RESTRICTED  
  
G/TBT/M/60  
 
23 September 2013  
(13-5051)  Page: 1/50  
Committee on Technical Barriers to Trade    
 
 MINUTES OF THE MEETING OF 17, 19 AND 20 JUNE 2013 
CHAIRPERSON: MR. JINGO KIKUKAWA 
NOTE BY THE SECRETARIAT1 
Contents 
 
1   ADOPTION OF  THE AGENDA ........................................................................................ 2  
2   ELECTION OF THE CHAIRPERSON ................................................................................ 2  
3   IMPLEMENTATION AND ADMINI STRATION OF THE AGREEMENT ................................. 2  
3.1   Statements from Me mbers under Article 15.2 ................................................................ 2  
3.2   Specific Trade Concerns.............................................................................................. 2  
3.2.1   New Concerns  ........................................................................................................ 2  
3.2.2   Previously Raised Specific Trade Concerns ................................................................. 16 
3.3   Exchange of Experiences ........................................................................................... 38 
3.3.1   Good Regu latory Pr actice ........................................................................................ 38 
3.3.2   Tran sparen cy ........................................................................................................ 38 
3.3.3   Special and Differential Treatm ent and Technical Assistance (preliminary 
discussion on the th ematic se ssion) .................................................................................... 39 
3.3.4   Conformity Assessment (prelimin ary discussion on the thematic session) ....................... 40 
4   TECHNICAL COOPER ATION ACTIVI TIES .................................................................... 41  
5   UPDATING BY  OBSERVERS ........................................................................................ 41  
6   DATE OF NE XT MEETING ........................................................................................... 42  
ANNEX 1 SUMMARY REPORT OF SEVENTH SPECIAL MEETING  ON PROCEDURES 
FOR INFORMATION EXCHANGE ...................................................................................... 43  
1   ONLINE NOTIFICATION: TBT NOTI FICATION SUBMISSION SYSTEM (TBT 
NSS) .......................................................................................................................... .... 43 
1.1   European Union: A journey to th e TBT NSS .................................................................. 44 
1.2   United States: Using the TBT NSS ............................................................................... 44 
1.3   Canada: Reflections on the proposed TBT NSS .............................................................. 44 
1.4   Di scussion  .............................................................................................................. . 45 
2   GOOD PRACTICES IN NOTIFICATION : USE OF NOTIFICATION FORMATS .................. 45  
2.1   European Union: EU proposal for a coherent use of notification formats ............................ 45 
                                               
1 This document has been prepared under the Secret ariat's own responsibility and is without prejudice 
to the positions of Members or to thei r rights and obligations under the WTO. G/TBT/M/60 
 
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  2.2   South Africa: Use of new notification formats ................................................................ 46 
2.3   Di scussion  .............................................................................................................. . 46 
3   FUNCTIONING OF ENQUIRY PO INTS ......................................................................... 46  
3.1   Information Services Provided by th e Brazilian WTO/TBT Enquiry Point to SMEs ................. 47 
3.2   Adding Value to the National Economy: USA WTO TB T Enquiry Point ................................ 47 
3.3   Experience and Operation of the Japan TBT Enquiry Point ............................................... 47 
3.4   The functioning of China's TBT Enquiry Point ................................................................ 48 
3.5   EU TBT Notification and Enquiry Point: Better communication with stakeholders and 
recent technical assi stance activities ................................................................................... 49 
3.6   WTO/TBT Enquiry Poin t – Malaysia's  Approach .............................................................. 50 
 
1  ADOPTION OF THE AGENDA  
1.1.  The Committee adopted the agenda contained in WTO/AIR/4126. 2  ELECTION OF THE CHAIRPERSON 
2.1.  The Committee elected Mr. Jingo Kikukawa (Japan) as the Chairman of the Committee. 
3  IMPLEMENTATION AND ADMINISTRATION OF THE AGREEMENT 3.1  Statements from Members under Article 15.2  
3.1.  The Chairman said that the list of stat ements submitted under Article 15.2 of the TBT 
Agreement was contained in document G/TBT/GE N/1/Rev.12, dated 18 February 2013. In total, 
since 1995, 128 Members had submitted at least one Statement on Implementation under Article 15.2. He recalled that this information was available, and regularly updated, on the TBT 
Information Management System (the "TBT IMS"
2).  
3.2  Specific Trade Concerns 3.2.1  New Concerns 
3.2.1.1  Ireland - Proposal to introduce standardised/plain packaging of tobacco 
products in Ireland 
3.2.  The representatives of Malawi, Dominican Republic and Cuba expressed their concern with 
the measure's consistency with both the TRIPS and TBT Agreements. Their full statements are 
contained, respectively, in G/TBT/W/368; G/TBT/W/366 and G/TBT/W/364. 
3.3.  The representative of Australia commended Ireland for its proposal to introduce plain 
packaging of tobacco products. He stated that tobacco plain packaging was a legitimate measure 
designed to achieve a fundamental objective - the protection of human health. Australia 
appreciated the interest Ireland had shown in Australia's tobacco plain packaging measure and looked forward to supporting Ireland as it de veloped its own measure. Tobacco plain packaging 
was endorsed by leading public health experts as well as the World Health Organization and was 
supported by extensive research reports and studies. Tobacco plain packaging was recommended in the guidelines for the implementation of Articl es 11 and 13 of the WHO FCTC to which Australia 
and Ireland were both parties. Australia was of  the firm view that Members had the right to 
implement measures necessary to protect public  health while complying with the relevant 
international treaty obligations, including the TBT Agreement. 
3.4.  The representative of New Zealand stated that his delegation supported Ireland's move to 
consider introducing controls on the packaging of tobacco products. The negative effects of 
                                               
2 http://tbtims.wto.org . G/TBT/M/60 
 
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  smoking could not be overstated. In New Zealand smoking was the single largest cause of 
preventable death and disease. WTO rules, incl uding those in the TBT Agreement, contained 
appropriate flexibilities to enable WTO Members to  regulate for health and other public policy 
purposes. New Zealand was determined to continue tackling the tobacco epidemic and takes a 
negative impact on public health of tobacco consumption very seriously. There was an extensive 
and compelling body of international research and scientific studies that established that plain packaging, as part of a comprehensive tobacco control programme, would contribute to the 
objective of improving public health. 
3.5.  The representative of Guatemala stated th at while her delegation shared Ireland's policy 
objectives related to public health and tobacco control, it was nevertheless concerned with the 
proposed legislation and encouraged Ireland to consider less trade restrictive alternative measures 
that would effectively achieve its own legitimate objectives.  
3.6.  The representative of Honduras expressed concern with the fact that the proposed Irish 
tobacco plain packaging measure was similar to that of Australia, which was currently under four 
dispute settlement proceedings in the WTO - including one initiated by Honduras - and whose 
consistency with WTO rules has been challenged in this Committee by a large number of WTO Members. In its formal dispute against Australia's measure Honduras was not challenging 
Members' right to adopt measures to protect pub lic health, provided they were WTO-compliant and 
had a solid scientific basis. In the case of Ir eland, such requirements were not met for the 
following reasons. First, the Irish Government's press release stated that there was strong evidence pointing to the fact that plain packagin g would increase the effectiveness of the graphic 
warnings, would reduce the misconceptions regarding the health of cigarettes and would also 
reduce the trademark attraction, particularly exercised on young people. Honduras invited Ireland to share the evidence used as a basis to make such assertions. In this respect, Honduras had 
already reviewed the studies used to adopt the Australian legislation and considered them to lack 
credibility because they had serious methodological shortcomings and did not show that plain packaging would effectively reduce the level of tobacco consumption. Second, the requirement for 
plain packaging was inconsistent with a number of obligations of the TBT Agreement. It was also 
inconsistent with the TRIPS Agreement (including certain provisions of the Paris convention) by affecting intellectual property rights, such as those concerning trademarks and geographical indications. Similarly to what Honduras indicated in the panel request in the Australian dispute, a 
possible similar Irish measure would cause serious effect of the main function of trademarks, 
which was to allow for producers to distinguish their products from those of their competitors. Such measure would also be more trade restrictive than necessary in attaining its objective. Apart 
from not achieving the reduction in tobacco consumption, plain packaging measures would also 
cause other negative consequences such as making impossible to communicate with the consumers through packaging that particular products were of premium quality. There would also 
be a price-based competition resulting in a drop in prices and, as a result, in an increase in 
tobacco consumption. Further, requiring tobacco prod ucts to be sold in plain packages would lead 
to an increase in illegal trade in tobacco products, facilitating the counterfeiting of packaging and making it more difficult to detect illicit products . In view of the foregoing, Honduras urged Ireland 
to reconsider its decision to start the adoption of plain packaging with respect to tobacco products 
and to, prior to taking such a decision, at least wait for the conclusion of the disputes lodged against Australia by Ukraine, Honduras, Dominican Republic and Cuba. 
3.7.  The representative of Nigeria stated that although her delegation recognized every country's 
right to take appropriate measures to protect its citizen’s health and welfare, it was also concerned 
with the compatibility of Ireland's proposed tobacco plain packaging measure with the obligations 
under the TBT and TRIPS Agreements. First, brand names needed to be attached to every product 
as a mark of identification for consumers. Second, these brand names also served as a defence against product imitation and faking, which could easily confuse consumers. Third, in case of any problem with respect to the product, such brand would make it easier to trace its origin. Lastly, 
like any other product, tobacco had some unique variations stemming from geographical and 
ecological differences. 
3.8.  The representative of Zimbabwe said that her delegation shared the concerns raised by the 
previous delegations regarding Ireland's proposal  to introduce standardized plain packaging of 
tobacco products. While Zimbabwe appreciated efforts to protect the health of consumers, the proposed measure would be inconsistent with the TBT and TRIPS Agreements inter alia because 
there was no scientific evidence that it would m eet the intended objectives. Developing countries, G/TBT/M/60 
 
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  such as Zimbabwe, rely on tobacco farming. The proposed measure would therefore negatively 
affect their employment creation efforts. Zimbabwe therefore urged Ireland to devise a less trade restrictive measure.  
3.9.  The representative of Norway recalled her de legation's usual stance that it was within the 
rights of each WTO Member to adopt measures necessary to protect public health as long as they 
would be consistent with the WTO Agreements. She recalled that plain packaging of tobacco products was a recommended measure under the WHO's Framework Convention on Tobacco 
Control (WHO FCTC). It was Norway’s firm opinion that the WHO FCTC and the relevant 
WTO Agreements were mutually supportive, and that it was thus possible to implement measures intended to regulate the packaging of tobacco products in line with both sets of binding obligations. Norway therefore supported Ireland's intent to introduce this kind of measure. 
3.10.  The representative of Ukraine said that her delegation was closely monitoring the issue 
concerning plain packaging of tobacco products and asked whether Ireland intended to notify the 
issue to the WTO. 
3.11.  The representative of the European Union informed that on 28 May 2013 the Irish 
government decided to begin the process of develo ping legislation introducing plain packaging for 
tobacco products sold in Ireland. She took note of Members' concerns and explained that Ireland 
was still at a very early stage of the process. Her delegation considered that it was therefore 
premature to discuss this issue in the context of the TBT Committee. She further noted that a 
number of the points that were expressed during this meeting by some Members did not fall under the scope of the TBT Agreement and hence were no t supposed to be discussed in this Committee. 
3.2.1.2  European Union - Transformation of still wine into sparklin g wine EC Regulation 
479/2008 of 29 April 2008 
3.12.  The representative of Australia said that his delegation was concerned that EC Regulation 
479/2008 of 29 April 2008 did not allow bulk still wi ne produced outside the EU to be transformed 
into sparkling wine in the EU. At the same time, the EU permitted still wine from one EU member state to be transformed into spar kling wine in another EU member state. The 
Regulation appeared to be inconsistent with the national treatment principle of the GATT as well as 
Art. 2.1 of the TBT Agreement. The issue was of genuine concern to the Australian wine industry, 
w h i c h  w o u l d  l i k e  t o  h a v e  s o m e  o f  t h e i r  w i n e  t r a n s f o r m e d  i n t o  s p a r k l i n g  w i n e  i n  t h e  E U .  H e  encouraged the EU to amend the Regulation as a matter of priority. 
3.13.  The representative of the European Union ex plained that the transformation from still into 
sparkling wine in the EU was subject to very strict  regulations, regardless of the origin of the still 
wine. As a result, most sparkling wine sold in the EU could not be produced from still wine from 
another country, regardless of whether this was a third country or a European one. In the 
exceptional cases where this was allowed by EU legislation, specific labelling rules were in place in order to avoid consumer deception. She explaine d that her delegation was discussing this issue 
with Australia bilaterally in the framework of the EU-Australia Agreement on trade in wine. 
3.2.1.3  European Union - Implementing Regulation (EU) No 481/2012 laying down 
rules for the management of a tariff quota for high-quality beef  
3.14.  The representative of Argentina noted that since 1 August 2009, when Council Regulation 
(EC) 617/2009, dealing with the opening an autono mous tariff quota for imports of high-quality 
beef, came into effect, Argentina began negotiations and exchanged information with the European officials so as to participate in this quota. As from that same date, technical work was 
undertaken in Argentina to rapidly submit the prot ocol of quality according to the requirements 
laid out in the regulation. Argentina's first application to participate in this new quota was submitted in 2009 and since then successive comments and clarification requests have been 
received from the DG Agriculture and Rural Development of the European Commission. In 
February 2012, the final version of the protocol of control and certification was submitted following the modifications made at the request of the European officials. However, four years after opening the bilateral negotiations and despite having comp lied with all the requirements requested by the 
EU, Argentina was still not authorised to send high-quality beef to Europe under this tariff quota 
opened in 2009. Argentina considered this to be an unjustified delay that created an unnecessary G/TBT/M/60 
 
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  obstacle to trade inconsistent with the TBT Agre ement. Further, the fact that Argentina was not 
authorized to export beef under this new quota system was inconsistent with the TBT Agreement's 
MFN clause because other countries that had similar conditions as those of Argentina have already received authorization to access this quota for a long time. Due to the foregoing, Argentina 
requested the EU to clarify the reasons for the lack of progress since February 2012. He requested 
the EU to promptly take a favourable decision on Argentina's application, publish this decision without delay in the official bulletin of the EU with the name of the Argentine body issuing the 
certification of authenticity, as established in  Art. 5 of Regulation 481/2012 concerning the 
management of the tariff rate quota so that Argentina could participate on equal terms with other Members that, for years, have enjoyed access to this tariff quota. 
3.15.  The representative of the European Union explained that Regulation 481/2012 related to the 
management of a tariff rate quota (TRQ) introduced by Council Regulation (EC) 617/2009. Her 
delegation had therefore doubts that this i ssue fell under the scope of the TBT Agreement. 
Regardless, she informed Argentina that the EU was currently in the process of examining the 
application it had submitted in order to benefit from this TRQ and was also discussing this issue 
with Argentina bilaterally. 
3.2.1.4  Peru — Act to Promote Healthy Eating Among Children and Adolescents  
3.16.  The representative of Mexico expressed her de legation's concern with the fact that this law, 
which would have an impact on international trade, have not been notified to the WTO. Mexico 
considered that the use of expressions in the measures such as "high in" casted doubts as to whether this was the least burdensome measure possible. Mexico referred to other alternative 
measures, such as the "daily meal guides", used in other countries and based on the Codex, which 
showed the absolute amount of certain nutrients and their percentage in the daily food values. 
Mexico also noted that the measure did not ment ion any scientific basis proving that the use of 
expressions to inform consumers a product was "high in" a given nutrient - as well as the 
prohibition to sell such products in schools - would reduce the obesity of the population. Furthermore, it was difficult to know the impact that this law would have since the regulation has 
not been issued with the list of the foods that would be appropriate for each age as well as the 
technical parameters that allow for that such determination. 
3.17.  The representative of the United States associated herself with Mexico's concerns, including 
the fact that this measure has not been notified  to WTO Members. She noted that the US shared 
Peru's concerns regarding nutrition and its impact on obesity and other non-communicable 
diseases. The US has been a key supporter of the work to implement the recommendations of the 2004 WHO Global Strategy on Diet, Physical Activity and Health through new Codex guidance on 
nutrition and labelling. However, the timeline fo r implementation included in Peru's approved 
legislation did not appear to consider a period between drafting of the implementing regulation and compliance with the regulation for notification of  the draft regulation to the TBT Committee, for 
consideration of trading partners concerns and for outreach and consultation with stakeholders. 
She therefore asked Peru to consider a longer time frame for development of the draft regulation in 
compliance with the TBT Agreement's notice and comment transparency obligations. She asked Peru extend the short timeframe of 120 days allott ed for labelling compliance upon the completion 
of the final regulation. For example, when the US  undertook major changes to its food-labelling 
regime, it allowed an 18-month period for compliance to reduce the costs associated with re-labelling of products, and an even longer period  for labelling requirements related to trans-fat. 
3.18.  She also expressed her delegation's concerns with the legislation's lack of a full analysis of 
the costs to Peru and domestic and internationa l food producers to implement the measure. In 
particular, the U.S. pre-packaged food industry has expressed concern over the economic impact 
of the inclusion of warning statements on a mandatory basis. She noted that alternative 
approaches could provide similar information to consumers, without the cost of mandatory product relabeling. Codex, for example, recommended mandatory nutritional labelling of products and recently expanded the list of nutrients for declaration to include saturated fat, sodium, sugars (and 
trans-fatty acids in countries where this nutrient was a public health concern). The Codex 
Committee on Nutrition for Foods for Special Dietary Uses  has also proposed Nutrient Reference 
Values for labelling purposes for sodium and saturated fat, which provide another means for 
consumers to identify foods "low" and "high" in nutrients. In addition,
 Codex has defined voluntary 
"low" claims, "no added sugars" claims, and conditions for health claims.  G/TBT/M/60 
 
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  3.19.  Given the foregoing, she requested Peru to delay finalization and implementation of its 
regulation to allow for adequate dialogue and consideration of comments from stakeholders, as 
well as a discussion of the rationale, details an d potential impact of this proposed regulatory 
approach and alternate approaches considered, and Peru's assessment of the costs and benefits 
associated with the proposed mandatory labelling requirements. 
3.20.  The representative of Argentina requested the measure to be reviewed in light of the 
obligation of Article 2.2 of the TBT Agreement that it should not be more trade restrictive than 
necessary for the achievement of a legitimate objective. 
3.21.  The representative of the European Union shared the concerns raised by Mexico, the US and 
Argentina, and urged Peru to notify the measure so as to give Members the opportunity to 
comment on it. She also stated that, while her delegation fully shared Peru’s public health 
concerns regarding the provision of adequate nutritional information to consumers, it considered 
that the approach taken by the notified draft was not the best way and most proportional way to achieve the objectives of empowering consumers to make an informed choice in order to foster 
effective competition and consumer welfare. In this respect, and in relation to the warning labels 
and implementing provisions establishing limits for certain nutrients as foreseen in the transitional provisions, the EU call the attention to the Codex's Guidelines on Nutrition Labelling  (CAC/GL 2-
1985 CODEX), which stated that the information contained in the nutrient declaration "should not 
lead consumers to believe that there is exact quantitative knowledge of what individuals should eat in order to maintain health, but rather to convey an understanding of the quantity of nutrients contained in the product". No nutrient thresholds have been established by the Codex for the 
nutrients targeted by the Peruvian legislation. The EU recognised that for certain nutrients there 
was evidence of a positive association between its intake and the risk of developing a disease or disorder, but there was no scientific evidence sugg esting an identifiable threshold above which the 
risk existed. The risk increased rather continuo usly when the nutrient intake increased above the 
levels recommended by nutritionists. 
3.22.  She also requested Peru to provide information on the foreseen deadlines for the entry into 
force of this legislation. According to the second transitional provision, some of its provisions would 
come into force 120 days after the publication of the implementing regulation. The EU considered 
that the adaptation to the new labelling requirements would require significant investment for manufacturers and a redesign of the packaging fo r some categories of products which were not 
defined yet. In this regard, the EU asked Peru to  postpone the entry into force of the measure and 
to provide a reasonable implementation period in accordance with Article 2.12 of the TBT Agreement. The EU noted that its own legislat ion on nutritional labelling was adopted in 2011 
but would only come into force in 2014. 
3.23.  The representative of Switzerland said that while his delegation shared most of the concerns 
raised by previous Members, it also shared Peru's health concerns regarding obesity and other 
non-communicable diseases and recognised that th ey posed a threat to the economies of many 
countries. He informed that cognizant of the re lationship between diet and health, the Swiss 
federal office of public health may issue recommendations on daily nutrient intake and may set nutrient thresholds for different food groups based on international standards. On a voluntary 
basis, producer would be able to reference on th e product these thresholds identified by WHO or 
Codex. In this respect, Switzerland was pleased to note that Peru was considering Switzerland's voluntary approach. At this stage Switzerland asked Peru the following clarifications: (i) why were 
WTO Members not notified about this new law? (ii) what were the timelines for the implementing 
regulations and when would they be notified to the TBT Committee?; (iii) how did this law comply with Codex guidelines on nutritional labelling? Wi th respect to the last question, he added that 
according to this Codex guideline, the information contained in nutrient declaration should not 
leave consumers to believe there were exact quantiti es of what individuals should eat in order to 
maintain health but rather to convey an understanding of the quantity of nutrient contained in the product. 
3.24.  The representative of Guatemala stated th at her delegation shared the view that healthy 
eating should be promoted in order to preven t diseases among the population. Nevertheless, 
Guatemala was concerned that the Peruvian measure might be more trade restrictive than 
necessary to achieve the stated legitimate objective of reducing obesity in order to fight 
non-communicable diseases. In this context, it was absolutely essential to know the scientific basis of the measure. G/TBT/M/60 
 
