RESTRICTED  
  
G/TBT/M/63  
 
19 September 2014  
(14-5262)  Page: 1/57  
Committee on Technical Barriers to Trade    
 
MINUTES OF THE MEETING OF 18-19 JUNE 2014 
CHAIRPERSON: MR. FILIPE RAMALHEIRA 
Note by the Secretariat1 
 
Contents 
1   ADOPTION OF  THE AGENDA ........................................................................................ 2  
2   ELECTION OF THE CHAIRPERSON ................................................................................ 2  
3   IMPLEMENTATION AND ADMINI STRATION OF THE AGREEMENT ................................. 2  
3.1   Statements from Me mbers under Article 15.2 ................................................................ 2  
3.2   Specific Trade Concerns.............................................................................................. 2  
3.2.1   Withdraw n concerns ................................................................................................ 2  
3.2.2   New Concerns  ........................................................................................................ 3  
3.2.3   Previously Raised Concerns ..................................................................................... 14 
3.3   Exchange of Experiences ........................................................................................... 49 
3.3.1   Transparency (Thema tic session of 17 June 2014). ..................................................... 49 
3.3.2   The Coherent Use of No tification Format s (G/TBT /35) ................................................. 50 
3.3.3   Good Regu latory Pr actice ........................................................................................ 50 
3.3.4   Other Matters ........................................................................................................ 54 
4   TECHNICAL COOPER ATION ACTIVI TIES .................................................................... 56  
5   UPDATING BY  OBSERVERS ........................................................................................ 56  
6   OTHER BU SINESS ...................................................................................................... 56  
6.1   Canada's new regulatory framework ............................................................................ 56 
7   DATE OF NE XT MEETING ........................................................................................... 57  
                                               
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/63 
 
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1  ADOPTION OF THE AGENDA  
1.1.  The Committee adopted the agenda contained in WTO/AIR/4305. 2  ELECTION OF THE CHAIRPERSON 
2.1.  The Committee elected Mr. Filipe Ramalheira (Portugal) as the Chairman of the Committee.  
3  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 
3.1  Statements from Members under Article 15.2  
3.1.  The Chairman said that the list of stat ements submitted under Article 15.2 of the TBT 
Agreement was contained in document G/TBT/GEN/ 1/Rev.13, dated 25 February 2014. He recalled 
that this information was available, and regula rly updated, on the TBT Information Management 
System (the "TBT IMS"). He stressed that while 128 Members had submitted at least one 
Statement on Implementation under Article 15.2, 31 Members had not yet fulfilled this obligation 
and he urged them to do so in a timely manner.  
3.2.  The representative of the United States thanked the Chairman for emphasizing the 
importance of 15.2 statements and commended Mali on their recently submitted statement. 
3.2  Specific Trade Concerns  3.2.1  Withdrawn concerns 
3.3.  The Chairman reported that the following Specific Trade Concerns were withdrawn from the 
Agenda at the request of the concerned Member:  
a. Argentina – Non-acceptance of 200 Grade Stainless Steel – withdrawn by India. 
b. Ecuador - Emergency Technical Regulation of the Ecuadorian Standardization Institute 
(RTE INEN) No. 088: "Surface tension agents" (G/TBT/N/ECU/117) – withdrawn by 
Mexico. 
c. European Union – Directive 2009/28/CE, Renewable Energy Directive (EU-RED) – 
withdrawn by the United States. 
d. Mexico - Draft Mexican Official Standard PROY-NOM-032-ENER-2013: Maximum 
electrical power limits for equipment and appliances requiring standby power. Test 
methods and labelling (G/TBT/N/MEX/263/Add.1)  - withdrawn by the Republic of Korea. 
e. Ecuador – Cosmetic products (G/TBT/N/ECU/111 G/TBT/N/ECU/116) – withdrawn by 
Mexico. 
f. New Zealand – Proposal to introduce plain packaging of tobacco products in New 
Zealand (G/TBT/N/NZL/62, G/TBT/N/NZL/62/Add.1) – withdrawn by Indonesia. 
g. Chile - Bovine meat (G/TBT/N/CHL/254, G/TBT/N/CHL/254/Add.1) – withdrawn by 
Paraguay.2 
                                               
2 This concern was not included in the Annotated draft Agenda. G/TBT/M/63 
 
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  3.2.2  New Concerns 
3.2.2.1  China - Safety Requirement for Lithiu m Ion Cells and Batteries used in Portable 
Electronic Equipment  
3.4.  The representative of Japan expressed his delegation's view that, while under Article 2.4 of 
the TBT Agreement the IEC62133 had to be used as  a basis for the Chinese draft regulation, these 
two instruments still differed in the following points: (i) approximately 70% of the test items 
proposed in the Chinese draft regulation did not conform to the relevant international standard; 
(ii) approximately 50% of the test items were not specified in the IEC62133; (iii) while the 
remaining 20% test items were identical to those specified in the IEC standard, the test procedures did not conform to IEC62133; (iv) the Chinese draft regulation contained test items 
that were not included in the notified document; and (v) given that the Chinese draft regulation 
should only cover single cells and assembled batteries, the inclusion of requirements for the 
circuitry of electronic devices was not appropriate. Furthermore, Japan believed that the objective of securing safety of electronic devices should be  achieved through safety regulations for electronic 
devices and not through those for lithium ion cells and batteries. 
3.5.  The representative of the Republic of Kore a highlighted that Korea had a similar regulation 
for lithium ion cells and batteries used in electronic equipment, which was fully aligned with 
relevant international standards. He pointed out that the Chinese requirements for markings and 
test methods regarding overcharge tests (Article  6.3), temperature cycling (Article 7.2), and 
thermal abuse (Article 7.8) differed from the corresponding international standards and had to be harmonized. Additionally, given that the Chinese dr aft regulation included requirements that were 
not specified in international standards, he as ked China to explain the scientific rationale and 
background to introduce those requirements. Kore a thanked China for the bilateral discussion in 
which the representative of Korea was informed that IEC62133 was being revised. However, given 
that the revised international standard would be published in June 2016, he requested China to 
harmonize the draft regulation with IEC62133 or , alternatively, recommended implementing the 
Chinese regulation after the revised international standard was published. Finally, Korea requested 
China to clarify ambiguous provisions of the draf t regulation, such as the safety requirement for 
system protection circuit (Article 11) and the requirement of testing to verify consistency (Article 12). 
3.6.  The representative of China explained that  the Chinese standard was drafted in order to 
protect the safety and health of consumers. In 2008, an ad hoc working group was established to 
develop the standard. Members of this working gr oup included more than 40 domestic and foreign 
lithium producers and scientific research institutes. Within three years, a final version of the draft 
standard was formulated. Addressing the concern that the Chinese standard was not in accordance 
with IEC62133, she noted that China had adopted a standard (GB/T28164 2011) identical to IEC62133; and that the standard under discussi on supplemented and improved the GB/T28164-
2011. She referred to similar cases found with other Members, such as the relationship between 
the IEC62133:2002 and the Japanese standards JIS C8712:2006 and JIS C8714:2007. Due to the 
different scope of application, the Chinese standard did not fully correspond to IEC62133. Instead, the Chinese standard adopted the relevant criter ia of IEC62133, when appropriate, and improved 
this international standard according to the characteristics of lithium batteries. In order to 
illustrate the effectiveness of the Chinese standard, she said that a number of proposals based on the national standard had been adopted by the IEC. 
3.2.2.2  Russian Federation – Measure affe cting import of Ukrainian dairy products. 
3.7.  The representative of Ukraine recalled that  on 7 April 2014, the Russian Federation imposed 
an import ban of dairy products on six Ukrainian producers, based on alleged incompliance with 
the requirements prescribed by the Russian technical regulation on milk and dairy products, 
adopted on 16 June 2012. He said that the measure was introduced suddenly and in a non-transparent manner, as it was not notified to the Ukrainian authorities, except for a short notice published on the website of the Russian Federal Service for Supervision of Consumer Rights 
Protection and Human Well-Being. Moreover, the Ukrainian producers had not received any 
documents regarding the results of the tests co nducted by the Russian authorities and were 
unaware of the details of alleged non-compliance with the Russian regulation. He also noted that 
the six Ukrainian producers had certificates of co nformity with the requirements of the Russian 
technical regulation, and that the import ban also affected producers of the occupied territory of G/TBT/M/63 
 
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  the Autonomous Republic of Crimea. Ukraine considered that the Russian measure was 
inconsistent with the non-discrimination principle contained in Article 2.1 of the TBT Agreement, and was unnecessarily trade restrictive, in viol ation of Article 2.2 of the TBT Agreement.  
3.8.  The representative of the Russian Federati on said that the import suspension of dairy 
products applied to five Ukrainian companies and did not constitute a general import ban on 
Ukrainian dairy products. More than twenty Ukrainian companies continued to export dairy products to the Russian Federation. The suspension was introduced due to inconsistencies of these 
products with the relevant Russian technical regulation, in particular regarding requirements on 
fat, proteins and moisture content. This was a TBT-compliant measure that was introduced in order to protect consumers and prevent deceptive practices. He explained that the measure was not notified to the TBT Committee because it was an implementing measure taken under an 
existing technical regulation.  
3.2.2.3  Thailand – Draft Notification of the Alcoholic Beverages Control, Re: Rules, 
Procedure and condition for Labels of Al coholic Beverages, issued under B.E. 
3.9.  The representative of Canada said that while her delegation recognised and supported 
Thailand's right to implement regulations aimed at protecting consumers' health and safety, and at 
providing them with adequate information, Canada was concerned that this proposed measure 
would be more trade restrictive than necessary to meet such objectives. Canada noted that 
Articles 2(2) and 3(1-6) of the proposed rules prohibited the use of wine labels that contained images of athletes, artists, singers or cartoons as well as messages affiliated with sport or music among other activities. She explained that some Canadian wine labels portrayed depictions of 
athletes, artists and singers, and other artistic depictions which may be considered cartoons. She 
a l s o  c l a r i f i e d  t h a t  C a n a d i a n  w i n e  l a b e l s  w e r e  n o t  i n t e n d e d  t o  a p p e a l  t o  c h i l d r e n  o r  p r o m o t e  irresponsible alcohol consumption, and that Canada had not witnessed any correlation between the 
sale of products labelled with sport figures or cartoon-like images with an uptake in youth or 
irresponsible drinking. She enquired about the me aning of "cartoon" under the proposed rules, 
asked what studies suggested that such labelling constraints would help achieve Thailand's policy 
objective, and questioned whether Thailand had considered less trade restrictive alternatives. 
Finally, Canada reminded Thailand of the spirit of the "APEC Wine Regulatory Forum", which was 
to eliminate unnecessary technical requirements and impediments to the trade of wine. 
3.10.  The representative of the European Union noted that the definitions of "label" and 
"container" set out in Article 1 were not in line with the CODEX STAN 1 1985 and asked Thailand 
to clarify the reasons for such deviation. He also noted that Articles 2(1) and 3(4), related to warning messages, were ambiguous and invited Thailand to adapt the wording of the draft 
regulation to that used under the existing advertising notification. The EU also raised concerns 
regarding the administrative complexity of the label approval process, which was intended to be dealt with by two separate government agencies. The EU asked for clarification regarding the 
division of tasks and responsibilities between th e agencies, and enquired about unnecessary delays 
in the approval of goods for free circulation. Finally, the EU expressed concerns about the time frame provided for compliance and asked Thailand to allow the sale of all products existing on the market until exhaustion of stocks. 
3.11.  The representative of Mexico echoed the views expressed by Canada and the EU and 
expressed her delegation's concern with the possibility that the proposed measure' had 
inconsistencies with the fundamental TBT principles of transparency and proportionality as well as 
certain provisions of the TRIPS Agreement. With respect to these IP-related concerns, she 
informed that they would be also raised before the TRIPS Council in due course. She requested Thailand to fulfil its WTO obligations and seek less trade restrictive alternatives to fulfil the 
measure's objectives. In this respect, she expressed the view that certain new labelling 
requirements contained in the draft regulation may not help Thai citizens obtain adequate information regarding the impact of the consumption of alcoholic beverages.  
3.12.  The representative of New Zealand recognised that the current draft regulation was less 
trade restrictive than the one submitted in 2010. However, New Zealand was concerned that 
Articles 2 and 3 of the draft were open to interpretation, which may lead to uncertainties as to whether certain labels were consistent with the regulation. New Zealand enquired whether the use 
of a trademark, and of a message certifying that an  alcoholic beverage was of a particular quality, 
standard or grade, would be permitted. New Zealand also asked for clarity regarding the G/TBT/M/63 
 
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  interpretation of the provisions on pictures of at hletes, artists and singers, and the definition of 
"recreation". She positively noted that the draft regulation allowed labels used before the entry into force of the regulation to be used for a pe riod of 180 days after the regulation came into 
force. However, she was concerned that the period may not be appropriate for alcoholic beverages 
with a longer shelf life and asked Thailand to consider extending it. 
3.13.  The representative of Thailand thanked Canada, the EU, Mexico and New Zealand for their 
comments, and assured them that their comments were going to be forwarded to the Department 
of Disease Control of the Ministry of Public Health. 
3.2.2.4  China – Regulations for the Supervis ion and Administration of Medical Devices 
(Order No. 650 of the State Council) (G/TBT/N/CHN/1022, G/TBT/N/CHN/1023, 
G/TBT/N/CHN/1024, G/TBT/N/CHN/1025, G/TBT/N/CHN/1026, G/TBT/N/CHN/1029) 
3.14.  The representative of Canada expressed his delegation's concerns with the far reaching 
effects of the measure on the medical device industry in China as well as foreign suppliers of these 
products. He noted that a number of draft administrative measures, notified in April and May 2014 
and designed to facilitate the implementation of Order No. 650, failed to illuminate exactly how 
interested parties would be affected. Canada asked China whether, under the draft measures, imported medical devices must undergo product testing and clinical trials in China.  In this respect, 
Canada reminded China that, in order to facilit ate trade, it was important to avoid unnecessary 
and duplicative testing and clinical trials as they could result in additional time and expenses being 
incurred by medical device exporters wishing to enter the Chinese marketplace. Canada also asked China to confirm whether testing done by accredited foreign entities could be also recognized. He 
said that Canada was also concerned with the fact that China's regulations apparently required 
foreign manufacturers to have marketing approval in the country in which they were headquartered prior to receiving marketing approv al in China. This requirement, he said, was 
problematic for Canadian exporters who may not necessarily choose to seek approval domestically. 
In addition, Canada requested China to clarify wh ich standards companies were required to meet 
with respect to Good Manufacturing Practice (GMP ) requirements for medical devices. For example, 
would China accept internationally recognized quality management standards (ISO 13485) or US 
Food and Drug Administration (FDA) GMP requirements? Finally, Canada expressed surprise at the fact that China notified such important regulatory changes with a limited comment period of only 30 days. Canada urged China to notify any amendments to the regulations or draft administrative 
measures for the recommended 60 day comment period.  
3.15.  The representative of the European Union welcomed the efforts of the Chinese authorities to 
amend the regulations on medical devices and the constructive dialogue between Chinese and EU 
authorities in this matter. He said that the EU nevertheless still had some concerns with the 
measure. He noted that all medical devices market ed in China (whether already registered in the 
country of origin or not) needed to comply with comprehensive Chinese authorization 
requirements. He also noted the requirement for the registration of medical devices in their 
country of origin. The EU did not understand the rationale for these requirements and considered 
them unnecessary and prone to create additional de lays for placing products in the Chinese market 
without any added patient benefit. As regards the Electromagnetic Compatibility (EMC) testing, he 
recalled that in previous meetings China had informed the Committee that the Chinese standard 
on EMC was identical to the IEC one. In this context, the EU reiterated the request that the CFDA accept test reports from foreign laboratories accredited by accreditation bodies who were members 
of ILAC, as an alternative to in country testing in China. This would avoid unnecessary duplication 
of testing, as medical devices imported into China were already tested in accordance with the IEC standard. It would also ensure that there was no disruption in the importation of medical devices 
into China due to a lack of necessary infrastructure to perform the EMC testing. In addition, and 
concerning the format of the registration certificat e, the EU considered that the certificate should 
exclude the documentation on "Product Technica l Requirements", which might be confidential. 
Finally, the EU asked the Chinese authorities to provide for a transitional period from six to twenty 
four months, due to the major changes introduc ed by the new provisions. Moreover, the new 
measures should not be applied retroactively. 
3.16.  The representative of the United States a ssociated herself with the concerns expressed by 
Canada and the EU. The US was particularly concerned with the fact that the measure did not 
provide sufficient transition periods for US industri es to fully adjust to the many new requirements 
it introduced, especially for Class I medical product conformity assessment procedures. She said G/TBT/M/63 
 
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  that for such devices the US industry was requesting that a transition period of two to three years 
be provided so they could make the changes needed to comply with the measure. She also said that the US was interested in understanding how China, after taking into consideration industry comments, determined the length of the transiti on period. Further, the US was concerned that 
Order No. 650 could create significant obstacles to trade through its seemingly unnecessary 
indigenous clinical trial requirements. In this respect, she asked how the comments submitted by US industry to CFDA were being considered so as to ensure the clinical trials requirements would 
not bring undue costs to these industries and delay Chinese patients' access to life saving medical 
technologies. 
3.17.  The representative of China informed that the CFDA was still receiving and considering the 
comments from Members on these notifications. 
3.2.2.5  Brazil - Higher Risk Medical De vices Good Manufacturing Practice (GMP) 
Certification (G/TBT/N/BRA/564) 
3.18.  The representative of India expressed concer ns with the procedures laid down in Resolution 
No. 11, published in March 2009, which, as from 1 May 2010, requires health products considered 
as having a "higher risk" to present a certificate at the time of their registration proving compliance with Brazil's Good Manufacturing Prac tices (GMP certificate). He noted that ANVISA 
would be responsible for issuing these GMP certificates on the basis of inspections conducted by 
ANVISA at the production facilities. He said that India's traders found this certification process time consuming and expensive, reportedly costing more than USD 20,000, with an approval timeframe of as long as four years. India asked Brazil to explain why such as process should not be 
considered more trade restrictive than necessary under the TBT Agreement's applicable disciplines. 
Additionally, he noted that certificates of confor mity with International Standard ISO 13485 were 
no longer accepted in Brazil for the purpose of this new GMP certification scheme. In this respect, 
he asked Brazil to indicate the scientific justification for deviating from ISO 13485, an 
internationally accepted standard dealing with Quality Management System for all types of medical devices, whether with lower or higher risk. India also asked Brazil to again accept ISO 13485.   
3.19.  The representative of Brazil said that the new ANVISA Resolution 15/2014, on good 
manufacturing practices certification for higher risk devices, replaced the previous measure on this 
matter, Resolution 25/2009. This draft measure wa s notified to the Committee during the public 
consultation period (notification G/TBT/N/BRA/564), so that Members could be acquainted with it 
and make comments. He explained that the new Resolution addressed a number of concerns 
previously raised by Members in past sessions of this Committee, including by improving the procedures for obtaining the certification of Good Manufacturing Practices (GMP), thus reducing 
processing times. He also highlighted the fact that the new regulation exempted lower risks 
products (classified as "class I" and "class II") from the manufacturing certification formalities, while maintaining the requirements of efficiency and safety that were necessary for registration. 
Due to the simplification in the procedures, he sa id that it was expected that a significant number 
of companies would benefit from lower processing  times. As regards requests for registration, 
revalidation and modification of higher risks products (classified as "class III" and "class IV"), he explained that under the new measure manufacturers would no longer need to wait for the 
issuance of GMP certification in order to have the analysis process started. In other words, product 
analysis could be initiated once the certification request was made, provided relevant documentation was presented. Brazil also highlighted that, along with its counterparts from other 
WTO Members, ANVISA – the Brazilian health surveillance agency – was part of the "Medical 
Device Single Audit Program" (MDSAP), a working group within the "International Medical Device Regulators Forum" (IMDRF). This initiative aimed at harmonizing models of inspection reports.  In 
this sense, the new Regulation allowed for the us e of third party inspection reports, within the 
scope of specific programs recognized by ANVISA. Interested companies would then have the option to use the services of MDSAP accredited certifying bodies in order to prepare inspection reports to be submitted to ANVISA. Brazil conclude d by emphasizing the importance it attached to 
confidentiality agreements between the health authorities of Members, an essential tool that 
enabled them to exchange inspection reports. G/TBT/M/63 
 
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  3.2.2.6   United States - Formaldehyde ; Emissions Standards for Composite Wood 
Products; Third-Party Certification Framework for the Formaldehyde Standards for Composite Wood Products (G/TBT/N/USA/827-828) 
3.20.  The representative of Indonesia said that while his delegation recognized the US' right to 
protect human health and the environment, it was nonetheless concerned with certain aspects of 
the US Environment Protection Agency (EPA)'s proposed rules to implement the Formaldehyde 
Standards for Composite Wood Products Act, entitled Formaldehyde Emissions Standards for 
Composite Wood Products and Third-Party Certification Framework for the Formaldehyde 
Standards for Composite Wood Products (notified in G/TBT/N/USA/827-828). One concern related to the EPA proposal that the formaldehyde emission standard would be applied respectively to: (i) hardwood plywood (maximum 0.05 ppm); (ii) me dium density fibreboard (maximum 0.11 ppm); 
(iii) thin medium density fibreboard (maximum 0,13 ppm); and (iv) particleboard (maximum 0,09 
ppm). In this respect, Indonesia asked the US whether the standards would also apply to the 
softwood plywood and, if it did not, whether Indone sian authorities were afraid that this technical 
requirement may lead to any discriminatory treatmen t. Further, given that the proposed technical 
requirement's objectives were human health as well as environmental protection, Indonesia also asked the US to explain the basis for the EPA allowing the use of different standards for different 
products. With respect to Conformity Assessment Procedures, Indonesia asked the US to explain 
the relation between the proposed standard and the requirements set up by the California Air 
Resources Board (CARB) Airborne Toxic Control Measures (ATCM). Given the similarities on testing parameters between these two standards, would the latter replace the former? If this was the 
case, would there be a transitional period? Indonesia was also concerned with the EPA's proposal 
product testing should be carried out once every three months. He expressed Indonesia's concern about the possibility that this requirement woul d create unnecessary burdens for producers, and 
asked US's views on the cost and transparency implications of such certification and testing 
process. Finally, he expressed his delegation's concern that the requirement that certifications must be conducted by third parties/agents located in US, as mandated in paragraph 770.7 of the 
EPA regulations (G/TBT/N/USA/828), would not only become a burden to related industries, but 
may also cause inefficiency as double certification may occur. 
3.21.  The representative of the United States ex plained that since it had proposed these rules on 
10 June 2013, which included an initial comment period of 60 days, the EPA had twice granted 
extensions to public comment periods for both proposals, as requested by numerous commenters, 
by noticed in the Federal Register. The Formal dehyde Emissions Standards for Composite Wood 
Products proposed rule was extended on 23 July 2013 and 21 August 2013 and closed on 9 
October 2013. In addition, she said that the EPA, on 8 April 2014 reopened, until 8 May 2014, the 
comment period for the implementation rule to try to obtained additional public input regarding potential modifications to the Agency's proposed treatment of laminated products. Further, she 
explained that the EPA also announced a public meeting, held on 28 April 2014, which provided 
the opportunity for further public comment on this set of issues. Then, based on input from public meeting participants, the EPA, on 9 May 2014, extended the comment period related to the treatment of laminated products under the re gulation until 26 May 2014. Comments submitted to 
date on this proposal could be found at docket  identification number EPA HQ OPPT 2012 0018, 
entitled Formaldehyde; Formaldehyde Emission s Standards for Composite Wood Products. She 
also informed that the Third Party Certification Framework for the Formaldehyde Standards for 
Composite Wood Products proposed rule was extended on 23 July 2013 (78 FR 44090) and 21 
August 2013 (78 FR 51696), and closed on 25 September 2013. Comments submitted to date on this proposal could be found at docket identification number EPA HQ OPPT 2011 0380, entitled 
Formaldehyde; Third-Party Certification Framework for the Formaldehyde Standards for Composite 
Wood Products. In this regard, she remarked th at, despite these many opportunities to provide 
comment in the development of these rules, the US  Inquiry Point and EPA confirmed that they had 
not received any written submissions from Indonesia. The EPA was carefully considering all 
comments as they worked to develop final rules. Therefore, the Agency would be still considering 
the issues, including those raised in comments. She said that these issues, and many others, 
would be addressed when the final rules were published; including a comprehensive response to 
comment document that would be placed in the dockets for the final rules. Finally, she said that 
additional information on these rules were still available in the US Government website both for proposed rule on the Economics Assessment for the Formaldehyde Emissions Standards for 
Composite Wood Product  as well as for the proposed rule on The Economics Assessment for the 
Third-Party Certification Framework for the Formaldehyde Standards for Composite Wood G/TBT/M/63 
 
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  Products.  She concluded by informing that that The Economics Assessment for the final rule would 
be available in the above referenced do cket when the final rules were issued. 
3.2.2.7  European Union - Regulation (EU) No 1169/2011 of the European Parliament 
and of the Council of 25 October 2011 on the provision of food information to consumers 
establishes the general principles, requirem ents and responsibilities governing food 
information, and in particular food labelling 
3.22.  The representative of Indonesia said that this EU food labelling measure should balance its 
environmental and health objectives with the obligation of not being unnecessarily trade 
restrictive. In this respect, Indonesia asked th e EU to provide the risk assessment or impact 
analysis it had made on the implementation of this regulation. He also urged EU authorities to consistently monitor the implementation of this regulation so as to prevent unfavourable excessive 
practices by the EU companies that could result in discrimination against particular products, such 
as Indonesian palm oil. 
3.23.  The representative of Malaysia expressed the interest of the Malaysian Government on this 
matter. 3.24.  The representative of the European Union re called that this EU Regulation was notified to 
WTO in April 2008 under G/TBT/EEC/191, and that, after the legislative procedure, was published 
in the EU Official Journal on 25 October 2011. He explained that the new requirements under this 
Regulation, which changed existing legislation on food and nutrition labelling, would apply from 13 
December 2014, except for the obligation to provid e nutrition information, which would only apply 
from 13 December 2016. He informed that the European Commission had produced, and updated 
regularly, a question-and-answer document to help food business operators to comply with the 
Regulation requirements and that the EU is ready to address any question Indonesia might have at 
bilateral level. 
3.2.2.8  Colombia - Draft Ministry of Commerce, Industry and Tourism Decree 
"Restructuring the National Quality Subsys tem and amending Decree No. 2269 of 1993" 
(G/TBT/N/COL/201) 
3.25.  The representative of Mexico understood the updating and amendments introduced by the 
draft Decree were meant to make clearer the Colombian framework for conformity assessment, 
technical regulations, accreditation, metrology, designation and market surveillance. She noted that Title III of the draft Decree specified three leve ls of risk for the preparation and issuance of 
technical regulations: (i) "moderate"; (ii) "medium"; and (iii) "high". Mexico was particularly 
concerned with the clarity of the criteria for th e distinction between the "moderate risk" category 
and the other two risk types, which may lead to confusion. In the same sense, she said that while 
the "medium" and "high risk" levels referred to specific conformity assessment schemes, labelling 
was a type of requirement for which conformity was assessed via inspection. However, there were technical regulations that established labelling requirements which did not necessarily concern 
"moderate" risks, for example health warnings or  sanitary requirements, which were implemented 
by means of labelling. In addition, Mexico's author ities noted that it was also necessary to clarify 
the risk associated with technical regulations that established different types of requirements, including those concerning safety and labelling, as it was not obvious which level were applicable. 
Mexico thus considered that the way the draft measure dealt with the criteria for "high risk" level 
may not be in accordance with the basic principl es of the TBT Agreement relating to conformity 
assessment procedures. This was so, said Mexico, because the establishment of this "high risk" 
category would result in the need of having a system of "double certification", that is, one 
certificate from a foreign body recognized under multilateral recognition arrangements, and another certificate issued by a third party. In this respect, she requested Colombia first, to explain 
the purpose of the draft Decree as well as the reasons why it was necessary to define, a priori, the 
risk level of technical regulations in light of the legitimate objective that Colombia sought to achieve by issuing such legislation. Second, she requested Colombia to explain the reason why it had chosen that particular parameter for determining the type of risk in the preparation and 
issuance of the technical regulation. Third, she requested Colombia to remove the possibility 
regulatory entities currently had in the draft Decr ee of not automatically accepting the results of 
conformity assessment procedures issued by conformity assessment bodies that were accredited in 
other countries and were party to multilateral re cognition arrangements. Mexico also asked for the 
inclusion of a transitional period of six months for the entry into force of the draft Decree, G/TBT/M/63 
 
