RESTRICTED
G/TBT/M/65
28 May 2015
(15-2757)  Page: 1/62
Committee on Technical Barriers to Trade   
 
 
MINUTES OF THE MEETING OF 18-19 MARCH 2015 
CHAIRPERSON: MR. FILIPE RAMALHEIRA 
Note by the Secretariat1 
 
 
 
1   ADOPTION OF  THE AGENDA ........................................................................................ 2  
2   IMPLEMENTATION AND ADMINI STRATION OF THE AGREEMENT ................................. 2  
2.1   Statements from Me mbers under Article 15.2 ................................................................ 2  
2.2   Specific Trade Concerns.............................................................................................. 2  
2.2.1   Withdraw n concerns ................................................................................................ 2  
2.2.2   New Concerns  ........................................................................................................ 2  
2.2.3   Previously raised Specific Trade Concerns .................................................................. 11 
2.3   Exchange of Experiences ........................................................................................... 60 
2.3.1   Preparation of the 7th Triennial Review ...................................................................... 60 
3   TWENTIETH ANNUAL REVIEW ................................................................................... 61  
4   TECHNICAL COOPER ATION ACTIVI TIES .................................................................... 61  
5   UPDATING BY  OBSERVERS ........................................................................................ 61  
6   OTHER BU SINESS ...................................................................................................... 62  
7   DATE OF NE XT MEETING ........................................................................................... 62  
 
                                               
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the positions of Members or to thei r rights and obligations under the WTO. G/TBT/M/65  
 
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1  ADOPTION OF THE AGENDA  
1.1.  The Committee adopted the agenda contained in WTO/AIR/TBT/1. 
2  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
2.1  Statements from Members under Article 15.2  
2.1.  The Chairman reminded the Committee of Members' notification obligation under Article 15.2 
of the TBT Agreement and further informed the Co mmittee that the latest list of statements 
submitted under Article 15.2 of the TBT Agreement were contained in document 
G/TBT/GEN/1/Rev.14, issued 23 February 2015. He informed the Committee that in total, since 1995, 129 Members had submitted at least one st atement of implementation under the above-
mentioned Article. Information on the list of statements was available, and regularly updated on 
the TBT Information Management System (" http://tbtims.wto.org/ ").  
 
2.2  Specific Trade Concerns  
2.2.1  Withdrawn concerns 
2.2.  The Chairman reported that the following Specific Trade Concerns had been withdrawn from 
the Agenda at the request of the concerned Member:  
a. Ecuador – Ministry of Public Health Executive Decree (Agreement) No. 00004522 
amending the Sanitary Regulations for the Labelling of Processed Foods for Human Consumption  - withdrawn by Brazil 
b. Ecuador – Systematic failure to publish notices at an early appropriate stage – 
withdrawn by Brazil 
2.2.2  New Concerns 
2.2.2.1  China - Administrative Meas ures on Cosmetic Labelling (AMCL) 
G/TBT/N/CHN/1064 
2.3.  The representative of  Canada commended China for notify ing its proposed changes to the 
requirements for the labelling of cosmetic products and welcomed the opportunity for foreign 
governments and industries to comment on the measure. China's proposed regulation would 
prohibit the widely accepted practice of over-labelling of cosmetic products and significantly disrupt production lines and schedules, increase costs for foreign manufacturers and create confusion among consumers who were accustomed to global branding of cosmetic products. Canada was 
deeply concerned that the proposed regulation would inflict a disproportionate burden for non-
Chinese manufactured cosmetics, permanently increasing the costs of doing business in China and placing foreign products at a competitive disadvantage when compared to domestic 
manufacturers. Furthermore, the new requirements compelling companies to use third-party 
facilities in China in order to verify claims would undermine China Food and Drug Administration's (CFDA's) efforts to have manufacturers take addi tional responsibility on themselves and self-
regulate their products. 
2.4.  Canada also expressed concerns with the entry into force date proposed in CFDA's draft. 
Canadian manufacturers had expressed their inability to comply with these new requirements within six months as significant adjustments to package design and production lines would be 
required. Given that compliance would be extremely labour intensive, Canada urged China to 
provide a more appropriate timeline. In addition, Canada requested that products already approved for sale remain on the market until their expiration date in order to minimize any further 
disruption or lost sales. While Canada ackn owledged the need to provide information to 
consumers, the new requirements did not appear  to provide any additional information to 
consumers. In this respect, Canada welcomed any additional details China would be able to 
provide on how the proposed changes would enhance consumer safety. Canada trusted that China 
would make proper adjustments to its current draft to ensure that there was a level-playing field G/TBT/M/65  
 
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  for Canadian and Chinese cosmetic manufacturers, consistent with China's most-favoured nation 
obligations and in compliance with its obligations under the TBT Agreement, taking into account widely accepted international practices in this sector.  
2.5.  The representative of the United States supported the public health objective of China's 
Administrative Measure on Cosmetic Labelling, indicating that the US also utilized labelling to 
educate consumers. When providing information on overlay labels before importing, the US Food and Drug Administration (FDA) required that stic kers be permanently affixed to the package such 
that they could not be easily removed, as cosmetics came in different shapes, sizes and materials 
(of particular concern were slick plastic tube containers), while not causing additional violations such as covering or obscuring required information on the original package. The US Federal Food Drug and Cosmetic Act (FDCA) required that labels contain the following information: (1) the name 
and place of business of the manufacturer, packer , or distributor; (2) a statement of the net 
quantity of contents; (3) a statement of identity; (4 ) a list of ingredients; and (5) in certain cases, 
a warning statement required by an FDA regulation  issued under the authority of section 602 or a 
colour additive regulation. The FDA's regulations also provided that, if the label for a cosmetic 
product contained any representation in a foreign language, then all of the information required to appear on the label under the FDCA must also appear in that foreign language. 
2.6.  She explained further that when providing in formation on overlay labels after import, the FDA 
required a written agreement be in place with the import broker that the importer would meet the conditions prescribed above. For the import of cosmetics, for which the importer was the operator of an establishment where the cosmetic was go ing to be repackaged and labelled, the FDA 
required evidence to establish the relationship be tween the importer and the cosmetic products at 
the time of import. If an agreement was not in  place, the product was subject to FDA refusal 
because the product appeared to be misbranded. The written agreement for import brokers 
needed to include (1) the compliant labelling information; (2) signature by the consignee; (3) the 
post office address of the person or operator; and (4) a statement that the cosmetic product would not be adulterated or misbranded upon the comple tion of processing, labelling, or repackaging. 
The agreement needed to be retained for two ye ars after the final shipment and both parties 
needed to have a copy. 
2.7.  If the repacker/e-labeler was not the person introducing the shipment to the United States, 
then the party doing so needed to be properly listed as the consignee in the entry/ importation 
records. It was a best practice to notify the appr opriate FDA District Office of upcoming entry of 
cosmetic products as it had the authority to inspect the consignee, after the release of the product, in order to verify that the relabelling or repackaging actually occurred in the agreed manner. This 
labelling exemption permitting over-labelling after import would be void, however, if the product 
was moved from the listed establishment without the required relabelling/repackaging. Cosmetic products that were allowed entry without conforming to FDA labelling specifications had to be 
repackaged or relabelled before distribution. If the original or revised labels declared a colour that 
was not certified or permitted by FDA, the product could be considered adulterated or misbranded and was subject to refusal by FDA.  
2.8.  The US was of the view that CFDA's proposal to ban over-labels on cosmetics imports 
appeared to be a departure from global norms and could lead to significant time-to-market delays 
and commercial losses for US cosmetics manufacturers. It could also negatively impact consumer safety in China by increasing counterfeiting an d grey-market products. The US hoped that China 
would suspend implementation of the labelling regu lation until further dialogue with Members and 
relevant stakeholders in order to develop a cosmetics labelling measure that addressed China's safety concerns without adversely affecting trade.  It needed to include a reasonable transition 
period, allowing importers to comply fully with the regulation, and ensure that domestic and 
foreign companies received the same regulatory treatment without unnecessary burdens on foreign producers. 
2.9.  The representative of  the Republic of Korea  welcomed the continuing efforts made by CFDA 
to amend the regulations on cosmetics labelling, reflecting the concerns raised by WTO Members. 
However, Korea had new concerns associated with the proposed cosmetic labelling regulation. Firstly, it was Korea's understanding that Article 7 of the regulation prohibited over-labelling such 
as using stickers on cosmetic products, which was broadly allowed in many countries, including the 
US, EU and Korea. This meant that manufacturers would have to delay their exports to China because the required registration number could only be issued after obtaining the sanitary G/TBT/M/65  
 
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  approval according to the labelling regulation. Fu rthermore, manufacturers had to make separate 
packaging for the Chinese cosmetic market only. Therefore, Korea was of the view that China's 
over-labelling ban would not only incur significan t burden but also generate extra costs for the 
cosmetic industry, in particular for SMEs. In th is regard, Korea requested China to revoke the 
over-labelling ban in the notified measure. 
2.10.  Secondly, Article 19 and Article 20 of the regulation stated that each efficacy indicated on 
the labelling had to be verified by the testing or ganizations designated by the Chinese authorities. 
Korea agreed that this verification needed to be credible. Nonetheless, given that verification on 
basic efficacy of cosmetics such as moisturiza tion was often conducted under the manufacturer's 
responsibility on a voluntary basis, requiring the ve rification by a third testing body appeared to be 
over-engineered regulation. The regulation would impose significant burdens and expenses to the 
cosmetic industry without any benefits to consumers and manufacturers. Korea sought further 
clarification on whether foreign testing bodies coul d also be designated by the Chinese authorities. 
In addition, Korea requested that China narrow the scope of cosmetic efficacy subject to 
verification by clarifying which efficacy claims needed to be proven and allow manufacturers to 
verify the efficacy of their own products. In co nclusion, Korea requested China to provide a two-
year transitional period so that manufacturers could be acquainted with the major changes 
introduced by the new provisions. 
2.11.  The representative of the European Union reiterated concerns sent to the Chinese 
authorities on 12 January 2015. He noted that the no tified draft introduced significant changes to 
the current requirements on the labelling of cosmetics products, which would essentially oblige 
economic operators to produce specific packaging for the Chinese market. Firstly, the notified draft 
stated that "Cosmetic labels ... shall not be modifi ed or supplemented by sticking, cutting, altering 
etc." Could Chinese authorities confirm whether they intended to prohibit the placing of stickers 
over the original label per se or whether only stickers that modified or altered the content of the 
original labelling were forbidden? In the EU, as well as in many other countries, cosmetic products could be labelled by means of stickers, provided those stickers were accurate and not easily 
detachable. Prohibiting the use of stickers would create a de facto  systematic requirement for 
China-specific primary and secondary packaging, substantially increasing costs for packaging design, as well as continuous costs regarding specific production lines for packaging production, product filing and inventory management. He asked if complete and accurate labelling information 
in the Chinese language by means of stickers might be accepted as a sound alternative to China-
specific labelling/packaging. The EU had recently received information that the Chinese authorities would allow the use of stickers on imported products, as long as all information indicated in the 
original language on the packaging was translated into Chinese.  
2.12.  Secondly, the notified draft required the products to display the name and address of the 
manufacturer and of the subcontractors when part of the production was done by subcontractors. 
The EU agreed that the name and address of the manufacturer or, in the case of imported 
products, of the Chinese enterprise responsible fo r the product, should be labelled on the product 
to establish clear and enforceable responsibility within China. However, additional labelling of the name and address of manufacturing subcontractor(s) was not necessary and might be confusing 
for the consumer. The EU therefore invited China to  consider requiring only the name and address 
of the manufacturer legally responsible for the product and to waive the requirement to provide the name and address of subcontractors. 
2.13.  Furthermore, the EU sought confirmation  that efficacy assessment and cosmetic claim 
verification could be conducted by any verifying organisation that was scientifically and technically competent to do so according to the criteria  and guidance established by the CFDA. Any 
requirement for third party verification by a Chinese organisation would be more trade-restrictive 
than necessary. The EU also considered that  the requirements regarding cosmetic claim 
substantiation should be aligned and compatible with international best practices and provide general criteria and guidance rather than regulate specific wording. Requirements for the 
publication of detailed claim substantiation reports on a website could be damaging to the 
intellectual and commercial property rights of a company. Therefore, the detailed efficacy information needed to be accessible only to official control authorities, who had appropriate 
training and expertise to assess scientific study reports and the compliance of cosmetic claims with 
legal requirements. Finally, as the notified draf t would bring significant changes to the current 
practices of the cosmetic industry and the compet ent authorities in China, the EU requested the 
granting of a transition period of at least 24 months. The EU also invited the CFDA to publish G/TBT/M/65  
 
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  practical guidance at an early stage during the transition period so as to ensure a harmonised 
understanding and smooth application of the new measures. 
2.14.  The representative of Japan, expressing support for the positions of Canada, EU, Korea and 
the US, recognized that the new draft Administrative Measures on Cosmetics Labelling was 
designed to greatly strengthen the present cosmetics labelling regulations in China. However, if 
the proposed measures were implemented, the gl obal cosmetics industry active in the Chinese 
market, including Japanese firms, would suffer an  immense economic blow. In addition, Chinese 
consumers would also suffer from conspicuous disadvantages. 
2.15.  The representative of China explained that cosmetic labelling was essential for consumers to 
understand basic information regarding cosmetic products and that it was one of the most 
important aspects of cosmetic supervision for most Members. In 2012, the CFDA had drafted the 
Cosmetics Label Instructions Regulations and Guidance for the Cosmetics Label Instructions 
(G/TBT/N/CHN/937) to solicit public opinion; however, it had never gone into effect and was now replaced by AMCL. Furthermore, in November 2014,  AMCL had been put online to solicit public 
opinion and the CFDA had subsequently received feedback from domestic as well as foreign 
cosmetic enterprises and industry associations. China assured Members that AMCL, which was still being drafted, would follow international rules and give full consideration to the valuable inputs 
from interested parties. 
2.2.2.2  China - Banking IT Equipment Security Regulation 2.16.  The representative of the United States sa id that the China Banking Regulatory Commission 
had on 26 December 2014 issued "Guidelines for Promoting the Application of Secure and 
Controllable Information Technology in the Banking Sector", including the accompanying 
Classification Catalogue of Banking Information Technology Assets and Indexes of Security and 
Controllability. Under the regulations, commercial banks would be required to purchase an 
increased percentage of information and communications technology (ICT) products to comply 
with a series of requirements, some of which had a potential to create unnecessary obstacles to trade. The regulations appeared to require government pre-approval for a wide range of 
commercial ICT and encryption products, including the disclosure of source code and other 
sensitive design information, which was a matter of enormous concern to industry. Other provisions of the Guidelines appeared to be of concern from a TBT perspective as well. The Guidelines required "tests and certification" to be conducted by state regulators and laid out 
product requirements that were based on design and descriptive characteristics (e.g. equipment 
that had intellectual property rights (IPR) owned and/or developed by Chinese-invested enterprises or "indigenous IPR") rather than performance requirements. The guidelines also 
required source code to be filed for registration  with the government bank ing regulatory body. The 
US was concerned that aspects of the December 2014 Guidelines went beyond usual practice for the regulation of ICT equipment in the commercial banking sector and asked China to provide its 
objective and rationale to extend certification and testing requirements to ICT products covered in 
the regulation. Furthermore, the US requested Chin a to suspend implementation of the regulation, 
conduct a transparent process, allowing meaningful opportunity for comment and enquiries by all interested stakeholders, and notify the TBT Committee. 
2.17.  The representative of the European Unio n, supporting the US statement, said that the 
regulation was another worrisome development in the area of IT and encryption in China. As with 
other similar measures, there had been a total lack of transparency, with no opportunity for public 
comments or publication in an official journal while the guidelines had only been communicated to 
banks. The guidelines clearly qualified as a technical regulation and contained conformity assessment procedures and hence should have been notified under the TBT Agreement. The EU 
requested China to abide by its obligations under the TBT Agreement to notify the regulation and 
postpone its application until consultations had been carried out. The guidelines would require Chinese banks to only procure equipment which incorporated indigenous technology manufactured domestically. With regard to conformity assessment procedures, foreign manufacturers would have 
to surrender key technologies to the Chinese author ities, putting at risk vital elements of their 
business. In addition, the scope of products affected was also of concern. As also indicated by European banks operating in China, the IT systems operating in China needed to be compatible 
with the global infrastructure. Therefore, preven ting foreign banks from using foreign technology 
could lead to security challenges for banking IT systems worldwide. The EU sought clarification on 
the objective and rationale of the guidelines and also on the relationship between this measure G/TBT/M/65  
 
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  and another set of Chinese measures in area of IT security, which were the subject of another 
specific trade concern (IMS item number 294) raised by the EU. The EU asked how the new regulations would coexist with the previous ones and emphasised the importance of international 
cooperation in this area to develop resilient syst ems, which deployed the best possible technology 
globally. 
2.18.  The representative of Japan stated that th e guidelines required that the banking information 
technology equipment contain indigenous Chinese intellectual property and that the equipment go 
through assessment procedures and obtain a certification based on a particular set of criteria. 
Japan questioned the consistency of these requirements with obligations under the TBT Agreement, particularly non-discrimination and refraining from imposing unnecessary trade restrictions. Japan called on China to ensure transparency on this issue as the guidelines had 
neither been notified to the TBT Committee no r publicised for public comment. Japan also 
requested that China clarify whether the guidelines were mandatory or voluntary. If the guidelines 
required that banking technology equipment undergo assessment procedures and obtain 
certification from the Chinese authorities, then the guidelines would appear to be applied in a 
mandatory manner. Japan requested details on the conditions of source code disclosure and underlined that it was difficult for companies to disclose their source codes since they contained 
vital information associated with inter-firm competition. Japan also sought clarity on the State 
Cryptography regulation which would apply to cryptography modules and on how the new regulation would fit with the existing security  regulations such as the Chinese Compulsory 
Certification (CCC) System, OSCCA regulations, and the Multi-Level Protection Scheme (MLPS). 
2.19.  The representative of  Canada said that while understanding China's desire to minimize 
threats to its ICT infrastructure, it was of the view that China's approach to "secure and 
controllable" ICT would decrease, not increase cyber security for China's network and banking ICT 
infrastructure. Associating himself with the concerns raised by the US, he emphasized that as 
drafted, China's national cyber security regime an d guidelines were far more trade restrictive than 
necessary to achieve their national security objectives. China's insistence on requirements to 
divulge and review source code, local content requirements for hardware, software and intellectual 
property, and mandatory adoption of Chinese encryption processes would violate national treatment obligations under Articles 2 and 5 of the TBT Agreement. Therefore, Canada requested 
that China explain why it must rely solely on locally sourced products to achieve its national 
security objectives with respect to secure and controllable ICT and on what grounds foreign-
sourced ICT was banned from Chinese networks. In addition, Canada sought further clarifications on how the testing of the foreign ICT products would be undertaken, which criteria would be 
assessed, and what the specific objective was of requiring the disclosure of intellectual property 
and encryption with respect to China's stated national security objectives. 
2.20.  The representative of China reported that  the rapid development of the global information 
technology and financial innovation had brought new challenges to the banking industry that 
required all Members to strengthen the security of the information network and operational management in the banking system. In 2014, China had issued guidelines for applying secure and 
controllable information technology to enhance cyber security and construct an IT risk control 
mechanism in the banking sector. Issuing of such guidelines was consistent with international 
practice and contributed to the stability of the global financial system. In February 2015, China 
Banking Regulatory Commission (CBRC) had pub lished a notice online to answer the main 
concerns of interested parties: With respect to the source codes, the guidelines did not require a 
full reveal of source codes, but only to keep a file of it. China assured Members that it would give full consideration to opinions of interested parties to finalize the method and process of source 
code filing. With respect to intellectual property rights, China only required proprietary intellectual 
property rights, instead of indigenously-develop ed technologies. The suppliers only needed to 
provide proofs of independent intellectual property ri ghts or legal proof of origin of their software. 
Furthermore, the guidelines only requested commercial banks to establish a working mechanism to 
prevent risks in IT systems and daily operations. This applied equally to both domestic and foreign 
products and enterprises. The CBRC had met with relevant enterprises and agencies such as USITO, IBM, Oracle and EMC from the US and JEITA from Japan regarding these points and it had 
also been agreed to build effective communication mechanisms together. 
2.21.  The representative of the European Union thanked China for its explanation although it did 
not address questions regarding transparency. He asked for further information on the distinction 
between "filing" of source code and "disclosure"  of source code. In addition, he asked for a G/TBT/M/65  
 
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  clarification as to whether the requirement for intellectual property (IP) rights from indigenous 
technology had been waived. 
2.22.  The representative of China clarified that IP rights did not need to originate in China but 
that the supplier had to hold IP rights. China was still working on the method for the filing of 
source code and was willing to work with  interested parties on this issue. 
2.2.2.3  Ecuador - Emergency Technical Re gulation (RTE) No. 088: "Surface tension 
agents", of the Ecuadorian Standardizat ion Institute (INEN) (G/TBT/N/ECU/117) 
2.23.  The representative of Mexico expressed concerns with respect to the Emergency Technical 
Regulation No. 088: "Surface tension agents", issued by Ecuador on 22 November 2013 and 
notified in document G/TBT/N/ECU/117. In particular, Mexico questioned the justification for the "emergency" measure and the requirements regarding accredited certification bodies that were to 
provide certificates of conformity prior to importation. Mexico's full statement is contained in 
document G/TBT/W/405. 
2.24.  The representative of Ecuador said that  the purpose of Technical Regulation No. 088 on 
surface tension agents was to prevent risks to hu man health and safety and the environment, and 
practices likely to mislead end-users. The regu lation was based on Andean Community (CAN) 
Decision 706 of 10 December 2008 on harmonization of legislation on domestic hygiene products 
and absorbent personal hygiene products, which was undergoing constant revision. It had been 
duly notified under the TBT Agreement. Taking into account comments from Members with respect 
to conformity assessment, Ecuador had amende d the regulation to facilitate, among other 
mechanisms, the submission of a first party declaration, thereby resolving in a satisfactory manner 
the problem of proving the product's conformity. 
2.2.2.4  Japan – Wood Use Points Programme (G/TBT/N/JPN/471 
G/TBT/N/JPN/471/Corr.1) 
2.25.  The representative of the Russian Federa tion said that Japan had implemented the Wood 
Use Points Program (WUPP) as of 1 April 2013 but notified it only on 4 November 2014 in 
document G/TBT/N/JPN/471. According to the programme, participating consumers who purchase 
new homes built with a minimum of 50.1% of wood products from selected varieties of conifers 
would be eligible to receive up to 300,000 Wood Use Points (with an equivalent value in Yen), which could be redeemed through the purchase of specified local products, or alternatively, donated to support certain local economic activities. The WUPP introduced a new conifers 
classification system, based on the criteria of "growing forest resources", compliance with which 
was mandatory for participation in the WUPP. Japan had approved a list of conifers for participation in the WUPP, of which 6 species were endemic to Japan and 5 originated from a 
limited list of WTO Members. Russia traditionally exported wood, inter alia  to Japan and was 
therefore concerned about this programme. Since WUPP was a technical regulation within the meaning of Annex 1 of the TBT Agreement, Ru ssia questioned why Japan had not notified 
Members of the products to be covered by the technical regulation at an early appropriate stage 
(Articles 2.9.1 and 2.9.2 of the TBT Agreement)  and had not allowed a reasonable interval 
between the publication of the regulation and its entry into force (Article 2.12 of the TBT 
Agreement). Russia also asked why Japan had not used relevant international standards - 
Appendices of the Convention on Internationa l Trade in Endangered Species (CITES) and the 
classification of the International Union for Conservation of Nature (IUCN) - as a basis for the technical regulation. None of the standards included conifers in its lists of products subject to trade 
limitations (Article 2.4 of the TBT Agreement). Furthermore, Russia wondered how WUPP would be 
consistent with Japan's WTO commitments, specifically the commitment to accord "… treatment no less favourable than that accorded to like products of national origin in respect of all laws, or use" 
(GATT Article 3.4) and the commitment to accord "… any advantage, favour, privilege … 
immediately and unconditionally to the like product originating in or destined for the territories of all other contracting parties" (GATT Article 1.1). 
2.26.  The representative of Japan stated that Japan had explained the Wood Use Points 
Programme and provided written answers in response  to Canada's questions in the context of past 
meetings of the Council of Trade in Goods. In addition, in light of interest shown and without 
prejudice to the applicability of the TBT Agreemen t, Japan had submitted a TBT notification on the G/TBT/M/65  
 
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  programme (G/TBT/N/JPN/471 and 471/Corr.1), circulated on 4 November 2014. The objective of 
the programme was, through promoting wood use, to contribute to proper management and conservation of forests, prevention of global warming, and promotion of a recycling-oriented 
society, as well as to serve for the development of rural areas. In order to achieve this objective in 
an effective and efficient manner, the eligibility criteria for wood were set out in the programme 
and some foreign species had also been designated as eligible wood. The program applied both to domestic and foreign wood and ensured that both were treated in a non-discriminatory manner, 
consistent with the WTO agreements. With respect to timeframe, the entitlement period had ended 
on 30 September 2014 and no points could be earned for works starting after this date. Furthermore, Japan had published the draft budget fo r the next fiscal year and it did not contain a 
similar programme. 
2.2.2.5  Russian Federation – Technical regula tions on safety of railway transport (TR CU 
No. 001/2011, No. 002/2011 and No. 003/2011)  
2.27.  The representative of Ukraine raised concer ns regarding technical regulations applied by the 
Russian Federation on railway transport safety : TR CU 001/2011 On Safety of Railway Rolling 
Stock, TR CU 002/2011 On Safety of the High-s peed Railway Transport and TR CU 003/2011 On 
Safety of Railway Transport Infrastructure. As a member of the Customs Union, the Russian 
Federation used two systems of conformity assessment procedures - mandatory certification and 
conformity assessment – covering a considerable list of products subject to mandatory certification of conformity in the area of railway transport. Ukraine considered this two system approach as 
overregulation and unnecessarily trade-restrictive, hence in violation of Article 2.2 of the TBT 
Agreement, which, inter alia, stipulated that technical regulations shall not be prepared, adopted 
or applied with a view to or with the effect of creating unnecessary obstacles to international trade. In particular, Paragraph 9 of Article 6 of TR CU 001/2011, paragraph 3 of Article 6 of TR CU 
002/2011 and paragraph 13 of Article 6 of TR CU 003/ 2011, specified that for the certification, the 
applicant should be a legal entity (or individual  entrepreneur) registered under the laws of the 
Customs Union member states in their territory, and be a producer or a seller, or, act as foreign 
supplier under a contract. These requirements provided less favourable conditions for suppliers 
from other WTO Members than those accorded to supp liers of like products of national origin (e.g. 
originating in the Customs Union). Hence, thes e requirements were inconsistent with the 
provisions of Articles 5.1.1 and 6.4 of the TBT Agreement. 
2.28.  In addition, she said, the requirement for mandatory registration resulted in additional costs 
for assessing the conformity of like products or iginating from WTO Members compared to those of 
national origin, leading to non-compliance with paragraph 2.5 of Article 5 of the TBT Agreement. 
This related to the registration of legal entities in the territory of the Customs Union or conclusion 
of contracts with existing legal entities, register ed in the territory of the Customs Union. Other 
Ukrainian concerns were related to the lack of recognition of equivalent technical regulations 
according to Article 2.7 and the refusal to negotiate and conclude agreements for the mutual 
recognition of results of conformity assessment procedures according to Article 6.3 of the TBT 
Agreement. In November 2013, Ukraine had prop osed a relevant draft agreement on mutual 
recognition of results of conformity assessment procedures; however, the Russian Federation and 
the Eurasian Economic Commission had insisted on using the mechanism provided for in the 
Agreement of the Customs Union member states on removing technical barriers in trade with CIS countries that were not Members of the Customs Union as of 17 December 2012. According to the 
mentioned mechanism, non-Members had to adopt the technical regulations of the Customs Union 
on an alternative or as single-option basis. Hence, the Customs Union Agreement required that non-members comprehensively adopt technical regu lations and conformity assessment procedures 
of the Customs Union to be able to supply products in its territory. This created unnecessary 
obstacles to international trade and a technical barrier by nature, as understood in the TBT Agreement. Ukraine requested that these concerns  be taken into positive consideration by the 
Russian Federation in good faith and with a view to ensuring compliance of the Customs Union's 
technical regulations with the provisions and princi ples of the TBT Agreement by addressing safety 
objectives in a less trade-restrictive manner. 
2.29.  The representative of the Russian Federation said that these technical regulations had been 
adopted in July 2011, before the accession of Russia to the WTO. Despite the fact that Russia was 
not a WTO Member at the time, it had provided a very reasonable period of three years between 
their adoption and entry into force, in full accordance with Articles 2.12 and 5.9 of the TBT 
Agreement. The decision on the adoption of th ese technical regulations contained very soft G/TBT/M/65  
 
