excluding vulnerabilities or back doors. Hence, the Common 
Criteria failed to address national  concerns on security requirements for telecoms networks.  
3.66.   The representative of India flagged that international standards would be relied on to the 
extent possible.  For IT products, testing carried out against CC Process under CCRA could be 
leveraged, alt hough additional tests would be conducted if required in the interests of national 
security. On 3GPP standards, he said that 3GPP was in the process of developing security 
assurance requirements for telecom network elements and had taken  the Mobility Manag ement 
Entity (MME) as the first element for which the standards and test suites were still under 
development. In response to a specific question on whether testing would be product -wise or 
batch -wise, India reported that the testing modalities were yet to be finalized. On the issue of a 
WTO notification, he noted that the matter had been under discussion in the WTO TBT Committee G/TBT/M/69  
 
- 16 - 
 
  since it had first been raised. All issues raised, comments, and suggestions were in the hands of 
the authorities and would be kep t in mind during the finalization process prior to entry into force. 
He concluded by informing the Committee that entry into force of in -country security certification 
had been postponed until 1 April 2017; until that date, such procedures could be carried  out in 
Indian or international standards agencies/labs as per licence conditions.  
3.2.3.4   China – Requirements for information security products, including, inter alia , the 
Office of State Commercial Cryptography Administration (OSCCA) 1999 Regulation on 
commerci al encryption products and its on -going revision and the Multi -Level Protection 
Scheme (MLPS) (IMS ID 294)  
3.67.   The representative of the European Union  reiterated his delegation's request for a 
meaningful update on the state of play of the revision of the OSCC A regulation on commercial 
encryption products, in particular the current status of the process. If the intention was still to 
finalize the revision, was it still on the agenda of the State Council legislative office? Was there a 
timeline to notify the dra ft to the TBT Committee for comments and to allow a transparent and 
open process in the finalization of this measure?  
3.68.   He reverted to more systemic points raised at previous meetings, particularly in light of a 
number of framework measures that had been de veloped over the years, creating a lot of 
uncertainty about the notion of critical infrastructure in China. The first such measure was the 
multi-level protection scheme (MLPS). More recently, the national security law had been passed 
which provided that al l key cyber infrastructure within China had to be "secure and controllable", 
without however defining the notion or its implications in terms of hardware and software 
requirements in IT networking equipment. Reference to "secure and controllable " was also made in 
the draft implementing guidelines concerning the banking and insurance sectors and in the draft 
cyber security law, on which the EU requested an update, urging due notification to the 
Committee. He reiterated the need to better understand the crite ria for defining an IT system as a 
critical infrastructure and how the concept of secur e and  control lable would affect this assessment.  
3.69.   The EU also reiterated its request for standardization activities in the field of information 
security in China to fully  take into account relevant international standards and also allow for 
meaningful participation of foreign companies. He recalled that the TC260, the relevant technical 
committee for information security standardization within the China standardization 
administration, had showed increased openness by allowing the participation of certain foreign 
stakeholders and indicated that the EU would welcome continued movement towar ds more 
inclusive participation . Finally, he stressed the importance of enhanced intern ational cooperation in 
this field as cyber security was a global issue, needing commitment to develop compatible regimes 
capable of enhancing security without hindering trade in commercial encryption products.  
3.70.   The representative of Japan  voiced support fo r the position of EU regarding this issue. Her 
delegation remained particularly attentive to how the various schemes and regulations within 
China could negatively affect the trade of information security products. She recalled that in the 
March 2015 meetin g, China had made a statement that "the revision of OSCCA is listed in the 
legislation plan and opportunity for public comment is also going to be arranged" . In this regard, 
Japan asked China to explain the current situation and future schedule of the revi sion. Flagging 
some cryptography -related regulations which had been stipulated in "Banking IT Equipment 
Security Regulation" and "Insurance Regulatory Commission (CIRC) Information and 
Communication Technology Regulation" and which had been notified to WTO , her delegation asked 
for confirmation as to whether or not IT security measures such as OSCCA would be applied to 
these regulations. Japan, moreover, expressed concern and interest with respect to the Draft 
Cybersecurity Law.  
3.71.   The representative of China  reported that the regulation on commercial encryption products 
had been listed in the 2016 legislation plan of the State Council of China and was currently being 
drafted in line with legislation law and rules on the formulation of administrative laws of Ch ina. 
Further, she confirmed that OSCCA would undertake scientific evaluation and public consultations G/TBT/M/69  
 
- 17 - 
 
  to ensure openness in the legislation process. She said that there were no further updates to be 
made and referred Members to the minutes of previous Comm ittee meetings.4  
3.2.3.5   Russia – Draft Technical Regulation on Alcoholic Drinks Safety, G/TBT/N/RUS/2 
(IMS ID 332)  
3.72.   The representative of the European Union  recalled the explanations provided by the Russian 
Federation at the previous meeting of the Committee on t he procedure for adoption of technical 
regulations by the Eurasian Economic Union, in particular with regard to consultations within its 
member States, and invited Russia to update the Committee on the status and timeline for 
adoption and implementation of  the draft technical regulation on alcohol products safety, which 
had been notified in 2012. Referring to the detailed comments submitted by the EU in writing to 
Russia in 2013 and the discussions in subsequent meetings of the TBT Committee, the EU 
represe ntative recalled Russia's explanation that most of the EU comments regarding wine, spirit 
drinks and beer would be taken into account  in the revised draft technical regulation. However, a 
revised text had neither been notified under the TBT Agreement nor p ublished. The EU requested 
Russia to re -notify the revised text to the TBT Committee as it would likely include substantial 
changes as compared to the original text notified in 2012. The EU also requested that sufficient 
time be provided for manufacturers to adapt their products to the requirements of the technical 
regulation.  
3.73.   The representative of Ukraine , joining the concerns expressed by the EU , noted that Item 4 
of Article 7 of the Draft Technical Regulations provided that "upon conformity (verification ) 
assessment of products, the applicant may only be either a legal entity, either an individual as a 
sole proprietor, or as a producer or seller, or as the agent of a foreign producer on the basis of a 
contract with said producer, which is registered pursu ant to the legislation of a Customs Union 
member state on its territory". He stated that the requirements of the Draft Technical Regulations 
relating to the applicants' mandatory registration on the territory of member s tates of the Customs 
Union put natio nal producers and producers from other Member s of the WTO in unequal conditions 
and thus violated Article 5 of the TBT Agreement.  
3.74.   Ukraine furthermore recalled that Article 5 provided that any fees imposed for assessing the 
conformity of products originatin g in the territories of other Members should be equitable in 
relation to any fees chargeable for assessing the conformity of like products of national origin. 
Since the producers from other countries had to bear the costs associated with registration of le gal 
entities on the territory of the Customs Union or contracting with existing legal entities registered 
in the territory of the Customs Union, the costs on conformity assessment procedures for those 
producers could be higher than the costs for producers from member States of the Customs Union.  
3.75.   The representative of Guatemala  indicated her delegation's interest in following discussions 
on this issue.  
3.76.   The representative of the Russian Federation  emphasized that the draft of the technical 
regulation on Alco holic Drinks Safety had been elaborated in order to establish unified 
requirements for commercial circulation of alcoholic products – for both imported and those 
produced domestically. He informed the Committee that the draft was still in development and 
that no substantial amendments had been made since the last Committee meeting. He reassured 
delegations that all concerns had been taken into account as provided for under Article 2.9.2 of the 
TBT Agreement, and would continue to inform interested Members o n further steps taken in this 
matter.  
3.2.3.6   Korea – Regulation on Registration and Evaluation of Chemical Material 
(IMS  ID 305)  
3.77.   The representative of the United States  thanked Korea for its receptiveness to stakeholder 
input, expressing hope for an ongoing, con structive dialogue that was open and transparent, with 
Korea continuing to consult with stakeholders and educating them on how to comply. She 
appreciated the Ministry of the Environment (MOE) opening the Ministerial Decree for amendments 
and public comment s in 2015 and expressed willingness to discuss the comments submitted to 
                                                
4 G/TBT/M/68, para. 2.80; G/TBT/M/67, para 2 .85; G/TBT/M/66, para.3.83; and  G/TBT/M/65/Rev.1, 
para. 2.68.  G/TBT/M/69  
 
- 18 - 
 
  ensure full understanding of what the US was seeking. The US remained concerned about the 
issue of implementation challenges for stakeholders. Firstly, the Help Desk and Authorities s eemed 
to be difficult to reach and lacked responsiveness to stakeholder enquiries. Secondly, notifications 
seemed to be taking much longer than the legal targets. Thirdly, there was also significant 
confusion over specific requirements and acceptance of no tifications and registrations.  
3.78.   On the issue of Confidential Business Information ( CBI) and the Chemical Controls Act 
(CCA), despite the assurances Korea provided in March, the United States was especially 
concerned about CBI and the announcement that info rmation submitted via the Statistical Survey 
under the CCA would be published on the Internet. The US asked Korea to reconsider MOE's plan 
to disclose company -confidential chemical information on the internet on 1 July 2016, as the 
submission deadlines for  companies had been too short and insufficient guidance had been 
provided by MOE. The US also requested that protection of CBI related to composition and volume 
under the CCA should be automatic, and that manufacturers should not have to submit a request 
for it. There could be limited scenarios where CBI was released to a requestor, but it should be 
based on agreed conditions, protocols and processes (e.g. for the purpose of medical 
emergencies). With respect to CBI in general, the US once again reiterated its support for strong 
protection of CBI that recognized specific chemical identities, specific uses, and compositions as 
information that should be protected and requested that the MOE extend the scope of such 
protection to more substances that qualified as hazardous under K -REACH. Korea was requested to 
confirm the impression given in its March 2016 intervention that specific uses would be protected 
and to elaborate further. As noted in the past, making CBI public or easily accessible could allow 
competit ors to freely acquire information that chemical companies had paid for through years of 
innovation, research, investment, and experience. Competitors could then use leaked information 
at little cost to them, which could stifle innovation and create a clear  disadvantage for US 
companies. Korean companies who also relied on these innovative US products for inputs of 
production would then be at a disadvantage if US companies decided to stop exporting due to 
these concerns.   
3.79.   Turning to the issue of guidance doc uments, his delegation hoped that Korea would 
continue best efforts to publish much -needed clarification and detailed guidance for use by US 
industry and that this would not present new challenges (i.e., changes in requirements or forms), 
as it had consist ently done in the past. Such guidance was essential to assist manufactures, 
importers and suppliers in ensuring accurate and consistent compliance with K -REACH. His 
delegation would welcome an outline of the guidance documents that MOE planned to publish o r 
update, along with timelines thereof, including brochures in English, as flagged during the March 
2016 meeting. He reiterated that more specific guidance was needed on all products that would be 
classified under the biocides group as the availability of existing guidance documents had not been 
clearly communicated to all stakeholders; moreover, the guidance documents themselves had also 
changed frequently. Chemicals continued to be added or removed from the toxic substances list 
without proper notice, opp ortunity for comment, or reasoning for the changes, causing uncertainty 
for chemical manufacturers and manufacturers using trace amounts of chemicals as inputs for 
production. K -REACH affected a wide range of products from chemicals to consumer products. T he 
US also noted its concern that guidance documents had only been published in Korean which 
forced stakeholders to have them translated, decreasing time available to come into compliance. 
To address this challenge, in March, it was suggested that these si gnificant documents should be 
allowed more time for public comment. In this respect, there was also a lot of confusion about the 
respective requirements of K -REACH and the CCA, especially since there was no English translation 
of the CCA implementing regul ations.  Finally, even though the CCA was only meant to apply to 
Korean manufacture rs, many foreign suppliers were receiving requests for 100% composition and 
additional information for chemical products. Explanation was sought as to whether Korea had 
considered US industry's request to translate the CCA.  
3.80.   On the issue of Data Acceptance for K -REACH registration and Article 13 of the Final 
Presidential Decree, the US delegation asked Korea to reconfirm the indication it had provided in 
March 2016 that computa tional toxicology techniques could be accepted in order to reduce 
duplicative testing. When such data was submitted, it was suggested that MOE accept the scientific 
expert's statement and not require additional evidence for the use of such data. During the  March 
2016 TBT meeting, the US had asked whether scientific expert statements could be accepted. An 
update on this was requested, as well as the acceptance by MOE of the EU REACH datasets to 
reduce duplicative testing for toxicity and ecotoxicity studies.  G/TBT/M/69  
 
- 19 - 
 
  3.81.   The representative of Australia  continued to express its interest in this issue and was 
monitoring the implementation of the regulations, which was of significant importance to 
Australian industry. While Australia supported the reporting of products conta ining hazardous 
substances so as to protect consumers and the environment, it considered that the current 
definition of "hazardous substance" was very broad. Australia thanked Korea for the notification 
dated 26 May 2016 on revised enforcement rules for ch emical substances and stated that it was 
reviewing the proposed amendments. Australia would welcome guidance material or any further 
information from Korea on the nature of the recent changes to regulations. Korea was encouraged 
to take a risk -based approa ch following international best practice, to ensure that the K -REACH 
provisions met Korea's consumer protection objectives whilst not unnecessarily distorting trade.  
3.82.   The representative of the Republic of Korea  assured the US and Australia that information 
regarded as CBI according to the "Unfair Competition Prevention and Trade Secret Protection Act" 
would be fully protected. Secondly, he announced that to help foreign companies, Korea planned 
to make brochures in English available in the second half of the  year. It also planned to notify 
relevant information whenever "Guidance on products and toxic agents" was revised. Thirdly, he 
noted that exporters could register chemical materials simply by submitting quantitative structure 
activity relationship (QSAR ) results which had internationally verified reliability, without additional 
evidence for omission of related test data. In addition, full text or test summar ies specified on 
dataset s which were used for EU REACH registration would be accepted. Fourthly, Kor ea 
recognized that even small amounts of a chemical substance could pose a huge threat to public 
health, as proven by a recent incident involving humidifier disinfectant, justifying the obligation to 
register and report all new substances under K -REACH reg ardless of the amount. However, 
chemical substances for the purpose of, inter alia , research and study were exempt from the 
reporting obligation. Lastly, Korea stated that it would continue to strengthen support for the 
smooth implementation of K -REACH and  CCA through the "Task Force on Support for Industry in 
Complying with Chemical Safety Rules".  
3.2.3.7   Indonesia - Technical Guidelines for the Implementation of the Adoption and 
Supervision of Indonesian National Standards for Obligatory Toy Safety, 
G/TBT/N/IDN/6 4 (IMS ID 328)  
3.83.   The representative of the European Union  sought confirmation that two parallel revision 
processes were ongoing and requested an update on both. He said the two revision processes 
concerned: (i) Toy Safety Decree No. 24, which dealt with conf ormity asse ssment procedures for 
toys; and  (ii) the revision of the applicable Indonesian national standard on toy safety for the 
purpose of aligning it with the latest edition of the ISO standard on toy safety (ISO 8124 of 2014). 
With respect to the Decre e No. 24, the EU expected that the revision would align the conformity 
assessment procedures between domestic and foreign products and remove the current 
discriminatory element for foreign products. He explained that under the current system, for 
domestic products, samples were taken from the production line every six months, while for 
foreign products there was a requirement to take samples from every imported batch. In the 
margins of the last TBT Committee meeting, the EU heard from the Indonesian delegat ion that 
consideration was given to allowing sampling from the production line also for foreign toy 
manufacturers, and to allow testing frequency of one year ; he sought confirmation of this.  
3.84.   Another important aspect for the conformity assessment procedure was the possibility for 
foreign test results to be used as a basis for any certificate that would be issued in Indonesia for 
compliance with the mandatory toy safety standards. The EU noted with serious concern that the 
two-year grace period for the accept ance of foreign test results expired on 17 April 2016. This 
grace period had not been extended further, and he reiterated the serious risk of trade disruption 
and the creati on of  bottleneck s at importation if foreign test results were not accepted given th e 
lack of adequate capacity of Indonesian labs. To address this issue, his delegation considered that 
Indonesia should allow test results issued by adequately accredited foreign labs, namely accredited 
by ILAC MRA signatories, as the basis for any certific ate issued by certification bodies approved by 
the Indonesian Ministry of Industry. Furthermore, the EU said Indonesian authorities should 
consider explicitly allowing subcontracting arrangements between Indonesian conformity 
assessment bodies and foreign bodies, without insisting on impracticable government -to-
government MRAs  to achieve that purpose.  
3.85.   Concerning the alignment of the Indonesian standard with the ISO standard, the EU 
expected that this would also address the current concerns about testing met hods for G/TBT/M/69  
 
- 20 - 
 
  formaldehyde, which it deemed were erroneously based on limits that applied to infant clothing 
rather than toys. The EU was confident that this issue would be addressed because alignment with 
the ISO standard for toys would allow the necessary rec tification to the Indonesian standard. He 
welcomed the opportunity for future bilateral exchanges with Indonesia in order to advance 
discussions.  
3.86.   The representative of the United States  reiterated her delegation's concerns with this 
regulation, and hoped t hat given the positive constructive bilateral discussions with Indonesia that 
these concerns were understood. However, the US expressed disappoint ment with several 
developments on this issue over recent months – namely that Indonesia had begun enforcing th e 
government -to-government MRA requirement despite commitments to work with the US to find a 
way to address ongoing concerns. The US understood that Indonesia had moved forward with 
enforcement despite an indication that further amendments to the regulatio n were being 
considered, and that the Ministry of Industry would resume that revision process as of June 2016. 
She reiterated the US request that the next revision of the regulation include permanent 
recognition of ILAC accreditation. Furthermore, the US r emained hopeful that the revised 
regulation would also address remaining concerns as related to testing frequency, sampling, 
documentation, and substance restrictions. Despite recent events, the US reaffirmed its interest in 
working with Indonesia as it co ntinued to revise this regulation. Once again, she urged Indonesia 
to notify the next draft of the regulation to the WTO at an early stage so that all stakeholders 
could have an opportunity to provide comments, and for those comments to be taken into accou nt. 
3.87.   The representative of  Canada  recognized the importance of enhancing toy safety to ensure 
appropriate protection of consumers. However, his delegation considered certain aspects of 
Indonesia's toy regulatory regime considerably more restrictive than nec essary and at odds with 
internationally recognized practices in the sector. More specifically, Canada was concerned with the 
provisions relating to in -country testing, sampling and testing frequency, and formaldehyde testing 
levels. These concerns had not been adequately addressed by Indonesia despite repeated 
interventions from Members. Canada understood that the 2 -year grace period had expired and 
that as of 17 April 2016, toy products had to be tested at a laboratory located in Indonesia. 
Canada urged In donesia to adhere to international best practices by allowing ILAC signatories and 
properly accredited ISO 17025 laboratories to test without requiring additional approval by the 
Ministry of Industry.  
3.88.   The differences in sampling criteria for domestic produ cts (every 6 months) and imported 
products (every shipment) adopted by Indonesia were deemed discriminatory towards imported 
products. Whilst Canada recognized the difference in the volume of products to be tested, it was 
considered to be at odds with Indo nesia's national treatment and MFN obligations. Canada 
requested that Indonesia confirm that the new formaldehyde test method had been implemented. 
Canada was also concerned that the 20ppm requirement was very close to existing feasible 
detection limits, m aking it difficult to conduct accurate tests, and in this light suggested that 
existing international standards and limits be used.  
3.89.   The representative of Japan  expressed her delegation's continued support for the positions 
of Canada, the US and the EU. She  reported that serious delays in exports had been caused by a 
sequence of events such as sampling, testing, SNI certification and pre -shipment inspection and in 
this light invited Indonesia to revise the requirements that her delegation considered to be mo re 
trade -restrictive than necessary. In addition, with respect to accreditation requirements for 
overseas laboratories, Japan expressed its strong concern about the expiration of the "Stay of 
Application for 2 years" on 30 April 2016.  
3.90.   Japan understood that  most toys imported to Indonesia had been tested by foreign 
laboratories. Regarding these toys, Japan considered that only using foreign laboratories located in 
countries with which Indonesia had an MRA and domestic laboratories would not ensure smooth 
and accurate testing. Japan strongly urged Indonesia to continue to accredit foreign laboratories 
located in countries not having an MRA with Indonesia, and revise the requests on overseas 
laboratories in order to secure full capability of laboratories for te sting. Finally, could Indonesia 
confirm whether or not there were any countries with which Indonesia had an MRA at this stage?  
3.91.   The representative of Mexico  supported the concerns expressed by other delegations, and 
hoped to maintain an open dialogue with I ndonesia with a view to being informed of developments 
with respect to this measure.  G/TBT/M/69  
 
- 21 - 
 
  3.92.   The representative of Indonesia  referred interested Members to his delegation's previous 
comments made at the last March TBT Committee meeting.5 Indonesia was planning to conduct a 
review on the implementation of the regulation to ensure that its application was effective and 
efficient. Indonesia assured Members that its policy was in alignment with the TBT Agreement, and 
that it placed utmost importance on consumer protect ion. He reiterated his delegation's openness 
to further discussion, including through bilateral mechanisms.  
3.2.3.8   India – Food Safety and Standards Regulation – Food Labelling Requirements, 
G/TBT/N/IND/34, G/TBT/N/IND/43, G/TBT/N/IND/46 , G/TBT/N/IND/53 (IMS ID 
298) 
3.93.   The representative of Switzerland  shared technical concerns expressed by several 
delegations at previous TBT Committee sessions , in the context of the new notification 
G/TBT/N/IND/53 regarding the Indian food labelling requirements. It was Switzerland' s 
understanding that the la test version of the standards extend ed its scope  without addressing the 
concerns expressed by Members at several Committee meetings  since 2013. The labelling 
requirements would be less trade restrictive if translations of interna tionally standardized elements 
of labels could be rectified by means of supplementary labels, i.e. stickers. Such practice was 
allowed in India for some non -essential aspects, and was also recommended by Codex standards 
as an alternative to re -labelling. The latest notified regulations did  not allow supplementary 
stickers for general mandatory information on products. Based on concerns expressed by India in 
previous meetings, Switzerland proposed that supplementary labelling should be provided or 
validated by the manufacturers, allowing them to use or approve stickers instead of repacking , 
thereby fulfilling the objective of consumer information .  
3.94.   The representative of the United States  recalled her delegation's intervention from the 
previous meeting and sou ght an update on the status of India's efforts to align domestic 
requirements with international standards. She understood that India had expected to complete 
those efforts by the end of 2014. The US appreciated the newest measure notified by India: "Draft 
Food Safety and Standards (Food Import) Regulations, 2016 ", G/TBT/N/IND/53, to which it had 
submitted comments on 14 April 2016.  
3.95.   The representative of Australia  reiterated his delegation's concern on India's delay in 
harmonizing India 's food standards an d associated labelling requirements with Codex standards. 
He recalled Australia's  previously expressed support for the Food Safety and Standards Authority 
of India (FSSAI 's) process of harmoni zing India 's food standards with those of Codex Alimentarius, 
which commenced in early 2013. Australia had provided FSSAI with extensive information about 
Australia 's food standards and their enforcement, and would continue to work with India to ensure 
the progress and completion of the Codex harmoni zation process. The  representative asked India 
to advis e, firstly, on when the process of harmonization with Codex standards would be finalized, 
and secondly, on whether India was planning another review of its standards and whether it had 
consider ed the issues raised by WTO  Members. In the affirmative, Australia  asked if this process 
would  be carried out through finali zation or extension of the Codex harmonisation process, or as a 
separate review. Australia recalled that India had undert aken to respond to Members' comments 
from the  November 2014 TBT Committee meeting, and sought advice on when a formal reply 
would  be provided. Although India had agreed at the June 2015 TBT Committee meeting to 
forward queries from WTO Members to New Delhi and to send a response to interested delegations 
in due course, no response ha d been received by Australia.  
3.96.   The representative of New Zealand  expressed her delegation's interest in the development 
of India's food safety standards and regulation and commended  the steps  undertaken by India in 
this respect. New Zealand welcomed the fact that food labels could  be affixed by the 
importer/ customs house agent ( CHA) as rectifiable labelling deficiencies upon arrival of imported 
food consignments in the custom bonded warehouse, ending  uncertainty for exporters. New 
Zealand also welcomed provision 7.3.1 of the regulation that required  laboratory analysis to follow 
Codex or ISO test methods and to fully support the adoption of internationally recogni zed 
standards and test methods. New Zealand continued t o have concerns with the arbitrary definition 
of shelf -life and the two separate registration processes, introduced in the regulation.  
                                                
5 G/TBT/M/68, para. 2.98.  G/TBT/M/69  
 
- 22 - 
 
  3.97.   The representative of Guatemala  expressed her delegation's systemic interest in this topic 
and its willingness to closely  follow the discussion on the measure in question.  
3.98.   The representative of India thanked  delegations for their interest in the matter and updated 
the Committee on certain issues raised in this meeting and in the previous meeting of March 2016. 
First, on the issue of harmonization with Codex standards, he informed the Committee that FSSAI 
had recently operationalized 33 Codex sta ndards, and that the direction issued  by the  authority 
dated 26 April 2016 was  available on its website. The harmonization of standar ds for olives with 
Codex was under the process of notification. The standards for pasta were also being revised.  
Second, he informed that the harmonization of additives with Codex was being finalized based on 
consideration of comments from stakeholders, su ch as the International Organi sation of Vine and 
Wine (OIV); further,  the revisions proposed in Draft Food Safety and Standards (Food Products 
Standards and Food Additives) Amendment Regulations, 2015 were being processed . The list of 
additives in the case of wine based on OIV ha d been approved and was in the draft notification 
process. Third, he informed that the FSSAI  was reviewing the existing regulation on packaging and 
labelling, where  a Draft Food Safety and Standards (Labe lling and Claims) Regulation  had been 
framed and was under consideration by the  Scientific Panel and Committee. The new draft 
Regulation took into consideration the U nited States' concern regarding the labelling requirement 
for bulk packi ng but until the regulation was  finalized and enforced the existing provisions of Food 
Safety and Standards (Packaging and Labelling) Regulation, 2011 should be followed. The 
delegation of India took note of other comments and suggestions and would  communicate them to 
the authorities in capital for co nsideration.  
3.2.3.9    European Union – Draft Implementing Regulations amending Regulation (EC) 
No. 607/2009 laying down detailed rules for the application of Council Regulation (EC) 
No 479/2008 as regards protected designations of origin and geographical indicati ons, 
traditional terms, labelling and presentation of certain wine sector products, 
G/TBT/N/EU/246, G/TBT/N/EU/246/Add.1 (IMS ID 345)  
3.99.   The representative of Argentina  reiterated concern on the European Union's unjustified 
delay and the various instances out side the regular procedure that had been used to avoid 
responding to this specific trade concern, which had been raised since 2009. Argentina had 
repeatedly said that Regulations (EC) 479/08 and 607/09 would seriously affect the image and 
prestige of Argen tine wines destined for the European market. The EU arbitrarily granted its 
member States the exclusive rights to use certain traditional expressions in each of their 
respective languages. Argentina considered this measure to restrict the right of other Me mbers to 
use these expressions on their labels. Despite Argentina's understanding that this European 
legislation was inconsistent with the TBT Agreement, it had submitted in 2009 a dossier for 
approval of the terms "Reserva" and "Gran Reserva". Argentina h eld that the substantive process 
of analy zing the dossier  had lasted two years and seven months (from July 2009 to March 2012) 
and the delay in completing the formal administrative steps (inclusion on the agenda of the 
College of Commissioners for its appr oval) had lasted for over four years. Argentina made 
numerous efforts bilaterally, multilaterally and also plurilaterally (in the framework of the World 
Wine Trade Group), but it had not received any positive response from the EU. This situation 
affected t he entry of high quality and differentially priced Argentine wines and placed wine exports 
at a disadvantage compared with those of competitors that identified and labelled their wines as 
high quality.  
3.100.   Argentina further expressed concern regarding the EU' s new regime as there was no 
information on how it would affect the Argentine application for registration. Argentina understood 
that the registration files that were initiated and processed in accordance with the legislation in 
force (Regulation (EC) No. 607/2009) must be concluded under the same regulations. 
Consequently, Argentina believed that the new European registration system should grant 
recognition to the traditional expressions "Reserva" and "Gran Reserva". Argentina reiterated its 
request for th e EU to include this item on the agenda of the next meeting of the College of 
Commissioners and to publish the relevant regulatory act in its Official Journal, in order for 
Argentine wines to enter the European market without discriminatory and unjustified  restrictions.  
3.101.   The representative of the United States  recalled previous concerns expressed at previous 
meetings: "…that this measure would severely restrict the ability of non -EC wine to use common 
or descriptive and commercially valuable terms, on the gr ounds that those terms are traditional to 
European wines. " This was a particular concern because some of these terms did not have a G/TBT/M/69  
 
