RESTRICTED  
  
G/TBT/M/66  
 
17 September 2015  
(15-4767) Page: 1/58 
Committee on Technical Barriers to Trade    
 
 MINUTES OF THE MEETI NG OF 17-18 JUNE  2015  
CHAIRPERSON: MS ALANA LANZA  
Note by the Secretariat1 
1   ADOPTION OF THE AGEN DA ................................ ................................ ........................  1 
2   ELECTION OF THE CHAI RPERSON  ................................ ................................ ................  1 
3   IMPLEMENTATION AND AD MINISTRATION OF THE AGREEMENT  ................................ . 1 
3.1   Statements from Members under Article 15.2  ................................ ................................ . 1 
3.2   Specific Trade Concerns  ................................ ................................ ...............................  2 
3.2.1    Withdrawn concerns  ................................ ................................ ................................ .. 2 
3.2.2    New Concerns  ................................ ................................ ................................ ..........  2 
3.2.3    Previously Raised Concerns  ................................ ................................ ....................... 15 
4   EXCHANGE OF EXPERIEN CES ................................ ................................ .....................  56 
4.1   Seventh Triennial Review  ................................ ................................ ............................. 56 
4.2   Status of Work on GRP (JOB/TBT/119/Rev.1)  ................................ ................................ .56 
4.3   TBT@20 Anniversary Event on 6 November 2015  ................................ ........................... 56 
5   TECHNICAL COOPERATIO N ACTIVITIES  ................................ ................................ .... 56 
6   UPDATING BY OBSERVER S ................................ ................................ ........................  57 
7   DATE OF NEXT MEETING ................................ ................................ ............................  58 
 
1  ADOPTION OF THE AGEN DA  
1.1.  The Committee  adopted the agenda contained in WTO/AIR/TBT/2.  
2  ELECTION OF THE CHAI RPERSON  
2.1.  The Committee elected Ms Alana Lanza (Honduras)  as the chairperson  of the Committee . 
3  IMPLEMENTATION AND A DMINISTRATION OF THE  AGREEMENT  
3.1  Statements from Members under Article 15.2  
3.1.  The Chairperson  reminded the Committee of Members' notification obligation under Article 
15.2 of the TBT  Agreement and further informed the Committee that the latest list of statements 
submitted under Article 15.2 of the TBT Agreement were contained in document 
G/TBT/GEN/1/Rev.14, issued 23 February 2015. She informed the Committee that in total, since 
the last meeting in March 2015, Ukraine and Sri Lanka had submitted revisions to their original 
                                                
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/66  
 
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  statements. She further informed the Committee that since 1995, 129 Members had submitted at 
least one statement of implementation under the above -mentioned Article.  Information on the list 
of statements was available, and regularly updated on the TBT Information Management System 
(http://tbtims.wto.org ).  
3.2  Specific Trade Concerns  
3.2.1   Withdrawn concerns  
3.2.  The Chairperson  reported that t he following Specific Trade Concerns had been withdrawn 
from the Agenda at the request of the concerned Member:  
a. Chinese Taipei – Amendment to Legal Inspection of Toy Commodities  - withdrawn by 
United States  (New) . 
b. Norway – The Regulation on L imitation in Use of Hazardous Chemicals  - withdrawn by 
the Republic of Korea  (New) . 
c. United States - Prohibition of Children 's Toys and Child Care Articles Containing Specified 
Phthalates  - withdrawn by China  (New) . 
d. Ecuador - Draft Technical Regulation of the Ecuadorian S tandardization Institute (RTE 
INEN) No.47: Metal Cable Tray, electrical conduit and trunking systems - withdrawn by 
Mexico  (New) . 
e. European Union – Alternatives to A nimal and New Cosmetic Regulations  – withdrawn by 
Canada  (Previously raised) . 
3.2.2   New Concerns  
3.2.2.1   European Union - Proposed modification of Regulation (EC) 1829/2003 referring 
to genetically modified organisms , G/TBT/N/EU/284  
3.3.  The representative of Argentina  said that, prior to this meeting his delegation had requested 
the European Union to notify this pr oposed regulation to the SPS  Committee, as the issue fell 
under the SPS Agreement. The proposed measure was however notified instead to the 
TBT Committee. He said that Argentina was seriously concerned over this new proposed 
regulation, which intended to a mend the current system for the authorization of GMOs, established 
in Regulation (EC) No.  1829/2003, with a view to allowing  EU member states to restrict or prohibit 
the use of GMOs and genetically modified food  and feed in all, or only in parts, of their territory, 
although such use had been authorized by the  European Commission. He recalled that EU member 
states already had the possibility to prohibit and restrict, at national level, the marketing and 
importation of biotech products, provided that they pr oduced scientific evidence that such products 
could pose a risk to health or the environment. However, the new proposal gave EU 
member  states broad scope for discretion, which was inconsistent with the WTO rules, as they 
would now be able to unilaterally r eject the authorizations approved by the European Commission 
under the current system, without having to provide any scientific proof. This would be a disguised 
discriminatory, arbitrary and unjustified restriction on international trade.  
3.4.  He said that acc ording to the text of the proposed regulation, the prohibitions or restrictions 
applied by EU member states should be based on factors other than those identified in the risk 
assessment by the European Food Safety Authority (EFSA) for the authorization of GMOs, i.e., 
factors other  than the risk to human and animal health, or to the environment. Argentina recalled 
that in the past, t he EU and its member states had  tried unsuccessfully to justify their restrictions 
on the use of GMOs using science -based argum ents, which was why the issue was brought before 
a WTO Panel in 2003 ( EC — Approval and Marketing of Biotech Products ). This Panel found in 2006 
that these restrictions were inconsistent with the SPS  Agreement. In order to avoid further 
contentions being r aised in the WTO and additional adverse rulings, the  European Commission 
appeared to be seeking, through the new proposed amendment to Regulation  (EC) No. 1829/2003, 
alternative means of evading its international obligations under the SPS Agreement in this  regard. 
Argentina believed that the measures under the proposed regulation that would enable EU G/TBT/M/66  
 
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  member states to restrict or prohibit GMOs were similarly incompatible with the WTO rules. This 
was so because this proposal  would create unnecessary obstacles  to international trade and would 
lack proportionality in restricting trade more than what would be necessary to fulfil the objectives 
sought by the EU member states.  
3.5.  Argentina considered that if the proposal would be adopted, it would create a high level of 
unpredictability in international commodity markets by unjustifiably impacting not only producers 
in the EU, but also those in third countries. This proposed measure would also affect the integrity 
of the EU's single internal market and free transit wit hin the EU. Although this could be attributed 
to a competition decision by the EU institutions, it would also adversely affect, either directly or 
indirectly, Argentina's exports to the EU. Argentina therefore requested the EU not to adopt the 
notified pro posal and instead, to implement, in a timely and proper manner, the current EU 
legislation on the approval and authorization of the use of GMOs throughout the territory of the 
EU, thus bringing its regulations into line with the  WTO rules.  
3.6.  The representati ve of Paraguay  said that that this proposal would give EU member states the 
power to prohibit the use of genetically modified (GM) food and feed after these products have 
been authorized by the European  Commission, including for those that had already been  on the 
market. Many of these products, he said, had  been used for a number of years in the European 
Union without any reports of negative effects to human or animal health or the environment. 
Under the new proposal, EU member states would not be allowed t o use justifications linked to the 
assessment of risks to health or the environment, which have already been comprehensively 
addressed in the Commission's authorization decision, based on studies conducted by the 
European Food Safety  Authority (EFSA), and by the EU procedures already available. The new 
proposed rules would mean, therefore, that the requirement that the measures applied by 
Members be based on scientific evidence in accordance with the SPS  and TBT Agreements would 
not be met.  
3.7.  He noted that t he EU was the main destination market for Paraguay's agricultural exports, 
receiving more that 32% of the Paraguayan soya exported worldwide. The entry into force of this 
EU proposal would therefore unjustifiably restrict trade, as there was no technical o r scientific 
basis to prohibit the use of such soya. It would also weaken the provisions established by EU's own 
food safety authority and, at the same time, undermine legal predictability in trade. The delegation 
of Paraguay requested the EU to reconsider  the amendment of the existing Regulation and 
suggested that a similar notification be made to the SPS Committee.  
3.8.  The representative of the United States  said that her delegation was still not convinced by 
the EU's rationale for notifying this measure to t he TBT Committee. For the US, given that the 
proposed regulation amended an SPS measure (Regulation (EC) No1829/2003) , it should have 
been notified to the SPS  Committee pursuant to Article 7 of the SPS Agreement. The US therefore 
asked the EU to make such notification to that Committee. In this respect, she recalled that the 
preamble to the amended Regulation specifically stated that its objective was to protect human 
and animal health, and that this measure was the subject of a WTO dispute regarding its 
consistency with the SPS Agreement.  
3.9.  She further observed that this proposed measure would amend the original SPS regulation so 
as to allow EU member states to implement bans on non -scientific grounds precisely because both 
the EU and its member states  have repeatedly failed to justify such actions with science -based risk 
assessments. In this respect, she recalled that the 2006 WTO Panel Report in EC — Approval and 
Marketing of Biotech Products  found nine EU member state bans to be in violation of Articles 5. 1 
and 2.2 as well as Article 5.7 of the SPS Agreement. It was therefore clear to her delegation that 
allowing EU member states to take a "case by case approach" to justifying bans and restrictions 
was not sufficient to circumvent the grounding in scientifi c principles and adequate risk 
assessments required by the SPS Agreement. She also noted that several members of the 
European Parliament have stated that this proposal appeared to raise serious concerns under WTO 
rules.  
3.10.   The representative of Canada  questio ned whether allowing EU  member  states to ban the 
use of GM events that have been deemed safe by the European Food Safety  Authority (EFSA) for 
consumers, livestock and the environment by a vigorous risk assessment, and approved by the 
European Commission, w as compatible with the EU's international trade obligations, especially 
those under the SPS and TBT Agreements. Furthermore, the proposal appeared to pose a G/TBT/M/66  
 
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  challenge to the concept of the EU single market and could potentially result in a patchwork of 
conflicting regulations across the EU. This measure, if implemented by one or more EU 
member  states, would have the potential to cause serious trade disruptions for the EU's 
international trading partners and would introduce further uncertainty with respect t o exports of 
GM crops to the EU. Furthermore, the use of terms and definitions, such as "use", lacked clarity 
and would result in further uncertainty for exporters.  
3.11.   The representatives of Brazil  and Chile said  that their respective delegations shared the 
concerns raised by other Members and requested the EU to also notify the proposed measure to 
the SPS Committee.  
3.12.   The representative of the European Union  explained that the proposed measure would 
amend the EU legislation on GM food and feed so as to provide  a legal basis for EU member states, 
if they so wished, to take a decision on the use of these products on their territory, subject to 
certain conditions. This proposal was not a renationalisation of the decision to authorise GMOs. GM 
food and feed would s till remain to be assessed by EFSA in accordance with harmonised 
science -based criteria, and they would also continue to be authorised at EU level, following an EU 
decision of authorisation. As such, the proposal would not introduce any restriction or ban.  It 
would  only provide the possibility for EU member states, if they so wished, to opt out from the EU 
decision of authorisation based on overriding reasons of public interest distinct from the 
assessment of risks to health or the environment. She explaine d that strict substantial conditions 
were provided for in the proposal to ensure compatibility with EU law and international obligations, 
i.e., measures adopted by EU member states shall be based on compelling grounds, could not be 
discriminatory and neede d to be proportionate. The mobility of GM food and feed was thus 
preserved under the proposal as EU member states could not restrict or ban the ir free circulation 
and import but only their use. Further, EU member states would not be allowed to restrict or ban 
the use of food and feed in case GMOs were present at trace level, or restrict or ban the use of 
products fed with GMOs.  
3.13.   She also explained the reason behind the EU's determination that neither the proposal, nor 
the national measures that could be tak en on the basis of the proposal, were SPS measures as 
defined in Annex  A of the SPS agreement. They were not such measures, she explained, because 
they did not relate to the protection of the life and health of human and animals. In this respect, 
she noted  that the reason why the proposal did not allow EU member States to use compelling 
grounds which related to the assessment of risks to health and to the environment, was precisely 
not to interfere with the EU risk assessment. However, for transparency reas ons, the EU drew 
Committee Members' attention both to the fact that this proposal existed and to the fact that it has 
been notified under the TBT Agreement. She indicated that the final date to submit comments was 
90 days, counted from 20 May 2015.  
3.2.2.2   Russian  Federation – Measure affecting import of Ukrainian food salt  
3.14.   The representative of Ukraine  voiced her delegation's concern regarding a ban of the 
Russian Federation on imports of food salt produced by Ukrainian State Enterprise Artyomsol . She 
said that th e ban was imposed on 26 January 2015 by Russia's Federal Service on Customers' 
Rights Protection and Human Well -being Surveillance ( Rospotrebnadzor ) under the pretext of 
violation of legislation in the sphere of sanitary and epidemiological safety. The ann ounced ground 
for prohibition was an alleged incompliance with the requirements for organoleptic indicators. She 
said that this measure was introduced suddenly and in a non -transparent manner and that, except 
for a short notice on the website of Rospotrebn adzor , there was no other information officially 
provided to Ukrainian Authorities. Russia did not provide any official results of examinations or 
tests, revealing any problem of inconsistency of the Ukrainian products.  
3.15.   She also noted that the Ukrainian pr oducer in question effectively applied a management 
system for quality and safety that was in accordance with the requirements under ISO standard 
9001:2008 and the quality of the product has been certified by both Ukrainian and Russian 
authorised bodies. T he food salt of the mentioned Ukrainian producer has been exported to Russia 
for many years. During recent  years, export of the salt products to Russia reached 55% of the 
company's production, more than half of which was food salt. Ukraine believed that th e Russian 
measure was thus not justified and was applied in a non -transparent and unpredictable manner, 
with a view of creating unnecessary obstacles to trade. As such, this measure was inconsistent 
with provisions of the Articles 2.1, 2.2 and 5.1 of the T BT Agreement. Ukraine asked Russia to G/TBT/M/66  
 
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  immediately lift this trade ban and bring the measure in line with the TBT Agreement as well as 
the commitments Russia has undertaken under its WTO accession.  
3.16.   The representative of the Russian Federation  said that the temporary suspension of imports 
of food salt produced by Ukrainian enterprise Artyomsol  was introduced due to the violation of the 
requirements of consumer protection technical regulations of the Eurasian Economic Union. In 
2014, the Russian competent auth ority – Rospotrebnadzor  - detected incompliances in food salt 
produced by Artyomsol . The products labels contained false information and the products 
themselves were not in compliance with the corresponding requirements for purity and iodine 
content. The l abel of salt indicated that it was iodized salt with 0.04 mg/g of iodine content 
according to the technical regulation of the Customs Union "on the labelling of food products" . 
However, laboratory tests had  indicated  a lower  amount of iodine in the salt pr oduced by this 
Ukrainian producer. Due to this fact, the surveillance at the State Boarder check -points and in 
retail network was enforced. As of the end of 2014 and early in 2015, there were large -scale 
detections of such products in the internal market t hat appeared to be deceptive practice in trade. 
The results of the tests confirmed incompliance with the existing requirements. Due to such 
incompliance, on 26 January 2015 Russia introduced a temporary import suspension of the 
mentioned products into its territory. The measures were imposed with the aim of protecting 
Russian consumers' right for reliable information on the products, and to prevent deceptive 
practices in trade, and to maintain, at the appropriate level of protection, the safety and life and  
health of population in full compliance with Article 2.2 of the TBT Agreement. She stressed that the 
suspension of import s was a temporary measure covering only one Ukrainian enterprise. It was 
not therefore a full -fledged import ban of all Ukrainian food  salt products. Nevertheless, since the 
implementation of measure, Ukrainian competent authorities had not taken any steps  to establish 
contacts with its Russian counterparts to resolve this issue. In order to resume the supplies of the 
products from this Ukraine enterprise to Russia, Ukraine should take steps to start such necessary 
communication at the bilateral level.  
3.2.2.3   China - Registration Fees for Drugs and Medical Device Products  
3.17.   The representative of Canada  expressed  his delegation's concern that this measure was 
published on, and was in  force since, 27 May 2015, without being first notified to the WTO. 
Members did not have therefore any "reasonable interval" between publication and entry into 
force, as required by Article 5.9 of TBT Agreement. Also of concern to Canada was the fact that 
China was not providing domestic registration fees for Class II medical devices. And also the fact 
that China was not providing for national treatment to Class III medical device manufacturers by 
charging imported medica l devices a first registration fee that was more than double the domestic 
registration fee. Based on the document released, Canada also believed that China failed to 
provide national treatment to drug manufacturers, with imported drug registration fees bei ng, in 
most cases, double what domestic drug manufacturers were charged. As a result, China was 
neglecting its responsibilities under Article III:2 of the GATT 1994 as well as Article 2.1 of the 
TBT Agreement by failing to provide the same treatment to imp orted drugs and medical device 
products as their domestically -made equivalents. Specifically, China was charging new, imported 
drugs a first -time registration fee of approximately 376,000  RMB for the clinical trial, and 
593,900  RMB for the production listi ng, compared to the 192,000  RMB and 432,000  RMB charged 
to domestic drug producers, respectively. For registering generic drugs with the CFDA, China 
charged approximately 367,600  RMB for imported product listings that did not require a clinical 
trial, comp ared to approximately 184,000  RMB for domestic equivalents. For generic drugs that 
required a clinical trial, China charged 502,000  RMB for imported drugs, compared to the 
318,000  RMB fee for domestic drug producers. In terms of medical devices, the first registration 
fee for Class III imported medical device products was approximately 308,800  RMB, whereas 
domestically made medical device products were only charged approximately 154,000  RMB. 
Canada asked China to explain why it was using two separate fee st ructures for domestic and 
imported drugs and medical devices?  
3.18.   He also said that Canada has recently learned about the accelerated service being offered 
by the CFDA to fast -track applications for drugs and medical devices. Canada asked China to 
confirm whe ther domestic and foreign firms would be charged the same fast -track fee. 
Additionally, it appeared that certain innovative imported products would not need to pay 
registration fees to the CFDA. It was Canada's understanding that the "innovative" definitio n was 
based on China's "Green Channel" framework, which has only accepted one imported product as 
innovative in over a year. Canada asked China to provide clear guidelines as to how it planned to G/TBT/M/66  
 
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  determine whether a product was innovative or not. Would the  same definition of "innovative" be 
applied to domestic and foreign products alike?  
3.19.   The representative of the United States  associated herself with Canada's concerns with the 
lack of notification and nature of the fee structure. She said that this final r egulation implemented 
a new fee system for the "evaluation and on -site investigation" for Class II and Class III medical 
devices. The new scheme was effective immediately, without consultation. Manufacturers of 
Class III medical devices were now required t o pay fees that were approximately twice as high as 
Chinese producers for the initial registration. China delegated the authority for all Class II 
registration fees to their provincial governments. The new fee system was broad and affected over 
50% of all medical device categories. The US asked China the following questions: (i)  why had it 
delegated registration and the collection of fees for Class II devices to provincial governments? 
(ii) what would be the criteria used by provincial governments when dete rmining user fees? 
(iii) why registration fees could be twenty times more costly for foreign manufacturers than 
domestic manufacturers and disproportionate to the conformity assessment procedures provided? 
She also said that the U.S. Food and Drug Administ ration (FDA) did not have user fees to perform 
any on -site medical device inspections. The FDA did use fees to recover costs associated with 
evaluations and on -site inspections for generic drug applications under the Generic Drug User Fee 
Amendments (GDUFA ) program, but the U.S. system for calculating user fees was transparent, 
and GDUFA fees were negotiated with industry in advance of becoming final.  
3.20.   The US also requested China to notify this regulation to the TBT Committee, so Members 
would be able to re view and comment on the fee structure for inspection and how it was justified. 
The US further requested China to suspend levying of registration fees until the scheme was 
notified with at least a 60 -day comment period and a reasonable interval for implemen tation. The 
US acknowledged that on -site inspections were necessary to promote public health and to ensure 
that products were safe and effective. The US also agreed that foreign inspections were more 
expensive. However, the US requested that the fees assoc iated with foreign inspections should 
also be transparent, non -discriminatory, and reflect input and concerns from the regulated 
industry.  
3.21.   The representative of Republic of Korea  said that his delegation was of the view that new 
licence application fees di scriminated between national and foreign medical device manufactures. 
Although Korea understood that on -site audit for medical device originating in a foreign country 
required additional cost (for example, related to hotel accommodation fees), China's on -site audit 
fee was more than double compared to those applicable to domestic medical devices. As a matter 
of fact, on -site audit was not compulsory according to Article  13 of the supervision and 
administration of medical devices. It was stipulated that on -site audit could be performed as 
quality inspection on imported medical devices, only if necessary.  Korea therefore requested China 
authority to separate the cost for on -site inspection from th e registration fees, which was the  
general practice performed by  many Members, including Korea.  
3.22.   The representative of China  said that before the measure at issue was published, for a long 
time China did not charge any fees for the registration of medical devices. She said that charging 
registration fees on drugs and me dical devices was a global norm and, in any case, these new 
Chinese fees were far lower than the international level. China understood that the long interval 
between the new fee system and the old system (whereby no fees were charged) might have 
caused som e Members to feel the fees have increased. With regard to different registration fee 
structures for domestic and foreign drug and medical devices, she clarified that the gap only 
related to the different costs needed for on -site inspection. Between domesti c and foreign 
products, the costs arising from communication, transportation, accommodation and others 
relating to on -site inspectors could differ greatly. In this respect, she noted that Article 5.2.5 of the 
TBT Agreement required that any conformity asse ssment fees on foreign products should be 
"equitable in relation to any fees chargeable for assessing the conformity of like products of 
national origin or originating in any other country, taking into account communications, 
transportation and other costs  arising from differences between location of facilities of the 
applicant and the conformity assessment body." Additionally, it was international common practice 
to charge differently on domestic and foreign products for on -site inspection. For example, 
according to the Prescription Drug Use Fee Act (PDUFA), the US FDA required foreign companies to 
pay USD  15,000 more than domestic ones.  G/TBT/M/66  
 
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  3.23.   Regarding transparency, she said that, according to Article 5.6 of the TBT Agreement, 
Members should notify WTO "whenever  a relevant guide or recommendation issued by an 
international standardizing body does not exist or the technical content of a proposed conformity 
assessment procedure is not in accordance with relevant guides and recommendations issued by 
international st andardizing bodies." However, in this case, the fee system did not belong to the 
"technical content" of a conformity assessment procedure, so China had no obligation to notify it. 
In fact, China did not find any notifications to the WTO by other Members of  similar fee structures.  
3.2.2.4   Chinese Taipei - GMO Labelling  
3.24.   The representative of Canada  said that while his delegation recognised and supported 
Chinese Taipei's right to implement regulations that provided consumers with adequate 
information to make informed choices, Canada also believed this objective could be satisfied 
through less trade restrictive voluntary measures. More specifically, Canada was concerned that 
mandatory labelling could mislead consumers by not providing them with straightforward 
meaningfu l information. Mandatory labelling should be reserved for legitimate health concerns and 
was not an appropriate tool to address concerns about food quality and fraud. The scientific 
consensus was that GM  products that have been safety assessed and approved  were safe for 
human consumption and therefore should not require additional labelling. More restrictive 
measures may be counterproductive to Chinese Taipei's efforts to modernise its food regulations 
and inadvertently create food safety concerns where the re were none. The recent trend for TFDA 
to pre -empt potential political or public reaction through trade restricting regulations was troubling 
to Canada.  
3.25.   The representative of the United States  said that her delegation shared Canada's concerns 
as this meas ure would significantly disrupt the US exports of agricultural products to 
Chinese  Taipei. The US was particularly concerned with the fact that the regulation would lower 
the labelling threshold to 0.9% from 5.0% and, at the same time, expand the scope of the label to 
include all processed food products regardless of the presence of foreign DNA or protein. The US 
also expressed concern with the fact that this measure entered  into force on 1 June 2015 instead 
of 1 January 2016, which was the initial date ann ounced for implementation. Such immediate 
implementation did not allow time for manufactures to modify their labels.  
3.26.   She also noted that the US exported processed foods to Chinese Taipei, including alcoholic 
beverages, amounting to approximately USD  659 million in 2014. US exports of genetically 
engineered (GE) products, and/or products derived from GE  plants, amounted to an estimated 
USD 2 billion in 2014. These amendments imposed significant burden on producers, exporters and 
importers of food containing  GE ingredients. Increased cost for food  to Chinese Taipei consumers 
could  cause companies to exit the market. The US therefore requested Chinese Taipei to return to 
its former labelling regulation of a 5.0% threshold for labelling of food where introduced  DNA or 
protein may be present. The former regulation worked well in addressing consumers' needs. On 
the other hand, the more stringent threshold for labelling and the immediate implementation date 
created an obstacle to trade for a wide variety of food pr oducts - from bulk commodities such as 
corn and soya bean to processed foods products  - and would have a negative impact on domestic 
food processing industries. Since the presence of authorised GE ingredients in food products did 
not pose a human health ri sk in comparison with the conventional foods on a categorical basis, 
there was no scientific evidence for these amendments and hence they would raise unjustified food 
safety concerns among the public.  
3.27.   The representative of New Zealand  said that her delegat ion considered that the labelling 
requirement promulgated through the regulations could be confusing to consumers and could 
therefore result in unjustified concerns. When applied to food that was highly refined and where 
processing removes all transgenic D NA and transgenic protein, the labelling requirements could 
raise unnecessary consumer concerns and potentially desensitize them to labels regarding GMOs. 
Consumers may not readily appreciate the difference between food derived GMO that no longer 
contained  transgenic DNA or transgenic protein, on the one hand, and food that did not contain 
these proteins, on the other hand.  
3.28.   The representative of Chinese Taipei  explained that on 24 December 2014 the Ministry of 
Health and Welfare was granted the authority to modify the regulations. This was promulgated on 
22 December 2014, including with respect to highly refined foods, which now should be labelled to 
protect the consumers' rights. According to that motion, the Ministry announced three regulations G/TBT/M/66  
 
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  which were:  (i) a draft amendment on labelling requirements for pre -packaged foods containing 
ingredients of genetically modified organisms (GMOs); (ii)  a draft amendment on labelling 
requirements for food additives containing ingredients of GMOs; and (iii)  a draft a mendment on 
labelling requirements for unpackaged food containing ingredients of GMOs. As from 26 February 
2015, for food that used GMOs during manufacturing processes although the final product did not 
contain transgenic DNA fragments or transgenic protei n, the new rules require that these products 
should display either of the following statements: (i) " this product is made of GMOs, but this 
product does not contain any transgenic DNA fragments or transgenic proteins "; or (ii)  "this 
product's raw materials  contain GMOs, but this product does not contain any transgenic DNA 
fragments or transgenic proteins ". The authority had  already held technical expert meetings to 
discuss labelling of highly refined foods with no transgenic DNA fragments or transgenic prot eins. 
Based on the conclusions reached after such meetings, on 29 May 2015 the authority announced 
the three regulations described above. These regulations would be notified  to the WTO very 
shortly. For foods that used GMOs directly during manufacturing pr ocess although the final product 
did not contain transgenic DNA fragments or transgenic proteins, one of the following  pieces of  
information was required to be labelled on the product: (i) " genetically modified , with genetic 
modification or used geneticall y modified organisms [the name of a particular organism] "; or 
(ii) "this product is made of genetically modified organism [name of a particular organism], but do 
not contain any transgenic DNA fragment or transgenic proteins " or " this product's raw materia ls 
contain genetically modified organisms [name of particular organism], but do not contain any 
transgenic DNA fragment or transgenic proteins ", or (iii)"this product do not contain any 
transgenic DNA fragments or transgenic proteins but it is made of gene tically modified organisms 
[the name of a particular organism] ", or "this product does not contain any transgenic DNA 
fragments or transgenic protein but with genetically modified organisms [the name of a particular 
organism] ". 
3.2.2.5   Chinese Taipei - Additional labelling standard of prefecture of origin for foods 
from Japan  
3.29.   The representative of Japan  expressed his delegation's concerns with Chinese Taipei's 
import restrictions on Japanese foods for radionuclides. He noted that Chinese Taipei had recently 
strengt hened its import restrictions, such as requiring certification of testing results of 
radionuclides and certification of prefectures of origin. In addition, in the TBT area, Chinese 
Taipei's Food and Drug Administration (TFDA) issued its public announcement , dated 15 April 
2015, requesting that the foods originating in Japan should, inter alia, indicate their prefectures' 
name of origin by a product label and sticker, and also a notice at stores and restaurants. He 
noted that these requirements were only imp osed on Japanese products. Japan considered that 
this TDFA requirement to indicate the prefectures' name of origin on each product would fall under 
the scope of TBT Agreement. Japan asked Chinese Taipei to clarify whether this requirement was 
mandatory or voluntary. He said that Japan's concerns with these measure stemmed more 
precisely from the following two reasons: (i) the fact that this measure may give consumers in 
Chinese Taipei the negative impression that Japanese foods were less safe than those fro m other 
countries; and (ii)  the fact that this measure may cause negative effects on the trade of Japanese 
foods by putting additional burden, such as additional cost or record keeping, imposed on 
distributers, retailers and restaurants. He also said that Chinese Taipei and Japan were closely 
engaged in bilateral consultations with a view to f inding a mutually acceptable solution to this 
matte r as Chinese Taipei was one  of Japan's most important trade partners.   
3.30.   The representative of Chinese Taipei  said tha t food products produced in certain areas in 
Japan were still subject to certain import management regulations. The purpose of the 
requirement for the attested documents was to validate the area of produc tion. There were s everal 
false declarations of origi n and forgery of labels recently happened in Chinese Taipei and because 
of these violations Chinese Taipei  had no choice but to implement the requirement to inspect the 
declaration of the origin of food products from Japan. Concerning the  measure announced  on 16 
April 2015, he responded to Japan  that this measure was voluntary in nature.  
3.2.2.6   Sweden - Chemical Taxation for Certain Electronics  
3.31.   The representative of the Republic of Korea  thanked the European Union for, but was still 
not convinced by, the explanati on the EU gave Korea bilaterally that the measure at issue – a 
Swedish tax scheme on chemicals enforced on certain electronics using flame retardants – was not 
a TBT  measure. Korea's understanding was that this measure imposed specific taxes on certain G/TBT/M/66  
 