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  transitional provisions. Following the entry into force of the technical regulations in July 2014, 
product certificates already issued were valid until the end of their validity, but not later than 1 August 2016. In addition, the production and circul ation on the market of products conforming to 
previously established specifications was also allowed until 1 August 2016. Moreover, the 
production and release into circulation of Eurasian Economic Union (EAEU) products that were not 
subject to mandatory assessment (confirmation) of compliance with mandatory requirements was also allowed until 1 August 2016. In fact, the Russian Federation and the EAEU had provided a 
five-year period between the adoption and entry in to force of the technical regulations to allow 
time for producers in exporting Members to adapt their products or methods of production to the 
new requirements. Conformity assessment procedures were the same for domestic and imported products. 
2.2.2.6  Indonesia - Regulation of the Mini ster 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 Agri culture No. 139/Permentan/PD.4, 10 December 
2014 (G/TBT/N/IDN/98) 
2.30.  The representative of Australia said that in December 2014, the Indonesian Government 
had issued a regulation limiting imports of beef  to prime cuts and some offal and manufactured 
meat. While the regulation had subsequently been  amended in January 2015 to allow imports of 
secondary beef cuts by state-owned enterprises in limited circumstances, Australia remained 
concerned that the measure effectively restricted the import of secondary beef cuts and offal. The 
regulations also imposed a number of requirements - including packaging, labelling and purpose of 
usage requirements - on imported beef products that did not apply to domestically-produced beef. 
Australia was concerned that this action by Indonesia unjustifiably restricted trade. Australian 
industry was already feeling the effects of the regulation, which had been introduced without 
notice or consultation with trading partners. Australia understood the complexities being faced by 
Indonesia as it sought to meet its food security goals and was working with Indonesia to help 
supply food security, including through cooperation to increase capacity in Indonesia's beef industry. Australia encouraged Indonesia to look at alternative policies that were WTO-consistent and that did not restrict high-quality Australian products which were a safe and reliable 
contribution to Indonesia's food supply. He requested that Indonesia explain in detail the 
objectives of the regulations and whether it considered that the import restrictions on secondary beef-cuts and offal under the decree met the defi nition of technical regulation under the TBT 
Agreement, and if so, on what basis. 
2.31.  The representative of the European Union shared concerns raised by Australia concerning 
the Indonesian Regulation, which effectively banned imports of most secondary cuts of meat and 
would allow only state-owned enterprises to bring them in at times of shortages. The EU asked 
how Indonesia ensured that these measures guaranteed that products imported from the territory of any Member were treated no less favourably than products of national origin, as required in Article 2.1 of the TBT Agreement and that they were not prepared, adopted or applied with the 
effect of creating unnecessary obstacles to internat ional trade as required in Article 2.2 of the TBT 
Agreement. The EU also wondered why Indonesia had not allowed a reasonable interval between 
the publication of these regulations and their entry into force, in order to allow time for producers 
in exporting Members to adapt to the requirements of the regulations as required by Article 2.12 of 
the TBT Agreement. 
2.32.  The representative of Canada supported the concerns raised by Australia regarding the 
broad scope of the proposed regulations and th e timeliness of the notification. Canada was 
concerned that the proposed measures might be unduly trade restrictive, and that no time had been provided for comments from trading partners. Canada also questioned the appropriateness of notifying the proposed regulations to the TBT Committee. Measures designed to address food 
supply and price volatility did not appear to be directly related to TBT objectives. Canada urged 
Indonesia to provide more clarity regarding its pr oposed measure and provide sufficient time for 
comments before bringing these proposed regulations into force. 
2.33.  The representative of Indonesia said that they were unable to provide detailed responses at 
the meeting but that they would report back to  their capital regarding these concerns. For a 
preliminary response, he explained that the objective of the regulation was to improve the G/TBT/M/65  
 
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  distribution chain of meat with a view to ensuring that price in the market reflected actual demand 
and supply of meat. Indonesia had identified some situations in which there was abundance of meat available (either domestically produced or imported) but without an appropriate price adjustment, due to flawed distribution chains. Th e provisions stipulated in the regulations were 
aimed at ensuring a fair market mechanism and preventing unnecessary disruption in the meat 
supply, which may cause anomalous price increases. Since the 60-day comment period provided for in the notification was still available, he suggested that Members also send written enquiries to 
the national enquiry point. 
2.2.2.7  Mexico – Standard on non-alcoholic and soft drinks 2.34.  The representative of El Salvador than ked the Mexican delegation for having attended 
consultations regarding their concern on the interpretation and implementation of a Mexican 
standard for juices and non-alcoholic drinks, which had resulted in the customs reclassification of 
one product exported from El Salvador. Despite the confirmation of El Salvador's classification of the product through laboratory analyses undertake n in Mexico, the Mexican authorities had still 
not changed their position with respect to the product's classification. El Salvador was of the view 
that the measure was going beyond what was established by the standard, hindering trade flows into the Mexican market. Therefore, El Salvador was approaching Mexico through various fora, 
including the WTO, to find a solution to this problem. 
2.35.  The representative of Mexico said that th ey had been informed of this concern only a few 
days earlier, following which bilateral discussions in Geneva and a conference call between 
authorities in capitals had already taken place. As regards the regional context, no concerns 
pertaining to Mexico had been raised during the December 2014 meeting of the TBT Committee 
established under the Free Trade Agreement between Mexico and Central America and which also provided a forum for raising specific trade concerns . Moreover, Mexico was not of the view that the 
issue involved a measure covered under the TBT Agreement or the TBT Chapter of the Mexico-
Central America Free Trade Agreement. The Mexican Government department responsible for the negotiations on market access had explained that the issue involved a discrepancy in tariff 
classification. The discrepancy aros e from the analysis of the physical and chemical characteristics 
of the product and the difference between "fruit juice based beverages" and "flavoured waters", 
within the meaning of the international Harmonized System nomenclature. For a proper technical opinion, it was advisable to consult the Explanatory Notes to the Harmonized System. Since the 
Explanatory Notes did not establish quantitative  limits for products of subheadings 2202.10 and 
2202.90, reference had been made to the Mexican Standard NMX 439 1983 "Foods, Non Alcoholic Beverages, Beverages and Soft Drinks: Classification and Definitions", which set out the criteria for 
distinguishing between the various types of beverages. It was not a matter of applying the 
Mexican standard but of referring to it in orde r to differentiate between "flavoured waters" and 
"fruit juice based beverages" and determine the difference between "mineral waters or aerated 
waters, containing added sugar or other sweetening matter, including flavoured waters" and "other 
non-alcoholic beverages". According to the results of the analyses carried out by Mexico's Customs Laboratory, the imported products were non-alcoholic fruit flavoured beverages, ready-made for consumption, whose ingredients consisted of water, added fruit juice in a proportion ranging 
between 2.5% and 4%, sugar (between 3% and 6.1%) and thickeners; therefore, they could not 
technically be considered as "fruit or vegetabl e beverages." Similarly, a beverage with a juice 
content of less than 10% of total product weight could not be said to be a juice based beverage 
but rather a beverage to which flavouring had been added, or, in other words, a flavoured 
beverage. In short, this issue was a tariff matter that did not lie within the purview of the TBT Committee and raised a systemic concern because otherwise the distinction between "tariff 
measures" and "non-tariff measures" would be lost. 
2.2.2.8  Canada - Tobacco Reduction (Flavoured Tobacco Products) Amendment Act, 
2013 – Bill 206 
2.36.  The representative of Indonesia said that  according the information they had received, the 
Government of Alberta Province (Canada) would soon enforce "Tobacco Reduction (Flavoured 
Tobacco Products) Amendment Act, 2013 – Bill 206", an amendment which would prohibit the use, 
distribution, and sale of "flavoured tobacco products", understood to be tobacco products with a 
characterising flavour. However, there was an indication that in practice, menthol cigarettes would 
get an exception to remain traded. The Act, which was going to be applied as of 1 June 2015, would presumably be a barrier for market access of clove cigarettes from Indonesia intended to be G/TBT/M/65  
 
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  sold in Alberta Province and was likely to set a precedent for other provinces in Canada. In 
addition, the Act would affect the production of  clove cigarettes in Indonesia. The export of 
tobacco products to Canada had recently dropped dramatically. The exception for menthol cigarettes was a form of discrimination, which contravened one of the basic WTO principles and 
was similar to the policy issued by the US government, which had later become the subject of a 
dispute between the US and Indonesia. Indonesia urged Canada (especially Alberta Province) to postpone the implementation of the regulation si nce it would lead to differences in treatment 
between clove cigarettes and menthol cigarettes in  Alberta Province. Indonesia did not see any 
scientific evidence for the effectiveness of the poli cy and suggested that Canada avoid this kind of 
policy to prevent unnecessary future disputes, similar to that between the US and Indonesia. 
2.37.  The representative of Canada said that cons idering the late submission of the specific trade 
concern, they were not in a position to provide a detailed response. Canada’s representative noted 
Indonesia’s concerns and said that he would discu ss them with provincial counterparts in Alberta. 
He added that both the Canadian Government and the Alberta Government were committed to 
dealing with smoking issues, which the measures  in question were designed to address. 
Furthermore, he indicated that Canada had a very transparent legislative process and that it took its WTO obligations seriously. 
2.2.3  Previously raised Specific Trade Concerns 
2.2.3.1  India – Pneumatic tyres and tubes for automotive vehicles
2  - IMS ID 133 
2.38.  The representative of the Republic of Kore a expressed his delegation's disappointment with 
India's lack of response to this concern raised  repeatedly by several Members and reiterated 
concerns regarding the Indian Quality Order on Pneumatic Tyres and Tubes for Automotive 
Vehicles, in particular the ISI marking fees and the discriminatory bank guarantee on foreign tyre 
manufacturers. The ISI marking fees were being le vied on all tyres with the ISI mark, even on 
those sold in other overseas markets. Korea was of the view that it was quite unfair and 
unjustifiable to impose a loyalty, even for the products heading to the other countries' markets. Also, India had mentioned at the previous TBT meeting in November 2014 that there was a 
possibility that goods sold in overseas markets might eventually land in India at a later date. The 
bank guarantee of USD 10,000 was intended to pr otect the interests of the Bureau of Indian 
Standards (BIS) and would be invoked in case of breach of any condition of the agreement signed 
between BIS and licensee. However, Korea could no t find any legitimate reference to back up 
India’s argument and requested once again that In dia take this issue more seriously and show a 
more positive attitude so as to resolve this issue as soon as possible. 
2.39.  The representative of Japan referred to Clause 10.2 of the revised agreement, according to 
which tyre manufacturers outside India were requ ired to pay a bank guarantee fee of USD 10,000 
per plant. Since this technical regulation would cause unnecessary competitive difference between factories inside and outside India, Japan requeste d that India consider amending the regulation. 
Since the TBT Committee meeting in June 2014, Japan had been requesting India to explain 
whether or not there was an actual case where the bank guarantee was actually used to compensate loses occurred as a result of a breach of the BIS license agreement and also whether or not India required a similar bank guarantee with respect to products other than tyres. At the 
TBT Committee meeting in November 2014, India had explained that the ISI marking fee was 
reasonable because it was not imposed discriminately inside and outside India. However, Japan considered that the ISI marking fee itself was expensive compared to other countries. Japan 
requested India to show evidence that the ISI marking fee was equivalent to or not expensive 
compared to other countries. Finally, as the EU and Korea had indicated before, it took quite a long time compared to other countries, namely four or five months, to complete the certification 
procedures. Japan requested India to consider shortening the time spent on certification 
procedures. 
2.40.  The representative of the European Union reiterated their concerns with regard to the 
Indian Order, which introduced a certification procedure with a mandatory marking for tyres. The 
EU requested once again that India reconsider its marking fee system, which currently applied to 
each ISI-marked tyre and not only on those tyres which were actually sold on the Indian market. 
The EU called for the removal of the royalty f ees, which were extremely burdensome and much 
                                               
2 G/TBT/N/IND/20, G/TBT/N/IN D/20/Add.1, G/TBT/N/IND/40 and G/TBT/N/IND/40/Rev.1. G/TBT/M/65  
 
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  more restrictive than necessary, or at least for the modification of their calculation to limit them to 
tyres sold on the Indian market. Furthermore, as  already indicated in previous meetings, the EU 
considered that the USD 10,000 bank guarantee that BIS could use in case of breach of the BIS agreement was both discriminatory and an unjustified practice, because it applied only to foreign 
manufacturers. India was therefore invited to remove this requirement. 
2.41.  The representative of India said that most  of the issues raised in the meeting had already 
been explained to interested delegations at many  occasions in previous meetings. The "Pneumatic 
Tyres and Tubes for Automotive Vehicles (Quality Control) Order, 2009", which had been issued on 
19 November 2009 and entered into force on 13 May 2011, applied to both domestic and foreign manufacturers. Pneumatic tyres could be imported into India only if they conformed to the specified standards and bore the Standard Ma rk of BIS. For this purpose, the foreign 
manufacturers desiring to export their goods to India were required to enter into an agreement 
with BIS to receive the BIS license, so that they could use the BIS Standard Mark. The foreign manufacturer was also required to furnish a bank guarantee of USD 10,000 in favour of BIS for 
due compliance of the provisions of the BIS Act, rules and regulations, and terms and conditions of 
the license. The performance bank guarantee had been  deemed necessary in view of a default by a 
foreign manufacturer in payment of its dues to BIS, which could not be retrieved even after taking 
up the matter with the Embassy of that country. In case of any violation of the BIS Act or non-
payment of the marking fee by a domestic manuf acturer, BIS could seek compensation through 
domestic courts, whereas the Act could not be enforced in foreign countries. The bank guarantee was intended to protect the interests of BIS during the tenure of the license and was invoked only 
in case of breach of any condition of the ag reement signed between the BIS and licensee. It 
essentially covered any possible loss of revenue for the BIS in cases of non-payment of requisite marking fee dues to BIS and also took care of legal expenses if any. It was also important to bear 
in mind that the bank guarantee remained with the concerned bank in the form of refundable 
security and should not be counted as expenditure. 
2.42.  He explained further that the BIS char ged the marking fee on all goods produced and 
marked with ISI. The marking fee was charged at the same rate to foreign as well as domestic 
manufacturers and varied from 0.01% to 0.2% of th e cost of the product. For example, if the cost 
of a commercial vehicle tyre was approximately Rs. 20,000, then the marking fee was Rs.2 per 
tyre, or 0.01%. Therefore, the marking fee could not be considered as exorbitant. Some Members 
had asked that the marking fee be calculated only on those goods exported to India. He clarified 
that the marking fee would not be charged in case the manufacturers supplied their goods to other countries without the ISI mark; however, if they covered that supply with the ISI mark, then they 
were liable to pay the royalty fee to BIS. Moreover, there was a possibility that the goods sold in 
overseas markets might eventually land in India on a later date. He underlined that it was previously not permitted to supply ISI marked prod ucts to any country other than India, and that 
the entire ISI marked production was required to be supplied to India only. However, as per 
demand of the international industry, this condition had been relaxed and ISI marked products could now be supplied to any part of world. Preference was given to ISI marked products in many countries, particularly those neighbouring India. As per the feedback received from many 
companies outside India, they obtained the BIS lic ence for selling ISI marked products in their 
country only, and not for exporting to India. 
2.43.  With respect to the concern that the certification process might take as long as four to five 
months, he mentioned that the process involved a visit to the applicant's factory to assess its 
capability as well as testing of samples in an independent lab. Hence, the process could take some time. However, the requests for inclusion of new varieties of tyres in an existing license were 
processed within two weeks. In response to a quer y from the previous meeting, he also explained 
t h a t  t h e  l i c e n s e  c o u l d  b e  r e n e w e d  f o r  a  p e r i o d  o f  u p  t o  t w o  y e a r s .  A s  p a r t  o f  t h e  B I S  p r o d u c t  certification scheme, surveillance was maintained  on the performance of BIS licensees through 
factory inspections, testing of factory samples an d market samples. Still, in many cases, renewal 
of licence had been granted even when no plan t inspection had been carried out during the 
operative period of the licence. As for the a dditional questions from Japan, they had been 
addressed during a bilateral meeting and also in writing. G/TBT/M/65  
 
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  2.2.3.2  India – Drugs and Cosmetics Rule s 2007 (G/TBT/N/IND/33) - IMS Item No. 
167 
2.44.  The representative of Canada thanked India for having provided additional clarifications on 
its Medical Device Regulatory System, in response to their letter sent on October 2014. 
Nonetheless, Canada remained concerned that India's plans to regulate medical devices might 
have important economic effects on the Canadian medical device manufacturers and might not be in compliance with TBT obligations. Regarding the Guidance Document on Common Submission 
Format for Registration/Re-Registration of Notified Medical Devices in India, which came into effect 
in January 2013, Canada was still very concerned with two of its provisions: the necessity for certificates/licenses to be notarized/attested by the Indian Embassy in the country of origin and the requirement for medical devices to be freely sold in the country of origin. These could be more 
trade restrictive than necessary given the fact that many Canadian products might be marketed 
only in jurisdictions other than the country of origin and certificates/licenses issued by leading jurisdictions, including Canada, should not require notarization. He asked whether India had 
considered less trade restrictive alternatives to pursue its objectives. 
2.45.  Furthermore, Canada would welcome clar ifications with regards to the Performance 
Evaluation Report requirements for diagnostic kits. In Canada's understanding, the "Consecutive 
batches" referred to in the Guidance Document re ferred to release testing, which normally aimed 
to prevent substandard lots from reaching the market and demonstrate that the device met its specifications. It also provided ongoing/real time monitoring of the manufacturing process. Canada sought confirmation that this type of release testing was what was being referred to in its 
Guidance Document. Canada also asked whether it would apply to all Notified Diagnostic Kits and 
whe the r it n e e de d  to b e d one  in I nd ia.  Canad a a ls o we lc ome d  any ad d iti onal d e tai ls  that I nd ia could provide on its future plans for medical devi ce regulation and the status of the Drugs and 
Cosmetics (Amendment) Bill, 2015, which, as they understood, had not been passed by Parliament 
yet. 
2.46.  The representative of the European Union reiterated their request for India, which already 
allowed the registration certificate number of the brand and the name and address of the 
registration certificate holder to be labelled by means of stickers, to also allow all aspects of cosmetics labelling, including the list of cosmetic ingredients or any other information relevant for the consumer, to be provided via stickers, which can be attached at customs bonded warehouses. 
Allowing the information to be provided after imports in customs warehouses was a very important 
trade facilitating measure that did not jeopardise India's legitimate health and safety objectives. This was particularly relevant for manufacturers that  exported small quantities and found it difficult 
to adapt the labels to different geographical regions requirements. 
2.47.  Secondly, as already mentioned during the June 2014 meeting of the TBT Committee, the 
Indian Central Government had amended the legal metrology Packaged Commodities Rules 2011 
to require that cosmetic products bear a red or brown dot at the top of the principal display panel 
for products of non-vegetarian origin and a green dot for products of vegetable origin. In the meantime, the EU had received information that as a result of an ongoing court case, the requirement could be withdrawn following the declaration of the Bombay High Court, allowing 
producers to decide whether to indicate the re d/brown/green dot or not. The EU appreciated 
receiving further information on this issue. Thirdly, the EU shared the objective of achieving sustainable cosmetics by restricting animal testin g for cosmetics ingredients. However, the EU was 
concerned about India's implementation of its import ban on animal testing for cosmetics 
ingredients, which did not take into consideration technical possibilities and options of derogations in exceptional circumstances. 
2.48.  Furthermore, the EU was still concerned with and sought further information on the 
application of a new importing checklist to check compliance of imported products with the Indian requirements. The EU was informed that through this  checklist, India required market operators to 
provide data and tests that were not provided for in the basic Cosmetics Law of 2010, while the 
previous checklist used by Drug Controller General of India (DCGI) had been in line with this law 
as well as the guidance document issued in 2013. Finally, the EU requested India to notify to the 
TBT Committee the latest draft amendments of the Drugs and Cosmetics Act and of the Drugs and 
Cosmetics Rules, 1945, which had already been made available for public consultation. G/TBT/M/65  
 
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  2.49.  The representative of the United States associated herself with the comments from Canada 
and the EU and stated that the US appreciate d the bilateral consultation on the Drugs and 
Cosmetics Rules held earlier during the week . She further requested India to notify the 
amendments to the TBT Committee and allow for comments from interested Members. 
2.50.  The representative of India said that ther e had been no change in the regulatory status 
regarding the question of allowing stickers to display all labelling information on cosmetics since 
the previous meeting, during which India had made a statement on this issue (Para 2.81 of 
G/TBT/M/64/Rev.1). Only the registration cert ificate number of the brand and the name and 
address of the registration certificate holder was permitted via stickers. Hence information pertaining to all other aspects of cosmetic labelling, including the list of cosmetics ingredients or any other information for the consumer, was not allowed via stickers under the Drugs and 
Cosmetics Rules. Furthermore, the current rules did not allow "stickering" for placing brown or 
green dots at the top of the principal display panel to reflect whether a cosmetic product had a non-vegetarian or vegetarian origin. India had already forwarded replies to the Canadian 
delegation regarding India's regulatory system on medical devices and was willing to provide 
further clarification on the matter. 
2.2.3.3  China – Provisions for the Administ ration of Cosmetics A pplication Acceptance. 
Cosmetics Label Instructions Regulation s and Guidance for the Cosmetics Label 
Instructions (G/TBT/N/CHN/821, G/TBT/N/CHN/937) - IMS ID 296 
2.51.  The representative of Canada reiterated concerns regarding China's Food and Drug 
Administration's (CFDA) burdensome approval and registration process for cosmetic products. The 
lack of progress in approving new ingredients was a serious barrier to trade. According to Canada, 
the "positive list" approach did not ensure an improvement in safety compliance and was redundant with regulation mechanisms already in pl ace. The "positive list" approach might actually 
prevent Chinese consumers from accessing safer and more innovative cosmetic products. CFDA's 
intention to define what was a "new" vs. an "existing" ingredient according to a positive list risked a characterization of thousands of ingredients that were already sold on the Chinese market as 
suddenly "new". Canada recognized that CFDA publ ished an annual report which outlined the CFDA 
approval rate of special and non-special import ed cosmetics. According to CFDA, 2,494 special 
cosmetics and 11,726 non-special imported cosmetics were approved in 2013. He asked China to clarify the share of these 2013 approved cosmeti cs that contained "new ingredients". Domestic 
cosmetic manufacturers were able to register "new ingredients" without an additional application 
process, and China applied a different registration process for its domestic cosmetics manufacturers than it did for importers. Stre amlining the approvals processes for imported 
cosmetics and applying the same registration process applied to domestic cosmetic products would 
create a fair trade environment for the cosmetic industry, consistent with the TBT Agreement. 
2.52.  The representative of Japan reiterated two specific concerns regarding guidance for 
application and evaluation of new cosmetic ingredients ("the Guidance"). Firstly, he noted that 
since the implementation of the Guidance in May 2011 only four new ingredients had been registered, and there remained significant difficulties  for export of cosmetic products to China with 
new ingredients. Japan therefore requested China to accelerate examination of new ingredients. 
Secondly, the Guidance required safety evaluation data to be submitted for each single molecule 
isolated from plant extracts and fermented solvents. This requirement was excessive and trade restrictive and this requirement did not feature in the safety evaluation practices for cosmetic 
ingredients of other countries, such as the United States, the European Union, and Japan. He 
asked China to revise the Guidance, so that cosm etic manufacturers were able to register new 
ingredients without the additional process of isolation of new ingredients. Finally, Japan requested 
clarification from China as to the scientific basis for requiring evaluation of single molecules 
isolated from a complex ingredient, as well as the product safety risk which could arise in evaluating a complex ingredient without isolation. 
2.53.  The representative of the European Union reiterated concerns in relation to the pace of 
progress on the procedure for the authorization of new ingredients. The EU was still of the opinion 
that the new registration procedure was not deliverin g with the speed, efficiency and predictability 
necessary. Given that several new ingredients were developed per year, and that only four had 
been registered in the last four years, the EU asked how did the new system of ingredient 
authorisation worked in practice, and whether there were any positive developments that could be shared by Chinese authorities at the meeting. An authorization procedure restricted to only certain G/TBT/M/65  
 
- 15 - 
 
  ingredients, such as UV filters, colorants and hair dyes, would be more adequate, as cosmetics 
were not pharmaceuticals. For the remaining ingredients, which represented the majority of cosmetic ingredients, the safety characterization and assessment should be done under the responsibility of the manufacturer. In this contex t, the EU suggested two proposals to China: to 
limit the procedure for registration of new ingredie nts to priority substances - i.e. higher risk 
substances - and allow a lighter procedure for lower risk substances; and, to share the safety responsibility for new ingredients between China' s Food and Drug Administration (CFDA) and the 
registrant company for low risk substances. Finally, he noted that EU concerns on the Chinese 
requirement on the labelling of cosmetics had alre ady been covered earlier in this meeting under 
the first new STC raised. 
2.54.  The representative of China reminded the Committee that since the notification of the 
measure in July 2011, the CFDA offered specialized training and guidance on the difficulties 
enterprises had met in the implementation of this measure. In addition to cooperation at the governmental level, CFDA had kept bilateral cha nnels open and formed several working groups on 
this issue with several Members. CFDA had paid great attention to the approval of new cosmetic 
ingredients. China continued to communicate with experts and industry associations in China and abroad, and was carrying out further research on this issue. In addition, China was seeking 
effective ways to administrate cosmetics through cooperation with Members. The approval 
procedure was being carried out in an orderly fa shion. By the end of 2014, CFDA had approved 
13,511 imported cosmetics applications. China rema ined available to discuss the issue bilaterally 
and welcomed further cooperation and valuable inputs from interested parties.  
2.55.  The representative said that the "inventory of used cosmetics ingredients in China" was still 
under drafting, and that it was not a "positive list" on cosmetic materials, but only developed to distinguish if one material was firstly used in cosmetics produced or sold in China. The document 
designed a sole standard on approving new cosmetic materials, to prepare for devolving 
responsibility of managing imported "normal cosmetic" registrations to provincial level authorities. CFDA had carried out two rounds of public consultation, and industry had added over 10,000 
existing materials to the document. Except for the materials banned for safety hazards, all 
cosmetic materials that had been used on the Ch inese market were going to be included in the 
document. She noted that all materials were to be marked by both their Chinese and INCI name. At the present stage, CFDA was still finalizing the document. 
2.56.  Regarding the "Adjustment of Cosmetic New Ingredient Registration Management" 
(G/TBT/N/CHN/1019), China explained it was issued to accelerate the approval procedure of new cosmetic materials through an adjustment on administration level. In addition, China noted that 
Cosmetics Label Instructions Regulations and Guidance for the Cosmetics Label Instructions 
(G/TBT/N/CHN/937) was replaced by Administrati ve Measures on Cosmetic Labelling (AMCL). 
2.2.3.4  India – New Telecommunicati ons related Rules (Department of 
Telecommunications, No. 842-725/2005-VA S/Vol.III (3 December 2009); No. 10-
15/2009-AS-III/193 (18 March 2010); and Nos. 10-15/2009-AS.I II/Vol.II/(Pt.)/(25-
29) (28 July 2010); Department of  Telecommunications, No. 10-15/2009-
AS.III/Vol.II/(Pt.)/(30) (28 July 2010) an d accompanying template, "Security and 
Business Continuity Agreement") - IMS ID 274 
2.57.  The representative of Canada reiterated concerns with respect to India’s test requirements 
for telecommunications products. India's in-country security testing regulations for 
telecommunications products would hinder or possibly shut Canadian exporters out of the Indian 
market. Canada disagreed with India’s blanket approach to testing in the telecommunications sector, and still did not understand why Common Criteria (CC) testing was not appropriate for 
India’s telecommunications framework, given that it was already internationally accepted. 
Recognition by India of foreign conformity asse ssment bodies accredited by signatories to the 
ILAC/IAF mutual recognition agreements (MLAs) to test and certify to India’s regulatory requirements would minimize the negative impact on companies wishing to export to India while 
at the same time providing assurance to India th at the recognized conformity assessment bodies 
were competent. Moreover, allowing accredited fo reign conformity assessment bodies to test and 
certify to India’s regulatory requirements would reduce testing costs and allow exporters to bring 
their products to the Indian market more quickly. He asked India to provide a detailed rationale 
and justification for deviating from Common Criteria testing. G/TBT/M/65  
 
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  2.58.  The representative of the United States acknowledged India's extension of the 
implementation date for in-country testing to Ma rch 2015, but noted with concern that this date 
was fast approaching, and there were continued concerns with India’s planned security testing of telecommunications equipment. She asked for confirmation as to whether the April 2015 
enforcement date would be extended. The US voiced serious and fundamental concerns with the 
new license amendment regime, especially with respect to the domestic testing requirement in the telecommunications sector. The US continued to disagree with India’s premise that domestic 
testing was either necessary or sufficient to meet India's legitimate security concerns, and noted 
that India had yet to articulate an explanation of how testing a product in-country in India advanced its security objectives. The testing requirement was difficult to reconcile with India’s certification under the Common Criteria Recognition Arrangement (CCRA), by which India had 
agreed to accept the results of CC tests conducted outside India. Having supported India’s CC 
certification, the US was particularly disappoin ted to see no change in the revised licensing 
amendment. 
2.59.  The representative of the European Union joined Canada and the US in reiterating concern 
about the imminent entry into force of the information security testing clearance and the related 
in-country testing requirements.  While thanking India for its willingness to engage in discussions 
with European Industry and with the EU, the EU was of the view that the system was not ready for 
implementation on 1 April 2015 and asked India to consider further postponement of the measure.. Until then, it was the EU's understanding that a status quo would apply and that foreign test results would continue to be accepted. The EU welcomed confirmation by India at previous 
meetings that relevant tests would have to be carried out according to international standards, 
namely the common criteria ISO/IEC 15408 Common Criteria standard, ISO 27000 for information security management systems, and the standard s developed by the third generation mobile 
technology partnership project, 3GPP and 3GPP2, as regards telecom and telecom network 
elements problems. The EU representative also und erstood that India was in the process of joining 
the 3GPP2, a step also welcomed by the EU towards ensuring lasting adherence by India to 
standards developed by this platform. Test resu lts from laboratories appointed by the Common 
Criteria Recognition Arrangement (CCRA) would continue to be accepted also beyond 1 April 2015 for the purpose of the required security assurance, which would be in line with India's obligations as a full member of the CCRA. The EU invited India to continue discussing with telecom equipment 
suppliers to develop working methods and procedures reflecting international practice. As for 
security aspects of mobile telecom elements which were not covered by the Common Criteria standard, the EU asked that India accept resu lts of qualified foreign laboratories holding 
accreditation from ILAC MRA signatories beyond 1 April 2015, and that India therefore not require 
exclusively in-country testing, but instead continue to accept foreign test results as a basis for any certification to be issued in India by appointed certification bodies.  
2.60.  He. The representative of Japan supported the Canadian, EU and US positions, and 
confirmed Japan's interest in the Unified Access Service Licence Agreement and requested India to 
ensure that Indian telecom regulations did not impede market access for foreign industries. 
2.61.  The representative of India recalled hi s statements from the previous meeting, and 
presented some updates on the current state of play. On the issue of whether compulsory in-
country testing would start from 1 April 2015, he informed Members that the requisite infrastructure was being planned and therefore the date of entry into force of in-country testing 
was likely to be extended. With respect to whether test certificates from foreign laboratories such 
as CCRA and ILAC would be accepted, he stated that the licensees shall induct only those network elements into their telecom network which had been tested as per relevant contemporary Indian 
or International Security Standards. The standards to be tested against were, for example: for IT 
and IT-related elements against ISO/IEC 15408 standards; for Information Security Management Systems against ISO 27000 series; for Standards, Telecom and Telecom related elements against 3GPP security standards and 3GPP2 security standards. These tests were to be conducted by any 
international agency/lab proficient in testing against these standards, such as CC labs in case of 
ISO/IEC 15480 standards, until 31 March 2015. As from 1 April 2015, the certification was to be provided only from authorized and certified agencies/labs in India. However, this date was likely to 
be extended. 
2.62.  He further stated that moving to an authorised nation from a consuming nation for testing 
under CCRA did not change India's position with re gard to the requirement for security testing and 
certification of telecom equipment from labs located in India due to national security G/TBT/M/65  
 