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  common definition across EU member States. Furthermore , she recalled her delegation's concerns 
about the enforcement of the regulation and how the Commission would ensure consistency of 
interpretation across EU member States, and requested an update from the EU on the status of 
the application that was submitted by the US wine industry six years ago.  
3.102.   She held that the continued  lack of transparency and fulsome response to repeated 
requests and interventions on behalf of the US was unacceptable and considered this issue as a 
serious trade concern that had negatively impacted  bilateral trade without resolution for years. 
Indeed, m any US suppliers were still unable to ship their products to the EU. The US failed to see 
why several other Members had already been granted permission to use various traditional terms, 
while other Members including the US continued to wait on their applic ations. The ongoing delay 
by the Commission continued to erode market access for US wines in EU member States, and the 
US asked the EU to clarify the basis for the delay in approving US applications.  
3.103.   On the question of approving the applications, the US he ard at the TBT Committee 
meeting in March that the EU would imminently make more information available about the status 
of the traditional terms of applications, as well as changes to the application review process  within 
the EU . She noted that the EU had not responded to the California Wine Institute 's proposed 
changes to the traditional terms legislation, submitted last August. She also said that the  
consistent delay and lack of information about the process was completely unacceptable . The US 
requested t he EU : (i) to explain the process and how it would work in the future ; and (ii) to 
provide deadlines to decide on the applications submitted by the US industry and for the 
completion of the internal review process.   
3.104.   The representative of the European Union  thanked Members for the interest in the EU's 
requirements on wine products. As noted at the last TBT Committee meeting, an internal 
assessment on traditional terms had been carried out within the EU involving stakeholders and 
experts from EU member States  (in accordance with Article 114(3) of Regulation (EU) 
No. 1308/2013 establishing a common organization of the markets in agricultural products). The 
alignment and simplification of wine labelling provisions and traditional terms rules, as well as the 
pending applications for traditional terms, were still under consideration in the context of the 
general reflection on the marketing rules for all agricultural products. Therefore, no proposals on 
traditional terms were expected shortly  and precise deadlines c ould not be provided at that stage . 
The EU would continue to make all possible and necessary efforts to simplify its current policy on 
protection of traditional terms and their indication on the labels of wines, taking into account trade 
partners' concerns . The concerns raised by the other Members were noted and he said these would 
be considered when carrying out the complex simplification exercise. The handling of the pending 
applications (whether from EU member States or other Members ) would be part of th is process . 
The EU representative expressed the EU's openness to hold bilateral discussion with trade partners 
at expert level.   
3.2.3.10   Chile - Proposed amendment to the Food Health Regulations, Supreme Decree 
No. 977/96, G/TBT/N/CHL/219, G/TBT/N/CHL/219/Add.1, G /TBT/N/CHL/221, 
G/TBT/N/CHL/282 (IMS ID 370)  
3.105.   The representative of Mexico  recalled concerns  previously raised  on Chile's Food Health 
Regulations, Supreme Decree No. 977/96, notified to WTO Members on 22 August 2014, and on 
its amendment, which was circulat ed to WTO Members on 9 July 2015. On 27 August 2015, Chile 
notified the replies to the comments submitted during the public consultation on this technical 
regulation. Mexico understood that the measure would be enforced from 27 June 2016 and 
elaborated sev eral specific concerns. First, the lack of scientific justification or international 
reference for the definition of the Chilean Ministry of Health on "critical nutrients". Second, Mexico 
considered the wording "high in …" to convey a distinction that may cause consumer confusion . 
Third, Mexico said that the classification of products as high in calories, fat, sugar and sodium was 
trade -restrictive and unjustified by scientific evidence. Fourth, she highlighted the trade impact of 
the new packaging of produ cts and the lack of transparency on the process of developing technical 
regulations. Finally, she stressed the lack of proportionality o f the measures in pursuing the  
legitimate objective. Mexico asked Chile to consider a meeting between their relevant reg ulatory 
bodies in order to further discuss the measures and to find less trade -restrictive alternatives.  
3.106.   The representative of the United States  strongly supported Chile's public health objectives 
of reducing obesity and related non-communicable diseases  (NCDs) , and the extensive bilateral G/TBT/M/69  
 
- 24 - 
 
  engagement on Chile's nutrition labelling regulation and its associated WTO notifications. The US 
appreciated the inclusion of an implementation review mechanism in the final measure, but asked 
Chile to consider comments received from foreign stakeholders in the context of this mechanism. 
As raised in past meetings, the US encouraged Chile to evaluate the impact of the "warning" 
element of the icons, and the use of 100 gram and 100 ml portion sizes. She reiterated the US 
request for a two -year implementation window from the date that the final regulation was 
published in order to allow industry time for  compliance with the labelling requirements based on 
nutrient thresholds.  
3.107.   In addition, the US emphasized five outstanding issues: first, whether concentrated fruit 
juice would be considered "sugar". Second, she asked how Chile would verify the addition of 
sodium, saturated fats, sugar, and honey as this information would help their industry comply  with 
these requirements give n that Chile had indicated that, in addition to the ingredient list, it would 
consider technical specifications of the product or its ingredients, audits of production methods, 
chemical laboratory analysis, and possible other means. Third, she as ked whethe r foods such as 
whole grain breakfast cereals, whole milk, yogurt, cooking oils, and cheese would be exempt from 
the measure. Fourth, she asked Chile to confirm whether voluntary claims would be allowed when 
the claim was not related to a nutrient that exce eds the relevant threshold. Fifth, the US requested 
Chile to develop guidance on these issues and to consult with all stakeholders in doing so.  
3.108.   The representative of Canada  reiterated his delegation's concerns with this measure. He 
appreciated Chile's resp onses (from August 2015) to the concerns raised by several Members in 
the previous Committee meetings, and expressed Canada's support for the objective of promoting 
healthy dietary choices and reducing obesity and related NCDs . Nevertheless, Canada encoura ged 
Chile to consider less trade -restrictive measures. He suggested that nutrient content limits based 
on actual serving sizes normally consumed at one sitting could provide an effective way of meeting 
the policy objective.  
3.109.   The representative of Costa Rica  reiterated the concerns raised in past meetings regarding 
this measure. Costa Rica continued to question the compatibility of the measure with the 
provisions of the TBT Agreement, especially regarding the lack of scientific evidence and the lack 
of basis on international standards such as those of the Codex Alimentarius. Costa Rica  would 
continue to monitor this matter.  
3.110.   The representative of Guatemala  reiterated concerns regarding the measure expressed in 
past Committee meetings. Her delegation shared Chi le's concerns about childhood obesity and 
expressed deference to Chile's right to adopt appropriate measures to address these issues.  
Nevertheless, it was not clear to Guatemala how the establishment of nutrient content thresholds 
and labelling requirement s could potentially reduce obesity since the level of a nutrient ingested by 
an individual depended on the habits of consumers. She said that any foodstuff had inherent 
nutritional characteristics, every individual had different nutritional needs and that it was 
impossible to decide what was good or bad solely on the basis of nutritional content.  
3.111.   She considered the requirement on the amendment to the Food Health Regulations related 
to the "High in" icon to raise the fear of obesity in consumers without con sidering other causes. 
This requirement did not take into consideration the Codex Guidelines that recommended labels to 
indicate the quantity of nutrients contained in the product rather than suggest that there are 
products to maintain health.  
3.112.   Guatemala un derstood that the measure would enter into force on 26 June and 
appreciated that Chile had taken  into account some concerns that had been raised by other 
Members. Nevertheless, she noted that the Chilean delegation did not answer Guatemala's 
question on ho w the measure would reduce obesity and why the measure , as designed , did not 
constitute an unnecessary obstacle to trade. Guatemala said the measure should be based on 
Codex standards, and on science. The lack of basis on the standards i n the Codex General  
Guidelines on Claims (CAC/GL 1 1979, point 3.5) was at odds with Chile's obligation under 
Article  2.4 of the TBT Agreement. Guatemala requested consultations with the Chilean Ministry of 
Health regarding the conditions for labelling and on the time -frame for products that were already 
on the market with a shelf life extending beyond the established date. She also asked whether an 
impact assessment was performed in the preparation of  the legislation that could be compared 
with the impact evaluation that the  Ministry of Health of Chile would elaborate in December 2016. 
Finally, her delegation expressed concern about the changes in labelling requirements in the G/TBT/M/69  
 
- 25 - 
 
  region, and stressed that Codex guidelines were not being taken into consideration. As a result, a 
range of different measures were being taken by Members to safeguard the legitimate objective of 
protecting public health, which was creating obstacles to trade.  
3.113.   The representative of Chile thanked Canada, US, Mexico, Costa Rica and Guatemala for 
their inte rest in Supreme Decree No. 977/96 , amendment to the food health regulations of the 
Ministry of Health, i n accordance with Law 20. 606 -  Nutritional Composition of Food and 
Advertising. H e reiterated what he had said in the TBT Committee meetings of March a nd 
November 2015 and affirmed that Chile's measure complied with the TBT Agreement. Chile's 
Ministry of Health had trained its inspectors and was holding meetings with the private sector on 
the application of this measure and the methods by which the thres holds would be determined . 
Industry would start to implement the regulation on 27 June together with a process of changing 
industrial production processes towards healthier products.  The population was increasingly 
interested in new measures to promote hea lthy lifestyles and to protect children given that  one out 
of three  children under the age of six in Chile was overweight  and that there was one death every 
hour due to obesity.  Therefore it was necessary to provide more information that contributed to 
better food choices. His delegation was  willing to discuss further  the implementation of the 
measure.   
3.2.3.11   India - Electronics and Information Technology Goods (Requirements for 
Compulsory Registration) Order, 2012, G/TBT/N/IND/47 G/TBT/N/IND/47/Add.1, 
G/TBT/IND/ 47/Add.1/Corr.1 (IMS ID 367)  
3.114.   The representative of the Republic of Korea  expressed appreciation for the efforts and 
cooperation of the Government of India to improve the Requirements for Compulsory Registration 
Order  (CRO) including by simplifying procedur es for certification renewal and for the positive 
consideration regarding the grace period for the observation of IS 16046. However, he highlighted 
that some concerns still remain unresolved particularly in relation to India's acceptance of test 
reports ge nerated under the  IECEE CB Scheme . He requested that India ensure consistency with 
Article 5.1 of the TBT Agreement6 and elaborated that acceptance of test results from laboratories 
accredited under the IECEE CB Scheme would remove unnecessary burdens on e xporters.   
3.115.   The representative of the European Union  expressed his gratitude for  a productive bilateral 
meeting on the EU's outstanding concerns regarding the CRO. He noted two unresolved issues 
regarding the  compulsory registration scheme, namely, the stre amlining of the registration 
procedure and the acceptance of foreign test reports. On the former, he reiterated the EU 's 
recommendation regarding the use of a single registration for multiple factories  where identical 
products with the same safety properti es are manufactured under the control of the same 
company which is the  brand owner . He recalled that India had informed the Committee that this 
point was being considered by the Ministry of Communication and Information Technology and he 
requested an updat e in this respect. On the issue of the acceptance of foreign test reports, he 
supported the comments of Korea and explained that under the current requirements, accepta nce 
of foreign  test reports generated under the IECEE CB scheme , or issued by laboratori es accredited 
to international standard ISO/IEC 17025 by an ILAC MRA signatory , applie d only to safety critical 
components. The EU urged India to consider improving their reliance on the IECEE CB scheme, 
and on laboratories accredited under the ILAC MRA, i n order to increase acceptability of test 
reports beyond safety critical components. He further noted that the current rules provide for a 
maximum validity of test reports of 90 days, while the general international practice was not to 
attach expiry dates to test reports. According to the EU, the main concern should be that the 
product covered by the test reports fully matched the product which was submitted for registration 
and in this regard having a maximum validity date of the test report did not seem t o contribute to 
achieving this objective. He requested that more flexibility be given, and that in justified cases 
where the product did not change, an older test report should be accepted for the purpose of the 
registration . 
3.116.   The representative of the United States  highlighted new concerns with CRO's Frequently 
Asked Questions ( FAQ), requirements on power supplies for servers, battery packs, and  the BIS 
mark, in addition to her delegation's previously expressed concerns.  
                                                
6 Article 5.1 state s "Members shall ensure that, in cases where a positive assurance of conformity with 
technical regulations or standards is required, their central gov ernment bodies apply the following provisions to 
products originating in the territories of other Members ." G/TBT/M/69  
 
- 26 - 
 
  3.117.   With respect to the CRO's FAQ , she s aid US industry was concerned that some of India 's 
explanations in the FAQ actually expand ed its scope. Most recently, India had published a revised 
FAQs dated 23 December 2015, to clarify the CRO expansion of November 2015 (notif ied in March 
2016). She st ressed that FAQ interp retations have a major impact, and that the ICT industry was 
forced to continually check for updates, additions, and changes to existing requirements that 
sometimes conflict ed with one another , which created confusion and a lack of pr edictability.  
3.118.   By way of example, she highlighted that an interpretation in the FAQ indicate d that 
detachable power supplies for servers must be registered . However, because this requirement  was 
issued in the FAQ, industry was not provided  an adequate trans ition period to adjust.  US industry 
understood that it was an internationally accepted practice to test and certify a "power supply" as 
a "critical component" of the server, not as a standalone device. She enquired as to need for 
registering the "power sup ply" as a standalone product if the replacement units were tested and 
certified as part of the registration process as a "critical component" of the server registration.  
Moreover, s he pointed out that the Department of Electronics and Information Technolog y (DeitY) 
of India had indicated in previous FAQ s that these products would be excluded from the CRO. She 
stated that US industry felt it had been  caught by surprise , and in light of the concerns raised , the 
US asked India to suspend implementation on deta chable power supplies for servers and to 
address industry 's concerns . 
3.119.   The US highlighted that India 's recent FAQ revision also prohibited mixed -cell batteries 
from the battery pack. She noted that mixed -cell batteries were addressed by the IECEE 
Committee on Technical Laboratories, as set  out in decision sheet 1087. She said that use of 
mixed -cell batteries seemed to be globally accepted in that numerous certification bodies offered 
certifications of said batteries without the restrictions imposed by India.  The US therefore ask ed 
India to reconsider its prohibition on mixed -cell batteries . 
3.120.   With respect to BIS mark, she recalled that on 10 February 2016 India had issued a CRO 
revision requiring registered goods to bear the BIS mark beginning 30 June 2016, but  notified to 
the TBT Committee on 18 May 2016.7 For the US, it was not clear whether  either the previously 
required certification statement or the mark would  be accepted , or only the mark.  In this respect, 
she queried  the relevance of the guidance issued o n 3 December 2015 by the Central Marks 
Department. She asked that India provide an update on its guidance in this respect.  
3.121.   She reminded India that US industry had submitted comments on 16 March 2016, which 
she hoped India would take into account. As a prio rity, the US requested that India extend the 
30 June deadline to 10 February 2017, in order to minimize the waste of current label inventories 
carrying the BIS registration statement and to avoid negative impacts on consumers and business 
clients.  Regardin g the exemption for Highly Specialised Exemptions (HSE), she  asked India to 
provide  an update on her delegation's request t hat India modify FAQ # 40 by adding that HSE shall 
be exempted if it was intended for sale to medium -to-large enterprises and not  available to normal 
consumers.  
3.122.   She reiterated concerns about the need for re -testing of products in India to a BIS 
standard that was equivalent to the international standard. She recalled that India said it was 
attempting to align with international standards , but account ed for unique circum stances in India. 
In this respect,  she asked India to elaborate, and i n particular  explain what  necessitate d re-testing 
in India. A s a member of the IECEE CB Scheme, India already ha d an MRA with other signatories 
and should  reciprocate approval of tests performed at IECEE CB accredited  laboratories outside of 
India, and she asked if  India in tended to fulfil this commitment.  
3.123.   Concerning the acceptance of laboratory test results, she asked for an update on the US 
request that BIS-recognized laboratories only require a product sample unit to conduct verification 
testing if they could not  resolve a suspected non -compliance issue from information exchanges 
between the Certification Body issuing a CB test report, the manufacturer, a nd the BIS -recognized 
laboratory . With regard to the 90 -day expiration of test reports, the US noted that India 's 
response that the time period was "adequate " did not sufficiently answer the question as to why 
this expiration was  necessary.  The expiration create d an unnecessary time limit, since the product 
did not change in 90 days , and the US again asked what risk factors or other concern India was 
trying to address with this requirement . Turning to brand -based certification processes, she 
                                                
7 G/TBT/N/IND/44/Add.5 . G/TBT/M/69  
 
- 27 - 
 
  enquired as to the status of the US request that India only require a product to be registered once 
rather than by each factory.  Regarding product  registration and renewal, she highlighted ongoing 
concerns about the costly wait times for the registration and renewal proc esses, and asked how 
India intended to address this problem.  Finally, she asked for an update on the US  request for a 
clear processing time for each step of the registration and renewal process , from application 
submission to final approval.  
3.124.   The representa tive of Canada  expressed support for the interventions of Korea, the EU and 
the US. Canada remained concern that the CRO may hinder or possibly exclude Canadian 
exporters from the Indian market due to delays in registration and testing.  He requested that I ndia 
provide an update on progress in harmonizing its national standards with international standards . 
He also asked for further information on the proposed date for entry into force, which was 
expected to be 1 June 2016. R ecognition of foreign conformity assessment bodies accredited by 
signatories to the ILAC and IAF MLAs  to test and certify to India's regulatory requirements would 
minimize the negative impact on compa nies wishing to export to India, and  would also provide 
assurance to India that the recog nized conformity a ssessment bodies were competent. Moreover,  
allowing accredited foreign conformity assessment bodies to test and certify to I ndia's regulatory 
requirements would reduce testing costs and allow exporters to bring their products to the India n 
market more quickly.  
3.125.   He recalled that at the last Committee meeting,  India noted that BIS required a n MRA in 
order to accept test results from non -BIS labs, even if they were ILAC/ IAF accredited and 
produced t est reports under the IECEE CB scheme.  Canada  queried the  rational e for the MRA 
requirement, and requested further information on the scope of said MRAs.  Finally, he noted that 
the substantive amendments to the Order with respect to the marking and labe lling requirements  
should be notified by India t o the TBT  Committe e, as already requested by Korea,  the EU and the 
US. 
3.126.   The representative of India referred the delegates to the  minutes of the previous TBT 
Committee meeting , as many of the issues raised (e.g. reliance of CB Scheme, recognition of 
foreign  labs and accredited conformity assessment bodies, expiry period of test results and validity 
period of registration) had already been responded to at previous  meeting s.8 He mentioned that an 
amendment had  been issued on 10 February 2016 which require d registered goods to bear the BIS 
mark, and that a transition period had been provided until 30  June 2016 to comply with this 
requirement . On harmonization with international standards , he inform ed the Committee that 
Indian Standards  for which compliance is ma ndated under the CRO (IS 616 and IS 13252 ) were 
identical to the corresponding international s tandards.  
3.127.   He explained that regarding the validity of test reports, a time period of 90 days had been 
prescribed for test reports  for registration. After registra tion of the product with BIS, the product 
could  be launched at any time.  He elaborated that the 90 -day period ensured that the report 
reflected the current status of the manufactured product.  
3.128.   He stated that the registration renewal process  for electronics and IT products  was a 
simple procedure. The process did not involve re -testing of product or inspection or visit to the 
factory  as the registered manufacturer could  register online, make payment of the requisite fees 
and enter the details of the product qu antity  with other requisite information , and the renewal was 
granted within 7 days . Regarding the need for a clear processing time , the timeline for the grant of 
registration was defined as  20 days, and  for inclusion was 10 days . He assured Members that 
these timelines were observed provided there were no discrepancies in the application, test report 
or other documents submitted by the applicant.  Finally he gave his assurances that other issues 
raised would be communicated to the capital for a response  
3.2.3.12   Peru  - Act to Promote Healthy Eating Among Children and Adolescents 
(IMS  ID 383)  
3.129.   The representative of Canada  assured his delegation's support to Peru's objective of 
reducing obesity and other NCDs , but reiterated the concern that this measure potentially devi ated 
from international standards and would be more trade restrictive than necessary to achieve its 
objective. He suggested that nutrient content limits based on actual serving sizes normally 
                                                
8 G/TBT/M/68, para. 2.128 ; G/TBT/M/67, paras. 2.123 -2.126.  G/TBT/M/69  
 
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  consumed at one sitting would provide an effective way of meetin g the policy objective and that 
such an approach could be implemented in a manner consistent with international standards. 
Canada requested an update on when these regulations would come into force.  
3.130.   The representative of Costa Rica  reiterated his delegatio n's concerns on this measure, and 
asked for an update on its implementation.  
3.131.   The representative of Mexico  expressed her delegation's support for the concerns raised by 
Canada regarding the act to promote healthy eating among children and adolescents in  Peru. She 
noted that Mexico had  referred to this issue at earlier meetings of the TBT Committee, and 
supported the request for an update on the implementation process.  
3.132.   The representative of Guatemala  stated that, despite Peru's right to safeguard its 
legitim ate objective of protecting the health of its population, consideration should be given to the 
provisions of the TBT Agreement on the need to base technical regulations on international 
standards. She reiterated her delegation's concerns about the measure and the comments 
repeatedly expressed in previous meetings of the Committee. She argued that the impact of eating 
certain foods did not depend on the pre -established values for the products, but on individual's 
diet and consumption habits. It is Guatemala' s belief that the measure at issue was not supported 
by scientific or technical basis to justify Peru's legitimate objective. Guatemala stated that 
provisions contained in the Supreme Decree deviate d from the Codex General Guidelines on 
Claims (CAC/GL 1 19 79, point 3.5), and therefore were not based on international standards, as 
provided by the TBT Agreement.   
3.133.   Furthermore, Guatemala recalled that the technical parameters of Supreme Decree 007 -
2015-SA differed from the previously notified measure. Guatemala  reiterated its concerns about 
the provisions of Article 3, which referred to recommendations of the WHO and the Pan American 
Health Organization, mainly in view of the publication of the PAHO Nutrient Profile Model on 
18 February 2016 containing parameter s for measuring foodstuffs and beverages and their content 
in terms of sodium, saturated fat and sugar. Guatemala requested a th orough and detailed 
explanation of the practical interpretation of this law, and clarification on the use of the PAHO 
Nutrient P rofile Model at  the domestic regulatory level and on the status of comprehensive 
regulations for entry into force of the Supreme Decree.  
3.134.   Finally, Guatemala expressed concern on the lack of harmonization in labelling regulations 
across the region, by not ta king into account Codex Alimentarius discussions, or the standards in 
force within that body. The difference between the measures to safeguard legitimate objectives of 
protection of health hindered  trade in food products.  
3.135.   The representative of Peru recall ed that the protection of public health was essential to 
ensuring welfare and improving the quality of life. He emphasized Peru's commitment to achieve 
this objective by developing and introducing legislation aimed at the effective promotion and 
protection  of public health and development. He said that Law No. 30021 – Ley de Promoción de 
Alimentación Saludable para niños, niñas y adolescentes, (Law to Promote Healthy Eating Among 
Children and Adolescents) ha d been enacted with the objective of reducing dise ases linked to 
excess weight or obesity and chronic non -communicable diseases among the most vulnerable 
segment of its population, namely children and adolescents.  
3.136.   He reported that the Mul ti-sectoral Commission continued  working on the regulatory 
provision s, in order to complete the implementation of Law No. 30021. The Commission's work 
include d the adverti sing and precautionary warnings for certain processes food, food products sold 
in educational institutions, promotion of nutrition education, establishme nt of an observatory for 
nutrition and the study of excess weight and obesity. The  Multi-sectoral Commission was also 
revising the Regulation establishing the technical parameters in respect of sugar, sodium and 
saturated fat content for processed foods an d non -alcoholic beverages, approved by Supreme 
Decree No. 007 2015 SA. Notification and pre -publication of regulations governing Law No. 30021 
would follow once the draft was  completed, allow ing sufficient time for Members to comment . G/TBT/M/69  
 
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  3.2.3.13   European Union — Revised Proposal for the Categorization of Compounds as 
Endocrine Disruptors of 19 February 2013 by DG Environment (IMS  ID 393)  
3.137.   The representative of Argentina  reiterated his delegation's  concern with the revision 
process being carried out by the European Unio n to define its criteria for identifying substances 
with endocrine disrupting properties. Argentina supported the need to provide stronger protection 
for human health and the environment, as long as this was done with due regard for the WTO 
Agreements, in particular SPS and TBT Agreements. Accordingly, Argentina requested the EU to 
ensure that the legislative proposal resulting from this process and the authorization criteria 
established be based on risk assessment, taking into account the actual exposure t o risk. His 
delegation was of the view that the risk -based approach must also continue to be the basis for 
defining maximum residue limits (MRLs) and import tolerances. A measure based on an approach 
that considered only the hazard and not the risk of its likelihood and severity may lead to 
disproportionate and unnecessarily trade restrictive measures, inconsistent with WTO obligations. 
Argentina expressed surprise that, having received news that the European Commission (EC) had 
already concluded its impact  assessment, information to that effect did not appear on the website 
recommended by the European Union at the last TBT Committee meeting for consulting 
developments on the matter. Taking into account that impact assessment was an essential tool to 
guide t he future decision on identifying endocrine disruptors, his delegation was concerned that 
the impact assessment concluded in an "accelerated" manner by the EC would not accurately 
reflect the scope of the impact of a future measure. Of particular concern w as the fact that such an 
acceleration of the process could be especially harmful to the analysis of economic and social 
impact.  
3.138.   Further, Argentina understood that the results of the impact assessment would be 
discussed in mid -June in the College of Commiss ioners "together with" the proposal from the EC, 
with no opportunity for interested third countries and representatives from the scientific 
community or the private sector to express their opinions on the risk assessment prior to the 
submission of the EC's  proposal. Consequently, Argentina once again urged the European Union to 
ensure that any measure adopted be based on sound scientific evidence, be applied in a 
transparent and non -discriminatory manner, and not constitute an unnecessary restriction on 
international trade. Moreover, his delegation drew specific attention to the fact that the countries 
producing raw materials were developing countries. Lastly, Argentina looked forward to the 
disclosure of the aforementioned impact assessment and the EC's leg islative proposal, and 
requested to be kept informed on both matters in due time.  
3.139.   The representative of Canada  expressed his delegation's continued concern with the EU's 
proposed approach for the categorization of compounds as endocrine disruptors, in part icular with 
respect to the EU's implementation of a hazard -based approach for the regulation of plant 
protection products.  Canada considered that such an approach could unnecessarily restrict trade, 
as may be the case with the categorization of endocrine -disrupting chemicals and that it had the 
potential to unnecessarily impede EU trade in food, feed and agricultural products for both imports 
and exports, without increasing the safety of consumers. Canada awaited the outcome of the 
impact assessments and th e EC's proposal for endocrine disruptors, and continued to urge the EU 
to recognize the importance of a risk -based approach in its evaluation of plant protection products 
and the setting of MRLs and import tolerances.  
3.140.   The representative of New Zealand  expressed her delegation's continued interest in the 
EU's regulatory approach to endocrines and looked forward to the report due in July and its on -
going engagement with the EU on the issue.  
3.141.   The representative of Chile expressed concern over the time periods involved, regretting 
that his delegation had not been able to provide comments. His delegation felt strongly that this 
measure should be based on risk analysis rather than hazard identification and would be following 
developments closely.  
3.142.   The representativ e of South Africa  thanked the EU for sharing information with his 
delegation in Brussels on the risk assessment carried out thus far and asked when the EU thought 
a notification would be submitted to the TBT Committee.  G/TBT/M/69  
 