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  electronic products using brome, phosphorus, chlorine additive flame retardants as well as 
brominated and chlorinated reactive flame retardants. However, in situations where there would 
not be appropriate substitutes for these chemicals this regulation would lead to significant barriers 
to international trade. Korea believed that Sweden  should have therefore notified and published 
this regulation in accordance with TBT transparency rules, especially those under Articles 2.9.1 
and 2.11. Korea also noted that un der Annex 1 of the EU's Low Voltage Directive, electronic and 
electric products must be designed to protect human, animals and property. In achieving this 
objective, flame retardants had  normally been used in the process of manufacturing of products to 
ensure safety in case of fire. Thus, the imposition of taxes on brome, phosphorus and chlorine, 
which were the basic elements of flame retardants, could be a serious obstacle in achieving the 
safety of these products. Korea therefore asked Sweden  to take into  account these points when 
implementing the measure at issue.  
3.32.   Korea further recalled that Section 3 of 15.1 in the regulation – titled "Proposed Rule of Tax 
on Certain Electronics"  – specified 13 products subject to the taxation scheme. However, it was 
very difficult to comply with the regulation due to the ambiguous scope of the regulated flame 
retardants. Korea asked Sweden  to provide a detailed list of all regulated substances, including 
CAS registration numbers. Korea also noted that under 3.2.6 – titled "Differentiation through Tax 
Deduction"  – products not containing brome, phosphorus or chlorine additive flame retardants 
would be provided a 50%  tax deduction. The measure also provided that products that did not 
contain brome, phosphorus and chlorine additive flame retardants, or brome, chlorine reactive 
flame retardants, would be eli gible for a 75% tax deduction. As it was very difficult to figure out 
which substances fell under one of these categories, Korea requested Sweden to provide the 
substance list and detailed guideline for tax deduction eligibility.  
3.33.   Finally, Korea submitted that, although it was well known that phosphorus flame retardant 
was a substitute for brome and chlorine flame retardants developed as part of halogen -free 
movement of the  flame retardant industry, it seemed unreasonable and controversial that 
phosphorus flame retardant itself was regulated under this Swedish regulation. Considering that 
phosphorus flame retardants were relatively less harmful to human and environment, Kore a 
requested Sweden  to reconsider the inclusion of this particular substance as among those 
regulated by the measure.  
3.34.   The representative of the European Union  informed the Committee that the Swedish 
Government was currently conducting consultations on this  matter, which might be subject to 
future legislation and that, at this stage, only a so-called "inquiry report" had  been finalised. He 
also said that Swed en was currently examining this "inquiry report" in order to decide whether to 
draft legislation in t his field. He explained that this report proposed two new excise duty regimes: 
an excise duty on certain electronic products and an excise duty on PVC floor, wall and ceiling 
coverings. Therefore, the possible future legislation did not seem to fall under the definition of 
technical regulation and/or conformity assessment procedure as defined in the TBT Agreement and 
it was therefore not necessary to notify it to the TBT Committee . 
3.2.2.7   Brazil - Draft Ordinance Act Nº. 374, 27 November 2014 (Portaria SDA/MAPA 
374/2014) Establishes quality requirements for wine and derivatives of grape and wine , 
G/TBT/N/BRA/613  
3.35.   The representative of the European Union  noted that some provisions of this draft measure 
differed from the recommendations of the International Organisati on of Vine and Wine (OIV), of 
which Brazil was a Member. Some of these differences would oblige EU wine producers to modify 
their labels and therefore entail higher production costs. In particular, the draft measure departed 
from the relevant OIV recommend ations as wel l as Codex  standards with regard to a minimum 
content for indicating on the label the grape variety of lower share  (this minimum content was 
15% under the relevant OIV Recommendation while under the draft Brazilian measure it was 
established a t 25% ), and also with regard to a requirement to classify wine according to colour. In 
this respect, the EU recalled that Article 2.4 of the TBT Agreement called for use of international 
standards and asked Brazil to indicate the reasons for these divergin g requirements.  
3.36.   The EU was also concerned with the draft measure's provisions on sugar content of these 
products, for which OIV Recommendations also existed. She noted that the draft measure, 
together with an earlier decision of February 2014 (" Decreto No . 8.198 "), was not in line with 
these OIV Recommendations, and was now creating problems at import point, in particular for G/TBT/M/66  
 
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  sparkling wines. The EU asked Brazil to clarify to what extent the draft measure would apply to 
wines imported from the EU, consider ing their "tipicity" (Article 52 of the Decreto No.  8.198 ). The 
EU said that it would welcome an interpretation of the draft measure in conjunction with the text 
of Decreto No.  8.198  so as to clarify applicable rules.  
3.37.   The EU further asked Brazil to provide  clarification with respect to the analytical parameters 
diverging from the OIV Recommendations, including on ashes and alcohol content. The EU was 
also concerned with the fact that the use of caramel would be only allowed in liquor wines, and not 
in other  wine-derived distillates. Additionally, the EU was concerned with: (i)  the prohibition of the 
terms "dry" or "reserve" on the label of grape and wine derivatives; (ii)  the high levels of alcohol 
and wine content in sangria; (iii)  the misleading use of the  term " moscato ", as well as the 
evocations of certain names protected in the EU, such as " conhaque ", "grappa " and " champanha ". 
3.38.   The representative of Brazil  said that up until 27 January 2015, a 60 -day public consultation 
period was held on the proposed mea sure. A number of comments and suggestions were made, 
both from various governments and the private sector, including from the EU. All comments were 
consolidated and were currently under appreciation of the relevant authorities. He also informed 
that the B razilian Ministry of Agriculture would hold a public hearing on this subject and interested 
parties that have contributed to the public consultation would be able to attend. The date of this 
public hearing would be communicated in due course. Finally, sinc e this TBT  notification referred to 
a proposed measure subject to public consultations, consequently the measure under discussion 
had not produced any affects  whatsoever in the trade of wine and derivatives of grape and wine.  
3.2.2.8   France – Ban on BPA in toys  
3.39.   The representative of the United States  said that, while her delegation recognised that this 
issue was still an ongoing legislative process, the US would nonetheless like to raise some concern 
with an amendment to France's Health Framework Law (No.  2302). Th is amendment, which was 
currently under discussion in the French Senate, would impose a complete ban on the presence of 
bisphenol -A ("BPA") in toys. She asked if France has assessed the legal compatibility of the ban in 
toys with the European Toy Safety Di rective and the Treaty for the Functioning of the EU. Given 
the functioning of the internal market, the US was of the view that this measure could cause 
significant trade disruptions. The US asked the EU to explain whether France intended to notify the 
implementing measures to the WTO if the ban were to be  adopted. The US also asked whether 
France had  undertaken a trade impact assessment and, i f so, whether a copy of what had  been 
considered could be provided.  
3.40.   The representative of the European Union  inform ed the Committee that the French 
Parliament was currently examining a draft Law on the Modernisation of the French Health System. 
In this context, the possibility of introducing a ban on BPA in toys was being discussed. However, 
the legislative process was  still ongoing and there was no stable text yet. Specifically, following the 
first reading of the proposal adopted by the National Assembly ( Assemblée Nationale ) on 14 April 
2015, the text would now have to be examined by the Senate. The EU therefore consi dered any 
discussion on this matter in the TBT Committee to be premature at this stage . 
3.2.2.9   Indonesia - MOI 69/2014 Article 3: LCR Requirements for LTE Devices - 
Requirement that Domestic Component Level (TKDN) of LTE TDD & FDD broadband 
services equipment  
3.41.   The representative of the United States  was concerned that an Indonesian  revised draft 
regulation – Technical Requirements of Telecommunication Devices and Set Based on Long -Term 
Evolution Technology Standard (KOMINFO) – which established technical specificat ions for 4G LTE 
products , including certification, conformity assessment and mandatory local content 
requirements, might create unnecessary obstacles to trade. Although US stakeholders were 
included in domestic public consultations, the US expressed concer n that the draft regulation had 
not been notified to the TBT Committee.  It appeared that the regulation would come into effect 
prior to the finalization of the  revision of its counterpart regulation – Ministry of Industry  
Regulation (MOI) 69/2014  – on the method  of calculating local content. Given that the ability of 
companies to comply with the KOMINFO draft measure depended on the MOI revision, the 
issuance of the draft before the MOI' s revision was completed  would create confusion.  The US was 
also concer ned that the KOMINFO draft would come into effect the day the regulation was G/TBT/M/66  
 
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  promulgated and leave companies no time to adjust to the new requirements. The KOMINFO draft 
required compliance with the European Telecommunications Standards Institute (ETSI) 3G PP TS 
36.104  (version 11.7.0 , release  11). Accredited and approved facilities had to test compliance with 
the ETSI standard. It was unclear to the US whether there were additional testing requirements 
that would have applied to devices and how those testin g requirements related to previously 
established testing requirements for cell phones. The US also requested further information on the 
testing and certification requirements contained in the two appendices to the draft regulation, and 
how those requiremen ts related to two other previously established regulations. The US thus urged 
Indonesia to delay adoption of the KOMINFO draft until  its notification to the TBT Committee and 
furthe r consultation could take place. The US also asked Indonesia  to indicate wh en the regulation 
would be finalized and to consider a workable timeframe.  
3.42.   The representative of Canada  shared the US' con cerns with respect to Indonesia' s intention 
to introduce local content requirements for smartphones using 4G/LTE technology as it coul d pose 
a significant barrier to trade. Canada asked for clarification on whether the new local content 
requirements were going to be notified to the WTO and what process they would follow so as to 
take Members' concerns into account (Article 2.9.2 of the T BT Agreement). In addition, Canada 
asked Indonesia to provide a justification for its approach and the objectives of the local content 
requirements. Canada  also inquired whether Indonesia had considered a less trade restrictiv e 
means for accomplishing the measure's  objectives. Like the US, Canada also request ed that 
Indonesia provide Members with an indication of when the regulations mig ht be finalized and to 
delay their  adoption or entry in to force until such time as consultations had taken place.  
3.43.   The repr esentative s of Japan  and Australia  associated themselves  with the US and Canada's 
concerns, in particular those related to transparency.  
3.44.   The representative of the European Union  associated him self with the concerns of previous 
delegations , in particular th eir request that the draft regulations be notified to TBT Committee  and 
that their implementation be postponed until such notifications have been carried out and other 
WTO M embers and their stakeholders had the opportunity to analyze and comment on them. T he 
EU referred to the requirement of the draft regulations that testing had to be carried out in 
Indonesia by laboratories accredited and approved by the Indonesian Administration. In order to 
avoid an unnecessary repetition of tests, the EU invited Indone sia to accept the results of tests 
carried out outside Indonesia in properly accredited laboratories , considering the global nature of 
mobile communication equipment markets and the availability of global agreements for 
accreditation of laboratories. Final ly, as the draft regulation required compliance with a specific 
standard , the EU invited Indonesia to consider ways to update the references to that standard in a 
manner that kept pace with the fast technological evolution in the sector. Thus, rather than 
making a reference to a dated version of a standard, it could have referred to the most recent 
available version to reflect the latest technological innovations.  
3.45.   The representative of Indonesia  explained that enhancing Indonesia's participation in the 
global value chain required strengthening the local industry in that sector. They were formulating 
the ministerial decree as they sought to ensure certainty in that sector and to increase confidence 
among stakeholders. They undertook the process through colla borating with the private sector and 
fostering the participation of international players by means of a transparent public consultation 
process. Indonesia assured the Committee that the draft would take into account all inputs and 
concerns from every stake holder and would be in line with international rules and standards as 
well as WTO provisions. As to the question of whether Indonesia  intended to notify the measures 
to the WTO, the representative said that he took note of this question but was unable to a nswer it 
at this juncture.  
3.2.2.10   Turkey - Toy Communique 01/2015  
3.46.   The representative from the United States  said that toy inspection  measure required that 
every import shipment of toys be detained in order for three or  four representative samples be 
taken from e ach "stock keeping unit " (SKU) in the shipment that had to be sent to a laboratory for 
phthalates and flame retardant t esting. Turkey also tested for azo  dyes in plastic toys , even 
though they were not found in plastics. Typically, a toy shipment contained  numerous SKUs. In 
addition , importers would have  to certify that the subject imports conformed to Tu rkey's toy safety 
regulations. Customs then would issue  a registration number valid only for that shipment and 
would also have to be presented to customs a t the port with a US $38 processing fee (100 G/TBT/M/66  
 
- 12 - 
 
  Turkish Liras). Moreover , the "CE marking " was already required for conformity assessment 
procedures according to the EU Toy Safety Directive, which Turkey had adopted. US toy companies 
reported that the measure resulted in hei ghtened costs and time delays. The US said that US  toy 
importers were incurring a US $60 testing fee per item, or approximately US $380 per truck  load, 
plus detention charges. Further, Turkish authorities took 3 -4 weeks to conduct the required  
laboratory tests while ship ments had to wait at the port. The US was concerned that the measure 
had the following negative effect s of: (i)  discriminating against imports; (ii) creating unnecessary 
obstacles to trade; (iii) being more trade restrictive tha n necessary; and (iv) treating companies 
with a track record of compliance unfairly. The US said that  in their various bilateral meetings the 
Turkish authorities , although there were sentiments from them that they were willing to resolve 
the issue , there h ad been no progress and the US had not received any responses to their 
follow -up enquiries. The US stressed the need to resolve the issue before September 2015 to avoid 
significant market disruptions and therefore requested suspension of the measure until a more 
reasonable measure could be developed and implemented for toy testing in Turkey.  
3.47.   The representative of Turkey  said that Turkish import controls subjected toy products to risk 
analysis under the "Risk Based Trade Control System" (TAREKS). As import c ontrols were carried 
out electronically and on a risk basis, only risky products were subjected to safety and conformity 
checks. In this regard, inspections were conducted as physical checks and controls, including 
document/marking checks. Products were se nt to accredited laboratories for testing only when 
there was doubt concerning product safety in terms of Communiqué 2015/10. She also noted that 
the relevant Communiqué was republished at the beginning of every year and contained neither 
legislative chang e nor additional technical requirements in connection with import checks for toys. 
As the Communiqué did not impose any new testing requirements on toy imports, Turkey was of 
the opinion that the measure did not have to be notified to the WTO or allow time  for comments. 
Turkey suggested that the US concerns might rather have been related to the procedures at 
Customs to verify the accuracy of the importers declarations. In this respect, she explained that 
Turkey faced serious toy safety issues in its domesti c market. The Ministry of Customs and Trade 
implemented strict verifications to ensure coherence between the domestic market and border 
procedures. Given the risk associated with toy products, Turkey was confident that similar 
practices have been applied b y both developed and developing countries to ensure consumer 
health, safety and protection in the framework of legitimate objectives. Turkey emphasized that 
they accorded national and foreign companies equal treatment as all firms were subject to the 
same rules and procedures when placing their products on the Turkish market, and were thus in 
accordance with the principle of non -discrimination embedded in the TBT Agreement as well as 
GATT 1994). However, he said that Turkey undertook to consider the concern s of the US carefully 
and to maintain their internal consultation process with the Ministry of Customs and Trade in this 
regard.  
3.2.2.11   Norway – Draft amendments to the Tobacco Control Act and the Tobacco 
Labelling Regulations relating to Standardised Tobacco Pr oducts  
3.48.   The representative of  Indonesia  appreciated Norway's intention to pursue a public health 
policy by protecting its citizens from the negative effects of tobacco consumption. Nevertheless, 
Indonesia was of the view that the enactment  of such a policy should be undertaken in a manner 
that would not be more restrictive than necessary. Moreover, the proposed amendments were not 
consistent with Article 2.2 of the TBT Agreement as well as with several provisions of the TRIPS 
Agreement. Indonesia stressed th at multiple researchers, using different analytical approaches and 
data sets, had failed to find any empirical evidence that plain packaging measures reduced 
prevalence in the general population, or among youth. After nearly two years of plain packaging 
implemented by one Member, there was no available survey evidence that plain packaging had a 
positive impact on consumer behaviour. Plain packaging had failed to bring about the declines in 
tobacco prevalence predicted by Members who adopted this measure. As  Indonesia was currently 
in a dispute on a similar issue against Australia, Indonesia urged Norway, as well as other 
Members in the process of adopting similar measures, to postpone their proposals until this 
dispute was solved. Additionally, Indonesia inv ited Members to evaluate alternative measures 
which were more effective in achieving the health objective at issue and, more importantly, 
consistent with the WTO covered agreements.  
3.49.   The representative of  Dominican Republic  joined  Indonesia's request to Me mbers which 
were considering the adoption of plain  packaging measures to wait until the dispute was resolved.   G/TBT/M/66  
 
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  3.50.   The representative of Zimbabwe  voiced concerns with the proposed measure. Zimbabwe's 
full statement is contained in document G/TBT/W/421.  
3.51.   The rep resentative of  Cuba said that while her delegation acknowledged Member's right to 
enact health measure, it nonetheless joined Indonesia's request to Norway to suspend the 
adoption of its plain packaging measure until the Australia dispute was resolved.  
3.52.   The representative of  Canada  expressed support for Norway's decision to propose this 
measure and said that his delegation was following with interest the ongoing international 
developments regarding plain packaging of tobacco products and how such measures in teracted 
with both international trade and public health. He referred to the problem of tobacco use in 
Canada and around the world. In Canada alone, 37,000 people died annually from tobacco use and 
it was Canada's leading cause of preventable death and dis ease. He also noted that tobacco 
products were the only goods subject to a legally -binding health treaty, the World Health 
Organization Framework Convention on Tobacco Control  (WHO FCTC). Canada invited Members to 
consider the complete economic picture reg arding tobacco control, including whether tobacco 
might be a net economic drain for many countries.  
3.53.   The representative of  Australia  reiterated  its support for the decision by other WTO 
Members to adopt mandatory plain packaging of tobacco products and wel comed Norway's 
decision to have undertaken a public consultation process. The important steps made by Norway in 
tobacco control demonstrate d that  efforts to delay the adoption of tobacco plain packaging 
measures ha d not been successful.  In Australia's view , tobacco plain packaging was not about the  
destruction of  intellectual prope rty rights. The measure prevented the use of packaging to  
advertise and promote a product that caused  significa nt damage to public health. Australia 
expressed its firm believed th at Members had the right to implement measures necessary to 
protect public health, while complying with relevant international treaty obligations, including the 
TBT Agreement.  Austra lia's plain packaging measure was  a legitimate  public health measure and i t 
was consistent with Australia's obligations under the WTO  covered a greement s. The measure was 
endorsed by leading public health experts , as well as the WHO, and it was  supported by extensive 
peer review research, reports and studies. Even though Australi a was currently d efending the 
measure in the WTO, i t would  be inappropriate for complainants in the WTO dispute underway 
against Australia to invoke these proceedin gs in an attempt to delay or discourage other M embers 
from adopting  their own similar legitimate tobacco control measures . 
3.54.   The representative of  Uruguay  expressed support for Norway's decision on this particular 
measure and reiterated its position regarding the consistency of measures on tobacco and the 
right of Members to adopt measures to prote ct public health.  
3.55.   The representative of  New Zealand  expressed support for Norway's decision to have 
undertaken a public consultation process. She also stated that there was an extensive and growing 
body of international research establishing that plain pac kaging formed part of a comprehensive 
tobacco control programme which would contribute to the objective of protection of public health. 
To date, there was no credible evidence showing otherwise. The TBT Agreement recognised the 
fundamental right of Members  to implement non -discriminatory measures necessary to protect 
public health and provided appropriate flexibilities for Members to do so. New Zealand believed 
that it was possible for Members to implement a tobacco plain packaging regime that was 
consisten t with the WTO covered agreements.  
3.56.   The representative of  Norway  welcomed the interest of other Members in Norway's recent 
proposal. She then explained Norway's long history in tobacco control. In 1973, the Parliament 
adopted the first Tobacco Control Act,  which banned tobacco advertising, established an age limit 
for the sale of tobacco and mandated health warnings. A national tobacco control strategy for the 
period 2013 -2016 was launched in February 2013. The strategy was focused on protecting children 
and young people from the negative effects of tobacco. The strategy's long term vision was a 
tobacco -free future in order to protect and promote public health. With this in mind, the 
government launched a public consultation on standardised tobacco packaging  in March 2015. The 
consultation process was both transparent and inclusive. In May 2015, the draft measure was 
notified to this Committee in accordance with Norway's TBT obligations. A consultation paper 
explaining the issue in detail was included as part  of the notification. The documents outlined the 
government's policy objectives and referenced the scientific evidence regarding the effectiveness 
of standardised packaging.  G/TBT/M/66  
 
- 14 - 
 
  3.57.   Norway believed that there was strong evidence that standardised packaging, as pa rt of a 
comprehensive  tobacco control programme, would  contribute to the objective of a t obacco -free 
generation/society and would improve  public heal th. Details of this evidence were set out in 
Norway's consultation package and interested Members were  encouraged to examine it . It was  
scientifically documented that tobacc o, when used as intended, caused  death  and disease. Indeed, 
smoking was  the single largest cause of preventable death and disease in Norway, with 
approximately 6,600 Norwegia ns dying each ye ar from smoking -related illnesses . The proposed 
legislation formed  the latest strand of comprehensiv e tobacco control legislation. Amongst other 
measures, Norway implemented smoke -free legislation, total bans on tobacco advertising and 
display of tobacco p roducts at points of sale. In addition, all tobacco pr oducts placed on the 
market should  carry combined text and g raphic health warnings.  
3.58.   Norway also explained that the draft legislation at issue was aimed  at restricting the 
promotion of tobacco products to further reduce the smoking prevalence in Norway by : 
(i) discouraging uptake of tobacc o use by young people; (ii)  encouraging and s upporting tobacco 
users who wanted  to quit and prevent relapse ; and (iii)  reshaping social norms and attitudes 
around tobac co use to promote health and wellbeing . More specific ally, the draft legislation was 
aimed  to reduce the attractiveness of tobacco products, especially for young people, by removing 
the advertisin g effect of the package design. In developing its proposal  on plain packaging, Norway 
closely examined the consistency of the proposal with its obligations under the WTO agreements, 
including the TBT Agreement . In this respect, Norway recalled that Article 2.2 of the 
TBT Agreement expli citly provided  that t he prote ction of human health was a legitimate objective.  
WTO Members may thus take measures to protect such objecti ve, provided that these measure 
were not more trade restrictive than nec essary to fulfil their objective(s). In Norway's view, the 
proposal on plain  packaging was  in line with WTO rules,  including those in the TBT Agreement . 
Further, plain packaging was  also a recommended measure under the WHO FCTC, to which 
Norway was  a party. The se obligations include d, for instance, the introduction of measures to 
prevent initiation, to  promote and support cessation and to decrease the consumption of tobacco 
products . Article s 11 and 13 of the WHO  FCTC, as well as their  implem enting guidelines, explicitly 
advise d the parties to that  Convention to introduce plain pac kaging as a measure to achieve the 
objective of protecting public health . It was Norway' s firm view that the WHO FCTC and the 
relevant WTO agreements were  mutually supportive, and that it was  possible to implement 
measures intended to regulate the packagin g of tobacco products in line with both sets of binding 
obligations . 
3.59.   Finally, with respect to  calls for its legislative process to be put on hold while th e disputes 
against Australia were resolved, Norway said that such disputes should not have any bearing  on 
Members adopting their own measures in favour of public health . The Norwegian national 
consultation process was closed on 9 June 2015  and the period for commen ts under the WTO 
notification rules, was  until 90 days after the date of notif ication (18 May  2015) . All comments 
received, both nationally and by WTO Members, would be studied by the Norwegian authorities.  
3.60.   The representative of  Mexico  said that the proposed measure from Norway had certain 
similarity with other measures adopted by other WTO Membe rs. He also indicated that Mexico 
would continue to f ollow closely the developments in the various bodies of the WTO for cases  such 
as this one,  initiated against Australia.  
3.61.   The representative of the World Health Organization (WHO)  stated that the use of a ll types 
of tobacco posed substantial risks to human health. Additionally, health, social and economic costs 
associated with tobacco use were greater in developing countries. Tobacco plain packaging was 
one of a number of complimentary measures to reduce t he demand for tobacco products. Evidence 
from well -qualified, respected and credible sources suggested that plain packaging would make 
restrictions on advertising, prohibitions on misleading packaging and health warnings more 
effective. It was reasonable t o expect prevalence of tobacco use to decline as a consequence of 
this measure, an expectation that was consistent with the early evidence from Australia. The body 
of empirical evidence was further supported by guidelines to Articles 11 and 13 of the WHO F CTC. 
The WHO concluded its intervention by requesting that all previous statements by the WHO on 
tobacco plain packaging be included in the record of this meeting.2  
                                                
2 The representative of the WHO made a statement during the November  2014 meeting of the TBT 
Committee (G/TBT/M/64/Rev.1, para 2.33), the full content of which is contained in G/TBT/GEN/175.  G/TBT/M/66  
 
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  3.2.2.12   China – Technical Specification for Natural Rubber  
3.62.   The representative of Indonesia  noted t hat at the previous meeting held in March 2015, her 
delegation conducted a bilateral meeting with China regarding the issue of technical specification 
for natural rubber and delivered official comments to the Chinese TBT enquiry point. In this 
respect , China had not provided a response to their comments. Indonesia also  informed the 
Committee that many Indonesian natural rubber exporters had encountered barriers to trade s ince 
January 2015. In Indonesia' s view, these barriers were caused by the imposition of  customs and 
excise policy on the importation of natu ral rubber, specifically rubber  TSNR under 
HS heading  4001. The policy required exporters to submit custom clearance documents , such as 
phytosanitary certificates, quality certificates from government, SPPSNI  (Chinese  translation 
version) or SPPSNI  (Indonesian/English bilingual version) . In addition, the required documentation 
was costly and lengthy to complete . Indonesia recalled Article 2.2 of the TBT Agreement, which 
stated that Members shall ensure t hat technical regulations should  not be prepared, adopted or 
applied with a view to or with the effect of creating unnecessary obstacle to international trade. 
The policy was not brought to the attention of the public so Indonesia requested China to  notify 
the measure to the TBT Committee.  Finally, Indonesia asked China to harmonise its custom 
clearance documents, as it would assist Indonesian exporters to comply with such requirements.  
3.63.   The representative of Malaysia  supported Indonesia's statement regardin g China' s Technical 
specification for natural rubber. As Malaysia was one of the major exporters of natural rubb er, his 
delegation had concern s with  the potential negative effects that this could have on Malaysian 
exporters. Altho ugh Malaysia acknowledged China' s right to introduce measures based on 
legitimate object ives, Malaysia joined Indonesia' s request to China to notify the measure to other 
Members in accordance with relevant p rovisions of the TBT Agreement.  
3.64.   The representative of China  thanked Indones ia and Malaysia for their interest in this 
measure.  Since China had bilaterally received Indonesia' s concerns, China kept continuous 
information exchange with Indonesia and requested more information to clearly identify the 
measure and the competent author ity responsible for it. Unfortunately, China did not find that 
there was such a technical specification for natural rubber . She therefore invited Indonesia and 
Malaysia to work with China to better understand and address the ir concerns.  
3.2.3   Previously R aised Concerns  
3.2.3.1   India – Pneumatic tyres and tubes for automotive vehicles , G/TBT/N/IND/20, 
G/TBT/N/IND/20/Add.1, G/TBT/N/IND/40, G/TBT/N/IND/40/Rev.1 (IMS ID 133)  
3.65.   The representative of Japan  requested that India consider amending the regulation at issue 
given that  Clause 10.2 of the revised agreement required tyre manufactures to pay a US $ 10,000 
bank guarantee fee per plant, causing an unnecessary competitive difference between factories 
within India and those outside. During previous bilateral discussions, India had agreed to try to 
consider reducing the bank guarantee fee. He had also asked if India would consider withdrawing 
this bank guarantee fee. Japan had questioned whether the fee was at a uniform rate given that 
India had said that the bank guarantee fee a pplied to all products in India, including those of 
foreign manufacturers. He requested an update from India on this question. On ISI marking, Japan 
considered the fee to be expensive in comparison with other countries and asked that India show 
evidence of  how the ISI marking fee was equivalent or cheaper than those of other countries. He 
said there was also no improvement in the lengthy certification process, which still took four or 
five months, much longer than in other countries. Japan asked India to at  least consider 
shortening the procedures for first licences, by simplifying the necessary application 
documentation.  
3.66.   The representative of the European Union  reiterated concerns it had raised in previous 
meetings about the certification procedure with a m andatory marking for tyres. He referred 
Members to his statement made at the previous TBT Committee meeting3 and highlighted in 
particular the EU's request that India align its procedures to international practices and remove the 
obligation to pay a markin g fee per marked tyre and to eliminate the discriminatory bank 
guarantee requirement.  
                                                