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  considerations. As stated earlier, the CC testing was limited to IT and IT-related products, and 
being a process based testing, largely addressed th e issues of commercial security consideration. 
It did not address the national security issues. Moreover, when an IT product was used in telecom network, it became a telecom network element where functional or operational requirements were 
governed by 3GPP or 3GPP2 standards. India beli eved that security testing of telecom equipment 
with respect to India's Department of Telecommunication’s user specification would not be considered an infringement of CCRA. However, in respect of testing of IT products to be used in 
telecom network which had already been tested und er CCRA, leverage would be given to the CC 
testing and additional tests, if required, would be carried out as per the prescribed systems, processes and standards.  
2.63.  India reiterated that in-country securi ty certification testing of telecommunications 
equipment had been mandated due to the fact that in the modern age, telecommunications 
equipment was vulnerable to the spyware and ma lware attacks. He said that network element 
wide test requirement would be part of the guidelines for in-country testing. Finally, he informed 
Members that the TSDSI (Telecommunications Standa rds Development Society of India), an Indian 
Telecom SDO, was already an organizational partner of 3GPP. 
2.2.3.5  China – Requirements for information security products, including, inter alia, the 
Office of State Commercial Cryptography Administration (OSCCA ) 1999 Regulation on 
commercial encryption products and its on-goi ng revision and the Multi-Level Protection 
Scheme (MLPS) - IMS ID 294 
2.64.  The representative of Canada expressed conc ern with China’s overall regulatory approach in 
the information technology sector, in particular, that it was overly burdensome and restrictive to 
international trade. Canada recognized that China was seeking to address security concerns, however avoiding duplication of conformity testing by recognizing foreign accreditation would 
significantly reduce the burden on industry and would be a net benefit for all parties. 
2.65.  The representative of the European Union requested that a link be established between this 
specific trade concern and the new specific trade concern raised on China - Banking IT Equipment 
Security Regulation. The EU requested clarification on the relationship between the guidelines for 
the banking sector and the existing framework fo r information security products. The extent, for 
instance, to which the commercial encryption regulation of the Office of State Commercial Cryptography Administration (OSCCA) would be rele vant for the implementation of the guidelines 
for equipment procurement by bank s. In addition, the EU inquired about the extent to which 
banking was considered as critical infrastructure, and whether the Multi-Level Protection Scheme would be relevant for the implementation of the guidelines. 
2.66.  The EU noted that the revision of the OS CCA regulation on commercial encryption products 
had been on the agenda of the State Council legisl ative office for several years. He requested an 
update on the process and the content of the re vised regulation, and when the measure was going 
to be notified to the TBT Committee. He requeste d an update on the implementation of the Multi-
Level Protection Scheme (MLPS) in light of the new cyber security strategy being implemented by 
China. In this respect, he emphasised the import ance of ensuring transparency, predictability for 
market access, and the need for a clear system of enhanced international cooperation to ensure 
compatible regimes enhancing security without hindering trade in commercial products, while 
contributing to the attainment of legitimate objectives. 
2.67.  The representative of Japan reiterated supp ort for the positions of Canada and EU on this 
issue, and said that Japan was concerned in particular with the various schemes and regulations 
within China on information security, and how they could negatively affect trade of information security products.   
2.68.  The representative of China informed th e Committee that the Regulation on Commercial 
Encryption Products had been listed in the 2015 Legi slation Plan of the State Council of China, and 
currently the Regulation was being drafted in line with the Legislation Law and Rules on 
F o r m u l a t i o n  o f  A d m i n i s t r a t i v e  L a w s  of  C h i n a .  C h i n a  s a i d  t h a t O S C C A  w o u l d  u n d e r t a k e  s c i e n t i f i c  
evaluations and public consultations to ensure op enness in the legislation process. On the MLPS, 
China suggested Members to refer to the minutes of the previous meeting. G/TBT/M/65  
 
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  2.2.3.6  Russian Federation – Draft on Tec hnical Regulation of Alcohol Drinks Safety 
(published on 24 October) (G/TBT/N/RUS/2) - IMS Item No. 332 
2.69.  The representative of the United States appreciated Russia's notification of this measure to 
the WTO, and for Russia's exclusion of the propos ed circulation procedure from the most current 
version of the draft text. However, the US remain ed concerned about several other provisions that 
were present in the original draft, notified by Russia in December 2012. Specifically, the proposed 
definition of whiskies, and the requirement that th ey be aged for no less than three years. The US 
also remained concerned that alcoholic beverages still required an expiration date. Additionally, 
she noted concerns outlined in previous US comments with respect to the standards for production facilities, and several conformity assessment procedures and their applicability to foreign manufactures. She requested that Russia clarify th at these requirements would not be applicable 
to producers already subject to controls by US authorities. In this vein, she recalled the previous 
statement by Russia that the 2012 draft was substa ntially modified in December 2013. In the 
interest of enhancing transparency and mitigating any undue burden for exporters of alcoholic 
beverages to Russia, she requested that Russia notify  its latest draft of this technical regulation 
and provide an additional comment period for stakeholder input. 
2.70.  The representative of Mexico reiterated concerns with this measure, and recalled that his 
delegation had sent written comments to Russia in December 2011 and April 2012, but had not 
yet received any formal responses. The concern was expressed for the first time in the Committee in March 2012, and had been reiterated in all the subsequent TBT Committee meetings. The issue 
was the lack of information on the state of preparat ion of the technical regulation on the safety of 
alcoholic beverages. In this respect, Mexico  requested the Russian Federation to provide 
information on the state of progress on the elaboration of the regulation and the current state of play with regard to its final adoption. He also asked Russia to explain how the comments of the 
Mexico were taken into account in relation to the final text of the regulation, and to provide a 
formal response to those comments. 
2.71.  The representative of the European Union requested an update on the status and timeline 
for adoption of this draft technical regulation, notified in 2012 and scheduled to be finalized before 
the end of 2014. The EU recalled detailed writte n comments in 2013, and reiterated in subsequent 
meetings of the TBT Committee. Russia had expl ained in previous TBT Committee meetings that 
most of the EU comments regarding wine and beer would be taken on board in the revised draft 
technical regulation on alcohol products safety. However, the EU noted that the revised text had 
not yet been notified under the TBT Agreement, no r had it been published. The EU asked whether 
Russia intended to re-notify the revised text to the TBT Committee, given that it would likely 
include substantial changes as compared to the text notified in 2012. A re-notification would give 
WTO Members a possibility to analyse how their comments have been taken into consideration. 
2.72.  The representative of Australia voiced continued concerns with elements of Russia's 
technical regulation on the safety of alcoholic drin ks and requested an update on the status of the 
measure. Both Australia and Russia shared the commitment to adopt internationally accepted standards for alcoholic products as recommended by the International Organisation of Vine and Wine (OIV), and to avoid creating unnecessary obstacles to trade in wine. He once again 
suggested that Russia consider adopting the OIV list of approved additives and processing aids, as 
set out in the "International Oenological Codex" and the "International Code of Oenological Practices". Australia remained concerned about the legal status of wines which conformed to the 
health warning statement under the previous legislation, and were in circulation at the time the 
draft regulation entered into force. He asked that Russia introduce a six-month transition period for these products to enable industry sufficient time to implement the stated labelling 
requirements. On the issue of wines which used an Australian geographical indication (GI) in their 
description and presentation, he asked whether Russia had considered his delegation's request that wines labelled with an Australian GI be considered as a "protected geographical indication" under the new technical regulations, and that the relevant exemptions from the regulations 
relating to wines with a "protected geographical in dication" be applied. He also reminded Russia of 
concerns over the requirements relating to the bottling location of wines which included a GI in their description and presentation. He enquired whether the Customs Union regulations required 
such wines to be bottled within the boundary of the GI stated in the description and presentation 
of the wine. G/TBT/M/65  
 
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  2.73.  The representative of the Russian Federation underscored that these concerns were raised 
previously, and invited Members to refer to th e answers provided during past TBT Committee 
meetings. Russia continued to work on the draft on the Technical Regulation of Alcohol Drinks Safety, and assured Members that it would take into account all constructive comments and 
proposals, and welcomed further cooperation with all the parties on this matter. 
2.2.3.7  Republic of Korea – Regulation on  Registration and Evaluation of Chemical 
Material (G/TBT/N/KOR/305) - IMS Item No. 305 
2.74.  The representative of the United States encouraged Korea to develop a strong definition of 
confidential business information (CBI) and include at least the possibility of protecting the specific 
chemical identity, composition, and uses, while respecting the legitimate government interest in allowing for reporting of generic chemical names, and for providing adequate hazard information to 
downstream users. K-REACH should include addition al provisions preventing any disclosure of CBI. 
Korea should tighten the definition of "hazardous substance" so as to avoid confusion and an overly broad application that would de facto prevent claims of CBI for any substance. The US 
considered that the phrase "other chemical substa nces that either pose or raise the concern of 
hazard or risk" should be deleted from the definition. She encouraged Korea to give greater consideration to stakeholder requests to delay the implementation date in light of the issues that 
had been raised. She asked that the role  of the Korean Chemical Manufacturers 
Association (KCMA) be defined and that there be a level playing field for both domestic and foreign registrants. 
2.75.  The representative of Japan was concer ned that products containing approximately 
500 hazardous substances, not less than 0.1% by weight and not less than 1 ton per year in total, 
had to be notified to the authority of the production, sales and import of them. Japan understood that the enforcement decree included an exception that in some cases the notification could be 
delayed until 30 April of the next year. However, chemical industries would still have the heavy 
burden of examining 500 hazardous substances through supply chains all at once. Japan reiterated its request for Korea to introduce the regulation in a stepwise manner according to the priority of 
hazardous substances. 
2.76.  The representative of the Republic of Ko rea informed the Committee that this measure had 
entered into force on 1 January 2015. With regard to the US concerns on CBI, he reiterated what 
had been said at the November meeting, that this  type of information was defined in the "Unfair 
Competition Prevention and Trade Secret Protecti on Act" and that the Ministry of Environment 
would decide what specific chemical identity, composition and uses could be considered CBI, taking into account commercial value of information and business activity. Therefore, information 
designated as a CBI during the registration process would be considered strictly confidential upon 
request. Information shared in the supply chain was limited to safety issues such as risk posed by chemical substances, limited usage and precaution s. Concerning the list of existing chemicals 
subject to registration, he said this list was in the final legislative process and would soon be 
notified to the WTO so as to give Members the opportunity to comment and to inform that there would be a three-year grace period from the date of entry into force of notice. Concerning the request to tighten the definition of "hazardous substance", the representative said that regretfully 
this would not be possible as Korea had undertaken considerable consultation with both domestic 
and international stakeholders prior to the very recent entry into force of this Act. So as to enhance transparency and ensure better understanding of measures, guidelines for Acts and 
Decrees were been prepared in English. Finally, he assured Members that other issues raised 
would be relayed to the competent authorities and that Korea would continue to cooperate on a bilateral level. 
2.2.3.8  Indonesia - Technical Guidelines fo r the Implementation of the Adoption and 
Supervision of Indonesian National Standards for Obligatory Toy Safety (G/TBT/N/IDN/64, G/TBT/N/IDN/64/Add.2) - IMS Item No.328 
2.77.  The representative of the United States noted that toy safety was an objective shared by 
many Members. However, her delegation still considered certain aspects of Indonesia's toy 
regulatory regime to be considerably more rest rictive than those adopted by other Members and, 
specifically, more restrictive than necessary to achieve the objective of protecting human health. 
In this respect, the US continued to have concerns related to laboratory accreditation, testing 
frequency, sampling, documentation, and substanc e restrictions as well as the requirement to G/TBT/M/65  
 
- 20 - 
 
  have a bilateral MRA in place by April 2016. Despite efforts by both the US Government and other 
trading partners, as well as the toy industry coalition, few of these concerns were addressed prior to the regulation coming into force at the end of April 2014. The US was particularly concerned that the increased costs and decreased quantity and variety of safe toys from compliant companies 
due to these restrictive requirements would cause consumers to look for alternatives in the grey 
market, thereby decreasing consumer safety. The US looked forward to receiving a copy of the revised technical guidance as well as the list of MOI-approved international labs. 
2.78.  The representative of the European Union ex pressed his delegation's view that the technical 
working group that was being formed in the Indonesi an Ministry of Industry could be a good tool 
for industry to collaborate with the Ministry with a view to finding viable solutions to amend Decree No. 24 so as to eliminate the current discriminating, unnecessary burdensome conformity 
assessment requirements contained therein (tests on every imported batch as compared with tests 
of samples taken from the production line every 6 months for domestic products). The EU asked Indonesia to provide further updates with respect to such revision initiatives. The EU also sought 
clarification on the application of the current two year grace period concerning the acceptance of 
foreign tests by laboratories accredited by ILAC MRA signatories. The EU asked whether this two year period applied individually to each lab as from the date of appointment or, rather, this was 
linked to the entry into force of the decree. The EU believed that there should be scope for 
acceptance of results from tests conducted by foreign laboratories on a permanent basis in view of the current capacity constraints in Indonesia, even beyond the grace period.  
2.79.  The EU also said that the inconsistencies stemming from the fact that in Indonesia toys 
were subject to two separate sets of labelling requirements: a toy specific one (Decree No. 24), 
and a general one (the revised general labelling requirements discussed separately under STC IMS ID 436).  
2.80.  These combined requirements meant that toys had to be handled manually twice: before 
shipment, according to the general requirements for labelling in Indonesian language, and after 
importation, in order to meet the specific labelling requirements under the toy regulation. It was 
the EU's understanding that the Ministry of Indust ry and the Ministry of Trade were responsible for 
managing this set of requirements. The EU expr essed its willingness to work together with 
Indonesia in aligning to this requirements and eliminating the inconsistencies. 
2.81.  The representative of Japan associated himself with the US and the EU and reiterated his 
delegation's previous request for Indonesia to revise its measure so as to make it consistent with 
TBT Agreement obligations, in particular by not being more trade-restrictive than necessary. 
2.82.  The representative of Indonesia said that, as stated in previous meetings, the Mandatory 
SNI for toys products was still valid and there was no updated information regarding the 
implementation of this regulation. Regarding concern on the differences in sampling criteria between domestic products (which was every 6 months) and imported products (for every 
shipment), Indonesia explained that this trea tment was based on the consideration that the 
domestic production capacity was of around 5,000 pieces of toys every 6 months, while imported 
products could exceed 5,000 pieces in one shipment. This was also based on the fact that Indonesia was a developing country where most toy producers were SMEs  with low production 
capacity. Regarding testing procedure, Indonesi a explained that the mandatory toy regulation 
stated that test results issued by foreign testing laboratories listed in the Mutual Recognition Agreement (MRA) under APLAC/ILAC scheme were accepted. Furthermore, foreign testing 
laboratories accredited by their respective accreditation bodies could be recognized provided that 
the countries where the laboratories were based had a bilateral agreement (MOU) on technical regulations with the Indonesian Government and the laboratories were appointed by the 
Indonesian Ministry of Industry. Indonesia has gran ted 2 years of grace period for the result to be 
recognized. However, this kind of special treatment during this grace period could only be extended beyond the period if the government of  the country where the laboratories were based 
already had a mutual recognition agreement with the Indonesian Government. G/TBT/M/65  
 
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  2.2.3.9  India - Food Safety and Standards Regulation - Food la belling requirements - 
IMS ID 298 
2.83.  The representative of the European Union said that India's ad hoc guidelines of January 
2014 note that only India specific food labelling requirements (such as vegetarian/non vegetarian 
logos) and the name and address of the importer could be affixed by the importer by means of 
stickers in customs warehouses. However, in most economies in the world food products could be labelled by means of stickers, provided that they are accurate and not easily detachable. This was 
a very important trade facilitating practice that, while duly protecting the consumer, at the same 
time allowed producers to serve different region s with different language requirements without 
having separate production lines. Given the forego ing, the EU considered India's labelling practice 
to be: (i) too burdensome; (ii) not in compliance with Article 2.2 and 2.4 of the TBT Agreement; 
and (iii) not in accordance with the Codex Stan dard for the labelling of pre-packaged foods 
(CODEX STAN 1 1985). According to this Codex Standard: ''If the language on the original label is not acceptable, to the consumer for whom it is  intended, a supplementary label containing the 
mandatory information in the required language may be used instead of relabelling''. This standard 
also stated that: ''in the case of either relabelling or a supplementary label, the mandatory information provided shall be fully and accurately reflect that in the original label.'' The EU 
therefore asked India to bring its implementing guidelines in line with Codex so as to allow all type 
of labelling information - and not only the Indian specific one - to be provided by stickers (for example at customs bonded warehouses). This was a sound alternative to labelling in the country of origin that would allow India to fulfil its legitimate objectives in a non-trade restrictive way.  
2.84.  The EU also noted that some specific parts of Indian food regulations were not in line with 
Codex standards (for instance, olives and whole-wheat pasta). In this respect, the EU asked if India intended to bring amendments to the India F ood Regulations any time soon in order to bring 
them closer to Codex standards. Additionally, with  respect to alcoholic drinks, the EU noted that 
currently the Indian legislation required that the labels of alcoholic drinks contained the full list of ingredients. As for food, the EU continued to request that India accept stickers providing such 
information. Finally, given that the Indian Food Safety and Standards Authority was preparing a 
technical regulation on alcoholic drinks as well as  an update of allowed food additives, the EU 
asked India what were the envisaged timeframes  for notifying these measures to the WTO. 
2.85.  The representative of Australia expressed continued concerns with India's food standards 
and their enforcement by the Food Safety and Stan dards Authority of India (FSSAI). He noted that 
Australia had previously supported the efforts of FSSAI to harmonize Indian food standards with CODEX standards, a process that began in early 2013 and was due to be finalised in 2014. 
Australia had provided extensive information to FSSAI about Australian food standards and their 
enforcement. Australia asked India to inform: (i ) when the process of harmonisation of India's 
food standards with Codex would be finalised; (ii) whether India was planning another review of its 
standards; and, if so, (iii) whether India would consider the issues raised by WTO Members and 
whether this review would be through finalisation or extension of the Codex harmonisation process, or a separate review. 
2.86.  The representative of Canada echoed the concerns expressed by the previous delegations. 
2.87.  The representative of India informed the Committee that there was no change in the 
regulatory status since the last meeting of the Committee and referred Members to the statements 
made by India on that occasion, as reflected in  the minutes of that meeting (Para 2.124 and 2.125 
of G/TBT/M/64/Rev.1). He also stated that additional issues raised would be communicated to the 
regulatory authority in the capital for response. 
2.2.3.10  European Union – Draft Implementi ng Regulations amending Regulation (EC) 
No. 607/2009 laying down detailed rules for th e application of Council Regulation (EC) 
No 479/2008 as regards protected designations of origin and geographical indications, 
traditional terms, labelling and presentati on of certain wine sector products 
(G/TBT/N/EEC/264, G/TBT/N/EEC/264/Add.1) - IMS ID 345 
2.88.  The representative of the United States recalled her delegation's previous concerns and 
requested the status of the applications submitted by the US wine industry over four years ago. 
The US noted that some of its suppliers that currently used the terms referred to in the EU G/TBT/M/65  
 
- 22 - 
 
  measure had been unable to ship their products. The US was also concerned with the lack of 
transparency in the application process for the use of traditional terms. This process continued to 
undermine US exports of wine to the EU.  
2.89.  The representative of Argentina associated himself with the statement of the US and 
reiterated his delegation’s concerns with the unjustified delay in resolving this long standing STC. 
By providing EU member states with the exclusive right to use certain traditional expressions, in each of their respective languages, the European me asures restricted the right of third countries to 
use these same expressions on their labels, seriously affecting Argentine exports of wine to the 
EU. Argentina argued that because traditional expressions were indications of quality, they would fall under the TBT Agreement and not under the TRIPS Agreement. Consequently, these expressions could not be registered as IP nor confer any exclusive rights for their use. This 
measure therefore constituted clear and flagrant discrimination against Argentina and any other 
producing country that wanted to place wines bearing traditional expressions such as "Reserva" and "Grand Reserva" on the European market. Th us, the EU measure was not adopted to protect 
consumers from being misled nor to guarantee the characteristics wines may have when 
associated with such expressions, considering the existence of multiple definitions for each one of 
these terms, all of them accepted by the EU th rough different mechanisms . This measure was not 
therefore consistent with the TBT Agreement.  
2.90.  In spite of being WTO inconsistent, and in order to help find a practical and constructive 
solution to avoid the barriers posed by the EU legislation, Argentina reported that in 2009 it 
submitted its file for the approval of terms "Reserva" and "Grand Reserva". After various 
exchanges, this dossier was then approved in March 2012 by the European Commission's Wine 
Management Committee. Although the substantive procedure was completed in March 2012, the final formal step, namely the adoption of the Argentine dossier by the College of Commissioners 
and its publication in the Official Journal of the EU, had not yet been taken. The substantive 
procedure took two years and seven months, from July 2009 until the approval of the dossier in 
March 2012, while the delay to comply a single administrative act of a formal nature had already 
reached three years, from March 2012 to March 2015. It was striking that the delay to finalize 
merely formal administrative ac ts had exceeded the time taken to end the substantive procedure 
that approved the dossier. It was not coherent that only one formal act required more time than the total amount of acts of the process, during which Argentina had also responded to objections 
by different entities and supplied additional inform ation in response to requests from the EC for 
clarifications regarding its documentation. He adde d that recently a new internal ad hoc group of 
DG-AGRI was revising all requests for recognition of traditional expressions, which could result in 
further delays for the final approval of the Argent ine requests. Argentina insisted that such delay 
was doubly unjustified: neither had the process been  concluded in a reasonable period of time, nor 
had a reasonable explanation been given for the delay. This delay constituted in and of itself an 
obstacle to trade and left Argentine wine in a disadvantageous position in relation to their other 
competitors that had access to such expressions. Argentina urged the EU to find a prompt solution, having asked them so through bilateral, multilateral and plurilateral channels, where several notes were sent to the EU by the World Wine Trade Group, to date without success. To this end, 
Argentina asked the EU, once more, to eliminate these unjustified restrictions on the Argentine 
exports of quality wines, taking the final formal step towards the approval of the Argentine requests, namely, to include the Argentine dossier  in the agenda of the next meeting of the 
College of Commissioners and to publish the corresponding final ruling in the Official Journal of the 
EU. 
2.91.  The representative of the European Union explained that an internal assessment on 
traditional terms has been carried out within the EU with stakeholders and experts from the EU 
member states (in accordance with Article 114(3) of Regulation no 1308/2013 establishing a 
common organization of the markets in agricultural products). This consultation, which was still ongoing, included the conditions and specificities under which these traditional terms could be 
used on the labels of products from third countri es. The possible derogations, based particularly on 
minimum requirements for production methods and controls under product specifications of the wines concerned, have been covered by this di scussion. Nevertheless, no final conclusions had 
been reached yet. The EU would continue to make the necessary efforts to bring new elements in 
its current policy on protection of traditional terms and their indication on the labels of wines in order to accommodate trade partners' concerns. In th is respect, he noted that the concerns raised 
by the US and Argentina had been taken into account in the assessment process currently carried G/TBT/M/65  
 
- 23 - 
 
  out in the EU. The procedures under consideration (whether from EU member states or third 
countries) would be taken once this evaluation would be finalized. 
2.2.3.11  Chile – Proposed amendment to the Food Health Regulations, Supreme Decree 
No. 977/963 - IMS ID 370 
2.92.  The representative of Canada said that, while his delegation supported Chile's policy 
objective of promoting healthy dietary choices in reducing obesity and related NCDs, it nonetheless 
encouraged Chile to consider a less trade restrictive labelling regime to achieve this goal, in 
particular since this measure deviated from international standards, was not based on science and 
was likely to be more trade restrictive than necessary. 
2.93.  The representative of the United States said that, while her delegation strongly supported 
Chile's public health objectives of reducing obesity and related NCDs, it was nevertheless 
concerned with various aspects of the proposed measure, such as the "warning" element of the 
icons, the prohibition on health claims and complementary information for products that carry icons, and the short implementation timeline. She also noted that the proposed measure may have 
a significant impact on trade. She urged Chile to explore less trade restrictive labelling measures 
that would include flexibility in the placement or shape of the icon, and reflect consumer information based on common serving sizes, which would help consumers achieve a balanced and 
healthy diet. She also requested an update on Chile 's rulemaking schedule, given recent leadership 
changes in its Ministry of Health. In this respect,  she noted that Chile had not provided a response 
to the comments and questions the US sent on August 2014 (including on the basis for the nutrient limits), and that Chile had not provided a recent opportunity to discuss our concerns 
bilaterally, despite repeated requests.   
2.94.  The representative of Mexico reiterated concerns with regard to the proposed amendment to 
the Food Health Regulations, Supreme Decree No. 977/96, issued by Chile and notified to WTO 
Members in document G/TBT/N/CHL/282. This concern was first raised in March 2013 and 
reiterated at several Committee meetings. Mexico's full statement is contained in document G/TBT/W/406. 
2.95.  The representative of the European Union reiterated the views his delegation expressed in 
previous meetings, in particular in November 2014. While fully supporting Chile's ultimate 
objective of fighting obesity and NCDs, it nonetheless disagreed on how such objective could be best met. He asked Chile to take a different approach, which was the one the EU embraced: to 
recognise the importance of the relationship be tween diet and health, while at the same time 
empowering consumers to make informed choices based on factual information. The EU also recalled the specific concerns it had expressed previously with this measure, in particular 
regarding: (i) the lack of scientific basis for the definition of the maximum levels for the concerned 
nutrients; (ii) the absence of international guidelines backing up the requirements in the measure; and (iii) doubts as to whether this measure was proportional and effective. 
2.96.  The representative of Australia said his delegation supported Chile's right to implement 
measures to provide consumers with information to make appropriate dietary choices and reduce 
the risk of diet-related NCDs, provided that such  measures were implemented in a WTO-consistent 
manner. In this respect, Australia suggested that there were other measures available to Chile to 
promote consumer health (also been envisaged by  other Members, including Australia), and which 
could achieve Chile's objective. Australia also thanked Chile for having clarified that the warning label would no longer take the form of an octagonal "STOP sign" but would instead be a coloured 
hexagon and that its size would be established in relation to the size of the total area of the 
products. Australia was particularly pleased that  Chile has changed the proposed front of pack 
labelling requirement based on suggestions by othe r Members. However, Australia also noted that 
this labelling scheme was still mandatory for some food categories, including some dairy foods. 
However, there were some inconsistencies betwee n the requirements for imported and domestic 
product. Finally, Australia noted that Chile has exte nded the original date of entry into force to 30 
June 2015.  
2.97.  The representative of Brazil reiterated its concerns about the new Chilean labelling 
requirements on food products, particularly rega rding the adequacy between the purposes and the 
                                               