- 30 - 
 
  3.143.   The representative of Colombia  shared  the concerns raised by other Members and looked 
forward to follow -up on the matter.  
3.144.   The representative of Guatemala  expressed concern over this revised proposal, which it 
considered could adversely affect trade, and flagged that it would continue to monit or the topic 
closely.  
3.145.   The representative of Thailand  registered his delegation's interest in the matter, stating 
that it would be following developments closely.  
3.146.   The representative of the European Union  stated that the European Commission was 
committed to presenting scientific criteria by the end of the first half of 2016 which would identify 
endocrine disruptors in the context of the implementation of the EU pesticides and biocides 
legislations. He announced that on 15 June 2016, the EC had adopted a commu nication on 
endocrine disruptors, accompanied by an impact assessment, which endorsed simultaneously: (i) a 
draft delegated act containing criteria applicable under the EU Biocidal Products Regulation; and 
(ii) a draft Commission Regulation adopted under t he so -called PRAC comitology procedure 
(Regulatory Procedure with Scrutiny) , including the criteria applicable to the chemical substances 
falling under the EU Plant Protection Products Regulation. He added that these documents would 
be published on the EC 's website to ensure transparency. The two draft measures including the 
criteria would then need to be adopted by the Commission under the relevant procedures. He 
assured that both measures would be notified to the WTO to allow any comments by third partie s 
to be duly taken into account.  
3.2.3.14   Indonesia – Ministry of Health Regulation 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, G/TBT/N/IDN/84/Add.1 ( IMS ID 389)  
3.147.   The representative of the European Union  reiterated concerns regarding 
Regulation  30/2013, issued by the Indonesian Ministry of Health on 16 May 2013, which 
introduced a mandatory health warning message on sugar, salt and fat content on the label of all 
processed food products. Regulation 30/2013 had been modified by Regulation 63/2015, which 
postponed the date of application of the measure until 2019. He asked for information on any 
studies undertaken by the Indonesian Ministry of Health on total diet, as we ll as on the timing for 
the adoption of implementing provisions and guidelines for this regulation. He urged Indonesia to 
notify these measures to the TBT Committee, while still in draft form, so that comments by 
Members could be taken into consideration. The EU requested clarification on the following issues 
related to the regulation: (i) how nutrition information and related health warnings would be 
placed on the label, the testing methods for nutrition levels and the conduct of risk assessment 
related to  NCDs; (ii) the possibility for Indonesia to accept test results issued by laboratories other 
than the ones accredited by the Indonesian National Accreditation Body (KAN) or by other 
competent institutions having an MRA with KAN; and (iii) the possibility to place stickers after 
importation, and before the placement of the products on the Indonesian market, for instance, in 
customs warehouses, as an alternative to labelling in the country of origin.  
3.148.   The representative of Canada  expressed support for Indone sia's objective of reducing the 
risk of NCDs and appreciated their transparency on the issue. Nevertheless, Canada was 
concerned about the potential trade impact of Indonesia's regulatory proposal requiring labels of 
all processed and fast foods to bear a health warning regarding content of sugar, salt and fat. He 
appreciated that the regulations would now be delayed until 2019 and hoped this delay would give 
Indonesia further opportunity to take into account Canada's concerns. Canada requested that 
Indones ia provide, in due course, an update on the acceptance of test results from accredited 
laboratories that use internationally recognized and appropriate methodologies. Finally, Canada 
encouraged Indonesia to notify further amendments to this regulation . 
3.149.   The representative of Australia  recognized Indonesia's right to implement measures which 
would provide consumers with information to make appropriate dietary choices and reduce the risk 
of diet -related NDCs. However, he stressed that such measures should be n o more trade 
restrictive than necessary in order to achieve this objective. Australia sought further clarification 
from Indonesia as to why it considered a mandatory health message on processed foods was 
necessary to achieve Indonesia's public health and c onsumer information objectives. Finally, he G/TBT/M/69  
 
- 31 - 
 
  reminded Indonesia of its obligation to notify the WTO of any proposed regulatory changes in a 
timely manner and to take into account comments received from Members.  
3.150.   The representative of Guatemala  expressed supp ort for the legitimate objective of 
informing the population about foods and their ingredients. However, she said that Guatemala 
shared the systemic concerns expressed by other Members and would continue to follow 
discussions closely.  
3.151.   The representative o f Indonesia  referred back to earlier comments contained in document 
G/TBT/W/445 . She stated that the purpose of Regulation 30/2013 was to ensure public health, 
particularly by addressing the risk of increasing threat from NCDs. She flagged that Indonesia w as 
currently continuing a study, guided by various international rules, on the volume of total diet 
which aimed to measure changes in the pattern of salt, sugar and fat consumption within various 
communities in Indonesia. The implementation of the regulati on would be further reflected through 
technical guidance which was still under discussion, elements of which included, inter alia , test 
results, inclusion of label, and designation of conformity assessment body. As a follow -up process, 
Indonesia was undert aking steps to increase public awareness on the prevention and control of 
NCDs, including its risk factors, in particular a reasonable diet of sugar, salt and fat, based on 
existing research results. She assured Members that the policy was in alignment wit h WTO 
regulation and that Indonesia placed utmost importance to consumer protection. Finally, her 
delegation was open to further discussion, including bilaterally.  
3.2.3.15   Ecuador – Resolution No. 116 of the Foreign Trade Committee of Ecuador of 19 
November 2013 a nd Technical Regulation of the Ecuadorian Standardization Institute 
RTE INEN 022 on the labelling of processed and packaged food products, 
G/TBT/N/ECU/19, G/TBT/N/ECU/19/Add.1 –Add.10 (IMS ID 411)  
3.152.   The representative of Mexico  reiterated concern s raised  in previous  meetings  about the 
labelling requirements for pre -packaged food products, established in Ecuadorian Technical 
Regulation RTE INEN No. 022. She appreciated the bilateral dialogue held with Ecuador at the vice-
ministerial level, where  Mexico reiterat ed its concerns with regard to the labelling and request ed 
evidence justifying how the measure meets its legitimate objective.  
3.153.   There remained a number of concerns. First, the definition of "food" in Article 3 of the 
Health Regulations differed from that contained in the Codex Alimentarius (CODEX STAN 1 1985). 
Second, she asked Ecuador to reconsider the definition of "processed food" also contained in that 
article as there is no international reference for distinguishing "food" from "processed food" or 
difference s in their provision of nutrients, and to explain the basis for its distinction in the Health 
Regulations. Third, that the definition of "nutritional claims" of that Article and paragraph 3.1.2. of 
the draft of the first revision of the Ecuadorian St andardization Institute Technical Regulation PRTE 
INEN No. 022 (1R) differed from the framework definition contained in Codex Alimentarius (CODEX 
STAN 1 1985, Section 2). Fourth, Mexico suggested that the term "health claims" defined in the 
Health Regulati ons and the PRTE INEN No. 022 (1R) be applied in accordance  with the provisions 
contained in the Codex Alimentarius Guidelines for Use of Nutrition and Health Claims (CAC/GL 23 
1997, Section 7), in accordance with Art icle 2.4 of the TBT Agreement. Fifth, Mexico considered 
the system of horizontal  colour -coded bars that feature d on product labels of Article 12 of the 
Health Regulations and paragraph 5.5.4 of PRTE INEN No. 022 (1R)  misled consumers as it 
stigmatized food products as "good" or "bad", based on the concentration of their components 
ignoring  the Codex Alimentarius General Guidelines on Claims (CAC/GL 1 1979, Section 3.5), 
which suggested not display ing or using any distinctive sign featuring words, illustrations or other 
graphical representations that could cause consumer s to be afraid of consuming food products.  No 
food product should be classified as "good" or "bad", or as "high" or "low" in nutritional content, as 
there was no scientific evidence to support such classifications. She stressed t hat no individual 
food product was  required to have a specific nutritional composition, as food may be very rich in a 
certain nutrient, but deficient in another. She further noted that balance was important in a 
person's diet and requested Ecuador to provide  the scientific evidence on which it based its 
definition of the limits of nutritional content ("high", "medium" and "low").  
3.154.   Mexico understood that Article 22 of the Health Regulations established that any processed 
food for human consumption containing t ransgenic components had to display the wording 
"CONTIENE TRANSGÉNICOS" (Contains transgenic components) on its labelling. Also, that 
paragraph 5.2 of PRTE INEN No. 022 (1R) in accordance to Annex B of Ecuadorian  Technical G/TBT/M/69  
 
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  Standard NTE INEN 1334 1, stated that the phrase "CONTIENE TRANSGÉNICOS" would be included 
in the main panel of the product label when the transgenic content exceeds 0.9% of the product. 
She advised caution  when treating this type of products differently given the debate on the risk of 
their consumption . Many international organizations and institutions such as the W HO, the Food 
and Agriculture Organization of the United Nations, the American Medical Association, the US 
Environmental Protection Agency, and the US Food and Drug Administrati on considered biotech 
products safe. She affirmed that the objective of conveying clear information to consumers could 
be jeopardized when labels distinguished between identical products without scientific evidence. 
Mexico had submitted formal comments and  request ed Ecuador to  organiz e a meeting between 
their relevant regulatory bodies to discuss in detail the measures adopted and to find alternative 
ways to minimize their impact on trade.  
3.155.   The representative of Canada  expressed concern with regard to the bu rdensome nature of 
the conformity assessment procedures for this regulation.  Canada had received industry 
complaints on the requirement to provide a verification checklist to demonstrate compliance on a 
per shipment basis. Adequate data management, coupled  with periodic audits, was a less 
burdensome method of achieving the same objective. Canada was of the view that the measure 
was already having a negative impact on trade. The process of providing samples to an Ecuadorian 
Accreditation Organization accredi ted laboratory for testing, in addition to self -certification, 
suggested this conformity assessment was duplicative, redundant and trade restrictive.  
3.156.   He said technical regulation INEN 085 required Canadian frozen french  fries industry to 
document every sin gle parameter line -by-line, its methods of verification and its conformity with 
(i) quality parameters (e.g. defects), (ii) physical parameters (e.g. cut size) and compositional 
requirements (e.g. ingredients, additives, etc.). This overly burdensome docum ent was four  pages 
long. He thanked Ecuador for the opportunity to provide comments and welcomed any information 
on their efforts to improve the product certification process.   
3.157.   The representative of Costa Rica  echoed concerns expressed by other delegations , in 
particular with regard to the lack of scientific evidence and the departure from the international 
standard. He asked Ecuador to consider less trade -restrictive measures which were aligned with 
the principles of the TBT Agreement.  
3.158.   The representative o f Guatemala  reiterated concerns regarding the lack of transparency in 
complying with TBT Agreement notification obligations and the lack of public consultation. The 
measure had a negative impact on trade, and was more restrictive than necessary. Although 
Guatemala did share the legitimate objective of combatting obesity, it was not convinced that the 
regulation would achieve this objective, but would rather create an unnecessary obstacle to trade. 
Codex guidelines were not being taken into consideration and  the labelling requirements ignored 
other causes of the problems besides processed food products. Guatemala asked Ecuador to 
reconsider the design and scope of this measure, and to share the scientific evidence on which the 
measure was based. Guatemala had  concerns that Codex guidelines were not being taken into 
consideration in labelling requirements in the region. As a result, a range of different measures 
were being taken by Members to safeguard the legitimate objective of protecting public health, 
which  was creating obstacles to trade.  
3.159.   The representative of Ecuador  thanked Members for their concerns and said that 
Resolution No. 116 was not related to mandatory technical regulations. With regard to RTE INEN 
No. 022, Ecuador had addressed concerns raised b y Members and had made some  changes . The 
graph would be situated on the upper left corner of the main or back panel. She highlighted that 
the threshold of 0.9% of the GM content for declaration of processed food was based on regulation 
CE2819 of the Europe an Parliament and Council on GM modified foods. She stressed that the 
categories for the concentration of nutritional components according to reference points on the 
content of salt, sugar and fat was based in international references such as the standards  
developed by the Ministry of Health of the UK and the Food Standards Agency in June 2003 and a 
study on the quantitative evaluation of alternative food sectors and food labelling sectors. She 
further stressed that these standards were assessed by the Swed ish Nutrition Recommendations 
Objectified (SNO) in 2005 and that roundtables were held to base the technical criteria on the 
parameters of international bodies. She  also noted that studies from the University of Texas and 
scientific journals highlighted th at colourings and artificial components led to altered properties in 
some foodstuffs and that this was related to the increase of obesity and chronic NCDs . Finally, she 
mentioned that the Pan -American Organization for Health's publication "Model of Profile  of G/TBT/M/69  
 
- 33 - 
 
  Nutrients" (November 2015) established that any amount of artificial sweetener can negatively 
alter taste from an early age.  
3.2.3.16   Russia - Safety of products for children and adolescents, G/TBT/N/RUS/29 
(IMS ID 418)  
3.160.   The representative of the European Union  requested information on the dates for adoption 
and entry into force of the amendments notified under G/ TBT/N/RUS/29 and requested that, once 
adopted, the final text be made available.  
3.161.   The representative of the Russian Federation  thanked the EU for commen ts on the draft 
amendments to the Customs Union's Technical Regulation on Safety of products for children and 
adolescents.  Recalling Russia's previous  statements, she stated that no fixed timeframe applied to 
the discussion among Eurasian Economic Union ( EAEU) members on the Regulation. Discussions 
were ongoing and a date for adoption had not yet been set.  She said Russia would continue to 
inform WTO Members on this process.  
3.2.3.17    India – Labelling regulations for canola oil (IMS ID 413)  
3.162.   The representative of Canada  reiterated concerns relating to the FSSAI 's advisory re -
affirming the position that the product in question must be labelled and marketed as "Imported 
Rapeseed - Low Erucic Acid Oil (Canola Oil)", which directly affected exports, marketing and sales 
of canola oil in India.  Canada was concerned that the regulation was more trade restrictive than 
necessary to achieve India's legitimate objective. Canada strongly encouraged India to accept 
"canola oil" as a synonym for "rapeseed - low erucic acid oil" , consistent with India's past practice, 
the existing Codex standard for naming of vegetable oils, as well as with India's application of the 
Codex standard to other vegetable oils (i.e. maize and arachis). Noting that the Supreme Court of 
India had ruled aga inst the FSSAI's interpretation of the regulation and that the decision had been 
sent to the Bombay High Court for final ruling, he asked when a ruling on the issue was expected. 
Canada encouraged India to consider an alternative measure regarding labellin g requirements for 
canola oil that did not unnecessarily create a barrier to trade.   
3.163.   The representative of Australia  said that her delegation remained concerned that India's 
Food Products and Food Additives Regulation only allowed canola oil to be used as a secondary 
term, which was not consistent with the Codex Standard for named vegetable oils, which 
permitted the use of synonym descriptors for "rapeseed oil", including canola oil. He said this was 
an unnecessary labelling requirement affecting all export ers of refined canola oil to India, and 
Australia called on India to remove it. Australia understood that the term canola oil was often used 
to describe domestic products that were available for sale in India. Australia called on India, once 
again, to comp lete the harmonization of its food standards with Codex as soon as possible.  
3.164.   The representative of India replied that there had been no change in the regulatory status 
since the previous meeting held in June 2015 and referred interested delegations to Indi a's 
intervention from that meeting.9 
3.2.3.18   Thailand – Draft Notification of the Alcoholic Beverages Control, Re: Rules, 
Procedure and condition for Labels of Alcoholic Beverages, issued under B.E. 
G/TBT/N/THA/437 (IMS ID 427)  
3.165.   The representative of the European U nion restated his delegation's concerns, expressed in 
previous TBT Committee meetings as well as in the still unanswered written comments submitted 
to Thailand in December  2015, with the strict labelling requirements included in the regulation and 
with the  lack of clarity of both the regulation and its implementing technical guidelines. The EU 
noted, in particular: (i) the lack of clarity of the provisions relating to the messages permitted on 
the label, which may lead to inconsistent interpretations by eco nomic operators; and (ii)  the 
impact that the Thai regulation may have on specific terms commonly used in the EU linked to the 
ageing or maturation process and to the conditions, quality or characteristics of the product 
concerned. The EU also asked Thaila nd to confirm the information that a working group has been 
created to review and amend the Thai regulation, and the technical guidelines, so as to clarify 
                                                
9 G/TBT/M/66, para. 3.167.  G/TBT/M/69  
 
- 34 - 
 
  some of their provisions. According to this information, stakeholders would be consulted and, in 
the meantime, enforcement would have been delayed. A request for confirmation of the above 
information had been  addressed to Thailand by several Members, including the EU, in March 2016. 
The EU asked Thailand to provide information on the outcome of considera tions on graphic health 
warnings and invited Thailand to notify any draft proposal to the TBT Committee, so that eventual 
comments by Members could be taken into consideration.  
3.166.   The representative of the United States  expressed her delegation's support to Thailand's 
efforts against excessive alcohol consumption and its detrimental health effects. She also said 
that, at the same time, the US hoped that, after further review, Thailand would be able to achieve 
these goals in a way which would not create unnece ssary obstacles to  international trade. In this 
respect, she said that the current regulation remained unclear in a number of ways, making it 
impossible for companies to comply with it. For instance, the US considered as problematic the 
following aspects o f the measure: (i)  that it lacked enforcement procedures; (ii)  that it lacked 
clarity on how labels would be determined to "directly or indirectly persuade consumption or make 
claims on the benefit or quality of an alcoholic beverage"; and (iii)  that it la cked definitions for 
terms such as "immoral" and "exaggerated statements". The US also posed the following 
questions: could Thailand please provide the scientific evidence and studies it said ha d informed 
the policy at issue? Could Thailand confirm that, u nder the measure, graphic warning labels would 
be required to cover more than 25% of the label? Was Thailand considering an evaluation of the 
regulation after 18 months?  If so, could Thailand explain the evaluation process and whether 
evaluation results wo uld be shared with trading partners?  Could Thailand confirm whether it 
intended to suspend implementation of the measure and set a timeline for when Thailand could 
provide new clarity on the regulations?   
3.167.   The representative of Canada  welcomed any new devel opments regarding Thailand's 
regulations on alcohol, including any inter -departmental working groups, and hoped that any new 
regulations would be developed in consultation with relevant stakeholders, including importers. He 
hoped, more specifically, that t he new regulations would take into account the fact that Canadian 
wine labels were not intended to appeal to children or promote irresponsible alcohol consumption.  
Canada understood that Thailand was still considering the use of graphic warning labels and would 
therefore appreciate an opportunity to comment on this particular aspect. Noting the recent design 
contest for graphic health warnings, Canada emphasized the importance of informing consumers of 
the dangers of excessive consumption or abuse of alcoho l. 
3.168.   The representative of New Zealand  expressed her delegation's support of Thailand's right 
to introduce new regulations to address specific public health concerns. New Zealand appreciated, 
in particular, that in seeking to address the harmful use of alcoh ol, the technical regulation at issue 
was directed toward achieving a legitimate public health objective. As previously raised in both 
written form and in this Committee, New Zealand was nonetheless still concerned that the new 
labelling requirements were unnecessarily trade restrictive, and that the regulation was unclear, 
and unworkable in practice. She also asked Thailand update Members on any discussions on the 
revision of the measure, and when updated regulations would be notified to the Committee. 
Additionally, would the regulations not be enforced until the new amendments were made? Finally, 
she asked Thailand for an update on the proposal to implement a graphic health warning label 
system for alcoholic beverages: was Thailand intending to introduce m andatory graphic health 
warnings on alcohol labels and if so, when did Thailand expect to notify WTO Members of the new 
draft regulation?  
3.169.   The representative of Australia  asked Thailand to confirm whether the Ministry  of Public 
Health was indeed planning to  draft amendments to clarify the current alcohol labelling and 
implementing guidance document. He also requested that the Thai government submit an official 
translation of the technical guidance to the TBT Committee in one of the WTO languages .  
3.170.   The repres entative of Chile said that, while his delegation supported the public policy 
objective Thailand was addressing with this technical regulation, Chile also considered that there 
should be a less trade -restrictive measure available. He also asked Thailand if  there would be a 
new draft on public health and whether such draft would be notified to the Committee for 
comment before its implementation. Finally, he noted that a series of questions Chile sent to 
Thailand on 9 March 2016 remained unanswered . G/TBT/M/69  
 
- 35 - 
 
  3.171.   The repre sentative of Japan  said that his delegation shared the concerns raised by the EU, 
US and Canada. Japan was still concerned with Thailand's  guideline dated 30 September 2015  and 
reiterated its request to Thailand to revise the examples listed therein , takin g account of its 
comments at previous TBT Committee meeting.  
3.172.   The representative of Guatemala  said that while her delegation recognized the need and 
legitimacy of protecting consumer health by reducing levels of alcohol consumption, it was 
nonetheless stil l not convinced that the measure in question, which established certain criteria with 
respect to labelling for alcoholic beverages, was effective in terms of reducing such consumption. 
In that light, Guatemala asked Thailand for a precise and detailed expl anation of the scientific 
evidence and other considerations which led it to conclude that the measure in question would 
effectively reduce consumption of alcoholic beverages without being more restrictive than 
necessary to achieve its legitimate goal. In t his respect, she noted that the measure could cover 
the use of certain expressions on a label that indicate the quality of the alcoholic beverage, such 
as "premium", "finest", "original" , "limited release", and "añejo". Guatemala was concerned that 
by bann ing the mentioning of such international terms of recognition, the measure would not only 
put in danger the recognition and description and the quality of the product, but it could also 
infringe the legitimate intellectual property rights that persons and companies have over the 
brands they own. Guatemala therefore considered that the terms that Thailand prohibited were not 
intended to stimulate consumption of alcoholic beverages. On the contrary, such terms provided 
objective and clear information to the c onsumer on the type and quality of the product being 
bought.  
3.173.   The representative of South Africa  associated himself with the concerns by previous 
delegations and reiterated the concerns expressed by his delegations in previous meetings.  
3.174.   The representative of Thailand  explained that the objective of this regulation was to fulfill 
the goal of addressing alcoholic -related problems and served the purpose of consumer protection, 
especially with respect to children and young people. The regulation did not intend to create any 
unnecessary obstacles to trade, and was therefore not contrary to Article  2.2 of the 
TBT Agreement. Following the notification of this regulation, the relevant Thai authorities ha d 
conducted numerous meetings with both private and public sect ors of concerned Members. 
Explanations and technical clarifications were provided in respect of how to comply with the 
regulation. He also clarified that the regulation has been uninterruptedly implemented and 
enforced since April 2015. He also said that a ny additional technical concerns and repeated 
questions (including comments raised during this meeting) should be sent to, and would be further 
considered by, the Thai TBT national enquiry point and the Office of Alcohol Control Committee 
under Department of Disease Control. Finally, as already indicated in previous meeting, Thailand 
explained that, in the case of any doubt, exporters were welcome to send the example of alcoholic 
beverage labels to the Thai Department of Disease Control, Ministry of Public Health, for advice or 
consultation.  
3.2.3.19    Ecuador – Draft Technical Regulation of the Ecuadorian Standardization 
Institute (PRTE INEN) No. 189: "Labelling of Alcoholic Beverages", G/TBT/N/ECU/243 
(IMS ID 433)  
3.175.   The representative of the European Union  recalled hi s delegation's concerns about 
Ecuador's Technical Regulation 189 on the labelling of alcoholic beverages, already expressed in 
previous Committee meetings, in particular  on (i) the obligation to state the name of the importer 
in the front label. In this re gard the EU referred to the Codex standard CODEX STAN 1 -1985 
(Rev.  1-1991), which did not establish any obligation regarding the information to be put on the 
front label ; (ii) the requirement that the labelling of alcoholic products be done in the country of 
origin, not allowing labelling or relabeling in a primary customs area. In this respect the EU 
referred to CODEX STAN 1 -1985 (Rev. 1 -1991), which allowed for the use of supplementary 
labels ; (iii) the need to undergo certification by a conformity assess ment body in order to verify 
compliance with labelling requirements. Here the EU recalled the Codex  Principles for Food Import 
and Export Inspection and Certification (CAC/GL 20 -1995), which established that inspection and 
certification systems should be f it for purpose, based on risk assessment and be efficient. Ecuador 
had previously informed the Committee that they were still in the process of analy zing the 
comments received from Members and the EU asked at what stage  this process  was. The EU 
looked  forward to receiving a reply to the ir comments submitted on 1 July 2014.  G/TBT/M/69  
 
- 36 - 
 
  3.176.   The representative of the United States  supported other Members' interventions and raised 
concerns, particularly with Ecuador's requirement that the name of the importer of alcoholic 
beverages be placed on the exported product  in the country of origin, with no flexibility for 
placement in customs bonded warehouses via the use of supplementary labels (stickers). At the 
previous TBT Committee meeting, Ecuador had noted that it was suspending  this regu lation and 
the US re quested that Ecuador confirm this  suspension through a notification to the WTO . She  
asked for an update on Ecuador's efforts to align the suspension with customs regulations.  
3.177.   The representative of Canada  asked Ecuador to confi rm the suspension of the regulation 
that required that labelling of alcoholic products be done in the country of origin. He indicated that 
the standard practice in the internationally traded spirits industry was to apply, in the country of 
production, gene ric front labels providing mandatory information. All country -specific information 
was then affixed on the back or secondary label in customs -bonded warehouses located in the 
importing country. Ecuador had indicated at previous TBT Committee meetings that the competent 
authorities were looking at revising the measure in view of the comments received. He invited 
Ecuador to provide an update on whether the comments had been taken into account and whether 
Ecuador would be notifying any amendments to the regula tion. 
3.178.   The representative of Chile, echoing the concerns expressed by the EU, US and Canada , 
indicated that Chile had received a positive response to its written comments submitted to the 
Ecuador ian Enquiry Point where  Ecuador confirmed that the suspension of the measure was under 
consideration. Chile asked Ecuador that they notify this suspension as  an addendum to the original 
notification . 
3.179.   The representative of Guatemala  questioned whether this measure was based on evidence 
showing that the measure sought to reduce consumption without being more restrictive than 
necessary to achieve that legitimate objective. Guatemala asked for information on the current 
situation of the measure and the various time periods involved.  
3.180.   The representative of Ecuador  confirmed  that No. 189  – Labelling of Alcoholic B everages 
was currently suspended  and stressed that its national authorities were still assessing the concerns 
and comments made by Members.  
3.2.3.20   China – Regulations for the Supervision and Administration of Medical Devic es 
(Order No. 650 of the State Council), G/TBT/N/CHN/1022, G/TBT/N/CHN/1023, 
G/TBT/N/CHN/1024, G/TBT/N/CHN/1025, G/TBT/N/CHN/1026, G/TBT/N/CHN/1029 
(IMS ID 428)  
3.181.   The representative of the Republic of Korea  recalled that his delegation had asked China to 
accept test reports issued by internationally accredited laboratories in previous TBT Committee 
meetings. China, however, had not taken on board this request, leading to unnecessary  duplication 
of testing for imported medical devices that had already been  tested, thus causing additional 
expenses and export delays. Korea therefore reiterated its request for China to accept 
internationally accredited laboratories' test reports and internationally recognized test reports if 
they were based on the same criteria th at China was adopting under its regulations. Korea 
expressed willingness to continue to work together with China on this matter, and hoped to find a 
reasonable solution as soon as possible.  
3.182.   The representative of the European Union  referred back to its conc erns raised during the 
last meetings of the Committee in relation to the issue of the clinical trials required for the 
registration in China for Class II or Class III medical devices, the delays in this registration 
procedure, and the requirement to regist er the medical devices in the country of origin. On the 
issue of duplicative clinical trials, during the March 2016 meeting the EU had asked for 
confirmation from China that during the marketing approval of medical devices , manufacturers 
might present data  obtained in clinical trials carried out abroad. The EU had also asked whether 
clinical trials would have to be performed for Class II and III in vitro  diagnostic medical devices on 
Chinese populations living in a Chinese mainland environment and whether r esults of testing on 
Chinese populations living abroad or on non -Chinese populations would not be accepted. As China 
had not been in a position to answer these questions at that stage, the EU reiterated its request 
for further clarification on this issue. Furthermore, the EU requested China to accept test reports 
from foreign laboratories accredited by accreditation bodies that were members of ILAC, as an G/TBT/M/69  
 