3 G/TBT/M/65, para. 2.40.  G/TBT/M/66  
 
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  3.67.   The representative of India said that as most of the concerns were not new and had been 
sufficiently explained in both previous Committee and bilateral meetings, he reque sted that 
interested Members refer to the minutes of the previous meeting.4 For the new questions, he said 
his delegation would forward them to capital for response.  
3.2.3.2   India – Drugs and Cosmetics Rules 2007 , G/TBT/N/IND/33 (IMD ID 167 ) 
3.68.   The representative of  Canada  raised the following two specific concerns with two provisions 
in the Guidance Document on Common Submission Format for Registration/Re -Registration of 
Notified Medical Devices in India, namely: (i)  the necessity for certificates/licenses to be 
notarized/attested by the Indian Embassy in the country of origin; and (ii)  the requirement for 
medical devices to be freely sold in the country of origin. Canada believed that these provisions 
caused unnecessary barriers to trade for the following two reason s: (i)  many Canadian medical 
devices were marketed outside the country of origin; and (ii)  requiring notarization of official 
government certificates/licenses from reputable jurisdictions was a burdensome regulatory 
requirement with no obvious benefit. Can ada also continued to have concerns with the Guidance 
Document on Common Submission Format for Registration/Re -Registration of Notified Diagnostic 
Kits in India and referred Members to questions raised at the previous TBT Committee meeting.5 
Finally, on co untry of origin labelling of medical devices, Canada understood that the Drugs and 
Cosmetics (Amendment) Bill, 2015 had not yet been passed by the Indian parliament and 
requested an update from India on when the final draft of the bill would be notified to  the TBT 
Committee.  
3.69.   The representative of the European Union  requested India to allow information to be 
displayed via stickers, attached at customs bonded warehouses, for all aspects of cosmetics 
labelling, including the list of cosmetic ingredients or any  other information relevant for the 
consumer, and not only the India -specific information, as was the current practice. He also 
requested an update on the state of play on the ongoing court case at the Bombay High Court 
concerning the Indian Central Govern ment amendment to the legal metrology Packaged 
Commodities rules 2011 requiring cosmetic products to bear a red or a brown dot at the top of the 
principal display panel for products of non -vegetarian origin and a green dot for products of 
vegetable origin.  Regarding the animal testing ban, established by Regulation 148C (Ban on 
animal testing of cosmetics), in force since May 2014, and Regulation 135B (Ban on import of 
cosmetics tested on animals), in force since October 2014, the EU requested clarification  on the 
following two issues: (i) whether the ban applied only to new ingredients (i.e. ingredients tested 
on animals after the ban entered into force); and (ii)  whether the ingredients that had been tested 
on animals for purposes other than cosmetics (e.g . for pharmaceuticals) could still be used in 
cosmetics. Finally, he requested India to notify the latest draft amendments to the TBT 
Committee.  
3.70.   The representative of India informed the Committee that India was seeking to align itself 
with international tr ends in this field by defining medical devices as distinct from drugs. He 
explained that, in order to follow international best practices, a separate chapter had been 
proposed in the draft Drugs and Cosmetics Amendment Bill 2015 for regulating medical devi ces. 
The draft bill had been placed in the public domain, consultations involving all stakeholders had 
been undertaken and comments and suggestions had been taken into account. On the concern for 
the need for notarization or attestation of certificates by the Indian embassy in the country of 
origin, he said this was required so as to prevent the submission of fabricated documents. The 
requirement for medical devices to also be sold in the country of origin ensured that safety and 
efficacy had been evaluated  by national regulatory authorities.  
3.71.   Concerning the performance evaluation report requirements for diagnostic kits, he said the 
purpose of this requirement was to ensure quality of devices as per the national standards 
prescribed at the time of registratio n. Each batch of imported notified in -vitro diagnostic medical 
device kits ("IVD kits") had to undergo testing at the National Institute of Biologicals ("NIB") 
before release into the Indian market. In reply to the question of whether stickers were allowed  on 
cosmetic products, he said there was no change in the regulatory status since the previous 
meeting. In this respect, he invited interested delegations to consult the minutes of the November 
                                                
4 G/TBT/M/65, paras. 2.41 -2.43.  
5 G/TBT/M/65 paras. 2.44 -2.45. G/TBT/M/66  
 
- 17 - 
 
  2014 TBT Committee meeting.6 Similarly, on the requirement for  products to bear a brown dot or 
green dot to reflect whether the product had non -vegetarian or vegetarian origins, there was no 
change in the legal status since the last meeting and the present rules did not allow this 
information on stickers. In response  to the concern on the prohibition on the import of cosmetics 
tested on animals, the Indian representative reported  that the Drugs and Cosmetics Rule  1945, as 
amended on 21  May 2014, prohibited testing on animals within the country. Rule  1945 was further 
amended on 13 October  2014 so as to also prohibit the import of cosmetics tested on animals. 
India believed that this was in line with EU 's own policy.  Concerning the issue of the checklist, 
raised in the previous TBT  Committee meeting, he said that, in vie w of the concerns on the quality 
of the imported cosmetics, this checklist had been amended so as to add clarity on the data or 
documents required for evaluation. This checklist was based on the provisions of the existing 
Drugs and Cosmetics Rule 1945 and did not require generating any new data prior to submission .  
3.2.3.3   China – Provisions for the Administration of Cosmetics Application Acceptance, 
Cosmetics Label Instructions Regulations and Guidance for the Cosmetics Label 
Instructions , G/TBT/N/CHN/821 G/TBT/N /CHN/937 (IMS ID 296)  
3.72.   The representative of Japan  reiterated the following two specific concerns with the 
"Guidance for Application and Evaluation of New Cosmetic Ingredients". Firstly, he requested that 
China accelerate the registration process of these p roducts as only four new ingredients had been 
registered to date and there continued to be significant difficulty in exporting cosmetic products 
with new ingredients. Secondly, Japan again asked China to revise the requirement to submit the 
data for each s ingle isolated molecule, in particular given that no explanation has been given on 
the scientific grounds for making such a requirement. Japan also raised a new concern about the 
disclosure of information. More specifically, Japan was concerned that compan ies were obliged to 
provide detailed information on manufacturing process, the reaction process and conditions of 
reaction. In some cases, this information appeared on the CFDA's website. While some 
improvements had been made, Japan requested that further action be taken so as to ensure that a 
company's confidential information not be disclosed.  
3.73.   The representative of the European Union  reiterated concerns it has raised during previous 
meetings, and in particular with respect to the pace of progress in the n ew ingredients 
authorization process. The EU was of the opinion that the new registration procedure did not 
deliver in an efficient and predictable manner. He referred the Committee to the statement 
delivered at the previous meeting of the Committee.7 In particular, he recalled the proposals that: 
(i) the authorization procedure should be limited to the procedure for registration of new 
ingredients when it concerned priority substances - i.e. higher risk substances – and to allow a 
lighter procedure for low er-risk substances; and (ii)  to share the safety responsibility for new 
ingredients between China's Food and Drug Administration (CFDA) and the registrant company .  
3.74.   The representative of China  said that the CFDA had offered specialized training and 
guidanc e on the difficulties enterprises had met in the implementation of this measure. In addition 
to cooperation at the governmental level, CFDA had formed several working groups with several 
Members. CFDA was also in contact with experts and industry associati ons, both within and 
outside China, so as to ensure that research was carried out.  China w ould keep the bilateral 
channel open and welcome d interested parties to continue to cooperate with China  and put 
forward valuable inputs.  
3.2.3.4   India – New Telecommunicatio ns related Rules (Department of 
Telecommunications, No. 842 -725/2005 -VAS/Vol.III (3 December 2009); No. 10 -
15/2009 -AS-III/193 (18 March 2010); and Nos. 10 -15/2009 -AS.III/Vol.II/(Pt.)/(25 -
29) (28 July 2010); Department of Telecommunications, No. 10 -15/2009 -
AS.III/Vol.II/(Pt.)/(30) (28 July 2010) and accompanying template, "Security and 
Business Continuity Agreement" (IMS ID 274)  
3.75.   The representative of Canada  reiterated concerns regarding India's test requirements for 
telecommunications products. As stated in previous meetings, his delegation believed that India's 
in-country security testing regulations for telecommunications products would hinder or possibly 
shut exporters out of the Indian market. Canada disagreed with India's blanket approach testing in 
                                                
6 G/TBT/M/64/Rev.1 para 2.81.  
7 G/TBT/M/6 5, para 2.53.  G/TBT/M/66  
 
- 18 - 
 
  the telecommunications sector and did not understand why Common Criteria (CC) testing was not 
appropriate for India's telecommunications framework, given that it was already internationally 
accepted. Canada believed that allowing accredited foreign conformity assessment bodies to test 
and certify to India's regulatory requirements would reduce testing costs and permit exporters to 
bring their products to the Indian market more quickly. Canada appreciated India's explanation 
given at the previous TBT Committee m eeting, but remained unconvinced that deviating from 
CC testing would enhance the security of these products. He requested that India provide an 
explanation of where this alternative approach might improve security.  
3.76.   The representative of the European Union  asked India to confirm whether the new 
requirements had been postponed beyond 1 April 2015. It was the EU's understanding that until 
the new requirements entered into force the status quo would continue to be applied, with foreign 
test results being accep ted and suppliers continuing to be allowed to self -certify their products. 
Following the entry into force of the new requirements, the EU understood that testing would be 
based on relevant international standards, as clarified by India in previous meetings . Concerning 
the security aspects covered by the Common Criteria Recognition Agreement ("CCRA"), test 
results from laboratories approved by CCRA members would be accepted with no additional in 
country testing, whereas other security aspects not covered by common criteria would not require 
any in country testing. He requested India not to require any in country testing as this did not add 
any value in terms of enhanced security and suggested that India instead accept test results of 
qualified laboratories ho lding accreditation from ILAC MRA signatories. Those test results could be 
the basis for certificates to be issued in India by certification bodies approved by the Indian 
authorities. He looked forward to continued discussion between India and interested W TO 
Members so as to ensure that the new requirements, when implemented, would reflect best 
international practice.  
3.77.   The representative of the United States  requested that India explain why the proposed 
revised telecommunications security regulations dating from May 2011, and subsequent updates, 
had not yet been notified to the WTO. She requested that they be notified as soon as possible so 
as to give Members and interested stakeholders adequate opportunity to comment. While noting 
the date for in -country tes ting had been extended, there had been no formal announcement of 
such extension. The US urged India to remove the in -country testing requirement from the 
proposed regulation, as such a requirement added significant additional costs for manufacturers. 
Given  India's certification under the CCRA, India had agreed to accept the results of CC tests 
conducted outside its territory. These tests were sufficient for the US and many other markets and 
she therefore asked that India explain why they were not sufficient  for the Indian market and why 
further in -country testing requirements were necessary for national security reasons. She 
encouraged India to allow telecommunications service providers to determine from whom to 
source, based on each company's ability to add ress any security concerns. This approach 
promoted market competition and, as a result, more secure products. A less trade restrictive 
approach would also contribute to India's domestic economic growth in the telecoms sector. She 
encouraged India to accept  international testing standards and sought India's assurance that test 
reports under the CCRA and 3GPP standards would be accepted regardless of whether the tests 
were performed in India or in accredited laboratories outside of India.  
3.78.   The representative of Japan  supported the Canadian, EU and US positions and confirmed 
Japan's interest in the new Unified Access Service Licence Agreement. She requested that India 
ensure the telecommunications regulations did not impede market access for foreign industry. O n 
the statement delivered by India at the previous TBT Committee meeting, she raised the following 
points: (i) concerning the suspension of compulsory in country testing, whether India could inform 
the Committee if a date had been set for when this suspens ion would be lifted; (ii) India stated 
that the testing based on common criteria was limited to IT and IT related products, and 
telecommunication work was governed by other standards. Therefore, security testing of 
telecommunication equipment did not infri nge CCRA. However, telecom devices were included in 
the scope of CCRA security certification. The CCRA provided that any products certified in a CCRA 
member state based on the common criteria could be accepted by the other member states 
without re -evaluati on of telecommunications device security. Japan had therefore a concern that 
telecommunications device security by India would impose a heavy burden on telecommunication 
device industry. The framework of CCRA had been promoting the development of security 
requirement based on the common requirement for telecommunication devices. India should 
therefore utilise CCRA; and (iii) India had stated that the additional testing would only be carried G/TBT/M/66  
 
- 19 - 
 
  out on IT devices which had already undergone CCRA evaluations and she requested that India not 
impose this excessive burden of a repeated security evaluation on industry.  
3.79.   The representative of India confirmed that the compulsory in -country testing obligation had 
been postponed until such a time as the required infrastruc ture was in place and no date had yet 
been set. Regarding the concern on security testing of equipment, he reiterated that the 
CC testing did not suffice as it was process -based and was used for certifying only the claims of 
the vendor about the security f eatures  incorporated in the product  without certifying that there 
were no other vulnerabilities . The Common Criteria certification  did not address national concerns 
on the security requirements of telecom networks. Telecom equipment was tested against 
3rd Generation Partnership Project (3GPP) standards for operational requirements, but 3GPP did 
not have security standards for telecoms equipment. Only in 2014, 3GPP created SA3 sub -group to 
work out the security standards for telecom equipment. He also explai ned that the requirement for 
mandatory testing was meant to address national security concerns. It could not be considered a 
trade barrier as it was applicable to all the manufactures or vendors irrespective of source of 
procurement including domestic manu facturers. As clarified in the past, India would rely on 
international standards as much as possible . IT product test ing carried out  against the CC process  
would be leveraged  without necessarily repeat testing. However, some additional test could be 
conduc ted if required in the interest of nation . He noted that different countries had different 
approaches to dealing with security testing of telecom equipment, including equipment sourced 
from specific countries or companies being banned. In some EU member st ates, equipment was 
being tested against domestic standards and in the UK equipment procured from Chinese vendors 
had to be tested at a laboratory established in the UK, where staff underwent security screening 
by the UK Government . 
3.2.3.5   China – Requirements fo r information security 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) 
3.80.   The representative of Canada  was particularly concerned that China's regime for regulating 
the information technology sector was overly burdensome and trade restrictive. While Canada 
recognized China's need to address security concerns, it was important t o avoid duplicating 
conformity assessment testing. Canada felt that China's approach to regulating IT security lacked 
coordination domestically and ran counter to well -established best practices. He requested that 
China explain the relationship between the  OSCCA and the MLPS in more detail.  
3.81.   The representative of the European Union  associated his delegation with the comments 
made by Canada. This very comprehensive Chinese regulatory framework , he said, required very 
cumbersome conformity assessment procedure s and discriminated against foreign product 
suppliers and products incorporating foreign technology vis -à-vis products incorporating domestic 
technology. He once again requested an update on the state of play on the revision of the OSCCA 
regulation on comm ercial encryption products. He also requested that China elaborate on the 
relationship between OSCCA regulation and MLPS and on the notion of critical infrastructure, which 
created a lot of uncertainty with regard to the implementation of the MLPS. He emph asised the 
importance of ensuring transparency, predictability for market access and the need for enhanced 
international cooperation in this area in order to ensure compatible regimes which harness security 
without hindering trade in commercial products.  
3.82.   The representative of Japan  reiterated its support for the positions of Canada and the 
European Union. Japan was paying particular attention to the various schemes and regulations 
within China and how these could negatively affect trade in information secur ity products. At the 
previous meeting of the Committee, China had made a statement that there would be an 
opportunity for public comment during the revision of the OSCCA. She requested that this process 
be opened up in a broader manner towards stakeholders  including Japan.  
3.83.   The representative of China  thanked delegations for their continued interest in the measure 
and said as there were no further updates on the issues raised. Members should thus refer to the 
minutes of previous meetings.  G/TBT/M/66  
 
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  3.2.3.6   Russian Federation  – Draft on Technical Regulation of Alcohol Drinks Safety 
(published on 24 October 2011) , G/TBT/N/RUS/2 (IMS ID 332)  
3.84.   The representative of the European Union  invited the Russian Federation to update the 
Committee on the status and timeline for adoption of this draft technical regulation, which had 
been notified in 2012. The EU had submitted detailed comments in writing in 2013, many of which, 
according to the Russian delegation at previous meetings, had been taken on board and would be 
reflected in the revi sed draft technical regulation. She asked when this revised text might be 
notified to the TBT Committee so as to allow Members the opportunity to analyse how their 
comments were taken into account.  
3.85.   The representative of Australia  said his delegation remai ned concerned with certain 
elements of this technical regulation. He requested an update on the status of the draft regulation 
and the implementation time -frame. Australia would prefer a six -month transition period for 
regulations relating to wine so as to  allow industry sufficient time to implement any labelling 
requirements.  
3.86.   The representative of the Russian Federation  thanked the EU and Australia for their 
comments but said these concerns had been replied to during previous TBT Committee meetings. 
The d raft technical regulation was still being developed. In May 2015, the Eurasian Economic 
Commission ("EEC") sent a corrected text of the technical regulations to the governments of 
Eurasian Economic Union member states, which took into account many of the c omments and 
suggestions of stakeholders and WTO  Members. Once approved, the new draft would be publicly 
available on the EEC website. Once published, the new draft would be put forward for adoption by 
the Council of the Eurasian Economic Union. This was no t expected to be before the third quarter 
of 2015 and a transition period for implementation would follow.  
3.2.3.7   Korea – Regulation on Registration and Evaluation of Che mical Material , 
G/TBT/N/KOR/305  (IMS ID 305 ) 
3.87.   The representative of the United States  asked Ko rea to confirm that this regulation would be 
amended by the second half of 2015 and that stakeholders' engagement would continue 
throughout the process. Confirmation was also requested as to whether the Ministry of 
Environment ("MOE") was considering furth er protection of companies' confidential business 
information ("CBI") by allowing direct reporting and the use of concentration ranges rather than 
exact composition percentages. Concerning the request that the definition of "hazardous 
substances" be tighte ned, the US understood a public notice had been issued in December  2014 
regarding the list of chemicals equivalent to the MOE's definition of hazardous chemicals and 
looked forward to receiving a copy of the public notice. Confirmation that "hazardous subs tances" 
under K -REACH were limited only to those regulated chemicals and no other was also requested.  
The US encouraged Korea to continue working with stakeholders to ensure that CBI claims were 
not unintentionally prohibited. She said that the US chemical  industry urgently needed more 
specific guidance on all products that would be classified under the biocides group under K -REACH 
implementation and looked forward to these documents being provided as soon as possible. The 
US supported a strong definition o f CBI that included at least the possibility of protecting the 
specific chemical identity, composition, and uses, while respecting the legitimate government 
interest of allowing reporting of generic chemical names, and providing adequate hazard 
information  to downstream users and that the Ministry of the Economy continued to consider 
provisions that prevent any compromise of CBI. Finally, she asked for confirmation that the Korean 
Government might consider delaying implementation as such a delay would allow  greater 
consideration to industry requests in light of the practical issues raised and would allow industry 
stakeholders adequate time to implement all of the necessary changes to K -REACH's broad and 
complicated scope.   
3.88.   The representative of Japan  said th at, concerning the Notification of Product Containing 
Hazardous Substances (Article 32), Japan understood the aim of reporting products which 
contained hazardous substances so as to protect consumers and the environment. However, as 
stated at the previous meeting, the obligation to investigate hazardous substances contained in 
products through supply chains all at once placed a heavy burden on industries. Japan requested 
that Korea introduce the regulation in a stepwise manner, according to the priority of hazardous 
substances, taking into account its hazards, usages and exposure situation. Additionally, with 
respect to the "Information Provision of Downstream User or Seller by Manufacturer or Importer G/TBT/M/66  
 
- 21 - 
 
  (Article 38 of the Enforcement Rule) ", Article 38 Paragr aph 2 of the enforcement rule (ministerial 
decree), Japan considered that the information on manufacturing volume and import volume was 
not necessary to ensure safety of downstream users or sellers and was considered confidential 
information by manufacture rs. Japan request that manufacturing volume and import volume be 
omitted from the information with which manufacturers or importer had to provide.  
3.89.   The representative of Australia  said the implementation of this regulation was being 
monitored with interest.  It was necessary to ensure regulatory quality in terms of predictability, 
transparency and adequate stakeholder consultation and recognized there had been significant 
consultation on this matter. It was also important to ensure the implementation of adequ ate 
checks and balances so as to protect commercial -in-confidence information from such registration 
and evaluation processes. Australia looked forward to receiving and reviewing further notifications 
on the regulations in future.  
3.90.   The representative of the  Republic of Korea  informed the Committee that his government 
had collected comprehensive opinions from all interested parties and stakeholders. There was now 
the intention to amend the regulation so as to resolve the challenges that stakeholders may face.  
This would be done by taking the following steps: (i)  by simplifying the document requirements; 
(ii) by clarifying targets of the report; and (iii)  by removing the redundant period. Regarding the 
reporting obligation, Korea explained that foreign manufact ures and producers could not be 
entitled to report directly because they were not the legal representative in Korea. However, in 
accordance with the first clause of Article 49, in a case where a foreign manufacturer or producer 
designated a Korean represen tative (with legal entity in Korea as a legal agent), they would be 
able to do direct reporting in  lieu of the foreign manufacturer or producer. Further detailed 
guidelines could be provided if necessary on this matter. On Japan's suggestion that Korea 
implement this measure on a stage -by-stage basis, he said that according to the law regarding 
hazardous chemical substances, this was not a new detail as it had been already regulated under 
the law for some time. He also said that the Korean Government would hold forums and discussion 
groups in response to Members' concerns, in particular on trade secret protection. The guidelines 
were being continuously supplemented and the reinforcement of the protection of CBI was also 
being done. There was also a 3 -year gr ace period from 1 January 2015 for implementation.  
3.2.3.8   Indonesia - Technical Guidelines for the Implementation of the Adoption and 
Supervision of Indonesian National Standards for Obligatory Toy Safety , 
G/TBT/N/IDN/64 G/TBT/N/IDN/64/Add.2 (IMS ID 328 ) 
3.91.   The repr esentative of the European Union  recalled concerns with regard to conformity 
assessment procedures introduced by Decree  No. 24 and asked if there was a plan to review the 
toy safety decree in order to create a level playing field as regards conformity asse ssment 
procedures. He said that the EU understood that the Ministry of Industry in Indonesia had 
approved some foreign laboratories and therefore required confirmation on what a laboratory 
needed to demonstrate in order to be approved as well as the timeli ne for approval, noting that 
the 2 -year grace period would expire in mid -April 2016. He further said that Indonesia should 
consider making the current arrangement under the 2 -year grace period a permanent 
arrangement in order for results from tests conduct ed by foreign laboratories which were 
adequately accredited by ILAC MRA signatories under international standard 17025  to be accepted 
on a permanent basis.  
3.92.   With regard to labelling requirements, he said that the EU had pointed out in the past to the 
existence of two separate sets of requirements: (i)  one related to general labelling; and (ii)  others 
stemming from Decree  No. 24. These requirements resulted in the affixing of the label at different 
points in time and different places, hence handling the prod uct twice in the country of exportation 
and after importation. The EU thanked Indonesia for recently providing a written reply to its 
concerns and requested Indonesia to clarify the extent to which, as stated in its reply, the general 
labelling requirement s for toys had been coordinated with the specific requirement under the toy 
safety decree in order to avoid unnecessary burden for toy manufactures. Indonesia was 
requested again to streamline those requirements.  
3.93.   The representative of the United States  said that she was concerned that Indonesia's toy 
regulatory regime included aspects that were more restrictive than those adopted by other 
Members. She stated her delegation's concerns related to lab accreditation, testing frequency, 
sampling, documentation, and substance restrictions, as well as the requirement to have a G/TBT/M/66  
 
- 22 - 
 
  bilateral MRA in place by April  2016. She said that they were informed that Indonesia was no 
longer recognizing any additional laboratories under the current process and that few concerns 
were addressed prior to the regulation coming into effect in April 2014.   
3.94.   The representative of Japan  said that several requirements of the Indonesian toy regulation 
would be more trade -restrictive than necessary. Regarding foreign testing laboratories of SNI  
certification, she expressed strong concern with the requirement of a Mutual Recognition 
Agreement (MRA) with Indonesia after two years of the enforcement. She requested information 
on any changes of the toy regulation, in particular with a view of revisi ng it in order to be 
consistent with the obligations under the TBT Agreement.  
3.95.   The representative of  Indonesia  stated that the objective to implement the Mandatory SNI 
for Toy safety was to protect human health and that foreign testing laboratories listed in the MRA 
under APLAC/ILAC scheme were still acceptable.  Based on the Ministry of Industry regulation No 
18 of 2014, there were 25 international laboratories that had been registered. She said that 
testing frequency per shipment was still valid  and the 2 -year grace period could only be extended 
if the government of the country where the laboratories conduct the testing had an MRA with the 
Indonesian Government. Indonesia had  conducted market surveillance in order to prevent unsafe 
toys in the grey market.   
3.2.3.9   India - Food Safety and Standards Regulation - Food labelling requirements 
(IMS ID 298)  
3.96.   The representative of the European Union  recalled that the C odex Standard for the labelling 
of pre -packaged foods (STAN 1 -1985) stated that ''If the language on the o riginal label is not 
acceptable, to the consumer for whom it is intended, a supplementary label containing the 
mandatory information in the required language may be used instead of re -labelling ". She 
additionally recalled that this standard also said that  ''in the case of either re -labelling or a 
supplementary label, the mandatory information provided shall be fully and accurately reflect that 
in the original label .'' She further said that in most economies, food products could be labelled by 
means of stick ers, provided that those were accurate and not easily detachable. She requested 
India to bring its implementing guidelines in line with the C odex standard and to allow all type of 
labelling information. She also requested confirmation that India was in the  process of amending 
specific parts of the Indian food standards to bring them further in line with the Codex standards. 
She also welcomed the fact that the Indian Food Safety and Standards Authority was preparing a 
specific technical regulation on alcohol ic drinks and o ne on food additives, and that India was in 
the process of launching a public consultation process . She requested the timeframes for notifying 
the draft regulations to the WTO TBT Committee and assurances that regulators from other WTO 
membe rs would have the opportunity to comment on those regulations.  
3.97.   The representative of Switzerland  requested information on why it was not possible to 
provide translated information to consumers by means of stickers instead of only industry specific 
suppleme ntary information.  
3.98.   The representative of the United States  sought an update on the status of India's efforts to 
better align their domestic requirements with international standards. She requested India to 
provide the timeline for the publication of the a mended FSSAI Rules. The US was concerned about 
how India planned to define whiskey and further requested India to provide the expected timeline 
for notification of the requirements to the SPS and TBT Committees.  
3.99.   The representative of Australia  sought an up date on: (i)  the anticipated date for the 
harmonisation of India's food standards with Codex; (ii)  the proposed date(s) for India's next 
review of its food standards; and (ii i) whether these would occur in parallel or simultaneously. He 
also asked India to  inform the time at which the process of harmonisation of its food standards 
with Codex would be finalised and to inform whether India was planning another review of its 
standards. He also requested information on whether India had considered the issues pr eviously 
raised by WTO Members and if so, if the process would be through finalisation or extension of the 
Codex harmonisation process, or a separate review.  
3.100.   The representative of Canada  shared the concerns expressed by other Members and 
looked forward to receiving India's responses to these concerns.  G/TBT/M/66  
 