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  following its publication in the Official Journal of Colombia. Finally, she requested an official reply 
to the comments already submitted by Mexico. 
3.26.  The representative of Japan asked Colomb ia to confirm whether, after the amendment to 
the Decree, its National Quality Subsystem (NQS) would cover safety related automobile parts and 
components with respect to the conformance certification requirement. If this were the case, Japan 
then requested Colombia to ensure that the conformance certification requirement for such 
products to be equivalent to those currently im posed under other existing laws and regulations. 
Specifically, [the registration and sale][the registration for marketing approval ] of automobiles 
should be permitted, as they were under the current certification system, by way of: (i) submission of a certificate of conformance  to the current Colombian laws and regulations; or (ii) submission of a certificate of conformance to relevant international standards. In this respect, he 
recalled that Colombia had already imposed conformance certification requirement for safety 
related automobile parts and components under the current certification system. Japan understood that the objective pursued by the amended NQS was the same as that of the current certification 
system. In this respect, as noted by Mexico, Japa n was concern with the fact that the draft decree 
would result in the duplication of certification of conformance requirements. Furthermore, if the NQS were to be amended to introduce a unique and exclusive certification system compared with 
the international standards, there would be co ncern from the viewpoint of the international 
harmonization of the vehicle regulations.  
3.27.  The representative of Colombia thanked Mexico and Japan for their comments and clarified 
that the draft was not seeking to do anything other than incorporate the best practices with 
respect to technical regulations, conformity assessment and metrology. He said that Colombia 
would discuss these issues bilaterally with the co untries concerned in the margins of the meeting. 
3.2.2.9  Ecuador - Draft Technical Regulation of the Ecuadorian Standardization Institute 
(PRTE INEN) No. 189: "Labelling of alco holic beverages" (G/TBT/N/ECU/243) 
3.28.  The representative of the United States firstly thanked the delegation of Ecuador for the 
very constructive bilateral meetings that had taken place during the week. She continued by 
saying that the US concerns on the conformity  assessment aspects of this measure would be 
addressed later in the agenda under "Ecuador - Resolution establishing the "General conformity assessment 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 marketed goods subject to Ecuadorian technical regulations". The US was concerned with the 
requirement that the name of the importer of al coholic beverages be placed in the country of 
origin, with no flexibility for placement in customs bonded warehouses via the use of 
supplementary labels (stickers). She asked if Ecuador had considered other less trade restrictive 
measures. 
3.29.  The representative of Ecuador said that the measure responded to a customs regulation 
implemented by SENAE in order to prevent the illegal entry of liquor into the country. Liquors were 
among the products with the highest rate of smuggling in Ecuador, particularly due to the low cost of the product in neighbouring countries. He explained that this measure was complemented by other policies implemented by the Ecuadorian health authorities, such as a recently launched 
campaign to reduce the consumption of liquors, in general, and raise awareness with respect to 
the particular health risks associated with the consumption of adulterated liquors. He said that one of the mechanisms considered by regulators was the ability to provide accurate information to 
consumers about the origin of beverages as well as details of those engaged in the manufacture 
and importation, through the labelling of the products. Accordingly, he noted that the Ecuadorian Standards Institute had developed a draft Regulation RTE No. 189 which was notified to the WTO 
in April 2014, in which the labelling parameters of products were set. This draft Regulation 
required that labels should be printed or put di rectly on the package by the manufacturer in the 
country of origin. For imported alcoholic beverages, he also noted that labelling or re-labelling was 
not allowed in primary zone. The draft regulation was open to comments and reviews of trading 
partners in order to assess their impact and for further revision if necessary. G/TBT/M/63 
 
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  3.2.2.10  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) 
3.30.  The representative of the United States recalled that this proposed EU measure would 
amend an existing Council Directive that regulated the maximum dimensions and weights 
authorized in national and international traffic for certain vehicles. More specifically on the 
proposed changes, the US noted that Article 8 of the Directive would be revised to allow for exceeding the maximum lengths in cases where attachments were made to the rear of the vehicle so as to increase their aerodynamic characteristics. Additionally, Article 9 would be changed so as 
to make it possible to exceed the maximum length to allow the construction of tractor cabs 
improving the aerodynamic characteristics of vehicles and improving road safety. The US noted that while revised Article 9 appeared to provide some leeway for the introduction of aero nosed 
trucks, at the same time, paragraph 2 of this sa me revised provision included constraints for the 
enjoyment of this option, including the requirement that such tractors would only be acceptable if the "blind spot" under the windscreen was reduced (compared to current tractor designs).  
3.31.  She recalled that from previous bilateral discussions between the US and the EU on this 
matter, the US had understood that the Commission would be developing test methods and technical specifications for type approval thro ugh an amendment Directive 2007/46/EC, or through 
a delegated act. The US remarked that, while the proposal allowed for derogations from the fixed 
dimensions, it still lacked details for how to eval uate an aerodynamic design of the cabin. The US 
was also concerned that the technical requirements developed by the Commission to support the proposal's requirements could unnecessarily restrict ex port to Europe of US trucks that were at the 
same time somewhat longer but more aerodynamic and fuel-efficient. She also said that the US 
was interested in any technical specifications developed for type approval that included the ability to use an aerodynamic cabin to qualify for such derogation (Art. 9 of the Commission proposal). 
She then expressed various additional questions he r delegation still had with respect to various 
aspects pf the proposed measure.  
3.32.  First, she recalled that the new Article 9.1 of the Commission's proposed revision to 
96/53/EC stated that "[t]he main purpose of these exceedances was to allow the construction of 
tractor cabs to improve the aerodynamic characteristics of vehicles or combinations of vehicles, 
and improving road safety." While the US believed that this revision had the potential to improve 
environmental performance of trucks while also facilitating expanded trade opportunities, it 
however remained concerned that conditions laid down in Article 9.2 - in particular Article 9.2(i) – 
would result in the imposition of design based criteria on tractor cabs that would exclude products that otherwise would meet the Commission's environmental and safety objectives. She thus 
asked: (a) would manufacturers be able to meet the visibility objectives expressed in Article 9.2(i) 
through technological means other than specific designs? How would the criteria be balanced against possibly competing objectives, such as increased aerodynamic properties?; (b) how would the conformity with Article 9.2(ii) be assess ed and balanced, both with the aerodynamic 
performance of a tractor as well as among the various aspects of damage reduction (i.e. balancing 
the need to reduce damage to the tractor cab (and  driver) itself with the competing need to avoid 
damaging other vehicles involved in a collision); What were the types of safety data that the 
measure would be relied on? 
3.33.  Second, she asked whether the Commission would publish the text of any draft delegated 
acts referred to in Article 9.2.5, so that interest ed stakeholders could comment or offer alternative 
ways to meet the policy objectives. 
3.34.  Third, with respect to Annex I, Article 1.5 of the current Directive, she asked the 
Commission to consider a more market based appr oach that would not unduly limit the designs of 
tractor cabs (specifically aero nosed traffic cabs). This was important because different types of 
trucks were used for different freight and distribution needs – operators would logically only use 
longer trucks on roads that could handle them.  Al ternatively, the US asked if a road signage could 
be used to indicate roads (e.g. signs containing small traffic circles) that were inappropriate or off 
limits to vehicles over a certain length. G/TBT/M/63 
 
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  3.35.  Finally, the US asked the EU to provide mo re information on DG Move's "informal group of 
70 companies" that discussed the details of th e delegated and implementing acts under the 
proposed revision of 96/53/EC. In this respect,  she asked whether there were any arrangements 
for companies that did not have a presence in Brussels to monitor and provide input into these 
discussions. 
3.36.  The representative of the European Union informed that this European Commission proposal 
was adopted on 15 April 2013 and only recently, on 15 April 2014, the Parliament adopted its 
general position, which was followed by the Co uncil position on 5 June 2014. The legislative 
process, which would entail discussions between the European Parliament, the Council and the Commission, would continue after the 2014 summer break. The Commission was well aware of the US concerns and said that they had to be fed in this process. He also explained that, regarding the 
questions on the implementation of Article 9.2,  as drafted in the Commission proposal, the 
Commission should receive the mandate to adopt de legated acts to complement the requirements 
which the new tractor cabs must meet; these shall take the form of technical characteristics, 
minimum levels of performance and design constraints. These delegated acts would also establish 
the procedures to issue the certificates regarding aerodynamic performance. The EU explained that it was, however, premature to engage in discussi ons on the content of the implementing measures 
in this Committee when the main text of the Directive had still not been decided upon. The EU 
remained open to discuss these issues as they would be further developed. The EU also emphasised the fact that technical content of the delegated acts foreseen under Articles 8 and 9 would be defined by an expert group which had already been created. This group, which was open 
to any company willing to apply, already had 70 participants, including one US Company providing 
rear aerodynamic devices (Article 8). Companies which were not based in the EU would need to subscribe to the group and received the docume ntation by mail in order to provide written 
comments; alternatively, such non-EU based comp anies could also choose to be represented by 
any business association taking part in the group. However, participation to the group remained subject to the agreement of the European Commission. Moreover, regarding the possible 
modification of Article 1.5 of Annex I of the curre nt Directive, the EU noted that no modification 
was foreseen in the near future. This criterion had been defined taking into account the size of the road infrastructure in EU member states. In this sense, the EU pointed out that some member states already had difficulties coping with vehicles  complying with the requirements of this Article, 
as their infrastructure was not always large enough. Finally, the EU also remarked that specific 
length limitations already existed (Article 7 of Directive 96/53/EC) for certain geographical areas, such as villages, national parks or mountains. 
3.2.2.11  Kingdom of Saudi Arabia - Certific ate of Conformity (not notified) and GSO 
marking requirements for toys 
3.37.  The representative of the United States expressed her delegation's appreciation for GSO's 
willingness to meet with the US bilaterally in Geneva, and for engaging in a frank discussion on the 
significant challenges involved in implementing systems of regional integration and coordinating seven member state national regu latory regimes in accordance with WTO Agreements. She noted, 
however, that the US had some concerns with respect to the lack of uniformity in transparency in 
the development of regional technical regulati ons and with the duplication of conformity 
assessment procedures – both regional and nation al being applied by some GCC members. The US 
also noted that the first technical regulation adop ted by the GCC was the Gulf Technical Regulation 
on Toys, notified in 2013 by Kuwait, Qatar, Saudi Arabia and Bahrain, but not by Oman and UAE. 
She mentioned, however, that the second GCC technical regulation, the Gulf Technical Regulation on the "G" Mark, had never been notified to the WTO. The UAE notified the Guidance Document on 
the Registration of Products Bearing the "G" Mark on 1 June 2014 and the comment period was 
open until 4 August 2014. Both documents appear ed had been approved by the GSO Board of 
Directors in 2009, and the measures published on the GSO website on 15 December 2013. In this respect, the US recalled the TBT Agreement's tran sparency obligations, and noted that while some 
GCC states had notified one or two of the measures, not all had. Five of these seven states had 
notified the Gulf Technical Regulation on Toys, and one of seven notified the Guidance Document for the Technical Regulation on the "G" Mark, while none had notified the Technical Regulation on 
the "G" Mark itself. Further, the US industry reported that some GCC Members may be 
implementing their own additional conformity a ssessment requirements, in addition to the "G" 
mark requirements, such as Saudi Arabia's Certificate of Conformity. She sought clarification on 
the status of this issue and stressed that the prec ise requirements themselves must also be clear, G/TBT/M/63 
 
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  definitive, and drafted in a way that would avoid conflicting information. The US asked Saudi 
Arabia when the "G" Mark requirement would enter into effect.  
3.38.  The US also expressed hope that any work at the GCC level would result in requirements 
that would be implemented in a consistent manner at the national level and that products would 
be mandated to test conformity with only one se t of requirements. Additionally, on the toy safety 
regulation, she noted that the GCC measure contai ned a requirement for a separate registration 
number for each toy model that was not found in any other country.  In this respect, she called 
Saudi Arabia's attention to the fact that registration numbers were typically assigned to a 
manufacturer.  Since the average toy company turned over about 75% of its inventory each year, the US believed that the burdens resulting from requiring a unique registration number per model could such that they would preclude many produc t s  f r o m  c o n t i n u i n g  t o  b e  o f f e r e d  i n  t h e  G C C  
market. Based on their productive bilateral discu ssion, the US requested follow-up discussions on 
whether the GCC was establishing procedures for eliminating potentially duplicative national conformity assessment requirements, such as the Saudi Certificate of Conformity or a voluntary 
Abu Dhabi Trustmark.  Finally, the US urged the GCC to consider the benefits and efficiencies to be 
found in relying on international systems of accreditation wherever possible.   
3.39.  The representative of the European Union supported the US comments and stressed the 
EU's appreciation for the technical harmonization efforts within the Gulf region. However, the EU 
also noted some inconsistency in the implementation practices of individual GCC states, an issue that the EU was also bilaterally discussing with them. 
3.40.  The representative of the Kingdom of Saudi Arabia thanked the US and the EU for the 
comments and asked that they be sent in written form so Saudi authorities could address them in 
due course. 
3.2.2.12  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) 
3.41.  The representative of the United States said that, as highlighted in the US interventions 
regarding previous versions of these requiremen ts, her delegation recognized and supported the 
objective of labelling products in official national languages in order to facilitate trade and protect consumers. However, the US remained concerned that these amendments appeared to deny the 
option of applying these labels while products were still in Indonesian Customs. Producers 
throughout the world had found that such "stickering" in Customs allowed greater flexibility and significantly reduced the costs for shipments destined for multiple markets with different national 
languages.  The US believed that this approach would meet the fundamental Indonesian language 
labelling requirements while preventing any unnecessary burdens on US and other Members' 
exporters. Finally, the US requested that Indone sia delay implementation of the new requirements 
so as to fully take into account the concerns of its key trading partners. 
3.42.  The representative of the Republic of Korea said that while his delegation supported 
Indonesia's efforts of protecting consumers, it was nonetheless concerned with certain aspects of 
the regulation's requirement that labelling be provided in Indonesian language. He noted that, 
under the measure, those labels containing product information should be understandable, and 
had to be embossed, printed or glued permanentl y on the goods and packaging. He explained, 
however, that, in practice, in order to attain the purpose of providing consumers with product 
information, labels could be affixed on products in various manners depending on products' 
features. For example, in case of a product which should provide much information, the size of its label would unlikely be small enough to be affixed on products and packaging permanently. 
Therefore, Korea was of the view that the Indone sian regulation of affixed mandatory labelling 
would be an excessive measure without considering the amount of information which would be differ from case by case.  Additionally, Korea rais ed concerns that this labelling scheme would lead 
to increased manufacturing cost thus resulting in higher product price for consumers. He noted 
that for electronics and information technology goods, which were developed by rapid innovation 
in technology, affixing stickers were the preferred and widely used labelling method. Hence, Korea requested Indonesia to allow for the possibility of fulfilling the labelling requirement by affixing 
stickers, and to provide Members with specific criteria of permanent sticker labelling. As the 
regulation was only notified to the WTO on 11 April 2014, and because this measure was expected G/TBT/M/63 
 
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  to be adopted and implemented by 25 June 2014 , Kore requested Indonesia to provide a grace 
p e r i o d  g r e a t e r  t h a n  6  m o n t h s  f r o m  t h e  d a t e  o f  a d o p t i o n  i n  o r d e r  t o  g i v e  a  s u f f i c i e n t  t i m e  f o r  manufacturers to adapt. 
3.43.  The representative of the European Union ec hoed the US concerns on this draft and recalled 
that it has recently submitted written comments to Indonesia on what it considered as a 
complicated and unnecessary barrier to trade. 
3.44.  The representative of Japan supported the comments made by previous delegations and 
invited Indonesia to ensure that the regulation was not more trade-restrictive than necessary. 3.45.  The representative of Indonesia explained that the labelling regulation was intended to 
provide consumers with correct, clear and truthful information on the products they buy. The 
Ministry of Trade issued Regulation No. 67 in 2013 in order to replace similar regulations issued, 
respectively, in 2009 and in 2010. He also informed that, based on comments received by some 
Members, Indonesia issued in June 2014 a revised version of the regulation under No. 10/2014. In this regard, he noted that the current regulations contained several improvements, such as: (i) an 
increase in the number of the products covered from 103 to 127; (ii) adjustments of HS codes; 
and (iii) a requirement for permanent labelling throug h embossed printing or firmly attached labels 
on the packages. He explained that importers or producers of products not listed in the attachment 
of the regulation may put labels in the Indonesian language, which was adjusted to the 
characteristics of the products. Those listed in the attachment of the regulations, and who had 
their products already distributed on the Indonesi an market, were granted a transitional period 
until 24 December 2014 so as to adjust to the required label. However, he said, for new products, 
the regulation would apply from 24 June 2014. Finally, he observed that some types of products 
were exempt 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 Director ate of Consumer Empowerment of the Ministry of 
Trade. 
3.2.2.13  Ecuador – Draft Technical Regula tion of the Ecuadorian Standardization 
Institute (PRTE INEN) No. 103: "Sugar  confectionery (G/TBT/N/ECU/123)  
3.46.  The representative of Panama raised concerns with conformity assessment procedures for 
these products, which had already been given accreditation in line with international standards. 
She thanked Ecuador for the bilateral meeting that had taken place and informed the Committee 
that her delegation would continue to work bilaterally with Ecuador on this issue. 
3.47.  The representative of Ecuador did not take the floor. 
3.2.2.14  Republic of Moldova – Tobacco (G/TBT/N/MDA/22) 3.48.  The representative of Ukraine noted that  the text of the proposed amendments to the 
"Tobacco Control Law" that were submitted to th e Parliament differed from the English translation 
provided in the TBT notification G/TBT/N/MD A/22. She reminded Moldova of the Committee's 
recommendation of allowing at least 60 days for comment and asked, given the nature of the amendments proposed, and their significant effect on  trade, that this be extended to 90 days. This 
extension, she said, should not delay the legislativ e process as the adoption of the amendments to 
Law No. 278-XVI was foreseen for the end of November 2014. She voiced several concerns with 
the proposed amendments. Firstly, they modified the Tobacco Control Law so as to require large graphic health warnings ("up to 75%") on the packaging of tobacco products thus creating 
consistency concerns both under the TBT and TR IPS Agreements. Such larger graphic health 
warnings were highly trade-restrictive as they left very little space for including trademarks. She thus asked Moldova to provide evidence that such large warnings were necessary and effective in 
protecting health. Secondly, the proposed amendments included a number of product 
requirements and labelling restrictions aimed at preventing misleading terms and labels, including banning colours, such as red and golden, and words such as "extra" and "slim". Products with a diameter of less than 7.5 mm would also be banned. She asked that Moldova explain what 
evidence it relied upon to determine that these were of a "misleading" nature. Thirdly, concerning 
the ban of ingredients and additives commonly used  in the manufacture of tobacco products, such G/TBT/M/63 
 
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  as menthol and vanilla, as well as "addictive ingredients or additives which have a potential of 
dependency", she asked Moldova to justify how this ban would protect human health. Finally, she asked if any alternative, less restrictive, trade measures had been considered and if so, why Moldova had chosen more trade restrictive measures. WTO Agreements, she said, did not restrict 
government efforts to ensure the health of their citizens, so long as positive, scientific evidence 
supported the proposed measures and such measures were not more trade-restrictive than necessary to achieve the stated health objective. She noted that, as Ukraine was the largest 
exporter of tobacco product to Moldova, it had substantial interest in ensuring that the proposed 
amendments were TBT-compliant.  
3.49.  The representative of the Republic of Moldova informed the Committee that this draft 
measure had been notified to the TBT Committee in accordance with transparency requirements. 
The relevant parliamentary committees were in the process of examining the amendments to the 
Law on Tobacco and Tobacco Products and this was st ill at a very preliminary stage. Any draft laws 
or amendments had to be passed in two read ings by the Moldovan Parliament. The very 
preliminary nature of the submission of the notification, he said, should be taken into 
consideration. He noted that the comment period had not yet closed and no comments or requests for bilateral consultations had yet been received. He requested Ukraine to submit their comments 
in writing. 
3.2.3  Previously Raised Concerns 3.2.3.1  European Union – Registration, Eval uation, Authorization, and Restriction of 
Chemicals - REACH (G/TBT/N/EU/73) (IMS ID 88) 
3.50.  The representative of China expressed concern with Commission Regulation (EU) No. 
1272/2013, published on 6 December 2013, which amended, with effect as from 27 December 
2015, the limit of concentration of Polycyclic Aromatic Hydrocarbon (PAH) to 0.5 mg/kg for toys, 
including activity toys and child care articles. Regarding the scientific justification for such limit 
change, China noted that, according to the draft re gulation notified by the EU in G/TBT/N/EU/73 
on 31 October 2012, 6 categories of consumer articles, including toys whose rubber or plastic 
components contained more than 1 mg/kg of any of the PAHs shall be prohibited from being 
placed on the EU market. China recalled that the EU had previously explained that the setting of 
this maximum PAH content had a strong scientific fo undation, and that the protection of children, 
as the most vulnerable segment of the population , had been considered when this value was set. 
However, without prior notice, the final Commis sion Regulation (EU) No 1272/2013, which was 
published in the EU Official Journal on 7 December 2013, stipulated that 0.5 mg/kg, rather than 1 mg/kg, shall be the maximum PAH content in the rubber or plastic components of toys. While the 
Chinese delegation recognized the sensitivity of toy products, China was not convinced of the need 
for such a substantial change in the final regulation. China requested the EU to provide scientific evidence and regulatory impact assessments (RIA ) justifying this change. Finally, turning to 
transparency, China understood that Commission Regulation (EU) No 1272/2013 constituted a 
substantial re drafting of the previously notified text. In line with the current discussion in the TBT 
Committee on "Coherent Use of Notification Formats" and, as the EU itself has proposed, Members should use the notification format "revision" to indicate that the notified proposed measure has 
been substantially re drafted prior to adoption or entry into force, and should normally open a new 
comment period. Therefore, China requested the EU  to use the format "revision" to notify WTO 
Members again and provide Members no less than 60 days for comments. 
3.51.  The representative of the United States sa id that, while sharing the goal of protection of 
human health and the environment, her delegati on was still concerned with the transparency, 
implementation burdens, and adverse impacts on SM Es as outlined in previous interventions on 
this measure. 
3.52.  The representative of Australia said that his delegation was still concerned with the volume 
of chemicals imported, irrespective of the hazard  they posed, was taken as a proxy for exposure. 
This policy subjected large imports of relatively benign substances to significant barriers to access 
the European market, which operated as a disincentive for exporters. Australia was further 
concerned that the implementation of REACH obligations was inconsistent and burdensome. Several EU member states had imposed costly inspection rules which fell for the most part on 
importers. In light of findings of the European Co mmission's recent review of REACH, Australia was 
interested in the practical steps the EU was taking to try to mitigate the impact of REACH on SMEs. G/TBT/M/63 
 
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  He suggested there may be other measures availabl e to manage the risks of industrial chemicals, 
which could achieve the EU's objective. For instance, screening on the basis of a chemical's potential risk to health and the environment would encourage continued access for chemicals of little regulatory concern and focus efforts on those chemicals with the greatest risk. 
3.53.  The representative of the European Union said that when G/TBT/N/EU/73 was notified on  
31 October 2012, the draft measure contained the lim it of 1 mg/kg for each of the 8 PHAs listed. 
The EU member states later made the decision to decrease the limit to 0.5 mg/kg for PAHs in toys 
and children's articles at the REACH Committee meeting of June 2013. He said the decision was 
taken according to the usual procedures provided  in the REACH regulation, and that the large 
majority of member states voted for the lower limit based on concerns about greater sensitivity of children and therefore a need for special protection . It was noted that the full transparency of the 
process was ensured, since the vote by member states only occurred more than 60 days after the 
expiry of the TBT notification comment period , and comments from Chinese authorities were 
discussed and considered. With respect to the Chinese request for scientific evidence and 
regulatory impact assessment justifying the change  to 0.5 mg/kg, the EU recalled that its 13 July 
2013 written reply to China contained extensive in formation in this respect. Nevertheless, he 
reiterated that the basis for the limit values derived from analysis by the European Commission 
and member states based on information provided in the report of the German competent 
authority for REACH in June 2010. The German repo rt provided an assessment that limits as low 
as 0.2 mg/kg for each individual PAHs should be established to ensure adequate protection, especially for children. Further assessment and discussions of the European Commission and 
member states, in which scientific uncertainties and analytical and practical considerations were 
taken into account, led to the adoption of the 0.5 mg/kg limit for articles intended for children, such as toys and child care articles. He said that  these values were adopted based on the generally 
accepted consideration that children displayed greater sensitivity to chemicals. Regarding the 
comments of Australia and the US on SMEs, the EU referred to previous responses detailed in the minutes of past meetings. 
3.2.3.2  India – Pneumatic tyres and tubes for automotive vehicles (G/TBT/N/IND/20 
G/TBT/N/IND/20/Add.1 G/TBT/ N/IND/40, G/TBT/N/IND/40/Rev.1) (IMS ID 133) 
3.54.  The representative of Japan expressed concern with Article 10.2 of the revised "Agreement 
for the Granting of BIS licence", under which only  foreign tyre manufacturers were required to 
provide a bank guarantee of USD 10,000. In this regard, Japan recalled that India had previously 
explained that the reason why the bank guarantee fee was not required for tyre manufacturers in 
India was because they were under the supervision of  the BIS. Similar to the deleted clause 6.3 of 
the previous agreement, this provision clearly had an impact on the competitiveness of tyre 
manufacturers depending on whether their plant was located inside of India or not, and he reiterated that this clause should be corrected. According to the information obtained from BIS, 
the bank guarantee was supposed to disburse expenses such as visiting costs of BIS persons for 
audit of overseas plants when any quality problems occurred with tyres manufactured in the overseas plants, or to compensate for the expens e of legal procedures conducted or following a 
breach of contract, such as non-payment of the marking fee. India had asserted at the last 
Committee meeting that bank guarantees for breach of contract were common international 
practice, and Japan requested that materials or documents be provided by India to this effect. Furthermore, he said that under this compulsory  standard the payment of the ISI Marking fee was 
required for all ISI marked tyres, including thos e which were exported outside the Indian market. 
Japan stressed that tyres exported outside of th e Indian market should be exempted. He recalled 
that during the last Committee meeting India had mentioned that the total payment structure of 
ISI Marking fee was equal to, or less expensive than, similar fees charged by other Members. 
However, said Japan, as of February 2014, when a certified factory applied for certification for a 
new tyre size, an additional certification fee per size of USD 90 was levied. In addition, since April 
2014, the renewal application fee of Rs500 had been  raised to Rs1,000. In light of this, Japan 
requested India to present evidence that the tota l payment structure of ISI Marking fee was equal 
to or less than similar fees levied in other Members. 
3.55.  The representative of the Republic of Kore a reiterated previous concerns that ISI Marking 
fees appeared to be significantly unjustifiable and unreasonable, given that they were levied on all 
tyres with the ISI mark regardless of their destin ation market, rather than only on tyres imported 
to India. Compared to similar marks issued by other countries, these fees were considerably 
higher for the ISI system, and were a signific ant barrier to trade. Korea urged the Indian G/TBT/M/63 
 
