RESTRICTED  
  
G/TBT/M/71  
 
 
2 June 2017  
(17-2991) Page: 1/70 
Committee on Technical Barriers to Trade    
 
MINUTES OF THE MEETI NG OF 29-30 MARCH  2017 
CHAIRPERSON: MS ESTHER PEH  (SINGAPORE)  
Note by the Secretariat1 
1   ADOPTION OF THE AGEN DA ................................ ................................ ........................  1 
2   IMPLEMENTATION AND A DMINISTRATION OF THE  AGREEMENT  ................................ . 1 
2.1   Statements from Members under Article 15.2  ................................ ................................ . 1 
2.2   Specific Tra de Concerns (STCs)  ................................ ................................ .....................  2 
2.2.1    Reported Resolutions  ................................ ................................ ................................  2 
2.2.2    Withdrawn concerns  ................................ ................................ ................................ .. 2 
2.2.3    New concerns  ................................ ................................ ................................ ...........  2 
2.2.4    Previously raised concerns  ................................ ................................ ........................ 13 
2.2.5    Exchange of Experiences  ................................ ................................ .......................... 67 
2.2.6    Other matters  ................................ ................................ ................................ ......... 69 
3   TWENTY -SECOND ANNUAL REVIEW  ................................ ................................ ..........  70 
4   TECHNICAL COOPE RATION ACTIVITIES  ................................ ................................ .... 70 
5   UPDATING BY OBSERVER S ................................ ................................ ........................  70 
6   DATE OF NEXT MEETING ................................ ................................ ............................  70 
 
 
1  ADOPTION OF THE AGENDA  
1.1.  The Committee  adopted the agenda contained in WTO/AIR/TBT/ 7. 
2  IMPLEMENTATION AND A DMINISTRATION OF THE  AGREEMENT  
2.1  Statements from Members under Article 15.2  
2.1.  The Chairperson  reminded the Committee of Members' notification obligation under 
Article  15.2 of the TBT Agreement and further informed the Committee that the latest list of 
statements on implementation submitted under this provision was contained in an annex to the 
Annual Review of the Implementation and Operation of the TBT Agreement (G/TBT/39 /Rev.1 ), 
issued  on 18 May 2017 . She informed the Committee that since the last meeting in November 
2016, Yemen  had submitted its statement and Ukraine and Indonesia had submitted revision s to 
their original statement s. She further informed the Committee tha t since 1995, 13 8 Members had 
                                                
1 This document has been prepared under the Secretariat's own responsibility  and is without prejudice 
to the positions of Members or to their rights and obligations under the WTO.  G/TBT/M/71  
 
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  submitted at least one statement of implementation. Information on the list of statements is 
available on the TBT IMS . 
2.2  Specific Trade Concerns (STCs)  
2.2.1   Reported Resolutions  
2.2.1.1   Ecuador — Propo sed Motor Vehicle Safety Regulatory Requirements 
(RTE  INEN  034) G/TBT/N/ECU/32 (ID 409)  
2.2.  The representative of Mexico  informed the Committee that Mexico's production sector had 
recently confirmed that its concerns regarding the Ecuadorian Technical Regulati on 
RTE INEN No. 034 had been addressed. Mexico thanked Ecuador for taking into account their 
comments that had been reiterated on a number of occasions since 2014 . 
2.2.2   Withdrawn concerns  
2.3.  The Chairperson  reported that the following STCs had been withdrawn from the agenda at 
the request of the concerned Member:  
a. Peru – Laboratorial certification of notebooks  
b. Indonesia — MOI 69/2014 Article 3: LCR Requirements for LTE Devices - Requirement 
that Domestic Component Level (TKDN) of LTE TDD & FDD broadband services 
equipment  
c. Colombia — Draft Resolution of the Ministry of Health and Social Welfare and the 
Ministry of the Environment and Sustainable Development adopting the Technical 
Regulation establishing the maximum levels of phosphorus and the biodegradability of 
surfactants in detergents and soaps, and introducing other provisions  
2.2.3   New concerns  
2.2.3.1   European Union - Organic production and labelling - Maté (erva -mate)  
2.4.  The representative of Brazil  stated that his delegation was raising this specific trade concern 
in order to  request from the EU that maté (erva -mate in Portuguese), undeniably an agricultural 
product, be considered as an organic product and labelled as such. He explained that even if maté 
was currently produced in Brazil totally consistently with the requiremen ts of the EU regulation on 
organic production and labelling (Council Regulation EC No 834/2007), that product could not , per 
se, receive the organic label in the EU. Brazil considered that, by refusing to recognize maté as an 
organic product, without any t echnical or scientific justification, the EU was according it less 
favourable treatment than to like products, in violation of Article 2.1 of the TBT Agreement, and 
creating unnecessary obstacles to international trade, failing to comply with Article 2.2 o f the same 
Agreement. He recalled his delegation's requests, bilaterally, for the EU to amend its organic 
regulations so as to allow the organic labelling of mat é and asked if any such amendment was 
under way and, if so, if an estimated date of entry into effect could be given.  
2.5.  The representative of the European Union  recalled her delegation's explanation, bilaterally, 
that maté was currently excluded from the scope of the EU organic legislation, since the product 
was not included in Annex 1 of the Treaty o n the Functioning of the European Union and therefore 
could not be certified as organic under the EU legislation and bear the EU organic logo. She noted, 
however, that whilst the European Commission had proposed to include maté within the scope of 
the futu re EU legislation on organics, inter -institutional discussions (trilogues) on the new EU 
organic regulation were currently on -going with co -legislators (European Parliament and Council), 
and it was difficult to ensure what the final outcome would be , as it would not depend only on the 
Commission. The EU undertook to inform Brazil once a final wording on the Commission proposal 
was agreed.  G/TBT/M/71  
 
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  2.2.3.2   European Union – Radio Equipment Directive , G/TBT/N/EU/93  
2.6.  The representative of China  raised concerns on Directive 2014/ 53/EU, also called RED, issued 
on 22 May 2014, which replaced the 1999/5/EC, R&TTE, and which covered a wide range of 
products, including mobile phones, base stations, gateways, WLANs, tablet PCs, desktop 
computers, Bluetooth/WiFi products, audio and video  products. She noted that the deadline of the 
transition period (12 June 2016 to 12 June 2017) was approaching. Despite this, there was still 
unclarified ambiguity in the Directive, and a large number of standards and guidelines had not 
been released. For example, many harmonized standards under the RED, including the draft CDMA  
standard, had not been released. She added that some versions of standards changed too fast and 
certification bodies could not work efficiently due to the lack of guidelines. As of 13 March, the 
restricted national identification programme required by Article 10 of the Directive had not been 
officially released, despite it having been revised three times. Additionally, as of 10 March, some 
EU member States including Germany, Ireland,  Greece, Austria and Portugal had not adapted their 
national laws to this Directive. China was concerned about the resulting uncertainty and 
unpredictability which constituted a significant risk for exporting enterprises, due to the complexity 
of products involved which needed a long time to adjust to the new requirement. Her delegation 
therefore urged the EU to publish official guidelines and harmonized standards at the earliest 
opportunity, and to use the relevant international standards where possible. F inally, she noted that 
if the EU could not provide a timetable, China would appreciate an extension of the transition 
period.  
2.7.  The r epresentative of the European Union  recalled that t he EU notified this measure to the 
TBT Committee on 15 February 2013 and p rovided 90 days for comments.  He underlined that t he 
Radio Equipment Directive, like all other New Approach Directives, la id down essential 
requirements for radio equipment devices but does not prescribe itself any detailed technical 
solutions. Harmonised standards were a voluntary mean s to demonstrate conformity with the law 
and neither their application nor their availability was mandatory. Th e RED provided  alternatives to 
harmoni zed standards in order to place equipment on the market, as provided for in Article 17.  
The responsibility for developing voluntary harmoni zed standards lay  directly with the European 
Standardisation Organisations who operate d on the basis of a request from the Commission. The 
preparation of harmoni zed standards for the Radio Equi pment Directive ha d been delegated to 
ETSI (European Telecommunications Standards Institute) and CENELEC (European Committee for 
Electrotechnical Standardization), so the unavailability  of harmoni zed standards depended  on 
them.  
2.8.  He stressed that t he partial  current unavailabilit y of voluntary standards applied  to 
equipment manufactured in any market  (i.e. EU or non -EU). In addition, the list of harmoni zed 
standards was being populated as long as thes e were sent by ETSI and CENELEC. In any case, a 
self-declar ation of conformity (as provided for in Article 17(2)) of the Radio Equipment Directive) 
could  be applied to the essential requirements in Articles 3(1)(a) and 3(1)(b) of the Radio 
Equipment Directive. This was an additional alternative to the certificatio n of notified bodies.  With 
respect to the standards aiming to cover Article 3(2) of the RED, he stated that ETSI has 
submitted roughly 70% of the necessary  standards. 65 of them had appeared in the Official 
Journal by 10 March 2017. The other standards ha d been identified with shortcomings or major 
non-compliance.  
2.2.3.3   China – Cyber security Law  
2.9.  The representative of the United States  expressed her delegation's continued concern about 
China's suite of measures, which appeared to be inconsistent with China's nati onal treatment 
obligations and to discriminate against foreign technologies and firms in the name of information 
security. US ICT companies were concerned that since no further clarity had been provided on the 
meaning of "secure and controllable", and that  it had been known and understood in the past to 
include references to domestic technology requirements, companies sourcing ICT products were 
already interpreting this language conservatively, in other words they believed they were required 
to purchase onl y domestic goods. A similar trend could be seen in banking and other industries 
that China had deemed to be critical infrastructure.  
2.10.   Of specific concern was China's Cybersecurity Law, which was scheduled to be implemented 
mid-2017, the recent sets of TC 26 0 standards released for public comment, China's un -notified 
draft cybersecurity review mechanism, and a new aviation sector -specific draft measure to G/TBT/M/71  
 
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  implement the Cybersecurity Law. Her delegation was also concerned that the final text of the 
Cybersecuri ty Law did not address US stakeholders' key concerns. Specifically, the law did not 
clearly define the scope of the affected "Critical Information Infrastructure", it stipulated domestic 
storage of any personal information or important data, and restricted  cross-border data flows, and 
it required what the US considered an unprecedented and unnecessarily trade -restrictive 
cybersecurity review for products to be eligible for sale in China. The US had sent a message to 
China's TBT Enquiry Point in January 2017  requesting information on the implementing timeline for 
this law and now asked China to elaborate on how the law would be implemented during the year.  
2.11.   China's National Information Security Standardization Technical Committee (TC 260) had 
released many dra ft standards for public comment in recent months, and regulators had released 
draft measures for public comment which would establish a new cybersecurity review mechanism 
and set aviation sector -specific implementation of the Cybersecurity Law. The US appr eciated that 
these voluntary standards and measures were open for public comment, and encouraged China to 
carefully consider the feedback received from the US and other stakeholders. While the draft 
standards released to date were identified as recommended  standards, her delegation was 
concerned that they would be de facto mandatory in nature. Indeed, on 11 January 2017, TC  260 
had released a Guide to Cybersecurity National Standards Project Application in 2017, calling for 
development of mandatory standard s to support implementation of the Cybersecurity Law on, 
among other things, critical information infrastructure protection.  
2.12.   Should TC 260 voluntary standards be incorporated into a technical regulation or conformity 
assessment procedure, the US would expe ct them to be notified to the WTO TBT Committee with a 
60-90 day comment period and at least a six -month interval between notification and 
implementation. Explanation was sought as to how these standards had been developed in 
accordance with China's obliga tions under the Code of Good Practice. She proceeded to ask several 
specific questions on these standards as well as on China's draft cybersecurity review mechanism 
and aviation sector -specific measure . 
2.13.   Firstly, China was asked to clarify the links between  these measures and the Ministry of 
Public Security's existing Multi -Level Protection Scheme (MLPS). Clarification was also sought on 
the links between these measures and the requirements stipulated in Cybersecurity Law Articles 
23 and 35 specifying that o perators of critical information infrastructure may only purchase ICT 
products having passed a national security review and listed on a catalogue of goods approved for 
sale in China. Secondly, the US requested an update on the status of the proposed standa rds. 
Could China clarify how TC 260 would take into account the comments it received? Would there be 
additional opportunities for stakeholders to review and comment on revised iterations of the 
standards? Finally, her delegation asked whether China intende d to notify any or all of the draft 
standards and China's draft cybersecurity review mechanism and aviation sector -specific measure 
to the Committee, in light of above -mentioned concerns.  
2.14.   Given the technically complex nature of the issues at hand and China 's approach which the 
US deemed to be both novel and having a potentially widespread impact in the commercial sector, 
China was requested to undertake in -depth consultations with the US Government, other WTO 
Members, and global stakeholders, and not to ado pt the draft standards as written.  
2.15.   The representative of Japan , voicing support for the position of the US, expressed its own 
concerns and strong interests with regard to the Cybersecurity Law, stating that Japan had 
submitted its opinions during the publ ic comments periods of the first draft in July 2015 and of the 
second draft in July 2016. Her delegation remained concerned about the unclear scope of the law 
and its relevant regulations, because definitions of terms used in them were deemed vague, and 
scope of standards or procedures for conformity assessment adopted in them not clearly defined. 
She recalled China's statement during the November 2016 Committee meeting, that "The 
Cybersecurity Law was a comprehensive and fundamental law in the field of sec urity and the 
relevant regulations would be revised and adjusted appropriately in line with the principles of the 
law." In this light, Japan requested China to make the related regulations, including Draft of 
Network Product and Services Security Review Me asures, consistent with international standards 
and practices.  
2.16.   The representative of the European Union  voiced support for the concerns raised by the US 
and Japan and recalled that his delegation had already raised these concerns at the previous G/TBT/M/71  
 
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  Committee meeting under the longstanding item on information security .2 His delegation 
nonetheless considered the Cybersecurity Law to be a new issue given its importance and recalled 
the EU's systemic concerns on the development of rules on information security in China. He 
observed that many different layers of regulations had been accumulating over the years, creating 
restrictions to the use of encryption products incorporating foreign technology, as well as 
uncertainty about the notion of "critical infrastructure ". The recently published draft measures on 
security review of network products and services introduced new concepts, in particular the notion 
of "secure and controllable" equipment, the reference to security review of network products and 
services, the re ference to an approved catalogue of equipment which would have to go through 
this security review and then be endorsed in a published list by the Cyberspace Administration of 
China. The EU deemed that the implementing rules of these concepts had not been d efined in 
sufficient detail, adding to the existing situation of uncertainty and unpredictability.  
2.17.   He recalled that at the November 2016 TBT Committee, China had indicated that the new 
Cyber security Law would set the new benchmark for any regulation in thi s field. In reply to the 
EU's question as to the relationship with other regulations like the MLPS or the regulation on 
commercial encryption products by the Office of State Commercial Cryptography Administration or 
with respect to sectoral guidelines for information security in banking and insurance sectors, China 
had indicated that all these measures would undergo review to be brought in line with its new 
Cybersecurity Law. His delegation asked China to clarify timelines for these different reviews. 
Refer ence was made  to detailed comments made by EU  as well as by European industry in reply to 
the call for comments on the draft measures on security review of network products and services. 
His delegation further urged China to take comments made by the EU an d European industry into 
account but also to notify these draft measures in any subsequent sectoral implementation to the 
TBT Committee in order to give adequate opportunity for WTO Members and their stakeholders to 
comment on any subsequent developments.  
2.18.   In summing up, he identified the following areas of concern to the EU: the uncertainty about 
the scope of the requirement s which was not specified in sufficient detail; unavailability of relevant 
standards; lack of opportunity for foreign stakeholders to p articipate sufficiently in the elaboration 
of the measures; on the issue of the scope of critical infrastructure, which sectors were impacted, 
and what equipment would need to undergo this security review; the modalities of the security 
review and the refe rence to a third party certification process which was potentially very intrusive 
into sensitive proprietary information held by companies and which should take due account of 
intellectual property concerns of equipment suppliers.  
2.19.   The representative of Australia  voiced support for the concerns raised by the US, EU and 
Japan. Whilst her delegation recognized the interests of each Member in protecting and 
safeguarding its cybersecurity, it believed that efforts to strengthen cybersecurity should be 
pursued w ith input from all relevant stakeholders, including governments, industry and civil 
society and acknowledged China's commitment to "international exchanges and cooperation for 
cyberspace governance" as expressed in Article 5 of the law. Australia agreed wi th comments from 
other Members that many details about the cyber security law and associated measures remained 
unclear and suggested that the implementation period be delayed until there was greater certainty 
around the scope and application of its provisi ons. 
2.20.   The representative of China , in response to questions raised on the new Cyber Security Law 
which would enter into force on 1 June 2017, said that the law addressed concerns raised by some 
Members in the Committee that China's cyber security measures w ere overlapping and uncertain. 
This fundamental and comprehensive law governing cyber security of China systematically defined 
the obligations and liabilities of various parts and bodies that constitute basic institutions in 
relation to equipment security,  network operation security, network data security and network 
information security. She recalled that China's cyber security policy was based on the principles of 
opening -up and globalization, in liking with the basic state policy of China, as stated by P resident 
Xi on many occasions.  
                                                
2 China – Requirements for information security products, i ncluding, inter alia, the Office of State 
Commercial Cryptography Administration (OSCCA) 1999 Regulation on commercial encryption products and its 
on-going revision and the Multi -Level Protection Scheme (MLPS) (IMS ID 294) ; China - Insurance Regulatory 
Commission (CIRC) Information and Communication Technology Regulation (IMS ID 489) . G/TBT/M/71  
 
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  2.21.   On the specific issue of the definition of "secure and controllable" , she clarified that: (i) the 
product or service providers should not use their product or service to illegally obtain users' data; 
(ii) providers should no t illegally control users' equipment; (iii) providers should not operate 
monopoly or seek illegal interest by making use of users' reliance on the product or service, for 
example, by withdrawing safety technical support without a justifiable reason or by f orcing users 
to upgrade. She further clarified that these terms had not been created by China and therefore 
they gave no preference to domestic technology requirement or domestic goods procurement.  
2.22.   Regarding the relationship between cyber security MLPS an d information security MLPS, she 
said that the Cyber Security Law was a fundamental law of China's cyber and information security, 
its purpose being to clarify responsibility and ensure safety of important targets. Information 
security MLPS was important t o protect national cyber safety, however, with the rapid 
development of information technology, it had to be revised, explaining the introduction of the 
cyber security MLPS, heralding a new phase for information security MLPS. She advised that both 
the reg ulation on Commercial Encryption Products and the information security MLPS would be 
revised in line with the principles of the Cyber Security Law and during this process, China would 
take its trading partners ' concerns into consideration and learn from th eir good practices. She 
noted that the responses provided should also be considered under similar concerns regarding 
cybersecurity on the agenda.3  
2.2.3.4   China - Tentative Administrative Rules on Enterprises Average Fuel Consumption 
and New Energy Vehicle Credit s and Administration Regulation on the Access of New 
Energy Vehicle Manufactures and Products , G/TBT/N/CHN/1187 G/TBT/N/CHN/1188  
2.23.   The representative of the United States  shared its understanding that the proposed measure 
required, beginning in 2018, that 8%  (based on a credit system) of all domestically made vehicles 
sold by a car maker or 8% of imported vehicles imported by a dealer into China should be new 
energy vehicles (NEVs), which are plug -in electric – both battery electric only and plug -in hybrid - 
or hydrogen fuel cell vehicles. She added that the measure indicated that the target would rise to 
10% in 2019 and 12% in 2020. The Ministry of Industry and Information Technology's (MIIT) 
stated purpose for the measure was to enhance energy conservation, speed the development of 
the NEV industry, and implement previously established industrial policies. To ensure compliance, 
the measure proposed suspending the sales of certain traditionally powered vehicles of any 
manufacturer or importer failing to reach the 8% target.   
2.24.   Whilst recognizing the importance of China's policy goal, the US was of the view that a 
modified plan allowing for more lead time for the auto industry would best meet China's goals 
while minimizing unnecessary disruption to the US and Chin ese auto industries and overall 
economies. To illustrate this view, she said that given the long lead time required to reengineer 
products, to secure sourcing, to make investments, and to test and qualify products in the auto 
industry, US regulators genera lly allowed an interval of several years between the adoption of 
significant new requirements and the date of mandatory compliance to allow the goals of those 
requirements to be met without undue disruption to the industry. She concluded by acknowledging 
comments submitted by Japan and the EU indicating that automakers around the world agreed 
that a single year was inadequate time for companies to comply without undue impacts on trade.   
2.25.   The representative of the European Union  expressed full support for the  environmental and 
climate objectives of China's measures aimed at enhancing fuel efficiency of conventional vehicles 
as well as the measures promoting the development of NEVs. Her delegation welcomed the 
Chinese commitment, expressed in reply to comments received, to modify and perfect the notified 
draft Tentative Administration Rules. She asked China which parts of the draft text would be 
amended and what the exact scope and direction of the changes would be. She then highlighted 
several important issues of concern which remained unaddressed in the explanations provided by 
China.  
2.26.   The NEV yearly ratios contingent upon sales of NEVs: The EU stressed that the uptake of 
NEVs in the coming years in the Chinese market would depend upon a complex set of condition s 
                                                
3 China – Requirements for information security products, including, inter alia, the Office of State 
Commercial Cryptography Administration (OSCCA) 1999 Regulation on commerci al encryption products and its 
on-going revision and the Multi -Level Protection Scheme (MLPS) (IMS ID 294) ; China - Banking IT Equipment 
Security Regulation (IMS ID 457)  G/TBT/M/71  
 
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  including price, convenience, available infrastructure, subsidies and other incentives. In this 
context, she underlined the need to ensure a level playing field with regard to subsidies and other 
incentives (e.g. attribution of circulation licences, purc hase subsidies at central and provincial 
level). The existing incentives were directly linked to compliance with the notified draft. The EU 
further stressed the importance of ensuring that foreign NEV manufacturers were granted equal 
access to the Chinese NEV incentives policy. In addition, she requested that China confirm that, 
following monitoring of  the market during 2017 and 2018, should the desired NEV target ratios 
(8% in 2018, 10% in 2019, and 12% in 2020) not be achieved at national level in 2018 an d/or the 
following years, China would assess the reasons for this and, where appropriate, take additional 
measures to facilitate the achievement of those targets in an equal way for the manufacturers and 
importers present in the Chinese market. Confirmatio n was also sought from China whether it  
would consider necessary adjustments in the notified draft.    
2.27.   The management of the credits and debit system: China was asked to consider accepting an 
alignment of the credits and debits regime for NEVs with that of  fuel consumption, and to allow 
them to be freely traded, as well as carried forward to following years during the full period (2016 -
2020). The EU also requested that Article 30 of the notified draft, which defined affiliated 
undertakings, be amended to en sure/clarify that fuel consumption credits could also be transferred 
between Joint Ventures of the same foreign shareholder and not only between Joint 
Ventures/subsidiaries of the same Chinese shareholder.  
2.28.   The fuel consumption targets set for the small vol ume manufacturers: The EU stressed that 
given that the overall number of vehicles domestically produced and imported by the Original 
Equipment Manufacturers (OEMs) producing less than 1,000 vehicles per year corresponded to 
0.02% of the entire Chinese mark et (0.03% for OEMs producing between 1,000 and 2,000 
vehicles per year), any flexibility granted to those manufacturers would have no detrimental 
impact on the overall Chinese CO 2 reduction objectives. Her delegation noted with concern that the 
notified dr aft did not contain any exemption for manufacturers producing or importing a very 
limited number of cars (e.g. less than 1,000 vehicles sold per year), and that the planned small -
volume manufacturers ( SVM) relaxation ratio was conditional on an annual line ar reduction of the 
Corporate Average Fuel Consumption (CAFC) of 6% or 8%. Given that fuel consumption reductions 
were a result of technological progress implemented over long periods (i.e. common 5 -year vehicle 
development cases), the EU suggested that it  may be feasible for SVM manufacturers to provide 
stepwise reductions over a long period. Regarding the extra consumption tax of 10% on super -
luxury cars, a measure that would affect the SVM selling less than 1,000 cars per year or between 
1,000 and 2,000,  her delegation believed that this, together with the CAFC target, would render 
the import of vehicles produced by SVMs into the Chinese market very difficult.  
2.29.   Specifically concerning the Administration Regulation on the Access of New Energy Vehicle 
Manuf acturers and Products, notified on 5  December 2016, and on which the EU had provided its 
comments on 16  January 2017, she reiterated her delegation's request for clarifications on certain 
provisions of the draft measure, on which China had not yet provided  a response. The most 
important issues raised by the EU were: (i) whether the corporate entity could share its general 
and common R&D capacities with its subsidiaries if these were located outside China; (ii) whether 
manufacturers were required to have the ir own testing facilities or whether access to appropriate 
testing facilities was sufficient; (iii) which international standards (ISO, IEC) were compatible with 
the Chinese standards necessary for NEV products to meet in order to apply for access; and 
(iv) whether the Chinese standards were already aligned with the UN Regulation No. 134 for 
"Hydrogen fuel cell vehicle safety" and with the draft Phase 1 GTR1 on safety of Electric Vehicles 
and, if not, whether there were intentions of doing so in the near fu ture. The EU remained 
available for discussions on a bilateral/technical level to ensure the necessary modifications of the 
notified drafts.  
2.30.   The representative of Japan  voiced support for the position of the US and the EU and 
flagged that his delegation ha d submitted comments on the draft measures. Regarding the draft 
regulation notified in G/TBT/N/CHN/1187, Japan supported China's policy positions with regard to 
reducing greenhouse gas emissions and implementing automotive technology development 
strategies ; moreover, he stressed that the Japanese automobile industry could contribute to the 
sound growth and further development of the automobile industry in China. Japan believed, 
however, that the newly -added provisions such as NEV credits would cause signifi cant impact on 
the automobile industry, and that their introduction should proceed carefully based on the results 
of further investigation and global findings. Firstly, Japan requested sufficient lead time in view of G/TBT/M/71  
 
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  the considerable time involved in the d evelopment of NEVs. Secondly, China was requested  to 
prepare for alternative compensation methods in cases where targets were not met, since it was 
foreseen that offsetting of NEV credit could not work due to the lack of available credits in the 
industry a s a whole. Thirdly, clarification was requested on the conversion rate between CAFC and 
NEV credits. Japan  requested  China to consider the above -mentioned points in the process for the 
official announcement and enforcement of the draft regulation, in order  to render it rational and to 
avoid unnecessary obstacles to international trade . 
2.31.   Regarding G/TBT/N/CHN/1188, Japan was particularly concerned that this regulation would 
also cause substantial impact on automobile manufacturers producing automobiles in Chi na. His 
delegation requested the following three points regarding the operation of the regulation: (i) the 
national and local monitoring platforms should be integrated into a single system; (ii) the 
monitoring and recording period should be limited, for ex ample, to five years; and (iii) adequate 
lead time should be provided for the creation of these systems. Japan recognized that the 
regulation would come into force in July 2017 and therefore proposed that  China consider its 
requests in the development proc edure of the guideline for the regulation, and not to impose 
unnecessary obstacles to international trade.  
2.32.   The representative of China  reported that China was facing energy and environmental 
challenges. The development of NEVs was crucial for energy saving  and environmental protection 
and it was also international practice to strengthen the administration of vehicles to solve these 
problems. She added that the Tentative Administrative Rules on Enterprises Average Fuel 
Consumption and New Energy Vehicle Cred its regulated vehicles produced and sold in China and 
that whilst they were not finalized, Members' comments would be taken into consideration. With 
the dramatic increase in the number of NEVs, China had been obliged to respond to the urgent 
need to protec t human safety because of higher risks inherent in the new technology. It was in 
this light that China had revised the 2009 Administration Regulation on the Access of New Energy 
Vehicle Manufactures and Products. The new Access Regulation had been publishe d online for 
public opinion from September 2016 and notified to the WTO on 5 December 2016. She underlined 
that in order to ensure safety and quality , the manufacturers of NEVs were required to ensure 
design capability. Companies were not required to estab lish R&D centres in China, or to use 
Chinese domestic control and energy systems. China maintained the non -discriminatory nature of 
the administrative rules and their consistency with the TBT Agreement.  
2.2.3.5   Dominican Republic - Requirements for importing steel  rebar - RTD 458 and 
other requirements  
2.33.   The representative of the United States  voiced the serious concerns of US manufacturers of 
steel rebar regarding unnecessarily restrictive trade barriers created by RTD 458, the Dominican 
Republic's technical regulat ion specifying standards and conformity assessment procedures 
thereof. Concerns related to inconsistent application of conformity assessment procedures, 
different procedures for domestically -produced rebar versus imported rebar, including 
requirements for only imported rebar to be tested in third -party laboratories located outside of the 
Dominican Republic, and frequently changing, and non -publicized requirements. She urged the 
Dominican Republic to notify to the WTO the April 2015 draft of RTD 458 and all mandatory 
conformity assessment procedures imposed on imports of steel rebar given that US exporters 
currently faced a great deal of uncertainty regarding the rules for importing rebar.  
2.34.   Explanation was sought as to why conformity assessment requirements fo r imported steel 
rebar were different than requirements for locally manufactured steel rebar. RTD 458 requirements 
subjected local manufacturers and importers to random inspections of the supplier's premises, 
including testing and sampling activities. For importers, in addition to random inspections and 
testing, every heat of imported steel rebar was required to also be sampled and tested by a third -
party laboratory for market entry. Due to an absence of third -party laboratories in the Dominican 
Republic ac credited to certify to RTD 458, samples had to be sent back to the US for testing before 
the rebar could be commercialized. The US held that this third -party testing requirement was 
costly, appeared redundant with random testing and inspections, and create d significant delays at 
the port. Furthermore, these additional requirements were not imposed on local manufacturers; in 
this light, the US asked how the Dominican Republic ensured that the principles of national 
treatment were applied when mandating confo rmity assessment procedures.  G/TBT/M/71  
 
- 9 - 
 
  2.35.   Finally, her delegation requested that the Dominican Republic review the RTD 458 import 
bond requirements which required 100% of the CIF value of the product to be posted as bond by 
importers. This requirement was not imposed on domestic manufacturers, and presented 
significant business concerns for small and large manufacturers. The US questioned why it was 
necessary for importers, and not domestic manufacturers, to post a bond. She thanked the 
Dominican Republic for their bil ateral engagement to explore a resolution to this issue, reiterating 
her delegation's support for the need to address the regulatory objectives with regard to steel 
rebar.  
2.36.   The representative of the Dominican Republic  clarified that RTD 458 for construction  
materials and deformed and plain steel bars for concrete reinforcement was jointly implemented 
by the Dominican Institute for Quality and the Ministry of Public Works and Communications. The 
regulation had been discussed and agreed on by a technical commi ttee, involving the interested 
parties at all stages of discussion, public consultation, and submission of comments. It had been 
notified on 18  November  2011, and there had been no indication at the time of any breach of 
international agreements. Moreover,  the regulation had been drawn up on the basis of the 
ASTM  A615 standard. She further clarified that with regard to labelling requirements, it had been 
agreed at national level that the CAFTA -DR Agreement should be taken into consideration and 
should allow  bars to be labelled as stipulated by the ASTM A615 standard; thus, there were no 
other requirements beyond those stipulated in the United States market or those specified at 
national level.  
2.37.   She reported that on 1  April 2015, the Ministry of Public Works a nd Communications had 
introduced aspects relating to the safety, strength and proper earthquake resistance of buildings, 
applicable to steel bars and therefore relating to the aforementioned RTD  458. The same ministry 
was currently preparing a revision of the regulation; as soon as the public consultation stage 
started, the WTO would be notified. In response to the question on import bond requirements, she 
stated that although RTD  458 required importers to have a performance bond to cover civil 
liability, i n practice the only requirement was a civil surety bond, which applied to domestic 
producers. Finally she expressed her delegation's willingness to continue engaging bilaterally with 
the US, in particular in order to reach an agreement to facilitate the pr oduct analysis and 
certification process. Customs clearance of the products currently took 48 hours.  
2.2.3.6   Republic of Korea - Household Chemical and Biocidal Products  
G/TBT/N/KOR/684, G/TBT/N/KOR/547, G/TBT/N/KOR/702  
2.38.   The representative of the United States  expressed appreciation for the opportunity for public 
comment provided by Korea's notification of the draft regulations on biocidal products. As US 
industry stakeholders had expressed concerns about the prohibitions on specific chemicals that the 
regulations w ould introduce, her delegation sought certain clarifications to enhance transparency 
and address these concerns.  
2.39.   In particular, confirmation was sought as to whether the proposed regulations notified in 
G/TBT/N/KOR/684 and G/TBT/N/KOR/702 were different v ersions of the same regulation. A 
request was made for English summaries of the notified regulations therein to facilitate non -
Korean companies submitting comments. Did G/TBT/N/KOR/684 propose a general ban on all 
products containing CMIT/MIT? Why was a ge neral ban considered appropriate to achieve Korea's 
regulatory objective and what risks did the regulators discern if, instead of the ban, other 
management options were used? Would current stockpiles of biocide containing a "toxic" 
substance be required to  meet the new labelling requirements? It was her delegation's 
understanding that any consumer product used to sterilize, sanitize, or preserve that contains a 
biocide must be labelled as "Contains Biocidal Substance (Substance Name, Toxic)", unless this 
substance was on a trade partner's list of approved active substances under its Biocidal Products 
Regulation. Was this understanding correct? Korea was asked to explain how the trade partner's 
approved listing conformed to its national circumstances and woul d therefore assist in adhering to 
its objectives. Could Korea explain the implementation timeline for the safety and labelling 
requirements? The US encouraged Korea to work with local and international industry stakeholders 
to ensure access to data adequat e risk assessment, and sufficient time to comply.  
2.40.   The Ministry of Environment (MOE) notice of the proposed regulation from 7 October 
referred to the Chemical Abstract Service (CAS) numbers for MIT and CMIT individually, and not 
the mixture of CMIT and MIT (three -to-one mixture ratio), which was a globally accepted mixture G/TBT/M/71  
 