3 G/TBT/N/CHL/219, G/TBT/N/CHL/219/Add. 1, G/TBT/N/CHL/221, G/TBT/N/CHL/282 G/TBT/M/65  
 
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  methods adopted. The measures seemed more trade restrictive than necessary to fulfil the 
objectives. Brazil was closely following developments on this issue. He thanked the Chilean delegation for their constructive bilateral discussion. 
2.98.  The representative of Costa Rica associated  herself with concerns expressed by the previous 
delegations.  
2.99.  The representative of Guatemala reiterated the concerns her delegation has expressed in 
previous meetings and requested Chile to explai n how the measure's thresholds on nutritional 
content, the position, colour and dimensions of the description in the form of a black and white 
stop sign on labelling, could reduce the level of obesity amongst Chilean consumers. She also asked how these requirements reflected the norms established in the Codex Alimentarius for food labelling. 
2.100.  The representative of Chile said that the Supreme Decree No. 977/96 had been notified to 
the WTO as G/TBT/N/CHL/282 on 22 August 2014 and th at this notification replaced all previous 
notifications and their addenda. The deadline for comments was 22 October 2014, and Chile 
received 28 sets of comments (12 from WTO Members and 16 from the private sector), which 
were transmitted to the relevant regulatory body. A public consultation was also held on the proposed amendment, to which over 300 comments were received from interested parties, 
including civil society and the private sector. The Chilean Government had also engaged in a 
nationwide dialogue on the relevance and significance of the regulation. Chile noted in this respect that although no final version of the regulations has yet been adopted, the process has reached its 
final stage. Chile explained that the adoption of the measure, which has been delayed due to 
internal circumstances, would take place in the near future. Chile assured Members of its intention 
to take all reasonable measures available to meet  its obligations under the TBT Agreement, and to 
respond to all queries and provide information to trading partners and WTO Members. 
2.2.3.12  India – Electronics and Informat ion Technology Goods (Requirements for 
Compulsory Registration) Order, 2012
4 - IMS ID 367 
2.101.  The representative of Canada voiced his delegation's continuing concern that this measure 
could hinder or possibly shut Canadian exporter s out of the Indian market due to delays in 
registration and testing. So as to minimize the negative impact on companies wishing to export to India while at the same time providing assurance that the recognized conformity assessment bodies were competent, he suggested that India recognize foreign conformity assessment bodies 
accredited by signatories to the ILAC and IAF MLAs to test and certify to India's regulatory 
requirements. This approach would reduce testing costs and allow exporters to bring their products to the Indian market more quickly. He noted that  substantive amendments to the Order, such as 
those with respect to marking and labelling requirements, should be notified to the Committee. 
2.102.  The representative of the United States reaffirmed her delegation's continuing concerns 
with the measure. She said that the Compulsory Registration Order (CRO) domestic testing 
requirements would only slow progress toward achiev ing the goals of "Digital India" thus inhibiting 
the likelihood of success as disruptions to the ICT equipment supply chain would persist and exacerbate with the expansion of products brought under the measure's scope. India's requirement for foreign products to retest to an Indian standard that was already tested to an 
identical international standard was a clear example of how India's CRO posed unnecessary 
restrictions. Regarding the requirement that testing be conducted solely in labs domiciled in India, she recalled previous interventions on this issue.  
2.103.  She noted that BIS-approved labs adhere to the mutual recognition principles as a 
member of the IECEE CB Scheme toward reciproc al approval of tests performed at IECEE CB 
accredited labs located outside of India. In this regard, she suggested that appointed labs should 
only require a product sample unit to conduct verification testing if the labs could not resolve a 
suspected non-compliance issue from information exchanges between the Certification Body issuing the CB Test report and/or the manufac turer. This would provide immediate relief to 
manufacturers and allow India's labs to learn how to correctly perform necessary testing. BIS 
should also remove the expiration date from the test report. No other national certification 
agencies have expiration dates on their test reports. She further stressed that accordance with 
                                               
4 G/TBT/N/IND/44, G/TBT/N/IN D/44/Add.1, G/TBT/N/IND/44/Add.2, G/TBT/N/IND/44/Add.3 G/TBT/M/65  
 
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  international best practices for testing and certification of IT and electronics equipment would help 
jumpstart Digital India's efforts and the Indian Government should work on collaborative consultations with industry and other stakeholders to come into alignment. This should promote the development of an MRA, proposed during Secretary Sharma's visit in January 2015 to institute 
international best practices for testing of telecom equipment. 
2.104.  She also noted the US' concern with the burdensome over-labelling and regulation by 
FAQs. In this respect, she requested that the lis t of products under the HSE exemption should be 
broadened to include all products that were not for the consumer market and posed little risk to 
average consumers. She noted the US industries' trade concerns with, and asked India to explain the rational of, the expanded list of products co vered by the CRO as of November 2014. Such an 
expanded list would create similar problems as those under the original product scope, including 
testing delays. These requirements involved multiple approvals for a single device without a 
resulting increase in product safety. It was also the US' understanding that that a market surveillance programme would be launched. She hoped that this program would be notified to the 
TBT Committee with a reasonable comment period. In this respect, the US asked if batteries that 
were part of a larger product would be included in this testing as companies were struggling to give clarity to their suppliers due to ambiguity over what batteries needed to be tested. 
2.105.  The representative of the European Unio n reaffirmed his delegation's views that the 
registration process was burdensome and that  the in-country testing requirements were 
unnecessary. The EU noted that the new expanded  compulsory registration scheme included 
fifteen new product categories, including mobile phones and some of their key components. This 
new scheme was published in India's official Gaze tte on 13 November 2014, entering into force 
6 months later, on 13 May 2015. In this respect, the EU asked if this new scheme would be notified to the Committee and if it would only be  applied once Members comments had been taken 
into account. The EU understood from the last TBT Committee that work was ongoing towards 
streamlining the registration process and that a technical advisory committee had been set up under the Department of Electronics and Information Technology of the Ministry of 
Communications and Information Technology. The EU therefore requested an update on any 
improvement to the registration process in terms of shorter times for processing applications and the possibility of having one product registration  number per product model rather than per each 
factory making the product. This was particularly important for factories streamlining registration 
procedures and for products with a short lifecycle for which the current delays in obtaining 
registration in the best of cases were 45 days, ha ving an adverse effect on the ability of product 
suppliers to timely market those products within the useful lifecycle of such products.  
2.106.  The EU noted that another point of concern was the validity of test reports. Currently, the 
validity period was limited to ninety days, which meant that an application for registration had to be submitted within ninety days of obtaining the test report. The EU considered this to be unduly 
restrictive and that, in principle, it was unnecessary to have the time limitation. If it predated 
ninety days, it would still cover products where the safety properties and design had not changed 
since the original test had been carried out. Thus, once registration has been obtained, the validity of the registration should not be subject to a time limitation, in particular the currently applicable 
short time limitation of two years. The EU said that products which had not undergone any design 
change in safety properties should have a special dispensation whereby renewals would be fast-tracked and would not need to undergo a fresh procedure to obtain new registration. The EU 
expressed appreciation for the flexibilities introduced with regard to labelling arrangements - in 
particular for products with very small physical dimensions - and encouraged India to continue working with the industry to find practical solu tions on a product-basis. The EU emphasised the 
potential of minimising burdens for foreign supplie rs by accepting test reports generated under the 
IECEE CB scheme or foreign laboratories with adequate accreditation. It encouraged India to maintain this possibility on a permanent basis for this measure. 
2.107.  The representative of India noted that the October 2012 Requirement for Compulsory 
Registration included fifteen categories of electronics items, which were based on their compliance 
to specified safety standards. Under this measure, both domestic and foreign manufacturers/importers/sellers/distributors of th e notified goods must conform to the specified 
standards. Industry needed to get goods tested with laboratories recognized by BIS, which, on 
meeting requisite standards, would grant a unique registration number. A self-declaration of conformity mark on their products in a prescribed manner was necessary, followed by the 
registration number. In November 2014, the Schedule of this new scheme had been expanded to G/TBT/M/65  
 
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  include 15 more products. Provisions of the comp ulsory registration scheme shall apply to these 
products also on expiry of six months from the date  of publication of notification in official Gazette, 
except for sealed secondary cells and batteries mentioned in serial no. 20 of the Schedule for which the provisions would apply on expiry of nine months. This expansion of product coverage 
has been done in due consultation with all stak eholders, and the standards notified are either 
adopted international (IEC) standards or based on  them. The draft Gazette notification has also 
been on DeitY's website for public opinion before it was finalized providing opportunity to any 
stakeholder to comment. The comments received had been duly considered before issuance of the 
Gazette notification.  
2.108.  He recalled that some delegations had su ggested that India should accept test reports 
issued under the IECEE CB scheme or by the labs accredited by ILAC MRA signatories, and also 
limit domestic testing only in cases of suspected non-compliance of products. There was no change 
in the regulatory system and referred interested  delegations to India's statement made in the 
previous Committee meeting. On a related concern of allowing foreign labs to perform the 
requisite testing, he noted that under the BI S Rules, the items covered by the Compulsory 
Registration Scheme were required to be tested at a lab in India recognized by the BIS or at a lab covered under Mutual Recognition Agreement with BIS. The BIS has so far signed MRAs with 
national standard bodies of three Members: Isra el, Sri Lanka and Pakistan and therefore, it was 
not possible to process applications from labs based elsewhere. Concerning the suggestion that tests should only be repeated if there was a change in design and components that affected safety properties, he explained that retesting was required in case there was a change in design. 
However, in case of a change in components of the product, only relevant safety tests could be 
performed at BIS-recognized labs. For a revision  of a standard or amendment to the existing 
standard, testing was required only for the additional or modified safety requirements. Recently, 
Amendment No. 1 was issued to IS 13252(Part- 1):2010 and would be implemented by 31 May 
2015. BIS has issued guidelines for implementation on 3 December 2014, available on BIS website (http://www.bis.org.in). In terms of these guidelines, only one sample  of any base model out of all 
registered models would require testing for few additional or modified requirements. An 
undertaking was required by the manufacturer for self-declaration that they have implemented the Amendment No. 1 and all the models covered under their registration conformed to IS 13252(Part-1):2010 including amendment No. 1.  
2.109.  He also noted that some delegations had ex pressed a need to expand the validity period of 
test reports beyond the existing level of 90 days. In this matter, he explained that there was no change in the status since previous Committee meeting. The period of 90 days for submission of 
test reports to BIS was defined in the BIS Rule for registration and was considered adequate. 
However, there was a development with respect to the validity of registration. The Policy Advisory Committee (PAC) had decided to increase the validity period of registration from one year to two 
years, and that all registrations granted previously  for one year shall be valid for two years. This 
decision was available on BIS website. Concerning the issue on registration per product and not per factory, he explained that the matter of single registration for multiple factories was under active consideration of the PAC. For this purpose, a list of criteria has been recently drafted and 
placed on DeitY's website for comments, which would be duly considered by the PAC before 
finalizing the criteria. 
2.2.3.13  Peru – Act to Promote Healthy Ea ting Among Children and Adolescents – IMS 
ID 383 
2.110.  The representative of Canada said that while his delegation supported Peru's objective of 
reducing obesity and other non-communicable diseases (NCDs), there were concerns that this 
measure may deviate from international standards and be more trade restrictive than necessary to 
achieve its objective. Canada asked Peru to clarify whether the proposed regulations were based on international standards and sound science. He asked whether Peru had considered less trade-restrictive alternatives. For instance, the Codex guidelines on health claims and nutritional 
labelling could be used as the basis for alte rnative approaches that could provide similar 
information to consumers without the cost of mandatory product relabelling. He requested an update on the Health Ministry's evaluation proc ess of comments received, and enquired whether a 
new draft would be developed. He asked Peru to indicate when these regulations would enter into 
force and encouraged Peru to provide a transition period to allow industry time to adjust to any new labelling requirements.  G/TBT/M/65  
 
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  2.111.  The representative of the United States expressed concern that nutritional labelling was 
only mandatory when either a voluntary claim was made or a consumption warning was required. 
She said that mandatory nutrient declaration for all food and alcoholic food would give consumers the most complete information to make dietary decisions as all foods contribute to daily nutrient 
consumption, unless nutritionally insignificant. She asked if Peru had considered alternative 
approaches. Nutrition panels could be regarded in a negative way by consumers if only the least healthy foods displayed nutrition information. Targeting only certain foods for nutrition labelling 
could make it more difficult for consumers to identify healthier foods, and stifle industry innovation 
to make food healthier. In the event that Peru amended the nutrient content levels notified under Resolution 231, she requested that Peru: (i) provide an opportunity for comments; (ii) provide an explanation for such a determination; and (iii) and extend the timeline for implementation. She 
also noted that the notification indicated that th ey considered the World Health Organization/Pan 
American Health Organization (WHO/PAHO) recommendations, as well as the guidelines issued by the Codex Alimentarius, in determining whether foods were high in the nutrients of concern. As the 
guidance from these bodies varied, she asked which specific guidance Peru has taken into 
consideration as the basis by which they determined the levels were appropriate for their population. As the Act did not define font, size, colour or placement of the advisory statement, she 
asked whether Peru was considering supplemental symb ols, icons or pictorial representation of an 
advisory statement. Additional documents would be helpful in enabling US industry to comply with 
the regulations. She requested an update on Peru 's timeline for the development of the guidance. 
She stressed the need for an extended period for compliance which would help reduce the costs 
associated with label design and label stock supply and rotation. Typically countries allowed a 
much longer time period for compliance when label redesign was required. For example, FDA issued two proposed rules in March 2014 (G/TBT/N/USA/893 and G/TBT/N/USA/894) that would, if 
adopted, require major changes to US pre-packaged food labels. The FDA proposed a compliance 
period of two years from publication of the fi nal rule, whereas there was than the 180 days 
allowed for compliance under Peruvian measure. 
2.112.  The representative of Colombia said his delegation had already provided comments on the 
measure and hoped to continue to raise this matter also within the framework of their sub-regional 
area, the Andes region.  
2.113.  The representative of Costa Rica shared the concern raised by Canada and the US and 
inquired whether the Peruvian Ministry of Heal th had reviewed and processed comments from 
Members and asked whether there  would be a new version of the regulations and if it would be published.  
2.114.  The representative of Guatemala reiterated its concerns raised in previous meetings 
regarding this measure and asked Peru to provide more feedback regarding the internal process of 
the regulation. 
2.115.  The representative of Peru reported that the situation had not changed much since the last 
TBT Committee. The Ministry of Health was still evaluating the comments that had been provided 
within the timeframe. He said they were still looking at how the regulation could avoid being trade restrictive. The final regulation would come into force, as required, six months after its publication. 
2.2.3.14  Indonesia – Ministry of Health Re gulation 30/2013 on the inclusion of sugar, 
salt and fat content information, as well as  health messages on the label of processed 
foods (G/TBT/N/IDN/84) - IMS ID 389 
2.116.  The representative of Canada said that while his delegation supported Indonesia's 
objective of reducing the risk of non-communicable diseases (NCDs), it had concerns that the 
proposed measure could have a significant impact on trade and could be more trade restrictive 
than necessary. He asked whether the requirement for the inclusion of a message identifying 
certain risks in relation to the quantity of sugar or fat ingested per day was necessary to achieve Indonesia's policy objective. Could Indonesia prov ide any scientific evidence supporting the use of 
such measures, and identify on which international standards the measure was based? He noted 
that Indonesia indicated at the November TBT Comm ittee meeting the possibility of accepting test 
results from other laboratories, including in the country of origin. He asked Indonesia: (i) to provide more information as to when it planned to address this issue; (ii) to provide an update 
regarding when it planned to announce which food categories would be required to carry the G/TBT/M/65  
 
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  mandatory labelling for sugar, salt and fat; (iii) to indicate when the regulation would enter into 
force and the transition period for industry to adjust. 
2.117.  The representative of the United States said that the Decree lacked clear guidance on how 
to implement and comply with the new labelling regulations. While Indonesia had allowed three 
years for compliance from the original publication date, companies were not in a position to start 
compliance until the additional guidance was made available. She requested a more definite timeline for when the Ministry of Health would issue further technical guidance for implementation. 
There were concerns with Indonesia's lack of acceptance of test results from laboratories other 
than those accredited by KAN or that have a MRA with KAN. She urged that test results from laboratories using appropriate or recognized methodologies be recognized. The US, for example recognized the appropriate method in the official methods of the Association of Analytical 
Communities (AOAC) International. Less trade restrictive approaches, such as following a process 
of random sampling and testing of products in commerce, could ensure the accuracy of label 
information for the vast majority of food and be verages. Finally, she asked Indonesia to confirm 
whether the total diet study was completed and to inform which food categories would be required 
to carry the mandatory labelling for sugar, salt and fat. 
2.118.  The representative of the European Union reiterated previous concerns and asked that the 
implementing provisions for this Regulation, whic h would address product coverage in detail, be 
notified in draft form with sufficient time for comments. He reiterated in particular its concerns with respect to the mandatory warning message on salt, sugar and fat content that would have to be included on the label of all processed food products. The EU invited Indonesia to consider 
whether the objectives of the Regulation could be  achieved with less trade-restrictive means. The 
EU asked for clarification on the following outstanding issues: the way of placing of nutrition information and related health warning, testing methods for nutrition levels and the conduct of risk 
assessment related to non-communicable diseases. Like the US, the EU was interested in learning 
about the results of the total diet study by the Indonesian Ministry of Health with the aim to determining types of food included in the high risk and low risk classifications.  
2.119.  The representative of Australia said that  while his delegation recognised and supported 
Indonesia's right to implement measures to provide consumers with information so as to make 
appropriate dietary choices and reduce the risk of diet-related NCDs, it also considered important 
that such measures would not be more trade-restrictive than necessary to achieve these 
objectives. While Indonesia would be one of the first countries in the world to implement a 
mandatory scheme for foods containing sugar, salt and fat, he noted that other countries were currently considering other less-restrictive measures available to promote consumer health. He 
asked Indonesia to clarify why it considered a mandatory health message on processed foods as 
the only option available to achieve its aim for public health and informed consumer choice. He noted in this respect that the Codex Alimentarius Guidelines on Nutrition Labelling (CAC/GL 
2-1985) set out the principles for nutrition labelling on an international level. One principle was 
that "the information should not lead consumers to believe that there is exact quantitative knowledge of what individuals should eat in order to maintain health, but rather to convey an understanding of the quantity of nutrients co ntained in the product." The application of a 
mandatory health message reflecting to levels of specific critical nutrients would not therefore be 
consistent with this principle. Australia also requested information on whether Indonesia would allow stickers containing the health message to be applied to the labels of processed foods after 
importation, and before being placed on the market to comply with the Decree. Australia was 
concerned that foreign companies importing food pr oducts would need to produce a separate label 
for Indonesia, thus resulting in extra costs and delays in bringing products to market. Australia 
further noted that the proposed nutrition declarations must be based on tests carried out by 
accredited labs and sought clarification on what methods would be used for the tests verifying the nutrition declarations and whether tests performed by foreign laboratories, or in-house laboratories of companies would be accepted. Australia also asked whether this proposed 
requirement would be enforced for both domestic and imported products and how compliance 
would be tested.  
2.120.  The representative of Indonesia said that the technical guidance that was being prepared 
to implement the measure would include inter alia the food categories to be covered by the 
measure. These implementing regulations would be notified to the WTO. He also confirmed that in 2014 the Ministry of Health conducted a study on total diet focusing on individual food 
consumption survey. This particular survey has accommodated the information on average weight G/TBT/M/65  
 
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  of food, and the percentage of people who consum e food according to food category and nutrition 
intake, specially energy, protein, carbohydrate, fa t and sodium content. Regarding the conformity 
assessment procedures, he explained that the Regula tion required that testing of sugar, salt and 
fat contents and other quality parameters must be conducted by laboratories accredited by the 
Indonesian National Accreditation Body (KAN) or by other competent institutions that have Mutual 
Recognition Arrangement (MRA) with KAN. Labora t o r y  t e s t  r e s u l t  m u s t  b e  p r o v i d e d  w h e n  
producers were to register or re-register at Nati onal Agency for Food and Drug Control (BPOM), or 
when they re-formulate ingredients of the products. The possibility to accept test results issued by 
other laboratories or laboratories of the country of origin would be addressed at a later stage.  
2.2.3.15  European Union – Revised Proposal  for the Categorization of Compounds as 
Endocrine Disruptors of 19 February 2013 by DG Environment - IMS ID 393 
2.121.  The representative of Canada raised concerns with the European Union's departure from 
internationally accepted risk assessment practices. The EU proposal was a hazard-based approach 
that created a level of uncertainty among exporting countries, and had the potential to disrupt 
international trade and increase costs for producers and consumers. Canada had submitted 
comments during the consultation process underscori ng the importance of considering a risk-based 
approach over a hazard-based approach. He asked when these comments might be reviewed, and 
once the EU had assessed all comments received, what the next steps would be. He also voiced 
concern with the potential application of default MRLs to Canadian exports under the hazard-based approach and requested clarification on th e interplay between Regulation 1107/2009 and 
Regulation 396/2005 in that regard. 
2.122.  The representative of Argentina shared the concern raised by Canada regarding the 
process proposed by the EU on defining criteria at the European level for the identification of 
endocrine disruptors. In spite of sharing the legitimate concern for the potential effect on the 
environment and public health of substances th at may have endocrine disrupting properties, 
Argentina was of the view that any decision made by the EU on this topic must respect agreed multilateral principles, and in particular the WTO Agreements on SPS and TBT, without creating 
unnecessary obstacles to trade. The future regulation  to be adopted by the EU should be based on 
science, avoiding unjustified negative impacts on in ternational trade, in particular for developing 
countries that produced raw materials. He urged the EU to conduct the entire process in a transparent manner, allowing comments to be submitted throughout.  
2.123.  The representative of the United Stat es thanked the EU for publishing its "Public 
Consultation on Defining Criteria for Identifying Endocrine Disruptors (EDs) in the Context of the 
Implementation of the Plant Protection Product Re gulation and Biocidal Products Regulation". The 
US had provided comments on 16 January 2015. While the US Government strongly supported 
strengthening public health and environmental prot ection by properly identifying, understanding, 
and regulating the use of plant protection products that may have endocrine disrupting properties 
the EU roadmap did not identify the scientific evid ence considered when developing each option, 
nor was there any explanation of why the evidence led to the selection. The roadmap only broadly 
noted that it convened expert groups and commi ssioned an EFSA scientific opinion. While the 
Roadmap identified Member State impact assessmen ts and provided links to them, there was no 
explanation of what aspects of those assessments were considered relevant. She noted that the 
roadmap appeared to have broad implications fo r the registration of pesticides and chemicals 
globally and could thus affect other EU legislation. She asked the EU to provide answers on a 
number of questions: Could the EU provide information on which existing EU measures were likely 
to be affected by each of the options and what were the next steps envisaged for regulating endocrine disruptors; If the EU would consider other approaches such as those based on the 
weight of scientific evidence or any others raised during the public consultation, and if so would 
Members have an opportunity to comment on them. Concerning the public consultation being convened in early June, she asked for additional information on the scope and how interested parties might participate. Could the EU provide a dditional information on which chemicals would be 
included in the impact assessment and the methodologies the EU used in determining which 
chemicals would be included? Given the significant trade impact and the uncertainty regarding what approaches the EU was considering, she requested that the EU continue to inform the 
Committee and all stakeholders of developments so as to assure them that their views were being 
considered during the regulatory development process.  G/TBT/M/65  
 
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  2.124.  The representative of the European Un ion reiterated the intention to carry out a 
comprehensive impact assessment to analyse different options for defining criteria for the 
identification of endocrine disruptors and their corresponding health, socio economic and environmental effects. In this context, the European Commission published in mid June 2014 a 
roadmap setting out the scope of such impact assessment and the policy options that would be 
assessed. He explained that at least two studie s supporting the impact assessment were needed. 
The first one had already started and would assess the chemicals that might be identified as 
endocrine disruptors under each of the various options for the criteria. As part of this impact 
assessment process, on 26 September 2014 the European Commission launched a public consultation on the definition of criteria for identifying endocrine disruptors in the context of the implementation of the EU's plant protection pr oducts regulation and the biocidal products 
regulation. This public consultation ended on 16 January 2015. The responses received to the 
public consultation were published on 2 February 2015. An analytical report of the responses would be provided in due course. This factual, quantitative report would feed into the work for the 
impact assessment whose outcome would not prejudge or constitute the announcement of any 
position on the part of the European Commission, but would allow the Commission to take an informed decision as regards further EU legislat ive work as appropriate. He said the European 
Commission would organize a conference in June 2015 informing Member States, MEPs, third 
countries and stakeholders about the on-going  impact assessment. Only when the impact 
assessment was concluded, would the European Commission present proposals for introducing criteria to identify endocrine disruptors in the EU's  plant protection products regulation and biocidal 
products regulation. The criteria might also have an impact on other pieces of EU legislation. 
Pending the new criteria, interim criteria were applicable both in the biocidal products and in the plant protection products regulations. Finally he said the EU would notify the new proposal to the 
WTO, allowing third parties comments to be duly taken into account. 
2.2.3.16  Ireland - Proposal to introduce standardised / plain packaging of tobacco 
products in Ireland (G/TBT/N/IRL/1 , G/TBT/N/IRL/1/A dd.1) IMS ID 380 
2.125.  The representative of Malawi expressed her delegation's concerns regarding the 
consistency of the proposed measure with the TBT and TRIPS Agreements. She also requested 
Ireland to abstain from any tobacco plain packaging legislation until the WTO disputes lodged against Australia's plain packaging measures had been concluded. Malawi's full statement is 
contained in document G/TBT/W/401. 
2.126.  The representative of Zimbabwe associated her delegation with the concerns raised by 
Malawi and reiterated concerns raised at the previous Committee meeting. Zimbabwe's full 
statement is contained in document G/TBT/W/403. 
2.127.  The representative of Guatemala, speaking also on behalf of the Dominican Republic, said 
while they shared the policy objectives of Irelan d on public health and tobacco control; they had 
concerns with regard to the proposed legislatio n and requested that Ireland consider less trade 
restrictive alternative measures that would effectively achieve its legitimate objectives. 
2.128.  The representative of Nicaragua said that this was a significant concern that had been 
raised in various meetings. He requested that the intervention made by his delegation at the 
TRIPS Council and included in the minutes of that meeting, also be referenced in the minutes of 
this meeting.5 
2.129.  The representative of Australia reiterated their strong support for the decision by Ireland 
to legislate for the mandatory plain packaging of tobacco products and in particular welcomed the 
passage of the Public Health (Standardised Pa ckaging of Tobacco) Bill 2014 through the Irish 
Parliament. The important steps made by Ireland in tobacco control demonstrated that efforts to 
delay the adoption of tobacco plain packaging measures in a number of countries had not been 
successful. Australia would continue to support Ir eland in its development and implementation of 
its tobacco plain packaging measures. Australia firmly believed that Members had the right to implement measures necessary to protect pub lic health, while complying with relevant 
international treaty obligations, including the TBT Agreement. Tobacco plain packaging was a 
legitimate measure designed to achieve a fundamen tal objective: the protection of human health. 
The adoption of tobacco plain packaging measures was a policy choice endorsed by leading public 
                                               
5 IP/C/M/78/Add.1  G/TBT/M/65  
 
- 31 - 
 
  health experts as well as the World Health Organization and was supported by extensive credible 
peer reviewed research, reports and studies. Australia's own tobacco plain packaging measure, currently being litigated in the WTO, was consistent with Australia's obligations under the WTO Agreements. Concerning Malawi's reference to the dispute that involved Australia, he said it was 
inappropriate for complainants in these disputes to invoke those proceedings in an attempt to 
delay or discourage other Members from developing or implementing their own legitimate tobacco control measures. 
2.130.  The representative of Norway reiterated comments already delivered in the TBT Committee 
and other fora, in that public health and tobacco control were topics of particular interest to 
Norway. It was Norway's opinion that it was within the right of each WTO Member to adopt measures in order to protect public health as long as the measures chosen were consistent with 
WTO agreements. It was clear that tobacco control policies and preventive measures such as the 
standardised packaging had the legitimate objectiv e of protecting public health. She stated that 
together with many other WTO Members, who were party to the WHO Framework Convention on 
Tobacco Control (FCTC), they took their obligations under the said convention seriously. These 
obligations included, among others, introduction of measures to prevent initiation, to promote and support cessation and to increase consumption of tobacco products. Packaging and labelling were 
subjects of Article 11 and 13 of the FCTC and th e latter explicitly advised the parties to the 
Convention to introduce plain packaging as a measur e to achieve the objective of protecting public 
health.  
2.131.  It was Norway's firm view that the FCTC  and the relevant WTO Agreements were mutually 
supportive and that it was possible to implement me a s u r e s  t h a t  w e r e  i n  l i n e  w i t h  b o t h  s e t s  o f  
binding obligations. Her delegation strongly supported Ireland's efforts to reduce smoking, and appreciated the bold action taken by the Irish Government. On 17 March 2015, the Norwegian 
Government launched public consultation on st andardised packing of tobacco products, which 
would be duly notified to the TBT Committee. In conclusion, she said Norway shared Australia's view that ongoing DSB cases should not have any bearing on measures adopted by Members in 
favour of public health.  
2.132.  The representative of Ukraine said that while her delegation shared Ireland's policy 
objectives related to public health protection and tobacco control, there were concerns over the 
proposed legislation. She encouraged Ireland to consider less restrictive trade measures and urged 
Members who had plans to implement tobacco plain packaging measures to await the conclusion of 
the dispute on the Australian plain packaging measure.  
2.133.  The representative of Cuba shared concerns  raised by other Members and called on Ireland 
to abstain from implementing measures pending the outcome of the proceedings against Australia.  
2.134.  The representative of Nigeria supported the statements made by Malawi, Zimbabwe, 
Ukraine and Cuba. As previously stated in the TBT Committee, Nigeria did not oppose Ireland's 
legitimate objective of protecting human health, but had concerns with the proposed measure. If 
the standardised tobacco plain packaging measure proposed by Ireland came into law, it would 
remove the ability of tobacco manufacturers to use trademarks on their products. As a significant producer of tobacco leaves, her delegation was concerned about the broader systemic implications 
and its practical commercial consequences on the national economy. Nigeria fully supported any 
form of regulation based on evidence, but in this  case there was no proof that plain packaging of 
tobacco products would be effective in discouraging smokers, rather it was Nigeria's opinion that it 
would exacerbate the situation. She noted that the proposed regulation was inconsistent with the 
EU obligations under the TBT and TRIPS Agreement. Her delegation looked forward to receiving more information on the status of the proposed measure and the future intentions of Ireland in 
light of the numerous concerns raised by Members.  
2.135.  The representative of New Zealand register ed its support for Ireland's decision to enact 
legislation requiring plain packaging for tobacco an d tobacco products. He said that there was an 
extensive and growing body of international resear ch which established plain packaging as part of 
a comprehensive tobacco control programme that would contribute to the objective of improving 
public health. New Zealand had not seen credib le evidence that proved otherwise. The TBT 
Agreement recognised the fundamental right of Members to implement non-discriminatory 
measures necessary to protect public health and that it was possible for Members to implement a G/TBT/M/65  
 