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  authorities to revoke or amend the requirement such that marking fees would be determined on 
the basis of importing country, not on ISI mark. Lastly, Korea asked why India required the USD 
10,000 performance bank guarantee for foreign manuf acturers only when breach of the license 
and civil liability problems could also arise with respect to domestic tyre manufacturers. Korea 
believed that this requirement clearly discriminated against foreign tyre manufacturers located 
outside India, and requested India to achieve the measure's stated objectives in a non-discriminatory and less trade restrictive manner. 
3.56.  The representative of the European Union once again asked that India reconsider its 
marking fee system, which currently applied to each ISI-marked tyre, and not only on those tyres 
which were actually imported into India. The EU requested that India remove the royalty fees, which were extremely burdensome and more restrictive than necessary; or at least to modify their 
calculation so as to limit them to tyres which were de facto  exported to India. Furthermore, the EU 
considered the USD 10,000 bank guarantee to be unjustifiably discriminatory because it only applied to foreign manufacturers. Pursuant to Article 3.4 of the BIS Agreement, it appeared that 
liability for the breach of the Agreement could alre ady be exerted on the authorized representative 
of the foreign manufacturer in India. India was therefore invited to explain the rationale for 
introducing a new bank guarantee when other legal means already existed to ensure compliance 
with the BIS Agreement, and therefore was asked to remove this provision. Finally, the EU asked 
India to confirm that it was now possible to renew licences for two or three years, without the need for additional plant inspection. 
3.57.  The representative of India said that "Pneumatic Tyres and Tubes for Automotive Vehicles 
(Quality Control) Order, 2009" was issued by Indi a on 19 November 2009, and came into force on 
13 May 2011. The Order applied to both domestic and foreign manufacturers, and prescribed quality standards for pneumatic tyres with the objective of ensuring safety of human life and 
vehicles. He explained that by virtue of this Orde r, pneumatic tyres could be imported in India only 
if they conformed to the specified standards and bore the Standard Mark of BIS. Foreign 
manufacturers desiring to export their goods to India were thus required to enter into an 
agreement with BIS for granting of the BIS license, so that those foreign manufacturers could use 
the BIS Standard Mark on goods to be exported to India while ensuring conformance to relevant Indian Standards. In addition, foreign manufacturers were required to furnish a bank guarantee of USD 10,000 in favour of BIS for due compliance with the provisions of the BIS Act, rules and 
regulations, and terms and conditions of the license. The bank guarantee was also intended to 
protect the BIS from any breach of terms and conditions of the license, and covered any civil liability that may arise during the period of the license or thereafter. He noted that bank 
guarantees were prevalent in international trade, specifically with regard to performance of 
contracts. India did not see any problem in main taining such bank guarantee requirement given 
that in case of breaches committed by domestic manufacturers the BIS could seek compensation 
through a court of law in India, while this would not be possible in case of breaches committed by 
foreign companies. A foreign manufacturer desiring to export pneumatic tyres to India had to ensure that the goods conformed to the specified Indian standards and were marked with the ISI 
Mark. For this purpose, the representative said the BIS charged a fee calculated on all the goods 
produced and marked with ISI. While some Members have requested that the fee be calculated 
only on those ISI marked goods which were exported to India, India did not understand the concerns expressed with the present calculation method, since as the owner of the ISI mark, the 
BIS was entitled to royalty fees on all the g oods marked with ISI. Moreover, there was the 
possibility that ISI marked goods initially sold in other markets could be later sent to India.  
3.58.  Finally, with respect to the pace of the certification process, he explained that India believed 
that BIS labs were managing their workload adeq uately. He noted various steps taken to expedite 
the granting of licences, and said that the time taken for processing applications had been reduced considerably. On the validity period of licenses, he informed delegations that under the BIS Certification Regulation 1988, a license once granted was extended from time to time, keeping in 
view inter alia the performance of the license holder. Therefore, there was no problem with 
extension of licenses, provided the licensee's perf ormance remained satisfactory and there was no 
breach of terms and conditions. G/TBT/M/63 
 
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  3.2.3.3  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) 
3.59.  The representative of Canada disagreed wi th India's blanket approach to testing in the 
telecoms sector as India's in-country security testing regulations for telecoms products would 
hinder or possibly even shut Canadian exporters out of the Indian market. While Canada appreciated India's security concerns, there were well-established international standards for evaluating the competencies of conformity assessment bodies, particularly ISO/IEC 17025 and 
ISO/IEC 17065. Furthermore, the International Laboratory Accreditation Cooperation (ILAC) and 
International Accreditation Forum (IAF) mutual recognition arrangements (MLAs) provided for peer review systems to ensure the competence of signatory accreditation bodies. She said recognition 
by India of foreign conformity assessment bodies accredited by signatories to the ILAC and IAF 
MLAs to test and certify to India's regulatory requirements would minimize the negative impact on companies wishing to export to India while at the same time providing assurance to India that the 
recognized conformity assessment bodies were competent. Finally, allowing accredited foreign 
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. 
3.60.  The representative of the European Union recalled past concerns expressed with this 
measure, including on the detailed product scope an d testing requirements, and the lack of testing 
capacity. He observed that the system did not ap pear to be ready for the implementation of the 
security clearance requirements as of 1 July 2014.  In light of this situation, he suggested that 
another postponement be considered, and that another year would be an adequate additional 
period of time to allow for full entry into force. The EU appreciated the efforts of Indian authorities 
to align the applicable Indian standards with the Common Criteria international standard, ISO/IEC 
15408. He also appreciated that specific aspects related to mobile telecom network elements 
which were not covered by the Common Criteria international standard, namely those developed by the 3rd Generation Partnership Project (3GPP), and the 3rd Generation Partnership Project 2 (3GPP2) would be taken into account when formulating relevant Indian standards. This was 
important for ensuring that India standards were aligned with relevant international standards, 
and the EU invited India to consider joining the ongoing standardization work in the 3GPP, which 
stemmed directly from the ITU, and in which the most important standardization organizations 
were already participating. 
3.61.  In relation to the testing procedures and the acceptance of foreign test results, the EU 
welcomed the earlier statement of India that test results of laboratories appointed by members of 
the Common Criteria Recognition Arrangement (CCRA)  would be accepted for the purposes of the 
required security clearance assurance, in line with the recent admission of India as a full certifying 
member under the CCRA. He sought confirmation of this point from India, and also enquired about testing for other security aspects not covered by the CCRA, such mobile telecom network elements 
covered by 3GPP standards. He requested that foreign laboratories holding accreditation from ILAC 
MRA signatories should be allowed to perform the required testing. He suggested that a certain margin should be allowed for telecom service provides to determine which of their vendors' 
products required formal testing and certification, and how to most effectively procure certified 
products. The EU also asked for clarification about testing modalities. It appeared that Indian authorities would favour batch testing of samples, which his delegation considered a burdensome 
testing modality. Instead, he suggested that initia l testing of a representative sample suffice, and 
that new testing only be required if there was a major hardware or software change affecting the information security of the product. He welcomed further engagement with Indian authorities with a view to developing workable testing methods and procedures reflecting international practice, 
which he believed was in the mutual interest of India and the EU and European industry. 
3.62.  The representative of the United States fu lly affiliated her delegation with the EU comments 
and expressed disappointment that India had not ye t articulated a plausible explanation of how in 
country testing in India was able to advance the objective of telecom security. The US further 
echoed the point made the EU concerning collaboration and engagement, in light of mutual interests of trade and meeting needs with re spect to importing equipment and exporting 
equipment. G/TBT/M/63 
 
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  3.63.  The representative of Japan supported the points made by the previous delegations and said 
that Japan was interested in a new Unified Access Service License Agreement. Finally, Japan 
requested that India ensure that its telecom regulations did not impede market access for foreign companies. 
3.64.  The representative of India reiterated that, due to the fact that telecommunication 
equipment was vulnerable to spyware and malware attacks, the in country security testing of 
telecom equipment had been mandated for national security reasons. For the purpose of security 
testing of telecom equipment, India believed that  the Common Criteria testing did not suffice, 
since it was limited to IT and IT related products. Moreover, as to process based testing, he said that Common Criteria largely addressed commercial security considerations, and not national security issues. When an IT product was used in  a telecom network, it became a telecom network 
element where functional or operational requ irements were governed by 3GPP or 3GPP2 
standards. In this regard, he noted that the 3G PP has already constituted a sub-group to prepare 
security standards and specifications of Telecom Equipment for Security Certification, since 
Common Criteria testing had no such test standards and testing mechanisms for telecom 
equipment. He stated that India also intended to use the 3GPP and 3GPP2 standards for testing and certification of telecom equipment. India emphasized that becoming an authorized nation from 
a consuming nation for testing under the CCRA did not change India's position with regard to the 
requirement of security testing and certification of telecom equipment from labs located in India, due to national security considerations. At the same time, he informed delegations that in respect of testing of IT products to be used in teleco m networks which have already been tested under 
CCRA, leverage will be given to the Common Criteria testing, and additional tests, if required, 
would be carried out as per the prescribed systems and standards. 
3.65.  With respect to concerns about testing bottlen ecks and delays due to non-availability of test 
facilities in India, he explained that it had already been clarified that testing and certification done 
under third party arrangements, such as Common Criteria, would continue to be accepted in the interim period, as would testing and certification done by independent vendor labs in case such a 
third party arrangement did not exist. He clarified that, if necessary, the Indian Government would 
extend the date for entry into force of requirement for security certification from labs located in India. He recalled that India's position had been  discussed and explained to the representatives of 
the EU, Japan and the US, including their industry and the United States-India Business Council 
(USIBC), at several occasions. In these discussi ons, it appeared that the reason for India's 
regulation was appreciated, and that there was a desire to cooperate on the issue. 
3.2.3.4  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) 
3.66.  The representative of the European Union ex pressed a desire to continue the ongoing useful 
dialogue with China on this matter, both in Geneva  and in Beijing. The EU first asked for an update 
on the regulation on commercial encryption by the Office of State Commercial Cryptography Administration (OSCCA), which had been under re vision for several years. He recalled China's 
assurance that the revision would aim to introduce a level playing field for all producers of 
commercial encryption products and would therefore eliminate the current prohibition on foreign producers and products containing foreign technology obtaining the necessary certification from 
OSCCA. He sought confirmation that this was still the direction being followed in the ongoing 
revision, and also asked about the timeline for the public consultation, and when a public call for comments could be expected domestically. The EU al so requested that a TBT notification be made 
in parallel or afterwards to ensure full transp arency of the process. He also reiterated his 
delegation's interest in learning more about the implementation of the multi-level protection scheme mentioned in past meetings, including whether consideration had been given to clarify the concept of critical infrastructure. He asked whether the current prohibition on use of encryption 
products with foreign technology and incorporating foreign technology was still appropriate to 
meet China's security concerns and ensure the nece ssary resilience of critical infrastructure to 
possible attacks. 
3.67.  On standards, the EU restated its general call for predictability, transparency and openness 
in China's standardization process in the field of ICT and ICT security. He noted that ICT standardization around the world followed an op en process with peer review, which was greatly G/TBT/M/63 
 
- 19 - 
 
  beneficial to the quality of the final outcome of standardization. He stated this was not always the 
case in China. For instance, the main standardization forum in China for the development of information security standards, the National Information Security Technology Standardization Committee (Technical Committee 260), did not allow participation of foreign owned or foreign 
invested enterprises. From the EU perspective, al l companies legally registered in China regardless 
of the nationality of their ownership, should be allowed to participate and provide inputs in this process. Failing this, he argued the Chinese standardization process would be deprived of the 
usual peer review in the global consortia or international standard setting bodies, and this could be 
detrimental to the reliability of the chosen algorithms  to ensure the required level of protection. He 
noted that numerous home-grown standards had b een developed in the Chinese ICT sector over 
recent years, often featuring unique Chinese te chnology. Foreign technology was not taken into 
account, and information necessary to develop products in compliance with these standards, such 
as the algorithms mentioned therein, was not made  available to foreign companies. This prevented 
innovative products featuring the best available security technologies from being placed on the 
Chinese market, thereby resulting in a less secure information security environment. Regarding 
the draft standards produced by Technical Commit tee 260, while foreign entities were unable to 
participate, he noted a positive trend of pub lishing draft standards for comment. However the 
comment period was often too short to allow for meaningful input – often 30 days or less – 
whereas the Code of Good Practice recommended a comment period of at least 60 days. The EU urged Technical Committee 260 to consider providing longer comment periods on draft standards. 
3.68.  Finally he stated that Chinese information security standardization would greatly benefit 
from being based on international standards and prac tices. He recalled that industry in this field 
was global, and that all stakeholders had to work to gether to ensure interoperability of solutions. 
He stressed that it was not in anyone's interest to fragment and compartmentalize the digital 
world at a national level. Increased openness and alignment to international practice was beneficial 
for all, as it increases the interoperability of information security products and equipment. He commended a positive recent example, wherein an algorithm developed by a Chinese company 
(algorithm ZUC TD-LTE) was submitted for peer  review to the 3GPP, and was subsequently 
accepted as a voluntary international standard in September 2011. In the view of the EU, this was a practice that should be consistently followed and would be of great benefit to China. He continued to recommend engagement by the Chinese authorities on these issues, and in this 
regard mentioned an upcoming event to be organized in the margins of the Government and 
Authorities Meeting on Semiconductors (GAMS). This meeting was taking place in Japan in mid-October, and would bring together industry and regulators from the countries participating in 
GAMS (China, Chinese Taipei, Japan, Korea, US and EU), which would offer a good opportunity to 
foster exchange of experience and dialogue on this issue.  
3.69.  The representative of Japan associated himself with the EU positions and said that Japan 
was closely following the negative impacts on IT trade of the various schemes and regulations 
within China. He additionally reported that several Japanese industries had last month submitted comments for "Security Criterion of Supplying Conduct for Information Technology Products" and "State Encryption Management Bureau's Administrative Approval Directories of State Council 
Departments", and Japan requested that China consider these comments. 
3.70.  The United States reiterated previously expressed concerns on this issue. 
3.71.  The representative of China said that, since there was no update on this issue, he would 
simply refer Members to the minutes of previous Committee meetings. 3.2.3.5  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) 
3.72.  The representative of Japan restated two concerns regarding the "Guidance for Application 
and Evaluation of New Cosmetic Ingredients" (hereinafter "the Guidance"). First, since the 
implementation of the Guidance in May 2011, only four new ingredients have been registered to 
date, and there had been significant difficulti es in exporting cosmetic products with new 
ingredients to China. Japan thus requested that China accelerate examination of new ingredients. Second, Japan considered as excessive and trade-restrictive the Guidance's requirement for safety 
data for each single molecule isolated from plant extracts and fermented solvents. Japan 
requested China to revise the Guidance in this respect, taking into account the practices of safety G/TBT/M/63 
 
- 20 - 
 
  evaluation of cosmetic ingredients in many other Members, such as Japan, the US and the EU, so 
that cosmetic manufacturers were able to register new ingredients without additional processes of isolation. Japan sought clarification from China on two additional points: (i) what were the scientific grounds for evaluating a single molecule isolated from a complex ingredient instead of a 
complex ingredient itself?; and (ii) what was the assumed risk in terms of the product safety 
evaluation of a complex ingredient, given that they were without isolation? 
3.73.  The representative of the Republic of Korea echoed Japan's concerns and said that, while 
Korea respected China's efforts to protect consumer safety, it was nevertheless concerned that the 
China Food and Drug Administration (CFDA) was carrying out excessive evaluation of new ingredients, and had approved only a small numbe r of new ingredients since 2011. He considered 
the CFDA's burdensome approval process for cosmet ics to be a serious barrier to trade. He also 
said that the "Adjustment of Cosmetic New In gredient Registration Management", which was 
notified to the TBT Committee in February 2014, permitted the temporary usage of new 
ingredients by companies which satisfied certain requirements. He noted that an additional 
m a n a g e m e n t  s y s t e m  n e e d e d  t o  b e  i n  p l a c e  i n  o r d e r  t o  c o m p l y  w i t h  t h e  r e q u i r e m e n t s  o f  t h e  
regulation, and only companies which had done so could register for temporary usage. Korea did not believe that there were any improvements in th is measure and, in fact, it seemed to be more 
burdensome than before. He said that under the revised regulation, China was treating cosmetic 
ingredients which had been proven to be safe in other Members as new ingredients. Therefore, he urged China to exempt ingredients with a proven sa fety record outside China from registration, or 
to consider a negative list approach rather than a positive list approach. Regarding the labelling 
requirements notified under G/TBT/N/CHN/937, he reiterated concerns about overlap and 
contradictions between the regulations of the CF DA and AQSIQ. Korea thus requested that China 
harmonize the CFDA regulation with the existing regulation of AQSIQ, which was based on ISO 
standards, so as to avoid unnecessary burden and confusion for manufacturers. 
3.74.  The representative of Canada echoed the comments of Japan and Korea, and said that the 
CFDA's burdensome approval and registration pr ocess for cosmetics and the lack of progress in 
approving new cosmetics ingredients was a serious barrier to trade. The creation of a positive list 
of ingredients prevented manufacturers from exporting cosmetics products into China, and reduced Chinese consumers' access to safer and more innovative cosmetics products. Moreover, China's related new ingredient registration process decreased the competitiveness of the cosmetic 
industry. Once a company dedicated time, money and resources to test and apply for registration 
of a new ingredient, that ingredient would no longer be considered as new and would be available for use by competitors at no additional cost. Canada noted that Chinese cosmetic manufacturers 
benefitted from a different domestic registration process for new ingredients that was much less 
burdensome than the one applied to foreign cosmet ic manufacturers. He requested an update from 
China in this regard. In addition, he asked that China explain the reasons for the differences in the 
approval process for domestic and foreign cosm etic manufacturers. Finally, he requested China 
explain why it was not accepting cosmetic ingredients already approved and considered safe in other leading foreign jurisdictions. 
3.75.  The representative of the European Un ion asked China to update the Committee on the 
measures taken since the last meeting on the list of ingredients that were authorized to be used in 
cosmetic products in China, and the procedure for the authorization of new ingredients. He 
recalled that at the last Committee meeting China had informed delegations that CFDA had issued 
a "Notice on Matters Relating to Adjustment of Cosmetic New Ingredient Registration 
Management", so as to improve the approval process for new ingredients. The EU was of the opinion that the new registration procedure would li kely not deliver with the speed, efficiency and 
predictability that was essential in this sector, where several new ingredients were developed 
every year. Taking into account that under the prev ious registration system only four ingredients 
had been approved in four years, he said the si tuation needed to be closely monitored to make 
sure that the new system provided for an efficien t approval of ingredients. From a systemic point 
of view, the EU reiterated that cosmetics were  not pharmaceuticals, and therefore a system 
whereby an authorization procedure would be restri cted to only certain ingredients, such as UV 
filters, colorants and hair dyes, would be more adequate. For the remaining majority of cosmetic 
ingredients, he suggested the safety characteri zation and assessment should be done under the 
responsibility of the manufacturer. Regarding the list of existing ingredients, the EU had learned that the list had been completed and corrected, and that there were additional ingredients that 
could be added to the list provided there was proof that the ingredients had been used in China. 
The EU had also recently learned that the list would only be used as a reference in order to take G/TBT/M/63 
 
- 21 - 
 
  stock of ingredients existing in China, but would not be an exhaustive "positive list". The EU 
sought a written confirmation to this effect. Last ly, he noted that significant further efforts were 
necessary to ensure that the registration of ingr edients, and of products with new ingredients, 
increased back to levels comparable to those prio r to the introduction of these requirements. The 
EU concluded by expressing its appreciation for the constructive regulatory dialogue between the 
European Commission's Directorate General for Health and Consumers, and China's Food and Drug Administration (CFDA). 
3.76.  The representative of China explained that  an inventory of cosmetics ingredients used in 
China was still being drafted. This was not a "positive list" of cosmetic materials, but only 
developed to distinguish if one material was firstly used in cosmetics produced or sold in China. This document was being prepared in order to design a sole standard on approving new cosmetic 
materials. In the two rounds of public opinion soli citing that CFDA had carried out, industry had 
submitted over 10,000 existing material to CFDA. Except the materials banned for safety hazards, 
all cosmetic materials that had been used in the Chinese market would be included in this 
document. She said that every material would be marked by both the Chinese and INCI name. At 
the present stage, CFDA was still finalizing th is document. She explained that "Adjustment of 
Cosmetic New Ingredient Registration Management" (G/TBT/N/CHN/1019) was issued to 
accelerate the approval procedure of new cosmetic materials through an adjustment at the 
administrative level. As for the "Cosmetics Label Instructions Regulations and Guidance", she noted there would be a new regulation on cosmet ics labelling before the end of 2014 due to the 
adjustment of CFDA's legislation plan, and it would be notified to the TBT Committee. 
3.2.3.6  Russian Federation – Draft on Tec hnical Regulation of Alcohol Drinks Safety 
(published on 24 October) (G/TBT/N/RUS/2) (IMS ID 332) 
3.77.  The representative of the European Union recalled that at the March 2014 Committee 
meeting, Russia informed the Committee that a revised version of the technical regulation on 
alcoholic drinks was being prepared. Russia noted that the widely accepted oenological practices of the International Organisation of Vine and Wine (OIV) and the Codex were being considered. As 
mentioned in previous meetings, the EU had a num ber of concerns regarding wines, beers, and 
protection of geographical indications (GI). The EU asked for confirmation that the new draft text being prepared addressed the concerns of WTO members and invited Russia to update the Committee on the status and timeline for adoption of the new draft technical regulation. 
3.78.  The representative of Mexico asked Russia to provide information on the current 
implementation of this technical regulation and that Mexico's comments be taken into account in 
the final version of the measure. 
3.79.  The representative of Australia expressed continued concerns with the measure and 
reiterated its shared commitment to adopt internationally accepted standards for alcoholic 
products, as recommended by the OIV as well as to avoid creating unnecessary obstacles to trade 
in wine. He recalled that Australia submitted comments on this notification on 6 February 2013, 
and his delegation's concerns focused on a number of commonly used additives and processing aids that did not affect the safety of the alcoholi c product. Australia noted that it had been joined 
in its concerns by a number of other Members, who considered the new measures to be both 
overly burdensome and repetitive. Australia welcomed, and asked for an update about, Russia's 
decision to 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, however, about th e 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 reiterated his delegation's request that Russia introduce a 
suitable transition period for these products so as to enable industry sufficient time to implement 
the stated labelling requirements. In addition, he  again raised the issue of wines which used an 
Australian GI in their description and presentation. In this respect, he enquired if Russia had considered Australia's request that wines labelled with an Australian GI be considered as a 
"protected geographical indication" under the new technical regulations, and asked that the 
relevant exemptions from the regulations relating to wines with a "protected geographical indication" apply. Australia also reminded Russia of it concerns over the requirements relating to 
the bottling location of wines which included a GI in their description and presentation. He asked 
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/63 
 
- 22 - 
 
  3.80.  The representative of the Russian Federati on said the draft technical regulation was still 
under development, and that the last public version of which was published on the website of the 
Eurasian Economic Commission and had been notified to the WTO. Under the normal process of adoption and implementation of technical regulation in the Custom Union, the next stage was 
internal coordination between countries of the Custom Union (Belarus, Kazakhstan and the Russian 
Federation). He hoped that the draft technical regulation would be finalized during this summer, after which it would be published on the Eurasian Economic Commission website. Following 
publication, the Russian Federation would await comment from trading partners. Thereafter, the 
Council of the Customs Union would adopt the text and a six month transition period would be provided before entry into force.  
3.81.  As to substance, he explained that the definitions of alcoholic products provided in the 
current text of the draft technical regulation were developed on the basis of international practices, 
including OIV definitions and the definitions pr ovided by the Codex Alimentarius and other 
international standards, taking into account the specificity of alcoholic consumption practices in the 
territory of the Custom Union. These definitions of alcoholic products were composed in such a 
way so as to allow consumers and regulatory author ities to properly identify type and category of 
each alcoholic products produced and consumed. Additives and processing aids, such as grape, 
must and concentrated must, and which did not affect safety of alcoholic products mentioned by 
the OIV, were fully reflected in the current version of the draft technical regulation, taking into account oenological practices authorized for use under the regulatory mechanisms of the member states of the Customs Union. Concerning food addi tives, such as food colouring, food stabilizers 
and flours, he clarified that the current version of the draft technical regulation did not set specific 
requirements on the use of additives in relation of  production of alcoholic products. He said such 
requirements were established in the Customs Union Technical Regulation on Food Safety, and in 
the Customs Union Technical Regulation on Safety Requirements of Food Additives, Flourings and 
Processing Aids. On the issue of GIs, he said that the regulation did not contain a list of alcoholic products with protected GIs. He states that this issue related to intellectual property rights, and 
not to the safety of alcoholic products. He concluded by stating that all comments of Members 
would be taken into account in the revision of the draft technical regulation. 
3.2.3.7  Korea – Regulation on Registrati on and Evaluation of Chemical Material 
(G/TBT/N/KOR/305) (IMS ID 305) 
3.82.  The representative of the United States asked Korea for an update on the status of the 
measure as well as to provide further information about how Korea planned to take into account 
the comments received to date to ensure a level playing field for domestic and foreign registrants. 
The US applauded Korea's decision not to subject small quantities of new chemicals to the full 
registration process, which was in line with the need to ensure that conformity assessment procedures were commensurate with actual risks. She however indicated that her delegation still 
had three key outstanding concerns. First, she recalled that Korea had stated in this Committee 
that confidential business information would be protected and that only safety-related data would be shared. Moreover, composition and processing information would not be required and would be kept confidential. The US again urged that th e K-REACH framework prevent any disclosure of 
confidential business information to the public or other manufacturers and importers throughout 
the supply chain. Likewise, her delegation believed  that applying confidential business information 
protections to chemical identity, composition, uses, processes, manufacturer/importer, and 
customer lists would significantly boost US and international business confidence and support 
further technological innovation in the chemical sector. Second, the US recommended that product exemptions under K-REACH should not require certification from the Ministry of Environment. 
Specifically, she recommended that the polymer e x e m p t i o n  b e  s i m i l a r  t o  t h a t  o f  U S  T o x i c  
Substances Control Act, which did not have any data requirements for reproductive/development screening, melting point, boiling point, and vapour pressure endpoints. Third, the US suggested that by products and impurities be exempted from hazard examinations.  
3.83.  The representative of Japan echoed the comments of the US. He then noted that for around 
500 hazardous substances covered by the measure (consisting of around 400 toxic substances and 
around 100 restricted/prohibited substances) it would become necessary, as of 1 January 2015, to 
notify the Korean authority of the production, sale and import of articles containing such 
hazardous substances in quantities not less than 0.1% by weight and not less than 1 ton/year in total. He further noted that, under the measure, the assessment of such substances thresholds 
would have to be undertaken against the backdrop of complicated supply chains, including G/TBT/M/63 
 