- 10 - 
 
  in the EU and the US with a different CAS number; clarification was sought as to whether this was 
the case. The US encouraged Korea to take a risk -based approach involving a restriction of  the use 
of these chemicals in some harmful products whilst avoiding to unnecessarily restrict them in 
circumstances where there was no danger to users, as was the case for many products approved 
by the US and the EU using CMIT/MIT in amounts that, based o n scientific testing, were not likely 
to cause harm to consumers and which would potentially no longer be permitted to be sold in 
Korea under the proposed regulation. Finally, she encouraged Korea to work with the US and 
concerned industry stakeholders to ensure that the least trade -restrictive approach necessary was 
taken to meet the legitimate objectives of protecting human health and safety.  
2.41.   The representative of Japan  voiced support for the position of the US. She requested Korea 
to take the opinions of  industry into consideration while developing the new act and its relevant 
regulations, given the significant impact on their activities. Korea was also requested to make the 
new act and regulations scientifically and technologically reasonable to avoid ca using negative 
impact on international trade.  
2.42.   The representative of the Republic of Korea  clarified that the regulation "Revised public 
notice on designation of products of risk concerns and safety and labelling standards" notified as 
G/TBT/N/KOR/684 did n ot ban the general use of CMIT/MIT. The prohibition did, however, extend 
to the use of CMIT and MIT in spray products as well as all forms of air fresheners, among 18 
products types designated and announced as of risk, to prevent any concerns about inhalat ion 
exposure of CMIT and MIT. He explained that CMIT and MIT could be used in liquids or solids, but 
not in air fresheners due to prohibition from sprays, following a situation in Korea where CMIT and 
MIT had been used in humidifier disinfectant and had po tentially caused pulmonary fibrosis to 
users.  
2.43.   He proceeded to inform that the new labelling requirements would be applied to products 
that were released or cleared from customs as of 18 months after the Public Notice announcement 
on 30 December 2016. Label ling requirements therefore did not apply to the current stockpile. In 
addition, companies could choose whether the word "toxic" was labelled or not. In other words, 
when an active substance was present in one of the 18 product types designated and announc ed 
as product of risk concerns, companies could choose to use either the wording "Contains Active 
Substance (Substance name, toxic)" or "name of component (e.g. substance name), function of 
the substance and/or its percent of the formula" on a label for pa ckaging. Korea's objective was to 
inform consumers about the active substances in products to enable them to exercise caution 
when choosing and using such products. Finally, his delegation informed the Committee that Korea 
would continue to consult with st akeholders on the issue, in a transparent manner.  
2.2.3.7   Italy – Labelling requirements of the origin of grains used in the preparation of 
dried pasta  
2.44.   The representative of Mexico  expressed concern regarding the decree drawn up by the 
Italian Ministries of Agricu lture, Food and Forestry, and Economic Development, on the origin 
labelling of wheat grain used to make durum wheat semolina pasta. This decree, announced on 
the Ministry of Agriculture's website on 20  December  2016, had been drafted to implement EU 
Regula tion No.  1169/2011 on consumer information requirements. The purpose of the measure 
was said to be to ensure adequate consumer information about certain aspects of dry pasta 
production. The measure included origin labelling requirements whereby labels must  indicate the 
country or area where the wheat grain used to make the pasta was grown, or the country or area 
where the grain was milled. The website also stated that the decree had been sent to Brussels for 
approval.  
2.45.   Her delegation deemed that the possibil ity that the EU might approve regulations with a 
similar purpose to the US country -of-origin labelling requirements for swine and cattle used in 
meat production – the subject of a case brought before the Dispute Settlement Body – was a 
matter of great impo rtance. Like the US measure, the Italian decree would require the labelling of 
dry pasta products to include the name of the country or area of origin of the grain used to 
manufacture the product, or the name of the place where the product was manufactured . Whilst 
understanding that the measure remained subject to review by the European Commission, Mexico 
requested that consideration be given to the Panel and Appellate Body reports ruling against the 
US measure, which found that, through origin labelling, t his measure accorded less favourable 
treatment to imports than to like domestic products. Indeed, Mexico believed that Italy's proposed G/TBT/M/71  
 
- 11 - 
 
  decree could affect the conditions of competition for foreign products in relation to domestic 
products and go against t he principle of non -discrimination provided for in Article 2.1 of the TBT 
Agreement. Furthermore, the measure could be inconsistent with Article 2.2 of that Agreement, 
as, in Mexico's view, alternatives less restrictive to international trade could be used  to ensure 
consumers were properly informed.  
2.46.   Finally, she stated that insofar as the decree constituted a preliminary draft technical 
regulation in line with the definition contained in Annex 1 of the TBT Agreement and would affect 
international trade, the  EU was asked to adhere to the principles of transparency established in 
Article 2.9, 2.11 and 2.12 of that Agreement, and to notify the measure to TBT Committee 
Members, so that comments could be made and taken into consideration. Her delegation looked 
forward to receiving clarification regarding the aforementioned aspects of the preliminary draft as 
well as an idea of its status before the European Commission.  
2.47.   The representative of the United States  referred to her delegation's previously raised 
concerns with Italy's proposed country -of-origin labelling requirements during the November 2016 
TBT Committee meeting4, and flagged that the US would expre ss similar concerns later in the 
agenda.5 Whilst voicing support for the points raised by Mexico, she highlig hted her delegation's 
particular concern with Italy's transparency practices related to these measures as they had not 
been notified to the WTO by the EC or by Italy, considering that they were not based on 
international standards, and appeared likely to h ave a significant impact on international trade. 
The US therefore urged Italy to postpone implementation of any further country -of-origin labelling 
measures pending their notification to the WTO followed by the taking into account of comments 
from affected  stakeholders.  
2.48.   The representative of Canada  joined Mexico in expressing grave concern with the proposed 
measure, considering the discriminatory and economically damaging effects of mandatory country -
of-origin labelling measures. His delegation believed tha t the proposed measure could result in 
added costs for economic operators throughout the pasta production supply chain, give rise to 
both cumbersome and unnecessary administrative procedures, thus encouraging discrimination 
within that supply chain, and ne gatively impact the competitiveness of the Italian pasta industry. 
He pointed out that as Italy's leading supplier of durum wheat, Canada was a high -quality input 
source, helping to ensure that Italian pasta producers are able to supply buyers at home and 
abroad, including in Canada. Thus, Canada was concerned that the proposed measure would 
negatively impact exports of Canadian durum wheat and in this light joined other delegations in 
requesting that, as a first step, Italy notify it to the Committee to pe rmit all Members to assess 
and comment on it, and for comments to be taken into account before deciding on any final 
measure.  
2.49.   The representative of the European Union  recalled her delegation's explanation in the 
November 2016 TBT Committee meeting6, that R egulation (EU) 1169/2011 on the provision of 
Food Information to Consumers allowed EU member States to introduce measures concerning the 
mandatory indication of the country of origin or place of provenance for certain categories of 
foods, following the spe cific notification procedure established for this purpose in the Regulation. 
Accordingly, she added, member States deeming it necessary to adopt such national measures 
had to notify them to the Commission and the other member States, and provide the reason s 
justifying them. The grounds on which the justifications were to be based were specified in the 
Regulation and included consumer protection. In addition, member States needed to provide 
evidence supporting their measures, for instance, that the majority of consumers in the member 
State concerned attached significant value to the provision of the origin indication. The EU 
confirmed that Italy had not notified to the Commission any draft on the indication of origin of 
grains used in the preparation of dried  pasta according to the above -mentioned procedure.  
2.2.3.8   Brazil – Regulation RDC No 123 on food additives and processing aids 
authorised for use in wine of  4 November 2016 G/TBT/N/BRA/649  
2.50.   The representative of the European Union  noted that the Brazilian Regulati on RDC No  123 
on food additives and processing aids authorized for use in wine had been adopted on 4  November 
                                                
4 G/TBT/M/70, paras. 2.49-2.51. 
5 European Union – Country of Origin Labelling (IMS ID  523) 
6 G/TBT/M/70, para. 2.53. G/TBT/M/71  
 
- 12 - 
 
  2016 and would enter into force on 7 November 2017. On 11 January 2016 , the EU had submitted 
comments on the draft regulation, which had been noti fied to the TBT Committee on 16 October 
2015, but had never received a reply from Brazil. Whilst her delegation appreciated that some of 
its comments had been taken on board by the Brazilian authorities in the adopted regulation, the 
EU believed that it st ill contained many divergences in relation to the relevant OIV 
recommendations which were of concern to the EU wine industry.  The EU therefore reiterated its 
invitation to Brazil to align the text with the relevant OIV recommendation, according to Article 2.4 
of the TBT Agreement. In addition, the EU asked Brazil to consider re -establishing a procedure for 
the inclusion of new additives and processing aids into the list, a procedure which had originally 
been foreseen in the draft as notified to the TBT Comm ittee. Finally, in order to facilitate the 
implementation of the regulation, the EU invited Brazil to consider providing for an exception for 
the wines already present on the Brazilian market until the exhaustion of stock.  
2.51.   The representative of Brazil  acknowledged that the measure underlying notification 
G/TBT/N/BRA/649 had been mistakenly submitted under the TBT Agreement and that its 
recirculation under the SPS Agreement had already been requested.7 For the sake of transparency, 
however, he stressed that the measure, now finally adopted as Resolution RDC 123/2016 of 
ANVISA, had been thoroughly examined in a public consultation procedure with comments 
received duly taken into consideration. Furthermore, the measure was consistent with the relevant 
internati onal standards for the use of food additives and processing aids, as it required compliance 
with the most up -to-date specifications from JECFA, FCC and the OIV. Brazil remained available for 
discussions on a bilateral basis.  
2.2.3.9   Viet Nam – Alcoholic Beverages G/TBT/N/VNM/86  
2.52.   The representative of Mexico  expressed concern about the Decree on Alcohol Trading drawn 
up by Viet Nam's Ministry of Industry and Trade, which had been notified to the TBT Committee in 
document G/TBT/N/VNM/86 on 26  August  2016. According to  the notification, the decree was due 
to enter into force in March 2017 with a view to protecting human health and safety. In particular, 
she flagged concerns raised by domestic industry regarding the mandatory requirements 
applicable to importers of alcoh olic beverages in Viet Nam, laid down in Article 35 of the decree. 
Firstly, Article  35.6 contained pre -import requirements for alcoholic beverages, such as 
shipment -by-shipment certification, compliance with food safety requirements provided for in the 
measure and in legislation, and the notification of the Ministry of Industry and Trade's food safety 
inspection authorities of the intention to import alcoholic beverages. Secondly, Article 35.7 
required the importer of these products to submit a written auth orization or approval showing that 
the alcoholic beverages were to be imported by an official distributor, in accordance with the 
licences granted for that purpose by the country's competent authorities. In Mexico's view, these 
provisions potentially expos ed importers of alcoholic beverages to more burdensome requirements 
than domestic traders or producers of these products, inconsistent with the principle of national 
treatment provided for in Articles 2.1, 5.1.1, 5.2.1 and 5.2.5 of the TBT  Agreement.  
2.53.   She t hanked Viet Nam for their recent bilateral meeting, during which her delegation had 
been informed about a new version of the measure, soon to be approved by the Vietnamese 
authorities and published and on which Members would be given time to submit comment s. Her 
delegation particularly welcomed the news that the provisions requiring the certification of each 
imported shipment would be removed, as would those requiring the submission of a written 
authorization or approval showing that the products were to be  imported by an official distributor. 
Mexico urged Viet Nam to adhere to the principles of transparency established in Article 2.9, 2.11 
and 2.12 of the TBT Agreement and to notify the new version to the WTO TBT Committee with a 
60-day comment period. She stressed that this would enable the new measure to be put to the 
consideration of Mexico's economic actors, and for the authorities to determine whether their 
concerns had been addressed by the new draft.  
2.54.   The representative of Viet Nam  noted that no formal  comments from WTO Members had 
been submitted during the 60 -day comment period on the draft decree. Moreover, the latest draft 
had been revised based on comments from stakeholders and developed in line with Vietnamese 
law. She reported that now the comment  period was over, the latest draft had been submitted to 
the government for consultation prior to adoption.  
                                                
7 G/TBT/N/BRA/649/Corr.1 . G/TBT/M/71  
 
- 13 - 
 
  2.2.4   Previously raised concerns  
2.2.4.1   European Communities – Regulation on the Registration, Evaluation and 
Authorization of Chemicals (REACH)  (IMS ID 88)  
2.55.   The representative of Canada  reiterated the concerns of Canadian small and medium -sized 
enterprises (SMEs) about the significant negative impact of various aspects of REACH on SMEs, 
including the "Only Representative" (OR) and "Letter of Access" (LoA) provisio ns for which the cost 
for substance LoA would be exceedingly high for their volume of business, as well as the 2018 
registration deadline for substances manufactured or imported in quantities from 1 to 100 tonnes. 
He explained that this would be especially  problematic in the case of chemical formulators who 
may combine multiple substances into their products. He stated that cosmetics, cleaners and 
paints are all examples of products from formulators who manufacture mixtures according to a 
formula. In these cases, the need to pay for LoA for dozens of chemicals could ultimately oblige 
them to exit the European market.    
2.56.   He explained that there were many substances used by SMEs for which the physico -
chemical properties were extremely well -known, and also trade d in high volumes. He continued by 
stating that it was worth exploring whether it would be possible to gradually extend the number of 
low-risk substances exempt from registration under Annex V of REACH. He said that Canada would 
appreciate more information  about the process for nominating such substances and he was 
encouraged that the EU had begun an evaluation of REACH and an open public consultation. He 
noted that numerous Canadian SMEs and the government had provided feedback through this 
process and exp ressed hope that the EU evaluation and fitness check would focus on burden 
reduction and simplification to address the disproportionate costs to SMEs.  
2.57.   The representative of the European Union  thanked Canada for the fruitful bilateral meeting. 
He reiterated  that no differentiation existed under the REACH registration obligations in the 
treatment of third countries' manufacturers exporting to the EU and domestic manufacturers. 
Importers or third countries' manufacturers using an OR were subject to the same ob ligations as 
regards the registration requirement in REACH as the EU producers of the same substance.     
2.58.   He highlighted that all substances registered in the lowest tonnage band (1 -10 tonnes/year) 
benefitted from reduced registration obligations in REACH ( i.e. less data had to be provided for the 
registration of substances in this tonnage band). He acknowledged that the Commission had noted 
in the REACH Review 2013 that there was a need to reduce the impact of REACH on SMEs and the 
Commission had already ad opted additional measures to assist SMEs in complying with their 
REACH obligations. He continued by stating that the registration fees to be paid to the European 
Chemicals Agency (ECHA) provided for a reduction of up to 95% for micro -enterprises compared 
to the fees for big companies. The Commission had contracted a study on "Monitoring the impacts 
on innovation, competitiveness and SMEs" (published in December 2015).8 The study was based 
on a robust survey among more than 1600 companies and identified spec ific issues of concerns 
among SMEs. The findings and recommendations of the report were being considered in the 
context of the REACH evaluation.  
2.59.   He explained that the scope of the ongoing evaluation of REACH was contained in the 
Roadmap that had been publi shed in May 20169 and a 12 -week public consultation had taken place 
until 28 January 2017.10 He noted that the Commission had warmly received Canada's feedback 
through the public consultation and this feedback, together with the submissions and 
recommendati ons from other stakeholders, as well as reports from EU member States and 
numerous studies already completed, would contribute to the elaboration of the EU's report on the 
operation of REACH. In January 2016, the Commission had adopted an Implementing Regu lation 
on joint submission of data and data -sharing under REACH with regards to the cost for substance 
LoAs. He explained that the objectives of this regulation were to reinforce the provisions of REACH 
and to increase the transparency of data and cost -sharing in Substance Information Exchange 
Forums (SIEFs) and, therefore, to prevent abusive practices as regards the price of LoAs towards 
SMEs in particular. He noted that based on the provisions of this Implementing Regulation and also 
of REACH, where agree ment on data -sharing within a SIEF was impossible to achieve, potential 
                                                
8 https://ec.europa.eu/growth/sectors/chemicals/reach_en  
9 http://ec.europa.eu/smart -regulation/roadmaps/docs/2017_env_005_reach_refit_en.pdf   
10 http://ec.europa.eu/growth/tools -database s/newsroom/cf/itemdetail.cfm?item_id=8952   G/TBT/M/71  
 
- 14 - 
 
  registrants had the possibility of bringing that data -sharing dispute to ECHA (more information on 
the process could be found on ECHA's website11). He continued that regarding the sugge stion to 
extend the list of exemptions from registration contained in Annex V to REACH, it should be noted 
that such modification would potentially be subject to Comitology (the set of procedures through 
which the European Commission exercises the implemen ting powers conferred on it by the EU 
legislator, with the assistance of committees of representatives from EU countries) and would only 
occur if the registration of the substance was "deemed inappropriate or unnecessary" based on 
Article 2(7)(b) of REACH.   
2.2.4.2   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)   
2.60.   The representative of the European Union  reiterated her delegation's concerns with the 
Indian measure at i ssue which introduced a certification procedure with a mandatory marking for 
tyres. The EU referred back to its statement at recent Committees concerning the ISI marking fee 
and the US$10,000 bank guarantee.  India was requested to align its procedures to i nternational 
practices and remove the obligation to pay a marking fee per marked tyre and to eliminate the 
discriminatory bank guarantee requirement. She recalled her delegation's request, during previous 
meetings of the TBT Committee, that India provide i nformation about the Scheme of Testing 
Inspections (STI) 15633/5 of November 2015, a measure which introduced the concept of "control 
unit", meaning 5,000 tyres of the same family. It required testing of every tenth control unit for 
load and speed performa nce, endurance test, bead unseating resistance test and tyre strength 
test. The EU had understood during bilateral discussions that the control unit had been modified to 
30,000 types of the same family and sought confirmation of this. The EU considered tha t these 
testing requirements were extremely burdensome and costly and asked what specific safety 
related objectives was India pursuing by requiring such a frequency of the tests. India had 
indicated previously that the new measure might be further amended following comments received 
on it; the EU asked for a state of play in this regard, an indication of possible changes in the 
requirements, and notification of the measure.  
2.61.   The representative of Japan  voiced support for the position of the EU regarding this  issue. 
His delegation remained concerned about the expensive marking fee and long time for 
certification. He said that, regrettably, misunderstandings regarding facts such as the basis of 
calculation of the marking fee had arisen between India and Japan a nd therefore his delegation's 
preferred option to reaching a satisfactory conclusion was through closed bilateral meetings.  
2.62.   The representative of the Republic of Korea  voiced support for the EU's statement.  He firstly 
recalled that India currently imposed  a guaranteed fee for each factory only to foreign enterprises, 
in violation of Article 2.1 of the TBT Agreement. Korea therefore requested India to remove the 
discriminative element between domestic and foreign enterprises. Secondly, his delegation 
deemed  that India required an excessively high usage fee compared with other countries; indeed 
most countries currently did not impose a mark usage fee. In this light, India was encouraged to 
at least reduce usage fees for the ISI mark.  
2.63.   The representative of India stated that the issues raised such as the bank guarantee 
requirement, marking fee amount, testing frequency and safety objectives were not new, and had 
been explained several times in the previous meetings. As there were no fresh updates, he 
referred Me mbers to responses provided in previous meetings. On the issue of notification, he 
referred Members to notifications G/TBT/N/IND/20 and G/TBT/N/IND/40 which had been filed 
when the measure was being introduced.  
2.2.4.3   China — Provisions for the Administration of  Cosmetics Application Acceptance 
G/TBT/N/CHN/821 (IMS ID 296)  
2.64.   The representative of Japan  reiterated its concerns regarding the "Guidance for Application 
and Evaluation of New Cosmetic Ingredients", in particular regarding the speed of examination, 
the sa fety evaluation requirement and information disclosure. She recalled that in previous 
meetings China had mentioned that the guidance would be revised in accordance with the revision 
of the "Regulations concerning Hygiene Supervision over Cosmetics". Japan asked China firstly to 
                                                
11 http://echa.europa.eu/support/registration/working -together/data -sharing -disput es/data -sharing -
disputes -in-practice   G/TBT/M/71  
 
- 15 - 
 
  clarify the details about the contents and schedule of the revision and, secondly, to provide a 
public comment process as foreseen in the TBT Agreement.  
2.65.   The representative of the European Union welcomed China's plans to set up a dif ferentiated 
approach between higher -risk priority cosmetic ingredients, requiring pre -market registration, and 
ordinary ingredients, requiring notification to competent Chinese authorities. The EU asked China 
to indicate the state -of-play and the planned t ime-frame both for the adoption of the above -
mentioned plans and of the new Chinese draft on Cosmetics Supervision and Administration 
Regulation.  
2.66.   The representative of China  thanked the EU and Japan for their continued interest in this 
measure. China recal led that Provisions for the Administration of Cosmetics Application Acceptance 
had been notified in 2011. Since then, China had offered specialized training and guidance on the 
difficulties enterprises had met in the implementation of this measure as well as cooperation at the 
governmental level. China stressed that great importance and attention was given to the approval 
of new cosmetic ingredients and stated that after three rounds of public consultations, a catalogue 
of cosmetic ingredients already used in China had been published.  
2.2.4.4   India – New Telecommunications -related Rules (Department of 
Telecommunications, No. 842 -725/2005 -VAS/Vol.III (3 December 2009); No. 10 -
15/2009 -AS-III/193 (18 March 2010); and Nos. 10 -15/2009 -AS.III/Vol.II/(Pt.)/(25 -
29) (28 Jul y 2010); Department of Telecommunications, No. 10 -15/2009 -
AS.III/Vol.II/(Pt.)/(30) (28 July 2010) and accompanying template, "Security and 
Business Continuity Agreement" (IMS ID 274)  
2.67.   The representative of Canada  said that his delegation still had concern s with India' s in-
country security testing requirements and reiterate d its comments provided at the last TBT 
Committee meeting.12 
2.68.   Similarly,  the representative of the United States  remained concerned that India's 
telecommunications conformity assessment requi rements could create an onerous and 
unnecessary trade barrier on Member companies, particularly SMEs. She asked if India could 
confirm that stakeholders would be informed of the new in -country testing effective date via a 
public notice, and if India would submit a notification to the TBT Committee. The US also 
requested that there be adequate time allowed between the announcement of the effective date 
and the actual effective date for producers to comply. She asked why currently available testing 
schemes, l ike the Common Criteria Recognition Arrangement (CCRA), were not sufficient for the 
Indian market. India had identified security concerns and circumstances that existed in most 
countries and the United States continued to note that these countries generall y did not require in -
country testing or an MRA. Security testing that would potentially compromise companies' 
proprietary information such as source code and other intellectual property would discourage 
companies from exporting high -quality telecommunicati ons equipment to the Indian market. This 
would unnecessarily hurt India's trading partners, as well as Indian consumers. Moreover, it was 
important that India honour its commitment under the CCRA to accept the results of CC tests 
conducted internationally,  and accept international testing standards and schemes regardless of 
whether the tests were performed in India or at accredited laboratories outside of India.  
2.69.   The representative of the European Union  echoed concerns raised by previous speakers . 
While he appreciate d the clarifications and explanations given by India at previous Committee 
meetings , it was now urgent to clarify the effective date of entry into force of the testing 
requirements. The EU  underst ood that the rules were currently postponed until 1  April 2017  and 
requested India to indicate whether a further postponement would  be granted. The system 
appeared not to be ready for full implementation and a further delay would therefore be 
necessary. The EU stressed the need to allow adequate time befor e the entry into force of these 
requirements in order for affected stakeholders to have an opportunity to review the final 
requirements , including any applicable standards and procedures. The EU's main  concerns were 
the following . On testing modalities , the EU was of the view that batch testing would be 
unnecessary and excessively burdensome  and suggested recourse to type testing , the results of 
which could then be applied to all products covered by the same production series.  On applicable 
standards , the EU welcome d previous clarifications provided by India concerning the leveraging to 
                                                
12 G/TBT/M/70 , para. 2.68.  G/TBT/M/71  
 
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  the maximum extent possible of the CC evaluation standard as well as the standard developed by 
the 3rd Generation (3G) Partnership Project.  
2.70.   On the  recognition of test result s carried out outside India, the EU echoed other delegations 
in challenging the requirement for in -country testing which did not  appear to add any value in 
terms of enhanced security of the covered equipment. In previous meetings, India ha d confirmed 
its intention to honour its commitments under the CCRAs  and to recognize test results generated 
by laboratories approved by CCRA members. For what was not covered by the CCRA, the EU  
consider ed that India should accept test results of qualified laboratories hol ding accreditation from 
ILAC MRA signatories and that these test results could be the basis for certificates to be issued in 
India by certification bodies approved by the Indian authorities. The EU was also of the view that 
some flexibility needed to  be pr ovided for companies which ha d a proven track record ; current 
rules fores aw a self -declaration of compliance. So for companies with a proven track record, who 
had consistently demonstrated their ability to self -certify products and to supply compliant 
products to the market, these products should continue to be accredited, and be certified by 
adequately accredited and competent in -house laboratories.  
2.71.   The representative of Japan  express ed support for the statements by Canada, US and EU.  
With regard to the U nified Access Service License Agreement, Japan remained interest ed in this 
new agreement and request ed India to ensure that its telecom regulations d id not impede market 
access for foreign industries.  In addition, the details of the testing modalities ha d not been clarified 
yet, even though the postponed date of entry into force of in -country security certification would 
be 1 April 2017.  From the viewpoint of influence on foreign industries, the way of implementing 
this regulation was important. Therefore, Japan asked India to clarify the details and current status 
regarding the implementation of in-country security testing.  
2.72.   The representative of India noted that most of the issues raised were not new , they were 
repetitive and had been responded to  many time s in the previous meetings of this Committee. As 
there was  no change in India' s position, and no fresh updates available , delegations were referred 
to the statements from the minutes of previous meetings.  
2.73.   The representative of the European Union  was intere sted in knowing when the measure 
would enter into force, or whether it was at all likely that the measure would be postponed.  
2.74.   The representative of India reiterated that there were no further updates on the matter.  
2.2.4.5   China – Requirements for information sec urity products, including, inter alia , the 
Office of State Commercial Cryptography Administration (OSCCA) 1999 Regulation on 
commercial encryption products and its on -going revision and the Multi -Level Protection 
Scheme (MLPS) (IMS ID 294)  
2.75.   The representati ve of the European Union  reiterated his delegation's interest in clarifying 
the implications and consequences of the adoption of the new Cybersecurity Law for the existing 
rules, notably the MLPS and the OSCCA regulation on commercial encryption products. He recalled 
that the OSCCA regulation had been under review for many years and requested an update 
concerning both the timing of the review of the OSCCA regulation and the process for the overall 
review of the MLPS along with the OSCCA regulation to bring them in line with the new 
Cybersecurity Law. He stressed the need for a transparent and predictable process for developing 
rules in the field of information security. Furthermore, he welcomed the public consultations on 
certain draft rules but pointed out that this was not yet systematic and only happened on an ad 
hoc basis , which didn't provide the required level of certainty and predictability for economic 
operators. Moreover, on transparency, he stressed the importance of openness and accessibility of 
the standardization process in this field. The EU recalled that any third party assessment of 
products for the purpose of information security would be carried out according to mandatory 
standards and stressed the importance that stakeholders were informed a nd given the opportunity 
to participate in the development of the relevant standards. In this respect the EU noted that 
despite some openings, the key technical committee for information security (TC 260) still refused 
access to some foreign invested enter prises  in China and hoped that wider access on a more 
regular basis would be granted. As a final point the EU underlined the importance of enhanced 
international cooperation in this field. Cybersecurity was a global issue and he stressed the need G/TBT/M/71  
 
- 17 - 
 
  for engag ement towards developing compatible regimes which would be capable of enhancing 
security without hindering trade in commercial encryption products.  
2.76.   The representative of the United States  echoed the concerns raised by the EU and said that 
an update on the  status of revisions to the 1999 Regulations on Commercial Encryption Products 
would be welcomed. The US remained troubled by what seemed to be a wide -spread effort by 
China to impose "secure and controllable" requirements, largely based on the MLPS system , on ICT 
products. The US asked how these requirements were consistent with China's WTO TBT obligations 
regarding national treatment. Furthermore, the US recalled that the MLPS was inflexibly 
prescriptive and could restrict the ability of consumers to purc hase technologies established as 
safe everywhere else in the world. The US underlined that the requirements laid out by MLPS 
effectively discriminated against foreign companies by mandating domestic IP and equipment 
usage in sectors deemed "critical". This  was of particular concern given the extensive scope of 
projects classified as level 3 or above. The US explained that other Members had rules to ensure 
security of critical infrastructure, but it seemed that China was now expanding the MLPS to include 
a wide array of commercial sectors that did not constitute critical infrastructure. The US concluded 
by stressing that this method appeared to preclude international competition. The US asked for 
further clarification as to the linkage between MLPS and the Cy bersecurity Classified Protection 
Scheme referenced in the Cybersecurity Law.  
2.77.   The representative of Japan  supported the positions of the US and EU regarding this issue. 
Japan stressed that it paid particular attention to the various schemes and regulations  within 
China, from the perspective of how they could negatively affect the trade of information security 
products. Japan recalled that at the last meeting, China had made a statement that the regulation 
on commercial encryption products and the Multi -Level Protection Scheme would be revised and 
adjusted appropriately in line with the principles of the Cybersecurity Law.13 In this regard, Japan 
asked China to explain the current situation and future schedule of the revision.  
2.78.   The representative of China  recalled that, as stated in their previous intervention14, both the 
regulation on Commercial Encryption Products and the information security MLPS would be revised 
in line with the principles of the Cyber security Law. China stressed that it would take its tradin g 
partners' concerns into consideration and would learn from their good practices. As had been 
previously explained, the relationship between cyber security and information security and the 
definition of "secure and controllable"  was "secure and trustworth y". China stressed that the clear 
definition would not give preference to domestic technology requirements or domestic goods 
procurement.  
2.2.4.6   Russia n Federation  – Draft Technical Regulation on Alcoholic Drinks Safety, 
G/TBT/N/RUS/2  (IMS ID 332)  
2.79.   The representa tive of Ukraine  noted that Item 4 of Article 7 of the Draft Technical 
Regulation stipulated that upon conformity assessment of products, the applicant may only be a 
legal entity or an individual (as a sole proprietor; or as a producer or seller; or as the agent of a 
foreign producer on the basis of a contract with the producer) registered pursuant to the 
legislation of a Customs Union member state. In her delegation's view, the mandatory requirement 
for applicants to register in the territory of the Customs  Union put national producers and 
producers from other WTO Members in unequal positions.  
2.80.   She underlined that any fees imposed for assessing the conformity of products originating in 
the territories of other Members should be equitable in relation to fees for like products of national 
origin. The costs for conformity assessment procedures for producers from other Members could 
include additional costs associated with the registration of legal entities on the territory of the 
Customs Union, hence higher than  the costs for producers from Customs Union member states. 
Ukraine urged the Russian Federation to remove unjustified technical barriers to trade and to bring 
the provisions of the mentioned Technical Regulation in line with the requirements of internation al 
practice.  
2.81.   The representative of the European Union  thanked Russia for the explanation provided at 
the November meeting on the status of the measure regarding the adoption procedure for this and 
                                                
13 G/TBT/M/70, para. 2.82.  
14 China – Cybersecurity Law . G/TBT/M/71  
 
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  other technical regulations by the Eurasian Economic Union,  in particular, the consultation process 
within its member states. His delegation asked Russia to update the Committee on any change of 
status or new information in relation to the timeline for adoption and implementation of the Draft 
Technical Regulation,  which had been notified in 2012. His delegation recalled Russia's statement 
from 2013, which stated that most of the EU comments regarding wine, spirit drinks and beer 
would be taken on board in the revised Draft Technical Regulation. He did however note that there 
was no revised text, and reminded Russia of the transparency provisions under Article 2.9 of the 
TBT Agreement. The EU representative requested a clarification on the state of play for the draft 
regulation. If the draft text notified in 2012 had  been modified and would include substantial 
changes in accordance with WTO Members' comments, the EU requested Russia to notify the 
revised text. Accordingly, the EU also requested that the implementation date of the final measure 
allow sufficient delay f or manufacturers to have time to adapt their products to the new 
requirements of the Technical Regulation.  
2.82.   The representative of the United States  thanked Russia for notifying the measure to the 
WTO and for the clarifications that Russia had provided to d ate. Notwithstanding those 
clarifications, her delegation continued to have concerns as previously outlined. These included the 
proposed definition of whiskeys, specifically the three -year minimum aging requirement, the 
requirement for an expiration date, the applicability of the standards for production facilities and 
several conformity assessment procedures to foreign manufacturers. To this end, the US reiterated 
its request for Russia to notify and revise Draft Technical Regulations and to provide an add itional 
comment period to enable stakeholders sufficient time to review and provide input before 
adoption. Her delegation had asked at the November 2016 meeting whether voluntary standards 
for distilled spirits were currently being applied with mandatory s tandards, and requested a 
relevant update on it. She enquired if the standards were applied as mandatory and how they 
would be applied once the Technical Regulation was finalized and implemented.  
2.83.   The representative of the Russian Federation  stated that th e Draft Technical Regulation on 
Alcohol Drinks Safety had been elaborated in order to establish uniform requirements for 
commercial turnover of alcoholic products, both imported and produced domestically. His 
delegation informed the Committee that to date the EAEU member states had some work ahead to 
finalize the regulation. He noted that the next round of consultations on the draft would be held in 
April 2017. His delegation reassured the Committee that all written comments of the WTO 
Members had been take n into account as provided for by Article 2.9.4 of the TBT Agreement. 
Russia would continue to inform the interested Members on further developments regarding the 
adoption of the draft regulation.  
2.2.4.7   Korea — Regulation on Registration and Evaluation of Chemic al Material, 
G/TBT/N/KOR/305, G/TBT/N/KOR/305/Add.1, G/TBT/N/KOR/478, 
G/TBT/N/KOR/547, G/TBT/N/KOR/592 (IMS ID 305)  
2.84.   The representative of the United States  said that while her delegation appreciated Korea's 
stakeholder engagement and receptiveness, two rec ent announcements had added to concerns 
about the compliance burden. Many US chemical companies were now considering withdrawing 
from the Korean market which would be to the detriment of Korean manufacturing sectors. She 
asked for a response to the 21 Dece mber request for information on potential changes to existing, 
or the inclusion of new requirements and procedures, as outlined in the "Plan for Safety 
Management of Chemical Consumer Products". The US strongly encouraged Korean regulatory 
specialists to a ttend future TBT Committee meetings. She thanked Korea for notifying Ministry of 
Environment (MOE) Notice No. 2016 -869, "Notice for Revised Version of the Act on Registration, 
Evaluation, etc. of Chemical Substances". This contained expansive new reporting  requirements for 
practically all chemicals and she requested that Korea issue an English -language translation or 
summary of the proposed measure. There appeared to be significant confusion and uncertainty 
with the measure, in particular for trace amounts used as inputs – with respect to specific 
requirements and acceptance of notifications and registrations. Chemicals also continued to be 
added or removed from the toxic substances list without proper notice, opportunity for comment, 
or justification. The U S remained very concerned about this lack of transparency and regulatory 
consistency. Concerning the planned disclosure of company confidential chemical information, she 
asked that Korea confirm that the Ministry of Environment had issued a revised public notice on 
30 May 2016 excluding non -hazardous substances. The protection of confidential information on 
composition and volume under the Chemical Controls Act (CCA) should be automatic, and with 
respect to K -REACH, the US reiterated their support for stron g protection of confidential G/TBT/M/71  
 