- 37 - 
 
  alternative to in -country electromagnetic compatibility testing in China and to exclude from the 
regist ration certificate the documentation on product technical requirements, which might be 
confidential. Finally, the EU again asked China to grant a transitional period of three years. Further 
guidelines detailing the relevant processes would be also welcomed . 
3.183.   The representative of Canada  acknowledged the response provided by China at the March 
2016 meeting regarding Order No. 650 of the State Council but requested further clarification of 
specific elements of the regulations. With regards to duplicative clini cal trials, Canada was aware 
that in 2014 and 2015 China had issued clinical trial exemption catalogues for Class II and 
Class III medical devices and the Medical Device Clinical  Trial Evaluation Guidelines. Canada 
understood from various news reports that  China would further expand the scope of the exemption 
catalogues and would publish a second batch of medical device clinical trial exemption catalogues 
in 2016. Canada acknowledged China's response that medical devices not listed in the catalogue 
could be  the subject of applications for exemption if relevant materials could be provided when 
registered to prove the safety and effectiveness of the medical devices. However, Canada 
remained concerned that the requirement for companies to apply for exemptions p osed an 
unnecessary administrative burden on Canadian medical device exporters.  
3.184.   In addition, Canada continued to have concerns with regards to Article 35 of Order No. 5, 
which stated that, for in vitro  diagnostic products, a focused clinical evaluation sho uld be 
conducted in China. As mentioned in the November 2015 Committee meeting, Canada was 
concerned that this constituted an unnecessary and duplicative clinical trial requirement for 
Canadian exporters of in vitro  diagnostic products that had received pr ior regulatory approval in 
other foreign jurisdictions, including Canada. Canada would appreciate an update from China on 
whether it intended to make changes to this regulation to allow in vitro  diagnostic products that 
had received prior regulatory approv al without requesting a duplicative clinical evaluation. With 
respect to Article 13 of Order No. 4 and Article 15 of Order No. 5, which required imported medical 
devices to "obtain market approval from the country (region) where the applicant's business 
registration was or the product was produced", Canada continued to be of the view that restricting 
access to products that might not be registered in the country of origin might create unnecessary 
barriers to trade while further limiting Chinese consumers' a ccess to life -saving and life -improving 
medical devices. Canada was aware that, at the November 2015 meeting of the US -China Joint 
Commission on Commerce and Trade, China had agreed that, in the area of market access, it 
would give imported medical devices  the same treatment as those manufactured or developed 
domestically. China was asked to provide clarification regarding this agreement, e.g. whether it 
applied to all imported medical devices, regardless of their country of origin, and whether it meant 
that imported medical devices were no longer required to be approved in their country of origin.  
3.185.   As mentioned in the March 2016 Committee meeting, Canada remained concerned  with 
the Electromagnetic Compatibility (EMC) testing that was required by Chinese regu lators in order 
for a medical device to be registered. The EMC standard that China used was identical to the one 
issued by the International Electrotechnical Commission (IEC), to which China was a member. 
However, China had not accepted test reports issued  by internationally accredited laboratories that 
abided by the IEC standard. Canada was aware that, in March 2016, the global safety science 
company UL had announced the launch of its new China Food and Drug Administration (CFDA) 
testing programme for medi cal device manufacturers. According to UL, this programme allowed 
medical device manufacturers outside of China the option to participate in and complete the 
required series of tests for CFDA approval at a local UL laboratory outside of China, with the 
support of onsite engineers from CFDA testing lab. China was requested to confirm that it would 
now accept the results of safety and EMC testing of medical devices conducted at UL laboratories 
outside of China. Canada was looking forward to working with China  in a constructive manner with 
a view to addressing these and other aspects of the regulation.  
3.186.   The representative of China  stated that Regulations for the Supervision and Administration 
of Medical Devices divided medical devices into three categories accor ding to the level of risk: 
Class I, II and III, from low risk to high risk, each one regulated differently. Class I medical 
devices  only needed to be filed, while Classes II and III needed to go through registration. 
Regarding manufacture, Class I medical devices only needed to be filed, while Classes II and III 
had to be examined and approved by CFDA. Regarding business operation, no special limits were 
set by CFDA on Class I medical devices, Class II medical devices needed to be filed, while Class III 
medical devices had to be licensed. The medical devices not listed in the catalogue could also G/TBT/M/69  
 
- 38 - 
 
  apply for exception if relevant materials could be provided when registered to prove the security 
and effectiveness of the medical devices.  
3.187.   In order to further impr ove the management of medical device registration and unify the 
clinical evaluation requirements of medical devices, in May 2015 CFDA had issued a Technical 
Guideline on Clinical Evaluation of Medical Devices. The guideline clarified the requirements for 
clinical trial. For data collection of clinical trial or clinical use of the same category of medical 
devices, the data obtained from clinical trial or clinical use could be generated either from China or 
abroad. For imported medical devices, if their clini cal trial was in accordance with relevant Chinese 
laws and the technical requirements in the guideline, applicants might submit the clinical trial data 
used when they were listed in other countries. The application files should at least contain ethics 
comm ittee opinion, clinical trials protocol and clinical trial reports. The applicants were also 
required to submit relevant supporting data on whether the clinical performance and/or safety of 
the product differed from ethics. CFDA was working on a second cat alogue of medical devices that 
could be exempted from clinical trials. This catalogue would also contain some of the in vitro  
diagnostic reagents products, which had not been included in the first catalogue. The catalogue 
was currently undergoing public co mment.  
3.188.   To address Members' concerns on market approval from the country of origin, China 
stressed the importance of this requirement in order to ensure the security and effectiveness of 
medical devices and to protect the health of Chinese consumers. If th e country/region where the 
applicant filing for registration or the production address was located did not administrate the 
product as a medical device, the applicant could submit market approval in the country/region 
where the registration or production a ddress was located. For the formality of the above -
mentioned certificates, CFDA had no additional requirements on the form. CFDA would continue  to 
communicate with relevant enterprises and associations - both foreign and domestic - on these 
measures and wo uld fully considered comments received from Members.  
3.2.3.21    Ecuador – Proposed Motor Vehicle Safety Regulatory Requirements  
(RTE INEN 034), G/TBT/N/ECU/32, G/TBT/N/ECU/32/Add.1 -6 (IMS ID 409)  
3.189.   The representative of Mexico  thanked Ecuador for taking into account Mexico's  comments 
on the recognition of foreign standards being  considered equivalent to those of the United Nations 
Economic Commission for Europe (UNECE ). However, she specified a number of persisting issues 
with regard to the current measure. Mexico und erstood that RTE INEN No. 034 on domestically -
produced or imported motor vehicle safety parts, notified to the WTO on 31 March 2016 , took into 
account  UNECE standards, including acceptance of conformity assessments based on the standards 
of the United Stat es (FMVSS), China (GB), Australia (ADR), Korea (KMVSS) and Japan (JIS).  
3.190.   Mexico reiterated its concern over the transition period for the entry into force of the 
regulation, as despite the initial establishment of a 180 -day deadline (six months), and extens ion 
to enable domestic industry to adapt to the new specifications of the measure, by granting a 
transition period of one year and six months, Mexico still considered that the period should have 
been extended to April 2017. This would allow for two years i n which to offset the trade losses for 
enterprises that exported vehicles to Ecuador . 
3.191.   Self-certification continued  to cause difficulties for those subject to the regulation . The 
measure appeared to be more burdensome than necessary, thus potentially violat ing the principle 
of proportionality enshrined in the TBT Agreement. As this was a sector that was highly regulated 
at an international level, there was no reason not to  accept this type of certification for vehicles 
circulating in Ecuador . Therefore Mexic o requested that Ecuador accept self -certification as a 
demonstration of compliance with the technical regulation by producers  and to extend the 
transition period by two years for compliance.  
3.192.   The representative of the United States  supported the objective s of Technical Regulation  
RTE INEN 034 and thanked Ecuador for its openness to explore solutions, find the least trade -
restrictive approach to its objective, and ultimately accept US Federal Motor Vehicle Safety 
Standards (FMVSS) compliant products.   
3.193.   US au tomotive regulations were amongst the most stringent and effective at protecting 
safety and reducing emissions. While lauding Ecuador for the change, she highlighted that the G/TBT/M/69  
 
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  requirement for third -party certification presented a problem for products built to FMVSS. 
Automotive products manufactured to US requirements would incur additional costs to acquire 
third-party certification since it was not a normal part of the US compliance process.  
3.194.   The requirement for third -party certification thereby put them at a  competitive 
disadvantage to products built under different compliance verification systems, as they would need 
to obtain it at an additional expense for the Ecuadorian market whereas products built under 
schemes relying on third-party certification had al ready spread those costs across their entire 
fleets. Manufacturers carried  out their own product testing and verification prior to selling 
automotive products in the US market. Moreover, the National Highway Traffic Safety 
Administration (NHTSA) provided s trong compliance oversight through random, anonymous 
purchasing and testing of products that are sold in the US market. NHTSA anonymously bought 
and tested automotive products subject to its regulations. It then provided diligent enforcement 
for those prod ucts found non -compliant. Recent high level cases had proven the effectiveness of 
the US system for rooting out problems with conformity of production. NHTSA 's Blue Ribbon Letter  
program me gave trading partner s the confidence that the automotive products e xported under the  
program me were subject to this same high standard safety compliance process in the United 
States.  The US further expressed confidence that the  program me could provide compliance surety 
as an alternative to third party certification.  The U S also offered any assistance necessary to help 
to assure Ecuador of the effectiveness of its regulatory processes and the Blue Ribbon Letter  
program me for compliance verification.   
3.195.   The representative of Canada  supported the interventions from Mexico and t he US on this 
issue. Most motor vehicles manufactured in Canada were actually built to similar standards as the 
US Federal Motor Vehicle Safety Standards (FMVSS) and they were called the Canadian Motor 
Vehicle Safety Standards. As the US delegate had indic ated in respect to the US standards, 
Canada also provided one of the most stringent and comprehensive performance outcomes with 
respect to vehicle safety. Canada strongly encouraged Ecuador to, in addition to the recognition 
that they had given for FMVSS s tandards, do the same for the Canadian version  of those 
standards. He further noted that the conformity assessment procedures were as important as 
technical regulations to facilitate trade. Obligations under the WTO required that compliance 
testing in conformity assessment procedures be no more trade restrictive than necessary. Canada 
requested that Ecuador consider self -certification of vehicles built to both the US and Canadian 
safety standards. Canada also encouraged Ecuador to maintain a flexible vehicl e certification 
process open to both type -approval and self -certification.  
3.196.   The representative of Ecuador  said many comments and concerns had been received which 
had been analy zed among the competent bodies and sectors involved. Based on this, Ecuador had 
made various modifications to the measure. Technical Regulation No. 034 had again been modified 
(third amendment), in relation to the safety element "Electronic stability control", and would be 
compulsory for the year 2020 models, which were previously comp ulsory for the 2018 year 
models.  In addition, the measures in this regulation could be fulfilled under the UNECE standards 
for the economic condition as well as the Australian, American, South Korean, and Japanese 
measures. These were already established i n Annex b to the modification 3 of the Regulation 034 .  
3.2.3.22   Kingdom of Saudi Arabia – Decree of the Saudi Arabian Ministerial Council on 
the sale and marketing of energy drinks of 4 March 2014, G/TBT/N/SAU/669, 
G/TBT/N/ARE/262, G/TBT/N/QAT/389, G/TBT/N/SAU/910 , G/TBT/N/SAU/912 
(IMS  ID 442)  
3.197.   The representative of the United States  supported the Gulf Cooperation Council 's (GCC) 
efforts to promote public health through increased consumer information and thanked the GCC for 
considering her delegation 's comments. As had been stated in US comments submitted in April, 
the US remained concerned that the size and content of the warning labels and restrictions on 
container size were unnecessarily trade restrictive and requested the GCC to provide scientific 
evidence for th ese requirements. She also asked the GCC to provide the timeframe to finalize this 
measure and to update on the next steps before implementation.  
3.198.   The representative of the European Union  supported the points made by the US. In 
particular, the EU shared co ncerns regarding the large discretionary restrictions which, on the 
basis of the notified draft, could be imposed on the marketing of these products by regional or 
local authorities.  Such an approach made it possible for lower level authorities to create b arriers to G/TBT/M/69  
 
- 40 - 
 
  trade and as such was a source of regulatory uncertainty. As stated in comments submitted to 
Qatar and other GCC Members on 8 June 2016, the EU was also concerned about the lack of clear 
scientific substantiation of the statement to be included on energy drinks. The EU thanked the 
Kingdom of Saudi Arabia for constructive bilateral discussions and reiterated his delegation's 
proposal to engage in bilateral dialogue.  
3.199.   The representative of the Kingdom of Saudi Arabia  thanked the EU and the US for t heir 
comments.  The GCC technical committee received Members' comments on the draft technical 
regulation for energy drinks which  would be discussed at their next meeting in October. As 
explained at the previous TBT Committee meeting, the objective of the De cree of the Saudi 
Arabian Ministerial Council was to protect public health. Finally, he indicated that this Decree would 
be reviewed and Members' comments would be taken in consideration .  
3.2.3.23    Brazil – Draft Technical Resolution nº 69, 9 September 2014, Regar ding the 
Requirement of Describing the Chemical Composition, in Portuguese, in the Label of 
Personal Hygiene P roducts, Cosmetics and Perfumes,  G/TBT/N/BRA/608  (IMS  ID 443) 
3.200.   The representative of Mexico  reiterated concern s regarding Brazil's Draft Resolution  No. 
69, of 9 September 2014, on the compulsory listing of product ingredients in Portuguese on the 
labels of personal hygiene products, cosmetics and perfumes. She focuse d on three points raised 
during the last meeting of the TBT Committee.10 Firstly, by f ailing to consider the existence of a 
widely accepted international nomenclature for the ingredients of cosmetic products 
(INCI  nomenclature), the proposed measure might not be in line with Article  2.4 of the 
TBT Agreement. Furthermore, Mexico was concerne d with the distinction that the draft made 
between products from the European  Union and imports from Brazil's other trading partners 
(specifically those of the Latin American region),  was in violation of the non -discrimination 
principle in Article  2.1 of t he TBT  Agreement. On 19 January  2015 Mexico had submitted formal 
comments to Brazil about the non -reliance on the INCI nomenclature system. Mexico had also 
requested an explanation of – or justification for – the benefits of translating the names of produc t 
ingredients into Portuguese, since these use a large number of raw materials with highly complex 
technical names. In response, Brazil had said that the matter was subject to domestic judicial 
proceedings. Mexico therefore requested Brazil to update Membe rs on how these judicial 
proceedings were progress ing and, if deemed appropriate, whether the comments made in regard 
to compliance with Article  2.1 and 2.4 of the TBT  Agreement could be taken into consideration.  
3.201.   The representative of Brazil  explained that  the measure at issue was not yet in force and 
the comments received at the last public consultation process were still under technical analysis by 
the Brazilian Health Regulatory Agency (ANVISA). He recalled that the draft resolution was 
developed in orde r to comply with a judicial decision based on Brazil's consumer law, which 
established the obligation for producers of cosmetics to display on the label the chemical 
composition in Portuguese. However , this decision had been appealed and its effects suspen ded 
until further decision of a higher court. The draft measure did not prevent the use of the INCI  (the 
International Nomenclature of Cosmetic Ingredients). All producers, regardless of origin, must 
comply with the requirement to use the INCI and translat e the chemical composition into 
Portuguese. The Brazilian Government believed  this regulation was in full compliance with WTO 
law.  
3.2.3.24   European Union – Common Criteria for Information Technology Security 
Evaluation (Common Criteria) Certification in the EU (I MS ID 448)  
3.202.   The representative of China  reiterated its concern about the refusal of EU member States' 
CC certification bodies to accept and process Chinese producers' applications, and about the lack 
of opportunity for Chinese companies to join CC -related s tandard organizations such as JIL 
Hardware Attack Subgroup. China ha d repeatedly asked the EU for additional information and to 
facilitate addressing concerns from the Chinese industry, and was disappointed that no meaningful 
information ha d been shared, w hile stating that the CC certification does not fall within the scope 
of the TBT Agreement.  
3.203.   According to China, Article 5 or Article 8 of the TBT Agreement appl ied to EU Certification 
Bodies, depending on the nature of the body ; if a central gover nmental body, both articles applied . 
                                                
10 G/TBT/M/68, para . 2.205 . G/TBT/M/69  
 
- 41 - 
 
  China referred to the following obligations for Members in this regard : national treatment, 
avoidance of unnecessary obstacles to international trade, prompt acceptance of applications, 
expeditious undertaking and completion of  conformity assessment procedures, publication of the 
standard processing period of each conformity assessment procedures or communication of the 
anticipated processing period. China also pointed out that while the EU stated that EU companies 
were treated discriminatorily under China's regulatory framework, dozens of foreign companies 
received production permits according to Chinese statistics, e.g. Giesecke & Dervrient from 
Germany received production and sales permission for cryptogram products. The EU wa s urged to 
comply with its obligations under the TBT Agreement and to address the raised concerns in a 
timely manner.  
3.204.   The representative of the European Union  thanked China for its continued intere st and 
noted that arguments had  been raised before by China . China, according to the EU, failed  to 
identify concrete measures, technical regulations or conformity assessment procedures, falli ng 
within the scope of the TBT A greement and its claims were not substantiated. The EU referred to 
previous statements putti ng forward its view regarding coverage of the TBT Agreement . In the EU, 
there was  no general mandatory requirement for certification of commercial encryption products, 
contrary to the situation in China which had led to several STCs.  
3.205.   As in this sector all  interested parties face d similar challenges, namely cyberattacks, a 
threat to information security, a combined effort for strengthened cooperation for the use of 
international security standards was called for, while approaches should not prevent authorit ies 
and IT system operators to produce and use the best technology available, regardless of 
ownership of technology or location of equipment manufactured. The EU noted the shared interest 
in aiming for interoperable solutions using the best technology to i ncrease information security. 
The EU invited China to continue to discuss these issues with the EU during existing bilateral 
dialogues on this matter.  
3.2.3.25   China - Administrative Measure on Cosmetics Labelling (AMCL), 
G/TBT/N/CHN/1064 (IMS ID 456)  
3.206.   The represent ative of Japan  welcomed the clarification made by China in previous 
meetings that this measure would allow "over -labelling" on imported cosmetic products but 
highlighted her delegation's three remaining concerns. First, regarding manufacturer labelling, 
Articles 14 and 15 of the draft measures required, inter alia , labelling of the names and addresses 
of manufacturing subcontractors, which Japan considered could actually cause consumer 
misunderstandings and market confusion. The manufacturer labelling shoul d only present the 
name and address of the company with final legal responsibility for the quality and safety of the 
products concerned. Second, regarding the promotional advertising of cosmetics efficacy claims, 
according to Article 19 and 20 of the draft  measures, testing results issued by an "efficacy 
assessment testing organization" had to be disclosed. It was Japan's view, however, that since 
testing results could include companies' know -how, they should not be disclosed and that in 
addition, the "effi cacy assessment testing organization" should not be limited to institutions inside 
China. Third, she stated that in order to promote appropriate operation, it was indispensable that 
China provide clear guidance - detailed regulations - in addition to the d raft measures themselves. 
Furthermore, as significant changes to existing labelling would be required to meet the conditions 
of the draft measures, and taking into consideration the negative influence on entry into the 
Chinese market, her delegation reques ted that China provide a plan, such as a two -year transition 
period, for the smooth implementation of the new labelling regulation. As the old implementation 
date of 1  July 2015 had already passed, she asked China to indicate when the new implementation 
date would be, and whether or not China would establish a public comment period.  
3.207.   The representative of the European Union  reiterated its concerns raised during recent 
meetings of the Committee, also sent to the Chinese authorities on 12  January  2015. In its written 
reply of 18 March 2015, China had indicated that it would consider the comments received. The EU 
welcomed the possibility of labelling cosmetic products by means of stickers, but nevertheless 
reiterated a number of issues included in the notified d raft. First, the requirement for products to 
display the name and address of the manufacturer and of the subcontractors when part of the 
production was done by subcontractors. Second, the need to confirm that the efficacy assessment 
and the cosmetic claim verification could be conducted by any verifying organization that is 
scientifically and technically competent to do so, according to CFDA criteria and guidance; it was 
the EU's belief that any requirement for third -party verification by a Chinese organiza tion would be G/TBT/M/69  
 
- 42 - 
 
  more trade  restrictive than necessary. Third, the need to align the requirements regarding 
cosmetic claim substantiation with international best practices; it was the EU's understanding that 
the process for the revision of the general legal f ramework for the placing on the market of 
cosmetics in China, i.e. the future Cosmetics Supervision and Administration Regulation, was on -
going, and asked China to confirm that the Administrative Measures for Cosmetic Labelling would 
be developed in parall el with this general framework and would not enter into force before the 
regulation did. Finally, the EU repeated its request to China for information on the implementation 
of the guidelines on the verification of efficiency of claims related to cosmetic p roducts presented 
by CFDA at the technical meeting with their EU counterparts in March 2015.  
3.208.   The representative of Australia  said that Australian businesses particularly valued 
transparency of regulations that impact their ability to operate in the Chines e market and 
expressed support for the comments from Japan, Canada and the EU on labelling requirements.  He 
said that his delegation would welcome clearer guidance and longer implementation timeframes in 
order to allow time for industry to adjust to these significant changes.  He further sought 
clarification on two aspects of the regulation that were raised at the last meeting: (i) whether 
animal testing for the safety of cosmetic products was not required when widely accepted 
alternatives were available; an d (ii) if all domestic and foreign cosmetic manufacturers were 
treated equally with respect to product registration and approval. Clarification would be welcome 
once the issues were finalized.  
3.209.   The representative of China  reported that the AMCL was current ly still being drafted and 
that CFDA would follow international rules and give full consideration to valuable inputs from 
interested parties before finalizing the measure.  
3.2.3.26   China - Banking IT Equipment Security Regulation (IMS ID 457)  
3.210.   The representative of Japan  reiterated its concern about and requested an information 
update on the revision of "the Guideline for promoting the Application of Secure and controllable 
Information Technology in Banking Sector ", issued in December 2014 . Concerns expressed related  
to requirements of source codes submission for risk assessment without clarifying the range of 
data scope being more trade restrictive than necessary in relation to the guidelines purpose. Japan 
asked China to revise the guideline in a transparent manner and in line with international 
standards.  
3.211.   The representative of the European Union  mentioned that the EU appreciated the 
suspension of the implementation of the banking guidelines and listed several issues of concern 
such as disclosure of source code and use of indigenous technology. The EU supported Japan's 
statement on international standards to be taken in to account and also underscored the 
importance of transparency and inclusiveness in the revision process, during which concerns raised 
should be addre ssed. The EU hoped that the revised regulation would  be notif ied to the 
Committee, providing opportunity for comments, and referred to the revised regulation on Chinese 
insurance advisor authority  as a good example in this regard. The EU requested an updat e on the 
process and timeline of the revision process.  
3.212.   The representative of the United States  supported the statements of Japan and the EU, 
and requested an update on the revision and adoption process of the guideline. She also 
mentioned China's transpare ncy obligations under the TBT agreement.  
3.213.   The representative of Canada  supported interventions from Japan, the EU and the US, and 
stated that the measures were more trade restrictive than necessary, while possibly decreasing 
cyber security for China's network and banking IT infrastructure. He asked China to indicate 
whether the suspension of implementation was permanent.  
3.214.   The representative of Australia  requested information on the status of the regulation.  
3.215.   The representative of China  thanked the respective  delegations for their intervention s and 
stated that there was still no timeline for the guideline currently under revision and that China 
would take comments into consideration.  G/TBT/M/69  
 
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  3.2.3.27   Indonesia - Regulation of the Minister of Agriculture No. 139/Permentan/PD.4 , 
10 December 2014, concerning Importation of Carcass, Meat and/or Processed Meat 
Products into the Territory of the Republic of Indonesia, and Regulation of the Minister 
of Agriculture No. 02/Permentan/PD.4, 10 January 2015, concerning the Amendment of 
the Regulation of the Minister for Agriculture No. 139/Permentan/PD.4, 10 December 
2014, G/TBT/N/IND/98, G/TBT/N/IND/98/Add.1 (IMS ID 461)  
3.216.   The representative of Australia  thanked Indonesia for the bilateral meeting held in the 
margins of the previous meeting  to discuss this and other issues, as well as Indonesia's statement 
replying to some of the concerns raised. His delegation, nevertheless, continued to have concerns 
about the proposed measures on the importation of meat and meat products and urged Indones ia 
to provide clarity on them. He noted that Indonesia had replaced Minister of Agriculture 
Regulations No. 139/2014 and No. 2/2015 with Minister of Agriculture Regulation No. 58/2015, 
which entered into force on 7 December 2015.  He said that the new regul ation did not address the 
concerns previously raised by Australia and other WTO Members, and retained trade -restrictive 
measures inconsistent with Indonesia's WTO obligations. The new regulation continued to prohibit 
the importation of a range of meat prod ucts and cuts, including certain types of offal. He 
underlined that Australian offal was produced for human consumption and was regulated under the 
same food health standards and legislation as meat for human consumption. Furthermore, 
Australian beef and o ffal had a reputation for quality, safety and reliability around the world and 
Australia prided itself in providing safe products. He stated that the new regulation actually 
imposed additional restrictions on imports of meat and meat products, including: n ew restrictions 
on how long meat products could be stored before arrival in Indonesia; and additional packing, 
labelling and purpose -of-use requirements on imported meat products that did not apply to 
domestic products.  He further underlined Australia's co ncern that the new regulation continued to 
allow only State Owned Enterprises (SOEs) and Regional State Enterprises to import secondary 
beef cuts and carcasses, and then only in limited defined circumstances at the direction of 
Government Ministers, in vol umes determined by Ministers in a "coordination meeting". Australia 
asked Indonesia to provide detailed information from Indonesia on how its new regulation was 
consistent with its WTO obligations, recalling Indonesia's statement that the measures are "to 
ensure that importers do not distort the market and cause the price to increase unfairly". Australia 
remained concerned that the measures would have the opposite effect of the intended result, as 
the limited numbers of importers would result in decreased s upply, leading to price increases for 
Indonesian consumers. His delegation looked forward to ongoing constructive bilateral discussions 
on the issue.  
3.217.   The representative of Brazil  echoed the concerns raised by Australia, recalling that 
Regulation No. 139/20 14 fell under the scope of Brazil's request for DSB consultations in the case 
"Indonesia - Bovine Meat" (DS506). Brazil considered that several requirements and procedures 
set forth in the regulation were not in conformity with WTO Agreements, especially t hose related 
to the obligation of local purchases (Article 5 of Regulation No. 139/2014); obligation of direct 
shipment (Article 20(1) of Regulation No. 139/2014); the discretion of the Ministry of Trade 
concerning the allocation of quantities allowed to e ach importer (Article 28 of Regulation No. 
139/2014); and restriction of intended uses for the imported products (Article 32 of Regulation No. 
139/2014).  
3.218.   The representative of the European Union  shared Australia's concerns. He pointed out that 
the requirem ents included in Regulation No. 58/2015 for production premises seemed to deviate 
from the provisions contained in Codex Alimentarius Guidelines for the use of the term "Halal", by 
not allowing the processing of non -Halal and Halal products within the same  premises. Indeed, the 
above -mentioned guidelines allow for the processing of both (Halal and non -Halal products), within 
the same premises or processing establishments, provided that appropriate measures are taken to 
prevent any contact between Halal and non-Halal products.  In addition, the same guidelines 
provided that Halal food could be transported using facilities which had been previously used for 
non-Halal products if proper cleaning procedures, according to Islamic requirements, were 
observed.  
3.219.   The r epresentative of Indonesia  thanked Members for their continued interest on the 
matter and for raising it before the Committee. Since the concerns raised were subject to the on -
going DSU process, he committed to informing the Committee once the process had been 
resolved.   G/TBT/M/69  
 