- 23 - 
 
  substance producers, article processors/assemblers  and sellers of the articles. Japan considered 
that if the assessment of so many hazardous substances were to start at the same time, this would be burdensome, in particular for businesses focused on importation. Japan was also concerned whether, once the law came into force on 1 January 2015, there would be sufficient 
lead time for distribution and/or trade of chemical s in Korea. He further noted that the number of 
around 500 substances was much larger than the 151 Substances of Very High Concern (SVHC) under the EU REACH. While Japan agreed that th e introduction of legislation to protect human 
health and the environment was the legitimate right of Korea, he nonetheless requested the 
Korean authority to take into account not only the seriousness of the hazards corresponding to the criteria for designation of hazardous substances, but also the actual conditions of use and exposure, and to introduce the regulation in a stepwise manner. 
3.84.  The representative of the Republic of Korea informed that at the 10th consultative group 
meeting, held on 25 April, additional comments from industry and stakeholders were appropriately 
reviewed. Such comments would be reflected in subordinate legal works within the intent of the 
draft regulation. A regulatory impact audit was conducted from 15 May to June, and several 
provisions, including the extension of reporting period, were eased to the extent possible. The Presidential and Ministerial Decrees to the Act would be published in September 2014 and the Act 
was scheduled to enter into force on 1 January 2015. He emphasized that under the draft 
regulation, small quantities of new chemicals were not subject to a full registration process and submission of dossiers was minimized and the regi stration period was significantly shortened. 
Regarding protection of confidential business inform ation, he explained that Article 29 of the Act, 
the provision dealing with chemical information within the supply chain, clearly specified that the 
scope of information to be provided excluded this kind of confidential information (e.g. those on composition, contents), and that manufacturing  volumes and the amount of used chemical 
substances were to be tentatively provided only for the safety reasons. Additionally, Korea 
informed that the official responses from the Mi nistry of Environment on the specific enquiries 
submitted in April would be forwarded to the US by  the end of June, and that the other issued that 
had been raised would be sent to the competent authorities. 
3.2.3.8  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) (IMS 328) 
3.85.  The representative of the European Union noted that, as planned, the measure entered into 
force on 30 April 2014. The EU still did not under stand the rationale of, on one hand, requiring 
imported toys samples to be taken from each shipment for the purpose of testing and certification, 
whereas, on the other hand, domestic production samples only needed to be taken every six 
months from the production line. The EU informed that it had recently learned that certain measures were taken as part of the implementation of the new requirement to alleviate some of 
the burden on foreign suppliers and importers of toys. These new measures were enacted through 
regulation by the Director General of the Indonesian  Ministry of Industry, as part of the Guidance 
on the implementation of the Toy Safety Decree. If the EU understanding was correct, under this 
regulation samples would no longer be taken by  individual batches and per each different toy 
model, but rather within a single shipment (which could contain many batches) and samples would 
be taken from all toys falling under the same Ha rmonized System code and per each trademark. 
The EU asked Indonesia to explain how such measure would alleviate the burden on foreign toy 
suppliers. The EU further noted that acceptance of testing performed at foreign laboratories 
accredited by ILAC MRA signatories were currently  granted for a period of two years. He asked 
Indonesia to confirm that continued acceptance of  foreign testing would be possible beyond this 
two year period, and what would be the conditions for such continuance. He underlined the 
importance of enabling certification bodies approv ed by the Indonesian Ministry of Industry to 
issue certificates on the basis of foreign test reports. He clarified that this did not mean the EU was asking that the full certification be conducted abro ad, but rather that foreign toy manufacturers be 
able to apply for certification in Indonesia on the basis of test reports issued in their home country 
by qualified laboratories.  
3.86.  The representative then highlighted a new element of concern, linked to the specific impact 
on toys of the new labelling requirements, which were discussed earlier on in this meeting under 
STC No. 12, which was covered by notification G/TBT/N/IDN/85. As mentioned earlier, the EU was concerned with the burdensome nature of such labelling requirements as the information to be 
provided appeared to go well beyond the essentia l elements of information which should appear on G/TBT/M/63 
 
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  labels. With respect to the application of this labelling regulation to toys, the EU pointed out that 
the requirement of permanently affixing labels on these particular products could, in itself, give rise to safety concerns. In the EU's view, perm anent labels could be removed by children playing 
with the toys. This could damage the toy and expo se its filling, ultimately exposing children to 
materials which were not supposed to be accessibl e to them. In this respect, the EU invited 
Indonesia to allow enough time for discussion with toy manufacturers on feasible labelling solutions capable of meeting Indonesia's policies objectives, while ensuring proportionality and the 
not compromising toy safety. He observed that the draft notified in G/TBT/N/IDN/85 had a 
planned date of adoption on 25 June 2014, with immediate entry into force. The EU asked Indonesia to postpone the adoption of this measure until discussion with WTO Members and affected stakeholders had taken place, and in an y event, to allow a reasonable interval between 
adoption and implementation. 
3.87.  The representative of the United States said that while her delegation fully supported the 
objective of protecting children worldwide from  unsafe toys, US industry continued to have 
questions about potentially duplicative in country testing requirements, onerous sampling 
requirements, documentation, and burdensome inventory requirements. The US considered that the new amendment did not appear to address these long standing concerns prior to the 
regulation coming into force at the end of April 2014.  
3.88.  The representative of Japan supported th e comments of the US and the EU and expressed 
his delegation's disappointment that the measure went into effect on 30 April 2014, despite the 
outstanding concerns expressed by Japan and other Members, including the fact that the testing 
requirement for each-and-every import shipment was unnecessarily frequent. Additionally, Japan 
still considered as unprecedented and unreasonable that only laboratories located in countries which had concluded bilateral mutual recognition agreements with Indonesia with respect to 
accreditation of foreign laboratories would be allowed to be accredited as testing laboratories. 
Other laboratories, he noted, even if they had been accredited during temporary two-year grace period, would not. Finally, Japan continued to be of the view that phthalate, azo and formaldehyde 
restrictions were stricter than necessary.  
3.89.  The representative of Indonesia explained that the current regulation required sample 
taking to be based on the batches of shipments. A shipment could consist of several batches which 
were determined in terms of each trademark of toys which fell within the same HS code. He said 
that this improved requirement would signific antly reduce the time for testing. Regarding 
acceptance of test results issued by foreign laboratories, Indonesia confirmed that it had granted a two year grace period for such results to be recognized. However, this special treatment during 
this grace period could only be further extended if the government of the country where the 
laboratories were based had entered into a mutual recognition agreement with the Indonesian Government. 
3.2.3.9  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) 
3.90.  The representative of Argentina reiterated its concerns regarding the EU's unjustified delay 
in resolving this longstanding specific trade concern. He recalled that Regulations (EC) Nos. 
479/2008 and 607/2009, which granted EU member states the exclusive right to use certain 
traditional expressions in their own languages, restricted the right of third parties to use those expressions on their labels, which seriously affected wine exports from Argentina to the EU. 
Argentina believed this legal regime was inconsistent with the TBT Agreement. In order to help 
find a practical and constructive solution to avoi d the barriers posed by this measure, and at the 
EU's invitation, in July 2009 Argentina submitte d its dossier on the terms "Reserva" and "Gran 
Reserva". Argentina's dossier was approved in March 2012 by the European Commission (EC) 
Wine Management Committee. Although the substantive procedure was completed in March 2012, 
the final formal step – 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. Argentina stressed that 
the substantive procedure took two years and seven months – i.e. from July 2009 until the 
approval of the dossier in March 2012 –, while the de lay to comply a single administrative act of a 
formal nature had already reached two years an d three months, i.e. from March 2012 to June G/TBT/M/63 
 
- 25 - 
 
  2014. It is striking that the delay to finalize a merely formal administrative act has almost equalled 
the time taken to end the substantive procedure that approved the dossier. It was not coherent that only one formal act required the same amount of time than the total amount of acts of this process, during which Argentina had also responded to objections by different entities and supplied 
additional information in response to requests from the EC for clarifications regarding its 
documentation. Moreover, he stressed that the de lay was doubly unjustified, since neither had the 
process been concluded in a reasonable period of time, nor had a reasonable explanation for the 
delay been given. The delay to resolve the issue definitively, which was approaching five years, 
constituted in and of itself alone an unnecessary  barrier to trade. He expressed Argentina's 
perception that no willingness had been shown to settle the matter, a situation that was clear from the fact that no date had ever been communicated for the inclusion of this item on the agenda of 
the College of Commissioners. Argentina once again requested the EU to lift the unjustified 
restrictions on its exports of quality wines by including this item on the agenda of the next meeting of the College of Commissioners and publishing the relevant regulatory act in its Official Journal. 
3.91.  The representative of the United States echoed the statement of Argentina, and recalled 
previous concerns and requests as to the status of  the applications that were submitted by the US 
wine industry four years ago. The US had learned in bilateral meetings that the EU was 
reconsidering this scheme on Traditional Terms for wine, which was appreciated. She requested 
additional information on this review, such as its objectives and parameters, whether the review process was transparent, and the scope of the stakeholder participation in the review, in 
particular, whether foreign stakeholders may participate in the process. The US requested 
information about the Wine Advisory Group, chaired by DG Agriculture, regarding its plans for the 
approval of the use of Traditional Terms on wi ne by the US and other leading wine producing 
nations. She noted that no information had been shared with key trading partners since the last 
traditional term application was approved in 2012. Sh e said that the lack of transparency in this 
process continued to have significant impact on  U S  e x p o r t s  o f  w i n e  t o  t h e  E u r o p e a n  U n i o n ;  
companies that legally use those terms in the US as well as third markets were unable to sell their 
wine in the EU.  
3.92.  The representative of the European Unio n informed the Committee that the new Regulation 
establishing a common organisation of the markets in agricultural products had been adopted by 
the European Parliament and the Council (Regulation (EU) n° 1308/2013). Following its publication 
in December 2013, an internal assessment on traditional terms had been carried out in accordance 
with Article 114(3) of that Regulation. He explaine d that the consultation included the conditions 
and specificities under which these traditional terms could be used on the labels of products from 
third countries. Possible derogations, based particularly on minimum requirements for production 
methods and controls under product specifications of the wines concerned, had been also covered by this discussion. The EU was making 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. The concerns expressed by the US and Argentina had been taken into 
account in the assessment process currently underway in the EU, which was of a complex nature. The procedures under consideration (whether from EU member states or third countries) would be 
taken once this evaluation was accomplished. The EU continued to be open to discussion with both 
trade partners bilaterally at expert level. 
3.2.3.10  India – Electronics and Informat ion Technology Goods (Requirements for 
Compulsory Registration) Or der, 2012 (G/TBT/N/IND/44, G/TBT/N/IND/44/Add.1 -
Add.3) (IMS ID 367) 
3.93.  The representative of Japan noted that gradual progress had been made in registrations 
under this Order. However, a survey of Japanese industry showed that as of 3 April 2014 - i.e. 3 
months after the date of full entry into force (3 January 2014) -, testing and registration procedures were still taking significant time. In the worst cases, said Japan, it took over 12 
months for testing and over eight months for registration. The launch of the products in the Indian 
market had been delayed significantly due to the le ngth of time taken for testing and registration 
procedures. Japan requested India improve aspects of testing and registration procedures to accelerate the process. Japan understood that BIS allowed only factories to be "applicants", and 
required registration on a per-factory basis. Even if one product model was manufactured at 
several factories, each of the factories was required to undergo testing and registration for the same model, which Japan saw as unnecessary duplication of the testing and registration. Japan 
thus requested India to allow a manufacturer (a brand owner) and its representative in India (an G/TBT/M/63 
 
- 26 - 
 
  importer) to be "applicants", and to change the cu rrent registration system to a per manufacturer 
(or per brand owner) basis, under which testing and registration would be required only for each manufacturer or brand owner, instead of each fact ory. He also expressed Japan's concern with the 
length of time for testing and suggested accepting CB certificates and CB test reports issued by 
National Certificate Bodies (NCB) of the other countries as a way to shorten testing time. Finally, 
Japan noted that BIS also took a long time to confirm test reports submitted for registration, even though they were issued by the laboratories whic h BIS itself accredited. Japan requested India to 
ensure that BIS completed registration procedures in three weeks from the time of application for 
registration, which was a common practice in other countries.  
3.94.  The representative of the Republic of Korea echoed Japan's concerns on this Order and 
reiterated Korea's full support for efforts to pr otect consumer safety. Korea understood that the 
Order notified under G/TBT/N/IND/44 required manufacturers to mark information on their 
certified products. He noted that, until recently, the BIS allowed manufacturers to mark information by affixing stickers. However, BIS had recently amended the regulation to require that 
information be either embossed/engraved on products or screen printed on products and 
packaging material. He noted that this amendmen t was published on the BIS website on 11 April 
2014, without any notification to the WTO. Si nce this amendment was subject to the TBT 
notification provisions, Korea recommended that India notify the amended regulation to the TBT 
Committee and provide WTO Members with an oppo rtunity to submit comments. Korea believed 
that affixing stickers on products to mark the registration number specified by the current regulation would be sufficient to achieve the purpose of the regulation, which was to inform 
consumers about whether products were certified or not. In addition, he explained that markings 
by screen printing, embossing or engraving information on products would increase production 
time and cost due to added manufacturing processes. As a result, this would lead to price 
increases for these products. Furthermore, given that electronics and information technology 
goods had a relatively short lifecycle and were developed by rapid technological innovation, Korea considered that affixing stickers would be more reasonable and less trade restrictive. Therefore, 
Korea requested that India continue to allow the marking requirement to be met through affixing 
stickers. 
3.95.  The representative of the European Union supported previous Members' interventions, and 
shared the concern about the need for further streamlining of the registration procedure that had 
resulted in long delays. Given the often short lifecycle of the products concerned, he said these 
long delays could effectively prevent meaningful market access. The EU continued to view the overall scheme as excessively burdensome in view of the low risk associated with the products 
concerned. As mentioned by Japan, given the conc rete risk of a testing bottleneck, he underscored 
the importance of ensuring the continued acceptance of test reports and certificates issued under the IECEE CB Scheme or by laboratories which were adequately accredited under the international 
standard ISO/IEC 17025 by an ILAC MRA signatory. In this respect, he recalled the assurances 
given by India in past meetings and requested furt her confirmation that this would continue to be 
the case in the future. He noted that, in principle, because India's standards were based on, and in many aspects fully aligned with, the corresponding IEC standards, the acceptability of IECEE CB 
Scheme test reports and certificates should not pose any problem. 
3.96.  He also stressed the need to extend the time validity of test reports, which was currently 90 
days. From the EU perspective, test reports should have a longer validity and testing should only 
be repeated if a product had been substantially changed in such a way that its safety properties 
were affected. The EU fully supported the concerns  of Korea surrounding the BIS labelling Order of 
11 April 2014, which introduced very extensiv e labelling requirements and represented a 
significant change compared to the current situat ion. Implementation of this requirement would 
imply significant costs and the requirements appe ared to be disproportionate compared to the 
consumer information objective pursued. He noted that the entry into force of the new labelling requirements was foreseen for 1 July 2014. Given the very short implementation period, the EU 
urged India to postpone the entry into force of this  Order and engage with industry in order to find 
practical solutions that fit the nature of the products and the needs of the sector concerned. 
3.97.  The representative of the United States supported the statements made by previous 
concerned Members. She recalled that India had implemented the testing requirements for the 
measure from 3 January 2014, and had delayed impl ementation of the labelling requirements until 
April 2014. With respect to the requirement that testing be conducted solely in labs domiciled in 
India, the US recalled its previous interventions on this issue and encouraged the BIS to accept G/TBT/M/63 
 
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  test reports under the IECEE CB Scheme, and to only require testing in cases of suspected non-
compliance. This would ease the burden on manuf actures of the in country testing requirements, 
while improving the capacity of Indian labs. Sh e reported concerns of US industry about the 
expiration of test reports and noted that no othe r national certification agency imposed expiration 
dates on test reports. She requested that India reconsider the annual re registration and re testing 
as there was no basis for this redundant testing. The US understood that at least 18 foreign labs had applied to be approved to perform testing as early as July 2013. She recalled that during the 
March 2014 Committee meeting, India indicated that BIS had recognized 11 labs, and asked for an 
update regarding the status of the other applications.  
3.98.  The US also continued to have concerns about India's practice of regulation by FAQs, rather 
than regulation through amendments which were notified to the TBT Committee for comment. The 
labelling requirements applying to the embossing/e tching of products were the latest hurdle. She 
also noted the current confusion across Indian Government agencies with respect to the Highly Specialized Equipment (HSE) exemption under the compulsory Order, and she encouraged India to 
promote inter-ministerial consultation amongst the Customs Agency, Department of Electronics 
and Information Technology (DeitY) and the Department of Commerce to ensure that the exemptions provided were in fact enforced at the border. On the requests for exemption, she 
requested that DeitY put in place a process to enable a manufacturer to make such a request 
through a simple form, with a reasonable timeframe for the process to be completed, and a contact person for related enquires. 
3.99.  The representative of India said this Order was issued in October 2012, and mandated 
fifteen categories of electronics items under the Compulsory Registration Scheme, based on their 
compliance to specified safety standards. The Order envisaged that manufacturers, importers, sellers and distributors of the notified goods must conform to the specified standards and obtain 
registration numbers from BIS after testing from BIS recognized labs. He noted that the Order was 
initially foreshadowed to come into force from 03 April 2013 but subsequently its entry into force 
was extended. The Order was uniformly applicable to both domestic manufacturers and foreign 
suppliers. Industry needed to have goods tested by laboratories recognized by BIS. On meeting 
requisite standards, BIS granted a unique registra tion number. Industry then needed to mark a 
self-declaration of conformity on their products in a prescribed manner, followed by the registration number assigned by BIS. Each regist ration was valid for two years, a period which 
could be renewed merely upon request if no ad verse issues came up during the period of 
registration. 
3.100.  The Indian representative also said that there were no issues relating to delays in testing 
or registration. With respect to testing, the recogniz ed labs were well on track. He noted the list of 
recognized labs was available on websites of DeitY and BIS, and said that these labs were well equipped, and worked under an international safety certification programme. In fact, three of the 
recognized labs had parent companies of foreign origin. At present, Indian authorities had received 
no feedback of any delay in testing. With respect to allowing other labs for testing purposes, he explained that labs aspiring to test under the scheme would have to seek recognition from the BIS, and noted the existence of a foreign lab recognit ion scheme under the BIS provisions. Second, on 
the registration side, he informed delegations th at as of 4 June 2014, 941 registrations had been 
granted covering over 5000 product models, and over 90% compliance had been achieved under the Compulsory Registration Order. Nevertheless, he said that suggestions made by concerned 
Members in this respect had been noted and would be communicated to Indian authorities. 
3.101.  He informed that, in order to address technical issues pertaining to the scheme, a 
Technical Advisory Committee (TAC) has been cons tituted under DeitY. Technical matters such as 
exemption on HSE fell under the purview of this Co mmittee. In this regard, the quantity restriction 
of 5 per model under the exemption for R&D or demo samples had already been removed, and 
there was no limit on the number of units being imported for R&D or demo purposes. Likewise, he reported that BIS had formed a Policy Advisory Committee (PAC) to address policy issues of the 
registration scheme. The issues relating to ne w labelling requirements were presently under 
consideration. G/TBT/M/63 
 
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  3.2.3.11  Ecuador - Resolution establishi ng the "General conformity assessment 
framework for Ecuador" and the "Handbook of procedures to be observed prior to all 
stages of the customs clearance, marketin g and market surveillance of manufactured, 
imported and marketed goods subject to Ecuadorian technical regulations 
(G/TBT/N/ECU/44, G/TBT/N/ECU/44/Add.1-Add.3) (IMS ID 398) 
3.102.  The representative of the United States indicated that US exporters continued to face 
significant barriers to their access to the Ecuadorean market as a result of these conformity 
assessment requirements, which, while may be needed  to ensure product safety and quality, were 
more stringent than necessary to accomplish such objective. The US was also concerned with Ecuador's inconsistent notification of measures. She further noted that Ecuador had issued new measures which were having a significant negative impact on trade given the absence of transition 
periods to adjust to new requirements and the failure of Ecuadorian officials to provide a way for 
exporters to be compliant with the new measures. The aim of these measures, she said, appeared to be to reduce imports in an effort to balance trade rather than addressing legitimate health, 
quality and safety concerns. For example, Ecuador had notified the Ecuadorian National Quality 
Council (CONCAL) Resolutions 009 2009 and 010 2010 (G/TBT/N/ECU/44) as final, without providing any comment period. Subsequent resolutions affecting conformity assessment 
procedures had also been notified in three ad denda to this notification. Most recently, the 
Ecuadorian Foreign Trade Committee (COMEX, Ministry of Production, Employment and Competitiveness) had published Resolution 116 in December 2013, which vastly expanded the list of products requiring a Certificate of Recognition and Conformity for export to Ecuador, compared 
to the procedure originally set forth under the measure notified as G/TBT/N/ECU/44. She asked 
when Ecuador would notify Resolution 116 to the WTO and allow for interested parties to 
comment, in accordance with Article 5.6.2 of the TBT Agreement.  
3.103.  The main concern the US had with COMEX Resolution 116 related to the ability of 
exporters to obtain the Certificate of Conformity. US exporters had particularly reported that there 
was insufficient information about the requirements to obtain these certificates and that the 
number of Conformity Assessment Bodies approved by the Ecuadorian Accreditation Organization 
to issue Conformity Assessment Certificates required for obtaining Format INEN-1 (Certificate of Recognition) was insufficient to meet demand for certifications. To add to this uncertain environment, Ecuador had provided the US industry with a list of US located bodies from which to 
obtain certifications. However, these bodies had asserted that they could not issue the requisite 
certifications. The US noted that Ecuador already had in place stringent measures to control the quality of goods entering the market and it was not clear what benefits additional attestations of 
conformity were conferring. Therefore, the US requested that Ecuador explain the legitimate 
objectives of the additional certification requirem ents for each product and encouraged Ecuador to 
suspend the measures until they could be notified to the WTO and commented on by all interested 
p a r t i e s .  I n  t h e  c a s e  o f  m e a s u r e s  t h a t  w e r e  j u stified, the US further requested that Ecuador 
suspend implementation for one year to allow economic operators to comply with the new requirements without interrupting trade, consistent  with the TBT Agreement's obligation to provide 
a reasonable interval between the publication of conformity assessment procedures and their entry 
into force. The US also noted that COMEX Resolution 116 had recently been the subject of Andean 
Community Secretariat-General Resolution No. 1695, dated 6 June 6 2014, which had found the measure to be a trade restriction and ordered its withdrawal. The US called on Ecuador to reflect 
on this decision and take the necessary actions in order to avoid further trade disruptions. 
3.104.  The representative of Costa Rica referred Members to the concerns they had raised at the 
previous meeting TBT Committee meeting and also  supported the concerns raised by the US. 
Costa Rica was looking forward to receiving more information from Ecuador on this issue. 
3.105.  The representative of Switzerland pointed out that Ecuador had notified 145 legislative 
projects since the Committee's discussion in October 2013 of this trade concern, which was widely 
seen as more restrictive than necessary if applied across the board, as it required third party 
certification and registration of the product with the Ministry of Industry as a preferred procedure 
for most products. Despite concerns expressed regarding its notification practice, Ecuador continued to notify technical regulations after their entry into force by using the emergency 
procedure, thus effectively preventing Members to comment on them in due course. Switzerland 
encouraged Ecuador to ensure that legislative projects with effect on trade were notified in advance, allowing for at 60 days for comments and providing a reasonable timeframe for industry 
to adapt to new requirements and procedures. Emer gency notification procedures were to be used G/TBT/M/63 
 