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  information on the uses and compositions of specific chemical identities, allowing for more 
substances that qualify as hazardous substances.   
2.85.   The representative of Japan  voiced support for the position of the US. The Act on the  
Registration and Evaluation of Chemical Substances (ARECs) had a significant negative impact on 
industr ies. Japan was still paying particular attention to the process of the draft ARECs and its 
relevant regulations such as the Presidential Directive and M inisterial Order, and expected that 
detailed requirements and implementation schemes would not be more trade restrictive than 
necessary.  
2.86.   The representative of Australia  continued to express his delegation's interest in this issue. 
Australia welcomed Korea' s plan to release brochures for businesses in English by the end of the 
year and sought clarification of when the brochures would become available.  
2.87.   The representative of the Republic of Korea  said that there did not appear to be a 
dramatically increased bu rden on industry to comply with the AREC (Amendment of Regulation of 
Registration and Evaluation of Chemical Material) , given that the amendment was a change in the 
method ology used to designate substances to be registered. Hence, the amendment did not 
increase the number of substances to be registered . Moreover, t he amendment contained a 
method  already introduced in the EU that would be completed in May 2018. This somewhat 
inconsequential method had not been developed by Korea but gave many benefits includ ing the 
protection of public health from chemical substances of risk. So as to minimize the burden on 
Korean and foreign companies , a notification system for new substances in small volume , instead 
of registration system , would be introduced. Korea would p rovide significant parts of the Safety 
Management Plan for Consumer Chemical Products in English during the first half of 2017, but it 
would be difficult to provide all guidance documents in English. Regarding the issue of Confidential 
Business Information  protection, companies could request protection of information from the 
Ministry of Environment , which after review could be protected unless it was a  hazardous chemical 
substance, under Chemicals Control Act and AREC.  Korea would continue to consult with 
stakeholders on this issue in a transparent manner.  
2.2.4.8   Indonesia - Technical Guidelines for the Implementation of the Adoption and 
Supervision of Indonesian National Standards for Obligatory Toy Safety, 
G/TBT/N/IDN/64 (IMS ID 328)  
2.88.   The representative of the United States  expressed regret for the lack of substantive 
progress on the matter, despite dialogue since 2012 on multiple technical issues. She requested an 
update on the s tatus of any revisions  since the US understood that Ministry of Industry intended  to 
revise the Ministerial Regulation in 2017. If  this were the case, the US urged Indonesia to notify 
the draft regulation to the WTO at an early enough stage to allow  stakeholders to provide 
comments and for those com ments to be taken into account. She reite rated her request that the 
next revision of the regulation allow toy testing to be performed by any ILAC/MLA -accredited 
laboratory on a permanent basis.  She indicated that dialogue had been held with US toy industry 
during which they had been informed that  the current mandatory in -country testing had  resulted 
in significant delays , increas ing the cost to US toy companies  of doing business in Indo nesia. 
Furthermore, she  remain ed hopeful that the revised regulation would  also address the US's 
remaining concer ns as they relate d to testing frequency, sampling, documentatio n, and substance 
restrictions. She reminded the Committee that in March 2015 with respect to  testing frequency , 
the Indonesian delegation had mentioned that it was reviewing the possibility of certification 
lasting for one year for both domestic production and imports.15 She requested an update on this 
review process and indicated that t he US would like to see this reflected in the next revision of the 
Ministerial Regulation , reaffirm ing their  interest in working with Indonesia in the revision process . 
2.89.   The representative of the European Union  joined the US in requesting an update on the 
review of Ministerial Decree No. 24 which his delegation deemed urgent and necessary in order to 
address the iss ue of the currently discriminatory testing requirements and also provide proper 
leverage to testing carried out by foreign laboratories holding adequate accreditation by ILAC/MRA 
signatories. He recalled that currently testing was carried out in accordance  to batch sampling at 
the time of import. An alternative would be to have samples taken in the country of origin, country 
of manufacturing or in the port of loading but this procedure was also very burdensome, lengthy 
                                                
15 G/TBT/M/65, para. 2.82.  G/TBT/M/71  
 
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  and costly and did not alleviate to an  appreciable extent the burden for exporters. This was 
particularly striking when compared to the testing procedures applied to domestically 
manufactured toys, for which samples were taken from the production line every six months.  
2.90.   On another issue, he no ted that since the end of April 2016, the grace period for the 
recognition of foreign test results had expired, effectively imposing in -country testing. In this light, 
the EU urged Indonesia to consider two options: either (i) to permit testing by laborato ries holding 
adequate accreditation by ILAC/MRA signatories on the basis of the national accreditation body of 
Indonesia being a member thereof, which the EU deemed sufficient and making a government -to-
government MRA unnecessary; or (ii) to explicitly per mit Indonesian certification bodies to enter 
into sub-contracting agreements with foreign laboratories for the recognition of foreign test results 
prior to certification in Indonesia. He concluded that another issue of continuing concern which 
could be add ressed in the on -going review was related to the discrepancies between Indonesian 
national standards for toys and the ISO standard for toys 8124, in particular concerning testing 
methods for formaldehyde and in relation to the speed with which Indonesian s tandards were 
aligned to any changes to the ISO standard.  
2.91.   The representative of Japan  expressed her delegation's continued support for the position of  
the US and  EU. Serious delays in exports were being caused by a sequence of events such as 
sampling, test ing, SNI certification and pre -shipment inspection . In particular, Indonesia was  
invited to revise the requirements for test frequency, whereby domestic products were tested once 
per six months whilst imported products were tested "each –and-every import sh ipment",  as they 
appeared to be more trade  restrictive than necessary . Regarding accreditation requirements 
whereby only overseas laboratories in countries with an MRA with Indonesia were recognized, it 
appeared that Indonesia had no such arrangements and therefore operators could not in fact use 
any foreign laboratories. Domestic laboratories may not have the capacity to run testing smoothly 
and accurately. Therefore, Japan strongly requested that Indonesia reconsider the requirements 
and accept testing re sults from foreign laboratories.  
2.92.   The representative of Canada  echoed the concerns of the United States,  the European Union 
and Japan and would continue to monitor developments.  
2.93.   The representative of Indonesia  stated that the draft Ministerial Regulation N umber 
55/2013, still under review and revision by its g overnment , was expected to  be completed by end 
2017. He assure d that the revision would be in line with WTO rules and that consumer protection  
was of  utmost importance to  Indonesia . He stated that comm ents would be conveyed to capital, 
that any development with the regulation would be duly notified, and that Indonesia was open  for 
further discussion including bilateral meeting s. 
2.2.4.9   European Union – Draft Implementing Regulations amending Regulation (EC) 
No. 607/2009 laying down detailed rules for the application of Council Regulation (EC) 
No 479/2008 as regards protected designations of origin and geographical indications, 
traditional terms, labelling and presentation of certain wine sector products, 
G/TBT/ N/EU/246, G/TBT/N/EU/246/Add.1 (IMS ID 345)  
2.94.   The representative of Argentina  reiterated his delegation's concerns regarding the EU's 
unjustified delay in addressing this specific trade concern, which had been raised by Argentina and 
other Members since 2009 . As had been said repeatedly, Regulations (EC) No 479/08 and 
No 607/09 were not consistent with the TBT  Agreement. The prohibition on the use of certain 
expressions such as "Reserva" and "Gran Reserva" on wines originating from third countries had 
had a s erious e ffect on the image and prestige of Argentine wines destined for the European 
market . This was clear and flagrant discrimination against Argentina and any other wine produc ing 
countries  seeking to place wines featuring the traditional expressions "R eserva" and "Gran 
Reserva" on the EU market.  
2.95.   So as to find a practical and constructive solution and notwithstanding its position that this 
measure was inconsistent with the TBT Agreement, Argentina had submitted its dossier for 
approval of the terms " "Reserva" and "Gran Reserva " which fulfilled all of the European 
Commission's substantive assessment.  However, since March 2012 the dossier had  been blocked 
pending its inclusion on the agenda of the College of Commissioners, for adoption and publication 
in the Official Journal of the EU. No proper justification or any reasonable explanation for this delay G/TBT/M/71  
 
- 21 - 
 
  had been forthcoming from the EU, despite  the nu merous requests made both in the TBT  
Committee and at the bilateral level.  Due to the EU announcing over thre e years ago that it was in 
the process of reviewing the use of traditional terms with a view to simplifying them , all 
applications for approval of traditional terms had come to a standstill . Regulation (EC) No 
607/2009 had therefore  become obsolete, at lea st with regard to the requests for approval of 
"traditional terms". This meant that Argentina had been in a situation of legal uncertainty for three 
years on the reform of the wine regime, and for five years on its  application for approval of the 
tradition al terms "Reserva" and "Gran Reserva".  
2.96.   The proposed reform had yet to be notified, despite the EU indicating that this would be 
done in 2016. No information was available regarding the proposal or its impact on applications for 
approval which, in the case of Argentina, had completed all the stages of internal evaluation. The 
EU had informed the Committee that trading partners' concerns would be taken into account in the 
review process that was currently underway. Argentina once again requested that the EU i nclude 
this item on the agenda of the next meeting of the College of Commissioners and publish the 
relevant regulatory act in its Official Journal so as to lift the unwarranted restrictions on Argentine 
exports of quality wines. The EU's refusal to apply i ts current standards  while awaiting reforms 
which had never materialized reflected a lack of will in resolving this trade concern. He urged the 
EU to submit the proposed amendment without delay and to explain how applications that had  
concluded the technic al approval process  would be treated. He again request ed the prompt 
conclusion of this process.  
2.97.   The representative of the United States  reminded the Committee of US concerns on this 
issue. US industry had lodged applications for the use of 13 traditional t erms in 2010. It was now 
2017 and no updates had been received despite repeated requests. The EU had failed to provide 
any valid justification for the delay and she urged the EU to expedite these applications. While the 
US was fully aware of the undergoing  revision of the application system for traditional terms, EU 
officials had made it clear that the revisions were merely simple technical changes to align the 
system with the Lisbon Treaty. Therefore, this did not seem to justify delaying the applications.  
She again requested the EU to provide a clear answer on their status and confirm the applications 
were indeed on hold pending the revisions or for some other reason. She also asked for 
confirmation that the technical revisions would not otherwise negative ly impact the applications 
and, in particular, that having already waited more than six years, US industry would not be 
required to re -submit their applications when the revision was finalized. She requested 
confirmation that the timeline  for providing further details about the revisions to the application 
system, was indeed mid -2017 as had been indicated by EU officials and that the revised regulation 
would be notified to the WTO. She recalled that at the last TBT meeting the EU had offered  
bilateral excha nge at a technical level on this issue.  While  this was welcome, the US  asked that 
respon ses to their repeated questions be presented in the Committee. In addition to the impact on 
US trade , these answers were of broader interest given that concerns ha d been reflected in the 
interventions by many WTO Members over the last six years. Moreover, the questions posed 
during this meeting  and in previous TBT meetings - including the status of applications, reasons 
for delay and timelines – should have straightforwa rd answers that did not  require technical 
expertise to understand.  
2.98.   The representative of the European Union  informed the Committee that, as had been 
explained in previous meetings, an internal assessment on traditional terms had been carried out 
within the  EU with stakeholders and experts from the member States (in accordance with 
Article  114(3) of Regulation n° 1308/2013 establishing a common organization of the markets in 
agricultural products). The alignment/simplification of the wine labelling provision s and of the 
traditional terms rules, as well as the pending applications for traditional terms, were still under 
consideration in the context of the general reflection on the marketing rules for all agricultural 
products. Therefore, no proposals on tradit ional terms we re expected in the near future  and 
precise deadlines could not be provided at this stage. The EU would continue to make efforts to 
simplify its current policy on the protection of traditional terms and their inclusion on wine labels, 
taking i nto account trading partners' concerns. This simplification exercise went beyond the 
current recast of the wine labelling regulation, which mainly covered the simplification of the 
procedures for the registration of new traditional terms. The concerns rais ed by Members had been 
noted and would be considered when carrying out this complex simplification exercise. The 
handling of the pending files which, she stressed, also included applications from EU m ember 
States, would  be included in the process. The EU remained available for  bilateral discussion s with 
trading partners at expert level.  G/TBT/M/71  
 
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  2.2.4.10   India - Electronics and Information Technology Goods (Requirements for 
Compulsory Registration) Order, 2012, G/TBT/N/IND/44, G/TBT/N/IND/44/Add.1 -5, 
G/TBT/N/IND/47 , G/TBT/N /IND/47/Add.1 -Add.3 , G/TBT/IND/47/Add.1/Corr.1 (IMS 
ID 367)  
2.99.   The representative of the Republic of Korea  thanked India  for its efforts to improve this 
regulation  by including the exempt ion of BIS marking on cells and the provision of an  additional 
grace per iod for the observation of  IS 16046. Nevertheless, Korea requested that India accept test 
reports which had been approved by the IECEE CB Scheme  in accordance with Article  5.1 of the 
TBT Agreement Such accept ance of  test results would alleviate the unneces sary burden to 
exporting companies.  
2.100.   The representative of the United States  reiterated concerns with India 's Compulsory 
Registration Order (CRO) requirements, which only allowed for product testing by a BIS -accredited 
lab and did not recognize test results  from internationally accredited labs, even under the IECEE 
CB scheme. The continual expansion of the list of products under the CRO created confusion and a 
lack of predictability. She questioned the criteria used to determine which products or categories of 
products should be included under the CRO. The US understood that MEITY had considered 
expanding the CRO product list, giving a ten -day comment period but had not notif ied this to the 
TBT Committee. She encouraged India to notify any products or categor ies of products being 
added to the list, and to allow a suitable comment period so as to allow trading partners the 
opportunity to provide comprehensive and constructive comments. She asked if foreign 
participants could participate in the Technical Advisor y Committee that had been established by 
MEITY to resolve  potential technical issues that could arise during CRO implementation. The US 
was disappoint ed that India had not added  an HSE exemption for products intended for sale only 
to medium -to-large enterp rises and not directly to the public .  
2.101.   India had noted that the BIS standards under the CRO were "identical to the corresponding 
international standards ". Requiring companies to retest to BIS standards, when they had already 
met the identical corresponding  international standards, created a burden leading to price 
increased and delivery delays for domestic consumers. She recalled that India had explained to the 
Committee in the previous meeting, that the retesting was necessary due to unique circumstances 
in India such as variations in plugs and sockets and tropical country testing, etc. US labs tested to 
different plug and socket standards for tropical environments for a number of different countries 
and she asked that India demonstrate what exceptional cir cumstances required retesting to BIS 
Standards by a BIS -recognized lab. As a member of the IECEE CB Scheme, India already had an 
MRA with other signatories and should therefore reciprocate approval of tests performed at IECEE 
CB-accredited laboratories out side of India.  
2.102.    The US was disappointed that its request that BIS -recognized laboratories only require a 
product sample for testing when they cannot resolve a suspected non -compliance issue through 
exchanges with the Certification Body and the manufacture r, did not qualify under the process laid 
out for CRO. She asked that an explanation be provided as to why the request did not qualify 
under the CRO. She also asked that India increase the sample delivery time as India allowed more 
time for products that w ere not available in stock or market. She questioned which provision of the 
CRO or other legislation allowed more time for the submission of product samples and how a 
company was to request more time for such products. Finally she asked for  an update on th e US 
request that product registration be required by the brand owner rather than by the factory.  
2.103.   The representative of Canada  supported concerns raised by other Members. The Order 
continued  to hinder or possibly shut Canadian exporters out of the Indian market due to delays in 
registration and testing.   
2.104.   The representative of the European Union  recalled two main points. Firstly, the EU was 
interested in further streamlining of the registration procedure in order to achieve shorter delays, 
and that consider ation be given for a single registration for multiple factories manufacturing the 
same product under the same brand and the responsibility of the same brand owner. Secondly, on 
testing, recognition of test results produced by foreign laboratories participa ting in the IECEE CB 
scheme or accredited by ILAC MRA signatories was currently granted only for safety critical 
components. He invited India to consider improving reliance on this arrangement beyond safety 
critical components and also to extend the validi ty of test reports for registration purposes past the 
current 90 days. India had indicated at the last TBT Committee meeting that beyond the specific G/TBT/M/71  
 
- 23 - 
 
  arrangements concerning the reliance on IECEE CB Scheme under the compulsory registration 
scheme, there wo uld be the possibility for foreign laboratories to seek recognition from BIS to 
perform any required tests under the scheme. The EU had looked into this further and understood 
that the legal basis for this would be in the BIS Act of 1986. Regulators' agree ment was necessary 
for this recognition to be granted and so far the responsible regulator – the Minister of Electronics 
and Information Technology - had not approved any laboratory outside India, and it did not seem 
to be willing to do so. He asked how In dia envisaged this general possibility for recognition of 
foreign labs operating, alongside the specific arrangements on the IECEE CB scheme under the 
Compulsory Registration Order.  
2.105.   The representative of India recalled that many of the issues highlighted, such as 
acceptance of test reports under the CB Scheme, were responded to and elaborated upon in 
previous meetings. He therefore invited interested delegations to refer to the minutes of previous 
meetings. He did however have a few specific updates to prov ide. T he streamlining of product 
registration and the renewal process was under continuous reform and automation. BIS had  
already defined model timelines and published these  on its website. Efforts were being made to 
accept softcopies of documents for BIS certification renewal  and registration of brand owners 
would be cons idered once the BIS Act 2016 had been implemented. R emaining queries  and 
suggestions of Members would be transmitted to authorities in capital for consideration and 
response.  
2.2.4.11   European Unio n — Revised Proposal for the Categorization of Compounds as 
Endocrine Disruptors of 19 February 2013 by DG Environment , G/TBT/N/EU/283 , 
G/TBT/N/EU/283/ Add.1, G/TBT/N/EU/384 and G/TBT/N/EU/384/Add.1 ; 
G/SPS/N/EU/166, G/SPS/N/EU/166/Add.1  (IMS  ID 393) 
2.106.   The rep resentative of Argentina  reiterated its concerns with the EU's approach to 
determining the criteria used to identify substances with endocrine disrupting characteristics, given 
their br oad scope and potential impact o n sanitary regulations and trade in agr icultural products.  
He thank ed the EU for its replies to comments on G/SPS/N/EU/166, which he understood to be 
related  to notification s G/TBT/N/EU/383  and G/TBT/N/EU/384 concerning the measure regulating 
the use of biocidal products.  Nevertheless, Argentin a considered that these responses did not 
justify several specific concerns. In particular, d espite repeated calls for the adoption of an 
approach that took into account a full risk analysis, the EU was solely using a hazard -based 
approach . While the EU ju stified this on the basis of constraints of the mandate imposed by the 
European Parliament and the Council in Regulation (EC) No. 1107/2009 and Regulation (EU) No. 
528/2012, Argentina considered these proposals to be at odds with EU's WTO obligations. 
Moreover, the proposal was also disproportionate, unnecessarily trade -restrictive and ignored 
international standards. According to th e Impact Assessment, the same level of human health 
protection could be achieved with Options 2 to 4, while Option 4 was ident ified as that which would 
register the lowest impact in socio -economic terms, both in the agricultural sector and in 
international trade.  The EU failed to explain the reason for preferring Option 2. In addition, 
Argentina recalled that the EU asserted that  applications for import tolerances concerning 
marketing of plant protection products would depend on the approval of the proposal  on repeals. 
In view of the division between the "criteria" and the "repeals" proposals, he said that the text on 
"repeals" wa s not being addressed in EU internal procedures and considered this to be of particular 
concern because the treatment of repeals covered cases of "insignificant risk" due to low exposure. 
It was not clear why the EU linked the decision to divide proposals with alleged transparency 
objectives and his delegation believed that this division created uncertainty and did not contribute 
to transparency.  
2.107.   While the  proposal aimed at  enhancing  protection of human health and the environment, 
the EU had opted for a pro posal that lacked  adequate scientific basis and that would  unnecessarily  
restrict  trade.  This was despite the Impact Assessment circulated by the EU which provided less 
restrictive alternatives . Argentina underscored the obligation for WTO Members to refra in from 
creating unnecessary obstacles to trade, as per Article 2.2 of the TBT Agreement. If adopted, this 
proposal would lead to the prohibition of safe substances without scientific justification.  The 
adoption of the proposal could mean that active subst ances that had already been approved 
following a strict risk assessment carried out by the European Food Safety Authority (EFSA) would 
henceforth be regulated in line with an approach based solely on hazard identification. Their 
approval could possibly be reviewed and their maximum residue limit (MRL) be set by default at 
the detection level of 0.01 parts per million (ppm), without the relevant scientific back up and in a G/TBT/M/71  
 
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  manner that contradicts the MRLs recommended at the CODEX level. Argentina regretted t hat the 
EU's approach did not take into account a full risk analysis despite being indicated as a feasible 
approach by EFSA and that the proposal's division created uncertainty regarding the possibility of 
approval of the repeals' provisions and the import  tolerances under Regulation No. 396/2005. 
Finally, Argentina requested the EU to retain both the repeals and the import tolerances in its 
proposal and, if the proposal on criteria was approved in the terms presented, to advance the 
proposal on repeals "in  parallel".  This would prevent a substantive modification of the proposal 
notified to the SPS and the TBT Committees and the creation of unnecessary barriers to trade in 
agricultural products.  
2.108.   The representative of the United States  reiterated  concerns reg arding the establishment of 
identification criteria for endocrine disruptors in the EU's proposal to amend Regulation 1107/2009 
and the  implement ation of Regulation 1107/2009 that require d the  withdraw al of existing 
authorizations for substances that trigg ered certain criteria without a risk assessment. While s he 
reiterated her strong support for strengthening public health and environmental protection through 
risk-based approaches based on available science, the US recalled concerns raised in previous 
meetings that the measures were insufficiently grounded on science and risk and could 
significantly disrupt trade. In particular, the US had concerns with the division of the draft 
measure in December 2016  into a proposal to establish criteria for identifying endocrine disruptors 
and a proposal to amend the derogation criteria from "negligible exposure" to "negligible risk". 
This contrasted with member States' assurances that risk assessments would be conducted 
through a derogation procedure at the information session held on the margins of the SPS 
Committee in October 2016. While the EU had indicated that the division of the draft measure 
notified to the SPS and TBT Committees aimed at greater transparency, the US believed that it 
significantly changed the cond uct of risk assessments on substances identified as endocrine 
disruptors. The US remained concerned that the proposed approach for the establishment of 
criteria for the categorization of compounds as endocrine disruptors  without  finalizing procedures 
for derogations could lead to more trade -restrictive regulatory outcomes than the proposal notified 
to the TBT Committee. This was because establishing MRLs or import tolerances would become 
effectively impossible for the EU and could have far -reaching detrimen tal consequences on trade, 
without contributing to the protection of human, animal or plant health.  
2.109.   The US thanked the EU for its replies to US written comments on 22 February 2017, but 
was disappointed that the EU provided justification for the establishm ent of criteria that ignored 
factors such as potency and exposure on the EU's law requirement to establish hazard -based 
criteria, rather than scientific evidence. The US understood the EU Commission's legal constraints 
and recalled that EU's responses refe rred that potency was not included in the criteria because it 
should not be considered at the hazard identification stage. Her delegation, nevertheless, noted 
that the EU was using these criteria not solely for hazard identification, but also to deny or 
withdraw authorizations for pesticides and the corresponding tolerances. Moreover, she posed a 
series of questions to the EU.  First, the US asked the EU to clarify the derogation procedures for 
"negligible risk" that would ensure a risk -based approach and ap proval and renewal eligibility 
regarding substances that triggered other cut -off criteria such as those classified as carcinogenic, 
mutagenic or toxic for reproduction  (CMR) . In particular, would "negligible risk" include exposure 
and potency? Second, the US asked the EU to define the meaning of "negligible risk" and to detail 
the scientific criteria to determine that an applicant meets the "negligible risk" standard. The EU's 
reply of 22 February 2017 to the US request for clarification on the meaning of " negligible risk" 
indicated that applicants could provide information to prove "negligible risk" and that, if "negligible 
risk from exposure" could be proven, the substance may be approved under restricted conditions 
and depending on results of comparative risk assessments. The US expressed disappointment with 
this reply because it did not specify the actual criteria that would be used to prove "negligible 
risk". Third, what was meant by "restricted conditions" and what criteria would be used to 
determine "r estricted conditions"? Fourth, what was the meaning and purpose of "comparative risk 
assessments"? Specifically, would these refer to the assessment of alternative pesticides for which 
similar uses were approved? Fifth, what would be the scientific basis f or conducting a "comparative 
risk assessment" if "negligible risk" was demonstrated? Sixth, how would "proof of negligible risk" 
differ from safety standards for substances that did not trigger the EU's hazard -based criteria? 
Seventh, how would the require ment to demonstrate "proof of negligible risk" apply to substances 
determined safe and approved for use for several years in the EU under a risk -based system? 
Would the EU recognize its own previous safety finding or would applicants be required to re -
subm it information? E ighth, was it possible to file an application for an import tolerance for a 
product if a substance was designated as an endocrine disruptor but not authorized for use in the G/TBT/M/71  
 
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  EU? If so, would that tolerance be set on the basis of a risk ass essment, as stipulated in 
Regulation 396/2005?  The US was particularly concerned that, according to the EU's reply on 22 
February 2017, only if the proposed derogation's amendment was adopted would it be possible to 
apply for an import tolerance. She noted  that the process for establishing import tolerances 
remained unclear if the amendment to the derogation was not adopted.   
2.110.   The US stressed the need for a risk -based approach and a non -discriminatory 
implementation of this measure. Consequently, the US aske d the EU to ensure that the process of 
derogation did not lead to arbitrary decisions , to implement risk assessment guidelines and 
processes that are consistent for all substances and to pursue a transparent and predictable 
approach through the risk manage ment process. The US remained concerned that while the 
implementation of Regulation 1107/2009 would severely impact US food and agricultural exports 
to the EU, it would not meaningfully contribute to enhancing human and environmental health. Her 
delegation  believed that there were less trade -restrictive alternatives that would achieve the level 
of human health and environmental protection sought by the EU. As noted in previous meetings, 
the US Environmental Protection Agency's Endocrine Disruptor Screening Program (EDSP) was an 
evaluation programme that had been reviewed by numerous independent scientific advisory panels 
since its launch in 1996 to ensure that risk management decisions were supported with robust 
scientific criteria and processes. Finally, th e US asked the EU to notify the revised proposal and to 
apply a science -based regulatory approach in which risk assessments were the main factor for the 
authorization of chemical substances, especially of tolerances for pesticide residues on food. The 
US, once again, expressed willingness to submit these questions in writing and looked forward to 
the responses.  
2.111.   The representative of Canada  expressed , as noted in comments to the EU's TBT and SPS 
notifications  in 2016,  his delegation's continued concern with  the EU's proposed approach for the 
categorization of compounds as endocrine disruptors, in particular with respect to the EU's 
implementation of a hazard -based approach for the regulation of plant protection products. 
Canada appreciated EU's replies to co mments on G/TBT/N/EU/383, G/TBT/N/EU/384 and 
G/SPS/N/EU/166 . While hazard identification was an important first step in the scientific risk 
assessment framework, it was also imperative that the potential adverse effects be put into 
context with considerati on of potency and the level of likely human and environment exposure 
based on conditions of use. Canada believed that derogation was not an appropriate means to 
include potency, exposure and subsequent evaluation of actual risk. His delegation considered t he 
establishment of MRLs and import tolerances to potentially mitigate the proposal's trade impact. 
Consequently, Canada was concerned about the division of the notified proposal into two parts, 
one of which contained the scientific criteria for derogation  (3.6.5 and 3.8.2 of Annex II, 
Regulation 1107/2009 ). The entry into force of the  hazard -based approach in categorizing 
endocrine disrupting chemicals without the amendments for derogation could restrict trade  more 
than the proposal notified by the EU . Canada estimated that the proposal could impact 60% of 
plant protection products for wheat and soy crops and 45% of Canadian canola production, which 
showed the high impact on trade and on farmers' access to safe plant protection tools necessary to 
maintain f ood production. He recalled that the European Crop Protection Association's letter to the 
EU Commission on 21 February 2017 mentioned that the proposal generated uncertainties and 
could negatively impact EU farmers' use of safe plant protection tools. In a ddition, his delegation 
expressed a number of specific concerns: the proposal unnecessarily restricted trade; there was no 
evidence that contributed more to human health than less restrictive alternatives; departed from 
scientific risk -based regulation of plant protection and biocidal products; and impact on Canadian, 
EU and third Members' farmers. Finally, Canada asked the EU to reconsider the hazard -based 
approach , to use an internationally recognized approach incorporating hazard and exposure under 
a science-based risk assessment and to recognize the importance of setting import MRLs in 
accordance with EU's WTO obligations. Canada would continue to monitor developments in this 
area, especially on the interplay between Regulation 1107/2009 and Regulation 3 96/2005  and the 
derogation's operationalization.  
2.112.   The representative of Thailand  echoed the statements of Argentina, the US and Canada 
and raised a number of specific concerns. First, the hazard -based approach  did not consider  
potency and exposure  and, the refore,  may not reflect the actual risk.  Second, the decision to set 
MRLs for endocrine disrupting substances at 0.01 mg/kg would  significantly impact  agricultural 
trade . Third, the definition of "negligible risk" remained unclear . Thailand once again requ ested  the 
EU to apply a risk -based regulatory approach  and to define "negligible risk". Her delegation hoped 
that the EU would take comments into account.   G/TBT/M/71  
 
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  2.113.   The representative of Ecuador  shared other Members' concerns, in particular the proposal's 
division.  She asked for clarification on this matter.  
2.114.   The representative of Brazil  joined the concerns of other delegations. While his delegation 
appreciated the EU's responses, Brazil remained concern that the hazard -based approach did not 
constitute an adequate risk assessment and was therefore unjustified under the SPS and TBT 
Agreements. Brazil echoed concerns on the division of proposals because it could lead to the 
approval of categorization criteria without the derogations. Consequently, substances could be 
prohibited without a definition of tolerance limits based on scientific assessments and create trade 
obstacles. His delegation remained open to discuss with the EU and trade partners and hoped that 
a WTO -consistent solution was achieved.  
2.115.   The representative  of New Zealand  thank ed the EU for the information exchange  and 
continued to follow this process.  Her delegation  echoed concerns raised by others, and hoped that 
the final shape of the proposal was one which did not unnecessarily restrict trade . She encour aged 
the EU to take into account comments from trading partners . 
2.116.   The representative of Colombia  once again shared concern s raised by other Members  and 
thanked the EU for its comments.  
2.117.   The representative of Guatemala  shared the concerns expressed by other M embers.  Her 
delegation  was following this matter closely and hoped the EU would take Members' concerns into 
account . 
2.118.   The representative of Uruguay  joined other Members' concerns.  
2.119.   The representative of the European Union  thank ed Members for their interest i n the 
proposal . The EU was well aware of trading partners ' concerns . Nevertheless, the mandate given 
by the EU Commission was to set criteria for the identification of endocrine disruptors through the 
implementation of pesticides legislation and not to mod ify endocrine disruptors' general approach. 
The draft pesticides regulation had been notified to the WTO and this approach adopted by co -
legislators in 2009. The EU Commission proposed to amend derogations for endocrine disruptors in 
the pesticide legislat ion in accordance with technical and scientific knowledge in June 2016. The EU 
reaffirmed its commitment to comply with its obligations and recalled that replies to written 
comments had been provided in February 2017. The proposal was divided between endoc rine 
disruptors' criteria and a technical amendment to the existing derogation in December 2016 to 
facilitate EU decision -making process. She stressed that this division changed the legal drafting 
and not the content to offer member States, the EU Parliame nt and Council the opportunity to 
discuss each aspect separately. While the decision -making process was ongoing, there was no 
formal vote on the criteria or the derogation's amendment at the Standing Committee on Plan, 
Animals, Food and Feed for Pesticides ' meetings in 21 December 2016 and 28 February 2017. The 
EU was reflecting on how to proceed further and noted that the current interim criteria for 
endocrine disruptors' identification would apply until agreement was achieved. This was 
undesirable for any  Member because they were not appropriate. The EU was committed to act in a 
fully transparent manner and would keep Members informed on further developments.  She stated 
that the EU Commission's website on endocrine disruptors was updated regularly.  
2.2.4.12   Peru - Act to Promote Healthy Eating Among Children and Adolescents , 
G/TBT/N/PER/89 , G/TBT/N/PER/89/Add.1, G/TBT/N/PER/89/Corr.1  (IMS  ID 383)   
2.120.   The representative of Mexico , whilst recalling her delegation's statement on this STC 
during the November 2015 TBT Comm ittee meeting16, expressed concern about the regulations 
implementing Law No. 30021, notified in document G/TBT/N/PER/89 on 20 September 2016, 
which established the provisions and steps to be implemented for the purposes of applying and 
complying with the l aw, with a view to protecting human health and safety in the Peruvian 
territory. Given that the regulations applied to imported processed foods, the Mexican industry had 
emphasized the measure's impact on its exports to Peru and her authorities supported t hese 
concerns. At a recent bilateral meeting, both parties had agreed to further technical level 
                                                