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  tobacco plain packaging regime that was consistent  with all of the WTO obligations including the 
respective obligations under the TBT Agreement. 
2.136.  The representative of Uruguay reiterated comments made at the TBT Committee and other 
fora within the WTO in favour of the legitima cy of generic packaging measures under the WTO 
Agreements. Many WTO Members were party to the FCTC and had adopted such measures. Article 
11 of the FCTC required the adopti on and implementation of effective measures with regard to the 
packaging and labelling of tobacco products. His de legation believed that the principles of public 
health fell within the competency of individual states and as such could legislate in the public 
interest. These principles were reiterated in the FCTC Punta del Este Declaration and other such declarations. Therefore measures taken by Members were consistent with both WTO and WHO commitments.  
2.137.  The representative of Canada supported Ireland's proposal to introduce standardised plain 
packaging for tobacco products. Canada followed with interest the ongoing international 
developments and held that such measures were in line with both international trade and public 
health. As a pioneer in the packaging labelling requirements for tobacco products, such 
requirements were a core component of the right to regulate in the public interest. As the discussions moved forward, he said Members might want to consider the complete economic 
picture regarding tobacco control and whether tobacco was actually a net economic gain to many 
countries. 
2.138.  The representative of Indonesia supported Malawi's concerns and referred Members to its 
concerns reflected in the minutes of the previous Committee meeting (G/TBT/M/64/Rev.1)  
2.139.  The representative of the European Unio n thanked delegations for their comments on the 
Irish Public Health (Standardised Packaging of Tobacco) Bill 2014 which had been enacted in March 
2015 with orders for commencement to be signed by the Minister for Health. The transitional 
periods for the Act were in line with those set ou t in the EU Tobacco Products Directive i.e. May 
2016 and would fully apply from May 2017. As alread y noted in previous meetings, the European 
Union reiterated that tobacco products had recognised harmful effects on human health. In that 
sense, Article 2.2 of the TBT Agreement included the protection of human health as a legitimate 
objective. The Agreement also recognised that any measure pursuant to this legitimate objective must not be more trade restrictive than necessary and create unnecessary obstacles to international trade. It should also be noted that Article XX(b) of the GATT 1994 emphasised the 
importance of public health by justifying measures "necessary to protect human … health". The 
legislation was in response to packaging design  strategies developed by tobacco companies in 
recent years which were clearly aimed at young people, including young women. This Act formed 
the latest strand of a comprehensive range of tobacco control legislation already in place in Ireland 
which included a ban on smoking in the workplace,  a ban on tobacco advertising and sponsorship, 
a ban on the display of tobacco products in shops and a requirement for all tobacco products to be 
stored within a closed container. In addition, all tobacco products placed on the market had to 
display combined text and graphic health warnings. Certain types of sale promotions were prohibited and selling tobacco products to those under 18 years of age was also forbidden. Legislation prohibiting the smoking of tobacco prod ucts in vehicles where children were present 
was enacted in December 2014 and would enter into law in 2015. 
2.140.  The EU explained that, in addition to the Public Health (Standardised Packaging of 
Tobacco) Act 2015, Ireland notified an explanatory memorandum that detailed the rationale of the 
measure and its expected health impacts, a regulatory impact analysis and several scientific 
studies on the impact of plain packaging on smoking prevalence. In parallel with the WTO notification, Ireland had also notified the measure to the European Commission in accordance with 
internal EU requirements for notification of draft national technical regulations under Article 8 (1) 
of Directive 98/34/EC and under Article 24 (2) of the Tobacco Products Directive 2014/40/EU. Ireland received detailed opinions and comments f r o m  s o m e  E U  M e m b e r  S t a t e s  o n  t h e  d r a f t  
measure within the framework of the internal notification procedure. These were analysed, 
considered and responded to by the Irish authorities. Comments received from WTO Members 
under the WTO TBT notification procedure, were being equally examined and written replies would be provided. G/TBT/M/65  
 
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  2.2.3.17  Ecuador – Resolution establishi ng the "General conformity assessment 
framework for Ecuador" and the "Handbook of procedures to be observed prior to all 
stages of the customs clearance, marketin g and market surveillance of manufactured, 
imported and marketed goods subject to Ecuadorian technical regulations6 - IMS ID 398 
2.141.  The representative of Canada was concerned with the burdensome nature of Ecuador's 
conformity assessment policy and practice requ irements, and local practice for conformity 
acceptance. He described the difficulties faced by a Canadian company to ship potato products to 
Ecuador. These included the certificate of confor mity to regulatory requirements (general and 
including technical regulations INEN 085 and 022) that had to be supported by a verification checklist to demonstrate compliance with compositional regulatory requirements, a verification checklist to demonstrate compliance with food labelling requirements (technical regulation: INEN 
022), a compliance report to demonstrate the actual lab analysis on key quality parameters and a 
certificate of plant compliance to GMPs. Once all of these documents were compiled (more than 16 pages), the exporter was advised that they need ed to be notarized and legalized through the 
Ecuadorian consulate or through a client in Ecuador. This process took a number of days to 
complete and became quite disruptive because of the number of people involved. Products were required to be segregated at the warehouse leve l until all documents were prepared which further 
complicated operations. However these necessary do cuments appeared to be redundant given that 
while a sanitary registration was required, other documents required appeared to be used to guarantee quality and compliance. He suggested that a certificate of conformity could be sufficient instead. He asked if there had been any recent changes to the policy or process that might 
alleviate concerns of importing companies and if it was possible to have a clear template for 
importing companies that would help ensure conformity while reducing the duplicate nature of some of the documents and processes. 
2.142.  The representative of Brazil highligh ted some concerns regarding the resolution 
establishing the "General conformity assessmen t framework for Ecuador" and the "Handbook of 
procedures to be observed prior to all stages of the customs clearance, marketing and market 
surveillance of manufactured, imported and ma rketed goods subject to Ecuadorian technical 
regulations". He asked if Ecuador could clarify whether international standards were taken into account, and if so, which ones. In some cases, exporters were experiencing difficulties in identifying accredited test laboratories and accredited certification bodies. The significant 
bureaucracy in the acceptance of tests made outs ide Ecuador, the lack of transparency in the 
procedures for complying with the new product requirements, and the procedures for the acceptance of "manufacturer's declaration of conformity" were burdensome and bureaucratic. 
Therefore, the measures seemed more trade re strictive than necessary. Specifically, on the 
"General conformity assessment framework for Ecuador", he sought clarification on transitional provision four and on how this provision relates to Article 2.1 of the TBT Agreement. He thanked 
Ecuador for the constructive bilateral discussions which had taken place and looked forward to 
continued engagement. 
2.143.  The representative of Ecuador informed  the Committee that Item 17 of the assessment 
framework guaranteed Ecuadorian citizens' right to safety, security, protection of human and 
animal life, and protection of the environment.  The Inter-ministerial Committee on Quality of 
Ecuador was, according to article 9.1 of the law on  the Ecuadorian System of Quality, established 
as the body in charge of formulating the policie s on the basis of which products would have to 
comply with technical regulations and conformity assessment procedures before they were traded. 
The Inter-ministerial Committee on Quality of Ecuador established resolutions 001, 002 and 005 with guidelines for the trading of products in accordance with the requirements of the technical 
regulations, and how they would be applied. Ecuador was of the view that the guidelines could not 
constitute trade restrictions as they sought to establish effective mechanisms to make it possible to evaluate compliance with the requirements. In any event, prior to placing products on the market, producers who were subject to technical measures had to submit a conformity certificate 
or an inspection that showed that there was compliance with the technical regulation that had 
been made available by the conformity body. The procedure is electronic for domestic and foreign 
products. 
                                               
6 G/TBT/N/ECU/44, G/TBT/N/EC U/44/Add.1, G/TBT/N/ECU/44/Add.2, G/TBT/N/ECU/44/Add.3. G/TBT/M/65  
 
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  2.2.3.18  Russian Federation – Measure affe cting import of Ukrainian confectionary 
products - IMS ID 399 
2.144.  The representative of Ukraine reiterated concerns raised continuously since March 2013 
with regard to the ban on the import of Ukrainian confectionery products into the Russian 
Federation. Despite efforts to reach a settlement, the relevant Russian authorities continued to act 
in a discriminatory and non-transparent manner. Ukraine still awaited Russia's written replies to the questions submitted such as: A request for scientific information, including laboratory test 
results with regard to products banned for importation since 29 July 2013 and 5 September 2014; 
Official detailed clarification and justification of keeping the ban and explanation as to the compliance of the measures with Articles 2.1 and 2. 2 of the TBT Agreement; and Official results of 
the inspection of Ukrainian factories that wa s conducted in October 2013. She reminded the 
Committee of Russia's proposal at the November 2014 meeting concerning bilateral consultations 
at the level of competent authorities of both countries and looks forward to such consultations. 
2.145.  The representative of the Russian Federati on explained that the suspension of imports of 
confectionary products was introduced because of labelling non-compliance under the technical 
regulation of the Customs Union on the labelling of food products, adopted on 9 December 2011. In July 2013, the Russian regulating authority Rospotrebnadzor had detected that the labelling of 
confectionary products produced by Roshen contained false information and were not in 
compliance with the requirements. In 2014, further non-compliance was detected in a whole range of Ukrainian companies, highlighting a decline in surveillance by the Ukrainian competent authorities. The measures introduced by the Russian Federation were in compliance with WTO 
rules, particularly with the provisions of the TB T Agreement – to protect Russian consumers' right 
to reliable information about the products, and to prevent deceptive practices. He considered Ukraine questioning Russia on the principle of na tional treatment to be unjustified, as these 
technical regulations applied equally to Russian producers. Following consultations in December 
2013, Ukrainian authorities had recognized that there had been non-compliance in Ukrainian products with the EAEU technical regulation requirements, and arrangements were made to rectify 
this. To date, Ukrainian authorities had still not undertaken the measures agreed upon so as to 
allow products onto the Russian market. In the meantime, other Ukrainian products were also found to be non-compliant with the conformity requirements. He said the competent authorities would continue discussions on a bilateral basis in order to avoid further restrictions. 
2.2.3.19  Ecuador – Resolution No. 116 of th e Foreign Trade Committee of Ecuador of 19 
November 2013 and Technical Regulation of the Ecuadorian Standardization Institute 
RTE INEN 022 on the labelling of proc essed and packaged food products 
7- IMS ID 411 
2.146.  The representative of Canada said that  while Canada supported Ecuador's objective of 
reducing the risk of non-communicable diseases, they were concerned that Ecuador's requirement 
for the inclusion of a graphic system indicating the concentration of various nutritional components 
in food products could deviate from international standards. He asked what scientific evidence was 
behind the categories for levels of concentration of nutritional components. Canadian industry had reported some market access challenges with respect to demonstrating compliance with the requirements of this regulation. The multiplicity of documents needed to prove that products were 
in conformity with the Ecuadorian regulation was overly burdensome and time-consuming. He 
looked forward to hearing Ecuador's views concerning this new regulation and its impact on trading partners. 
2.147.  The representative of the United States raised concerns regarding the overly burdensome 
and duplicative process to demonstrate conformity with labelling elements. These included a label 
review as part of the Sanitary Food Registration process and a certificate to demonstrate 
compliance with Ecuador's commodity standards. These requirements did not appear to add value 
in ensuring the safety of the products in question. She said US suppliers continued to encounter difficulties complying with the certificate of conformity requirements and reported that they had been unable to self-certify through use of accreditation with ISO standards. US suppliers had to 
provide per lot or per shipment laboratory tests from an OAE accredited lab, in addition to self-
certification, thereby undermining the use of self-certification. While Suppliers should have records available if audited, there should be no need to produce them with every shipment. She asked 
Ecuador to provide an update on recognizing third party testing. Concerning the choice to declare 
                                               
7 G/TBT/N/ECU/19/Add.3, G/TBT/N/ECU/19/Add.5, G/TBT/N/ECU/19/Add.6, G/TBT/N/ECU/19/Add.8. G/TBT/M/65  
 
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  total fats versus saturated fats, Codex had estab lished a NCD-NRV for saturated fat; however, no 
such recommendation existed for total fats. Further, in the last amendment, the reference to WHO/FAO as a basis for determination of nutrient co ntent limits had been deleted. She noted that 
Codex has not established an NCD-NRV for sugar. The US and other WTO Members had enquired 
as to the basis for the nutrient content limits, but no national level research had been supplied to 
support the determined levels. Regarding the mandatory requirements, she reiterated the US position that for foods derived from genetically modified organisms that had been found to be 
substantially equivalent to conventional counterparts, mandatory "Contains Transgenics" labelling 
could create an erroneous impression that the product was less safe than conventional products. Genetically engineered products that had been ev aluated through risk-based safety assessments in 
accordance with international guidelines, such as through the Codex Alimentarius Commission, 
should not require different labelling. She said that in addition to confusing consumers, such 
labelling might also increase costs to industry, consumers, and government authorities. Rather than a mandatory labelling requirement, a voluntary approach would allow for consumer choice 
and encouraged Ecuador to reconsider its mandatory approach to biotech labelling. Concerning 
Articles 5.2 and 5.3 of the measure notified in G/ TBT/N/ECU/19/Add.8, on the proposal to base its 
biotech labelling requirement on a 0.9% threshold, she asked for clarification of how this threshold 
would be calculated. She sought confirmation that the measure would exempt foods which did not 
contain transgenic protein or DNA, such as highly processed products, from genetically engineered crops; foods which may be produced using genetically engineered processing aides; and foodstuff derived from animals fed with genetically engineered feed. 
2.148.  The representative of Mexico reiterated concerns regarding Resolution No. 116, in 
particular the "certificate of recognition" requirem ent that applied to a range of products. He also 
raised concerns with Ecuador's draft first revision, PRTE INEN 022 (1R), of the Ecuadorian 
Standardization Institute Technical Regulation entitled "Labelling of processed and packaged food 
products", notified to WTO Members in document G/TBT/N/ECU/19/Add.8. Mexico's full statement is contained in document G/TBT/W/407. 
2.149.  The representative of Brazil sought clarification on whether the technical regulation was 
based on an international standard and if so, which one. The signs to be displayed on products 
followed a system of coloured bars to indicate the amount of certain ingredients and Brazil asked Ecuador to clarify the technical criteria they had adopted and whether Ecuador had considered less 
trade restrictive measures to fulfil the same ob jective. Concerning the required labelling on 
genetically modified organisms and threshold of 0.9%, he asked what criteria or international standard had been followed in that regard. 
2.150.  The representative of Guatemala was conc erned that the speed of implementation and the 
lack of prior notification of the measure. While the regulation was derived from Codex 
Alimentarius, there was a clear departure from it in that it was not science based, was stricter than 
necessary, and other less trade restrictive measures had not been considered. Foodstuff could be 
characterised as good or bad on the sole basis of the nutritional content because of a number of inherent nutritional characteristics. Even when  exporters sought to comply with the various 
measures, the necessary conditions for compliance were not available. Therefore the necessary 
procedures to assess conformity were not available. In conclusion, given the uncertainty that 
foreign exporters had to deal with, he asked that Ecuador reconsider the design and the scope of the measure. 
2.151.  The representative of Costa Rica said they  had a number of concerns regarding the sign to 
be placed on the label on the basis of a sodium, fats and sugars content, as prescribed under RTN 
022. Food products that were processed and packaged had to comply with resolution 14413 of 22 
August 2014. He reiterated that they considered the system Ecuador had relied upon was not 
based on scientific evidence. There were also concerns with the requirements for the list of products with transgenic ingredients. He questioned the scientific substantiation of that proportionality against what was in Article 2.2 of the TBT Agreement. He requested clarification on 
how the terms were dealt with under the final regulation and supported the concerns raised by 
other delegations. 
2.152.  The representative of the European Union joined other delegations' concerns on the 
Ecuadorian Technical Regulation 022 which imposed nutrition food labelling obligations comprising 
"high in" warnings and a traffic light warning system. While fully sharing Ecuador's public health objectives regarding the provision of adequate nutritional information to consumers, the EU G/TBT/M/65  
 
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  doubted that the approach taken in the notified dr aft was the best way to achieve those objectives 
or that it was proportional to the aim pursued of enabling consumers to make an informed choice in order to foster effective competition and consumer welfare. The representative recalled previous interventions recorded in the minutes on the lack of proportionality of the measure, its departure 
from Codex guidelines and the use of the "high in" warnings of the previous meeting of this 
Committee (G/TBT/M/63).  
2.153.  The representative of Ecuador recalled what had been stated previously in the TBT 
Committee in that Resolution No. 116 neither created nor introduced technical regulations, but 
rather incorporated and withdrew subparagraphs  subject to the Certificate of Recognition 
requirement and was clearly an administrative measure for the purposes of customs control. She stated that each regulation established, inter alia , its scope of application, its date of entry into 
force, and its conformity assessment mechanis ms, and all had been notified to the TBT 
Committee. The Resolution only provided for the submission of a supporting document with the 
customs declaration as part of an internal administrative procedure, and consequently, it was not a 
technical regulation. Resolution No. 116 could not be considered a restriction to trade, as it was 
consistent with multilateral regulations. 
2.154.  On the Regulation RTE022 "Food Labelling", Ecuador reported that the Ministry of Health 
conducted a National Survey on Health an d Nutrition in 2012, which showed Ecuador's 
epidemiological profile was on an upward tren d in the number of non-communicable diseases 
affecting all segments of the population, regardless  of age, place of resi dence or socio economic 
level. This inspired the Ecuadorian Government to develop policies geared towards the prevention 
of chronic diseases, which meant ensuring that people had access to appropriate, clear, accurate 
and non-misleading information on the content and characteristics of food. Hence the Sanitary Regulations for the Labelling of Processed Foods for Human Consumption, which provides that 
"any food processed for human consumption shall comply with Ecuadorian Technical Regulation 
RTE INEN 22 on the labelling of processed and packaged food products. There shall also be a system of horizontal colour coded bars (…)". The reference framework for the Sanitary Regulations 
was the international resolutions reaffirming the decisions adopted by the World Health Assembly, 
to promote the implementation of the WHO Global Strategy on Diet, Physical Activity, and Health by introducing policies and measures designed to promote healthy diets and to encourage the implementation of all of the WHO recommendations for the promotion of food and non-alcoholic 
beverages for children, including food with a high content of saturated fats, trans fatty acids, free 
sugars or salt and by fostering policies that favo ur the production of food conducive to a healthy 
diet and that facilitate access thereto. Besides the measure was notified to the WTO on 12 March 
2014 and a number of comments were received from Member, chiefly relating to the positioning of 
the label, the prohibition on the use of children and animals in advertising, and the use of self-adhesive labels, amongst others.  
2.155.  On the other points raised, she stated that the distinction between the terms "food" and 
"processed food" referred to in the Sanitary Regulations was based on international and national standards: the General Standard for the Labelling of Pre Packaged Foods (CODEX STAN I 1985), and Article 259 of Ecuador's Organic Law on Health; The definition of the health claim referred to 
in the Sanitary Regulations corresponded to the definition contained in the document "Guidelines 
for Use of Nutrition and Health Claims" (CODEX  CAC/GL 23 1997). She said evidence of the 
importance to consumers and their preference and understanding of graphical labelling of the kind 
used by Ecuador was based on a variety of studies, including a Full Regulatory Impact Assessment 
in the United Kingdom showed that traffic light labelling had led consumers to make more healthy 
choices. A study conducted in New Zealand in 2014 assessed the impact on consumer choice in 
relation to a selection of processed foods of four different types of food labelling, and showed that 
traffic light food labelling was the best way of communicating the nutritional content of processed foods. Similarly, a systematic review of 38 scientifi c articles assessing the impact of front of pack 
labelling on consumers revealed that participants identified the healthier options more easily when 
the label appeared on the front of the package. Furthermore, she stated that Ecuador was 
complying with indicator 3.3.1 of the Pan American  Health Organization's Plan of Action. Ecuador 
considered that there were enough technical and scientific arguments to justify the need for the 
measure and as part of its comprehensive public policy, the Government of Ecuador was also 
developing other strategies to promote healthy nutrition. G/TBT/M/65  
 
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  2.2.3.20  France – Recycling Triman Mark: "Draft Decree on a common set of symbols 
informing the consumer about recyclable pr oducts subject to a system of extended 
producer responsibility associated with wast e sorting instructions" (G/TBT/N/FRA/153) 
- IMS ID 420 
2.156.  The representative of Canada acknowledg ed that France's proposed labelling scheme for 
products was based on environmental considerations. There were, however, a number of questions 
following the recent amendments to the TRIMAN  regulations, published on 26 December 2014. 
Canada was of the view that environmental and safety labels on products should be clear and 
comprehensible for the consumer. Internationally developed and recognized symbols for recycling of products, such as the green dot recycling compliance logo and Möbius recycling marker, had been used effectively for many years. He aske d that France confirm that manufacturers could 
place the TRIMAN mark on their product websites so as to satisfy the marking requirements under 
the regulation. He noted that the 26 December 2014 amendments included a reference to the equivalency of other recycling marks from other European Union Member States and asked that 
France confirm that this also applied to internationally developed and recognized recycling marks 
that were used by some of those Member States . He asked for clarification on whether France 
would accept products bearing recycling marks used by other European Union Member States in 
lieu of the TRIMAN mark from WTO Members who are not European Union Member States, in 
accordance with its most favoured nation obligations under Article 2.1 of the TBT Agreement 
2.157.  The representative of the European Union informed the Committee that the decree 
introducing a recycling symbol (the so called 'T RIMAN logo') had been published on 26 December 
2014 and entered into force on 1 January 2015. According to the adopted decree, the waste 
sorting instructions, which had to contain at least the recycling symbol ('TRIMAN logo'), had to be affixed, preferably on the product, but could be affixed on the product packaging, accompanying 
product manual or on any supporting me dia (including dematerialised forms). 
2.2.3.21   Russian Federation – Safety of products for children and adolescents 
(G/TBT/N/RUS/29) - IMS ID 418 
2.158.  The representative of the European Union requested the Russian authorities to provide an 
update on the timeframe for the adoption of the amendments notified under notification 
G/TBT/RUS/29. The Russian authorities had in formed the TBT Committee during the last 
Committee meeting that the amendments were still under development and that the estimated 
date for adoption was January 2015 at the earliest, with an expected entry into force in July 2015. 
He asked whether the adoption did happen in Janua ry 2015 and for confirmation that the foreseen 
timing for the entry into force of the amendments in July 2015 was still valid. He also requested 
that the final adopted text be made available. 
2.159.  The representative of the Russian Federation  said that timeline for the implementation of 
the technical regulation revealed the need for changing certain requirements applied under the 
measure. Such amendments to the technical regula tion were developed and accordingly notified as 
required by the TBT Agreement. The comments re ceived were being considered and the draft 
amendments to the technical regulation were under development. The amendments would most 
likely be adopted in April 2015, and accordingly enter into force in October 2015. Until then, the 
amendments to the current version of tec hnical regulation were to be applied. 
2.2.3.22  India – Labelling for Canola Oil – IMS ID 413 2.160.  The representative of Canada reiterated concerns relating to the Food Safety and 
Standards Authority of India (FSSAI) import cleara nce notice that the product must be labelled 
and marketed as "Imported Refined Rapeseed Oil - Low Erucic Acid". He stated that India's 
decision to apply such labelling requirements di rectly affected exports, marketing and sales of 
canola oil in India. These changes to India's labe lling regulations were not notified to the WTO and 
could be more trade restrictive than necessary to  achieve India's legitimate objective of food 
safety. Moreover, the requirements differed from the international standard, namely the relevant 
guidelines recommended by Codex Alimentarius. The Bombay High Court had ruled in favour of an 
importer, by issuing a stay order against the FSSA I labelling guidelines for "canola oil" and this 
had been upheld by the Supreme Court. A final ru ling was yet to be issued by the Bombay High 
Court and he requested India to provide information on the status and possible next steps. He G/TBT/M/65  
 
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  encouraged India to consider an alternative measure that would follow Codex Alimentarius 
guidelines, and not create an unnecessary barrier to trade. 
2.161.  The representative of Australia remained concerned with the requirements that the use of 
the term "canola oil" was only permitted as a se condary term. His delegation believed that this 
regulation contradicted the Codex Alimentari us Standard for named vegetable oils, which 
permitted the use of synonym descriptors for "rapeseed oil", including "canola oil" (Codex Standard 210 - 1999, section 2.1.16). This was an unnecessary labelling burden for Australian 
exporters of refined "canola oil" to India and the term "canola oil" was often used to describe 
domestic products that were available for local sale in India. He said that India's Plant Quarantine Order 2003, which outlined India's import quaranti ne requirements for plants and plant products, 
allowed the use of the alternative terms "rape and ca nola". Australia supported FSSAI's initiative of 
harmonising India's food standards with Codex that commenced in early 2013. 
2.162.  The representative of India stated that th ere was no change to the regulatory status since 
the last TBT Committee meeting and requested concer ned delegations to refer to the statement at 
that meeting which was reflected in paragraph 2.206 of G/TBT/M/64/Rev.1. 
2.2.3.23  Egypt – Bottled water - IMS ID 421 2.163.  The representative of Turkey reiterated it s ongoing concerns on the export of bottled water 
to Egypt. Exporters from Turkey were unable to ob tain import permission from Egypt's Ministry of 
Health Supreme Committee for Water as the periodic control of the source could not be maintained based on Egyptian Standard No. 2007/1589. Bilateral efforts including an invitation for the technical committee to visit Turkey in April and a meeting request with the relevant Egyptian 
authorities in October 2014 had not been replied to. Turkey had received a letter from the Ministry 
of Trade, Industry and SMEs in which requirements for putting bottled water into the Egyptian market were explained but these procedures were, in Turkey's view, only for domestic producers 
as the Supreme Committee did not grant permission to Turkish firms. He again posed the following 
questions: (i) what were the requirements for exporting bottled water to Egypt; (ii) from which countries did Egypt allow importation of bottled water; (iii) how did the Egyptian authorities 
maintain periodic control of the source of the bottled water coming from these countries; and, 
(iv) whether they conducted inspection visits, or required test reports or certificates. Turkey reiterated its readiness to invite a technical committee from Egypt to conduct inspection visits and control the water source if this was the requir ement applied by Egypt to its trading partners. 
Egypt's current policies and practice were contrary to the principle of non-discrimination and also 
constituted an unnecessary obstacle to international trade in violation of Articles 2.1 and 2.2 of the TBT Agreement. He invited Egypt to cooperate with Turkey to find a mutually satisfactory solution 
and recalled Egypt's existing obligations under WTO Agreements in general, and the TBT 
Agreement in particular.  
2.164.  The representative of Egypt said that five bilateral meetings had been held with the 
Turkish delegation on the side-lines of th e TBT Committee between July 2013 and November 
2014. At these meetings, Egypt had confirmed the necessity for companies to abide by the Egyptian Standard No. 2007/1589 to export bottled water to Egypt. This standard was publicly available at the Egyptian Organization for Standardization website
8 and at their Headquarters in 
Cairo. A copy of the standard had been provided to the Turkish delegation in November 2014.  
2.165.  Regarding Turkey's concerns on the conformity of the Egyptian Standard with Codex 
standards and WHO guidelines and on the work be ing undertaken to update the standard, she said 
that the Egyptian Standard for "Bottled Water (other than Natural Mineral Water)" was in 
conformity with the relevant Codex Alimentari us Standard No. 227/2001 and the WHO Guidelines 
Reference Vol – 1 – 2006. Updating the current standard did not imply that it was not in 
accordance with international standards but was rather a reflection that the country was keen to 
adhere to the latest scientific research and risk  assessments published by these organizations. 
Both developed and developing countries had similar practices to ensure consumer health safety and protection through continuous or periodic revision of standards. Public health and safety 
regulations remained a priority for Egypt. The prerequisite to export bottled water applying the 
HACCP system with an EU reference had been removed but applying HACCP was still otherwise 
                                               
8 www.eos.org.eg G/TBT/M/65  
 
- 39 - 
 
  mandatory for companies seeking to export bottled water to Egypt pursuant to Ministerial Decree 
No. 50 of 2008.  
2.166.  Egypt reconfirmed that equal treatment was accorded to both national and foreign 
companies equally as long as the companies were in compliance with the Egyptian Standard No. 
2007/1589. In 2012, the Egyptian authorities had suspended 13 Egyptian bottled water companies 
due to their non-compliance with the Standard. Since October 2013, all companies requesting permission to export bottled water to Egypt, including Turkish companies, were advised by the 
Supreme Committee of Water of the Ministry of Health to comply with the Egyptian Standard. 
Moreover, the Egyptian authorities had provided th e Turkish delegation with the requirements and 
procedures needed to obtain prior permission for commercially developed water resources. After completion of this step, conducting regular checks and inspection visits to the water sources would 
apply. More than 50 foreign companies, including Turkish ones already present in Egypt, were 
registered with the Ministry of Health for export ing natural mineral water to the Egyptian market. 
No Turkish company had requested permission to export bottled water since October 2013. Egypt 
believed that it was in compliance with Article 2. 1 of the TBT Agreement and that compliance with 
the Egyptian standard was not more trade restrictive than necessary as it was vital to protect human health and safety. 
2.2.3.24  United Kingdom – Proposal to intr oduce plain packaging of tobacco products 
(G/TBT/N/GBR/24) - IMS ID 424) 
2.167.  The representative of Malawi expressed her delegation's concerns regarding the 
consistency of the proposed measure with the TBT Agreement. She also requested the United 
Kingdom to abstain from any tobacco plain packaging legislation until the WTO disputes lodged 
against Australia's plain packaging measures had been concluded. Malawi's full statement is contained in G/TBT/W/402. 
2.168.  The representative of Indonesia appreciate d the attention given by the United Kingdom to 
the harm of consuming tobacco products. However, in Indonesia's view, the proposal submitted by 
the UK Government related to plain packaging of tobacco products violated Article 2.2 of the TBT 
Agreement and also several provisions of the TRIPS Agreement. Studies by researchers, using 
different analytical approaches and data sets, ha d failed to find empirical evidence that plain 
packaging measures were reducing the prevalence of smoking in the general population or among 
youth. After nearly two years of plain packag ing implemented by one Member, there was no 
available survey evidence that plain packagin g was having a positive impact on consumer 
behaviour. Plain packaging had failed to bring about the decline in tobacco prevalence. As 
Indonesia was currently in a dispute on a similar issue against Australia, he urged the UK to 
postpone their proposal until this dispute was solved. 
2.169.  The representative of Australia reiterated its delegation's strong support for the decision by 
the UK to legislate for the mandatory plain packaging of tobacco products. Australia welcomed the 
passage of the UK's regulations for standardis ed packaging by the UK Parliament, which it 
understood would come into force in May 2016. He said that the decision followed the assessment of evidence of positive public health impacts of standardised packaging, including the findings of an independent review. Moreover, the important steps made by the UK in tobacco control 
demonstrated that efforts to delay the adoption of tobacco plain packaging measures in a number 
of countries had not been successful. Australia would continue to support the development and implementation of the UK's tobacco plain pack aging measures. In the interest of time, he 
requested that the issues highlighted by his dele gation on Ireland Plain Packaging measures, also 
be considered for this specific trade concern. 
2.170.  The representative of Guatemala said that it supported the legitimate objectives pursued 
by the UK related to public health and tobacco control. However, Guatemala had concerns about 
the proposed legislation and urged the UK to consider less restrictive alternative measures that effectively achieved its legitimate objectives. 
2.171.  The representatives of Zimbabwe, Nicaragua, Nigeria, New Zealand, Norway and Uruguay 
requested that their comments delivered under Ireland – Proposal to introduce plain packaging, 
also be taken into account for this specific trade concern. G/TBT/M/65  
 