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  only in urgent and justified cases. Switzerland also asked Ecuador to clarify its stance on using 
international standards and whether the requirem ent to design regulations based on product 
performance rather than descriptive characteristi cs (TBT Agreement, Art. 2.8) was part of its 
general framework for technical regulation. Recalling that under Article 5 of the TBT Agreement 
conformity assessment procedures shall not be more restrictive than necessary, Switzerland drew 
attention to the work of the TBT Committee, in particular to the "indicative list of approaches to facilitate acceptance of the results of conformity assessment". Switzerland had made positive 
experiences in applying as widely as possible le ss burdensome methods of conformity assessment, 
which reduced the burden of compliance, reduce d time to market and helped combating anti-
competitive behaviours, eventually benefiting the consumer. 
3.106.  The representative of Ecuador said that Resolution N° 001 of 2 May 2013 (published in the 
Official Registry N° 04 of 30 May 2013), had been  issued by the Inter-Ministerial Committee for 
Quality, an inter-agency body formed by seve ral governmental and regulatory agencies of 
Ecuador. In accordance with the provisions of the Ecuadorian Quality System Law, it established 
the general framework for conformity assessment and the "Handbook of Procedures" to be 
observed prior to all stages of customs clea rance, marketing and market surveillance of 
manufactured, imported and marketed goods subject to Ecuadorian technical regulations. The 
Handbook established that products subject to Ecuadorian technical regulations must demonstrate 
compliance with these through the certification of conformity assessments prior to importation or marketing. The certification had to be obtained from a certification body, whose accreditation had been issued or recognized by the Accreditation Bo dy of Ecuador (OAE) or from one which had been 
appointed by the Ministry of Industry and Producti vity. He said that, subsequently, Resolution N° 
002 of 11 July 2013 (published in the Official Ga zette in 22 August 2013), and Resolution N° 001 
2014 (published in the Official Gazette N° 264 in June 10 2014), introduced several changes to the 
original Resolution N° 001-2013-CIMC in order to take into account cases where there were no 
bodies accredited by the OAE. In such cases, th e importer or consignee could submit a suppliers' 
declaration of conformity to the Ecuadorian Standardization Institute according to standard NTE 
INEN ISO/IEC 17050 1, attaching the reports or tests results issued by a laboratory accredited and 
recognized by the Ecuadorian Accreditation Agency and demonstrating compliance with the relevant Ecuadorean or equivalent technical regulations or international standards for the product. He concluded by saying that these Resolutions only set out the procedures to be followed by 
business operators to comply with Ecuadorean technical regulations, both for products produced in 
Ecuador and those imported. They were not therefore intended to create unnecessary obstacles to trade. 
3.2.3.12  Thailand - Draft Thai Industrial  Standard for Ceramic Tiles (TIS 2508-2555) 
(G/TBT/N/THA/407) (IMS ID 401) 
3.107.  The representative of the European Unio n expressed concerns regarding the divergences 
between the mandatory Thai Industrial Standard and the relevant ISO standards for ceramic tiles. 
The EU considered that the requirement to fix th e TISI marking on each and every tile, and not 
alternatively on the packaging, was burdensome, costly and not in line with ISO 13006:2012. In addition, water absorption thresholds were also not in line with this ISO standard. Furthermore, 
the mandatory Thai Industrial Standard requir ed product testing and an onsite audit of a 
manufacturer's quality control system by the Thai Industrial Standards Institute (TISI), which appeared to be an overly burdensome conformi ty assessment procedure. The EU asked whether 
test results from EU laboratories and certificates from EU conformity assessment bodies would be 
accepted. Further to Thailand's statement at the March 2014 Committee meeting, the EU asked Thailand for an update on possible amendments to the Thai industrial standard for ceramic tiles.  
3.108.  The representative of Thailand said that the Thai Industrial Standard on Ceramic Tiles (TIS 
2508:2555 (2012)) used as reference, and was to a large extent not different from, ISO 
13006:1998, the content of which had not changed in the revised version in ISO 13006: 2012. Where it was not possible for the manufacturers or importers to display the TISI Mark on the 
product, the marking could be put on the product and/or packaging. Regarding the acceptance of 
test reports, according to Article 5 of the Industrial Product Standard Act B.E. 2511 (1968), TISI accepted test reports from laboratories designated to be inspection bodies. However, as an interim 
measure and to cope with a great number of applications for licences, TISI would accept test 
reports from the laboratories complying with ISO/IEC 17025 under ILAC/APLAC conditions during a period of one year commencing on 23 July 2013. After this period, only reports from laboratories 
designated to be inspection bodies according to Article 5 of the Industrial Product Standard Act G/TBT/M/63 
 
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  B.E. 2511 (1968) would be accepted. Otherwise, the laboratories to be accepted would have to 
enter into an agreement on MRA/MLA with TISI. 
3.2.3.13  Russian Federation – Measure affect ing the import of Ukrainian confectionary 
products (IMS ID 399) 
3.109.  The representative of Ukraine stated that Ukraine continued to have concerns regarding 
Russia's ban on import of Ukrainian confectionery, which had been enacted on 29 of July 2013 by 
the Resolution/Decision of the Federal Service on Customers' Rights Protection and Human Well-
being Surveillance of the Russian Federation (Rospotrebnadzor) (No. 01/8612-13-23). Since the 
discussions in the March 2014 TBT Committee meeting,  the ban had been expanded to the transit 
of Ukrainian confectionery products to the occu pied territory of the Autonomous Republic of 
Crimea. Answers provided by Russia after eight months of consideration were vague, contradictory 
and triggered more questions. Russia still seemed undecided whether the ban was applied for 
consumer rights protection or to ensure comp liance with the labelling requirements. In its 
answers, the Russia had stated that the import ban was related neither to violation of sanitary 
requirements nor to technical regulations of the Cu stom Union but due to violation of Art.10 of the 
Federal Law №2300-1 of 7 February 1992 on consumers' rights protection. At the same, Russia 
had indicated the possibility of reviewing Rospotre bnadzor's Decision after full compliance with the 
requirements of the Custom Union, referring in particular to the Technical Regulation on "Food 
products in sphere of its labelling". Ukraine be lieved that the measure was unjustifiably strict, 
discriminatory, and more trade-restrictive than necessary to fulfil a legitimate objective, taking into account of the risks non-fulfilment would create. Ukraine had not yet received any response to 
additional questions raised at the March 2014 meeting and requested a clear explanation as to 
why the ban had been introduced and continued to be maintained. Ukraine asked how the ban complied with the TBT Agreement and the official re sults of the inspection of Ukrainian factories 
conducted in October 2013, which still had not been provided to the Ukrainian producers and 
authorities. As of 1 January 2014, Ukraine had officially informed Rospotrebnadzor of the 
conformity of confectionary products produced by certain factories (in Kiev, Vinnitsa, Mariupol and 
Kremenchug) to Russian quality requirements for food products. However, Russia had disregarded 
the updated information and claimed that the meas ure could not be reviewed in accordance with 
Art.2.3 of the TBT Agreement. Ukrainian authorit ies and producers were open, fully cooperative 
and constructive in resolving this concern with the Russian authorities. In this respect, Ukraine 
recalled that that it had ensured enforcement of it s part of the agreed roadmap for the elimination 
of trade barriers between Russia and Ukrain e for 2013–2014. Ukraine expected unbiased 
cooperation from Russia because this was in the interest of both countries as mutually important 
trading partners, mindful of their obligations as WTO Members. Ukraine called upon Russia to 
immediately lift the trade ban and bring its meas ure in line with the TBT Agreement as well as 
commitments it signed at accession. 
3.110.  The representative of Russia indicated that the measure affecting confectionery products of 
the Ukrainian company Roshen was introduced due to inconsistencies of these products with 
Russian labelling requirements, as already explai ned during the previous TBT Committee meeting. 
During the previous year, some Ukrainian companies exporting food products to Russia had failed 
to comply with the technical regulations of Russi a and the Customs Union. The import ban on the 
confectionary company Roshen had been introduced on the basis of numerous laboratory tests, the 
results of which were provided to Ukraine during bilateral consultations held in August, October 
and December of 2013. More than 90% of tested pr oducts had failed to meet the requirements of 
the applicable technical regulation. During the bilateral consultations held in December 2013, the State inspection service of Ukraine on the Protec tion of Consumers' Rights had recognized the 
inconsistencies of Ukrainian products with the Russian requirements. Moreover, during the course 
of consultations, an agreement had been reached to resume the export of confectionary products to the Russian market. Unfortunately, said Russia, Ukraine still had not taken the steps necessary to implement such an agreement. He emphasized th at the ban only applied on the entire territory 
of Russia and was, consequently, not extended to the whole territory of the Custom Union. G/TBT/M/63 
 
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  3.2.3.14  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 
(G/TBT/N/ECU/19/Add.3, G/TBT/N/EC U/19/Add.5, G/TBT/N/ECU/19/Add.6, 
G/TBT/N/ECU/19/Add.8) (IMS ID 411) 
3.111.  The representative of Costa Rica said that the difficulties Costa Rican exporters have been 
facing in complying with the measures' conformity assessment procedures were affecting their 
capacity to access the Ecuadorian market. However, it was also their understanding that the 
Ecuadorian authorities were also allowing suppliers' declaration of conformity, which could facilitate the demonstration of conformity with technical requirements. Costa Rica asked Ecuador to supply more information about the status of im plementation of the regulations and explain how 
Ecuador had taken into account the concerns expressed by Costa Rica and other Members at the 
March 2014 Committee. 
3.112.  The representative of the European Union thanked Ecuador for having eventually notified 
Technical Regulation 022 on Labe lling of Processe d and Packaged Food Products, which imposed 
nutrition food labelling obligations comprising "high in" warnings and a colour coded warning system. While fully sharing Ecuador's public health  concerns regarding the provision of adequate 
nutritional information to consumers, the EU doubted whether the approach taken in the notified 
draft was the best way to achieve these objectives and whether it was proportional to the aim pursued, which was to empower consumers to make an informed choice in order to foster effective competition and consumer welfare. The EU asked whether Ecuador had considered alternative, less 
restrictive measures that would encourage the consumer to actually read the contents of sugar, fat 
and salt on the products in question and make the appropriate choice, in particular taking into account that the consumption of limited quantities of products high in sugar, fat or salt could 
reasonably be part of a healthy diet. The Codex Guidelines on Nutrition Labelling (CAC/GL 2-1985 
CODEX) stated that the information contained in the nutrient declaration "should not lead consumers to believe that there is exact quantitative knowledge of what individuals should eat in 
order to maintain health, but rather convey an understanding of the quantity of nutrients 
contained in the product". No nutrient thresholds had been established by Codex for the nutrients targeted by the Ecuadorian legislation. The EU recognised that for certain nutrients there was evidence of a positive association between its exce ssive intake and the risk of developing a disease 
or disorder but there was no scientific evidence suggesting an identifiable threshold above which 
the risk existed. The risk increased rather cont inuously when the nutrient intake increased above 
the levels recommended by the nutritionists. Furthermore, "high in" warnings, such as those 
proposed by the Ecuadorian legislation, were not foreseen by the applicable Codex guidelines on 
nutrition labelling and risked demonizing some foods while their consumption in moderation could be part of a healthy diet. The EU recalled that according to Codex guidelines, the information to be 
provided in nutrition labelling was only factual, providing, among others, the energy value and the 
amounts of protein, carbohydrate fat, saturated fat, sodium and total sugars. In this regard, the EU noted that Ecuador's departure from these internationally recognised practices would have a significant impact on foreign manufacturers that would need to adapt their packaging for the 
Ecuadorian market only.  
3.113.  On the specific contents of the techni cal regulation, recalling Article 2.2 of the TBT 
Agreement, the EU inquired about the scientific ba sis to impose warning statements for products 
containing any level of caffeine or taurine. The EU also noted that EU legislation provided less 
burdensome nutrition labelling requirements for packages whose largest surface had an area of 
less than 80 cm2 and an exemption for packages wh ose largest surface had an area of less than 
25 cm2. The EU invited Ecuador to consider a less stringent approach. In addition, the EU noted 
that according to the second transitional disposition of the regulation, it would come into force on 29 August 2014, barely four months after its publication, while the adaptation to the new requirements would require significant investment for manufacturers and a redesign of the 
packaging for some products. The EU asked Ecuado r to temporarily suspend the application of the 
measure and provide sufficient time for its im plementation. The EU informed that its own 
legislation on nutritional labelling had been adopted in 2011 and would come into force in 2014.  
3.114.  The representative of the United States welcomed Ecuador's notification in 
G/TBT/ECU/19/Add.8, which extended the date for compliance with the revisions to Ecuador's 
nutritional labelling until 15 August 2014 and increa sed flexibility for the placement of the "traffic-
light" icons, allowing them to be placed on the back of the package alongside the nutrition panel, G/TBT/M/63 
 
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  in addition to the front of the package. Further,  Ecuador had clarified that duty free goods were 
exempt from the traffic light labels. While these trade facilitating improvements and continuing 
bilateral discussions were appreciated, the US re mained concerned that imported foods would not 
be able to come into compliance by the new enforcement date of 15 August 2014 and that the 
modifications had been introduced after the notifica tion of the regulations to the WTO as final and 
without a comment period. The US recalled that Ecuador had clarified during an April 2014 bilateral discussion that all foods subject to the new labelling would need to be re-registered under 
Ecuador's Sanitary Food Registration Process. Th e US had previously raised the challenges of 
completing this onerous re registration process both bilaterally, during the November 2012 TBT 
Committee meeting, and in a letter to Ecuador's Ministry of Health, dated 4 October 2012. The US also considered as burdensome and duplicative the measure's per shipment requirement for a 
certificate of conformity to verify nutritional labelling, in particular because Ecuador already 
required a certificate of conformity for compliance with commodity standards and food products a l s o  n e e d e d  t o  u n d e r g o  a  l a b e l  r e v i e w  a s  p a r t  o f  t h e  S a n i t a r y  F o o d  R e g i s t r a t i o n  p r o c e s s .  
Consequently, argued the US, such additional certificate would provide no information that was not 
already gathered by the other two requirements. The US also recalled that at the March 2014 TBT 
Committee meeting, it had been joined by the EU and Brazil in questioning the need for a 
certificate of conformity in regards to nutritional information and the lack of practical guidance on 
how to obtain it. While Ecuador had provided a list of accredited labs and clarified (during an April 2014 bilateral discussion) that they would accept ISO/IEC 17050 Part 1 in fulfilment of the certificate of conformity requirement, US suppliers had nevertheless been unable to locate 
accredited labs willing to issue the ISO certificate. Alternatively, the US was pursuing the 
possibility of State authorities issuing the certificate, but this took time and might not offer a workable solution in time for foods to complete the re-registration process by August 2014. 
Furthermore, at the March 2014 TBT Committee meeting, Ecuador had indicated that a Supplier's 
Declaration to Demonstrate Conformity (SDOC) would be accepted. The US sought confirmation of their understanding that an SDOC would only be accepted if a supplier entered in a "supplier's 
agreement", or MoU, with the Government of  Ecuador. The US also asked whether such 
agreements placed limits on the amount of product that could be imported. 
3.115.  The US also said that Ecuador's lack of transparency had resulted in multiple and costly 
label changes. The Ecuadorean National Associ ation of Manufacturers of Food and Beverage 
estimated that some firms had invested up to two million dollars in new labels before the 
announcement of the recent changes. While the US  understood the valid public health objectives 
that Ecuador sought to achieve through the changes to its Sanitary Regulations for the Labelling of 
Processed Foods for Human Consumption, it continued to emphasize the need for stakeholder 
input at an early and appropriate stage, and a reasonable time for compliance after the publication of final regulations in order to minimize the costs.  While placement of the icons on the back of the 
label was helpful, the size remained unchanged at 20 percent of the total label. The large size of 
the icon could still interfere with supplier's ability to declare other important mandatory as well as brand information. The US continued to request that Ecuador suspend implementation of its new requirements on nutritional labelling, and the related conformity certification, for one year. 
3.116.  The US was also concerned with the mandatory requirements to label food and beverage 
products with the statement: "Contains Transgeni cs". The US recalled its long standing position 
that for foods derived from genetically modified organisms that had been found to be substantially 
equivalent to conventional counterparts, mandating "Contains Transgenics" labelling might create 
an erroneous impression that the product was less safe than conventional products. Genetically engineered products that had been evaluated through risk based safety assessments in accordance 
with international guidelines, such as through the Codex Alimentarius Commission, should not 
require different labelling, absent material diffe rences from their conventional counterparts. In 
addition to confusing consumers, such labelling would likely also increase costs to industry, 
consumers, and government authorities. The US  encouraged Ecuador to consider a voluntary 
approach to biotech labelling, which would allow for consumer choice without mandatory 
requirements that might create concerns in the ey es of the consumer about products that had the 
same quality and that were equally safe. Finally, the US noted that according to Articles 5.2 and 
5.3 of the measure notified in G/TBT/N/ECU/19/Add.8, Ecuador was proposing to base its biotech 
labelling requirement on a 0.9 % threshold. The US sought clarification on how this threshold would be calculated. In addition, the US sought confirmation that the measure would exempt foods 
which did not contain transgenic protein or DNA, such as highly processed products, such as oil, 
sugar, and syrup, from genetically engineered  crops; foods which may be produced using G/TBT/M/63 
 
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  genetically engineered processing aides, such as  cheese, beer, and yogurt; and foodstuff derived 
from animals fed with gene tically engineered feed. 
3.117.  The representative of Switzerland said that while sharing Ecuador's concerns on the 
necessity to combat non-communicable diseases, Switzerland was of the view that the colour-
coded "traffic light" warning system foreseen under the project would unfairly discriminate against 
certain products without conveying sound information to consumers. No nutrient threshold was established under the relevant Codex standard, according to which information contained in the 
nutrient declaration should not lead consumers to believe that there was exact quantitative 
knowledge of what individuals should eat in or der to maintain health, but rather convey an 
understanding of the quantity of nutrients contained in the product. Switzerland was concerned with the use of diverging warning messages by some Members, in this case, pictograms conveying 
negative messages on various types of foods containing certain nutrients. 
3.118.  The representative of Brazil said that Br azil shared the concerns raised by Members and 
would continue to follow the discussions with interest.  
3.119.  The representative of Ecuador said that the Foreign Trade Committee (COMEX) Resolution 
No. 116 established the certificate of recognit ion as a supporting document to the customs 
declaration for all goods shipped as from the entry into effect of the Resolution in December 2013. 
The Resolution was not in itself a technical regulation, but rather an internal administrative 
resolution addressing Customs matters and introducing controls on the marketing of products on the basis of regulations which, in several cases, were already in force in the country. Ecuador reiterated that the Resolution was therefore not su bject to the notification procedures set forth in 
the TBT Agreement. Technical Regulation (RTE INEN) No. 022 of the Ecuadorian Standardization 
Institute had been amended on a number of occasions, precisely to take into consideration the concerns raised by trading partners. The most recent amendment had been issued by the Under 
Secretariat for Quality of the Ministry of Indust ry and Productivity and notified in document 
G/TBT/N/ECU/19/Add.8, repealing the draft noti fied in document G/TBT/N/ECU/19/Add.7. The 
Technical Regulation sought to lay down the la belling requirements for processed and packaged 
food products and it applied to all processed foods with health registration certificates that were 
marketed in Ecuador. It would enter into force on 29 August 2014 and provide for a labelling alternative that involved the affixing of additional permanent adhesive labels or indelible or printed stamps or seals either in the country of origin or  at the marketing destination of the product. The 
aim of labelling was to guarantee the right of cons umers to appropriate, clear, accurate and non-
misleading information on the content and characteristics of processed and packaged food, thereby enabling them to make the right choices as regards the purchase and consumption of such 
goods. The Regulation took into account the requir ements previously developed by the Ministry of 
Public Health and set forth in Ministerial Decision  No. 00004522 of this body ("Sanitary regulations 
for the labelling of processed foods for human co nsumption"), whereby information was provided 
by means of a "traffic light" rating system indicating high, medium or low levels of salt, sugar or 
fat. These labelling regulations sought to combat heart disease and diabetes, which were among the leading causes of mortality and morbidity in Ecuador, and thus to curb the high rates of excess weight and obesity caused by a lack of information on food consumption. Finally, with regard to 
the conformity assessment certificate, the Regulation provided for the alternative of a supplier's 
declaration of conformity (in accordance with Standard NTE INEN–ISO/IEC 17050 1), duly legalized by the relevant authority and submitte d together with the valid health registration 
certificate, as issued or recognized by the relevant national authority of the country of destination. 
3.2.3.15  India – Food Safety and Standard s Regulation - Food labelling requirements 
(IMS ID 298) 
3.120.  The representative of the European Union reiterated their concerns regarding the 
implementation of the Indian food safety and stan dards regulation – food labelling requirements - 
dating from August 2011. In October 2011 and January 2014, India had issued ad hoc  guidelines 
that spelled out that certain India specific information, such as the vegetarian/non-vegetarian 
logos and the name and address of the importer, were considered "rectifiable" information and 
could be affixed by the importer in customs warehouses. However, the same guidelines defined that several of the compulsory labelling elements, such as list of ingredients, were "not rectifiable", 
which meant that they could not be provided by me ans of stickers and had to be, instead, printed 
on the food packages. The EU noted that in most economies in the world, food products could be 
labelled by means of stickers provided they were accurate and not easily detachable. This was a G/TBT/M/63 
 
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  very important trade facilitating practice that, while duly protecting the consumer, allowed 
producers to serve different regions with different  language requirements without having separate 
production lines. The Codex Standard for the labelling of pre-packaged foods (CODEX STAN 1-1985) stated that ''[i]f the language on the origin al 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 relabeling''. This standard also stated that ''in the case of either 
relabeling or a supplementary label, the mandatory information provided shall be fully and 
accurately reflect that in the original label.'' The EU was therefore of the opinion that the October 
2011 Guidelines, were too burdensome and not in compliance with Articles 2.2 and 2.4 of the TBT 
Agreement. In this context, the EU recommended India to bring its implementing Guidelines in line with Codex and allow all types of labelling informat ion - and not only the Indian-specific ones - to 
be provided by stickers (for example at cu stoms 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.  
3.121.  Regarding alcoholic drinks, the EU noted that  the Indian legislation required that the labels 
of alcoholic drinks contained the full list of ingredients. This was a different practice than that used in other Members. For instance, according to the EU legislation, spirits and wine drinks entering 
and circulating in the EU were not obliged to have a full list of ingredients in their labels. As 
stickers were not allowed in India, and the labels had to be pre-registered in different Indian States by the state excise authorities, it was not clear to market operators what exactly was expected by the food safety authority (FSSAI) to be stated on the labels for each type of alcoholic 
drink. It was important to note that there could be different ways to label certain ingredients or 
additives. In addition, the formal process for State approval of labels took place only once a year 
at fixed periods according to the fiscal cycles of th e given state. In this context, India was urged to 
provide some more detailed information to market operators regarding the formulation of 
ingredients and to allow sufficient time for implem entation, which, depending on the excise cycle, 
should be up to 9-12 months. The EU considered f undamental to ensure that the approval of labels 
by Indian State authorities took place before th e implementation date. Otherwise, the requirement 
to list ingredients in the label of alcoholic drinks could result in a major market access disruption. Besides the transition periods, it was also fundamental to ensure that all the products already exported to India could be marketed until stocks we re exhausted. Finally, the EU wished to receive 
further information from India regarding the planned new technical regulation on alcoholic drinks 
and the envisaged timeframe for notifying it to WTO. 
3.122.  The representative of Japan said that the implementation of the Guidelines had significant 
negative effect on food products imported from Japan into India. Japan shared the concerns 
expressed by the EU, in particular the fact that certain ingredients or nutrition information were "not rectifiable" and not allowed to be labelled by means of stickers. Japan recalled that Article 2 of 
the Codex General Standard for the Labelling of Pre-packaged Foods defined "label" as "any tag, 
brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed or impressed on, or attached to, a container of food" and that Article 8.2.1 specifically stated that "[i]f 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 relabeling." In addition, Article 8.1.1 st ated that "Labels in pre-packaged foods shall be 
applied in such a manner that they will not be come separated from the container." This well 
balanced standard reflected the real world practices where many countries, including Japan, 
allowed food products to be labelled by means of stickers, provided they were accurate and not easily detachable, achieving the goal of consumer protection while avoiding unnecessary trade 
disruption. Therefore, Japan urged India to review its Guidelines based on the Codex Standard in 
accordance with 2.4 the TBT Agreement. In addi tion, said Japan, the Guidelines were overly 
burdensome and costly especially for companies exporting various items in small quantities to 
India and were not, therefore, consistent with Article 2.2 the TBT Agreement. 
3.123.  The representative of India said that th e Food Safety and Standards Authority of India 
(FSSAI) had issued the Foods Safety and Standards (Packaging and Labelling) Regulation 2011 in 
August 2011. It contained general labelling requirements that required, for instance, that: (i) 
every pre-packaged food shall carry a label containing the required information; and (ii) the label 
shall be applied in such a manner that it would remain attached to the container. In October 2011, FSSAI had published the "ad hoc guidelines related to clearance of imported food", according to 
which absences of the vegetarian/non-vegetarian logo and name and address of importer were 
considered "rectifiable labelling deficiencies", which could be dealt with via sticker labels in the G/TBT/M/63 
 
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  customs bonded warehouse at the port. However, absence of the full information, when required, 
would not be rectifiable with sticker labels: (i) name and address of the manufacturer; (ii) list of ingredients; (iii) production date; (iv) best before  or expiry date; (v) batch or code or lot number; 
(VI) net weight or volume; or (VII) nutritional information. He explained that if a sticker got 
detached from the package, it lost its purpose of making consumers aware. Therefore, in the 
August 2011 regulations, there was a requirement that  the label be such that it remained attached 
to the container. Stickers had been subsequently allowed for making minor corrections, such as 
indicating vegetarian or non-vegetarian, in customs warehouse but not for making the entire 
specified information available. Furthermore, if stickers with all mandatory information were allowed on packages, it could be misused by unscrupulous traders for manipulating or tampering with the labels of imported food. India did not have tracking and tracing facilities to identify the 
source of such food items if a manipulation of labelling was detected at a subsequent stage in the 
market. In this context, India did not see any problem in maintaining its existing labelling requirement. 
3.2.3.16  Chile – Proposed amendment to the Food Health Regulations, Supreme Decree 
No. 977/96 (G/TBT/N/CHL/219, G/TBT/N/CHL/219/Add.1; G/TBT/N/CHL/221) (IMS ID 370) 
3.124.  The representative of Canada said that while supporting Chile's policy objective of 
promoting healthy dietary choices and reducing obesity and related non-communicable diseases, 
Canada urged Chile to, when reviewing the measure, consider a science-based and less trade restrictive alternative to achieve its policy goals, which was based on international standards. 
Canada asked if and when the 17 December 2013 regulations would enter in force and which 
elements of the regulations were under revision. In addition, Canada urged Chile to notify any amendments to the regulations, allowi ng for a full 60-day comment period. 
3.125.  The representative of Mexico expressed her delegation's concern that the measure was not 
complying with the TBT Agreement's requirement th at it should not be more restrictive than 
necessary to fulfil their legitimate objectives. She asked that Chile change the measure to comply 
with this obligation by promoting public policies  that helped the population to obtain accurate 
information on food nutrients, so that they could make food choices based on their particular needs. Mexico noted that Law 20.606 (published on 6 July 2012) required "manufacturers, producers, distributors and importers of food prod ucts to display on the packaging and labels the 
ingredients they contain, including all additives,  in descending order of proportion, and nutrition 
facts, as a percentage of composition, a unit of weight, or under the nomenclature specified by the 
technical regulations in force". In addition, th e proposed amendments to Law 20.606 laid down 
criteria for classifying foods as "high in" certain constituents, with a view to reducing their 
consumption among the Chilean population and thus  addressing the health problem of obesity. 
She noted that the Chilean Ministry of Health was responsible for determining which foods 
contained high amounts of calories, fats, sugars, salt or other ingredients, and which must be 
labelled "high in calories", "high in salt", or the like, without scientific justification regarding the way in which this contributed to achieving the legitimate objective pursued. She recalled that the Codex Alimentarius discouraged the use of any label or labelling – such as "high in calories" or 
"high in salt" which employed words, pictures or other devices that may lead the consumer to fear 
consuming a food product. Mexico questioned the scientific foundation for the measures promoted by Chile. Similar to Canada, Mexico also asked for an update on the process for review and entry 
into force of the regulation. In addition, Mexico asked whether Chile considered redefining the 
phrase "high in …" in order to describe the concentration of the product using another, similar formulation, so as not to scare consumers.  
3.126.  The representative of Brazil recalled that Brazil had expressed its concerns during the 
March 2014 meeting of the TBT Committee and was en gaged in bilateral talks with Chile on this 
issue. 
3.127.  The representative of Switzerland comme nded the openness of the Chilean legislative 
process, which allowed the bill to be improved and the reaching of a final version of the regulation 
containing warnings that were more neutral and that allowed the use of stickers. While Switzerland shared Chile's concerns on the prevalence of  obesity and other diseases, it nevertheless 
considered that such measures could be made less trade restrictive if they were more in line with 
international standards and did not discriminate according to the selling method. Switzerland had been informed that the legislation was being reconsidered. While this could be an opportunity to G/TBT/M/63 
 