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  3.25.  The representative of Peru stated that the measure's objective was to reduce obesity and 
other risks to non-communicable diseases through: organizing educative campaigns in schools to 
promote healthy eating; increasing physical activity; promoting healthy cafeterias/kiosks; informing consumers about the content of proc essed food; and supervising advertisement and 
marketing of food and alcohol, especially when di rected to children and adolescents. The technical 
regulation necessary to implement this law (which was approved on 10 May 2013) had to be in place in no more than 60 days after the entry into force of the law. At this moment, the Peruvian 
competent authorities were in the process of drafting this implementing measure. In conformity 
with Peru's obligations under the WTO Agreements  and Andean Community rules, this draft would 
be notified to the WTO and a 90-day comment period would ensue. Peru would then be able to, based on these comments, re-evaluate the regulati on. The final version of the regulation would 
then be published, entering into force 6 months after publication. 
3.2.1.5  United States - Energy Conservati on Program for Consumer Products: various 
products (G/TBT/N/USA/842 and G/TBT/N/USA/842/Corr.1, G/TBT/N/USA/848) 
3.26.  The representative of China first shared some background of his delegation's concerns with 
the US measure. Between January and March this  y e a r ,  t h e  U S  D e p a r t m e n t  o f  E n e r g y  ( D O E )  
notified 19 TBT measures under the U.S. Energy Policy and Conservation Act of the 1975 , as 
amended (as known as "EPCA"), 16 of which we re about energy conservation programme. The 
product scope ranged from microwave ovens, se t-up boxes to water heaters and lamps. While 
China supported the objective of the US of improv ing energy efficiency, it also hoped that these 
measures would not create unnecessary obstacles to trade due to the large number of the 
notifications and the wide coverage of products that China had special trade interests. China sent 
written comments on five of the notifications on 7 May 2013, namely: notifications G/TBT/N/USA/481/Add.6 and G/TBT/N/USA/739 (regar ding testing procedures for residential 
furnaces and boilers); notifications G/TBT/N/U SA/775 and Add.1 (regarding tests and procedures 
for residential clothes dryers); and notification G/TBT/N/USA/778 (regarding test procedures for set-up boxes). China asked the US to take its co mments into account when finalizing the measures 
with a view to reducing unnecessary barriers to trade. 
3.27.  The representative of the United States stated that the critical importance of energy 
efficiency to the larger environmental, energy se curity and other policy goals, were well known. 
She recalled that Persistent Obama has repeatedly emphasized that these goals were a key 
priority for the US. The activities of the DO E to implement the EPCA were among the most 
important across the US government in its effort to achieve these priorities. Indeed, DOE maintained an extensive program to improve ener gy efficiency of consumer products, including 
electrical appliances, lighting and other consumer products. DOE's program to improve energy 
efficiency of consumer products under EPCA consisted of four integrated parts: (i) testing; (ii) labelling; (iii) energy conservation standards and (iv) certification, compliance, and 
enforcement. Under this program, DOE set minimum energy requirements for products to be sold 
in the US market. The setting of these requirements was done through rulemakings based on an extensive impact analysis to ensure its requirements were technologically feasible and economically justified. This impact analysis was extremely robust as it incorporated factors relating 
to performance, utility, estimated energy savings;  economic expertise, impact on competition, as 
well as other relevant variables. These procedures ensured that DOE's proposed minimum energy requirements and the related testing procedures were based on the best technical and scientific 
evidence, were economically efficient, and woul d contribute significantly and efficiently to 
achieving US energy conservation goals. DOE's te sting requirements consisted of test procedures 
that manufacturers of covered products must use as the basis for certifying to DOE that their 
equipment complied with applicable energy conser vation standards and for making representations 
about the efficiency of this equipment on labels. Specifically, these test procedures also provided 
the protocols upon which the Federal Trade Comm ission based its energy guide label for these 
products. In implementing these programmes, DOE employed rule making procedures that were 
fully consistent with the US requirements under its administrative procedures act and associated 
body of law. These procedures also had implications for a robust public consultation, taking comments from a variety of stakeholders, incorporating these comments into the final rules. In 
this regard, she welcomed the comments from Ch ina on the five measures that it listed and 
assured China that these comments would be considered as the US Department of Energy moved forward on the particular rules to finalize them. G/TBT/M/60 
 
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  3.2.1.6  United States - Proposed Signif icant New Use Rules on Certain Chemical 
Substances  
3.28.  The representative of China said that his delegation appreciated the efforts of the US to 
strengthen the controls of chemicals and thanked it for bilaterally providing clarifications on the 
measure. China was nevertheless still concerned with the following issues: (i) the clarification of 
the CAS registered number; (ii) the explanation of the term "significant new use"; and (iii) the alignment of the OPPTS test method with those approved under the GSS. 
3.29.  The representative of the United States thanked China for its further questions on USAl814, 
EPA's Significant New Use Rule (referred to as a "SNUR") for eight chemical substances. She noted 
that in their bilateral discussions, the US relayed detailed information to China in response to its questions on technical elements of this programme. The US would be glad to respond bilaterally 
these further questions. 
3.2.1.7  China – Innovative medical inst ruments and provisions for simplifying 
application materials for re-registration of  medical instruments (G/TBT/N/CHN/965 and 
G/TBT/N/CHN/966) 
3.30.  The representative of the European Union expressed concerns with two separate yet related 
notifications from China, namely G/TBT/N/ CHN/965 and G/TBT/N/CHN/966. The first concern 
related to an announcement by China’s Food and Drug Administration (CFDA), issued on 20 March 
2013 (CFDA Notice 98), notified to the TBT Committee as G/TBT/N/CHN/965. CFDA Notice 98 appeared to give preferential treatment to innovative medical devices manufactured in China, which contained Chinese indigenous innovation (intellectual property rights). While the EU 
appreciated China’s efforts to put in place a streamlined approval procedure for innovative medical 
equipment, it saw no reason why this procedure would only be available for those Chinese devices. 
The EU reminded China that, in accordance with  Article 5.1 of the TBT Agreement, "conformity 
assessment procedures should be prepared, adopted and applied so as to grant access for 
suppliers of like products originating in the territories of other Members under conditions no less favourable than those accorded to suppliers of like products of national origin or originating in any 
other country". The EU urged China to revise the CFDA Notice in order to also allow imported 
innovative medical devices to qualify for the expedited approval procedure.  
3.31.  The EU said that the second concern under this item of the agenda related to another CFDA 
Notice, on the re-registration of Medical Devices, notified to the TBT Committee as 
G/TBT/N/CHN/966. To recall, all medical devices sold in China needed to have their registration 
renewed every 4 years and any changes to these products would also trigger the need for re-registration. While the EU welcomed China’s efforts to simplify the submission file for 
re-registration of medical devices, it was concerned with the re-registration procedure in China, 
which was only partly addressed by the notified draft. For instance, there was still no time limit foreseen for the completion of the registration proc ess. In the European industry’s view, it should 
be possible to foresee a deadline for completing the procedure at most 6 months following the 
submission of the re-registration file, at least for re-registrations of products that did not undergo any significant changes. Furthermore, it was not clear under what conditions products would qualify for this simplified re-registration procedure. The EU considered that this should be possible 
in all cases where the product was not subject to  changes, or where the changes were minor as 
compared to the previous registration. In this respect, the EU asked whether the CFDA was planning to issue some guidance on the type of changes for which re-registration was required.  
3.32.  Finally, and in relation to both measur es, the EU noted that China has submitted both 
notifications G/TBT/N/CHN/965 and G/TBT/N/CHN/966 under Article 5.7.1 of the TBT Agreement, 
providing a comment period of 30 days. The EU as ked what urgent problems of health, safety, 
environmental protection of national security have  arisen, or threaten to arise, which have led 
China to choose the urgency notification procedur e for these two measures. In the absence of such 
an explanation, the EU invited China to provide the normal time period of 60 days for providing 
comments on these two notifications. The EU also asked information on the timeline foreseen for 
the entry into force of these measures.  
3.33.  The representative of the United States raised concerns with respect to the measures that 
were notified as G/TBT/N/CHN/965 and G/TBT/ N/CHN/966. She stated that on 20 March 2013, G/TBT/M/60 
 
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  China's food and drug administration issued Circular No. 98 on the CFDA website for a 2-day 
comment period. Circular No. 98 included two draf t regulations: Annex I, called "Procedures for 
Special Examination and Approval of Innovative Medical Instruments (For Trial Implementation)", and Annex 2, called "Provisions for Simplifying A pplication Materials for Reregistration of Medical 
Instruments". On 30 March 30, the US Enquiry Point requested that China notify these measures. 
China notified Annex I and Annex 2 as G/TBT/N/CHN/965 and G/TBT/N/CHN/966, respectively, on 4 June 2013 with a 30 day comment period. In addition, on 30 March 2013 the US submitted 
comments on CFDA Circular No. 98, noting that Article 2 of Annex 1 limited priority treatment only 
to products that were manufactured in China, and that used Chinese indigenous innovation, and urged CFDA to apply the procedures equally to all products sold in China regardless of where they 
were developed or manufactured, consistent with China's trade-related commitments. 
Transparency in medical devices issue has been a recurring concern of regulated community in 
China, in particularly the US industry. It put unnecessary burden on these industries, depriving 
them of the ability to provide full well-reasoned comments in China's regulatory system.  
3.34.  With respect to the measure that was notified in G/TBT/N/CHN/965, she noted that its text 
differed from that of the 20 March draft posted on the CFDA website. It seemed that China have revised certain problematic language contained in the earlier draft. The US was currently reviewing 
this revised draft. With respect to the measure that was notified as G/TBT/N/CHN/966, she said 
that this measure was a commendable effort to streamline CFDA's re-registration process by reducing the application material required for re-registration and by allowing for the re-use of information from the initial product registration. The measure also exempted devices with 
minimum changes from needing to submit test reports. However, certain burdensome 
requirements remained. For example, since the time frame for registration was identical to that for 
the initial product registration, the US was still having difficulty with registration approval times 
where products were waiting in queue for approval.  
3.35.  The representative of Switzerland stated that, as an important exporter of medical devices, 
Switzerland strongly supported programmes intended to facilitate market access and was therefore 
in favour of a streamlined process for reregistrati on of medical devices. He asked China to inform 
the Committee about the foreseen date of entry into force of these regulations as well as to confirm that innovative products falling under this regulation were considered innovative independently of their country of origin. 
3.36.  The representative of China explained that the special approval procedures for the 
innovative medical devices (trial) included requirements for special approval process in order to 
promote the development of innovative medical devices at an operating level. Likewise, the 
provisions for simplifying the application materials for medical device re-registration were drafted 
to improve the re-registration process of medical devices. It distinguished different circumstances of application and simplified application document s. China started drafting these two documents in 
October 2012 and in March 2013 it published the Notice soliciting public comments on the special 
approval procedures for the Innovative medical devices and the provisions for simplifying the application materials for medical device re-registration (also known as Circular 98). During this period China received 527 comments, mostly posi tive, from 124 organizations, enterprises and 
individuals, (including foreign ones such as the EU Chamber of Commerce in China, the American 
Chamber of Commerce in China, the US Advanced Medical technology Association, the American Association of Medical Imaging and Technology Alliance, Johnson & Johnson medical company, 
Siemens AG). On 4 June 2013, China notified these two documents as G/TBT/N/CHN/965 and 
G/TBT/N/CHN/966.  
3.2.1.8  China – China Food and Drug Admini stration (CFDA) EMC Enforcement Notice for 
medical devices of 19 December, 2012 
3.37.  The representative of the European Union explained that the measure enforced in-country 
testing on electro-magnetic compatibility (EMC) for Class III medical devices as of 1 January 2014, 
and Class II medical devices as of 1 January 2015. This EMC testing was mandated in the context 
of China’s registration procedure for medical devices, and was carried out in order to ascertain 
compliance with Chinese mandatory standard YY0505:2012, which appeared to be equivalent to IEC standard 60601-1-2 (2
nd edition, 2004). While the EU appreciated such equivalence, it asked 
China to accept test reports from foreign laboratories accredited by accreditation bodies who were 
members of ILAC, as an alternative to in-country testing by a Chinese laboratory. This would avoid unnecessary duplication of testing, as medical devi ces imported into China were already tested in G/TBT/M/60 
 
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  accordance with the IEC standard. It would also ensure that, beginning in 1 January 2014, there 
would not be disruption in the importation of medical devices into China due to a lack of necessary infrastructure to perform the EMC testing. In this regard, the EU noted that currently there were only around 10 laboratories accredited by the CF DA to perform the required EMC testing – this 
appeared insufficient to comply with the influx of  heavy activity resulting from the enforcement of 
the CFDA notice as of 1 January 2014, and would likely lead to longer registration timelines and higher compliance costs for industry. In this context, the EU reminded China that, in accordance 
with Article 5.1.2 of the TBT Agreement, "confo rmity assessment procedures shall not be more 
strict, or be applied more strictly, than is necessary to give the importing Member adequate confidence that products conform with the applic able technical regulations or standards, taking 
account of the risks non-conformity would create". EU also requested China to notify this Notice in 
accordance with its obligations under the TBT Agreement, in particular Article 5.6.2. 
3.38.  The representative of China said that on  19 December 2012 it issued a notice of the 
issuance of work a plan for the implementation of medical devices standard YY0505:2012, which 
was an identical transposition of the IEC international medical electrical equipment electromagnetic 
compatibility test standard IEC 60601-1-2, set to ensure a safe environment for medical devices so as to protect public health. As IEC standard 60601-1-2 was the recognized international 
standard in this area and has been widely used in WTO Members, the promulgation of this Chinese 
measure at issue would not have significant impact on international trade. 
3.2.1.9  Indonesia - Ministry of Trade Regulation 82/M-DAG/PER/12/2012 on imported 
cell phones, handheld and tablet computers 
3.39.  The representative of the European Union expressed concern that this regulation was not 
notified under the TBT Agreement in its draft stage and other WTO Members did not have a 
possibility to comments on it. This Regulation provided for stricter controls on imported cell 
phones, handheld and tablet computers. The EU in dustry reported that following the entry into 
force of the Regulation, considerably more time was needed to put the products concerned on the Indonesian market. The Regulation required three ty pes of labels to be attached to the products: 
conformity of International Mobile Equipment number (IMEI), type label (SKPLBI) and type 
approval number label (POSTEL). The EU consider ed these labelling requirements excessive and 
was also concerned with burdensome pre-shipment inspections for every import taking place at the port of loading by an appointed representative  of the Indonesian government. In addition, the 
SKPLBI and POSTEL must be available already at  the pre-shipment inspection stage, while the 
usual practice was after custom clearance. The EU asked Indonesia to consider less time-
consuming and burdensome procedures on imports of cell phones, handheld and tablet computers. 
3.40.  The representative of the United States associated herself with the concerns raised by the 
EU and noted that the Indonesia measure, which we nt into effect on 1 January 2013, was notified 
to the Import Licensing Committee. She also noted that the labelling provisions of this measure 
were related to G/TBT/N/IDN/47 , which was notified to this Committee in December 2010. 
However, in May 2013, Indonesia's Ministry of Communication and Information Technology, KOMINFO, published additional technical guidance for registering product information, which was not notified. The US asked Indonesia to clarify the legitimate objective for the measure and 
whether these requirements were the least trade restrictive approach that could be taken to 
address its stated objective. In particular, US asked Indonesia to state the objective for requiring product identification numbers up to a year in advance as this seemed unnecessarily burdensome. 
She also noted that the Indonesian Ministry of Communication and Information Technology has 
issued additional technical guidance related to the regulation at issue in Postel Notification 5/2013  
on 14 May 2013. The US asked Indonesia to notify  this additional measure and expressed concern 
about the lack of transparency with such technica l requirements. It also noted that the measure at 
issue was published at a later point than the entry into force of new wireless certification requirements which were due to start on 1 Marc h 2013. Finally, the US asked Indonesia to delay 
implementation of this technical guidance and to provide a sufficient implementation period for 
companies to comply. 
3.41.  The representative of Indonesia explained that the measures have been notified to the 
Committee on Import License under G/LIC/N/2/IDN/13, dated on 8 February 2013. This 
notification containing two regulations namely: (i) Regulation of Minister of Trade of Indonesia No. 
82/M-DAG/PER/12/2012, dated 27 December 2012, on Provision of the Import of Cellular Phones, 
Handheld Computer and Computer Tablet, and (ii) Re gulation of Minister of Industry Regulation of G/TBT/M/60 
 
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  Minister of Industry of Indonesia No. 108/M-IND/PER/11/2012, dated 12 November 2012, on 
Registration of Cellular Phones, Handheld Computer  and Tablet. Therefore, these measures did not 
fall under the scope of the TBT Agreement. With regard to labelling requirements, he noted that both of these regulations referred to "Obligatory Label Affixing on any Goods", which was notified 
under G/TBT/N/IDN/47. Concerning the certification for telecommunication equipment, his 
delegation would inform and encourage the Ministry of Communication and Information (KOMINFO) to notify the regulation under the relevant provisions of the TBT Agreement. 
3.2.1.10  Indonesia – Ministry of Health Re gulation 30/2013 on the inclusion of sugar, 
salt and fat content information, as well as  health messages on the label of processed 
foods 
3.42.  The representative of the European Unio n requested Indonesia to suspend the application 
this technical regulation until a TBT notification has been submitted to the Committee and 
Members have been provided sufficient time to comment on it. She also recalled the need to provide a sufficient implementation period for industry to be able to adapt to the new 
requirements. She also stated that while the EU shared and supported Indonesia’s goals of 
providing nutritional information to consumers, an d preventing diet-related chronic diseases, it 
also wondered whether these objectives could not be achieved with less trade restrictive means, 
such as, for example, awareness raising campai gns, or a general message promoting healthy 
lifestyle and eating habits, rather than through a warning message applicable to all pre-packaged 
products.  
3.43.  She also expressed her delegation's uncertainty as to how these requirements would apply. 
First, Article 3.2 of the measure indicated that the labelling requirements would be "implemented 
gradually” for different processed foods depending on the risk of non-communicable diseases that a certain food presented. How, and under which ti meline, would this "gradual implementation" be 
achieved? Second, Article 3.3 of the measure indicated that further details as to the type of 
processed foods covered by the Regulation woul d be specified in a subsequent Ministerial 
Regulation. When would this Regulation be issued  and notified to the TBT Committee? Third, the 
Regulation stated, in its Article 3.4, that the inclusion of the nutrition information and health 
warnings shall be made in accordance with the legislation. Which legislation was Indonesia referring to? Would Indonesia issue additional implementing measures or guidelines on compliance with the Regulation, and notify them to this Committee? Finally, would Indonesia allow stickers 
placed after importation, and before being placed on the market in Indonesia (for instance, in 
customs warehouses) as a means to show compliance with the Regulation? 
3.44.  The representative of the United States associated herself with the comments of the United 
Sates. While the US shared Indonesia's concerns regarding nutrition and its impact on obesity and 
other non-communicable disease, it was also concerned over the adverse impact of mandatory health warning on processed foods containing sugar,  sodium and fat. She call Indonesia's attention 
to important alternative regulatory approaches (including those consistent with the 
Codex Alimentarius) that provided similar information to consumers without the misleading effect of mandatory health messages that may unfairly position certain foods in the eyes of consumers. The health message required by the measure at issue may be particularly misleading since this 
seemed to be required by the mere presence of certain nutrients, namely sugar, sodium and fat, 
which were also necessary components of a healthy di et. In this respect, she sought clarification of 
the testing provisions set forth in Article 6 of the measure, which seemed to establish a strict 
testing procedure that would not allow minimum normal variations between batches and would 
possibly include unnecessary shipment by shipment inspections. She concluded by reminding Indonesia of its obligation to notify new labelling requirements to the TBT Committee and take 
WTO Members comments into account. 
3.45.  The representative of Brazil stated that hi s delegation shared the concerns expressed by the 
EU and the US and encouraged Indonesia to notify  promptly the measure at issue so that other 
Members would be able to evaluate its scope and impact. 
3.46.  The representative of Indonesia informed that the regulation at issue was issued by the 
Minister of Health on 11 April 2013 and would be gradually implemented 3 years after 
promulgation. The measure's objectives were consumer protection and the reduction of certain 
diseases such as stroke, heart disease and di abetes. Furthermore, the regulation was also 
designed to educate the public through health messages. With regard to the obligation of G/TBT/M/60 
 
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  notification, Indonesia said that it would inform and encourage the relevant Ministries, in particular 
the Ministry of Health, to notify the regulation under the applicable provisions of TBT Agreements. 
3.2.1.11  Russia – Safety of light industry products 3.47.  The representative of the European Union expressed concern with this measure, aimed at 
the protection of human life and health, which subjected all textile and clothing, footwear and 
leather products to detailed mandatory conformity certification procedures. The EU considered that subjecting these relatively low risk products to compulsory certification of compliance created an 
unnecessary barrier to trade. While the EU shared Russia's legitimate objective of consumer health 
protection, it believed that this objective could be ensured by less strict means, for example random inspections. Moreover, the EU posed various questions with respect to how this legislation would be implemented: when would the conformity certificate need to be provided by testing? 
Should a self-declaration of the manufacturer be sufficient for all the products covered by the 
measure? Which standards would be applicable? Furthermore, the EU noted that the measure also provided for extensive labelling and marking requirements, some of them of limited use for the 
customer. The EU considered that mandatory labelling requirements should be limited to essential 
elements, leaving the remaining information at the discretion of the producer or distributor. The 
EU concluded by asking Russia to take into account, and provide a written reply to, the written 
comments on this notification that her delegation sent to them on 8 May 2013. 
3.48.  The representative of the Russian Federa tion explained that this technical regulation, 
developed in accordance with Article 2.2 of the TBT Agreement, was introduced in December 2011 
and entered into force in July 2012, prior to the Russian Federation's accession to the WTO. This 
technical regulation of the Customs Union actually replaced the national legislation and 
substantially facilitated regulation in this field in the market of all the member states of the customs Union. Under paragraph 4 of Article 11 of this measure, mandatory certification was only 
required for three kinds of textile products that had direct contact with the skin, for example 
underwear. All other textile products were only  subject to self-declaration of conformity. 
Furthermore, during the implementation of this technical regulation, in practice, it was decided 
that certain provisions therein had to be amende d. Accordingly, under the new draft amendments, 
imports of raw materials for manufacturing of final products would not be subject to confirmation of conformity. Instead, only final products woul d be subject to conformity assessment. The draft 
amendments were notified by the Russian Federation in document G/TBT/N/RUS/14. 
3.2.1.12  European Union - Proposal for a Re gulation on Fluorinated Greenhouse Gases 
3.49.  The representative of the United States said that while her delegation supported the global 
efforts to phase down the consumption and reduction of climate damaging HFCs, it was also 
concerned with the development process and implem entation difficulties of this regulation, as 
currently proposed. US appliance manufactures we re particularly concerned with the proposed 
changed to ban the use of Hydro fluorocarbons (HFCs) with a global warming potential of 150 or 
more in residential refrigerators by January 2015. On process, she first noted that some US 
stakeholders have been eager to participate and offer input on the development of this proposed regulation but were not given the access given to other stakeholders. She wished to understand the EU Commission's policy on such discussions, and whether there was guidance to regulatory 
agencies on access by stakeholders from the US and other countries.  
3.50.  She also asked the EU to clarify the role of the impact assessment study in formulating DG 
Climate's proposed legislation. In the development of its proposal, DG Climate commissioned an 
impact assessment by a consultancy to evaluate alternative options for the regulation. In fact, this 
report considered a ban for refrigerators/freezers and concluded that a ban on domestic (residential) refrigeration was not recommended because of its low effectiveness and "a strict 
regulatory instrument such as a ban would need to be justified with a substantial contribution to 
the EU's emission reduction targets." It conclude d that this was therefore "unlikely, given the 
limited potential of these options." She considered  that the ban on refrigerators/freezers did not 
meet the minimum effectiveness criterion in the consultant's report, and would contribute to a 
very limited extent to the overall necessary emi ssions reduction while adding costs. Furthermore, 
despite this recommendation in DG Climate's impact  assessment, its proposal contained a ban with 
an aggressive timetable that would unduly impact exports of US refrigerators to the EU and would 
involve extensive product redesign and considerable expense to retrofit factories in order to safely 
handle flammable products. She asked the EU to reconsider this ban and its aggressive timetable.  G/TBT/M/60 
 