16 G/TBT/W/429 . G/TBT/M/71  
 
- 27 - 
 
  exchanges between the authorities responsible for the measure and the competent authorities in 
Mexico.  
2.121.   She drew particular attention to the annex to the regula tions, entitled "Technical 
Parameters for determining whether foods and non -alcoholic beverages have a high sugar, sodium 
and saturated fat content as referred to in Law No. 30021", and on which Mexico's concerns 
centred. The annex contained criteria for e stablishing the existence of excessive quantities of 
sodium, free sugars or saturated fats, with a view to determining whether products should be 
marked "high in" or "containing an excessive amount of" these elements. In this respect, Mexico 
believed that the measure complied with the definition of technical regulation provided in Annex 1 
of the TBT Agreement, and that the formulas for determining the inclusion on product labels of 
warnings concerning the high or excessive content of certain critical nutrie nts could be tendentious 
in some cases and mislead consumers, instead of fulfilling the objective of accurately informing 
buyers of the nutritional aspects of processed foods enabling them to make informed choices and 
also safeguarding Peru's interest in p rotecting its population from NCDs such as obesity. To 
illustrate the point, she explained that the Peruvian regulations prescribed that "light" products or 
plain water – with zero calories – must display the warnings "high in" or "containing an excessive 
amount of" free sugars or sodium, since the calculation for determining the inclusion of these 
warnings required that the total calorie content of the processed food product be divided between 
its fat, sodium or free sugar content. Her delegation believed that this could give consumers an 
inaccurate perception of "light" products or zero calorie foods and cause them to consider such 
foods "harmful". In this light, she noted that the Codex Alimentarius General Guidelines on Claims 
(CAC/GL 1 1979) prohibited "claims which could give rise to doubt about the safety of similar food 
or which could arouse or exploit fear in the consumer" and those "implying that a balanced diet or 
ordinary foods cannot supply adequate amounts of all nutrients" and therefore believe d that Peru 
could be in contravention of its commitment to base its technical regulations on international 
standards or relevant parts thereof, as established in Article 2.4 of the TBT Agreement.  
2.122.   Lastly, as discussed bilaterally, Mexico encouraged further exchange between the Mexican 
and Peruvian technical teams, to look at the scientific and technical information that had led to the 
determination of certain criteria for the inclusion of warnings regarding critical nutrient content on 
labels affixed to proc essed foods, and which had been considered when assessing the risks that 
nonfulfillment  of the legitimate objective of protecting the health and safety of the Peruvian 
population would create, in accordance with Article 2.2 of the TBT Agreement.  
2.123.   The repres entative of the United States  said that whilst her delegation supported the 
objective of improving consumer awareness of nutrients to encourage healthy eating, concern 
remained about the potential wholesale adoption of the PAHO Nutrient Profile, and the 
development of a list of food products with "high" contents of sugar, salt, and saturated fat, rather 
than promotion of an overall healthy diet. Via their notification, Peru had indicated that the 
technical parameters would be based on the ratio of each nutr ient to a product's total energy 
content, rather than an assessment of the nutrient's relation to total dietary intake. The US sought 
clarification on the methodology employed to determine the technical parameters and the ultimate 
objective of the proposed  labelling requirement. The proposed application could result in consumer 
confusion and decrease incentives for product innovation and reformulation. Moreover, her 
delegation believed that consumers benefitted from having information both on individual nut rients 
and on foods in the context of an overall diet. For example, she said that products using non -sugar 
sweeteners to reduce calories may have a higher ratio of sodium and/or saturated fat than higher -
calorie products made with sugar and noted that the criteria to determine if the sugar content was 
"high" applied to "free sugars", not "sugars", but no definition of "free sugars" had been supplied 
in the drafts.  
2.124.   The US went on to ask Peru for confirmation that it would continue to allow nutrient 
content c laims on foods requiring an "advertising warning" as consumers may benefit from being 
given information on other nutrients that would be beneficial and encouraged in the diet. For 
example, a product may be high in sodium but also high in dietary fiber, and  within the range of 
acceptable daily sodium intake based on a set number of calories. She also noted that a similar 
labelling scheme recently promulgated in Chile exempted packages with fewer than 30 square 
inches of available labelling space, and urged P eru to consider a similar exemption for small 
packages.  G/TBT/M/71  
 
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  2.125.   The representative of Guatemala  reiterated its statements at previous meetings, 
emphasizing the importance of protecting the health of the population. Her delegation 
nevertheless was concerned that th ese measures and others taken in the region could be an 
unnecessary obstacle to trade.  
2.126.   The representative of Peru reiterated its commitment to achieving legitimate objectives for 
the protection of public health, specifically through the effective protectio n of the health of the 
most vulnerable segments of its population, including children and adolescents, in accordance with 
its international trade commitments. He stated that Law No. 30021 – "Law to Promote Healthy 
Eating Among Children and Adolescents", ha d been enacted with the objective of reducing 
diseases linked to excess weight or obesity and chronic NCDs among children and adolescents. 
Peru was still reviewing the comments received on the draft regulations, which had been notified 
to the WTO and the A ndean Community on 9 September 2016, in order to determine whether it 
was relevant to include them in the final regulations for publication in the Official Journal.  
2.127.   He underlined that the final regulations implementing Law No. 30021 would enter into 
force 180 days after their publication. Law No. 30021 provided for a period of 60 days to comply 
with its provisions and of 120 days to adapt to specific provisions on advertising and warnings. 
Both periods would begin upon the entry into force of these regulati ons. Peru remained available 
for further bilateral discussions.  
2.2.4.13   Ecuador – 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 o f processed and packaged food products, 
G/TBT/N/ECU/19, G/TBT/N/ECU/19/Add.1 –Add.1 1 (IMS ID 411)  
2.128.   The representative of Mexico  reiterated the concern with respect to the technical 
regulation, the objective of which was "to regulate and control the labelling  of processed foods for 
human consumption, in order to guarantee a person's constitutional right to timely, clear, accurate 
and non -misleading information concerning the content and characteristics of these foods, which 
enables the consumer to make the cor rect choice when purchasing and consuming them". Her 
delegation referred to Ecuador's latest notification G/TBT/N/ECU/19/Add.11 of 18 December 2015 
and recalled that it had expressed trade concerns in the communication submitted to the TBT 
Committee on 15 January 2016 (G/TBT/W/430) and the November 2016 Committee meeting.  
2.129.   Mexico appreciated the recent bilateral meeting on their concerns regarding the provisions 
of the regulation but nevertheless maintained that the measure was a technical regulation within  
the meaning of Annex 1 of the TBT Agreement and that concerns remained in a few areas. Firstly, 
regarding the inclusion of colour -coded charts on labels affixed to processed foods, showing a 
"high", "medium" or "low" concentration of total fats, sugars an d salts, she noted that the phrase 
"contains transgenics" was also required. While relevant international standards should be used as 
a basis for technical regulations in accordance with Article 2.4 of the TBT Agreement, Mexico 
considered these expressions  to be inconsistent with the General Guidelines on Claims of the 
CODEX Alimentarius (CAC/GL 1 -1979, 3.5), which prohibited claims "which could give rise to doubt 
about the safety of similar food or which could arouse or exploit fear in the consumer" and th ose 
"implying that a balanced diet or ordinary foods cannot supply adequate amounts of all nutrients". 
Secondly, her delegation believed that the above -mentioned expressions could mislead the 
consumer, since they tended to stigmatize food products as "good " or "bad" whilst  the relevant 
international standards did not currently provide for any distinction to be made as regards GMO 
content of food product labels. Finally, Mexico considered that the measures on advertising, which 
prohibited the use of real or fictitious images of persons and animals in labelling, could be 
inconsistent with the provisions of Article 20 of the WTO TRIPS Agreement, since they might 
unjustifiably encumber the use of a trademark in the course of trade.  
2.130.   In view of the above, Mexico r equested that Ecuador: provide an explanation on the 
reasoning and the scientific evidence justifying the use of the colour -coded graphic system, as well 
as information about the results of this scheme; provide justification for or, if appropriate, 
envisag e the elimination of the requirement for the label to include the word "transgenic", where 
present; and reconsider the restrictions on advertising on labels.  G/TBT/M/71  
 
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  2.131.   The representative of Guatemala  reaffirmed its support for the legitimate objective of 
protecting human health, as indicated in previous meetings. Nevertheless, his delegation 
expressed concern that these measures could constitute a trade barrier and that within the region 
there was not enough harmonization with regard to food labelling as evidenced by  the different 
measures in each country.  
2.132.   The representative of Ecuador  reiterated that Resolution No. 116 established labelling 
requirements and was not a technical regulation. Ecuador noted that with regards to the 
Regulation on Food Labelling, the Minis try of Health had conducted consultations with the private 
sector and the health sector for the promotion of health and equality and had assessed the 
implementations of these laws. The technical regulation was under review and some of its 
modifications wou ld include, inter alia , the calculation of the sugar content through a graphic 
labelling, the content and the concentration allowed per unit, the graphic system that would be 
used for milk, and the GMOs indications. She concluded by stating that comments r eceived after 
the regulation's notification were currently being taken into account.  
2.2.4.14   Russia - Safety of products for children and adolescents, G/TBT/N/RUS/29 
(IMS ID 418)  
2.133.   The representative of the European Union  requested further information concerning the  
timeframe for the adoption and entry into force of the amendments notified under notification 
G/TBT/N/RUS/29. The EU asked whether the amendments had been adopted since the last 
meeting of the TBT Committee, and if so, Russia was asked to clarify the date  of adoption and the 
date of entry into force. Finally, the EU requested that Russia provide the final adopted text once 
available.  
2.134.   The representative of Ukraine  support ed the statement made by the EU and expressed her 
delegation's  interest in following th e discussions on th e matter . 
2.135.   The representative of the Russian Federation  thanked delegations for comments on the 
draft amendments to the technical regulation. He informed the Committee that the Eurasian 
Economic Union had concluded consultations on the dr aft. These amendments were expected to  be 
adopted at the meeting of the Council of the Eurasian Economic Commission  in April 2017. Russia  
would  inform WTO Members of the results of th is meeting.  
2.2.4.15   Thailand – Draft Notification of the Alcoholic Beverages Cont rol, Re: Rules, 
Procedure and condition for Labels of Alcoholic Beverages, issued under B.E. 
G/TBT/N/THA/437 , G/TBT/N/THA/437/Add.1, G/SPS/N/THA/221/Add.1  (IMS ID 427)  
2.136.   The representative of New Zealand  expressed support for Thailand 's right to introduce ne w 
regulations to address specific public health concerns. New Zealand appreciated that in seeking to 
address the harmful use of alcohol, the technical  regulation was directed toward s achieving a 
legitimate public health objective. New Zealand restated its concern that the labelling 
requirements in their current form were unclear and may be difficult to implement in practice. New 
Zealand requested that  Thailand update Members on the progress of any intended revisions to the 
regulations and implementing guida nce. 
2.137.   The representative of the United States  thanked  Thailand for the additional information 
provided in early March 2017 through the US  WTO TBT Enquiry Point in relation to this regulation . 
The US remained concerned  with the regulation, including its vagu e language and the excessive 
enforcement discretion it confer red on individual officers, which in her delegation's view create d a 
very real risk of trade disruption. At the November 2016  TBT meeting , she recalled that the Thai 
delegate had said  the regulat ion relate d to advertising and not labelling, and that terms related to 
the quality of wine could  be used. However, the US delegation understood that  the regulation very 
specifically applie d to the wording and messaging that could  be placed on an alcohol l abel and 
packaging. She asked Thailand to  confirm that her delegation's  interpretation was correct.  
2.138.   The US reiterated its request that  Thailand suspend this regulation until clearer guidance 
could  be shared with its WTO partners, given the risk of trade di sruption. She asked if Thailand 
could  clarify whether it had, or intend ed to, provide much needed updates to th is regulation or 
guidance . The US underst ood that Thailand may be planning to review the implementing G/TBT/M/71  
 
- 30 - 
 
  guidelines relating to the regulation. She asked for  confirm ation on  whether this was the case, and 
that Thailand provide further information on th e review process and timelines.  The US  specifically 
asked that Thailand notify the implementing guidelines, and ensure that stakeholders were 
provided s ufficient opportunity to provide input during any review and revision process. Finally, the 
US emphasize d the importance of any changes being enshrined in such a way as to provide 
exporters with certainty regarding the rules apply ing to their products, and  that these rules could 
not be easily changed without sufficient consultation.  
2.139.   The representative of the European Union  reiterate d concerns regarding the Regulation on 
Criteria, Procedures and Conditions for Labels of Alcoholic Beverages (B.E 2558/2015), a pplicable 
since 19 October 2015.  As stated in previous TBT Committee meetings and in the written 
comments submitted in December 2015, which ha d not been answered, the EU again express ed 
concerns with the strict labelling requirements included in the Regula tion and with the lack of 
clarity of both the Regulation and the implementing technical guidelines. The EU sought  
clarification on whether a revision of both the Regulation and the implementing  guidelines was 
under consideration and on whether stakeholders  were to be consulted on any modification. She 
asked for an update on the state of play of this revision process.  The EU also requested  
information on the outcome of considerations on graphic health warnings and invite d Thailand to 
notify to the TBT Commit tee any draft proposal on labelling of alcoholic beverages or graphic 
health warnings, so that eventual comments by Members could be  taken into consideration.  
2.140.   The representative of Canada  requested an  update from Thailand regarding its regulations 
on alco hol including the scientific evidence on which its measure was based. Canada was grateful 
for Thailand 's commitment to continue including stakeholders in the development of its measures.  
Canada  looked forward to reviewing and commenting on this process and  hoped the results of the 
regulatory process we re consistent with the TBT Agreement. Canada  asked Thailand to ensure  that 
any new regulations would reduce uncertainty and provide clarity for wine and spirits exporters. 
Canadian wine labels were not intende d to appeal to children or promote irresponsible 
consumption of alcohol.  Canada underst ood that Thailand was still considering the use of graphic 
warning labels , and asked for the  opportunity to comment.  
2.141.   The representative of Australia  acknowledged the ri ght of Members to take measures 
necessary to protect public health, and recognized Thailand's efforts to address a legitimate public 
health concern through its labelling regulations for alcoholic beverages. He noted that this 
regulation had entered into fo rce on 15 April 2015, and that manufacturers and importers had 
been required to comply since 18 October 2015. Australian exporters faced ongoing uncertainty 
regarding the implementation of the regulations, and Australia remained keen to work with 
Thailand and their importers to comply with the new requirements. However, clear guidance was 
required, and Australia encouraged Thailand to create guidance material for industry and trading 
partners, allowing stakeholders to use compliant labels rather than submit ting labels for approval 
on a case -by-case basis. Finally, Australia continued to request Thailand consider implementation 
arrangements for the new regulations that did not require products currently on the market to be 
removed from sale.  
2.142.   The representativ e of Japan  shared concerns raised by other Members. Japan requested 
Thailand to provide an update on the discussion on the revision of the measure.  
2.143.   The representative of Guatemala  recognized the need to protect the health of consumers, 
and the legitimate o bjective of Thailand to reduce the level of alcohol consumption within its 
population. However, Guatemala was not convinced that this regulation, which established certain 
criteria for the labelling of alcoholic beverages, would be effective in reducing co nsumption. 
Guatemala requested a detailed and precise explanation of the scientific evidence or other 
considerations that led to the conclusion that the measure in question would reduce consumption 
of alcoholic beverages, without being more trade -restricti ve than necessary. Guatemala considered 
that the information prohibited on labels under the regulation was not intended to stimulate 
consumption, but to provide  objective and clear information to consumers in terms of quality -
related characteristics. Final ly, she said Guatemala shared the concerns raised by other Members.  
2.144.   The representative of Thailand  welcomed the opportunity to provide explanations and 
respond to concerns about this technical regulation related to advertising of alcoholic beverages. 
He sa id there was ample evidence showing that advertising of alcoholic beverages was a strong 
measure that increased alcohol consumption and consequently, alcohol -related health and social G/TBT/M/71  
 
- 31 - 
 
  problems. He explained that this technical regulation prohibited the use  of falsified, exaggerated, 
misleading, and socially disruptive messages on labels and packages of alcoholic beverages. These 
practices were also prohibited in other countries. To facilitate implementation of this regulation, 
Thailand had developed and rev ised a technical guidance document for this regulation. Thailand 
had developed and revised a technical document for this regulation.  The newly -revised document 
would be published in early April 2017 . However, Thailand believed there was always room for 
improvement, and was therefore evaluating the implementation and impact of this regulation to 
see whether and how it could be improved. Thailand reiterated its belief in free trade, while also 
fulfilling due responsibilities to protect health of citizens. Th ailand used and would continue to use 
prudent measures that were not more trade restrictive than necessary and avoid trade disruption.  
2.2.4.16   China – Regulations for the Supervision 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 
(IMS ID 428) 
2.145.   The representative of the European Union  reiterate d concerns on the Chinese regulations 
notified under G/TBT/N/CHN/1022 -1026 and G/TBT/N/CHN /1029. The comments had been  sent to 
the Chinese authorities on 23 June 2014 and raised subsequently in the TBT Committee meetings . 
The EU refer red to its concerns  raised during the last meetings  of the  TBT Committee in relation to 
the issue of the clinical  trials required for the registration in China for Class II or Class III medical 
devices , the delays with this registration procedure, and the requirement to register the medical 
devices in the country of origin. She highlighted the repeatedly raised conce rn with regards to the 
unnecessary duplicative clinical trials to be conducted in China. In the November 2016 Committee 
meeting, the EU had expressed concern  that the draft lists of Class II and Class III devices which 
would be exempted from clinical trial s were limited. In addition , the EU asked China  to accept 
clinical trials conducted in foreign countries and to remove the obligation to conduct clinical trials 
in China for products not listed in the catalogues. The EU had also asked whether  clinical tria ls 
would have to be performed for C lass II and III in -vitro diagnostic medical devices on Chinese 
populations living in a Chinese mainland environment and whether results of testing on Chinese 
populations living abroad or on non -Chinese population would no t be accepted. As China had not 
been in a position to fully answer these questions at that time , the EU again requested further 
clarification on this issue,  in particular , on whether data from clinical trials abroad were sufficient  
for the registration cer tificate . Furthermore, the EU requested that China accept test reports from 
electromagnetic compatibility (EMC) testing from laboratories accredited internationally, as an 
alternative to in -country testing. Finally, the EU reiterated its request that China  grant a 
transitional period of three years and issue guidelines detailing the relevant processes.  
2.146.   The representative of  the Republic of Korea  reiterate d concerns raised on the Regulations 
for the Supervision and Administration of Medical Devices in previo us TBT Committee meetings . 
China did not recognized test reports issued by internationally accredited laboratories when 
registering medical devices, leading to unnecessary duplication of testing for imported medical 
devices that ha d already been tested, thus causing  additional expenses and registration delay s. 
Korea reiterated its requests for China to recognize test reports issued by internationally 
accredited laboratories. According to the written responses from China to Korea's questions with 
regards to the WTO Trade Policy Review, Article 57 of the Regulations stipulated that test reports 
issued by inspection institute s jointly accredited by the CNCA and the CFDA were recognized . As 
Article 57 d id not limit the location of laboratories to the territory o f China , any testing laboratories 
whether in China or abroad  could be accredited.  Korea request ed that  China accredit international  
testing institutes to avoid duplicat ion of testing, additional cost  and inspection delay.  
2.147.   The representative of Canada  acknowledged  China's  response at the previous TBT 
Committee meeting and considered t he updates  a positive step  regarding  Priority Approval 
Procedure for Medical Devices and the number of medical devices exempted from clinical trials . 
Nevertheless , Canada raised concern  that the requirement for compani es to apply for exemptions 
was an unnecessary administrative burden. He considered that the requirement on imported 
medical devices to obtain ma rket approval from the country or region  where the applicant 's 
busines s registration was or the product was produced, would restrict access to products not 
registered in the country of origin , creating unnecessary barriers to trade and limiting  Chinese 
consumers ' access to life -improving medical devices. Canada restated its commitment to  working 
with China  with a view to addressing these and other aspects of the regulation in a constructive 
manner.  G/TBT/M/71  
 
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  2.148.   The representative of China  had responded to these concerns  at the previous meetings  of 
the Committee . Since there was no update , the interested delegations were requested to refer to 
the minutes of the meeting held in November 2016 .17 
2.2.4.17   Kingdom of Saudi Arabia – Decree of the Saudi Arabian Ministerial Council on 
the sale and marketing of energy drinks of 4 March 2014,18 (IMS  ID 442)  
2.149.   The representative of the European Union  reiterated concerns with regard to the impact on 
trade of the measures which Saudi Arabia and other GCC countries were applying and/or 
developi ng in the area of energy drinks . The EU  had requested that clear, proport ionate, science -
based, and non-discriminatory requirements be established by the GCC countries, and be 
uniformly applied by all authorities . His delegation thanked  Saudi Arabia for its willingness to 
accept EU contributions on the issue, and in particular to consider EU comments within the GCC 
regulatory process in this area.  The EU asked Saudi Arabia to provide an update on the state of 
play of the regulatory development of the measure.  
2.150.   The representative of the United States  support ed the GCC 's public hea lth objective of 
working to curb  excessive caffeine consumption but nevertheless support ed other Members ' 
interventions on this important matter.  While the US applauded recent efforts by the GCC and GSO 
to solicit input from the private sector as they cont inued to develop regulation in this area, her 
delegation requested that the GCC and GSO take into account the feedback from the private sector 
in developing final regulations. The US had submitted its comments in 2015 and 2016, and 
requested that considera tion be given to its remaining concerns, in particular regarding size and 
content of the warning labels, as well as container size limitations. The US understood that these 
regulations were still in development and requested  any additional information Saud i Arabia could  
provide on the status of the regulatory process.  In addition, the US requested information on what 
concerns the GCC had identified with regard to energy drinks. Her delegation appreciated the 
efforts to engage with industry on this issue and  welcomed collaboration and further bilateral 
engagement.  
2.151.   The representative of the Kingdom of Saudi Arabia  reiterated that, concerning The Saudi 
Ministerial Council Decree regarding energy d rinks and the GSO draft requirement on  handling of 
energy drinks , the requirements were not to impede market access but rather to protect consumer 
life and health. His delegation had engaged in positive bilateral discussion with its interested 
trading partners to ensure that such requirements would not create unnecessa ry obstacles. Saudi 
Arabia committed to notify the Committee if there was any update and to continue discussions 
bilaterally.  
2.2.4.18   European Union – Common Criteria for Information Technology Security 
Evaluation (Common Criteria) Certification in the EU (IMS ID 448)  
2.152.   The representative of China  reiterate d their concerns with the  refusal  of EU member 
States' CC certification  bodies to accept and process Chinese producers' applications and about the 
lack of opportunity for Chinese companies to join the CC -related st andard organizations.  China had 
repeatedly requested additional CC -related information and urged the EU to take  a constructive 
approach to address the concerns of the Chinese industry.  China expressed disappointment with 
the EU's claim that CC certificatio n was not within  the scope of the TBT Agreement  and stated that 
her delegation believe d the issue fell in  either Article 5  "Assessment of Conformity by Central 
Governmental Bodies " or Article 8 "Assessment of Conformity by Non -governmental Bodies " of the 
TBT Agreement , depending on the nature of CC certification bodies . The EU  was urged  to comply 
with the obligations under the TBT Agreement and to address raised concerns  in a timely manner.  
2.153.   The representative of the European Union  thank ed China for their continued interest in th e 
matter and  reiterate d that China had failed to identify any concrete measures , technical 
regulations or conformity assessment procedures , falling within the scope of the TBT Agreement. 
                                                
17 G/TBT/M/70, paras. 2.160 -2.161.  
18 G/TBT/N/ARE/262, G/TBT/N/QAT/389, G/TBT/N/SAU/669, G/TBT/N /SAU/789, G/TBT/N/ARE/299, 
G/TBT/N/BHR/426, G/TBT/N/KWT/309, G/TBT/N/OMN/23, G/TBT/N/QAT/423, G/TBT/N/SAU/910, 
G/TBT/N/YEM/29, G/TBT/N/ARE/301, G/TBT/N/BHR/428, G/TBT/N/KWT/311, G/TBT/N/OMN/240, 
G/TBT/N/QAT/425,G/TBT/N/SAU/912, G/TBT/N/YEM/31.  G/TBT/M/71  
 
- 33 - 
 
  The EU referred the Committee to their statemen ts in previous meetings19 regarding  the 
obligations of  IT system operators to ensure the security of communicated information as well as 
the absence of any compulsory certification for commercial encryption products. He expressed his 
delegation's availabili ty for further bilateral discussions with China.  
2.2.4.19   China - Administrative Measure on Cosmetics Labelling (AMCL), 
G/TBT/N/CHN/1064 (IMS ID 456)  
2.154.   The representative of Japan  acknowledged the clarification provided by China that this 
measure would allow "over -labelling" on imported cosmetic products. On the other hand, Japan 
asked China to consider the remaining three concerns . Firstly, on manufacturer labelling, Articles 
14 and 15 of the draft measures should only present the name and address of compan ies with 
final legal responsibility for the quality and safety of the concerned products . Secondly, regarding 
the promotional advertising of cosmetics efficacy claims foreseen in articles 19 and 20 of the draft 
measure, testing results should not be disclosed  withou t limitation  since they could include 
companies ' know-how and the "efficacy assessment testing organization " should not be limited to 
institutions inside China.  Thirdly, Japan declared as indispensable a clear guidance - detailed 
regulations - in addition to the draft measures themselves. Furthermore, taking into consideration 
the negative influence on distribution of products  into the Chinese market , Japan requested China 
to provide a sufficient transition period for the smooth implementation of the new la belling 
regulation. Japan asked China when the new implementation date would be.  Finally, Japan recalled 
that at the June  2016 TBT meeting, China had mentioned that this draft AMCL would be revised 
according to the contents of "Regulations concerning Hygie ne Supervision over Cosmetics" which 
were the superior regulations to the draft measures. Japan asked that a public comment process 
be provided for the revision of the "Regulations concerning Hygiene Supervision over Cosmetics" in 
accordance with TBT rules . In addition, Japan requested an explanation from China regarding the 
details of discussion on manufacturer labelling and efficacy assessment testing in the studies of the 
reviewing process.  
2.155.   The representative of New Zealand  shared the concerns expressed by Members regarding 
requirements for labels to include the names and addresses of manufacturing subcontractors, 
requirements for third party verification of efficacy assessments and cosmetic claims and timelines 
for product registration and approval. New Zealand sought clarifications on whether animal testing 
for the safety of cosmetic products would continue to be required for imported cosmetic products if 
widely accepted alternatives become available. Finally, New Zealand welcomed any updates on the 
timeline for entry into force of these measures.  
2.156.   The representative of the European Union  reiterated the concerns raised  during recent 
meetings of the TBT Committee, also sent to the Chinese authorities on 12 January 2015. In its 
written reply of 18 March 2015 , China indicated that it would consider the comments received. The 
EU welcomed the possibility of labelling cosmetic products by means of stickers, but reiterated a 
number of issues included in the notified draft. Firstly, the requirement to display the n ame and 
address of the manufacturer and of the subcontractors when part of the production was done by 
subcontractors. Secondly, the need to confirm that the efficacy assessment and the cosmetic claim 
verification could be conducted by any verifying organiz ation scientifically and technically 
competent to do so according to the criteria and guidance established by the China Food and Drug 
Administration (CFDA). The EU believed that any requirement for third party verification by a 
Chinese organization would b e more trade restrictive than necessary. Thirdly, the need to align the 
requirements regarding cosmetic claim substantiation with international best practices. The EU 
understood that the process for the revision of the general legal framework for the placi ng on the 
market of cosmetics in China, i.e. the future Cosmetics Supervision and Administration Regulation, 
was on -going, and requested confirmation that the Administrative Measures for Cosmetic 
Labelling, developed in parallel with this general framework , would not enter into force prior to the 
regulation. Furthermore, the EU reiterated its request for information on the implementation of the 
guidelines on the verification of efficiency of claims related to cosmetic products presented by 
CFDA at the techn ical meeting with their EU counterparts in March 2015. Finally the EU asked 
China when the drafting process of th e measure would be finali zed and whether the question of 
labelling in Chinese ha d been reviewed.    
                                                
19 G/TBT/M/68 , para. 2.214, G/TBT/M/69, paras. 2.204 -205, G/TBT/M/70, para. 2.172.  G/TBT/M/71  
 
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  2.157.   The representative of Australia  reiterated its interest in this issue and welcomed an update 
on the status of the regulations. He supported the comments from Japan, New Zealand and the EU 
on labelling requirements. Australia agreed that any requirements for third party verification by a 
Chinese orga nization would be more trade restrictive than necessary. Australia would welcome 
clearer guidance and longer implementation timeframes in order to allow time for industry to 
adjust to the significant changes. Australia emphasized the importance that domest ic and foreign 
cosmetic manufacturers be treated equally with respect to product registration and approval. 
Australia noted that the regulations were still being drafted and welcomed clarification on these 
issues once finalized.  
2.158.   The representative of China  reiterated that cosmetic labelling was essential for consumers 
to understand basic information of cosmetic products. She stated  that the AMCL was still being 
drafted  and that CFDA would follow international rules and give full consideration to valuable 
inputs from interested parties. China confirmed the possibility for imported products consistent 
with China 's relevant regulations to be attached with labels in Chinese.  
2.2.4.20   China - Banking IT Equipment Security Regulation (IMS ID 457)  
2.159.   The representative of Japan said that her delegation still had concerns about the Chinese 
banking IT equipment security regulation. Japan asked China to provide updated information about 
the revision of "the Guideline for promoting the Application of Secure and controllable Informa tion 
Technology in Banking Sector" as China had stated (at the Committee's previous meeting) that it 
had been reviewing it. In addition, with regard to the statement that "the opportunity to hear the 
comments of stakeholders is going to be arranged to issu e the final draft", Japan asked China to 
clarify the specific way and future schedule of this stakeholder consultation. Regarding the 
requirement for the submission of source codes for risk assessment, Japan was concerned that, 
without clarifying the scope  of data, it would be more trade restrictive than necessary in the light 
of the Guideline's purpose. Therefore, Japan asked China to revise the Guideline not to be more 
trade restrictive than necessary in accordance with international standards, and to ens ure 
transparency during the review process.  
2.160.   The representative of the United States  said that  China 's measures for "secure and 
controllable " technology in the banking sector continue d to affect sales of foreign technology to 
banks in China. Without China a nnouncing that such rules (or other measures restricting or 
limiting the use of foreign technology products in the banking sector ) would  not be imposed at a 
later date, the banking sector remain ed reluctant to purchase foreign technology products, which 
raised concerns with regard to national treatment. Chinese regulators ha d pressed forward with 
similar cybersecurity measures in other commercial sectors. The draft China Insurance Regulatory 
Commission 's ICT rules replicate d much of the troubling language f rom the suspended draft ICT 
banking measure.  The United States urge d China to uphold its transparency commitments by 
notifying relevant technical regulations to the WTO TBT Committee, publicly soliciting comments, 
and taking into account stakeholder commen ts from the  United States Government , industry, and 
foreign governments before implementing any similar cybersecurity measures in the banking or 
other commercial sectors.   
2.161.   The representative of the European Union  joined other delegations in reiterating his  
delegation's interest and concern with regard to the development of specific IT security 
requirements for the banking sector. This one, similar to the requirements for the insurance sector 
that would be discussed subsequently20, set specific implementation  requirements relevant to the 
general approach to information security that had been discussed earlier. While the EU appreciated 
the fact that the Chinese authorities had decided to undertake a review of the initial draft based on 
the comments received, hi s delegation shared the concerns expressed by Japan and the US 
concerning disclosure of the source code, the mandatory use of indigenous technology, and the 
restrictions concerning the use of equipment incorporating foreign technology which would stem 
from these requirements. The EU understood that the adoption of the Cybersecurity Law added a 
new dimension to discussions; hence, the on -going review would have to take into account the 
elements of the new Cybersecurity law. The EU requested China to undertak e a revision process in 
a transparent and inclusive manner that allowed not only for adequate opportunities to participate 
                                                
20 China - Insurance Regulatory Commission (CIRC) Information and Communication Technology 
Regulation (IMS ID 489)  G/TBT/M/71  
 
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  in the Chinese domestic process but that was also accompanied by a TBT notification so as to allow 
adequate opportunities for WTO Mem bers themselves to submit comments.  
2.162.   The representative of Australia  said that his delegation would be grateful for further 
information from China on the status of the regulations , including whether they w ould be 
permanently withdrawn.  
2.163.   The representative of China  said that the  Guideline for Promoting the Application of Secure 
and Controllable Information Technology in Banking Sector (2014 -2015)  had expired  and China 
had no timetable for further development of any guidelines . China would  fulfill its internat ional 
obligation to ensure the openness and transparency of the commercial banking sector. China 
would take comments from interested parties into consideration  and welcome d foreign producers 
in the b anking IT system to establish an industry dialogue mechan ism.  
2.2.4.21   China - Registration Fees for Drugs and Medical Device Products (IMS ID 466)  
2.164.   The representative of the Republic of Korea  reiterate d concerns on this measure . The 
Notice on Measures of the Administration of Charging Standard for Drug and Medical Devic es 
Registration (NDRC Price  (2015), No.1006) published on  27 May  2015, appeared to be 
discriminatory as the application fees for first registration of domestically manufactured medical 
devices were different to that of imported medical devices. At the November 2015 TBT Committee 
meeting, China had explained that the application fees for imported medical devices were higher 
because the fees include d site inspection costs. These costs should be separate to the registration 
fees, so as to ensure  transparency a nd fairness. Korea  request ed that China  charge the costs of 
any on-site inspection audit separate ly from the registration fees rather than requiring  that the 
inspection costs and fees be paid together when applying for a marketing authorization.  
2.165.   The repre sentative of Australia  said his delegation continue d to share concerns raised by 
others regarding the fee structures and process requirements for domestic and imported drug and 
medical device products. He asked that China outline how the fee structure and process 
requirements for imported products were proportionate to the testing process requirements 
including for the costs of transportation, accommodation and allowances . Concerning the domestic 
prices being based on a "provincial price", he asked China what the provincial price was, how it 
was determined and whether the same testing processes and requirements were applied for the 
provincial price . Australia understood that the regulations allow ed for small and micro business 
with an innovative medical devi ce to have their registration fees waived for first -time registration. 
He asked China to provide additional information about how innovative products were defined  and 
whether domestic and imported pr oducts could be considered innovative. Australia acknowle dged 
that on -site inspections were necessary to promote public health and inspections at foreign 
facilities could be more expensive. However, fees associated with foreign inspections should be 
transparent, non -discriminatory, and include industry consultat ion prior to implementation. 
Australia looked forward to receiving China's response to their questions.  
2.166.   The representative of Canada  said his delegation remained  concerned about important 
aspects of the regulation and about the general lack of clarity and  transparency regarding 
registration fees for drugs and medical device products. China' s approach of combining registration 
fees with on -site inspection fees for fo reign manufacturers created  a lack  of transparency 
regarding those  fees. In order to enhan ce transparency, Canada requested that the on -site 
inspection fees be published separately from the registration fees for foreign manufacturers and 
that China publish the registration fees to be levied by China' s provinces on domestic 
manufacturers. In doing  so, it would be clear what manufacturers were  being charged and for 
which services . This would ensure that the registration fees conform ed to  China' s WTO nationa l 
treatment obligations, and that the on -site inspection fees were reasonable and correspond ed to 
cost of service.  
2.167.   The representative of China  said that the registration fees were  cost based  and should not 
be discussed in the TBT Committee . On the issue of transparency,  Article 5.6 of the TBT 
Agreement did not apply given that the fee system did  not belong to the "technical content" of a 
conformity assessment procedure. Therefore China had no obligation to notify the measure and 
indeed could not find any notification  of similar regulations  by any Member .  G/TBT/M/71  
 