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  3.2.3.28   Indonesia - MOI 69/2014 Article 3: LCR Requirements for LTE Devices - 
Requirement that Domestic Component Level (TKDN) of LTE TDD & FDD broadband 
services equipment, G/TBT/N/IDN/103 (IMS ID 472)  
3.220.   The representative of Canada  shared the conce rns of the United States, mentioned at the 
last TBT Committee meeting11, regarding Indonesia's intention to introduce local content 
requirements for smartpho nes using 4G/LTE technology. The se were additional requirements to 
other Indonesian local content re quirements, whereby telecom service providers and 
telecommunication operators were forced to allocate 50% of capital expenditures to local 
companies. Canada sought clarification on whether these new local content requirements had been 
notified to the WTO a nd whether Indonesia planned to take Members' concerns into account when 
finalizing these draft regulations, as per their obligation under Article 2.9.2 of the TBT Agreement. 
By providing treatment that was less favourable to foreign firms than that accord ed to like 
products of national origin, Indonesia's approach was at odds with the provisions of Article 2.1 of 
the TBT Agreement. Canada r equested that Indonesia justify  the approach and indicate the 
legitimate objective pursued. Canada also enquired wheth er Indonesia had considered less trade -
restrictive means given the objective of the regulation and what would be the consequences for a 
foreign company if it were to sell 4G -enabled equipment that did not meet the local content 
threshold in Indonesia. He asked when KOMINFO was planning to finalize the regulation. He noted 
that there were many competent telecoms test labs worldwide and joined other delegations in 
recommending that Indonesia accept test results from duly accredited lab oratories  regardless of 
their location.12 He sought clarification as to whether local testing of software might count towards 
the local content requirements and whether the Ministry of Industry  intended  to release the 
formula for local content calculation by the end of June.  
3.221.   The r epresentative of Australia  acknowledged that Indonesia had  notified the WTO of 
changes to regulations on LTE technologies on 17 March 2016  and confirmed Australia's ongoing 
interest in this issue. He sought explanations on the consistency of the local cont ent requirements 
with the TBT national treatment obligations.  
3.222.   The representative of Chinese Taipei  raised concern regarding Indonesia's local content 
requirements for 4G smartphones. As Indonesia was one of its main trading partners in South East 
Asia, Chinese Taipei hoped that Indonesia could provide a detailed clarification on the measure and 
bring it into consistency with  WTO rules . 
3.223.   The representative of Indonesia  explained  that the regulation concerned  a set of  technical 
standards which dealt  with, amo ng others, administration procedures for 4G services, ensuring 
compatibility of such device with the existing system in Indonesia. The objective of the measure 
was to ensur e consumer protection and to bolster business environment fields in the sector, and 
applie d to both local and foreign device manufacturers. He said that  the nature of the system 
allowed  businesses to make adjustments including resubmitting application for certification.  
3.2.3.29   Chinese  Taipei  – GMO  Labelling,  G/TBT/N/TPKM/168, 
G/TBT/N/TPKM/168/A dd.1, G/TBT/N/TPKM/168/Rev.1 (IMS ID 467)  
3.224.   The representative of Canada  said that while recognizing and supporting Chinese Taipei's 
right to implement regulations that provided consumers with adequate information to make 
informed choices, Canada believed th at mandatory labels should only be used to convey important 
information about the health and safety of a product. Products of biotechnology that had been 
assessed as safe and authorized for sale did not pose any risk to human health or safety and 
should th erefore not require labelling. Canada believed that this objective could be best achieved 
through voluntary, industry -led market -driven initiatives, as these were less trade restrictive. 
Voluntary standards could also help ensure that labelling claims were  truthful and not misleading. 
He reiterated Canada's concern that, in the absence of identified safety risks, mandatory GMO 
labelling could be misleading to consumers, as it implied that there might be "issues" with the 
product, where in fact there were no ne. 
3.225.   The representative of Australia  said that while Australia recognized Chinese Taipei's right 
to implement measures that provided consumers with the information necessary to make informed 
                                                
11 G/TBT/M/6 8, para. 2.243 .  
12 G/TBT/M/67, paras. 2.230 and 2.232.  G/TBT/M/69  
 
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  food choices, he asked that Chinese Taipei reconsider the proposed  requirement to label food 
products with no altered characteristics and no discernible GM material . Australia had outlined 
their concerns in previous meetings of the Committee .  
3.226.   The representative of New Zealand  welcomed Chinese Taipei's engagement both bi laterally 
and in the Committee on the regulations on pre -packaged food, food additives and unpackaged 
food containing ingredients of GMOs. New Zealand considered that the labelling requirements 
promulgated through the regulations could be confusing to cons umers, resulting in unjustified 
concerns. When applied to food that was highly refined, where processing removed all transgenic 
DNA and transgenic proteins, the labelling requirements could raise unnecessary consumer 
concern and potentially desensitize the m to labelling regarding GMOs. Consumers might not 
readily appreciate the difference between food derived from GMOs that no longer contained 
transgenic DNA or transgenic protein and food that did not contain transgenic DNA or transgenic 
protein. Food or fo od ingredients containing GMOs that were highly refined or where the 
processing removed all transgenic DNA or transgenic proteins had the same composition and 
characteristics as non -GMO food. There was no food safety concern for the consumer. Therefore, 
New Zealand encouraged consideration of an exemption in the regulation for foods and/or 
ingredients produced using GMO, where the final product did not contain transgenic DNA and 
and/or transgenic proteins and for highly refined ingredients.  
3.227.   The representati ve of Chinese Taipei  thanked Members for their continued interest in the 
measure regarding GMO labelling and the traceability system. Concerns had been noted on the 
potentially misleading message conveyed by mandatory labelling, the 3% threshold for labell ing, 
the exemption of highly refined products, the traceability system, and the implementation time -
frame.  
3.228.   He said the issue of GMO labelling had been the subject of heated discussion since 1998 
and while the debate continued on the differences between pro ducts of biotechnology and 
conventional food products, Chinese Taipei noted that there had been an increase in notifications 
on GMO -related measures in recent years with products subject to labelling requirements and 
threshold levels for labelling varying amongst Members. He explained that these requirements for 
GMO labelling were introduced in response to requests from consumer groups to be  informed when 
food contained GMO ingredients. During the regulatory process, Chinese Taipei had fully observed 
the pr inciple of transparency by notifying the measure at all stages of the process. Following 
technical expert meetings w here comments from interested parties were reviewed, the threshold 
of 3% was considered appropriate and the measure was implemented on 31 De cember 2015 . 
3.229.   GMO labelling was required in highly refined food if GMO food raw materials were directly 
used in the manufacturing process, and the final product did not contain transgenic DNA fragments 
or transgenic proteins. Products that used highly refin ed food in the manufacturing process did not 
require GMO labelling. The traceability system did not impose any additional burden on GMO food 
producers as it applied to all food businesses so as to track the flow of food through the supply 
chain.  
3.230.   Chinese T aipei believed consumers had the right to be informed of food containing GMO 
ingredients but that the presence of GMO labelling was not a critical factor in consumers ' 
purchasing behaviour and he asked that other Members share the results of their studies 
conducted on how consumer habits were affected by GMO labelling. If further information was 
required about the details of this labelling regulation, Chinese Taipei would be happy to provide 
assistance.  
3.2.3.30   China - Registration Fees for Drugs and Medical Device  Products (IMS ID 466)  
3.231.   The representative of the Republic of Korea  noted that, following  the registration fee policy 
published  on 27 May 2015, the application fees for first registration were differently priced 
between Chinese manufacturers and importers.   
3.232.   He recalled the explanation given by China, according to which the difference came  from 
the on -site inspection fees of importers . To ensure transparency as well as non -discriminatory 
treatment between Chinese manufacturers and importers,  Korea requested C hinese authorities to  G/TBT/M/69  
 
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  separate the costs for on -site inspection from the registration fees, which was a general practice 
performed globally, including in Korea.  
3.233.   The representative of Canada  acknowledged China's response provided at the March 2016  
TBT Commi ttee meeting13 regarding registration fees for drugs and medical device products.  
Canada remained concerned about important aspects of the regulation and about the general lack 
of clarity and transparency regarding this measure.  
3.234.   In particular,  Canada contin ued to have concerns regarding China's Medical Device 
Registration Fee Schedule published on 27 May 2015, which had entered into force without any 
notification to the WTO, failing to give Members a "reasonable interval between the publication of 
requiremen ts concerning conformity assessment procedures and their entry into force", as per 
Members' obligation under the TBT Agreement  
3.235.   As already mentioned at the previous Committee meeting14, Canada was concerned with 
China's approach of combining registration fee s with on -site inspection fees for foreign 
manufacturers and with respect to the lack of transparency regarding the registration fees for 
domestic products, which were to be levied by China's provinces.  Canada asked that China publish 
the on -site inspectio n fees separately from the registration fees for foreign manufacturers as well 
as the registration fees to be levied by China's provinces on domestic manufacturers so that it was 
clear what manufacturers were being charged and for which services . 
3.236.   Finally, as raised at the March  2016 WTO TBT Committee meeting15, Canada had recently 
taken note of China's WTO notification G/TBT/N/CHN/1169, issued on 26 February 2016, regarding 
new registration categories of chemical drugs , and sought additional information conc erning the 
changes,  in particular regarding the rationale for the changes to the drug registration categories.  
Regarding registration categories 1 to 5 for chemical drugs, Canada asked whether China was 
going to charge different registration fees for these  categories and whether this would result in 
drug registration fees that differed from those announced on 27 May 2016 . 
3.237.   Furthermore, Canada had been made aware by industry of regulatory exclusivity periods 
associated with the new drug classes (5 years for C lass 1, 3-4 years for Class 2, and z ero years for 
Class 3, 4 and 5). Canada would appreciate if China could provide clarification as to what these 
regulatory exclusivity periods involve d and the rationale for the differing periods.  
3.238.   The representative of Australia  continued to express the interest of his delegation in this 
issue. Australian businesses had  raised concerns with the Australian Government regarding the 
introduction of the new fee schedule and resulting processes . Australia continued to share 
concerns raised by other delegations regarding the fee structures and process requirements for 
domestic and imported drug  and medical device products. He asked China to outline how the fee 
structure and process requirements for imported products were proporti onate to the testing 
process requirements including for the costs of transportation, accommodation and allowances . 
3.239.   The representative of Australia recalled that s ome of the domestic prices were based on 
what was termed a "provincial price". He asked China to confirm what the provincial price was, 
how it was determined and whether the same testing processes and requirements applied for the 
provincial price.  Australia understood that the regulations allowed for small and micro business 
with an innovative medi cal device to have their registration fees waived for first time registration 
and asked for additional information on how innovative products were defined, what the criteria 
were, and whether domestic as well as imported products could be considered as inn ovative.  
3.240.   Australia acknowledged that on -site inspections were necessary to promote public health 
and ensure that products were safe and effective and also that inspections at foreign facilities 
might be more expensive. However, fees associated with foreign  inspections needed to be 
transparent and non -discriminatory and include industry consultation prior to implementation.  
                                                
13 G/TBT/M/68, para . 2.256.  
14 G/TBT/M/68, para . 2.252.  
15 G/TBT/M/68, para. 2.253.  G/TBT/M/69  
 
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  3.241.   The representative of Malaysia  joined the concerns of other delegations, and reiterated 
that any fees imposed for assessing the conformi ty of products originating in the territories of 
other Members should be equitable  and consistent with the TBT Agreement.  
3.242.   The representative of China  said that medical devices criteria were  available on the 
website of CFDA. In the absence of other updates  on the measure, she invited interested Members 
to refer to the minutes of the last meeting.16 
3.2.3.31   Turkey - Toy Communiqué 01/2015 (IMS ID 473)  
3.243.   The representative of the United States  recalled her intervention made at the previous TBT 
Committee meeting. The US did not understand the continued disconnect between Turkey's 
Ministry of the Economy and Ministry of Customs. The US had thought their concerns had been 
addressed through the issuance of the 2016 Toy Communiqu é. However, US toy shipments were 
still being s ubject to duplicative testing so she asked again when Turkey Customs would begin to 
adhere to the 2016 Communiqu é and cease duplicative testing on toy shipments destined for the 
Turkish market.  
3.244.   The representative of Canada  thanked Turkey for its willingnes s to address Canada's 
concerns. A letter dated 21 January 2016 stated that in -country toy verifications would cease in 
2016. This had also been reiterated by Turkey at the March 2016 TBT Committee meeting. Despite 
these assertions, Canada's toy industry co ntinued to face delays as virtually every shipment was 
being subjected to additional local testing prior to entry into Turkey. Canada understood that toys 
carrying the "CE" mark continued to be tested, regardless that this marking signified that products 
had been assessed to meet high safety, health, and environmental protection requirements. 
Therefore, products bearing this mark should not have to undergo further testing.  
3.245.   The representative of Mexico  supported the concerns raised by the US and Canada and 
requested an update from Turkey.  
3.246.   The representative of Turkey  reiterated that following a comprehensive domestic 
consultation process, all verifications in question of the Ministry of Customs and Trade for toys had 
ceased. According to Communiqué 2016/10 o f the Ministry of Economy, toy imports were subject 
to risk analysis under the Risk Based Trade Control System (TAREKS), whereby import controls of 
toys were carried out electronically and on a risk basis. Inspections were conducted as physical 
checks and controls, including document/marking checks. Products were sent to accredited 
laboratories only when there were doubts concerning product safety within the framework of the 
communiqué. Laboratory testing was done on exceptional basis and was not systematic . Turkey 
was ready to discuss further with trading partners on this issue and he asked that Members submit 
the specific information on their claims so that they could be carefully and thoroughly examined.  
3.2.3.32   Brazil - Draft Ordinance Act N o. 374, 27 November 2014 (Portaria SDA/MAPA 
374/2014), G/TBT/N/BRA/613 (IMS ID 478)  
3.247.   The representative of the European Union  appreciate d that the Brazilian authorities ha d 
recently opened a public consultation regarding Ordinance N o. 43, 18 May 2016, notified as 
G/TBT/N/BRA/6 75, which revised  draft Ordinance Act N o. 374 establishing quality requirements for 
wine and derivatives of grape and wine , notified as G/TBT/N/BRA/613.  The EU thank ed the 
Brazilian authorities for the bilateral contacts that had taken  place during the rev ision of the 
ordinance. The EU was currently analysing the text of the revised ordinance and would  provide 
Brazil with comments accordingly.  
3.248.   The representative of the United States  expressed concern with  Brazil 's wine regulations , 
and noted several specifi c issues including:  proposed minimum and maximum content 
requirements for alcohol in table and fine wines versus sparkling wine ; volatile acidity ; chloride 
sodium ; and, ash content . The US asked Brazil to explain the health and/or safety rationale behind 
these requirements , which were more restrictive than those set by other Members . Also of 
particular concern to the US was  Brazil 's proposed definition of "cooler ", which was limited to 
products containing sugar, but not other sweeteners, and require d a mini mum of 10 % fruit juice 
                                                
16 G/TBT/M/68 , para. 2.256.  G/TBT/M/69  
 
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  by volume.  The US found  this definition to be unnecessarily restrictive and emphasize d that these 
requirements would prevent wine with added flavours  and certain wine coolers exported from the 
US from entering the Brazilian market. I n this respect, she asked that Brazil explain the legitimate 
objective achieved through the en forcement of these requirements. The US was also  aware of 
Brazil 's recently notified revised wine standards , and she said her delegation was  currently 
reviewing t hese standards and intend ed to submit comments by the 19 July 2016 deadline. Finally, 
she requested Brazil to provide a timeline for expected implementation of these revised  wine 
standards . 
3.249.   The representative of Brazil  stated that the measure at issue ha d been revoked by the 
Brazilian Ministry of Agriculture , and a new draft measure (Portaria SDA/MAPA No. 43/2016) was 
currently under public consultation, and open for comments from 18 May  to 18 July 2016 . This 
new measure ha d been not ified as G/TBT/N/BRA/675 , and he invite d the EU, the US and any other 
interested Member to present their comments.  Notwithstanding this recent development, Brazil 
noted that the old measure did not  change labelling and quality criteria currently in force, which 
were in accordance  with MERCOSUR rules.  He repeat ed that the intention was not to disturb wine 
trade flows between Brazil and its trading partners.  Members' comments from this meeting would 
be transmitted to  capital , and he said Brazil would provide answers at the next TBT Committee 
meeting.  
3.2.3.33   China - Insurance Regulatory Commission (CIRC) Information and 
Communication Technology Regulation (IMS ID 489)  
3.250.   The representative of the European Union  noted that on  19 April 2016, China notified to 
the TBT Committee the draft provision s on insurance system informatization developed by the 
China Insurance Regulatory Commission . He said that t he quality of the regulatory process clearly 
benefit ed from the opportunity given to interested WTO Members and their stakeholders to provide 
commen ts, and shared the expectation that this approach would be applied to any other measure 
develop ed by China  in this area. These draft revisions were a specific implementation in the 
insurance sector of the general approach to information security laid down in the series of 
framework regulations ; the other important measures related to the multilevel protection scheme 
and the national security law , which  were already mentioned in another STC17, but were still 
relevant in this particular case. The EU's comments  on the TBT notification were sent on 10 June 
2016, and are publicly available on the EU TBT notification database website.  
3.251.   As a general remark, the EU acknowledged the need to reinforce network and information 
security in the insurance sector.  Cyber  threats were complex and continuously evolving , and  
industry and regulators need ed to respond to the emerging security risks in the financial sector, 
requiring sophisticated  advanced technology measures. The management of cybersecurity risk  was 
a global challe nge which the EU took a close interest in . Its fundamental position in  the 
development of its cyber -related policy was to be geographically and technologically neutral , so 
that policies in this area d id not cause market fragmentation or distortion and d id not favour or 
require the use of domestic products for technology ; for example, it was not required that EU 
businesses segment certain activities in the EU,  nor were EU products or solutions favoured. The 
EU would expect similar treatment from their global  trade partners. In particular, this applie d to 
the policies implemented in the financial and insurance sectors, but also to any sector operating 
essential and critical IT systems. The EU emphasised that policies in this area should not unduly 
hamper econo mic growth and innovations , but need ed to be in line with international best 
practices , reflect ongoing discussions at international level  (e.g. in the Financial Stability Board), 
and fully live up to WTO obligations .  
3.252.   As specific comments, the EU firstly noted that Article 20 and Article 56 of the notified 
draft refer red to the need to classify information systems in accordance with the MLPS. The EU 
was concerned that a possible mandating of MLPS level three would prevent foreign ICT products 
manufactured outside China,  and incorporating foreign technology , to be used in such core 
systems in insurance institutions.  The EU requested  clarification from China regarding this aspect.  
                                                
17 China – Requirements for information security products, including, inter alia, the Office o f State 
Commercial Cryptography Administration (OSCCA) 1999 Regulation on commercial encryption products and its 
on-going revision and the Multi -Level Protection Scheme (MLPS) on page 16 . G/TBT/M/69  
 
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  3.253.   Secondly, the EU observed that the  draft refer red to the need for insurance ins titutions to 
induce in their system "secure and controllable hardware equipment and software products". This 
appear ed to cross reference the language in the national security law of 2015 concerning the use 
of core technologies in information technology cri tical infrastructure and the development of the 
internal structure which are secure and controllable. As it has been mentioned in the related 
STC18, the notion of "secure and controllable " was nowhere defined in detail . The EU was 
concerned that those notio ns might be interpreted in light of the MLPS criteria for critical 
infrastructure , meaning that only products manufactured domestically and incorporating 
indigenous technology were deemed secure and controllable.  
3.254.   As the t hird point, the EU noticed that the notified draft contain ed revisions , which 
require d insurance institutions to obtain the ownership of the source code of the equipment they 
induce d in their system via contracts with equipment vendors , in order to control the authorized 
use of their sourc e codes . The fact that the source code was an essential asset for information 
security equipment manufacturers ha d been repeatedly mentioned in the discussions concerning 
information security. The impor tance of the source code related  to the core propriet ary information  
and business secrets around which information security equipment development was based ; 
accordingly,  it would be impossible to comply with this requirement without putting at risk the 
whole viability of the business in this area. Moreover, t he notified draft requir ed insurance 
institutions to protect information security products with special protection for indigenous 
intellectual property owned by insurance institutions . The EU requested an explanation of the 
meaning of this requirement: its  current understanding was that, reading these provisions in 
conjunction, insurance institutions should become the owner of the intellectual property rights over 
the encryption technology use d in their system.  
3.255.   As a fourth point, the EU noted that the notif ied draft refe rred to the use of products and 
technologies complying with "national standards" and encryption requirements , and also refer red 
to the application of national cryptographic application requirements for the financial sector and 
insurance insti tutions , to gradually achieve the general application of cryptographic technologies. 
This appear ed to require the use of domestic algorithms in the encryption technology , which is 
used in equipment to be procured for institutions . The  combined fact of usin g national standards 
and domestic encryption technology was clearly cause for concern , since it  reinforce d the effect of 
the other provisions concerning the disclosure of the source code and possibly further qualif ied the 
meaning of secure and controllable  equipment.  The EU encouraged China to develop a framework 
which built on and took  fully into account international standards and practices and worked 
towards interoperable solutions in line with the approach of other global regulatory authorities.  
3.256.    The re presentative of the United States  associated her delegation with the comments of 
other s and thanked  China for notifying the CIRC draft rule on "Supervision Rules on Insurance 
Institutions Adopting Digitalized Operations ". Although the review of the updated  draft revealed  
the improvement of some problematic provision s, including the requirements on "indigenous IP " 
and "domestic algorithms ", the US still found  many draft provisions problematic. The US asked for 
their comments to be seriously considered by the  relevant agencies and to be addressed before 
the rule was adopted in final form and implemented. The US noted that China 's current plan to 
finalize the rule the day following conclusion of the comment period suggest ed that the comment 
process was simply p erfunctory , and expressed the hope that the draft regulation would be 
developed in an open, transparent, and least trade -restrictive manner.  
3.257.   With respect to Article 53 regarding the "Secure and Controllable  – Highest Priority ", the 
US was  still concerned over wide -spread efforts by China to impose "secure and controllable " 
requirements on companies using ICT products , which  unnecessarily disadvantage d foreign ICT 
firms.  While  the requirement of "indigenous R&D" was removed in Article 55, Article 53 still 
demanded institutions  to give preference in procurement to products that were "secure and 
controllable ". Pursuant to the regulations, these  institutions  needed to promote gradual 
implementa tion of secure and controllable  technologies . Given the lack of defi nition of "secure and 
controllable ", the regulations were of major concern for US ICT companies ; to the US' knowledge 
and understanding, the meaning of "secure and controllable " in the past included references to 
domestic technology requirements , and compa nies sourcing ICT products were already interpreting 
this language conservatively, meaning that domestic goods must be procured. Similar trends 
occurred  in banking, telecommunications and other industries that China ha d deemed critical 
                                                
18 See previous footnote.  G/TBT/M/69  
 
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  infrastructure. The US asked China to provide a clear definition of "secure and controllable " and to 
confirm  that no nationality -based conditions or restrictions on the purchase, sale or use of ICT 
products exist or were implicitly recommended.  
3.258.   The US also raised concerns ab out Article 54 regard Domestic Cryptography and  Article 
25(e) regarding  Security Mechanism . While China explicitly removed the mandate for domestic 
encryption, there is still a reference to the "national implementation requirements on cryptography 
in the f inancial sector " without specifying in the meaning of these requirements in  Articles 54 and 
25(2) . The US was concerned that a Chinese domestic encryption standard would be mandated,  
given that China 's national requirements on cryptography in the financial  sector generally 
promote d all-around adoption of domestic algorithms . For example,  the January 2014 "national 
work plan for promoting application of cryptography in financial sector " called for complete 
adoption of Chinese domestic cryptographic standards  and related specifications by 2019 for 
products such as internet browsers, PCs, laptops, mobile phones, and servers.  Although items not 
having cryptography as their core function could still be sold in China, the regulation  from 2014 
cover ed products that  overlap ped with non -core function items. The US asked China to confirm 
that Article 54 did not require domestic encryption.  
3.259.   Furthermore, MLPS  of Article 56 and "Classification and security  levels " of Article 20 
appeared  to discriminate against foreign pr oviders by mandating that all insurance institutions 
within China follow the MLPS and requiring that everything from security level 3 and above use 
domestic intellectual property (IP). The US stated that MLPS was inflexibly prescriptive and could 
restrict the ability for consumers to purchase technologies established as safe everywhere else in 
the world. Next to that, it was likely to be discriminatory against foreign companies . While other 
Members ha d rules to ensure security of critical infrastructure, Ch ina was including non -critical 
infrastructure without providing an explanation for it. The US suggested that China adopt a non -
discriminatory approach and focus on legitimate security concerns within a clearly -defined 
category of critical information infra structure.  
3.260.   Moreover, Article 57 regarding Information Security System Certification  require d that  an 
information security system  certification be accredited by China 's National Certification and 
Accreditation Administration (CNCA), which may unnecessarily raise cost s or cause potential 
threats for confidential information.  It was unclear what the specific requirements for certification 
would be, whether there were other options for certification, and what kind of information would 
be requested from a compan y to ensure it met licensing requirements.  The US stated that China 
should recognize relevant international certification results to remove unnecessary or duplicative 
requirements.  
3.261.   The US also reiterated its general concerns that China seem ed to be expandi ng its "secure 
and controllable " doctrine in a way that disadvantage d foreign companies, despite positive 
assurances bilaterally that this would not occur . In the circumstances where regulation may be 
necessary , the US asked China to ensure transparent pro cess consistent with its commitments in 
the TBT Agreement . The US reemphasize d the importance of avoiding onerous testing and 
certification requirements for encryption technology that would either be unnecessarily 
burdensome, discriminatory, or include a r eview of source code, or other sensitive business 
confidential information.  
3.262.   The representative of Canada  understood China's desire to minimize threats to its ICT 
infrastructure . He agreed with the concerns raised by the EU and the US and reiterated the 
concerns raised by Canada at the November and March TBT Committee meeting s to which 
additional clarifications were still being awaited . It was Canada's view that China's approach to 
"secure and controllable" ICT would decrease, rather than increase, the cybe rsecurity of China's 
network and insurance ICT infrastructure . 
3.263.   With respect to the Draft Supervision Rules on Insurance Institutions Adopting Digitalized 
Operations, he requested further information on: (i) the definition and criteria for determining 
secur ity levels, and clarification on how this article would function in relation to the MLPS ; (ii) how 
the provisions related to testing by third party institutions in Article 22  would be operationalized; 
and (iii) if China could clarify whether Article 25(2) which described the security management 
mechanism requirements, including the use of technologies and products that complied with 
national standards and encryption requirements, was referencing other existing legislation or if the 
terms would be uniquely d efined for those rules.  G/TBT/M/69  
 