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  3.101.   The representative of India said that there was no change in the regulatory status since 
the previous Committee meetings and referred delegations to its statement made in the 
Committee meeting of November 2014 .8 He also said that Codex did not prescribe that the 
labelling requirement could be met through additional sticker(s) and that the core information 
regarding, for instance, product ingredients, composition, nutrition values, and best before dates, 
could o nly be provided by the manufacturer and no one else. He explained that the label had to be 
an inseparable part of the container/package. He further said that permitting additional stickers as 
a means of information from any other source, or even the manufa cturer, was likely to 
compromise the sanctity of information, which was the basic requirement for a consumer to make 
informed choices. With regard to harmonization of regulations with Codex, he said that the 
standards that were being formulated by the Food  Safety and Standards Authority of India were 
increasingly harmonized with international standards. However, India had to consider 
harmonisation in view of its own ground realities and local requirements or adaptations.  
3.2.3.10   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 (IMS ID 
345)  
3.102.   The representative of Argentina  said that  the fact that this trade concern has  been flagged 
almost contin uously over the past six years  by several Members  reflected  not on ly the protection 
granted by the EU  to this specific  sector  - to the detriment of wine producers from other regions  - 
but also the clear lack of progress in finding a solution. He said that the situation had  affected the 
entry into the EU market of high quality and differentially priced wines fr om Argentina, thereby 
placing Argentine  wine exports at a disadvantage compared with those of certain c ompetitor s from  
EU countries with  access to European consumers who prefer red wines identifie d and labelled as of 
a high quality. He said that the EU legal regime was inconsistent with the obligations under the 
TBT Agreement , including those prohibiting discrimination, as these traditional expressions were 
indications of quality that fe ll under the TBT Agreement an d not under the TRIPS Agreement. He 
said th at the  multiplicity  of definitions for each term accepted  by the EU showed that the objective 
of the EU policy  was neither to protect consumers from being misled nor to preserve the 
characteristics that wines may  have when associated with those  terms.  
3.103.   He then recalled that,  despite its pos ition that the EU legal regime was  inconsistent with 
the TBT Agreement, and in order to reach a prac tical and constructive solution, Argentina 
submitted in 2009  its dossier for approval of the terms " Reserva " and " Gran Res erva". He said that  
Argentina responded to the objections raised and supplied additional information in response to 
requests from the European Commission for clarifications . He reported that Argentina's dossier 
was discussed and examined by the European Co mmission Win e Management Committee in 
March  2012 and since then Argentina has been awaiting comple tion of the final steps. He said that 
the situation was incoherent  as the substantive process la sted two years and seven months, while 
the formal administrati ve decisions ha d still not been adopted after more than three years  (since 
March 2012) . He noted that a new ad  hoc group within the Commission's Directorate General for 
Agriculture and Rural Development was currently reviewing all the requests for recognit ion of 
traditional terms  and that, further  delaying  the final approva l of Argentina's requests . He noted 
that Argentina had expected a favourable so lution at a multilateral , plurilateral and bilateral level 
despite not  receiving a positive response or a va lid explanation to justify  EU's delays. He concluded 
by saying that the  delay in resolving  the issue was unjustified and requested  the EU to lift the 
restrictions so as to include the  item on the agenda of the next meeting of the College of 
Commissioners f or adoption and publication of the relevant regulatory act in its Official Journal.  
3.104.   The representative of the United States  said that this EU measure would severely restrict 
the ability of non -EC wine to use common or descriptive and commercially valuable terms, on the 
grounds that those terms were traditional to European wines. She said that this  was a concern  
particularly when some of these terms did not have a common definition across all EU  member 
states. She noted that some US  suppliers which currently  used these terms remained unable to 
ship their products to the EU. The US did not understand why some countries had already been 
granted permission to use some traditional terms, while other countries, including the US, 
continued to wait on their applicat ions for years. She reported that in a conversation with the 
                                                
8 G/TBT/M/64/Rev.1 , Paras. 2.124 and 2.125.  G/TBT/M/66  
 
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  Commission on 8  June 2015, the Commission stated that it was not acting on the applications 
pending the completion of a review of the regulations and simplification of the entire process. She 
suggested that the existing applications be reviewed while the simplification process was ongoing. 
She also said that while her delegation appreciated that the European  Commission shared 
information and solicited feedback, this process still lacked transparen cy as not all necessary 
information on the comment procedures has been provided. She thus requested the EU to inform 
the time at which it would publish information about its review of the traditional terms regulations 
and notify the simplification process to the WTO. The EU had not responded to the WWTG's 
October 2014 letter and that the Commission had declined an invitation to speak on the issue of 
applications at the 30 April  2015 WWTG Intersessional meeting in Brussels.  
3.105.   The representative of the European  Union  said that an internal assessment on traditional 
terms had been carried out within the EU with stakeholders and experts from its member  states. 
The consultation was still ongoing and included conditions and specificities under which the 
traditional t erms at issue could be used on the labels of products from third countries. She stated 
that the possible derogations, based particularly on minimum requirements for production 
methods and controls under product specifications of the wines concerned, had be en covered by 
the discussion and that no conclusion had been reached. The EU would continue to make 
necessary efforts to bring new elements in its current policy on protection of traditional terms and 
their indication on the labels of wines in order to acc ommodate trade partners' concerns. She 
informed the TBT  Committee that the concerns raised by Argentina and the US had been taken 
into account in the assessment process currently being carried out in the EU  and that the EU 
continued to be open to discussio n with trade partners bilaterally.  
3.2.3.11   Chile – Proposed amendment to the Food Health Regulations, Supreme Decree 
No. 977/96 , G/TBT/N/CHL/219 G/TBT/N/CHL/219/Add.1 G/TBT/N/CHL/221, 
G/TBT/N/CHL/282 (IMS ID 370)  
3.106.   The representative of Canada  said that while  his d elegation supported Chile's policy 
objective of promoting healthy dietary choices, r educing obesity and related non -communicable 
diseases (NCDs ), his delegation remained concern ed that these regulations, notified on 19 August 
2014, contained the following flaws:  (i) they deviat ed from international standards;  (ii) they were  
not be based on science ; and (iii) they were likely to be more trade restrictive than necessary.  He 
thus urged  Chile to consider a less trade restrictive alternative to achieve its polic y goals. He 
recalled that Canada had submitted written comments in October 2014, but ha d yet to receive a 
response  from Chile . As the D ecree appeared to be  with the " Contraloría General de la República 
de Chile " (General Comptroller Office of the Republic  of Chile - CGR) for approval , he also 
requested an update on  status of the measures and the timelines for their implementation .  
3.107.   The representative of Mexico  reiterated  its concerns , noted in document G/TBT/W/406 , 
regarding the amendments to Supreme Decree  No. 977 in respect of the labelling of food products. 
Like Canada, Mexico was aware that a version  therein,  dated 16  April 2015, was  currently with the 
Comptroller' s Office. Mexico  was concerned about the measure's possible infringement of Articles 
2.4 an d 2.2 of the TBT Agreement as well as Article  20 of the TRIPS  Agreement . Mexico asked 
Chile to inform the current status of this measure and its technical content. Mexico also asked 
Chile to inform the basis for its determination of  the amounts beyond whic h foods were  considered 
to contain excessive salt, sugar and fat. It also request that Chile modify the clas sification of 
foods, which made  a distinction between solid and liquid foods, so as to take into account 
internation al parameters and ensure food wo uld instead be  classified according to the category to 
which it belonged . 
3.108.   The representative of the European Union  recalled the concerns  expressed at the previous 
TBT Committee meeting regarding notification G/TBT/N/CHL/282.  The EU had submitted written 
comments with respect to  this notification and would welcome a written reply  from Chile . He also 
requested  an update on the status of the measure and an explanat ion on how the concerns of 
WTO M embers were being taken into account  by Chile . 
3.109.   The representative  of the United States  said that her delegation strongly supported Chile's 
public health objectives of reducing obesity and related NCDs , and appreciated the extensiv e 
bilateral engagement on Chile' s nutrition label ling regulation.  The US recognized that th e 
finalization of the regulation was imminent  as a draft ha d been signed by the President of Chile  
and was now in the "Contraloría General de la República de Chile " (General Comptroller Office of G/TBT/M/66  
 
- 25 - 
 
  the Republic  of Chile - CGR) for legislative review. However , guidance was requested regarding 
where the process st ood as the US was concerned that the final regulation would  contain elements 
which could affect as much as US $250 million in exports  annually.   
3.110.   With respect to the substantive provisions, the US noted that t he version of the regulation  
being currently considered require d a "stop-sign" shaped icon on the front of pre -packaged foods 
that exceed ed certain thresholds of saturated fat, sugar, sodium, or calories. Recognizing that 
there was no single correct approach to nutrition label ling, US industry was concerned about the 
nature of this requirement, as it may constitute an obstacle to international trade. She asked if 
Chile had considered a less -trade restrictive approach . The US was  also disappointed that Chile did 
not adopt a product /category -based methodology for determining whether labels were required 
based on serving sizes of a typical daily consumption diet. She highlighted that a 100g or 100ml 
portion for all foods d id not reflect typical daily cons umption of many foods  (such as butter, gum 
or white bread), and would  likely mislead  consumers, since many nutrient -dense foods may have 
to bear warning icons.  The US positively recognize d that Chile would  allow health claims and 
trademarks on foods that m ust bear icons. Such information would provide positive information on 
foods where the nutrient content of saturated fat, sugar, calories and salt ha d either been reduced, 
or the food was a good source of other nutrients that could  be useful in reducing th e incidence of 
disease. She said t his would  provide incentive to industry to reformulate and make foods healthier.  
3.111.   The US also expressed its belief that a  single extended period for implementation and 
compliance with nutrient threshold -based  labelling requ irements  was needed, preferably 2  years 
from the date the final regulation was published.  Staggered phase -in periods would raise costs for 
industry by requiring multiple label changes.  Her delegation  planned to monitor the impact of 
Chile's requirements on  US pre-packaged food exports. She asked if Chile was considering an 
evalua tion of the regulation after 18  months  and, i f so, whether the evaluation process could be 
explained and the results shared with tra ding partners.  
3.112.   The representative of Australia  expressed his delegation's support for  Chile's right to 
implement measures to provide consumers with information to make appropriate dietary choices 
and reduce the risk of diet -related NCDs, provided that such mea sures were implemented in a 
WTO-consistent m anner.  He appreciate d, in particular,  the clarification provided by Chile on issues 
such as the form of the warning label on packaging. Australia was also pleased that Chile ha d 
changed the proposed front -of-pack labelling requirement based on suggestions by Australia and 
other Members . However, he note d that the labelling scheme was still mandatory for some food 
categories , including some dairy foods . There were also some inconsistencies between the 
requirements for imported and domestic product s. Noting t hat Chile had extended the date of 
entry into force to 30 June 2015 , Australia look ed forward to working with Chile and receiving 
further notifications on proposed amendments.  
3.113.   The representative of Guatemala  reiterated concerns expressed over this measure and 
requested Chile to  respond to the issues raised by Guatemala in writing. Information on the status 
of the measure and the intended implementation procedure was also requested.  
3.114.   The representative of Brazil  reiterated the importance of providing informa tion on the 
scientific basis of the Chilean measure as well as the international standard that was taken into 
consideration in accordance with  Article 2 of the TBT Agreement.   
3.115.   The representative of Costa Rica  stated that the Chilean measure require d specia l labelling 
and impose d restrictions with regard to advertising . Costa Rica believed these requirements could 
violate Chile's obligations under  the TBT and TRIPS Agreement s. Furthermore, comments made 
during the public consultations did not appear to have been taken into account. Costa Rica was 
concerned  in particular with the measure's possible significant impact on trade  as a result of the 
imposition of warning message, the application of thresholds for certain foods without 
consideration of portions , and the limitation of trademarks . He believed that the current 
description with regard to colour codes and nutrient content d id not comply with the 
TBT Agreement , especially with respect to the absence of a scientific basis and lack of conformity 
with interna tional standards  (i.e. Codex  guidelines ). 
3.116.   The representative of Colombia  said that his delegation had submitted written comments 
and requested a written response from Chile.  G/TBT/M/66  
 
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  3.117.   The representative of Chile said that on 16 April 2015, Chile's Minister of Health  and the 
President of the Republic  issued and signed  Decree  No. 13. On 20 April, this Decree was brought 
before the "Contraloría General de la República de Chile " (General Comptroller Office of the 
Republic  of Chile – CGR). He explained that the CGR was a body independent from the 
Executive  Power, which was in charge of examining the legality of measures such as 
Decree  No. 13. On 16 June 2015, Decree  No. 13 was withdrawn from CGR so that certain 
modifications requested by this body could be introduced and C GR would then be able continue the 
legality review process, which was expected to be completed by the end of June  2015.  
3.2.3.12   India – Electronics and Information Technology Goods (Requirements for 
Compulsory Registration) Order, 2012 , G/TBT/N/IND/44,  G/TBT/N/IND /44/Add.1, 
G/TBT/N/IND/44/Add.2, G/TBT/N/IND/44/Add.3, G/TBT/N/IND/47 (IMS ID 367)  
3.118.   The representative of Canada  remained concerned with the Electronics and Information 
Technology Goods Order of 2012  as it could hinder or possibly shut Canadian exporters ou t of the 
Indian market due to delays in registration and testing.  He again suggested that India recognize 
foreign conformity assessment bodies accredited by signatories to the ILAC and IAF  to test and 
certify to India's regulatory requirements . This would minimize the negative impact on companies 
wishing to export to India while provid ing assurance that the recognized conformity assessment 
bodies were competent. Allowing accredited foreign conformity assessment bodies to test and 
certify  would reduce testin g costs and allow exporters to bring their products to the Indian market 
more quickly.  Noting that the Bureau of Indian Standards (BIS) required a mutual recognition 
agreement (MRA) to accept tests results from non -BIS laboratories , even if they were ILAC - or 
IAF-accredited , Canada ask ed for the  rationale for requiring a n MRA and for details about the 
scope of these agreements. Finally, he noted that substantive amendments to the Order, such as 
those with respect to marking and labelling requirements, shoul d be notified to the 
TBT Committee.  
3.119.   The representative of the European Union  said that his delegation continue d to regard the 
compulsory registration scheme for electronic products to be  excessively burdensome . Since the 
last Committee meeting, India had n otified the expansion of the compulsory registration scheme 
to fifteen new product categories  in notification G/TBT/N/IND /47. However, this notification was 
made  only after publication of the expansion order . He appreciated that India had extend ed the 
date of entry into force for seven of the fifteen categories until 13 August 2015, whereas for the 
remaining  eight, the entry into force remain ed 15 May 2015. The EU invited India to postpone the 
entry into force for all fifteen categories until it had review ed the comments receive d from 
WTO Members.   
3.120.   Concerning the EU's request for streamlining the registration process, he expressed his 
delegation's appreciation with the fact that a technical advisory committee ha d been set up , under 
the Department of Electron ics and Information Technology of the Ministry of Communication and 
Information Technology, to  look into possible improvements to the process . The EU sought 
confirmation that this committee was active ly consider ing allowing one product registration 
number per product  model in case s of multiple factory location s under the responsibility of the 
same manufacturer and when the product was sold under the same brand. The EU also believed  
that consideration should be given to a shorter processing time for applicat ions, especially for 
some products  with a short life cycle. The EU  request ed acceptance of test reports generated 
under the IECEE  CB scheme or by laboratories which were accredited to ILAC  MRA signatories. On 
validity of the test report , he reiterate d that there was no reason , in principle , to limit this validity 
to ninety days in order for the application for registration to be filed with product safety 
characteristics that ha d not changed. Finally , with respect to the validity of registration, the EU  
believed that the limit of two years should be interpreted flexibly if the product ha d not undergone 
any safety property  changes.  
3.121.   The representative of the United States  appreciate d the continued interaction on the 
implementation of the Compulsory Registration  Order  (CRO) . She recalled that at the March  2015 
TBT Committee  meeting, India had stated that the validity period of registration was increased 
from one to two years, and that registration for multiple factories was under active consideration 
by the Polic y Advisory Committee. She welcome d any updates that India could  provide on these 
developments.  Furthermore, feedback received from US industry indicated that the registration 
renewal form was currently being reviewed, and she encourage d India to ensure tha t only 
information necessary for renewal was required in the form.  The US also appreciate d that in the G/TBT/M/66  
 
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  past, India ha d reviewed and expanded the list of products under the High Specialized Equipment 
exemption  and urged that this list be further broadened t o include all products that were not for 
the consumer market and pose d little risk to average consumers. For example, products that were 
IT products installed, operated, and maintained by professionals trained to manage the product's 
inherent safety risks.  
3.122.   The US also stressed that, d espite positive engagement , it continue d to hav e serious 
concerns with the CRO' s requirement that foreign products be retested to an Indian standard that 
was identical to an international standard, particularly when the product s had already been tested 
to that international standard . She viewed t his as an example of how India' s CRO posed 
unnecessary restrictions.  Noting India' s explanation that under the BIS Rules , items covered by 
the CRO were required to be tested at a lab in India recognized by the BIS or at a lab covered 
under an MRA  with BIS , the US stated that as a member of the IEC EE CB Scheme, India already 
effectively ha d an MRA with other m embers of this scheme. The US, therefore, did not understand 
the reason for requiring an additional MRA on the top of the existing agreement India already ha d 
with IECEE  CB Scheme members. The US thus  again request ed India to recognize test results from 
accredited labs located outside India. In addition, the US  request ed that appointed  labs only 
require a product sample unit to conduct verification testing if the labs could not resolve a 
suspected non -compliance issue from information exchanges between the certification body 
issuing the test report and/or the manufacturer. This would pr ovide immediate relief t o 
manufacturers and allow India' s labs to improve testing.  She noted India' s response that the 
expiration of test r eports within 90  days was adequate, but assure d India that such an expiration 
period was not deemed adequate by indus try, and that this practice d id not align with international 
norms as no other national certification agencies ha d expiration dates on their test reports. The 
US, therefore, request ed India to eliminate this expiration period.  
3.123.   The US further noted that a l imited amount of time was provided between  India' s 
March  2015 notification and the entry into force of the expanded list of 15 products subject to the 
CRO requirements. She requested that additional time be provided for traders to comply with 
these newly n otified requirements.  The US  also encourage d India to continue its collaborative 
consultations with industry and other stakeholders to bring its safety testing regime into alignment 
with international best practices  for testing and certification of IT and electronics equipment as this 
would  help jumpstart "Digital India"  efforts.  
3.124.   The representative of Switzerland  asked why low  risk electronic products  - such as LED 
lamps, mobile phones,  cash registers and power banks  - were submitted to compulsory 
registrat ion. He recall ed that India was requesting in -country testing for these products  and that 
foreign test results were not recognised even if carried out by l aboratories working under IECEE  CB 
schemes. He said that s uch conformity assessment appeared to be  more restrictive than necessary  
and, this respect, he drew India's attention to the fact that Article  5.1 of the TBT Agreement 
provided  a strong case for less burdensome procedures  for low risk consumer products. He also 
noted that tests were valid for 90 days only and were to be renewed every two years . India ha d 
not yet provided an explanation for this restrictive practice.  Switzerland again invited India to 
accept conformity assessment ba sed on IECEE  CB schemes.  
3.125.   The representative of India noted that most of the concerns raised had been explained in 
previous meetings. As there was no change in the regulatory status, he requested interested 
delegations to refer to India's statement contained the minutes of the last TBT Committee meeting 
in March  2015.9 He fu rther said that the single registration for multiple factories was under active 
consideration by the Policy Advisory Committee  ("PAC"), which had recently approved a list of 
criteria . The scheme for single registration was being prepared by the BIS and the  Department of 
Electronics and Information Technology  ("DeitY") and would be placed on the BIS website for 
stakeholders ' consultations before finalization. He added that DeitY  had initiated surveillance for 
notified goods and samples were being picked  up from the manufacturer' s location. India stated 
that t he surveillance provisions form ed part of the initial CRO  under Gazette Notification No.  1975 
of 3 October  2012, which came into force on 3 July 2013  and h ence no separate notice period for 
surveillance was required.   
3.126.   India provided clarification s on cells and batt eries covered by the new Order. Sealed 
secondary cells and batteries co ntaining alkaline or other non -acid electrolytes for use in portable 
                                                
9 G/TBT/M/65 , paras. 2.107  to 2.109 . G/TBT/M/66  
 
- 28 - 
 
  applications were covered under compulsory registration . These cells or batteries need ed to be 
separately registered e ven if used in other products. He added that i f the battery was an integral 
part of the host product and non -detachable, it would be tested as part of the host product and a 
separate registrati on for the battery in such a case was not required.  In response to  a query on 
the addition of new models to already registered and existing series , he clarified th at as per the 
series guidelines  up to ten models would  constitute one series. More models cou ld be added to a 
registered series up to a count of ten in the series, provided the new models compl ied with the 
series criteria.  Concerning marking/labelling on cells , he said  that BIS ha d already notified labelling 
requirements for the self -declaration m ark under the compulsory registration scheme vide Order 
No. BIS/DGO/(405)/ 2014, dated 31 July 2014. Para graph  7(vi) of the O rder clarifie d that where 
the products were too small in size and the statement could not be marked on the product, the 
same could b e done  on the packaging and accompanying documents.  Finally, he took note of the 
additional concerns raised and which had not been clarified in previous meetings, and said that 
these would be  forward ed to capital for a suitable response in due course.  
3.2.3.13   Peru  – Act to Promote Healthy Eating Among Children and Adolescent , 
G/TBT/N/PER/59  (IMS  ID 383)  
3.127.   The representative of Canada  said that while his delegation  supported Peru's objective of 
reducing obesity and other NCDs, there were concerns that this measure may  deviate from 
international standards and be more trade restrictive than necessary to achieve its objective.  Since 
final technical parameters for sugar, salt and fat levels in food were published on 18 April 2015, he 
asked how Peru had established these le vels and whether they were based on international 
standards.  He stressed in this regard that e xisting Codex guidelines on health claims and 
nutritional labelling could be used as the basis for alternative approaches that could provide similar 
information t o consumers without the cost of  mandatory product relabelling. Canada asked  how 
food warning labels were to be affixed to products  and whether  these labels could be affixed at a 
customs bonded warehouse in Peru prior to entering the market . Additionally, Peru had failed to 
provide explicit instructions on how products were to be determined to be "high" in sugar, salt or 
fat and on the type of enforcement mechanisms to be used to ensure that products were properly 
labelled. He requested Peru to provide detai ls on the product certification process and the 
post-market enforcement mechanisms . Finally, he asked when these regulations would enter into 
force and encouraged Peru to provide a transition period to allow industry time to adjust to any 
new labelling req uirements.  
3.128.   The representative of Mexico  shared the concerns expressed by Canada and recalled 
concerns expressed on previous meetings. In particular, Mexico referred to the "Regulation that 
establishes the technical parameters for non -alcoholic food and bev erages with respect to their 
sugar, salt and fat contents". He asked Peru to explain the basis for the regulation in accordance 
with the first sentence of Article 2.4 of the TBT Agreement , in particular on how Peru defined 
technical parameters and what was  the rationale behind the division of foods into liquids and 
solids. He also asked on which international standard Peru had used as a basis for the 
differentiation and establishment of the parameters, as well as the basis for the exceptions in the 
applicat ion of tho se technical parameters that were included in the Regulation. Finally, he 
requested Peru to elaborate on the next steps for implementation of this measure.   
3.129.   The representative of the United States  said that her delegation wa s monitoring the 
devel opment of Peru's regulations to implement the Healthy Eating Act. While the US  support ed 
Peru's public health objectives of reducing obesity and related  NCDs as well as the objective of 
encouraging healthy eating, concern s remained  over the potential impac t of the Act and the 
recently notified Supreme Decree on US pre -packaged foods export ed to Peru (amounting to 
USD 258.7 million in 2014 ). In terms of process concerns, she noted that Peru had committed to 
allow trading partners to comment on nutrient conte nt limits in the Supreme Decree. The US, 
therefore, urged Peru to notify Supreme Decree 007 -2015-SA, establishing technical parameters 
for labelling the content of sugar, salt and saturated fat in pre -packaged foods and beverages , 
which was published domes tically  on 18 April 2015. She added  that the US had submitted an 
enquiry point request for notification of this measure on 24 April 2015.   
3.130.   With respect to the scope of labelled foods, the US stated that nutrition panels were a 
valuable tool for consumers i n making informed choices  and encourage d labelling for all 
pre-packaged foodstuffs. She added that Codex and the WHO Global Action Plan for the Prevention 
and Control of NCDs  advocate d nutritional label ling of all pre -packaged foodstuffs.  The US was G/TBT/M/66  
 
- 29 - 
 
  concer ned that nutritional labelling was only mandatory when either a voluntary claim was made 
or a consumption warning was required.  She asked if Peru had considered alternative approaches 
as nutrition panels may be regarded by consumers in a negative way if on ly the least healthy 
foods were required to display nutrition information. Targeting only certain foods for nutrition 
labelling could make it more difficult for consumers to identify healthier foods.  In contrast, 
mandatory nutrition de claration for all foo ds and non -alcoholic beverages g ave consumers the 
most complete information to make dietary decisions because all foods contribute d to daily 
nutrient consumption , unless nutritionally insignificant.  
3.131.   The US also asked Peru to explain whether t he consumptio n warning, as specified in the 
Act, w ould apply to signifi cantly more foods and non -alcoholic beverages than those specified in 
notification G/TBT/PER/59. With r espect to nutrient limits, Peru' s proposed threshold for the 
amount of sodium would require a c onsumption warning and nutrient facts panel that wa s 
significantly lower than what would correspond with the  Codex NRV -NCD of 2000 mg/day. She 
asked Peru to clarify how it determined and chose the proposed limit , rather than the Codex NRV. 
The US also noted that while Codex ha d not established a nutrient reference value for sugar, the 
WHO recommend ed that no more than 10 % of calories come from free sugars. She asked Peru to 
clarify  the basis by which it established the per -portion n utrient content limit for  sugar. Noting that 
Peru's nutrient content limits notified in G/TBT/PER/59 more closely align ed with typically 
consumed portions , the US asked  Peru to explain why it determined an across -the-board nutrient 
threshold based on 100  gram, or 100  millilitre , amounts was appropriate for its population. For 
example, a 100  gram portion was well over a typical serving and daily consumption of butter, gum 
or white bread.  Recognizing that Codex also allow ed for the use of serving sizes if the number of 
servings conta ined in the package was stated, the US asked if Peru would instead consider using 
thresholds based on actual serving sizes of more specific food types that would vary to reflect the 
consumption patt erns of the Peruvian population. Furthermore, she asked w hy Peru had not 
provide d for labelling putting the "consumer  advisory " into the context of daily dietary 
consumption, especially for foods where the customary portion consumed was typically larger or 
smaller than the 100g/ml baseline or where the food may p rovide other valuable nutrients.  
3.132.   With respect to compliance guidance,  the US noted the comments submitted to Peru on 
18 August 2014, and asked whether Peru was considering supplemental symbols, icons or pictorial 
representation of an advisory statement ass ociated with nutrient thresholds. Additional guidance 
documents would be helpful in enabling US industry to comply with the regulations. She requested 
an update on Peru's timeline for the development of the guidance. She reiterated the importance 
of an ext ended period for compliance , which would help reduce costs associated with label design 
and label stock supply and rotation. Typically , countries allowed a longer time period for 
compliance when label redesign was required. For example, FDA issued two prop osed rules in 
March 2014 (G/TBT/N/USA/893 and G/TBT/N/USA/894) that would, if adopted, require major 
changes to US  pre-packaged food labels. The FDA proposed a compliance period of two  years from 
publication of the final rule, whereas the Peruvian Resoluti on 30021 allowed only 180  days for 
compliance.   
3.133.   The representative of Guatemala  reiterated the concerns raised by her delegation at  
previous meetings . She was particularly concerned that Peru had published the regulation on 
18 April 2015 with no scientific  or technical basis for the values  therein. She requested Peru to 
provide clarifications on the regulation and the issues raised by Guatemala in its previous written 
comments.  
3.134.   The representative of Costa Rica  said that his delegation supported the concern s raised by 
the previous delegations. W hile his delegation shared the health concerns associated with obesity 
and NCDs, the necessity of implementing any health measure in this area must be justified by 
technical and scientific information.  Costa Rica cons idered that Peru's Supreme 
Decree  007-2015-SA lacked such necessary technical and scientific justification. He recalled that 
this Decree implemented the fi rst transitory provision of " Ley 30021 " (Law  30021 ) on the 
promotion of hea lthy eating for children a nd adolescents . This first transitory provision of this 
Law called for the establishment of  technical requirements for determining whether a food product 
contains high levels of sugar, sodium and saturated fat. However, Decree  007-2015-SA did not 
comply wi th the mandate of Law 30021 that it was supposed  to implement given that the values 
established therein  cannot be considered as being "high" just b ecause  they were based on a 
document called "Recommendations from a Pan American Health Organization Expert C onsultation G/TBT/M/66  
 