- 36 - 
 
  2.2.4.22   Brazil - Draft Ordinance Act N o. 374, 27 Nov ember 2014 (Portaria SDA/MAPA 
374/2014  replaced by Portaria SDA/MAPA No. 43/2016 ) establishes Quality 
Requirements for Wine and Derivatives of G rape and Wine, G/TBT/N/BRA/613, 
G/TBT/N/BRA/675 (IMS ID 47 0) 
2.168.   The representative of the United States  referred to  its written concerns submitted in July 
2016 on Brazil's proposed quality requirements for wine and derivatives of grape and wine. The US 
remained concerned regarding some aspects of the proposed regulation including: restrictions of 
terms such as "reserve " and "dry"; a lack of clarity and restriction on the types of sweeteners, as 
well as colours, aromas and flavours, allowed in wine beverages and coolers; MRLs for pesticides; 
and differing limits set for various analytical parameters, such as ash content,  acidity, and differing 
alcohol levels for different types of wines. She asked Brazil to explain how the concerns were being 
taken into account and when to expect a response to their comments. Brazil had previously 
indicated that the proposed regulation wa s a MERCOSUR directive and conformed to international 
standards. The US requested further information on how such a restrictive regulation met the 
MERCOSUR directive, the international standards used and the deviations from the norms.  The US 
was concerned that the proposed standard did not contain a basket category for wines that would 
not fit within another category and urged Brazil to consider the regulatory approaches of the 
United States and other wine producing Members. She asked whether Brazil had con sidered 
creating a basket category similar to "other than standard wine" or "wine specialty product" 
categories used by the United States and other countries. The US noted that this addition would 
help to facilitate trade in a variety of products and asked  Brazil to provide an update on the 
regulatory process and timelines of implementation. She requested Brazil to notify a revised draft  
according to G/TBT/35 for coherent use of notification formats. The United States observed that if 
finalized without chan ges, the regulation would have real trade impacts for US wine exports which 
were US$2.4 million annually with growth potential and would drive out wine coolers  which were 
freely and safely sold in the United States from the Brazil market.  
2.169.   The representativ e of the European Union  thanked the Brazilian Authorities for the bilateral 
contacts that had taken place during the revision of the Ordinance and the public consultation held 
on the revised text. The EU referred to her submitted comments on 18 July 2016 a nd asked Brazil 
for and update on the revised draft. She recalled that Brazil informed the November 2016 TBT 
Committee meeting that the Brazilian Ministry of Agriculture would organize a public hearing on 
the final text and asked for the dates the text wou ld be adopted and published and for the public 
hearing.  
2.170.   The representative of Brazil  thanked the US and the EU for raising their concerns and 
indicated that G/TBT/N/BRA/675 had mistakenly been submitted as a new notification.  He noted 
that the same measure  (Draft Ordinance 43/2016) had been published for a second time, so had 
been treated as revised notification G/TBT/N/BRA/613/Rev.1. Brazil said that the draft measure 
had been duly scrutinized under public consultation procedures and the comments received were 
being examined on an egalitarian basis by the competent authorities. He could not at that stage 
confirm when the regulatory process would be concluded. Brazil remained open to continue 
bilateral discussions and to provide all information deemed necess ary. 
2.2.4.23   China - Insurance Regulatory Commission (CIRC) Information and 
Communication Technology Regulation G/TBT/N/CHN/1172 (IMS ID 489)  
2.171.   The representative of the United States  remained  very concerned with China' s suite of 
measures that appear ed to discrimina te against foreign technologies and firms in the name of 
information security. These included, amongst others,  China' s Cybersecurity Law and draft 
insurance sector informatization rules.  She welcomed the notification of the CIRC  draft Supervision 
Rules on Insurance Institutions Adopting Digitalized Operations and for opening the second 
reading of the Cybersecurity Law for public comment through the National People 's Congress. US 
comments, and subsequent meetings with China, highlighted that  many draft provi sions were 
problematic. These concerns include d the unclear definition of "secure and controllable "; 
requirements for insurance institutions to give priority to purchasing "secure and controllable " 
technologies; the reference to the "national implementatio n requirements on cryptography in the 
financial sector " without specifying what they were; and the requirement for information security 
system certification to only be satisfied by a Chinese accredited in stitution. The US had  discussed 
these concerns with China in depth previously,  and therefore did not wish to repeat them. She G/TBT/M/71  
 
- 37 - 
 
  noted that the U S was deeply concerned about the overall cybersecurity policy trend in China  and 
looked forward to continued cooperation and  discussion on  these important issues.  
2.172.   The representative of Canada  referred to the draft Network Product and Services Security 
Review Measures released on 4 February 2017  by the Cyberspace Administration of China . He 
asked that China e xplain why there was only a 30 -day comment period (until 4 Mar ch 2017). He 
also requested clarification on whether China intended  to notify the draft Review Measures to the 
WTO. Canada had provided China with its written comments on 4 March 2017  and looked forward 
to receiving a response .  
2.173.   The representative of the European Union  joined others in reiterating concerns both on a 
systemic level and relative to this specific area with respect to the development of information 
security requirements which, if implemented, would have the effect of mandat ing insurance 
institu tions in China to progressively phase out non -domestic cryptographic products. This would 
be tantamount to a ban on procuring foreign cryptography products compared with domestic 
products and would prevent insurance institutions from using the most develop ed and innovative 
encryption products and solutions  which would hav e the unintended consequence of weakening 
rather than strengthening information and network security. The draft that had been  notified to 
the TBT Committee appeared to introduce the concept  of "secure and controllable ", which is then 
also used  in the National Security Law and the Cybesecurity Law, which  lacked precision and 
created  uncertainty with respect to its meaning. In addition, the draft rule required insurance 
institution s to obtain t he ownership of the source code of the equipment . This  was the most 
valuable and crucial asset of equipment manufacturers  and t his obligation could not be complied 
with without putting at risk the viability of their business. In addition , the draft would m ake 
national standards and encryption requirements based on national algorithms  compulsory. All 
these aspects were a source of serious concern  and therefore the EU urged China to address them, 
to revise the measure and to notify a revised draft to the WTO for comments . Similar to the 
banking issue , he request ed that the domestic process allow for adequate participation of 
interested parties . The EU also requested that  China clarify the relationship between the sectoral 
requirements and the general framework  set out in the Cybersecurity Law.  
2.174.   The representative of Japan  support ed the positions of others in this concern and 
considered that the regulation contained unclear articles regarding terms definitions, concrete 
requirements for examination and evaluatio n, and s cope. Market access of foreign companies to 
China might be hampered by this regulation, depending on its implementation. Japan request ed 
China to clarify the terms definitions, the concrete contents of requirements and scope of 
regulation, and to e nsure transparency. Article 25  was of particular concern as it required  
insurance institutions to use technologies and products complying with national standards and 
encryption requirements. Those requirements might be implemented in a way that was  more tr ade 
restrictive than necessary. In addition, conformity assessment procedures in the requirements 
could be regarded  as questionable, if it contained  requirements for, inter alia , disclosure of source 
code. Japan asked that  China clarify which requirements or conformity assessment procedures 
were being concretely applie d. It would appear  that foreign companies were being treated less 
favourably  than domestic companies, even if those requirements would be equally applied to 
foreign and domestic companies. Jap an request ed China not to apply those requirements. 
Moreover, it was Japan 's view that the MLPS (Multi -Level Protection Scheme) referred to in Article 
56 might cause discrimination against  foreign companies by requiring Chinese intellectual property 
in cor e technologies or by requiring domestic certification in China. Japan requested clarification of  
the implementation procedure of MLPS  and that China  revise the draft regulation so as to not be 
more trade restrictive than necessary in accordance with intern ational standards.  
2.175.   The representative of Australia  supported the concerns raised by others regarding this 
measure. While understanding China's desire to protect ICT infrastructure, Australia questioned 
whether the proposed measures would achieve this objec tive. She emphasized the importance of 
avoiding onerous testing and certification requirements that would either be unnecessarily 
burdensome, discriminatory, or include a review of source code, or other sensitive confidential 
information. Australia would w elcome further information from China about the details of the 
provisions, including the objectives, definitions of key terms and the certification requirements, 
and current status of the reforms. Australia was still awaiting responses to a number of quest ions 
raised at previous TBT meetings and would also welcome further opportunity to consult on the 
measures. She suggested that the implementation of the measures be delayed pending greater 
clarity on different aspects.  G/TBT/M/71  
 
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  2.176.   The representative of China  informed  the Committee that China had  provided very detailed 
information at previous meetings and requested Members to refer to minutes thereof.21 China had 
also provided the definition of "secure and controllable", under the STC22 raised earlier. So as to 
show good  will in fulfilling its transparency obligations, China had notified the regulation despite 
not believing the major content of the regulation fell under the scope of the TBT Committee. 
Bilateral channels remained open and Members ' comments would be taken i nto consideration as 
appropriate.  
2.2.4.24   Brazil - Toy Certification; Ordinance No. 489, No. 310 and draft Administrative 
Rule No. 321, G/TBT/N/BRA/612 , G/TBT/N/BRA/612/Add.1  (IMS ID 478)  
2.177.   The representative of Canada  appreciated Brazil 's continued engagement on it s toy safety 
measures which had been  notified in Ordinance No. 563 on 29 December 2016, revoking previous 
rulings. Whilst Canada appreciated that some issues had been addressed in the new ordinance , 
some remained of concern . Canadian industry was concerned  with the requirement that toy 
companies label packaging with a Conformity Identification Tag, which must include a product 
family -specific registration number obtained through the new Object Registration system prior to 
importation and after testing and c ertification of the toy by an official certifying party. This 
requirement would  require some importers to retool their entire supply chain. Further, once the 
product was tested, it would  need to remain in the warehouse until a registration number was 
provided which was particularly challenging for supply chains . Concerns also remained on the 
documentation requirements in Ordinance 563  such as  submit ting detailed documentation to the 
official certifying party, including the traceability procedure adopted by the supplier for the product 
and a description which must include extensive information such as a list of raw materials used for 
the manufacturing of the toy. These requirements would be onerous and would  also require the 
disclosure of proprietary and conf idential business information . Canada was of the view that 
INMETRO should align with international toy standards such as ISO 8124 which would  allow Brazil 
to achieve its stated purpose of toy safety without adding unnecessary burden to toy companies. 
In ad dition,  INMETRO should not request confidential business information nor have unnecessary 
requests which would  not help a testing facility determine whether the product would pass the 
safety requirements. Furthermore, INMETRO should explore other options t hat would allow 
importers to label products with Conformity Identification Tags after the product ha d been 
imported into the country.  Finally, Canada suggested that INMETRO consider establishing "trusted 
trader "-like program mes for importer s that had  demon strated continued compliance.  
2.178.   The representative of the European Union  shared the  concerns raised by Canada and 
asked what the timeline for the implementation of the new ordinance was. The EU understood that 
this ordinance consolidated all the previous or dinances in the field of conformity assessment and 
also the substantive safety requirements for toys. While Ordinance 563 contain ed some 
improvements compared to the notified draft (such as the removal of the requirement to film the 
testing of toys), t he EU was disappointed to see that the final ordinance confirmed the  obligation 
for the registration of individual toys with INMETRO according to the concept of product family. On 
the timeline , the EU understood that the ordinance would  enter into force 24 mon ths from its 
publication for production and importation of new toys, thereby giving a  two-year phase -in period . 
The EU hoped that during this period there would be scope for the regulator INMETRO to discuss 
with affected industries implementation modalitie s capable of alleviating the challenges impl ied by 
the new procedures. The EU sought  confirmation from Brazil that toys being  subject to mandatory 
(third party) conformity assessment must be registered with INMETRO following the issuance of 
the certificate  by the conformity assessment body. Furthermore, from the EU's understanding, the 
registration obligation would apply per each product family rather than each producer/importer 
which implie d, for instance , that identical toys produced by the same brand own er, if they were 
manufactured in different sites, would be subjected to separate registration requirements. 
Therefore, the EU industry remained concerned with what was perceived as a too narrow definition 
of product family as set out in clause 4.5 of annex  2 to Ordinance 563. The EU underlined the EU 
industry's request that registration per producer and importer be allowed instead , combined with a 
requirement for toy manufacturers to have an internal traceability system capable of tracking 
relevant data on each toy, such as production line, date and batch number, to enable effective 
enforcement of product recalls . After registration, toys would be subjected, according to art icle 12 
of the Ordinance, to a non-automatic import licensing regime which would impl y that the importer 
                                                
21 G/TBT/M/68, para. 2.271, G/TBT/M/69, paras. 3.276 -3.278 and G/TBT/M/70 , para. 2.211.  
22 China - Banking IT Equipment Security Regulation (IMS ID 457) . G/TBT/M/71  
 
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  must obtain consent from INMETRO in order for the toys to be placed on the market. The EU 
stated that the procedure would be quite onerous  and although the EU understood the rationale 
behind the measure, which was to increase the tracea bility of toys and facilitate recall of toys in 
case of safety issues, this procedure would have the potential of adding significant costs and 
delays in marketing toys. The EU then recalled another issue, already expressed by Canada, 
related to the burdens ome documentation requirements. Furthermore, the EU underlined two 
additional issues which were of concern for E U industry regarding the testing requirements 
concerning the migration of certain dangerous chemical elements from the toys foreseen by 
Ordinanc e 563. The EU underlined that the Ordinance would make these testing requirements also 
applicable to inaccessible components in toys for which there was no risk of migration , inconsistent 
with similar requirements in other jurisdictions (for instance the E U toy safety requirements 
exempted inaccessible components from this kind of testing ). Therefore, the EU asked INMETRO to 
consider revising this clause. In addition the EU noted some inconsistencies related to the 
standards referenced in the Ordinance with  respect to the MERCOSUR standard for toy safety. The 
EU invited INMETRO to review this aspect in order to eliminate any such discrepancies. The EU 
thanked Brazil for its availability to discuss this issue bilaterally . 
2.179.   The representative of the United Stat es noted that Ordinance 563 had been  notified as 
final. The US highlighted that the requirements for family registration, age grading and warning 
label size coupled with concerns about missing or conflicting testing requirements, requirements to 
supply con fidential business information, and expiration of conformity certificates every three 
years combine d to make Brazil a difficult environment for toy manufacturers to bring new products 
to market successfully. The US remained concerned that these requirement s would make  it 
impos sible for small and medium -size companies to export new and innovative toys to Brazil 
leading to a reduction in consumer choice in the market. The US asked what outreach INMETRO 
had plann ed for stakeholders  so as  to help them understan d the new r equirements in Ordinance 
563. T he US noted industry 's uncertainty regarding test methods for conformity with the material 
requirements . The US asked for clarification that  Ordinance 512 represented  the administrative 
procedure to register a toy,  among other products or services , and understood that the text of the 
ordinance had been revised. She asked what the timeline was  for the final guidelines . The US  toy 
industry worked to stay engaged with INMETRO since it first proposed to amend the confor mity 
assessment procedures in 2014 with Ordinance 489. They had provided written comments, 
participated in public hearings, and requested bilateral meetings to note concerns with Brazil 's 
proposed requirements on toys.  Despite this, to date, it seemed  few of the options addressed in 
these com ments had  been considered  in the final measure.  
2.180.   The representative of Brazil  recalled the Committee that on 29 December 2016, 
INMETRO 's Ordinance 563/2016  had entered into force , which set the final technical regulation  for 
toys in its Annex I (notified as document G/TBT/N/BRA/597/Add.1) and the applicable conformity 
assessment procedures in its Annex II (notified as document G/TBT/N/BRA/612/Add.1). Brazil 
stressed that the objective of the revised  Brazilian technical re gulation and conformity assessment 
procedures for toys was the protection of consumer health and the prevention of accidents 
involving children. Brazil recalled that during the regulatory revision, all comments received had 
been duly taken into considerati on by the competent Brazilian authorities , for example, the 
removal, in the final measure, of the filming requirements present in the draft ordinance. 
Furthermore, Brazil underlined that the registration and certification require ments in the final 
measure did not differ significantly in methodology from what ha d been required since 2010 for 
other types of products, such as t yres, fire extinguishers, and baby carriages. From Brazil's  
perspective the registration would be necessary in order to assure the trac eability of the products ' 
certification and to enhance authorities ' ability to verify the products ' compliance with applicable 
technical requirements. Brazil stressed that the validity of certificates was defined according to the 
type of products, their po tential risks, and their life cycle. Furthermore, certificates would be 
subject to periodic evaluation  where their frequency depended  on the detection of non -
conformance  in the products examined. The certification would be done by family of products, so 
as to reduce the costs involved in the process, since tests were made on the more complex 
products of a same family, i.e. those liable to more requirements, and their results extended to the 
other s. The timeline for the measure 's implementation  was 24 months  for production/importation 
of toys and 42 months for its commercialization. On outreach with the private sector,  nothing had 
been decided yet, but the Brazilian authorities were open to consider options such as the 
preparation of guide lines on the measure  for interested stakeholders.   G/TBT/M/71  
 
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  2.2.4.25   China - Interim Measures for Quality Management of Commercial Coal, 
G/TBT/N/CHN/1057 (IMS ID 477)  
2.181.   The representative of Australia  thanked China for continued bilateral discussions on the 
new coal standard and conformity asses sment measures which had been notified as urgent in 
September 2014, and became effective in January 2015. China was Australia's second largest coal 
export market and there was great interest from Australian industry and exporters regarding the 
implementati on and application of the measures. Australia supported China's environmental 
objectives of improving air quality by promoting the efficient and cleaner use of coal, and also 
supported China's efforts to improve the quality of coal used in China's energy a nd industry 
sectors. Australia remained committed to being a reliable supplier to China of high quality thermal 
and metallurgical coal with low levels of impurities. Australia had previously raised questions about 
the measures, but had not yet received any  formal response to queries raised through the China's 
TBT enquiry point over previous years.  
2.182.   The representative of China  noted that her delegation had explained this measure in detail 
many times at previous meetings. In addition, China and Australia had constructive bilateral 
consultation regarding this issue. She emphasized again that the measures were non -
discriminatory and that they were in line with the TBT Agreement.  
2.2.4.26   India - The Stainless Steel Products (Quality Control) Order, 2015, 
G/TBT/N/IND/50 (IMS ID 486)  
2.183.   The representative of the European Union  reiterated her delegation's concerns with this 
measure, and recalled written comments to this notification sent by the EU on 23 October 2015. 
The notified draft was similar to other certification measur es adopted by India for steel products, 
such as the steel and steel products (Quality Control) Order, 2006 (notified as G/TBT/N/IND/32). 
The notified draft further extended the scope of the existing BIS mandatory certification system to 
three additional st eel products, such as stainless steel plates, sheets and strips.  
2.184.   The EU was  concerned that these measures could constitute an unnecessary barrier to 
trade and discriminate against foreign producers . She recalled concerns about the necessity and 
costs relat ed to BIS mandatory certification requirements, and the re -testing by BIS -authorized 
laboratories of the covered steel products which had already been tested against relevant 
international standards. The EU took  note of India's comments raised  at the previ ous TBT 
Committee meeting on  insufficiency of international standard s and on the need to consider 
manufacturing practices in India. Nevertheless, the EU understood that  third party conformity 
assessment procedure s were required regardless of the intended u se and considered them 
unjustified for intermediate products  that did not directly reach  the final consumers nor posed 
health risks.  In addition, the measure did not cover a  substantial number of non -standard stainless 
steel products. The EU again asked In dia to accept test results from accredited laboratories 
attesting compliance with international standards. Finally, the EU reiterated that the factory 
inspections required by the BIS certification system would be of no added value for the EU steel 
mills wh ich already had put in place quality management systems (QMS) as defined in ISO 9001.  
2.185.   The representative of India said that concerns relating to re -testing, cost of certification, 
the inspection requirement and health objectives were not new and had been r esponded to several 
times at previous meetings of the Committee.23 Concerning equivalence with international 
standards, India had informed at the previous Committee meeting that the standards referred in 
Stainless Steel (Quality Control) Order 2015 (namely IS 5522:2014; IS 6911:1992; and IS 
15997:2012) were not harmonized with international standards because they had been developed 
taking into consideration manufacturing practices followed in the Indian market. Moreover, India 
had also indicated at this Comm ittee meeting that there was no ISO standard equivalent to IS 
15997 and IS 5522.  India updated the Committee that IS 6911:1992 on stainless steel plate, 
sheet and strip was currently under revision by including 21 more grades out of which 18 grades 
were in ternationally accepted grades.  
                                                
23 G/TBT/M/68, para. 2.316, G/TBT/M/69, paras. 3.307 -3.308 and G/TBT/M/70, paras. 2.229 -2.231.  G/TBT/M/71  
 
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  2.2.4.27   European Union - Restriction on Polycyclic Aromatic Hydrocarbons (PAHs) in 
Tyres as specified in Anne x XVII of REACH, G/TBT/N/EEC/52 (IMS ID 480)  
2.186.   The representative of China  appreciate d the EU's efforts on restrictions of Polycyclic 
Aromatic Hydrocarbons (PAHs). However, a s previously raised, China was concerned about the 
test method ISO 21461, referenced in Entry 50 of Annex XVII of REACH (1907/2006/EC). China 
believed that  ISO 21461 was not suitable for conformity assessme nts related to efforts to restrict 
PAHs, as it was an unusual and indirect quantitative method for the determination of PA Hs. In 
contrast, the GC -MS and HPLC  test methods , specified in some technical regulations and 
international standards, were more accur ate and mature methods to determine PAHs. While in 
general China encourage d adoption of  international standards, China believe d that using test 
method ISO 21461 was unscientific, inappropriate, could  cause misleading results and involved  
significant costs for tyre manufacturers. China request ed the EU to provide a scientific rationale for 
the test method, to conduct a timely review , and make revisions accordingly.  
2.187.   The representative of the European Union  reiterate d, as already stated during the last TBT 
Committee meeting, that the measure in question had been  notified under the TBT Agreement on 
21 January 2004 (G/TBT/N/EEC /52, so -called REACH regulation ). He recalled that the  REACH 
legislation was extensively discussed with WTO Members, economic operators an d other interested 
stakeholders. Concerning the method for determination of aromaticity of oil in vulcanised rubber 
compounds (ISO 21461) raised by China , he pointed out that the EU had applie d this method – 
which is an international standard – since Janua ry 2010. The equipment needed for this test 
(nuclear magnetic resonance spectroscopy) was an instrument typically available in speciali zed 
laboratories.  
2.188.   The EU also announced  that the European Committee on Standards (CEN) would  soon be 
asked to develop a h armoni zed analytical method for the analysis of the content of the 8 
carcinogenic PAHs (listed in Entry 50 of Annex XVII to REACH ) in plastic and rubber, which would  
most likely be a chromatographic method. This request was made to support compliance with the 
restriction in Entry 50(5) of the mentioned annex and could potentially be also used in the future 
in support of Entry 50(2) with respect to  tyres. The EU said t he request to CEN would  probably be 
made in the summer of 2017 ; however, it  could  take up t o five years before a harmoni zed me thod 
at EU level was available. As stated during the November 2016  TBT Committee meeting, the EU 
would welcome further details on validated chromatographic methods, suitable for the analysis of 
PAHs in rubber tyres, to wh ich the Chinese authorities refer red. He said s uch information could 
then also be taken into account by CEN for the development of the new method.  
2.2.4.28   India - Draft Food Safety and Standards (Alcoholic Beverag es Standards) 
Regulations, 2015, G/TBT/N/IND/51  (IMS ID 494)  
2.189.   The representative of the United States  supported India's efforts to develop a world -class 
alcoholic beverage regulation that effectively upheld public safety, positioned the Indian alcoholic 
beverage industry and food service and retail sectors  for growth, facilitated trade, and expanded 
the coffers by permitting products that would accrue excise charges. However, there were a 
number of areas where India had proposed standards that fell outside of widely accepted 
international standards and coul d restrict trade more than necessary to achieve India's objective. 
It appeared that the recently released revisions of the draft standards that affected alcoholic 
beverages (i.e. Alcoholic Beverage Standards, Food Additives, and Food Imports) had not taken  US 
comments into full consideration.  
2.190.   The US thanked India for withdrawing the application of the Food Imports Regulation to 
Duty Free Shops, and for favo urably revising the Alcoholic Beverage Standard definitions for 
Tennessee Whiskey and Bourbon; all ot her concerns, which the US had previously relayed through 
official comments, bilateral meetings, and WTO TBT Committee meetings, remained unaddressed. 
The US requested that those be taken into consideration in any future revisions. India was also 
asked if they intended to provide a response to questions and comments on these standards and 
whether, if India relied on specific scientific information in preparing these standards, this could be 
shared with the United States. Her delegation welcomed the opportun ity to discuss the process 
India had followed in order to create this standard.  G/TBT/M/71  
 
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  2.191.   The US proceeded to ask if India had considered existing regulations of other countries in 
developing these standards, for example, the United States Code of Federal Regulatio ns, Title 27, 
Chapter I, Subchapter A, which was free and publically available. She said that the US would 
welcome regulator -to-regulator dialogue to discuss the rationale behind the formation of its 
regulations. The US also asked when India would complete  its final draft Alcoholic Beverage 
Standard. Would the draft be notified to the WTO? When did India intend to enforce this standard? 
She requested that India provide an adequate transition period to allow industry adequate time to 
comply.  
2.192.   The representat ive of Canada  said that his delegation continued to follow the development 
of India's proposed regulation on food safety and standards related to alcoholic beverages. He 
referred to Canada's previous comments24 concerning the draft regulation's maximum alco hol 
content limits for whiskies and would appreciate receiving an update on this issue. Canada also 
asked India to consider modifying its health warning label to state that "Consumption of alcohol 
can be injurious to health" or "Consumption of alcohol can pose health risks" instead of 
"Consumption of Alcohol is injurious to health". He said that Canada found it unclear whether the 
regulation was now final and when it was expected to enter into force. He asked India to provide 
an update.  
2.193.   The representative o f the European Union  appreciated that India had always been 
cooperative and interested in hearing the position of the EU and EU industry in the preparation of 
the Regulation on Alcoholic Beverages Standards. At the November 2016 TBT Committee meeting, 
the EU had explained in detail a number of concerns in relation to the Indian draft alcoholic 
beverages regulation notified under G/TBT/N/IND/51. The EU had also, at an earlier date, provided 
detailed written comments on the notified draft (in January 2016). T he EU recalled that on 
6 September 2016, the Food Safety and Standards Authority of India (FSSAI) had published a new 
draft to the Official Gazette (Draft Food Safety and Standards (Alcoholic Beverages Standards, 
2016). However, to the EU's knowledge, it s eemed that India had not notified this draft to the 
WTO. The list of food additives permitted in alcoholic beverages had recently been adopted by the 
competent Indian authorities and had been notified to the WTO on 22 September 2016 but only 
via the WTO -SPS notification system, and not via the TBT Committee. Therefore, the EU asked 
India to allow a reasonable time for comments before the entry into force.  
2.194.   With respect to the new draft Regulations, the EU underlined that most of the EU's 
concerns were set o ut in comments sent to India in January 2016, and these remained valid. The 
EU was particularly concerned about a number of inconsistencies between the new text and 
current international practices (i.e. the oenological practices and definitions as set by t he 
International Organisation of Vine and Wine (OIV) and CODEX). In order to be fully in line with 
Article 2.4 of the TBT Agreement, India needed to align its draft alcoholic beverages regulation 
with those international practices and standards. Finally, t he EU asked the Indian authorities to 
provide a reasonable transition period for manufacturers to comply with the new provisions and to 
allow the sale of products already present on the Indian market until exhaustion of stocks.  
2.195.   The representative of Japan  supported the concerns of previous speakers. He noted that at 
the last meeting of the Committee India had stated that the measure was at the final phase of 
examination and would soon be finalized. Therefore, Japan asked India to provide the current 
status of the measure.  
2.196.   The representative of New Zealand  said that her delegation was of the view that wine 
should be seen as a single ingredient product, and noted that numerically -based labelling 
requirements, such as the numerical definitions of wine categorie s, failed to take into account 
seasonal and regional variances in wine production, thereby constituting an unnecessary burden 
on wine producers. New Zealand looked forward to hearing how India would respond to the 
concerns of wine producers and importers, and appreciated an update about how comments made 
by Members had been taken into account.  
2.197.   The representative of India informed the Committee that  the Draft Regulations on alcoholic 
beverages standards were still under consideration by authorities and the c omments received from 
WTO Members, as well as domestic stakeholders, were currently being examined. India maintained 
that the draft standards were in line with international standards, keeping in view the prevailing 
                                                
24 G/TBT/M/69, para. 3.313.  G/TBT/M/71  
 
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  Indian conditions. Regarding composition al limits for which Codex standards did not exist, it was 
noted that although these parameters were not available in Codex, they were important to ensure 
the safety of the product. These quality parameters had to be fixed by the Food Authority.  
2.198.   Regarding the question of whether stickers would be allowed to be placed on alcoholic 
beverages at port before customs clearance, delegations were informed that stickers would be 
allowed in case of: (i) name and address of the importer; (ii) FSSAI's logo and licence  number; 
(iii) logo for an indication of vegetarian or non -vegetarian; and, (iv) category or sub -category 
along with generic name, nature and composition. On Mexico's concerns expressed at a previous 
meeting about its alcoholic beverage "Tequila", India in formed the Committee that "Tequila" had 
now been deleted as it was a geographical indication. All geographical indications had been 
removed and products having geographical indications would have to conform to the requirements 
of their country of origin. O n the timing of any planned notification of a further list of additives, 
India informed that comments regarding additives had been finalized, and, once approved by the 
Scientific Committee and Food Authority;  the final draft would be notified to the TBT Co mmittee. 
Also, a request had been made to remove compositional limits from whiskies for the reason that 
certain type of whiskies exceeded the proposed limit of 50%. The matter had been considered but 
could not be accepted as per the recommendations of the Scientific Panel. In the context of Draft 
Food Import Regulations, India said that the labelling requirements for duty -free sales at airports 
had been exempted. In addition, India had received some more replies from the capital that would 
be transmitted to  concerned delegations in writing after the meeting.  
2.2.4.29   China - Formula Registration Regulation fo r Infant and Follow -up Formula,  
G/TBT/N/CHN/1165 (IMS ID  493)  
2.199.   The representative of the United States  supported China's objective of ensuring that 
products inten ded for infants and toddlers were safe and effective. However, the US shared the 
concerns of other Members and sought to ensure that trade would not be disrupted as a result of 
Decree 26, and wanted to gain full understanding of the measure and its process es. She recalled 
that at the last TBT Committee meeting, China indicated that the purpose of limiting the number of 
products on the market under the Decree 26 was to avoid "consumer confusion" and "deceptive 
trade practices". The US asked China to explain what consumers were confused about, what the 
deceptive trade practices were and how these would be prevented by the measure. The US 
expressed her delegation's confusion as to whether infant formula brands were restricted under 
Decree 26 or just recipes/for mulations and requested China to provide the scientific basis for the 
restrictions. She also recalled that China said that infant formula was designed to be a 
replacement for breast milk and that there should not be many formulations available. The US 
questioned this position and requested scientific explanation. She also noted that US infant 
formula production facilities already had to comply with CNCA registration requirements under 
Decree 145. In this light, the US asked under what circumstances addition al inspections would 
need to be carried out by CFDA and if China could clarify how this regulation and Decree 145 
would operate together.  
2.200.   The representative of the Republic of Korea  expressed her delegation's concerns about 
China's Registration Regulation  for Infant and Follow -up Formula which had taken effect on 1 
October 2016. While the Korean government fully understood the need for a strict control of infant 
formula products, concerns remained regarding duplication of site inspection and product 
regist ration required by CFDA and CNCA, as well as CFDA's measure to limit the number of 
products allowed for registration to nine. She observed that these new measures would restrict the 
rights and freedom of Chinese consumers to choose from various safe and hy gienic products. 
Korea indicated that the CFDA's requirement to register products that had already been on the 
Chinese market constituted a duplication of the regulation enforced by CNCA and that the 
additional time and costs arising from the registration process by CFDA could inhibit the free trade 
which was the fundamental principle of WTO. Korea requested the Chinese Government to fully 
support the exemption of site inspection, to streamline the registration procedures and required 
documents for foreign establishments and their products already registered with CNCA, and to 
expedite the registration of products that had already been imported to China to avoid duplication 
of the registration process.  
2.201.   The representative of the European Union  shared the objec tive of China to ensure the 
highest level of protection. However, the EU reiterated her concerns conveyed in written 
comments and during the November 2016 TBT Committee regarding some aspects of the new G/TBT/M/71  
 
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  regulatory regime. Firstly, the limitation of each ma nufacturing company to a maximum of nine 
registered recipes within three product lines would have a serious and unnecessary negative trade 
impact on the current exports. The EU did not find a justification to this limitation, neither on the 
basis of food s afety nor on the basis of any other legitimate objective. Secondly, the anticipated 
transition period of one year was, in her view, insufficient, and reiterated the proposed period of 
18 months. Thirdly, according to the technical guidance published by CFD A in October 2016, China 
was planning to allow the sale of products that were legally produced before 31 December 2017 
under the old regime, only if these products were actually and physically imported into China by 
1 January 2018. In contrast, Chinese pro ducts that were produced before 31 December 2017 could 
be sold in China throughout their shelf life. The EU indicated that this constituted an unequal and 
discriminatory treatment of imported product and would exacerbate the negative economic 
consequences of the regulation and requested China to consider the comments and modify the 
rules accordingly.  
2.202.   The representative of Japan  shared the concerns raised by the US, Korea and the EU and 
understood that China was keen on ensuring food safety, especially on i nfant formula. However, 
he stated that it seemed impossible to justify the limitation of the number of products on the basis 
of legitimate objectives. Japan emphasized, as had been pointed out in previous meetings, that 
the measure would have serious and u nnecessary negative impact on trade and asked China to 
reconsider the measure, taking into account the concerns raised by Members.  
2.203.   The representative of China  stated that her delegation attached great importance to the 
safety of infant formula milk powder and that it had always been the most stringently regulated 
food in China. She indicated the huge demand and rapid development, while faced with challenges 
of market disorder and consumer confusion caused by too many brands and formula in the 
market. It was  noted that before drafting this regulation, China had carried out market analysis 
and scientific evaluation. China said it was internationally recognized that infant formula should 
only be a nutritional supplement to breastfeeding, that the composition of  infant formula milk 
powder should be similar to breast milk, and that there should not be too many kinds of formulas. 
She informed that China's research concluded that large foreign infant formula manufacturers had 
no more than three brands. To address Me mbers' concerns on on -site inspection, China clarified 
that it mainly focused on the R&D data of milk powder formulas and manufacturers' capacity to 
turn formulas into production. She also noted Members' concerns on possible duplicative 
inspections and ind icated that China would try to avoid such duplications by more communication. 
China emphasized that the regulation was applied in a non -discriminatory manner and was in line 
with the TBT Agreement.  
2.2.4.30   Indonesia — Halal Product Assurance Law No. 33 of 2014  (IMS ID 502)  
2.204.   The representative of the United States  thanked Indonesia  for their bilateral engagement . 
The US wanted to work with Indonesia to ensure that the law achieved the objective without 
creating any unnecessary barriers to trade. While appreciating th e need for consumers to know 
that products were halal, she expressed concern about the mandatory requirement that both 
"halal" and "non-halal" products be labelled. If consumers knew that only the products that have 
halal labels were halal, was it necessar y for a non -halal label to be added to non -halal products. 
Mandatory labelling  for both halal and non -halal would  create confusion for consumers and be 
costly and challenging to implement. From her understanding,  both Indonesian and int ernational 
private s ectors expressed concern  that the mandatory labe lling requirements could  significantly 
restrict access to current and future products currently enjoyed by Indonesian consumers , or could 
affect products that were necessary for health purposes. This measure could also  impose 
significant burdens on both international and Indonesian SMEs  and disrupt Indonesian 
manufacturing and exports.   
2.205.   The new registration requirement for foreign halal certificates  appeared to be 
cumbersome, duplicative, and more trade restri ctive than necessary to achieve the objectives. It 
was also not clear if  the same registration requirements would apply to local products. She 
request ed that Indonesia modify this registration requirement to reflect the fact that Badan 
Penyelenggara Jamina n Produk Halal (BPJPH ) already conduct ed verifications of foreign halal 
agencies issuing halal Certificates for imported goods.  
2.206.   She noted that there had been  a number of concerns on whi ch she hoped to work with 
Indonesia in order to have them addressed through the implementing regulations . She asked that G/TBT/M/71  
 