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  3.264.   Canada also noted that, following Article 31 , where data was from within the territory of 
China, the data centres handling the information should be located within China.  This article  also 
required that the design of the computing facility comply with national standards as well as the 
requirements of the China Insurance Regulatory Commission (CIRC).  Canada had concerns that 
these requirements could be overly restri ctive for the intended purposes of ensuring secure data 
infrastructur e, and sought clarifications as to why these measures were necessary for the 
insurance sector in China.  
3.265.   On Article 53 , which provided guidelines as to the type of equipment and software that 
insurance institutions should consider purchasing (i.e. secure an d controllable hardware equipment 
and software products),  Canada asked China to clarify whether foreign -made software and 
equipment would qualify under these draft regulations, and if not, could China explain why it was 
necessary to impose such a limitatio n. 
3.266.   Article 54 highlighted the objective to work towards an "all -round application of domestic 
cryptography in the electronic insurance policy and insurance sector". Canada asked how this 
would work in practice and for any additional information about the o bjective.  
3.267.   As regards Article 55, Canada also  requested clarification on the meaning of "indigenous IP 
protection" as well as information on CIRC's associated expectations regarding the implementation 
and interpretation of this Article.  
3.268.   On Article 56, Can ada asked China to  provide additional information on what level of 
security might be required, as it appeared to reference MLPS security requirements but was non -
specific . In addition, Canada asked China to indicate how this article would function in relat ion to 
Article 20, which also appeared to set out security requirements .  
3.269.   Furthermore, Canada noted that Article 81 would allow the CIRC to authorize an 
"accredited information security monitoring agency " to conduct a "risk penetration test ". Canada 
reques ted clarifications as to: (i) whether the accredited information security agencies would be 
state or private entities; (ii) what agency or agencies would be accrediting the information security 
monitoring agencies in question; (iii) whether such tests woul d be covered by non -disclosure 
agreements signed on mutually agreed terms between the insurance institution, CIRC and the 
relevant information security monitoring agency or agencies; (iv) whether insurance institutions 
would be advised before or, at least,  following the conduct of any such test; and (v) whether the 
article would require separate "risk penetration tests ", one authorized by CIRC and one authorized 
by the insurance institution. Canada also understood that Article 81 could entail the surreptiti ous 
accessing of sensitive and potentially undisclosed business information and/or trade secrets by 
third parties, which could  be of concern to insurance institutions. Canada inquired whether CIRC 
had considered alternative means to reach the goal of Artic le 81 (e.g. through tests to be 
conducted internally by the insurance institution itself) and what the rationale was for excluding 
such alternatives.  
3.270.   Finally , Canada  requested China to provide additional information on the "security 
certification" process  and asked whether China would be adhering to international standards of 
accepting third -party test reports in this regard.  
3.271.   The representative of Japan  supported the positions of previous speakers on this issue . 
She recalled that last October, China had issued the draft proposal for public comment  to which 
Japan submitted its opinion, and that China had notified th e issue to the WTO in April. Although 
the article on the requirement for the  application of Chinese domestic cryptography ha d been 
reconsidered , it was Japan's view that the articles regarding terms definitions, concrete 
requirements for examination and evaluation and scope of the regulation were still unclear. Japan 
was concerned that market access of foreign companies to China might be hampered by this 
regulation, depending on its implementation.  Japan requested China to clarify the terms 
definitions, the concrete contents of requirements and scope of regulation, and to ensure 
transparency.  
3.272.   Article 25 stated that "An insurance institution shall t ighten management of cryptographic 
devices and operators, and use technologies and products complying with national standa rds and 
encryption requirements, " and Article 54 also stated  that "An insurance institution should, G/TBT/M/69  
 
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  according to the national implemen tation requirements of cryptography in financial sector, work 
towards all -round application of cryptography in electronic insurance and insurance sector. " Those 
requirements might be implemented in a way which was more trade  restrictive than necessary 
upon import of relevant products, and conformity assessment procedures of those requirements 
could be regarded as questionable, for example if they contain ed requirem ents for source code 
disclosure. Japan sought clarifications as to which requirements or confo rmity assessment 
procedures were to be applied in concrete, and claimed that  foreign companies were at a 
disadvantage compared with domestic companies.  
3.273.   In addition, Article 53 provided that "Insurance institutions shall […] steadily introduce the 
applicati on of secure and controllable equipment". Depending on the content of measures and 
requirements for secure and controllable equipment, there could  be similar concerns in Article 25. 
Japan requested China to bring Article 53 in consistency with the TBT agre ement in view of 
principles of non -discrimination and of not being more trade -restrictive than necessary.  
3.274.   Moreover, it was Japan's view  that the MLPS , referred  to in Article 56 , might cause 
discrimination of foreign companies at some levels, by requiring C hinese intellectual property in 
core technologies or by requiring domestic certification in China. Japan sought clarifications as to  
the implementation procedure of MLPS. Finally, Japan request ed that t he revised draft regulation 
be transparently implement ed based on the opinions of Japan and other Members . 
3.275.   The representative of Australia  said that Australian industry and enterprises had a great 
interest in any potential regulations that might impact their ability to operate in the Chinese 
market.  ICT and c ybersecurity were global issues and to be most effective, required globally 
consistent solutions . Australia encouraged the use of internationally accepted approaches to 
encryption and ICT security, thereby minimizing conflicts across systems and ensuring b est 
practices globally.  He requested further information on the status of the regulations and , 
specifically, on whether they would be notified to the TBT Committee.  He also sought clarification 
on the definition of "secure and controllable ICT" in Article 53 as it was unclear what was expected 
of ICT systems so as to fulfil this criterion.  
3.276.   The representative of China  recalled that the provisions on insurance system 
informatization were aimed at ensur ing information security in the insurance sector. He dr ew 
Members' attention to the fact that the rule was drafted in a very transparent manner, and 
assured that China valued comments and input from domestic and foreign stakeholders. He 
informed that the draft rule was first open for public comment in October 201 5, and that the CIRC, 
China's insurance regulator, substantially changed the relevant provisions of the rule based on the 
comments and suggestions of the relevant stakeholders. The CIRC officials respectively exchanged 
information on this rule with represe ntatives from the USITO  and the EU Chamber of Commerce in 
December 2015. Moreover, China had notified the revised draft rule to the WTO TBT Committee in 
April 2016 as G/TBT/N/ CHN/ 1172 with a 60 -day comment period and a 6 -month implementation 
period startin g from the date of circulation by the Secretariat. For these reasons, China did not 
understand some Members' concerns regarding transparency. China assured Members that the 
rule was applied in a non -discriminatory manner, also with regard to commercial enc ryption. China 
informed that dozens of foreign companies had already obtained production licences in China. 
China' s requirements regarding "secure and controllable " did not discriminate against foreign 
products, services and technology either.  
3.277.   In response to the concerns of Members about the term "secure and controllable", China 
provided more clarity on the criteria for the determination of what constituted "safe and 
controllable ", for the sake of transparency. First, the user 's information system should not be 
remotely controlled without their knowledge. Second, the user 's data and information should not 
be obtained without their prior consent. Third, the products or services providing a user's 
information system should not stop services without a justifiab le reason. China pointed out that 
the term "secure and controllable" had not been created by China and was globally used.  
3.278.   Moreover, China stated that its notification of this rule to the WTO did not necessarily 
mean China's agreement that the rule would co nstitute a trade barrier or fall within the scope of 
the TBT Agreement. The WTO TBT Committee encourage d Members to notify trade facilitating 
measures and encourage d notification when a Member was unsure  about  his obligation to notify. 
China recalled that this rule was basically a requirement for an insurance service provider to 
establish and maintain a secure information system. For a measure to be considered a technical G/TBT/M/69  
 
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  regulation within the meaning of Annex 1 of the TBT Agreement, it had to pass a three -tier test: 
(i) the document must apply to an identifiable product or group of products; (ii) the document 
must lay down one of more characteristics of the product; (iii) compliance with the product 
characteristics must be mandatory. China stated that Membe rs' concerns about data residency, 
cross-border data transfer and other related issues had clearly gone beyond the scope of the TBT 
Agreement, and hence the TBT Committee was not an appropriate forum for such issues.  
3.279.   The United States  noted that it was very important for Members to understand this 
measure, to be able to comment on it and to have a reasonable interval for implementation. The 
US was unsure whether China would implement the measure on 18 June, which would not give 
enough time for compliance, and sought confirmation in this regard.  
3.280.   The representative of China  asked where the information about the 18 June  date for the 
implementation of this rule came from, and restated that the measure had been notified to the 
TBT Committee in April 2016 and th at a 60 -day comment period and a  six-month transition period 
had been provided.  
3.281.   The representative of the United States  said that the implementation date of 18 June was 
mentioned during the recent bilateral discussions.  
3.282.   China  drew Member's attention to the  notification form China submitted to the Committee 
for clarity on the matter.  
3.283.   The representative of Canada  added that, although some light was shed on the measure, 
there were many outstanding and unanswered technical questions. Canada would be grateful if  
China could answer those specific questions in writing due to their quantity  and highly technical 
nature.  
3.2.3.34   Brazil - Toy Certification; Ordinance No. 489, No. 310 and draft Administrative 
Rule No. 321, G/TBT/N/BRA/612 (IMS ID 478)  
3.284.   The representative of the European Union  thank ed Brazil  for their engagement on this  
issue and the information provided in the bilateral meeting . His delegation understoo d that 
Ordinance 489  aimed to consolidate all existing rules on conformity as sessment for toys,  while 
Ordinance 310 dealt with safety requirements and standard s. With respect to conformity 
assessment procedures, he asked Brazil to confirm the timeline for completing this work. The EU 
understoo d that this was in  the final deliberation phase and expect ed an outcome by autumn of 
this year. Regarding specifically draft Ordinance 489, the EU was concerned  with the new 
requirement for registration of each product for traceability purposes. The EU understood that this 
requirement aimed at  (i) establish ing a direct link betw een the Brazilian National Institute of 
Metrology, Q uality and Technology (INMETRO)  and each toy manufacturer or importer ; (ii) 
facilitating  the enforcement of product recall ; and (iii) enabling  consumers to access information 
about toys through a database  that match ed a registration number on the toy with the number for 
the product in the database. While the EU  support ed the policy objective of the  proposal, it asked 
Brazil to consider less burdensome alternatives . The EU toy industry proposal was to use a  
registration system per each producer or importer combine d with a requirement  for toys 
manufacturers to have a n internal tra ceability system  capable of tracking relevant data on each 
toy, such as production line,  date and batch number, to  enable effective  enforcement of any 
product recalls . The EU representative highlighted the importance of further dialogue and  
engagement between INMETRO  and stakeholders in order to develop solutions that took into 
account the specificity of toy business and the already existing burden on  toy manufacturers 
around the world to comply with  traceability requirements of the  US and EU toy safety regulations.  
3.285.   Concerning draft O rdinance 310, the EU  request ed Brazil to ensure consistency between its 
requirements and MERCOSUR seri es of standards MM 300 on toy safety. His delegation 
appreciated  that the proposed amendment to Administrative R ule 321 pursuant a requirement to 
film toy testing would  be removed  from the draft  as it was an unprecedented  require ment for 
testing laboratori es.  
3.286.   The representative of the United States  thanked  Brazil for its detailed response to their 
intervention in March  and for clarifying t hat the filming requirement would  be removed.  She asked G/TBT/M/69  
 
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  Brazil to confirm : (i) whether sticker labels w ith the registra tion number would  be allowed to be 
affixed to the product or package; (ii) whether the final draft measure would  be notified to the TBT 
Committee ; (iii) whether  there would  be transition periods for var ious products and, i f so, their 
duration and the produ cts they would be conferred to. The US continued to monitor Brazil's 
progress with respect to the requests made by Members. She was concerned about the impact of 
these requirements on the  trade with Brazil in this sector, particularly the high costs that 
Ordinance 489 would impose on the toy industry because of the sheer number of products . The US 
did not understand how the proposed changes would result in any improvement in safety.  For 
example, the requirements for toy companies to register toys in a "family of products ", was overly 
burdensome.  Moreover,  concern was expressed that the Registration System wou ld increase costs 
without comparable improvements in safety.  The US delegation understoo d the objective of 
improving consumer information , but noted tha t it was unclear how the registration system and 
labelling requirement increase d consumer safety beyond the current system.   
3.287.   The US delegation  was further concerned that a reduction in consumer choice in the 
market could result  in many  small and medium -sized enterprises abandon ing the Brazilian toy 
market.  She asked Brazil to clarify which methods INMETRO was consider ing for reducing the 
impact on these small and medium -sized businesses . Regarding confidential information, she 
further asked Brazil to clarif y: (i) the methods to protect the information it would require  to be 
submitted by industry ; (ii) the methods to address potential CBI leaks ; and (iii) whether  legal 
liability would be one of such methods.  She expressed the US 's willingness to work  with Bra zil on 
this matter bilaterally.   
3.288.   The representative of Canada  expressed appreciation for  Brazil 's engagement on its toy 
safety measures.  He was  concerned that these ordinances impose d unjustified costs to the toy 
industry without resulting in any benefit  in consumer safety in comparison  to the internationally 
recognized certification systems already in place for toys.  On Ordinance 489, Canada was 
concerned that the requirement for factory audits for each product family would add  unnecessary 
complexity and c osts. He urged  Brazil to consider a review of the ordinance and permit a Suppliers 
Declaration of Conformity or sampling by any laboratory accredited by the International Laboratory 
Accreditation Coo peration . Canada understood that Braz il contemplated chan ges to A dministrative 
Rule 321 regarding the requirement for  laboratories to film the testing of toys in order to register. 
He asked Brazil to  provide an update on the status of Administrative R ule 321.  
3.289.   The representative of  Mexico  supported  the concerns of other delegations and expressed 
willingness to dialogue with Brazil on update s of this measure and ways to avoid it becoming a 
barrier to trade.  
3.290.   The representative of Brazil  clarified that the comments made both in this Committee and 
in the public consu ltation in regards of the filming and recording requirements had been taken into 
consideration, but that it was not possible to ensure that the requirements would  be eliminated . 
He said that the purpose of the measure was to create a direct link between INMETRO  and the 
producers , as well as establish ing a registration procedure to facilitate access by consumers to 
certification information. This would improve the Brazilian framework of conformity assessment in 
terms of transparency and traceability. Brazil believed  that the requirements of the measure 
conform ed to international best practices and  recall ed that the final rule was not yet in force. He 
said that INMETRO held a public consultation in 2014 and was considering the inputs it received. 
He recalled t hat this registration system was implemented in other sectors in Brazil without 
difficulties . Concerning timeline s, he expect ed to have a final rule by August 2016. Regarding 
confidentiality of information, he said that INMETRO had a  strict policy which wa s consistent with 
ISO/IEC 17065. His delegation would  take all comments made back to capital and provide answers  
at the next meeting of the TBT Committee.  
3.2.3.35   Colombia – Testing Requirements to be met by Toys and their Components and 
Accessories , G/TBT/N/COL/1 09, G/TBT/N/COL/109/Add.1 (IMS ID 479)  
3.291.   The representative of Canada  thanked Colombia for the  video -conference meeting  where 
they discussed the recognition of third -party conformity assessment resu lts and certificates 
between the two Member s. His delegation  understood that a draft amendment  of Resolution 3388  
was notified by Colombia on May 13  2016 and that comments would be received by 12 August  
2016. Canada was planning to  provide co mments on the new draft , but understoo d that local 
testing requirements in  Colombia would  still be required for imported toys. Canada was  of the view G/TBT/M/69  
 
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  that these requirements would be  discriminatory and at odds with Colo mbia's Most Favoured 
Nation and Na tional Treatment obligations. He urged  Colombia to u se their  mutual membershi p in 
Multilateral Recognition Arrangements (MLAs), such as the International Accreditation Forum (IAF) 
and the International Laboratory Accreditation Cooperation, to mutually recognize conformity 
assessment results in toys. He also  thanked Colombi a for its  engagement on this issue.  
3.292.   The representative of Colombia  said that both the draft and resolution 3167 had been 
notified recently,  providing Members with the opportunity to comment  in accordance with their 
obligation of transparency . He confirmed that the deadline for c omments was  12 August 2016 and 
invited  Members to make comments. His delegation was aware that Canada had held  discussions 
with the Ministry of H ealth of Colombia and looked forward  to receiv ing their comments in wr iting. 
3.2.3.36   Korea – Standards an d Specifications for Wood Products, G/TBT/N/KOR/563 , 
G/TBT/N/KOR/599 (IMS ID 491)  
3.293.   The representative of the United States  thanked Korea for considering allowing the use of 
visual grading for plywood and for accepting data submitted by its industry stakehol ders. An  
update was sought on priority requests made at the March 2016 TBT Committee meeting.  Her 
delegation was  particularly interested to know whether Korea would  suspend enforcement of the 
standards for plywood, glued laminated timber, and orien ted stra nd board until Korea had  a 
suitable method for allowing conformity assessment to be conducted in the c ountry of origin.  In 
addition, the US requested an update from Korea on the following requests:  (i) that the  Korea 
Forest Service (KFS) recognize the US  Department of Commerce (DOC) PS 1 standard for plywood 
and did not require on -going testing on a per lot basis at the port of entry in Korea when the 
products have been marked in accord ance with PS 1 by a qualified US certification body (b ased on 
the testin g data recently submitted by APA, the KFS accepts PS 1 plywood of less than 12 mm that 
meets its strength requirements, irrespective of the Korea Forest Research Institute (KFRI) 
plywood standard's "five ply minimum requirement"); that t he KFS recognize  American National 
Standards on glulam along with the structural glulam standard and did not require on -going 
testing on a per lot basis at the port of entry when the products have been marked in accordance 
with those  standard by an appropriate US  certificati on body;  that the KFS accept  certified glulam 
that uses visually graded lumber in its core pursuant to provisions in the KFRI glulam standard and 
test data provided which  demonstrates that necessary st rength properties have been met; that t he 
KFS recognize  US DOC PS 2 standard for oriented strand board, reco gnize  grades and span ratings 
for construction applications, and did not require on -going testing on a per lot basis at the port of 
entry when the products have been marked in accordance with PS 2 by a q ualified US certification 
body;  that t he KFS recognize  the voluminous data already gathered related to negligible 
formaldehyde emissions for the above products and did not require on -going testing on a per lot 
basis at the port of entry in Korea when the p roducts have been marked in accordance with PS 1, 
PS 2, or the American National Standards f or glulam by an appropriate US certification body; and 
that the Korean government pass  the Foreign Quality Ins pection Institute Law allowing US  entities 
possessing  appropriate credentials (such as accreditation to ISO 17065) to conduct con formity 
assessment within the US  that is recognized by the Government of Korea.   
3.294.   The representative of Malaysia  echoed concerns raised by the US, in particular with regard 
to the tr ansparency of the conformity assessment procedures , the procedures for the designation 
of Foreign Qual ity Inspection Institute (FQII), and the acceptance of test report s issued by foreign 
testing bodies. His delegation wa s ready to engage with Korea  on the matter . 
3.295.   The representative of Canada  expressed appreciation for the level of engagement and 
collaboration demonstrated by his Korean counterparts. His delegation shared concerns raised by 
the US on the issue of standards, in particular t he new standard fo r Oriented Strand Board (OSB)  
and requested that the KFS recognize CSA standard O325 for construction sheathing, including the 
grade and span ratings for structural construction applications. Further, Canada  request ed Korea 
not to  require testing at or bey ond the point  of entry when the products had  been marked in 
accordance with CSA O325 by a qualified North American certification body , noting that standard 
CSA O325 was harmonized with the US  DOC's  PS 2 standard.  Canada also looked forward to 
Korea' s adopt ion of a law or regulations regarding FQIIs  that would  allow Canadian entities with 
the appropriate mandate and experience to conduct conformity assessment within Canada that is 
recognized by the Government of Korea. As his delegation understood  that such a law may not be 
in place until late 2016, Canada requested that until such a time, forest products continue to be 
imported without hindrance due to uncertainty over conformity assessment procedures.  G/TBT/M/69  
 
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  3.296.   The representative of Chile expressed support for the co ncerns raised by other 
delegations . 
3.297.   The representative of the Republic of Korea  stressed that his delegation had abided by due 
process in submitting a notification to Members and providing a 60 -day comment period, 
promulgated on 30 December 2015 with a 6 -month grace period. Implementation would begin  on 
1 July 2016. Secondly, KFS had held some meetings on environmental law, in particular on the 
sustainable use of wood, which was needed for the designation of FQII through government 
process. The Korean natio nal assembly had concluded its role at the end of May 2016 so KFS 
would resubmit it for FQII approval , at which point KFS would reinitiate the process of legislation 
on the notification on designation. Lastly, he stressed that Korea's notification on the O SB 
standard was not only for the purpose of structure but also for more general purpose, for example 
the manufacture of furniture interior. Furthermore, like EU practice, Korea had submitted its 
notification on the OSB standard on the quality standards tre aty which was the same as the ISO 
standard. The performance standard adopted by the US and Canada was different from Korea's 
notified OSB standard. However, Korea was in the process of amending the notification regarding 
the plywood standard to accept 3 pl y restructural plywood, as mentioned by the US and Canada, 
so as to specify Korea's bending strength requirement.  Korea remained  open to hold transparent 
discuss ions with concerned parties on its notification of wood products.  
3.2.3.37   China - Interim Measures for Quality Management of Commercial Coal, 
G/TBT/N/CHN/1057 (IMS ID 477)  
3.298.   The representative of Australia  thank ed China for continued bilateral discussions over 
many months on the new coal standard and conformity assessment measures which had been  
notified as "urgent " in September 2014, and which had become effective in January 2015. 
However, Australia  remained significant ly concern ed with the regulation and asked for  a formal 
response to queries raised through the China TBT enquiry point over previous years  and which 
remained unanswered. China being Australia's second largest coal export market , its industry  and 
exporters continue d to have great interest in the implem entation and application of the  measure . 
3.299.   Australia had noted  that prod uction from Chinese coal m ines wa s estima ted to have 
dropped by only 4.5% in 2015, compared with a total drop in imports from all countries of around 
32%.  Australia support ed China's environmental objectives of improving air quality and promoting 
the ef ficient and cleaner use of co al, as well as  efforts to improve th e quality of coal used in its  
energy and industry sectors.  Australia remain ed committed to being a reliable supplier to China of 
high quality thermal and metallurgical coal with low levels of impurities. However, Austral ia 
consider ed it important to implement these measures in a way that enhance d trade in coal and 
maintained  competition between imports and domestic production. With this in mind , Australia 
requested  China to r espond to the following queries.  Firstly, it ap peared that China ha d based the 
standard o n the interim measure on globalCOAL's Standard Coal Trading Agreement , which was 
not recogniz ed as a standard for testing coal quality.  As provided for in the TBT Agreement, 
Australia asked for the reason for using  the globalCOAL Standard Coal Trading Agreement 
measure rather than the relev ant and internationally recogniz ed ISO standard  ISO 13909, and also  
how the globalCOAL standard Coal Trading Agreement applie d to domestic and imported coal.  
3.300.   Secondly, on conform ity assessment procedures,  China was urged  to accept the test 
results undertaken in other countries at internationally accredited testing facilities. This would 
reduce duplication and costs, and would enable tests to be undertaken in a more expeditious 
manner, prevent ing potential delays at points of import when test results ha d to be received prior 
to unload.  China was requested to  provide an update on any improvements to timeframes and 
capacity for testing impor ted coal after arrival in China and to expla in what interaction there was 
between national accredited testing authorities to discuss test res ults obtained in China where 
these test results differ ed from results obtained elsew here. Wh at review or appeal process exist ed 
to question cases of Chinese te st results differing from Australian o r other countries' test results? 
Moreover, Australia questioned whether China had given consideration to an independent review 
or appeal process in the case of differences in results between tests conducted outside Chi na and 
at Chinese ports, or different results between tests at different Chinese port s, on the same 
shipment of coal.  
3.301.   Australia continue d to have concerns as to how over 3.6 billion tonnes of Chinese domestic 
coal were being tested . Further, Australia aske d how China was ensuring consistency between G/TBT/M/69  
 
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  testing conducted on imported coal and domestic Chinese coal . China was asked to provide details 
of the authorities that undert ook testing of domestic coal in China.  In this regard, what had  been 
the results of the tests conducted for domestic coal which ha d been undertaken thus far, and what 
happened  to the domestic coal that d id not meet the quality standard ? How was China ensuring 
consistency of testing across all of the import entries  into China by sea, rail and road ? As 
requested , Australia ha d provided multiple c omments on the measure to China' s TBT enquiry point 
and asked when  a formal response  would be received from China . Australia looked forward to 
continued discussion s with China on the implementation o f the measure.  
3.302.   The representative of China  stressed that i nterim measures for quality management of coal 
had co me into force in January 2015 and referred the Committee back to her delegation's answer 
to specific concerns of Australia from the November 201 5 meeting.19 China further share d a set of 
statistics with M embers. Due to domestic and international economic downturn and other factors, 
China's coal consumption and import  volume had significantly decreased in 2015.  In 2014, coal 
consumption in China was valued at  4.12 billion ton nes, down to 3.96 billion ton nes in 2015 , a 
drop of 3.88%. The import volume of coal in 2014 was 2.91 billion  tonnes, down by 29.9% to 2.04 
billion tonnes in 2015. Against  this background, coal imports  from Australia represented  0.709 
million ton nes, down by 24.97% - 5 points lower than the total volume of coal imports to China. It 
was therefore  China's bel ief that  the interim measures ha d not placed any trade restrictions on 
Australia.  
3.2.3.38    European Union - Restriction on Polycyclic Aromatic Hydrocarbons (PAHs) in 
Tyres as specified in Annex XVII of REACH , G/TBT/N/EEC/52 (IMS ID 480)  
3.303.   The representative of China  reiterated its concern about test method ISO 21461, 
referenced in Entry 50 of Annex XVII of REACH (1907/2006/EC) . While appr eciating the EU's 
restrictions on PAHs, China stated that ISO 21461  was not suitable for related conformity 
assessments as it was an indirect quantitative, unscientific and inappropriate method to determine 
PAHs, causing misleading test results. The tests also induce d a high cost. GC-MS and HPLC , test 
methods specified in technical regulations and international standards, were more accurate and 
mature according to China. China asked the EU to provide the scientific rationale for using this 
test, to conduct a timely review and revise accordingly.  
3.304.   The representative of the European Union  repeated that the REACH regulation had been 
notified under the TBT agreement in 2004 and had been extensively discussed with WTO Members 
and other stakeholders. The ISO 21461  test method was an international standard, applied by the 
EU since 2010. The necessary equipment ( nuclear magnetic resonance spectroscopy ) was a 
standard instrument in specialized laboratories. The EU invited China to share  more details about 
the alternat ive tests referred to by China.  
3.2.3.39   India - The Stainless Steel Products (Quality Control) Order, 2015, 
G/TBT/N/IND/50 (IMS ID 486)  
3.305.   The representative of the European Union  reminded the Committee that his delegation had 
provided written comments on the draft Stainless Steel Products (Quality Control) Order, 2015 on 
23 October 2015 and reiterate d concerns it had raised during previous meetings . He recalled that 
the notified draft followed  similar certification measures adopted by India for steel products, such 
as the measure notified under G/TBT/N/ IND/32 - Steel and Steel Product s (Quality Control) Order, 
2006, and further extended  the scope of the existing Bureau of Indian Standards (BIS) mandatory 
certification system to three  other steel products, namely  stainless steel plates, sheets and strips.  
3.306.   The EU was generally concerned that these measures constituted  an unnecessary technical 
barrier to trade. In particular, the EU reiterate d its concerns about the necessity and costs related 
to the BIS mandatory certif ication require ments and the re -testing by BIS -authoriz ed laboratories 
of steel products that had already been tested against the relevant  international standards. The EU 
therefore  asked India to confirm that the standards referred in the notified measure were 
equivalent to relevant international standards and , if so, urged India to refer to them in the text as 
well. Finally, the EU ask ed whether factory inspections would be required by the BIS certification 
scheme. According to the EU, factory visits to EU  steel mills that operated quality management 
system s as defined in ISO 9001 would be of no added value.  
                                                