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  reduce certain effects on trade, it was important to continue to engage with international partners 
and ensure that previously raised comments remained taken into account in any amendment. 
3.128.  The representative of Costa Rica indicated that they shared the concerns raised by other 
Members and welcomed an update on the current status of the regulation. 
3.129.  The representative of Guatemala joined  the delegations of Mexico and Canada in 
reiterating concerns regarding the measure and re quested that Chile provide information on the 
status of the Regulation, in particular on the inte rnal processes, changes that would be introduced, 
and as the entry into force of the Regulation.  
3.130.  The representative of Australia supported Chile's right to implement measures to provide 
consumers with information to make appropriate dietary choices and reduce the risk of diet related 
non-communicable diseases, provided that such measures were implemented in a manner that 
was consistent with Chile's WTO obligations. There could be other measures available to promote 
consumer health, which could achieve Chile's objective and which were being considered by other countries, including Australia. Australia appreciated the clarification provided by Chile that the 
warning label would no longer take the form of an octagonal "STOP sign" and that it would instead 
be a "coloured hexagon", the size of which would be established in relation to the size of the total area of the products. Australia was pleased that Chile had modified the proposed front of pack 
labelling requirement based on suggestions it had received by other Members, including Australia. 
However, in Australia's view, the labelling scheme was still mandatory for some food categories including some dairy foods. In addition, there were some inconsistencies between the requirements for imported and domestic products. Australia also sought clarification as to whether 
the regulation came into force on 17 June 2014, i.e. six months after its publication in the Official 
Journal of Chile, which had occurred on 17 December 2013. 
3.131.  The representative of Chile said that child obesity and related non-communicable diseases 
had taken on epidemic proportions in Chile in recent years. Law 20.606 on the nutritional 
composition of food and on food advertising and it s implementing regulations were one of the first 
regulatory steps Chile had taken to address this countrywide problem, whereas other strategies of 
a promotional nature had been in place for years. As mentioned in the March 2014 meeting, on 17 
December 2013, the final version of the regulations that implement Law 20.606 – Ministry of Health Decrees 12 and 28 – was published in the Official Journal. However, in March 2014 a new government had come into power and the new Health Authority in Chile, after analysing both the 
aforementioned regulations, had decided that they needed to be revised, mainly, but not 
exclusively, because Decree 12 was highly inco nsistent with the Sanitary Regulations for 
Foodstuffs and other internal regulations. The Mini stry of Health had issued two decrees, published 
in the Official Journal on Saturday 14 June 2014,  which postponed the entry into force of Decrees 
12 and 28 by one year. Additionally, the Ministry  of Health had created a multidisciplinary 
committee composed of skilled professionals in th e areas of food advertising and the nutritional 
labelling of food and representatives of other go vernment agencies, for the purpose of revising 
current regulations and drafting new regulatory pr oposals. These proposals, expected to be ready 
in July or August 2014, would be duly notified to the WTO, with a 60 day period granted for comments in accordance with Article 2.9 of the WTO TBT Agreement. Any comments received 
during this process would be duly analysed and answered. 
3.2.3.17  Peru - Act to Promote Healthy  Eating Among Children and Adolescents 
(G/TBT/N/PER/59) (IMS ID 383) 
3.132.  The representative of Canada said that while her delegation supported Peru's objective of 
reducing obesity and other non-communicable diseases, it was nevertheless concerned that this 
measure might be more trade restrictive than necessary to achieve this objective. She asked 
whether Peru had considered less trade restrictive alternatives to pursue its objectives and 
whether the proposed regulations were based on international standards and sound science. She also inquired when the regulations would come into force and encouraged Peru to provide a transition period to allow industry time to adjust to any new labelling requirements. 
3.133.  The representative of Mexico supported the comments made by Canada and recalled the 
concerns Mexico had already expressed at the prev ious meeting. She welcomed the notification of 
the technical regulation and requested an update on its status.  G/TBT/M/63 
 
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  3.134.  The representative of Switzerland, endo rsing the remarks made by Canada and Mexico, 
inquired about the scope of the regulation and the level at which a product needed to be labelled 
with a warning saying that it was "detrimental to health". Switzerland was concerned with use of negative warning messages and the multiplication of uncoordinated parameters on them.  
3.135.  The representative of Peru said that the Peruvian Law to Promote Healthy Eating Among 
Children and Adolescents, notified as G/TBT/N/PER/59 on 20 May 2014, was a draft technical 
regulation establishing parameters for determining whether an industrially processed food product 
or non-alcoholic beverage had a high sugar, sodium or saturated fat content and providing for the 
gradual reduction of trans fats. Comments received until the deadline of 18 August would be reviewed by the multi-sectoral commission drafting the technical regulation. 
3.2.3.18  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) 
3.136.  The representative of Canada supported In donesia's objective of reducing the risk of non-
communicable diseases. However, according to information available, Canada was concerned that 
the regulatory proposals might have a significant impact on trade and were likely to be more trade restrictive than necessary. She asked whether Indonesia had considered less trade restrictive 
alternatives to pursue its objective. At the March 2014 meeting, Indonesia had indicated that 
testing for sugar, salt and fat content must be conducted by accredited in country laboratories. She asked whether Indonesia had considered opening up such testing to foreign laboratories and if not, whether this would be considered. Canada welcomed an update regarding when the regulation 
would enter into force and what type of transition  period it would provide for industry to adjust. 
3.137.  The representative of the European Union welcomed the clarifications received from 
Indonesia on 10 June 2014. However, the EU rema ined concerned about certain provisions of the 
notified Regulation and considered that further explanation was needed with respect to the new 
mandatory nutrition labelling requirements. The EU recalled that implementing regulations, which Indonesia intended to issue to address product covera ge in detail, needed to be notified to the TBT 
Committee while still in draft form, providing suff icient time for Members to comment on them. 
The EU was also interested in receiving an update on the guidelines to be developed by the Indonesian Ministry of Health and the National Agency for Drugs and Food, which would regulate other details of the Regulation and which would al so need to be notified. The EU reiterated 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 and invited Indonesia to consider whether the objectives of the Regulation could be achieved with less trade-restrictive 
means. In particular, the way of placing of nutri tion information and related health warning, the 
conduct of risk assessment related to non-communicable diseases, as well as testing methods for nutrition levels, still required Indonesia's clarification. The EU was interested in receiving more 
detailed information on how the Indonesian authorities were going to address a possibility for 
accepting test results issued by laboratories other than those accredited by the Indonesian 
National Accreditation Body (KAN). The EU also reiterated that compliance with the Codex Alimentarius Guidelines on nutrition labelling would require also the amount of saturated fat and 
sodium or salt to be labelled. Lastly, Finally, th e EU deeply regretted Indonesia’s confirmation that 
it will not allow stickers placed after importation of the products, and before their being placed on 
the market in Indonesia – for instance, in customs warehouses – as means to show compliance 
with the Regulation. This would have been a sound alternative to labelling in the country of origin 
that would allow Indonesia to fulfil its legitimate objectives in a non trade restrictive way. 
3.138.  The representative of Switzerland said that, as various other Members, Switzerland was 
concerned that the measure deviated from the Codex Guidelines on Nutrition Labelling (CAC/GL 2-
1985 (Rev. 1 - 1993) and other recommendations building on that guideline, whereby labelling should not lead consumers to believe that there was an exact quantitative knowledge of what individuals should eat to maintain good health, but rather convey an understanding of the quantity 
of nutrients contained in the products. He also asked why the conformity assessment procedure 
required the approval of the label by an auth ority. Switzerland urged Members to adopt less 
restrictive measures, which were consistent with international standards, guidelines and 
recommendations and invited Members to share experiences in this regard.  G/TBT/M/63 
 
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  3.139.  The representative of the United States welcomed Indonesia's plans to take into account 
Members' concerns during the three year transition period and hoped this process would take 
place effectively. She asked how the trade impacts of this particular approach were evaluated to ensure that it was no more trade restrictive than necessary to achieve Indonesia's public health 
objectives. She also inquired whether Indonesia had considered using the Codex Nutrient 
Reference Values for labelling purposes for sodium and saturated fat, which provided another means for consumers to identify foods "low" and "high" in nutrients of concern and the Codex 
"low" claims, "no added sugars" claims, and other conditions for health claims. In addition, she 
asked for more information on the research Indonesia had conducted to assess how consumers would receive and understand the information communicated by the mandatory health message. The US also continued to seek clarification of the testing provisions set forth in Article 6 of MOH 
Regulation 30/2013, which seemed to establish a strict testing procedure that would not allow 
minimum normal variations between batches and would possibly include unnecessary shipment-by-shipment inspections. Such a high level of ov ersight was, in the view of the US, unnecessary 
given the low risk posed to consumers by the inclusion of nutritional information. Random testing 
and sampling was sufficient for monitoring and enforcement of the accuracy of nutritional declarations. In order to conserve limited regula tory resources, the US suggested that Indonesia 
consider using existing international tools, such as the nutritional databases maintained by FAO, 
the International Union of Food Science and Nutrition, and the industry-driven eatright.com, which helped verify the accuracy of nutritional declarations without additional testing. 
3.140.  The representative of Australia supported Indonesia's implementing measures to help its 
citizens make informed dietary choices, so as to reduce their risk of developing diet related non 
communicable diseases. However, the proposed measure could be modified and implemented differently, such that there was no unnecessary impact on trade. For example, Indonesia could 
consider other less restrictive measures to promote consumer health, which were being considered 
by other countries, including Australia. As the proposed nutrition declarations needed to be based on tests carried out by accredited labs, Australia asked 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 wished to know how these requirements would apply and how the gradual impl ementation of the Decree would take place, in 
particular how the risk of the products with respect to non-communicable diseases would be 
assessed. Moreover, Australia asked where the nutritional information and related health warning 
needed to be placed on the label and whether Indonesia would allow stickers to be placed after importation, and before being placed on the market in Indonesia. 
3.141.  The representative of Indonesia underlined that the labelling requirements involved health 
messages, not health warnings. Further, the re gulation did refer to the Codex Standard for 
Labelling. Indonesia also clarified that it did not intend to prevent or prohibit the public from 
consuming particular foods. The legitimate objective of the regulation was to increase consumers' 
awareness on the importance of knowing the amount  of sugar, salt and fat in the processed food 
they consumed and the recommended daily intake. Such awareness was important to control the risk factors that contributed to non-communicable diseases. Indonesia was now preparing 
technical regulations for the implementation of the Regulation, which would clarify all aspects that 
were currently not specified in the Regulation, which would be notified to the WTO. 
3.2.3.19  European Union - Revised Proposal  for the Categorization of Compounds as 
Endocrine Disruptors of 19 February 2013 by DG Environment (IMS ID 393) 
3.142.  The representative of Mexico expressed co ncerns relating to the process leading to the 
registration of pesticides and the re-classificati on of compounds as endocrine disruptors on the 
basis of a regulatory focus, which did not seem to be risk-based. Mexico asked for an update on 
the status of this proposal.  
3.143.  The representative of the United States reverted to concerns previously raised in 2013 and 
2014 in the Committee on DG Environment's proposal. The EU had released its roadmap for the 
impact assessment on defining criteria for identi fying endocrine disruptors in the context of plant 
protection regulation two days earlier. This document, which outlined the four policy options that would be analysed with respect to the attainment of the EU's health and environmental objectives 
as well as their economic impact, would be reviewed by the US in light of the concerns articulated 
in previous meetings. The US reiterated its request for active public participation and transparency, including the opportunity for public comment on draft impact assessments, G/TBT/M/63 
 
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  proposed regulatory actions and the supporting scientific opinions, which would be taken into 
account in finalizing any measure.  
3.144.  The representative of the European Union said that the EU would carry out a 
comprehensive impact assessment that would analyse different options for defining criteria for the 
identification of endocrine disruptors and their corresponding health and socio-economic effects 
once incorporated in different pieces of EU legislation. In this context, the European Commission had published two days earlier a roadmap outlining the impact assessment structure and the 
options to be assessed and would be organizing a three-month public consultation and comment 
period. The European Commission would present proposals for introducing criteria to identify endocrine disruptors in different pieces of EU legislation only after the conclusion of the impact assessment. 
3.2.3.20  China – China Food and Drug Admi nistration (CFDA) EMC Enforcement Notice 
for medical devices of 19 December 2012 (IMS ID 387) 
3.145.  The representative of the European Union said that their concerns on the issue had been 
addressed under specific trade concern number 4.  
3.146.  The representative of the United States was concerned with China's plans to restrict 
electromagnetic compatibility testing (EMC) for medical devices to CFDA approved facilities in 
China and require retesting of medical devices. The US said that this would significantly increase 
both cost and time to market for the products at issue and might create unnecessary trade barriers. She noted that China no longer accepted EMC test reports generated outside of China by qualified international laboratories, including IECEE CB scheme laboratories. Referring to Article 9 
of the TBT Agreement, she asked why China consider ed it necessary to mandate domestic testing, 
given the serious potential impact on trade associated with costs and burdens to foreign producers of duplicate and redundant testing. She inquired whether China had concerns about the quality of 
CB Scheme test reports and whether China had conveyed these concerns to IEC and planned to 
participate in the IECEE CB Scheme in a manner that would address those concerns. She also noted the option of CFDA acceptance of test reports from foreign laboratories accredited by 
signatories of ILAC. Further, the US requested clarity on the IEC standards referenced in these 
measures as the notifications appeared to reference outdated versions of the relevant IEC standards. Finally, she expressed concern with  China's failure to notify these conformity 
assessment procedures to the Committee and take comments into account, as required by Article 
5.6 of the TBT Agreement. 
3.147.  The representative of China said that YY 2012 0505 Medical Electrical Equipment Part 1 2: 
General Requirements for Safety, EMC standard Requirements and Test Standards for Medical 
Devices Industry, was an identical transposition of the IEC international medical electrical 
equipment electromagnetic compatibility test standard IEC 60601 1 2, which was set to ensure a safe environment for medical devices so as to protect public health. As IEC 60601 1 2 was a 
recognized international standard used widely by WTO Members, China did not expect the 
promulgation of YY 2012 0505 to have a significant impact on international trade. 
3.2.3.21  Peru — Implementing Regulation s of 14 November 2012 for Moratorium on 
Planting Genetically Engineered Crops (IMS ID 392) 
3.148.  The representative of the United States said that Peru's November 2012 implementing 
regulation for the moratorium on planting geneticall y engineered crops needed to be notified to the 
WTO in accordance with the TBT Agreement, as  had already been expressed during previous 
Committee meetings as well as Peru's November 2013 Trade Policy Review. The Implementing 
Regulations of the Biotech Moratorium would require the National Agrarian Health Service (SENASA) at the Ministry of Agriculture and Irrigation to conduct conformity assessment 
procedures (i.e., testing to ensure that there was no presence of genetically engineered materials 
in the seeds) to confirm compliance with the moratorium. In light of the fact that the measure's conformity assessment procedures were not in accordance with the relevant guides and recommendations issued by international standardizing bodies, and given that it might have a 
significant impact on the trade of WTO Members, she asked why the measure had not been 
notified. She also asked Peru, in case it had considered that the measure was in accordance with guidelines and recommendations issued by international standardizing bodies, to identify them. G/TBT/M/63 
 
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  She said that, in addition to the unclear, potentially trade disrupting conformity assessment 
procedures, the implementing regulations included pe nalty provisions that were overly restrictive. 
The US disagreed with Peru's assertion that the moratorium was not a technical regulation and considered it to be a measure designed to protect the environment. The US also disagreed with 
Peru's position that such notification was not nece ssary due to an exception under Article XX of the 
GATT as this provision did not relieve Members of  their notification obligations under the TBT 
Agreement. 
3.149.  The representative of Peru, referring to their inputs already provided during earlier 
Committee meetings, reiterated the view that the Moratorium on Planting Genetically Engineered 
Crops did not need to be notified to the TBT Committee as it was not a TBT matter, but rather an environmental matter related to biodiversity. 
3.2.3.22  Ecuador − Resolution No. SENAE-DGN-2013-0300-RE relating to post entry 
control of imported alcoholic beverages (IMS ID 394) 
3.150.  The representative of Canada said that  on 9 August 9 2013, Ecuador had approved a new 
customs regulation on spirits imports covering whisky, vodka, tequila and rum, which had been 
published in Ecuador's Official Registry No. 86 on 23 September 2014 and, as Canada understood, had entered into force 30 days thereafter. Canada was concerned that the regulation might be in 
violation of Articles 2.1 and 2.2 of the TBT Agreem ent since it applied only to imports and because 
its Article 4 stipulated that liquor that was not properly labelled at its origin could be returned to the country of export. However, 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, various other market-specific information on the back or secondary 
label. In this respect, Canada was concerned that Ecuador's requirements to label at the point of origin might be more trade restrictive than necessary to fulfil a legitimate objective and thus not in 
compliance with Article 2.2 of the TBT Agreemen t. In addition, Canada was concerned that 
transition period provided did not comply with ar ticle 2.12 of the TBT Agreement. According to the 
information received, the came into force after its publication on 23 September 2013. The 
resolution did provide for a transitional provision, but with a deadline of only four months from its 
publication, after which no imported alcoholic beverages could be sold in the Ecuadorian territory without the new required labelling.  
3.151.  The representative of the United States associate herself with the concerns expressed by 
Canada and referred Members to the US intervention under specific trade concern number 11. 
3.152.  The representative of Ecuador said that the resolution was a customs measure 
implemented by the National Custom Service of Ecuador (SENAE) with the aim of reducing the 
illegal entry of alcoholic beverages into the country, in light of the high rates of contraband in 
these products. Ecuador was of the view that the TBT Committee was not the right forum to address this issue. Nevertheless, the customs authority of Ecuador had been revising the measure 
with the aim of looking at other mechanisms that would achieve the same objectives without 
affecting trade flows. 
3.2.3.23  China – China Food and Drug Ad ministration (CFDA) Notice 191 of 16 
December 2013 – Free Sales Certificate for Imported Cosmetics (IMS ID 415) 
3.153.  The representative of Canada noted that , as previously expressed by Canada and other 
WTO Members, China's new interpretation regardin g "Free Sale Certificates" (FSC) required that 
licensing applications submitted to Chinese evaluation centres for imports of cosmetic products 
prove that the products had been sold or manufactured in the country of origin. This requirement 
was contrary to China's previously accepted interp retation where the certificate of free sale only 
had to state that a cosmetic product was permitted to be sold in the country of origin. Canada was 
concerned that Chinese manufacturers were exempt from premarket registration, which could 
result in a more accessible and preferential market access for domestic manufacturers, as this additional demand caused significant delays to the launch of new products and increased costs for importers. The discriminatory treatment also had a negative impact on Chinese consumers and 
reduced their timely access to innovative and safer cosmetics products. He asked China to explain 
the necessity for requiring FSC from importers but not from its own manufacturers.  G/TBT/M/63 
 
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  3.154.  The representative of the European Union recalled its previous interventions that these 
new FSC requirements were problematic, in particular with respect to certain cosmetic products 
that were designed and produced to satisfy Chinese consumer needs and were therefore not necessarily placed and marketed in the origin market, even though they respected the highest 
safety standards. A FSC attesting sale in the count ry of origin was therefore not available in such 
cases. For other products that were innovative and to be soon marketed in the country of origin, requiring a FSC to initiate registration in China would delay entry of the product in the Chinese 
market. In a fast developing market, it was of crucial importance that cosmetics manufacturers 
could start approval procedures in different market s, in parallel, as soon as possible and without 
having to wait for the approval in the country of origin. The EU asked if China had considered alternatives to the FSC for these particular cases and if it considered that its FSC requirement 
would be in line with the provisions of th e TBT Agreement regarding conformity assessment 
procedures. A practical short term solution would be for the CFDA to accept submission of the marketing statement at a later stage in the evalua tion process. In the longer term, the EU asked 
China to suspend the implementation of Notice 191 and reconsider the need to provide FSC for 
cosmetics. The EU considered that the Chinese cosmetics legislation seemed to be developed enough, with rigorous procedures that provided adequate consumer protection levels without 
having to rely on foreign approvals. Finally, the EU welcomed China's efforts to provide advice to 
companies, which had helped them find practical solutions and the bilateral dialogue between CFDA and DG SANCO on the matter. 
3.155.  The representative of the United States said that China had sent a Notice to evaluation 
centres to require, in licensing applications for imported cosmetics, that a certificate be submitted 
to prove that the product had been sold in the Country of Origin (COO) or country of manufacture. This had resulted in a sudden re interpretation of Chinese regulatory requirements, which had long 
accepted CFS statements that the product was "permitted to be sold" in the COO. The US strongly 
disagreed with the China's assertion that the measure had little influence on international trade and questioned how this re interpretation enhanced safety to Chinese consumers. CFS had never 
been intended to be, or presented as, a proof of marketing of the product in the country of origin 
and China had always and consistently accepted foreign CFS on this basis. The US also disagreed with China's claim that this action prevented Chinese consumers from being used as test cases for ingredients not used elsewhere. Cosmetics products manufactured in the US needed to comply 
with all relevant US safety and other regulations, and then undergo extensive mandatory testing 
and assessment programs by Chinese authorities. These requirements were far more strict and burdensome than regulations applied to Chinese domestic products (in the case of "non special 
use" products). The US requested an immediate suspension of this new interpretation for at least 
six months and asked how China planned to take comments submitted by the US industry into account. The US also asked China to notify this change to the WTO Secretariat so as to allow for 
Members to provide written comments and take those comments into account, in accordance with 
TBT obligations and the Committee's decisions and recommendations. She noted that the immediate implementation of this re interpretation, with no prior notice, had already greatly impacted US companies as many hundreds of applications had been rejected by CFDA. 
3.156.  The representative of China said that Noti ce 191 was only a reiteration of Articles 3 and 4 
of Provisions for the Administration of Cosmetics Application Acceptance (G/TBT/N/CHN/821). 
CFDA had already approved a large number of denied applications after submission of the required 
documents within a 90 day period. As of the release of Notice 191 until 16 April 2014, CFDA had 
approved 2,914 imported cosmetics applications, which was higher than the average number for 
the same period over the past four years. 
3.2.3.24  Ecuador – Ministry of Public Health Executive Decree (Agreement) No. 
00004522 amending the Sanitary  Regulations for the Labelling of Processed Foods for 
Human Consumption (IMS ID 416) 
3.157.  The representative of Canada indicated that while Canada supported Ecuador's objective of 
reducing the risk of non-communicable diseases, it was concerned that the regulatory proposals 
might have a significant impact on trade and be mo re trade restrictive than necessary. In addition, 
in accordance with Article 2.9 of the TBT Agreement, Canada strongly recommended that Ecuador 
notify the measure, along with a copy of the full  text of the proposed regulation, to the WTO and 
allow for a comment period. Furthermore, she asked whether the measure had already entered 
into force, possibly on 29 May 2014, as some reports indicated. If so, Canada was concerned that 
Ecuador had not provided trading partners the approp riate transition period prior to the entry into G/TBT/M/63 
 
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  force of the measure, as required by the TBT Agreement. She invited Ecuador to provide an 
update on how Members' concerns were being taken into account in any amendments to this regulation. 
3.158.  The representative of the United States a ssociated herself with the concerns expressed by 
Canada on this issue and referred Members to the US intervention under specific trade concern 
number 14 (Resolution No. 116 of the Foreign Trade Committee of Ecuador of 19 November 2013 and Technical Regulation of the Ecuadorian Standardization Institute RTE INEN 022 on the 
labelling of processed and packaged food products.) 
3.159.  The representative of Ecuador explained that the Decree's objective was to better regulate 
the labelling of processed foods for human consumption in order to guarantee the constitutional 
right of citizens to appropriate, clear, precise and non-misleading information about the contents 
of these foods, thus allowing them to make ri ght decisions when purchasing and consuming such 
products. The Decree amended technical regulation  RTE INEN 22 on labelling of processed and 
packages food products, which had been notifi ed as G/TBT/N/ECU/19/Add.1 on 29 April 2010. The 
amendment introduced a graphical system, which described "high", "medium" or "low" content 
with regard to the following three ingredients: salt, sugar and fat. This graphic system was designed on a per 100mg/100ml measurement basi s. The reason why the amendment did not use 
measures in terms of "portions" was to avoid be consistent with the objective of giving consumers 
clear information about what they were consuming, in particular in the case of "snacks", "soft drinks", and "sweets" containing high levels of the three ingredients listed above, and which might 
cause harmful health effects. Ecuador explained that using "portions" to express nutritional 
content would require providing such information in terms of proportion. This, could, in turn, 
confuse consumers and lead them to believe that it would not be problematic to eat many small portions given that, individually, each portion had low levels of salt, sugar or fat. He also informed 
that the amendment included requirements with respect to the declaration of transgenic content 
and non-caloric colorants. Transgenic labelling would be required, in accordance to the parameters found in INEN 334/1, if transgenic content corresp onded to at least 0.9% of the product's overall 
ingredients. Without prejudice of further revisions and amendments, Ecuador informed that the 
measure was expected to enter into force in August 2014. 
3.2.3.25  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 wa ste sorting instructio ns" G/TBT/N/FRA/153 
(IMS ID 420) 
3.160.  The representative of Canada remained concerned that the Decree may create 
unnecessary obstacles to international trade, contrary to France's WTO obligations, and may not 
achieve its environmental objective. She requeste d the EU to clarify the exact meaning of the 
TRIMAN mark as the written response from the EU was that: "the TRIMAN logo pursues a different 
objective than … the 'green dot'… [which] means that the person who puts … products on the 
market for household use has contributed to the costs of recovery and recycling." Canada had understood the TRIMAN mark to signal that the product was subject to extended producer responsibility, and was therefore duplicative of the intention of the "green dot". She suggested 
that the TRIMAN mark, even if intended to guide the consumer to recycling practices, may not 
serve any purpose beyond that conveyed by the internationally recognized "Mobius" recycling 
mark. Canada was of the view that the TRIMAN mark may be an indicator that the packaging was 
recyclable, but conveyed no further detail to help the consumer on how or where to recycle. Citing 
Articles 2.2 and 2.4 of the TBT Agreement, Canada requested the EU to clarify why the TRIMAN mark was needed when an internationally reco gnized symbol would serve the same purpose. 
Furthermore, it was unclear how France could, in accordance with its most favoured nation 
obligations under Article 2.1 of the TBT Agreemen t, extend an exemption to other EU member 
states in the application of the TRIMAN mark where alternative marks existed, and not to other WTO Members. 
3.161.  The representative of the United States reiterated concerns previously raised concerning 
this proposed measure and asked if France had considered whether the cost to implementing it 
would be disproportionately high as compared to the stated policy objectives of simplifying waste 
sorting activities and increasing the recycling rate. The US also asked how requiring most products 
be labelled solely for the French market would be compatible with Articles 34 and 36 of the Treaty 
on the Functioning of the European Union Treaty . The US was of the view that this proposed G/TBT/M/63 
 