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  Indonesia update the Committee on the content and status of the implementing regulations, as 
well as the timeline on the issuance of the final regulati ons, and that the  draft implementing 
regulations be notified to the WTO  prior to being finalized so as to allow  for comment s from 
stakeholders and for those  comments to be taken into account. Clarification on where and how the 
official draft regulation would  be disseminated  was also requested .  
2.207.   The representa tive of the European Union  reiterate d serious concerns with this measure . 
The law was very broad in scope and affected , among others, food and beverages, 
pharmaceuticals, chemical and biological products, all consumer goods and cosmetics, as well as 
relate d services  as it required  mandatory halal certification and labelling for all products placed on 
the Indonesian market. Article 4 of the law provided  that products that enter , circulate  and are 
traded within  Indonesia must be halal certified. The Law would  be implemented gradually in three 
stages, and be fully enforced from 2019.  She asked Indonesia  to clarify  whether, after that date, 
products not certified and labelled in accordance with the Law would be allowed  on th e Indonesian 
market. Not allowing thos e products would amount to a total ban on the importation of non -Halal 
products . She also asked that Indonesia clarify whether non -halal products intended for export to 
Indonesia would be subject to mandatory labelling or any other type of restriction for international 
trade.  
2.208.   The Halal Product Assurance Law d id not specify the requirements that ha d to be fulfilled 
by exporters in order for a product to be certified as halal. Certain halal requirements had  been set 
out in separate regulations, depending on t he products (for example , for imports of carcasses and 
meat).  Both the lack of transparency on the rules of implementation  and this fragmented approach 
create d uncertainty as to the requirements applicable at any point in time. She reminded 
Indonesia that under WTO rules, measures should not be more trade restrictive than necessary 
and that the non -discrimination principle should be taken into account, as well as transparency 
provisions.  By keeping  halal certification and labelling voluntary,  this would be  less trade 
restrictive and more in line  with TBT objectives.  
2.209.   She requested further information and the intended timeline on the draft government 
decree (RPP)  being developed so as to implement the Halal Product Guarantee Law , and that 
Indonesia notify the Halal Product Assurance Law to the WTO , as well as any subsequent 
implementing rules while still in draft form, allowing time for any comments by Members to be 
considered . In accordance with Article 2.12 of the TBT Agreement, Indonesia should allow for a 
reasonable interval of time between the publication and the enforcement of adopted measures. 
She requested confirmation that a government decree on tariffs and  halal certification process was 
being  prepar ed and remind ed Indonesia of its transparency obligat ions under TBT rules. 
Information on the recently adopted Regulation of the Ministry of Religious Affairs N° 42/2016 on 
organi zation and working procedures including the administrative and organi zational structure of 
the Halal Product Assurance Organising Agency (BPJPH)  was also requested .  
2.210.   The representative of Australia  recognised the importance of halal product assurance to 
Indonesian consumers. She welcomed Indonesia 's decision to delay the introduction of the 
regulations for three years to November 201 9. Australia was interested in working with Indonesia 
on the implementation of the measures so as to avoid creating unnecessary barriers to trade. She 
reminded Indonesia of its obligation to notify the proposed regulations, including any new halal 
product standards , to the WTO , giving sufficient time for comment. Indonesia should also publish 
the regulations sufficiently in advance so as to ensure businesses had time to adapt to the 
changes. Australia was still awaiting a response to their request for clari fication on several aspects 
which was submitted in October 2016 to the Ministry of Religious Affairs. In particular, Australia 
highlighted the need for clarification on the timing of the release of the next draft, or final version 
of the regulations. She r eiterated Australia's support for measures that achieved legitimate policy 
objectives, so long as these measures were not more burdensome than necessary, as this could 
result in higher prices for both producers and consumers.  
2.211.   The representative of Indonesi a stated that the Halal Product Assurance Law was 
scheduled to be applicable in 2019. By that time, all products being distributed and sold in 
Indonesia would be classified into two categories, halal and non halal. The Law did not prohibit the 
sale and cir culation of non -halal products but provided better information to consumers. Only 
products which were derived from, or consisted of, animal products would be required to have 
halal or non -halal labels. Thus the scope of the Law covered production process, products 
transportation (separation of halal and non -halal products), and products distribution. Various G/TBT/M/71  
 
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  ministries and government agencies were still discussing the shape and form of the implementing 
regulations as well as the substantial elements to ensu re consistency with other rules. There was 
not yet any specific timeline but Indonesia was foreseeing incremental progress until the end of 
2017. Mutual recognition of certification for foreign certification bodies was done through an 
agreement with BPJPH.  The mutual recognition for halal certification was expected to be conducted 
between the BPJPH and foreign bodies responsible for providing halal certification.  This would most 
likely be established under the Ministry of Religious Affairs . In the meantime,  Majelis Ulama 
Indonesia (the Indonesian Council of Religious Scholars) would continue to provide halal 
certifications. Indonesia remained available for bilateral discussion with interested delegations.  
2.2.4.31   Thailand — Milk Code - Draft Act on Controlling to th e Marketing Promotion on 
Food for Infant and Young Children and Other Related Products BE G/TBT/N/THA/471 , 
G/TBT/N/THA/471/Rev.1  (IMS ID 503)  
2.212.   The representative of the United States  said that while the US fully supported public health 
objectives that aime d at increasing levels of breastfeeding, concerns remained with Thailand's 
proposed measure. The US had submitted comments to the TBT Enquiry Point in January which 
highlighted several Codex standards relevant to the  measure, including the Standard on Infa nt 
Formula and Formulas for Special Medical Purposes Intended for Infants, Standard on Follow -up 
Formula, Canned Baby Foods, and Processed Cereal -based Foods for Infants and Young Children, 
as well as the Codex Guidelines for Nutrition and Health Claims . She asked if Thailand had 
considered these standards and to explain any deviations from them. Given that the new draft did 
not take into account Guidelines for Nutrition and Health Claims even though those standards in 
particular were referenced i n WHA 63.2 3 on Infant Nutrition, she requested an explanation of how 
the provisions regarding nutrition and health claims reflected Codex Guidelines. The US reminded 
Thailand that the WHO 's Guidance on Ending the Inappropriate Promotion of Foods for Infants and 
Young Children was not an international standard according to the criteria established by the TBT  
Committee.  The US adherence to the application of the WHO' s International Code of Marketing of 
Breast -Milk Substitutes was voluntary, and complemented by simil ar codes developed by leading 
US medical professional societies on the marketing of these products . The US proposed deeper 
technical engagement with Thailand on how to achieve this health objective without unnecessarily 
impacting trade in products appropriate  for infants and young children . She also invited Thailand 
to explain how the revised draft code would interact with the Food Law and the Food Labelling 
Regulation and whether they might be superseded by the Milk Code.  
2.213.   The representative of the European U nion said her delegation  continued to follow with 
interest the new draft Milk Code. She reminded  Thailand  of the need to ensure that the draft Milk 
Code was aligned with relevant international standards and, therefore, the need to take into 
consideration t he ongoing revision taking place within the Codex Alimentarius of the  Standard on 
Follow -up Formula. T he Thai draft Milk Code should not be more trade restrictive than necessary  
so as to not violate Article s 2.2 of the TBT Agreement, and i n accordance with  Article 2.12, 
Thailand should allow for a reasonable interval between the publication and enforcement of the 
measure. The EU was closely following  the developments on the draft, so as to ensure that its 
concerns were  taken into account , and asked for  information on the timing for its adoption.  
2.214.   The representative of Australia  said that his delegation recognized the rights of Members 
to take measures necessary to protect public health and understood Thailand's efforts to address a 
legitimate public health c oncern. As a reliable supplier of high quality dairy products to Thailand, 
Australia encouraged Thailand to implement the measure in a trade facilitating manner where the 
transparent implementation of regulations minimized disruptions to trade and provided  
opportunities to allow producers and manufacturers to comply with new regulations.  
2.215.   The representative of Canada  said that while  supporting  Thailand's public health objecti ve 
of promoting breast feeding, his delegation support ed the concerns expressed by t he US, the EU 
and others related to the sole use of guidance from the WHO in developing technical regulations. 
In this context, Canada remind ed the Committee  that the T BT Agreement strongly encouraged  
Members to base their measur es on international standar ds. Canada encouraged  Thailand to 
consider the standard on infant formula and formulas for special medical purposes intended for 
infants, the standard on follow -up formula, canned baby foods, and processed cereal -based foods 
for infants and young children,  as well as the Codex guidelines for nutrition and health claims in 
the development and implementation of relevant measures .  G/TBT/M/71  
 
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  2.216.   The representative of New Zealand  thanked Thailand for notifying the draft measure to the  
TBT Committee . New Zealand had  submitted  comments through the WTO process, and had  also 
engaged bilaterally with Thailand on the issue. While supporting the objective of promoting breast -
feeding, New Zealand  continued to have concerns about the intended application of the draft 
legislation, and its potential impact on trade. New Zealand looked forward to further engagement 
with Thailand and updates on the development of this legislation.  
2.217.   The representative of Thailand  reiterated that  breast fee ding offered substantial and 
lifelong benefits to in fants. The rate of exclusive breastfeeding in Thailand was among the lowest 
in the world. Several factors contribute d to this phenomenon including sales promotion of milk 
formula for infants and young children. Therefore, there was a strong nee d for a regu lation that 
controlled marketing promotion of milk products that were specifically marketed for infants and 
young children. Thailand had  been using Codex as its guide to develop its quality and safety 
standards for food including milk products. However, some issues were not sufficiently covered by  
Codex, and therefore other international ly recognized guidelines had been  used, while ensuring  
that their application did not contradict  Codex. A lthough this regulation concerned  control of 
marketing promoti on, th is regulation still allowed  health and nutrition claims of m ilk products as 
long as they were  not misleading. The draft Act d id not prohibit industry from showing  health and 
nutrition claim s on the labels. Furthermore, in general the draft Act d id not proh ibit the use of 
trademarks, brand names, logos, and symbols of products. In line with other existing food -related 
laws i n Thailand, exaggerated claims and  misleading advertisement s were criminal o ffenses and 
punishable by law.  Thailand was a firm believer in free trade and would not do anything that 
restricted trade unnecessarily . Comments and support from other M embers was welcome in 
helping Thailand achieve the target of having a 50% breastfeeding uptake by 2025.  
2.2.4.32   Russian Federation — Rules of cement certi fication G/TBT/N/RUS/48, 
G/TBT/N/RUS/49 (IMS ID 497)  
2.218.   The representative of Mexico  recalled that her delegation had expressed concern about the 
measure at previous TBT Committee meetings .25 Whilst  recognizing  the legitimate objective to 
protect human health and safety pursued by the Ru ssian measure,  she said that her authorities 
had received reports from Mexican industry that the authorization procedure applied by Russian 
customs to imports of the product  had changed.  On the one hand,  the importation  of shipm ents of 
cement required  that various documents be presented to demonstrate compliance with the 
measure (e.g. a quality certificate, laboratory results from the year prior to importation, and a 
copy of the contract under which the foreign manufacturer deleg ates the power to conduct 
certification procedures and acknowledges responsibility for the product's discrepancies with the 
regulations' requirements). In addition, s hipments were subject to checks at the point of entry, on 
the basis of which a conformity certificate permitting the entry of the products would  be granted or 
refused.  
2.219.   Mexico expressed concern that until March 2016, it had not been a problem to import g rey 
cement into Russia whereas , according to industry, gaining entry authorization for shipme nts of 
cement from non -Eurasian third countries now appeared  to be a more burdensome process than 
for shipments from Eurasian countries. Industry had  also informed that the certification authorities 
that used to assess its products had  refused to issue quality certification of cement imports, 
claiming that they did not have t he competence to do so. This had  affected importers' compliance 
with the new requirements of the Russian measure and Mexico therefore request ed the Russian 
delegation to clarify which b odies were authorized to carry out these procedures.  Furthermore, she 
reported, since the rejection of some entry authorizations for cement shipments in 
September  2016, it had  been impossible to obtain such authorization.  In light of the above, her 
delegat ion believe d that Russia may be infringing Article 5.1.1, 5.1.2 and 5.2.1 of the TBT 
Agreement by applying the conformity assessme nt procedure established in the  measure in a 
manner more burdensome for imported cement than for domestic cement and that from  Eurasian 
countries. Mexico also deemed that Russia may be failing to ensure that assessment procedures 
were undertaken and completed as expeditiously as possible, as required under other provisions of 
the Agreement.  Mexico thanked  Russia for taking their comments into consideration and requested  
clarification regarding the application of the conformity assessment procedure to shipments of 
cement from third countries destined for countries in the Eurasian region.  
                                                
25 G/TBT/M/69, para. 3.343  G/TBT/M/71  
 
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  2.220.   The representative of Ukraine  expressed conc ern that the conformity assessment 
procedures contained in the Russian rules of cement certification which required additional 
inspections by certification bodies for imports of cement from third countries, and mandatory 
registration on the territory of Cu stoms Union member states, violated Article 5 of the TBT 
Agreement. Ukraine urged Russia to take these issues into consideration to ensure that the 
requirements of the abovementioned rules were in line with the requirements of international 
practice and di d not cause unnecessary technical barriers to trade.  
2.221.   The representative of the European Union  acknowledged that Russia had notified, on 
8 March  2016, the Go vernment Resolution No. 930 of 3 September 2015 "On A mendments of the 
Single List of Goods Subject t o Mandatory Certification" adding cement to the list of goods subject 
to mandatory certification  (G/TBT/N/RUS/48 ). Russia had also notified the "Order of Federal 
Agency for Technical Regulati on (Rosstandart) No. 1 -st of 11 January 2016 "Conformity 
assessme nt. Rules of cement certificat ion" (GOST standard 56836 -2016) , on 12 April 2016 
(G/TBT/N/RUS/49), setting out the relevant  rules for cement certification. She pointed out that t he 
GOST standard had been updated on 30 January 2017 and made more restrictive in the following 
respects: i t was now mandatory for foreign producers/exporters  to have an official representative 
established in the Russian Federation  in order to obtain  certification to export their products; all 
foreign producers were now required to  be officially qualified to produce cement and such approval 
was to  be issued by an unspecified Russian agency. Further, t he information requested from 
producers/exporters was deemed  too extensive and could  be used for collecting business sensitive 
information. The checks of documents had been  extended from 10 days to 30 days, and every 
shipment of foreign cement had to  be stopped on the border for additional verification.  Both 
measures had already been adopted and were in force at  the time of their notificat ion. The EU 
therefore  reiterate d its request to Russia to suspend the measures and re -notify them under the 
TBT Agreement at a draft stage,  allowing Members' comments  to be taken into account.  She 
added that the sam e applies to the amended un-notified GOST  standard.  
2.222.   On the content of the measures, her delegation raised the following points . Section 8.2, 
fourth sentence, of the notified GOST standard provided that for imports from third countries the 
certification body should conduct additional inspection co ntrols for each batch of cement. This 
included sampling at the border, as well as the testing and control of all characteristics set out in 
the standard according to which the certificate of conformity had been granted. On the basis of the 
results, the cer tification body had to make a decision whether to confirm, suspend or terminate 
the certificate of conformity. It was the EU's understands that this provision set a requirement for 
"additional inspection control" of each cement batch arriving in Russia fro m third countries, 
including sampling at the border, testing and checking according to the standard. The EU asked 
Russia for the reasons and justification for such a requirement and underlined that the presence of 
additional requirements for conformity ass essment affecting only imported products might  
contravene both Articles 5.1.1 and 5.1.2 of the TBT Agreement.  
2.223.   In relation to the additional inspection controls, the EU raise d further  questions : (i) what 
was meant by shipment (whether it would mean each wa gon, whole train or yearly production);  
(ii) by whom and how would these samples be taken from imported cement; (iii) how would the 
tests be performed, what would be the length of the tests, and whether after sampling and testing, 
the imported cement would  be allowed to proceed further to the unloading point and/or to the end 
consumer or whether the imported cement would  be held at the border until the results of the 
testing were known and a decision on the certificate of conformity taken (understoo d by the  EU to 
take on average 28 days ).  
2.224.   The EU again requested further clarification on the following issues. Firstly, the EU asked 
Russia to confirm their understanding that certificates issued by a certification body had to be 
registered with Rossacreditation.  If this was the case, Russia was asked to clarify the reasons for 
which such a registration might be refused or delayed. Secondly, the EU asked Russia to clarify 
whether the certification bodies had to be registered with and empowered by Rossacreditation to 
issue certificates of conformity under the notified GOST standard . Furthermore, the EU understood 
that many EU manufacturers had been  granted certificates during the middle of 2016 , which 
further to an audit by Rossaccreditation, had been  withdrawn. In addition, her delegation reported 
that certificates recently issued to EU exporters had been  rejected by the customs officials. What 
were the reasons for such withdrawals and reject ions by Federal Customs Service?  G/TBT/M/71  
 
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  2.225.   The representative of the Russian Federati on recalled that Government Resolution No.  930 
of 9 September 2015 "On A mendments to the Single List of Goods Subject to Mandatory 
Certifica tion" had added cement to the above -mentioned list. Both this r esolution and the relevant 
new standard GOST -R 56836 -2016, adopted by the Federal Agency for Technical Regulation and 
Metrology , had been notified to the WTO. He maintained that t he necessity for inclusion of cement 
into the list of goods subject to mandatory certification had been  determined by a sharp decr ease 
in quality of cement sold in Russian market and by the emergent problems with safety, health and 
environmental protection. In particular , state supervision at construction sites had revealed serious 
problems caused by low -quality cement , the main issu es of which were: (i) hazardous content of 
carcinogenic hexavalent chromium (CrVI)  in cement; (ii) high alkali content in cement leading  to 
early-age cracking in concrete and negative impact on the metal support structure; (iii) low 
compressive strength; and (iv) insufficient frost resistance. In the opinion of Russia, t hese serious  
problems constitute d a danger to life and health directly due to the content of a carcinogen and 
indirectly due to the quality and reliability deterioration in buildings and con structions. The list s of 
certification bodies and of issued certificates were available on the website of the Federal 
Accreditation Body. Regarding the inspection control  for cement, the GOST -R provided  for two 
forms : (i) inspection control at a production  site; and (ii) inspection control of the products at the 
border. He pointed out that t here were no additional certification requirement s in the GOST -R. His 
delegation deemed that while i nspection contr ol at a production site presumed  a complex control 
of production, conducted not less than once every six months with additional inspections on an 
unscheduled basis, c ontrol of products was a simpler and less costly procedure. He concluded by 
confirming that t he list of documents and tests required to obtain a  certificate for cement, as well 
as the requirements defined by GOST -R, were equal for all manufacturers.  
2.2.4.33   United Arab Emirates — Control scheme to restrict the use of hazardous 
materials in electronic and electrical devices  G/TBT/N/ARE/265  (IMS ID 496)  
2.226.   The representative of the European Union  reiterated her delegation's concerns with regard 
to key issues of the measure . First , regarding the lists of exemptions in Annexes 3 and 4 of the 
notified draft, the EU noted that they did not include many relevant exe mptions included in similar 
regulations as was the case in the EU's own legislation on the matter. In particular, exemptions for 
the use of mercury and other substances currently used for the production of light sources, such 
as bis (2 -ethylhexyl) phthalat e (DEHP), butyl benzyl phthalate (BBP) , dibutyl phthalate (DBP) and 
diisobutyl phthalate (DIBP),  would be forbidden without appropriate transition, which would 
certainly disrupt trade in this area.  
2.227.   Second, regarding the enforcement of the restrictions laid  down by the notified draft, the 
EU noted that Article 4.1 was unclear and did not specify whether the restrictions listed in Annex 2 
only applied when the electrical and electronic devices were placed on the market for the first time 
or also to the follow ing marketing stages. Therefore, the EU requested the UAE authorities to 
clarify whether and how the restrictions listed in Annex 2 applied to electrical and electronic 
equipment already on the market. Third, she stated that re -use, refurbishment and exten sion of 
lifetime of products already on the market were beneficial for the protection of the environment. 
Spare parts therefore needed to be available. In this respect, the EU asked the UAE  authorities 
whether exceptions for the repair of products placed o n the market before the application of the 
notified draft could be considered. Fourth, the EU highlighted that in Article 9.4 of the notified draft 
the list of exemptions in Annexes 3 and 4 related to "products", instead of "applications in a 
product", whe reas the headings of Annexes 3 and 4 referred to "applications". In this respect, the 
EU asked the Emirati authorities to explain the exact scope of application of the exemptions at 
hand. Fifth, regarding the procedure for conformity assessment, the notifi ed draft referred in 
Article 5 to "Model A" and to a submission to the Emirates Authority for Standardization and 
Metrology (ESMA); in Article 6 to registration; and in Article 8 to an application. Clarification was 
sought on the exact procedure for the pl acing on the market of products following the assessment 
by the manufacturer and the drawing up of a Declaration of Conformity, and in particular on 
whether a prior authorization by the UAE authorities was required.  
2.228.   The EU representative noted that UAE 's draft measure had been  notified on 3 August 2015 
and a subsequent redrafted version to which her previously stated concerns related  had been  
notified in December 2015. She observed that the UAE had still not responde d to her delegation's 
comments at the thr ee previous TBT Committee meetings. In the course of bilateral contacts, the 
UAE had nevertheless indicated that EU comments would be given full consideration. However, to 
date no amended draft measure had been made available. The EU sincerely hoped that t he UAE G/TBT/M/71  
 
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  could provide a response to its comments, and kindly requested an update on the status of the 
measure . 
2.229.   The Chairperson  took note of the EU's statement and request that the Secretariat convey  
the EU concerns to the delegation of the UAE. 
2.2.4.34   Egypt — Manu facturer Registration System (Decree No. 43/2016 and Decree 
No. 992/2015) G/TBT/N/EGY/114 and G/TBT/N/EGY/115  (IMS ID 505)  
2.230.   The representative of Turkey  reiterate d concerns on this measure.  Despite attempts at 
both the bilateral and multilateral leve l to im prove the situation, many Turkish firms were still 
awaiting  registration  by the GOEIC , even though they had completed the very burdensome dossier 
process. The preparation p rocess of the documents required  long and different approval 
procedures . Companies h ad to collect several documents which in many cases included fees . These 
documents firstly had  to be approved by Cha mbers  of Commerce or equivalent bodies, followed by 
governorships. The y had to be authenticated and translated into Arabic by an accredited translator 
and both the original  and Arabic versions had to be approved by the Egyptian Consulates. This 
excessive paperwork, numerous administrative steps  and lengthy procedures increase d the cost 
and time of bringing products to the Egyptian market which  damage d the competitiveness of 
trading partners' products . 
2.231.   Turkey ha d serious concerns regarding the non -transparent application of the system as it 
remained unclear how  applications were being evaluated and whether the completion of the 
process was subje ct to any time limits. Firms had yet to be informed why their registration 
processes  had not yet been completed . No response had been provided regarding the formal 
requests for an update on the status of these fi rms' registration processes . Turkey believed  that 
both the burdensome pre -application requirements and the non -transparent implementation of the 
registration system create d unnecessary obstacles to trade. There had been a  decline in Turkey 's 
exports to Egypt since the commencement of the registratio n system. Turkey was concern ed with 
the relationship between Decree No.  43/2016 and Decree No. 991/2015 which stipulated  
registration alongside pre-shipment inspection as one of the requirements for importation of a 
product into Egypt. Thus Turkey was further concerned regarding the rationale of this double 
registration which was even more burdensome and costly for foreign companies. Given all these 
concerns , the product registration system was indeed a barrier to trade and acted  as a quantitative 
restricti on. He requested that Egypt withdraw  the measures and review them in light of WTO 
principles and obligations.  
2.232.   The representative of the United States  noted that Egypt had stated at the previous TBT 
Committee meeting further guidance on how to comply wit h Decree 43 (and 991) was available on 
the relevant website. However  the US continued to have concerns  over Egypt 's level of 
transparency during the adoption and enforcement of these measures, the burdensome nature of 
the requirements, and the lack of transpa rency of the registration process since the list of 
registered companies was neither available to the public nor to the companies involved. Egypt 's 
written response to a question on the inadequate period of time given to consider stakeholder 
comments , was that the registration requirements were administrative in nature and had not 
imposed further burdens on producers or companies in the exporting markets. One of the key 
points of stakeholder comments was to understand what burdens may  exist – and how they could 
be mitigate d in a manner that allowed the Member to fulfill its objective in a timely manner.   
2.233.   While Egypt had stated that a two -month transitional period had been sufficient to carry 
out the registration process for over a thousand registrations, thi s was not clearly not the case as 
it had been over a year since Decree 43 had been implemented and the US continued to receive 
complaints from companies stating that despite submitting all required documentation, they 
experienced serious difficulties with registration. As of November 2016 some 18,000 applications 
were pending approval with the Minister of Trade. She requested an update from Egypt on the 
number of registration applications received from importers and the number of applications 
approved, reje cted, reviewed or processed from March 2016 to March 2017 by the Minister of 
Trade, given Egypt had indicated that the registration approval process was not burdensome. She 
requested information on the average and maximum times from submission of an applic ation until 
notice of final action on the application. US  overall exports to Egypt of the products covered were 
down 42% from 2015 to 2016. This highlighted the importance of notifying the first draft of a 
measure with a 60-day comment period. Upon publica tion of the measure and after consideration G/TBT/M/71  
 
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  of the stakeholder comments, Egypt should have allowed an adequate time for producers to 
become accustomed to the new requirements —normally at least six months after publication. She 
emphasized that the provision  of greater time for implementation would also allow Egypt to 
process the required documentation in a manner that avoid ed backlog s and unnecessary 
disruption in trade for foreign importers already re gistered with the Trade Ministry  and other 
relevant minis tries. Since this measure specifically targeted imports, she questioned whether 
Egypt ensured that the measure was consistent with its national treatment commitments.  The US 
continued to receive feedback from US companies that they had given up on the Egyp tian market 
altogether as a result of Egypt 's immediate implementation and lack of transparency. There was 
continued  confusion about the specifics of the documents and certifications that were to be 
accepted to demonstrate compliance, as well as the backlo g of applications which prevented 
approvals or hindered registration. The US  requested that Egypt suspend implementation of the 
measure until all stakeholder comments were taken into account and that Egypt change its 
approach from a horizontal one that imp oses the same requirements across many industries to 
one that takes into account the various global norms, risk factors, and practices across different 
industries and commodities. Additionally, she asked that Egypt recognize that international 
standards an d best practices to control for quality differ by industry particularly in relation to 
Quality Management System certification. This requirement appeared to be a duplication of 
existing requirements for registration and certification implemented by other m inistries.  The US 
had numerous other detailed questions on this measure, and she urged Egypt  to continue to 
engage with trading partners so as to address these concerns  in order to  ensure that Egypt 's 
approach was not more trade restrictive than necessary.   
2.234.   The representative of the European Union  thanked Egypt for notifying the se measures and 
for the replies received on 9 June 2016 to the written comments sent by the EU on 1 April 2016. 
The EU had submitted  a second set of comments  on 17 August 2016  to whi ch Egypt replied  on 7 
November 2016 . While appreciating  the bilateral engagement  with the Egyptian authorities , the EU 
wished to reiterate its concerns expressed in the comments sent to Egypt, in particular  regarding 
the entry into force of the legislation . She  requested that Egypt suspend the application of the 
measures, review them in light of the principles and obligations laid down in WTO law and re -notify 
them under the TBT Agreement.  
2.235.   The EU was concerned by the possible duplication of procedures and t he lack of clarity of 
the requirements to be fulfilled by European economic operators. Industry had reported that t he 
application of the Egyptian decrees was causing serious difficulties. In particular, companies were 
facing lengthy delays in the registrat ion process. The process appeared to be very non -
transparent, as the list of registered companies was n either made available to the public, nor to  
the companies involved. The EU asked that  Egyptian authorities consider improving the 
implementation of the d ecrees by creating a publicly accessible database of registered companies, 
providing an opportunity of appeal to companies in case of refused registration, shortening the 
delays and providing clarification on the documents required for registration.  Finally she requested 
that Egypt take EU comments into account.  
2.236.   The representative of Switzerland  thanked Egypt for the constructive bilateral discussion. 
Switzerland supported concerns raised by the other Members as Swiss manufacturers continued to 
face difficu lties when exporting products to Egypt. He asked for an update from Egypt on whether 
the circumstances that gave rise to the adoption of the measure still existed.  
2.237.   The representative of Ukraine  supported concerns raised by other Members. While 
thanking Eg ypt for notifying the decrees, she said these decrees had caused difficulties for 
Ukrainian businesses trying to access the Egyptian market, in particular, new business. She 
requested that Egypt reconsider the system of registration of factories and align Egyptian 
legislation and procedures in accordance with requirements under WTO Agreements.  
2.238.   The representative of Canada  echoed the concerns raised by other Members and  would  
continue  to monitor developments.  
2.239.   The representative of Australia  supported conce rns raised by others. Australian industry 
was already feeling the effects of the regulations and had voiced their concerns to the Australian 
Government that the new registration and certification requirements created an unnecessary 
barrier to trade. She en couraged Egypt to take a risk -based approach to certification and G/TBT/M/71  
 
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  conformity assessment requirements. She expressed hope that Egypt would work productively 
with Australia on the implementation of the measures.  
2.240.   The representative of South Africa  supported the concerns of other delegations and asked 
for clarification on whether Decree No. 43/2016 had been replaced by Decree 992/2015. In 
bilateral discussion Egypt informed South Africa that Decree No. 43/2016 had replaced Decree 
992/2015. He sought confirmati on as to the veracity of this statement and the status of Decree 
992/2015.  
2.241.   The representative of Egypt  informed the Committee that since its entry into force, Egypt 
had continuously communicated with their trading partners through the Committee, TBT enquir y 
points, and through bilateral meetings in Geneva. Egypt had responded to all questions and 
requests for clarification. He referred Members to the statements delivered at the June and 
November 2016 Committee meetings .26 With regard to implementation, and i n reference to the 
quality control system certificate, the only requirement was that it be  issued by entities accredited 
by national or regional accreditation bodies accredited by ILAC/IAF  or an Egyptian or foreign 
governmental entity approved by the Minis try of Foreign Trade. A copy of the certificate was 
accepted given that the Egyptian authorities could access an electronic version on the database of 
the accredited certification service providers. Manufacturing plants and companies owning 
trademarks paid  a one -off registration fee. The registration  fees were in accordance with WTO 
rules and in compliance with Article VIII of GATT 47.  Concerning the duration of the registration 
process, he underlined that this was largely dependent upon manufacturers' subm ission of the full 
file including all data and certificates. Egyptian manufacturing plants and companies were subject 
to registration, surveillance and inspection requirements by numerous Egyptian regulatory 
authorities.   Egypt also confirmed that decree N o. 992/2015 was no longer into effect.  
2.242.   Egypt fully respected its commitments under the WTO , and believed the decree in question 
was not trade more restrictive than necessary, and was in  full compliance with the TBT Agreement. 
He said Egypt remained open f or consultation with trading partners and that ne w comments would 
be conveyed to capital and responses would be provided to interested delegation in due course.  
2.2.4.35   Kenya — East African Community (EAC) alcoholic beverage standards   
G/TBT/N/KEN/472, G/TBT/N/KE N/473, G/TBT/N/KEN/474, G/TBT/N/KEN/475, 
G/TBT/N/KEN/476, G/TBT/N/KEN/477, G/TBT/N/KEN/479, G/TBT/N/KEN/482 
G/TBT/N/KEN/483 (IMS ID 510)  
2.243.   The representative of the European Union  reiterated support for Kenya and other Members 
of the East African Community (EAC) in their efforts to ensure the quality standards of alcoholic 
beverages consumed in their territories. Instead of elaborating on the details of the nine  sets of 
comments that the EU ha d submitted to Kenya on the differe nt technical regulations drafts,  the 
representative highlight ed a common request that technical regulations for alcoholic drinks should 
be aligned to the Recommendations of the International Organisation of Vine and Wine (OIV), 
including the International Code of Oenological Practices, a nd to the CODEX standard on Labelling 
of Pre -packaged Foods (CODEX STAN 1 -1985).  The EU believe d that widely accepted international 
standards and practices correctly address ed Kenyan legitimate objectives.  
2.244.   The EU representative asked Kenya, as in the prev ious intervention, to provide his 
delegation  with an update on the revision process of the technical standards  at issue . The EU 
underst ood that a meeting of the responsible Technical C ommittee of the East African Community 
had taken  place in February 2017 and that the s tandards were currently under public consultation. 
The EU invited  Kenya to debrief the TBT  Committee on the status of the revision and on how the 
comments presented by other WTO Members were taken into account in the standard s' revision 
proce ss. Furthermore, the EU invited  the Kenyan representatives to explain to the TBT  Committee 
what process was foreseen  in order to incorporate the s tandards into the appropriate technical 
regulations. His delegation recalled the transparency provisions conta ined under Article  2.9 of the 
TBT Agreement, where by WTO Members who notif ied technical regulations may be subject to 
receive suggestions for amendments, should consider that these amendments be introduced in the 
draft text , and that comments be taken into  account.  
                                                