19 G/TBT/M/65, para . 2.9. G/TBT/M/69  
 
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  3.307.   The representative of India welcomed the opportunity to update the Committee on the 
latest develop ments. The Ministry of Steel had  issued the Stainless  Steel Products (Qua lity 
Control) Order 2016 on 10 June 2016, based on the draft notified to the WTO and covering  three 
products under IS:5522, IS:691 1 and IS:15997. The order was available on the Ministry' s website  
and would come into force three months after the date of publication in the official Gazette. The 
Quality Control Order aimed  to ensure the quality and durability of stainless steel products 
intended for critical end -use applications. Many of the steel products were also  used as final 
products. He pointed out that t he order applied equally to both domestic and foreign 
manufacturers. Regarding the  concern raised on the additional cost burden for steel companie s, 
his delegation reported that the BIS cost of certification involved  marking fee, testi ng charges and 
other nominal charges  and was comparable to the fees charged by other Members in similar 
schemes. On the requirement of tes ting by BIS -recognized labs, such testing was carried out as 
per the test methods and requirements defined in Indian S tandards.  
3.308.   Concerning a  suggestion made by the EU delegation that steel mills operating with the ISO 
9001 quality management system should be exempt from the requirement of factory inspections , 
India was of the view that product certification differed  from QMS certification. Visits to factory 
premises as well as on -site verification testing  were part of the BIS Conformity Assessment 
Scheme. On the other hand, ISO 9001 certification did not cover factory testing as per Indian 
Standards.  All remaining concern s and suggestions would  be forwarded to the relevant Indian  
authorities for consideration.  
3.2.3.40    India - Draft Food Safety and Standards (Alcoholic Beverag es Standards) 
Regulations, 2015, G/TBT/N/IND/51  (IMS ID 494)  
3.309.   The representative of the European Union , recalling its concerns raised at the March 2016 
TBT meeting as well as written comments on the notified draft provided in January 2016, asked 
India to update the Committee on the current state of play  and to explain  how and to what extent 
India had  taken Memb ers' comments into account.  He reiterate d that, due to a number of 
inconsistencies between the notified draft and current international practices , notably the 
oenological practices and definitions as set by the International Organisation o f Vine and Wine 
(OIV) and Codex , there wa s an expectation that , in order to be fu lly in line with Article  2.2 of the 
TBT Agreement, India would align  its draft alcoholic beverages regulation with those international 
practices and standards.  In particular, r egarding wines , the notified draft established  that alcohol 
content in wine should not be more than 15.5% by volume. Some wines actually exceed ed that 
limit and, as OIV did  not provide for maximum alcohol strength in wines , India wa s recommended 
to remove such a limit. Moreover, t he content of sugar, as set in the notified draft related to ''dry'', 
''medium'' and ''sweet'' wine , was also not in line with the OIV standard. Regardin g beers, the 
notified draft set  a maximum level of 8% alcohol by volume whereas the maximum al cohol by 
volume level which may be obtained with traditional brewing (i.e. without fortification)  was in the 
range of 15 to 18%. Furthe rmore, the notified draft limited  the type of flavours that could  be used 
in the production of beers to natural flavours.  The EU recommend ed that  those requirements be 
amended.  Regarding spirits, a maximum al cohol content of 50% by volume wa s fixed in the 
notified draft for some distillates  and the definitions/requirements for prod ucts such as brandy and 
cognac we re not in l ine with OIV standa rds. For other spirits such as vodka and w hisky t he Indian 
requirements we re not in line with widely accepted practices. In this context, and in order to avoid 
unnecessary restrictions in international trade, the EU recommended that India align its 
requirements to OIV standards when available and, in the ir absence, to align its requirements to 
widely accepted practices.  
3.310.   The EU representative invite d India to fully align its labelling provisions with the Codex 
standard for the labelling of  pre-packaged foods (CODEX STAN 1 -1985) and to modify and clarify 
the proposed ''allergen and health warnings''.  Regarding  the list of additives allowed in the 
production of alcoholic bevera ges, the European Union welcomed  India's statement at the March 
2016 meeting that the list of additives would be amended , and requested  an update on the  
matter.  Finally, the EU asked the Indian authorities to provide a reasonable transition period for 
manufacturers to comply with the new provisions and to allow the sale of products already present 
on the Indian market until exhaustion of stocks.  
3.311.   The representative of the United States , while voicing support for India' s efforts to develop 
safe and effective standards for regulating alcoholic beverages, expressed concern th at there we re 
a number of areas where India  had proposed standards that fe ll outside of widely accepted G/TBT/M/69  
 
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  international norms and standards, and may restrict trade more than necessary.  Following up on 
comments submitted in February, she noted that the Indian  standard set  a number of 
compositional limits f or which standards did  not exist in Codex Alimentarius , for example, chemical 
contaminants in alcoholic beverages. India also set limits with regard to pH, carbon dioxide, and 
sugar levels that seem ed to pert ain to the quality of alcoholic beverages more than the safety  
thereof . Her delegation would welcome an update on whether India intended  to include a number 
of additives commonly used in winemaking in the list of permitted additives , and in particular 
sought a response to specific additives requests the US had  included in its comments on 
G/SPS/N/IND/108 , G/TBT/N/IND/51 and G/SPS/N/IND/119, submitted the previous year.  Further, 
India was asked to provide  scientific justification for these limits , as well as reference to specific 
scientific studies if any had been used in setting them.  
3.312.   Her delegation was also concerned with the labelling r equirements associated with the  
measure and asked India to clarify whether stickers would  be allowed to be placed on alcoho lic 
beverages at port before the items went through customs.  She reiterated her delegation's request 
for a response to comments submitted on 1 February on o ther important issues and concerns , 
including  irregular serving size measurement s, limits for alcoho l by volume (abv) that would 
prohibit many ciders, wines, and distilled spirits from being exported to India, and several 
compositional requirements that were either unclear or of concern . In summing up, she flagged 
her delegation's readiness to discuss th e process India had followed in order to create this 
standard.  Had India considered existing regulations of other countries and international standards 
on alcoholic beverages? Her delegation would welcome the opportunity to explain its own 
regulations and the rationale behind their formation.  Finally, the US requested a timeline for 
implementation of the measure, the provision of an adequate transition period to allow industry to 
comply with the measure, and an indication of when India planned to release an  updated list of 
allowable additives, as it had committed.  
3.313.   The representative of Canada  announced that his delegation continued  to follow the 
development of India' s proposed regulation , and encouraged India to ensure that it was  not more 
trade restrictive than necessary to meet its legitimate objectives and did not discriminate among 
like products. He asked India to confirm whether its intention wa s for the proposed regulations to 
supersede existing standards for alcoholic beverage s manufactured or sold in India. He further 
noted that India wa s proposing to limit the range for alcohol content for whiskies from 36% to 
50%; however, as certain types of whisky exceeded 50%, he requested the removal of this 
limitation.  
3.314.   The representative of New Zealand  expressed  her delegation's belief  that wine should be 
seen as a sin gle ingredient product and noted  that numerically based labelling requirements such 
as the numerical definitions of wine categories fail ed to take into account both seasonal and 
regional variants in  wine production, thereby constituting an unnecessary burden on particular 
wine producers. Her delegation looked forward to hearing how India planned to  respond to the 
concerns of wine producers and importers and requested  an update on how comments made by  
Members in March had  been taken into account.  
3.315.   The representative  of Australia  reported that the Food Safety Standards Authority of India 
had recently met with Australia' s Agriculture Counsellor in Delhi and that progress had been made 
on the  issue. His d elegation also looked forward to India's favourable response to comments 
submitted on 28 January 2016.  
3.316.   The representative of Chile thank ed India for the meetings held in Delhi between Indian 
regulatory authorities and the Chilean  agricultural delegate. His delegation had also submitted 
comments with regard to the standards and regulations of India and suggested the possibility of 
separating brandy and pisco within the classifications of alcoholic beverages. He thanked India for 
its replies and encourage d them to continue moving towards international standards in the OIV 
and the Codex , as well to incorporate their concerns and comments into the development of the 
regulation.  
3.317.   The representative of Japan  echoed concerns raised by other Members and recalled Ind ia's 
announcement at the previous  meeting that the draft measure was still under consideration by the 
Indian authorities pending finalization and that comments were being considered appropriately in 
finalizing the measure. In this light, Japan requested an update on the status of the revision of the 
regulations as well as a  timeline for adoption  and urged India to take into consideration Japan's  G/TBT/M/69  
 
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  comments on notification G/TBT/N/IND/51  whilst ensuring  the consistency of the proposed 
regulation with internati onal standards and practice . 
3.318.   The representative of South Africa , whilst support ing India' s endeavours to provide its 
citizens with safe and high quality alcoholic beverages, remained concerned th at the draft 
regulation contained  provisions that were not in  line with the oenological practices and definitions 
set by the OIV, the ISO and Codex. As India wa s an important market for South African alcoholic 
beverage exports, his delegation request ed India to amend the draft regulations in line with the 
internatio nal standards as developed by the OIV, ISO and Codex , in accordance with the obligation 
under Article 2.4 of the TBT Agreement . 
3.319.   The representative of Guatemala  expressed her delegation's systemic interest in the  topic, 
and committed to  following discussion s closely on the measure.  
3.320.   The representative of India recalled that the FSSAI had published the "Draft Food Safety 
and Standards (Alcoholic Beverages Standards) Regulation, 2015" on its website on 29 Oct ober 
2015, seeking  comments from all stakeholders, fo llowed by its notification document 
G/TBT/N/IND/51 with a 60 -day comment period . The draft measure was still under consideration 
by the Indian authorities  pending  finalization. He assured that all comments and suggestions 
submitted by Members and stakehold ers would  be duly considered at the time of finalization of the 
Draft Regulation , after referral  to the Scientific Panel. Further, his delegation inform ed that in 
addition to the food additives already permitted by Indian  regulations for inclusion in alcoh olic 
beverages , a further list of additives in alignment with OIV s tandards had  been approved by the 
Indian Food Authority, and would be notified to the WTO in due course . Finally, in response to 
questions on a l ikely date for adoption, he inform ed that th e measure would probably be finalized 
within the year, after due consideration of  comments by all Members and stakeholders.  
3.2.3.41   Indonesia - Halal Product Assurance Law No. 33 of 2014  (IMS ID 502)   
3.321.   The representative of the United States  expressed gratitude to  the Indonesian 
Government, including the Ministry of Religious Affairs, for bilateral meeting s held in Geneva and 
in Jakarta.  Her delegation recognize d the importance for Indonesian consumers of knowing 
whether products are halal and expressed its commitm ent to work ing with Indonesia  to ensure 
that, once the law was implemented, this objective would be achieved without creating any 
unnecessary barriers to trade.  She reiterated her delegation's hope that previously raised concerns 
would be addressed in the implementing regulations . It was her delegation's understanding that 
the Ministry of Religious Affairs, in conjunction with a number o f other government ministries, wa s 
currently drafting the new implementing regulations ; an update on their content and sta tus was 
welcomed . Finally, the US  urged Indonesia to ensure that drafts be submitted to the WTO TBT 
Committee prior to being finalized in order to allow for sufficient notice and comment from all 
stakeholders and to allow time for those comments to be take n into account.  
3.322.   The representative of New Zealand  noted  that some  issues in the draft regulation  still 
remain ed unclear, and welcome d the opportunity to learn more and to provide feedback on the 
draft. She also note d Indonesia' s obligation to notify regul atory changes to the WTO, and recalled 
that the current initial implementation date mentioned in the draft was 1 Nov ember  2016 for food 
and beverages . Her delegation asked Indonesia to ensure that WTO Members would be  given 
adequate time to comment on the  issue.  
3.323.   The representative of the European Union  shared concerns raised by the US and New 
Zealand, and considered that the draft law had  a very broad scope , affecting , inter alia , food and 
beverages, pharmaceuticals and cosmetics. His delegation understood that t he law would require 
mandatory h alal certification, which would imply significant additional costs for economic 
operators , and that it would be implemented gradually and enforced as from 2019. However,  
certain halal requirements had  already been set out in separate regulations ( i.e., for imports of 
carcasses and meat). The EU considered that t he lack of transparency on implementing rules and 
this fragmented approach create d uncertainty as to which  requirements were applicable at any 
point in time. According to recent information, a draft implementing regulation would be si gned 
and published in July 2016; his delegation would appreciate information on any developments in 
this respect and on the time frame for the ad option of the said regulation. He furt her noted the 
EU's request that Indonesia notify the law, i n accordance with Article 2.9 of the TB T Agreement , as G/TBT/M/69  
 
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  well as any subsequent implementing rules, and allow reasonable time for Members'  comments to 
be taken into consideration. Finally, t he EU requested  clarification on whether the provisions on 
mandatory labelling would also apply to non -halal products and on any other potentia l trade 
restrictions that the l aw may bring to such products.  
3.324.   The representative of Australia  urged Indonesia to comply wi th its international trade 
obligations and notify the Halal Product Assurance Bill and related regulations to the WTO , 
providing  an opportunity for trading partners to submit co mments. Australia was aware that 
Indonesia' s Ministry of Religious Affairs had  issued a decree establishing a new halal certification 
body (BPJPH) , which would  come into effect fro m 1 November 2016.  His delegation requested 
confirm ation that interim arrangements would  be put in place to ensure that imports from 
1 November 2016 would not be adversely affected.  Would  the halal standards applied by BPJPH be 
the same as the standards cu rrently applied by Indonesia' s existing halal certification body?  
3.325.   The representative of Indonesia  explained that Law No. 33 of 2014 on H alal Product 
Assura nce addressed  certain aspects regarding halal standards , including obtaining a halal 
certificate. The halal standard ensured  the certainty of halal products for public consumption  and 
had been created in accordance with well -known international principles of protection, justice, 
assurance, accountability, transparency, effectiveness and efficiency. She pointed out that the law 
covered food, beverages, drugs, cosmetics, chemical products, biological products and genetically 
engineered products in which the e lements and process followed the Sharia to en sure that 
products were  halal for consumption  and utili zation . Implementation of the law would be divided 
into three stages: firstly food and beverages, secondly cosmetics, chemical products, and 
genetically eng ineered products, and finally drugs and biological products.  
3.326.   She reported that Indonesia was  in the process of establishing an agency responsible  for 
providing halal certification  (Implementing Agency of Halal Products Assurance)  which would  
collaborate wi th non -government institutions to make necessary arrangements for matters related 
to halal issues. The treatment of halal had to  be free of najis (defiled) and non -halal material at all 
times, in accordance with Codex General Guidelines for Use of the Term  "Halal" CAC/GL -24-1997. 
She further reported that  Indonesia wa s in the process of establishing the halal standard , namely 
RSNI for Halal Management System , i.e. RSNI 099001. The standard was being  developed by a 
technical committee on halal, involving rel evant stakeholders. Further procedures  related to the 
Halal Accreditation and Certification Scheme, including the conformity assessment , would  be dealt 
with by KAN (National Ac creditation Body of Indonesia) and public consultation with various 
stakeholders , including representatives from countries based in Jakarta , had recently  been 
concluded. As a follow -up process, the government would  develop regulation concerning 
Implementation of Halal Product Assurance.  
3.327.   Indonesia summed up by recalling that Quran and  Sunnah we re the primary indispensable 
normative references for the stand ards. Moreover, each country had  its own fatwa (school of 
thought) and fiqh for halal standard s, developed according the beliefs of each society; her 
delegation therefore encouraged M embers to respect the prevailing fatwa and fiqh in each c ountry. 
She reminded Members of Indonesia's willingness to work together,  in order to support and 
strengthen the multilateral trading system.  
3.2.3.42   China - Formula Registration Regulation fo r Infant and Fo llow-up Formula,  
G/TBT/N/CHN/1165 (IMS ID  493)  
3.328.   The representative of the Republic of Korea  raised a number of issues in respect of the 
Chinese measure at issue and recalled that her delegation had raised the matter at the March 
meeting of the Committee, bu t had not received an official response. Instead, the CFDA (China 
Food and Drug Administration ) had published the Regulation on its website on 6 June 2016 and it 
would go into effect  on 1 October  2016. While the Korean government fully underst ood the need 
for strict control of infant formula , there were several reasons for concern. First, a ccording to the 
regulation, infant formula products manufactured/distributed in or imported to China ha d to be 
registered at the CFDA. Article 8 stipulate d that an applic ant needed to  submit , inter alia , a 
formula composition research report and safety data , and Article s 13 and 14 rendered  on-site 
inspection and product quality test by a qualified agency compulsory. According to Article 9, one 
company could not register mo re than 3 series of products , and 9 product formula s. As such, the 
new regulation  restrict ed Chinese customers ' rights and freedom to select and purchase safe and G/TBT/M/69  
 
- 62 - 
 
  sanitary products. The a dditional cost and time needed for duplicate registration would  be a 
burden to exporting companies  and could pose an unnecessary barrier to trade . 
3.329.   She explained that products being exported to the Chinese market had been  assessed by 
the Certification and Accreditation Administration of China (CNCA) during the site -inspectio n in 
2014 and facilities and formula composition had been  registered. In other words, all Korean dairy 
product exporting companies had been  audited by the CNCA in 2014 and information , including 
formula compositions , had been  submitted to get registration of facilities of exporters, product 
types and individual products. Therefore, the requirement of registration at the CFDA for infant 
formulas in accordance with the new Regulation, including repeated submission of data and on -site 
inspection, was duplicati ve.  
3.330.   Accordingly, the Korean Government made the following requests: China was (i) asked to 
recognize the Korean formula products (and their compositions ) previously assessed and 
registered by the  CNCA in 2014 after the CFDA 's new regulation came  into effe ct; (ii) asked to 
simplify the registration process for new infant and follow -up formula product compositions in 
order to ensure  that on -site inspection and expert assessment s were not duplicated ; and (iii) was 
requested to allow registration of new formul a products through scientific demonstration of 
ingredients and compositions without limitation on the number of brands or formula compositions, 
if obvious differences in ingredients were scientifically demonstrated . 
3.331.   The representative of the European Union  continue d to have serious concer ns about some 
aspects of the draft measure . First, the limitation : the draft measure  appeared to apply to each 
company setting a maximum of 9 recipes within 3 product lines. This was a major concern for the 
EU as it would h ave a serious and unnecessarily negative trade impact on current exports from the 
EU to China. The impact of such a limitation would be aggravated by the fact that the limitation fell 
on production companies  – these would be deprived of the possibility of serving major brands of 
infant formula that, as outlined above, currently rel ied on them as production partners for their 
products.  It was estimated that, without modification of this article, the number of brands on the 
Chinese market would be reduced by 80%. The EU could not find a justification for this limitation, 
neither on the basis of food safety nor on the basis of other legitimate objective s. China was 
therefore requested to remove it.  
3.332.   Second, the inspection regime would imply on -site inspections by the Chinese agency 
CFDA, which would be added on top of other inspections by other Chinese agenc ies (AQSIQ/CNCA) 
in accordance with China Food Safety Law. Therefore the EU wishe d to renew its request to China 
to consolidate these inspections.  Third, the  EU consider ed that the new registration and approval 
procedure require d an appropriate transition time (from the current system ) in order to avoid 
disruption of trade . A period of 18 months seem ed reasonable. In this regard, the recent 
publication by CFDA  of a revised measure to become applicable on 1 October 2016  was of great 
concern  to the EU . It was unclear how companies could  continue to place products on the market 
without an appropriate transition period.  
3.333.   The representative of Japan  shared the conce rns raised by the EU and Korea. In Japan's 
view, how th e regulation would contribute to achieve a legitimate objective based on scientific or 
other related information  needed to be assessed . Replies received to date from China were not 
satisfactory. China was requested to reconsider the quantitative limitation of the product 
registration  and take into account that the regulation would seriously restrict the business 
opportunities for manufacturers in Member countries . 
3.334.   The representative of New Zealand  said that China was a major export market for New 
Zealand, including for infant formula. New Zealand note d that the regulation ha d recently been 
published and look ed forward to working with CFDA to ensure a smooth transition to the new 
regulatory environment fo r imported products.   
3.335.   The representative of the United States  said that her delegation had provided comments 
on 4 March , and US industry had also provided comments and were still waiting to hear a reply. 
The US want ed to ensure that trade would  not be disr upted and to gain a full understanding of 
China's draft measure as the process mov ed forward. The US remained  concerned about the issue 
of limitations on the production of different brands, the potentially duplicative inspection G/TBT/M/69  
 
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  requirements and the need f or clarification on the coverage of what age groups for formula this 
measure would  apply to.  
3.336.   The representative of China  explained that China attache d great importance to the safety 
of infant formula milk and powder quality. Infant formula milk powder ha d always been the most 
stringently regulated food in China. China 's infant formula milk powder market was very different 
from foreign ones. On the one hand, China  had great market demand and rapid industrial 
development in this area ; on the other hand, many  problematic situations appeared, such as 
consumers ' confusion caused by too many brands and formula s. China had issued the Formula 
Registration Regulation for Infant and Follow -Up Formula to urge enterprises to improve R&D 
capabilities, and prohibit the u se of exaggerated advertisements to mislead consumers.  This 
regulation would  further regulate China 's infant formula milk powder market to ensure high quality 
of milk powder. In fact, it was also beneficial to the development of related enterprises, both 
domestic and abroad.   
3.337.   The representative of China noted that b efore drafting th e regulation, China had  carried 
out research in infant formula milk powder.  Theoretically, she noted, infant formula milk powder 
should only be the nutritional supplements to bre astfeeding. Therefore, the composition of infant 
formula milk powder should be similar to breast milk and there should not be too many formulas. 
Also, research  data reflect ed that, in general,  large foreign infant formula milk powder 
manufacture rs had no more than three  brands in production and sales.  
3.338.   To address Members ' concerns about  on-site inspection, China  clarified that the on -site 
inspection mainly focuse d on the R&D data of milk powder formulas and manufacturers ' capacity 
to turn formulas into prod uction. It focuse d on different aspects compared to the systematic 
inspections held in the past. China had also noted Members ' concerns on possible duplicative 
inspections. China would endeavour to avoid such duplication by more internal communication. 
The regulation had been notified in January 2016 and had offered a 60-day comment period and a 
transition period of more than six months  – the transparency obligations under the TBT Agreement  
had thus been fulfilled . 
3.2.3.43   Russia - Rules of cement certification , G/TBT/N/RUS/48 and 
G/TBT/N/RUS/49  (IMS ID 497)  
3.339.   The representative of the European Union  recalled that having  raised the  issue during the 
March 2016  meeting of the Committee,  Russia had notif ied on 8 March 2016 , as G/TBT/N/RUS/48, 
the Gov ernment Resolution No . 930 of 3 September 2015 "On A mendments of the Single List of 
Goods Subject to Mandatory Certification" adding cement to the list of goods subject to mandatory 
certification. Russia had also notified the Order of Federal Agency for Technical Regulation 
(Rosstandart) No. 1 -st of 11 January 2016 "Conformity assessment. Rules of cement certification" 
(GOST standard 56836 -2016), on 12 April 2016 as G/TBT/N/RUS/49, setting out the relevant rules 
for cement certification. However, both measures had already  been adopted and were in force at  
the time of their notification . The EU therefore asked Russia to suspend the measures and re -
notify them under the TBT Agreement at a draft stage, allowing WTO Members' comments to still 
be taken into account.  On the content of  the measures, the EU raised several concerns.  
3.340.   Section 8.2 , fourth sentence , of the notified GOST standard provided that for imports from 
third countries the certification body should conduct additional inspection control s of each batch of 
cement. This in cluded sampling at the border, as well as the testing and control of all 
characteristics  set out in the standard according to which the certificate of conformity had been 
granted. On the basis of the results, the certification body had to make a decision as to whether to 
confirm, suspend or terminate the certificate of conformity.  It was the EU's unders tanding that this 
provision set  a requirement for "additional inspection control" of each cement batch arriving in 
Russia from third countries, including sam pling at the border, testing and checking according to 
the standard. The EU asked Russia for the reasons and justification for such a requirement and 
underlined that the presence of additional requirements for conformity assessment affecting only 
imported products might contravene both Articles 5.1.1 and 5.1.2 of the TBT Agreement.  
3.341.   In relation to the additional inspection controls, the EU raised further  questions:  (i) what 
was the meaning of shipment (whether it would mean each wagon, whole train or yearly  
production); (ii) by whom and how would these samples be taken from imported cement; (iii) how G/TBT/M/69  
 
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  would the tests be performed, their length and whether after sampling and testing, the imported 
cement would be allowed to proceed further to the unloading poin t and/or to the end consumer , or 
whether the imported cement would be held at the border until the results of the testing were 
known and a decision on the certificate of conformity was taken (whether it should take on 
average 28 days).  
3.342.   The EU also request ed a clarification on the following issues. First ly, it requested 
confirmation that  the certificates issued by a certification body ha d to be registered with 
Rossacreditation. If the answer was positive, Russia should clarify  the reasons for which such a 
registration should be  refused or delayed . Secondly, the EU asked Russia to clarify whether the 
certification bodies ha d to be registered with and empowered by Rossacreditation to issue 
certificates of conformity under the notified GOST standard.  
3.343.   The repres entative of Mexico  thank ed Russia for the bilateral meeting they had held on 
15 June 2016 an d share d some of the concerns expressed by the EU. She noted that Mexico would  
follow up on this STC.  
3.344.   The representative of the Russian Federation  recalled  that t he Government Res olution No. 
930 of 3  September "On A mendments to the Single List of Goods Sub ject to Mandatory 
Certification"  had added cement to the above -mentioned list. He further stated that t he resolution 
had been  notified to the WTO under  document G/T BT/N/RUS/48.  The necessity for inclusion of 
cement in the list of goods subject to mandatory certification had been  determined by a sharp 
decrease in cement quality in the Russian Federation and by the urgent problems of safety, health 
and environmental pr otection.  The new standard GOST -R had been  adopted by the Federal Agency 
for Technical Regulation and Metrology and notified to the WTO under  document G/TBT/N/RUS/49.  
The l ists of certification bodies and of issued certificates we re available on the websit e of the 
Federal Accreditation Body.  Russia  noted that following the entry into force of Regulation No. 930, 
more than 250 certificates ha d been issued to date, including certificates for cement imported to 
the Russian Federation from WTO M embers.  Russia h ad taken note of concer ns raised by the EU 
and Mexico and would  continue to work with them as  well as with other interested M embers on 
this matter.  
3.2.3.44   Thailand - Milk Code - Draft Act on Controlling to the Marketing Promotion on 
Food for Infant and Young Chil dren and Other Related Products BE , G/TBT/N/THA/471 
(IMS ID 503)  
3.345.   The representative of the United States  said that, while her delegation strongly supported  
efforts to ensure that the marketing of infan t and follow -up formulas would  not nega tively impact 
breast feeding, it nonetheless  remained concern ed with the following aspects of the Thai  measure 
at issue. With respect to the use of international standards, she noted that there were several 
Codex Alimentarius standards that were  relevant to this measure, including one for  infant formula 
and formulas for special medical purposes intended for infants. There were, more specifically, 
standards for follow -up formula , canned baby foods  and processed cerea l-based foods f or infants 
and young children, as well as t he Codex G uidelines for nutrition and health claims. In this respect, 
she asked Thailand to explain how it ha d considered these existing standards , and why it ha d 
deviated from the m in certain areas. She also expressed her delegation's view that, conversel y, 
the new WHO guidance on ending the inappropriate promotion of foods for infants and young 
children20 was not an international standard in accordance  with the criteria established by the 
TBT Committee. She additionally noted, in this respect, that in the US the  adherence to the 
application of the 1981 WHO's International Code of Marketing of Breast -milk Substitutes  was 
voluntary. In the US, this International Code was also complemented by some more codes 
developed  by leading US medical professional societi es on the marketing of these products.  
3.346.   The US also had  questions about whether the regulatory approach outlined in the Thai 
draft measure could  be more trade restrictive than necessary. She request ed Thailand to provide 
the scientific explanation for its complete ban on the marketing and advertising of infant and 
                                                