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  3.51.  The representative of Japan associated himself with the comments made by the US and 
stated that Japan was also concerned with the measure's prohibition of pre-charging (Article 12) 
and the allocation mechanism for produced/imported HFCs amounts (Article 14). Firstly, the prohibition of pre-charging air conditioning equi pment with HFCs and the requirement to charge 
the equipment with HFCs at the place of installati on would increase HFCs emissions due to leakage 
from the equipment rather than pre-charge in a factory, as not only Japan industry but also European industry pointed out. This implied that this environmental regulation lacked rationality. 
Secondly, Article 14 allocated quotas of HFCs to HFCs producers and importers in the EU based on 
the amounts from 2008 to 2011. However, with regard to the controlled equipment which was produced and charged outside the EU, the quota allocation of HFCs was not taken into account in this mechanism. Given the foregoing, Japan cons idered that, as a consequence of Article 12 
(Prohibition of pre-charging) and Article 14 (Quo ta allocation) of the measure, the EU would 
practically stop importing air-conditioners. Japan therefore requested the EU to withdraw these provisions of the measure. 
3.52.  The representative of Korea stated that wh ile his delegation respected the efforts of the EU 
to protect the environment, like other delegations, it also had some concerns with this measure, 
which required that HFC gas should not be charged into refrigeration, air-conditioning and heat 
pump before it was place on the market or before it was made available to the end-user for its 
final installation. To comply with these requirements, manufacturers had to remove HFC gas which had already been inserted in the product during tests. These kinds of additional processes might be significant burdensome to manufacturers, requ iring huge amount of investment and might also 
lead to lowering performance of equipment. Moreover, the precise level of refrigerant was a critical 
factor for the performance and energy efficiency. Th e regulation required only a certified person to 
charge HFCs after its installation, so manufacturers might not guarantee the performance of the 
products because it was not clear who was responsible for degradation in some cases. Korea also 
wondered if the prohibition of pre-charge was the only best way for achieving the objective of the regulation of monitoring and managing the amount of HFC gas usage in the EU. For instance, 
allowing manufacturers and importers to report the level of HFC gases charged and the total 
volume of exported products could be a less trade restrictive alternative. 
3.53.  The representative of the European Union recalled the US request to exclude household 
refrigerators and freezers from the proposal’s ban on products containing HFC. The EU confirmed 
that the preparatory study carried out by the external contractor concluded that banning these 
products would only result in low additional emission reductions. However, this was due to the fact that the vast majority of manufacturers which su pplied the EU market have already converted to 
the use of non-HFC technologies. Therefore, in view  of the low additional costs of this conversion, 
a ban on HFCs in these appliances was deemed ap propriate to safeguard the emission reductions 
achieved in the past by avoiding a shift back to  HFCs. Regarding the US concerns on transparency, 
the EU explained that it has extensively consulte d stakeholders throughout the review process, 
starting with an expert committee assisting the preparatory study and including an internet consultation open to all entities registered in th e European Commission's transparency register and 
a subsequent stakeholder meeting, which US stakeholders also attended. Due to the great number 
of sectors concerned, it was not always possible to accommodate all meeting requests and priority 
had to be given to meetings with associations representing a larger range of stakeholder interests, for example the American Chamber of Commerce in the EU. However, individual companies, 
including US domestic refrigeration equipment manufacturers, had the opportunity to put forward 
their specific concerns, which were taken into account.  
3.54.  Concerning the Japanese and Korean concerns  on the prohibition to charge refrigeration, air 
conditioning and heat pump equipment with HFCs before it was placed on the market and 
installed, the EU clarified that this ban applied without discrimination to all equipment, whether produced in the EU or imported, and also covered equipment with capped valves. This measure ensured that equipment would be installed and filled with HFCs by certified persons, as only those 
were allowed to access bulk HFCs. This reduced the risk of accidental release of HFCs during 
installation by using unqualified persons; a risk which was in particular high in the case of split air-conditioners, which represented a large share of HFC in pre-charged equipment and were sold 
in large quantities in retail shops. In line with  this objective, equipment that was hermetically 
sealed during manufacturing and did not allow for opening of the refrigerant circuits was exempted 
from this requirement. In addition, the ban on pre-charging reduced the risk of leakage during 
packaging and transportation. After intensive consul tation with various stakeholders, the EU came 
to the conclusion that CO
2 emission savings would out-weight potentially higher emissions G/TBT/M/60 
 
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  occurring during filling on the installation site compared to filling in a controlled environment in the 
factory, all the more so since, in many cases an adaptation or topping up of the charge size after 
installation was necessary. Furthermore, the ban on  pre-charging ensured that also the quantities 
for the first fill of imported equipment were covered by the HFC phase-down mechanism. Without 
this measure, alternative options would be needed  to avoid a circumvention of the phase-down by 
imports of HFCs inside equipment. The share of  around 11% of the total EU HFC supply today 
could increase dramatically due to the scarcity of bulk HFCs on the EU-market under the phase-
down mechanism, if the first fill of imported equipment was not accounted for under this 
mechanism. In sum, the EU has concluded that the ban on pre-charging would be the least restrictive option for non-EU manufacturers, after also considering alternatives such as product bans or an inclusion of HFC-containing equipment in the phase-down mechanism. A reporting 
obligation for importers of HFC containing equipment was already foreseen in the proposal but 
would not prevent an increase of the imported quantities. With regard to the Japanese concerns related to the allocation of quotas for those importers who have not imported HFCs between the 
reference period of 2008 to 2011, the EU explained that, according to the draft regulation, 5% of 
the overall quantitative limits should be reserved for importers and producers who have not imported or produced more than 1 tonne of fluo rinated greenhouse gases in the reference period. 
3.2.1.13  Peru — Implementing Regulation s of 14 November 2012 for Moratorium on 
Planting Genetically Engineered Crops  
3.55.  The representative of the United States considered that these implementing regulations 
included unclear conformity assessment procedures  t h a t  n e e d e d  t o  b e  s t r e a m l i n e d  i n  o r d e r  t o  
avoid further trade disruptions. She therefore urge d Peru to notify the measure to this Committee 
and take WTO Members' comments into consideration. She recalled Peru's position that such notification was unnecessary due to an exception under GATT Article XX. The US however 
considered that this GATT provision did not relieve Peru of its independent notification obligations 
under the TBT Agreement. Peru's prior practice appeared to be consistent with this point. For example, Peru notified its labelling rules for genetically-engineered foods in June 2011 using the 
TBT template form and allowed until 15 September 2011 for comments to be submitted 
(G/TBT/N/PER/37). 
3.56.  The representative of Peru stressed that in his delegation's view the moratorium on planting 
genetically engineered crops for ten years was not a technical regulation within the meaning of the 
TBT Agreement and, consequently, it did not have to  be notified to this Committee. Instead, this 
moratorium was an environmental measure meant to protect biodiversity. Peru was considered as one of the ten countries with the highest level of biodiversity in the world for its multiple 
ecosystems, genetic resources and aboriginal an d indigenous cultures. The measure's objective 
was to strengthen the national structures and ensu re the sustainability of the national lines of 
production. This law established a 10-year moratorium to the entry in Peru of live GMOs, including 
live animals and live plants, thus avoiding th eir release into the environment. The following 
activities were however excluded  from the moratorium, under certain conditions: GMOs used for 
research purposes; GMOs used for medical or veterinary purposes; and GMOs and other GMO-based imported products, used for direct animal or human consumption or for their processing. 
Peru also had separate, specific legislation dealin g with the risks of the use of biotechnology, such 
as Law n. 27.104 of 1999 (" Ley de Prevención de Riesgos Derivados del Uso de la Biotecnología "), 
and Supreme Decree n. 108-2002-PCM (" Reglamento de la Ley de Prevención de Riesgos 
Derivados del uso de la Biotecnología "). Finally, Peru noted that the measure at issue was in line 
with international agreements signed by Peru and has not resulted in any trade impacts given that 
the seeds traded or transported to Peru were for animal consumption. 
3.2.1.14  European Union — Revised Proposal  for the Categorization of Compounds as 
Endocrine Disruptors of 19 February 2013 by DG Environment 
3.57.  The representative of the United States stated that under existing EU legislation on 
chemicals, pesticides and other products, the Comm ission was due to develop measures related to 
endocrine disruptors by the end of 2013. The outc ome of this work, led by DG Environment, would 
form the basis of amendments to  EU REACH, the EU Biocides Directive, the Plant Protection 
legislation, the Cosmetics Directive and other EU legislation. The DG Environment's work as of 
February 2013 has resulted in an approach that would categorize substances into two categories: 
(i) known endocrine disruptors; and (ii) suspected endocrine disruptors. The EU has noted its view that the categorization was similar to its approach to carcinogenic, mutagenic and reprotoxic G/TBT/M/60 
 
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  substances. We see substantial differences, and believe this approach to endocrine disruptors 
raises several concerns. Endocrine disruption was a mode of action rather than an adverse event 
like cancer or birth defects. The EU was embarking on a course that diverged significantly from approaches to endocrine disruptors, such as th at of the US Environmental Protection Agency 
(EPA). EPA screened and tested substances before determining if the weight of evidence indicated 
that they produced adverse effect. It then based regulatory decisions, such as to register or re-register a substance, on a risk analysis that took into account both the hazard and the likely 
exposure. In the approach under discussion in the EU, however, a substance could be 
de-registered if it was assigned to a category that met the cut-off, without a risk assessment or the weight of evidence indicating that an adverse event was likely. US industry was concerned about this work because categorization and the development of lists of substance according to 
those categories (such as suspected EDs) would likely precipitate decisions to stop using those 
substances, or switch to alternatives, that would maybe be less well understood without any scientific justification. In turn these decisions could result in significant and unwarranted 
dislocations in trade. 
3.58.  Given the foregoing, the US asked the EU the following: (i) please clarify the relation of the 
work streams under way in the Commission related to endocrine disrupting substances, and the 
relation of these to potential changes to EU REACH, and other EU legislation, such as Cosmetics; 
(ii) please identify the specific inconsistencies and errors that DG Environment identified in the recent report by EFSA (European Food Safety Authority); (iii) please explain how DG Environment's ED hazard identification a pproach differed and concurred with EFSA's 
recommendations; (iv) please indicate when other WTO Members would have the opportunity to 
formally comment on the EU's new approach to endocrine disruptors and whether these comments would be taken into account; (v) please confirm that notification and comment would happen only 
after the new approach would be agreed and actually adopted in its specific EU legislation (such as 
plant protection, biocides or REACH).  
3.59.  The representative of South Africa associated himself with the comments made by the US 
and requested the EU to notify the proposed amen dments to the criteria for identification of 
endocrine disruptors and the proposed residue thre shold for food and feed treated with possible or 
potential endocrine disruptive compounds as soon as possible so as to allow trading partners, especially developing countries, at least a period of 90 days to provide comments, before any new 
regulations in this regard were adopted by the European Commission. 
3.60.  The representative of the European Union explained that several pieces of EU legislation 
contained specific provisions as regards endocrine disruptors. This was the case for the plant 
protection products Regulation, the biocidal prod ucts Regulation, the REACH Regulation, the water 
framework Directive, and the cosmetics Regulation . It was therefore judged essential to determine 
horizontal scientific criteria for the identification of endocrine disruptors applicable across all 
relevant pieces of legislation. The objective wa s to ensure a harmonised and coherent approach 
when dealing with endocrine disruptors, as well as  coherence and predictability to all players. In 
this context, the European Commission has been working for a number of years to collect and develop scientific information on this matter. For instance, a study with a scientific review and an 
overview of the assessment methods for endocrine disruptors was published in early 2012. In June 
2012, an EU conference gathering the world's experts on endocrine disruptors and around 300 stakeholders was organised. In March 2013, a report outlining experts’ opinions on key scientific 
issues relevant to the identification of endocrine disruptors was published by the EU Joint Research 
Centre. Finally, in March 2013 the European Food Safety Authority published its scientific opinion as regards endocrine disruptors. 
3.61.  She further explained that the European Commission would probably adopt by September 
2013 a Recommendation with the criteria for identifying endocrine disruptors. This Recommendation would use the World Health Organiza tion definition of endocrine disruptors and 
was likely to establish a system with several categories – comparable to what has been done in 
the UN Global Harmonised System for Classification and Labelling for the classification of 
substances identified as carcinogens, mutagenic or toxic to reproduction (CMRs). Substances would be allocated to one of these categories based on strength of evidence in a weight-of-
evidence approach. The Recommendation would also define the criteria for placing substances in 
the categories. Once the Recommendation with the horizontal criteria was adopted, the plant protection products Regulation and the biocidal pr oducts Regulation would have to be amended to 
render the criteria legally binding in the context of those Regulations. As a consequence, G/TBT/M/60 
 
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  substances identified as endocrine disruptors would not be approved as active substances for use 
in plant protection products, nor for biocidal products. As regards REACH and other legislation, a direct implementation of the criteria into REACH was not envisaged. However, the horizontal criteria would be taken into account when identifying substances as endocrine disruptors for 
inclusion into the so-called candidate list of Substances of Very High Concern, which may fall under 
the authorisation regime. As regards the consultation process, it has been conducted in full transparency and the scientific community and WT O Members have had several opportunities to 
comment on the methodology for the identification  of endocrine disruptors. The EU has made a 
presentation on the development of criteria for identification of endocrine disruptors at the 
meeting of the OECD Endocrine Disruptors Testing and Assessment Advisory Group already in 2009 and then again in 2010 and 2011. Members of the Committee, notably the US, were 
represented at the EU Conference on Endocrine Disruptors held in June 2012. In February 2013, 
the Commission shared with the EPA a paper with possible elements as a basis for the criteria for identifying endocrine disruptors. The EPA comments were considered by the European 
Commission. There have been also several bilateral discussions with the EPA on this matter. 
3.2.2  Previously Raised Specific Trade Concerns 
3.2.2.1  European Union - Registration, Ev aluation, Authorization and Restriction of 
Chemicals (REACH)
3 (IMS ID 88) 
3.62.  The representatives of India, China, the United States, Argentina, Australia, the Philippines 
and Brazil reiterated concerns expressed at past meetings with respect to REACH. In addition, the 
representative of India referred to a number of  outstanding issues: the opaque and arbitrary 
functioning of the Substance Information Exchange Fora (SIEF), including the prohibitive costs 
associated with them; definitions of a micro, small and medium size enterprise (SME); the cost associated with hiring an Only Representative (OR); and the request for merchant importers to 
directly undertake registration. He also raised a new issue: Commission Regulation 836/2012, 
which prescribed a threshold concentration of 0.05% for the use of lead in jewellery. In this respect, he asked whether the EU had issued guidance to parents for avoiding mouthing of 
jewellery and inquired on the rationale for exempt ing crystal glass and vitreous enamel from the 
scope of the regulation.  
3.63.  Concerning the notification G/TBT/N/EU/73, the representative of China was concerned 
about the restriction of polycyclic aromatic hydrocarbons (PAHs), in particular with respect to the 
stringent and uniform limit of 1 ppm established for PAHs, which could result in over protection for 
a large number of products that did not pose a risk. He also requested clarification regarding the testing methodology associated with the measure.  
3.64.  The representative of the United States also raised four new issues under this trade 
concern: the proliferation of redundant national registries of nanomaterials within the EU; the 
proliferation of inconsistent interpretations of the term "article" within the EU; the uncertainty of 
whether ORs would be able to submit an application for a REACH authorisation; and the lack of 
transparency in the processes of the Community Rolli ng Action Plan (CORAP). She also inquired on 
the role of the national registries of nanomaterials, on whether the EU intended to establish an EU-wide registry of nano-products, on the view of the European Commission regarding programmes 
that singled out a single class of chemicals without articulating the benefits of doing so, and on the 
steps that the EU was taking to address the numerous concerns regarding the measure.  
3.65.  The representative of Australia was interested in hearing about practical steps the EU was 
taking to try to mitigate the impact of REACH on SMEs, given the findings of the Commission’s 
recent review of REACH. Like the United States, the representative of Brazil was also concerned 
with the proliferation of inconsistent interpretations of the term "article" within the EU.  
3.66.  The representative of Argentina stated that REACH created competitive distortions when 
substances were produced by a reduced group of competitors, as registration costs within SIEF 
                                               
3 The relevant notifications and documents ar e: G/TBT/N/EEC/52 and A dds.1-7; Add.3/Rev.1, 
G/TBT/N/EEC/295, G/TBT/N/EEC/295/Add.1; G/ TBT/N/EEC/297, GG/TBT/N/EEC/297/Rev.1, 
G/TBT/N/EEC/297/Rev.1/Add.1; G/TBT/N/EEC/333, G/TBT/N/EEC/333/Add.1, G/TBT/N/EEC/334, 
G/TBT/N/EEC/334/Add.1; G/TBT/N/EEC/335, G/TBT/N/EEC/335/Add.1; G/TBT/N/EEC/336, 
G/TBT/N/EEC/336/Add.1; G/TBT/ N/EU/73; and, G/TBT/W/208. G/TBT/M/60 
 
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  were distributed among competitors on equal parts,  regardless of their market share. Moreover, 
the larger companies were usually the owners of the information within the SIEF. Thus, the incidence of the registration cost per tonne and the information access cost would leave outside of competition those firms with lesser volume. The need to register a product through a legal 
European entity (OR) also put foreign companie s at a disadvantage – indeed this requirement 
posed a number of risks, including: that the OR co uld legally cease to exist or could change, and, 
there were also risks pertaining to confidential information about clients and trade volumes. 
According to REACH, these issues could be resolved through negotiations. However, these 
negotiations would cause a legal cost that probably would not be justified when the volume market share was reduced. 
3.67.  The representative of the European Union said that information on the estimation of 
exposure to PAHs arising from the use of consumer articles as well as conditions of use of these 
articles was available in the 2010 report by the German competent authority for REACH. She also 
said that there were currently no standard analytical methods to test PAHs but that some EU 
member states had their own analytical methods, and that a two year transitional period from the 
adoption of the measure was foreseen. With respect to Commission Regulation 836/2012, she explained that the 0.05% limit was based on the opinion delivered by the risk assessment 
committee, and that the social economic committ ee exempted crystal glass and vitreous enamel 
after examining the evidence presented on the comparative effect in relation to lead. As to the national registries of nanomaterials, she informed that the European Commission had not found incompatibilities with the internal market rules, but was preparing an impact assessment for a 
possible future harmonising measure, one of the options being a harmonised registry. Regarding 
the interpretation of term "article", she said that the European Commission sustained that the 0.1% threshold for substance of very high concern applied to articles as produced or imported, 
and not to components or homogenous parts of articles. Further, the European Court of Justice 
was the only authority that could decide on the correct interpretation of the term. On the CORAP processes, she clarified that since 2013 most of the background documents were published. 
Finally, regarding ORs, she said that, as was clarified by the European Chemicals Agency (ECHA) 
guidance documents, an OR could submit an application for a REACH authorisation. 
3.2.2.2  India – Pneumatic tyres and tubes for automotive vehicles (G/TBT/N/IND/20, 
G/TBT/N/IND/20/Add.1; G/TBT/N/IND/40/Rev.1) (IMS ID 133) 
3.68.  The representative of Japan requested India to correct the discrimination in article 10.2 of 
the revised "Agreement for the Grant of BIS Licence" under which only foreign tyre manufacturers 
were required to provide a bank guarantee of US D10,000. He also requested a revision of the ISI 
Marking Fee calculation method which was based on the total number of ISI marked tyres, 
including tyres destined for export outside the Indian market. 
3.69.  The representative of the European Union reiterated the longstanding concerns about the 
Indian Quality Order on Pneumatic Tyres and Tubes for Automotive Vehicles, which included a 
certification procedure with mandatory marking fo r tyres, and the requirement regarding the bank 
guarantee of USD10,000 for the payment of royalty fees. Of particular concern were the royalty fees to be paid on the total production of tyre s marked and produced with ISI marking, and not 
only those which were actually imported to India. She urged India to remove the royalty fees, or 
to modify their calculation to limit them to tyres which were de facto  exported to India. 
3.70.  The representative of Korea also reiterat ed previous concerns regarding marking fees and 
performance bank guarantees. He said that the manner in which marking fees were calculated – 
on the basis of the total number of tyres produc ed and marked with the ISI symbol – was unfair 
and needed to be reviewed; it needed to reflect the total number of ISI-marked tyres imported to 
India. Compared with similar marks issued by other countries, fees were considerably higher for 
the ISI system, and in general most countries did not charge marking fees for tyres. He also requested India to repeal the USD10,000 perfor mance bank guarantee required for foreign 
manufacturers outside India. 
3.71.   The representative of India answered th at the performance bank guarantee was intended 
to protect the Bureau of Indian Standards (BIS) fr om breach on behalf of the licensee during the 
tenure of the licence, and that such guarantees were customary in the international sphere. He 
also said that the marking and overall fees were comparable or even lower than those charged by 
other Members for similar schemes. G/TBT/M/60 
 
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  3.2.2.3  China – Testing and Certification Requirements for Medical Devices (IMS ID 
143) 
3.72.  The representatives of the European Union, Brazil and the United States recalled their 
previous concerns about the on-going revision  of China's Order 276 on Medical Devices and 
requested China to notify any revision to the TB T Committee. In particular, the representative of 
the European Union noted that on 23 April 2013 Chinese authorities announced the revocation of 
China Compulsory Certification ( CCC) requirements for eight catego ries of medical devices, which 
had been a longstanding concern of EU industry in China, and hoped that this was the first step to 
ensure that medical devices imported into China were not subject to duplicative regulatory controls due to the overlapping responsibilities of the General Administration of Quality Supervision, 
Inspection and Quarantine (AQSIQ) and the Stat e Food and Drug Administration (SFDA). She 
asked China for an update on the status of the revision, and recalled the specific EU industry 
concerns: registration procedures, differences between China's and international standards, 
insufficient acceptance of foreign clinical trial data and test results, and the need for approval of 
the products in the country of origin or manufacture. She stressed the need for China to: notify 
this legislation to the TBT Committee; allow Members a reasonable time to provide comments; take Members' comments into account; and provide for an adequate implementation period of at 
least one year between the publication of the Order and its entry into force. The representative of 
Brazil recalled the need for greater convergenc e of China's applicable mandatory standards to 
international ones, as well as the need for more flexibility in accepting medical devices on the 
Chinese market which had been made in compliance with international standards. 
3.73.  The representative of China noted that the revision of Order 276 on medical devices had 
started in 2006 and that the State Council of China had been open to public consultations online 
since September 2010. She explained that China had received comments from various 
organisations and that the Legal Affairs Office of the State Council was still revising this regulation 
while taking into account comments received from stakeholders. 
3.2.2.4  India – Mandatory Certification for Steel Products (G/TBT/N/IND/32, 
G/TBT/N/IND/32/Add.1; G/TBT/N/IND/32/Add.2) (IMS ID 224)  
3.74.  The representative of the European Union thanked India for suspending the application of 
the mandatory third party certification for certain steel products until 1 October 2013. Her 
delegation considered third party certification to be inappropriate and too burdensome for 
intermediate steel producers. She inquired about the implementation of this mandatory third party 
certification, given that the European industry cont inued to report significant difficulties during the 
certification procedure, including long delays for issuing certificates, extensive and detailed 
information to be provided, mandatory factory insp ections, the lack of feedback on reasons for 
refusal of applications, and the lack of recognition of test results carried out by foreign laboratories. Finally, she asked India to take measures to ensure equal treatment for domestic and 
foreign manufacturers, and invited India to institute a more expeditious procedure for the steel 
products subject to third party certification with clear deadlines and possibility to challenge the refusal of the application. 
3.75.  The representative of Japan reiterated three concerns with regard to the technical 
regulation. First, he considered that technical regulations were not needed for intermediate 
products such as steel products because the objective of securing consumer's health safety should be achieved by safety regulations for final pr oducts. Second, the scope of the regulation was 
unclear and India needed to clarify which products were covered. His delegation considered that 
the measure, if put into effect as scheduled, would create unnecessary obstacles for customs procedures, disrupt Japanese high-quality steel supply. Finally, he asked India to postpone the 
commencement of operation and implementation of the regulation until its scope of application 
was clarified. 
3.76.  The representative of India reiterated that product coverage, HS codes, titles and Indian 
standard numbers had been provided, and that th e regulation applied to intermediate products 
because this affected the performance of the final product. G/TBT/M/60 
 