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  2.172.  The representative of the European Union stated that the UK's Draft Regulation on 
"Standardised Packaging of Tobacco Products" was notified on 3 September 2014 
(G/TBT/N/GBR/24). The UK Government had tabled the standardised packaging regulations in Parliament with the intention that these regula tions be debated before the end of March 2015, 
would apply to the whole of the UK, and enter into force at the same time as the EU Tobacco 
Products Directive in May 2016. Tobacco products had recognised harmful effects on human health. Article 2.2 of the TBT Agreement included the protection of human health as a legitimate 
objective and it was also recognised that any measure pursuant to this legitimate objective must 
not be more trade restrictive than necessary an d create unnecessary obstacles to international 
trade. It was also noted that Article XX (b) of the GATT 1994 emphasized the importance of public health by justifying measures "necessary to pr otect human […] health". The UK Regulation aimed 
at restricting the promotion of tobacco products to further reduce the smoking prevalence in the 
UK by: (i) discouraging uptake of tobacco use by young people; (ii) encouraging and supporting tobacco users who want to quit; and (iii) reshaping social norms and attitudes around tobacco use 
to promote health and wellbeing. He added that the measure would be latest in a comprehensive 
range of tobacco control legislation already in place in the UK. Under existing legislation, there was already a ban on advertising tobacco products to the general public, a ban of tobacco sponsorship 
to sports and cultural events; and companies were forbidden to give free samples of tobacco. 
Furthermore, pictorial warnings on tobacco products were required in the UK and the sale of tobacco products from vending machines was prohibited. As from 2015, tobacco displays in all shops would be prohibited. 
2.173.  He explained that the UK had also made  available, through the TBT notification, an 
explanatory memorandum that detailed the ration ale of the measure and its expected health 
impacts, an impact assessment and several scientific studies on the impact of plain packaging on 
smoking prevalence. In parallel with the WTO notifi cation, the UK had also notified the measure to 
the European Commission in accordance with internal EU requirements. The UK had received detailed opinions on the draft measure from some EU member states which were analysed and 
considered by the UK authorities. As regards th e comments received from WTO Members, he said 
that these were equally examined and written replies would be provided. 
2.2.3.25  Thailand – Draft Notification of the Alcoholic Beverages Control, Re: Rules, 
Procedure and condition for Labels of Al coholic Beverages, issued under B.E…. 
(G/TBT/N/THA/437) - IMS ID 427 
2.174.  The representative of Canada said that its concerns had been expressed in a letter to 
Thailand's enquiry point on 27 May 2014 and at previous TBT Committee meetings. His delegation 
appreciated that comments from trading partners had been taken into account and that Thailand 
could consider a different approach to the graphic warning labels. Concerns remained about the proposed measures that prohibited the use of wine labels that contained: images of athletes, 
artists, singers or cartoons; and messages affiliated with activities such as sport, music and 
contests. Some terms and definitions lacked clarity and could result in uncertainty for wine exporters. For example, some Canadian wine labels could breach Clause 2 (2) and Clause 3 (1-4 and 6) of the proposed rules as they portrayed depictions of athletes, artists and singers or other 
artistic depictions which could be considered "carto ons". Canadian wine labels were not intended to 
appeal to children or promote irresponsible alcohol consumption. There was no correlation between the sale of products labelled with sport or cartoon-like images with an uptake in youth or 
irresponsible drinking. He recognized Thailand 's right to implement regulations to protect 
consumer health and safety, and provide consumer s with adequate information to make informed 
choices. Canada was, however, concerned that Thailand's proposed labelling regulations could be 
more trade restrictive than necessary to meet their objective, and could have an undue impact on 
the trade of Canadian alcoholic beverages to Thailand. He asked if Thailand had any studies to suggest such labelling requirements would help achieve its policy objectives and whether it had considered any less trade restrictive alternatives. Canada and Thailand participated in the APEC 
Wine Regulators Forum to discuss regulatory cooperation and trade facilitation where the spirit of 
the group was to eliminate unnecessary technical requirements and impediments to the trade of wine. 
2.175.  The representative of the United States expressed concerns with Thailand's recently 
adopted measure on alcoholic beverage labelling. The US had submitted comments on the original 
text notified by Thailand and noted that many of these comments were not reflected in the 
measure adopted on 25 December 2014. The US supported Thailand's desire to address public G/TBT/M/65  
 
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  safety and health concerns related to excessive alcohol consumption, but requested the 
opportunity for further consultation to define a less trade restrictive solution. She emphasized that the measure, as written, would cause confusion fo r exporters, as its vague and unclear language 
was open to misinterpretation or different interpretations by various government officials, which 
could result in unnecessary obstacles to trade, including impediments to new entrants into the 
market. She urged Thailand to reconsider this measure, taking into account the comments provided. Given the need for guidance on how the measure would be implemented, Thailand 
should allow for adequate transition periods to facilitate industry's adjustment to the new labelling 
scheme. The US understood that Thailand was now reviewing alternative labelling measures and requested clarification on what options were being considered. She asked for confirmation that Thailand was considering disbanding the National Alcohol Policy Committee. Given the roll of this 
committee, she asked who would ensure that policies took all stakeholder input into account.  
2.176.  The representative of Mexico expressed his delegation's concerns regarding the 
consistency of the proposed measure with the TBT Agreement and its effect on trade in alcoholic 
beverages. The measure could also violate the Agreement on Trade Related Aspects of Intellectual 
Property Rights (TRIPS Agreement). Mexico's full statement is contained in G/TBT/W/408. 
2.177.  The representative of the European Union reiterated concerns regarding the Regulation on 
"Criteria, Procedures and Conditions for Labels of Alcoholic Beverages" (B.E 2558/2015) notified by 
Thailand on 28 March 2014 and published in the Royal Gazette on 22 January 2015. His delegation regretted that none of the issues previously rais ed had been properly addressed in the final act. 
There remained concerns about the strict labelling requirements proposed in the notified draft and 
its departure from international standards. Referri ng to Article 2.4 of the TBT Agreement, the EU 
invited Thailand to clarify the reasons for a deviation from the definition of a label and a container as provided in the text of CODEX STAN 1-1985. Regarding Clause 2 and 3 of the adopted 
regulation, the EU was concerned that the lack of clarity in the provisions of the notified draft 
relating to messages on labels may lead to inconsistent interpretations by economic operators. He requested Thailand to explain how it intended to interpret and enforce these clauses. The 
administrative complexity of the label approval process, to be dealt with by two separate 
government agencies, and the short implementation deadlines for compliance constituted serious market access barriers. Lack of information rega rding implementation and the transition period 
was a concern. He requested Thailand to provide appropriate guidelines for implementation, to 
extend the transition period to one year, and to allow the sale of all products existing in the 
market until stocks had been exhausted.  
2.178.  On a positive note, the EU said that the use of graphic health warnings was not part of the 
recently adopted regulation, but remained concerned about its possible introduction in the future. 
He requested further clarification on the status of  this proposed measure and welcomed Thailand's 
commitment, at the last meeting, to notify the TB T Committee. He requested Thailand to take into 
consideration less trade restrictive measures or, failing this, to clarify on which basis and evidence 
Thailand considered that different, less costly and burdensome alternatives than the indication of a graphic health warning, would be insuffi cient to address the objective pursued. 
2.179.  The representative of Australia recognised the right of governments to take measures 
necessary to protect public health and the Thai Government's efforts to address a legitimate 
concern through its proposed labelling regulation  for alcoholic beverages. He, however, sought 
clarifications on the impact of the proposed regulation for importers and was concerned that 
Clause 2 and 3 could cause uncertainty for importers as to whether certain labels were consistent 
with the regulation. In Clause 2 (1-2), it was unclear what constituted an "unfair message to 
consumers" and what terminology on labels would be prohibited under the regulation. He asked if 
descriptions of the taste and quality of wine wo uld be permitted or considered to "indirectly 
persuade consumption". Would descriptors such as "finest", "premium" or "prestige" and images associated with a brands heritage such as a mountain or vineyard still be permitted? In Clause 3 (4), he said that the definition of a "cartoon" was unclear and asked if, for example, artistic 
drawings and illustrations that were well-established elements of the trademark would be 
prohibited under these measures. Moreover, the label approval process appeared to be administratively burdensome, as importers/manufacturers required the approval of two 
government agencies. What were the responsibiliti es of these agencies in the process? Given the 
ambiguity in the application of these provisions, and the importance of providing certainty to commercial parties who needed to design, print and affix new labels in order to comply with the G/TBT/M/65  
 
- 42 - 
 
  Thai requirements, Australia requested the Thai Government to provide further details on these 
aspects of the regulation. 
2.180.  The representative of Thailand said that the regulation on "Alcoholic beverages control, 
rules, procedures and condition of labels of alcoholic beverages" was notified as G/TBT/N/THA/47 
and had been presented in the Royal Gazette on 22 January 2015. The regulation would be fully 
implemented in March 2015. Products which were imported before March would be allowed to be sold until 22 August 2015. The National Commit tee on Alcoholic Beverages Policy (NCABP) was 
taking into account all concerns received from all stakeholders and was also carefully considering 
how to deal with the pictorial labelling obligations that must be fulfilled. Thailand assured Members that it would provide further details through the notification process without delay and would convey the concerns raised to the relevant authorities.  
2.2.3.26  Indonesia – Regulation of Mini ster of Trade No. 10/M-DAG/PER/1/2014 
concerning Amendment of Regulation of Minister of Trade No. 67/M-DAG/PER/11/2013 
concerning Affixed Mandatory Label in Indonesian Language for Goods 
(G/TBT/N/IDN/85) - IMS ID. 436 
2.181.  The representative of the European Union said that the EU continued to have concerns 
with the burdensome, time-consuming and costly compulsory registration procedure for sample 
labels as a precondition for obtaining the labelling certificate (SKPLBI). The EU had raised this 
concern during the last TBT Committee meeting and sent written follow-up comments on 13 November 2014. The EU considered that the objectives of consumer protection and of 
prevention of fraud or malpractices could be achieved through a general requirement for local 
manufacturers and foreign manufacturers/importers to submit a sample label for information to 
the Indonesian authorities prior to first placing of a product on the Indonesian market. The requirement for permanently affixed labels thro ugh engraving, embossing and the like, and the 
correlated prohibition to affix labels in the form of stickers while products were still in the 
Indonesian customs was excessively constraining for many products and not in tune with market reality for globally traded products.  
2.182.  Concerning the requirement that labels for automotive spare parts sold directly to 
consumers must adhere firmly to the product or  packaging unless a letter of exemption from the 
mandatory labelling in the Indonesian language was obtained, the EU pointed out that international practice did not require, in addition  to the homologation markings, specific printings 
on tyres themselves. The EU invited Indonesian authorities to consider that automotive spare 
parts, and in particular tyres, with a markin g attesting conformity to UNECE regulations be 
accepted on the Indonesian market without further requirements at customs. Further labelling 
requirements could apply at the point of sale to  the general public without requiring any marking 
on the product itself, for example by affixing labe ls to the packaging of tyres or by providing the 
required information by signs, brochures or other similar ways. Finally, he reminded the 
Committee that the EU had already raised concerns on the application of labelling requirements for 
toys, in relation to G/TBT/N/IDN/64 - Technical Guidelines for the Implementation of the Adoption and Supervision of Indonesian National Standards for Obligatory Toy Safety (STC IMS Item no. 328).
9 
2.183.  The representative of Japan urged Indonesia to ensure that the regulation was not more 
trade restrictive than necessary.  
2.184.  The representative of Indonesia said th at the Regulation of the Minister of Trade 
concerning affixing label in Bahasa Indonesia language was to protect consumers from unclear or 
wrong interpretation of information. It replaced the previously notified regulation (G/TBT/N/IDN/47). The principles of the regulation were: (i) non-discrimination for domestically 
produced and imported goods traded in the domestic market; (ii) affixing label in Bahasa 
Indonesia to be clear and easy to understand; (iii) labelling must be fixed (permanent) for goods and packaging as using sticker was not allowed; (iv) the label would contain information or clarification regarding the identity of the good and business; and (v) information on how to use or 
a danger symbol or warning sign must be included for items related to safety, health, security and 
the environment. Goods which were sold in bulk and packaged directly in front of the consumers 
                                               
9 Indonesia - Technical Guidelines for the Implementati on of the Adoption and Supervision of Indonesian 
National Standards for Obligatory Toy Safe ty (G/TBT/N/IDN/64, G/TBT/N/IDN/64/Add.2)  G/TBT/M/65  
 
- 43 - 
 
  and imported goods as classified in the regulation  were exceptions to the regulation. Some types 
of products were also exempted from this regulation, such as basic materials for production processes, products in bulk, temporary imported products and several other categories. Exemption was also given to producers, trademark holders, general importers and suppliers of automotive 
products who submitted a letter of exemption to the Directorate of Consumer Empowerment of the 
Ministry of Trade. Indonesia welcomed bilateral discussion with Members on more specific aspects 
of the regulation. 
2.2.3.27  China – Regulations for the Supervis ion and Administration of Medical Devices 
(Order No. 650 of the State Council)
10 - IMS ID 428 
2.185.  The representative of Canada remained concerned about China's Order No. 650 of the 
State Council "Regulations for the Supervision and Administration of Medical Devices" which was 
broad and confusing and could have far reaching effects on the medical device industry in China 
and foreign suppliers of medical devices. Canada recognized that China had issued a number of implementing measures with respect to Order No. 650 in the past months. However, several 
elements of the regulatory framework remained unclear and worrisome.  
2.186.  Specifically, regarding Article 13 of Order No. 4 and Article 15 of Order No. 5, he 
understood that the new requirement was that imported products for which registration or listing 
applications were being made should have obtained market approval from the country (region) 
where the applicant's business registration was or the product was produced. Canada requested 
clarification on this new interpretation and on which types of document were now required. Such a requirement would be an issue for Canadian expo rters who may not necessarily seek regulatory 
approval domestically. Could applications be made for Canadian-originating medical devices or in-
vitro diagnostic products which received approvals in other leading jurisdictions, such as the US or EU, but which were not approved in Canada? If not, could a Canadian company registered in a 
country for which it had received approvals, such  as the US or EU, for its Canadian-originating 
medical devices or in-vitro diagnostic products that was not approved in Canada, be considered? 
2.187.  In addition, Canada noted that under Or der No. 4 and Order No. 5, China required the 
applicant to provide registration inspection samples of Class II and III medical devices and in-vitro 
diagnostic products. Canada was concerned that this form of duplicative type testing was unnecessary and burdensome with regard to imported devices that had already been approved in other markets. He further noted that Article 22 of Order No. 4 stated that clinical trials should be 
conducted for Class II and III medical devices. However, it was not clear whether foreign clinical 
trial data was acceptable or whether the trials must be conducted in China. It was Canada's understanding that Class II and III medical devices had to pass a quality test under the 
"effectively operated quality assurance system" before applying for clinical trial. Could China 
confirm this new procedure and provide further information on this quality test and the standards being tested. Further information was also requested on the "effectively operated quality 
assurance system" and on whether foreign labs could provide this testing. Article 35 of Order No. 5 
specifically stated that, for in-vitro diagnostic products, a focused clinical evaluation should be conducted in China. Canada was concerned that this constituted an unnecessary and duplicative clinical trial requirement for exporters of in-vitro diagnostic products that had received prior 
regulatory approval in other leading foreign jurisdictions, including Canada. This requirement 
would result in additional time and expense bein g incurred by Canadian medical device exporters 
wishing to enter the Chinese market. 
2.188.  Canada was also concerned with the suggested registration fees that would discriminate 
against foreign manufactures. According to do cuments released in the media, domestic 
manufacturers would benefit from preferential registration fees. He hoped that China would 
implement registration fees that were aligned with its WTO obligations. China was asked indicate 
when an official price list would become available and also when a final combined catalogue of medical devices would be released. 
2.189.  The representative of the European Union reiterated its concerns on the Chinese 
regulations regarding medical devices notified in G/TBT/N/CHN/1022-1026 and 1029 and 
subsequently raised at the TBT Committee in June and November 2014. He noted that Order No. 
                                               
10 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. G/TBT/M/65  
 
- 44 - 
 
  650 established that clinical trials were required for the registration of Class II (moderate) or Class 
III (higher risk) medical devices in China. Article 17 of Order No. 650 stated that if the safety and effectiveness of the medical device could be proven  by using the data obtained from the clinical 
trial of similar products or during clinical applications, then the product was exempted from clinical 
trials and listed in a catalogue. Therefore, th e EU understood from Order No. 650, that medical 
devices not listed in the catalogue would have to be the subject of clinical trials to be conducted in 
China. The EU was still concerned that the draft lists of Class II and Class III devices which would 
be exempted from clinical trials were limited. Moreover, the regulatory mechanism to update such 
lists tended to lag significantly behind the pace of innovation in the medical technology sector. The EU, therefore, requested that the China Food and Dr ug Administration (CFDA) put in place a robust 
system that allowed swift updates of the exem ption catalogues, as needed. The EU was also 
concerned that for products not listed in the catalogues, duplicative and redundant clinical trials 
would have to be conducted in China. Due consideration needed to be given to studies which have taken place outside of China, especially where stud ies had been conducted in a jurisdiction which, 
like China, was a member of the International Medical Device Regulators Forum (IMDRF). In most 
cases, the results of studies would be valid acro ss populations and would not need to be repeated 
or may only require smaller bridging studies to ensure that the original data was relevant for 
China. The EU reiterated the importance of avoiding any duplication of clinical trials which would 
cause additional delays in placing products on the Chinese market without any added benefit. The EU remained concerned regarding the requirement for registration of medical devices in the country of origin. He failed to understand the rati onale for the requirement, as all medical devices 
marketed in China (whether already registered in the country of origin or not) needed to comply 
with comprehensive Chinese authorization requirements.  
2.190.  Concerning the Electromagnetic Compatibility (EMC) testing, the EU reiterated its request 
that CFDA accept test reports from foreign laboratories accredited by bodies that were members of 
ILAC, as an alternative to in-country testing in China. The EU stressed that the registration certificate should exclude potentially confidential "Product Technical Requirements" documentation. 
Finally, the EU requested that Chinese authorities provide a three year transitional period as the 
new provisions introduced major changes. Further guidelines detailing the relevant processes would also be welcome. 
2.191.  The representative of the Republic of Ko rea said that overseas manufactures could produce 
medical devices for export rather than for the domestic market due to national regulations, 
medical environment or for other reasons. Howeve r, the notified regulation (G/TBT/N/CHN/1026 
and 1029) required foreign exporters to submit a marketing certificate authorized in their country 
of origin for approval in China. Such a requirement would create additional delays to enter the 
Chinese market without any added patient benefit. He requested that China exclude this requirement for imported medical devices. Furthermore, he understood that Chinese authorities 
required notarization of the marketing certificat es. Korea asked that China exclude the marketing 
certificates authorized by the government of the country of origin from the registration requirement for imported medical devices and av oid the requirement of a Chinese version of 
marketing certificates. Concerning the registrati on fees, Korea had been informed by domestic 
industry that the Chinese authorities were finalizing regulations on registration fees for medical 
devices. Korea asked China to notify the measures  so that manufacturers and stakeholders could 
submit their comments and concerns. 
2.192.  He noted that the Chinese standard on Electromagnetic Compatibility (EMC) was identical 
to the IEC standard but China did not accept test reports issued by internationally accredited laboratories that abided by the IEC standard. This would lead to unnecessary duplication of testing 
and additional delays and costs for foreign exporters as medical devices imported to China were 
already tested in accordance with the IEC standa rd. Therefore, Korea requested China to accept, 
for approval of overseas medical devices, the test reports which were from internationally accredited laboratories or were internationally recognized test reports tested consistently with 
China's technical requirements. 
2.193.  The representative of China said that the Regulations for "Supervision and Administration 
of Medical Devices" categorized medical devices according to the level of risk with Class I, II and 
III from low to high risk. For administration, Class I medical devices only needed to be filed, while 
Class II and III devices had to be registered. In manufacturing, again Class I medical devices only had to be filed, while Class II and III devices needed to be examined and approved by CFDA. 
Concerning business operations, there was no special limits set by CFDA on Class I medical G/TBT/M/65  
 
- 45 - 
 
  devices, but Class II medical devices needed to be filed and Class III medical devices licensed. She 
said that notifications G/TBT/N/CHN/1022-1026 an d 1029 were drafted to enforce the Regulations. 
Before implementation, CFDA had held specialized training to help enterprises and organizations understand these measures. She added that CFDA had communicated directly with relevant 
foreign and domestic enterprises and associations and had taken comments into account, including 
those received from the EU and US chambers of commerce in China. Comments from all Members, interested parties and stakeholders would continue to be taken into account. 
2.2.3.28  Ecuador – Draft Technical Regula tion of the Ecuadorian Standardization 
Institute (PRTE INEN) No. 189: "Labelling of alcoholic beverages" - IMS ID 433  
2.194.  The representative of Canada noted that the new customs regulation on spirits imports 
covering whisky, vodka, tequila and rum had been approved on 9 August 2013, published in the 
official registry on 23 September 2014 with entry into  force 30 days later. As this regulation would 
apply to imports only, it might be in violation of  Article 2.1 of the TBT Agreement. The proposed 
requirement for the labels to be affixed in the count ry of origin was also of concern. The standard 
practice in the internationally traded spirits industry was to apply, in the country of production, 
generic front labels providing mandatory information and to affix, in the import market, other market specific information on the back or secondary label. He said that the regulation could be 
more trade restrictive than necessary to fulfil its objective and requested that Ecuador explain how 
it complied with Article 2.2 of the TBT Agreemen t and whether a less trade restrictive alternative 
had been considered. He also asked if comments from Members would be taken into account and whether Ecuador would notify any amendments to the regulation. 
2.195.  The representative of the United States expressed her delegation's concerns regarding the 
requirement included in the regulation for a certif icate of conformity and referred to their remarks 
on Ecuador's general framework for conformity assessment (G/TBT/N/ECU/44, Addenda 1, 2, 3). 
With respect to the standard, she noted that it requires the name of the importer of alcoholic 
beverages to 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. What was the 
status of the possible revision of the measure to be less trade restrictive, given the potential added 
costs to any alcoholic beverage producers exporting to Ecuador? Finally, noting that many countries allow country-specific label changes in customs bonded warehouses, what was the reason for not allowing this common international practice. She strongly encouraged Ecuador to 
incorporate specific language allowing for such practice. 
2.196.  The representative of Mexico reiterated his delegation's concerns with the fact that the 
measure did not provide for any possibility of labelling or relabelling in the primary area of the 
product and with the requirement that the name of the Ecuadorian importer be affixed on the 
label. These requirements could be in contraventio n of the TBT Agreement, sp ecifically Article 2.2, 
as it was debateable whether this measure constituted the least restrictive alternative to fulfil the 
legitimate objective pursued. He requested that th e requirement of a label of origin with the name 
of the importer in Ecuador be removed, and that Ecuador replies to the comments formally submitted by Mexico on 2 July 2014. 
2.197.  The representative of the European Un ion shared the concerns expressed by other 
delegations. He noted that the EU had submitted comments on 1 July 2014 and was still awaiting a 
reply from Ecuador. He expressed concern about th e fact the regulation required the name of the 
importer to appear on the front label. He asked Ecuador to reconsider whether such a requirement 
was necessary as this information did not seem to be addressed to consumers nor did it seem to 
be justified. He also expressed concern regardin g the requirement that the labelling of alcoholic 
products must be done in the country of origin and that labelling or relabelling was not allowed in 
a primary customs area. Such obligation would create serious burden and costs for EU 
manufacturers who would need to print and affix different labels for the Ecuadorian market only, constituting an important obstacle to international trade. He thus invited Ecuador to consider allowing labelling with stickers at customs warehouses prior to import. This proposal was a widely 
accepted way to proceed and would allow Ecuador to comply with its policy objectives. 
Additionally, he requested Ecuador to clarify th e rationale behind the requirement for imported 
products to obtain a certificate issued by an accredited conformity assessment body and to explain 
why self-certification was not an appropriate option in order to achieve their policy objectives. 
Could Ecuador clarify the relationship between this technical regulation and Resolution No. SENAE-DGN-2013-0300-RE relating to post entry control of imported alcoholic beverages, and how this G/TBT/M/65  
 
- 46 - 
 
  technical regulation would apply to products that were already on the Ecuadorian market prior to 
its entry into force. The representative of Chile shared the concerns raised by other Members on 
the proposed draft regulation. He reported that their concerns had already been communicated in 
writing to Ecuador. He thanked Ecuador for their willingness to have bilateral discussions in which 
Ecuador was able to clarify the issues.  
2.198.  The representative of Ecuador said the aim of the draft technical regulation 189 on 
labelling of alcoholic beverages was to protect human health and safety, and prevent deceptive 
practices. The measure applied to both domestically produced and imported beverages. Both 
regulation 189 and resolution 300 were being analysed nationally and WTO Members would be informed as soon as a decision was adopted. 
2.2.3.29  China - Safety Requirement for Lithiu m Ion Cells and Batteries used in Portable 
Electronic Equipment (G/TBT/N/CHN/1016) IMS ID 425 
2.199.  The representative of the Republic of Korea noted that many Members adopted technical 
regulation on lithium ion cells and batteries which were harmonized with international standards. 
Korea had also enforced similar technical regulation concerning safety of lithium ion cells and 
batteries. However, many of China's test requirements for their safety regulation did not correspond with either the current IEC62133 or its draft revision. He requested that China 
harmonize those requirements with international standards. Concerning Article 11, he asked that 
China eliminate the requirement from the Nation al Standard or exclude it from mandatory 
requirements since the safety requirement for sy stem protection circuit could be complied by 
portable electronic equipment manufacturers rather than cells and batteries manufacturers. Korea 
would continue to work together with Chin a so as to find a reasonable solution. 
2.200.  The representative of China said that as lithium batteries were the cause of many injuries 
and even death, China had drafte d a national standard safety requirement in order to protect 
consumer's health and safety. An ad hoc wo rking group established in 2008 developed this 
standard. The working group consisted of more than 40 lithium producers and science research 
institutes, both domestic and abroad, including many foreign enterprises. After three years of in-
depth discussion and industry surveys, and three rounds of requests for comments, a final version 
of the draft standard was formulated. She said that, due to a different scope of application, the Chinese standard did not directly correspond to  IEC62133. It adopted the relevant criteria of 
IEC62133, when appropriate, and improved the IEC standard according to the characteristics of 
the lithium battery. A number of proposals based on this Chinese standard had been adopted by 
the IEC, which illustrated its effectiveness. The Chinese standard, based on the relevant international standard, did not violate any TBT Agreement provision or principle. 
2.2.3.30  Kingdom of Saudi Arabia – Certific ate of Conformity (n ot notified) and GSO 
marking requirements for toys - IMS ID 435 
2.201.  The representative of Canada expressed his delegation's concerns regarding the 
requirement to register each product model with a unique registration number present on its 
packaging. Such requirements were not found in any other country and presented a significant burden for toy manufacturers. The registrati on scheme was intended to improve product 
traceability and to reduce fraud related to the "G" mark, but toy manufacturers had in place 
traceability measures that rendered such requirement unnecessary, as evidenced by toy safety 
regimes maintained by Canada, the US, the EU and other Members. He strongly encouraged the Gulf Cooperation Council (GCC) members, throug h the GCC Standardization Organization (GSO), 
to allow registration numbers to be assigned to each manufacturer rather than to each model. He 
also expressed concern regarding differences in inte rpretation of regional technical regulations by 
GSO members, such as labelling requirements for affixed labels or imprinted labels and the 
requirement of additional random testing on prev iously assessed products. The lack of consistency 
encumbered compliance and market access. He ob served that GSO required testing for the "G" 
Mark on toys, but there was little information on how labs outside of the gulf region could be 
accredited to apply such tests and asked GSO to provide guidance on the matter. Finally, Canada 
remained interested in the progress of standards harmonization of GCC members and on the 
notification process. He asked whether a protocol for a single notification from the GSO had been 
considered to replace separate GCC country notifi cations. Canada looked forward to receiving a 
response to the letter sent on this matter in 2014. G/TBT/M/65  
 