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  measure would effectively block free movement of trade within the EU for products that were 
legally labelled and traded within the rest of the single market. The US was particularly concerned with the lack of a harmonized approach to sorting waste in France with some regions and municipalities more advanced than others. In the least advanced regions, she said, where there 
was no provision of different waste bins to sort household waste, the relevance of giving sorting 
instructions to the consumer without a specific consumer education programme was questionable. France was therefore urged to consult with producers and manufacturers from other countries for 
alternative options that would be less costly and increase recycling rates. She asked if there were 
any consumer education programmes in place or planned for the future as France could achieve the same policy objective by developing a consumer education programme with a systemic long-term impact on recycling habits without negatively impacting trade. 
3.162.  She also said that, while the US was plea sed that "glass" was specifically exempted from 
the scope of the proposal in the law published on 3 January 2014, it understood that other packaging, including outer packaging and aluminium and plastic closures, would still be subject to 
the recycling logo requirement. From a practical standpoint, the US was unclear on how companies 
would be able to comply with some of these requirements. She asked whether the logo would be required to be included on the product label, indicating that it was referring to the closure, if it was 
not possible for the logo to be on the packaging and how this information would be made clear to 
the consumer. It was also unclear at what point in the supply chain the labels could be affixed: in the country of origin or in a bonded warehouse. The US also asked for clarification on where the logo was required to be placed and how large the logo was required to be. Given the potential 
disruption to international trade, the US encouraged France to allow further comment and 
consideration of the proposal taking specific acco unt of the concerns relayed by trading partners 
and the difficulties and costs this measure would add to products being exported to France. The US 
was concerned with the proposed requirements' compliance with the obligations under Article 2.2 
of the TBT Agreement, as it would likely create an unnecessary obstacle to international trade and be stricter than necessary to meet the objective pursued.  
3.163.  The representative of Mexico stressed her country's interest in this issue and in the replies 
to be submitted by the EU.  
3.164.  The representative of the European Union said that detailed explanations of the French 
draft decree had already been provided at the TBT Committee meeting in March 2014 
(G/TBT/M/62). The EU stated that the legislation was still at a draft stage and that there had been 
certain changes in the draft aimed at simplifying the obligations in the measure. For instance, in the case of tyres and furniture, the TRIMAN logo  may be affixed on the packaging of the product 
or on the accompanying document of the produc t and not on the product directly. The exemption 
for glass packaging was also maintained. 
3.2.3.26  Russian Federation – Safety of  products for children and adolescents 
(G/TBT/N/RUS/29) (IMS ID 418) 
3.165.  The representative of the European Unio n recalled that amendments to this technical 
regulation were still under development and no precise date was provided for the adoption and 
implementation of the notified draft. The EU wa s still concerned with the ban introduced by the 
draft technical regulation of "artificial or synthetic leather". The EU stated that the concept of 
"artificial or synthetic leather" did not exist because leather was defined as "a product of animal origin" by the International Council of Tanners. The EU was of the view that a lack of clear 
understanding of materials defined as "artificial or synthetic leather" could lead to potential 
misinterpretations. Regarding the absorption requirement for certain first layer articles for sporting purposes, the EU reiterated that properties of sy nthetic fibres allowed these articles to keep the 
body dry, and hygroscopicity testing should not be required. The EU also considered the wide 
range of labelling and marking requirements in the technical regulation to be excessive when compared to the information needed to be provided to the consumer. In this respect, the EU invited Russia to consider limiting mandatory labelling requirements to only absolutely essential 
elements, such as the composition of the product, with other information left to the discretion of 
the producer or distributor. Concerning conformi ty assessment procedures, the EU recalled that 
the technical regulation allowed for compliance to be demonstrated through certificates of 
conformity or declarations of conformity, depend ing on the product. The EU considered textile, 
clothing, leather and footwear to be low risk products. It would therefore follow that compulsory third party conformity certification would, in this case, create unnecessary barriers to trade in the G/TBT/M/63 
 
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  form of additional burdensome and onerous requir ements. The EU suggested that, instead, a self-
declaration by the manufacturer be deemed sufficien t proof that these products were safe. The EU 
sought clarification on which standards were being referred to in the technical regulations and if GOST standards would continue to apply. Finally, the EU again stressed that its concerns related to 
technical requirements and conformity assessment procedures were the same with regard to the 
Customs Union's technical regulation on "safety of light industry products", notified as G/TBT/N/RUS/31 on the same day as G/TBT/N/RUS/29.   
3.166.  The representative of Norway associated he rself with the statement and concerns raised by 
the EU and looked forward to updates and written replies from Russia. 
3.167.  The representative of Ukraine said that, lik e previous delegations, Ukraine also considered 
that because textile, clothing, leather and footwear were low-risk products, the conformity 
assessment procedures established under the Russian measure were too time-consuming and 
costly for producers and, consequently, constituted unnecessary barriers to trade. He also said that the global practice was to ensure safety of input materials rather than imposing mandatory 
conformity assessment procedures through compulsory third party certification. He said that the 
stated objective of the regulation, such as safety and consumer protection, would hardly be achieved through such compulsory requiremen ts. He added that both of these technical 
regulations included certain sanitary requirements to footwear which were the same as that in the 
mandatory Customs Union common sanitary, epidemiological and hygienic requirements to products of 28 May 2010. Given the forgoing, he asked Russia to clarify the need for these requirements. Ukraine also expressed concern wi th the wide range of labelling and marking 
requirements included in Article 9 of the technical regulation on the safety of products for children 
and adolescents. Ukraine considered this requirement to also be more trade restrictive than necessary to fulfil the objective of consumer protection.   
3.168.  The representative of the Russian Federa tion welcomed the comments of the EU, Norway 
and Ukraine on the amendments to the Customs Union technical regulation on the safety of 
products for children and adolescents. Concerning  the timelines, he said that the technical 
regulation entered into force in 2012 with a transi tion period for economic operators that expired 
in 2014. In practice, implementation of the te chnical regulation had revealed the need for 
liberalization of certain requirements applied under the measure. Amendments to the technical regulation were developed and notified as G/TB T/N/RUS/29. Public hearings on amendments to 
the technical regulation started in December 2 013 and, based on requests from WTO Members, 
were extended until April 2014. Comments from interested parties had been received and were being considered in the draft amendments currently under development. He added that procedures 
for the introduction of amendments to technical regulations were similar to those for the 
introduction of the regulation itself. He stated th at the amendments were at the stage of internal 
coordination and would probably be adopted no earlier than September 2014 and would enter into 
force around March 2015. He cautioned, however, th at this was only an estimate and clarified that 
the existing technical regulation would continue to be applied before the amendments entered into force.  
3.169.  On the substance of the measure, he clarif ied that it only applied to products used by 
children and adolescents and that products used by adults were less stringently regulated by 
another technical regulation on the safety of ligh t industry products. Russia was of the view that 
more stringent requirements for products used by children were necessary for attaining the 
legitimate objective of ensuring their safety and health. It also served as scientific justification for 
corresponding stricter conformity assessment procedures. Russia also explained that a number of international standards were included in the list of standards attached to the technical regulation 
and that compliance with these standards, such as ISO standards, was equal to compliance with 
the technical regulation. Russia clarified that there was no ban on "artificial leather". Instead, Annexes 14 and 15 to the technical regulation simply established some additional requirements for "polymer based" or "artificial leather". More strict requirements had also been established in the 
technical regulation for "first layer articles" that had contact with skin. For other goods, in the 
"second" or "third layer", the requirements were not as strict. He said that labelling requirements were mandatory and were established by the technical regulation for consumer protection. 
According to paragraph 1 of Article 9 of the technical regulation, a manufacturer could choose to 
meet the labelling requirements in different ways: by placing the label on the product itself, or by attaching the label to the package of the product or  group of products, or by inserting a card to 
the product. He also said that the mandatory sign  of distribution marking in the markets of the G/TBT/M/63 
 
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  member states of the Customs Union represen ted compliance with the requirements of the 
Customs Union technical regulation.   
3.2.3.27  India – Labelling Regulations for Canola Oil (IMS ID 413) 3.170.  The representative of Canada stated that as of May 2014, India's Food Safety and 
Standards Authority (FSSAI) had apparently banned the marketing and labelling of canola oil. The 
High Commission of Canada to India had been notified that the product be labelled and marketed as: "imported refined rapeseed oil - low erucic acid" and canola oil as an additional trade name 
could be used. Previously, canola oil products had been labelled as canola oil and "ingredients: 
imported refined canola oil" and had entered India for several years without incident. She said that India's seemingly irrevocable decision to impose new labelling requirements to shipments directly and immediately affected export, marketing and sale of canola oil in India. In Canada's view, India 
was in violation of the TBT Agreement for having failed to notify to the WTO the changes to its 
labelling regulation and because this regulation was more trade restrictive than necessary to achieve a legitimate objective. Canada also expr essed concern that the labelling requirements for 
canola oil contained in India's Food Products Standard and Food Additives Regulation 2011 did not 
conform to the relevant international guidelines recommended by the Codex Alimentarius Commission, as Codex standards deemed canola oil and low erucic acid rapeseed as synonyms. 
India's labelling requirements appeared to discriminate against the legitimate term canola oil. 
Since India's regulation differed from this relevant international standard from the Codex, Canada was of the view that India's regulation also viol ated Article 2.4 of the TBT Agreement. She noted 
that the FSSAI was not allowing suppliers to comply with the new labelling requirements by way of 
temporary use of stickers as an alternative solution and importers were required to re-export the 
shipments in bond with no exception.  
3.171.  The representative of India said that Canola oil was an edible vegetable oil produced from 
rapeseed bearing low erucic acid. Canola oil had been imported to India for several years, mostly 
from Canada. For India, canola oil was nothing but a given trade name. Consistent with the way this product was listed in the Codex standard, the appropriate marking for imports into India was 
"imported rape rapeseed low erucic-acid oil (canol a oil)" or "imported refined rapeseed low erucic 
acid (canola oil)". The objective of this marking was to ensure that consumers could make an informed choice. This was only a simple change of product declaration on the labels. Instead of writing only the trade name, suppliers were now required to declare the actual ingredient on the 
product label for the purpose of informing cons umers. In India's view, this would not be 
characterized as a measure more trade restrictive than necessary. Since this was an old regulation, dating back to 2011, India urged Canada to start following it as any previous non-
adherence to the regulation did not imply that such situation could continue in the future. 
3.2.3.28  Egypt – Bottled water (IMS ID 421) 3.172.  The representative of Turkey said that  Turkish bottled water exporters were unable to 
obtain import permission from Egypt's Supreme Committee for Water in the Ministry of Health for 
the following reasons: (i) bottled water could not be imported into Egypt as periodic control of its source could not be maintained based on Egyptian Standard No. 2007/1589; and (ii) bottled water could only be imported from producers based in EU member states that had applied the HACCP 
system. He recalled that although in June 2013 Egypt had explained that the mandatory Egyptian 
food product standards were being revised in a ccordance with "Codex Standard 227-2001" and 
"WHO Guidelines for Drinking Water Quality, 2011", no further explanations had been provided 
thereafter. Exporters were still unclear about certain aspects of the measure. For example, if any 
conformity assessment procedures existed for the ex port of bottled water to Egypt, such as the 
steps to be taken for the control of water at its source, they should be published and notified to 
the Committee, consistent with Article 5.6 of the TB T Agreement. Turkey was also of the view that 
this current Egyptian practice was contrary to the principle of non-discrimination and also constituted an unnecessary obstacle to international trade, contrary to Articles 2.1 and 2.2 of the TBT Agreement. He invited Egypt to cooperate with  Turkey on this matter and bring its legislation 
and implementation into compliance with TBT Agreement rules.  
3.173.  The representative of Egypt said that impo rts of bottled water were subject to the Egyptian 
Standard No. 1589/2007, mandated by the Ministerial Decree No. 130/2005, which was notified to 
the TBT Committee as G/TBT/N/EGY/1. She said that this standard was publicly available at the 
Egyptian Organization for Standardization and at their website ( http://www.eos.org.eg ). Egypt G/TBT/M/63 
 
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  applied this decree equally to domestic bottled water companies. Her delegation stated that the 
Egyptian standard was in conformity with th e relevant CODEX standards and WHO guidelines. 
Therefore, it was fully compliant with Article 2.1 of the TBT Agreement. Furthermore, she said that 
compliance with this Egyptian standard was not more trade restrictive than necessary as the 
measure was necessary for consumer health, safety and protection. Finally, Egypt confirmed that 
the requirement that bottled water may only be imported from EU producers applying the HACCP system had been removed. 
3.2.3.29  Italy - Testing requirement on impo rt of steel cutlery products (IMS ID 395) 
3.174.  The representative of India noted that Italy did not allow utensils and cutlery made of 
grade 200 stainless-steel and only accepted it ems made of grade 202 and 304 stainless steel. 
India stated that grade 200 stainless-steel co ntained 13% chromium and was considered food 
safe. Moreover, other EU member states, such as  France, Germany and the UK, allowed the import 
of utensils and cutlery made of grade 200 stainless steel. He added that the stainless steel grades from India had passed three tests (N1, N2 and N3) prescribed by the Bureau of Indian Standards 
but these tests were not acceptable in Italy. The testing method in Italy was rigorous. It required a 
s e r v i n g  t o n g  b e  k e p t  i n  a c i d  f o r  m o r e  t h a n  f o u r  d a y s  t o  d e t e r m i n e  i t s  f o o d - s a f e n e s s .  I n d i a  considered this testing method to be inappropriate and more trade restrictive than necessary to 
fulfil its objective given that serving tongs held food for only a short time. These requirements had 
created an unnecessary obstacle goods exported from India. He therefore requested to be 
provided with the scientific justification for maintaining such technical requirements. India was also concerned by the lack of harmonization amon g the EU member states in this matter. 
3.175.  The representative of the European Union stated that this requirement was not harmonised 
at the EU level and therefore the EU member stat es could maintain or adopt national rules in 
accordance with Article 6 of Regulation No. 1935/ 2004 of the European Parliament and Council on 
materials and articles intended to come into contact with food.. He added that the Italian Decree 
of 21 March 1973, as amended, set up a "positive list" of components (plastics, rubber, cellulose regenerated paper and cardboard, glass and stainless steel) that could be used in the manufacture 
of packaging, containers, utensils that came into contact with foodstuff or in substances for 
personal use. The import of grade 200 stainless steel was not allowed in Italy because it was not included in the authorised list of this Italian legislation. The EU said that, at the request of stakeholders, the lists could be updated with new substances or materials after an evaluation by 
the National Health Institute of Italy and an opinion of the High Council of Health of Italy. The 
documentation to be submitted with an application for inclusion in the list was also defined in the Italian legislation. Migration tests had to be conducted on the steel that was the subject of an 
application, and the tests had to be performed by laboratories operating to the standard EN 
ISO/IEC 17025 ("General requirements for th e competence of testing and calibration 
laboratories"). The steel designation name had to be specified in accordance with internationally 
recognised rules, such as the standard UNI EN 10088 1:2005. If the steel could not be matched 
with these rules, a statement with the complete casting chemical analysis to identify the stainless steel concerned had to be provided. In reply to  the Indian authorities stating that grade 200 
stainless steel was not allowed in the Italian market in spite of meeting the Italian requirement of 
13% chromium and being food safe, he said that this had to be underlined in the request by the 
applicant for the inclusion of grade 200 stainless steel in the "positive list". He added that the stainless steel also had to comply with the overall and specific migration limits established in the 
Italian Decree of 21 March 1973 for chromium, nickel and manganese. 
3.2.3.30  India – Drugs and Cosmetics Rules 2007 (G/TBT/N/IND/33) (IMS ID 167) 3.176.  The representative of the European Unio n recalled that the India's Drugs and Cosmetic 
Rules were published in the Gazette of India in May 2010 and its implementation, initially 
scheduled to take place as from April 2011, was deferred to March 2013. On 2 January 2013, the Indian Government had issued Guidelines on th e Registration of Imported Cosmetics. These 
Guidelines had established that the label of imported cosmetics had to bear the registration 
certificate number of the brand and the name and address of the registration certificate holder. 
The EU welcomed the fact that these same Guidelines established that the "stickering of labels containing the registration certificate number of the brand and the name and address of the 
registration certificate holder may be allowed to be carried out after import at a suitable place 
approved by the licensing authority". However,  the EU requested India to confirm whether 
providing information via stickers at customs-bonded warehouses to all aspects of cosmetics G/TBT/M/63 
 
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  labelling, including the listing of cosmetic ingredients or any other information for the consumer, 
was also allowed. He said that allowing information to be provided after import in customs-bonded warehouses was an important trade facilitating measure that did not jeopardise India's legitimate health and safety objectives. This was relevant for manufacturers that exported in small quantities 
and found it difficult to adapt the labels to different geographical region requirements. The EU 
hoped that India could take this suggestion in to account and amend the January 2013 Guidelines 
on the Registration of Imported Cosmetics. 
3.177.  The representative of India said that the Drug and Cosmetics (Amendment) Rules 2007 for 
the import and registration of cosmetics were finalized vide GSR No. 426(E), dated 19 May 2010. 
As per this notification, registration of cosmetics was to be made effective as from 1 April 2011. Subsequently, via GSR 733(E), dated 29 September 2012, the Rules for import and registration of 
cosmetics were implemented with effect as from 1 April 2013. He informed that, to date, about 
400 registration certificates and 190 product endo rsements had been issued. There were no major 
issues reported regarding the registration proced ure for the import of cosmetics. His delegation, 
however, had noted the concerns and suggestions of the EU regarding the labelling requirement. 
These would be forwarded to the concerned capital-based authorities and their response would be communicated to the EU in due course. 
3.2.3.31  Ireland – Proposal to introduce standardised/plain packaging of tobacco 
products in Ireland (G/TBT/N/IRL/1) 
3.178.  The representative of Nicaragua noted that, as indicated in a study undertaken over three 
decades by the Institute for Health Metrics and Evaluation at the University of Washington, 
evidence showed such kind of measures did not succeed in getting people to give up smoking . 
Nicaragua also considered that it would be premature to implement such a tobacco packaging measure while the TBT and TRIPS consistency of a similar measure by Australia was currently 
been challenged before the DSB by four Members, with forty Members acting as third parties to 
the dispute. Nicaragua therefore encouraged Irel and to abstain from adopting the measure until 
the report of this panel was finalized. He stressed that plain packaging measures would have a 
negative effect on the Nicaraguan economy, which largely depended on the production and export 
of tobacco products, with 35,000 direct employees and many more that indirectly benefited from 
the tobacco industry, including in the tourist industry. While Nicaragua shared the objective of protecting human health by using effective tobacco control measures, it opposed the attainment of 
such objectives by regulations that were more trade restrictive than necessary and which would be 
inconsistent with international law.  
3.179.  The representative of the Dominican Repu blic supported the statement made by Nicaragua 
and also urged Ireland to suspend the application the measure until the DSB had ruled on the case 
against Australia.  
3.180.  The representative of Guatemala support ed the statements made by Nicaragua and the 
Dominican Republic. She encouraged Ireland to consider less trade-restrictive measures while 
allowing for the achievement of its legitimate objective. 
3.181.  The representative of Australia reiterated his delegation's strong support for the decision 
by the Irish Government to legislate for mand atory plain packaging of tobacco products and 
welcomed the recent decision by the Irish cabine t to approve draft legislation which would require 
tobacco products sold in Ireland to be plain pack aged and carry graphic health warnings. Australia, 
he said, was of the firm view that Members ha d the right to implement measures necessary to 
protect public health, while complying with relevant international treaty obligations, including the 
TBT Agreement. Tobacco plain packaging was a legitimate measure designed to achieve the fundamental objective of the protection of human health. This approach was endorsed by leading 
health experts as well as the WHO and suppor ted by extensive peer review and research. 
Concerning the Australian measures that were currently before the DSB, he said that his country was vigorously defending its measure within the mechanisms of the WTO. It was therefore inappropriate for the complainants in ongoing WTO disputes, including this one against Australia, 
to invoke those proceedings as an attempt to delay or discourage other Members from developing 
or implementing their own legitimate tobacco-control measures, particularly when a number of those Members had delayed the prosecution of those very dispute settlement proceedings.  G/TBT/M/63 
 
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  3.182.  The representative of Cuba associated he rself with the statements made by Nicaragua, 
Dominican Republic and Guatemala and reiterated Cuba's concern with the fact that this measure 
was being implemented while the Australian measure was being challenged before the DSU. The statement delivered by the representative of Cuba is contained in full in G/TBT/W/391. 
3.183.  The representative of Honduras associated himself with the statement made by Nicaragua 
and called Members' attention to the five disputes against the Australian tobacco plain packaging 
measure, the decisions of which would help to give an answer to this matter. 
3.184.  The representative of Norway commended Ireland on its measures to combat the tobacco 
epidemic, and said that it was well within the right of WTO Members to adopt measures necessary 
to protect public health insofar as they were co nsistent with the WTO Agreements. Norway recalled 
that plain packaging of tobacco products wa s the recommended measure under the Framework 
Convention on Tobacco Control (FCTC). It was the opinion of Norway that the FCTC and the 
relevant WTO Agreements were mutually supportive, and that it was possible to introduce measures for the regulation of tobacco products in line with both sets of obligations. 
3.185.  The representative of New Zealand support ed Ireland's decision to commence the process 
of introducing a plain packaging regime for all tobacco products. There was an extensive and 
growing body of international research that es tablished that plain packaging, as part of a 
comprehensive tobacco control programme, would contribute to the objective of improving public 
health. The WTO Agreements did not prevent Members from taking legitimate action to protect the health of their citizens. WTO rules, including those in the TBT Agreement, included appropriate flexibilities to enable WTO Members to regulate for health and other public policy purposes. New 
Zealand was therefore confident that Members would be able to introduce plain packaging regimes 
in a manner consistent with their obligations both under the WTO Agreements and the commitments undertaken under the WHO FCTC. 
3.186.  The representative of Zimbabwe associated his delegation with the concerns expressed by 
Nicaragua, Cuba, Dominican Republic, Guatemala and Honduras. While Zimbabwe appreciated the 
efforts made by Ireland to protect public health, the proposal appeared to be inconsistent with 
Article 2.2 of the TBT Agreement as this technical regulation would be more trade restrictive than 
necessary to fulfil its stated legitimate obje ctive. Furthermore, the measure would impact 
negatively on employment, economic performance and poverty alleviation efforts in Zimbabwe, where tobacco farming was the major economic activity and source of livelihood for many farmers. 
Tobacco contributed significantly to Zimbabwe's GDP and was a major export. 
3.187.  The representative of Chinese Taipei said that his delegation shared Ireland's objective 
with regard to public health and the fight against tobacco. Chinese Taipei followed with great 
interest the ongoing Australian plain packaging case  in the DSB, and believed that the rules of the 
WTO, including those under the TBT Agreement,  were drafted to balance the interest in 
liberalization of world trade, in one hand, with th e right of each Member to pursue public health 
policy objectives, on the other.  
3.188.  The representative of Uruguay was of the view that the Irish plain packaging measure was 
compatible with WTO rules. In implementing such a measure, Ireland would be merely exercising 
its sovereign right to protect public health by givi ng effect to the obligations it had undertaken as a 
party to the WHO FCTC, in particular its Article 11 and relevant implementing guidelines. His 
delegation supported the statement made by Aust ralia that ongoing DSB cases should not have 
any bearing on Members adopting measures in favour of public health. 
3.189.  The representative of Ukraine associated her delegation with the statements made by 
Members concerned with the measure's consistency with the TBT and TRIPS Agreements. Ukraine 
considered that this measure was more trade restrictive than necessary to fulfil the stated 
objective and could, in fact, have the contrary effect of stimulating illicit trade and therefore 
raising even more health and economic problems. Ukraine also believed that it would be prudent 
for Ireland to await the outcome of the disputes  lodged against the Australian plain packaging 
legislation before enacting its own similar legislation. Ukraine stressed that Ireland should consider 
policy options to influence human behaviour that strike a balance between trade and health so that 
they complement each other. G/TBT/M/63 
 
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  3.190.  The representative of Canada stated that Canada continued to follow with interest ongoing 
international developments in the regulation of tobacco products and how such measures 
interacted with both international trade and public health. Canada noted that it had been a pioneer in plain package labelling requirements for tobacco products, and it considered such requirements 
to be a core component of the right to regulate in the interest of the Canadian public. Tobacco use 
continued to be a significant problem around the world. This suggested that Members should consider the complete economic picture regarding tobacco control, including whether tobacco was 
a net economic drain for many countries.  
3.191.  The representative of Indonesia asked Ireland to defer any final decision on the 
implementation this measure until the Australian dispute brought by five WTO Members, including 
Indonesia, had reached its conclusion. 
3.192.  The representative of the European Union thanked delegations for their detailed comments 
on Ireland's Public Health (Standardised Packaging of Tobacco) Bill 2014. Tobacco products, he 
said, were not ordinary commodities given the harmful effects they had on human health. Health 
protection policies should therefore be given hi gh importance, in particular, those aiming at 
reducing smoking prevalence among young people. The EU considered, in line with 
recommendations of the World Health Organization (WHO) that a high level of health protection 
should be taken as a base for legislative proposals in this area. In this respect, he recalled that 
Article 2.2 of the TBT Agreement included the protec tion of human health as a legitimate objective 
and that any measure pursuant to such legitimate objective must not be more trade-restrictive than necessary or create unnecessary obstacles to in ternational trade. Further, Article XX(b) of the 
GATT 1994, emphasised the importance of public health by justifying measures "necessary to 
protect human... health". He informed that the Irish Government had approved the text of the Public Health (Standardised Packaging of Tobacco) Bill 2014 on 10 June 2014, which, in line with 
WTO obligations, had been immediately notified as a draft measure to the WTO, allowing 90 days 
for comments. In parallel, Ireland had also notified the European Commission in accordance with internal EU requirements for EU member states. He also noted that, in Ireland, reducing the use of 
tobacco products had been a public health policy priority for many years, as over 5,000 people 
died from tobacco related diseases in Ireland a nnually. This Bill followed a range of measures 
already adopted in Ireland that aimed at reducing the consumption of tobacco products. A core objective of this Bill was to reduce the attractiveness of tobacco products especially among young 
people. The Bill was also designed to meet ot her commitments arising from the EU's recent 
Tobacco Products Directive. He said both the EU  and Ireland looked forward to considering the 
views of other WTO Members concerning any legiti mate trade-related issues or any unintended 
consequences arising from this public health initiative. In line with Ireland's EU and WTO 
commitments, the timeline for the legislative process would provide the appropriate opportunity for comment by interested parties. 
3.3  Exchange of Experiences 
3.3.1  Transparency (Thematic session of 17 June 2014). 3.193.  The Chairman presented his report on th e thematic session on transparency held on  
17 June 2014. In concluding his report, he noted that the presentations had been very informative 
and helpful in sharing ideas and good practices; th ey had also showed the challenges involved in 
implementing the TBT Agreement' s transparency provisions. The comments and questions made 
during the discussion had helped the Committee dig deeper. He encouraged delegations to reflect 
further on effective means of implementing and be nefitting from the transparency obligations of 
the TBT Agreement. He said that he had found  the discussion on regional coordination on 
transparency particularly interesting; this was perhaps a topic the Committee could consider 
during the upcoming triennial review in 2015. He also noted that, while not a new issue, different 
forms of "Alert" systems were growing and becoming more advanced as the examples provided by Kenya and the United States had shown. He drew the Committee's attention to a suggestion from Canada that the WTO could look into developing a centralized alert system for TBT notifications. 
Finally, the Chairman encouraged Members to cont inue making use of the on line TBT NSS. The 
Chairman's full report, including a brief summary of each presentation, circulated in document G/TBT/GEN/167.  G/TBT/M/63 
 