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  3.2.2.5  Brazil - Health Products Good Manuf acturing Practices (GMP) Requirements for 
Health Products (G/TBT/N/BRA/328) (IMS ID 233) 
3.77.  The representative of the European Unio n recalled Brazil's information at the last TBT 
Committee meeting that it had adopted several measures to improve the National Health 
Surveillance Agency's (ANVISA) inspection capaci ty. Such measures included the augmentation in 
the number of Good Manufacturing Practices (GMP) inspectors, and the publication of a draft resolution aimed at, inter alia , optimising conditions for the concession of GMP certificates. The EU 
understood that several hundred medical devices were still awaiting GMP inspections, thus pending 
authorization to be placed on the Brazilian market. The EU welcomed efforts taken by Brazilian authorities to accelerate inspections, but stressed that it would take a long time before the situation was regularized. Therefore, the EU called on Brazil to consider interim steps, such as 
temporary authorization of foreign GMP certificates. She suggested that ANVISA could continue 
issuing GMP certificates, however on the basis of inspection reports carried out by bodies established outside the Brazilian territory and shar ed on a confidentiality basis. This would allow 
Brazil to safeguard consumer health and safety, optimise resources, and guarantee inspections 
being carried out within three months after filing  of a request. The EU enquired if Brazil was 
considering these suggestions and asked for an update on the situation and steps to be taken. 
3.78.  The representative of the United States  supported the EU's intervention and recalled 
previously raised concerns on this issue. 
3.79.  The representative of Brazil referred to the minutes of previous meetings containing 
explanations on this subject. With regard to th e Brazilian authorities' work to improve ANVISA's 
inspection capacities, he informed that improvem ents had been taken in the certification process 
due to the relocation of experts from other area s. Further measures under consideration included 
an increase in the number of GMP inspectors by opening a new public selection process, and a new 
regulation allowing for the mutual recognition and acceptance of GMP certificates issued by foreign 
authorities. He said that Brazil remained open to alternative approaches, such as confidentiality agreements between health agencies in Brazil an d other Members to exchange inspection reports, 
and recalled that Brazil had joined the International Medical Device Regulators Forum (IMDRF). 
3.2.2.6  Korea – KS C IEC61646:2007 St andard for Thin-film Solar Panels 
3.80.  The representative of the United States reca lled their intervention on this issue at the March 
2013 Committee meeting that detailed concerns regarding methodologies and scientific flaws 
employed in Korea's environmental study, which had led to the continued exclusion of a certain 
type of solar panel from its certification programme manufactured in the US. She said this would enable eligibility for certain voluntary government programs and de facto  determine access to the 
Korean market. While the US appreciated engagement  with Korea on this issue, the results thereof 
had rather been disappointing. She requested anew to incorporate the specification for this type of solar panel in relevant Korean IEC standard as well as in its certification programme. 
3.81.  The representative of the European Union recalled their past statements on this issue and 
welcomed Korea's replies and updates. 
3.82.  The representative of Korea referred to a bilateral meeting held between Korea and the US 
in Seoul on 11 June 2013. As to the US concern regarding test methods on thin film solar panels, 
Korea welcomed the US positive response to its suggestion of holding an expert-level dialogue. 
Moreover, Korea underlined that the related certification system for thin film solar panels was not mandatory but voluntary, thus not leading to any restrictions in entering the Korean market. The 
Korean government had conducted a two-year, co mprehensive feasibility study to review the 
possibility of including CdTe and CIGS modules in the scope of KS C IEC61646:2007. This study 
was conducted to assess the effect to the environment of solar panels being damaged and 
discarded during and after their use. As no relevant international standards existed on the 
assessment of the degree of hazardous waste from thin film solar panels, Korea conducted tests based on the US EPA method and the EU method. Re sults of the feasibility study were discussed at 
the International Symposium held in March 2012. Korea informed that it was reviewing the 
necessity of conducting a feasibility study, as we ll as setting usage restrictions and recovering 
waste from thin film solar panels with regard to silicon-based solar panels. He informed that Korea has decided to adopt a certification system for CI GS modules that satisfied national environmental G/TBT/M/60 
 
- 20 - 
 
  standards, and was working on setting out criteria as well as installing necessary facilities for 
certification. Korea planned to complete these procedures by January 2014. 
3.2.2.7  India – Telecommunication s Related Rules (IMS ID 274)  
3.83.  The representative of the European Union asked India to confirm the postponement of the 
entry into force of the new security clearance requ irements from 1 April to 1 October 2013. The EU 
was concerned with the absence of final guidelines on applicable standards and the actual scope of testing. He also suggested limiting mandatory testing to critical elements only. Moreover, the EU 
remained concerned with the requirement for in-country testing, and reiterated its request that 
India maintain the current level of acceptance of test results and certificates issued by foreign laboratories and approved under the Common Criteria Recognition Arrangement (CCRA). Finally, with regard to testing methods, he reiterated  the EU's request that relevant international 
standards for information security be referenced in  the final guidelines, and asked for an update on 
the availability of the final guidelines. 
3.84.  The representative of the United States al so requested confirmation of the postponement of 
the security clearance requirements' entry into force to October 2013. The US expressed continued 
disappointment with the lack of progress in addressing serious concerns with the licensing amendment, including (i) the requirement for telecommunications equipment vendors to test all 
imported information and communications technology (lCT) equipment and labs domiciled in India; 
(ii) the requirement to allow the telecommunicati ons service providers and government agencies 
to inspect a vendor's manufacturing facilities and supply chain, and to perform security checks at any time during the supply of the equipment; and ( iii) the imposition of strict liability and possible 
blacklisting of a vendor for taking inadequate precautionary security measures. She echoed the 
comments made by the EU on the need to make use of international standards and arrangements for conformity assessment. As an in-country te sting requirement would impose costs and burdens 
on economic operators outside as well as inside India, the US was concerned about capacity, 
competence and independence of some of the labs  established in India. Criteria and systems to 
assure the competence and independence of testing laboratories were well established in 
international standards and systems of conformi ty assessment. She pointed out that India's 
legitimate security concerns could be addressed in a less costly and trade restrictive approach, and welcomed the opportunity to further discuss this issue on a bilateral basis. 
3.85.  The representative of Japan supported the concerns expressed by the EU and the US. Japan 
understood that the implementation of the Unif ied Access Service License Agreement had been 
postponed to 1 October 2013. Japan asked India to ensure that its telecommunications regulations would not impede market access for foreign companies. 
3.86.  The representative of India clarified that security, certification and testing by Indian labs 
would be mandatory as of 1 October 2013. With regards to the accreditation process and related 
security concerns, he stressed that the decision on in-house testing had been made with a view to 
taking into account security concerns on telecom equipment. He pointed out that the CCRA system 
was not very conducive in terms of securi ty aspects of telecom equipment testing. 
3.2.2.8  China – Requirements for informatio n security products (including, inter alia, 
the OSCCA 1999 Regulation on commercial encryp tion products and its on-going revision 
and the Multi-Level Protection Scheme (MLPS) (IMS ID 294) 
3.87.  The European Union recalled that this was an issue that it had raised on multiple occasions. 
The European Union was grateful to China for the bilateral dialogue so far; however, it wished to 
take the opportunity of this meeting to reiter ate some systemic concerns about the Chinese 
regulatory landscape on ICT security and request for a specific update on a number of items. The 
systemic concerns were principally on the regu latory framework - including the standards to 
support it, which were being developed in an opaque way, with no opportunity to provide input 
into the standard-setting process. Despite the repeated assurance given by Chinese authorities 
that all enterprises in China would be treated equally, the fact remained that this principle had numerous exceptions in the way in which this regulatory framework and standardisation process 
unfolded. The relevant technical committees remained largely foreclosed to inputs from foreign 
companies, even if established in China; the implementation of the Multi-Level Protection Scheme G/TBT/M/60 
 
- 21 - 
 
  was equally not very transparent, and this crea ted a rather unpredictable business environment 
posing a lot of difficulties to EU companies wishing to plan their business in China in this sector.  
3.88.  The representative of the European Unio n also requested China for specific updates on 
several issues. First, on the on-going revision of the regulation on commercial encryption products 
managed by the Office of State Commercial Crypto graphy Administration (OSCCA), he reiterated 
the European Union’s expectation that the process would be finalized in a transparent way, that the text would be notified and that the revision would restore a level playing field among domestic 
and foreign operators and eliminate discriminatory elements that characterize the current version, 
such as the prohibition on the use of foreign technology. On the MLPS, he indicated that the EU would welcome more transparency and predictabili ty regarding its implementation (particularly 
since this scheme concerned sectors beyond those covered traditionally by national security 
exceptions) , as well as further clarification on the criteria and rationale for the classification of IT 
systems as critical infrastructure. He encouraged  Chinese authorities to review the requirements 
that only home-grown Chinese technology coul d be used in such systems. The EU further 
requested an update regarding the standards on  radio frequency based mobile phone payments 
developed by the China Electronic Standardisation Institute (CESI) technical committee. The EU expressed concern with the fact that the standard s in question made reference to algorithms, but 
did not contain the algorithms as such; these would be later determined by OSCCA. This raised 
questions as to the accessibility and licensing conditions on which these algorithms would be made available. Finally, he requested an update regarding the announcement by the People's Bank of China that all banking financial payment systems would need to integrate Chinese algorithms, and 
he asked for clarification on the relationship be tween the announcement by the Bank of China and 
the parallel publication by OSCCA of a series of 14 standards related to the implementation of this policy.  
3.89.  The representative of Japan reiterated suppo rt for the EU's position. Japan paid particular 
attention to the various schemes and regulations within China with regard to how these could 
negatively affect trade of in formation security products. 
3.90.  The representative of the United States re called his delegation's previous statements in the 
Committee since March 2011 and shared the concerns outlined by the EU on the lack of 
transparency and potential trade impact of China' s development of standards, technical regulations 
and conformity assessment procedures on encryption requirements for commercial products. She 
requested China to provide an update on its development of technical regulations in this area. The 
US welcomed China's statement at the March meeting that OSCCA would ensure openness and public consultation in the formulation of these requirements. She said that information security 
measures aimed at banking, education, healthcare, transportation and other public utilities would 
have a significant impact on trade. She noted the obligations of the Code of Good Practice on the activities of central government standardizing bo dies, and particularly the requirement for public 
comment. The US was concerned with the short comment period of 10 days in standards' 
development and the lack of limited ability of US companies to participate in this process. She recalled that the TBT Agreement applied to products  of enterprises produced in the territories of 
other WTO Members, not simply to enterprises within China. 
3.91.  The representative of China replied that no  update did yet exist on the OSCCA Regulation on 
commercial encryption products and MLPS. She referred Members to the minutes of the last 
meeting and welcomed their continued interest in monitoring these measures. As for the five 
standards for radio frequency-based mobile payment, she clarified that they were voluntary. 
Further, algorithm E was only a symbol for text description which has not specified any specific algorithm and the technical content of this algorithm was not covered by this standard. 
3.2.2.9  China – Provisions for the Administ ration of Cosmetics Application Acceptance 
(G/TBT/N/CHN/821; G/TBT/N/CHN/937) (IMS ID 296) 
3.92.  The representative of Japan asked for conf irmation on the latest situation concerning the 
postponement of the implementation of this labe ling regulation for cosmetics. He expressed two 
concerns on the application and evaluation of th e new cosmetic ingredients system. First, Japan 
requested China to accelerate the examination of new ingredients as only three new ingredients have been approved since the implementation of this system. Second, as regards safety 
assessment of compound materials, Japan consider ed that the requirement of each constituent 
being isolated and assessed separately was unnece ssarily trade-restrictive. Japan requested China G/TBT/M/60 
 
- 22 - 
 
  to review the current regulations, taking into acco unt the practices of safety evaluation of cosmetic 
ingredients currently taken in many countries, including Japan, the US and EU. 
3.93.  The representative of the European Union expressed appreciation for the constructive 
regulatory dialogue between the European Commission and China's State Food and Drug 
Administration (CFDA). This cooperation contributed to progress on a number of issues of bilateral 
interest; however, there was still a lack of sufficient progress in the approval of new ingredients and of cosmetic products with new ingredients. Only three new ingredients (and one product 
containing a new ingredient) have been approved  during the last three years, although 120 
applications have been made and several hundred new ingredients have been introduced safely 
outside China during this time. The EU believed that  further efforts were necessary to ensure that 
the registration of ingredients and of products with new ingredients increased to levels comparable 
with those prior to the introduction of these requ irements, and welcomed an update from China on 
steps being taken to solve the situation. Secondly, on the new draft requirements on the labelling of cosmetics (notified under G/TBT/N/CHN/937), th e EU recalled its concerns that they might 
introduce duplication of, or even conflict between, requirements of the CFDA and the 
Administration of Quality Supervision, Inspection and Quarantine (AQSIQ). At the last TBT Committee meeting, China had indicated that the CFDA was still in the process of analysing all 
comments received and that, given the large amount of input from stakeholders, the 
implementation of this measure could be postponed. She therefore asked for an update from China on the state of play of this notification.  
3.94.  The representative of the United States a ssociated herself with the points made by Japan 
and the EU, particularly on the issue of the virtual standstill in approvals for cosmetics containing 
new ingredients. She supported the comments from the EU on the issue of a potential overlap of the requirements outlined in notification G/TBT/ N/CHN/937 with AQSIQ regulations. With respect 
to G/TBT/N/CHN/821, the US expressed concern abou t the CFDA's creation of a "positive list" of 
ingredients and requested China to instead allow companies to demonstrate that ingredients were "existing" by means other than appearance on a po sitive list. She asked for clarification of CFDA's 
stated intention to devolve responsibility for managing imported "normal cosmetic" registrations to 
provincial-level authorities, and inquired whether these would have adequate training and resources. She thanked China for their bilateral engagement on this issue, and particularly for their assurance of treating imported normal cosmetics in the same manner as locally manufactured 
products. She also requested that CFDA address existing concerns on the failure to provide 
alternative means of labelling small packages that  lacked enough surface area to carry all the 
information as required. 
3.95.  The representative of China said that her delegation has been cooperating closely with their 
trading partners in the implementation of the re gulation. China believed that specific technical 
issues could be solved by means of bilateral communications between technical experts and, in 
this respect, it has formed a working group on  this issue with the EU, Japan and Korea. She 
reiterated that the cosmetic label instruction regulation and guidance had been notified on 21 December 2012 as G/TBT/N/CHN/937. China has received comments from, inter alia , the EU, the 
US, and Japan. She clarified that the former SFDA was reformed into a new department known as 
CFDA that was still under the procedure of adjustment. China was processing and analysing 
comments at this stage, and would postpone the proposed date of adoption and entry into force due to the great amount of comments received. 
3.2.2.10  Korea – Regulation on Registration and Evaluation of Chemical Material (IMS 
ID 305) 
3.96.  The representative of the United States stated that the requirement under the measure for 
all new materials to be registered could have far reaching impacts and particularly seriously 
disrupt product development for semi-conductors, phones, LED TV’s and many other household and industrial products. The US was also concerned with the sharing of proprietary information within the supply chain as well as with the oner ous and burdensome reporting requirements under 
the measure, which would be expensive and disproportional to the benefits it could bring. The US 
requested an update from Korea on the status of the Act and implementing deadline, and asked 
Korea whether industries would have the opportunity to provide comments. 
3.97.  The representative of Korea informed th at the Act on Registration and Evaluation of 
Chemical Materials has been implemented taking in to account examples from other countries, G/TBT/M/60 
 
- 23 - 
 
  such as the EU's REACH. Korea would provide mu ltilateral support to smooth the implementation 
of the Act, including an advance notice regarding substances subject to registration, establishment 
and operation of a chemical substance data proce ssing system, training, and public relations. On 
the registration requirement, he said that the pu rpose of the Act was to protect public health and 
the environment from the potential risk that new chemicals might have, and to prevent 
manufacturers and importers from avoiding meetin g the requirements. Therefore, all new chemical 
substances, regardless of volume, were subject to registration. Only a small volume of chemical 
materials were exempted, or excluded, from registration, such as substances contained in 
machines or in solid form and substances used for tests and research. He noted that Article 38 of the Act specified that if a foreign seller felt difficulties to share confidential business information with domestic importers, the foreign seller was allowed to appoint a proxy to fulfill its obligations. 
Moreover, the purpose of the mandatory annual report was to obtain data from manufactures, 
sellers and importers, and to designate chemical s subject to be registered. Korea was of the 
opinion that the burden was not as heavy on manufactures, sellers, and importers, because the 
annual report was an extension of business. Korea would operate integrated electronic systems 
with regard to information overlapping with other laws. He informed that the competent authorities would notify WTO Members when publishing a draft of the subordinate regulations, and 
would invite comments from stakeholders. The Presidential and Ministerial decrees as well as the 
Act were to be enacted on 1 January 2015. Subordinate regulations would be drafted by December 2013 at the latest and would be followed by the legislative process, including internal consultations, notice and promulgation by the first half of 2014. Various foreign and domestic 
stakeholders would be consulted, including the in dustries concerned and private organizations.  
3.2.2.11  France – Loi No. 2010-788: The Na tional Commitment for the Environment 
(Grenelle 2 Law) (IMS ID 306) 
3.98.  The representative of India asked France to provide more details about the scope of the 
measure, including whether the measure was to be based on an international standard, and 
whether any impact assessment had been carried out on this measure. 
3.99.  The representative of Argentina reiterated his delegations' previously raised concerns and 
recalled that at the March 2012 Committee meeting the EU delegation stated that the results of 
the experiment would be made available at the beginning of 2013. He asked for an update on this aspect and also whether the results had already been submitted to the French Parliament, and 
how they could be accessed. The representative of Cuba echoed the statement of Argentina. 
3.100.  The representative of the European Union reiterated the view that the Grenelle 2 Law did 
not contain technical regulations and provided only for an experiment concerning environmental 
labelling. She invited Members to refer to minutes of past meetings with respect to the objective 
and scope of the experiment. The results of the experimental phase were currently being 
evaluated. As noted in the March 2013 Committee meeting, a report on the results would be 
submitted to the French Parliament in the summe r of 2013. Once the evaluation was completed, 
her delegation was prepared to share information about the results of the experiment. 
3.2.2.12  European Union - Directive 2009/ 28/EC, Renewable Energy Directive  
(EU - RED) (IMS ID 307) 
3.101.  Indonesia The representative of Indonesi a requested that the European Union delegation 
provide information on the calculation method for determining sustainability criteria under Article 
17 of the amendment of Directive 2009/28/EC.  He also asked for further detail about 
"environmental protection" in relation to Article 17(2) of the Directive. Finally, with respect to the 
notified amendment, he asked for clarification about the Articles which included technical regulations. He reiterated the request that the EU reply in writing to all his delegation's questions. 
3.102.  The representative of Argentina reiterated concerns previously expressed by his delegation 
at the June 2012 and March 2013 meetings, including with regard to the proposal for amendments 
to Directive 2009/28/EC and 98/78/EC on the qu ality of fuel, which was put forward by the 
European Commission to the European Parliament and the European Council on 17 October 2012. 
Argentina shared Indonesia and other biofuel producers' concerns regarding Directive 2009/28/CE 
for its impact on biofuel trade, as the European market was its main destination. He said that the importance his delegation attached to this topic and product was evidenced by Argentina's G/TBT/M/60 
 
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  repeated recourse to the DSB, a path that it was obliged to take in light of the lack of a 
satisfactory response from the EU to Argentina's concerns. While his delegation shared the EU's objectives of sustainability and conservation, th e implementation of these measures must be in 
line with multilateral trade agreements, and must not impose unnecessary trade obstacles on the 
products of other Members.  
3.103.  The representative of Malaysia expressed her delegation's concern with the discriminatory 
treatment of palm-based biofuel under the EU - RE D. Palm-based biofuel was given a lower default 
greenhouse gas emission saving value compared to biodiesel from other competing raw materials, 
such as rapeseed oil. She explained that this disadvantaged palm based biodiesel in terms of 
access to the EU market. Malaysia has conducted research on the greenhouse gas emissions saving of palm based biodiesel, and the results indicated high emissions savings compared to the 
EU assessment under the EU - RED. She urged the EU to consider the technical data Malaysia 
submitted to the Joint Research Centre of the European Commission and the European Commission. A revision of default values for palm-based biodiesel using the data offered by 
Malaysia would provide further market opportunities for Malaysian biodiesel producers. 
3.104.  The representative of the European Union explained that they notified the draft Renewable 
Energy Directive to the TBT Committee in July 20084 due to the existence of TBT elements in the 
original proposal's Articles 18(2) and 18(3). These elements were, however, not retained in the 
final Directive. Moreover, the recent proposal for the amendment of the Directive did not fall within the scope of the TBT Agreement, and had therefore not been notified. She stated that Indonesia's 
concerns about sustainability criteria for biofuels  fell outside the scope of the TBT Agreement. Her 
delegation therefore considered that the TBT Committee was not an appropriate forum for 
discussing this issue, or providing a reply to th ese queries. The EU remained open to further 
bilateral exchange in this regard. 
3.2.2.13  Colombia – Commercial Truck Diesel Emissions Regulation Proposed 
modifications to Resolutions 910 of 2008 and 2604 of 2009 on Diesel Emissions. 
(G/TBT/N/COL/185, G/TBT/N/COL/186) (IMS ID 318) 
3.105.  The representative of Mexico said that these proposed measure would violate fundamental 
principles established in the TBT Agreement, in particular with regard to: proportionality; being 
more restrictive than necessary to achieve the legitimate objective sought; lack of scientific evidence; lack of transparency; and not being ba sed on international standards. She requested 
that Colombian authorities provide an official response to the comments submitted by Mexico 
during the public consultation period. Further, she asked Colombia to present the scientific and 
technical evidence upon which the measure was based, including evidence of how it would comply 
with their legitimate objective. Should the prop osed measure not be amended, Mexico requested 
that Colombia provide a sufficient transition period between publication and entry into force. 
3.106.  The representative of Canada expressed it s support for the concerns outlined by Mexico, 
and hoped that Colombia's regulations would be developed in a transparent manner consistent 
with the TBT Agreement. 
3.107.  The representative of Colombia noted that a formal response had already been provided to 
comment submitted by Mexico, Japan and the United States. He requested that Canada formally 
present comments and explain their concerns about transparency. He noted that the Minister of 
the Environment was currently reviewing the meas ures in question, and hoped that revisions 
would be made available soon. 
3.2.2.14  Peru - Draft Supreme Decree approving the Regulations Governing the 
Labelling of Genetically Modified Foods (G/TBT/N/PER/37, G/TBT/N/PER/37/Add.1) 
(IMS ID 320) 
3.108.  The representative of the United States requested an update from Peru on the status of its 
proposed labelling requirements, and recalled concerns about potential impacts on trade. She 
suggested that mandatory labelling requirements for genetically engineered foods that were substantially equivalent to conventional foods could give the false impression that the labelled food 
                                               