- 30 - 
 
  on the Marketing of Food and Non -alcoholic Beverages to Children in the Americas ."10 Costa Rica 
noted that this document was no t clearly endorsed by all m embers of the Pan  American Health 
Organization  ("PAHO"). Instead, this was a document merel y based on personal opinions of the 
participants.  Additionally, Costa Rica considered that the " food values" expressed therein did  not 
comply with relevant international "food codes" for they lacked scientific basis and were not  based 
on international stan dards. That was to say, they did not show any  scientific basis linking the 
nutritional characteristics of a specific food with health risks related to obesity/overweight and 
other NCDs. Finally, he expressed his delegation's concern that this Peruvian labe lling scheme 
would affect consumers by not only creating confusion , but also by considerably cont ributing to the 
increase in informal supply of food  products and beverages that were not produced under known 
health standards.  
3.135.   The representative of Peru reported that Law  30021  was promulgated on 17 May 2013  to 
promote healthy eating among children and adolescents . This law established in its first 
complementary provision the technical parameters for determining whether processed foods and 
non-alcoholic bevera ges had  a high sugar, sodium and saturated fat content, and also provid ed for 
the gradual reduction and eventual eliminat ion of trans -fats. These parameters were specified in a 
draft regulation ( Decree  007-2015-SA), notified to the TBT  Committee on  20 May 2014 
(G/TBT/N/PER/59) , with a 90-day comment period, which expired on 31 July 2015.  On 18 April 
2015, Peru published the final version of such regulat ion. Regarding the timefram es for the 
implementation of this  Decree, she said that, although the final ver sion of this regulation had been 
already published, this was but only one  of the various other  component s of Law  30021. This law, 
in fact, contained  numerous other components, including the promotion of nutrition education and 
the implementation of a monit oring study of n utrition and obesity, which would have to  be 
developed in a comprehensive manner by an inter-sectoral commission  created for such purpose.  
As the consideration of these elements was still pending before that multi -sectoral commission, 
she e xplained that it was difficult to stipulate, in the short term, a date for the entry into force of 
"Ley 321". Consequently, stakeholders had a reasonable period of time to adapt their products to 
the new requirements. With regard to the basis supporting  the nutritional parameters established 
in Decree  007-2015-SA, Peru stressed that they  were based on recommendations from a 
consultation made to experts from PAHO on the promotion and advertisement of foodstuffs and 
non-alcoholic beverages targeting children . These recommendations were ratified by the "Plan of 
Action for the Prevention of Obesity in Children and Adolescents" during the "53rd Directing Council 
of the PAHO" and the "66th Session of the Regional Committee of WHO for the Americas. " Peru also 
stated that , in any event,  the nutritional levels established in Decree  007-2015-SA took into 
consideration the parameters established by  the Codex  Guidelines on Nutrition Labelling . 
3.2.3.14   European Union – Revised Proposal for the Categorization of Compounds as 
Endoc rine Disruptors of 19 February 2013 by DG Environment (IMS ID 393)  
3.136.   The representative of the United States  said that , while strongly supporting  the 
strengthening of public health and environmental protection by properly identifying , 
understanding, and regu lating the use of plant protection products that may have endocrine 
disrupting properties , the US had been raising concerns with the EU process for identifying 
endocrine disruptors  for several years. T he US submitted extensive comments on the EU Public 
Consultation on Defining Criteria for Identifying Endocrine Disruptors (EDs)  in January 2015 and 
also participated  in the EC  conference on the impact assessment criteria to identify endocrine 
disruptors, which took place on  1 June 2015. While the US was pleased to hear Commissioner 
Andriukaitis stress ing in his speech at that  conference that the Commission would do its " best to 
be open and transparent,"  that event concluded with no notable outcomes or indication of any 
specific actions the EU would undertake i n response to the con sultations that were held on that 
occasion. As emphasized in the past,11 the US was  concerned about the lack of transparency and 
urged the Commission to consider publishing a report, including outcomes of the conference and 
next steps. Furth er, none of the options outlined  by the EU in its roadmap appeared to take risk 
into consideration , as required under WTO obligations.  The proposal , as drafted , could thus impact 
billions of dollars of trade worldwide  and potentially result in the wit hdrawal a large number of 
substances, as well as  the products that contain them, from the EU .  
                                                
10 http://iris.paho.org/xmlui/handle/123456789/3594 . 
11 See G/TBT/M/65, para. 2.123.  G/TBT/M/66  
 
- 31 - 
 
  3.137.   The representative of Canada  said that his  delegation had present ed the potential trade 
impacts of ED regulations in the EU at a conference organized by DG  SANTE  in Brussels on 1 June 
2015. While awaiting the outcome of the  roundtable and the release of the preliminary report  of 
the Commission, Canada renew ed its request for further clarifications on the interplay between 
Regulation s 1107/2009 and 396/2005. Canada  believed that m oving to a more restrictive 
hazar d-based cut -off criterion would raise  concerns over how maximum residue limits  under 
Regulation 396/2005 would be established and renewed. Canada shared the EU' s objective s of 
ensuring food safety and a safe  environment. However, Canada also considered that a risk -based 
approach , as opposed to a hazard -based one,  would equally achieve  this objective , while also 
ensuring that g lobal agricultural trade remained  unimpeded. In fact, the EFSA Scientific Committee 
had reach ed a similar conclusion in its  2013 Scientific Opinion on the hazard assessment of 
endocrine disruptors, stating that "ED s can be treated like most other substances of concern for 
human health and the environment and be subject to risk assessment  and not just hazard 
assessment". The EU's hazard -based approach could thus disrupt trade in food and feed and 
unnecessarily create a level of uncertainty among exporting countries , while increasing costs for 
agricultural and agri -food stakeholders in both the EU and exporting countries such as Canada.  
3.138.   The representative of Australia  indicated that Australia had provide d a submis sion to the 
European Commission' s endocrine disruptor impact assessment public consultation process in 
January 2015. As the EU wor ked towards  develop ing any new policy  for endocrine disruptors, it 
was important to ensure that the new or amended regulations were no more trade -restrictive than 
necessary to fulfil the EU 's legitimate objective.  In addition, if the proposed new regulatio n was  not 
in accordance with an international standard, the proposal would need to be notified to the WTO so 
that Members had adequate time to provide input s. He requested  an update on the outcomes of 
the public consultation process and the EU' s plans to t ake forward the endocrine disruptor review.  
3.139.   The representative of New Zealand  said that her delegation continued to follow  with 
interest the evolution of the EU's regulatory approach to endocrine disruptors  and thank ed the EU 
for the opportunity to submit comments during the public consultation  process .  
3.140.   The representative of the European Union  said that, as mentioned in previous meetings , 
the EU had  initiated a comprehensive impact assessment that would  analyse different options for 
defining criteria for t he identification of endocrine disruptors and their corresponding health, 
socio-economic and environmental effects , once incorporated in diffe rent pieces of EU legislation. 
In this context, the European Commission had published , in mid -June 2014, a roadmap  setting  out 
the scope of th e impact assessment, and presenting the policy options that were being assessed. 
At least two sequential studies supporting the impact assessment were needed. The first one had 
started and would assess which chemicals might  be identified as endocrine disruptors under each 
of the various options for th e criteria. The second one would assess the socio -economic, health 
and environmental impacts of the incorporation  of the various options for the criteria into the 
relevant legislatio n. A public consultation on the definition of criteria for identifying endocrine 
disruptors in the context of the implementation of the EU's regulations on plant protection 
products  and biocidal products  had been carried out between September  2014 and Janu ary 2015 
to collect information relevant to the impact assessment . The responses received under such 
consultation were published on 2  February  2015 and a n analytical report of the responses would 
be provided by the Commission by the  summer  of 2015. The fac tual and  quantitative report would  
feed into the work for the impact a ssessment , the outcome of which would  not prejudge or 
constitute the announcement of any position on the part of t he European Commission. Instead, it 
would  allow the Commission to take a n informed decision as regards further EU  legislative work, 
as appropriate.  
3.141.   She also informed  the Committee that the Commission had organized a series of 
roundtable  meetings  between April and May  2015 as well as  a public conference on 1 June  2015, 
informin g EU member s tates, MEPs, third countries and stakeholders about t he ongoing impact 
assessment. Detailed information about the impact assessment as such, including the web-stream 
and the presentations given at the conference, was available on the website o f DG SANTE.12 The 
European Commission would  present proposals for new criteria to identify  endocrine disruptors in 
the EU' s plant protection products and biocidal products regulation s only after the conclusion of the 
impact assessment. She added that the cr iteria might  also have an impact on other pieces of EU 
legislation. Pending the new criteria, interim criteria were applicable in both the biocidal products 
                                                
12 http://ec.europa.eu/health/endocrine_disruptors/events/ev_20150416_en.htm . G/TBT/M/66  
 
- 32 - 
 
  and plant protection products r egulations. The E U would  notify the new proposal to the WTO in 
order  to allow third parties ' eventual comments to be duly taken into account.  
3.2.3.15   Indonesia – Ministry of Health Regulation 30/2013 on the inclusion of sugar, 
salt and fat content information, as well as health messages  on the label of processed 
foods, G/TBT/N/IDN /84 (IMS ID 389 ) 
3.142.   The representative of Canada  said that while supporting Indonesia's objective of reducing 
the risk of non -communicable diseases  (NCDs), his delegation was concerned about Indonesia' s 
regulatory proposal requiring labels for all processed a nd fast foods containing sugar, salt and fat. 
Presenting total values of th ese nutrients and including a health warning on the labels could  have a 
significant impact on trade and was likely to be more trade restri ctive than necessary. Canada had  
concerns about how t his nutritional information would be placed on the product and whether this 
information could  be affixed after importation of the good but before it was placed on the mar ket. 
Canada also questioned whether Indonesia' s requirement to include a mes sage identifying certain 
risks in relation to the quantity of sugar or fat ingested per day was  necessary to achieve its policy 
objective and asked whether  Indonesia could  provide any scientific evidence suppo rting the use of 
such measures and also identif y on which international standards they would be based.  Referring 
to Indonesia's statement at  the March 2015 TBT Committee meeting13 regarding the  possibility of 
accepting test results from other laboratories, including from the country of origin , he asked that 
Indonesia provide an update on the acceptance of test results from accredited laboratories that 
used internationally recognize d and appropriate methodologies. In addition, he asked Indonesia to 
provide a timeline as to when it would announce whi ch foo d categories would require the 
mandatory labelling for sugar, salt and fat , when the  regulation  would  enter into force and what  
the transition period for industry to adjust  would be.  Furthermore, as Indonesia had indicated that  
technical guidance for this regulation was being prepared , he asked for an update on the status 
and expected publication date of such technical guidance and also encouraged  Indonesia to n otify 
further amendments to the  regulation.  
3.143.   The representative of the European Union  reiterated h er delegation's  concerns with regard 
to the Indonesian Ministry of Health  regulation,  issued on 16 May 2013, introducing  a mandatory 
health warning message on sugar, salt and fat content on the label o f all processed food products. 
The EU was also interest ed in seeing the results of the total diet study undertaken by the 
Indonesian Mi nistry of Health with the aim of determining types of food to be included in high risk 
and low risk classifications. As reiterated in previous occasions, the EU looked forward to the 
issuance  of implementing provisions for the r egulation, address ing product c overage in detail as 
well as providing further  technical guidance. The EU requested  that both measures be notified to 
the TBT Committee while still in  draft form so that Mem bers were provided with sufficient time for 
comments . In particular, t he EU wished  to receive clarification and detailed information on three 
issues : (i) on how  nutrition information and related health warning s would be placed on the label, 
on testing meth ods for nutrition levels and on the conduct of risk assessment relat ed to NCDs; 
(ii) on the possibility for Indonesia to accept test results issued by laboratories other than the ones 
accredited by the Indonesian National Accreditation Body (KAN) or by oth er competent institutions 
having a Mutual Recogniti on Arrangement (MRA) with KAN; and (iii)  on the possibility to place 
stickers after importation, and before the placement of  the products on the market in Indonesia, 
for instance, in customs warehouses,  as an alternative to labelling in the country of origin.  
3.144.   The representative of the United States  noted  that the Decree of the Indonesian Ministry of 
Health  (MOH) lacked  clear guidance on how to implement and comply with t he new labelling 
regulations. While Indonesia allowed three years for compliance from the original  publication date, 
companies were  not in a position to work towards  compliance until the additional guidance was 
made available. Therefore, the US  request ed a more definite timeline as to when t he MOH would  
issue further technical guidance for implementation, as promised during previous discussions in 
the TBT Committee, especially since the measure had already entered into force. In addition, the 
US disagreed  with Indonesia's lack of acceptance o f test results from laboratories other than those 
accredited by , or having an MRA with, KAN, and continued to request recognition of test results 
from laboratories using appropriate or recognized methodologies, especially given the level of risk 
associated  with nutritional information and other labe lling elements. In the case of the US , for 
example, they recognize d the appropriate method from the Association of Analytical Co mmunities 
(AOAC) International. Furthermore, the US encourage d Indonesia to take int o account less trade 
                                                
13 G/TBT/M/65, para. 2.120.  G/TBT/M/66  
 
- 33 - 
 
  restrictive approaches , such as following a process of random sampling and testing of products in 
commerce , which could  ensure the accuracy of label information for the vast m ajority of food and 
beverages. Finally, the US  indicated its  continued interest in the findings of the total diet study, 
which Indonesia had conducted and referred to during the previous TBT Committee meeting.   
3.145.   The representative of Australia  said that his delegation recognized and supported 
Indonesia' s right to im plement measures to provide consumers with information to make 
appropriate dietary choi ces and reduce the risk of diet -related NCDs,  consistent with WTO 
obligations. Indonesia would  be one of the first countries in the world to implement a mandatory 
scheme  for foods containing sugar, salt and fat . He asked for clarification as to why Indonesia 
considered  that a mandatory health message on processed foods was necessary. In this respect, 
he recalled that the Codex Alimentarius Guidelines on Nutrition Labellin g (CAC/GL 2 -1985) set out 
the principles for nutrition labelling at the  international level. One of these principle s was that " the 
information should not lead consumers to believe that there is exact quantitative knowledge of 
what individuals should eat in  order to maintain health, but rather to convey an understanding of 
the quantity of nut rients contained in the product" . The application of a mandatory health message 
referring to levels of specific critical nutrients was  not consistent with this principle . Australia 
sought  clarification on how the risk assessment of products would  be undertaken with respect to 
NCDs and whether Indonesia would  define the size and location of the mandatory health message 
on the package.  
3.146.   Furthermore, he expressed his delegati on's belief that t he justification behind the 
mandatory labelling statement seemed  to be inconsistent with current nutritional advice. In 
Australia, for instance, dietary advice no longer included  a recommendation to moderate total fat 
content in the diet.  The most recent evidence supported by the latest Dietary Guidelines for 
Austr alians, published in 2013, advised  limiting the intake of s aturated fat but not total fat. Rather, 
Australia used  other forms of nutrition labels , such as the mandatory declarati on of key nutrients 
through a Nutrition Information Panel and voluntary nutrien t content and health claims, and 
encourage d nutrition information on food labels supported by effective and sustained nutrition 
education to address the rising level s of NCDs. I n this regard, Australia supported  the requirement 
for sugar, salt and fat content to be indicated on the l abel of processed foods as part of the 
nutrient information panel, which was a mandatory requirement in  many countries.  
3.147.   He also said that, according  to the information Australia had, nutrition labelling was  
regulated under Indonesian law but ap plied only  to nutritionally fortified and functional foods. As 
the Decree at issue did  not address the specific requirem ents for nutrition labelling, Australia  noted 
that the Codex General Standard for the Labelling of Pre -packaged Fo ods (CODEX STAN 1 -1985) 
required  nutrient labelling to be expressed as "g" or "kcal" per 100  g or per 100  ml, or 
per package if it was just one portion. Therefore, Australia suggeste d maintaining consistency with 
Codex Standards when  developing these requirements. In addition, Australia requested 
information on whether Indonesia would  allow stickers containing the health message to be 
applied to the labels of processed foods after imp ortation, and before being placed on the market. 
Furthermore, Australia noted  that the proposed nutrition declarations needed to  be based on tests 
carried out by accredited labs and sought clarification on the  methods  that would be used for the 
tests verif ying the nutrition declarations and whether tests performed  by foreign laboratories, or 
in-house laboratories of companies, would be accepted. Australia also sought  clarification on 
whether the proposed requirement would  be enforced for both domestic and i mported products 
and how compliance would  be tested. Finally, Australia noted that this Indonesian  Decree was 
published in the Of ficial Gazette on 16  April 2013 and would  enter into force three years after 
promulgation. Noting that the Decree was only  notified to t he WTO on 13 January 2014, he  
encourage d Indonesia to notify any further amendments and guides on the operation o f the 
Decree to the TBT Committee . Referring to Indonesia's statement from the previous 
TBT Committee meeting regarding an implementin g Decree, he requested  that this other Decree 
be notified to the TBT Comm ittee in a timely manner so as to allow WTO Members  sufficient time 
to provide comments.  
3.148.   The representative of Mexico  observed that this trade concern was similar to others raised 
during the meeting, where Members had called for further transparency regarding food labelling  
measures. His delegation was also interested in receiving updates on the measure and providing 
comments.  G/TBT/M/66  
 
- 34 - 
 
  3.149.   The representative of  Indonesia  said that t he imp lementing  regulation of the Ministry  of 
Health No.  30 (2013), which was  being discussed with stakeholders internally , would, as stated in 
the previous meeting,  cover some criteria regarding the types of processed food categories  as well 
testing and other technical requirements. The  implementing regulation would be notified after the 
conclusion of the discussions on the draft . For further details, he suggested that comments be 
summited to the Indonesia TBT Enquiry Point . 
3.2.3.16   Ecuador – Resolution establishing the "General  conformity assessment 
framework for Ecuador" and the "Handbook of procedures to be observed prior to all 
stages of the customs clearance, marketing and market surveillance of manufactured, 
imported and marketed goods subject to Ecuadorian technical regula tions , 
G/TBT/N/ECU/44, G/TBT/N/ECU/44/Add.1, G/TBT/N/ECU/44/Add.2 
G/TBT/N/ECU/44/Add.3 (IMS ID 398)  
3.150.   The representative of Canada  said that  burdensome documentary requi rements and local 
practices had made Ecuador' s current conformity assessment system unwie ldy for importers. As 
Canada had stated at the March  2015 Committee meeting , in light of comments received from the 
industry ,14 Ecuador' s conformity assessme nt requirements had  multiple levels of redundancy that 
create d impediments to trade. Several verific ation checklists, additional compliance reports, as 
well as local notarization requirements were  needed for individual shipments of potatoes , for 
example. These burdensome and redundant requirements create d extended delays in processing 
at importation and increase d costs to importers. Canada was of the view  that a sanitary 
registration and a certificate of conformity would be sufficient to ensure the quality and compliance 
of produc ts. The multiple requirements did  not appear to provide any additional level  of safety, 
security, protection of human and animal life, or protection of the environment, but rather seem ed 
to be more trade restrictive than necessary to m eet the Member's objectives. Canada welcome d 
information from Ecuador on any steps being taken to  mitigate these impediments to trade.  
3.151.   The representative of Ecuador  reiterated her delegation's position that the resolution was 
necessary to ensure compliance with measures related to security, the protection of human, 
animal and plant life, the preservat ion of environment, and the protection of the consumer. As per 
Article 9.1 of the Law on the Ecuadorean Quality System, the Inter -ministerial Committee on 
Quality was responsible for developing policies to define products that had to comply in a 
compulsory  manner with technical regulations and conformity assessment procedures. In this 
context , Resolut ions 001, 002, 005 of the Inter -ministerial Committee amended  Resolutions  9 and 
10 of the National Quality Council, which established guidelines regarding the implementation of 
each technical regulation. Therefore, the measures did not constitute a barrier  to trade. O n the 
contrary, they sought to establish efficient mechanisms, allowing for the assessment of compliance 
with the requirements established in techn ical regulations, via a certificate of conformity 
assessment or inspection together with its recognition certificate.  Similarly, domestic producers of 
goods subject to technical regulations need ed to submit a certificate of conformity or inspection 
from an  accredite d or designated body to the Sub -secretariat for Quality of the Ministry of Industry 
and Productivity . The procedures for  imported as well as domestically produced goods were 
conducted electronically.  
3.2.3.17   Ecuador – Resolution No. 116 of the Foreign T rade Committee of Ecuador of 19 
November 2013 and Technical Regulation of the Ecuadorian Standardization Institute 
RTE INEN 022 on the labelling of processed and packaged food products , 
G/TBT/N/ECU/19/Add.3, G/TBT/N/ECU/19/Add.5, G/TBT/N/ECU/19/Add.6 
G/TBT /N/ECU/19/Add.8 G/TBT/N/ECU/19/Add.9 G/TBT/N/ECU/19/Add.10 
(IMS  ID 411)  
3.152.   The representative of Canada  said that his delegation  supported Ecuador' s objective of 
reducing the risk of non -communicable diseases (NCDs) and acknowledge d Ecuador' s efforts at the 
previous meeting to provide references to some of the scientific basis for adopting their  appro ach. 
Nevertheless, he questioned the scientific evidence behind the established categories for the level 
of concentr ation of nutritional components.  In addition, Canada still had  concerns regarding the 
burdensome nature of the conformity assessment procedures . Specifically, Canada had  received 
industry complaints on the requirement to provide a verification checklist to demonstrate 
compliance on a per  shipment basi s. Canada believed that, alternatively, adequate data 
                                                
14 G/TBT/M/65, para. 2.141.  G/TBT/M/66  
 
- 35 - 
 
  management coupled with periodic audits was a less burdensome method of achieving the same 
objective. Canada was concerned that the regulation was  already having an impact on trade and 
that it m ight be more trade restrictive than necessary. Canada welcome d Ecuador' s views 
concerning the restrictive elements o f their law and whether they were  trying to improve the 
product certification process.  
3.153.   The representative of Mexico  reiterated his delegation's conc erns expressed in previous 
Committee meetings, which were also contained in document G/TBT/W/407. He asked Ecuador to 
provide information that would justify technical regulation RTA INEN 022, which was possibly in 
violation of Articles 2.2 and 2.4 of the T BT Agreement and Article 20 of the TRIPS Agreement. 
Mexico was particularly concerned that the nutritional labelling was not based on the nutritional 
intake of daily dietary requirements, regardless of whether they were  processed food or not. 
Mexico was al so concerned about the compatibility of Ecuador 's conformity assessment procedures 
with the obligations of the TBT Agreement.  
3.154.   The representative of the European Union  said Ecuador's Technical Regulation  022 on the 
labelling of proces sed and packaged food p roducts imposed nutrition food la belling obligations 
comprising "high  in" warnings and a traffic light warning system.  While the EU fully shared 
Ecuador' s public health objectives regarding the provision of adequate nutritional information to 
consumers , the EU doubted  that the approac h taken in the notified draft was  the best way to 
achieve these objectives and was proportional to the aim pursued, which should be to empower 
consumers to make an informed choice in order to foster effective co mpetition and co nsumer 
welfare. Recalling the EU's previous interventions,15 she underlined her delegation's concerns 
regarding the lack of proportionality of the m easure, its departure from Codex  guidelines and th e 
use of the "high  in" warnings.  
3.155.   The representative of the United States  recalled the US's  previous interventions requesting 
that Ecuador suspend i ts implementation of Resolution  116 in order to allow Members to comment 
on the measure and provide specific information on how Ecuador could take the least trade 
restrictive approach to its conformity assessment procedures. Reiterating this request, the US 
asked that Ecuador provide formal justification in a TBT notification concerning the legitimate 
objective achieved by the institution of this technical regulation not  already fulfilled by other 
pre-market import requirements. Since the last TBT Committee meeting , the US had been working 
bilaterally with Ecuador to outline  concerns and suggestions regarding Resolution  116 and looked 
forward to a response to these recomm endations.  
3.156.   Regarding Technical Regulation of the Ecuadoria n Standardization Institute 
RTE INEN No. 022 on the labelling of proces sed and packaged food products, recalling previous 
interventions , she reiterated  that requiring multiple certifi cates to demon strate conformity of 
labelling elements - in addition to a label review as part of the Sanitary Food Registration process 
and a certificate to demonstrate compliance with Ecuador's commodity standards  -, was overly 
burdensome and duplicative and would, in any case, add  no value in ensuring the safety of the 
products in question . US suppliers had  continued to encounter difficulties coming into compliance 
with the certificate of conformity requirements  and had reported that they had been unable to 
self-certify through use of acc reditation with ISO standards. In addition, US suppliers had  been 
asked to provide per lot or shipment lab tests from an Ecuadorean Accreditation Organization 
(OAE) accredited lab in a ddition to self -certification, which undermined  the use of self -certification. 
Suppliers needed to  have records available if audited, but should not need to produce them with 
every shipment. In this context, she asked for an update on Ecuador's  progress in recognizing 
third party  lab tests .  
3.157.   The US als o ask ed Ecuador to inform the basis for requiring an advisory sta tement on 
foods based on their "natural"  content, noting that no international guidance existed for  the 
determination of " natural" content of foods. Regarding the mandatory requirements to label f ood 
and beverage products with the statement: "Contains Transgenics", the US recalled its long 
standing position that for foods derived from genetically modified organisms that had been found 
to be substantially equivalent to conventional counterparts, man dating such labelling could create 
an erroneous impression that the product was less safe than conventional products. Rather than a 
mandatory labelling requirement, a voluntary approach would allow for consumer choice without 
                                                
15 G/TBT/M/65, para. 2.152.  G/TBT/M/66  
 
- 36 - 
 
  creating concerns in the eyes of the consumer that such products were unsafe. Therefore, the US 
encouraged Ecuador to reconsider its mandatory approach to biotech labelling.  
3.158.   The representative of Costa Rica  reiterate d his delegation's  concern with regard to the 
measure in question  and requested an update on the status of the measure and on how Ecuador 
had taken trade concerns  raised into consideration.  
3.159.   The representative of Guatemala  reiterated her delegation's concerns as expressed in 
previous meetings regarding the lack of transparenc y and respect of timelines for the development 
of this measure, which could be an obstacle to trade. Ecuador had indicated that the objective of 
the measure was to ove rcome obesity in its population. H owever, the labelling requirements 
prejudiced food as t he only cause of the problem. In addition, th e regulation deviated from Codex  
guidelines . Furthermore, there was no scientific evidence indicating that the regulation was apt to 
achieve its objective. She urged Ecuador to reconsider the design and scope of  the measure.  
3.160.   The representative of Ecuador  said that , as indicated in pre vious meetings, Resolution  116 
did not create any new obligatory technical regulations . She underlined that all technical  
regulation s in Ecuad or established  their scope of applicatio n, entry into force and mechanisms for 
conformity assessment and were notified to the TBT Committee in line with the transparency 
provisions of the TBT Agreement . Resolution  116 only provided  for the presentation of a 
supporting document together with the Customs Declaration as part of an internal administrative 
process. Therefore, it was not a technical regulation and did not constitute a trade barrier  
inconsistent with the TBT Agreement.  
3.161.   With respect to regulation RTA  INEN 022, she explained that the Min istry of Health's  
national study on health and nutrition, conducted in 2012, had revealed an increase in NCDs 
among the Ecuadorean population, independent of their age or socio -economic status. Therefore, 
policies had been establish ed to prevent such disea ses and to raise awareness of consumers 
regarding the content and characteristics of foods . In addition, Ecuador was complying with 
paragraph 3.3.1 of the "Action Plan for the Prevention Obesity in Children and A dolescents " of the 
Pan American Health Organ ization (PAHO), which had established  that a "number of countries that 
have norms in place for front -of-package labelling that allow for quick and easy identification of 
energy -dense nutrient -poor products and sugar sweet ened beverages, which take into 
consideration Codex norms. "16  
3.2.3.18   Russian Federation - Safety of products for children and adolescents , 
G/TBT/N/RUS/29 (IMS ID 418)  
3.162.   The representative of the European Union  requested further information concerning the 
timeframe for the adoption of amendments not ified under G/TBT/N/RUS/29. The EU asked Russia 
to confirm the information given at the previous meeting of the TBT Committee that the 
amendments were still under development and that the estima ted date for adoption was 
April 2015 at the earliest, with ent ry into force expected in October 2015. The EU also requested  
to receive the final adopted text once available.  
3.163.   The representative of the Russian Federation  explained that the actual implementation of 
the original technical regulation had revealed the need  to change certain requirements. Draft 
amendments to the technical regulation had been developed and duly notified. While Russia was 
interested in the rapid adoption of the amendments, it had been delayed due to the accession of 
two new members to the Eura sian Economic Union, with whom amendments needed to be 
coordinated. Regarding the timeline, while it was difficult to provide a specific date, it was 
expected that the amendments would be approved in a few weeks. The current version of 
technical regulation  would be applied until the adoption of the amended version.  
3.2.3.19   India – Labelling Regulations for Canola Oil (IMS ID 413)  
3.164.   The representative of Canada  reiterated concerns relating to the Food Safety and 
Standards Authority of India reaffirming India's positio n that this  product mus t be labelled and 
marketed as: " Imported Rapeseed - Low Erucic Acid  Oil (Canola Oil)."  He said that the labelling 
                                                
16 http://www.paho.org/hq/index.php?option=com_docman&task=doc_view&Itemid=270&gid=28890&lang=pt . G/TBT/M/66  
 