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  2.202.  The representative of the European Union thanked the Kingdom of Saudi Arabia for the 
useful bilateral meeting and for the informatio n that had been provided. He expressed his 
delegation's support for harmonisation efforts being made within the Gulf region, including towards setting up a single notification process for the region, and said the EU was willing to exchange 
experience and provide any clarification regarding the EU's own experience with technical 
harmonisation in the toy safety or other sectors, as this may help ensuring more uniform implementation across the region. A single notification process would certainly be a positive 
development, specifically on the toy issue. He  noted that, to the EU's understanding, a guide 
document on the registration process was being prepared and that input from foreign industries was welcomed. This would provide flexibility concerning registration and would streamline the procedures as well as address the main concerns raised so far by industry, as outlined by Canada. 
The EU would relay the information to its stakeholde rs and invite them to work with the technical 
committee preparing such guide document. During the bilateral meeting the EU had also shared 
concerns regarding additional duplicating conf ormity assessment procedures in some Gulf 
countries. Saudi Arabia had explained that the procedures should not be seen as duplicative 
conformity assessments but rather as market surveillance tests that were not a condition for introducing toys in the Gulf market. The EU took this information on face value and would confirm 
it on the ground. The EU had received confirmation at the bilateral meeting that foreign tests 
results would be accepted and requested Saudi Arabia to confirm this to the TBT Committee. 
2.203.  The representative of the Kingdom of Saudi Arabia thanked Canada and the EU for their 
positive remarks regarding the technical harmon isation efforts undertaken by Saudi Arabia and 
other GCC member states through the GSO. He noted that the single notification effort was driven 
by the points raised by Canada and the EU. He reported that Saudi Arabia had established a dialogue with the TBT Committee to streamline and coordinate notification efforts by GSO 
members. Regarding the requirement on fixing the 'G' mark, he explained that the mark had to be 
affixed as indicated in clause 6 of the technical regulations on GCC marking. However if it was not possible considering the nature of the product, the mark had to be placed or affixed on the 
container if any, or on the enclosed documents. On the issue of duplicative conformity assessment 
requirements, he assured delegations a certificate of conformity was not required, but rather a certificate from a third body recommending that all documents were authentic. 
2.2.3.31  Russian Federation – Measure affect ing import of Ukrainian dairy products - 
IMS ID 426 
2.204.  The representative of Ukraine shared her delegation's concerns regarding the import ban 
on dairy products imposed by the Russian Federation. The measure was still being applied in a 
non-transparent manner with a lack of cooperation and constructive communication from the 
Russian Federation in resolving the trade concern. Ukrainian producers were still unaware of the specifics of the technical regulation. The requested laboratory tests results of Ukrainian dairy 
products conducted by the relevant Russian authorities had still not been received. The most 
efficient way to resolve the market access problem was a clear understanding of where and to what extent Ukrainian dairy products presumably  did not meet Russian regulations requirements. 
In this regard, she asked the Russian Federation to provide, in writing, scientific justification for 
the measure, including the laboratory tests results.  
2.205.  The representative of the Russian Federation said that the temporary import restriction of 
certain Ukrainian enterprises' dairy products was introduced due to lack of conformity with the 
labelling and identification requirements estab lished by technical regulation from the Russian 
Federation and the Eurasian Economic Union (EAEU). Distribution within the territory of the Russian Federation of food products that were not in compliance with the provisions of the 
technical regulation was prohibited. The prohibition to import dairy products concerned only some 
enterprises and was not a ban on all Ukrainian dairy products. She further noted that in order to resume product supply, Russia urged the competent authorities responsible for safety and quality 
control of exported products, as well as for consumer protection activities, to start bilateral 
consultations. The earlier competent authorities started the bilateral work the sooner Ukrainian 
products would be back in the Russian market. G/TBT/M/65  
 
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  2.2.3.32  European Union – Proposal for a Dire ctive of the European Parliament and of 
the Council amending Directive 96/53/EC of 25 July 1996 laying down for certain road vehicles circulating within the Community  the maximum authorised dimensions in 
national and international traffic and the ma ximum authorised weights in international 
traffic (COM(2013) 195 final) (G/TBT/N/EU/109) - IMS ID 434 
2.206.  The representative of the United States no ted that EU's regulatory objectives for adjusting 
truck length requirements was to increase fuel efficiency and the reduction of greenhouse gas 
emission of trucks. Her delegation applauded the removal of truck length restrictions. She noted 
the requirements that vehicles benefitting from removal of these restrictions offered increased fuel efficiency and maintained vehicle safety. She expressed her delegation's concern that these requirements do not become barriers to trade. She asked the EU to consider flexibility on 
maximum turning radius, before entry-into-force. There were options for dealing with the issue of 
turning radius other than through restrictive rules on goods. Road signage or rules related to road 
use could effectively address concerns related to vehicle routing. Long haul trucks need not have 
access to all roadways to provide major environmental and economic benefits to EU citizens. 
Additionally, the benefits of aerodynamic improvements increased with road speed and aerodynamic long haul trucks could improve shipping efficiency if routed along major highway 
corridors where turning radius was least problematic. Preventing sales based on turning 
requirements only pertinent to local roadways was therefore unnecessarily restrictive. 
2.207.  The representative of the European Union thanked the US for their renewed interest in the 
amendment of Directive 96/53/EC. The European Commission proposal had been adopted on 15 
April 2013 and had been subsequently forwarded to the European Union co-legislators. The 
European Parliament had recently adopted the final text and it was expected that the Council would follow shortly. The initial proposal of the Commission allowing for a derogation on the 
maximal length of cabs and trailers would be maintained. This length extension would be allowed 
only if certain aerodynamic and safety criteria we re met and, in any case, vehicles would still be 
subject to the requirement that vehicles or vehicles combinations in motion must be able to turn 
within a swept circle having an outer radius of 12.5 metres and an inner radius of 5.3 metres 
(Article 1.5 of Annex I of current Directive 96/53 /EC). He noted that no modification of such 
requirement was foreseen in the near future. This criterion had been defined taking into account the size of the existing infrastructure in the EU and some Member States already had difficulties 
coping with vehicles complying with this requirement as their infrastructure were not always large 
enough. Splitting the turning circle requirement of  point 1.5 of the Annex according to different 
types of infrastructures was not envisioned, as vehi cles or vehicle combinations would use all types 
of infrastructure during their life time and should consequently be suitable for all. Specific length 
limitations already existed (Article 7 of directiv e 96/53/EC) for certain areas such as villages, 
national parks or mountains, but those needed to be limited as much as possible. 
2.2.3.33  Ecuador - Equivalence Agreement N° 14.241 with the European Union 
regulations - IMS ID.453 
2.208.  The representative of the United States reminded Ecuador of their notification obligations 
as a WTO Member and the need to notify Agreement No. 14 421 and Resolution 042-2014 to the 
WTO. She expressed concerns regarding the fact that Ecuador had not provided information on 
which EU standards and regulations were equiva lent or what products were verified under 
Agreement No. 14 421. The Technical Report issued on 30 May 2014 proposed the adoption of 
European rules in order to help the Ecuadorian industry. She enquired how European standards 
and regulations would help more than other international standards and other examples of regulation from other WTO Members. She also  asked how other WTO Members would have the 
opportunity to engage in a similar equivalence agreement. 
2.209.  The representative of Mexico expressed his delegation's concerns regarding the 
consistency of Agreement No. 14 241 and Resoluti on 042-2014 with the TBT Agreement. He noted 
that Mexico had submitted a number of questi ons at the TBT Committee meeting of November 
2014, but no replies had been received. Mexico's full statement is contained in document 
G/TBT/W/404. 
2.210.  The representative of Brazil said his delegation shared the concerns raised by other 
delegations, in particular regarding the consiste ncy of the provisions of the Agreement no. 14.241 
with Article 2.1 of the TBT Agreement. G/TBT/M/65  
 
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  2.211.  The representative of Ecuador informed the Committee that Ecuador had established a 
mechanism allowing for the recognition of equivalence to EU technical regulations. The mechanism 
applied to the standards and quality levels maintained by the EU on products marketed in Ecuador and subjected to technical regulations before conformity assessment. She explained that the 
agreement sought to include policies that could possibly retain products of a higher quality for the 
benefit of the population of Ecuador as well as implementing controls and quality analysis of 
imported goods within the framework of Ecuador's national and international laws. All Members 
had a legitimate right to undertake such action . She noted that Agreement 14.241 regulated the 
conformity equivalence of standards and quality level for products emanating from the EU and explained that the agreement did not establish details regarding the various products. The TBT 
Agreement set forth a possibility of evaluating the recognition of equivalence of conformity to 
facilitate trade between different parties. She emphasised that the agreement had only recognised 
the equivalence of technical regulations and evaluation procedures, in a non-automatic manner, for the products to be subjected to the Ecuadori an technical regulations and to those emanating 
from the EU, as allowed under 2.7 and 6.1 of the TBT Agreement She also denied that the 
mechanism could in any way bring discrimination against products from non-EU countries since the arrangement was fully justified by the TBT Agreement. As was the case with all WTO Members, 
Ecuador had a right to consider and evaluate the po ssibility of subscribing in future agreements of 
mutual recognition in order to address concerns in this area. 
2.2.3.34  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) - IMS ID 
442 
2.212.  The representative of Switzerland thanked the Kingdom of Saudi Arabia for notifying and 
providing delegations with an offi cial translation of its regulation. However, he concerns regarding 
the Saudi Arabian Ministerial Council Decree "on th e sale and marketing of energy drinks" of 3 
March 2014, the objective of which was food safety and the proposed entry into force was 21 January 2014. He recalled that the decree contained several restrictions on sales, advertisement 
and marketing, as well as product labelling in the form of a mandatory statement. The mandatory 
statement for so-called "energy drinks" required a compulsory warning as follows: "This product has no health benefits, having more than 2 cans a day could lead to health damages". It also contained warnings related to several groups such as youth and athletes. The warnings were to be 
put on the product itself as well as on refrigerators, dedicated exclusively to energy drinks and 
separated from other food products. He noted the interval of only 15 days between the end of the 
comment period and the entry into force and recalled in particular Art. 2.12 of the TBT Agreement, 
which required that, except in urgent circumstan ces, a reasonable deadline for adaptation should 
be allowed. He asked how Saudi Arabia intended to allow producers to adapt and to confirm the date of entry into force of the measure. Switzerland shared Saudi Arabia's intention regarding 
public health, but reiterated that certain specific questions remained unanswered on why it was 
decided to go beyond relevant Codex standards on nutrition, and why it was decided to ignore standards on claims, that request a sufficient body  of scientific evidence providing truthful and 
non-misleading information. Saudi Arabia should inform the Committee on the substance that 
allegedly raised food safety concerns that justify the measure. 
2.213.  Based on available information, he expressed his delegation's belief that the decree, which 
went further than relevant international standards, required negative warnings linked to 
unspecified food safety concerns, as well as far-re aching restrictions on sales, seemed more trade 
restrictive than necessary and imposed high costs on producers. His delegation was willing to continue engaging bilaterally with Saudi Arabian authorities and encouraged them to report to the 
Committee on the status of the regulation. 
2.214.  The representative of the European Unio n, thanked the Kingdom of Saudi Arabia for its 
notifications of the measures regulating the labelling and marketing of energy drinks, but 
requested a written reply to his delegation's submission. He noted that the latest notified draft 
contained an obligation for energy drinks' cans to contain the statement "warning of the harmful 
effects of energy drinks" preceded by the word "WARNING!" along with the following health warning: "This product does not have any health benefits; consuming more than two cans per day 
may negatively affect your health; this warning concerns people such as pregnant and lactating 
women, those who are less than sixteen years old and suffering from heart diseases, high blood pressure and diabetes patients, people allergic to caffeine and athletes during exercise". He asked 
Saudi Arabia for information on the studies and risk assessment conducted showing that energy G/TBT/M/65  
 
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  drinks had "harmful effects" on health. He also asked for information about the scientific grounds 
on which Saudi Arabian authorities stated that "consuming more than two cans per day may negatively affect" human health and that energy drinks had specific effects on people "who are 
less than sixteen years old' and "athletes during exercise". In this regard, he noted the Scientific 
Committee on Food adopted in 1999 an Opinion on Caffeine, Taurine and Glucuronolactone as 
constituents of so-called "energy" drinks, which did not provide grounds to establish such warning labels. The European Food Safety Authority had re cently published a draft scientific opinion on the 
safety of caffeine updating the previous opinio n in light of new scientific evidence. The draft 
opinion was open to public consultation until the 15 March and, to date, did not provide grounds to establish such warning labels. He asked that Saudi Arabia explain the rationale for imposing labelling requirements stating that energy drinks did "not have any health benefits" and recalled 
the international Guidelines on Nutrition Labelling (CAC/GL 2-1985), according to which "the 
information should not lead consumers to believe that there is exact quantitative knowledge of what individuals should eat in order to maintain health, but rather to convey an understanding of 
the quantity of nutrients contained in the produc t'. He noted that the notified draft prohibited 
"advertising of any energy drink or promotional campaigns for any energy drink via any readable, audible or visible media organ, or by any other means" and that it also prohibited "sponsoring any 
sport, social or cultural event, or taking any procedure leading to promotion" and the "free 
distribution of energy drinks to consumers of all ag e groups". It also prohibited "the sale of energy 
drinks in restaurants and canteens in government facilities; education and health facilities; halls and public and private sports clubs". He asked Saudi Arabia to provide information on any impact 
assessment carried out in relation to the measures, and in particular on the envisaged effects of 
these restrictions on the sale, advertising and sponsoring of energy drinks. 
2.215.  The representative of the Kingdom of Saudi Arabia thanked Members for their interest in 
the matter. He confirmed that bilateral discussions to explain Saudi Arabia's position were held 
with delegations where discussions were focused on Saudi Arabia's GSO technical regulation on energy drinks and that the revised regulation wo uld most likely be produced before the end of 
2015. His delegation would keep Members updated on the matter and written responses would be 
forwarded to respective delegations in due course. 
2.2.3.35  Brazil – Draft Technical Resolutio n nº 69, 9 September 2014, Regarding the 
Requirement of Describing the Chemical Co mposition, in Portuguese, in the Label of 
Personal Hygiene Products, Cosmetics and Perfumes (G/TBT/N/BRA/608) - IMS ID 443 
2.216.  The representative of Mexico referred to paragraph 2.39 of the previous minutes 
(contained in document G/TBT/M/64/Rev.1) and as ked that these be considered as part of the 
record for the current meeting. In addition, he considered that Brazil's proposal (as contained in 
the draft resolution) could be contravening fundam ental principles of the TBT Agreement, including 
conformity with international standards, by failin g to consider the existence of a widely accepted 
international nomenclature for the ingredients of cosmetic products (INCI nomenclature). Mexico 
was also concerned that the distinction being 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 most favoured nation (MFN) principle. Thus, Mexico had formally submitted 
comments on 19 January 2015 requesting Brazil: 
a. to explain why the INCI nomenclature system was not accepted given that it was 
globally recognised by regulators as well as by the main product manufacturers and raw 
material producers;  
b. to provide justification of the benefits of translating the names of product ingredients 
into Portuguese considering that these products used a large number of raw materials 
with highly complex technical names that lay consumers were not familiar with and 
would be incapable of distinguishing between;  
c. to revoke the provision in question, or, if appropriate, to modify the wording so as to 
allow, explicitly, for the use of the International Nomenclature of Cosmetic Ingredients 
(INCI). It was noted that Mexico allowed the of the International Nomenclature of 
Cosmetic Ingredients in the technical regulation on labelling of such products (NOM 141 SSA1/SCFI 2012 - Labelling of Pre Packaged Cosmetic Products Health and Commercial 
Labellin g which had been in force since 2012); and, G/TBT/M/65  
 
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  d. to explain the rationale of the measure and the reasons why it was necessary to 
translate the product ingredients in relation to the legitimate objective pursued by Brazil, bearing in mind the INCI nomenclature. 
2.217.  The representative of the European Union reiterated concerns sent to Brazilian authorities 
on 19 January 2015. He said that the Brazilian authorities intended, by the notified draft, to 
introduce obligatory labelling requirements that list in Portuguese all ingredients of the product formulation on the labels of personal hygiene products, cosmetics and perfumes marketed in 
Brazil. The EU asked Brazil to consider accepting the internationally used International 
Nomenclature of Cosmetic Ingredients known as INCI instead of requiring the list of ingredients in Portuguese.  
2.218.  The EU believed that using INCI had various benefits. For instance, the names helped 
users to identify products with ingredients they knew they were sensitive to. Scientists and 
dermatologists were also assured that inform ation would be referenced by a uniform name, 
eliminating the possibility of confusion or misidentification from the use of multiple names for the 
same material. The INCI names ha d been adopted by many countries worldwide, including the EU. 
Indeed, according to the EU Cosmetics Regulation, all cosmetic products sold in the EU had to display a complete ingredients list using identical terms across the whole EU. Ingredient names 
had, by law, to be those listed in the INCI dictionary. 
2.219.  The representative of Canada supported the comments made by Mexico and the EU.  
2.220.  The representative of Brazil referred to th e minutes of the last meeting. On process, he 
noted that notification G/TBT/N/BRA/608 referred to a draft measure regarding the requirement of 
describing the chemical composition of personal hygiene products, cosmetic products and 
perfumes in the label of the product in Portuguese . A public consultation period had been opened 
for 120 days, until January 2015. The Brazilian Health Surveillance Agency (ANVISA) had received 
a number of contributions from interested parties and it was currently examining them. The 
measure would then be notified to the Committee. As had been previously explained, according to 
the Brazilian Consumer Protection Code, consumers in Brazil had the right to receive clear and 
appropriate information regarding the products and services available to them. The proposed 
regulation stemmed from a court ruling stating that ANVISA needed to ensure that information regarding the chemical composition of personal hy giene products, cosmetic products and perfumes 
was available to consumers in Portuguese. This ru ling was being appealed but, while there was no 
decision, it had to be implemented.  
2.221.  With respect to the measure itself, he said that it was important to clarify that the 
proposed measure did not affect the use of the International Nomenclature of Cosmetic 
Ingredients (INCI) nomenclature. The current legislation determined that the description of 
ingredients on personal hygiene products, cosmetic  products and perfumes had to follow INCI. The 
proposed measure aimed at providing the same information in Portuguese in addition . ANVISA was 
currently analyzing ways to facilitate complianc e, such as the possibility of providing the 
information on outer boxes or leaflets, in case of small products. The proposed measure also contained references to information on Portug uese names for the ingredients. Once the new 
regulation was approved, a transitional period would be granted for both domestic and foreign 
manufacturers to adapt. 
2.2.3.36  China - National Standard of the P.R.C., Safety Technical Specifications for 
Children's Footwear - IMS ID 444 
2.222.  The representative of the European Union noted that his delegation had sent comments on 
5 December 2013 and received a reply from the Chinese authorities on 31 October 2014 
answering all of the concerns of the EU except fo r one, which the EU had raised in its follow-up 
written comments of 14 January 2015. The notified dr aft set up five categories of odour ratings for 
new footwear for children, and the corresponding testing requirements. The odour ratings set up in the notified draft seemed to go beyond health an d safety concerns and bore many aspects related 
to the quality of the product. In the EU's opinion,  odour was, per se, not harmful or necessarily an 
indication of risks to human safety and the environment as perfectly safe materials could emit a 
strong odour (e.g., rubber and soap) whereas very dangerous materials could generate no odour. 
The EU considered that the testing procedure for unpleasant odours based on the olfactory sense G/TBT/M/65  
 
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  was not an accurate or precise enough practice for measuring the shoe's potential risks to humans 
or to the environment. Therefore, the EU sugg ested that Chinese authorities reconsider this 
requirement and remove the odour testing and rating  requirements of the notified draft. Should 
the requirement be maintained, the EU requested further information on the implications of the 
test operator's finding on the odour rating. And, in this context, the EU would appreciate further 
information on whether such an odour rating would have to be labelled on the product - and whether the specific odour rating entailed a prohib ition or any restriction on the marketing of the 
product in China. 
2.223.  The representative of China thanked the EU for its interest in its odour rating requirement 
for children's footwear (China Light Industry  Standard QB/T 2880-2007 "Children's Leather 
shoes"). This was the first standard which defined odour ratings for Children's leather footwear. 
Six years of implementation showed, in practice, the odour ratings was effective and easy to 
operate, it had played a positive role in leadin g enterprises to use green materials in the current 
level of science and technology. During the odour test, the tester's operating time was very short 
and at a certain distance away from the shoe, so it was less likely to cause injury - there had, to 
date, been no report of any injury to the tester s. The average result was given by three or more 
testers, which could reduce the chance of subjective judgement. 
2.224.  China said that human olfactory determin ation methods similar to the method in GB 30585 
were commonly used in the international levels. For example, European Standard EN 13725: 2003 adopted the physiological human sense in dynamic olfactory, used for the determination of odour 
concentration of air quality. On textiles, Oeko/Tex Standard 100 specified the test reference of 
odour is SNV 196 651 in which the procedure of the test was the method of human olfactory; and, 
SNV 196 651 had been practiced for quite a long time and still worked. In addition, other industries such as car production (e.g., the US standard SAE J 1351) also used human olfactory 
method to determine the odour in the car.  
2.225.  On labelling, China said that the odour rating did have to be labelled on the product and in 
China the product standard reference needed to be labelled. In China's experience, low price and 
low quality shoes were more likely to fail the odour test. Moreover, in China's view, the application 
of this standard could guide production comp anies to actively use green and environmental 
materials, and could also be useful for parents to avoid buying children's shoes which emitted strong odour. 
2.2.3.37  Russian Federation – Measure affect ing imports of Ukrainian juice products -
IMS ID No. 439 
2.226.  The representative of Ukraine reiterate her delegation's concern regarding the ban on 
imports of all Ukrainian juice products, including baby food, to the Russian Federation, which had 
been enacted on 29 of July 2014 by the Federal Service on Customers' Rights Protection and 
Human Well-being Surveillance (Rospotrebnadzor). She reminded the Russian delegation about 
the request for information and clarifications whic h had been sent about eight months ago, on 15 
August 2014, to the TBT/SPS Enquiry Point of the Russian Federation in accordance with provisions of Articles 10 and 2.5 of the TBT Agre ement. No response had been received from the 
Russian Federation.  
2.227.  Ukraine considered that the ban imposed by the Russian Federation was discriminatory in 
that it accorded treatment less favourable than that accorded to like products of national origin, and to like products originating in other countries. It was thus not justified, was applied in a non-
transparent and discriminatory manner and created unnecessary obstacles to trade. As such it was 
inconsistent with provisions of Articles 2.1, 2.2 and 5.1 of the TBT Agreement. Ukraine welcomed the proposal from the Russian Federation presented at the TBT Committee meeting in November 
2014 concerning bilateral consultations at the level of the competent authorities of both countries 
and looked forward for such consultations. 
2.228.  The representative of the Russian Federation said her authorities had introduced 
restrictions to the supplies of juice products, produced in Ukraine, towards which necessary 
conformity confirmation procedures had not been  provided. Despite this the products had been 
labelled with a Single market circulation sign for the Eurasian Common Economic Space, an action that represented a violation of the legislation of the Russian Federation and Eurasian Economic G/TBT/M/65  
 
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  Union legal acts. The large-scale detection of such products in the internal market circulation 
appeared to constitute deceptive practice. For the restriction to be lifted, the Russian Federation called on the competent authorities of Ukraine to participate in bilateral consultations. 
2.2.3.38  Russian Federation – Measure affect ing imports of Ukrainian beer products - 
IMS ID No. 440 
2.229.  The representative of Ukraine reiterated her delegation's concern regarding the ban on 
import of Ukrainian beer products to the Russian Federation. The grounds for this prohibition had 
initially been announced as non-compliance with legislation on consumers' rights protection, in 
particular, labelling requirements. She said that the measure was applied in a non-transparent and unpredictable manner. The ban had been in forc e for seven months and the Russian Federation 
had not taken any concrete steps contributing to its lifting. Ukraine considered that the ban was 
discriminatory in nature, that it accorded treatment less favourable than that accorded to like 
products of national origin and to like products originating in other countries. Moreover, the measure created unnecessary obstacles to trade. It was thus inconsistent with provisions of the 
Articles 2.1, 2.2 and 5.1 of the TBT Agreement.  The representative of Ukraine reminded the 
Russian Federation about its request for providing written official clarification and justification for the measure and the manner in which it was is applie d in terms of the provisions of the Article 2 of 
the TBT Agreement. It was noted that the Russian Federation, at the November 2014 Committee 
meeting, had made a proposal for bilateral consultations at the level of competent authorities to discuss possible ways of solving the problem. 
2.230.  The representative of the Russian Federati on said that the suspension of certain beer 
products and beer-containing beverages produc ed by some Ukrainian enterprises had been 
introduced in the Russian Federation due to a violation of technical regulation requirements in the consumer protection area, more specifically due to non-compliance with labelling requirements. 
Numerous cases had been detected and the measure had been introduced to prevent deceptive 
practices and to maintain the appropriate level of protection for human life and health, and safety. As such, the measure did not contradict the obligations of the Russian Federation under the 
articles 2 and 5 of the WTO TBT Agreement. Ru ssia stressed that the suspension encompassed 
only certain Ukrainian enterprises that produced beer, and was not a ban to import into the territory of the Russian Federation of all the beer products from Ukraine. In order to resume the 
supplies of the products from these Ukrainian ente rprises he reiterated the Russian call to the 
competent authorities of Ukraine responsible for th e quality and regulation of such products to 
engage in consultations. Russia remained ready to assist in this regard 
2.2.3.39  Ecuador - Draft Technical Regula tion of the Ecuadorian Standardization 
Institute (RTE INEN) No. 047: "Metal ca ble tray, electrical conduit and trunking 
systems" (G/TBT/N/ECU/53/Add.2) - IMS ID 454 
2.231.  The representative of Mexico reiterated those concerns set out in paragraph 2.67 of 
document G/TBT/M/64/Rev.1 (the November 2014  meeting of the Committee) and asked that 
these be considered as part of the record for the current meeting. He noted that the Ecuadorian technical regulation established packaging requirements for metal cable tray, electric conduit and trunking systems, including the requirement to indi cate the country of origin and the name of the 
importing company. Mexico considered that, on the basis of Article 2.1 of the TBT Agreement, this 
requirement could be discriminatory and produce pr otectionist effects, since it applied solely to 
imported products. Moreover, the requirement was different from the one normally specified for 
this type of product and this entailed an increase in product costs. The Regulation also established 
that products with the Ecuadorian Standardization Institute (INEN) seal of quality were not subject to the requirement of a certificate of conformity for marketing purposes; this seal was only issued 
for Ecuadorian products, and this, on the basis of Article 5.1.1 of the TBT Agreement, could have a 
discriminatory effect on imported products. 
2.232.  Taking into account the provisions of Arti cle 2.4 of the TBT Agreement, Mexico considered 
that the products covered by the technical regulation in question needed to be governed 
essentially by the provisions of International Electrotechnical Commission (IEC) Standard No. 
61537, "Cable tray systems and cable ladder sy stems for cable management", rather than 
Ecuadorian Technical Standard INEN 2486, which did not have product safety tests as its main 
objective.  G/TBT/M/65  
 
- 54 - 
 
  2.233.  He noted that the manufacturer or distributor was required to obtain a raw material 
conformity certificate; in other words, the raw material certificate had to be appended to the conformity certificate for the finished product. This would imply the establishment of requirements that would be in breach of Article 5.1.2 of the TBT Agreement, as they would generate 
unnecessary duplication given that the finished product certificate was the document that best 
served to guarantee that the raw material was suited to the type of product and that it also met the specific manufacturing standard. In view of the foregoing, Mexico had formally submitted 
comments to Ecuador on 25 July 2014, along with the following requests: 
a. to give consideration to all the comments submitted by Mexico as regards compliance 
with the principles of non-discrimination and proportionality governing technical regulations and conformity assessment procedures, and the preparation of technical 
regulations in accordance with international standards, as laid down in the TBT 
Agreement;  
b. to eliminate the specific packaging requirement for imported products and to make the 
necessary change to ensure compliance with the principle of non-discrimination provided 
for in the TBT Agreement; 
c. to take international standard IEC 61537 as a basis for fulfilling the objective pursued by 
Technical Regulation No. 047, and if this was not deemed appropriate, to provide the 
necessary justification. In this regard, it was requested that Ecuador revisit the making compliance with Ecuadorian Technical Standard NTE INEN 2486 compulsory (for the reasons set out above); 
d. to eliminate the exemption from the requirem ent of a conformity assessment certificate 
for products with the Ecuadorian Standardization Institute (INEN) quality seal, because of its discriminatory basis; and,  
e. to eliminate the requirement for presentation of a raw material conformity assessment 
certificate, or if Ecuador maintained that requirement, to provide justification for its inclusion among the requirements under this regulation. 
2.234.  The representative of Ecuador said that the purpose of technical regulation 047 was to 
prevent risks to the health and safety of persons while at the same time avoiding any prejudice to 
final users. Ecuador explained that the regulation  had its basis on various international standards 
such as IEC 61537, ANSI/UL 568 O NEMA VE1 Y NEMA VE2, ISO 9227, UL 568, EN 50085, IEC 
60529, IEC 62262. Ecuador further elaborated that the technical regulation had been notified in 
accordance with the TBT Agreement and that the regulation demonstrated the conformity of the 
product with various mechanisms including the presentation of the declaration of first part. The 
representative of Ecuador concluded by saying that her authorities had taken into account 
comments made by Members and had revised the regulation as far as it related to the product regulation and the labelling of the product. 
2.2.3.40  Ecuador - (PRTE INEN) No. 111: En ergy efficiency. Clothes dryers. Labelling - 
IMS ID 455
11  
2.235.  The representative of Mexico expresse d concern about the above-mentioned regulation. 
Mexico's full statement is contained in document G/TBT/W/409. 
2.236.  The representative of the United States supported the concerns raised by Mexico. 
2.237.  The representative of Ecuador said that the objective of the measure was to provide 
energy efficient products which would both impr ove the environment as well as their quality. 
Ecuador reported that the Ministry for Electricity and Renewable Energy tried to have 
commercialized products with high energy efficien cy and have a system that promoted awareness 
amongst consumers. This action combined standards and labels with the intention to enable 
                                               