4 G/TBT/N/EEC/200. G/TBT/M/60 
 
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  or feed was substantively different from, or less safe than, the conventional equivalent. Her 
delegation believed that a voluntary labelling would allow for consumer choice at a lower cost and with less trade disruption. She sought clarification as to how Peru was taking the comments of other Members into consideration when finalizing the measure. Should Peru decide to move 
forward with the implementation of the regulation, she requested further clarity on the scope of 
the requirements as well as the implementing mechanism for monitoring, supervision, verification and compliance. Additionally, she asked for an extension to implementation period beyond the 
currently envisaged 180 days, in order to provide sufficient time for industry to adapt to the new 
requirements. 
3.109.  The representatives of Chile and Colombia recalled their respective previously expressed 
concerns on this measure, and specific questions regarding the public consultation to which their 
delegations awaited a response. They also asked for an update of the measure at issue. 
3.110.  The representative of Peru said the meas ure continued to evolve. The expected date of 
entry into force was not yet clear. The final measure would reflect comments received from other 
Members. 
3.2.2.15  Indonesia - Technical Guidelines fo r the Implementation of the Adoption and 
Supervision of Indonesian National Standards for Obligatory Toy Safety - Draft Decree of 
the Ministry of Industry on Mandatory Impl ementation of Indonesia National Standard 
and Technical Specification for Toys  (G/TBT/N/IDN/64) (IMS ID 328) 
3.111.  The representative of the European Union expressed appreciation for recent bilateral 
discussions with Indonesia on this issue. He note d that on 12 April 2013 the Indonesia Ministry of 
Industry adopted Decree No. 24, concerning the mandatory application of the Indonesian national 
standard for toys. The text of the final Decree was almost identical to the text that had been notified in draft form
5, and therefore, the concerns the EU ha d expressed with regard to the draft 
text as notified remained. He noted that the testing requirements provided for in Decree No. 24 
appeared to lay down different and more burdensome procedures for imported products as compared to domestic products. For domestic products, mandatory testing had to be carried out 
on samples taken every six months from the same production line. For imported products, samples 
are taken from each imported shipment, which would lead to more frequent testing if a company imported more frequently than every six months. He stressed that this constituted less favourable treatment for imported products versus domestic products. He asked about the rationale for this 
differentiation in testing. Regarding the laborato ries approved for conducting testing required 
under Decree No. 24, he noted that Article 5 of that Decree provided that such laboratories were to be accredited by the National Accreditatio n Body of Indonesia (KAN) and appointed by the 
Minister of Industry. He enquired whether applications for accreditation from foreign laboratories 
would be accepted. Further, he asked whether fore ign laboratories that were accredited by an 
accreditation body that was a signatory to the IL AC MRA would be accepted, without having to be 
separately accredited by KAN. With respect to th e factory audit, he submitted that the conformity 
assessment procedures provided by Decree No. 24 foresaw not only mandatory testing, but also a factory audit of the quality management systems of the companies and manufacturers. These audits would be conducted at least once per year, and Article 11 of Decree No. 24 established that 
these audits could only be carried out by Indonesian government officials. He reiterated the 
request that companies holding ISO 9001 certification delivered by an accreditation body signatory to the IAF MRA should be exempted from such audits. He also said that it was unclear how the 
restrictions on the use of Phthalates and Azo dyes  should be interpreted. He therefore welcomed 
the imminent adoption of technical guidelines to clarify how the Indonesian standards for toy safety should be applied. Finally, he noted that  Decree No. 24 set the entry into force for the new 
requirements on 12 October 2013, which was 6 months from adoption. However, given that 
technical guidelines supporting the decree and application of the standard were not yet available, he invited Indonesia to consider further postponement of the entry into force of these measures. 
3.112.  The representative of the United States stressed that the areas of concern raised by the EU 
were equally shared by US industry and the US  government, and requested a response from the 
Indonesian delegation on these questions. Fu rthermore, she also requested a delay in the 
implementation of the measure, given the level of uncertainty and lack of clarity with respect to 
                                               
5 G/TBT/N/IDN/64. G/TBT/M/60 
 
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  technical aspects of the measure. Finally, she expressed appreciation for on-going bilateral 
engagement with Indonesia on this issue. 
3.113.  The representative of Indonesia inform ed that the draft regulation on Mandatory 
Implementation of Indonesia National Standard (SNI) for Toys was stipulated through Decree of 
Minister of Industry No. 24/M-IND/PER/4/2013 dated 12 April 2013, entering into force six months 
thereafter. With respect to the procedures for sa mpling, testing and marking, he explained that 
requirements would be set out in technical guidelin es on the implementation of Indonesia National 
Standard (SNI) for Toys. The Government of Indonesi a, and in particular the Ministry of Industry 
(responsible for the regulation), was still in the process of discussing the guidelines with relevant stakeholders. He said that Indonesia had based its conformity assessment procedures on international standards ISO/IEC Guide 67:2004, Conformity assessment – Fundamentals of 
product certification. Indonesia was also a signatory of ILAC/APLAC mutual recognition 
arrangement (MRA) for testing and calibration labo ratories. Therefore, an MRA could be envisaged 
with other APLAC/ILAC signatory countries. Howe ver, he explained that establishment of a 
government (or regulator) to government (or regu lator) MoU was a necessary element of an MRA, 
since not all Members' accreditation bodies were government entities. He also stated that questions with regard to chemical phylates and ax o-dyes would be clarified in technical guidance. 
His delegation would respond to EU concerns in writing, and encouraged both the US and the EU to 
continue to engage with Indonesia bilaterally. 
3.2.2.16  Russian Federation – Draft Techni cal Regulation of the Customs Union on 
alcoholic products safety (G /TBT/N/RUS/2) (IMS ID 332) 
3.114.  The representative of the European Union re iterated previous concerns expressed with this 
measure, including a detailed written comments sent to Russia in March 2013. Her delegation 
continued to await a response to those comments, including information on whether and how they 
have been taken into account. She also inquired about the current status of the draft text and 
timeline for its adoption. Regarding the information requested under the notification procedure for alcoholic products, given that it was already prov ided under other administrative procedures, it 
was duplicative and did not provide any health and safety-related added value. She therefore 
requested confirmation that the notification syst em would be withdrawn from the draft technical 
regulation and not be introduced in any Russian specific national legislation. She asked why a notification procedure that has been consider ed by the members of the Customs Union as 
inappropriate was still being considered by Russi a alone under Russian Resolution No. 474 of June 
2013. Finally, should this procedure constitute a conformity assessment procedure, she requested that it be notified by Russia to the TBT Committ ee, and that sufficient time be provided for 
comments. 
3.115.  She also sought confirmation that th e production control and conformity assessment 
procedures would not be applicable to production sites that had been already controlled by EU 
national authorities. Regarding wines, she sought confirmation that enrichment with "concentrated 
must", "rectified concentrated must" or "sucrose" would be allowed under the measure for all types of wines, since these were oenological prac tices used in quality wines and widely accepted 
internationally level. Regarding beers, while the de crease of compulsory malt content from 80% to 
50% was welcomed, the limit on sugar content should be eliminated and the use of fruits and 
additives should be allowed in beer production. She asked that definitions for some products, such as "Cognac", "Calvados" and "Champagne", which were currently absent from the regulation, be 
added to the final version along with measures to adequately protect EU geographical indications. 
Finally, she sought confirmation that the ban on PET packaging would be withdrawn from the draft 
technical regulation, and would not be introduced in any Russian specific national legislation. On 
this point, she informed that a Russian proposal to  ban PET packaging on drinks sold in quantities 
over one-half litre was foreseen to be adopted before mid-July. She asked Russia to explain which health and safety risks this ban would address. She suggested that Russia reconsider this measure 
and notify it to the TBT Committee. The representa tive hoped that EU concerns and suggestions be 
duly taken into account before the final technical regulation on alcoholic drinks was adopted. 
3.116.  The representative of the United States echoed that concerns expressed by the EU, and 
noted that the most recent draft of Eurasian Customs Union Technical Regulation on Alcoholic 
Beverage Product Safety included a notification procedure for alcoholic beverages. She requested a 
response to US comments sent in December 2011 and also on 5 March 2013 and asked for an update on the status of the technical regulation, in particular its provisions to establish a G/TBT/M/60 
 
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  notification procedure. She asked Russia to clarif y its national notification procedure, created by 
amending Federal Law SF 171 in December 2012, which duplicated the notification procedure in the draft Eurasian Customs Union Technical Regulation. She asked Russia to confirm whether it has adopted a resolution on 5 June 2013 that woul d render this notification procedure mandatory, 
with an entry into force of 1 October 2013. If this  were the case, it would be regrettable that the 
decision to finalize this requirement was taken without taking into account concerns expressed by trading partners. Her delegation believed that the notification procedure would be burdensome and 
duplicative since it would add to the already complex scheme of documentation required to assess 
conformity, such as state registration and declaration of conformity. She expressed was further concerned that entry into force was foreseen for 1 October 2013. This short transparent transition period would not provide enough time for US expo rters to adapt without trade disruption. She also 
asked Russia to clarify the scope of the measur e that was adopted on 5 June 2013, and in 
particular, if any additional requirements have been added beyond what was originally proposed in the draft. She stated that the US had several concerns with this technical regulation, and 
requested in particular that Russia consider diffe rent practices for the aging of whiskies, which 
depended on different factors including climate. Under the current system, several US whiskies could not be shipped to Russia because of the th ree-year aging requirement. In addition, the 
measure did not include several processing aids and additives commonly used in winemaking 
countries. The United States also referred to Eurasian Customs Union's list and requested that it be expanded to include all processing aid and additives commonly used internationally.  
3.117.  The representative of Australia said his delegation had submitted comments on Russia's 
notification in February 2013, which included concerns on restrictions or bans on commonly used 
additives and processing aids, identified by the OIV, which did not affect the safety of alcoholic products. Australia considered that restricting the use of, or banning, these oenological practices 
would limit Australia's ability to continue to provide quality wine to the Eurasian Customs Union. 
He recalled his delegation's suggestion that Russia consider adopting the OIV list of approved additives and processing aids, as set out in  the International Oenological Codex and the 
International Code of Oenological Practices. He continued to seek clarification about the legal 
status of wines which conformed to the health warning statement under the previous legislation, and were in circulation at the time the draft regulati on entered into force. If such wines were to be 
affected, he suggested that Russia introduce a six-month transition period for those products so as 
to enable industry sufficient time to implement the new labelling requirements. He asked Russia to 
confirm whether wines labelled with an Australian GI would be considered as a protected GI under the new technical regulations, and whether the relevant exemptions from the regulations for 
protect GIs would apply to them. He also requested clarification about requirements relating to the 
bottling location of wines that include a GI in their description and presentation. He asked whether the Eurasian Customs Union regulations required such wines to be bottled within the boundary of 
the GI stated in the description and presentation of the wine. Finally, his delegation asked for an 
update on Russia’s consideration of the comments it had received to date on the issue. 
3.118.  The representative of Argentina expresse d concerns with this measure, and asked Russia 
to bring it into conformity with the provisions of the TBT Agreement, without creating unnecessary 
trade obstacles. 
3.119.  The representatives of New Zealand and Mexico supported the statements of other 
Members, and recalled comments and concerns prev iously submitted to Russia. New Zealand, in 
particular, stated that the notification procedure duplicated requirements that were found 
elsewhere and were unnecessarily burdensome. His delegation understood that the notification procedure was adopted on 5 June 2013 without sufficient changes to address the duplication with 
other requirements. He reiterated that this was more trade restrictive than necessary to achieve 
Russia’s objectives, and asked that Russia streamline this process and to remove the duplicative requirements. He also noted that the notification procedure would enter into force in October 2013, and requested that Russia provide a full six months before entry into force to allow 
exporters to comply with this regulation without disruption to trade. Mexico requested a response 
to its comments that were submitted in 2011. 
3.120.  The representative of Russia said the draft technical regulation was being developed in 
order to establish unified requirements for turnover of alcoholic products - both imported and 
domestically produced in the single market. A public hearing on the draft technical regulation was completed in December 2011, prior to Russia's accession to the WTO. In accordance with the TBT 
Agreement, all interested parties were given opportunity to provide their comments during a G/TBT/M/60 
 
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  60-day comment period and even comments received thereafter were being carefully examined. 
Moreover, a number of issues were solved and ques tions answered bilaterally with other Members. 
With regard to the definitions of various alcoholic products, he noted that the minimum malt content under the definition of beer was decreased from 80% to 50%. In addition, the ban on use 
of PET bottles was eliminated from the text of the draft, except with regard to the strong spirits. 
The draft provisions on the notification procedur e were also excluded from the text. In this 
respect, he asked that questions on Russia's notification procedure be submitted in writing. He 
mentioned that in accordance with Resolution No. 474, as of 5 June 2013 a legal entity would have 
to provide information on the product to the Federal Service of Alcohol Market Regulation in electronic form, including an electronic signat ure on the notification by the legal entity. 
Information provided in such notifications would be publicly available at the website of the Federal 
Service of Alcohol Market Regulation. The objectives  of the notifications procedure were exclusively 
related to information and greater transparency of the market. Given that at all stages of the procedure information would have to be provided by electronic means, his delegation believed that 
it would not be burdensome for economic operators. His delegation would continue to engage in 
bilateral consultations with interested WTO Members,  making an effort to take into account their 
different positions, even if these positions often contradicted each other, as was the case with 
definitions of certain alcoholic products. 
3.2.2.17  European Union – Directive 2011/62/E U of the European Parliament and of the 
Council amending Directive 2001/83/EC on the Community code relating to Medicinal 
Products for Human Use, as regards the Prevention of the Entry into the Legal supply 
Chain of Falsified Medicinal Products (IMS ID 334) 
3.121.  The representative of India reiterated his delegation's previous comment that Indian 
authorities were having problems in certifying compliance with third-party Good Manufacturing 
Practices (GMP), like those of the EU, as required  under this Directive. While he noted that there 
was a clause in the Directive stating that the GMP were equivalent to the WHO GMP, nevertheless third party certification by Indian authorities needed to clearly indicate compliance with EU GMP, 
which was a problematic issue for Indian regulators. He also expressed concern with the definition 
of falsified medicinal products, which did not include parameters of quality, safety and efficacy. It was still unclear to Indian industry whether generics that were in transit through the EU market could be subject to seizure. Finally, he requested a sufficient time period for compliance with the 
Directive. 
3.122.  The representative of the European Union said that the Directive was notified to the TBT 
Committee in 2009, and had been extensively discussed at previous meetings of the Committee 
and also bilaterally. Starting in early 2012, a number of meetings with third countries and 
information sessions were organised in order to ensure that all public authorities were aware of the Directive's provisions and in particular the written confirmation. A template for the written 
confirmation, as well as a "questions and answers" document, has been made available to market 
operators and competent authorities. She stressed that the template for the written confirmation 
clearly stated that EU GMP rules for active substances were equivalent to WHO GMP rules for active substances. She reported that several countries have confirmed readiness to issue the 
written confirmation, while other countries have requested that the European Commission (EC) 
include them on the list of countries for which the written confirmation was waived. She said all relevant information on this was available on the EC website. The EC expected a smooth 
implementation of the rules by July 2013, and a postponement of the deadline was not possible. 
3.2.2.18  European Union – Draft Implementi ng Regulations amending Regulation (EC) 
No. 607/2009 laying down detailed rules for th e application of Council Regulation (EC) 
No 479/2008 as regards protected designations of origin and geographical indications, 
traditional terms, labelling and presentati on of certain wine sector products 
(G/TBT/N/EEC/264, G/TBT/N/EEC/264/Add.1) (IMS ID 345) 
3.123.  The representative of Argentina reiterated his delegation's concern that these measures 
were not consistent with the EU's obligations under the TBT Agreement. Nevertheless, Argentina 
had engaged in discussions with the European authorities to overcome the obstacles and avoid the halting of shipments to the EU. At the EU's invi tation, Argentina submitted in July 2009 its dossier 
on the terms "Reserva" and "Gran Reserva". Alth ough this dossier has been approved by the 
European Commission's Management Committee for Wine in March 2012, has still not been adopted within the Commission and published in th e official gazette. Despite several requests, the G/TBT/M/60 
 
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  EU has still not provided a satisfactory response  as to the cause of the unjustified delay to 
conclude this process, that have already amounted to 15 months since the approval. High quality Argentine wines continued to suffer a significant price disadvantage, as compared with competitor countries that could accede the European market wi th their wines clearly identified and labelled as 
being of high quality for whom better prices were obtained. He said that Argentina has worked in 
good faith, both bilaterally and multilaterally, to obtain a positive response, or valid explanation for the delay. However, to date it has only received copies of the statements delivered by the EU at 
the previous two TBT Committee meetings, where they stated that the draft regulation with regard 
to the expression "Reserva" and "Gran Reserva" has been subject to a vote within the Management Committee for Wine and its formal adop tion by the Commission was pending. Finally 
he noted that the number of times and Members raising this STC clearly indicated that the EU was 
protecting this sector.  
3.124.  The representative of the United States requested the EU to provide an update on the 
status of applications submitted by US wine industry in June 2010. These wine suppliers were still 
unable to ship their products to the EU market. She informed that the World Wine Trade Group6 
has sent a letter to the EU's Directorate Genera l of Agriculture on 4 June 2013, to which no 
response was received to date, expressing their joint concern with the lack of progress on this 
issue and their discontent with the process of unilateral recognition of terms. She reiterated the 
view that this application process was more trade restrictive than necessary. 
3.125.  The representative of the European Unio n thanked the delegations of Argentina and the 
United States for their continued interest in the EU's regulation on wine products and said that 
discussions on the applications submitted by the US  and Argentine industries were continuing and 
she had no further updates on the issue. 
3.2.2.19  Viet Nam – Decree No 38 Detailing the Implementation of Some Articles of 
Food Safety Law (G/TBT/N/VNM/22, G/ TBT/N/VNM/22/Suppl.1) (IMS ID 356) 
3.126.  The representative of the European Union recalled concerns on the complexity and 
unnecessary burden that this measure would cause due to the multiple declarations of conformity 
and related documents that had to be submitted to Vietnamese authorities prior to Importation, 
and the number of different ministries involved. This Decree would have an impact on imports into Viet Nam due to the lack of clarity on the applic able requirements, scope of products covered, and 
authorities responsible for implementation. She also highlighted the lack of an inter-ministerial 
circular clarifying the responsibilities of the authorities involved and list the products covered. She 
requested Viet Nam to suspend the application of  the Decree until this circular, and any other 
implementing acts, have been notified to the WTO, giving Members sufficient time to comment. 
She also requested that a sufficient transition period be provided when all details regarding 
implementation have been adopted and published. She also requested that Viet Nam provide a reply to the comments submitted by the EU on 25  February 2013 and also engage with the EU 
industry to ensure equally treatment between domestic and imported products. 
3.127.  The representative of Australia reiterated concerns raised at the previous Committee 
meeting. While his delegation supported Viet Nam's right to implement measures to protect the 
health of its consumers, it was important such measures were no more trade restrictive than 
necessary to achieve the objective. Given that it was still unclear how Decree 38 would be 
implemented, he encouraged Viet Nam to delay its full implementation until arrangements for 
implementation had been fully considered and clearly communicated to trade partners. He 
encouraged Viet Nam to continue to notify the WTO of any technical circulars guiding the operation 
of the Law on Food Safety. 
3.128.  The representative of New Zealand endors ed the statements made by other delegations 
and reiterated his delegation's request that all regulatory changes brought about by the 
implementation of Decree 38 by clear notification as early as possible. His delegation encouraged 
Viet Nam to ensure adequate time for industry to prepare for, and adjust to, such regulations prior 
to their entry into force. 
3.129.  The representative of the United States su pported the concerns raised by the EU, Australia 
and New Zealand and said that her delegation continued to have significant concerns with both the 
                                               
6 Argentina, Australia, Canada, Chile, Georgia, Ne w Zealand, South Africa and the United States. G/TBT/M/60 
 
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  technical components and implementing circulars of Decree 38. She urged Viet Nam to conduct the 
implementation, in particular when made across the three corresponding ministries, in a transparent and efficient manner so as to avoid trade disruption. 
3.130.  The representative of Viet Nam said, with respect to the issue of responsibilities in food 
management, which were already regulated for in  the Food Safety Law that, her delegation 
understood the need for transparency in drafting technical regulations and had already notified some technical regulations and requirements to both the SPS and TBT Committees. She informed 
Viet Nam has received comments from many delegations and has also contacted the US Embassy 
in Viet Nam and other Members to arrange meetings  with their concerned ministries, although no 
response has been received so far with respect to this invitation. 
3.2.2.20  Brazil - Draft ANVISA Resolution on Used, Refurbished, Rented or Lent Medical 
Devices (G/TBT/N/BRA/440) (IMS ID 362) 
3.131.  The representative of the European Union reiterated concerns regarding ANVISA's draft 
resolution. The EU requested that equipment reconditioned overseas should be allowed for 
importation to Brazil as long as it complied with the health and safety performance requirements. 
She recalled that Brazil had informed the Committee at the March meeting that a final draft was not yet available and that a public hearing would be organised. She asked if the EU's suggestions 
would be taken into account, and for an update on the timeline for adoption of the Resolution. 
3.132.  The representative of Switzerland shared the concerns raised by the EU. As an important 
exporter of new and refurbish medical devices, Sw itzerland was of the opinion that any refurbished 
equipment, independent of its place of first installation, should be allowed for importation to Brazil 
so long as it complied with national health, safety and environmental requirements. While his 
delegation shared Brazil's objective of avoiding medical devices being exported to Brazil for final 
disposal, he requested Brazil to inform the Committee on which less trade restrictive alternatives 
the authorities were considering to assure Brazil's legitimate objective. 
3.133.  The representative of Brazil noted the continued interest in this issue and referred the 
Committee to previous minutes where information had already been provided. He emphasized that 
one of the main objectives of the draft regula tion was to avoid used medical equipment being 
exported to Brazil as a means of final disposal of those products. Another important objective was to make producers of new medical equipment take responsibility for their appropriate disposal. The draft measure, he said, was open for public cons ultation for two months in 2011, and a significant 
number of comments were received. ANVISA was or ganizing a public hearing on the issue where 
stakeholders could exchange views in an open and transparent manner with Brazilian regulators 
and developments on this issue would be communicated to Members. 
3.2.2.21  Israel - Warning Regulations on Alcoholic Beverages (G/TBT/N/ISR/609) (IMS 
ID 364)  
3.134.  The representative of the European Union requested that Israel provide a written reply to 
their comments submitted on 17 September 2012, and also an update on the adoption procedure. 
The EU was concerned that the draft regulation  introduced two different types of warnings 
addressing the alcohol content of liquor. This wa s contrary to scientific studies, where excessive 
consumption was harmful to health, and not the alcoholic beverage itself. Therefore differentiation 
between strong intoxicating liquors and intoxicating liquors as regards the warning message, as 
laid down in the notified draft regulations, coul d mislead consumers who might conclude that some 
alcoholic beverages were more harmful than others. She also asked for clarification on where the 
warning message was to be affixed, and whether an additional label or sticker being added in the 
distribution phase might be acceptable to the Isra eli authorities. If warnings and information had 
to appear on the front label, EU producers would have to make front labels for the Israeli market 
only, which would have a burdensome and costly impact on imports. Finally, her delegation 
considered the strict provisions of the warning concerning size, colour of text, and the black frame to be unjustified. This information, she said, could be provided to the consumer in a less restrictive manner  
3.135.  The representative of the United States recalled previous interventions on this issue and 
noted that her delegation remained watchful re garding the outcome of Section 2 of the draft G/TBT/M/60 
 