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  requirements directly affected exports, marketing and sales of canola oil in India. Canada 
expressed concern that these  changes to India's labelling regulations were not notified to the WTO 
and could be more trade restrictive than necessary to achieve India's legitimate objective of food 
safety. Moreover, the requirements differed from the international standard, namely th e relevant 
guidelines recommended by Codex Alimentarius. Canada was encouraged by a Bombay High Court 
ruling, upheld by the Supreme Court of India, which issued  a Stay Order against the FSSAI' s 
labelling guidelines for canol a oil in favour of an importer. A final ruling was yet to be issued by the 
Bombay High Court and he requested India to provide information on the status and possible next 
steps. He encouraged India to consider an alternative measure to the currently enforced labelling 
requirements for ca nola oil that would  not unnecessarily create a barrier to trade.   
3.165.   The representative of Australia  sought an update  on the status of the measure and said 
that Australia remained concerned over  the regulation's requirement  that the use of the term 
"canola oi l" was only permitted as a secondary term. His delegation believed that this regulation 
contradicted the Codex Alimentarius Standard for named vegetable oils, which permitted the use 
of synonym descriptors for "rapeseed oil", including "canola oil" (Codex Standard 210 - 1999, 
section 2.1.16). This was an unnecessary labelling burden for Australian exporters of refined 
"canola oil" to India and the term "canola oil" was often used to describe domestic products that 
were available for local sale in India. He said that India's Plant Quarantine Order 2003, which 
outlined India's import quarantine requirements for plants and plant products, allowed the use of 
the alternative terms "rape and canola". Australia supported FSSAI's initiative of harmonising 
India's fo od standards with Codex that commenced in early 2013. They also requested an update 
to the legal proceedings on the matter, further to the Supreme Court decision of January 2015.  
3.166.   The representative of India informed the Committee that there was no change i n 
regulatory status since the previous meeting. Therefore, the concerned delegations were 
requested to refer to the statement s made by India in the Com mittee meetings of November 
2014.17 In addition, India maintained that  the labelling requirement for "Cano la Oil"  was strictly as 
per Section 2.1.16 of Codex STAN 210 -1999, wherein it was specified as " Rapeseed oil – low 
erucic acid (low erucic acid turnip rape oil; low erucic acid colza oil; canola oil) is produced from 
low erucic acid oil – bearing seeds of varieties derived from the Brassica napus L., Brassica rapa L. 
and Brassica juncea L., species."  India would therefore have had no ob jection if the Label 
mentioned " Canola Oil" as " Rapeseed Oil  - Low Erucic Acid (Canola)". India objected in the event 
that a product was labelled only as "Canola Oil"  without a m ention of the source, that is, 
"Rapeseed Oil" . The FSSAI had maintained that it had no issues if " Canola Oil " was  mentioned in 
parenthesis under "Rapeseed Oil – Low Erucic Acid", as mentioned in the Co dex. 
3.2.3.20   Thailand – Draft Notification of the Alcoholic Beverages Control, Re: Rules, 
Procedure and condition for Labels of Alcohol ic Beverages, issued under B.E., 
G/TBT/N/THA/437 (IMD ID 427)  
3.167.   The representative of Canada  reiterated concerns his delegation  had expressed at previous 
TBT Committee meetings as well as th rough a letter sent to Thailand' s enquiry point in May 2014. 
Canada understood that the regulation entered into force in March  2014 and thus remained 
concerned about the measure 's prohibition of  the use  of wine labels that contained: (i)  images of 
athletes, artists, singers or cartoons; and (ii) messages  affiliated with certain activities , such as 
sport, music and contests . Some of the terms and definitions in the regulations lacked clarity and 
could therefore result in uncertainty for wine exporters. For example, some Canadian wine labels 
portrayed depictions of the prohibited and other artistic depictions which could be considered to be 
"cartoons" and, consequently, be also considered to be in  breach of the regulations, if imported 
into Thailand. He said that Canadian wine labels were not , however,  intended to appeal to children 
or promote irresponsible alcohol co nsumption. Moreover, Canada had not witnessed any evidence  
that the sale of products wi th the prohibited labelling increased youth or irresponsible drinking.  
3.168.   Given the forgoing, he said that while Canada recognized Thailand's right to implement 
regulations to protect consumer s' health and safety  and provide them with adequate information 
to make informed choices , Canada  was nonet heless still concerned that these  proposed labelling  
regulations could be more trade restrictive than necessary to meet their objective, and could have 
an undue impact on the trade of Canadian alcoholic beverages to Thailand. In this respect, he 
asked Thailand to point to studies suggesting  that such labelling constrai nts would help achieve 
                                                
17 G/TBT/M/64/Rev.1, para 2.206  (see also G/TBT/M/65, para 2.161).  G/TBT/M/66  
 
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  Thailand' s policy objective s. He also asked whether Thailand had considered any less trade 
restrictive alternatives to achieve these policy objective s. He noted in this respect that Thailand 
could be considering a different approach to the graphic warning labels.  He further inquired 
whether Thailand would be issuing an implementation guidance document.  
3.169.   The representative of Mexico  thanked Thailand for the responses to its comments, received 
on 11 June, but noted that the answers provided by Thailand were still unclear, so his delegation 's 
concerns persisted, in particular regarding confusing language of some provisions of the techni cal 
regulation. He urged Thailand to consider Mexico's request, contained in communication 
G/TBT/W/408, in the sense that, when preparing and adopting this measure, it should apply the 
proportionality principle contained in Article 2.2 of the TBT Agreement , be in accordance with 
international standards, where those standards exist, as provided in Article 2.4 of the TBT 
Agreement, and give due consideration to comments from trading partners ' comments on the final 
version of the technical regulation.  
3.170.   The repr esentative of the European Union  associated  herself with the statements made by 
Canada and Mexico,  and reiterated her delegation's concerns regarding the regulation on Criteria, 
Procedures and Conditions for Labels of Alcoholic Beverages (B.E 2558/2015), n otified by Thailand 
on 28 March 2014, and published in the Royal Gazette on 22 January 2015. She also noted that a n 
additional notification was submitted on 27 April  2015 and that the  measure entered into force on 
22 April 2015, with a transitional period of 6 months for compliance with the new requirements. 
The EU thanked Thailand for  having provided  clarifications and asked for information on the 
absence of an approval process for labels in the Act and for Thailand to confirm that information. 
The EU regr etted that most of the issues previously raised had not been p roperly addressed in the 
final A ct. There remained concerns about the strict labelling requirements proposed in the notified 
legislation and its departure from international standards.  
3.171.   Referrin g to Article 2.4 of the TBT Agreement, the EU invited Thailand to clarify the 
reasons for a deviation from the definition of a label and a container as provided in the text of 
CODEX  STAN  1-1985. In this respect, she noted that Thailand had removed the defi nition of 
"label" and added the definition of "packaging materials ". The EU expressed its concern that  the 
wording of the definitions was too broad and it was thus open to different interpretations. 
Regard ing Clauses  2 and 3 of the adopted regulation, the EU was concerned that the lack of clarity 
in the provisions of the notified draft re lating to messages on labels could  lead to inconsistent 
interpret ations by economic operators. She  requested Thailand to explain how it intended to 
interpret and enforce th ese clauses, in particular Clause  2(2), that dealt with messages that 
directly or indirectly persuade d the consumption  of, or made  claims on the benefit or quality of , an 
alcoholic beverage. Thailand had clarified that cartoon images that had been register ed as 
trademarks of alcoholic beverages prior to the enforcement of the legislation were not prohibited. 
However, the EU remained concerned that specific terms linked to the ageing or maturation 
process related to the conditions, quality or characteristics  of the product could be considered 
contrary to the notified provisions. The EU also believed that the administrative complexity of the 
label approval process and the short implementation deadlines for compliance constituted serious 
market access barriers and again requested Thailand if it could allow the sale of all products 
existing on the market unti l stocks were exhausted. The EU also invited Thailand to provide 
appropriate guidelines for implementation and to extend the transition period to one year. T he EU  
also inquired whether there was any mechanism of appeal for decisions taken on the label 
approval proces s. The EU welcomed that graphic  health  warnings were not part of the adopt ed 
regulations, but as Thailand' s reply of 11 June 2015 said that warnin g pictures were still under 
consideration , the EU remained concerned about their possible introduction. The EU requested 
clarification on the outcome of these considerations and the status of this proposed measure, in 
particular, regard ing the notification  to the TBT  Committee to which Thailand had committed itself 
during their previous meetings. The EU  reiterated requests that Thailand take into consideration 
less trade restrictive measures, or failing this, to provide clarification on which basis and evid ence 
they consider that different, less costly and burdensome alternatives, than the indication of a 
graphic health warning, would be insufficient to address the objective pursued.  
3.172.   The representative of the United States  said that they had submitted commen ts on the 
original text notified by Thail and as G/TBT/N/THA/437 in March  2014 and noted that many of 
these comments were not reflected in the final mea sure. The US supported Thailand' s desire to 
address its valid public safety and health concerns related t o excessive alcohol consumption, and 
requested further consultation to define a solution that addressed this concern without re stricting G/TBT/M/66  
 
- 39 - 
 
  trade unnecessarily. In this respect, she pointed out that the Act's vague language was open to 
misinterpretation and t here was no  technical guidance on how it would  be enforced . She also 
requested that Thailand delay implementation of the measure until such guidance was provided . 
Such delay was particularly important because the lack of implementing  guidance could lead to  
significant market access issues for US exports of alcoholic beverages to Thailand.  
3.173.   The representative of Australia  recognized the right of governments to take measures  
necessary to protect public health , including the Thai Government's efforts to address  a legitimate 
concern through its proposed labelling regulation for alcoholic beverages. He noted that the 
regulation entered into force on 15  April 2015 and that importers/manufacturers had until 
October  2015 to comply with the provisions. Importers and s uppliers required guidance to ensure 
compliance and Australia unde rstood that the Thai  Government planned to provide such guidelines 
and undertake consultations to assist industry in the development of labels in accordance with the 
new requirements. He wel comed a timeframe for the release of these guidelines. However, 
Australia still remained concerned that Clause s 2 and 3 could cause uncertainty for importers as to 
whether certain labels were consistent with the regu lation. For instance, in Clause  2 (1-2) it was 
unclear what constituted an "unfair message to consumers"  and what terminology on labels was 
prohibited under the regulation. He asked if, for example, descriptions of the taste and quality of 
the wine would be permitted. He asked whether certain descriptors  (such as "fine st", "premium" or 
"prestige") as well as  certain images associated with a brands heritage (such as a "mountain " or 
"vineyard ") would still be permitted. He said that the defi nition of a "cartoon" in Clause  3 (4) was 
unclear and aske d if, for example, artistic drawings a nd illustrations that were well -establ ished 
elements of the trademark  would be prohibited under these measures. Moreover, he considered 
that the label approval process appeared to be administratively burdensome, as 
importers/manufacturers required the approval of two government agencies. He enquired , in this 
respect,  what the responsibilities of these agencies in the process were.  
3.174.   The representative of South Africa  associated himself with Australia's statement , includin g 
the concern a bout the label appr oval process and provisions in Clauses  2 and 3. South Africa would 
send their comments to the TBT enquiry point in due course.  
3.175.   The representative of Chile shared the concerns of the previous delegations and said that 
although labelling of alcoholic beverages could seek legitimate objectives, such as protecting public 
health, it had to be as least trade restrictive as possible.  
3.176.   The representative of New Zealand  acknowledged and supported Thailand's right to 
introduce new reg ulations to address specific public health concerns. He reiterated that the new 
labelling requirements  that had been notified in April  2015 were unclear, subjective , and open to 
interpretation , thus leading to uncertainties and, ultimately, to making the m easures unnecessarily 
trade restrictive . He asked for clarity on the definition of several  terms in the regulation s and 
whether there would be an appeal process if a company would choose to challenge a decision 
made by the Alcohol Control Committee. The re gulation provided that labels used p rior to the date 
of enforcement  could continue to be used for a period of a 180 days after entry into force. 
However , New Zealand was concerned that this pe riod was  inappropriate for alcoholi c beverages 
with a longer she lf life. He requested continued engagement with stakeholders so as to clarify the 
process, implementation and enforcement and that the transitional grace period be extended until 
implementation guidelines were issued.  
3.177.   The representative of Thailand  thanked  representatives for their comments. Thailand's full 
statement is contained in document G/TBT/W/422.  
3.2.3.21   Ecuador – Draft Technical Regulation of the Ecuadorian Standardization 
Institute (PRTE INEN) No. 189: "Lab elling of alcoholic beverages" , G/TBT/N/ECU243 
(IMS ID 433 ) 
3.178.   The representative of Canada  remained concerned that the labelling re quirements 
contained in Ecuador' s customs regulation as published in the  official registry in September  2013, 
and the related tec hnical regulation notified on 8  April 2014, wer e more trade restrictive than 
necessary. The requirement that the labelling of products had to be done in the country of origin 
was a concern. The s tandard practice in the internationally traded spirits industry was to apply 
generic front labels in the cou ntry of production that provided mandatory information and to affix, G/TBT/M/66  
 
- 40 - 
 
  in customs bonded warehouses in the import market, other market -specific information on the 
back or secondary label. He asked why  Ecuad or did not allow this standard practice and how 
deviating from it was necessary to achieve its objective of protecting human health and preventing 
deceptive labelling. The regulation also required that the name of the Ecuadorian importer be 
included on the label that had to be affixed in the country of orig in. He asked whether previous 
concerns in this respect have been taken into account in revising the measure, as Ecuador had 
indicated it would.  He noted that the customs regulations published in 2013 were not notified to 
the WTO and hoped that any updates on this issue would be forthcoming and transparent.  
3.179.   The representative of Mexico  reiterated his delegation's concerns over the draft technical 
regulation and the fact that the proposed measure request ed labelling at origin and d id not provide 
for any possi bility of labelling or relabelling in a primary customs area. He recalled that one of the 
labelling requirements (to include the name of the Ecuadorean importer in the label) was 
established in a Resolution of Ecuador 's Customs National Service, dated 9 August 2013. In this 
regard, he also requested the removal of the requirement to indicate the name of the importer in 
Ecuador in the labelling affixed at origin. Finally, he said that any updates on the issue would be 
appreciated.  
3.180.   The representative of the European  Union  shared the concerns expressed by other 
delegations  and asked for a reply to the comments the EU submitted to Ecuador on 1  July 2014. 
He recalled their previously expressed concerns  with: (i) the obligation to state the name of the 
importer in  the front label; (ii) the requirement that the labelling of alcoholic products shall be 
done in the country of origin, not allowing labelling or re -labelling  in a primary customs area; and 
(iii) the need to undergo certification by a conformity assessment  body in order to verify 
compliance with labelling requirements. He asked Ecuador to clarify the relationship between this 
technical reg ulation and Resolution No.  SENAE -DGN-2013-0300-RE that related to post -entry 
control of imported alcoholic beverages, an d also how this technical regulation applied to products 
that had already been placed on the Ecuadorian market on its entry into force.  
3.181.   The representative of the United States  expressed her delegation's concerns regarding the 
requirement included in the re gulation for a certificate of conformity. The regulation  required that 
the name of the importer of alcoholic beverages be placed on the exported product in the country 
of origin, with no flexibility for placement in customs bonded warehouses via the use of  
supplementary labels, including stickers. She noted that Ecuador had previously informed that 
they were reviewing the comments received with the possibility of revising the measure so as to 
be less trade restrictive . The US inquired as to the status of th is review, given the potential added 
costs to any alcoholic beverage producer exporting to Ecuador. In view of the fact that  many 
countries allowed country -specific label changes in customs bonded warehouses, she asked why 
Ecuador did not allow this common  international practice and encouraged them to accept and to 
incorporate specific language allowing for it in existing and future norms and standards.  
3.182.   The representative of Chile expressed concern and requested Ecuador to provide an update 
on this matter.  
3.183.   The representative of Ecuador  explained that the rationale behind Resolution  No.300 of the 
National Customs Service of Ecuador SENAE -DGN-2013-0300-RE, "Resolutions Back Control of 
Imported Alcoholic Beverages" on labeling for these products, was to avoid i llegal imports and 
fraud due to the lower prices of these products in neighbouring markets. With regard to PRTE 189 
on the basis of the objectives set out in the TBT Agreement, this project had  the objective to 
protect the health and lives of people and pr event practices that may mislead consumers on 
alcoholic beverages. This regul ation established  requirements for the labeling of liquor to be sold in 
Ecuador, without any distinction between drinks. Ecuador received several comments on the draft 
regulation which was notified in 2014 to the WTO. She said that the regulation was still being 
analysed and did not have a commencement date and assured Members that they would be 
informed of the date when it was determined.  G/TBT/M/66  
 
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  3.2.3.22   China – Regulations for the Supervision an d 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)  
3.184.   The representative of Canada  thanked China for the clari fication th ey provided on 
Order  No. 650 of the State Council "Regulations for the Supervision and Administration of Medical 
Devices ". Canada considered that  certain aspects of that  regulation were still adversely affect ing 
Canadian manufact urers of medical devices. H e noted, in this respect, that China' s "Medical Device 
Registration Fee Schedule " was put into force without any notification to the WTO and that China 
failed to provide  Members  with a " reasonable interval between the publication of requirements 
concerning  conformity assessment procedure s and their entry into force", as required by 
Article  5.9 of the TBT Agreement . He repeated his  delegation's previous request for a status 
update on Article  13 of Order  No. 4 and Article  15 of Order  No. 5. It was his underst anding that 
before an imported medical device could be registered , or its applications listed, the product had to 
have obtained m arket approval from the country  (region) where the applicant' s business was 
registered , or where the product was produced. Cana da requested clarification o n this new 
interpretation and  on the  types of document s that  were required. Canada believed that s uch a 
requirement would be a problem  for Canadian exporters who may not necessarily seek regulatory 
approval domestically.  For exa mple, could ap plications be made for Canadian -originating medical 
devices , or in vitro diagnostic products , which have received approvals in other leading 
jurisdictions, such as the US or EU, but were not approved in Canada? Moreover, the Orders  
required d uplicative clinical trials. As China was a member of the International Medical Device 
Regulators Forum  (IMDRF), due consideration to clinical results from other Members of this 
regulatory body would be preferable. In lieu of requiring a new clinical trial,  China could hav e 
considered requiring a "bridge  study " to ensure that the original data was relevant to China. 
Requiring a complete, duplicative clinical trial could lead to additional delays and costs for foreign 
exporters of medical devices without any added benefit. He therefore asked China to confirm 
whether clinical trial results from jurisdictions that were members of the IMDRF were acceptable.  
3.185.   In addition, Canada ask ed for clarification on Article  17 of Order No.  650, specifically as it 
related to the catalogue of products exempt from requiring China -based clinical trials. Ther e was a 
limited list of exempted  products and it lacked an effective regulatory mechanism to update and 
remain relevant with recent trends in the medical technology sector. He  therefore inquired whether 
China was developing a system that would allow for prompt updates to the catalogue. If the list 
was not updated to include more relevant exemptions, costly and unnecessary clinical testing 
would be required for foreign exporters  without any added benefit. He also asked if China could 
indicate when a final combined catalogue of Medical Devices would be released.  
3.186.   Canada also understood that Class  II and III medical devices also had to  pass a quality 
test under the " effectively ope rated quality ass urance system"  before applying for  a clinical trial . 
He thus asked China to confirm this new procedure and pro vide further information on that  quality 
test and the standards being tested. He asked if it was the same as the product inspecti on 
required as part of the registration approval process. He also  requested further information on the 
effectively operated quality system and whether foreign labs could provide that testing. In 
addition, Canada noted that Article  35 of Order  No. 5 specifi cally stated that  for in vitro diagnostic 
products  a focused clinical evaluation should be conducted in China. Canada was concerned that 
this constituted an unnecessary and duplicative clinical trial requirement for Canadian exporters of 
in vitro diagnosti c products that had received prior regulatory approval in other leading foreign 
jurisdictions, including Canada. This duplicative requirement would result in additional time and 
expense being incurred by Canadian medical device exporters wishing to enter t he Chinese 
market.  
3.187.   Canada was also concerned with the Electromagnetic Compatibility  (EMC) testing that was 
required by Chinese regulators in order for a medical device to be registered. The EMC standard 
that China used was identical to the one issued by t he International Electrotechnical 
Commission  (IEC), of which China was a member. However, China had not accepted test reports 
issued by internationally accredited laboratories that abided by the IEC  standard. Canada 
requested that China, in an effort to li mit duplicate testing and unnecessary costs, accept test 
reports that were consistent with China's technical requirements although they originated from 
internationally accredited laboratories . G/TBT/M/66  
 
- 42 - 
 
  3.188.   The representative of the Republic of Korea  said that the fact that China did not accept test 
reports issued by internationally accredited laboratories  would lead to unnecessary duplication of 
testing . This would, in turn, result in additional time and cost for exporters, since medical devices 
imported to China were a lready tested by internationally accredited laboratori es. He requested that 
China accept test reports issued by internationally accredited laboratories or internationally 
recognized test reports which had been made using the criteria contained in China's r egulations . In 
addition, some medical device exporte rs manufactured product s specifically for export as the 
regulations and medical environments differed between the country of origin an d the importing 
country. That was  why China's requirement that a foreign exporter had to submit manufacturing 
and marketing certificates authorized in their country of origin to obtain an approval in China was 
untenable. This requirement created additional delays when entering the Chine se market and thus 
became a non -tariff barrier to trade. He requested that the Chinese authorities removed the said 
registration requirement and continued to collaborate on this matter, and find a reasonable 
solution as soon as possible.  
3.189.   The representative of the European Union  reiterated his delegation's previous concerns 
over the Chinese  regulations regarding medical devic es notified in G/TBT/N/CHN/1022 -1026 and 
1029. He noted that Order  No. 650 established that clinical trials were require d for the registration 
of Class  II (moderate) or Class  III (higher  risk) me dical devices in China. Article 17 of 
Order  No. 650 stated that if the safety and effectiveness of the medical device could be proven by 
using the data obtained from the clinical trial of similar products or during clinical application s, 
then the product was exempted from clinical trials and listed in a catalogue. Therefor e, the EU 
understood from Order  No. 650, that medical devices not listed in the catalogue would have to be 
the subject of clinical trials to be conducted in China. The  EU was nonetheless still concerne d that 
the draft lists of Class  II and Class  III devices which would be exempted from clinical trials were 
limited. Moreover, the regulatory mechanism to update such lists tended to lag significantly behind 
the pace of inn ovation in the medical technology sector. The EU, ther efore, requested that the 
China's Food and Drug Administration  (CFDA) put in place a robust system allowing swift updates 
of the exemption catalogues, as needed.  
3.190.   The EU was also concerned that for prod ucts not listed in the catalogues, duplicative and 
redundant clinical trials would have to be conducted in China thus  causing  additional delays in 
placing products on the Chinese market without any added benefit. Due consideration needed 
therefore to be gi ven to studies which have taken place outside of China, especially where studies 
had been conducted in a jurisdiction which, like China, was a member of the IMDRF. In most 
cases, the results of studies would be valid across populations and would not need t o be repeated 
or may  only require smaller bridging studies to ensure that the original data was relevant for 
China. Concerning th e Electromagnetic Compatibility  (EMC) testing, the EU reiterated its request 
that CFDA accept test reports from foreign laborat ories accredited by bodies that were members o f 
ILAC, as an alternative to in -country testing in China. The EU stressed that the registration 
certificate should exclude potentially confidential "Product Technical Requirements" documentation. 
Finally, the E U requested that Chin ese authorities provide a three -year transitional period as the 
new provisions introduced major changes. The EU also said that f urther guidelines detailing th e 
relevant processes would be also welcome.  
3.191.   The representative of China  said that notifications G/TBT/N/CHN/1022 -1026 and 1029 
were drafted to enforce the "R egulations for the Supervision and Administration of Medical 
Devices ". Before it was implemented, CFDA held specialized training to help relevant enterprises 
and organizations understand these measures. The CFDA also communicated directly with relevant 
foreign and domestic enterprises and associations on these measures and fully con sidered 
comments received from M embers, including those from the EU and the American Chambers of 
Commerce in Chin a. China welcomed all Members to  contribute to these measures and undertook 
to take comments from all stakeholders into account. She explained that sale certifications in the 
country of origin ensured the safety and effectiveness of medical devices and protected Chinese 
citizens. A list of medical  devices exempt of clinical trial had been issued i n catalogues of 
exemptions, 488  Class II and 79  Class III.  
3.2.3.23   Kingdom of Saudi Arabia – Certificate of Conformity (not notified) and GSO 
marking requir ements for toys (IMS ID 435)  
3.192.   The representative of Canada  expre ssed his delegation's concern  regarding the 
requirement  to register each product with a unique registration number present on its packaging. G/TBT/M/66  
 
- 43 - 
 
  Such requirements were not found in any other countr y and presented a significant burden for toy 
manufacturers. Canada questioned whether any consideration had been given to the possibility of 
assigning registration numbers to each manufacturer  rather than each model . Such process, which 
had been proven eff icient in other countries, such as Canada, the European  Union , the United 
States,  would accomplish the measure's objectives without undue burden to toy manufacturers. In 
Canada' s view, the measure was not precise enough for several reasons . First, there we re 
differences in  the interpretation of regional technical regulations by  GSO members, such as 
labelling requirements for affixed labels or imprinted labels and the requirement of additional 
random testing on previously assessed products. Second, regarding  third-party certification, it was 
unclear which third party was  being referred to. Third, the possibility of having an exemption  
allowing toy manufacturers to put a w eb address on their instructions  manual  with a link to 
materials in Arabic was not entire ly clear . Canada asked whether these  three uniformity  issues had 
been clarified and if not, if there was any intention of providing  an update  on this matter . Finally, 
regarding testing, Canada was of the view that the measure lacked cla rity on required tes ts for the 
"G" Mark on toys sold in the GCC. Finally, Canada requested  the Kingdom of  Saudi Arabia to 
provide more information about possible accreditation of laboratories outside the Gulf region .  
3.193.   The representative of  the Kingdom Saudi Arabia  stated that  most of the issues raised were 
explained in the previous meeting.18 He also noted that his dele gation would appreciate if in the 
future new specific trade  concerns could be sent in written form so as to facilitate full responses . 
3.2.3.24   Ecuador – Proposed Motor V ehicle Safety Regula tory Requirements (RTE INEN 
034) (IMS ID 409)  
3.194.   The representative of Canada  echoed the concerns that were raised at the previous 
meeting by the US, Mexico and Brazil.19 This included concerns with the lack of scientific evidence 
provided by Ecuador with respect to its conclusion  that vehicles built in accordance with  US Federal 
Motor Vehicle Safety Standards  (FMVSS) no longer met their  public safety requirements. In 
Canada's view, this regulation was more trade -restrictive than necessary t o fulfil the stated 
objectives  as the  measure only took into  account the requirements established by UN  Economic 
Commission for Europe  (UNECE) standards. Other international standards established to fulfil the 
same objectives, f ollowed by other countries, had not been considered. As most of the motor 
vehicles man ufactured in Canada were built in accordance with  the FMVSS, Ecuador' s shift to 
UNECE  standards and its refusal to accept US  safety standards was  a matter of concern for 
Canada. US vehicle safety st andards , and by extension Canadian safety standards , provide d the 
most stringent performance and outcomes with respect to vehicle safety. Consequently, Canada  
strongly encourage d Ecuador to continue to allow the use of FMVSS and EPA  standards . 
3.195.   The represen tative of Mexico  reiterated the concerns contained in G/TBT/W/410, in 
particular, the possible failure to conform to Articles 2.4 and 5.1.2 of the TBT  Agreement. Mexico's 
main concerns focused on the short deadline for the entry into force of the measure a nd the 
requirement for third -party certification. In Mexico's view, third -party certification in the 
automobile sector should be exceptional as it was an internationally -regulated sector, in which 
vehicles were usually certified in their country of origin.  Therefore, Mexico expressed concerns with 
the need to submit a conformity certificate issued by a particular accredited body. Mexico also 
shared Canada's concern regarding the refusal to consider other international vehicle -safety 
standards and requested Ecuador to take due account of the comments that had been presented, 
so as to introduce the relevant changes in the technical regulation.  
3.196.   The representative of the United States  said that , while her delegation supported the 
automotive safety and environmen tal protection objec tives pursued by the measure, the US  was 
nonetheless puzzled by the unusual way that Ecuador notified  a significant revision of its technical 
regulation. A  full notification of the third  revision of this measure would have been more 
transparent, and in line with notification obligations under the  TBT Agreement. US industry ha d 
offered comments to the sixth  Addendum on 8 November 2013, and requested INEN to continue 
accepting self -certification of  FMVSS  and US Environmental Standards. The se comments were 
however never acknowledged or replied  to by Ecuador. The US thus asked: w hat was the scientific 
evidentiary basis for concluding that, despite a long history of accepting certification to FMVSS as 
meeting its domestic safety requirements, FMVSS no longer met its publi c safety requirements? 
                                                
18 G/TBT/M/65, para. 2.203.  
19 G/TBT/M/65, paras. 2.254 -2.258.  G/TBT/M/66  
 
- 44 - 
 
  Why stakeholders were  not afforded the opportunity to provide data to demonstrate the 
effectiveness of FMVSS in achieving Ecuador's desired safety outcomes?  
3.197.   She stressed that this  regulation , which was finalized in October 2014 , had substantially 
disrupted trade of autos and trucks from the US to Ecuador. Furthermore, with the adoption of 
UNECE standards exclusively in Ecuador, the introduct ion of new vehicles developed in accordance 
with FMVSS would be d elayed until versions designed to UNECE requirements were developed, 
presuming US automotive companies intend ed to design new versions accordingly. This could have 
a significant impact on trade, in particular since the majority of vehicles imported by Ecua dor were 
models that did not have UN ECE versions. She therefore requested  Ecuador to  reconsider the final 
regulation and include acceptance of US FMVSS and US EPA automotive requirements.  
3.198.   The representative of the European Union  requested Ecuador to clarif y the timeline for the 
implementation of the new regulation. He encouraged Ecuador to manage the transition to the 
new regulatory framework for vehicle safety in such a way that it would minimise any possible and 
unintended trade disruptions. This implied allowing adequate t ime for producers in exporting 
Members to adapt the design of their vehicles and their production lines to the new requirements 
in accorda nce with Article 2.2 of the TBT  Agreement. The EU recalled their statement at the last 
TBT Committe e meeting about the benefits of international harmonisation in the motor vehicle 
sector.20 International harmonisation, wh en based on a high  level of human health, safety and 
environmental protection , was a powerful instrument for trade facilitation. In thi s regard, the 
harmonisation activities undertaken by UNECE 's World Forum for Harmo nisation of Vehicle 
Regulations  (WP.29) , most notably UNECE's 199821 and 195822 Agreements , were an effective way 
to address technical barriers to trade in the automotive secto r. Harmonised technical requirements 
developed under those agreements provided significant economic benefits by reducing compliance 
costs which would otherwise arise from the need to comply with different sets of national 
requirements . The 1958 Agreement a dded to the benefits of technical harmonisation the 
advantages of a system of mutual recognition of approvals of vehicle systems, parts and 
equipment. Additionally, both agreements were also seen as instruments of empowerment and 
technical development for emerging and developing  countries that decided to join them . 
3.199.   Reacting to the EU's points, the representative of the United States  noted that there was 
no consensus among WTO Members that the UN regulations adopted pursuant to the 
1958 Agreement were "inter national standards", according to the six  principles of the 
November  2000 TBT Committee Decision.23 In particular, the standard development process for 
the UN Regulations raised questions with respect to their consistency with the principles set out in 
paragraphs 8, 9 and 10 of that Decision. In contrast, the 1998 Agreement appeared to better 
reflect the principles of the TBT Committee Decision. Nevertheless, the US was of the view that at 
the present time there was no international standard for the majority  of automobile safety 
standards.  
3.200.   The representative of the European Union  underscored the importance of global 
harmonization in the motor vehicle sector, particularly with respect to trade facilitation. 
Additionally, he stated that the UNECE was the only global forum engaged in this matter and 
therefore, the benefits derived from this work should be recognized regardless of the qualification 
of UNECE regulations as "international standards". In the EU's view, the work undertaken by the 
UNECE should be supp orted and developing countries should be encourage d to participate in this 
work.  
3.201.   The representative of the United States  agreed on the importance of international 
harmonization and hoped that developing countries could participate in the process of the 19 98 
Agreement.  
                                                