11 G/TBT/N/ECU/152, RTE INEN 005 (G/TBT/N/ECU/1/A dd.4) INEN 036 (G/TBT/N/ECU/39/Add.3) INEN 
047 (G/TBT/N/ECU/53/Add.3) INEN 072 (G/TBT/N/ECU/87/Add.4) INEN 077 (G/TBT/N/ECU/95/Add.4) INEN 091 (G/TBT/N/ECU/125/Add.1) INEN 109 (G/TBT/N/ECU /184/Add.1) INEN 196 (G/TBT/N/ECU/226/Add.1). G/TBT/M/65  
 
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  consumers to reduce energy consumption and increase energy efficiency. Ecuador would take into 
account all comments made by Members with regard to the conformity assessment of the technical regulation to try to facilitate the presentation of a statement which would solve any problems encountered by Members. 
2.2.3.41  Israel - Resistance to ignition of mattresses, mattress pads, divans and bed 
bases (G/TBT/N/ISR/666, G/TBT/N/ISR/666/Add.1) - IMS ID 440 
2.238.  The representative of the European Union reminded the Committee that in November 
2014, Israel had provided information that the entr y into force of the notified draft was suspended 
due to on-going court proceedings at the Israeli Supreme Court. He asked Israel to provide an update on the current status of the notified draft especially as, according to the information received by the EU, while the Supreme Court case was still on-going, it however seemed that the 
standard was made mandatory as from 16 February 2015 by the Israeli Ministry of Economy. He 
requested Israel to consider recognising other relevant standards such as EN 597-1 and that the Israeli standard SI 5418 be a voluntary standard. 
2.239.  The representative of Israel said that this standard on resistance to ignition of mattresses, 
mattress pads, divans and bed bases was not yet mandatory. The date on which the standard 
would be mandatory had been delayed again for a pe riod of one year. He explained that the Israeli 
standard was an adaptation of the British standard BS 7177 in relation to parts pertaining to 
mattresses for domestic use. Since it was expected that the British standards would be revised, the revision would have an effect on the open flame resistance test. The Ministry of Economy had initiated a risk assessment survey on the impact of mattresses containing flame retardants with 
regard to public health and safety against the risk of open fire ignition of unprotected mattresses.  
2.2.3.42  European Union – Common Criteria for Information Technology Security 
Evaluation (Common Criteria) certif ication in the EU - IMS ID 448 
2.240.  The representative of China reported that despite considerable expenses and resources, 
since 2009, not a single Chinese-manufactured secu rity smartcard chip had been granted Common 
Criteria EAL4+ Certificate by EU member states. In addition, no Chinese company had become a 
member of CC-related standard organisations, though many Chinese companies had submitted 
their applications for the membership of CC-related standard organisations such as JIL Hardware Attack Subgroup. She urged the EU member countries involved in CCRA to grant Chinese companies membership and to process Chinese ma nufacturers' applications for CC approval of 
security chips on an equal footing and in a timely manner.  
2.241.  The representative of the European Union said that encryption for national security was 
limited to a few sectors closely linked to national security matters and that the required level of 
certification for different commercial applications was set by the market. Certification schemes 
were voluntary and neither the EU nor its member states imposed mandatory cryptography standards or conformity assessment procedures as a condition for access to the EU market. It was 
up to individual companies to ensure secure tran smission of data over their systems and networks 
and procure equipment with the most appropriate technology available to meet their needs. Hence, the EU failed to see the relevance of China's concerns under the TBT Agreement. Nonetheless, the EU reiterated its invitation to China to detail the concerns with supporting 
evidence and its willingness to further discuss these issues bilaterally. The EU then highlighted 
some key differences and approach in this area be tween the EU and China. Unlike in China, where 
encryption certification for commercial products was mandatory, the European voluntary 
certification schemes and related supporting European standards were based on international 
standards for security evaluation, in particular the common criteria standards and global practices. Some Chinese companies were able to claim EAL certificate in the EU while no foreign companies 
had ever received a commercial encryption licence  from OSCCA.  There was an absence of an 
equal level playing field as Chinese companies enjoyed far better conditions for access to the market, including voluntary encryption certification in the European Union, and opportunities to participate in standardisation work. The EU would like to see a rebalancing of the situation. 
2.242.  The representative of China regretted that  they had not received enough information from 
the EU. He said that they had requested the EU to provide a list of the evaluation and certification 
bodies involved in the CC certification but had not received such information. They had observed G/TBT/M/65  
 
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  that a lot of governmental bodies were involved in processing and issuing CC certificates in EU 
member states and at the EU level, the EU Commission required its private banking industry to ensure that its information security system was secure. In view of the above, it was China's 
opinion that China and EU were taking similar actions.  
2.243.  The representative of the European Union explained that it had not refused to provide the 
information requested by China but as the request was received only a few hours before the 
meeting commenced, it was just not possible to compile the information. On the legal issues of the 
coverage of the TBT Agreement, the EU was of th e view that it was important to read terms in 
context of everything that had been said about ce rtification bodies, be they governmental bodies 
or non-governmental bodies, and in any event qu alified by the chapeau of Article 5 ("where a 
positive assurance of conformity … is required") . According to the EU, the conditions set out in 
Article 5 had not been fulfilled in this case and the argument being put forward in this particular 
case was not relevant to TBT. 
2.244.  The representative of China responded by urging EU colleagues to recall that on the 
margins of the November 2014 meeting, China had already bilaterally provided clear and plentiful 
information to the EU, including on the refusal of  the EU member states to accept and process 
China's CC certification applications. With regard to the coverage of the TBT Agreement, China 
responded that Article 5 (assessment of conformity by central governmental bodies) and/or Article 
8 (assessment of conformity by non-government al bodies) of the TBT Agreement explicitly 
indicated the relevance of the TBT Agreement to CC certifications carried out in the EU member 
states.  
2.2.3.43  European Union – Limits for hexava lent chromium in toys (2009/48/EC) - IMS 
ID 449 
2.245.  The representative China raised concerns with the existing and proposed limit values for 
hexavalent chromium ("chromium VI") in toys or toy components in the EU toy safety directive 
2009/48/EC. The EU toy safety directive sets the limi t values of chromium VI for three types of toy 
materials as 0.02mg/kg, 0.005mg/kg, and 0.2mg/kg respectively, which were even more stringent 
than those in drinking water as specified in the WHO Guidelines for Drinking-water Quality or 
foodstuffs as prescribed in Members' national st andards. He requested the EU to provide scientific 
evidence, including children's physiological absorption data, to justify such stringent limit values for chromium VI in toys or toy components placed on the EU market. 
2.246.  Regarding the EU Scientific Committee on Health and Environment Risks (SCHER) proposal 
for a revision of the existing limit values for chromium VI in the current EU toy safety directive, he requested the EU to provide information on th e recent developments. The EU did not specify 
testing method for migration limits from toys or components of toys in dry, brittle, power-like or 
pliable material, or migration limits in liquid or sticky toy material. The stringent requirements of the EU and the absence of testing methods and the extremely expensive testing continued to 
cause great difficulties for exporters of toys to the EU, both from China and other Members. He 
requested the EU to adapt its requirements regarding migration limits of chromium VI to the current technological level of the toy industry and the existing conformity assessment capability. He further requested the EU to lower its requirements on migration limits of chromium VI to a 
level not higher for foodst uff or drinking water. 
2.247.  The representative of the European Union said that the current limits in Directive 
2009/48/EC were to provide a high level of protecti on of children from exposure to chromium VI, 
as there were other sources of exposure such as  drinking water and the air. The current limits 
were based on science and there was evidence that they were not only technologically feasible and achievable by industry but were also detectable according to available testing methodologies. The 
EU representative referred to his statement at the previous meeting for relevant background 
information regarding the European Commission's request to SCHER. The final Opinion of SCHER was published on 10 February 2015. The draft Opinio n had been open for public consultation and 
comments were carefully considered and taken into account before issuing the final opinion. On 
the basis of the risk assessment Opinion on the toxicologically safe limits (calculated on the basis 
of a risk of one cancer occurrence in a million),  the European Commission, as part of its risk management tasks, would consider whether the current migration limits for chromium VI needed 
to be revised. The evaluation would take into account available technology in the industry and 
available testing methodologies for the detection of chromium VI in toys. If the Commission G/TBT/M/65  
 
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  decided to propose a revision of the current limits, any such proposal would timely and duly 
notified in accordance with the TBT Agreement's notification procedures.  
2.2.3.44  Ecuador – Cosmetic produc ts (G/TBT/N/ECU/116) - IMS ID 417 
2.248.  The representative of Mexico said that RTE INEN No. 093 stipulated, in respect of 
cosmetics covered by the technical regulation, that the "marketing, retailing and/or import thereof 
were subject to submission to the National Health Authority of the mandatory sanitary notification (NSO), along with, inter alia, technical information (product information file, including the cosmetic 
product safety report) and the NSO identification code for cosmetic products issued by the National 
Health Authority". Ecuador could be infringing Ar ticle 2.2 of the TBT Agreement, on the basis of 
available scientific and technical information, as it was not necessary to request a safety assessment report for such products.  
2.249.  He explained that the technical regulation also stipulated that cosmetics were to be 
manufactured in accordance with the good manufacturing practice requirements established in Ecuadorian Technical Standard NTE INEN ISO 22716. This could involve further violation of Article 
2.2 of the TBT Agreement, because globally, good manufacturing practice certification tended to 
be voluntary. The regulation required labelling and any instructions for use and disposal, as well as any other manufacturer's information, to be in Spanish. This requirement could be inconsistent 
with Article 2.2 of the TBT Agreement, as in dividual product names and the International 
Nomenclature of Cosmetic Ingredients (INCI) could not be translated into Spanish, since they were personal names. The measure could infringe Arti cle 5.1.1 of the TBT Agreement as regards access 
to Ecuador for Mexican products, since, according to information from the Mexican cosmetics 
industry, there were no cosmetics certifying body in Ecuador that could issue the "certificate of 
conformity of products and systems". He requested Ecuador to give consideration and respond to the comments submitted by Mexico with respect to compliance with the principle of 
proportionality. He also requested information on the analysis that had been conducted by Ecuador 
on available alternatives in support of the deci sion to enforce the ISO 22716 guidelines. He further 
requested information regarding compliance by the bodies accredited to issue the "certificate of 
conformity of products and systems". Could Ecuador explain the urgent problems which arose or 
threatened to arise, which led it to adopt the "emergency" technical regulation. Would Ecuador consider allowing a transitional period to allow for comments and possible adjustments to the measures prior to adoption? 
2.250.  The representative of Brazil had concerns with the measure due to the lack of accredited 
test laboratories and accredited certification bodies. Products imported from the EU had 
preferential treatment under Agreement 14.241, as discussed in a previous STC. He sought 
clarification from Ecuador regarding developments on the availability of the necessary 
infrastructure.  
2.251.  The representative of Ecuador said that technical regulation RTN 093 for cosmetic products 
was based on a decision of the Andean Community regarding legislation for cosmetic products and 
also Annex 2 of the Good Manufacturing Processes for the Cosmetic Industry in the Andean Community. Ecuador would take into account all comments made by Members with regard to conformity assessment of the technical regulation to try to facilitate the presentation of a 
statement which would solve problems encountered by Members. 
2.2.3.45  Ecuador – Certification of Ceramic Tiles II - IMS ID 419 
2.252.  The representative of Brazil said that the new regulation of certification of ceramic tiles 
posed significant difficulties for Brazilian exporters. Ecuador did not accept manufacturer's 
declaration of conformity nor Brazilian third-party certification. Brazilian procedures for third-party certification on ceramic tiles were established by the Brazilian Institute of Metrology (INMETRO) 
and products had to comply with the relevant Conformity Assessment Procedures, which were 
updated in 2014. He requested that Ecuador accept certification of conformity issued by INMETRO's accredited certification bodies. 
2.253.  The representative of Ecuador said comments by Members had been taken into 
consideration and that the regulation had been modified with regard to labelling and G/TBT/M/65  
 
- 58 - 
 
  demonstration of the conformity. The Service of Ecuadorian Accreditation accepted the 
accreditation of AENOR and INTERTEK for the technical regulation. 
2.2.3.46  Ecuador - Proposed Motor Vehicle Sa fety Regulatory Requ irements (RTE INEN 
034)12 IMS ID 409 
2.254.  The representative of the United States said that while her delegation supported the 
automotive safety and environmental protection objectives pursued by the measure, it was 
nonetheless puzzled by the unusual way used by Ecuador to notify a significant revision of its 
technical regulation for vehicle safety through several addenda. A full notification of the third 
revision of this measure would have been more transparent, and in line with notification obligations under the TBT Agreement. US industry had offered comments to the sixth
 Addendum 
on 8 November 2013, and requested INEN to cont inue acceptance of self-certification to US 
Federal Motor Vehicle Safety Standards and US Environmental Standards. These comments were 
however never acknowledged or replied to by Ecuador. What was the scientific evidentiary basis for concluding that, despite a long history of accepting certification to FMVSS as meeting its 
domestic safety requirements, FMVSS no longer met its public safety requirements? Why were 
stakeholders not afforded the opportunity to provide data to demonstrate the effectiveness of FMVSS in achieving Ecuador's desired safety outcom es? The regulation finalized in October 2014 
had substantially disrupted trade of autos and truc ks from the US to Ecuador. Furthermore, with 
the adoption of UNECE standards exclusively in Ecuador, the introduction of new vehicles developed to FMVSS would be delayed until versio ns designed to UNECE requirements were 
developed, presuming US automotive companies inte nd to design new versions accordingly. This 
could have a significant impact on trade, in particular since the majority of vehicles imported by 
Ecuador were models that did not have UNECE versions. She requested that Ecuador reconsider the final regulation, and include acceptance of US FMVSS and US EPA automotive requirements. 
2.255.  The representative of Mexico said that this topic was of particular concern because, apart 
from the fact that formal comments were submitted to Ecuador on 12 November 2013, bilateral 
meetings have been held with the Ecuadorian Government, where the main concerns were 
expressed and reiterated. Despite this dialogue and these efforts, Mexico's observations were not 
incorporated in the most recent publication of the technical regulation. Mexico's full statement is contained in document G/TBT/W/410. 
2.256.  The representative of Brazil shared the concerns raised by the US and Mexico and 
expressed his delegation's view that a number of requirements under the new technical regulation 
seemed to be more trade-restrictive than necessary to fulfil the stated objectives, and that this measure was conceived only taking into account the requirements established by UNECE. Other 
international standards established to fulfil the same objectives, followed by other countries, had 
not been considered. Products that met high standards of safety and quality were not allowed on to the Ecuadorian market, despite being based on international standards. The new measure also 
did not allow for "self-certification" for automotive products. He requested Ecuador to accept such 
certificates, which was line with practices followed in many other countries and also in the region. Also, due to the number the changes required for complying with the new technical regulation, Brazil also requested an extension of the transition period allowed for manufacturers. 
2.257.  The representative of the European Union requested Ecuador to clarify the timeline for the 
implementation of the new regulations. He then provided some general comments about efforts for 
international harmonisation in the motor vehicle sector. International harmonization, when based 
on a high level of human health, safety and environment protection, played an important role in 
trade relations in this sector. Within the EU, the motor vehicle industry was the second largest manufacturing sector being traded after machinery. It was undeniable that the most effective 
instrument for international harmonisation in the motor vehicle sector was the UNECE's "1958 
Agreement", which grouped 58 countries globally. The "1958 Agreement" allowed for the development of international standards in the form of UN regulations, and their technical requirements are recognized as sufficient for ac hieving the high level of protection of human 
health, safety and the environment desired by the participating countries. Such regulations were 
also applied by countries other than its contracting parties. This international harmonisation was 
                                               
12 G/TBT/N/ECU/32, G/TBT/N/EC U/32/Add.1, G/TBT/N/ECU/32/Add.2, G/TBT/N/ECU/32/Add.3, 
G/TBT/N/ECU/32/Add.4, G/TBT/N/ECU/32/Add.6. G/TBT/M/65  
 
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  also the basis of a robust system of mutual re cognition among these 58 contracting parties and 
was therefore a powerful instrument for trade facilitation.  
2.258.  The EU noted that these reasons supported the view that harmonization in the motor 
vehicle sector should be promoted and that Members should participate in such efforts within the 
limit of their resources, as stated in Article 2.6 of the TBT Agreement. Thus, a domestic regulatory 
approach in the vehicle sector that recognised the relevance of, and expressed a commitment to be aligned with, these UN regulations would be, in the EU's view, fully consistent with the spirit 
and the letter of Articles 2.4 and 2.5 of the TBT Agreement. With regard to conformity 
assessment, he said that it was clear that different  options could be envisaged. In this respect, it 
was important to be aware that the administrative and judicial capabilities to enforce and perform an effective market surveillance system clearly play ed a role in the choice of the most appropriate 
conformity assessment procedure. These factors must be taken into account when a Member 
needed to make a choice between various conformity assessment procedures, such as self-declaration /supplier's declaration system or type-approval system. This is recognised in 
Article 5.1.2 of the TBT Agreement, which und erlines the need that conformity assessment 
procedures should give the importing Member adeq uate confidence that products conform with the 
applicable technical regulations or standards, taking into account the risks non-conformity would 
create. The EU has been operating a "type-approval system" for the motor vehicle sector for many 
years. This conformity assessment option has show n to be an efficient way to manage and enforce 
the high risk associated with motor vehicles and has allowed for a rational use of public resources by the EU. 
2.259.  The representative of Ecuador reported that Ecuador had recently adopted a new series of 
safety standards for vehicles within the framework of the measure at issue. This was a first step 
towards signing the 195813 and 199814 Agreements of the UNECE.15 They were adopting standards 
under the UNECE's "58' Agreement". Ecuador stated that it had encountered in the technical 
standards of the UN, international standards that had been developed on the basis of a system that was created for the UNECE's "World Forum for Harmonization of Vehicle Regulations (WT.29) 
and also contracting parties provided the guarantees  required to regulate the safety of vehicles 
and protection of its citizens. Ecuador said that the system they had opted for sought to ensure that vehicle production would be safe throughout the production cycle of each model. WT.29 was an open forum where the contracting parties were able to discuss the regulations and provide 
updates on the standards that were coming into force. International vehicle manufactures present 
in Ecuador offered models in other markets th at complied with the minimum standards of the 
Ecuadorian measure at issue (RTE INEN 034) and other standards which were far more 
demanding. Open dialogue had been maintained from the outset of developing this measure, 
leading to inputs by manufacturers, importers and assembling companies that had subsequently 
aligned their models to comply with the new Ecuadorian standards. 
2.2.3.47  Russia - Alcoholic Beverages Storag e Technical Conditions Order Number 59n - 
IMS ID 372 
2.260.  The representative of the United States noted that importers of US distilled spirits products 
continued to have issues obtaining the necessary "a ctivity" license from FSR, and even when such 
licences were granted, the storage requirements mandated by the regulation were difficult to meet 
and inconsistent with international standards. She urged Russia to revise this regulation and to take into account its obligations under the TBT Agreement, particularly in relation to consistency 
with international standards and the restrictiveness of its conformity assessment procedures.  
2.261.  The representative of the European Union supported the US comments and considered that 
the licensing system set out by this order was complicated, burdensome, trade restrictive, non-
transparent and in some cases impossible to comply  with. He noted that EU exporters of alcoholic 
beverages were particularly concerned with the approaching renewal of the necessary "activity" 
                                               
13"Agreement concerning the adoption of uniform  technical prescriptions for wheeled vehicles, 
equipment and parts which can be fitted and/or be used on wheeled vehicles and the conditions for reciprocal 
recognition of approvals granted on the basi s of these prescriptions," of 20 March 1958. 
14 "Agreement Concerning the Establishing of Gl obal Technical Regulations for Wheeled Vehicles, 
Equipment and Parts which can be fitted and/or be used on Wheeled Vehicles", of 25 June 1998. 
15 A presentation on these Agreements made by the UNECE to the TBT Committee during a "Workshop 
on Regulatory Cooperation between Members", held ba ck-to-back with the Committee's regular meeting, is 
available at: https://www.wto.org/english/tratop_e/tbt_e/docs_wkshop_nov11_e/s3_f_1_unece_e.ppt .   G/TBT/M/65  
 
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  license by the Federal Service for Alcohol Market  Regulation due in 2015 as they continued to 
encounter serious difficulties in meeting the alcoholic beverages storage conditions, which were inconsistent with international standards. For example, under the Order number 59n it was not possible to store jointly alcoholic and non-alcoholic products intended for the formation of gift sets. 
The EU asked Russia to consider revising Order number 59n in light of its obligations under the 
TBT Agreement so as to ensure that the licensing  system would be transparent and the technical 
conditions for storage of alcoholic drinks in line with international standards.  
2.262.  The representative of the Russian Federation said that in accordance with Federal Law 
No. 171-FZ "On state regulation of production and turnover of alcohol drinks" it was necessary to 
obtain a licence for the production and turnover of alcohol products (including those for warehousing). He clarified that this was not an import licensing requirement, but instead an 
activity licence. Order 59n established qualificat ion requirements for the organization, which would 
carry out the activities of the warehouse of alcohol drinks, but not requirements for the product, process or production method. This order was therefore not a technical regulation and, in any 
case, these qualification requirements were neither burdensome, nor applied on a discriminatory 
basis. Russia intended to clarify the need to preserve these qualification requirements and would inform interested WTO Members. 
2.3  Exchange of Experiences 
2.3.1  Preparation of the 7
th Triennial Review 
2.263.  The Chairman provided a report, on his ow n responsibility, on the First Thematic Session 
on the Seventh Triennial Review. The report, he said , was intended to capture the main points that 
he discerned from the discussions during the 17 March 2015 meeting as well as facilitating 
Members' future deliberations on the Seventh Triennial Review. The full report is contained in document JOB/TBT/125 (dated 25 March 2015).
16 He reminded Members that, in line with the 
mandate in Article 15.4 of the TBT Agreement, the Committee was scheduled to complete the 
Seventh Triennial Review on 4-5 November 2015. Members were thus encouraged to come forward with any submission they intended to make before 1 June 2015 , in good time before the 
next thematic session, to be held on 16 June 2015. 
2.264.  The representative of the United States  informed the Committee that her delegation was 
exploring the idea of contributing a document for the Triennial Review discussing the possibility of 
having more robust discussions on the notification of regional technical regulations. 
2.265.  The representative of the European Unio n said that conformity assessment would be a 
good topic to develop in the 7th Triennial Review. He said that the European Union was working on 
some ideas building on what had been discussed in the thematic sessions. He said that the topic 
could cover: how to design efficient conformity assessment solutions capable of meeting 
regulators' needs without imposing unnecessary burdens on manufacturers; the role of accreditation in the assessment of the competence of conformity assessment bodies; mechanisms 
to facilitate the acceptance of conformity asse ssment results generated in other Members. The EU 
was also considering a submission on transparency. 
2.266.  The representative of Japan stated that Japan was considering making a proposal relating 
to conformity assessment procedures. De tails were still under consideration. 
2.267.  Reverting to some of the discussion held du ring the thematic session, the representative of 
Ecuador said that his delegation had some doubts about the utility of the document submitted by 
Mexico. Ecuador was of the view that, since a pape r relating to the same subject was about to be 
approved (on good regulatory practices), it might be premature to develop directives or guidelines 
on the same subject, and therefore was against the proposal from Mexico. In response, the representative of Mexico referred to the discussion held during the thematic session and reflected 
in the Chairman's report (JOB/TBT/125) and noted that the delegation of Mexico was, of course, 
willing to discuss the matter further in the future.   
                                               
16 At the time of the meeting a draf t hard copy was provided at the ba ck of the room for Members. The 
version later circulated takes into account co mments provided by Members on that draft. G/TBT/M/65  
 
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  2.268.  On the Swiss proposal, Ecuador stated that considering that the Triennial Review was 
about the implementation of the TBT Agreement, di scussion needed to be limited to measures that 
sought a legitimate objective in terms of the policies of Members and not in certain other areas mentioned by other Members. The representative of Chile said that while he was in favour of the 
thematic sessions in general, his delegation was against the proposal from Switzerland. 
3  TWENTIETH ANNUAL REVIEW 3.1.  The Committee adopted the Twentieth Annual Review of the Implementation and Operation 
of the TBT Agreement as contained in G/TBT/36. The Committee took note of document 
G/TBT/CS/2/Rev.21 containing a list of those standa rdizing bodies that have accepted the Code of 
Good Practice since 1 January 1995. 
4  TECHNICAL COOPERATION ACTIVITIES 
4.1.  The Secretariat provided information on the TBT Advanced Course which had taken place 
from 9-20 March. It featured a new component which was that each participant, with the guidance 
of coaches had developed an action plan to addr ess a specific implementation challenge in their 
country. Participants were expected to report back periodically on the implementation of the action 
plans and the Secretariat envisaged inviting them back to Geneva for a follow up session in 2016, 
for which the Secretariat would request the necessary funding in the context of biannual TA plan. A 
document containing information on the Secretariat's technical assistance activities was made 
available.17  
4.2.  The representatives of Chinese Taipei, Chile,  Ukraine, Trinidad and Tobago and Peru thanked 
the Secretariat for the technical assistance activities that had been held.  
5  UPDATING BY OBSERVERS 
5.1.  The representative of the Gulf Standardization Organization (GSO) thanked the Committee 
for granting GSO observership18 status. He said that GSO was a non-profit organisation that 
served as an umbrella organisation for the GCC standards, meteorology, conformity assessment 
and accreditation. It was a regional standardisat ion organisation although it was a sub-regional 
organisation by ISO designation that worked under the umbrella of the Gulf cooperation council, 
GCC for the Arab states of the Gulf. GSO members were the United Arab Emirates, Kingdom of 
Bahrain, Kingdom of Saudi Arabia, Oman, State of Qatar, State of Kuwait and Yemen with the headquarters based in Saudi Arabia where it had administration and financial autonomy. The GSO had already issued more than sixteen thousand  standards and technical regulations covering 
various economy sectors. GSO would work towards achieving the objectives of the TBT Agreement 
by using and promoting the use of international standards, guidelines and recommendations where they exist for the protection of human health sa fety and the environment within the Gulf region. 
5.2.  The representative of the IEC informed the Committee that the full report on the IEC 
activities for developing and industrialising countries was available on their website.19 Since 
January 2015, affiliate countries participating in the IEC free programme for developing countries, 
had a new leader. Since the last TBT Committee meeting, Haiti and Mongolia had established a 
national electro technical committee and Mongolia and Bhutan had upgraded to affiliate plus. The mentoring programme for affiliates was going strong  with two new partnerships being in the final 
stage. The first ACAS e-learning modules were launched on 18 March 2015. IEC would hold two 
IEC EX events, one in Poland in April 2015 with the collaboration of UNECE, and the other in 
Ghana, upon the request of the AFSEC in July 2015. 
5.3.  The representative of the OIML reminded the Committee that OIML's main role was to 
develop model technical legislation, covering measurements and measuring instruments used 
when legal proof was needed. This work was conducted by experts from OIML member states and corresponding members who worked in project groups. One of the many focuses was the 
development of the operating procedures for this technical work. This had become a much more 
                                               
17 G/TBT/GEN/171/Rev.2. 
18 Ad hoc observership status. 
19 http://www.iec.ch/about/globalreach/ . 
 G/TBT/M/65  
 
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  open and transparent development procedure and through the website, all early stages of the 
work could be completed by a much more consen sus based procedure even though as an inter-
governmental treaty organisation there were restrictions for the final approval. Work was also under way to improve support for developing legal metrology infrastructures in developing 
countries. 20 May 2015 was World Meteorology day and the theme for this year was 
"measurement and light" as UNESCO had designated  2015 as the International Year of Light and 
Light-based Technology. 
5.4.  The Committee took note of information provided by the representatives of the Codex 
Alimentarius Commission20 and UNECE.21  
6  OTHER BUSINESS 
6.1.  The Chairman said that in line with the fax he had sent on 6 March 2015, he recalled that the 
Secretariat was exploring the possibility of orga nising an anniversary event for the TBT Committee 
on 6 November 2015. There would be numerous events in 2015 to mark the 20th Anniversary of 
the WTO. This event could be an opportunity to share with a wider audience various issues the 
Committee had worked on since the establishment of the WTO. The Secretariat, in cooperation 
with the incoming chairperson and in consultation with the Members would develop a draft outline of the programme for the TBT Committee's consideration. 
6.2.  The representative of India agreed with the proposal to use the opportunity of TBT@20 to 
look back and take stock of what had been achiev ed in the past twenty years and his delegation 
would like to be involved in further development of the programme. While the suggestion was to have the workshop open to public; it would be useful for Members to consider further the nature of 
participation. On the proposed content, his delegation had reservations on "review of issues which 
members have considered in some depth over the years." While it was a good idea to highlight success, he said it was not appropriate to deliber ate in a public event, those issues which the 
Committee deliberated in depth but could not reach a consensus on. His delegation had sensitivity 
on some issues such as economic benefits of international standards being deliberated in the proposed forum. The programme should be developed carefully, taking into consideration all 
Members' sensitivities. 
6.3.  The Chairman asked the Secretariat to prepare a draft programme.  
7  DATE OF NEXT MEETING 7.1.  The next regular meeting of the Committee is scheduled for 17-18 June 2015. It will be 
preceded by a thematic session to be held on 16 June 2015. 
 
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20 G/TBT/GEN/177. 
21 G/TBT/GEN/178.