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  amendment, which created two distinct warning labe ls for alcoholic beverages. She requested that 
Israel share the scientific rationale behind the split warning statements where those products 
containing more than 15.5% alcohol by volume were obliged to carry a distinct and stronger warning statement. She asked that an update be provided when this issue would be discussed in 
the new Knesset and looked forward to working with Israel to resolve concerns on this issue. 
3.136.  The representative of Israel thanked the US and EU for their comments, and informed the 
Committee that all concerns had been forwarded to the Minister of Health and to the Economics 
Committee of the Israeli Parliament. She said that the provisions on the size and design of the 
warning labels were still being examined by the Committee. As to the timeline of the legislative process, she explained that since the Committee had only reconvened two months earlier, after the election, this measure has not yet been discussed. 
3.2.2.22  India – Electronics and Information Technology Goods (Requirements for 
Compulsory Registration) Order, 2012 (IMS 367) 
3.137.  The representative of Canada stated that her delegation had submitted comments on 
India's proposed measure on 18 December 2012. She noted that Canada was concerned that 
India's new regulations, and the short timeframe provided to comply with them, could hinder or shut Canadian exporters out of the Indian market. She said that there were well-established 
international standards for evaluating the competencies of conformity assessment bodies, 
particularly ISO IEC 17025 and ISO IEC 10765. ILAC and IAF provided mutual recognition arrangements for a peer review system to ensure  the contents of signatory accreditation bodies. 
She said that recognition by India of foreign conformity assessment bodies accredited by 
signatories to the ILAC and IAF MLAs would minimi ze the negative impact on companies wishing to 
export to India while at the same time providing assurance to India that these recognized bodies 
were competent. Allowing accredited foreign conformity assessment bodies to test and certify to 
India's regulatory requirements would also reduce  testing costs and allow exporters to bring their 
products to the Indian market more quickly. 
3.138.  The representative of the European Union associated his delegation with Canada's 
comments and thanked India for bilateral discussions. He welcomed the fact that the entry into 
force of the measure was postponed from 3 Apri l to 3 July 2013 and that, subject to certain 
conditions, an additional three-month delay could be obtained by individual manufactures. He also referred to a circular issued by the Department of Electronics and Information Technology of the 
Indian government on 29 May 2013. This circular provided that safety critical components would 
be accepted if they were either certified or tested by a certification body that was a signatory to the IECEE CB scheme, or were accredited according to the relevant international standard 
IEC17025 by an accreditation body that was a signat ory to the ILAC MRA. He asked India to clarify 
the meaning of the phrase "until further orders". Did it mean that it was a temporary measure or would these arrangements be permanently available to foreign manufacturers wishing to export to 
India? He also reiterated the EU's general co ncern about the necessity and proportionality of 
India's compulsory registration system. In this re spect, he urged India to consider whether a less 
burdensome conformity assessment procedure coul d not be equally effective in achieving the 
legitimate objective of protecting health and sa fety since the products concerned were office 
equipment and goods which would rarely give rise to safety problems and accidents. Further, he 
underlined that the EU was still not comfortable with the mandatory frequency of testing, which 
must occur every two years pursuant to the Indian  measure. The EU instead believed that testing 
should only be repeated if products were substantially changed in such a way that their safety 
properties were affected.  
3.139.  The representative of the United States associated her delegation with the comments 
made by Canada and the EU and thanked India fo r their bilateral discussions. She asked India to: 
(i) confirm 3 October 2013 as the measure's implementation date; and (ii) clarify the meaning of the phrase "until further orders" in the measure;  and (iii) explain the use of the IECEE CB scheme 
in the circular that was issued on 29 May 2013. She expressed concern with the product coverage 
of the measure since it covered highly specialized industrial equipment where consumer product 
safety issues would rarely arise. She also expressed concerns with: (i) the in-country testing requirements and lack of testing capacity; (ii) the inconsistency with IECEE CB scheme 
requirements; and (iii) the propensity to regulate via FAQs and notices of a general manner, rather 
than through proposed regulation and comment. Finally, she welcomed India's indication of G/TBT/M/60 
 
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  additional flexibilities with respect to the extension for implementation and the use of the 
IECEE CB scheme. 
3.140.  The representative of Korea acknowledged India's consumer safety efforts and appreciated 
the postponement of the entry into force of the measure from 3 April 2013 to 3 July 2013, 
although, depending on the status of product tests and registration, some manufacturing units 
would still be provided an additional grace period of three months. In particular, this grace period 
would be granted to products for which tests have been completed and registration forms have 
been submitted to the BIS before 3 July 2013. However, in the case of products submitted to BIS-
recognized labs before  that date, but for which test reports were not available, manufacturers 
would have to pay $1,000 - 2,000 a month for each model until they submitted a request for registration to the BIS with complete test reports. She explained that the reason why 
manufacturers could not register before the effective date – even in cases in which they submitted 
products for testing before the date – was that laboratories did not complete the tests in time. She noted that Korea did not think that it was fair that manufactures should be held responsible for 
such delays. She therefore asked the Indian au thorities not to impose any charges in these 
situations.  
3.141.  The representative of Switzerland echo ed the comments made by the EU, the US and 
Korea and asked India for further clarifications regarding the matters raised by these delegations.  
3.142.  The representative of India clarified that although the order technically entered into force 
on 3 July 2013, it would de facto enter into force only on 3 October 2013 as some manufacturers 
have been provided a grace period of three months. He said that that although India believed 
adequate time has been given for companies to comp ly with this order, it would nevertheless take 
into account the specific comments made by delegations in this respect. On the issue of compliance with the IEC standards, he explained that because the relevant Indian standards were 
mostly based on ISO IEC standards, there should not be any specific problems for Members to 
comply with them. He also underlined that India had an adequate number of testing labs which could manage any backlog that may occur in terms of testing. Regarding the circular issued on 29 
May 2013, he reiterated that the circular primarily pertained to the safety critical components. He 
clarified that the phrase "further orders" was a terminology used to express that the government was deliberating upon the issue and that the order stood as it was unless changes would be made in the drafting process by the BI S. Finally, with respect to Korea's concern regarding an imposed 
fine of $1,000 - 2,000, he explained that test re ports would be provided at an early stage. 
3.2.2.23  Chile – Proposed amendment to the Food Health Regulations, Supreme Decree 
No. 977/96. (G/TBT/N/CHL/219 and G/TBT/N/CHL/219/Add.1) (IMS ID 370) 
3.143.  The representative of Brazil stated that , given the growing problem of childhood obesity, 
his delegation considered the combat of diseases caused by the consumption of certain foods to be 
a legitimate objective. However, it was not clear to Brazil what the scientific basis for the Chilean 
measure was and how it could be reconciled with the Codex guidelines. Brazil also believed that 
the measure's objective could be addressed by more effective and less trade-restrictive public policies so as to stop it from conflicting with Ar ticle 2.2 of the TBT Agreem ent. Brazil acknowledged 
that it may be justified to introduce labelling on certain types of food with a view of indicating the 
presence of ingredients or substances that caused, for example, allergies or that were related to 
food intolerance, as those components may harm human health per se. Brazil was concerned, however, with the introduction of warning signs to indicate that certain foods contained a given 
amount of calories, fat or salt. The WHO's dietary guidelines considered the daily intake of 
nutrients that a balanced diet should contain whereas the proposed measure seemed to isolate food from the context of daily intake, which, as a result, could mislead consumers. His delegation 
hoped that the implementation of the measure could be delayed in order for it to be further 
clarified. 
3.144.  The representative of Mexico voiced her delegation's concerns with the proposed 
amendment. These are contained in full in document G/TBT/W/372. 
3.145.  The representative of Guatemala reiterat ed comments made at the previous TBT meeting. 
While Guatemala shared Chile's legitimate objectives of providing consumers with sufficient 
information about the food which they consume and reducing non-communicable diseases, it also G/TBT/M/60 
 
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  recalled that technical regulations should not be more trade restrictive than necessary to fulfil a 
legitimate objective. He asked Chile to respond to Guatemala's comments which were made in February 2013 and called upon Chile to consider alternative less trade-restrictive measures. 
3.146.  The representative of the European Union thanked Chile for their bilateral dialogue and 
asked it to provide a written reply to the EU's comments to the notification which were submitted 
on 7 March 2013, explaining how these comments would be taken into account. She also reminded Chile to notify any follow-up rules relevant to this measure. She stated that the law itself was 
never notified to the WTO and Members did theref ore not have the opportunity to comment on it. 
She further noted that Article 5 of Law 20.606 established that the Ministry of Health would determine categories of foods to be labelled as "high in calories", "high in salt" or an equivalent designation. The Ministry would also determin e the content, form, size, messages, signs or 
pictures used for the labels. However, "high in"-warnings, such as those proposed by the Chilean 
legislation, were not foreseen by the applicable CODEX guidelines on nutritional labelling and risked stigmatising some foods whose moderate consumption could be part of a healthy diet. The 
EU was concerned with the measure's proportionality to the aim pursued, which was to empower 
consumers to make an informed choice in order to foster effective competition and consumer welfare. Furthermore, this approach would have a discriminatory effect on foreign manufacturers 
that needed to adapt their packaging for the Chil ean market. Given the foregoing, the EU was not 
convinced that the Chilean approach was the best way to achieve such legitimate objectives. She therefore invited Chile to consider less trade-restrictive measures.  
3.147.  She made four specific points regarding the Chilean measure. First, she asked Chile to 
explain the rationale behind imposing additional wa rnings and its compatibility with Article 2.2 of 
the TBT Agreement. Second, she recalled that the "Guidelines on Nutrition Labelling" (CAC/GL 2-
1985 CODEX) stated that information contained in a nutrient declaration "should not lead 
consumers to believe that there is exact quantitative knowledge of what individuals should eat in 
order to maintain health, but rather to convey an understanding of the quantity of nutrients 
contained in the product". She noted that no nutrient thresholds have been established by the 
CODEX for the nutrients targeted by the Chilean legislation. Although, there was evidence of a 
positive association between the intake of certain nutrients and the risk of developing a disease or disorder, there was no scientific evidence suggesting  an identifiable threshold above which the risk 
existed. Third, according to the draft notified under G/TBT/N/CHL/219, the warnings would need to 
be placed in the middle of an octagonal icon, - a STOP sign - which must occupy not less than 20% 
of the main face of the packaging, must be locate d in the upper right corner, and must have a size 
of at least 4 square centimetres. These burdensome  and prescriptive requirements raised concerns 
regarding the labelling of small packages. Further, it  was not clear if stickers would be accepted in 
order to comply with the regulation. Should the additional warnings be eventually imposed, she 
asked Chile to consider less trade-restrictive size and placement requirements. In this respect, she 
drew Chile's attention to the EU's legislation, which provided less burdensome nutrition labelling 
requirements for packages whose largest surf ace had an area of less than 80cm², and an 
exemption from labelling for packages whose largest surface area was less than 25cm². Four and last, she asked Chile to provide information on the foreseen deadlines for the entry into force of 
these modifications, an important matter since the adaptation to the new requirements would 
require significant investment for manufacturers and a redesign of the packaging for some categories of products. She also asked Chile to postpone the entry into force of the modifications 
and provide a reasonable implementation period  in accordance with Article 2.12 of the TBT 
Agreement. In this regard, she drew attention to the fact that the EU's legislation on nutritional labelling was adopted in 2011 but would only come into force in 2014. 
3.148.  The representative of the United States associated her delegation with the comments 
made by Brazil, Mexico, Guatemala and the EU. She asked that Chile, in conjunction with 
mandatory nutrition labelling, to consider a voluntary claims approach in line with international standards such as the Codex Guidelines for Use of Nutrition and Health Claims. She noted that the 
Codex contained guidance for establishing conditio ns for voluntary "low", "free" and "no added" 
claims in tandem with mandatory nutrition labelling. Another option for Chile would be to express nutrition content of a food as a percentage of the daily intake reference values. She explained that 
it was the US understanding that Chile has established a special committee with members from 
the Ministries of Economy and Health, and a repres entative from the office of the president, to 
develop a draft regulation that would take into ac count the trade concerns raised by stakeholders 
at previous TBT Committee meetings. It was moreover the US understanding that the Chilean 
Ministry of Economy has put forward an alternativ e approach that would be preferable to that G/TBT/M/60 
 
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  proposed by the Ministry of Health. Under this alternative approach the information displayed 
would indicate how many calories and how much saturated fat, sodium and sugar was contained in each serving of a particular food based on daily intake reference values. Such alternative approach would be consistent with Chile's legislation and provided more useful information on foods to the 
consumer, minimizing the chance that they would be misled. This alternative proposal would also 
decrease the number of foods that must be labe lled with "high in" claims. She asked Chile to 
confirm that the Ministry of Health's final regula tion would not include "STOP signs" as the primary 
means to communicate nutritional information to consumers, and that nutritional thresholds would 
be based on portion sizes by food category. The US encouraged Chile to delay finalization and 
implementation of this regulation to allow for adequate dialogue and consideration of comments from stakeholders. Further, the current timetable to implement the regulation by July 2013 did not 
leave sufficient time for industry compliance or discussion of trading partners' concerns.  
3.149.  The representative of Switzerland said that while sharing Chile's views regarding obesity 
related to non-communicable diseases, his delegation also had some concerns with the draft 
measure, which have been sent to Chile in writing after their bilateral consultations. His delegation 
looked forward to hearing how these concerns woul d be reflected in the draft regulation and also 
invited Chile to consider Switzerland's voluntary approach regarding the referencing of nutrition 
thresholds on products. 
3.150.  The representative of Australia said that while his delegation supported Chile's right to 
implement measures to provide consumers with information in order for them to make appropriate 
dietary choices and reduce the risk of non-communicable diseases, it was important that such 
measures were no more trade-restrictive than necessary to achieve the objective. He noted that 
Law No. 20.606 was published in the official gazette on 7 June 2012 with a one year implementation date. Since the overarching law was not notified to the WTO, Members did not 
have the opportunity to submit comments until the implementation phase. Australia was 
concerned with the mandatory nature of the fron t-of-pack nutritional labelling requirements and 
with the lack of clarity around many issues related to the law's implementation. He underlined that 
there were less trade-restrictive measures available that were being considered by other countries, 
including Australia. He encouraged Chile to delay implementation of the law until the arrangements for implementation have been fully considered and clearly communicated to trading partners. He also encouraged Chile to continue notifying the WTO of any further amendments, as 
well as guides, on the operation of the Food Health Regulations.  
3.151.  The representative of Argentina said that his delegation shared the concerns of other 
delegations with the negative trade effects of  the provisions of both the law 20.606 and its 
regulation on the nutritional composition of foods and their advertising. He reiterated his 
delegation's previously expressed view that the Chilean measures did not meet the provisions of 
Article 2.2 of the TBT Agreement as they were excess ive in relation to the legitimate objective they 
sought to achieve, and asked the Chilean authorities to provide responses to Argentina's 
comments.  
3.152.  The representative of Canada said that her delegation supported Chile's policy objective of 
promoting healthy dietary choices and reducing obesity and related non-communicable diseases. 
However, Canada was concerned that the regulatory proposals would deviate from international 
standards, may not have a scientific basis and would likely be more trade-restrictive than necessary. Canada therefore encouraged Chile to consider less trade-restrictive alternatives. She 
noted that Canada has raised this issue with Chile in several fora, including the TBT Committee 
and on the margins of APEC in Indonesia, as well as bilaterally, via the Canadian embassy in Chile. Canada has been assured that Chile was reconsidering its regulations with a view to making them 
WTO compliant. She asked Chile to provide an u pdate regarding this regulatory review and 
timelines for the measure's implementation. 
3.153.  The representatives of Colombia and Costa Rica echoed the comments made by Brazil, 
Mexico, Guatemala, the EU, the US, Switzerland, Australia, Argentina and Canada. They also 
thanked Chile for its replies concerning some of the concerns which they have has previously 
raised. 
3.154.  The representative of Chile stated that obesity was becoming epidemic in Chile, 
particularly among those aged under 14. This law was one of the first measures which Chile has 
adopted to address this problem and was based on the understanding that the public needed to be G/TBT/M/60 
 
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  able to make informed decisions about their food consumption and avoid excessive consumption of 
substances which lead to obesity. She said that the Chilean government was currently working on the final version of this regulation. She also explained that during the preparation of the final draft, Chile welcomed a number of experts from other co untries, including the EU and US, and integrated 
their contributions as well as developments in the TBT Committee. It was precisely due to the 
large number of comments and developments being taken into account that the implementation 
process would take longer than expected and the deadlines for implementation would be modified 
accordingly. She also clarified that Chile was no longer envisaging an octagonal shaped warning 
"STOP sign" but instead a smaller one, different from that originally proposal. Finally, she ensured that Chile would continue to keep Members informed of developments. 
3.2.2.24  Korea – Draft amendment of Ordi nance and Regulation of Motor Vehicle 
Control Act (G/TBT/N/KOR/342 and G/TBT/N/KOR/342/Add.1) (IMS ID 375) 
3.155.  The representative of the European Union reiterated her delegation's concerns with the 
measure and noted that, despite several reminders, the EU has not received any replies to its 
comments sent to Korea on 1 March 2012. The Korean draft introduced a system of 
self-certification of certain car parts. Manufacture rs or importers of these parts would have to be 
registered with the relevant Korean authority (the Ministry of Land, Infrastructure and Transport, 
or MoLIT), and apply the self-certification mark (t he KC mark) on the product before placing it on 
the Korean market. She also noted that in acco rdance with Article 2.4 of the TBT Agreement, 
where international standards existed or their completion was imminent, Members shall use them as a basis for their technical regulations, unless such standards were inappropriate or ineffective to 
achieve the legitimate objective pursued. She said that Korea has not provided any explanation, 
scientific evidence or any other relevant information as to why the relevant UN Regulations and e-mark would be inappropriate or ineffective in attaining Korea's objective. She reiterated the EU's 
request that car parts certified as complying with UN Regulations, and marked with the 
international "e-mark", be accepted on the Kore an market. She further asked Korea to in the 
meantime accept stickers to affix the KC mark for the indefinite future, or until any eventual 
acceptance of the e-mark. She said that her delegation also remained concerned with the fact that 
the implementing legislation to the amended Or dinance and Regulation – MLTM Notice no. 2013-
70 on "Guidelines for Motor Vehicle & Vehicle Parts Self-Certification" - was published by the MoLIT on 22 February and entered into force on 22 May, without ever having been notified to the WTO. 
She requested the suspension of the requiremen ts until these TBT Agreement obligations were 
complied with, or, at a minimum, to ensure a flexible implementation with a view to minimizing trade distortions. 
3.156.  The representative of Korea noted that the Korean authorities have been in contact with 
the EU regarding this issue many times and in its last official response of 26 March 2013 Korea has 
fully addressed the concerns raised by the EU. Korea said that its regulation was harmonized with 
relevant international standards and many countries, including the US and the EU, operated similar 
certification schemes for automotive parts under which they required the use of their own marks. While Korea did not see any reason why parts with an e-mark instead of a KC-mark would be admitted, it would however allow stickers to be used for small parts. Korea noted that the 
regulation entered into force on 22 February 2013 and that it was thus not possible to grant an 
additional grace period. The regulation, which was notified to the WTO in December 2011, granted 
a three-month grace period to ensure that manufacturers would have time to get acquainted with 
it. 
3.2.2.25  European Union – Tobacco products, nicotine containing products and herbal 
products for smoking. Packaging for retail sa le of any of the aforementioned products 
(G/TBT/N/EU/377) (IMS ID 377) 
3.157.  The representatives of Cuba, Dominican Republic, Malawi, and Zimbabwe expressed their 
concern on the consistency of the proposed EU measure with the TRIPS Agreement and/or the 
TBT Agreement. Their full statements are contai ned, respectively, in G/TBT/W/365, G/TBT/W/367, 
G/TBT/W/369 and G/TBT/W/370. 
3.158.  The representative of Nicaragua expressed concerns regarding the most recent 
developments of the EU's proposed measure. He no ted, in particular, that the presentation of the 
draft report on 10 April 2013, made by the rapporteur of the European Parliamentary Committee 
on the Environment, Public Health and Food Safety, Linda McAvan, suggested a series of G/TBT/M/60 
 
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  amendments which, in Nicaragua's point of view , increased the trade-restrictive nature of the 
measure. Of particular concern for his delegation were the proposals to adopt plain packaging for cigarettes and roll-your-own tobacco, the requirement for authorization of new products and the restriction of distribution and sales of tobacco products. Nicaragua considered that because the 
draft directive was more trade-restrictive than necessary and lacked scientific basis, it was not in 
accordance with Article 2.2 of the TBT Agreement.  He encouraged the EU to consider less trade-
restrictive alternatives. Nicaragua also believed th at the proposal of introducing plain packaging 
can, in particular, could not be justified under the WHO's Framework Convention on Tobacco 
Control (FCTC), as the EU's proposed measure extended beyond the requirements of this Convention. He explained that Nicaragua ha s about 23 tobacco producers which together 
generated 35,000 direct jobs and 45,000 indirect jobs. Nicaragua's tobacco exports were valued 
up to 185 million dollars. He also underlined that the tobacco industry helped to stimulate 
Nicaragua's tourist sector as the tobacco production sites attracted many visitors. The EU's proposed directive could therefore cause serious economic and social adverse effects to his 
country.  
3.159.  The representative of Guatemala explained that while her delegation shared the policy 
objective of the EU to improve public health by  discouraging the use of tobacco products, it was 
nonetheless unclear how the proposed regulation  would achieve such legitimate objective. 
Furthermore, as the EU's measure appeared to be more trade-restrictive than necessary to achieve that legitimate objective, Guatemala asked the EU to consider less trade-restrictive alternatives. 
3.160.  The representative of Honduras stated th at her delegation shared the concerns expressed 
by other delegations, in particular those related to the compatibility of the proposed measure with 
WTO Agreements, particularly the TRIPS and TBT Agreements. While Honduras understood the 
need to protect human health, it considered that the measure was more trade-restrictive than 
necessary. 
3.161.  The representative of Mozambique said that  while his delegation recognised EU's right to 
protect its citizens, it also associate itself with the concerns expressed by Malawi, Nicaragua, Cuba 
and other Members, which would hopefully be taken into consideration by the EU. 
3.162.  The representative of Australia reiterated  his delegation's previous support of the EU's 
proposal to revise the Tobacco Products Directive. Like Australia, the EU was a strong supporter of 
effective tobacco control and as parties to the WHO FCTC both Members shared common goals. He 
noted that one of the objectives of the EU pr oposal was to implement the WHO FCTC. He also 
underlined that the significant public health ch allenge resulting from tobacco use was a global 
issue which all WTO Members must face. He commended the EU and its member states for the 
tobacco control measures it had implemented to date. He noted that under the proposal EU member states would be allowed to implement plain packaging of tobacco products as far as it was 
compatible with the Directive and EU law. He said that Australia particularly welcomed the 
announcement by the current EU presidency, Irel and, that it would be taking the lead by 
introducing legislation to mandate plain packaging of tobacco products. Australia was of the firm view that Members had the right to implement measures necessary to protect public health while 
complying with relevant treaty obligations, including the TBT Agreement. He viewed the proposed 
EU Directive as a legitimate measure designed to  achieve the fundamental objective of protecting 
human health, in particular protecting young people against smoking initiation and uptake.  
3.163.  The representative of Norway stressed that  public health and tobacco control were topics 
of particular interest to her delegation and than ked the EU for notifying the proposal at such an 
early stage in the process. In Norway's view, it  was within the rights of each WTO Member to 
adopt measures which were necessary to protect pub lic health as long as they would be consistent 
with WTO obligations. Norway considered the FC TC and the relevant WTO Agreements to be 
mutually supportive, and that it was possible to implement measures intended to regulate the use of tobacco products in line with both sets of binding obligations. Norway strongly supported the EU 
in its efforts to combat the tobacco epidemic.  
3.164.   The representative of New Zealand underlined his delegation's support for the EU's 
consideration of introducing controls on the packaging of tobacco products as part of their 
comprehensive tobacco control regime. In New Zealand, smoking was the single largest cause of 
preventable death and disease. He noted that WTO rules included appropriate flexibilities to enable G/TBT/M/60 
 