26 G/TBT/M/69;  G/TBT/M/70.  G/TBT/M/71  
 
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  2.245.   The representative of Kenya  informed the Committee that i n July 2016, Kenya had notified 
the TBT Committee on the regional harmonized Alcoholic Beverage Standards. Following the 
notification , Kenya had received comments from the EU and the US. Th e EAC Alcoholic Beverage 
Standards were regional harmonized standards. EAC Standards were developed by the EAC 
Technical Committees comprising of technical experts from member states, and adopted by the 
member states for implementation upon approval by the  EAC Council of Ministers. For the 
standards in question, a  Regional Technical Committee Meeting of the EASC/TC/007, Alcoholic and 
Non-alcoholic Beverages was held from 20 -24 February  2017 in Kenya. The Technical Committee 
discussed the comments that were raised on the EAC harmonized Alcoholic Beverages Standards, 
most of which were technical in nature, and incorporated some changes in to the standards. The 
revised standards would be released for public review in April 2017, and would be notified to the 
TBT Committee in accordance with the requirements of the TBT Agreement. Kenya was available 
for further discussions with the delegations of the EU, US and others with a view to addressing 
their concerns.  
2.2.4.36   European Union - Quality Schemes for Agricultural Produc ts and Foodstuffs 
G/TBT/EU/139 , G/TBT/EU/139/Add.1 (IMS ID 512) 
2.246.   The representative of the United States  said that Denmark had applied for the registration 
of the terms "danbo " and "havarti " as protected geographical indications through the EU Quality 
Schem es for Agricultural Products and Foodstuffs. However, as had been noted in previous 
interventions by the United States, Codex had well -established standards for these two cheeses: 
50 years for "danbo " and 30 years for "havarti" . While the US understood tha t the EU would prefer 
to discuss this issue in a more GI -focused forum, there was a TBT component to the issue  - this 
was demonstrated by the EU 's own notification  – and international Codex standards  existe d. Both 
of Denmark 's applications had been pending  since 2014. Acceptance of the applications would 
result in the prohibition of the use in the EU of the two names for any cheese produced outside 
Denmark.  Accordingly, approval of the applications would effectively ban from the European 
market long -used co mmon name cheeses that were based on the international compositional 
standards established by Codex.  The US questioned why the EU needed to undertake this trade -
restrictive measure  and asked the following questions: (i) i f the pending EU -level applications  by 
Denmark were approved, would the EU prohibit imported cheeses from using the Codex -
standardized terms on the products ' labels, even if those cheeses conformed to the Codex 
standard?  and (ii) if approved , would the EU seek to use international treaties to prohibit cheeses 
being sold in other markets from using the Codex -standardized terms on the products ' labels, even 
if those cheeses conform ed to the Codex standard?  
2.247.   The representative of Uruguay  shared the concern expressed by the US, particularly on th e 
"danbo" cheese.  
2.248.   The representative of the European Union  said that the procedure for granting of 
protection to the terms " danbo" and "Havarti" as Geographical Indications (GIs) in the EU had not 
yet been finali zed. Therefore, the EU  had no comments on t he matter . Moreover,  the EU note d 
that the elements raised by the US delegation pertain ed to intellectual property rights, in particular 
to GIs. The EU consider ed, therefore,  as had been stated in the November 2016  TBT Committee 
meeting, that any issues co ncerning intellectual property rights should not be discussed in the TBT 
Committee , but were more appropriately addressed  in TRIPS Council.  The EU invited the US to 
consider discussions on this issue through appropriate WTO channels, as well as bilaterally . 
2.2.4.37   The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu — Draft  
of the Organic Agriculture Act, G/TBT/N/TPKM/225, G/TBT/N/TPKM/Add.1 (IMS ID 
511)  
2.249.   The representative of the European Union  thanked Chinese Taipei for its response to EU 
comments. The EU continued to have concerns with the one-year time period for the conclusion of 
a new bilateral agreement in organics with trading partners that had been previously recognized 
for organic equivalence. According to the responses provided by Chinese Ta ipei, if the one -year 
timeframe for the conclusion of a new bilateral protocol was not respected, the current/existing 
bilateral protocol or agreement would  be revoked.  The EU insisted that the implementation period 
of one year did not allow trad ing partne rs sufficient time to negotiate and conclude a new bilateral 
protocol or agreement , as this process could  require ratification by co -legislators of the trad ing 
partner in question The EU consider ed the penalty imposed for exceeding the one -year timeframe G/TBT/M/71  
 
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  to be disproportionate , as such a measure, if implemented, would be more trade restrictive than 
necessary in order to fulfill a legitimate objective. Chinese Taipei 's reply of November 2016 
indicated that the new organic law would  not require new implementi ng laws. The EU had concerns 
about how some of the new provisions would  be implemented (e.g . those related to the system of 
control bodies), in the absence of new implementing laws.  
2.250.   The EU underst ood that the meas ure was still under development and  request ed that EU 
comments be taken into account,  in particular the possibilit y of a reasonable extension of the 
timeframe foreseen in order to reapply for equivalence . She noted that in simi lar circumstances 
the EU granted  a five-year extension. She also request ed clarification on the establishment and 
implementation o f the system of control bodies and  an update on the current status and foreseen 
timeline for adoption of the notified measure.  
2.251.   The representative of the Separate Customs Territory of Taiwan, Penghu,  Kinmen and 
Matsu  assured the EU that the comment on the one -year period for concluding equivalence 
equipment for organic agriculture products would be taken into account along with comments from 
other WTO Members and domestic stakeholders. The draft was s till under review and would 
undergo legislative process for approval after final review. Article 3 of the draft provided a 
definition  of product coverage and process stage. The Organic Agriculture Act was the primary law 
more details would be elaborated in  secondary regulations. Chinese Taipei would keep WTO 
Members  informed on the timeline for adoption of the measure, and in the meantime Chinese 
Taipei remained available to engage with all WTO Members on possible bilateral agreement.  
2.2.4.38   China — National Stand ards on Limits of Volatile Organic Compounds for 
Furniture , G/TBT/N/CHN/1094 , G/TBT/N/CHN/1095 , G/TBT/N/CHN/1096 , (IMS ID 
509)  
2.252.   The representative of the European Union  thanked China for constructive bilateral 
exchanges on the issue and reiterated the most important of its continuing concerns. The proposed 
"mandatory standards" included unnecessary deviations from well -known, international ISO 
standards. In case such standards became mandatory, products which were currently assessed on 
the basis of internati onal standards would have to be assessed for the Chinese market on the basis 
of specific tests. Some of these specific tests required a complex and costly assessment, such as 
multiple test chambers and a new test chamber for mattresses. There were signific ant doubts 
among industry about the relevance of the tests with regard to the presence of harmful elements 
to be measured – Total Volatile Organic Compound (TVOC) measured a sum of harmful and 
harmless substances - and also about the replicability of the t ests. China had indicated in June 
2016 that deviations from international standards would be justified by realistic conditions of use. 
It was the EU's understanding that the notified standards were still under development. The EU 
appreciated the openness o f China in engaging with the relevant stakeholders with a view to 
revising the draft standard. The EU understood that TVOC requirements would be applied on a 
voluntary basis and sought confirmation of this, as well as clarification about which parts of the  
standard would remain voluntary and which would be mandatory. In particular, the EU wished to 
know whether either the TVOC limits set out in the standards, or the testing methods and their 
annexes would be considered as voluntary, or both. Moreover, would  this differentiation apply to 
all three notified draft standards? The EU also asked for information from the Chinese authorities 
about the intended status, voluntary or mandatory, of the other limits and requirements included 
in the notified drafts (e.g. formaldehyde emissions).  
2.253.   The EU encouraged the Chinese authorities to accept equivalent international standards, in 
particular ISO standards, for the product categories covered by the notified drafts. Should China 
consider that the relevant ISO standards c ould be improved, the EU invited China to bring its 
proposals for discussion to the ISO as this would enable improvements to be considered without 
creating differences between Chinese and international standards and would thus avoid 
unnecessary barriers to  trade. The EU also asked for a timeline for the adoption of the notified 
drafts.  
2.254.   The representative of China  stated that detailed technical replies to comments had been 
given to the EU in writing. She stressed that the Chinese standards were based on the relevant 
international standards, including ISO 16000 series of standards. China emphasized that 
deviations from the relevant international standards were aimed at simulating real conditions in 
which the products were used so that the testing results could  be more scientific and were thus G/TBT/M/71  
 
- 55 - 
 
  allowed under the TBT Agreement. However, China indicated its readiness to engage with the EU 
at the technical level.  
2.2.4.39   Korea - Amendment of the Notifications on Warning Messages on Smoking and 
Drinking  G/TBT/N/KOR/664, G/TB T/N/KOR/664/Add.1  (IMS ID 518)  
2.255.   The representative of Japan  supported  Korea's measures to reduce the harmful use of 
alcohol. However, Japan recognized that sufficient transition period should be provided for this 
regulation. As referred to in the comments o n Korea 's TBT notification, his delegation had concerns 
that the one-year transition period set by Korea was insufficient for liquor exporters to take 
appropriate measures against the new regulation. According to Japanese liquor exporters, the 
representati ve noted that: (i) it might take more than half a year to use up all stocks of old labels; 
and (ii) it might take more  than one year for some products, especially high -grade and expensive 
ones, to be purchased by consumers through importers, distributors a nd retailers because it might 
be retained in warehouses or stores for a certain period. Therefore, joining  the Members with the 
same concerns on this issue, the representative of Japan request ed Korea to take appropriate 
measures to reduce burdens on expor ters, such as the extension of the transition period.  
2.256.   The representative of Mexico  reiterate d the concern s expressed at the November  meeting 
regarding the "Amendment of the Notification on Warning Messages on Smoking and Drinking ", 
notified by Korea in doc ument G/TBT/N/KOR/664 on 29 July 2016, and in the addendum thereto, 
notified on 8  December 2016, which inform ed that the title of the notification would  be changed to 
"Notifications on Warning Messages on Excessive Drinking" . Recalling the statement in the  
November 2016 meeting27, her delegation thanked  Korea for considering  Members' comments on 
the previous version of the regulation made within the framework of the TBT Committee . These 
comments addressed the warning messages associating the consumption of a lcoholic beverage s 
with liver and stomach cancer, which were to be included on the labels of alcoholic beverages 
imported into Korea.  
2.257.   Mexico thanked  Korea for being open to bilateral meetings . Her delegation noted that 
Korea had provided clarification on t he amendments to the warning messages to be included on 
labels  in the new version of the regulation. Korea also informed  that one of the messages had 
been changed and that regulated parties may choose to include one of the three messages on the 
labels of a lcoholic beverages that were to be imported into and marketed in Korea.  Referencing 
Article 2.2 of the TBT Agreement , her delegation requested  Korea to indicate the scientific basis for 
deciding to include messages associat ing cancer with the consumption o f alcohol.  
2.258.   The representative of the United States  thanked  Korea for the bilateral meeting  on this 
subject. Her delegation supported Korea' s efforts to protect public health by informing consumers 
of the risks of excessive alcohol consumption. Although Kor ea had notified the regulation to the 
WTO, the US wa s troubled that Korea had finalized and adopted the requirement prior to the end 
of the comment period. To alleviate confusion between translations that var ied slightly in the level 
of directedness betwee n alcohol consumption and various maladies and in order for producers to 
better understand what they were asked to print on the warning labels of their products, the US  
asked Korea to provide an official English translation of the warning messages.  Further more, her 
delegation had  made several requests to review th e scientific information used by  the Ministry of 
Health and Welfare during the preparation of the warning messages , and she asked when  Korea 
intend ed to provide such scientific information.  Despite  information received during the bilateral  
meeting about non-acceptance of the im plementation timeline extension, the US urged Korea to  
delay the enforcement of the warning label requirements until 2 March  2018 to allow industry a 
reasonable period of time  to comply with the regulation.  
2.259.   The US enquired w hen Korea would respond to its comments and those of the US industry. 
If the regulation was already finalized , she asked  how Korea would respond. Her delegation was  
disappointed that Korea had not allow ed for sufficient stakeholder input on a measure that would  
increase costs and resources for US  exporters and close trading partner s in an important market. 
The representative  also express ed its concern s with frequent changes to the labels.  
G/TBT/N/KOR/664/Add. 1 proposed additional changes to warning label s even before the 
implementation of such notified by G/TBT/N/KOR/664  was to go into effect on 2 March 2017. She 
                                                
27 G/TBT/M/70, para 2.25.  G/TBT/M/71  
 
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  noted that such change would  force the industry to revise the label again after they changed the 
label in accordance with G/TBT/N/KOR/664 .  
2.260.   The representative of the European Union  thanked  Korea for having notified this measure 
as a draft, which aim ed at reinforcing the health warnings on the labels  of alcoholic beverages.  
Korea had first notified its draft on 29 July 201 6 and had provided 60 days for WTO M embers to 
comment. However, the EU was informed that the notified draft had entered into force on 
3 September 2016,  invalidating the 60 -day comments period , contrary to the provisions of  
Article 2.9.2  of the TBT Agreement .  
2.261.   The representative of EU share d Korea's objective of fighting excessive alcohol 
consumption, especially by some  particularly vulnerable categories of consumers. However, having 
examined the notified draft, his delegation raised the following issues. The draft measure required 
that at least one of the three possible warnings be  included in th e labels of alcoholic beverages. In 
accordance with its understandi ng of the warnings, the EU noted that the measure  establish ed a 
direct link be tween alcohol and the occurr ence of certain health problems, without mention ing 
consumption patterns.  The EU consider ed that the majority of the negative effects on health of 
alcoholic beverages were related to higher levels of consumption and to certain c onsump tion 
patterns, and suggested that the Korean authorities  consider re -drafting the health warnin gs in a 
way that better reflected  the fact that alcoholic beve rages were  more likely to cause certain 
diseases when linked with higher levels of consumptio n and certain consumption patterns.  
Following the notification of the draft amendment on 29 July 2016, Korea had notified on 
8 December 2016 an addendum which modified one of the three possible warnings. The modified 
warning referred to increased risk rath er than to direct causality, which was welcomed by the EU. 
On this basis, the EU suggested that Korea redraft the other tw o warnings in a similar sense, 
namely  referring to the increased risk and taking into account the fact that the majority of the 
negati ve effects on health were related to higher levels of consumption and to certain consumption 
patterns.  
2.262.   Concerning  the transition period provided for the application for the measure, the EU 
underst ood that, by 3 March 2017, all products imported to Korea should comply with the 
measure . However, the latest related no tification to the WTO had taken effect  on 8 December 
2016. In this respect, his delegation recalled Article 2.12 of the TBT Agreement , and the WTO 
Ministerial Decision on the concept of "reasonabl e interval",  normally mean ing a period of no  less 
than six months. Taking into account that the notification of the addendum of December 2016 had 
a direct impact on the obligations of manufacturers and/or importers to affix a certain warning in 
order to pl ace products on the Korean market, the EU ask ed the Korean authorities to provide  a 
reasonable transition period, preferably 18 months , so that manufacturers could  have the 
necessary time to adapt their products to the new requirements of the technical reg ulation and to 
implement th e necessary changes. The measure required  that, by 3 September 2017, only 
product s complying with the measure could  be sold to final consumers, which meant  non-
compliant remaining stocks should  be withdrawn from the market . Marke t withdrawal of products  
which had  been legall y made available in the market wa s highly burde nsome. In the EU's view, it 
was only justified when  non-complia nce could lead to serious risk, but the  labelling issue of a 
product complying with the prev iously a pplicable regulation did  not seem to justify such 
withdrawal. Therefore, the EU requested that Korea allow  the sale of products already present ed 
on the Korean market until stocks we re exhausted.  
2.263.   The representative of Australia  recognized Korea's decision to amend and expand its 
technical regulations with the aim to provide its consumers with adequate information to make 
informed healthy food and drink choices. His delegation also recognized that warning labels for 
alcoholic beverages addressed a legitimate  public health concern. Australia sought further 
information about recent changes to the National Health Promotion Act related to alcohol and wine 
labelling. His delegation requested that Korea provide an official English translation of the 
proposed health  warning statements. He questioned the direct link between alcohol consumption 
and certain diseases and requested that Korea share the scientific basis for mandating alcohol 
warning labels to directly associate alcohol consumption with the various diseases  on the proposed 
labels. Australia requested that Korea postpone the implementation of the new measure in order 
to allow for a proper consultation period in accordance with Korea's obligations under the TBT 
Agreement. His delegation noted that the new requ irements had come into force from 
3 September 2016, before the period for presentation of comments by WTO Members expired on 
27 September 2016. He further noted that one of the proposed warning labels was then later G/TBT/M/71  
 
- 57 - 
 
  amended on 8 December 2016 and his deleg ation also requested an appropriate transition period 
to allow time for businesses to adjust.  
2.264.   The representative of Canada  thanked Korea for the bilateral meeting. That said, Canada 
echoed the concerns raised by other delegations and would continue to mon itor developments 
regarding Korea's health warning measures for alcoholic beverages.  
2.265.   The representative of New Zealand  acknowledged and supported Korea's right to introduce 
new regulations to address specific public health concerns. New Zealand appreciated  that, in 
seeking to address the harmful use of alcohol, this measure was directed towards achieving a 
legitimate public health objective. However, New Zealand shared the concerns expressed by other 
delegations relating to the scientific information used t o prepare the labels, clarification of the 
grace period for compliance with the new requirements, and the request for an extended 
adaptation period during which alcohol with previous labelling requirements could be imported and 
sold. In particular, New Zea land noted that there had been inconsistencies in unofficial translations 
of the proposed warning labels. To avoid further confusion and to ensure manufacturers'  full 
understanding on what they should print on their labels, her delegation requested that Ko rea 
provide an official English translation of the warning labels. Her delegation asked for clarification as 
to whether the warning messages related to pregnancy risks could be represented pictorially on 
labels, or if they must be provided in writing. The representative of New Zealand thank ed Korea 
for the ir engagement and made itself available for further  discussions . The representative  hoped 
that these comments would  be taken into account in order to ensure that the final labelling 
requirement was not mor e trade -restrictive than necessary to achieve the legitimate objective 
pursued.  
2.266.   The representative of Chile echoed the comments made by other delegations. His 
delegation reiterated New Zealand's requests to: (i) verify scientific information to be containe d on 
the label; (ii) allow necessary time for industry and countries to adapt to the legislation; and 
(iii) to have the legislation in an official language in order to check back with industry in countries.  
2.267.   The representative of the Republic of Korea  said that "Amendment of the notification on 
Warning Messages on Smoking and Drinking " notified as  G/TBT/N/KOR/664 ha d been implemented 
from 3 September 2016 and the regulation authority of Korea had provide d a 12-month grace 
period for Members to prepare the ne w label. Therefore, Korea did not  plan to provide any 
additional grace period.  His delegation  would keep consulting with stakeholders related to this 
regulation in a transparent manner.  
2.2.4.40   Kazakhstan, Russian Federation — The amendments No. 2 to the Technica l 
Regulation of the Customs Union on Safety of Toys (TР МС 008/2011) G/TBT/N/KAZ/7, 
G/TBT/N/RUS/73 (IMS ID 514)  
2.268.   The representative of Ukraine  expressed concern regarding a number of inconsistencies 
between the texts and the TBT Agreement.  Ukraine believed that the conformity assessment 
procedure foreseen in the Customs Union Technical Regulations "On safety of toys" (TR CU 
008/2011) differed significantly from international practice on declaration of conformity and 
created unjustified barriers to internatio nal trade. The regulation indicated that stricter conformity 
assessment procedures were envisaged for all toys and that certification bodies were required to 
register only in the territory of the Customs Union. Her delegation considered that Kazakhstan and  
the Russian Federation should justify such strict requirements for conformity assessment 
procedures with a scientifically substantiated clarification and urged them to align with 
international practice and avoid causing unnecessary technical barriers to t rade.  
2.269.   The representative of the European Union  associated his delegation with the concerns of 
Ukraine on the proposed requirement for the prevention of negative impact of toys on the 
development and health of children. Whilst fully supporting the objectiv e pursued by the Eurasian 
Economic Union (EAEU) of enhancing the safety of toys, the EU believed that the requirement had 
no scientific basis, bore no relation to toy safety, nor was there any global precedent on the 
matter. The EU understood the proposed amendment to require an evaluation of each toy by a 
council of experts in order to be placed on the market and considered that this process could result 
in arbitrary decisions based on very subjective assessments relying on moral criteria than bear no 
relation with toy safety. Moreover, it appeared that there was a lack of objective criteria to G/TBT/M/71  
 
- 58 - 
 
  perform the proposed evaluation and it remained unclear how this process could translate into a 
certification of compliance. The EU asked further clarification as to  which products were the main 
sources of concerns. The EU's representative urged Kazakhstan and the Russian Federation to 
withdraw this amendment and to consider alternative ways to ensure suitability of toys for 
different age groups, such as age grading. The EU recalled that ISO/TR 8124 (Part 8):2016 on age 
determination guidelines provided technical guidance of the appropriateness of toys by age. 
Finally, his delegation had been informed at the previous TBT Committee meeting that the period 
of public cons ultations had been extended until November  2016 and understood that further 
stakeholder consultations had been carried out by the Ministry of Industry and Trade of the 
Russian Federation until March 2017. The EU requested an update on the proposed amendmen t 
(was a revised proposal being prepared?) and clarification on the next steps in the process. He 
registered his delegation's willingness to engage in future dialogue with the competent authorities 
of the EAEU and to share the EU's experience on the implem entation of the EU toy safety 
legislation.  
2.270.   The representative of the United States  expressed support for the legitimate desire of the 
Eurasian Economic Commission (EEC) to protect the emotional well -being of children and looked 
forward to discussions with EEC members to find a solution that did not unnecessarily restrict 
trade. She flagged that her delegation would provide comments if Armenia, Belarus, and the 
Kyrgyz Republic intended to adopt this technical regulation.  The US asked Russia an d Kazakhstan 
to explain what criteria w ould determine if toys were likely to result in the Article 4 risks to 
children, whether  these criteria would be made public and h ow long it wou ld take to make this 
determination.  Were domestic toys subject to the same evaluati on? T he US  unders tood that the 
basis for this new requirement was increased imports of fantasy dolls  and asked Russia and 
Kazakhstan to clarify whether  the evaluations would  apply to all or subcategories of toys and the 
age grading of toys subject to this measu re. She said that targeting specific product lines rather 
than application of the criteria to all toys raised  concern s on the legitimacy of the process.  
2.271.   The representative of Kazakhstan  emphasized that the questions regarding certification 
requirements an d standards related to the provisions of Technical Regulation "On Safety of Toys" 
currently in force and which were not being reviewed by the present draft amendments. The 
Technical Regulation "On Safety of Toys " had been adopted in September 2011, enterin g into force 
on 1 July 2012.  To date, the competent authorities had not received any information regarding 
problems in the application of the technical regulation. She added that her delegation would be 
ready to answer all questions and comments upon recei pt from Ukraine and other interested 
parties in writing.  
2.272.   In response to questions from the US, she recalled that the draft amendments envisaged 
the establishment of requirements aimed at ensuring the protection of children from possible 
negative impact on  their development and mental health, preventing aggressive behaviour, fear 
and anxiety . Public consultation on the draft amendment had been announced on 16 June 2016 
with completion planned for 31 August 2016.  Whilst the draft amendments were under active  
discussion, the public consultation had been prolonged until 30 November 2016, upon request of 
interested parties.  She elaborated that the rationale behind the amendments was that the 
domestic market had been flooded by toys, predominantly dolls, inducing  children to aggressive 
behaviour, instilling fear, and misconstruing the true anatomical structure of the human body. 
Such toys, psychologists warned, might negatively affect children's mental health and 
development. Qualified psychological and pedagogica l expertise of certain types of toys, taking 
into account a possible psychological role in child development, had become increasingly important 
in Kazakhstan.  She clarified that a working group was in the process of discussing the types of 
toys to be subje ct to the expertise, as well as the relevant criteria and methodology. Her 
delegation assured Members that all comments and constructive proposals could be sent either to 
its TBT Enquiry Point or to the EEC and would be taken into account as provided for b y 
Article  2.9.4 of the TBT Agreement.  
2.273.   The representative of the Russian Federation  expressed support for the substance of the 
statement made by Kazakhstan and said that the list of replies to comments received had been 
published on the EEC website on 20 Fe bruary 2017. The results would be considered by the EAEU 
member states and by the working group responsible for the preparation of the draft. He 
reassured that all WTO Members' concerns were taken into account as provided by Article 2.9.4 of 
the TBT Agreem ent. G/TBT/M/71  
 
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  2.2.4.41   India — E-waste (Management) Rules, 2016 (IMS ID 515)  
2.274.   The representative of the Republic of Korea  express ed concern that whilst the E -waste rule 
(2016), revision of E -waste rule (2011), had been implemented from 1 October 2016, it had not 
been notifie d to the WTO. This prevented Members from submitting comments at an appropriate 
stage, which led to Korean stakeholders not having sufficient time to adapt to the regulation.  In 
light of Article 2.9.2 of the TBT Agreement , he request ed a 24 -month grace per iod for 
implementation . The E -waste rule (2016) obliged manufacturers to collect 30% of e -waste as of 
1 May 2017. However, waste electrical and electronic equipment (WEEE) was frequently sold on 
the Indian second -hand market. Moreover, according to a MAIT -GTZ report, 95% of total e -waste 
in India was distributed via informal routes. It was generally accepted that traditionally second -
hand electrical and electronic equipment in India was used for more than 20 years, while the 
average lifespan for electric eq uipment such as refrigerators and air -conditioners described in 
implementation guidelines was under ten years. These factors made it difficult to accomplish the 
2017 target collection rate owing to the lack of WEEE collection. In accordance with Article 2. 2 of 
the TBT Agreement India should avoid technical regulations that create an unnecessary obstacle to 
trade. Korea suggested that India lower the target collection rate to take into account the average 
lifespan of electrical and electronic equipment.  
2.275.    The representative of Japan  voiced support for the concerns raised by Korea  and asked  
India to provide a sufficient grace period , and to r eview the target collection rate based on actual 
market distribution and lifecycle of electrical and electronic equipment  in India.   
2.276.   The representative of India said that the measure in question was primarily focused on the 
safe collection and disposal of electronic waste within India in an environmentally sound manner. 
The concerns raised did not seem to relate to any techn ical regulation, standard or conformity 
assessment procedures as defined under the TBT Agreement. His delegation therefore believed 
that the TBT Committee was not the appropriate forum for this discussion.  
2.2.4.42   Ireland — Public Health (Alcohol) Bill 2015 G/TBT/ N/IRL/2  (IMS ID 516) 
2.277.   The representative of Mexico  referred the Committee to Mexico's statement at the previous 
meeting .28 Mexico continued to have concerns regarding the labelling requirements contained in 
the measure . These included the requirement for pro duct labels to display warning messages, 
including a warning symbol regarding consumption during pregnancy, and the Irish Ministry of 
Health's website address. Mexico believed that less burdensome labelling requirements could be 
introduced for imported pro ducts, which still fulfilled the legitimate objective pursued. The 
inclusion of the pregnancy symbol and website address es on labels did not inform consumers of 
the implications of consumption of alcoholic beverages. Ireland could fulfill the legitimate ob jective 
pursued through campaigns to raise awareness of the harmful effects on health caused by the 
excessive consumption of alcohol. Furthermore, the bill banned the use of the following in alcoholic 
beverage advertising: images of social gatherings and p roducts being consumed; images featuring 
the product alongside foods; descriptions of how the beverage was made; trademarks; and 
warning symbols and messages designed to be included on labels. There were also restrictions on 
advertising alcoholic beverages  on television, at the cinema and in printed matter. While these 
policies purported to tackle the harmful consumption of alcohol, she asked what , in accordance 
with Article 2.2 of the TBT Agreement, was the technical and scientific evidence used when 
asses sing the risk of non fulfilment . Finally Mexico asked what the measure's approval status 
before the European Commission was and when comments submitted by Mexico might be replied 
to. 
2.278.   The representative of the European Union  informed the Committee that i n parallel with 
notifying the WTO, Ireland had  also notified the measure to the European Commission in 
accordance with internal EU requirements for notification of draft national technical regulations 
under Article 5(1) of Directive (EU) 2015/1535.  Ireland had received comments from the 
Commission and detailed opinions and comments from some EU member States within the 
framework of the internal n otification procedure. These were  currently being analysed and 
considered by the Irish authorities . Comments receive d from WTO Members under the TBT 
notification procedure would be  equal ly examined and written replies  provided in due course.  
                                                
28 G/TBT/M/70  G/TBT/M/71  
 
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  2.2.4.43   Uganda — Alcoholic beverages specifications, G/TBT/N/UGA/434; 
G/TBT/N/UGA/435, G/TBT/N/UGA/437, G/TBT/N/UGA/438, G/TBT/N/UGA/439, 
G/TBT/N/UGA/440, G/TBT/N/UGA/441 (IMS ID 519)  
2.279.   The representative of the European Union  expressed support to Uganda and other 
Members of the East African Community in their efforts to apply  quality standards for alcoholic 
beverages. In this regard, the Euro pean Union recall ed in its entirety its intervention at the last 
Committee  meeting29 regarding concerns about Uganda's alcoholic beverages specifications. In 
particular, the EU reiterated the importance of WTO Members bas ing their technical regulations on 
international standards, in this case the Recommendations of the International Organisation of 
Vine and Wine (OIV), including the International Code of Oenological Practices, and the CODEX 
standard on Labelling of Prepackaged Foods (CODEX STAN 1 -1985). The EU believe d that widely 
accepted international standards and practices correctly address ed Uganda's  legitimate objectives 
as established under Art icle 2.2 of the TBT Agreement.  
2.280.   Referring to its previous intervention at this meeting on the Kenyan measures30, the EU 
requested Uganda to provide an update on the revision process of these technical standards. The 
EU underst ood that a meeting of the responsible technical committee of the East African 
Community (EAC)  had taken  place in February 2017 , and that the s tandards were now under 
public consultation. The EU invited  Uganda to brief the Committee on the status of the revision and 
on how the comments presented by other WTO Members were being taken into account in the  
revision process. Furthermore, the EU asked Uganda  to explain the process foreseen to incorporate 
these revised standards into the appr opriate technical regulations. Finally, t he EU recalled  the 
transparency provisions contained in Article 2. 9 of the TBT Agreement , and the importance of 
taking comme nts and suggestions of other Members  into account.  
2.281.   The representative of Kenya  informed delegations that a meeting of the relevant EAC 
technical committee had been held in February 2017 in Kenya, and that comments were being 
considered. She said that the r evised draft East African Standards were due to be released for 
public comments.  
2.282.   The representative of Uganda  explained that the EAC undertook a process to harmonize 
standards for alcoholic beverages in 2014. During the national adoption phase, Uganda noti fied 12 
standards to the WTO, consistent with the TBT Agreement transparency provisions. Comments 
received from the EU and other Members on the draft standards had been processed, and duly 
responded to by Uganda. The EAC secretariat had convened a technica l committee meeting on 
alcoholic and non -alcoholic beverages on 20 -24 February 2017. He said that both the British High 
Commission and the French Embassy in Nairobi had participated in that meeting. The regional 
meeting considered comments received from tr ading partners including those submitted by the 
EU. To that end, new East African Standards had been developed. He explained that Uganda would 
subject the draft standards to the formal national adoption mechanism, and that they would be 
notified according to the transparency procedures of the TBT Agreement.  
2.2.4.44   Russian Federation — Medical devices, G/TBT/N/RUS/51, G/TBT/N/RUS/52, 
G/TBT/N/RUS/53, G/TBT/N/RUS/55 (IMS ID 520)  
2.283.   The representative of Ukraine  highligh ted some inconsistencies of the notified regulation s 
with the requirements of the TBT  Agreement. Firstly Ukraine stated that the draft agreement 
required  the mandatory state registration of medical devices by an expert  certification body (based 
on an examination of safety, quality and effectiveness) regist ered on the territo ry of a member of 
the Customs Union . This requirement was not only inconsistent  with international practice , but i n 
her delegation's view  put national producers and those  from other WTO Members  in unequal 
positions. Moreover, conformity assessment procedure s for medical devices differ ed significantly 
from international practice, which required  a manufacturer to declar e the conformity of products to 
the requirements of a technical regulation. In the case in question, a stricter procedure was 
envisaged for all medical devices  whereby only conformity assessment bod ies could issue 
certificate s of conformity. Finally, Ukraine noted that the draft agreement specifie d requirements 
for implementation, installation, repair  and disposal of medical p roducts that were inconsistent  
with international practice. Her delegation t herefore requested Russia  to further clarify the 
                                                
29 G/TBT/M/70, paras. 2.33-2.34. 
30 Kenya — East African Community (EAC) alcoholic beverage standards (IMS ID 510) . G/TBT/M/71  
 
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  information to be included in the "labe lling" and the information to be included in the "operational 
documentation". Ukraine called  on Russia to remove unjustified technical barriers to trade and to 
bring the provisions of the draft documents on medical devices in line with international practice.  
2.284.   The representative of the United States  appreciated the efforts of the Russian Federatio n 
and the Eurasian Economic Union (EEU) to update its rules for the registration, safety, and 
efficiency inspec tions of medical devices. The US  recognized that the intent of the Federation and 
the EEU in updating these regulation s and the supporting guidan ce was  to provide its citizens with 
access to the latest lifesaving innovative products, while ensuring the safety and efficacy of the 
medical devices and treatments offered.  The US welcomed the Federation 's participation in the 
IMDRF (International Medica l Devices Regulators Forum) and its efforts to harmonize its medical 
device regulatory framework to the regulatory principles and guidance developed by this body. The 
US also recognized the outreach efforts of the Russian Ministry of Health to US national regulators, 
in an effort to learn more about US  best practices in this critical sector for public health  and 
encouraged further engagement via such fora.  
2.285.   As indicated in TBT meetings since 2014, her delegation nevertheless remained  concerned  
that the Russ ian Federation  and the EEU measures d id not align with IMDRF best practices in 
terms of product classification , transparency, guidance , and timelines for market authorization.  
Furthermore,  the US pointed out that the implementation of  these new measures was resulting in 
delay s in access to innovative medical devices and improved health outcomes for patients in the 
Russian  Federation  and in the  EEU markets.  The US asked for an implementation update , in 
particular the number of new and existing medical device s that ha d been registered, and the 
number of new and re -registrations that ha d been filed, but not yet processed.   
2.286.   The US reiterated its request for a respon se to the enquiry expressed by US  industry via 
the WTO enquiry point on notifications G/TBT/N/RUS/ 51, 52 -53 and 55 back in  June 2016.  Finally 
the US called  Russian and EEU officials to consider a meeting with industry to discuss their 
concerns with the implementation of Russia 's new medical device registration, as well as the EEU 
draft agreement and gu idance.  As a final remark the US pointed out that addressing these 
concerns would  ensure that as  the Russia n Federation  and the EEU transition ed to a new set of 
regulations on medical devices , there would be an adequate supply of the current devices on 
market, while promoting the introduction of novel, lifesaving devices already in the pre -
registration process.  
2.287.   The representative of the European Union  acknowledged the effort s of the Russian 
authorities regarding common rules in the field of medical devices.  She noted that while the drafts 
were notified on 10 and 11 May 2016, all four notification s listed the proposed date of adoption 
and final date  for comments as 5 July 2016. In this light , she pointed out that  the normal time 
limit for comments on notifica tions of at least 60 days had not been provided and requested 
clarification on this . In relation to G/TBT/N/RUS/51, the EU understood that the notified draft 
establishe d a long review time of dossiers presented in the framework of technical testing for 
medical devices as part of their "expert evaluation"  and believed that this would not allow the 
market to adequately keep up with the pace of innovation , inviting the Russian authorities to 
explain the necessity of such a long review time. For the sake of com parison, she noted that t he 
timeline for expert evaluations in the EU was normally between 30 and 60 days, in contrast with 
the notified draft which seem ed to establish a timeline of over 300 days.  
2.288.   On G/TBT/N/RUS/52, the EU noted that the proposed date of  adoption of the notified draft 
rules was 5 July with a  proposed date of entry into force of 1 January 2017. The EU recalled the 
necessity of adequate transition times, in particular for registration procedures, to ensure the non -
disruption of market acces s. The EU stated that generally a transition period of three  to five years 
was provided for such measures, ensuring a viable transition for the medical device sector, both 
because of the technical complexity involved in regulating the sector and the large number of 
medical devices involved. Furthermore, the EU stressed that the use and recognition of 
international standards (especially ISO standards) and best practices (notably for the recognition 
of clinical information) were essential for market access fo r medical technologies around the world 
and in this regard referred to Article 2.4 of the TBT Agreement. The EU asked Russia to consider a 
longer transition period and the use and recognition of international standards and best practices.  
2.289.   Regarding  G/TBT/ N/RUS/53, the EU understood that all the relevant information regarding 
"safety and efficiency" of a medical device ha d to be put on the label of that medical device. The G/TBT/M/71  
 