20 G/TBT/M/65, paras. 2.257 -2.258.  
21 "Agreement Concerning the Establishing of Global Technical Regulations for Wheeled Vehicles, 
Equipment and Parts which can be fitted and/or be used on Wheeled Veh icles", of 25 June 1998.  
22 "Agreement concerning the adoption of uniform technical prescriptions for wheeled vehicles, 
equipment and parts which can be fitted and/or be used on wheeled vehicles and the conditions for reciprocal 
recognition of approvals gra nted on the basis of these prescriptions," of 20 March 1958.  
23 G/TBT/9, 13 November 2000, para. 20 and Annex 4 . G/TBT/M/66  
 
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  3.202.   The representative of Ecuador  said that her delegation had incorporated the UNECE 
regulations for harmonisation of vehicles and noted that this system provided security for the 
entire lifecycle of each model. She then stated that a consolidat ed international forum should be 
held that that would duly discuss regulations and adopt the best forms of standards. Vehicle 
manufacturers present in Ecuador offer models in other markets that comply with either the 
minimum requirements of the RTE034 or e ven more stringent requirements.  In Ecuador's view, 
the development of the technical regulation at issue led to important cooperation amongst 
importers and manufactures. The period of implementation was constantly being assessed by the 
Ecuadorian authoriti es so that the time periods were feasible. Consequently, Ecuador informed the 
Committee that there was a new transition period until October 2015 and therefore Ecuador would 
be accepting self -certification until October 2015.  
3.2.3.25   China - Safety Requirement for  Lithium Ion Cells and Batteries used in Portable 
Electronic Equipment , G/TBT/N/CHN/1016 (IMS ID 425)  
3.203.   The representative of the Republic of Korea  noted that many Members adopted technical 
regulation s on lithium ion cells and batteries which were harmonized  with international standards. 
Korea had also enforced  a similar technical regulation. However, many of China's test 
requirements for their safety regulation did not correspond with either the current IEC62133 or its 
draft revision.  In the previous TBT Com mittee  meeting , Korea raised concerns regarding the 
inconsistency between the proposed regulation and international standards.24 Nevertheless, the 
proposed regulation was adopted and published on 5  December  2014 without any revision.  He 
requested China to  harmonize those requirements with international standards  and to take into 
account the discussions under the IEC . Conce rning Article  11 of the measure, he encouraged China 
to eliminate the requirement from the National Standard , or exclude it from mandatory  
requirements , since the safety requirement for system protection circuit s could be complied with 
by portable electronic equipment manufacturers rather than cel ls and batteries manufacturers.  
3.204.   The representative of China  said that , as lithium batteries were  the cause of many injuries 
and even death s, China had drafted a national standard safety requirement in order to protect 
consumer's health and safety. T his standard  was developed by an ad  hoc working group 
established in 2008 . This  working group consisted  of more than 40  lithium producers and science 
research institutes, both domestic and abroad, including many foreign enterprises. After three 
years of in -depth discussions, industry s urveys and three rounds of requests for comments, a final 
version of the draft standard was formulated. She said that, due to a different scope of application, 
the Chinese standard did not dir ectly correspond to IEC62133. While it  adopted, when appropria te, 
the relevant criteria established under IEC62133 , the Chinese standard also improved the 
IEC standard according to the characteristics of the lithium battery. In fact, a  number of proposals 
based on this Chinese standard had been adopted by the IEC  itself, which illustrated its 
effectiveness. The Chinese standard, based on th e relevant international standard  (IEC), did not 
therefore violate any TBT Agreement provision or principle.  
3.2.3.26   Ecuador – Cosmetic products , G/TBT/N/ECU/116, G/TBT/N/ECU/116/Add.1, 
G/TBT/N/ECU/116/Add.2, G/TBT/N/ECU/116/Add.3, G/TBT/N/ECU/111, 
G/TBT/N/ECU/111 /Add.1, G/TBT/N/ECU/111/Add.2, G/TBT/N/ECU/111/Add.3 
(IMS  ID 417)  
3.205.   The representative of Mexico  reiterated concerns that were expressed in the last 
Committee meeting25, in particular that this measure might not conform to  Articles 2.2 and 5.1.1 
of the TBT  Agreement. He asked Ecuador whether they had considered alternative measures to 
facilitate compliance with the conf ormity assessment procedures.  
3.206.   The representative of Ecuador  explained that the measure was based on certain Andean 
regulations on the harmoniza tion of legislation on cosmetic products, as well as Annex  2 of the 
good manufacturing practices within the Andean Community for cosmetics. She then stated that 
although they had amended the measure to facilitate compliance with regard to conformity 
assess ment procedures, her delegation would take into account the comments made by Members.  
                                                
24 G/TBT/M/65, para. 2.199.  
25 G/TBT/M/65, para. 2.248.  G/TBT/M/66  
 
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  3.2.3.27   Brazil – Draft Technical Resolution nº 69, 9 September 2014, Regarding the 
Requirement of Describing the Chemical Composition, in Portuguese, in the Label of 
Personal Hy giene Products, Cosmeti cs and Perfumes , G/TBT/N/BRA/608 (IMS ID 443)  
3.207.   The representative of Canada  expressed concerns regarding Brazil' s proposed regulation 
requiring the  translation of cosmetic ingredients into Portuguese for labels of cosmetics and 
person al care products. Canada believed that this regulation could be more trade -restrictive than 
necessary gi ven the available alternatives. The "International Nomenclature f or Cosmetic 
Ingredients"  (INCI) was  an internationally recognized standard for disclosu re of ingredients on 
cosmetic product labels , which  Canada, the US, the EU and Japan fully endorse d. As Canada, 
Japan and the EU were  multilingual jurisdictions , Canada  believe d that  this framework was the  
most effective in conveying information to consume rs and health care providers. By adopting a 
harmonized ingredie nt labelling regime, Brazil would  help reduce the costs associated with 
developing c ountry -specific original packaging , along with allowing a more streamlined inventory 
management system for fo reign producers of cosmetics and personal care products . Canada also 
noted that Brazil, as a recent Steering Committee member of the "International Cooperation on 
Cosmeti cs Regulation"  (ICCR), Brazil was  encouraged to pursue technical regulations that  would 
"minimize barriers to trade" , instead of  creating new ones. Canada hoped that Brazil would  
evaluate th e possibility of using the INCI  system for their disclosure of ingredients on cosmetic 
product labels, leaving the translation to Portuguese as a volun tary option. In this respect, Canada 
recalled that the Brazilian "National Health Surveillance Agency"  (ANVISA ) was previously in 
support of adopting the  INCI system for the disclosure of ingredie nts on cosmetic product labels. 
However , Brazil was  required to adopt a mandatory Portuguese regulation following a 
Federal  Court decision. Consequently, Canada requested  Brazil to provide an update on the status 
of this court case . Additionally, Canada asked whether Brazil had the intention of  notifying any 
new and future developments.  
3.208.   The representative of Mexico  reiterated concerns on the draft technical regulation26, in 
particular, for the reasons outlined by Canada with respect to the translation into Portuguese and 
the non -use of INCI  nomenclature. He then noted  that in the last meeting, Brazil indicated that 
they would study the comments submitted by Members, including those from Mexico. He therefore 
requested Brazil to provide an update of the current status of their analysis and asked if Brazil was 
planning to  use the INCI  nomenclature or eliminate the requirement of translation into Portuguese.  
3.209.   The representative of the European Union  referred to the information provided by Brazil 
during the last TBT Committee.27 At that time, Brazil indicated that alternative measures were 
being explored regarding the mandatory indication of labelling requirements in Portuguese. For 
example, allowing the Portuguese language label o n stickers, secondary packaging or leaflets.  
Therefore, the EU requested Brazil to provide an upda te with respect to the current state of play of 
these alternative measures.  
3.210.   The representative of Brazil  reiterated her delegation's statement during the previous 
Committee meeting.28 She noted that since that meeting there had been no further updates on 
this issue. Finally, she explained that t he proposed regulation stemmed from a court ruling stating 
that ANVISA needed to ensure that information regarding the chemical composition of personal 
hygiene products, cosmetic products and perfumes was available t o consumers in Portuguese. This 
ruling was being appealed but, while there was no decision, it had to be implemented.  
3.2.3.28   Kingdom of Saudi Arabia – Decree of the Saudi Arabian Ministerial Council on 
the sale and marketing of energy drinks of 4 March 2014 , G/TB T/N/SAU/669 
(IMS  ID 442)  
3.211.   The representative of the European Union  thanked the Kingdom of Saudi Arabia for its 
notifications of the measures regulating the labelling and marketing of energy drinks and noted 
that her delegation had submitted comments on thes e notifications. She then explained that in the 
previous Committee meeting the EU conveyed to Saudi Arabia an invitation to share the scientific 
studies and the risk  assessment with respect to the measure at issue.29 The EU renewed this 
                                                
26 G/TBT/M/64/Rev .1, para. 2.39 and G/TBT/M/65, para.  2.216.   
27 G/TBT/M/65, paras. 2.220 -2.221. 
28 G/TBT/M/65, paras. 2.220 -2.221.  
29 G/TBT/M/65, para. 2.214.  G/TBT/M/66  
 
- 47 - 
 
  invitation and encou raged Saudi Arabia to update the Committee on the current status of these 
measures. Finally, the EU requested Saudi Arabia to provide a written reply to their latest 
submission.  
3.212.   The representative of Switzerland  reiterated concerns with regard to the meas ure at issue. 
He then thanked the Kingdom of Saud i Arabia for notifying the measure and for the good bilateral 
discussions. Switzerland recalled that the measure contained several restrictions on sales, 
advertisement and marketing, as well as product label ling in the form of a mandatory statement. 
Switzerland was of the view that although the measure had entered into force, the GSO could still 
review it. While Switzerland shared Saudi Arabia's public health  objectives , it nonetheless 
reiterated that certain  specific questio ns remained unanswered on why Saudi Arabia decided to go 
beyond relevan t Codex standards on nutrition and why it also decide d to ignore standards on 
claims  that request ed a sufficient body of scientific eviden ce providing truthful and non -misleading 
information.  In addition, Switzerland asked Saudi Arabia  to reflect  on the question of whether 
negative warnings linked to social groups , such as "youth", "athletes " or to use "during exercise", 
were really necessary. Switzerland asked Saudi Ara bia to explain the expected impact from such 
unique measure and whether  alternatives  were considered.  
3.213.   The representative of  the Kingdom Saudi Arabia  stated  that the measure was not designed 
to prevent or limit the importation of energy drinks, but rather to control the consumption of such 
products in a manner that ensured the protection of human health. It was a known fact that Gulf 
countries were leaders in the prevalence of health diseases, such as high blood pressure and 
diabetes. The main ingredients o f energy drinks were caffeine, taurine and inositol. The labelling 
requirements were meant to inform the consumer in a clear and transparent manner about the 
ingredients so as to enable them to make informed decisions regarding the consumption of such 
products. Saudi Arabia stressed that the entry into force of the measure was delayed more than 
once in response to the concerns of WTO Members. Finally, he informed the Committee that the 
GSO Technical Committee would continue working on revising the Gulf ener gy drinks technical 
regulation and the GCC Members would notify the Committee on this issue as it unfolds.  
3.2.3.29   Ecuador - (PRTE INEN) No. 111:  Energy efficiency . Clothes dryers . Labelling : 
RTE INEN 111; RTE INEN 077; RTE INEN 072; RTE INEN 094; RTE INEN 124; RT E INEN 
109; RTE INEN 110; RTE INEN 112; RTE INEN 117; RTE INEN 122; RTE INEN 123, y RTE 
INEN 133 (IMS ID 455)  
3.214.   The representative of  Mexico  reiterate d the concern s outlined  by his delegation in 
document G/TBT/W/409.  He reported that c onsultations with various stakeholders had revealed 
that there we re still some pending processes with regard to th ese technical regulation s. Mexico 
expressed particular concern with regard to how conformity assessment procedures were being  
carried out. Certificates were requeste d per batch or per  type, and he questioned if this wa s 
compatible with Article 5.1 of the TBT Agreement. Finally, he asked Ecuador to explain how it had 
taken into consideration the comments made by Mexico at the last Committee meeting.  
3.215.   The representative of Ecuador  underscored that the objective of the measure was to 
promote energy efficiency and environmental protection. The  Government of Ecuador had  issued  
Resolution  No. 111, among  others , to ensure that relevant products on the Ecuadorian market 
were highly energy efficient . These measures involved a combination of regulations and a labelling 
system, with the intention  to provide information enabling  consumers to reduce energy 
consumption and increase energy efficiency . In line with the scope of applicat ion, in particular 
Resolution  No. 111, which covered  clothes driers, products would  have to comply with the 
requirements on energy efficiency.  She noted that Ecuador was currently implementing an energy 
efficiency policy related to this matter.  She reitera ted that e lectrical products would need to 
comply with the  requirements as established by the national authority , which require d that the 
products be labelled in terms of  class of energy efficiency  performance . In response to the 
concerns expressed by M embers, Ecuador explained that it had  already made amendments to the 
technical regulations to facilitate  compliance  with the requirements.  G/TBT/M/66  
 
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  3.2.3.30   Ecuador – Certification of Ceramic Tiles II , G/TBT/N/ECU/31 
G/TBT/N/ECU/31/Add.4, G/TBT/N/ECU/31/Add.5, G/TBT/N/ECU/31/A dd.6, 
G/TBT/N/ECU/31/Add.7 (IMS ID 419)  
3.216.   The representative of Brazil  reiterated his delegation's previous concerns with the 
Ecuadorian technical regulation on ceramic tiles , as recently modified . In general , he said  the 
measure d id not seem to be in compli ance with Articles 2.2, 2.5, 2.7 and 6.1 of the TBT 
Agreement.  He noted that t he Ecuadorian technical regulation ha d led to significant reduction of 
Brazilian exports in 2013 , and to a complete disruption of exports in 2014 and the first half of 
2015.  At the same time , Ecuador continue d to import ceramic tiles f rom other trading  partners.  
Brazil also expressed concern with what it considered to be very burdensome procedures for 
obtaining product certification . An example of such procedures was the requireme nt to have a 
marking engraved  on the back of each tile, instead of being signalled on the carton , as was the 
usual industry practice.  Regarding the information that can be placed on the carton, stickers were 
not allowed , which impose d further  difficulties.  Another new requirement  that Brazil also 
considered problematic was the need to perform tests for each shipment , instead of testing 
products according to their types.  He said that, a ccording to industry, the cost of sampling and lab 
testing as well as ins pection and the issuance of certificate of conformity , now fell  on each 
shipment.  Moreover, warehousing costs ha d also risen since the process now took  four months as 
opposed to just 45 days.  
3.217.   The Brazilian representative also reported that e xporters contin ued to encounter problem s 
due to the la ck of accredited laboratories as the  only accredited lab available for Brazilian 
exporters was not able to cater to the demand.  Tests were made in third countries , since this 
laboratory maintain ed only commercial faci lities in Brazil.  Moreover, Ecuador d id not accept 
manufactures ' declaration of conformity , nor Brazilian third party certification. The fact that other 
countries were able to export to Ecuador raise d additional concern s on possib le discriminatory 
aspects of this  measures. Brazil reiterate d the request that Ecuador accept certificates of 
conformity issued by certification bodies accredited by the Brazilian Institute of Metro logy 
(INMETRO) . 
3.218.   The representative of Ecuador  informed that T echnical Regulation RTE  INEN 033 entered 
into force on 7  October  2008 as a binding requirement for ceramic tiles of domestic or imported 
origin marketed in Ecuador. She stressed that  Ecuador had taken into consideration comments 
from Members  – in particular the concern expressed  by Brazil – and had modified the regulation 
with regard to labelling and conformity assessment procedures.  She noted, in this respect, the fact 
that Ecuador already counted with the services of various accreditation bodies, such as SAE 
("Servicio  de Acred itación Ecuatoriano"), AENOR  ECUADOR ("Asociación Española de Normalización 
y Certificación en Ecuador), and Intertek. She said that the Ecuadorian authorities were  currently  
working with national and foreign producers to  review the technical regulation , and that a  new 
amendment was expected to be finalized in  the next semester.  
3.2.3.31   European Union – Common Criteria for Information Technology Security 
Evaluation (Common Criteria) certification in the EU (IMS ID 448)  
3.219.   The representative of China  reiterated previou s concerns about the refusal of Common 
Criteria ( CC) evaluation and the validation bodies of EU member states to accept and process 
applications of Chinese producers for CC certification , and the lack of opportunities for Chinese 
companies to join CC -related standard ization  organizations , such as JIL Hardware Attack 
Subgroup.  China  had repeatedly asked the EU to provide additional CC -related information , and to 
take a constructive approach to address the concerns of the Chinese Industry. Her delegation  was 
disappointed that so far no meaningful information had been provided by the EU. R ather , the EU 
delegat ion had  responded by simply claiming that CC certification d id not fall within the scope of 
the TBT  Agreement. With regard of the coverage  of the TBT  Agreement, China  believe d that 
depending on the nature of CC validation bodies of the EU member states, either Article 5  of the 
Agreement  (on assessment of confo rmity by central government bodies),  or Article 8  (on 
assessment of conformi ty by non -governmental bodies ), was applicable. In the case o f central 
governmental bodies, she said those  articles apply. The obligations imposed on Members  under 
the TBT  Agreement  in this regard include , among st others, national treatment, avoidance of 
unnecessary obstacles to  international trade, prompt acceptance of applications, expeditious 
undertaking and completion of conformity assessment procedures, publication of the standard G/TBT/M/66  
 
- 49 - 
 
  processing period of each conformity assessment  procedure,  or communication of the anticipated 
processing period.  
3.220.   The representative of the European Union  recalled his delegation's previous statement that 
neither the EU , nor its member state s, had put in place  mandatory cryptographic standards or 
conformity assessment procedures on commercial encryp tion products as a condition for their 
access to the EU market.  He therefore failed to see the relevance of China's concerns under the 
TBT Agreement.  The EU  reiterate d its willingness to further discuss these issues bilaterally , where 
there should be recip rocal willingness by the Chinese side to discuss EU concerns about a different 
matter in China.  He stated that i n China there was a regulatory framework that mandate d 
certification as a condition to access the market , which formally discriminated against foreign 
companies, and against foreign technology vis -à-vis domestic technology.  The representative  
stress ed the absence of a level playing field between the EU and China.  He said that in the EU  
Chinese companies ha d already received certificates, o ne of th em up to security level  4+, which 
demonstrated that there were opportunities for Chinese companies to receive certificates f rom 
European certification bodies approved under the CCRA.  
3.221.   With respect to China's  argument regarding the sco pe of the provisions of  the 
TBT Agreement in the  field of conformity assessment, he replied that solely because a conformity 
assessment body may be owned by the state , this did not  mean, ipso facto, that  even the 
activities of this conformity assessment bod y that were not relate d to a technical  regulation 
providing for mandatory third -party conformity assessment or the enforcement of a technical 
regulation were covered by the TBT Agreement . As mentioned by the EU at the last Committee 
meeting, Article  5 of the Agreement began  with a chapeau s tating  that "Members shall ensure 
that, in cases where a positive assurance of conformity with technical regulations or standards is 
required, their central government bodies apply the following provisions to products originating in 
the territ ories of other Members"  the obligations  provided therein. As regards non -governmental 
bodies, similar reasoning would apply . In this latter respect, he noted that the  definition of a 
"non-governmental body " in Annex  1.8 to the TBT  Agreement referred  to a "[b]ody other than a 
central government body or a local government body, including a non -governmental body which 
has legal power to enforce a technical regulation." He said that none of these  situations could 
therefore  be qualified to exist at the moment in  the EU so as to bring the matter raised by C hina 
under the ambit of the TBT  Agreement.  Finally, regarding  informat ion about testing organisations  
recognised under the CCRA, he drew China's attention to the information already available on the 
CCRA website . 
3.222.   The representative of China  clarified that Chinese enterprises ha d achieved  a high level of 
CC certificate s in Norway,  but Norway was not an EU member state.  Therefore, China maintained 
its concern s about the fact  that no Chinese enterprises ha d achieved  a high level CC  certificate in 
any EU member  state.  
3.2.3.32   European Union – Limits for hexavalent chromium in toys (2009/48/EC) 
(IMS  ID 449)  
3.223.   The representative of China  expressed continued concern  with the existing and propo sed 
limit values for hexavalent  chromi um ("chromium  VI") in toys , or toy components , in the EU Toy 
Safety D irective 2009/48/EC.  Regarding the existing limit values , China still question ed the 
scientific evidence on which the  EU based  the limit values for chromium  VI in three types of toy 
mater ials, which he noted were  more stringent than those for drinking water , as specified in the 
WHO Guidelines for Drinking -Water  Quality30, or those for foodstuffs as prescribed in Members ' 
national standards.  With regard to the proposed limit values , China  thanked the EU for the update 
provided in a bilateral meeting.  
3.224.   The representative of the European Union  reported  that there were no new developments 
on this matter.  With regard to the current limits  for chromium  VI, he stated  that they were  based 
on science and that there was evidence that these limits were technologically feasible, achievable 
by industry , and detectable according to available testing methodologies.  As reported at the last 
Committee meeting , the European Commission had requested an opinion fr om the EU 's Scientific 
Committee on Health and Environmental Risks  (SCHER)31, and the final opinion  on toxicologically 
                                                
30 http://www.who.int/water_sanitation_health/dwq/guidelines/en/ . 
31 http://ec.europa.eu/health/scientific_committees/environmental_risks/index_en.htm . G/TBT/M/66  
 
- 50 - 
 
  safe limits for chromium  VI was issued on 10 February 2015. As part of its risk management tasks , 
the European  Commission would  consider w hether the current migration limits for chromium  VI 
would need to be revised , taking into account the final opinion of SCHER.  He reiterated that  this 
evaluation would  certainly take account  of available technology in the industry and available 
testing meth odolo gy for detection of chromium  VI in toys.  If the European  Commission did decide 
to make a proposal for a revision of the current limits, any such proposal would be subject to an 
extensive stakeholder consultation, impact assessment and would be  duly notified in accordance 
with TBT  Agreement . However, he said that at this time there were no plan s to proceed with such 
a proposal.  
3.2.3.33   China - Administrative Measures on Cosmetic Labelling (AMCL) , 
G/TBT/N/CHN/1064 (IMS ID 456)  
3.225.   The representative of Canada  expres sed appreciation for China's assurances that they 
would  consider public comments when drafting the final version of the Administrative Measures on 
Cosmetic Labelling.  Canada welcome d any opportunity for foreign governments and industries to 
comment on prop osed legislation. In the spirit of public consultation, Canada reiterate d concerns 
related  to China' s draft labelling requirements for cosmetic products , and the registration and 
approval framework for cosmetics and their ingredients.  Canada believe d that, in its current form,  
the prop osed new requirements for China -specific primary and secondary original packaging would 
significantly disrupt production lines and schedules, increase costs for foreign manufacturers and 
create confusion among consumers who were accustomed to global branding.  Denying the use of 
over-labelling would be a departure from global norms and Canada expect ed this regulation to 
cause significant delays in time -to-market  (TTM) for new products.  He also asked China to confirm  
whether it was planning to allow "over -labelling stickers " for imported products if they contain ed 
all language s included  on the original packaging . Canada was also concerned with the new 
"information and claim verification requirements"  that woul d compel companies to  use third -party 
facilities in China in order to verify the efficacy of claims, which would undermine the efforts  of the 
China Food and Drug Administration  (CFDA)  to have  manufacturers take additional respons ibility 
for themselves and self -regulate their p roducts in China.  Canada hope d that China would either 
permit efficacy testing by third -party labs outside of China,  or would allow in-house company 
testing, as long as those labs were able to conform to CFDA  criteria and guidance.   
3.226.   Canada also requested t hat China allow a longer implementation period. Canadian 
manufacturers ha d expressed their inability to comply with these new requirements within a six 
month period, since significant adjustments to package design and production lines would be 
required. Ca nada support ed Korea' s request , as expressed in the last TBT  Committee meeting32, of 
having a two -year transition period in order to allow foreign companies to acquaint themselves 
with the new regulations.  He highlighted the importance of ensuring that products already 
approved for sale be able to  remain on the market until their expiration date in order to minimize 
any fur ther disruption or lost sales. Canada was also concerned about the stated requirement of 
including o n the label the name of all sub -contractors used in the manufacturing process. He 
requested that China elaborate on how this information would enhance consumer safety.  He 
stressed his delegation's hope that, a s China continue d to review its draft regulation, that it would 
make the proper adju stments to ensure that there was a level -playing field for foreign and Chinese 
cosmetic manu facturers consistent with China' s MFN obligations , including in particular its  
obligations under the TBT Agreement, taking into account widely accepted internationa l practices 
in this sector.  
3.227.   The Canadian representative expressed appreciation for China's introduction of the 
"Adjustment of cosmetic ingredient registration management " on 1 April  2014, in order to expedite 
the approval process of new cosmetic material.  However, Canada continue d to be concerned with 
CFDA's burdensome approval and registration process for cosmetics and their ingredients.  Canada 
underst ood that the "positive list " being developed by China was more of a guideline of ingredients 
currently us ed in China, acting as a benchmark for future ingredient approvals. Canada hope d that 
China w ould continue to improve upon their new ingredient approval process so that Chinese 
consum ers would be able to  access the safest and most innovative products on th e mark et. By 
way of example , he mentioned that  of the 20,000 cosmetic ingredients listed in INCI, only 8,783 
were included China' s approved ingredient list. Canada hope d that with the introduction of a 
                                                
32 G/TBT/M/65, para.  2.10. G/TBT/M/66  
 
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  streamlined approval process, the num ber of approved i ngredients would  approach the 20,000 
benchmark.  
3.228.   Canada was further  concerned that domestic cosmetic manufacturers were able to register 
"new ingredients " without an additional application process. If so, China would be providing 
preferential treatment to domestic producers, thereby contravening their obligations under 
Article  2.1 of the TBT Agreement. He asked China to confirm that all cosmetic manufacturers were 
treated equally with respect to product registration and approval. He said that streamlining t he 
approval  process for imported cosmetics and applying the same registration process applied to 
domestic cosmetic products would  create a fair trade environment for the cosmetic industry, 
consistent with the TBT Agreement .  
3.229.   Finally,  Canada expressed conce rn with, and hoped that changes would be made 
concerning,  China's  requirement for  animal testing for the safety of cosmetic products , even  when 
alternative testing was available and acceptable by most other regulators. Examples of tests where 
suitable alte rnatives to animal testing exist ed and have been  proven efficacious include tests on 
"skin irritation", "photo -toxicity", and "skin  corrosion" .  
3.230.   The representative of Japan  said that, if  the proposed new draft "Administrative Measures 
on Cosmetics Labellin g" were implemented, the global cosmetics industry in the Chinese marke t, 
including Japanese firms, could  suffer an i mmense economic blow, and China's domestic 
consumers could also suffer visible disadvantages.  She outlined the four main reasons why Japan 
believed these negative effects would occur. First, she noted that Article  7 of the draft measures 
stipulated that "c osmetic labels shall  ensure complete and clear contents and shall be free of 
missing characters or unstable adhesion, and shall not be modi fied or supplemented by st icking, 
cutting, altering, etc."  It was not clear to Japan however if this provision would nonetheless permit 
the continued use of  sticker labels in the Chinese market, as currently  permitted.  She explained 
that the use of sticker s as labels for cosmetics in accordance with the laws of each country was 
generally accepted. China e xplained that a purpose of the  prohibition on the use of all sticker 
labels was to prevent illicit companies from re-labelling products with stickers . Howe ver, Japan 
consider ed that allowing the  use of certain kinds of sticker labels  would  fulfil China's objective, i.e. 
those  stickers that were difficult to remove and rarely peel  off. If sticker labels were totally 
prohibited and only printed labels were per mitted, this, in her view, could make these draft 
measures more trade -restrictive than necessary  for the attainment of its objective . For the 
forgoing reasons, Japan was of the view that the continued acceptance of the use of sticker labels 
should be clear ly stipulated.  
3.231.   Second, regarding manufacturer labelling, she noted that Articles  14 and 15 of the draft 
measures require d labelling of not only the name and address of the company legally responsi ble 
for the concerned cosmetics'  quality and safety, but als o the names and addresses of 
manufacturing subcontractors . However, given that the purpose of labelling the name and address 
of the manufacturer was to explicitly show consumers and regulatory authorities the locus of the 
final legal responsibility for pro duct quality and safety, Japan was concerned  that labelling the 
names of all manufacturing subcontractors might conversely  lead to consumer misunderstanding  
and market confusion.  Japan was therefore of the view that the  manufacturer labelling should only 
present the name and address of the responsible company and  for imported goods, a company 
inside China with final legal responsibility for the quality and safety of the concerned cosmetics.  
3.232.   Third, regarding promotional advertising of cosmetics efficacy cla ims, the Japanese 
representative noted that according to Article  19 and 20 of the draft measures , and considering 
the importance of cosmetics efficacy claims as a business practice, cosmetics efficacy claims must 
be tested by an "efficacy assessment testin g organization " with the testing results disclosed on a 
designated website. However, "cosmetics efficacy " and its assessment methods include d 
know -how gained through many years by compan ies, which led to  concerns that disclosing results 
without limitation would reduce corporate motivation for research and development and would 
ultimately  obstruct fair competition. For these reasons, Japan was of the view that  test results 
should not be disclosed. In addition, she stated that all institutions - not only the ones in China but 
also those located outside its territory  -, that would meet the requirements of an  "efficacy 
assessment testing organizations" should be recognized as such.   
3.233.   Finally, she said that in order to enhance understanding and ensure the appropri ate 
application  of the draft measures , clear guidance in addition to the draft measures was G/TBT/M/66  
 