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  WTO Members to regulate for health and other public policy purposes. This right was explicitly 
expressed in the ability to issue legitimate regu latory objectives under the TBT Agreement. New 
Zealand also welcomed the ability of individual EU member states to introduce plain packaging under this draft directive as well as Ireland's efforts to do so. New Zealand expected the EU to 
regulate in a manner that would be consistent both with its obligations under the WTO Agreements 
and the FCTC. 
3.165.  The representative of the European Un ion explained that the proposal had been put 
forward by the Commission on 19 December 2012, and was now going through the EU's legislative 
process, in which both the European Council and the Parliament would have to give their approval in order for the proposal to be adopted. Once adopted, the Directive would become applicable 18 months later, and products not in compliance with the Directive would be able to be placed on the 
market for an additional 6 months. The proposal was notified to the WTO on 18 January 2013, and 
Members were provided with 90 days to comment on the draft. Three Members had submitted comments: Malawi, Malaysia and Chinese Taipei. The European Union would reply to these 
comments in writing in the next few weeks.  
3.166.  She also responded to some of the points raised by Members during this meeting and the 
March 2013 TBT Committee meeting. Firstly, with re gard to the draft Directive's requirements on 
ingredients, she explained that the prohibition of  tobacco products with characterising flavours, 
contained in Article 6 of the proposal, did not prohib it the use of individual additives provided that 
they did not result in a characterizing flavour. She said that the use of additives which were essential for manufactures' tobacco products and did not result in a characterizing flavour shall not 
be prohibited. A ban on tobacco products with characterising flavours was deemed necessary and 
proportionate in relation to the legitimate objectives of the measure. It was also in line with the guidelines on the implementation of Articles 9 and 10 of the FCTC. She also explained that 
scientific studies and market data demonstrated that flavours influenced and enhanced smoking 
initiation. For instance, a Eurobarometer survey from 2012 confirmed that flavours played a bigger 
role in smoking initiation in young people than in other age groups. In particular, the growing 
trend of using fruit and other flavourings, such as vanilla and chocolate in tobacco products has 
been shown to serve as an inducement to young people to start smoking. Products with characterising aromas or tastes could also easily influence consumers' perception of harm. For the particular case of menthol, evidence suggested that the availability of menthol cigarettes increased 
the likelihood of experimentation and regular smok ing. She further explained that, in addition to 
the ban of tobacco products with characterising flavours, the proposal included a ban of a limited number of individual additives (Article 6, para. 4) which gave the impression that a tobacco 
product had health benefits, presented reduced health hazards or increased mental alertness and 
physical performance. Secondly, with regard to  the packaging and labelling, she said that the 
proposal foresaw a mandatory combined health warning (which included a picture and a text 
message) on 75% of the two main surfaces of cigarettes and roll-your-own products. It also 
foresaw a ban on promotional and misleading elements. She noted that, in the EU's view, these requirements were proportionate and non-discriminatory. The proposed size of the health warnings balanced the legitimate objective of informing consumers and discouraging smoking initiation with 
the economic interests at stake. She highlighted th at the Guidelines for implementing Article 11 of 
the FCTC concluded that the effectiveness of health warnings increased with size, and recommended FCTC Parties to cover as much of the principal display areas as possible. As certain 
packet shapes could mislead consumers to believe that a product was less harmful than others, a 
certain standardisation of package appearance and a minimum number of cigarettes per package 
was also required. She further noted that, while the draft Directive did not mandate cigarettes to 
be sold in plain packaging, EU Member States maintained the right to regulate autonomously 
aspects not covered by the prescriptions of the Directive or other Union legislation. Any such national rules concerning aspects not covered by Union legislation should be adequately justified and compatible with the Treaty on the Functioning of the European Union and with international 
agreements binding on the Union.  
3.167.  The European Union concluded by underlining once again that the draft Directive was the 
result of thorough consultations with all stakehol ders involved, and provided for a broad range of 
measures which were non-discriminatory and proportionate to the legitimate health objectives 
pursued. It joined a broad array of legislative and non-legislative initiatives (such as excise duties, public awareness campaigns, bans on smoking in public places, prohibition of advertising), at both 
EU and Member State level, to increase awaren ess of tobacco risks, reduce the appeal and 
attractiveness of tobacco products, and therefore contribute to a decrease in smoking rates and G/TBT/M/60 
 
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  smoking initiation, particularly among youngsters. This draft was therefore fully consistent with the 
EU's international commitments, including its obligations under the WTO TBT Agreement, and throughout the legislative process WTO aspects would duly be taken into account.  
3.3  Exchange of Experiences  
3.3.1  Good Regulatory Practice 
3.168.  The Committee held a second thematic discussion on Good Regulatory Practices (GRP) on 
17 June 2013. The Chairman's oral summary re port is contained in G/TBT/GEN/143/Add.1. 
3.169.  Referring to the report, the representative of China asked the Chairman to clarify what he 
had meant with "TBT-plus" outcomes. He specific ally asked whether the inclusion of Regulatory 
Impact Assessments (RIA) in the non-exhaustive li st of voluntary mechanisms, designed to guide 
Members in the efficient and effective implementation of the TBT Agreement, constituted a "TBT-
plus" outcome.  
3.170.  The representative of Cuba associated he rself with the concerns expressed by China. She 
said that it remained important to share best prac tices in the area of GRP and that the situation of 
implementation has been unsatisfactory.  
3.171.  The Chairman emphasized that the Committee was, as per its mandate from the Sixth 
Triennial Review, in the process of identifying a non-exhaustive list of voluntary mechanisms to 
implement the TBT Agreement in a more efficient an d effective way. This work was not intended to 
add or detract from the disciplines of the TBT Agreement. 
3.3.2  Transparency 3.3.2.1  Seventh Special Meeting on Pr ocedures for Information Exchange  
3.172.  Pursuant to its 1995 decision to convene, on  a biennial basis, "regular meetings of persons 
responsible for information exchange, including persons responsible for Enquiry Points and notifications"
7, the TBT Committee held its Seventh Special Meeting on Procedures for Information 
Exchange on 18 June 2013. The Chairman delivered an oral summary report of that Meeting 
(G/TBT/GEN/151). A more detailed summary of th e meeting is contained in Annex 1, below. 
3.3.2.2  Coherent Use of  Notification Formats 
3.173.  A representative of the Secretariat (SPS Committee) made a presentation on the SPS 
Committee's experiences with notifications. She said that the SPS Committee has periodically 
reviewed its transparency obligations an d its recommended procedures and formats.8 
Recommended formats had last been revised in 2008 when the SPS Committee adopted a format 
for addenda that gave clear checkmark options for Members to indicate the purpose of their 
addenda. She explained that a "revision" was defined by the SPS Committee as a document that had replaced a previous notification. "Corrigenda"  were defined as corrections of errors that 
stemmed from the submission itself, or from the Secretariat's handling of the notification. She 
underlined that since the SPS Committee last revised its recommendations and adopted new formats for addenda, revisions and corrigenda, 25 % of the notifications were addenda. Very few 
revisions and corrigenda have been submitted. She explained that the system for on-line 
submissions of SPS notifications had been active for more than 18 months and that close to 50% of all notifications had been received through this system. She said that, from the Secretariat's perspective, notifications had been processed and published much faster when submitted on-line. 
Members had also indicated that the submission of notifications online had saved substantial 
amounts of time. 
3.174.  The representative of the United States underlined that in arriving at a common 
understanding of the meaning of notification format s, due regard had to be paid to the efficiency 
of the notification process as well as institutional differences in Members' regulatory systems. 
                                               
7 G/TBT/1/Rev.10, page 35. 
8 G/SPS/7/Rev.3. G/TBT/M/60 
 
- 39 - 
 
  3.175.  The representative of the European Union highlighted that the EU's paper on the use of 
notification formats9, referred to the SPS Committee's docu ment setting out recommendations on 
the use of notification formats. The representative  suggested that it would be useful to mirror the 
good practices of the SPS Committee when providing guidance to Members on the uniform use of 
notification formats.  
3.176.  The representative of India asked for clar ification regarding what the EU wanted as an 
outcome of their proposal for a coherent use of notification formats. 
3.177.  The representative of the European Union replied that his delegation hoped that the 
outcome would constitute recommendations giving clear and practical guidance as well as 
examples of when new notifications, addenda, revisions and corrigenda should be used. He suggested that the EU proposal could form the base of a Committee recommendation if Members 
so wished.  
3.178.  The representative of the Philippines as ked whether it was the ambition of the Committee 
to follow the practices stated in the EU's propos al or rather to imitate the guidance of the SPS 
Committee.  
3.179.  The representative of the United States suggested that a way forward to standardize 
practices for notification formats could be to develop a basis for commonality in Members' 
notification practices. She hoped that criteria for formats could be structured to encapsulate both 
the diversity of notification practices and provide a common basis.  
3.180.  The Chairman noted that although the EU proposal constituted a good foundation, it was 
not necessary to adhere to a single proposal. He encouraged Members to make use of this 
opportunity to think about their current notification practices and make additional proposals. He 
said that the deadline for submitting comments should be on 6 September 2013.  
3.3.3  Special and Differential Treatmen t and Technical Assistance (preliminary 
discussion on the thematic session) 
3.181.  At the request of the representative of Ecuador, a communication10 regarding the 
preparation of the thematic session on Special and Differential Treatment (SDT) and technical 
assistance in October 2013 was circulated. 
3.182.  The representative of China expressed his delegation's support of Ecuador's proposals for 
the upcoming thematic session. His delegation believed that more concrete work needed to be 
carried out by the TBT Committee in order to enhanc e the effective implementation of Article 12 of 
the TBT Agreement. He noted that the principle contained in Article 12 of the TBT Agreement was 
as important as the principles of transparency, non-discrimination and the use of international standards, and should thus be applied throughout the entire regulatory lifecycle. He noted that 
there was no specific guidance document regardin g best practices in the field of SDT and that 
China considered it important to work towa rds the development of such guidelines. The 
representative invited Members, particularly de veloped Members, to share experiences on how 
Article 12 had been implemented in the preparation, adoption and application of technical 
regulations, standards and conformity assessment pr ocedures. These could include, as required by 
Article 12, what active and meaningful consideration had been given to the special development, financial and trade needs of developing Members in  the regulatory life cycle, and what measures 
had been taken by Members to facilitate active and effective participation of developing Members 
in the work of international standardizing bodies and international systems for conformity assessment. 
3.183.   The representative of Argentina expressed his delegation's support of Ecuador's proposal 
and China's statement. He drew attention to the work of the CTDSS on the implementation of the 
relevant provisions of the SPS Agreement, and note d that similar work could be carried out by the 
TBT Committee.  
                                               
9 JOB/TBT/48. 
10 JOB/TBT/49. G/TBT/M/60 
 
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  3.184.  The representative of India supported the previous delegations' statements. He noted that 
in the context of discussion on specific trade concerns, developing countries had pointed out that 
their SMEs were facing difficulties when attempting to conform to the regulations of other Members. He stated that his delegation wished to enhance the Committee's work in this field by 
sharing experiences and developing guidance do cuments. India also asked the Secretariat to 
prepare a background paper highlighting the va rious aspects of Article 12 of the Agreement. 
3.185.  The representatives of the Dominican Re public, Cuba and Indonesia supported Ecuador's 
proposal. 
3.186.  The representative of the Philippines ex pressed her delegation's support of Ecuador's 
proposal and suggested holding an informal meeting to discuss how Members can move forward in 
this regard. 
3.187.  The representative of Brazil expressed his delegation's readiness to participate in the 
structuring of the thematic discussion on Article 12 of the TBT Agreement. 
3.188.  The representative of South Africa support ed Ecuador's proposal and the statements made 
by other delegates. He also said that South Africa would appreciate if the Secretariat would 
develop a background paper outlining how developed country Members were implementing Article 12 of the Agreement. 
3.189.  The representative of Mexico supported the suggestion made by the Philippines to hold an 
informal meeting to lay out the foundations of the thematic session.  
3.190.  The representative of the United States en couraged Members to consider the topic of best 
practices on technical assistance developed in the Fifth Triennial Review with respect to demand 
driven technical assistance which she underlined had been a long standing element of the 
Committee's work. 
3.191.  The representative of the European Union welcomed Ecuador's proposal. He asked if the 
Secretariat could provide a background note on the Committee's work, but also developments 
taking place elsewhere in within the WTO, on the topic of SDT and technical assistance. 
3.192.  The representative of the WTO Secretaria t noted the request by Members for a background 
note on the topic of SDT. He explained that a first note on the topic could be found in document 
JOB(05)/269. 
3.193.  The representative of Ecuador expressed his delegation's appreciation of the EU's 
comments and welcomed the incorporation of these in the preparation of a background note on 
SDT by the Secretariat.  
3.194.  The representative of China asked whether informal consultations would be held regarding 
the session on SDT and technical assistance.  
3.195.  The Chairman underlined that a programme based on Members' comments would be 
developed and circulated in due course before informal consultations would take place. 
3.3.4  Conformity Assessment (preliminar y discussion on the thematic session) 
3.196.  The representative of the United States proposed that, regarding the thematic session on 
Conformity Assessment Procedures, three main elemen ts were of particular interest: the results of 
conformity assessment procedures, the internationa l system of accreditation and the development 
of technical infrastructure. 
3.197.  The representative of South Africa supported the ideas underlined by the US and added 
that the topic of Mutual Recognition Agreements (MRAs) was also important. G/TBT/M/60 
 
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  4  TECHNICAL COOPERATION ACTIVITIES 
4.1.  The representative of UNECE updated the Committee on activities in the Working Party on 
Regulatory Cooperation (WP6).11 He said that at the annual meeting in November 2013, a 
recommendation on a reference to standard s (Recommendation D) would be revised.12 He invited 
all organizations and interested parties to take part in this revision. A workshop would also take 
place at the November meeting, covering topics such as education on standard related issues. 
4.2.   The representative of Codex Alimentarius informed the Committee that the FAO/WHO 
Project and Fund for Enhanced Participation in Codex would meet from 1-5 July 2013.13 
4.3.  The representative of Senegal suggested to the Committee that there would be more training 
activities on the TBT Agreement, for example region al workshops covering subjects such as market 
access difficulties.  
4.4.  The Chairman informed the Committee that an Advanced Course on the TBT Agreement had 
taken place from 10-21 June. This intensive course was carried out as part of the WTO Trade 
Related Technical Assistance plan 2012/2013. Twen ty-four participants from developing countries 
took part in this activity, which included presenta tions, interactive discussions, simulation exercise 
and visits to international standard setting bodies.  
4.5.  The representative of South Africa thanked the Secretariat for organizing this activity and 
said the knowledge their participant gained would help South Africa to further improve their 
implementation of the TBT Agreement. 
5  UPDATING BY OBSERVERS 5.1.  The representatives of IEC and Codex Alimentarius
14 updated the Committee on their 
activities. The representative of Codex Alimentari us highlighted the work of its Committee on Food 
Labelling. Given the number of STCs raised on this subject, she considered that the work of this Codex Committee could be of interest to the TBT Committee. 
5.2.  The representative of OIML informed that Rwanda, Uganda and Yemen became 
corresponding members. OIML was also workin g with UNIDO and the ITC on a number of 
programmes to reinforce legal metrology as part of quality infrastructure in developing countries. 
With UNIDO, a metrology school for all African countries - AFRIMETS15 would be organized in 
2014, concentrating entirely on legal metrology. With ITC there were some on-going programmes concerning control of pre-packages. 
5.3.  The representative of South Africa proposed that the Committee grant ad hoc  observership 
status to ILAC and IAF. As a signatory to both IAF and ILAC Mutual Recognition Arrangements, he 
said South African goods were accepted in 61 economies, represented by 73 accreditation bodies. The purpose of ILAC and IAF was to establish multilateral arrangements between their member 
accreditation bodies, which enhanced the acceptance of products and services across national 
borders by removing the need for additional testing, inspections or certification, thereby helping to reduce bureaucracy and costs for businesses. Multilateral arrangements also provided 
governments and regulators with an intern ationally recognized stamp of approval. 
5.4.  The representative of the United States thanked South Africa for supporting ILAC and IAF's 
request for observer status in the Committee. As this issue was still under discussion internally, 
she was not able to lend her support at the time, but would bring it back to capital for further 
discussion. 
5.5.  The representative of the European Union thanked South Africa for supporting the application 
of ILAC and IAF. However, he reminded the Committee that there was a formal impediment to 
granting this request as the guidelines for observer status clearly stated that observer status was 
                                               
11 http://www.unece.org/trade/wp6/welcome.html  
12 http://www.unece.org/index.php?id=32879  
13 ftp://ftp.fao.org/Codex/Meetings/cac/cac36/cac36_14e.pdf  
14 G/TBT/GEN/152 and G/TBT/GEN/153 
15 http://www.afrimets.org/SitePages/Home.aspx  G/TBT/M/60 
 
- 42 - 
 
  only granted to inter-governmental organizations. In the EU's view, ILAC and IAF should be invited 
to events where their presence could add a valuable  contribution but this did not qualify them for 
permanent observer status. He requested that the WTO Secretariat provide a legal clarification on 
how the guidelines for observer status should be interpreted. 
5.6.  The Chairman proposed that all Members s eek advice from their relevant authorities on 
pending requests for observer status, including the proposal from South Africa and said he would 
revert to pending requests at the next meeting of the Committee. 
6  DATE OF NEXT MEETING 
6.1.  The next meetings of the TBT Committee will take place on 30-31 October 2013. It will be 
preceded by a thematic sessions on Special and Differential Treatment and Technical Assistance, 
and Conformity Assessment Procedures on 29 October. 
  
_______________ 
 
  
 G/TBT/M/60 
 
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  ANNEX 1 
SUMMARY REPORT OF SEVENTH SPECIAL MEETING  
ON PROCEDURES FOR INFORMATION EXCHANGE 
1.1.  Pursuant to its decision to hold, on a bienni al basis, "regular meetings of persons responsible 
for information exchange, including persons resp onsible for enquiry points and notifications"1, the 
TBT Committee held its Seventh Special Meeting on Procedures for Information Exchange on 18 June 2013.
2 The Special Meetings are organized to provide Members with an opportunity to 
discuss issues relating to information exchange and to review periodically the functioning of 
notification procedures and the operation of enquir y points. The meetings are also used to follow-
up on decisions and recommendations agreed by the TBT Committee during its triennial reviews. The Seventh Special Meeting was organized in three panel sessions dealing with (i) online 
notification; (ii) use of notification formats; and (iii) functioning of enquiry points.
3 
1  ONLINE NOTIFICATION: TBT NOTIFICATION SUBMISSION SYSTEM (TBT NSS) 1.2.  The representative of the Secretariat presen ted the TBT Notification Submission System (TBT 
NSS), which had been developed in response to the mandate of the Sixth Triennial Review.4 He 
explained that the TBT NSS allowed Members to submit notifications online, and was aimed at facilitating the submission and processing of noti fications by Members and the Secretariat. At the 
time of the meeting, the TBT NSS was functional but remained in a state of live testing. Three 
Members had taken part in the testing phase (United States, European Union, Canada) and were submitting notification through the TBT NSS. The Secretariat reported that in the testing phase, Members had identified a number of issues and bugs in the TBT NSS.
5 In light of this, a number of 
fixes and upgrades were planned. For instance: the implementation of a new homepage to provide 
Members' with an overview of the status of notifications; a template function to reduce repetitive data entry; improved navigation and more prom inent buttons; and, implementation of an email 
alert system. The Secretariat would continue to work with Members to develop and enhance the 
TBT NSS towards an official launch before the end of 2013. He stressed that the objective of the TBT NSS was to improve efficiency in the work of the Secretariat and Members, which was 
especially important given the growing number of notifications submitted. Other Members were 
encouraged to participate in the live testing phase. 
1.3.  The representatives of Switzerland and South Africa indicated their interest in beginning to 
use the TBT NSS. The representative of South Africa also noted that identifying products and 
assigning product codes (i.e. HS and ICS codes) covered by notified measures was challenging, 
and wondered to what extent the TBT NSS would enab le precise identification of relevant products. 
1.4.  The representative of Uganda asked about the level of resources needed to use the system. 
1.5.   The representative of Japan enquired whether notifications submitted through the old 
approach would continue to be accepted once the TBT NSS was officially launched and enquired 
how Members could obtain their user names and passwords for the TBT NSS. 
1.6.  The representative of Ecuador asked if use of the TBT NSS would become mandatory in the 
future, and if there was a deadline envisaged in this respect.  
1.7.  The representative of Brazil requested confir mation that online submission of a notification 
would replace the old approach of notification (e.g. by email). 
1.8.  The representative of Cuba emphasized th e importance of the development angle, and hoped 
that the TBT NSS could improve transparency and implementation of other provisions of the TBT 
Agreement across the regulatory lifecycle. 
                                               
1 G/TBT/1/Rev.10, page 35. 
2 The programme for the Special Meeting is contained in G/TBT/GEN/150. 
3 Presentations made during all three sessions can be downloaded at: 
http://www.wto.org/english/tratop_e/tbt_e/special_meeting_june13_e.zip . 
4 G/TBT/32, para. 18.  
5 For instance, in a few cases, some information had be en lost in the issued notification (e.g. HS codes). 
Also, it was noted that in the testing phase, submission of notifications through the TBT NSS was more time and resource intensive as compared to the old approach fo r submitting notifications (i.e. by email, fax or post). G/TBT/M/60 
 