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  EU asked Russia for clarification regarding the information to be included in the "la belling" and the 
information that ha d to be included in the "operational documentation". On G/TBT/N/RUS/55, the 
EU understood that, in addition to the registration procedures for medical  devices in the framework 
of the Eurasian Economic Union (EEU), the "r ecognition by expert reports" was required for each 
individual EEU Member. The EU requested  clarification by Russia on whether such decisions of the 
Board of the EEU regarding medical devices registered under the new rules could be fully and 
directly appli cable (and enforceable) in all members of the EEU without such additional 
"recognition by expert reports".  
2.290.   The representative of the Russian Federation  recalled that the Agreement on Common 
Principles and Rules of Medical Devices Circulation in the Eurasi an Economic Union had been  
signed in December 2014 and that a package of documents had been  developed for the 
implementation of the agreement. He underlined that whilst all of these documents ha d already 
been adopted by the Eurasian Economic Commission, they would  enter into force only after 
ratification of the  agreement by all the EAEU members. Moreover, he noted that overall the entry 
into force of the implementing documents would  not introduce  dramatic changes in requirements 
and conformity assessment pr ocedures, since the transitional period would  last until 31 December 
2021. Indeed, his delegation  stressed that previously issued certificates of registration of medical 
devices would  remain  valid during th is transitional period.  
2.2.4.45   Russian Federation — Phar maceutical products - Resolution 1314 of the 
Government of the Russian Federation on determining compliance of medicinal products' 
manufacturers with the requirements of Good Manufacturing Practice (non -notified); 
draft decisions of the Board of the Eurasi an Economic Union G/TBT/N/RUS/54,  
G/TBT/N/RUS/58, G/TBT/N/RUS/63 (IMS ID 521)  
2.291.   The representative of the United States  supported Russia's objective of ensuring that 
pharmaceutical products were safe and effective. However, her delegation continued to have 
concerns about the status of the measure. US understood that one of the implementing acts 
notified to the WTO dealt with Good Manufacturing Practice (GMP) requirements 
(G/TBT/N/RUS/58). Industry had expressed concerns that there were reportedly not enough 
trained officials to conduct timely GMP inspections of all the proposed sites. The representative 
asked about the status of the inspections. She asked for confirmation and an update about the 
understanding that draft amendments by the Russian government wou ld allow the marketing 
authorization application to be filed in parallel with the GMP inspection request. She noted that US 
industry and local stakeholders in Russia had reported their concerns regarding GMP requirements 
causing significant delays in the r egistration of new medicines and that lives of Russian patients 
could be at stake. Regarding agriculture, the requirements could lead to a shortage of veterinary 
medicines for livestock, which could then negatively impact Russia's goals of increasing its f ood 
production.  
2.292.   As the Russian delegation had stated at the November meeting that the previously issued 
registration certificates would be valid for a certain transitional period, the US representative 
asked about the length of the transitional period. He r delegation also enquired about the possibility 
of providing a transition time so that Russian citizens would not lose access to innovative lifesaving 
medicines and that Russian livestock and pets would not be at increased risk to infectious 
diseases. She  asked if Russia would require that clinical trials for orphan drugs be conducted in 
Russia. Finally, she encouraged Russia to discuss potential solutions to this issue with 
stakeholders, such as patients, hospitals, and industry. The industry stakeholders  from the US 
stood ready to help facilitate these discussions.  
2.293.   The representative of the European Union  reiterated its concerns regarding measures the 
Russian Federation had adopted to introduce certification requirements for medicinal products, 
both for human and animal use, which was also raised at the November meeting. The most 
significant concern related to Resolution 1314 of the Government of the Russian Federation on 
Determining Compliance of Medicinal Products' Manufacturers with GMP requirements, o f 
3 December 2015. The representative mentioned that the Resolution had not been notified to the 
WTO, while it introduced a requirement of inspection and certification of production sites of 
medicines with regard to GMP, including foreign manufacturing sit es, which was a pre -condition to 
obtaining a marketing authorization in the Russian Federation. He noted that the resolution had a 
significant effect on trade and was subject to the TBT notification obligation which enabled WTO 
Members' review.  G/TBT/M/71  
 
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  2.294.   His delega tion understood that the resolution had been adopted on 3 December 2015, and 
had started to apply to foreign manufacturing sites since 1 January 2016 with two concrete 
consequences: (i) the GMP certification requirement already applied to new products with out a 
previously accepted market authorization; and (ii) renewal of marketing authorization would 
require GMP certificates as of 1 January 2017. The representative stressed that, in accordance with 
the TBT Agreement, sufficient delay should be provided bet ween the adoption of the measure and 
its entry into application so that manufacturers could adapt to the requirements of the measure. 
Regarding the resolution, he stated that one month would clearly fall short of this. The 
representative noted that: (i) th e measure foresaw a delay for the examination of foreign 
manufacturing sites of up to 160 business days, much longer than the transition period; and 
(ii) the number of foreign manufacturing sites supplying medicines to the Russian Federation was 
very high.  The representative noted that, at each site, an inspection by the Russian authorities 
was needed as a condition for the necessary GMP certification, when a new imported product was 
manufactured without a currently existing marketing authorization, or when ever currently 
accepted marketing authorizations expired. Therefore, for a smooth entry into force of the 
measure, which avoided trade disruption, substantial resources would need to be allocated by the 
Russian Federation. It was, however, understood that the inspection capacity made available by 
the Russian Federation would be far from the level required for such a smooth entry into force, 
especially at that point in time, when the measure had already been in force for almost one year. 
For veterinary produ cts, it appeared that not only sites manufacturing final products needed to be 
inspected, but also those manufacturing active pharmaceutical ingredients (APIs), which increased 
the burden for industry and the requirements in terms of inspection capacity fo r the Russian 
Federation. The representative pointed out that the lack of notification, and therefore of 
transparency, towards WTO Members, the absence of an appropriate transition period and the 
mismatch between required inspection capacity and the resour ces allocated by the Russian 
Government resulted in a very difficult situation for industry, affecting, in particular, foreign sites, 
due to the additional difficulties of the inspection process abroad. It was already restricting imports 
of medicines into the Russian Federation and, unless additional measures were taken, the negative 
impact could become much more severe once currently accepted marketing authorizations 
expired.  
2.295.   The EU representative therefore requested that: (i) the measure be notified to th e WTO, so 
as to make possible the review by WTO Members with a view to taking into consideration their 
comments for the finalization of the measure; (ii) appropriate transition time and additional 
accompanying measures be taken by the Russian Federation, i ncluding in the area of organization 
of inspections, so as to ensure that the GMP certification requirement could be timely complied 
with by foreign manufacturers without a negative impact on their exports to the Russian 
Federation. It was understood that no action had yet led to such a transition period, while the 
measure was fully in place since the beginning of this year, except for the draft amendments to 
Law 61 on veterinary pharmaceuticals only, which was posted for public discussion in December 
2016 as a new adoption; and (iii) the specific issue for veterinary products of double inspection on 
sites manufacturing APIs and on final products be reconsidered by the Russian Federation. His 
delegation trusted that the development, adoption and entry into a pplication of these measures 
would be fully compliant with the obligations laid down in the TBT Agreement, in particular with 
regard to the need to provide sufficient delay between the adoption of the measure and its entry 
into application so that manufact urers could adapt to the requirements of the measure.  
2.296.   The representative of the Russian Federation  thanked the delegations of the US and the EU 
for their interest. The Federal Law No. 429 -FZ as of 22 December 2014 amended Federal Law No. 
61-FZ of 12 April 2010 "On the Circulation of Medicines" and introduced the compulsory 
requirement that the production of pharmaceutical products should comply with the GMP 
provisions in order to adequately protect human life, health and safety. The Resolution of the 
Govern ment of the Russian Federation No. 1314 as of 3 December 2015 mentioned by the 
interested Members approved the Rules of Pharmaceutical Products Manufacturers Inspections in 
order to implement the Federal Law No. 61 -FZ. The Resolution set out the fee for th is service, 
which was equal for domestic and foreign manufactures. The Rules of Inspections did not contain 
provisions discriminating against foreign operators.  
2.297.   The representative explained that the Schedule of Inspections of Foreign Manufactures was 
publically available on the official website of the Ministry of Industry and Trade of the Russian 
Federation and that it had listed almost one hundred inspections in the second half of this year. 
According to the Resolution, the Ministry of Industry and Trade of the Russian Federation, with G/TBT/M/71  
 
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  respect to pharmaceutical products for humans, and the Federal Service for Veterinary and 
Phytosanitary Supervision ("Rosselkhoznadzor"), with respect to pharmaceutical products for 
animals, were authorized to control and mo nitor the application of pharmaceutical products GMP 
conformity certification system. The quantity and frequency of inspections depended on the 
number of requests for inspections, but not on the location of a production site. He mentioned that 
the work reg arding the draft decisions of the Board of the Eurasian Economic Commission was still 
ongoing. The adoption of these decisions would require changes in legislation of the EAEU 
members. In any case, certificates issued previously would be valid for a certai n transitional 
period. His delegation took note of concerns raised today and would continue to cooperate with 
interested Members.  
2.2.4.46   European Union – Country of Origin Labelling (IMS ID 523)  
2.298.   The representative of the United States  stated that eight European m ember States 
(France, Finland, Greece, Italy, Lithuania, Portugal, Romania and Spain) were in the process of 
developing and implementing country of origin labelling (COOL) schemes for milk and meat, and 
certain processed food products containing dairy, mea t and wheat ingredients. She indicated that 
the measures would require the labelling of processed food products containing meat, dairy and 
wheat to indicate the origin of those ingredients, including the countries where various stages of 
processing have oc curred. She explained that the US industry had raised a number of concerns 
regarding the new COOL requirements in various EU member States, which appeared likely to 
have a significant impact on trade in meat, dairy, and wheat products used as ingredients i n 
processed foods. The US highlighted the following concerns: first, the fact that EU countries had 
taken an inconsistent approach, with COOL requirements differing between the eight member 
States, therefore subjecting dairy, meat and wheat exports to a va riety of different rules in the EU, 
and potentially undermining the ability of products to move across borders seamlessly within the 
Single Market. In this regard, the US observed that the Commission's own assessments had 
suggested mandatory COOL would hav e a "re-nationalization " effect on the Single Market. Second, 
the US pointed out that some of the measures included a mutual recognition clause that may 
explicitly favour certain countries, by excluding processed foods imported from selected countries 
such as other EU member States, Turkey or the EFTA countries that are part of the European 
Economic Area.  
2.299.   Third, the US was concerned about the transparency practices of the EU and the member 
States related to these measures. In this regard, the US stressed t hat the measures had not been 
notified to the WTO either by the Commission or the member States. From a US perspective these 
measures should be notified as they were not based on international standards, and appeared 
likely to have a significant impact on international trade. The US recalled that this potential impact 
on trade was identified by the European Commission itself in its 2015 impact assessment of 
mandatory country of origin labe lling, which noted that the measures would likely create a shift 
amon g processors to fewer suppliers. Furthermore, the US underlined that without notification of 
the measures, US industries had not been able to obtain authoritative versions of the regulations, 
and had not been provided with an opportunity to provide input. Moreover, the US stressed that 
the measures were expected to enter into force imminently. The US then questioned whether the 
EU and the member States were allowing a "reasonable interval" as called for in the TBT 
Agreement between publication and entry int o force. Given the potential trade impacts of these 
measures, US hoped EU member States would proceed deliberately, taking carefully into account 
WTO obligations and the feedback of trading partners in the development and implementation of 
these measures.  She recalled that her delegation had previously raised this issue with the 
Commission and member States at the November 2016 TBT Committee meeting but that despite 
this, the Commission and member States still had not notified proposed COOL measures, and ha d 
not solicited or taken into account feedback on these measures from industry. Finally the US 
stressed that in the meantime, COOL had entered into force in France, and other measures in Italy 
and Lithuania would soon enter into force. The US requested tha t the EU and its member States 
postpone implementation of any further COOL measures until they were notified to the WTO, and 
comments taken into account by affected stakeholders.  
2.300.   The representative of Brazil  shared the concerns of the United States with re spect to the 
lack of notification of COOL requirements adopted by some EU member States. Brazil was also 
concerned with the potential negative impact of such requirements on international trade, as they 
might discourage the use of imported inputs in the pr oduction of dairy and meat. In order to 
address these concerns, Brazil pointed out that its government and exporters should be given the G/TBT/M/71  
 
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  opportunity to discuss the measures adopted, prior to their implementation. More fundamentally, 
Brazil stressed that it  should have access to the texts of those measures and be able to analyse 
them properly. Brazil expected that the EU would be able to comply with the transparency 
requirements of the TBT Agreement, and also to remove any measure that might constitute less 
favourable treatment to products of foreign origin.  
2.301.   The representative of Indonesia  echoed the concerns of Members regarding the COOL 
regulation. Whilst fully understanding the intention behind the COOL regulation which was 
affiliated with consumer protect ion, Indonesia stressed that it should not pose unnecessary trade 
barrier to products from other Members. Furthermore, Indonesia stressed that the labelling 
requirements raised significant and systemic concerns due to the probability of different treatment  
between products originating from the EU and non -EU. Indonesia had received an indication that 
local food processors would receive incentives to use locally produced dairy and meat ingredients. 
Indonesia asked the EU to be transparent and show how the afo rementioned regulation was 
consistent with its obligations towards the WTO.  
2.302.   The representative of New Zealand  thanked the United States for raising this issue which it 
had been following with some interest. New Zealand encouraged the EU to notify any draft  
proposals for mandatory country of origin labelling in EU member States, in accordance with the 
transparency obligations of the WTO TBT Agreement, to enable interested Members to assess the 
impact of the measures and provide comments.  
2.303.   The representative of Canada  echoed the concerns raised by others in particular the 
negative impact COOL measures may have on international trade and the potential segmentation 
of the European Union Single Market. From Canada's perspective, mandatory COOL measures may 
cause d iscrimination within food supply chains, as food processors begin to favour locally -sourced 
ingredients, negatively impacting imported food ingredients to the EU. Furthermore, Canada was 
concerned by the lack of transparency of the EU Commission and its me mber States in making 
information about the COOL measures publicly available, including the process for approving these 
measures. Canada underlined that the failure to notify these measures would undermine the ability 
for WTO Members to properly assess and  issue comments thereto. Therefore, given the likely 
impact these measures may have on trade, Canada trusted that any COOL measures would be 
developed in consultation with relevant stakeholders along the supply chain and that WTO 
Members will have an oppor tunity to comment on the draft measures, as required under the TBT 
Agreement. Canada strongly urged the EU Commission to engage with member States to ensure 
the prompt notification of these COOL measures and to ensure their consistency with all applicable 
WTO obligations.  
2.304.   The representative of Australia  recognized the rights of Members to apply labelling 
requirements to fulfil legitimate policy objectives in a manner that was no more trade restrictive 
than necessary. Australia encouraged greater transparen cy by the EU and its member States 
regarding the various new COOL measures. Australia stressed that neither the European 
Commission nor relevant member States had notified the measures to the WTO and should do so 
as they were not based on international sta ndards and might have an impact on international 
trade. Australia recalled that in the absence of notification, it had not been provided with an 
opportunity to provide comments. Moreover, Australia stressed that the measures for some 
member States had alre ady taken effect and others were expected to enter into force imminently. 
Australia reminded the EU and member States of the requirement to notify at an "early 
appropriate stage" and to allow a reasonable period between publication and entry into force.  
2.305.   The representative of Mexico  supported the comments made by other Members with 
respect to the EU COOL measures. Mexico would welcome a bilateral meeting to obtain technical 
information with respect to the labelling of foodstuffs and their components. Mexico reiterated 
what was said in the earlier STC31 referring to GI labelling for pasta in Italy and pointed out that 
country of origin labelling was a very sensitive issue. Referring to the case brought to the DSB by 
the US on Country of Origin Labelling for mea t products, the EU was asked to take into 
consideration the panel and appellate body reports thereof where it was stated that indication of 
origin regulations do distort competition in the market and provide less favourable treatment to 
foreign producers t han to national producers. Finally, Mexico recalled the case law in the previous 
                                                
31 Italy – Labelling requirements of the origin of grains used in the preparation of dried pasta . G/TBT/M/71  
 
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  TBT case with respect to the commitments taken by the various Members in the Dispute 
Settlement Body.  
2.306.   The representative of Uruguay  shared the concerns expressed by other dele gations with 
respect to the requirement for COOL particularly with respect to milk and meat products since this 
was a non -tariff barrier and gave incentive to local producers not to use imported products. 
Uruguay, like others, urged the EU to notify the me asures to the TBT Committee.  
2.307.   The representative of the European Union  stated that , as explained in the previous TBT 
Committee32, Regulation (EU) 1169/2011 on the provision of Food Information to Consumers 
allowed member States to introduce measures concern ing the mandatory indication of the country 
of origin or place of provenance for certain categories of foods, following the specific notification 
procedure established for this purpose in the Regulation. Accordingly, the EU stressed that 
member States deem ing it necessary to adopt such national measures had to notify them to the 
European Commission and the rest of the member States, and provide the reasons justifying 
them. Furthermore, the EU specified that the grounds on which the justifications had to be based 
were specified in the Regulation and included consumer protection. In addition, the EU recalled 
that member States needed to provide evidence supporting their measures, for instance, that the 
majority of consumers in the member States concerned attac hed significant value to the provision 
of the origin indication. The EU explained that certain member States had notified draft national 
measures according to this procedure and that some of those measures had been adopted, while 
others were currently unde r assessment by the EU Commission. Finally, the EU pointed out that 
the member States measures adopted to date had a limited duration in time, affected a limited 
category of products and did not apply to third countries, but to domestic products. The EU to ok 
note of the concerns raised.  
2.308.   The representative of Canada  expressed appreciation for the explanation given by the EU 
on the notification procedure for these measures to the Commission and understood that a number 
of elements needed to be included in the  application by the member States, including the 
objectives of that measure, similar to the requirement contained in Article 2.9.2 of the TBT 
Agreement. Canada recalled the Committee's 2012 recommendation on transparency, with a view 
to enhancing the pract ical application of the concept of "significant effect on trade of other 
Members".33 
2.2.4.47   Colombia - Testing Requirements to be met by Toys and th eir Components and 
Accessories G/TBT/N/COL/109 , G/TBT/N/COL/109/Add.3  (IMS ID 479)  
2.309.   The representative of Mexico  thanked Colombia for consider ing her delegation's comments 
during the public consultation period of the previous version of the Resolution on the Technical 
Regulation requirements for toys, their components and accessories manufactured in, imported 
into, and m arketed in Colombia. Concern s were raised about  the most recent version of Colombia's 
resolution notified on 9 February  2017 in document G/ TBT/N/COL/109/Add.3, which aimed  to 
protect human health and safety through the implementation of safety requirements  for imported  
toys and toy components . Mexico recognized  Colombia's right to pursue its objective and sought 
clarification on several aspects of the regulation. Article 5.12 of the regulation stated  that "Toys 
intended for children under three years of age  shall not contain phthalate -type plasticisers […] in 
quantities exceeding 0.1% by weight of the product" ; she asked whether  the requirement applie d 
only to toys made of soft plastics, and  the basis of the requirement. Article 6.1.4 of the regulation 
required the use of a flame -retardant treatment in the production of toys ; Mexico asked whether  
the carcinogenic effects of this treatment  had been considered and said that her industry no longer 
used flame -retardant treatment to toys for this reason . Referring  to Article 5.4 of the TBT 
Agreement, she  asked whether Colombia had  used relevant international standards as a basis for 
its conformity assessment procedure  (CAP) and  whether  it had considered accepting European toy 
safety standards , such as  the provision s of Part 2 ("Flammability") of European Standard 
EN-71-2:2011 on toy safety , to prevent flammability of products . Referring to Article 8  of the 
regulation , "Doc ument demonstrating conformity", which denot ed the certificate of conformity that 
must be prese nted as a g uarantee of compliance with the  resolution issued by a certification body 
accredited by ONAC, in accordance with Decree No.  1074 of 2015, "Single Decree Regulating the 
Commerce , Industry and Tourism Sector". She said that t he Mex ican Industry in terpreted  
                                                
32 G/TBT/M/ 70, para. 2.53.  
33 G/TBT/1/Rev.13, 5.3.1.2(b).  G/TBT/M/71  
 
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  paragraph 2 of Article 2.2.1.7.5.6 ("Laboratory testing") of Decree No.  1074 to mean that 
laboratory reports from other countries would not be accepted for issuing conformity certificates.  
Mexico believed  that not accepting laboratory tests or co nformity certificates issued by foreign 
bodies, or allowing tests to be carried out in  laboratories only within Colombian territory  might be  
in violation of Article s 5.1.1, 5.1.2  and 5.2.1 of the TBT Agreement . 
2.310.   Recalling the commitments in Arti cles 5.1.1 a nd 5.2.1 of the TBT Agreement, Mexico 
asked : (i) what would  be required from toy importers to demonstrate compliance with Article 8 of 
the Resolution ; (ii) were  foreign laboratory tests accepted for issuing the conformity certificates ; 
(iii) which certific ation bodies were recognized and which were accredited by ONAC to issue 
conformity certificates and laboratory tests .  
2.311.   The representative of Colombia  pointed out that comments had  not been received from 
Mexico  with respect to the health requirements for to ys, accessories and components  and 
reminded  them of the transparency requirem ents of the TBT Agreement that provided  a 90-day 
public consultation period  for technical regulation  which Colombia had exceeded with a deadline of 
8 May 2017. Mexico was urged to  provide their concerns to the TBT enquiry p oint within the 
period, and in any case in time for the next meeting.  
2.2.4.48   European Union — Directive 2014/40/EU on the approximation of the laws, 
regulations and administrative provisions of the member States concer ning the 
manufacture, presentation and sale of tobacco and related products and repealing 
Directive 2001/37/EC (IMS ID 513)   
2.312.   The representative of Indonesia  informed the Committee that his delegation continued to 
have serious concerns with the EU Tobacco D irective, which appeared to violate Article 2.1 of the 
TBT Agreement.34  
2.313.   The representative of the European Union  noted that, on 10 February 2017, replies to 
Indonesia's comments had been provided . The EU consider ed that Indonesian concerns would be 
better addressed at the bilateral level and remain ed available  to meet with the I ndonesian 
Delegation.  
2.2.5   Exchange of Experiences  
2.314.   The moderators  for the thematic sessions made the following reports:  
a. Ms. Lucy Ikonya (Kenya) on good regulatory practice (G/TBT/GEN/214) ; and,  
b. Mr. Fabrizio Sacchetti (EU) on conformity assessment procedures (G/TBT/GEN/213).  
2.315.   The representative of the United States  said that the session s had been informative. With 
respect to conformity assessment and, more specifically, the EU proposal about  what factors 
regulators consider when designing and implementing conformity assessment procedures, she 
noted that the US was interested in furthering an exchange of experiences and discussion at the 
Committee on this issue. It could, she said, be useful t o have a write -up on this issue with a view 
towards an area of potential future Committee work. She added that the US was currently 
considering how best to guide regulators in this area and therefore had some relevant experience 
to share.  
2.316.   The representativ e of Australia  echoed the US ' comments and was generally supportive of 
furthering work in this area. In addition, Australia considered it important to consider the role that 
risk assessment played when choosing the conformity assessment process.  
2.317.   The Chairp erson  noted the importance of conformity assessment procedures and the 
growing level of interest in this topic within the Committee.  
                                                
34 The full statement is available in the document G/TBT/W/449, circulated on 11 April 2017.  G/TBT/M/71  
 
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  2.2.5.1   Other Decisions and Recommendations Adopted by the Committee  
2.318.   The Chairperson  drew the Committee's attention to document G/ TBT/1/Rev.13 which 
contains the latest compilation of the Committee's Decisions and Recommendations. In doing so, 
she took the opportunity to remind Members that the 8th Triennial Review of the TBT Agreement 
would take place in 2018. She recalled that this  process was driven by substantive proposals from 
Members  and, as with previous triennial reviews , typically start ed with a discussion about timing 
and approach during the preceding year – meaning by November 2017. In this regard, the revised 
compilation o f Committee Decisions and Recommendations was a good source of inspiration for 
the upcoming Review.  
2.2.5.2   Topic of the next Thematic Session  
2.319.   The Chairperson  recalled that the Seventh Triennial Review mandated the Committee "to 
continue to hold thematic sessions in 2017 and 2018" and that there was a full day set aside for 
thematic sessions on 13 June 2017. Earlier, she had encouraged Members to contemplate topics of 
interest for future thematic sessions and consultations had been held with Members in November 
2016 as well as January 2017. The topics of Members ' interest were contained in her 19 December 
2016 fax and included: GRP (covered in March 2017),  conformity assessment (covered in March 
2017), risk assessment; standards; implementation of standards by SMEs;  the Code of Good 
Practice and non -governmental bodies; forestry management; Members ' general approaches to 
regulatory cooperation; and, e -commerce and labelling. On E-commerce and labelling, she recall ed 
that El Salvador had first proposed this topic in J OB/TBT/213, and that a more detailed proposal 
was contained in JOB/TBT/225.  
2.320.   The representative of El Salvador  said that her delegation wished to consider the topic of 
labelling and e -commerce in June. She said that the current WTO Agreements had been conce ived 
and designed in an era that pre -dated electronic trade. New systems were in place and these 
carried certain challenges to businesses. El Salvador wished to discuss how labelling requirements 
impacted trade in products sold online (e.g. through platfor ms such as Amazon, eBay).  
2.321.   The representative of Guatemala  supported the proposal. She also suggested that the 
Committee could consider international and regional standardization in this area so as facilitate 
trade, in particular, for smaller businesses in  developing countries.  
2.322.   The representative of the European Union  shared that from the EU perspective, the most 
important policy challenge related to e -commerce from a product regulation point of view was how 
to ensure regulatory compliance of products sold on-line with the applicable requirements in the 
country where the customer was based. Enforcement of product rules on products sold on -line was 
particularly challenging and, in the EU 's view, this topic – would be an area of interest to consider. 
For examp le, what were the challenges that products sold on -line raised from the point of view of 
compliance and enforcement? Clearly these were products that were being shipped through 
different channels from those which were taken into account by regulators when setting the rules. 
This topic could, therefore, in fact, rather be addressed under a broader discussion on conformity 
assessment and market surveillance. The EU would, hence, rather see this discussion in the 
context of a broader discussion on enforcement of rules and compliance of products.  
2.323.   The representative s of India, Egypt  and Ecuador  said that El Salvador's proposal – which 
had only recently been submitted – was under examination in their capitals; they therefore 
reserved their comments for the moment and said that their views and suggestions would be 
forthcoming at a later stage.  
2.324.   The Chairperson  noted that there appeared to still be some reservations on the topic of e -
commerce and labelling for June. She then turned to Members for views on other possib le topics 
for consideration in June.  
2.325.   The representative of South Africa  recalled that during the Seventh Triennial Review, 
South Africa had proposed that the Committee consider risk assessment as part of GRP. He 
welcomed more detailed discussion on the st eps necessary to undertake a proper risk assessment 
and how a risk assessment assisted regulators in the process of regulating; especially developing G/TBT/M/71  
 
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  country regulators who were not very familiar with all the steps that were needed to carry out a 
risk asse ssment.  
2.326.   The representative of the United States  noted that there appeared to be some momentum 
in the area of conformity assessment and there might be a possibility for some form of outcome in 
this area. She recalled, in this vein, the Chair's statement on the fast approaching triennial review. 
There was therefore benefit, in the US view, to having a thematic session that specifically dealt 
with the perspective of how regulators dealt with conformity assessment in respect of shaping 
their choice of appropria te procedure in different situations (including risk assessment). This 
followed on the EU proposal.  
2.327.   The representative of the European Union  said that the topic of risk assessment had many  
facets, including risk assessment when deciding on a particular co nformity assessment approach in 
a given risk management context. Clearly one option would be for the Committee to focus on this 
particular aspect in at least one of the thematic sessions. The EU supported the suggestion by the 
US in this regard. Neverthele ss, this did not exhaust the topic of risk assessment. There were 
aspects of risk assessment also relevant to GRP, as had been mentioned by South Africa. There 
were also additional aspects that were more specialized to risk assessment which might also be 
worth exploring. For instance, in standardization, when drafting standards there was also risk 
assessment carried out at the level of the standardization development process to determine the 
technical solutions to be adopted in order to address certain risk s. There were other aspects as 
well – hence, one thematic session might not be enough. If a choice had to be made, the EU would 
focus on risk assessment as a determinant of the choice of conformity assessment policies and 
approach, and this would be the pr iority for the EU in June.  
2.328.   The representative of Chinese Taipei  agreed that a thematic session on the topic of risk 
assessment would be very useful and recalled its earlier submission on risk assessment as 
contained in JOB/TBT/211.  
2.329.   The representative of the United States  supported the EU proposal.  
2.330.   The representative of Kenya  also supported addressing risk assessment in June.  
2.331.   In concluding, the Chairperson  noted that risk assessment was a very broad topic, which 
cut across several areas of work in the TBT Agreement, such as CAP, GRP and potentially other 
areas. She noted a sense of momentum in this area and proposed that the Committee discuss the 
topic of risk assessment with the understanding that she would continue to hold consultations on 
the specifics o f what could be addressed under risk assessment at the June thematic session. She 
also stated her intention to hold an informal meeting at the end of April, and that she remained 
open for consultations with interested Members on how best to scope out the t opic of risk 
assessment.  
2.2.6   Other matters  
2.2.6.1   Academic work on TBT notifications  
2.332.   The representative of the United States35 presented a paper analysing W TO Members' TBT 
notifications  and their link to goods trade . The speaker highlighted, inter alia , that over 92%  of 
global goods exports are covered by TBT notifications. He underscored that the pervasiveness of 
technical regulations reinforced the need to ensure that these regulations did not become 
unnecessary barriers to trade. The full presentation is available in G/TBT/GEN/ 215.36 
2.2.6.2   ePing  and the Enquiry Point Guide  
2.333.   The Secretariat  presented ongoing work on ePing  and on the Enquiry Point Guide. The full 
statements are contained in G/TBT/GEN/ 221. He said that the team had  been working with ITC 
and UNDESA to organize an  ePing event during the 6th Global Review of Aid for Trade , on 13  July 
                                                
35 Mr. Jeff Okun -Kozlowicki, Economist at the US Department of  Commerce . 
36 http://www.trade.gov/td/osip/  
 G/TBT/M/71  
 
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  2016. This day would be dedicated to standards and the purpose of th e ePing event was to 
showcase the facility  to a wider community , beyond SPS and TBT. He took the opportunity to 
thank Mrs  Lotte Drieghe  and Ms Sanya  Alleyne – who would both be leaving the Secretariat – for 
their hard work  on their respec tive projects.  
2.334.   The representative of the Australian  delegation asked the Secretariat to make available the 
results of its ePing survey and reiterated his country's support for ePing . She noted that Australia 
had transitioned to using ePing as its notificat ion distribution system and continue d to receive  
positive  feedback from businesses . The application saved time both for them and the Enquiry Point  
itself which now did not need to review  and send on notifications.  
3  TWENTY -SECOND ANNUAL REVIEW37 
3.1.  The represent ative of the United States  thanked the Secretariat for the additional information 
provided in this year's report. The inclusion of more graphs, charts and analysis helped in 
explaining the activity of the Committee and the volume of issues deal t with. 
4  TECH NICAL COOPERATION  ACTIVITIES  
4.1.  The representative of Canada  informed the Committee that the Canadian Enquiry Point would 
host staff from the Trinidad and Tobago Enquiry Point where they would spend four days with 
Canada's Enquiry Point to learn some of the procedures and processes followed by Canada, as well 
as hold meetings with officials from the regulatory secretariat at the Treasury Board Secretariat, 
the Standards Council of Canada and regulators from the Canadian Food Inspection Agency.  
4.2.  The representa tives of BIPM, ISO, UNIDO , IEC and ARSO  updated the Committee on their 
activities  related to Technical Assistance Activities .38 
4.3.  The Secretariat  made available a document on its  Technical Assistance  activities contained in 
G/TBT/GEN/ 220.  
5  UPDATING BY OBSERVE RS 
5.1.  The representatives of WHO, Codex , BIPM, ISO and UNECE  updated the Committee on their 
activities .39  
6  DATE OF NEXT MEETING  
6.1.  The next regular meeting of the Committee will be held on 14 -15 June 2017, with one  day 
set aside for thematic sessions on 13 June 2 017. 
 
__________  
                                                
37 G/TBT/39/Rev.1  
38 G/TBT/ GEN/216 , G/TBT/GEN/217, G/TBT/GEN/220, G/TBT/GEN/218 and G/TBT/GEN/219.  
39 G/TBT/GEN/222, G/TBT/GEN/223, G/TBT/GEN/224, G/TBT/GEN/216, G/TBT/GEN/217, 
G/TBT/GEN/225.