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  indispensable. Furthermore, given that  the new labelling under this proposed scheme would 
require significant changes to existing labelling  processes, the implement ation date of 1  July 2015 
stipulated in Article 34 of the  draft measures was completely unfeasible. Without a sufficient grace 
period, she said, the supply of products to the Chinese market would  become very difficult. It 
could also cause harmful environme ntal effects from the disposal of a large volume of stock. Given 
these  considerations , she stressed that a  sufficient implementation plan  with, for example, a 
two-year transition period,  would be essential for the smooth implementation of the new labelling  
regulation.  
3.234.   The representative of the European Union  reiterated concerns from the March 2015 
TBT Committee meeting, and also those sent to the Chinese authorities on 12 January 2015. The 
EU noted in  its written reply of 18 March 2015, China indicated that  it would  consider the 
comments received. H owever , it did not provide any reply on the specific issues raised by the EU.  
In general , the EU again highlighted  that the notified draft introduce d significant changes to the 
current requirements on the labellin g of cosmetic products in China,  which would essentially oblige 
economic operators to produce specific packaging for the Chinese market.  Additionally, a s the 
notified draft would  bring significant changes to the current practices of the cosmetic industry a nd 
the competent auth orities in China, the EU requested  the Chinese authorities to consider granting 
a transition  period of at least 24 months. The EU also invite d the Chinese authorities , and 
especially the CFDA , to publish practical guidance early during  the transition period in order to 
ensure harmonised understanding and smooth application of the new measures.  
3.235.   He said that s ince the March  2015 meeting , the EU ha d received information that the 
labelling of cosmetic products by means of stickers would be accepted in China. He requested that  
China confirm this information , and provide further information on requirement s relating to  the 
stickers, such as their language or their required place on the product or packaging.  He also 
explained that the  notified d raft require d products to display the name and address of the 
manufacturer and of subcontractors , when part of the production was completed by 
subcontractors. The EU agree d that the name and address of the manufacturer , or in the case of 
imported products,  of the Chinese enterprise responsible for the product, should be labelled on the 
product to establish clear and enforceable responsibility within China. However, the EU considered  
that additional labelling of the name and address of manufacturing subcontr actors was not 
necessary and might be confusing for the consumer. The EU therefore invited the  Chinese 
authorities to consider requiring only the name and address of the manufacturer legally 
responsible for the product , and to waive the requirement to prov ide the name and address of 
subcontractors.  
3.236.   Furthermore, the EU requested  confirmation that the efficacy assessment and cosmetic 
claim verification could  be conducted by any verifying organisation that was scientifically and 
technically competent to do so , according to the criteria and guidance established by the CFDA. 
The EU believe d that any requirement for third -party verification by a Chinese organisation would 
be more tr ade-restrictive than necessary. The EU also consider ed that the requirements regard ing 
cosmetic claim substantiation should be aligned and compatible with international best practices , 
and provide general criteria and guidance rather than regulate specific wording. He stated that 
requirements for the publication of detailed claim substan tiation reports on a web site could be 
damaging to the intellectual and commercial property rights of a company. The EU was of the view  
that the detailed efficacy information should be accessible only to official control authorities , who 
have appropriate tr aining and expertise to assess scientific study reports and the compliance of 
cosmetic cla ims with legal requirements. The EU therefore invite d the Chinese authorities to clarify 
that efficacy assessment reports issued by foreign verifying organisations would be accepted by 
the Chinese authorities, and to remove the obligation to publish the detailed efficacy reports on a 
publicly accessible web site. 
3.237.   The representative of the Republic of Korea  noted that his delegation was aware that  China 
was considering the elimination of the ban on "over -labelling" in  the regulation s. Korea expressed 
appreciation for China' s continuing efforts to accommodate Members'  concerns. He stressed that 
"over -labelling" was a key practice in the export  and import procedure of cosme tic products.  Korea 
remained nonetheless concerned with the  efficacy assessment and cosmetic claim verification  as 
outlined in the regulation . Under Article  19 and 20 of the administrative measures for cosmetic 
labelling , notified to the TBT Committee on D ecember 2014, all efficacy claims  on labelling were 
required to be verified by a testing organization designated by Chinese authorities. Korea was of 
the view that this requirement would  only increase unnecessary burdens and expenses to G/TBT/M/66  
 
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  exporting c ompanies  without any added  value . Korea also acknowledge d that information on labels 
must be valid . However , for basic efficacies, such as moisturizing and cosmetic astringent, which 
had been broadly tested and widely admitted, Korea did not see the need to  requir e individual test 
to prove efficacy. Therefore, Korea request ed that China reduce  and clarif y the scope of cosmetic 
efficacy claims that were require d to be proven. Korea also  request ed that Ch ina allow 
manufacturers to self -verify the efficacy of the prod ucts, instead of requiring third-party 
verification. Finally, Korea request ed China to provide at least a 24-month  transitional period, so 
that companies would be able to  adapt themselves to this regulation.  
3.238.   The representative of China  explained that label ling was essential for consumers to 
understand basic information regarding cosmetic products and that it was one of the most 
important aspects of cosmetic supervision for most Members. In 2012, the CFDA had drafted the 
"Cosmetics Label Instructions Regulat ions and Guidance for the Cosmetics Label Instructions" 
(notified in G/TBT/N/CHN/937) to solicit public opinion. However, this regulation had never gone 
into effect and was now replaced by the " Administrative Measures on Cosmetic Label " ("AMCL"). In 
Novemb er 2014, AMCL was made available online so as to solicit public comments and the CFDA  
had subsequently  received feedback  from domestic as well as foreign cosmetic enterprises and 
industry associations.  China pledged to  accept constructive opinions and to c omply with 
international practice . She also clarified that, once finalized, this measure would allow 
"over -labelling " on imported cosmetic products . 
3.2.3.34   China - Banking IT Equipment Security Regulation (IMS ID 457)  
3.239.   The representative of Japan  reiterated his de legations previous concerns and noted that on 
13 April 2015 China notified banks in China of its intention to review the "Guideline for promoting 
the Application of Secure and controllable Information Technology in Banking Sector 2014 -2015". 
He requested C hina to: (i)  provide for sufficient exchange of views with stakeholders; (ii)  revise 
the Guideline in accordance with international common standards; (iii)  ensure transparency; and 
(iv) provide a review schedule with reference to the aforementioned points.  He asked whether 
China had notified foreign financial institutions, and if not, what would be the concrete manner of 
notification.  
3.240.   The representative of the United States  referred to the Chinese notification dated 
13 April 2015 that suspended the banking rules on which the US had issued a statement in the 
previous TBT  Committee. She requested that China notify any subsequent revisions of the banking 
rules to the Committee, and conduct a transparent process allowing meaningful opportunity for 
comments and i nquiries by all interested stakeholders.  
3.241.   The representative of Australia  said that his country was monitoring the progress of this 
issue as its industry and businesses were interested in any potential regulations that may impact 
their ability to operate in  the Chinese market. He thanked China for suspending the regulations 
during a period of continued public, business and industry stakeholder consultation. He requested 
to be kept abreast of developments and the status of the regulation, including on a bilat eral level.  
3.242.   The representative of the European Union  welcomed the suspension of the regulation and 
invited China to conduct the review process in a transparent and inclusive manner. He said that, 
under the TBT Agreement, any further revisions had to be not ified in order to provide 
WTO Members, and their affected stakeholders, with an opportunity to comment. The EU remained 
available for bilateral engagements with China on this issue.  
3.243.   The representative of China  updated the Committee on three aspects saying that: (i)  the 
regulation was suspended and was under revision; (ii)  China did not require a full reveal of source 
code, but only to keep a file of it. China would improve the rules and ensure that the legitimate 
interests of domestic and foreign enterprise s be protected; and (iii)  given that China attached 
great importance to the protection of intellectual property rights, China only required enterprises 
to prove a legitimate source of software intellectual property.  G/TBT/M/66  
 
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  3.2.3.35   Indonesia - Regulation of the Minister o f Agriculture No. 139/Permentan/PD.4, 
10 December 2014, concerning Importation of Carcass, Meat and/or Processed Meat 
Products into the Territory of the Republic of Indonesia, and Regulation of the Minister 
of Agriculture No. 02/Permentan/PD.4, 10 January 2015, concerning the Amendment of 
the Regulation of the Minister for Agriculture No. 139/Permentan/PD.4, 10 December 
2014, G/TBT/N/IDN/98  (IMS ID 461)  
3.244.   The representative of Canada  thanked Indonesia for its written response regarding the 
proposed measures f or the importation of meat products. Canada remained concerned with the 
broad product coverage of the regulations and the lack of clarity surrounding its intended 
objectives. He questioned the appropriateness of notifying the proposed regulations to the 
TBT Committee. Measures designed to address food supply and price volatility did not appear to be 
directly related to TBT objectives. The proposed measures could further be unduly trade restrictive 
and inconsistent with the national treatment obligations of the TBT  Agreement and the GATT. He 
urged Indonesia to provide clarity regarding its proposed measure, specifically with regards to how 
those measures fell within the scope of the TBT  Agreement and, if they do, how those measures 
were consistent with Indone sia's national treatment obligations. He also urged Indonesia to 
continue to provide sufficient scope for comment before bringing those proposed regulations into 
force.  
3.245.   The representative of Australia  said that his delegation was still concerned that the 
regulations allowed only State Owned Enterprises  (SOEs) to import secondary beef cuts and that 
those imports could only be undertaken in limited circumstances. He asked how Indonesia 
considered this restriction to be consistent with Indonesia's WTO obligati ons. He expressed his 
ongoing concern that additional packing, labelling and purpose of use requirements were being 
imposed on imported meat products and not on domestic products. He asked Indonesia to confirm 
this understanding and to clarify the purpose of the regulations in relation to these measures. He 
also noted that Indonesia had raised concerns about the safety of offal imports. Australian offal 
was produced for human consumption and was regulated under the same food health standards 
and legislation  as meat for human consumption. Australian beef and offal had a reputation for 
quality, safety and reliability around the world. He added that food safety was, however, an 
SPS issue.  
3.246.   The representative of Indonesia  stated that the Indonesian Ministry of Ag riculture 
Regulation  139/2014 was not aimed at limiting imports or disturbing trade relations but rather to 
protect Indonesian consumers' health from risks that arose from diseases carried by offal that 
contained residual hormones.  Both Regulations also co ntained halal provisions under which only 
establishments that produced Halal -products alone, and operated under the halal system, were 
eligible to export meet to Indonesia. The butcher that had done the actual slaughtering was 
required to be a Muslim and w as only eligible if he fulfilled all the requirements stipulated by the 
Government. Further, Indonesia's requirements for manual slaughtering in poultry were consistent 
with the Codex  Alimentarius Commission's CAC -GL 24-1997. Additionally, the requirement 
regarding transportation in the same container, contained in Article  21, was not excessive and had 
to be respected. This measure was aimed at separating halal products from non -halal products to 
preserve its pureness in observance of the Islamic Sharia on handling of halal products. Container 
was defined as "a place that had specific technical requirements for storing and distributing 
carcasses, meat and/or processed meat products."  Indonesia said that the aforementioned 
requirements applied non -discriminat orily to locally produced carcasses, meat and processed 
products. They were also highly essential to implement the "Halal Assurance System" within 
Indonesia's territory.  Indonesia was also of the view that directing STEs to import secondary cuts 
was not in consistent with Indonesia's WTO obligations and that the regulation would not lead to 
price increases as it was intended to address price fluctuations.  
3.2.3.36   Canada - Tobacco Reduction (Flavo ured Tobacco Products) Amendment Act, 
2013 – Bill 206 (IMS ID 463)  
3.247.   The representative of  Indonesia  reiterated concerns with regard to the amendment which 
would prohibit the use, distribution and sale of "flavoured tobacco products". In particular, he 
stressed his delegation's concern with respect to the exception for menthol cigarettes. Indonesia 
acknowledged Canada's right to pursue public health objectives. However, Indonesia was also of 
the view that this policy should be prepared in such a manner so as not to infringe Canada's 
WTO obligations. Indonesia noted that the exce ption for menthol cigarettes was a form of G/TBT/M/66  
 
- 55 - 
 
  discrimination, which contravened one of the basic WTO principles and was similar to the p olicy 
issued by the US G overnment, which had later become the subject of a dispute between the US 
and Indonesia. Finally, Indonesia urged Canada to  postpone the implementation of the regulation.  
3.248.   The representative of Canada  thanked Indonesia for the bilateral discussions and said that 
his delegation would discuss these issues with their provincial counterparts. He then noted t hat 
Alberta had recently announced that the sale of menthol -flavoured tobacco products would also be 
prohibited on 30  September  2015. He stated that Canada was committed to deal with youth 
smoking issues and that this legislation would be notified followin g internal consultations.  
3.2.3.37   Ecuador - Emergency Technical Regulation (RTE) No. 088: "Surface tension 
agents", of the Ecuadorian Standardization Institute (INEN) , G/TBT/N/ECU/117 
(IMS  ID 453)  
3.249.   The representative of Mexico  reiterated his delegation's concerns as contained in document 
G/TBT/W/405. He then asked Ecuador whether the technical regulation had undergone changes to 
facilitate its compliance as Mexico 's private sector remained  concerned  with fulfilment of this 
measure.  
3.250.   The representative of Ecuador  explained that this  regulation was based on Andean 
Community  (CAN) Decision  706 of 10 December 2008 on harmonization of legislation on domestic 
hygiene products and absorbent personal hygiene products, which was undergoing constant 
revision.  This technical re gulation was notified under the TBT  Agreement and entered into force on 
the 11 April 2015. Taking  into account comments from Members with respect to conformity 
assessment, Ecuador had amended the regulation to facilitate, among other mechan isms, the 
submis sion of a first-party declaration,  thereby resolving in a satisfactory manner the problem of 
proving the product's conformity.  
3.2.3.38   Russian Federation – Technical regulations on safety of railway transport 
(TR CU No. 001/2011, No. 002/2011 and No. 003/2011) (IM S ID 460)  
3.251.   The representative of  Ukraine  reiterated concerns with regard to the technical regulations, 
in particular, the negative effects on trade for Ukrainian railway transport products. She then 
noted that Ukrainian producers effectively applied quality  management systems according to the 
requirements of ISO  9001:2008. Ukrainian products met the requirements of the Russian 
standard, had  valid certificates of compliance issued by Ukrainian Certification Body, conformed  by 
the certificates of conformity wi th Technical Regulations of the Customs Union issued by the 
authorized Certification Bodies of Belarus and included in Russia 's Register of Certification of the 
Federal Railway Transport. Regardless of the reasoned concerns, Russia refused to recognize the  
certificates issued by Ukrainian and Belarus authorities. She insisted on the position that the 
measure was inconsistent with Articles  2.1, 2.2 and 5.1 of the TBT  Agreement and called upon 
Russia to immediately lift this trade ban. Finally, Ukraine reques ted Russia to take into account the 
above concerns in good faith and with a view of ensuring compliance of the Customs Unions 
technical regulations  by addressing  objectives of safety in a less trade -restrictive manner and in 
accordance with the provisions and principles of the TBT Agreement.   
3.252.   The representative of  the Russian Federation  thanked  Ukraine for their interest i n the 
technical regulation. He noted  that these measures  had been adopted in July 2011, before the 
accession of Russia to the WTO. Despit e the fact that Russia was not a WTO  Member at the time, it 
had provided a very reasonable period of three  years between their adoptio n and entry into force. 
He stressed that t he decision on the adoption of these technical regulations contained very soft  
transitional provisions. Following the entry into force of the technical regulations in July 2014, 
product certificates already issued were valid until the end of their  validity, but not later than 
1 August  2016. In addition, the production and circulation on the market of products conforming to 
previously established specific ations was also allowed until 1  August  2016. Moreover, the 
production and release into circula tion of Eurasian Economic Union  (EAEU) products that were not 
subject to mandatory assessme nt of compliance with mandatory requir ements was also allowed 
until 1  August  2016. In fact, Russia  and the EAEU had provided  a five -year period between the 
adoption and entry into force of the technical regulations so as to allow time for producers in 
exporting Members to adapt their products or methods of production to the new requirements. 
Conformity assessment procedures were the same for domestic and imported products.  He noted G/TBT/M/66  
 
- 56 - 
 
  that the decision of the adoption of the technical regulations contained a l ist of the standards 
which ensured compliance with the technical regulation. Finally, he explained that 90% of 
standards in this list were GOSTs,  interstate standards applied throughout the Commonwealth of 
Independent States, in particular in Ukraine and t he Russia.  
4  EXCHANGE OF EXPERIEN CES 
4.1  Seventh Triennial Review  
4.1.  The Chairperson  reported on the 16 June  2015 Thematic Session held on the Seventh 
Triennial Review.  Her full report, provided on her own responsibility as Chairperson, is contained in 
document JOB/TBT/134 . 
4.2.  In response to some questions about clarification on dates, the Secretariat  explained that the 
deadline for submissions on the Seventh Triennial Review  had been 1  June 2015  – this was a date 
that Members had agreed in the preparatory process. The  10 July 2015 date mentioned by the 
Chairperson was an encouragement for M embers to submit any further comments on other 
Members' proposals, or revisions  to their own proposals, by that date . This would facilitate the 
preparation of the first draft of the triennial review report by the Secretariat.  
4.2  Status  of Work on GRP (JOB/TBT/119/Rev .1) 
4.3.  The former chairman of the TBT Committee, Mr. Filipe Ramalheira  (Portugal), in his capacity 
as Friend of the Chair, updated the Committee on the status of work on GRP. Hi s report is 
contained in document G/TBT/GEN/ 181. 
4.4.  The representative of Brazil  reported that during the consultations, Brazil had understood 
that Members' concerns were not limited to the issue of disclaimers but also other issues under 
consideration in the  SPS Committee. Therefore, during the Chairperson's consultations, Brazil had 
presented considerations on the potential systemic implications of the matter.  
4.5.  The representative of India thanked the Friend of the Chair for his tireless effort in bringing 
consensus in the matter. He said that India was ready to engage in the SPS Committee for 
exploring the possibility of resolving the issue horizontally, without prejudice to India's present 
position in the TBT  Committee.  
4.6.  The representative of China  welcomed th e new ideas from Brazil to consider, in parallel, the 
pending issues in the SPS  Committee. China was of the view that a horizontal approach – i.e. one 
undertaken across both Committees on comparable issues  – including with respect to the text and 
the discl aimer, would provide not only consistency and balance, but also an opportunity for 
Members to demonstrate and restore confidence in the multilateral trading system.  
4.3  TBT@20 Anniversary Event on 6 November 2015  
4.7.   The Secretariat  updated the Committee on  the s tate of play of the TBT@ 20 event. In 
marking the 20th anniversary of the WTO, the Secretariat had been organising a series of events 
since the beginning of the year . The last Committee meeting of the year (in early November  2015) 
presented an  opportunity t o organize such an event with the participation of capital -based 
TBT experts. The purpose, as had been previously reported, would be to take  stock and reflect on 
the work of the  Committee over the last twenty  years. Like other Secretariat "@20 events", the  
intention was that the TBT@ 20 would be  open to the general public  and be organized as a side 
event to the November TBT Committee meeting. The programme of this event was being 
developed and would be shared with Members in due course. The S ecretariat was o pen to ideas 
from delegations on the content of this programme. In this respect, one idea that had been 
considered was to hear views from the original negotiators of the TBT  Agreement. The TBT@20 
event will be held in the morning of 4  November  2015 at the WTO.  
5  TECHNICAL COOPERATIO N ACTIVITIES  
5.1.  The representative of Malaysia  referred to a national WTO Workshop on TBT Agreement that 
had been held from 27 -28 May 2015 in Putrajaya, Malaysia, and expressed gratitude for the G/TBT/M/66  
 
- 57 - 
 
  assistance rendered to Malaysia. He rep orted that the workshop had received an overwhelming 
response from Malaysian authorities and that the Malaysian Government had found the workshop 
beneficial to its authorities as it had provided practical guidelines on the implementation of the 
TBT Agreeme nt. In addition, the participants had been updated on current issues being discussed 
in the Committee.  
5.2.  The representative of Mexico  thanked the Secretariat for a national workshop on the TBT and 
SPS Agreements that had been held in Mexico form the 28 -30 April 2015.  
5.3.  The Chairperson  invited Members to take note of the document containing information on 
TBT-related technical assistance activities undertaken or planned by the WTO  Secretariat for the 
2015/2016 biennial.33 She drew delegations' attention to the un usually high demand for 
TBT-related technical assistance: the WTO Annual Report on Technical Assistance and Training34 
showed that more TBT -related technical assistance requests had been received and delivered in 
2014 than in any other year since 1995. When  combined, requests for TBT and SPS technical 
assistance activities corresponded to 25% of all requests made in all WTO areas in 2014.  
5.4.  A number of observers reported on their technical assistance related activities. The 
representative of ISO reported that ISO was currently working on a new programme to help 
developing country members to engage in ISO activities .35 The representative of IEC reported that 
a conformity assessment regional seminar had been held in Singapore in June 2015 with the 
participation of  seven IEC members. She reiterated IEC's willingness to provide WTO  Members 
with assistance related to conformity assessment activities. Specifically on metrology , the 
representative of BIPM noted that BIPM had its own capacity building and knowledge trans fer 
programme that was aimed at helping states with emerging metrology  systems; a workshop had 
been organised in Mozambique earlier in 2015 involving a wide number of countries. The 
representative of OIML reported that his organization was trying to improv e its work in supporting 
countries and economies with emerging meteorology systems. He said that in May 2015, in 
association with the General Administration of Quality Supervision, Inspection and Quarantine of 
China (AQSIQ), they had organised a seminar on  legal metrology . 80 participants from 15 
countries had attended this seminar, in which key problem areas were identified and action plans 
developed to address them. A follow -up event was planned to be held in October  2015.  
6  UPDATING BY OBSERVER S 
6.1.  The repres entative of the OECD  presented  two recent submissions36 to the TBT  Committee 
She said that in March  2012, the Council of the OECD had adopted a new , updated international 
instrume nt to address regulatory policy  management . This was a "whole -of-government " activity 
that needed to  be addressed by sectoral ministries, regula tory and competition agencies: the 
recommendation on regulatory policy and governance . It addressed: consultation and citizen 
engagement;  regulatory impact assessment  (RIAs); export evaluati on; multilevel coherence; risk 
and regulation;  institution al responsibility for policy coherence ; and oversight by, and the role in 
general of , regulatory agenc ies through the twelve principles. It was further reported that in 
October 2015, the OECD would  launc h the "regulatory policy outlook", the first evidence -based 
analysis of the progress made by OECD countries to improve the way they regulate using the 2012 
recommendation as a benchmark .37 This new policy outlook would assess  the progress of countries 
in establishing the conditi ons for good regulation, reviewed  stakeholder engagement an d export 
evaluation and developed  suggestions and recommendations to use in a more strategic manner to 
inform the development and delivery of regulations. The OECD Regula tory Policy C ommittee would 
work towards unbundling the components of the 2012 recommendation in order to develop more 
operational guidance on its implementation.  
6.2.  It was also reported that the OECD had undertaken work on the theme of interna tional 
regulat ory cooperation. The 2012 recommendation contained  one principle that invited  
governments that developed  regulatory measures to give consideration to all relevant international 
standards and frameworks for cooperation in the same field. I nternational regul atory cooperation 
                                                
33 G/TBT/GEN/171/Rev.3.  
34 WT/COMTD/W/2 09, circulated on 27  May 2015. 
35 http://www.iso.org/iso/home/about/iso -and-developing -countries.htm .  
36 G/TBT/GEN/179 and G/TBT/GEN/ 180. 
37 http://www .oecd.org/gov/regulatory -policy/2012 -recommendation.htm . G/TBT/M/66  
 
- 58 - 
 
  system s were not well  understood and , consequently, the Regulatory Policy C ommittee of the 
OECD was collecting evidence on the practices of regulators and their oversight bodies to 
implement regulatory international cooperation.  She said that the aim was to understand the 
benefits and costs of a selected number of international regulatory mechanisms and that part of 
this work was to look at mutual recognition agreements, the role of international organisations  
(including the WTO and ISO ), as well as  the role of good regulatory practices in various contexts. 
She said that the Trade and Agriculture Committee  of the OECD was also undertaking work on 
international regulatory cooperation with particular  emphasis to the trade aspect. T he objectiv e 
was to enhance the understanding of international regulatory cooperation as a mechanism to 
reduce or avoid unnecessary barriers to trade and increase trade opportunities.  The final goal was 
to develop a practical tool with which policy makers could diagn ose situations of policy regulatory 
divergence and identify the most appropriate international cooperation mechanisms.  
6.3.  The representative of BIPM recalled that as an  intergovernmental organization,  member 
states act together on matters related to measurem ent science and measurement standards. The 
main actors are the national metrology institutes and laboratories worldwide. This is an area where 
interest was growing. In this respect, he informed that the Republic of Azerbaijan had recently 
joined BIPM as an  Associate State. On the other hand, BIPM membership had lost the 
Dominican  Republic (as a Member State) and Sri Lanka (as an Associate State) due to repeated 
failures to pay their dues. In total, the number of countries participating as BIPM members and 
associates was around a hundred. He also welcomed the US paper on quality infrastructure that 
had been presented at the June  2015 thematic session and noted that the BIPM's role was to 
underpin the proposal with the scientific elements ensuring measurements  worldwide were 
appropriate and comparable. He said that the BIPM operated the CIPM Mutual Recognition 
Arrangement that provided mutual recognition at national laboratory level and also underpinned 
the mutual recognition of the 49,000  accredited laboratori es under the ILAC umbrella. The BIPM 
had together with the OIML and many national metrology laboratories worldwide recently 
celebrated the World Metrology Day, a major promotional event for quality infrastructure.  
6.4.  The representative of the OIML noted that "World Metrology  Day" (20  May) was an event that 
promoted the importance of metrology  as a fundamental element of a national quality 
infrastructure. TBT delegations w ere encouraged to participate in the activities of next year's 
event, which would be on th e theme of measurement in a dynamic world. Noting the importance 
of national quality infrastructure in the context of the TBT Agreement's Seventh Triennial Review, 
the representative of the OIML reminded Members of the importance of legal metrology  as a 
significant conformity assessment activity in the regulatory framework of most countries.  
6.5.  The representatives of UNECE  and IEC also reported on their activities.38  
6.6.  The Chairperson  took note that a new request for observer status had been received from 
Interg overnmental Authority on Development  (IGAD). She informed Members that a document 
containing all pending requests for observer status, together with the original requests and 
available background documentation, had been circulated in RD/TBT/1/Rev 1. She  suggested that 
delegations review this document. In addition, the complete list of observers and requests for 
observer status had been revised and was contained in document G/TBT/GEN/2/Rev 8.  
7  DATE OF NEXT MEETING  
7.1.  The regular meeting is scheduled for 4 -6 Nove mber 2015, pre ceded by a thematic session to 
be held on 3 November 2015 .39 A TBT@ 20 event will be held in the morning of 4 November as a 
side event to the regular Committee meeting. Tentative dates for the meetings in 2016 are 
contained in  JOB/TBT/127 . 
 
__________  
                                                
38 G/TBT/GEN/183 and G/TBT/GEN/182.  
39 JOB/TBT/106/Rev.1