- 44 - 
 
  1.9.  The representative of Korea supported the introduction of the TBT NSS, which he believed 
would improve transparency of the notification process. 
1.10.  The representative of the Secretariat expl ained that use of the TBT NSS was voluntary, and 
would remain so even after the official launch. In other words, Members would continue to be able 
to submit notifications through the old approach  (e.g. by email). For new users, Members were 
invited to contact the WTO Secretariat for instructions.6 However, he reminded Members that the 
system remained in a state of live testing, and, therefore, additional time and resources could be 
needed to submit notifications through the TBT NSS. Once the TBT NSS was officially launched, it 
would be less time and resource intensive than th e old approach for submitting notifications. On 
the issue of product codes (the question raised by South Africa) the system could assist Members 
in identifying product codes through integration of the searchable list of the HS and ICS codes into 
Box 4 of the online notification form.  
1.1  European Union: A journey to the TBT NSS 1.11.  The representative of the European Union
7 presented his delegation's experience with the 
TBT NSS.8 He first stated that the TBT NSS was intuitive to use and had accelerated the processing 
of notifications by the Secretariat. His delegati on had already submitted over ten notifications 
online. However, submitting notifications through the TBT NSS in the current testing phase was 
time consuming, due to the need to follow up on notifications and double check for errors. He 
stressed the need for improvements before the official launch of the system, namely, the removal of all bugs, the publication of a help manual, and an email alert system. In terms of future 
developments, his delegation sought ways to further automatize submission of notifications to the 
WTO, and suggested a solution whereby Members could submit a PDF form directly to the TBT 
NSS. Finally, he encouraged other Members to begin using the TBT NSS, and take part in the live testing phase. 
1.2  United States: Using the TBT NSS 
1.12.  The representative of the United States
9 shared the experiences of her delegation with the 
TBT NSS. She said that while the United States had submitted seven notifications without incident 
through the TBT NSS, three notifications had enco untered issues and delays in submission, and 
another two were eventually submitted using the old approach to avoid delays. She said that it currently took longer to use this system than to submit notifications via the old approach, and that 
in order for the TBT NSS to become a long-term viable option for submitting notifications, 
additional improvements were necessary. Neverthe less, she appreciated the collaboration with the 
WTO Secretariat and noted that feedback and the co ncerns of the United States – as well as other 
Members – were being taken into account. 
1.3  Canada: Reflections on the proposed TBT NSS 
1.13.  The representative of Canada
10 welcomed the introduction of new technologies such as the 
TBT NSS, which helped to increase efficiencies, streamline processes and strengthen ties between 
Members. However, she believed that there was scope for further improvements to the usability as 
well as the efficiency of the TBT NSS, in order to ensure widest possible uptake across the WTO Membership. In particular, she highlighted the need for: more intuitive navigation and layout (e.g. 
larger boxes and more prominent buttons), maki ng the TBT NSS faster and less burdensome to 
use, and new ways of storing information in the system (e.g. the implementation of a template 
function, and allowing Members to assign an internal identification number to notifications under preparation in the TBT NSS). 
                                               
6 Please contact Ms Una Flanagan, una.flanagan@wto.org . 
7 Mr Cyril Hanquez, Application Arch itect, DG Enterprise and Industry. 
8 Presentations can be downloaded at: 
http://www.wto.org/english/tratop_e/tbt_e/special_meeting_june13_e.zip . 
9 Ms MaryAnn Hogan, USA WTO TBT Enquiry Point, National Center for Standards and Certification 
Information (NCSCI). 
10 Ms Andrea Spencer, Manager Information and Re search Services, Standards Council of Canada. G/TBT/M/60 
 
- 45 - 
 
  1.4  Discussion 
1.14.  The representative of South Africa asked how long it took to complete a notification through 
the TBT NSS, in light of the fact that many developing countries struggled with inconsistent and 
slow internet connections. 
1.15.  The representative of the European Union explained that submitting a notification online 
through the TBT NSS was just like using a regular electronic form, and that anybody with 
experience using these types of forms should not face any particular challenges. For instance, the 
EU team was able to prepare their first notification on the TBT NSS in less than two minutes. 
Rather, he stressed the impact of the TBT NSS on Members' internal workflows for preparing notifications. He noted that the TBT NSS was designed with two accounts per Member, which enabled officials of Ministries to log on to the system and prepare a notification, before final 
validation and submission by the notification authority (through the TBT NSS). 
1.16.  The representative of the United States noted that the TBT NSS allowed Members to easily 
save a notification in progress. Therefore, if a Member were to lose internet connection, so long as 
the notification was being saved periodically, they  could simply log back into the TBT NSS later 
and continue to edit the notification. She suggeste d that Members take this precaution as a way to 
insure against losing work. 
1.17.  The Chairman concluded the session by encouraging other Members to participate in the live 
testing phase of the TBT NSS. He understood that the Secretariat would continue to work on 
developing the TBT NSS, and the Committee would look forward to further updates on its status in the near future. 
2  GOOD PRACTICES IN NOTIFICATI ON: USE OF NOTIFICATION FORMATS
11 
2.1.  In the Fifth Triennial Review12, the Committee recommended establishing common 
procedures for notification formats. This recommendation was recalled in the Sixth Triennial 
Review13, in which additionally the Committee agreed to exchange experiences on Members' use of 
notification formats. 
2.1  European Union: EU proposal for a coherent use of notification formats 
2.2.  The representative of the European Union14 presented on EU's proposal for a coherent use of 
notification formats.15 She underlined that the EU had in its submission under the Sixth Triennial 
Review16, pointed out several difficulties associated with Members' notification practices. She said 
that it was particularly problematic when Members notified modifications to an already adopted 
text as an addendum. Since an addendum also se rved to communicate other kinds of information, 
notifying modifications as addenda could result in other Members failing to identify important new measures, and thus not being able to comment on  the measure. She noted that the EU notified 
amendments to already adopted measures as new notifications with new periods for Members to 
comment on the relevant measures. The EU considered that the following information should be notified using addenda: amendments made to a draft measure during the legislative process, the 
final adopted text and other non-compulsory but useful information related to the status of the 
original notification.  
2.3.  She stated that the EU used revisions to no tify replacements of previously notified measures 
that had not yet been adopted. Revisions typically included cases where substantial re-drafting of 
the previously notified draft measure had taken place. She underlined that a new comment period 
was always given to Members when a revision wa s notified. The representative further explained 
that the EU used corrigenda when obvious clerical errors had occurred in original notifications. She 
underlined that the EU's practices in notification were consistent with the recommendations issued 
                                               
11 G/TBT/32, para. 15. 
12 G/TBT/26, para. 43.  
13 G/TBT/32, para. 15. 
14 Mrs. Jana Krestynova, European Commission,  DG Enterprise and Industry, Unit C.3.  
15 Circulated as JOB/TBT/48.  
16 G/TBT/W/54, paras. 33-38.  G/TBT/M/60 
 
- 46 - 
 
  by the SPS Committee17 and that these could constitute a good basis for work in the TBT 
Committee. Clear guidance from the TBT Committee on the use of notification formats was needed.   
2.2  South Africa: Use of new notification formats 
2.4.  The representative of South Africa
18 presented on her delegation's experience with the use of 
notification formats. She explained that the South African Bureau of Standards managed and ran 
the national Enquiry Point and was responsible for the decisions taken by the WTO TBT Committee. 
She said that South Africa introduced a general template in 2012 for notifying any amendments or 
corrigenda. She underlined that one of the biggest challenges that South Africa had met in notifying measures was indicating the rationale for measures. Although Article 2.2 of the TBT Agreement had provided some guidance, she said th at South Africa would appreciate if a guidance 
list could be produced by the WTO Secretariat. Another challenge for South Africa when notifying a 
measure had been the indication of the correct HS-codes and the usage of hyperlinks. She said that HS-codes were sometimes not indicated by other Members and instead only ICS-codes were 
used. Hyperlinks would often open up in foreign la nguages and it was difficult to navigate to the 
original page and find appropriate translations. She concluded by highlighting that South Africa strived to make their national Enquiry Point and th eir notifications as user-friendly as possible.  
2.3  Discussion 
2.5.  The representative of the Russian Federation asked how the EU notified errors that were 
more substantial than clerical errors. He asked whether these would be notified as revisions or 
corrigenda.  
2.6.  The representative of the European Union replied that corrigenda would not be used in such 
cases. She said that such errors could either be notified as revisions or addenda. She explained 
that revisions were used for substantial changes where main provisions had changed and when the 
original notification could not be considered to be the same. A new comment period was therefore 
necessary in such cases. In the EU's opinion, a ddenda were rather used to notify minor changes 
which did not necessitate a new comment period for Members. 
2.7.  The representative of the United States as ked the representative of the European Union to 
clarify the EU's practices when notifying new meas ures. Did the EU notify amendments to adopted 
measures as new notifications?  
2.8.  The representative of the European Union replied that the EU notified amendments as new 
notifications if these included technical regulations or conformity assessment procedures that fell 
under the TBT Agreement. The EU regarded these am endments as new pieces of legislations, thus 
deserving a new comment period. She also said that the EU's approach in this matter was 
consistent with the recommendations of the SPS Committee.  
2.9.  The representative of the United States noted that the US and the EU had diverging 
approaches regarding this matter and suggested this could be tied to the institutions and 
procedures used to develop the relevant measur es. She noted that an addendum could be used 
effectively to track the progression of a measure, but also agreed with the EU that more consistency across the use of notification formats would be useful. 
3  FUNCTIONING OF ENQUIRY POINTS
19  
3.1.  In the Sixth Triennial Review, the Committ ee reiterated the importance of well-functioning 
enquiry points to the implementation of the TBT Agreement. In this regard, the Committee recommended that Members share experiences on challenges faced by enquiry points in 
responding to comments and requests, with a view to improving their functioning; and, agreed to 
discuss the functioning of enquiry points, incl uding with respect to building support among 
interested stakeholders in the private sector for the services of the enquiry points. 
                                               
17 These recommendations are outlined in document G/SPS/7/Rev.3, paras. 35-42.  
18 Mrs. Ronel Greyvenstein, WTO/TBT Enquiry Office r at the South African Bureau of Standards.  
19 G/TBT/32, paragraph 16. G/TBT/M/60 
 
- 47 - 
 
  3.1  Information Services Provided by th e Brazilian WTO/TBT Enquiry Point to SMEs 
3.2.  The representative of Brazil20 indicated that the National Institute of Metrology, Quality and 
Technology (INMETRO)21 acted as the Brazilian TBT Enquiry Point. He said that INMETRO was 
under the responsibility of the International Affair s coordination within the Brazilian Ministry of 
Development, Industry and Foreign Trade. The re presentative explained that besides functioning 
as Brazil’s Enquiry Point, INMETRO provided Brazilian Small and Medium sized Enterprises (SMEs) with information on matters related to the TBT Agreement. INMETRO also assisted the Brazilian 
Ministry of Foreign Affairs on TBT matters in relevant negotiations, managed the export alert 
system and provided training activities to intere sted parties. The representative highlighted that 
INMETRO produced competitiveness studies and technical documents in an attempt to enhance exporter awareness of technical barriers to trade. The representative finally underlined that 
INMETRO had hosted the First Meeting of the Enquiry Points of Americas in order to strengthen the 
working relationships amongst TBT Enquiry Points.  
3.3.  The representative of the United States asked the Brazilian representative to elaborate on the 
level of engagement of Brazilian SMEs in terms of requesting information or providing comments 
to INMETRO.  
3.4.  The representative of Brazil replied that unfortunately to date very few comments had been 
communicated to INMETRO. Raising awareness amongst SMEs remained a priority for Brazil's 
Enquiry Point. 
3.2  Adding Value to the National Economy: USA WTO TBT Enquiry Point 3.5.  The representative of the United States
22 explained that the US TBT Enquiry Point was 
responsible for identifying and notifying proposed measures at federal and state level and to 
provide associated texts of standards, technical regulations and conformity assessment procedures to the WTO Secretariat. Its responsibilities also in cluded distributing US TBT notifications and other 
Members’ notifications to interested parties via the on-line registration service “Notify US”
23. She 
explained that many different stakeholders used  “Notify US”, and that the business sector 
represented the majority of its customers. She underlined that companies and WTO Member 
economies can benefit greatly from TBT Enquiry Points, for example, by directly lowering costs of 
trade, reducing the information asymmetries, an d increasing exports and access to new markets. 
She finally said that the cooperation and exchange of experiences with other TBT Enquiry Points was very important and that the US Enquiry Point has participated in several events in this 
respect. 
3.3  Experience and Operation of the Japan TBT Enquiry Point 3.6.  The representative of Japan
24 explained that the work of the Japanese TBT Enquiry Point was 
divided between the International Trade Division in  the Ministry of Foreign Affairs and the Business 
Service Department of Japan’s External Trade Orga nization (JETRO), depending upon the nature of 
the TBT enquiry or notification. He said that the Japanese TBT Enquiry point was small, yet 
effective and active through extensive cooperation with relevant Ministries and the Japanese 
Mission in Geneva. The main responsibilities of the Japanese Enquiry Point were to respond to enquiries from other WTO Members, submit noti fications to the WTO Secretariat, comment on 
notifications made by other Members and to provide advice on TBT matters to relevant 
stakeholders. He underlined that some of the challenges were to maintain an effective and active 
TBT Enquiry Point with limited resources, improve its internal coordination, as well as raise awareness of TBT matters and about the Enquiry Point.   
3.7.  The representative of Norway asked how Ja pan dealt with incoming notifications with such 
limited resources and what system Japan used to distribute notifications to relevant authorities. 
                                               
20 Mr. Rogerio Corr êa, Head of the Division of overcoming Tec hnical Barriers to Trade – INMETRO, Brazilian 
WTO/TBT Enquiry point.  
21 www.inmetro.gov.br. 
22 Ms. MaryAnn Hogan, United States WTO Enquiry Point.  
23 www.nist.gov/notifyus. 
24 Dr. Daisuke Tanaka, Deputy Director, International Trade Division, Economic Affairs Bureau, Ministry 
of Foreign Affairs, Japan.  G/TBT/M/60 
 
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  Given that Japan had multiple Enquiry Points, the re presentative of Korea asked if certain priority 
enquiries were handled by one Enquiry Point, or if all enquiries were gathered together in one 
single place. The representative of Zambia asked whether the Ministry of Foreign Affairs was 
responsible for notifying the WTO Secretariat of new measures, and the representative of Senegal 
asked Japan to clarify if there was one single national authority that was responsible for TBT notifications. The representative of Cuba asked for clarification regarding in which cases the 
Japanese Enquiry Point would operate via email. The representative of the United States asked 
how Japan liaised with regulatory agencies to ensure notification of a proposed regulation. 
3.8.  The representative of Japan replied to Norway that Japan's TBT Enquiry Point did not 
distribute incoming notifications to the relevant Ministries. He clarified that the WTO had a mailing 
list system that informed each Ministry (if they were users of the mailing list system) of incoming 
notifications from every Member country. Regarding Korea’s query, the representative replied that 
Japan had two enquiry points that have the same status and position and that neither had priority over the other. The representative answered to Za mbia and Senegal that a notification to the WTO 
was firstly prepared in the relevant Ministry that had proposed the measure but that the Ministry 
of Foreign Affairs and the TBT Enquiry Point fi nalised and sent the notification to the WTO 
Secretariat. The representative replied to Cuba th at when it was important to respond to enquiries 
quickly, emails were used. When it was important to get in touch directly with relevant Ministries 
of another Member country, diplomatic channels were used. Regarding the question from the United States, the representative replied that th e Japanese TBT Enquiry Point adapted its methods 
of liaising depending on the TBT matter in questi on, and that it frequently contacted officials of 
relevant Ministries directly.  
3.4  The functioning of China's TBT Enquiry Point 3.9.  The representative of China
25 clarified that the Enquiry Point was situated within the General 
Administration of Quality, Supervision, Inspection  and Quarantine (AQSIQ). He explained that the 
Enquiry Point was responsible for preparing, chec king and submitting China’s TBT notifications. 
The Enquiry Point's also provided information on  the TBT Agreement to stakeholders, provided 
training, responded to reasonable enquiries of other Members, received comments on China’s 
notified measures and transferred these comments to the relevant government bodies. An additional important task of the Enquiry Point was to translate other WTO Members’ TBT notifications into Chinese, and that much effort was put into preparing translations within three 
days. Many of China’s SMEs faced serious language  obstacles when complying with other Members’ 
measures and the Enquiry Point thus provided translations online for interested stakeholders.
26  
3.10.  The representative of the United States aske d if China translated the notifications as well as 
the relevant full texts, and how the Chinese Enquiry Point determined which notifications to 
translate. The representative also asked if the AQSIQ provided guidance to Chinese agencies on what constituted TBT/SPS measures. Lastly, th e representative asked about the number of 
comments received from Chinese enterprises regarding other WTO Members’ notifications. The 
representative of Trinidad and Tobago enquired as to the languages of translations provided by the 
Chinese Enquiry Point. The representative of Co te d’Ivoire asked if the Chinese Enquiry Point 
provided any assistance to SMEs to ensure compliance with the requirements of other Members’ 
markets. The representative of Viet Nam asked if the Chinese Enquiry Point translated all relevant 
texts upon the request of Chinese enterprises. The re presentative of Brazil asked if the full texts of 
translated and notified technical regulations and conformity assessment procedures could be made 
available on-line for all WTO Members. The representative also suggested that China make full 
texts of their own regulations available online in file formats which were easier to translate. 
3.11.  The representative of China replied, first, that the Chinese Enquiry Point did not translate 
the full texts and other attachments to notifications into Chinese. Rather, it was the TBT 
notifications themselves which were translated into Chinese, and distributed to relevant ministries or trade unions. Second, he noted that guides did exist regarding how relevant Ministries must notify measures in order to comply with the TBT Agreement. Third, he stated that information in 
the form of brochures had been distributed to raise awareness of other Members’ measures and 
that the Enquiry Point was in contact with lead ing enterprises and trade unions that provided 
comments on other Members’ measures. Fourth, he said that the Enquiry Point had many 
                                               
25 Professor Lizhou Wang, Deputy Director General of China’s TBT Enquiry Point.  
26 http://www.tbt-sps.gov.cn/Pages/home.aspx. G/TBT/M/60 
 
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  branches throughout China with experts in different fields who were able to provide assistance 
regarding compliance with TBT requirements. He noted that the Enquiry Point translated notifications and comments with the help of technical experts. Lastly, he explained that it remained beyond China's responsibility to provide full texts in a WTO working language, but 
submitted that Members may request extracts of the text translated into English from the 
responsible agency indicated in the notification. He noted that Brazil's suggestion of an appropriate file-format would be communicated to the responsible regulatory bodies.  
3.5  EU TBT Notification and Enquiry Point: Better communication with stakeholders and 
recent technical assistance activities 
3.12.  The representative of the European Union
27 showed a promotional awareness raising video 
on the work of the EU TBT Enquiry Point and the be nefits of private sector participation in the TBT 
notification procedure. She then recalled that  the EU TBT Notification and Enquiry Point was 
located within the European Commission’s DG Enterprise and Industry, and was responsible for the TBT notification procedure information provision in respect of technical regulations and conformity 
assessment procedures. Standards, in this respec t, were handled by European standardisation 
bodies, and all EU Member States operated their own national TBT Enquiry Point. Her delegation believed that active communication with relevant stakeholders was crucial to ensure effective 
implementation of TBT obligations, and noted that the 2012 Commission report on the functioning 
of the TBT Agreement notification procedure had concluded that further awareness-raising could 
trigger enhanced comments from EU economic oper ators. She informed the Committee that the EU 
TBT website
28 could be accessed publically, and included an alert system for economic operators 
and other parties. Finally she reported that the EU TBT Enquiry Point had hosted study visits from 
two WTO Members, Ukraine and Malaysia, which had enabled experience sharing on the functioning of TBT Enquiry Points.  
3.13.  The representative of Mexico asked whether each EU Member State could notify 
independently, or whether the EU TBT Enquiry Point carried out all notifications. The 
representative of South Africa asked Brazil, th e United States and the EU how awareness was 
raised regarding their national Enquiry Points, especially amongst SMEs. The representative of 
Cote d’Ivoire asked the presenters whether the activities of the different Enquiry Points had a 
budget designated for them. The representative also asked whether subscriptions to Enquiry Points were subject to a charge.  
3.14.  The representative of the European Union re plied to Mexico that there were two ways a TBT 
measure could be notified: either by the European Commission or by the individual Member State. 
She however underlined that EU legislation covered the majority of technical regulations and 
conformity assessment procedures in question , and that these would be notified by the 
Commission. Member States were responsible for notifying their own legislation. She clarified that when Member States received comments from other WTO Members, it was the Commission that 
replied. Regarding South Africa’s question, awaren ess raising took the form of the video presented 
at the Meeting, maintaining regular contact with professional associations, and by working on improving the user-friendliness of the EU TBT databa se. The representative replied to Cote D'Ivoire 
that there was no budget allocated for the TBT Enqu iry Point’s activities but that it was a public 
service and that subscription to the database was free of charge.  
3.15.  The representative of the United States rep lied to South Africa that in the past, the US had 
drawn up marketing plans which detailed the indu stries to target and how to target them. 
However, this approach had proven time consum ing and difficult. The US had therefore instead 
used promotional materials and brochures and di stributed these to international visitors and 
industry. She explained that the US also had a news-feed which regulatory provided around 4000 
subscribers with brief details on new notifications. She noted that the US Enquiry Point also took 
part in export training events organized by  the US commercial service and would sometimes 
present through webinars on such occasions. Fi nally, she highlighted that the Enquiry Point 
attempted to make contact with individuals in government offices who they knew could reach out 
to relevant manufacturers and industry sectors.  
                                               
27 Mrs. Jana Krestynova, European Commission,  DG Enterprise and Industry, Unit C.3.  
28 http://ec.europa.eu/enterprise/tbt .  G/TBT/M/60 
 
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  3.6  WTO/TBT Enquiry Point – Malaysia's Approach 
3.16.  The representative of Malaysia29 stated that the Malaysian Enquiry Point, SIRIM, was 
handled by the Standards Research and Manageme nt Centre, SIRIM Berhad, under the Malaysian 
Ministry of Finance. Its primary responsibilities included the handling notifications, providing 
technical advice to the Malaysian National Mirror Committee for TBT (NMC TBT), and arranging 
programmes to enhance awareness amongst regulatory  agencies on TBT notification obligations. 
She also said that the Enquiry Point produced a WTO/TBT newsletter30, informing up to 400 
different stakeholders on TBT matters. The Malays ian Enquiry Point moreover provided an export 
alert system to stakeholders, which sent email warnings whenever foreign regulations in relevant sectors were subject to change. 
3.17.  The representative of Uganda underlined that Uganda had faced challenges in fulfilling 
notification requirements as regulators some times did not inform the Enquiry Point of the 
enactment of new regulations. He asked the representative of Malaysia if Malaysia had a mechanism in place to inform its Enquiry Point of new regulations that must be notified to the WTO 
Secretariat. The representative of the United States also asked how Malaysia ensured that that the 
notification authority was aware of draft regulations. She also asked if Malaysia had any legislation 
or institutional framework in place for the development of regulations and for enabling public 
comment. 
3.18.  The representative of Malaysia replied that Malaysia had indeed missed out on certain 
regulations that should have been notified and that it was up to relevant regulatory bodies to 
inform the Enquiry Point. The representative expl ained that there was no mechanism in place to 
ensure notification but that it was something Malaysia and the NMC TBT was working on. The 
representative underlined that as soon as a regu latory body had produced a draft regulation, a 
public comment session, albeit in-house, was held where relevant stakeholders could participate. 
The representative nonetheless explained that it remained a challenge to inform all relevant 
stakeholders of such occasions.  
 
 
__________  
                                               
29 Mrs. Anuja Balachabdran, WTO/TBT Enquiry Point, SIRIM Berhad.  
30 Available on www.sirim.my/web/srmc/wto/tbt-notification-newsletter .