20 Maternal, infant  and young child nutrition: Guidance on ending the inappropriate promotion of foods 
for infants and young children , Report by the Secretariat (doc. A69/7 Add.1, 13 May 2016 ), available at 
http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_7Add1 -en.pdf?ua=1&_ga=1.199082543.1886800211.1468765934 . See 
also WHA Resolution WHA69.9  (29 May 2016), footnote 1, available at  
http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_R9 -en.pdf   G/TBT/M/69  
 
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  follow -up formula for babies up to 36 months of age. More specifically, the US asked Thailand to 
provide the  scientific explanation of how a ban on health claims and trad emark information on 
labels would contribute to the accomplish ment of the desired goal of increasing and sustaining 
breastfeeding in Thailand's specific context . She also asked for available information on any 
assessment Thailand made  with respect to the potential regulatory impact s of the proposed 
measure. Additionally , she noted that the draft  provided for the punish ment of  violation s of its  
advertising and ma rketing requirements under the T hai criminal code , including the imposition of  
prison time for certain offences. She then a sked Thailand to provide the  reasoning behind 
imposing such criminal penalties as well as any additional detail with respect to t he procedures for 
prosecution.  
3.347.   Finally, the US request ed Thailand to allow for sufficient time , both  after the publication of 
the final rule and before implementation and enforcement of the regulation , so that industry would 
be able to come into compliance  with the new requirements . In this respect, she also asked 
Thailand to confirm if it was indeed planning to provide for a 180 -day transition period following 
ratification.  
3.348.   The representative of Australia  noted that  the Thai draft measure propose d measures that 
had similarities to new WHO g uidance on ending the inappropriate promotion of foods for infants 
and young children, wel comed by WHO members, including Australia, at the World Health 
Assembly last month.21 He explained that in Australia the marketing of infant formulas was  
conducted under th e auspices of a voluntary, self -regulatory Code of Conduct between 
manufacturers and importers of infant formula. This Code of C onduct app lied to the marketing and 
promotion of formulas for infants up to 12 months of age only. Australia recognise d, however,  that 
countries regulate marketing of infant formulas in different ways so as to sui t their own national 
circumstances. As a reliable supplier of high quality dairy products to Thailand, Australia would 
encourage Thailand to develop and implement standards for the marketing of food for infants and 
young children in a manner that would be  as trade f acilitating as possible. In this respect, Australia 
was concerned about the allowance for unspecified Ministerial requirements on marketing products 
under the legislation. Australia also asked Thailand for clarification on whether the proposed 
regulations would exclude nutritional labelling  on products. Australia also requested  more time for 
exporters, importers and manufacturers to adapt to  Thailand' s new regulation.  Finally, he 
underscored Australia's belief in promoting harmoni zation with relev ant Codex standards in this 
area. 
3.349.   The representative of the European Union  express ed his delegation's  concern s with this 
draft regulation , in particular, as regards certain definitions, which would either deviate from the 
releva nt Codex Alimentarius standa rds, or whish, in some cases,  would seem redundant. The EU 
also asked Thailand to explain more clearly  the rationale for setting out certain restrictions  in the 
proposed measure . Finally, t he EU asked Thailand to  reply to the written comme nts submitted to it 
in February 2016.  
3.350.   The representative of New Zealand  noted that Thailand was  an important export market 
for New Zealand products, including in particular infant formula products. She said that she looked 
forward to an update as to how comment s her delega tion had already sent to Thailand bilaterally 
had been taken into account.  
3.351.   The representative of Thailand  informed that the draft measure was  still undergoing its 
legislative process . Thus , he said, the estimated time-frame until its adoption could only be  
confirmed at a later stage. Further, a s the draft measure was notified at an early stage, Members'  
comments submitted previously had already been taken into account in the revision of the draft by 
the Ministry of Public Health. He said that this measure  aimed to protect , in a non -discriminatory 
manner,  the health of mothers and children . This measure was therefore in full compliance with 
the TBT  Agreement , including the obligations under Articles  2.2 to 2.6. Compliance with 
Article  2.4, in particular, stem med from the fact that  the proposed measure was developed based 
on the WHO's International Code of Marketing of Breast -milk Substitutes , as well as the relevant 
WHA R esolutions . Thailand considered this WHO instrument,  also known as the "Milk Code",  as an 
international standard for the protection  of children's health from the eff ect of BMS marketing 
practices. Thailand further  believe d that the new WHO g uidance on ending the inappropriate 
promotion of foods for infants and young children , together with a recently adopted 2016 WHA 
                                                
21 See previous footnote.  G/TBT/M/69  
 
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  Resolution22, stipulated  clearly that follow -up formula and growing -up milk that were marketed for 
feeding infant and young children up to the age of three , were all  breast -milk substitu tes that 
should not be promoted. Moreover, the advertisement of milk products that were marketed as 
suitable for children over the age of 12 months may be used to cross -promote the products for 
younger children. Thus, under the proposed measure, products intende d for young children of ages  
one to three  would  be regulated together with infant formula . Thailand thus intended  to follow the 
recommendation of the Milk Code , similar ly to other countries that ha d already implemented the 
regulation to control the marketing promotion of food products for childre n up to 36 months, or 
even 60 months.  
3.352.   He also clarified that the notified draft measure did not regulate trademark information on 
labelling  so as to respect intellectual property rights . Moreover, after reviewing the draft with other 
related  agenc ies, and  taking into account comments  received by Members, Thailand ha d revised 
the draft so that  the section on labelling requirements had been removed. Thailand also believe d 
that the rev ised measure on health claims complied  with Codex Guidelines for Use of Nut rition and 
Health Claims. Additionally, he clarified that the  draft proposed a different level of monet ary fines 
for those who violated  the marketing requirements. However, there would  not be prison time for 
any violation of these r equirements. S imilar ly to the penalty clause in many other Thai laws  (e.g., 
the Food  Act and the Public Health Act), under the proposed measure, imprisonment would only 
occur for those who failed to comply with summons , or those who obstruct ed officials in 
performing their duty.  
3.2.3.45   United Arab Emirates - Control scheme to restrict the use of hazardous 
materials in ele ctronic and electrical devices , G/TBT/N/ARE/265 (IMS ID 496)  
3.353.   The representative of the European Union  said that his delegation shared the UAE's 
objective of protect ing human health and the environment. Nonetheless he wished to raise the 
following  issue of concern to his delegation. Firstly, r egarding the lists of exemptions in Annexes 3 
and 4 of the notified draft, the EU noted that they did  not include many relevant exem ptions 
included in similar regulations on the restriction of the use of certain hazardous substances in 
electrical  and electronic equipment, as was the case in the EU's own legislation on the matter. In 
particular , exemptions for the use of m ercury and oth er substances currently used for the 
production of light sources,  such as  bis (2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate 
(BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) , would be forbidden without 
appropriate transition, which w ould certainly disrupt trade in this area.  Secondly, r egarding the 
enforcement of the restrictions laid down by the notified draft, the EU note d that Articl e 4.1 wa s 
unclear and d id not specify whether the restrictions listed in Annex 2 only appl ied when t he 
electrical and electronic devices we re placed on the market for the first time or also to the 
following marketing stages. Therefore, the EU requested  the UAE authorities to clarify whether and 
how the rest rictions listed in Annex 2 applied  to electrical  and electronic equipment already on the 
market. The r e-use, refurbishment and extension of lifetime of products already on the market 
were beneficial for the protection of the environment. Spare parts therefore need ed to be 
available. In this respect, the  EU ask ed the UAE authorities whether exceptions for the repair of 
products placed on the market before the application of the notified draft could be considered. 
Thirdly,  the EU highlight ed that in Article 9.4 of the notified draft the list of exemptions in Annexes 
3 and 4 related to "products", instead of "applications in a product" , whereas the headings of 
Annexes 3 and 4 refer red to "applications "; explanation was sought as to the exact scope of 
application of the exemptions at hand.  Fourthly, regarding  the procedure for conformity 
assessment, the notified draft refer red in Article 5 to "Model A"  and to a submission to the 
Emirates  Authority for Standardization and Metrology (ESMA); in Article 6 to registration;  and in 
Article 8 to an application. Clarification was sought on the exact procedure for the placing on the 
market of products following the assessment by the manufacturer and the drawing up of a 
Declaration of Conformity, and in partic ular on whether a prior authoriz ation by the UAE 
authorities was required. Finally, the EU request ed an update on the status of the measure.  
3.354.   The Chairperson  took note of the EU's statement and asked that their concerns be brought 
to the attention of the UAE.  
                                                
22 See previous footnote.  G/TBT/M/69  
 
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  3.2.3.46   European Communities – Regulation on the Registration, Evalu ation and 
Authorization of Chemicals (REACH)  (IMS ID 88)  
3.355.   The representative of Canada  expressed concern about several aspects of the REACH 
regulation affecting SMEs negatively, in particular the "Only Representative" (OR) and  "Letter of 
Access" (LoA) prov isions and upcoming 2018 registration deadline for substances manufactured or 
imported in quantities from 1 to 100 tonnes.  Canada had raised concerns in this regards before.  
3.356.   The cost for substance LoA was exceedingly high for some Canadian exporters for t heir 
volume of business ( the LoA cost to register eight substances , for example,  exceeded EUR 200,000 
for an enterprise doing CAN$2.5 million in annual business ), while t he requirement to register  
would not exist if substances we re purchased in the EU, exp orted to Canada, and then re -imported 
to the EU . In addition, it seemed that a number of lead registrants and OR consultants were using 
their position to freeze out late entrants and non -EU SMEs, trying to use the LoA and OR processes 
for economic advantag e. Canada asked the EU to explain the process for appealing /applying  
excessive LoA fees, why Substance Information Exchange Forums (SIEFs)  were permitted to use 
the LoA process to effectively freeze out non -EU SMEs or  late entrants to the EU market and urg ed 
the EU to ensure that SEIFs were not permitted to do so. Canadian SMEs had approached REACH 
helpdesks and would appeal LoA fees in due course. Canada stated that the EU should do more to  
ensure that SMEs and late entrants to the EU market were not undul y affected by these  
administrative and anti -competitive processes, which were not adding to the goals of the 
regulation.  
3.357.   Canada also suggested that the EU consider extending the number of low -risk substances 
exempt from registration under Annex V of REACH , including substances for which the psycho -
chemical properties were extremely well -known and traded in high volumes. Canada asked the EU 
what the process would be to nominate such substances. He also referred to the planned "fitness -
check" of REACH, which  was to include a review of support measures for SMEs, registration 
requirements for low tonnage substances, and the effect of the regulation on competitiveness of 
SMEs and downstream users. Canada asked the EU for more information on the time -frame for th e 
public consultation, which was part of the "fitness -check".  
3.358.   The representative of Israel  recognized the EU's objective to  protect human health and 
environment from risks posed by chemicals , but supported Canada's concern regarding the fact 
that some pro vision s of the REACH regulation were more trade restrictive than necessary to 
achieve the objective. Israel referred to high costs of compliance, the administrative burden and 
lack of clarity on the obligations affecting Israeli manufactures and exporters,  both SMEs exporting 
low volumes of chemicals to the EU and larger companies that exported small amounts of a 
specific chemical. She asked that the EU provide more transparency and clarity on these matters 
and to consider how to avoid trade -restrictive imp acts of REACH.  
3.359.   The representative of the European Union  stated that third countries' manufacturers 
exporting to the EU and domestic manufacturers  were not treated differently under REACH. 
Importers or third countries' manufacturers u sing an OR  were subjec t to the same registration 
requirements as the EU producers of the same substance.  He noted that all substances to be 
registered in the lowest tonnage band (1 -10 tonnes/year) benefit ted from reduced registration 
obligations . Reductions on registration fees  of up to 95% were provided for micro enterprises in 
comparison with big companies. The European Commission acknowledged that obligations under 
REACH did burden SMEs and, in this respect, the Commission had already taken corrective 
measures. I n January 201 6, the Commission adopted an Implementing Regulation on joint 
submission of data and data -sharing under REACH , increasing transparency of data and cost -
sharing in SIEFs and thereby preventing abusive practices related to the price of LoA, in particular 
towards SMEs.  G/TBT/M/69  
 
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  3.2.4   Exchange of Experiences  
3.2.4.1   Thematic session s on Standards and Regulatory Cooperation between Members  
3.360.   The Chairperson  asked the three moderators of the thematic sessions to provide their 
summary reports.23  
3.361.   The representative of the Secretariat  repor ted on the teleconference arrangement used in 
order to enhance participation of capital -based delegates at the thematic sessions. He stated that 
capital -based officials had been allowed to listen -in (audio) to the discuss ion. Participation was 
limited . Loo king ahead, the Secretariat intended to improve this facility. He thanked the 
Committee for agreeing to provide the audio recordings on the website to facilitate the interest of 
a wider audience.24  
3.362.   The representative of Chile thanked the Secretariat for the teleconference  arrangement  
which was important to his regulators. He stated that his regulators were also interested in the 
possibility of web -based streaming  in the future .  
3.363.   The representative of Canada  expressed appreciation for the teleconference arra ngement 
as it had facilitated enhanced capital -based participation, which had aided the Canadian delegation 
in Geneva in providing accurate answers to the questions posed by Members.  
3.364.   The representative  of Pakistan  appreciated the effort made by the Secret ariat; she hoped 
that it would be further pursued as it was a real and concrete wa y of enhancing capital -based 
participation.  
3.2.4.2   Topic of the next Thematic Session  
3.365.   The Chairperson  suggested the following topics for the thematic sessions in November: 
(i) transparency; (ii) technical assistance; and (iii) regulatory cooperation between Members. The 
first topic on transparency would include the Eighth Special Meeting on Procedures for Information 
Exchange which the Committee had agreed on at its 7th Triennial Re view. The mandate for the 
Eighth Special Meeting was pursuant to the Committee's 1995 decision which stated "regular 
meetings of persons responsible; or information exchange, including persons responsible for, 
Enquiry Points and Notifications are to be con vened". The transparency  thematic session , including 
the Eight h Special Meeting, would be held on 8 November 2016. There would also be thematic 
sessions on technical assistance and regulatory cooperation between Members. The Chairperson 
proposed that on tr ansparency the Secretariat would produce a first draft programme for 
discussion.25 On technical assistance, the Chair was open to Members ' proposals for speakers and 
presentations.  
3.366.   On the topic of regulatory cooperation between Members, the Chairperson rec alled that in 
the 7th Triennial Review Report, the Committee had agreed "to hold thematic sessions on 
regulatory cooperation between Members in June and November 2016 ". The intent of these 
thematic  sessions was to exchange experiences and allow for factual  information sharing. A 
number of specific proposals for topics had been made in the 7th Triennial Review Report, 
including on energy efficiency and food labelling. Given that the Committee had now covered the 
topic of energy efficiency, she proposed that it consider the topic of food labelling at its November 
2016 thematic session on regulatory cooperation between Members.  
3.367.   The representative of the European Union  said that the comfort zone for Members was 
narrower on this issue than on energy efficiency, and consideration needed to be given to the 
sensitivities of various delegations in the development of a programme. The EU's support and 
engagement would depend on the content and objective of the discussions. He indicated that, at 
this stage, the EU would  have been content to explore the identification of such comfort zones in 
order to organize a thematic session. He stated that a main topic for the discussions would be to 
raise awareness about activities in relevant international organizations  such as the Codex 
                                                
23 The summary reports are contained  in G/TBT/GEN/198 and G/TBT/GEN/199.  
24 The audio files was su bsequently made available on the WTO website at 
https://www.wto.org/english/news_e/news16_e/tbt_14jun16_e.htm  
25 A draft programme was circulated in a fax from the Chairperson on 26 August 2016.  G/TBT/M/69  
 
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  Alimentarius or the World Health Organization . The EU was aware of the number of STCs on the 
agenda concerning issues related to food labelling and cautioned that the Committee should not 
over reach , through the thematic sessions – as has been highl ighted during the 7th Triennial 
Review.  With this caveat, the EU would be happy to continue to the work with the Chair and 
interested Members.  
3.368.   The representative of Switzerland  supported the proposal. Reflecting on the session the 
Committee had held on en ergy efficiency, he said that it had been an informative and relevant 
event  where  delegations had engaged in a manner  that had focused Members' attention upon a 
specific relevant issue, which  was positive for the Committee . The aim for a session on food 
labelling, a comparable issue with global objectives, would be to share factual information and 
experiences with respect to on -going, new or emerging issues in that particular area. Switzerland 
had taken note of all the parameters that had been mentioned by the EU delegation and supported 
this approach . His delegation would work diligently in consultation with all interested Members 
during the summer to help elaborate the proposal for an outline of the thematic session. 
Switzerland welcomed all colleagues' pa rticipation and proposals to ensure a good discussion, 
giving due respect to Members sensitivities.  
3.369.   The Chairperson  noted the comments of the EU and Switzerland and reiterated that the 
intent of thematic sessions was to provide factual information sharing,  and to exchange 
experiences. She acknowledged that there had not been any strong objections to her suggestion 
but she recogni zed the Committee still had some work to do to ensure that all Members were 
comfortable with the approach taken as well as the pro gramme proposed for the thematic session. 
She would follow up on Members ' offers to work on preparing a programme for this thematic 
session. She intended to consult with Members over the summer and hold an informal meeting in 
September.  
3.370.   The representative of Chile said that the topic was important to his country and hoped that 
the Committee would dedicate at least half a day to the discussion.  
3.2.4.3   Other Matters  
3.2.4.3.1   ePing  
3.371.   The representative of the Secretariat  informed the Committee that on 13 June 2016 it held 
an information session and presented, in collaboration with UNDESA and ITC, the main features of 
the pilot SPS/TBT Notification Alert System developed thus far. Delegations had also heard from 
the Enquiry Point of Uganda regarding their experience as a pilot country where the alert system 
had already been rolled out. Since the adoption of the Committee's recommendation for an alert 
system at the end of last year, the Secretariat had been working closely with UNDESA to build on 
an existing SPS/TBT notification alert system (called ePing) which UNDESA had already started to 
develop in light of needs identified in LDCs. The WTO had reached out to  the ITC to join the 
initiative since ITC had developed a variety of complementary trade information tools with large 
numbers of subscribers and worked closely with SMEs, expected to be amongst the main 
beneficiaries of the system. The three organizations were in the final phase of signing a tripartite 
MOU to anchor this collaboration. The objective of the initiative was to  offer a publicly available, 
reliable and sustainable service which enabled timely access to SPS/TBT notifications of interest , 
which could facilitate dialogue between  the public and private sector in addressing potential trade 
problems at an early stage. Delegations were encouraged to subscribe to the pilot version and to 
provide feedback via www.epingalert.org . The Secretariat intended to launch the alert system 
during the Committee's Special Meeting on Procedures  for Information Exchange, scheduled for 
8 November. Capacity -building efforts would continue after the expected launch in November and 
the Secretariat would offer online training via Skype to interested Enquiry Points.  
3.2.4.3.2   Private Standards  
3.372.   The representativ e of China , referr ing to Article 4.1 of the TBT Agreement, recalled 
concerns by Members about "private standards " and the trade impacts thereof during the previous 
reviews of the implementation and administration of the TBT Agreement. He recalled that duri ng 
the 5th, 6th and 7th Triennial Reviews, it had been agreed to exchange information and 
experiences on "reasonable measures" taken by Members to ensure that non -governmental G/TBT/M/69  
 
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  standardizing bodies involved in the development of standards within their terri tories, accepted 
and complied with the Code  of Good Practice . Considering current discussion s on the topic within 
the WTO and outside, China had commenced the process of drafting a paper on "Best Practice 
Guidelines regarding Private Standards ". It was in the interest of the whole Membership to 
encourage private standard setters and Members hosting such bodies to follow internationally 
recognized best practices in the preparation, adoption, application, certification, usage and 
supervision of private standa rds. The application of a voluntary "Best Practice Guidelines regarding 
Private Standards " by private standard setters and Members that hosted them could help private 
standards to make positive contributions to Members' economic, environmental and social 
progress while avoiding the creation of unnecessary barriers to trade. The representative of China 
invited interested Members to participate in this drafting exercise and assured Members that the 
drafting of this paper, and participation in the exercise its elf, would be without prejudice to the 
rights and obligations of Members under the WTO, or to the views expressed by any Member 
regarding the scopes of the relevant WTO Agreements.  
3.373.   The representative of India said that the proliferation of private standar ds was a reality in 
business today since these standards had been generally put in place to achieve some crucial 
objectives such as health, quality, safety and environment. They could become barriers to trade 
due to burdensome and non -transparent complianc e requirements. It was against this backdrop 
that India welcomed China's statement. He supported the basic idea elaborated by the delegation 
of China and expressed interest in being involved  in the proposed drafting exercise.  
3.374.   The representative of Egypt  said that, given the increasing importance of private standards 
to trade, an exchange of views would be very helpful to avoid creating unnecessary barriers to 
trade. She was interested in obtain ing more information from China on their proposal and to 
partic ipate in a discussion on this issue.  
3.375.   The representative of Brazil  expressed interest in China's efforts in this regard  and 
welcomed new ideas and approaches to generate a fruitful discussion on this matter.  
3.376.   The representative  of the Russian Federation  expressed appreciation for this effort to find a 
mutually satisfactory solution on the issue of private standards and guidelines. He stated that a 
broad and transparent discussion would be beneficial for the whole membership in light of the 
increased number of  private standards. He stated Russia's interest in working with China and other 
interested Members on this matter.  
3.377.   The representative  of South Africa  stated that private standards had been an issue that, 
from time to time, had arisen in the Committee's dis cussions but had not really been addressed 
fully. He expressed interest in contributing to this process. He noted that the SPS Committee had 
done work on this topic and asked if it would be possible to make available information or a 
briefing document from  a SPS colleague, within the Secretariat, to inform the TBT Committee on 
the progress within the SPS Committee on this matter.  
3.378.   The representative of Pakistan  supported China's initiative and expressed interest  in the 
drafting exercise. She highlighted that  market access was closely linked with this issue. Therefore, 
the development of parameters for private standards, based on established principles within the 
TBT Agreement, would bring transparency and stability to the system. She implored other 
Members to  be open to the approach.  
3.379.   The representative of the United States  cautioned that she thought it was premature for 
the Committee to discuss any reactions to this initiative considering a formal paper had not yet 
been presented to the Committee. She indicate d that she had spoken bilaterally with China about 
the initiative  and she thought the idea needed to be better shaped prior to any further 
conversation within the Committee.  
3.380.   The representative of the European Union  stated that an examination and discussio n of the 
paper could only be undertaken if and when it would be formally submitted to the Committee. 
However, the EU's position on this issue was well known and unchanged. Private standards, 
whateve r their definition or meaning (there wa s no agreement in t his regard , as discussions in the 
SPS Committee demonstrated ), were documents which did not meet the definition of standards G/TBT/M/69  
 
- 71 - 
 
  under the TBT Agreement, and, as such, were outside the scope of the Agreement and, hence, of 
the Committee's work.  
3.381.   The representat ive of China  reiterated that the drafting exercise was without prejudice to 
the rights and obligations of Members of the WTO, or the views of Members with respect to the 
scope of the relevant WTO Agreement. However, China understood the scope of Article 4. 1 of the 
TBT Agreement as relevant to private standards. He said that some Members  had varying views on 
this issue and highlighted that during the 5th and 6th Triennial Reviews , Members had raised 
concerns about private standards whereby the Committee agre ed on the need to further 
strengthen the implementation of Article 4 of the TBT Agreement.  
3.382.   The representative of Japan  expressed his view that , as stated by the EU, private 
standards did not fall under the scope of the TBT Agreement.  
3.383.   The Chairperson  sugges ted that the Committee consider this issue upon the circulation of a 
formal written proposal from China.  
4  TECHNICAL COOPERATIO N ACTIVITIES  
4.1.  The representative of the IEC updated the Committee on recent technical assistance 
activities. These included visits  by IEC regional directors to Botswana, Morocco, Namibia, South 
Africa and Tunisia. A training session organized by the IEC Asia Pacific Regional Centre had taken 
place in Singapore focussing on good electrotechnical standardization practices and the role of 
technical secretariats. The Philippines had also hosted a training session for experts at national 
technical committees. On conformity assessment, a seminar on IECX had taken place in Singapore 
and a seminar focussing on the  CB scheme, cables and househ old equipment had taken place in 
Azerbaijan. A webinar within the framework of affiliate conformity assessment status (ACAS) h ad 
also been held with Ecuador.26 
4.2.  The representatives of ARSO  and the UNECE  updated the Committee on their activities .27  
4.3.  The Secret ariat informed the Committee that funding would be provided by the WTO ITTC for 
a limited number of government officials to attend a Workshop on Transparency  taking place , back 
to back with the Committee's Eighth Special Meeting for Procedures for Informat ion Exchange  on 8 
November 2016.28 The objective was to provide additional  training on transparency provisions and 
on the various online tools, including the TBT Information Management System, the Notification 
Submission System and the new notification aler t system (ePing) . Invitations for this activity would 
be sent to eligible  Members and Observers through their permane nt missions . 
5  UPDATING BY OBSERVER S 
5.1.  The representative of the ACP said that the ACP Group had long recognized the enormous 
significance of no n-tariff barriers, and TBT in particular . The ACP had benefitted from the technical 
assistance support of the ACP -EU TBT Programme for a year and a half and this had led to an 
increase in TBT -related activities both in Geneva and in the ACP community in ar eas such as 
quality infrastructure. He thanked the ACP EU TBT Programme for its most valuable assistance to 
projects in capitals, at the regional level and in Geneva. The ACP group in Geneva was working 
with its members to make their work more effective in  the TBT Committee and acted as a platform 
for coordination, cooperation and communication on TBT -related matters.  This increased 
engagement would also benefit other WTO Members. He thanked the ACP -EU TBT Programme for 
its invaluable assistance and hoped t hat the work on TBT would continue beyond the current terms 
of the programme. Much work still needed to be done and support from donors wishing to work 
wish ACP would be welcome. He welcomed the news that financing for some capital -based officials 
was to b e provided to attend the November Workshop on Transparency and offered to work with 
the WTO Secretariat on that task.  
                                                
26 The full report is available on the IEC website: 
http://www.iec.ch/about/globalreach/partners/international/pdf_wto/iec_wto_2016_ 06_en_iec.pdf  
27 These statements were circulated in documents G/TBT/GEN/200 and G/TBT/GEN/201.  
28 Eighth Special Meeting on Procedures for Information Exchange . G/TBT/M/69  
 
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  5.2.   The representatives of BIPM and OIML updated the Committee on their activities.29 
5.3.  The representative of the IEC reported that Tanzania had  established its national 
electrotechnical committee. Burkina Faso, Guinea and Namibia had adopted their first national IEC 
standards, which , in the cases of Guinea and Namibia, upgraded them to affiliate class. Under the 
IEC mentoring programme, a partner ship had been established between Mexico and Ecuador so as 
to reinforce the Ecuadorian national electroctechnical committee.30  
5.4.  The representative of Trinidad and Tobago  made a statement  in support of granting ad hoc 
observership status to the CARICOM Regio nal Organization for Standards and Quality  (CROSQ ).31 
The representatives of South Africa , Uganda , Jamaica , Japan , Canada , China  and Barbados  also 
took the floor in support of this request.  
5.5.  The Committee  agreed  to grant ad hoc observer status to  CROSQ .32 
6  DATE OF NEXT MEETING  
6.1.  The next regular meeting of the Committee is scheduled for 10-11 November 2016 . The full 
schedule of meetings is contained in JOB/TBT/189/Rev.1, issued on 24 June 2016 . 
__________  
  
                                                
29 These statements were circulated in documents G/TBT/GEN/202 and G/TBT/GEN/203.  
30 The full rep ort is available on the IEC website: 
http://www.iec.ch/about/globalreach/partners/international/pdf_wto/iec_wto_2016_06_en_iec.pdf  
31 G/TBT/W/ 447. 
32 The changes are reflected in G/TBT/GEN/2/Rev.12, issued  on 23 August 2016 .