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  3.3.2  The Coherent Use of No tification Formats (G/TBT/35) 
3.194.  The Chairman recalled that the European Union had circulated a paper in June 2014 
entitled "A Coherent Approach to Notification  Formats" (JOB/TBT/48) and that a substantial 
amount of work had been undertaken since th en. The Committee had also heard from the SPS 
Secretariat on related working practices; there had been a number of informal discussions; and, 
several delegations had tabled written comments. The latest revision of the Committee's draft recommendation was contained in document JOB/ TBT/68/Rev.2, circulated on 14 June 2014. 
3.195.  The representatives of Japan and the United States expressed support, and made some 
textual suggestions, to the document. Japan, supported by Chinese Taipei, suggested changing the 
word "full" to "draft" in the first line of the first box (New Notification), while the US suggested some clarifying wording in the box on "Revisions ". The representatives of South Africa, Chinese 
Taipei and the European Union also expressed support to the document. South Africa stressed the 
i m p o r t a n c e  o f  t r a c k i n g  t h e  l i f e  c y c l e  o f  T B T  m e asures, while Chinese Taipei and the EU noted, 
respectively, the balance achieved in this docume nt and that a general level of support appeared 
to have been reached.  
3.196.  The Chairman proposed that the Committee adopt the text with the minor modification 
suggested by Japan.  
3.197.  The Committee adopted the recommendation as contained in G/TBT/35. 
3.3.3  Good Regulatory Practice 
3.198.  The Chairman gave the floor to the fo rmer Chairman of the TBT Committee, Mr. Jingo 
Kikukawa (Japan) to report on his consultations held during the week aimed at finalizing the work 
of the Committee on its "Non-Exhaustive List of Voluntary Mechanisms and Related Principles of 
Good Regulatory Practice (GRP)". The report is set out in full in document G/TBT/GEN/168. 
3.199.  All delegations that took the floor thanked the former Chairman for his efforts.  
3.200.  The representative of China said that his delegation valued greatly the GRP document. It 
was China's understanding that this document was about facilitating an improved implementation 
of the TBT Agreement; it was expected to provide guidance in improving domestic regulations with 
the aim of implementing the TBT Agreement. Ne vertheless, when reviewing recent DSB cases, 
such as US Tuna II, questions about the legal implications of this Committee document had arisen, in particular whether the document - once adopted - could serve as interpretative instrument in DSB proceedings. China also noted the view of other Members with respect to how to address 
these concerns. China stressed that it was open to continue to constructively engage in further 
discussions.  
3.201.  China thanked all Members, the Secretariat and the Chairman for efforts made to bring 
forward discussions on GRP. At the same time, it did not think the "Rev.4" had been intended as 
the final version of this document. There had been a clear indication that comments could still be made before 30 April 2014 – and there had been no way of foreseeing what those comments 
would be. China noted that in the comments it ha d submitted before that deadline (JOB/TBT/93), 
it had requested, among other things, the insertion of the word "some" in para. 3. China also stressed that it had engaged cooperatively and constructively during the informal meetings. 
Because the document was of great value, it merited the time invested so as to ensure an in-depth 
communication on the views of different Members. This approach was, in China's view, necessary 
in order to reach consensus. Moreover, there were other important topics that needed to be discussed as well, as had been mentioned in the Chairman's summary. China also stressed the fact 
that there remained opportunities to further discuss these issues. 
3.202.  The representative of the Republic of  Korea expressed deep disappointment that the 
Committee had failed to achieve consensus on the GRP document. This document, he stressed, 
had been prepared in accordance with the Committee's mandate from the Sixth Triennial Review 
Report (G/TBT/32) – and had been the subject of  the Committee's work for over one year and a 
half. He recalled the Chairman's observation that this document had received wide and active engagement by all Members. He noted that alth ough Members had been aware that the document G/TBT/M/63 
 
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  was up for adoption at this meeting, the membership was now facing a challenge essentially about 
divergent views on the "legal nature" of the document. Korea stressed that this GRP document was simply intended to serve as guidance, i.e. as a complementary tool to help Members implement the TBT Agreement more effectively and efficiently. It was not, therefore, a treaty. 
Moreover, the mandate for this work came from the Committee's own Sixth Triennial Review 
Report. It was this Report that provided a clear legal "umbrella" of the GRP document. There was, 
in Korea's view, no need for disclaimer about legal nature because the Sixth Triennial Review 
report clearly specified that the Committee's mandate was to:  
"…identify a non-exhaustive list of voluntary mechanisms and related principles of 
GRP, to guide Members in the efficient and effective implementation of the TBT Agreement across the regulatory lifecycle,…" (paragraph 4(a) of G/TBT/32) 
3.203.  Korea called Members' attention that the words "non-exhaustive" and "voluntary" in the 
above text were not mandatory language. He aske d why it would be then necessary for the GRP 
document to have a legal disclaimer in terms of its general interpretation, let alone a specific link 
to the Vienna Convention on the Law of Treaties. Even if the GRP guidelines were not followed, no 
Member would go to formal dispute settlement proceeding with a claim of violation of the GRP guidelines which were voluntary in nature. Members could not afford to unnecessarily spend time 
on never ending negotiations of a text that was voluntary in nature and which was only intended 
to facilitate implementation of the TBT Agreement. These were not the DDA negotiations. The Committee, he argued, was a forum to seek improvement over practices. For Korea, it was important for the Committee to show flexibility and creativity so as to be able to move forward and 
finish the remaining task as early as possible.  
3.204.  The representative of South Africa said that the use of non-committal wording, such as 
"voluntary", "may" and "could" – instead of "shall" as  well as a clear expression that the proposed 
steps and examples of mechanisms in the document were not legally binding, unless already 
contained as a legal provision in the TBT Agreement, would address the concerns South Africa had. He was of the view that the document contained a comprehensive, although non exhaustive list of 
voluntary mechanisms and related principles of GRP that was derived from the best practices of a 
representative group of WTO Members. The current document provided an excellent guideline for regulators on what good regulatory practice could entail. South Africa was of the view that if regulators incorporated steps outlined in the document in their respective regulatory activities, the 
technical regulations and conformity assessment pr ocedures developed by such regulators would 
most likely not create unnecessary obstacles to international trade. This would contribute towards greater compliance with TBT Agreement thereby also reducing the number of specific trade 
concerns (STCs) discussed in TBT Committee meetings. The representative of South Africa 
encouraged delegations to finalize the draft document and noted that, once finalized, this 
document could be revised an updated over time, for instance during the Committee's triennial 
reviews.  
3.205.  The representative of Indonesia shared the concerns expressed by China about the 
possible legal implication of the document. Indonesia was of the view that it was important for 
Members to make clearer the status of the document to prevent possible misinterpretation of the 
document in the future. 
3.206.  The representative of India expressed disappointment that agreement had not been 
possible and associated himself with the concerns raised by the delegation of China. If Members 
agreed with the fundamental principle that the do cument did not cast any legal obligation and was 
voluntary in nature, then there need not be any issue with explicitly stating that the document 
could not be referred to when seeking any eventual legal interpretation in the future.  
3.207.  The representative of the European Union noted that the document had almost been 
brought to a close and regretted that the process had come to a halt. The EU considered important 
to understand the nature of the concerns raised before deciding whether they were founded. Turning to the text itself, the EU considered that the starting point was that any text had to be 
interpreted in accordance with the ordinary mean ing to be given to the words it contained. The 
GRP guidelines contained many words which described them as "non-exhaustive", "voluntary", and "illustrative". The text also contained statements to the effect that Members need not follow the 
suggested steps or that they did not need to fo llow a defined sequence and that their application 
depended on their level of development and admi nistrative capacity. Further, any illustrative G/TBT/M/63 
 
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  examples given were always preceded by the qualif ication: "may include, for instance". In other 
words, said the EU, in no way could it be inferred from the document an intention from the drafter – let alone the TBT Committee itself – to create any binding obligation for Members. Moreover, in 
no way did the document sought to interpret specific terms or provisions of the TBT Agreement, 
which would be a fundamental precondition for a Pane l or the AB to rely on this document in the 
interpretation of a term or a provision of that Agreement. Instead, the guidelines set out a non-
exhaustive list of practices that Members themselv es, based on their own experiences, considered 
as good practices to ensure / improve the qualit y of the outcome of their regulatory processes. 
And this was done without prejudice as to whethe r the actual outcome of the regulatory processes 
was in itself compatible with the TBT Agreement. In other words, the Committee was not interpreting the meaning of "not more trade rest rictive than necessary". The guidelines merely 
stated that it was useful to evaluate the impact of proposed initiatives, to evaluate alternative 
options, to seek the views of stakeholders, in or der to ensure and maximize the chances that the 
outcome would be compatible with the TBT Agreement. 
3.208.  In response to China's explanation that its concern had arisen from the Appellate Body 
decisions in US-Clove Cigarettes and US Tuna II,  the EU considered that these findings were 
inappropriate as they took place in fundamentally different contexts. In those cases there was full 
symmetry between the terms of the TBT Agreement an d the language used in the Doha Ministerial 
Decision (in US-Clove Cigarettes), and the TBT Committee Decision on Principles for International Standards (in US Tuna II). In US-Clove Cigare ttes it was about a "reasonable interval" between 
publication and entry into force of a technical re gulation under Article 2.12 of the TBT Agreement 
and the Ministerial Decision used the wording "should normally be understood as" in order to give 
meaning to this term. In US Tuna II, the issue was about the term "openness" of an international standardization body under Annex 1.4 of the TBT Agreement, a term which was specifically 
referred to in the TBT Committee Decision with the language – openness "should mean". In these 
cases there was no "soft" language, such as "may", "on a voluntary basis", "for instance", "include". In other words, there had to be – in order for a document to be relied on in the 
interpretation of a provision in a WTO Agreement – the same language used in both documents 
and a clear expression of the will of the drafters of the other document that that was intended to 
give meaning or to clarify the meaning of that provision. There was no such indication in the draft GRP guidelines before this Committee.  
3.209.   On the question of the systemic implic ations for the Committee's work, the EU noted that 
Article 15.4 of the TBT Agreement mandated a revi ew of the operation and implementation of the 
Agreement. Anything that the TBT Committee did cl early had a reference to the TBT Agreement for 
that was the framework in which the Committee operated. The Committee could not therefore 
place itself outside of this box. Therefore, the view that documents produced by the Committee did 
not have any interpretive value was incorrect given that whatever the Committee did was 
anchored in the TBT Agreement. This did not mean, however, that it was possible to make the leap 
to say that any document could be relied on in dispute settlement as for that one would have to check the nature of the document. In the specific  case of the GRP Guidelines, the EU considered 
that there was no indication that they bore specific ally on the interpretation of any provision of the 
TBT Agreement. In fact, these guidelines refl ected an agreement among Members that this 
document should not be binding on Members (i.e., they should be voluntary in nature).  
3.210.  The EU concluded by inviting delegations that had raised concerns to detail them so they 
could be better understood. The EU was concerned th at this document could be diluted to such an 
extent that it would undermine current and future  work of the TBT Committee. Furthermore, this 
disagreement on the legal nature of the docu ment itself had prevented the Committee from 
looking at other important issues in the text; these different discussions needed to take place in 
parallel.  
3.211.  The representative of Argentina said that his delegation also regretted the lack of a 
consensus. However, listening to the different posi tions, there did appear to be a consensus on the 
fact that the document was not binding, that it was voluntary, only illustrative, and that there 
were no new obligations. So, if that was the case, why could a disclaimer, as suggested by China, not be acceptable to all? 
3.212.  The representative of Brazil said, in regard to the legal status of the document, that the 
document was a non-exhaustive list of voluntary mechanisms. In this regard, Brazil considered 
that it did not affect the rights and obligations in relation to the TBT Agreement. It was not G/TBT/M/63 
 
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  intended to create any additional obligations. Brazil was open to consider options that would give 
comfort to all Members regarding this point.  
3.213.  The representative of Chinese Taipei said that the document achieved a good balance 
between different positions from various Members.  He noted that regulatory impact assessment 
(RIA) was one of the most important tools in GR P and encouraged Members to continue to share 
their experience in conducting RIAs. He recommend ed that the Committee to hold a workshop that 
focused on RIAs to guide Members in an effi cient and effective implementation of the TBT 
Agreement.   
3.214.  The representative of Mexico associated herself with the comments made by Korea and the 
EU and expressed her delegation's disappointment with in the lack of consensus over this 
document that was mandated by the 6th Triennial Review. These Guidelines were entirely 
voluntary in nature and were not prescriptive in any sense, and, as such, they did not add or 
diminish Members' rights and obligations.  
3.215.  The representative of Cuba supported the document and noted that Cuba had made 
comments on it in three occasions. Nevertheless, if there were Members that had outstanding 
concerns, these had to be taken into account. 
3.216.  The representative of the United States a ssociated herself with the concerns expressed by 
the EU and expressed her delegation's disappointm ent with the current situation. She noted that 
her delegation had been engaged both in the WTO and elsewhere – as the ideas applied to all work on in the TBT realm – for a long time. This was, essentially, about helping Members find new ways to strengthen implementation of the TBT Agreemen t while keeping the guidance voluntary. It was 
clear to all that this was not a legally binding document. This had always been the spirit of the 
Committee's work. She recalled and commended the TBT Committee's ability to lay out a task, define the problem, roll up its sleeves and work collaboratively towards an outcome. She reiterated 
that this was the only Committee that regularly put out 30 page consensus documents that were 
of value to all.  
3.217.  She also noted a number or remaining substantive issues had not been addressed because 
delegations had been held up by discussion on the legal nature of the document. First, the US felt 
that there was room to breach differences on th e subject of Special and Differential Treatment. 
She recalled that in March 2014, the US had asked countries who would like SDT to explain what they wanted to have in the second column of the document. The US had been asked to provide 
examples of what it did to take into account the interests of other countries, including developing 
countries, to operationalise these provisions. The US had thus come forward with several ideas that were practices that the US had in place that could be used and these could be included in the 
column to illustrate how this was operationalized as a means of addressing the particular needs 
and interests of developing countries. A second element that the US wanted to see addressed was in Section D, where some points that had existed in previous versions could be reintegrated in a 
way that could be broadly acceptable. The US remained open to continuing this work. However, 
the US did need to have from the proponents, those countries that were particularly concerned about the legal interpretative issues of the text, a more specific understanding of what their needs were. In this respect, she expressed her delegation's view that a broad disclaimer that pulled in 
the Vienna Convention, or a broad disclaiming saying that this current document had no 
interpretive value, would have serious systemic consequences with respect to Article 15 (as noted by the EU) as well as Article 13 of the TBT Agreement. 
3.218.  The representative of Canada associated  herself with statements form the EU, Korea, 
Mexico and the US. She recalled that the process employed in the development of the document 
was very positive as it had engaged a wide variety of delegations, which had been given sufficient 
time to consider the various versions. Canada had thus expected that the current meeting was 
simply about making some minor adjustments to the document given that all Members had 
appeared to be on the same page and the intention was to close the text. This would have enabled the Committee to go forward with new work. What was surprising was that delegations with 
concerns had not put all its concerns on paper so that these could have been considered 
beforehand. It was therefore important that delegations followed the established process 
considering the few meetings that the Committee had.  G/TBT/M/63 
 
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  3.219.  The representative of China understood the EU as confirming that the document at hand 
could indeed serve as interpretative instrument in future disputes, and that the US had agreed 
with such a view. This was precisely China's concern. While China fully supported the Secretariat's and Chair's work and all the effort Members had em ployed in this process, this was a point that 
needed to be addressed. China was of the view that Members could make an interpretation of a 
particular provision as provided for in Articles IX  and X of the WTO Agreement. In the TBT context, 
most Members shared the view that this docume nt would not be put before the DSU proceedings; 
indeed, this was the common intention in the Committee. China's objective was therefore simply 
to make this clear in the text itself. That was the reason for China's comments - and China was disappointed that its comments had not been refl ected in the Rev.4 draft. On the systemic 
concerns expressed by some Members about China's disclaimer on the Vienna Convention - China 
believed that Members could work on a consensus proposal. If the actual intention was to have a 
completely voluntary, non-binding document not subject to the DSU, this could be stated.  
3.220.  The representative of the United States noted that there were key differences, under the 
Vienna Convention, between various types of docu ments, such as Committee recommendations or 
decisions and Ministerial Decisions. A disclaimer of the sort that China was seeking would therefore have a significant impact on the systemic work of the Committee. 
3.221.  The representative of the European Un ion supported the US statement. There were 
different kinds of documents at issue. The Committee was working on a document that was a self-
addressed guidance on how to strengthen the impl ementation of the TBT Agreement. Clearly there 
were different categories of documents. One could not infer from the current document on GRP 
any intention to elaborate interpretation that coul d be relied on in a dispute settlement context. In 
this respect, he reiterated that the EU was not of the view that the intention was for the current 
document to be relied upon for interpretative purposes in a DSU context. Practical, illustrative 
guidance on domestic regulatory processes did no t lead to any new interpretation of obligations 
arising from the TBT Agreement that would have implications for DSU. The language that China was seeking was simply not appropriate for this type of document. So, before seeking solutions, it 
was important to identify the problem. He requeste d China to articulate its concern. If China was 
able to demonstrate that it held a valid concern, then the Committee could look into how to best to address it.  
3.222.  The Chairman noted that there was still significant interest in advancing work on GRP. 
Indeed – as the former Chair had said – the Committee had a clear mandate from the Sixth 
Triennial Review to "identify a Non-Exhaustive List of Voluntary Mechanisms and Related Principles of Good Regulatory Practice". It was important not to lose momentum. It could be useful, as 
suggested by Canada suggested, to take a step back to consider the best approach for reaching a 
positive outcome on this document. With a view to safeguarding the Committee's processes, and the beneficial work that it could provide, the Chairman said he would be consulting with Members 
on how the Committee could overcome the present issue. 
3.3.4   Other Matters 3.3.4.1  Seventh Triennial Review 3.223.  The Chairman noted that, in light of the mandate in Article 15.4, the Committee was 
scheduled to complete its Seventh Triennial Review of the Operation and Implementation of the 
TBT Agreement at its last meeting in 2015. While th is sounded a while away, it was actually only 
three meetings down the road. As with previous 15.4 reviews, the process would be driven by 
substantive proposals from Members against specific deadlines. The Chairman suggested that, 
guided by previous practice, Secretariat develop a proposed timeline and that the Committee hold 
a brief informal meeting after the summer break to consider this work programme. This would 
enable the Committee to agree on an efficient process.  
3.224.  The Committee so agreed. 
3.3.4.2  Next Thematic Session 3.225.  The Chairman noted that during 2013 and 2 014, following the adoption of the last triennial 
review, the Committee had held thematic sessions on various cross cutting issues related to the G/TBT/M/63 
 
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  operation and implementation of the Agreement, in cluding on good regulatory practice, standards, 
transparency, conformity assessment procedures, te chnical assistance, and special and differential 
treatment. The Chairman recalled the mandate for the Committee's thematic sessions derived from the Sixth Triennial Review, paragraph 26 of G/TBT/32: 
"Considering the substantive body of recommendations and decisions before the 
Committee, both existing and those contained in this Report, Members agree on the need to focus and deepen their work. Noting that follow-up is a long-term endeavour, 
Members see benefit to dedicating time to thematic topics in response to the specific 
decisions and recommendations in this Report, as well as those contained in previous triennial review reports, in order to press for greater progress on these issues." 
3.226.  The Chairman noted that the Committee would hold its next thematic session on  
4 November 2014, the day before its regular Committee meeting. In 2014, the Committee had 
been following the 2013 cycle of topics set in the Sixth Triennial Review, as well as submissions from Members.  
3.227.  The representative of Brazil reiterated hi s delegation's interest in discussing the topic of 
mutual recognition agreements (MRAs). Internal cons ultations were taking place in Brazil on this 
matter and Brazil might provide a submission on th e matter in due time should Brazil pursue this 
option. 
3.228.  The representative of South Africa mentioned Special and Differential treatment and 
conformity assessment as possible topics for the next thematic session, following the cycle 
established during 2013. In particular, on conformi ty assessment, the topic of metrology could be 
worth exploring in more depth. 
3.229.  The representative of the United States said that perhaps the time was ripe to return to 
conformity assessment. She recalled South Africa's  detailed presentation on MRAs on a previous 
occasion and she was interested in the Brazil's upcoming submission. There were also other issues 
of interest in addition to mutual recognition; the US recalled the discussions on international systems for conformity assessment (Article 9) as we ll as TBT Article 6.4 on national treatment in 
respect to burdensome and duplicative conformi ty assessment procedures. The latter was a theme 
that had come up in many of the interventions related to STCs. The US was also open to discuss 
transparency. In this respect, she recalled that on e of the issues that work on GRP had shown was 
how important transparency was to preventing unne cessary obstacles to trade. It had also shown 
the valuable experiences between WTO notification processes and domestic internal process and 
how these were effectively used and what the pr ocesses were to take into account comments.  
3.230.  The representative of the European Union associated himself with the proposals to revert 
to conformity assessment; there was scope for diving deeper into the issues that had been 
discussed at the last thematic session but also to introduce new topics. Looking at the 6th Triennial Review report, there was an interest in understanding how the choice of conformity assessment 
was linked to the type of enforcement mechanisms in  place. In this respect, he referred to market 
surveillance and product liability systems. He su pported going back to the topic of technical 
assistance as a component of Special and Differential Treatment. In this regard, the EU contribution at previous thematic session had been quite robust and it was now time for others to 
come forward on their experience in designing effective programmes for TA and success stories.  
3.231.  The representative of Canada made a proposal in respect of 15.2 Statements. She noted 
that there were still 32 countries that had not yet made their statement and over 100 that had. If 
countries were willing – hopefully all 32 – the Committee could work on "twinning or partnering" 
where a country that had done its 15.2 statement could work with a country that had not. This would avoid only depending on Secretariat assistance. The form of assistance could be one of 
cooperation without any particular timeline.  
3.232.  The Chairman thanked delegations and note d that there appeared to be some convergence 
on the issue of conformity assessment. Other issu es had also been raised: MRAs, 15.2 statements, 
SDT, TA and transparency. The Chairman as ked interested Members to communicate any 
proposals to the Secretariat (or to himself) on the themes to be addressed at the next thematic G/TBT/M/63 
 
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  session by 31 July 2014. After that, the Secretariat would prepare a draft programme based on the 
input received as well as topics suggested at the current meeting. 
4  TECHNICAL COOPERATION ACTIVITIES 4.1.  The representatives of ISO and the ITC u pdated the Committee on their technical assistance 
activities. 3  
4.2.  The Secretariat brought the Committee's attent ion to the recently published Handbook on the 
TBT Agreement, available free of charge on the WT O website. The Secretariat also made available 
a document containing information on the Secretariat's technical assistance activities.4 
5  UPDATING BY OBSERVERS 5.1.  The representative from ISO informed the Committee that his organization was in the 
process of developing a communication document on using and referencing ISO and IEC standards 
to support public policy. This publication contained benefits of using international standards, 
relevant principles and disciplines of the TBT Ag reement; methods of using ISO/IEC standards to 
support technical regulations and other public policy  approaches, as well as national policies and 
examples of using standards in support of public policy. This document would be available by the 
end of 2014. He also highlighted the 2014 ISO General Assembly, taking place in Rio de Janeiro from 9-11 September where the agenda included a discussion on how international standards can 
better support global trade in services. Finally, he said, as ISO's current strategic plan would 
conclude in 2015, consultations had begun with ISO members and stakeholders, on strategic directions that ISO should take for its next  five year period (2016-2020). International 
organizations, including the WTO Secretariat, would also be asked for input, and he encouraged 
the Committee to involve their ISO Members' perspectives in providing comments to ISO.  
5.2.  The representative of the IEC updated the Committee on its activities.
5 
5.3.  The representative from Codex Alimentarius provided and update on their activities.6 She 
added that, in light of the discussions in relation to Codex Food Labelling Texts, Members might be 
interested in the upcoming Session of the Committee on Food Labelling which would take place in Rome from 21-24 October. The committee would consider a proposal for new work on the review 
of the General Standard for the Labelling of Pre-pa ckaged Foods, addressing in particular the issue 
of date marking. She encouraged Members to foll ow the discussions on the revision of the General 
Standard on Labelling in the Committee on Food Labelling.  
5.4.  The representative of UNECE reminded the Committee that the Working Party on Regulatory 
Cooperation and Standardization Policies (WP6) was the only UN intergovernmental body that had 
the promotion of good practice and the developm ent of implementation of technical regulations 
and standardization policies as the core-standin g items in its agenda. She drew delegations 
attention to the recently shared "Zero draft" of the UN Sustainable Development Goals - when 
adopted in September 2015, these goals would be th e overarching guide of the work of the United 
Nations. Goal 17 which promoted strong inclusive and sustainable economic growth and decent 
work for all, contained direct relevance to the work of the TBT Committee "to increase trade-
related capacity building assistance to developing countries, including support for building their capacity to meet product regulations and standards". 
6  OTHER BUSINESS 
6.1  Canada's new regulatory framework  
6.1.  The representative of Canada updated the Committee on the proposed new regulatory 
framework for federal food inspection which would bring together federal food inspection 
regulations in Canada into one overarching sy stem and thereby replacing 13 different food 
                                               
3 G/TBT/GEN/169 and G/TBT/GEN/172. 
4 G/TBT/GEN/171. 
5 G/TBT/GEN/170. 
6 G/TBT/GEN/173. G/TBT/M/63 
 
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  regulations with one set of regulations. The new fr amework for federal food inspection provided an 
overview of the proposed regulations including draft regulatory text for key elements of the regulations and highlighted some significant regu latory proposals, such as grade standards, 
labelling and standards of identity, and membership  requirements for buyers and sellers of fresh 
fruit and vegetables. She encouraged Members to  provide comments on the proposed framework 
document by the 31 July deadline. The proposed regulation would be notified for consultation towards the end of 2014, at which time Members would be given the opportunity to provide final 
comments. The Safe Food for Canadians Act and associated regulations were anticipated to come 
into force by June 2015. 
7  DATE OF NEXT MEETING 7.1.  The next regular meeting of the TBT Committee is scheduled for 5-6 November 2014. It will 
be preceded by a thematic session on 4 November 2014.  
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